UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-K

☒	~~Annual Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934~~☒	Annual Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
	For the fiscal year ended March 31, 2023
		For the fiscal year ended March 31, 2024
☐	~~Transition Report pursuant to 13 or 15(d) of the Securities Exchange Act of 1934~~☐	Transition Report pursuant to 13 or 15(d) of the Securities Exchange Act of 1934
	~~Commission File Number: 333-156091~~	Commission File Number: 333-156091

Alterola Biotech, Inc.

(Exact name of registrant as specified in its charter)

Nevada		82-1317032
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

47 Hamilton Square Birkenhead Merseyside United Kingdom		CH415AR
(Address of principal executive offices)		(Zip Code)
Registrant’s telephone number: +44 151 601 9477
Securities registered under Section 12(b) of the Exchange Act:
Title of each class	Name of each exchange on which registered
None	Not applicable
Securities registered under Section 12(g) of the Exchange Act:
Title of each class None

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒

Indicate by checkmark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the proceeding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or emerging growth company.

	☐ Large accelerated Filer	☐ Accelerated Filer
	☒ Non-accelerated Filer	☒ Smaller reporting company
		☐ Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant's executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

State the aggregate market value of the voting and non-voting common equity held by non-affiliates computed by reference to the price at which the common equity was last sold, or the average bid and asked price of such common equity, as of the last business day of the registrant’s most recently completed second fiscal quarter. $10252,~~661,171~~ 884.

Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date: ~~807~~1,~~047~~467,~~948~~475,452 shares as of June 28, ~~2023~~2024.

Table of Contents

TABLE OF CONTENTS

Page
PART I
Item 1.	Business	3
Item 1A.	Risk Factors	15
Item 2.	Properties	31
Item 1B.	Unresolved Staff Comments	32
Item 3.	Legal Proceedings	31
Item 1C.	Cybersecurity	32
Item 4.	Mine Safety Disclosure	31
Item 2.	Properties	33
Item 3.	Legal Proceedings	33
Item 4.	Mine Safety Disclosure	33
PART II
Item 5.	Market for Registrant’s Common Equity and Related Stockholder Matters and Issuer Purchases of Equity Securities	3234
Item 6.	[RESERVED]	3436
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	3436
Item 7A.	Quantitative and Qualitative Disclosures About Market Risk	3639
Item 8.	Financial Statements and Supplementary Data	3639
Item 9.	Changes In and Disagreements With Accountants on Accounting and Financial Disclosure	3740
Item 9A.	Controls and Procedures	3740
Item 9B.	Other Information	3841
Item 9C	Disclosure Regarding Foreign Jurisdictions that Prevent Inspections	3841
PART III
Item 10.	Directors, Executive Officers and Corporate Governance	3842
Item 11.	Executive Compensation	4347
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	4448
Item 13.	Certain Relationships and Related Transactions, and Director Independence	4549
Item 14.	Principal Accountant Fees and Services	4550
PART IV
Item 15.	Exhibits, Financial Statement Schedules	4651
Item 16.	Form 10-K Summary	4651

Table of Contents

PART I

Item 1. Business

~~Recent~~Our ~~Developments~~Business

OnOur ~~August~~goal ~~26,~~is ~~2022,~~to weprovide ~~entered~~better ~~into~~medicines afor ~~letter~~patients ofaround ~~intent (~~the ~~“LOI”)~~world. ~~dated~~We ~~August~~believe ~~25,~~in ~~2022~~harnessing ~~with~~the ~~Bright~~therapeutic ~~Green~~potential ~~Corporation~~of ~~(“Bright~~cannabinoids ~~Green”),~~and acannabinoid- ~~Delaware corporation~~like compounds, which ~~with~~can abe ~~binding~~developed ~~provision~~into ~~for~~valuable ~~Bright~~treatments ~~Green~~for toseriously ~~acquire~~ill apatients. ~~25%~~Rather ~~interest~~than ~~(the~~just ~~“Share~~focusing ~~Purchase”)~~on inone ~~our~~method ~~company~~of ~~from~~identifying, researching ~~existing~~and ~~shareholders~~developing insuch ~~exchange~~medicines, ~~for~~we ~~$4,000,000~~are ~~(the~~interested ~~“Purchase~~in ~~Price”).~~developing ~~The~~new ~~LOI~~medicines ~~also~~from ~~has~~all asources ~~non-binding~~including ~~option~~botanical, ~~for~~traditional ~~Bright~~chemical ~~Green~~synthesis toand ~~acquire~~biosynthetic ~~all of our outstanding capital stock~~methodologies.

~~The~~On ~~Share~~May ~~Purchase~~28, ~~was~~2021, ~~subject~~we acquired toABTI Pharma Limited, a ~~Share~~company ~~Purchase~~registered ~~Agreement~~in ~~which~~England ~~was~~and ~~executed~~Wales on(“ABTI ~~October~~Pharma”), 03with the purchase of all of its capital stock in exchange for 600,000,000 ~~2022~~shares of our common stock pro rata to the ABTI Pharma shareholders.

~~Since~~As ~~then,~~a onresult ~~April 4th, 2023, Bright Green announced their intention to complete the purchase~~ of the ~~Company~~acquisition, we ~~but~~ are ~~yet~~a topharmaceutical ~~deliver~~company ~~the~~working ~~full~~with ~~funds~~cannabinoid asand ~~per~~cannabinoid-like ~~the SPA dated October 03, 2022~~molecules. ~~Negotiations~~We ~~for~~have ~~the~~three ~~completion~~areas of ~~the deal are ongoing.~~focus:

~~The Purchase Price for the~~1) ~~SPA~~Development ~~dated~~of ~~October~~regulated ~~03,~~pharmaceuticals ~~2022~~(human ~~was~~and ~~divided~~animal ~~equally~~health) ~~among~~and ~~the~~regulated ~~following~~food ~~shareholder~~products. ~~companies~~This has ~~for~~been ~~their~~achieved ~~shares,~~via ~~controlled~~the bystrategic ~~affiliates~~acquisition of ~~our~~ ~~company~~Phytotherapeutix ~~namely: Phyotherapeutix Holdings~~ Ltd ~~(Colin Stott), Equipped4 Holdings Limited (Dominic Schiller) and TPR Global Limited (Timothy Rogers)~~.;

~~These shareholder affiliates,~~2) ~~through~~Production ~~their~~of ~~respective~~low ~~companies,~~cost ~~have~~of ~~committed~~goods toActive ~~enter~~Pharmaceutical ~~into~~Ingredient ~~loan~~(API) ~~agreements~~and ~~with~~food-grade ~~our~~ingredients (supported ~~company~~by tothe ~~provide~~strategic upacquisition toof ~~$4,000,000~~Ferven ~~USD~~Ltd); ~~of working capital.~~and

~~With respect to the non-binding~~3) ~~option~~Formulation, ~~for~~and ~~Bright~~drug ~~Green to acquire all of our shares~~delivery, inproviding ~~the~~improved ~~SPA dated October 03~~bioavailability, ~~2022~~solubility we and ~~Bright~~stability ~~Green~~(supported by ~~agreed~~the toexclusive ~~work~~licensing inof ~~good~~IP ~~faith~~ and intechnology afrom ~~reasonable~~Nano4M ~~time-frame to reach a binding agreement to be executed in a final set of definitive documents (“Definitive Agreement”~~Ltd).

AsPhytotherapeutix ~~part~~Ltd, ofa ~~the strategic~~subsidiary ~~partnership~~of ~~and~~ABTI ~~pursuant~~Pharma toLtd, ~~the~~has ~~terms~~generated ~~and~~a ~~subject~~number ~~to the conditions~~ of ~~the~~molecules ~~arrangement,~~with wepatents ~~plan to gain access to Bright Green’s planned cannabis and cannabis extracts~~pending, ~~derivatives,~~some ~~products~~of ~~and~~which ~~research~~have ~~services,~~demonstrable ~~and~~pharmacological ~~Bright Green will in turn benefit from our established~~activity, ~~industry~~similar ~~relationships~~to ~~and~~that ~~sector~~of ~~expertise~~CBD. ~~The~~This ~~parties~~means ~~believe~~that asome ~~successful~~of ~~collaboration~~these ~~will~~molecules ~~create~~are aanticipated ~~strong pathway~~ to ~~secure,~~have ~~provide and~~a ~~supply~~similar ~~cannabis~~market ~~and~~potential ~~derivative~~to ~~products~~CBD toacross ~~the~~a ~~pharmaceutical~~range of ~~industry~~therapeutic areas.

OnFerven ~~October 7~~Ltd, ~~2022~~another subsidiary of ABTI Pharma Ltd, weis ~~appointed~~looking to produce cannabinoids by fermentation. The exclusively licensed organism has the potential to be genetically ~~David~~modified ~~Hitchcock~~to asproduce ~~our~~multiple ~~CEO,~~cannabinoids ~~and~~at ~~Terry~~an ~~Rafih~~anticipated asvery alow ~~member~~cost of ~~our~~goods. ~~board~~It is anticipated that the selected genetically modified organisms will grow very quickly, which in turn, reduces the cost of ~~directors~~production.

~~Our~~Nano4M ~~Business~~ Ltd is a company which has exclusively licensed its nano-formulation patents and know-how to ABTI Pharma Ltd.

~~Our~~As ~~goal is to provide prescription medicines for patients around the world. We believe in harnessing the therapeutic potential~~ of ~~cannabinoids~~April ~~and~~18, ~~cannabinoid- like compounds~~2023, ~~which~~ ~~can~~we beacquired ~~developed~~intellectual ~~into~~property from ~~valuable~~Alinova ~~treatments~~Biosciences toLtd. ~~seriously~~We ~~ill~~acquired ~~patients.~~Alinova’s ~~Rather~~joint ~~than~~interest ~~just~~in ~~focusing~~the onpatent ~~one~~family ~~method~~ of ~~identifying,~~PTX ~~researching and~~0001. ~~developing~~We ~~such~~paid ~~medicines~~35, ~~we are interested~~ 000 Sterling in ~~developing~~cash ~~new medicines from all sources including botanical~~and 5,000,000 shares ~~traditional~~of ~~chemical synthesis~~ABTI ~~and biosynthetic methodologies~~Stock.

~~On May 28~~Additionally, ~~2021,~~ we ~~acquired~~may consider ~~ABTI~~entering ~~Pharma~~into ~~Limited~~Joint Venture Partnerships, aor ~~company~~acquire ~~registered~~companies inwith ~~England~~complimentary ~~and~~portfolios ~~Wales~~or ~~(“ABTI~~enter ~~Pharma”),~~into ~~with~~Licensing Agreements to enhance the ~~purchase~~product ofportfolio. ~~all~~These ofare ~~its~~strategies ~~capital~~the ~~stock in~~Company ~~exchange~~may ~~for~~implement ~~600,000,000~~and ~~shares~~any ofsuch ~~our~~opportunities ~~common~~will ~~stock~~be ~~pro~~assessed ~~rata~~on toa ~~the~~case ~~ABTI~~by ~~Pharma~~case ~~shareholders~~basis and on their merit at the time.

AsAlterola aand ~~result~~ABTI ofPharma Ltd ~~the~~management ~~acquisition, we~~have ~~are~~extensive aexperience, ~~pharmaceutical~~know-how ~~company~~and ~~working~~connections ~~with~~in the cannabinoid medicines sector, and ~~cannabinoid-like~~are ~~molecules.~~looking Weto ~~have~~utilize ~~three~~this knowledge ~~areas~~and experience for the development of ~~focus:~~such medicines from existing cannabinoids and cannabinoid-like molecules.

~~1) Development of regulated pharmaceuticals (human and animal health) and regulated food products. This has been achieved via the strategic acquisition of Phytotherapeutix Ltd.;~~3

2)Table ~~Production~~ of ~~low cost of goods Active Pharmaceutical Ingredient (API) and food-grade ingredients (supported by the strategic acquisition of Ferven Ltd); and~~Contents

3)Our ~~Formulation,~~address ~~and~~is ~~drug~~47 ~~delivery,~~Hamilton Square ~~providing~~Birkenhead ~~improved~~Merseyside ~~bioavailability,~~CH41 ~~solubility~~5AR ~~and~~United ~~stability~~Kingdom. ~~(supported~~Our bytelephone ~~the~~number ~~exclusive~~is ~~licensing~~+44 of151 IP601 9477. Our website is www.alterolabio.com. The company has a fully operational US$ and ~~technology~~a ~~from~~£ ~~Nano4M~~sterling ~~Ltd)~~bank account in the United Kingdom with the HSBC Group.

3We do not incorporate the information on or accessible through our websites into this Annual Report, and you should not consider any information on, or that can be accessed through, our websites a part of this Annual Report.

~~Table of Contents~~Competition

~~Phytotherapeutix~~Pharmaceutical Ltd, a subsidiary of ABTI Pharma Ltd, has generated a number of molecules with patents pending, some of which have demonstrable pharmacological activity, similar to that of CBD. This means that some of these molecules are anticipated to have a similar market potential to CBD across a range of therapeutic areas.Sector

~~Ferven~~The cannabinoid-based ~~Ltd,~~and ~~another~~cannabinoid-like pharmaceutical ~~subsidiary of~~medicine ~~ABTI~~research ~~Pharma~~and ~~Ltd,~~development sector is ~~looking~~and towill ~~produce~~likely ~~cannabinoids~~remain ~~by fermentation~~competitive. ~~The~~In ~~exclusively~~general, ~~licensed organism has~~ the ~~potential~~biotechnology toand bepharmaceutical industries ~~genetically modified~~are ~~to produce multiple cannabinoids at an anticipated very low cost of goods. It is anticipated that the selected genetically modified~~characterized ~~organisms~~by ~~will~~rapidly ~~grow~~advancing ~~very~~technologies, ~~quickly~~intense competition, ~~which~~and ina ~~turn,~~strong ~~reduces~~emphasis ~~the~~on ~~cost~~proprietary ofdrugs ~~production~~/ medicines.

~~Nano4M~~We ~~Ltd~~expect isthat Alterola will be required to compete with a ~~company~~variety ~~which~~of multinational pharmaceutical companies and specialized ~~has~~biotechnology ~~exclusively~~companies, ~~licensed~~as ~~its~~well ~~nano-formulation~~as ~~patents~~drugs and ~~know-how~~processes tobeing ~~ABTI~~developed ~~Pharma~~at ~~Ltd~~universities and other research institutions. Our competitors may develop or may already have developed drugs comparable or competitive with our pipeline drug candidates. Competitive therapeutic treatments for diseases, disorders and medical conditions that are included in our pipeline development projects have already been approved by the pharmaceutical regulatory bodies around the world (e.g. FDA, EMA etc.) and used / prescribed by the medical community and any new treatments that may enter the market would face fierce competition.

AsWe are aware of a ~~result~~number of ~~the~~companies ~~acquisition of~~that ~~assets~~are ~~and~~engaged ~~intellectual~~in ~~property~~cannabinoid-based drug ~~from~~/ C2medicine ~~Wellness~~development. ~~Corp~~In addition, several other U.S.-based oncompanies ~~December~~are 2,in ~~2021,~~early ~~Alterola~~stage ~~now~~discovery ~~has~~and ~~the~~preclinical ~~following~~development ~~assets~~utilizing synthetic and/or ~~intellectual~~plant- derived cannabinoids ~~property:~~such as CBD and/or THC.

~~Novel cannabinoid molecules and their associated intellectual property;~~Non-Pharmaceutical Sector

~~Novel~~Due ~~cannabinoid~~to ~~pro-drugs~~Federal regulation, ~~and~~it ~~their~~is ~~associated~~not ~~intellectual~~currently ~~property;~~possible to sell THC or CBD-containing products for non- pharmaceutical use (e.g., as food ingredients or dietary supplements) in the USA.

~~Novel~~Although ~~proprietary~~the ~~cannabinoid~~Hemp Farming Act of 2018 effectively ~~formulations~~removed hemp (defined as cannabis with less than 0.3% THC) from Schedule I controlled substances, ~~designed~~the FDA has yet to ~~target~~establish ~~lymphatic~~guidelines to ~~delivery,~~legally ~~and~~sell ~~their~~hemp ~~associated~~containing ~~intellectual~~products ~~property;~~as food ingredients or dietary supplements.

~~Novel~~However, it ~~proprietary~~is ~~nano-encapsulated cannabinoid~~possible ~~formulations,~~to indevelop ~~self~~cannabinoid-~~dissolving~~ ~~polymers,~~containing ingredients and ~~their~~products ~~associated~~in ~~intellectual~~the ~~property;~~food ~~and~~sector in Europe through the Novel Food Approvals route.

~~Cannabinoids~~Again, this sector is and ~~cannabinoid pro-drug~~will ~~formulations~~likely ~~for~~remain ~~topical~~competitive ~~ocular~~in ~~delivery,~~territories where it is legal to develop and ~~their~~sell ~~associated~~such ~~intellectual~~products. ~~property~~Further it is also possible to develop cannabinoid-containing ingredients in the cosmetics sector.

~~Additionally~~For both pharmaceutical and non-pharmaceutical markets, weestablished companies may ~~consider entering~~have ~~into~~a ~~Joint~~competitive ~~Venture~~advantage ~~Partnerships,~~due orto ~~acquire~~their ~~companies~~size ~~with~~and ~~complimentary~~experiences, positive ~~portfolios~~cash orflows ~~enter~~and ~~into~~institutional ~~Licensing~~networks. Many ~~Agreements~~of toour ~~enhance~~pharma and non-pharma competitors ~~the~~may ~~product~~have ~~portfolio~~significantly greater financial, technical and human resources than we do. ~~These~~Due ~~are~~to ~~strategies~~these ~~the~~factors, ~~Company~~our competitors may ~~implement~~have a range of competitive advantages and ~~any~~may ~~such~~obtain ~~opportunities~~regulatory ~~will~~approval beof ~~assessed~~their onactive pharmaceutical ingredient a(API), ~~case~~or bymedicines; ~~case~~or ~~basis~~food ingredients or food products or cosmetic ingredients before we are ~~and~~able onto ~~their~~develop ~~merit~~or atcommercialize ~~the~~our ~~time~~pharma or non-pharma active ingredients or products. Our competitors may also develop ingredients or products that are safer, more effective, more widely used and less expensive than ours.

~~At present~~Furthermore, ~~the~~some ~~Company~~of isthese ~~waiting~~competitors tomay ~~hear~~make ~~whether~~acquisitions ~~Bright~~or ~~Green~~establish ~~Corporation~~collaborative ~~will~~relationships ~~exercise~~among themselves or ~~its~~with ~~option~~third parties to ~~acquire~~increase ~~the~~their ~~remaining~~ability ~~75%~~to ofrapidly ~~the~~gain ~~Company’s~~market ~~common~~share ~~stock~~and/or increase their ingredient or product lines.

Alterola and ABTI Pharma Ltd management have extensive experience, know-how and connections in the cannabinoid medicines sector, and are looking to utilize this knowledge and experience for the development of such medicines from existing cannabinoids and cannabinoid-like molecules.4

~~Our~~Table ~~address~~of is 47 Hamilton Square Birkenhead Merseyside CH41 5AR United Kingdom. Our telephone number is +44 151 601 9477. Our website is www.alterolabio.com. The company has a fully operational US$ and a £ sterling bank account in the United Kingdom with the HSBC Group.Contents

WeMergers and doacquisitions ~~not~~in ~~incorporate~~ the pharmaceutical and biotechnology and non-pharmaceutical industries may result in even more resources ~~information~~being onconcentrated oramong ~~accessible~~a ~~through~~smaller ~~our~~number ~~websites~~of ~~into~~competitors. ~~this~~Smaller ~~Annual~~and ~~Report~~other early-stage companies, such ~~and~~as ~~you~~ours, may ~~should~~also ~~not~~prove ~~consider~~to ~~any~~be ~~information~~significant oncompetitors, orparticularly ~~that~~through ~~can~~collaborative bearrangements ~~accessed~~with ~~through~~large and established companies. We aim to compete with large and small companies in recruiting and retaining qualified scientific, management and commercial personnel, and using our ~~websites~~management knowhow and expertise in the sector to develop ingredients and products in a ~~part~~regulatory ofcompliant ~~this~~manner, ~~Annual~~as ~~Report~~well as licensing in or joint-venturing with a partner and / or in acquiring technologies complementary to our development programs.

~~Competition~~Intellectual Property

~~Pharmaceutical~~Through the ~~Sector~~acquisition of ABTI Pharma, Alterola has acquired ABTI Pharma’s internal and licensed IP portfolio, which includes:

~~The cannabinoid-based~~1) ~~and~~IP ~~cannabinoid-like pharmaceutical~~including ~~medicine~~patent ~~research~~applications ~~and~~pertaining ~~development sector~~to isnovel ~~and~~compounds ~~will~~for ~~likely~~development ~~remain~~of ~~competitive. In general, the biotechnology and~~ pharmaceutical ~~industries~~ ~~are~~drug ~~characterized by~~candidates ~~rapidly advancing technologies, intense competition,~~ and atheir ~~strong~~therapeutic ~~emphasis on proprietary drugs / medicines.~~use;

We2) ~~expect~~IP ~~that~~(including ~~Alterola will be required to compete with a variety of multinational pharmaceutical companies and specialized biotechnology companies~~organisms, asprotocols ~~well as drugs~~ and ~~processes~~knowhow) ~~being~~pertaining ~~developed~~to atlow ~~universities~~cost ~~and~~of ~~other~~goods ~~research~~production ~~institutions.~~of ~~Our~~Active ~~competitors may~~Pharmaceutical ~~develop~~Ingredient or may already have developed drugs comparable or competitive with our pipeline drug candidates. Competitive therapeutic treatments for diseases, disorders and medical conditions that are included in our pipeline development projects have already been approved by the pharmaceutical regulatory bodies around the world (~~e.g. FDA, EMA etc.~~API) and ~~used~~food-grade /ingredients; ~~prescribed by the medical community~~ and ~~any new treatments that may enter the market would face fierce competition.~~

~~We are~~3) ~~aware~~IP ofincluding agranted ~~number~~patents ofpertaining ~~companies~~to ~~that~~particle ~~are~~engineering ~~engaged~~technology, ~~in cannabinoid-based drug / medicine development. In addition~~formulation, ~~several other U.S.-based companies are in early stage discovery~~ and ~~preclinical~~drug ~~development~~delivery ~~utilizing~~technologies, ~~synthetic and/or~~which ~~plant-~~will ~~derived cannabinoids such~~provide ~~as CBD~~improved ~~and/or~~drug ~~THC~~performance.

4Through an asset purchase from Alinova Biosciences Ltd, the Company acquired Alinova’s interests pertaining to the patent family of PTX 0001.

~~Table~~Regulatory ofMatters ~~Contents~~Pharmaceuticals USA

~~Non~~As a development stage company that intends to have its pipeline drug candidates approved in the U.S., we are subject to extensive regulation by regulatory agencies. The U.S. Food, Drug, and Cosmetic Act and its implementing regulations set forth, among other things, requirements for the research, testing, development, manufacture, quality control, safety, effectiveness, approval, labeling, storage, record keeping, reporting, distribution, import, export, advertising and promotion of our drugs (medicines). Generally, our activities in other countries will be subject to regulations that are similar in nature and scope as those in the United States, although there can be important differences. Additionally, some significant aspects of regulation in the European Union are addressed in a centralized way through the European Medicines Agency (“EMA”) and the European Commission, but country-~~Pharmaceutical Sector~~ specific regulation remains essential in many respects. The process of obtaining regulatory marketing approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes and regulations require the expenditure of substantial time and financial resources and we may not be successful.

~~Due~~Given that the active ingredients present in our APIs, food ingredients, and cosmetic ingredients are in some cases considered to ~~Federal~~be ~~regulation~~controlled substances, in certain jurisdictions it/ isterritories, ~~not~~there ~~currently~~are ~~possible~~additional regulations which are applicable to ~~sell~~the ~~THC~~research, ordevelopment, ~~CBD-containing~~import, ~~products~~receipt, ~~for~~possession, ~~non- pharmaceutical~~storage, ~~use~~preparation, ~~(e.g.~~extraction, synthesis, biosynthesis, manufacture, processing, analysis, release, formulation, dispensing, packaging and labelling, import/export, transport, commercialization, advertising and supply / distribution of Controlled Substances. This means that some of Alterola’s compounds may need to be compliant with competent authorities such as ~~food~~the ~~ingredients~~DEA or(USA), ~~dietary~~The ~~supplements~~Home Office (UK), inand the ~~USA.~~corresponding authorities in each country.

~~Although~~We ~~the~~intend ~~Hemp~~to ~~Farming~~conduct ~~Act~~ some of ~~2018~~our ~~effectively removed~~research ~~hemp~~and ~~(defined~~development asrelating ~~cannabis~~to ~~with~~our ~~less~~drug ~~than~~candidates ~~0.3%~~in ~~THC)~~the ~~from~~United ~~Schedule~~States, Iat ~~controlled~~which ~~substances~~time, ~~the~~our ~~FDA~~research ~~has~~and ~~yet~~development, tofuture manufacturing, ~~establish~~distribution, ~~guidelines~~ and sale of our drugs will become subject to ~~legally~~the ~~sell~~United ~~hemp~~States ~~containing~~Federal ~~products~~Controlled asSubstances ~~food~~Act ~~ingredients~~of or1970 and ~~dietary~~regulations ~~supplements~~promulgated thereunder.

~~However, it is possible to develop cannabinoid- containing ingredients and products in the food sector in Europe through the Novel Food Approvals route.~~5

~~Again this~~Table ~~sector~~of is and will likely remain competitive in territories where it is legal to develop and sell such products. Further it is also possible to develop cannabinoid-containing ingredients in the cosmetics sector.Contents

~~For both~~While ~~pharmaceutical~~cannabis ~~and~~containing greater ~~non-pharmaceutical~~than ~~markets,~~0.3% ~~established~~THC ~~companies~~is ~~may have~~ a ~~competitive~~Schedule ~~advantage~~I ~~due~~controlled tosubstance, ~~their~~drugs ~~size~~approved ~~and~~for ~~experiences, positive~~medical ~~cash~~use ~~flows~~in ~~and~~the ~~institutional~~United ~~networks. Many~~States ofthat ~~our~~contain ~~pharma~~cannabis or ~~and~~cannabis ~~non-pharma competitors may~~extracts ~~have~~must ~~significantly~~be ~~greater~~placed ~~financial,~~in ~~technical~~Schedules ~~and~~II-V ~~human~~or ~~resources than~~de-scheduled, wesince ~~do.~~approval ~~Due~~by tothe ~~these~~FDA ~~factors,~~satisfies ~~our~~the ~~competitors~~“accepted medical ~~may~~use” ~~have~~requirement. aIf ~~range~~any of ~~competitive~~our ~~advantages~~cannabis-derived ~~and~~pipeline ~~may~~drug ~~obtain~~candidates ~~regulatory~~will receive approval ofby ~~their~~the ~~active pharmaceutical ingredient (API)~~FDA, orit ~~medicines;~~must orbe ~~food~~listed ~~ingredients~~by the orDEA ~~food~~as ~~products~~an orappropriately ~~cosmetic~~scheduled ~~ingredients before~~controlled ~~we are able~~substance toor ~~develop~~de-scheduled orto ~~commercialize~~be ~~our~~allowed ~~pharma~~for orcommercialization. ~~non-pharma active~~Because ~~ingredients~~hemp or(cannabis containing ~~products.~~not ~~Our~~more ~~competitors~~than ~~may~~.3% ~~also~~THC) ~~develop ingredients~~and orits ~~products~~derivatives ~~that~~were ~~are~~recently ~~safer~~de-scheduled, ~~more~~the ~~effective,~~development ~~more~~of ~~widely~~these ~~used~~compounds ~~and~~would ~~less~~follow ~~expensive~~the same ~~than~~process ~~ours~~of other APIs.

~~Furthermore~~Consequently, the manufacture, importation, exportation, domestic distribution, storage, sale, and legitimate use of some of ~~these~~our future ingredients and ~~competitors~~/ or drugs may ~~make~~be ~~acquisitions~~subject orto ~~establish~~a ~~collaborative~~significant ~~relationships~~degree ~~among themselves or~~of ~~with~~regulation ~~third~~by ~~parties~~the toDEA. ~~increase~~In ~~their~~addition, ~~ability~~individual tostates ~~rapidly~~in ~~gain~~the ~~market~~United ~~share~~States have also established controlled substance laws and~~/or increase~~ ~~their~~regulations. ~~ingredient~~Though orstate-controlled ~~product~~substances ~~lines~~laws often mirror federal law, because the states are separate jurisdictions, they may separately schedule our ingredients and / or drugs.

Mergers and acquisitions in the pharmaceutical and biotechnology and non-pharmaceutical industries may result in even more resources being concentrated among a smaller number of competitors. Smaller and other early-stage companies, such as ours, may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. We aim to compete with large and small companies in recruiting and retaining qualified scientific, management and commercial personnel, and using our management knowhow and expertise in the sector to develop ingredients and products in a regulatory compliant manner, as well as licensing in or joint-venturing with a partner and / or in acquiring technologies complementary to our development programs.Europe

~~Intellectual~~It ~~Property~~is the company’s intention have its ingredients and pipeline drug candidates approved in countries in addition to the USA and hence we are subject to extensive regulation by other international regulatory agencies, and the applicable local laws and regulations.

~~Through~~Similarly to the U.S. Food, Drug, and Cosmetic Act in the ~~acquisition~~USA and its implementing regulations, there are similar laws and regulations in Europe for the research, testing, development, manufacture, quality control, safety, effectiveness, approval, labeling, storage, record keeping, reporting, distribution, import, export, advertising, and promotion of ~~ABTI~~our ~~Pharma~~drugs (medicines). Again, ~~Alterola~~our ~~has~~activities ~~acquired ABTI~~in ~~Pharma’s~~Europe ~~internal~~will be subject to regulations that are similar in nature and ~~licensed~~scope IPas ~~portfolio~~those in the United States, ~~which~~although ~~includes:~~there can be important differences.

1Our pipeline candidates may be developed or approved through the Centralized Procedure or Decentralized Procedure through the or through the Mutual Recognition Procedure (MRP) IPthrough ~~including~~the ~~patent~~European ~~applications~~Medicines ~~pertaining~~Agency to(“EMA”) ~~novel~~and ~~compounds~~the ~~for~~European ~~development~~Commission; however it should be noted that country-specific regulation remains essential in many respects. The process of ~~pharmaceutical~~obtaining ~~drug~~regulatory ~~candidates~~marketing approvals and ~~their~~the ~~therapeutic~~subsequent compliance ~~use;~~with the appropriate national, federal, state, local and foreign statutes and regulations require the expenditure of substantial time and financial resources and we may not be successful.

2)Again, IPgiven ~~(including~~that ~~organisms~~the active ingredients present in our APIs, ~~protocols~~food ingredients and ~~knowhow)~~cosmetic ~~pertaining~~ingredients are in some countries are considered to ~~low~~be ~~cost~~controlled ofsubstances in ~~goods~~certain ~~production~~European ofjurisdictions ~~Active~~/ ~~Pharmaceutical~~territories, ~~Ingredient~~there ~~(API)~~are additional regulations which are applicable to the research, development, import, receipt, possession, storage, preparation, extraction, synthesis, biosynthesis, manufacture, processing, analysis, release, formulation, dispensing, packaging and ~~food-grade~~labelling, ~~ingredients;~~import/export, transport, commercialization, advertising and supply / distribution of Controlled Substances. This means that Alterola needs to be compliant with each competent authority in each European country as applicable.

~~3) IP including granted patents pertaining to particle engineering technology, formulation, and drug delivery technologies, which will provide improved drug performance.~~Japan

5It is the company’s intention have its pipeline drug candidates in due course approved in Japan and hence we are subject to extensive regulation by the pharmaceutical regulatory authority of Japan: the Pharmaceutical and Food Safety Bureau (PFSB) of the Japanese Ministry of Health, Labor and Welfare (MHLW), and the Japanese applicable local laws and regulations.

~~Table~~Japan has its own laws and regulations for the research, testing, development, manufacture, quality control, safety, effectiveness, approval, labeling, storage, record keeping, reporting, distribution, import, export, advertising and promotion of ~~Contents~~our drugs (medicines).

~~Through~~Again, ~~the~~given ~~acquisition~~that ofthe active ~~assets~~ingredients present in our APIs, food ingredients and ~~intellectual~~cosmetic ~~property~~ingredients ~~from~~are C2in ~~Wellness~~some ~~Corp.~~countries onare ~~December~~considered ~~02,~~to ~~2021~~be controlled substances in Japan, ~~Alterola~~there ~~now~~are ~~has~~additional regulations which are applicable to the ~~following~~research, ~~assets~~development, import, receipt, possession, storage, preparation, extraction, synthesis, biosynthesis, manufacture, processing, analysis, release, formulation, dispensing, packaging and ~~intellectual~~labelling, ~~property:~~import/export, transport, commercialization, advertising and supply / distribution of Controlled Substances. This means that Alterola needs to be compliant with the Japanese competent authority requirements.

~~• Novel cannabinoid molecules and their associated intellectual property;~~6

•Table ~~Novel~~of ~~cannabinoid pro-drugs, and their associated intellectual property;~~Contents

•The ~~Novel~~process ~~proprietary~~of ~~cannabinoid~~obtaining regulatory ~~formulations,~~marketing ~~designed~~approvals toand ~~target~~the ~~lymphatic~~subsequent ~~delivery,~~compliance with the appropriate national and ~~their~~local ~~associated~~statutes ~~intellectual~~and ~~property;~~regulations of Japan require the expenditure of substantial time and financial resources and we may not be successful.

•Rest ~~Novel~~of ~~proprietary~~the ~~nano-encapsulated cannabinoid formulations, in self dissolving polymers, and their associated intellectual property; and~~World

•It ~~Cannabinoids~~is ~~and~~the ~~cannabinoid~~company’s intention ~~pro-~~have its pipeline drug ~~formulations~~candidates ~~for~~in ~~topical~~due ~~ocular~~course ~~delivery~~approved in other countries around the world (Rest of World) and hence we are subject to extensive regulation by the various national pharmaceutical regulatory authorities which govern the various countries, and the ~~their~~applicable ~~associated~~local ~~intellectual~~laws ~~property~~and regulations.

InDifferent countries ~~addition~~have different laws and regulations for the research, ~~Alterola~~testing, ~~via~~development, ~~ABTI~~manufacture, ~~Pharma~~quality ~~Ltd~~control, ~~have in~~safety, ~~principle~~effectiveness, ~~agreements to~~approval, ~~bring~~labeling, instorage, ~~additional complimentary~~record ~~technologies~~keeping, ~~with~~reporting, ~~incumbent~~distribution, IPimport, export, advertising, and promotion of our drugs (medicines).

~~Regulatory~~Again, ~~Matters~~given ~~Pharmaceuticals~~that the active ~~USA~~ingredients present in our APIs, food ingredients and cosmetic ingredients are in some countries are considered to be controlled substances in some countries, there are additional regulations which are applicable to the research, development, import, receipt, possession, storage, preparation, extraction, synthesis, biosynthesis, manufacture, processing, analysis, release, formulation, dispensing, packaging and labelling, import/export, transport, commercialization, advertising, and supply / distribution of Controlled Substances. This means that Alterola needs to be compliant with each competent authority in each country as applicable.

AsThe aprocess ~~development~~of ~~stage company~~obtaining ~~that intends to have its pipeline drug candidates approved in the U.S., we are subject to extensive regulation by~~ regulatory ~~agencies. The~~marketing ~~U.S.~~approvals ~~Food, Drug,~~ and ~~Cosmetic~~the ~~Act~~subsequent ~~and~~compliance ~~its~~with ~~implementing regulations set forth, among other things, requirements for~~ the ~~research,~~appropriate ~~testing~~national, ~~development,~~ ~~manufacture~~federal, ~~quality control~~state, ~~safety,~~local ~~effectiveness,~~and ~~approval,~~foreign ~~labeling, storage, record keeping, reporting, distribution,~~statutes ~~import, export, advertising~~ and ~~promotion~~regulations of ~~our drugs (medicines). Generally, our activities in~~ other countries will be subject to regulations that are similar in nature and scope as those in the United States, although there can be important differences. Additionally, some significant aspects of regulation in the European Union are addressed in a centralized way through the European Medicines Agency (~~“EMA”) and the European Commission, but country~~ex- ~~specific regulation remains essential in many respects. The process of obtaining regulatory marketing approvals and the subsequent compliance with appropriate federal~~US, ~~state,~~Europe ~~local~~ and ~~foreign~~Japan) ~~statutes and regulations~~ require the expenditure of substantial time and financial resources and we may not be successful.

~~Given~~The ~~that~~Regulatory ~~the active ingredients~~Process ~~present~~for in our APIs, food ingredients, and cosmetic ingredients are in some cases considered to be controlled substances, in certain jurisdictions / territories, there are additional regulations which are applicable to the ~~research,~~approval development, import, receipt, possession, storage, preparation, extraction, synthesis, biosynthesis, manufacture, processing, analysis, release, formulation, dispensing, packaging and labelling, import/export, transport, commercialization, advertising and supply / distribution of ~~Controlled~~New Substances. This means that some of Alterola’s compounds may need to be compliant with competent authorities such as the DEA (USA), The Home Office (UK), and the corresponding authorities in each country.Medicines

WeThe ~~intend~~Company tooperates ~~conduct~~in ~~some~~a ofhighly ~~our~~controlled ~~research~~new ~~and~~drugs ~~development~~/ medicines regulatory environment. Strict regulations establish requirements relating to ~~our~~demonstration ~~drug~~of quality, ~~candidates~~safety inand ~~the~~efficacy ~~United~~of ~~States,~~a atmedicine. ~~which~~Regulations ~~time,~~also ~~our~~cover preclinical and clinical research and development, ~~future~~ manufacturing, ~~distribution~~and reporting procedures, both pre- and ~~sale~~post- ofapproval. ~~our~~Failure ~~drugs~~to ~~will~~comply ~~become~~with ~~subject~~regulations tocan ~~the~~result ~~United~~in ~~States~~stringent ~~Federal~~sanctions, ~~Controlled~~including ~~Substances~~product recalls, ~~Act~~withdrawal of ~~1970~~ approvals, seizure of products and criminal prosecution. Further, many countries have stringent regulations ~~promulgated~~relating to ~~thereunder~~the possession and use of cannabis or cannabinoid or cannabis-based medicines or medicines containing cannabinoid-like compounds.

~~While~~Before ~~cannabis~~obtaining ~~containing~~regulatory ~~greater~~approvals ~~than~~for ~~0.3%~~the ~~THC~~commercial issale aof ~~Schedule~~our Ifuture ~~controlled~~drug ~~substance~~candidates, ~~drugs~~we ~~approved~~must ~~for~~demonstrate ~~medical~~that ~~use~~the inproposed ~~the~~medicine ~~United~~demonstrates ~~States~~quality, safety, ~~that~~and ~~contain~~efficacy. ~~cannabis or~~From ~~cannabis~~a ~~extracts~~quality ~~must~~perspective bethis ~~placed~~is indone ~~Schedules~~through ~~II-V~~demonstrating orappropriate ~~de-scheduled,~~chemistry ~~since~~and ~~approval~~manufacturing bycontrols ~~the~~(CMC), and ~~FDA~~from ~~satisfies~~a ~~the~~safety ~~“accepted~~and ~~medical use”~~efficacy ~~requirement.~~perspective, Ifthis ~~any~~is ofdone ~~our~~through ~~cannabis-derived~~demonstrating ~~pipeline~~that our drug candidates ~~will~~are ~~receive~~safe ~~approval~~and byeffective ~~the~~in ~~FDA,~~preclinical studies itand ~~must~~clinical betrials. ~~listed~~Historically, by the ~~DEA~~results asfrom anpreclinical ~~appropriately~~studies ~~scheduled~~and ~~controlled~~early ~~substance~~clinical ortrials ~~de-scheduled~~often tohave benot ~~allowed~~accurately ~~for~~predicted results ~~commercialization.~~of ~~Because~~later ~~hemp~~clinical ~~(cannabis containing~~trials. ~~not~~In ~~more~~addition, ~~than~~many ~~.3%~~pharmaceuticals ~~THC)~~have ~~and~~shown ~~its~~promising ~~derivatives~~results ~~were~~in ~~recently~~clinical ~~de-scheduled,~~trials ~~the~~but ~~development~~subsequently offailed to ~~these~~establish ~~compounds~~sufficient ~~would~~safety ~~follow~~and ~~the same~~efficacy ~~process~~results ofto ~~other~~obtain ~~APIs~~necessary regulatory approvals.

~~Consequently,~~We ~~the~~expect to incur substantial ~~manufacture,~~expense ~~importation~~for, ~~exportation,~~and ~~domestic~~devote ~~distribution,~~a ~~storage,~~significant ~~sale~~amount of time to, the development of quality ingredients and ~~legitimate~~products ~~use~~as well as preclinical studies and clinical trials. Many factors can delay the commencement and rate of ~~some~~completion of ~~our~~clinical ~~future~~trials, ~~ingredients~~including ~~and~~the inability to recruit /patients orat ~~drugs~~the ~~may~~expected berate, ~~subject~~the inability to afollow ~~significant~~patients ~~degree~~adequately after treatment, the failure to manufacture sufficient quantities of ~~regulation~~materials byused for clinical trials, and the ~~DEA~~emergence of unforeseen safety issues and governmental and regulatory delays. InIf ~~addition,~~a ~~individual~~drug candidate ~~states~~fails to demonstrate safety and efficacy in ~~the~~clinical ~~United~~trials, ~~States~~this ~~have~~failure ~~also~~may delay development of other drug candidates and ~~established~~hinder ~~controlled~~our ~~substance~~ability ~~laws~~to develop and ~~regulations.~~/ ~~Though~~or ~~state-controlled~~conduct ~~substances~~related ~~laws~~preclinical ~~often~~studies ~~mirror~~and ~~federal~~clinical ~~law~~trials. Additionally, ~~because~~if ~~the~~we ~~states are~~have ~~separate~~pipeline ~~jurisdictions~~candidate failures, ~~they~~we may ~~separately~~also ~~schedule~~be ~~our~~expected ~~ingredients~~to experience challenges, delays or even the inability to obtain additional financing at acceptable terms and /conditions to develop these or ~~drugs~~other drug candidates.

Table of Contents

~~Europe~~Governmental authorities in all major markets require that a new drug be approved or exempted from approval by the appropriate regulatory authorities before it is marketed, and have established high standards for technical appraisal, which can result in an expensive and lengthy approval process. The time to obtain approval of a new medicine or indication varies by country and some drugs are never approved. The lengthy process of conducting new product or formulation development, preclinical studies and clinical trials, seeking approval and the subsequent compliance with applicable statutes and regulations, if approval is obtained, are very costly and require the expenditure of substantial resources.

ItUnited is the company’s intention have its ingredients and pipeline drug candidates approved in countries in addition to the USA and hence we are subject to extensive regulation by other international regulatory agencies, and the applicable local laws and regulations.States

~~Similarly~~In tothe United States, the Public ~~U.S.~~Health Service Act and the Federal Food, Drug, and Cosmetic Act, inas amended, and the ~~USA~~regulations promulgated thereunder, and ~~its~~other federal ~~implementing~~and state statutes and regulations govern, ~~there~~among ~~are~~other ~~similar~~things, ~~laws~~the safety and ~~regulations~~effectiveness instandards ~~Europe~~ for our drugs and the ~~research,~~raw ~~testing,~~materials ~~development,~~and ~~manufacture,~~components ~~quality~~used ~~control,~~in ~~safety~~the production of, ~~effectiveness~~testing, ~~approval~~manufacture, labeling, storage, record keeping, ~~reporting~~approval, distribution, ~~import,~~ ~~export,~~ advertising, and promotion of ~~our~~drug ~~drugs~~candidates ~~(medicines).~~on ~~Again,~~a ~~our~~product-by-product ~~activities in Europe will be subject to regulations that are similar in nature and scope as those in the United States, although there can be important differences~~basis.

~~Our~~Preclinical ~~pipeline~~tests ~~candidates~~include ~~may~~in bevitro ~~developed~~and orin ~~approved~~vivo ~~through~~evaluation of the ~~Centralized~~drug ~~Procedure~~candidate, orincluding ~~Decentralized~~animal ~~Procedure~~studies ~~through~~to ~~the~~assess orpotential ~~through~~safety ~~the~~and ~~Mutual~~efficacy. ~~Recognition~~Certain preclinical ~~Procedure~~tests ~~(MRP)~~must ~~through~~be ~~the~~conducted ~~European~~in ~~Medicines~~compliance ~~Agency~~with ~~(“EMA”)~~good ~~and~~laboratory ~~the~~practice ~~European~~regulations. ~~Commission;~~Violations ~~however~~of itthese ~~should~~regulations becan, ~~noted~~in ~~that~~some cases, lead ~~country-specific~~to ~~regulation~~invalidation ~~remains~~of ~~essential~~the instudies, ~~many~~requiring ~~respects.~~them ~~The~~to ~~process~~be ofreplicated. ~~obtaining~~In ~~regulatory~~addition, ~~marketing~~non-clinical ~~approvals~~studies (Chemistry and ~~the~~Manufacturing ~~subsequent~~Controls, ~~compliance~~CMC) ~~with~~are ~~the~~undertaken ~~appropriate~~to ~~national,~~evaluate ~~federal,~~a ~~state,~~new ~~local~~drug’s chemistry, and ~~foreign~~to ~~statutes~~determine, ~~and~~amongst ~~regulations~~other ~~require~~things, the ~~expenditure~~active ofingredients’ ~~substantial~~and ~~time~~finished ~~and~~product ~~financial~~formulation’s ~~resources~~stability and webatch-to-batch ~~may not be successful~~reproducibility.

~~Again~~After laboratory analysis and preclinical testing, ~~given~~a ~~that~~Sponsor ~~the~~files ~~active ingredients~~an ~~present~~Investigational New Drug Application, or IND, to begin clinical development (clinical trials in ~~our~~humans). ~~APIs~~Typically, ~~food~~a ~~ingredients~~manufacturer conducts a three-phase human clinical development program which itself is subject to numerous laws and ~~cosmetic~~regulatory ~~ingredients~~requirements, ~~are~~including inadequate ~~some~~monitoring, ~~countries~~reporting, record keeping and informed consent. In Phase I, small clinical trials are ~~considered~~conducted to bedetermine ~~controlled~~the ~~substances~~safety and tolerability of drug candidates. In Phase II, clinical trials are conducted to assess safety and gain preliminary evidence of the efficacy of drug candidates, and to determine appropriate dose ranges in ~~certain~~patients ~~European~~with ~~jurisdictions~~the target /indication. ~~territories~~In Phase III, ~~there~~clinical trials are ~~additional~~conducted ~~regulations~~in ~~which~~appropriate ~~are~~patient ~~applicable~~populations to provide sufficient data for the ~~research,~~statistically valid evidence of safety and efficacy. The time and expense that will be required for us to perform this clinical development, ~~import,~~can vary ~~receipt,~~and ~~possession~~is substantial. We cannot be certain that we will successfully complete Phase I, ~~storage~~Phase II or Phase III clinical trials within any specific period, ~~preparation~~if at all. Furthermore, ~~extraction~~the FDA, ~~synthesis~~the IRB are responsible for approving and monitoring the clinical trials at a given site, ~~biosynthesis~~the Data Safety Monitoring Board, ~~manufacture~~where one is used, ~~processing~~or we may suspend the clinical trials at any time on various grounds, ~~analysis~~including a finding that subjects or patients are exposed to unacceptable health risk. Given that a number of our clinical trials are likely to be performed using drug candidates containing controlled substances, ~~release~~there is the added requirement for compliance with DEA regulations (or equivalent competent authority in ex-US countries where the preclinical studies and clinical trials may be conducted). DEA requirements for State and Federal DEA Registration for receipt, ~~formulation~~storage, and dispensing of controlled substances vary from state to state and the DEA Registration process can be lengthy and requirement multiple site visits by DEA personnel. This is further complicated if the controlled substance needs temperature regulation as well as controlled access / storage. Failure to gain or delay to gaining the necessary DEA registrations at one or more non-clinical (CMC), laboratory or manufacturing or packaging ~~and~~or labelling sites, ~~import/export~~preclinical study sites, ~~transport~~analytical laboratories or clinical trial sites may delay the delivery of materials to key stakeholders. For example, ~~commercialization~~delay of delivery of investigational product to a clinical trial site, ~~advertising~~may ~~and~~ultimately ~~supply~~delay /the ~~distribution~~initiation, conduct or completion of ~~Controlled~~clinical trials critical for the approval of the ~~Substances~~product. ~~This~~These ~~means~~failures ~~that~~or ~~Alterola~~delays ~~needs~~may delay also the development of other drug candidates and hinder our ability to bedevelop ~~compliant~~and ~~with~~/ ~~each~~or ~~competent~~conduct related ~~authority~~preclinical studies and clinical trials. Additionally, if we have failures or delays in ~~each~~DEA ~~European~~registrations ~~country~~in aspivotal ~~applicable~~or critical programs, we may also be expected to experience challenges, delays or even the inability to obtain additional financing at acceptable terms and conditions to develop these or other drug candidates.

~~Japan~~8

ItTable ~~is the company’s intention have its pipeline drug candidates in due course approved in Japan and hence we are subject to extensive regulation by the pharmaceutical regulatory authority~~ of ~~Japan: the Pharmaceutical and Food Safety Bureau (PFSB) of the Japanese Ministry of Health, Labor and Welfare (MHLW), and the Japanese applicable local laws and regulations.~~Contents

~~Japan~~If ~~has~~the ~~its~~clinical ~~own~~data ~~laws and~~from ~~regulations~~these ~~for~~clinical ~~the~~trials ~~research,~~(Phases ~~testing~~I, ~~development,~~II ~~manufacture,~~and ~~quality~~III) ~~control,~~are deemed to support the safety, and effectiveness of the drug candidate for its intended use, ~~approval~~and the preclinical and quality data are also acceptable, ~~labeling~~then we may proceed to seek to file with the FDA, ~~storage~~a New Drug Application, ~~record~~or ~~keeping~~NDA, ~~reporting,~~with ~~distribution,~~the ~~import~~US FDA seeking approval to market a new drug for one or more specified intended uses. We have not completed our non-clinical (CMC) studies or preclinical studies or clinical trials for any candidate drug for any intended use and therefore, ~~export~~we cannot ascertain whether the clinical data will support and justify filing an NDA. Nevertheless, ~~advertising~~if and ~~promotion~~when ofwe ~~our~~are ~~drugs~~able ~~(medicines)~~to ascertain that the clinical data supports and justifies filing an NDA, we intend to make such appropriate filing.

~~Again,~~The ~~given~~purpose ~~that~~of the ~~active ingredients~~NDA ~~present in our APIs, food ingredients and cosmetic ingredients are in some countries are considered~~ is to beprovide ~~controlled~~the ~~substances in~~FDA ~~Japan,~~with ~~there~~sufficient ~~are~~information ~~additional~~so ~~regulations~~that ~~which~~it ~~are~~can ~~applicable~~assess towhether the ~~research,~~candidate ~~development,~~drug ~~import,~~has ~~receipt,~~a ~~possession,~~positive ~~storage,~~benefit ~~preparation, extraction, synthesis, biosynthesis, manufacture, processing, analysis, release, formulation, dispensing, packaging and labelling, import~~/~~export, transport,~~ ~~commercialization,~~risk ~~advertising~~ profile and ~~supply~~whether /it ~~distribution~~should ofapprove ~~Controlled~~the ~~Substances.~~drug ~~This~~candidate ~~means~~for ~~that~~marketing ~~Alterola~~for ~~needs~~specific tointended ~~be compliant with the Japanese competent authority requirements~~uses.

The ~~process~~fact ofthat ~~obtaining~~the FDA has ~~regulatory~~previously ~~marketing~~granted ~~approvals~~a ~~and~~candidate ~~the~~drug ~~subsequent~~an ~~compliance~~IND, ~~with~~or designated a drug as an orphan drug for a specific intended use, or granted it Breakthrough status, or fast track status or an expedited review does not mean that the ~~appropriate~~drug ~~national~~has ~~and~~been ~~local~~approved ~~statutes~~for ~~and~~marketing. ~~regulations~~Only ofafter ~~Japan~~an NDA has ~~require~~been approved by the ~~expenditure~~FDA ofis ~~substantial~~marketing ~~time~~allowed. ~~and~~A ~~financial~~request ~~resources~~for ~~and~~orphan wedrug ~~may~~status ~~not~~(orphan drug designation) must be ~~successful~~filed before the NDA is filed. The orphan drug designation, though, provides certain benefits, including a seven-year period of market exclusivity subject to certain exceptions.

~~Rest~~The NDA normally includes, but is not limited to, sections describing the quality safety and efficacy of the ~~World~~medicine. The quality section describes the chemistry, manufacturing, and controls, the preclinical (non-clinical) section describes the non-clinical pharmacology, safety pharmacology, drug metabolism, and pharmacokinetics (DMPK) and toxicology, human pharmacokinetics and bioavailability, and the clinical section describes the efficacy and safety results of the clinical trials, and the proposed labeling which contains, among other things, the intended uses of the candidate drug. Importantly for drug candidates containing controlled substances, studies investigating the medicine’s potential for abuse are also undertaken and reported.

ItWe iscannot ~~the~~take ~~company’s~~any action ~~intention~~to ~~have~~market ~~its~~any ~~pipeline~~new drug ~~candidates~~or biologic drug in ~~due~~the ~~course~~United States until our appropriate marketing application has been approved inby ~~other~~the ~~countries~~FDA. The ~~around~~FDA has substantial discretion over the ~~world~~approval ~~(Rest~~process and may disagree with our interpretation of ~~World)~~the ~~and~~data ~~hence~~submitted. weThe ~~are~~process ~~subject~~may tobe ~~extensive~~significantly ~~regulation~~extended by requests for additional information or clarification regarding information already provided. As part of this review, the ~~various~~FDA ~~national~~may ~~pharmaceutical~~refer the application to an appropriate advisory committee, typically a panel of clinicians. Satisfaction of these and other regulatory ~~authorities~~requirements ~~which~~typically ~~govern~~takes several years, and the ~~various~~actual ~~countries~~time required may vary substantially based upon the type, complexity and novelty of the drug. Government regulation may delay or prevent marketing of potential drugs for a considerable period and impose costly procedures on our activities. We cannot be certain that the ~~applicable~~FDA ~~local~~or ~~laws~~other regulatory agencies will approve any of our drugs on a timely basis, if at all. Success in preclinical or early stage clinical trials does not assure success in later-stage clinical trials. Even if a drug receives regulatory approval, the approval may be significantly limited to specific indications or uses and ~~regulations~~these limitations may adversely affect the commercial viability of the drug / medicine. Delays in obtaining, or failures to obtain regulatory approvals, would have a material adverse effect on our business.

~~Different~~Even ~~countries~~after we obtain FDA ~~have~~approval, ~~different~~we ~~laws~~may be required to conduct further studies which may be additional preclinical studies or clinical trials (e.g. Phase IV trials) and ~~regulations~~provide additional data on safety and effectiveness. We are also required to gain separate approval for the ~~research,~~use ~~testing,~~of ~~development,~~an ~~manufacture,~~approved drug ~~quality~~as ~~control,~~a ~~safety~~treatment for indications other than those initially approved. In addition, ~~effectiveness~~side effects or adverse events that are reported during clinical trials can delay, impede or prevent marketing approval. Similarly, adverse events that are reported after marketing approval ~~labeling,~~can ~~storage,~~result ~~record~~in ~~keeping,~~additional ~~reporting,~~limitations ~~distribution~~being placed on the drug’s use and, ~~import~~potentially, ~~export~~withdrawal of the drug from the market. Any adverse event, ~~advertising~~either before or after marketing approval, ~~and~~can ~~promotion~~result ofin ~~our~~product ~~drugs~~liability ~~(medicines)~~claims against the company.

7As an alternate path for FDA approval of new indications or new formulations of previously-approved drugs, a company may file a Section 505(b)(2) NDA, instead of a “stand-alone” or “full” NDA. Section 505(b)(2) of the Food, Drug, and Cosmetic Act was enacted as part of the Drug Price Competition and Patent Term Restoration Act of 1984, otherwise known as the Hatch-Waxman Amendments. Section 505(b)(2) permits the submission of an NDA where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference. Some examples of drugs that may be allowed to follow a 505(b)(2) path to

~~Table of Contents~~9

~~Again,~~Table given that the active ingredients present in our APIs, food ingredients and cosmetic ingredients are in some countries are considered to be controlled substances in some countries, there are additional regulations which are applicable to the research, development, import, receipt, possession, storage, preparation, extraction, synthesis, biosynthesis, manufacture, processing, analysis, release, formulation, dispensing, packaging and labelling, import/export, transport, commercialization, advertising, and supply / distribution of ~~Controlled Substances. This means that Alterola needs to be compliant with each competent authority in each country as applicable.~~Contents

approval are drugs that have a new dosage form, strength, route of administration, formulation or indication. The Hatch-Waxman ~~process~~Amendments permit the applicant to rely upon certain published nonclinical or clinical studies conducted for an approved drug or the FDA’s conclusions from prior review of ~~obtaining~~such studies. The FDA may require companies to perform additional studies or ~~regulatory~~measurements ~~marketing~~to ~~approvals~~support ~~and~~any changes from the ~~subsequent~~approved ~~compliance~~drug. ~~with~~The FDA may then approve the ~~appropriate~~new ~~national,~~drug ~~federal,~~for ~~state~~all or some of the labeled indications for which the referenced listed drug has been approved, ~~local~~as ~~and~~well ~~foreign~~as ~~statutes~~for any new indication supported by the NDA. While references to nonclinical and ~~regulations~~clinical data not generated by the applicant or for which the applicant does not have a right of ~~other~~reference ~~countries~~are ~~(ex-US~~allowed, ~~Europe~~all development, process, stability, qualification, and ~~Japan)~~validation ~~require~~data related to the ~~expenditure~~manufacturing and quality of ~~substantial~~the ~~time~~new ~~and~~drug ~~financial~~must ~~resources~~be ~~and~~included wein an ~~may~~NDA ~~not~~submitted beunder ~~successful~~Section 505(b)(2).

~~The~~To ~~Regulatory~~the ~~Process~~extent that the Section 505(b)(2) applicant is relying on the FDA’s conclusions regarding studies conducted for an already approved drug, the applicant is required to certify to the FDA concerning any patents listed for the approved drug in the FDA’s “Orange Book” publication. Specifically, the applicant must certify that: (i) the required patent information has not been filed; (ii) the listed patent has expired; (iii) the listed patent has not expired but will expire on a particular date and approval is sought after patent expiration; or (iv) the listed patent is invalid or will not be infringed by the new drug. The Section 505(b)(2) application also will not be approved until any non-patent exclusivity, such as exclusivity for obtaining approval of ~~New~~a ~~Medicines~~new chemical entity, listed in the Orange Book for the reference drug has expired. Thus, the Section 505(b)(2) applicant may invest a significant amount of time and expense in the development of its drugs only to be subject to significant delay and patent litigation before its drugs may be commercialized.

~~The~~In ~~Company~~addition ~~operates in a highly controlled new drugs / medicines regulatory environment. Strict regulations establish requirements relating~~ to ~~demonstration of~~regulating ~~quality, safety~~ and ~~efficacy~~auditing ofhuman ~~a medicine. Regulations also cover preclinical and~~ clinical ~~research and development~~trials, ~~manufacturing~~the ~~and reporting~~FDA ~~procedures,~~regulates ~~both pre-~~ and ~~post-~~inspects ~~approval. Failure to comply with regulations can result in stringent sanctions~~equipment, ~~including product recalls~~facilities, ~~withdrawal~~laboratories ~~of approvals, seizure of products~~ and ~~criminal~~processes ~~prosecution.~~used ~~Further,~~in ~~many countries have stringent regulations relating to~~ the ~~possession~~ manufacturing and ~~use~~testing of ~~cannabis~~such ordrugs ~~cannabinoid~~prior orto ~~cannabis-based~~providing ~~medicines~~approval orto ~~medicines~~market ~~containing~~a ~~cannabinoid-like compounds~~drug.

~~Before~~Orphan ~~obtaining~~Drug ~~regulatory~~Designation approvals for the commercial sale of our future drug candidates, we must demonstrate that the proposed medicine demonstrates quality, safety, and efficacy. From a quality perspective this is done through demonstrating appropriate chemistry and manufacturing controls (CMC), and from a safety and efficacy perspective, this is done through demonstrating that our drug candidates are safe and effective in ~~preclinical studies and clinical trials. Historically,~~ the ~~results from preclinical studies and early clinical trials often have not accurately predicted results of later clinical trials~~U. ~~In addition, many pharmaceuticals have shown promising results in clinical trials but subsequently failed to establish sufficient safety and efficacy results to obtain necessary regulatory approvals~~S.

WeUnder ~~expect~~the toOrphan ~~incur~~Drug ~~substantial~~Act, ~~expense~~the ~~for,~~FDA ~~and~~may ~~devote~~grant aorphan ~~significant~~drug ~~amount~~designation ofto ~~time~~a drug intended to, ~~the~~treat ~~development~~a ofrare ~~quality~~disease ~~ingredients~~or ~~and~~condition, ~~products~~which asis ~~well~~a asdisease ~~preclinical~~or ~~studies~~condition that ~~and~~affects ~~clinical~~fewer ~~trials.~~than ~~Many~~200,000 ~~factors~~individuals ~~can~~in ~~delay~~the United States. If the ~~commencement~~disease ~~and~~or ~~rate~~condition ofaffects ~~completion~~more ofthan ~~clinical~~200,000 ~~trials~~individuals in the United States, ~~including~~orphan drug designation may nevertheless be available if there is no reasonable expectation that the ~~inability~~cost toof ~~recruit~~developing ~~patients~~and atmaking the ~~expected~~drug ~~rate,~~would ~~the~~be ~~inability~~recovered tofrom ~~follow~~sales ~~patients~~in ~~adequately~~the ~~after~~United ~~treatment,~~States. In the ~~failure~~United toStates, ~~manufacture~~a ~~sufficient~~drug ~~quantities~~that has received orphan drug designation ofis ~~materials~~eligible ~~used~~for financial incentives, such as opportunities for grant funding towards clinical ~~trials~~trial costs, tax credits for certain research and ~~the~~user ~~emergence~~fee ofwaivers ~~unforeseen~~under ~~safety~~certain ~~issues~~circumstances. ~~and~~The ~~governmental~~Orphan ~~and~~Drug ~~regulatory~~Act ~~delays.~~provides Ifthat, if a designated drug ~~candidate~~ ~~fails~~is toapproved ~~demonstrate~~for ~~safety~~the ~~and~~rare ~~efficacy~~disease or incondition ~~clinical~~for ~~trials~~which it was designated, ~~this~~the ~~failure~~approved ~~may~~drug ~~delay~~will ~~development~~be granted seven years of ~~other~~orphan drug ~~candidates~~exclusivity, ~~and~~which means the FDA ~~hinder~~generally ~~our~~will ~~ability~~not toapprove ~~develop~~any ~~and~~other /application orfor ~~conduct~~a ~~related~~drug ~~preclinical~~containing ~~studies~~the ~~and~~same ~~clinical~~active ~~trials.~~moiety ~~Additionally,~~for ifthe wesame ~~have~~indication ~~pipeline~~for ~~candidate~~a period of ~~failures~~seven years, weexcept ~~may~~in ~~also~~limited becircumstances, ~~expected~~such toas ~~experience~~a ~~challenges,~~showing ~~delays~~of orclinical ~~even~~superiority over the ~~inability~~drug towith ~~obtain~~orphan ~~additional~~drug ~~financing~~exclusivity. ~~at acceptable~~Orphan ~~terms~~drug ~~and~~exclusivity ~~conditions~~does tonot ~~develop~~prevent ~~these~~the FDA from approving a different drug for the same disease or ~~other~~condition, or the same drug ~~candidates~~for a different disease or condition.

~~Governmental~~Orphan ~~authorities in~~drug ~~all~~designation ~~major~~must be ~~markets~~requested ~~require~~before ~~that~~submission aof ~~new~~an ~~drug~~application befor ~~approved~~marketing orapproval. ~~exempted~~Products ~~from~~that ~~approval~~qualify byfor ~~the~~orphan ~~appropriate~~designation ~~regulatory~~may ~~authorities~~also ~~before it~~qualify isfor ~~marketed,~~other ~~and~~FDA ~~have~~programs ~~established~~that ~~high~~are ~~standards~~intended ~~for~~to ~~technical~~expedite ~~appraisal,~~the ~~which~~development ~~can result in an expensive~~ and ~~lengthy~~ approval process~~. The~~ ~~time~~and, toas ~~obtain~~a ~~approval~~practical ofmatter, aclinical ~~new~~trials for ~~medicine~~orphan orproducts ~~indication~~may ~~varies~~be bysmaller, ~~country~~simply ~~and~~because ~~some~~of ~~drugs~~the ~~are~~smaller ~~never~~patient ~~approved~~population. ~~The~~Nonetheless, ~~lengthy~~the ~~process~~same ~~of conducting~~approval ~~new~~standards ~~product~~apply orto orphan- ~~formulation~~designated ~~development,~~products ~~preclinical~~as ~~studies~~for ~~and~~other ~~clinical~~drugs. ~~trials,~~Orphan ~~seeking~~drug ~~approval~~designation ~~and~~does ~~the~~not ~~subsequent~~convey ~~compliance with~~any ~~applicable~~advantage ~~statutes and regulations~~in, ifor ~~approval~~shorten isthe ~~obtained~~duration of, the ~~are~~regulatory ~~very~~review ~~costly~~ and ~~require~~approval ~~the expenditure of substantial resources~~process.

~~United States~~Europe

InThe drug development process in Europe is essentially the ~~United~~same ~~States,~~as that required to develop drugs in an acceptable manner in the ~~Public~~ ~~Health~~USA, ~~Service~~in ~~Act~~that ~~and~~a drug must meet the ~~Federal~~requirements for ~~Food,~~quality ~~Drug,~~safety and ~~Cosmetic~~efficacy. ~~Act,~~The asinternational ~~amended,~~regulators ~~and~~(including the ~~regulations~~FDA) ~~promulgated~~have ~~thereunder,~~a ~~and~~system ~~other federal~~which ~~and~~allows ~~state~~them ~~statutes~~to ~~and~~mutually ~~regulations~~recognize the ~~govern,~~standards ~~among~~of ~~other~~drug ~~things,~~development. This is called the ~~safety~~ICH ~~and~~standard ~~effectiveness~~(international ~~standards~~Conference ~~for~~on ~~our~~Harmonization). ~~drugs~~This ~~and~~avoids the ~~raw~~need for ~~materials~~pharmaceutical ~~and~~companies ~~components~~to ~~used~~repeat intheir costly drug development programs for different jurisdictions / international territories. There are nuances between the ~~production~~requirements of, ~~testing,~~the ~~manufacture~~USA, ~~labeling,~~Europe ~~storage,~~and ~~record~~Japan ~~keeping,~~– ~~approval,~~but ~~distribution,~~the ~~advertising, and~~standards ~~promotion~~to ofwhich ~~drug~~development ~~candidates~~programs onmust abe ~~product-by-product~~conducted are ~~basis~~essentially the same.

810

Table of Contents

~~Preclinical~~There ~~tests~~are ~~include in~~essentially ~~vitro and in vivo evaluation of the drug candidate, including animal studies to assess potential safety and efficacy. Certain preclinical~~three ~~tests~~mechanisms ~~must~~for beobtaining ~~conducted~~a inmarketing ~~compliance~~authorization ~~with good laboratory practice regulations. Violations of these regulations can, in some cases, lead to invalidation of the studies, requiring them to be replicated. In addition, non-clinical studies~~ (~~Chemistry and Manufacturing Controls, CMC~~MA) ~~are~~in ~~undertaken to evaluate a new drug’s chemistry, and to determine, amongst other things, the active ingredients’ and finished product formulation’s stability and batch-to-batch reproducibility.~~Europe

~~After laboratory analysis and preclinical testing, a Sponsor files an Investigational New Drug Application, or IND, to begin clinical development (clinical trials in humans~~1). Typically, a manufacturer conducts a three-phase human clinical development program which itself is subject to numerous laws and regulatory requirements, including adequate monitoring, reporting, record keeping and informed consent. In Phase I, small clinical trials are conducted to determine the ~~safety~~Centralized and tolerability of drug candidates. In Phase II, clinical trials are conducted to assess safety and gain preliminary evidence of the efficacy of drug candidates, and to determine appropriate dose ranges in patients with the target indication. In Phase III, clinical trials are conducted in appropriate patient populations to provide sufficient data for the statistically valid evidence of safety and efficacy. The time and expense that will be required for us to perform this clinical development can vary and is substantial. We cannot be certain that we will successfully complete Phase I, Phase II or Phase III clinical trials within any specific period, if at all. Furthermore, the FDA, the IRB are responsible for approving and monitoring the clinical trials at a given site, the Data Safety Monitoring Board, where one is used, or we may suspend the clinical trials at any time on various grounds, including a finding that subjects or patients are exposed to unacceptable health risk. Given that a number of our clinical trials are likely to be performed using drug candidates containing controlled substances, there is the added requirement for compliance with DEA regulations (or equivalent competent authority in ex-US countries where the preclinical studies and clinical trials may be conducted). DEA requirements for State and Federal DEA Registration for receipt, storage, and dispensing of controlled substances vary from state to state and the DEA Registration process can be lengthy and requirement multiple site visits by DEA personnel. This is further complicated if the controlled substance needs temperature regulation as well as controlled access / storage. Failure to gain or delay to gaining the necessary DEA registrations at one or more non-clinical (CMC), laboratory or manufacturing or packaging or labelling sites, preclinical study sites, analytical laboratories or clinical trial sites may delay the delivery of materials to key stakeholders. For example, delay of delivery of investigational product to a clinical trial site, may ultimately delay the initiation, conduct or completion of clinical trials critical for the approval of the product. These failures or delays may delay also the development of other drug candidates and hinder our ability to develop and / or conduct related preclinical studies and clinical trials. Additionally, if we have failures or delays in DEA registrations in pivotal or critical programs, we may also be expected to experience challenges, delays or even the inability to obtain additional financing at acceptable terms and conditions to develop these or other drug candidates.Procedure

~~If the clinical data from these clinical trials (Phases I, II and III~~2) ~~are deemed to support~~ the safety and effectiveness of the drug candidate for its intended use, and the preclinical and quality data are also acceptable, then we may proceed to seek to file with the FDA, a New Drug Application, or NDA, with the US FDA seeking approval to market a new drug for one or more specified intended uses. We have not completed our nonDe-~~clinical (CMC)~~Centralized studies or preclinical studies or clinical trials for any candidate drug for any intended use and therefore, we cannot ascertain whether the clinical data will support and justify filing an NDA. Nevertheless, if and when we are able to ascertain that the clinical data supports and justifies filing an NDA, we intend to make such appropriate filing.Procedure

~~The~~3) ~~purpose of~~ the ~~NDA~~Mutual ~~is to~~Recognition provide the FDA with sufficient information so that it can assess whether the candidate drug has a positive benefit / risk profile and whether it should approve the drug candidate for marketing for specific intended uses.Procedure

~~The~~Centralized ~~fact that the FDA has~~Procedure previously granted a candidate drug an IND, or designated a drug as an orphan drug for a specific intended use, or granted it Breakthrough status, or fast track status or an expedited review does not mean that the drug has been approved for marketing. Only after an NDA has been approved by the FDA is marketing allowed. A request for orphan drug status (~~orphan drug designation~~CP) ~~must be filed before the NDA is filed. The orphan drug designation, though, provides certain benefits, including a seven-year period of market exclusivity subject to certain exceptions.~~

The ~~NDA~~advantage ~~normally~~of ~~includes,~~the centralized ~~but~~procedure is ~~not~~that ~~limited~~it torequires a single application which, ~~sections~~if ~~describing~~successful, ~~the~~results ~~quality~~in ~~safety~~a ~~and~~single ~~efficacy~~marketing ofauthorization with the ~~medicine.~~same ~~The~~product information ~~quality~~available ~~section~~in ~~describes~~all ~~the~~EU ~~chemistry~~languages and valid in all EU member states / countries, ~~manufacturing,~~as ~~and~~well ~~controls~~as Iceland, ~~the~~Liechtenstein, ~~preclinical~~and ~~(non-clinical)~~Norway. ~~section~~The ~~describes~~scientific assessment of the ~~non-clinical~~marketing ~~pharmacology,~~authorization ~~safety~~application ~~pharmacology,~~is ~~drug~~carried out by ~~metabolism,~~the ~~and~~Committee ~~pharmacokinetics~~on Human Medicinal Products (~~DMPK~~CHMP). ~~and~~The ~~toxicology,~~scientific ~~human~~review ~~pharmacokinetics~~process ~~and~~consists ~~bioavailability,~~of ~~and~~alternating ~~the~~periods ~~clinical~~of ~~section~~active ~~describes~~evaluation and periods during which the ~~efficacy~~clock ~~and~~is ~~safety~~stopped ~~results~~in oforder to give the ~~clinical~~applicant ~~trials,~~time ~~and~~to ~~the~~resolve ~~proposed~~any ~~labeling~~issues ~~which~~identified ~~contains,~~during ~~among~~the ~~other~~evaluation. In ~~things~~total, the ~~intended~~duration ~~uses~~ of the ~~candidate~~process ~~drug.~~is ~~Importantly~~up ~~for~~to ~~drug~~210 ~~candidates~~‘active’ ~~containing~~days ~~controlled~~before ~~substances,~~an ~~studies~~opinion ~~investigating~~is issued by the ~~medicine’s~~CHMP. ~~potential~~Once an opinion ~~for~~has ~~abuse~~been ~~are~~given, ~~also~~it ~~undertaken~~is ~~and~~forwarded ~~reported~~to the European Commission which then has 67 days to issue a legally binding decision on the marketing authorization.

9Once a marketing authorization has been granted, the applicant can start to market the medicine in any EU Member State of its choice. However, in practice before a medicine is marketed, it will be subject to pricing negotiations and a review of its cost-effectiveness. This is carried out at national level by Member States to determine reimbursement criteria. Initially, the centralized procedure was mandatory only for biotechnology medicines, as was the case with the previous concertation procedure. Over time, however, the mandatory scope of the centralized procedure has been gradually expanded and by 2005, it included orphan medicines (medicines for rare diseases) as well as human medicines that contain a new active substance (not previously authorized in the Union before 20 November 2005) and that are intended for the treatment of AIDS, cancer, neurodegenerative disorders, diabetes, auto-immune and other immune dysfunctions, and viral diseases. In 2009, the centralized procedure also became mandatory for advanced therapy medicines. The centralized procedure is also optional for other medicines that contain a new active substance not authorized in the Union before 20 November 2005, and for products which are considered to be a significant therapeutic, scientific, or technical innovation, or for which an EU-wide authorization is considered to be in the interests of public health.

~~Table~~The ofDecentralized Procedure ~~Contents~~(DCP)

WeIn ~~cannot~~the ~~take~~decentralized ~~any action~~procedure, tothe ~~market~~applicant ~~any~~chooses ~~new~~one ~~drug~~country oras ~~biologic drug in~~ the ~~United~~reference ~~States~~Member ~~until~~State ~~our~~when ~~appropriate~~making ~~marketing~~its application ~~has~~for ~~been~~marketing ~~approved~~authorization. byThe ~~the~~chosen ~~FDA.~~reference ~~The~~Member ~~FDA~~State ~~has~~then ~~substantial~~prepares ~~discretion~~a ~~over~~draft ~~the~~assessment ~~approval~~report ~~process~~that ~~and~~is ~~may~~submitted ~~disagree~~to ~~with our interpretation of~~ the ~~data~~other ~~submitted.~~Member ~~The~~States ~~process may~~where beapproval ~~significantly~~is ~~extended~~sought ~~by requests~~ for ~~additional~~their ~~information~~simultaneous consideration orand ~~clarification regarding information already provided~~approval. AsIn ~~part of~~allowing ~~this~~the ~~review,~~other ~~the~~Member ~~FDA~~States ~~may~~access ~~refer~~to ~~the~~this ~~application~~assessment toat an ~~appropriate~~early ~~advisory committee~~stage, ~~typically~~any aissues ~~panel~~and ofconcerns ~~clinicians. Satisfaction~~can ofbe ~~these~~dealt ~~and~~with ~~other~~quickly ~~regulatory~~without ~~requirements typically takes several years~~delay, ~~and~~which ~~the~~sometimes ~~actual~~is ~~time~~known ~~required~~to ~~may~~occur ~~vary~~with ~~substantially based upon~~ the ~~type,~~mutual ~~complexity~~recognition ~~and~~procedure ~~novelty~~(MRP, ofsee ~~the drug~~below). ~~Government regulation may delay or prevent marketing of potential drugs for a considerable~~Compared ~~period~~with ~~and~~the ~~impose~~MRP, ~~costly~~the ~~procedures~~decentralized onprocedure ~~our~~has ~~activities.~~the Weadvantage ~~cannot be certain~~ that the ~~FDA~~marketing orauthorization ~~other~~in ~~regulatory agencies will approve any of our drugs on a timely basis, if at~~ all. ~~Success~~chosen inMember ~~preclinical~~States oris ~~early~~received ~~stage clinical trials does not assure success in later-stage clinical trials. Even if a drug receives regulatory approval~~simultaneously, ~~the approval may be significantly limited to specific indications or uses~~ ~~and~~enabling ~~these~~simultaneous ~~limitations~~marketing ~~may adversely affect the commercial viability~~ of the ~~drug /~~ medicine. ~~Delays~~and inreducing ~~obtaining,~~the oradministrative ~~failures~~and ~~to obtain~~ regulatory ~~approvals, would have a material adverse effect on our business~~burden.

~~Even~~The ~~after~~Mutual ~~we obtain FDA~~Recognition ~~approval,~~Procedure ~~we may be required to conduct further studies which may be additional preclinical studies or clinical trials~~ (~~e.g. Phase IV trials~~MRP) and provide additional data on safety and effectiveness. We are also required to gain separate approval for the use of an approved drug as a treatment for indications other than those initially approved. In addition, side effects or adverse events that are reported during clinical trials can delay, impede or prevent marketing approval. Similarly, adverse events that are reported after marketing approval can result in additional limitations being placed on the drug’s use and, potentially, withdrawal of the drug from the market. Any adverse event, either before or after marketing approval, can result in product liability claims against the company.

AsThe anmutual ~~alternate~~recognition procedure ~~path~~has ~~for~~been ~~FDA~~in ~~approval~~place ofsince ~~new~~1995 ~~indications~~and orevolved ~~new~~from ~~formulations~~the ~~of previously~~multi-~~approved~~state ~~drugs,~~licensing ~~a company may file a Section 505(b)(2) NDA, instead of a “stand-alone” or “full” NDA~~procedure. ~~Section~~The ~~505(b)(2)~~applicant ofmust ~~the~~initially ~~Food,~~receive ~~Drug,~~national ~~and Cosmetic Act was enacted as~~approval ~~part~~in ofone ~~the~~EU ~~Drug~~Member ~~Price Competition and Patent Term Restoration Act of 1984~~State, ~~otherwise~~referred ~~known~~to as the ~~Hatch-Waxman~~“Reference ~~Amendments.~~Member ~~Section~~State” ~~505~~(bRMS)~~(2) permits~~ ~~the~~and ~~submission~~then ofseek ~~an NDA where at least some of the information required for~~ approval ~~comes from studies not conducted by or~~ for ~~the~~ ~~applicant and for which~~ the ~~applicant~~medicine ~~has~~in ~~not obtained a right of reference. Some examples of drugs that may be allowed to follow~~other, aso-called ~~505(b)(2)~~‘Concerned ~~path~~Member toStates’ ~~approval~~in ~~are drugs that have~~ a ~~new~~second ~~dosage~~step ~~form,~~based ~~strength,~~on ~~route of administration, formulation or indication. The Hatch-Waxman Amendments permit~~ the ~~applicant~~assessment todone ~~rely~~in ~~upon certain published nonclinical or clinical studies conducted for an approved drug or~~ the ~~FDA’s conclusions from prior review of such studies~~RMS. ~~The~~This ~~FDA~~process ~~may~~has ~~require companies to perform additional studies or~~significant ~~measurements~~differences ~~to support any changes~~ from the ~~approved~~former ~~drug.~~multi-state ~~The~~licensing ~~FDA~~procedure, ~~may~~notably ~~then approve~~ the ~~new~~requirement ~~drug~~that ~~for~~disagreements ~~all~~between orMember ~~some~~States ofmust ~~the labeled indications~~now ~~for~~be ~~which~~resolved ~~the~~at ~~referenced~~EU ~~listed drug has been approved, as well as for any new indication supported by the NDA~~level. ~~While~~Disagreements ~~references~~are tohandled ~~nonclinical and clinical data not generated~~ by the ~~applicant~~Co-ordination orGroup for ~~which~~Mutual ~~the~~Recognition ~~applicant does not have a right of reference are allowed, all development, process, stability, qualification,~~ and ~~validation~~Decentralized ~~data~~Procedures ~~related to the manufacturing and quality of the new drug must be included in an NDA submitted under Section 505(b)(2).~~–

To the extent that the Section 505(b)(2) applicant is relying on the FDA’s conclusions regarding studies conducted for an already approved drug, the applicant is required to certify to the FDA concerning any patents listed for the approved drug in the FDA’s “Orange Book” publication. Specifically, the applicant must certify that: (i) the required patent information has not been filed; (ii) the listed patent has expired; (iii) the listed patent has not expired but will expire on a particular date and approval is sought after patent expiration; or (iv) the listed patent is invalid or will not be infringed by the new drug. The Section 505(b)(2) application also will not be approved until any non-patent exclusivity, such as exclusivity for obtaining approval of a new chemical entity, listed in the Orange Book for the reference drug has expired. Thus, the Section 505(b)(2) applicant may invest a significant amount of time and expense in the development of its drugs only to be subject to significant delay and patent litigation before its drugs may be commercialized.11

InTable ~~addition to regulating and auditing human clinical trials, the FDA regulates and inspects equipment, facilities, laboratories and processes used in the manufacturing and testing~~ of ~~such drugs prior to providing approval to market a drug.~~Contents

10Human (CMDh), a body representing Member States, which is responsible for any questions in two or more Member States relating to the Marketing Authorization (MA) of a medicinal product approved through the mutual recognition or the decentralized procedure. If there is a disagreement between Member States on grounds of a potential serious risk to public health, the CMDh considers the matter in order to reach an agreement within 60 days. If resolution is not possible by the CMDh, the procedure is referred to the CHMP in a procedure called a referral. The CHMP will then carry out a scientific assessment of the relevant medicine on behalf of the EU. In contrast to the previous (multi-state) procedure, the outcome of the CHMP is binding on the Member States involved once it has been adopted by the European Commission. The timelines for assessment by CHMP is 60 days. Since the introduction of the decentralized procedure, the mutual recognition procedure is used for extending existing marketing authorizations to other countries.

~~Table~~There are other nuances to Marketing Authorization approval of ~~Contents~~medicines in Europe compared with the FDA. For example, a Pediatric Investigation Plan (PIP) is a development plan aimed at ensuring that the necessary data are obtained through studies in children, to support the authorization of a medicine for children. All applications for marketing authorization for new medicines have to include the results of studies as described in an agreed PIP, unless the medicine is exempt because of a deferral or waiver.

Orphan Drug Designation in ~~the U.S.~~Europe

~~Under~~In the ~~Orphan~~European ~~Drug Act~~Union, it ~~the~~is ~~FDA~~also ~~may~~possible ~~grant orphan drug designation~~ to aobtain ~~drug~~an intended to treat a rare disease or condition, which is a disease or condition that affects fewer than 200,000 individuals in the United States. If the disease or condition affects more than 200,000 individuals in the United States, orphan drug designation ~~may~~for ~~nevertheless~~a bepipeline ~~available if there is no reasonable expectation that the cost of developing and making the~~ drug ~~would be recovered from sales in the United States~~candidate. InThis ~~the~~also ~~United~~entitles ~~States,~~ a ~~drug~~company ~~that~~to ~~has received orphan drug designation is eligible for~~ financial incentives, such as ~~opportunities~~a ~~for~~reduction ~~grant~~of ~~funding~~fees ~~towards~~or ~~clinical trial costs, tax credits for certain research and user~~ fee waivers ~~under~~and ~~certain~~ten ~~circumstances.~~years ~~The~~of ~~Orphan~~market ~~Drug~~exclusivity ~~Act~~following ~~provides that, if a designated~~ drug isapproval. ~~approved~~This ~~for~~period ~~the~~may ~~rare~~be ~~disease~~reduced to orsix ~~condition~~years ~~for~~if ~~which it was designated,~~ the ~~approved~~orphan drug ~~will~~designation becriteria ~~granted~~are ~~seven~~no ~~years~~longer ~~of orphan drug exclusivity~~met, ~~which~~including ~~means~~where ~~the~~it ~~FDA generally~~is ~~will~~shown ~~not~~that ~~approve~~the ~~any other application for a~~ drug ~~containing~~is ~~the~~sufficiently ~~same active moiety for the same indication for a period of~~profitable ~~seven~~not ~~years,~~to ~~except~~justify inmaintenance ~~limited circumstances, such as a showing~~ of ~~clinical~~market ~~superiority over the drug with orphan drug~~ exclusivity. ~~Orphan drug~~The ~~exclusivity~~definition ~~does~~of ~~not~~what ~~prevent~~qualifies ~~the~~as ~~FDA from approving~~ a ~~different~~rare ~~drug for the same~~ disease orin ~~condition,~~Europe oris ~~the~~slightly ~~same drug for a~~ different to ~~disease~~the orUSA ~~condition~~definition.

~~Orphan~~To ~~drug designation must be requested before submission of an application for marketing approval. Products that~~ qualify for orphan designation ~~may~~in ~~also qualify for other FDA programs that are intended to expedite the development and approval process and~~Europe, as a ~~practical~~medicine ~~matter,~~must ~~clinical~~meet ~~trials for~~a ~~orphan~~number ~~products may be smaller, simply because~~ of the smaller patient population. Nonetheless, the same approval standards apply to orphan- designated products as for other drugs. Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process.criteria:

~~Europe~~• it must be intended for the treatment, prevention or diagnosis of a disease that is life-threatening or chronically debilitating;

~~The~~• ~~drug~~the ~~development~~prevalence ~~process in~~of ~~Europe~~the iscondition ~~essentially~~in the ~~same~~EU asmust ~~that~~not ~~required~~be tomore ~~develop~~than ~~drugs~~5 in ~~an acceptable manner in the USA~~10,000 inor ~~that~~it ~~a drug~~ must ~~meet~~be ~~the~~unlikely ~~requirements for~~that ~~quality~~marketing ~~safety~~of ~~and efficacy. The international regulators (including~~ the ~~FDA)~~medicine ~~have~~would agenerate ~~system~~sufficient ~~which~~returns ~~allows them~~ to ~~mutually~~justify ~~recognize~~ the ~~standards~~investment ofneeded ~~drug development. This is called the ICH standard (international Conference on Harmonization). This avoids the need~~ for ~~pharmaceutical~~ ~~companies~~its ~~to repeat their costly drug~~ development programs for different jurisdictions / international territories. There are nuances between the requirements of the USA, Europe and Japan – but the standards to which development programs must be conducted are essentially the same.;

~~There~~• ~~are~~no ~~essentially~~satisfactory ~~three mechanisms~~method ~~for~~of ~~obtaining~~diagnosis, prevention or treatment of the condition concerned can be authorized, or, if such a ~~marketing~~method ~~authorization~~exists, ~~(MA)~~the inmedicine ~~Europe~~must be of significant benefit to those affected by the condition.

1)As with the ~~Centralized~~USA, ~~Procedure~~European Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process.

2)In the ~~De-Centralized~~same ~~Procedure~~way that there is no guarantee that any medicines developed by Alterola will be approved in the USA, there is similarly no guarantee that any of Alterola’s medicines will be approved in Europe.

~~3) the Mutual Recognition Procedure~~Non-Pharmaceuticals

~~Centralized~~Food, ~~Procedure~~Drinks & ~~(CP)~~Dietary Supplements

The advantage of the centralized procedure is that it requires a single application which, if successful, results in a single marketing authorization with the same product information available in all EU languages and valid in all EU member states / countries, as well as Iceland, Liechtenstein, and Norway. The scientific assessment of the marketing authorization application is carried out by the Committee on Human Medicinal Products (CHMP). The scientific review process consists of alternating periods of active evaluation and periods during which the clock is stopped in order to give the applicant time to resolve any issues identified during the evaluation. In total, the duration of the process is up to 210 ‘active’ days before an opinion is issued by the CHMP. Once an opinion has been given, it is forwarded to the European Commission which then has 67 days to issue a legally binding decision on the marketing authorization.USA

~~Once~~According ato ~~marketing authorization~~the ~~has been granted~~FDA, ~~the~~it is ~~applicant~~currently ~~can~~illegal ~~start~~ to market ~~the~~THC ~~medicine~~or inCBD ~~any~~by EUadding ~~Member~~it ~~State~~to ofa ~~its~~food ~~choice.~~or ~~However,~~labeling init ~~practice before~~as a ~~medicine~~dietary issupplement. ~~marketed,~~Based iton ~~will~~available beevidence, FDA ~~subject~~has toconcluded ~~pricing~~that ~~negotiations~~THC and aCBD ~~review~~products ofare ~~its~~excluded ~~cost-effectiveness.~~from ~~This~~the isdietary ~~carried~~supplement ~~out at~~definition ~~national~~under ~~level~~section by201(ff)(3)(B) ~~Member~~of ~~States~~the toFD&C Act ~~determine~~[21 ~~reimbursement criteria~~U.S.C. ~~Initially,~~§ ~~the~~321(ff)(3)(B)]. ~~centralized~~Under ~~procedure~~that ~~was~~provision, ~~mandatory~~if ~~only~~a ~~for~~substance ~~biotechnology medicines,~~(such as ~~was~~THC ~~the~~or ~~case~~CBD) ~~with~~is ~~the~~an ~~previous~~active ~~concertation~~ingredient ~~procedure.~~in ~~Over~~a ~~time,~~drug ~~however,~~product that ~~the~~has ~~mandatory~~been ~~scope~~approved ofunder ~~the~~section ~~centralized~~505 ~~procedure has~~of ~~been~~the ~~gradually~~FD&C ~~expanded~~Act ~~and~~[21 byU.S.C. ~~2005~~§ 355], itor ~~included~~has ~~orphan~~been ~~medicines~~authorized ~~(medicines~~ for ~~rare~~investigation ~~diseases)~~ as ~~well~~a asnew drug ~~human~~for ~~medicines~~which ~~that~~substantial ~~contain a~~clinical ~~new~~investigations ~~active~~have ~~substance~~been ~~(not~~instituted ~~previously~~and ~~authorized~~for inwhich the ~~Union~~existence ~~before~~of 20such ~~November~~investigations ~~2005)~~has ~~and~~been ~~that~~made public, ~~are~~then ~~intended~~products ~~for~~containing ~~the~~that ~~treatment~~substance ofare ~~AIDS, cancer,~~excluded ~~neurodegenerative~~from ~~disorders,~~the ~~diabetes,~~definition ~~auto-immune~~of ~~and~~a ~~other~~dietary ~~immune~~supplement. ~~dysfunctions,~~FDA ~~and~~considers ~~viral~~a ~~diseases.~~substance Into be ~~2009,~~"authorized ~~the~~for ~~centralized procedure~~investigation ~~also~~as ~~became~~a ~~mandatory~~new ~~for~~drug" ~~advanced~~if ~~therapy~~it ~~medicines.~~is ~~The~~the ~~centralized~~subject ~~procedure~~of isan ~~also~~Investigational ~~optional~~New ~~for~~Drug ~~other~~application ~~medicines~~(IND) that ~~contain~~has agone ~~new~~into ~~active~~effect. ~~substance~~Under ~~not~~FDA’s ~~authorized~~regulations in(21 ~~the~~CFR ~~Union before 20 November 2005~~312.2), ~~and~~unless ~~for~~a ~~products~~clinical ~~which~~investigation ~~are~~meets ~~considered~~the tolimited becriteria ain ~~significant therapeutic,~~that ~~scientific~~regulation, an orIND ~~technical~~is ~~innovation,~~required or for ~~which~~all anclinical ~~EU-wide~~investigations ~~authorization~~of isproducts ~~considered~~that toare besubject into ~~the~~section ~~interests~~505 of ~~public health~~the FD&C Act.

1112

Table of Contents

~~The~~There ~~Decentralized~~is an exception to ~~Procedure~~section 201(~~DCP~~ff)(3)(B) if the substance was "marketed as" a dietary supplement or as a conventional food before the drug was approved or before the new drug investigations were authorized, as applicable. However, based on available evidence, FDA has concluded that this is not the case for THC or CBD. FDA is not aware of any evidence that would call into question its current conclusions that THC and CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act. FDA continues to review information that is submitted to FDA on this issue, but to date this has not caused FDA to change their conclusions.

InGiven the ~~decentralized~~legal ~~procedure, the~~/ ~~applicant chooses one country as the reference Member State when making its application for marketing authorization. The chosen reference~~regulatory ~~Member~~situation ~~State~~at ~~then~~present ~~prepares~~in ~~a draft assessment report that is submitted to~~ the ~~other~~USA, ~~Member~~at ~~States where approval is sought for their simultaneous consideration and approval. In allowing the other Member States access to~~ this ~~assessment at an early stage~~time, ~~any~~Alterola ~~issues~~will ~~and~~not ~~concerns can~~ be ~~dealt~~looking ~~with quickly without delay, which sometimes is known~~ to ~~occur~~commercialize ~~with~~cannabinoid-containing ~~the~~ingredients ~~mutual~~or ~~recognition procedure (MRP, see below). Compared~~products ~~with~~in the ~~MRP~~food, ~~the~~drinks ~~decentralized~~or ~~procedure~~dietary ~~has~~supplements ~~the~~sector ~~advantage that the marketing authorization~~ in ~~all chosen Member States is received simultaneously, enabling simultaneous marketing of~~ the ~~medicine and reducing the administrative and regulatory burden~~USA.

~~The~~Europe ~~Mutual~~- ~~Recognition Procedure~~Novel Food Application (~~MRP~~Europe)

~~The~~Under ~~mutual recognition procedure has been in place since 1995 and evolved from the multi-state licensing procedure. The applicant must initially receive national approval in one~~ EU ~~Member State~~regulations, ~~referred to as the “Reference Member State” (RMS) and then seek approval for the medicine in other,~~ ~~so-called~~any ~~‘Concerned~~food ~~Member States’ in a second step based on the assessment done in the RMS. This process has significant differences from the former multi-state licensing procedure, notably the requirement~~ that ~~disagreements~~was ~~between~~not ~~Member~~consumed ~~States~~“significantly” ~~must~~prior ~~now be~~to ~~resolved~~May at1997 ~~EU level. Disagreements are handled by the Co-ordination Group for Mutual Recognition and Decentralized Procedures – Human (CMDh), a body representing Member States, which~~ is ~~responsible~~considered ~~for any questions in two or more Member States relating~~ to ~~the~~be ~~Marketing Authorization (MA) of~~ a ~~medicinal~~“Novel ~~product approved through the mutual recognition or the decentralized procedure~~Food”. IfThe ~~there is a disagreement~~category ~~between~~covers ~~Member~~new ~~States on grounds of a potential serious risk to public health~~foods, ~~the~~food ~~CMDh~~from ~~considers~~new ~~the matter in order to reach an agreement within 60 days. If resolution is not possible by the CMDh~~sources, ~~the~~new ~~procedure~~substances isused ~~referred to the CHMP~~ in afood ~~procedure~~as ~~called~~well aas ~~referral.~~new ~~The CHMP~~ways ~~will~~and ~~then~~technologies ~~carry~~for ~~out~~producing ~~a scientific assessment of the relevant medicine on behalf of the EU~~food. InThere ~~contrast to the previous (multi-state) procedure, the outcome of the CHMP~~ is ~~binding on the Member States involved once it has been adopted by the European Commission. The timelines~~ ~~for~~a ~~assessment~~specific ~~by CHMP is 60 days. Since the introduction of the decentralized~~ procedure, ~~the mutual recognition procedure is used~~ for ~~extending~~ ~~existing~~gaining ~~marketing~~a ~~authorizations~~Novel toFood ~~other~~Approval ~~countries~~in Europe.

~~There~~The ~~are~~novel ~~other~~food ~~nuances~~status toof ~~Marketing~~CBD ~~Authorization~~extracts ~~approval~~was ofconfirmed ~~medicines~~ in ~~Europe~~January ~~compared with the FDA~~2019. ~~For~~This ~~example,~~means ~~a Pediatric Investigation Plan (PIP) is a development plan aimed at ensuring~~ that ~~the~~applicants ~~necessary~~need ~~data are obtained through studies in children,~~ to ~~support~~apply ~~the~~for authorization of ~~a medicine~~CBD ~~for~~extracts ~~children.~~and ~~All~~isolates ~~applications~~using the ~~for~~procedure ~~marketing authorization~~ for ~~new~~full ~~medicines~~applications ~~have~~(rather tothan ~~include~~a ~~the~~traditional ~~results~~food) ofoutlined ~~studies as described~~ in ~~an agreed PIP, unless~~ the ~~medicine~~European isFood ~~exempt~~Standards ~~because~~Agency of(EFSA) ~~a deferral or waiver~~guidance.

~~Orphan~~In ~~Drug~~general, ~~Designation~~the process is as follows: (1) The applicant submits a Novel Food application; (2) the application is reviewed and if compliant validated by the European Commission to see if it falls within the scope of Novel Food Regulation (EU) 2015 / 2283 (EC validity check); (3) the European Food Standards Agency (EFSA) undertakes a suitability check to see if the application fulfils the requirements of article 10(2) of (EU) 2015 / 2283; (4) EFSA reviews and performs a risk assessment and gives an opinion within 9 months of receipt of a valid application (5) the EC drafts an implementing act authorizing the placement on the market of a Novel Food and updating the EU list, within 7 months of the EFSA opinion. This process can take approximately 18 months from receipt of a valid application, although it can take longer in ~~Europe~~some cases.

InGiven the ~~European Union, it~~legal isand ~~also~~regulated ~~possible~~process toin ~~obtain~~Europe, anAlterola ~~orphan~~intends ~~drug designation for a pipeline drug candidate. This also entitles a company~~ to ~~financial~~submit ~~incentives such~~Novel asFood aapplications ~~reduction~~for ofcannabinoid-containing ~~fees~~ingredients ~~or fee waivers~~ and ~~ten~~/ ~~years~~or ~~of market exclusivity following drug approval. This period may be reduced to~~products ~~six~~in ~~years if~~ the ~~orphan~~food, ~~drug~~drinks ~~designation~~or ~~criteria~~dietary ~~are~~supplements nosector ~~longer~~in ~~met~~Europe, ~~including~~ where it is ~~shown~~legal ~~that the drug is sufficiently profitable not~~ to ~~justify~~do ~~maintenance of market exclusivity~~so. ~~The~~It ~~definition~~may ofbe ~~what~~several ~~qualifies~~years asbefore awe ~~rare~~can ~~disease~~obtain approval inand ~~Europe~~commence iscommercialization ~~slightly~~of ~~different~~such ~~to the~~ingredients, ~~USA~~if ~~definition~~ever.

ToRest ~~qualify~~of ~~for~~The ~~orphan designation~~World ~~in Europe, a medicine must meet a number of criteria:~~(RoW)

•Given itthe ~~must~~varying legal beand ~~intended~~regulated processes for regulatory approval of for cannabinoid-containing ingredients and / or products in the ~~treatment~~food, ~~prevention~~ drinks or ~~diagnosis~~dietary supplements sector in countries outside of athe ~~disease~~USA ~~that~~and Europe, Alterola will consider gaining such approval in countries / territories where it is ~~life~~legal to do so. These will be considered on a case-~~threatening~~by-case orbasis ~~chronically~~as ~~debilitating;~~appropriate. It may be several years before we can obtain approval and commence commercialization of such ingredients, if ever.

• the prevalence of the condition in the EU must not be more than 5 in 10,000 or it must be unlikely that marketing of the medicine would generate sufficient returns to justify the investment needed for its development;Cosmetics

• no satisfactory method of diagnosis, prevention or treatment of the condition concerned can be authorized, or, if such a method exists, the medicine must be of significant benefit to those affected by the condition.USA

AsA ~~with~~cosmetic is defined in the ~~USA~~Food, ~~European~~Drug and Cosmetics Act 201(i) as "(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, ~~Orphan~~or ~~drug~~otherwise ~~designation~~applied ~~does~~to ~~not~~the ~~convey~~human body or any ~~advantage~~part inthereof for cleansing, beautifying, promoting attractiveness, or ~~shorten~~altering the ~~duration~~appearance, and (2) articles intended for use as a component of, ~~the~~any ~~regulatory~~such ~~review~~articles; ~~and~~except ~~approval~~that ~~process~~such term shall not include soap."

In the same way that there is no guarantee than any medicines developed by Alterola will be approved in the USA, there is similarly no guarantee that any of Alterola’s medicines will be approved in Europe.13

12Table of Contents

~~Table~~Under the FD&C Act, cosmetic products and ingredients are not subject to premarket approval by FDA, except for most color additives. Certain cosmetic ingredients are prohibited or restricted by regulation, but currently that is not the case for any cannabis or cannabis-derived ingredients. Ingredients not specifically addressed by regulation must nonetheless comply with all applicable requirements, and no ingredient – including a cannabis or cannabis-derived ingredient – cannot be used in a cosmetic if it causes the product to be adulterated or misbranded in any way. A cosmetic generally is adulterated if it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of ~~Contents~~use prescribed in the labeling, or under such conditions of use as are customary or usual (section 601(a) of the FD&C Act [21 U.S.C. § 361(a)]).

~~Non-Pharmaceuticals~~Alterola may choose to supply active ingredient(s) to cosmetic companies within the USA where it is legal to do so. However, although the company is focused upon producing low cost of goods ingredients, there is no guarantee that the company will be able to produce cosmetic ingredients at the purity required of at a cost of goods which will enable the company to compete within other suppliers of cosmetic ingredients to cosmetic companies. Alterola has no intention in producing its own cosmetic products. It may be several years before we can obtain approval and commence commercialization of such ingredients, if ever.

~~Food, Drinks & Dietary Supplements~~Europe

~~USA~~The use of CBD in cosmetics is harmonized within the European Cosmetic Regulation 1223/2009, under entry 306 ‘Narcotics, natural and synthetic’ of Annex II, and has been for some time. The regulation prohibits use of cannabis and cannabis extracts in cosmetics, as they are controlled substances in Schedule I of the 1961 Single Convention on Narcotic Drugs. However, CBD specifically is not referenced in this convention. At the beginning of 2019, the European Commission (EC) added two entries to its database of cosmetics ingredients for CBD to differentiate between: CBD “derived from extract or tincture or resin of cannabis” and CBD “synthetically produced”. Both entries contain the same text: “Cannabidiol (CBD) as such, irrespective of its source, is not listed in the Schedules of the 1961 Single Convention on Narcotic Drugs. However, it shall be prohibited from use in cosmetic products (II/306) if it is prepared as an extract or tincture or resin of Cannabis in accordance with the Single Convention. Please note that national legislations on controlled substances may also apply.” Essentially, use of naturally-derived CBD from cannabis plants is prohibited in the EU but use of hemp-derived or synthetically-produced CBD is allowed. However, the Single Convention’s banned ingredients list does not include cannabis seeds or leaves without tops, meaning use of CBD derived from these parts of the cannabis plant is not currently prohibited.

~~According~~It ~~to the FDA, it~~ is ~~currently~~Alterola’s ~~illegal~~ intention to ~~market~~supply ~~THC~~active oringredient(s) ~~CBD~~to bycosmetic ~~adding~~companies itwithin tothe aEU ~~food~~where ~~or labeling~~ it asis alegal ~~dietary~~to ~~supplement~~do so. ~~Based on available evidence~~However, ~~FDA~~ ~~has~~although ~~concluded that THC and CBD products are excluded from~~ the ~~dietary~~company ~~supplement~~is ~~definition~~focused upon ~~under~~producing ~~section~~low ~~201(ff)(3)(B)~~cost of ~~the~~goods ~~FD&C Act [21 U.S.C. § 321(ff)(3)(B)]. Under that provision~~ingredients, ifthere ~~a substance (such as THC or CBD)~~ is anno ~~active~~guarantee ~~ingredient in a drug product~~ that ~~has been approved under section 505 of~~ the ~~FD&C~~company ~~Act~~will ~~[21~~be ~~U.S.C.~~able §to ~~355],~~produce orcosmetic ~~has~~ingredients ~~been~~at ~~authorized~~the purity ~~for~~required ~~investigation~~of asat a ~~new drug~~cost ~~for~~of ~~which~~goods ~~substantial clinical investigations have been instituted and for~~ which ~~the~~will ~~existence~~enable ~~of such investigations has been made public, then products containing that substance are excluded from~~ the ~~definition~~company ~~of a dietary supplement. FDA considers a substance~~ to be ~~"authorized~~compete ~~for~~within ~~investigation~~other assuppliers ~~a new drug" if it is the subject~~ of ancosmetic ~~Investigational~~ingredients ~~New~~to ~~Drug~~cosmetic companies. ~~application~~Alterola ~~(IND) that~~ has ~~gone~~ ~~into~~no ~~effect.~~intention ~~Under~~in ~~FDA’s~~producing ~~regulations~~its ~~(21~~own ~~CFR~~cosmetic ~~312~~products.~~2),~~ ~~unless~~It amay ~~clinical~~be ~~investigation~~several ~~meets~~years ~~the~~before ~~limited~~we ~~criteria~~can inobtain ~~that~~approval ~~regulation,~~and ancommence ~~IND~~commercialization ~~is required for all clinical investigations~~ of ~~products~~such ~~that~~ingredients, ~~are~~if ~~subject to section 505 of the FD&C Act~~ever.

~~There~~Rest is an exception to section 201(ff)(3)(B) if the substance was "marketed as" a dietary supplement or as a conventional food before the drug was approved or before the new drug investigations were authorized, as applicable. However, based on available evidence, FDA has concluded that this is not the case for THC or CBD. FDA is not aware of ~~any evidence that would call into question its current conclusions that THC and CBD products are excluded from~~ the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act. FDA continues to review information that is submitted to FDA on this issue, but to date this has not caused FDA to change their conclusions.World

Given the varying legal /and regulated processes for regulatory ~~situation~~ atapproval ~~present~~of for cannabinoid-containing ingredients and / or products in the ~~USA,~~cosmetic atsector ~~this~~in ~~time~~countries outside of the USA and Europe, Alterola will ~~not~~consider begaining ~~looking~~such toapproval ~~commercialize~~in ~~cannabinoid-containing~~countries ~~ingredients~~/ orterritories ~~products in~~where ~~the~~it ~~food,~~is ~~drinks~~legal orto ~~dietary~~do ~~supplements~~so. ~~sector~~These will inbe ~~the~~considered ~~USA~~on a case-by-case basis as appropriate.

~~Europe - Novel Food Application (Europe)~~Employees

~~Under~~At ~~EU regulations~~present, ~~any~~ ~~food~~there ~~that~~is ~~was~~one active ~~not~~employee ~~consumed~~other ~~“significantly”~~than ~~prior~~our toofficers ~~May~~and ~~1997~~directors. isThe ~~considered~~officers, todirectors beand asenior ~~“Novel~~managers ~~Food”.~~oversee ~~The~~all ~~category covers~~responsibilities ~~new~~in ~~foods~~corporate administration, ~~food~~business ~~from~~development ~~new~~and ~~sources,~~research ~~new~~and ~~substances~~development. ~~used~~If infinances ~~food~~permit, ashowever, ~~well~~we asintend ~~new~~to ~~ways~~expand ~~and~~our ~~technologies~~current ~~for~~management to ~~producing~~retain ~~food.~~skilled ~~There~~directors, ~~is a~~officers ~~specific~~and ~~procedure~~employees ~~for~~with ~~gaining~~experience arelevant ~~Novel~~to ~~Food~~our ~~Approval~~business ~~in Europe~~focus.

The novel food status of CBD extracts was confirmed in January 2019. This means that applicants need to apply for authorization of CBD extracts and isolates using the procedure for full applications (rather than a traditional food) outlined in the European Food Standards Agency (EFSA) guidance.14

InTable general, the process is as follows: (1) The applicant submits a Novel Food application; (2) the application is reviewed and if compliant validated by the European Commission to see if it falls within the scope of Novel Food Regulation (EU) 2015 / 2283 (EC validity check); (3) the European Food Standards Agency (EFSA) undertakes a suitability check to see if the application fulfils the requirements of article 10(2) of (EU) 2015 / 2283; (4) EFSA reviews and performs a risk assessment and gives an opinion within 9 months of receipt of a valid application (5) the EC drafts an implementing act authorizing the placement on the market of a Novel Food and updating the EU list, within 7 months of the EFSA opinion. This process can take approximately 18 months from receipt of a valid application, although it can take longer in some cases.Contents

Given the legal and regulated process in Europe, Alterola intends to submit Novel Food applications for cannabinoid-containing ingredients and / or products in the food, drinks or dietary supplements sector in Europe, where it is legal to do so. It may be several years before we can obtain approval and commence commercialization of such ingredients, if ever. Property

13We do not own any real property. We maintain our corporate offices at 47 Hamilton Square Birkenhead Merseyside CH41 5AR United Kingdom. One of the company directors has a beneficial ownership in the property, which is leased on “arm’s length” terms.

~~Table~~Legal ~~of Contents~~Proceedings

~~Rest~~From time to time, we may become party to various lawsuits, claims and other legal proceedings that arise in the ordinary course of ~~The~~our ~~World~~business. ~~(RoW)~~We are not currently a party, as plaintiff or defendant, to any legal proceedings that we believe to be material or which, individually or in the aggregate, would be expected to have a material effect on our business, financial condition or results of operation if determined adversely to us.

~~Given~~Smaller ~~the~~Reporting varying legal and regulated processes for regulatory approval of for cannabinoid-containing ingredients and / or products in the food, drinks or dietary supplements sector in countries outside of the USA and Europe, Alterola will consider gaining such approval in countries / territories where it is legal to do so. These will be considered on a case-by-case basis as appropriate. It may be several years before we can obtain approval and commence commercialization of such ingredients, if ever.Company

~~Cosmetics~~The Company is a “smaller reporting company” as defined in Rule 12b-2 under the Exchange Act. There are certain exemptions available to us as a smaller reporting company, including: (1) not being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes Oxley Act; (2) scaled executive compensation disclosures; and (3) the requirement to provide only two years of audited financial statements, instead of three years. As long as we maintain our status as a “smaller reporting company”, these exemptions will continue to be available to us.

~~USA~~Item 1A. Risk Factors

AAn ~~cosmetic~~investment isin ~~defined~~our insecurities involves a high degree of risk. In addition to the ~~Food~~other information contained in this Annual Report on Form 10-K, ~~Drug~~prospective ~~and~~investors ~~Cosmetics~~should ~~Act~~carefully ~~201(i)~~consider the asfollowing ~~"(1)~~risks ~~articles~~before ~~intended~~investing toin beour ~~rubbed,~~securities. ~~poured,~~If ~~sprinkled~~any of the following risks actually occur, as well as other risks not currently known to us or ~~sprayed~~that onwe currently consider immaterial, ~~introduced~~our ~~into~~business, operating results and financial condition could be materially adversely oraffected. ~~otherwise~~As ~~applied~~a toresult, the ~~human~~trading ~~body~~price orof ~~any~~our ~~part~~common ~~thereof~~stock ~~for~~could ~~cleansing~~decline, ~~beautifying,~~and ~~promoting~~you ~~attractiveness,~~may lose all or ~~altering~~part ~~the~~of ~~appearance,~~your investment in our common stock. The risks discussed below also include forward-looking statements, and ~~(2)~~our ~~articles~~actual ~~intended~~results ~~for~~may ~~use~~differ assubstantially afrom ~~component~~those ofdiscussed in ~~any~~these ~~such~~forward-looking ~~articles;~~statements. ~~except~~See ~~that~~“Cautionary ~~such~~Note ~~term~~On ~~shall~~Forward-Looking ~~not~~Statements” ~~include~~in ~~soap~~this Annual Report on Form 10-K." In assessing the risks below, you should also refer to the other information contained in this Annual Report on Form 10-K, including the financial statements and the related notes, before deciding to purchase any of our securities.

~~Under~~Risk ~~the~~Related ~~FD&C Act, cosmetic products and ingredients are not subject~~ to ~~premarket approval by FDA, except for most color additives. Certain cosmetic ingredients are~~Covid prohibited or restricted by regulation, but currently that is not the case for any cannabis or cannabis-derived ingredients. Ingredients not specifically addressed by regulation must nonetheless comply with all applicable requirements, and no ingredient – including a cannabis or cannabis-derived ingredient – cannot be used in a cosmetic if it causes the product to be adulterated or misbranded in any way. A cosmetic generally is adulterated if it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling, or under such conditions of use as are customary or usual (section 601(a) of the FD&C Act [21 U.S.C. § 361(a)]).19

~~Alterola may choose~~Our tobusiness ~~supply~~and ~~active~~future ~~ingredient(s)~~operations tomay ~~cosmetic~~be ~~companies~~adversely ~~within~~affected ~~the~~by ~~USA~~epidemics ~~where~~and ~~it is legal to do so. However~~pandemics, ~~although~~such ~~the~~as ~~company is focused upon producing low cost of goods ingredients, there is no guarantee that~~ the ~~company~~recent ~~will~~COVID-19 ~~be able to produce cosmetic ingredients at the purity required of at a cost of goods which will enable the company to compete within other suppliers of cosmetic ingredients to cosmetic companies~~outbreak. ~~Alterola has no intention in producing its own cosmetic products. It may be several years before we can obtain approval and commence commercialization of such ingredients, if ever.~~

~~Europe~~For the year ended March 31, 2024, COVID-19 has not had any material impact on our operations, supply chain, liquidity or capital resources. However, we may face risks related to health epidemics and/or pandemics and/or other outbreaks of communicable diseases, which could result in a widespread health crisis that could adversely affect general commercial activity and the economies and financial markets of the world as a whole. For example, the outbreak of COVID-19, which began in China, has been declared by the World Health Organization to be a “pandemic,” has spread across the globe, including the United States of America. A health epidemic or pandemic or other outbreak of communicable diseases, such as the current COVID-19 pandemic, poses the risk that we, or potential business partners may be disrupted or prevented from conducting business activities for certain periods of time, the durations of which are uncertain, and may otherwise experience significant impairments of business activities, including due to, among other things, operational shutdowns or suspensions that may be requested or mandated by national or local governmental authorities or self-imposed by us, our users or other business partners. For example, due to COVID-19, we have been unable to travel across the relevant jurisdictions pertaining to our business and foresee this as an ongoing issue. While it is not possible at this time to estimate the full impact that COVID-19 could have on our business, potential users or other potential business partners, the continued spread of COVID-19, the measures taken by the local and federal government, actions taken to protect employees, and the impact of the pandemic on various business activities could adversely affect our results of operations and financial condition.

The use of CBD in cosmetics is harmonized within the European Cosmetic Regulation 1223/2009, under entry 306 ‘Narcotics, natural and synthetic’ of Annex II, and has been for some time. The regulation prohibits use of cannabis and cannabis extracts in cosmetics, as they are controlled substances in Schedule I of the 1961 Single Convention on Narcotic Drugs. However, CBD specifically is not referenced in this convention. At the beginning of 2019, the European Commission (EC) added two entries to its database of cosmetics ingredients for CBD to differentiate between: CBD “derived from extract or tincture or resin of cannabis” and CBD “synthetically produced”. Both entries contain the same text: “Cannabidiol (CBD) as such, irrespective of its source, is not listed in the Schedules of the 1961 Single Convention on Narcotic Drugs. However, it shall be prohibited from use in cosmetic products (II/306) if it is prepared as an extract or tincture or resin of Cannabis in accordance with the Single Convention. Please note that national legislations on controlled substances may also apply.” Essentially, use of naturally-derived CBD from cannabis plants is prohibited in the EU but use of hemp-derived or synthetically-produced CBD is allowed. However, the Single Convention’s banned ingredients list does not include cannabis seeds or leaves without tops, meaning use of CBD derived from these parts of the cannabis plant is not currently prohibited.15

ItTable ~~is Alterola’s intention to supply active ingredient(s) to cosmetic companies within the EU where it is legal to do so. However, although the company is focused upon producing low cost~~ of goods ingredients, there is no guarantee that the company will be able to produce cosmetic ingredients at the purity required of at a cost of goods which will enable the company to compete within other suppliers of cosmetic ingredients to cosmetic companies. Alterola has no intention in producing its own cosmetic products. It may be several years before we can obtain approval and commence commercialization of such ingredients, if ever.Contents

14 Risks Relating to Our Financial Condition

~~Table~~There ofare ~~Contents~~doubts about our ability to continue as a going concern.

~~Rest~~We have generated no revenue and have an accumulated deficit of ~~the~~$12,406,419 ~~World~~through March 31, 2024. These factors raise substantial doubt about our ability to continue as a going concern.

~~Given~~There ~~the~~can ~~varying~~be ~~legal~~no ~~and~~assurance ~~regulated~~that ~~processes~~sufficient ~~for~~funds ~~regulatory~~required ~~approval~~during ofthe ~~for~~next ~~cannabinoid-containing~~year ~~ingredients~~or ~~and~~thereafter /will orbe ~~products~~generated infrom ~~the~~operations ~~cosmetic~~or ~~sector~~that infunds ~~countries~~will be available from ~~outside~~external sources, such as debt or equity financings or other potential sources. The lack of additional capital resulting from the ~~USA~~inability to ~~and~~generate ~~Europe~~cash flow from operations, ~~Alterola~~or ~~will~~to ~~consider~~raise ~~gaining~~capital ~~such~~from ~~approval~~external insources ~~countries~~would /force ~~territories~~us ~~where~~to itsubstantially iscurtail ~~legal~~or tocease dooperations and sowould, therefore, have a material adverse effect on its business. ~~These~~Furthermore, there can be no assurance that any such required funds, if available, will be ~~considered~~available on attractive terms or that they will not have a ~~case-by-case~~significant ~~basis~~dilutive aseffect ~~appropriate~~on our existing stockholders.

~~Employees~~We seek to overcome the circumstances that impact our ability to remain a going concern through a combination of the growth of revenues, with interim cash flow deficiencies being addressed through additional equity and debt financing. We anticipate raising additional funds through public or private financing, strategic relationships or other arrangements in the near future to support its business operations; however, we may not have commitments from third parties for a sufficient amount of additional capital. We cannot be certain that any such financing will be available on acceptable terms, or at all, and our failure to raise capital when needed could limit our ability to continue operations. Our ability to obtain additional funding will determine the Company’s ability to continue as a going concern. Failure to secure additional financing in a timely manner and on favorable terms would have a material adverse effect on our financial performance, results of operations and stock price and require us to curtail or cease operations, sell off our assets, seek protection from our creditors through bankruptcy proceedings, or otherwise. Furthermore, additional equity financing may be dilutive to the holders of our common stock, and debt financing, if available, may involve restrictive covenants, and strategic relationships, if necessary, to raise additional funds, and may require that we relinquish valuable rights.

At Because ~~present,~~we ~~there is one~~have ~~active~~a ~~employee~~limited ~~other~~operating ~~than our officers and directors. The officers~~history, ~~directors~~you ~~and~~may ~~senior~~not ~~managers~~be ~~oversee~~able ~~all responsibilities in corporate administration, business development and research and development. If finances permit, however, we intend~~ to ~~expand~~accurately ~~our~~evaluate ~~current management to retain skilled directors, officers and employees with experience relevant to~~ our ~~business focus~~operations.

~~Property~~We have had limited operations to date. Therefore, we have a limited operating history upon which to evaluate the merits of investing in our company. Potential investors should be aware of the difficulties normally encountered by new companies and the high rate of failure of such enterprises. The likelihood of success must be considered in light of the problems, expenses, difficulties, complications and delays encountered in connection with the operations that we plan to undertake. These potential problems include, but are not limited to, unanticipated problems relating to the ability to generate sufficient cash flow to operate our business, and additional costs and expenses that may exceed current estimates. We expect to continue to incur significant losses into the foreseeable future. We recognize that if the effectiveness of our business plan is not forthcoming, we will not be able to continue business operations. There is no history upon which to base any assumption as to the likelihood that we will prove successful, and it is doubtful that we will generate any operating revenues or ever achieve profitable operations. If we are unsuccessful in addressing these risks, our business will most likely fail.

We doare ~~not~~dependent ~~own any real property.~~on Weoutside ~~maintain~~financing ~~our~~for ~~corporate~~continuation ~~offices at 47 Hamilton Square Birkenhead Merseyside CH41 5AR United Kingdom. One~~ of ~~the~~our ~~company directors has a beneficial ownership in the property, which is leased on “arm’s length” terms~~operations.

~~Legal~~Because ~~Proceedings~~we have generated no revenues and currently operate at a loss, we are completely dependent on the continued availability of financing in order to continue our business operations. There can be no assurance that financing sufficient to enable us to continue our operations will be available to us in the future.

~~From~~We ~~time~~will need additional funds to ~~time,~~complete wefurther ~~may become~~development ~~party~~of toour ~~various~~business ~~lawsuits,~~plan ~~claims~~to ~~and~~achieve ~~other~~a ~~legal~~sustainable ~~proceedings~~level ~~that~~where ~~arise~~ongoing inoperations ~~the~~can ~~ordinary~~be ~~course~~funded out of ~~our business~~revenues. We ~~are~~anticipate ~~not~~that ~~currently a~~we ~~party~~must raise $25,000,000 asfor ~~plaintiff~~our oroperations ~~defendant~~for the next 12 months, toand ~~any~~$81,000,000 ~~legal~~in ~~proceedings~~total ~~that~~for weour ~~believe~~initial toclinical development beprograms. ~~material~~We orwill ~~which,~~require ~~individually~~further orfunding into ~~the~~fully ~~aggregate, would~~implement beour ~~expected~~business plan to ~~have~~its afullest ~~material~~potential ~~effect~~and onachieve our ~~business,~~growth plans. ~~financial~~There ~~condition~~is orno ~~results~~assurance ofthat ~~operation~~any additional financing will be available or if ~~determined~~available, ~~adversely~~on terms that will be acceptable to us.

~~Smaller Reporting Company~~16

~~The~~Table Company is a “smaller reporting company” as defined in Rule 12b-2 under the Exchange Act. There are certain exemptions available to us as a smaller reporting company, including: (1) not being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes Oxley Act; (2) scaled executive compensation disclosures; and (3) the requirement to provide only two years of audited financial statements, instead of three years. As long as we maintain our status as a “smaller reporting company”, these exemptions will continue to be available to us.Contents

~~Item~~Our failure to obtain future ~~1A.~~financing ~~Risk~~or ~~Factors~~to produce levels of revenue to meet our financial needs could result in our inability to continue as a going concern and, as a result, our investors could lose their entire investment.

AnOur investment in our securities involves a high degree of risk. In addition to the other information contained in this Annual Report on Form 10-K, prospective investors should carefully consider the following risks before investing in our securities. If any of the following risks actually occur, as well as other risks not currently known to us or that we currently consider immaterial, our business, operating results ~~and financial condition could be materially adversely~~ ~~affected.~~may ~~As a result~~fluctuate, ~~the~~which ~~trading price of our common stock~~ could ~~decline,~~have ~~and~~a ~~you~~negative ~~may~~impact ~~lose~~on ~~all or part of your investment in~~ our ~~common stock.~~ability ~~The~~to ~~risks~~grow ~~discussed below also include forward-looking statements, and~~ our ~~actual~~client results may differ substantially from those discussed in these forward-looking statements. See “Cautionary Note On Forward-Looking Statements” in this Annual Report on Form 10-K. In assessing the risks belowbase, ~~you~~establish ~~should~~sustainable ~~also~~revenues ~~refer to the other information contained in this Annual Report on Form 10-K, including the financial statements~~ and ~~the~~succeed ~~related notes, before deciding to purchase any of our securities~~overall.

15Our results of operations may fluctuate as a result of a number of factors, some of which are beyond our control including but not limited to:

~~Table~~• ofgeneral ~~Contents~~economic conditions in the geographies and industries where we sell our services and conduct operations; legislative policies where we sell our services and conduct operations;

~~Risk~~• ~~Related~~the tobudgetary ~~Covid 19~~constraints of our customers; seasonality;

~~Our business~~• ~~and~~success ~~future~~of ~~operations~~our ~~may~~strategic begrowth ~~adversely affected by epidemics and pandemics, such as the recent COVID-19 outbreak.~~initiatives;

~~For~~• ~~the~~costs ~~year~~associated ~~ended~~with March 31, 2023, COVID-19 has not had any material impact on our operations, supply chain, liquidity or capital resources. However, we may face risks related to health epidemics and/or pandemics and/or other outbreaks of communicable diseases, which could result in a widespread health crisis that could adversely affect general commercial activity and the ~~economies~~launching and financial markets of the world as a whole. For example, the outbreak of COVID-19, which began in China, has been declared by the World Health Organization to be a “pandemic,” has spread across the globe, including the United States of America. A health epidemic or ~~pandemic~~integration ~~or other outbreak~~ of ~~communicable~~new ~~diseases, such as the current COVID-19 pandemic, poses the risk that we,~~ or ~~potential~~acquired ~~business~~businesses; ~~partners~~timing ~~may be disrupted or prevented from conducting business activities for certain periods~~ of ~~time,~~new ~~the~~product ~~durations~~introductions of which are uncertain, and may otherwise experience significant impairments of business activities, including due to, among other things, operational shutdowns or suspensions that may be requested or mandated by ~~national~~ ~~or local governmental authorities or self-imposed by~~ us, our ~~users~~suppliers ~~or other business partners. For example, due to COVID-19, we have been unable to travel across the relevant jurisdictions pertaining to our business~~ and ~~foresee this as an ongoing issue. While it is not possible at this time to estimate the full impact that COVID-19 could have on~~ our ~~business,~~competitors; ~~potential~~product ~~users or other potential business partners, the continued spread of COVID-19, the measures taken by the local~~ and ~~federal~~service ~~government~~mix, ~~actions taken to protect employees~~availability, ~~and~~utilization ~~the impact of the pandemic on various business activities could adversely affect our results of operations~~ and ~~financial condition.~~ pricing;

~~Risks~~• ~~Relating to~~the ~~Our~~mix, ~~Financial~~by ~~Condition~~state and country, of our revenues, personnel and assets; movements in interest rates or tax rates; and

~~There~~• ~~are~~changes ~~doubts~~in, ~~about our~~and ~~ability~~application toof, ~~continue~~accounting asrules; achanges ~~going~~in ~~concern~~the regulations applicable to us; and litigation matters.

WeAs ~~have~~a ~~generated~~result ~~no revenue, and have an accumulated deficit~~ of ~~$9,576,247~~these ~~through March 31~~factors, we ~~2023.~~may ~~These~~not ~~factors~~succeed ~~raise~~in ~~substantial~~our ~~doubt~~business ~~about~~and ~~our~~we ~~ability~~could togo ~~continue as~~out aof ~~going concern~~business.

~~There~~ As ~~can~~a ~~be no assurance~~growing ~~that sufficient funds required during the next year or thereafter will be generated from operations or that funds will be available from external sources~~company, ~~such~~we ashave ~~debt~~yet ~~or equity financings or other potential sources. The lack of additional capital resulting from the inability~~ to ~~generate~~achieve ~~cash~~a ~~flow~~profit ~~from operations, or to raise capital from external sources would force us to substantially curtail or cease operations~~ and ~~would,~~may ~~therefore,~~not ~~have~~achieve a ~~material~~profit ~~adverse~~in ~~effect~~the onnear ~~its business. Furthermore~~future, ~~there can be no assurance that any such required funds,~~ if ~~available,~~at ~~will be available on attractive terms or that they will not have a significant dilutive effect on our existing stockholders~~all.

We ~~seek~~have tonot ~~overcome~~yet ~~the circumstances~~produced ~~that~~any ~~impact our ability to remain a going concern through a combination of the growth of~~ revenues, ~~with~~or ~~interim~~profit ~~cash flow deficiencies being addressed through additional equity~~ and ~~debt~~may ~~financing.~~not ~~We anticipate raising additional funds through public or private financing, strategic relationships or other arrangements~~ in the near future ~~to support its business operations; however~~, weif ~~may~~at ~~not have commitments from third parties for a sufficient amount of additional capital~~all. We cannot be certain that ~~any~~we ~~such financing~~ will be ~~available~~able onto ~~acceptable~~realize sufficient revenue ~~terms,~~to orachieve atprofitability. ~~all~~Further, ~~and~~many of our ~~failure~~competitors tohave ~~raise~~a ~~capital~~significantly ~~when~~larger ~~needed~~industry ~~could~~presence ~~limit~~and ~~our~~revenue ~~ability~~stream but have yet to ~~continue~~achieve ~~operations~~profitability. Our ability to ~~obtain additional funding will determine the Company’s ability to~~ continue as a going concern. ~~Failure~~is todependent ~~secure~~upon ~~additional~~raising ~~financing~~capital infrom afinancing ~~timely~~transactions, increasing ~~manner~~revenue and onkeeping ~~favorable~~operating ~~terms~~expenses ~~would~~below ~~have a material adverse effect on~~ our ~~financial~~revenue ~~performance,~~levels ~~results~~in oforder ~~operations and stock price and require us~~ to ~~curtail~~achieve orpositive ~~cease~~cash ~~operations~~flows, ~~sell~~none ~~off~~of ~~our~~which ~~assets,~~can ~~seek protection from our creditors through bankruptcy proceedings, or otherwise. Furthermore, additional equity financing may~~ be dilutive to the holders of our common stock, and debt financing, if available, may involve restrictive covenants, and strategic relationships, if necessary, to raise additional funds, and may require that we relinquish valuable rightsassured.

16Risks Related with Management and Control Persons

~~Table~~We are dependent on the continued services of ~~Contents~~our key staff and if we fail to keep them or fail to attract and retain qualified senior executive and key technical personnel, our business will not be able to expand.

~~Because~~We are dependent on the continued availability of Timothy Rogers (Executive Chairman), David Hitchcock (Chief Executive Officer, CEO), Colin Stott (Chief Operating Officer, COO), Dominic Schiller (Chief IP Officer), Hunter Land (VP Translational Research, USA) and Guy Webber (Preclinical Development Director), and the availability of new employees to implement our business plans. The market for skilled employees is highly competitive, especially for employees in our industry. Although we ~~have~~expect that our planned compensation programs will be intended to attract and retain the employees arequired ~~limited~~for ~~operating~~us ~~history~~to be successful, ~~you~~there ~~may~~can ~~not~~be no assurance that we will be able to ~~accurately~~retain ~~evaluate~~the services of all our ~~operations~~key employees or a sufficient number to execute our plans, nor can there be any assurance we will be able to continue to attract new employees as required.

We have had limited operations to date. Therefore, we have a limited operating history upon which to evaluate the merits of investing in our company. Potential investors should be aware of the difficulties normally encountered by new companies and the high rate of failure of such enterprises. The likelihood of success must be considered in light of the problems, expenses, difficulties, complications and delays encountered in connection with the operations that we plan to undertake. These potential problems include, but are not limited to, unanticipated problems relating to the ability to generate sufficient cash flow to operate our business, and additional costs and expenses that may exceed current estimates. We expect to continue to incur significant losses into the foreseeable future. We recognize that if the effectiveness of our business plan is not forthcoming, we will not be able to continue business operations. There is no history upon which to base any assumption as to the likelihood that we will prove successful, and it is doubtful that we will generate any operating revenues or ever achieve profitable operations. If we are unsuccessful in addressing these risks, our business will most likely fail.17

WeTable ~~are dependent on outside financing for continuation~~ of ~~our operations.~~Contents

~~Because~~Our welack ~~have generated no revenues and currently operate at a loss, we are completely dependent on the continued availability~~ of ~~financing in order to continue~~adequate ~~our~~D&O ~~business~~insurance ~~operations.~~may ~~There~~also ~~can~~make beit nodifficult ~~assurance~~for ~~that financing sufficient to enable~~ us to ~~continue~~retain ~~our~~and ~~operations~~attract ~~will~~talented beand ~~available to~~skilled usdirectors inand ~~the future~~officers.

WeIn ~~will~~the ~~need~~future ~~additional~~we ~~funds~~may be subject to ~~complete~~additional ~~further~~litigation, ~~development~~including ofpotential ~~our~~class ~~business~~action ~~plan~~and tostockholder ~~achieve~~derivative aactions. ~~sustainable~~Risks ~~level~~associated ~~where~~with ~~ongoing~~legal ~~operations~~liability ~~can~~are difficult beto ~~funded~~assess ~~out~~and ofquantify, ~~revenues. Although~~and ~~certain~~their ~~shareholder~~existence ~~affiliates,~~and ~~through~~magnitude ~~their~~can ~~respective~~remain ~~companies,~~unknown ~~have~~for ~~committed~~significant toperiods ~~enter~~of ~~into~~time. ~~loan~~To ~~agreements~~date, ~~with~~we ~~our company~~have tonot ~~provide~~obtained updirectors toand ~~$4,000,000~~officers ~~USD~~liability of(“D&O”) ~~working~~insurance. ~~capital,~~Without weadequate ~~anticipate~~D&O ~~that~~insurance, wethe ~~must~~amounts ~~raise~~we ~~$25,000,000~~would pay ~~for~~to indemnify our ~~operations~~officers ~~for~~and ~~the~~directors ~~next~~should 12they ~~months, and~~be ~~$81,000,000~~subject into ~~total~~legal ~~for~~action ~~our~~based ~~initial~~on ~~clinical~~their ~~development~~service ~~programs.~~to Wethe ~~will~~Company ~~require~~could ~~further~~have ~~funding~~a material toadverse ~~fully~~effect ~~implement~~on our ~~business plan~~financial tocondition, ~~its~~results ~~fullest~~of ~~potential~~operations and ~~achieve~~liquidity. Furthermore, our ~~growth~~lack ~~plans.~~of ~~There~~adequate isD&O noinsurance may ~~assurance~~make ~~that~~it ~~any~~difficult ~~additional~~for ~~financing~~us ~~will~~to beretain ~~available~~and orattract ~~if available,~~talented onand ~~terms~~skilled ~~that~~directors ~~will~~and beofficers, ~~acceptable~~which tocould usadversely affect our business.

Our ~~failure~~personnel tomay ~~obtain future~~voluntarily ~~financing~~terminate ortheir torelationship ~~produce~~with ~~levels~~us ofat ~~revenue~~any totime, ~~meet~~and ~~our~~competition ~~financial~~for ~~needs~~qualified ~~could~~personnel ~~result~~is inintense. ~~our~~The ~~inability~~process toof ~~continue~~locating asadditional personnel awith ~~going~~the ~~concern~~combination of skills and~~, as~~ aattributes ~~result,~~required to carry out our ~~investors~~strategy could ~~lose~~be ~~their~~lengthy, ~~entire~~costly ~~investment~~and disruptive.

~~Our~~If ~~operating~~we ~~results~~lose the services of ~~may~~key ~~fluctuate~~personnel or fail to replace the services of key personnel who depart, ~~which~~we could ~~have~~experience a severe negative ~~impact~~effect on our ~~ability~~financial results toand ~~grow~~stock price. The loss of the services of any key personnel, marketing or other personnel or our ~~client~~failure ~~base~~to attract, ~~establish~~integrate, motivate ~~sustainable~~and ~~revenues~~retain additional key employees could have a material adverse effect on our business, operating and ~~succeed~~financial ~~overall~~results and stock price.

Our ~~results~~officers ofand ~~operations~~directors ~~may~~and ~~fluctuate~~affiliates ashave asubstantial ~~result~~control ofover aus ~~number~~and ofour ~~factors,~~policies ~~some~~and ofwill ~~which~~be ~~are~~able ~~beyond~~to ~~our~~influence ~~control~~corporate ~~including but not limited to:~~matters.

•Our ~~general~~officers ~~economic~~and ~~conditions~~directors presently inbeneficially ~~the~~own ~~geographies~~approximately ~~and~~66% ~~industries~~of ~~where~~our wecommon ~~sell~~stock. Additionally, our ~~services~~officers and ~~conduct~~directors ~~operations;~~are ~~legislative~~able ~~policies~~to ~~where~~exercise wesignificant influence ~~sell~~over all matters requiring approval by our ~~services~~stockholders, including the election of directors, the approval of significant corporate transactions, and ~~conduct~~any ~~operations;~~change of control of our company. They could prevent transactions, which would be in the best interests of the other shareholders. Our officers, directors and affiliates’ interests may not necessarily be in the best interests of the shareholders in general.

•The ~~the~~elimination ~~budgetary~~of monetary ~~constraints~~liability against our directors, officers and employees under our Articles of Incorporation and the existence of indemnification rights to our ~~customers;~~directors, ~~seasonality;~~officers and employees may result in substantial expenditures by our Company and may discourage lawsuits against our directors, officers and employees.

•Our ~~success~~Articles of Incorporation contain provisions that eliminate the liability of our ~~strategic~~directors ~~growth~~for ~~initiatives;~~monetary damages to our Company and shareholders. Our bylaws also require us to indemnify our officers and directors. We may also have contractual indemnification obligations under our agreements with our directors, officers and employees. The foregoing indemnification obligations could result in our company incurring substantial expenditures to cover the cost of settlement or damage awards against directors, officers and employees that we may be unable to recoup. These provisions and resulting costs may also discourage our company from bringing a lawsuit against directors, officers and employees for breaches of their fiduciary duties, and may similarly discourage the filing of derivative litigation by our shareholders against our directors, officers and employees even though such actions, if successful, might otherwise benefit our Company and shareholders.

•Our ~~costs~~officers ~~associated with the launching or integration of new or acquired businesses; timing of new product introductions by us, our suppliers~~ and ~~our~~directors have ~~competitors;~~limited ~~product~~experience ~~and~~managing ~~service~~a ~~mix,~~public ~~availability, utilization and pricing;~~company.

•Our ~~the~~officers ~~mix,~~and bydirectors have ~~state~~limited ~~and~~experience ~~country~~managing a public company. Consequently, ofwe may not be able to raise any funds or run our ~~revenues,~~public ~~personnel~~company successfully. Our executive’s officers’ and ~~assets;~~directors’ ~~movements~~lack inof ~~interest~~experience ~~rates~~of managing a public company could cause you to lose some or ~~tax~~all ~~rates;~~of ~~and~~your investment.

~~• changes in, and application of, accounting rules; changes in the regulations applicable to us; and litigation matters.~~18

AsTable ~~a result~~ of ~~these factors, we may not succeed in our business and we could go out of business.~~Contents

AsOur aCompany ~~growing company,~~has wean ~~have~~outstanding ~~yet~~material weakness related to ~~achieve~~its ainternal ~~profit~~controls ~~and~~over ~~may~~financial ~~not achieve a profit in the near future, if at all~~reporting.

WeOur ~~have~~management ~~not~~is ~~yet~~responsible ~~produced~~for establishing and ~~any~~maintaining ~~revenues~~adequate orinternal ~~profit~~control ~~and~~over ~~may~~financial ~~not~~reporting (as defined in Rule 13a-15(f) under the ~~near~~Securities ~~future,~~Exchange ifAct atof ~~all~~1934). Management Wehas ~~cannot~~assessed bethe ~~certain~~effectiveness ~~that~~of weour ~~will~~internal becontrol ~~able~~over tofinancial ~~realize~~reporting ~~sufficient~~as ~~revenue~~of March 31, 2024 based on criteria established toin ~~achieve~~Internal ~~profitability.~~Control-Integrated ~~Further,~~Framework ~~many~~issued by the Committee of ~~our~~Sponsoring ~~competitors~~Organizations ~~have~~of the Treadway Commission. As a ~~significantly~~result ~~larger~~of this ~~industry~~assessment, ~~presence~~management ~~and~~concluded ~~revenue~~that, ~~stream~~as ~~but~~of ~~have~~March ~~yet to~~31, ~~achieve~~2024, ~~profitability~~our internal control over financial reporting was not effective. Our management ~~ability~~identified tothe ~~continue~~following asmaterial aweaknesses ~~going~~in ~~concern~~our isinternal ~~dependent~~control ~~upon~~over ~~raising~~financial ~~capital~~reporting, ~~from~~which ~~financing~~are ~~transactions,~~indicative ~~increasing~~of many ~~revenue~~small companies with small staff: (i) inadequate segregation of duties and ~~keeping~~effective ~~operating~~risk ~~expenses~~assessment; ~~below~~and ~~our~~(ii) ~~revenue~~insufficient ~~levels~~written inpolicies and ~~order~~procedures tofor ~~achieve~~accounting ~~positive~~and ~~cash~~financial ~~flows,~~reporting ~~none~~with respect to the requirements and application of ~~which~~both ~~can~~US beGAAP ~~assured~~and SEC guidelines.

17We plan to take steps to enhance and improve the design of our internal control over financial reporting. During the period covered by this annual report on Form 10-K, we have not been able to remediate the material weaknesses identified above. To remediate such weaknesses, we hope to implement the following changes during our fiscal year ending March 31, 2025: (i) appoint additional qualified personnel to address inadequate segregation of duties and ineffective risk management; and (ii) adopt sufficient written policies and procedures for accounting and financial reporting. The remediation efforts set out in (i) and (ii) are largely dependent upon our securing additional financing to cover the costs of implementing the changes required. If we are unsuccessful in securing such funds, remediation efforts may be adversely affected in a material manner.

~~Table~~This annual report does not include an attestation report of ~~Contents~~our registered public accounting firm regarding internal control over financial reporting. Management’s report was not subject to attestation by our registered public accounting firm pursuant to an exemption for non-accelerated filers set forth in Section 989G of the Dodd-Frank Wall Street Reform and Consumer Protection Act.

~~Risks~~ Remediation ~~Related~~of ~~with~~Material ~~Management and Control Persons~~Weakness

We are ~~dependent~~unable onto remedy our controls related to the ~~continued~~inadequate ~~services~~segregation of ~~our~~duties ~~key~~and ~~staff~~ineffective ~~and~~risk ifmanagement until we ~~fail~~receive financing to ~~keep~~hire ~~them~~additional employees. orWe ~~fail~~use toan ~~attract~~outsourced ~~and~~controller ~~retain~~to ~~qualified~~provide ~~senior~~the ~~executive~~controls for accounting and ~~key~~financial ~~technical personnel~~reporting. On October 10, ~~our~~2023, ~~business~~we ~~will~~hired Mr. ~~not~~Nathan beThompson ~~able~~as toour ~~expand~~Chief Financial Officer.

WeLimitations ~~are dependent~~ on the ~~continued availability~~Effectiveness of ~~Timothy Rogers (Executive Chairman), David Hitchcock (Chief Executive Officer, CEO), Colin Stott (Chief Operating Officer,~~Internal COO), Dominic Schiller (Chief IP Officer), and Guy Webber (Preclinical Development Director), and the availability of new employees to implement our business plans. The market for skilled employees is highly competitive, especially for employees in our industry. Although we expect that our planned compensation programs will be intended to attract and retain the employees required for us to be successful, there can be no assurance that we will be able to retain the services of all our key employees or a sufficient number to execute our plans, nor can there be any assurance we will be able to continue to attract new employees as required.Controls

Our ~~lack~~management, including our Chief Executive Officer and our Chief Financial Officer, does not expect that our disclosure controls and procedures or our internal control over financial reporting are or will be capable of ~~adequate~~preventing or detecting all errors or all fraud. Any control ~~D&O~~system, ~~insurance~~no ~~may~~matter ~~also~~how ~~make~~well itdesigned ~~difficult~~and ~~for~~operated, uscan provide only reasonable, not absolute, assurance that the control system’s objectives will be met. The design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to ~~retain~~their costs. Further, because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that misstatements, due to error or fraud will not occur or that all control issues and ~~attract~~instances ~~talented~~of fraud, if any, within the company have been detected. These inherent limitations include the realities that judgments in decision- making can be faulty and ~~skilled~~that ~~directors~~breakdowns may occur because of simple error or mistake. Controls can also be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of controls. The design of any system of controls is based in part on certain assumptions about the likelihood of future events, and ~~officers~~there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Projections of any evaluation of controls effectiveness to future periods are subject to risk.

In the future we may be subject to additional litigation, including potential class action and stockholder derivative actions. Risks associated with legal liability are difficult to assess and quantify, and their existence and magnitude can remain unknown for significant periods of time. To date, we have not obtained directors and officers liability (“D&O”) insurance. Without adequate D&O insurance, the amounts we would pay to indemnify our officers and directors should they be subject to legal action based on their service to the Company could have a material adverse effect on our financial condition, results of operations and liquidity. Furthermore, our lack of adequate D&O insurance may make it difficult for us to retain and attract talented and skilled directors and officers, which could adversely affect our business. 19

~~Our~~Table ~~personnel may voluntarily terminate their relationship with us at any time, and competition for qualified personnel is intense. The process~~ of ~~locating additional personnel with the combination of skills and attributes required to carry out our strategy could be lengthy, costly and disruptive.~~Contents

IfRisks weRelating ~~lose the services of key personnel or fail~~ to ~~replace the services of key personnel who depart, we could experience a severe negative effect on~~ our ~~financial~~ ~~results~~Common and stock price. The loss of the services of any key personnel, marketing or other personnel or our failure to attract, integrate, motivate and retain additional key employees could have a material adverse effect on our business, operating and financial results and stock price.Stock

~~Our~~We ~~officers~~will ~~and~~likely ~~directors~~conduct ~~and~~further ~~affiliates~~offerings ~~have~~of ~~substantial~~our ~~control~~equity ~~over~~securities usin ~~and~~the ~~our~~future, ~~policies~~in ~~and~~which ~~will~~case beyour ~~able~~proportionate tointerest ~~influence~~may ~~corporate~~become ~~matters~~diluted.

~~Our officers~~We ~~and~~will ~~directors~~likely ~~presently~~be ~~beneficially own approximately 47.5% of~~required ~~our~~to ~~common~~conduct ~~stock.~~equity ~~Additionally,~~offerings asin ~~per~~ the ~~SPA~~future ~~dated~~to ~~October~~finance ~~2022,~~our ~~Bright~~current ~~Green~~projects ~~has~~or ~~acquired~~to ~~25%~~finance ofsubsequent ~~our~~projects ~~company,~~that ~~subject~~we decide to ~~the terms~~undertake. ~~and~~If ~~conditions~~our ofcommon ~~the~~stock ~~SPA.~~shares ~~Our~~are ~~officer~~issued ~~and~~in ~~directors~~return ~~and~~for toadditional afunds, ~~lesser~~the ~~extend~~price ~~Bright~~per ~~Green~~share ~~are~~could ~~able~~be tolower ~~exercise~~than ~~significant~~that ~~influence~~paid ~~over all matters requiring approval~~ by our ~~stockholders,~~current shareholders. ~~including~~We ~~the~~anticipate ~~election~~continuing ofto ~~directors,~~rely ~~the~~on ~~approval~~equity sales of ~~significant~~our ~~corporate~~common ~~transactions, and~~stock ~~any~~shares ~~change~~in oforder ~~control~~to offund our ~~company~~business operations. ~~They~~If we ~~could~~issue ~~prevent~~additional ~~transactions,~~common ~~which~~stock ~~would~~shares beor insecurities ~~the~~convertible ~~best~~into ~~interests~~shares of ~~the~~our ~~other~~common ~~shareholders. Our officers~~stock, ~~directors~~your ~~and~~percentage ~~affiliates’~~interest ~~interests may not necessarily be~~ in ~~the~~us ~~best~~could become ~~interests of the shareholders in general~~diluted.

~~The~~Our ~~elimination~~common ofstock price ~~monetary~~may ~~liability~~be ~~against~~volatile ~~our directors, officers~~ and ~~employees~~could ~~under~~fluctuate ~~our~~widely ~~Articles~~in ~~of Incorporation and the existence of indemnification rights to our directors~~price, ~~officers~~which ~~and~~could ~~employees may~~ result in substantial ~~expenditures~~losses byfor ~~our Company and may discourage lawsuits against our directors, officers and employees~~investors.

Our ~~Articles~~common ofstock ~~Incorporation~~is quoted ~~contain~~on ~~provisions that eliminate~~ the ~~liability~~OTC ofMarkets ~~our directors for monetary damages to our Company and shareholders. Our bylaws also require us to indemnify our officers and directors. We may also have contractual indemnification obligations~~ under ~~our~~the ~~agreements with our directors~~symbol, ~~officers and employees~~“ABTI.” The ~~foregoing~~market ~~indemnification~~price ~~obligations~~of ~~could result in~~ our ~~company~~common ~~incurring~~stock ~~substantial~~is ~~expenditures~~ likely to ~~cover~~be ~~the~~highly ~~cost~~volatile ~~of settlement or damage awards against directors, officers~~ and ~~employees~~could fluctuate ~~that~~widely wein ~~may~~price bein ~~unable~~response to ~~recoup.~~various ~~These provisions and resulting costs may also discourage our company from bringing a lawsuit against directors~~factors, ~~officers~~many ~~and employees for breaches~~ of ~~their~~ ~~fiduciary~~which ~~duties,~~are ~~and~~beyond ~~may similarly discourage the filing of derivative litigation by~~ our ~~shareholders against our directors~~control, ~~officers and employees even though such actions, if successful, might otherwise benefit our Company and shareholders.~~including:

~~Our~~▪ ~~officers~~government ~~and~~regulation ~~directors have~~of ~~limited~~our ~~experience~~products ~~managing~~and ~~a public company.~~services;

~~Our~~▪ ~~officers~~the ~~and~~establishment ~~directors have~~of ~~limited~~partnerships ~~experience~~with ~~managing~~pharmaceutical, ~~a public company. Consequently~~food, wecosmetic ~~may~~research ~~not~~and bedevelopment ~~able~~(R to& ~~raise~~D) ~~any funds or run our public company successfully. Our executive’s officers’~~ and ~~directors’~~/ ~~lack of experience of managing a public company could cause you to lose some~~ or ~~all~~manufacturing ~~of your investment.~~companies;

18▪ intellectual property disputes;

~~Table~~▪ additions or departures of ~~Contents~~key personnel;

~~Risks~~▪ ~~Relating~~sales toof our ~~Common~~ ~~Stock~~common stock

We▪ ~~will likely conduct further offerings of~~ our ~~equity~~ability ~~securities~~to inintegrate ~~the~~operations, ~~future~~technology, inproducts ~~which~~and ~~case your proportionate interest may become diluted.~~services;

We▪ ~~will likely be required to conduct equity offerings in the future to finance~~ our ~~current~~ability ~~projects or~~ to ~~finance~~execute ~~subsequent projects that we decide to undertake. If~~ our common stock shares are issued in return for additional funds, the price per share could be lower than that paid by our current shareholders. We anticipate continuing to rely on equity sales of our common stock shares in order to fund our business ~~operations. If we issue additional common stock shares or securities convertible into shares of our common stock, your percentage interest in us could become diluted.~~plan;

~~Our~~▪ ~~common~~operating ~~stock~~results ~~price may~~below ~~be volatile and could fluctuate widely in price, which could result in substantial losses for investors.~~expectations;

~~Our~~▪ ~~common~~loss ~~stock is quoted on the OTC Markets under the symbol, “ABTI.” The market price~~ of ~~our~~any ~~common~~strategic ~~stock is likely to be highly volatile and could fluctuate widely in price in response to various factors, many of which are beyond our control, including:~~relationship;

▪ ~~government~~industry ~~regulation of our products and services~~developments;

▪ ~~the~~economic ~~establishment of partnerships with pharmaceutical, food, cosmetic research~~ and ~~development~~other (Rexternal &factors; D) and ~~/ or manufacturing companies;~~

▪ ~~intellectual~~period-to-period ~~property~~fluctuations ~~disputes;~~in our financial results.

▪Because ~~additions~~we orhave ~~departures~~no revenues to date, you should consider any one of ~~key~~these ~~personnel;~~factors to be material. Our stock price may fluctuate widely as a result of any of the above.

▪In ~~sales~~addition, the securities markets have from time to time experienced significant price and volume fluctuations that are unrelated to the operating performance of particular companies. These market fluctuations may also materially and adversely affect the market price of our common stock.

~~▪ our ability to integrate operations, technology, products and services;~~20

▪Table ~~our~~of ~~ability to execute our business plan;~~Contents

▪Our ~~operating~~existing ~~results~~stockholders may ~~below~~experience ~~expectations;~~significant dilution from the sale of our common stock pursuant to the EMC2 Purchase Agreement.

▪The ~~loss~~sale of our common stock to EMC2 in accordance with the Purchase Agreement may have a dilutive impact on our shareholders. As a result, the market price of our common stock could decline. In addition, the lower our stock price is at the time we exercise our put options, the more shares of our common stock we will have to issue to EMC2 in order to exercise a put under the Purchase Agreement. If our stock price decreases, then our existing shareholders would experience greater dilution for any ~~strategic~~given ~~relationship;~~dollar amount raised through the offering.

▪The ~~industry~~perceived ~~developments;~~risk of dilution may cause our stockholders to sell their shares, which may cause a decline in the price of our common stock. Moreover, the perceived risk of dilution and the resulting downward pressure on our stock price could encourage investors to engage in short sales of our common stock. By increasing the number of shares offered for sale, material amounts of short selling could further contribute to progressive price declines in our common stock.

▪The ~~economic~~issuance ~~and~~of ~~other~~shares pursuant ~~external~~to ~~factors;~~the ~~and~~EMC2 Purchase Agreement may have significant dilutive effect.

▪Depending ~~period-~~on the number of shares we issue pursuant to~~-period~~ ~~fluctuations~~the inEMC2 Purchase Agreement, it could have a significant dilutive effect upon our ~~financial~~existing ~~results~~shareholders. Although the number of shares that we may issue pursuant to the Purchase Agreement will vary based on our stock price (the higher our stock price, the less shares we have to issue), there may be a potential dilutive effect to our shareholders, based on different potential future stock prices, if the full amount of the Purchase Agreement is realized. Dilution is based upon common stock put to EMC2 and the stock price discounted to 91% of the lowest sales price on the purchase date.

~~Because~~EMC2 wewill ~~have~~pay ~~no revenues~~less tothan ~~date,~~the ~~you~~then-prevailing ~~should~~market ~~consider~~price ~~any one~~ of ~~these~~our ~~factors~~common tostock bewhich ~~material.~~could ~~Our~~cause ~~stock~~the price ~~may fluctuate widely as a result~~ of ~~any~~our ofcommon ~~the~~stock ~~above~~to decline.

InOur ~~addition,~~common stock to be issued under the ~~securities~~EMC2 Purchase Agreement will be purchased at 91% of the lowest sales price on the purchase date. EMC2 has a financial incentive ~~markets~~to ~~have~~sell ~~from~~our ~~time~~shares immediately upon receiving them to ~~time~~realize ~~experienced~~the ~~significant~~profit between the discounted price and ~~volume~~the ~~fluctuations~~market ~~that~~price. ~~are~~If ~~unrelated~~EMC2 tosells our shares, the ~~operating~~price ~~performance~~ of ~~particular~~ ~~companies~~our common stock may decrease. ~~These~~If ~~market~~our ~~fluctuations~~stock price decreases, EMC2 may ~~also~~have ~~materially~~further ~~and~~incentive ~~adversely~~to ~~affect~~sell such shares. Accordingly, the ~~market~~discounted sales price in the Purchase Agreement may cause the price of our common stock to decline.

19We have never declared or paid any cash dividends or distributions on our capital stock. And we do not anticipate paying any cash dividends on our common stock in the foreseeable future.

~~Table~~We ofhave ~~Contents~~never declared or paid any cash dividends or distributions on our capital stock. We currently intend to retain our future earnings, if any, to support operations and to finance expansion and therefore we do not anticipate paying any cash dividends on our common stock in the foreseeable future.

~~Our~~The ~~existing~~declaration, ~~stockholders~~payment ~~may~~and ~~experience~~amount ~~significant~~of ~~dilution~~any ~~from~~future dividends will be made at the ~~sale~~discretion of the board of directors, and will depend upon, among other things, the results of our ~~common~~operations, ~~stock~~cash ~~pursuant~~flows and financial condition, operating and capital requirements, and other factors as the board of directors considers relevant. There is no assurance that future dividends will be paid, and, if dividends are paid, there is no assurance with respect to the ~~EMC2~~amount ~~Purchase~~of ~~Agreement~~any such dividend.

~~The~~We ~~sale~~may ofbecome ~~our common stock~~involved ~~to EMC2~~ in ~~accordance~~securities ~~with~~class ~~the~~action ~~Purchase~~litigation ~~Agreement~~that ~~may have a dilutive impact on our shareholders. As a result, the market price of our common stock~~ could ~~decline.~~divert Inmanagement’s ~~addition,~~attention ~~the~~and ~~lower~~harm our ~~stock price is at the time we exercise our put options, the more shares of our common stock we will have to issue to EMC2 in order to exercise a put under the Purchase Agreement~~business. ~~If our stock price decreases, then our existing shareholders would experience greater dilution for any given dollar amount raised through the offering.~~

The ~~perceived~~stock ~~risk~~market in general, and the shares of ~~dilution~~early-stage companies in particular, have experienced extreme price and volume fluctuations. These fluctuations have ~~may~~often ~~cause~~been ~~our~~unrelated ~~stockholders~~or disproportionate to ~~sell~~the ~~their~~operating ~~shares,~~performance ~~which~~of ~~may~~the ~~cause~~companies ainvolved. ~~decline~~If these fluctuations occur in the future, the market price of our ~~common~~shares ~~stock.~~could ~~Moreover,~~fall ~~the~~regardless ~~perceived risk~~ of ~~dilution~~our ~~and~~operating performance. In the ~~resulting~~past, ~~downward~~following ~~pressure~~periods onof ~~our~~volatility ~~stock~~in the market price ~~could~~of ~~encourage~~a ~~investors~~particular tocompany’s ~~engage~~securities, insecurities ~~short~~class ~~sales~~action oflitigation ~~our~~has ~~common~~often ~~stock~~been brought against that company. ByIf ~~increasing~~ the ~~number~~market price or volume of our shares ~~offered~~suffers ~~for~~extreme ~~sale~~fluctuations, ~~material~~then ~~amounts~~we may become involved in this type of ~~short~~litigation, ~~selling~~which would ~~could~~be ~~further~~expensive ~~contribute~~and todivert ~~progressive~~management’s ~~price~~attention ~~declines in~~and ~~our~~resources ~~common~~from ~~stock~~managing our business.

~~The issuance of shares pursuant to the EMC2 Purchase Agreement may have significant dilutive effect.~~21

~~Depending~~Table ~~on the number~~ of ~~shares~~ we issue pursuant to the EMC2 Purchase Agreement, it could have a significant dilutive effect upon our existing shareholders. Although the number of shares that we may issue pursuant to the Purchase Agreement will vary based on our stock price (the higher our stock price, the less shares we have to issue), there may be a potential dilutive effect to our shareholders, based on different potential future stock prices, if the full amount of the Purchase Agreement is realized. Dilution is based upon common stock put to EMC2 and the stock price discounted to 91% of the lowest sales price on the purchase date.Contents

~~EMC2~~As ~~will~~a ~~pay~~public ~~less~~company, we may ~~than~~also ~~the~~from ~~then~~time to time make forward-~~prevailing~~looking ~~market~~statements ~~price~~about offuture ~~our~~operating ~~common~~results ~~stock~~and ~~which~~provide some financial guidance to the public markets. Projections may not be made timely or set at expected performance levels and could ~~cause~~materially affect the price of our ~~common~~shares. Any failure to meet published forward-looking statements that adversely affect the stock price could result in losses to ~~decline~~investors, stockholder lawsuits or other litigation, sanctions or restrictions issued by the SEC.

Our common stock ~~to be issued~~is ~~under~~currently ~~the~~deemed ~~EMC2 Purchase Agreement will be purchased at 91% of the lowest sales price on the purchase date. EMC2 has~~ a ~~financial~~“penny ~~incentive to sell our shares immediately upon receiving them to realize the profit between the discounted price and the market price. If EMC2 sells our shares~~stock,” ~~the~~which ~~price~~makes ofit ~~our~~more ~~common~~difficult ~~stock~~for ~~may decrease. If~~ our ~~stock~~investors ~~price decreases, EMC2 may have further incentive~~ to sell ~~such~~their shares. ~~Accordingly, the discounted sales price in the Purchase Agreement may cause the price of our common stock to decline.~~

WeOur ~~have~~common ~~never~~stock ~~declared~~is currently ordeemed ~~paid~~a ~~any~~“penny ~~cash~~stock,” ~~dividends~~which ormakes ~~distributions~~it onmore difficult for our ~~capital~~investors ~~stock~~to sell their shares. ~~And~~The weSEC dohas ~~not~~adopted ~~anticipate~~rule ~~paying~~3a51-1 which ~~any~~establishes ~~cash~~the ~~dividends~~definition onof ~~our~~a ~~common~~“penny stock in,” for the ~~foreseeable~~purposes ~~future~~relevant to us, as any equity security that has a market price of less than $5.00 per share or with an exercise price of less than $5.00 per share, subject to certain exceptions. For any transaction involving a penny stock, unless exempt, Rule 15g-9 requires:

We• ~~have~~that ~~never~~a ~~declared~~broker or ~~paid~~ ~~any~~dealer ~~cash~~approve ~~dividends~~a orperson’s ~~distributions~~account onfor ~~our~~transactions ~~capital~~in ~~stock.~~penny Westocks, ~~currently~~and ~~intend~~• tothe ~~retain~~broker ~~our~~or ~~future~~dealer ~~earnings,~~receive iffrom ~~any,~~the toinvestor ~~support~~a ~~operations and~~written agreement to ~~finance~~the ~~expansion~~transaction, ~~and~~setting ~~therefore~~forth wethe doidentity ~~not~~and ~~anticipate~~quantity ~~paying~~of ~~any~~the ~~cash~~penny ~~dividends on our common~~ stock into ~~the~~be ~~foreseeable future~~purchased.

~~The~~In ~~declaration,~~order ~~payment and~~to ~~amount~~approve ofa ~~any~~person’s ~~future~~account ~~dividends~~for ~~will~~transactions bein ~~made~~penny ~~at the discretion of the board of directors~~stocks, ~~and will depend upon, among other things,~~ the ~~results~~broker ofor ~~our~~dealer operations, cash flows and financial condition, operating and capital requirements, and other factors as the board of directors considers relevant. There is no assurance that future dividends will be paid, and, if dividends are paid, there is no assurance with respect to the amount of any such dividend.must:

We• ~~may~~obtain ~~become~~financial ~~involved~~ information and investment experience objectives of the person, and • make a reasonable determination that the transactions in ~~securities~~penny ~~class~~stocks ~~action~~are ~~litigation~~suitable for that ~~could~~person ~~divert~~and ~~management’s~~the ~~attention~~person has sufficient knowledge and ~~harm~~experience ~~our~~in ~~business~~financial matters to be capable of evaluating the risks of transactions in penny stocks.

The ~~stock~~broker ~~market~~or indealer ~~general,~~must ~~and~~also ~~the shares of early-stage companies in particular~~deliver, ~~have~~prior ~~experienced extreme price and volume fluctuations. These fluctuations have often been unrelated or disproportionate~~ to ~~the~~any ~~operating~~transaction ~~performance of the companies involved. If these fluctuations occur~~ in ~~the~~a ~~future~~penny stock, ~~the~~ ~~market~~a ~~price~~disclosure ofschedule ~~our~~prescribed ~~shares~~by ~~could fall regardless of our operating performance. In~~ the ~~past,~~SEC ~~following~~relating ~~periods~~to ~~of volatility in~~ the ~~market~~ ~~price~~penny ofstock ~~a particular company’s securities~~market, ~~securities class action litigation has often been brought against that company.~~ ~~If the market price or volume of our shares suffers extreme fluctuations~~which, ~~then we may become involved~~ in ~~this~~highlight ~~type of litigation, which would be expensive and divert management’s attention and resources from managing our business.~~form:

20• sets forth the basis on which the broker or dealer made the suitability determination and • that the broker or dealer received a signed, written agreement from the investor prior to the transaction.

~~Table~~Generally, brokers may be less willing to execute transactions in securities subject to the “penny stock” rules. This may make it more difficult for investors to dispose of ~~Contents~~our common stock and cause a decline in the market value of our stock.

AsRisks aRelated ~~public company, we may also from time~~ to ~~time make forward-looking statements about future operating results and provide some financial guidance to the public~~Acquisition markets. Projections may not be made timely or set at expected performance levels and could materially affect the price of our shares. Any failure to meet published forward-looking statements that adversely affect the stock price could result in losses to investors, stockholder lawsuits or other litigation, sanctions or restrictions issued by the SEC.Activities

~~Our~~ We ~~common~~have ~~stock is~~made ~~currently~~and ~~deemed~~expect ato ~~“penny~~continue ~~stock,”~~to ~~which~~engage ~~makes~~in itacquisition ~~more~~activities ~~difficult~~that ~~for~~could disrupt our ~~investors~~operations toand ~~sell~~harm ~~their~~our ~~shares~~operating results.

Our ~~common~~growth ~~stock~~depends isupon ~~currently~~market ~~deemed~~growth, aour ~~“penny~~ability ~~stock,”~~to ~~which~~enhance ~~makes~~our itexisting ~~more~~products, ~~difficult~~and ~~for~~ our ~~investors~~ability to ~~sell~~introduce ~~their~~new ~~shares.~~products ~~The~~on ~~SEC~~a ~~has~~timely ~~adopted~~basis. ~~rule~~We ~~3a51-1~~intend to continue ~~which~~to ~~establishes~~address the ~~definition~~need ofto adevelop ~~“penny~~new ~~stock,”~~products ~~for~~and ~~the~~enhance ~~purposes~~existing ~~relevant~~products tothrough ~~us,~~potential asacquisitions ~~any~~of ~~equity~~other ~~security~~companies, ~~that~~product ~~has a market~~lines, ~~price~~technologies, ofand ~~less~~personnel, ~~than~~, ~~$5.00~~by ~~per~~a ~~share~~transaction orthat ~~with~~may aninvolve ~~exercise~~the ~~price~~acquisition of ~~less~~our ~~than~~company ~~$5.00~~by ~~per~~companies ~~share,~~looking ~~subject~~ to ~~certain~~enhance ~~exceptions~~their value. ~~For~~Acquisitions ~~any~~involve ~~transaction involving~~numerous ~~a penny stock~~risks, ~~unless~~including ~~exempt,~~the ~~Rule 15g-9 requires~~following:

• ~~that a~~ ~~broker~~Difficulties in integrating the operations, systems, technologies, products, and personnel of the acquired companies, particularly companies with large and widespread operations and/or ~~dealer~~complex ~~approve~~products; a• ~~person~~Diversion of management’s ~~account~~attention ~~for~~from ~~transactions~~normal indaily ~~penny~~operations ~~stocks,~~of the business and the challenges of managing larger and more widespread operations resulting from acquisitions;

~~• the broker or dealer receive from the investor a written agreement to the transaction, setting forth the identity and quantity of the penny stock to be purchased.~~22

InTable ~~order to~~of ~~approve a person’s account for transactions in penny stocks, the broker or dealer must:~~Contents

• ~~obtain financial~~ ~~information~~Potential difficulties in completing projects associated with in-process research and ~~investment~~development intangibles; • Difficulties in entering markets in which we have no or limited direct prior experience ~~objectives~~and where competitors in such markets have stronger market positions; • Initial dependence on unfamiliar supply chains; • Insufficient revenue to offset increased expenses associated with acquisitions; and • The potential loss of ~~the~~key ~~person~~employees, customers, distributors, vendors and other business partners of the companies we acquire following and continuing after announcement of acquisition plans.

~~• make a~~Acquisitions ~~reasonable~~may ~~determination~~also ~~that~~cause ~~the~~us ~~transactions in penny stocks are suitable for that person and the person has sufficient knowledge and experience in financial matters~~ to ~~be capable of evaluating the risks of transactions in penny stocks.~~:

~~The~~• ~~broker~~Issue common stock that would dilute our current shareholders’ percentage ownership; • Use a substantial portion of our cash resources or ~~dealer~~incur ~~must also~~debt; ~~deliver~~• Significantly increase our interest expense, ~~prior~~leverage and debt service requirements if we incur additional debt to ~~any~~pay ~~transaction~~for inan aacquisition; ~~penny~~• ~~stock,~~Assume liabilities; • Record goodwill and nonamortizable intangible assets that are subject to impairment testing on a ~~disclosure~~regular ~~schedule~~basis ~~prescribed~~and bypotential ~~the~~periodic ~~SEC~~impairment ~~relating~~charges; • Incur amortization expenses related to certain intangible assets; • Incur tax expenses related to the ~~penny~~effect ~~stock~~of ~~market, which,~~acquisitions inon ~~highlight~~our ~~form:~~intercompany research and development cost sharing arrangement and legal structure; • Incur large and immediate write-offs and restructuring and other related expenses; and • Become subject to intellectual property or other litigation.

~~• sets~~Mergers and acquisitions ~~forth~~are ~~the~~inherently ~~basis~~risky onand ~~which~~subject ~~the~~to ~~broker~~many factors outside of our control, and no assurance can be given that our previous or ~~dealer~~future ~~made~~acquisitions will ~~the~~be ~~suitability~~successful ~~determination~~and will not materially adversely affect our business, operating results, or financial condition. Failure to manage and successfully integrate acquisitions could materially harm our business and operating results. Prior acquisitions could result in a wide range of outcomes, from successful introduction of new products and technologies to a failure to do so. Even when an acquired company has already developed and marketed products, there can be no assurance that product enhancements will be made in a timely fashion or that pre-acquisition due diligence will have identified all possible issues that might arise with respect to such products.

~~• that~~From time to time, we have ~~the~~made ~~broker~~acquisitions orthat ~~dealer~~resulted ~~received~~in acharges ~~signed~~in an individual quarter. These charges may occur in any particular quarter, ~~written~~resulting ~~agreement~~in ~~from~~variability in ~~the~~our ~~investor~~quarterly ~~prior~~earnings. In addition, our effective tax rate for future periods is uncertain and could be impacted by mergers and acquisitions. Risks related to ~~the~~new ~~transaction~~product development also apply to acquisitions.

Generally, brokers may be less willing to execute transactions in securities subject to the “penny stock” rules. This may make it more difficult for investors to dispose of our common stock and cause a decline in the market value of our stock. 23

~~Risks~~Table ~~Related~~of ~~to Acquisition Activities~~Contents

WeAcquisitions, ~~have~~joint ventures ~~made~~or ~~and~~other ~~expect to~~strategic ~~continue~~transactions tocreate ~~engage~~certain inrisks ~~acquisition~~and ~~activities~~may ~~that~~adversely ~~could~~affect ~~disrupt~~ our ~~operations~~business, ~~and~~financial ~~harm~~condition ~~our~~or ~~operating~~ results of operations.

~~Our~~Acquisitions, partnerships ~~growth~~and ~~depends~~joint ~~upon~~ventures ~~market~~are ~~growth,~~part of our ~~ability~~growth tostrategy. ~~enhance~~We ~~our~~evaluate ~~existing~~and ~~products,~~expect ~~and~~in ~~our~~the ~~ability~~future to ~~introduce~~evaluate ~~new~~potential ~~products~~strategic ~~on a timely~~acquisitions ~~basis.~~of, Weand ~~intend~~partnerships toor ~~continue~~joint toventures ~~address~~with, ~~the~~complementary ~~need~~businesses, toservices ~~develop~~or ~~new~~technologies. ~~products~~We ~~and~~may ~~enhance~~not ~~existing~~be ~~products~~successful ~~through~~in ~~potential acquisitions~~identifying ofacquisition, ~~other~~partnership ~~companies,~~and ~~product~~joint ~~lines,~~venture ~~technologies,~~targets. ~~and~~In ~~personnel~~addition, ~~or,~~we ~~for~~may ~~example~~not asbe aable ~~result~~to ofsuccessfully ~~the~~finance ~~intended~~or ~~acquisition by Bright~~integrate ~~Green~~any businesses, services byor atechnologies ~~transaction~~ that ~~may~~we ~~involve~~acquire ~~the~~or ~~acquisition~~with ofwhich ~~our~~we ~~company~~form bya ~~companies~~partnership ~~looking~~or tojoint ~~enhance their value~~venture. ~~Acquisitions involve numerous risks, including the following:~~

·We ~~Difficulties~~may innot ~~integrating~~be ~~the~~able ~~operations,~~to ~~systems,~~identify suitable ~~technologies,~~acquisition ~~products,~~candidates ~~and~~or ~~personnel~~complete ofacquisitions in the ~~acquired companies~~future, ~~particularly~~which ~~companies~~could ~~with~~adversely ~~large~~affect ~~and~~our ~~widespread~~future ~~operations~~growth; ~~and/~~or ~~complex~~businesses that ~~products;~~we ·acquire ~~Diversion~~may ofnot ~~management’s~~perform ~~attention~~as ~~from~~well ~~normal~~as ~~daily~~expected ~~operations~~or ofmay ~~the~~be ~~business~~more ~~and~~difficult ~~the~~or ~~challenges~~expensive ofto ~~managing~~integrate ~~larger~~ and ~~more~~manage ~~widespread~~than ~~operations~~expected, ~~resulting~~which could ~~from~~adversely ~~acquisitions;~~affect ·our ~~Potential~~business ~~difficulties~~and inresults ~~completing~~of ~~projects~~operations. ~~associated~~In ~~with~~addition, ~~in-~~the process ~~research~~of integrating these acquisitions may disrupt our business and ~~development~~divert ~~intangibles;~~our resources.

21In addition, acquisitions outside our current operating jurisdictions often involve additional or increased risks including, for example:

~~Table~~• managing geographically separated organizations, systems and facilities; • integrating personnel with diverse business backgrounds and organizational cultures; • complying with foreign regulatory requirements; • fluctuations in exchange rates; • enforcement and protection of ~~Contents~~intellectual property in some foreign countries; • difficulty entering new foreign markets due to, among other things, customer acceptance and business knowledge of these new markets; and • general economic and political conditions.

·These ~~Difficulties~~risks inmay ~~entering~~arise ~~markets~~for a innumber ~~which~~of reasons: we ~~have~~may nonot orbe ~~limited~~able ~~direct~~to ~~prior~~find ~~experience~~suitable ~~and~~businesses ~~where~~to ~~competitors~~acquire inat ~~such~~affordable ~~markets~~valuations ~~have~~or ~~stronger~~on ~~market~~other ~~positions~~acceptable terms; we ·may ~~Initial~~face ~~dependence~~competition onfor ~~unfamiliar~~acquisitions ~~supply~~from ~~chains~~other potential acquirers; ·we ~~Insufficient~~may ~~revenue~~need to ~~offset~~borrow ~~increased~~money ~~expenses~~or ~~associated~~sell ~~with~~equity or debt securities to the public to finance acquisitions; and ·the ~~The~~terms ~~potential~~of ~~loss~~these offinancings ~~key~~may ~~employees,~~be ~~customers~~adverse to us; changes in accounting, ~~distributors~~tax, ~~vendors~~securities or other regulations could increase the difficulty or cost for us to complete acquisitions; we may incur unforeseen obligations or liabilities in connection with acquisitions; we may need to devote unanticipated financial and ~~other~~management resources to an acquired business; ~~partners~~we ofmay not ~~the~~realize ~~companies~~expected operating efficiencies or product integration benefits from an acquisition; we ~~acquire~~could ~~following~~enter markets where we have minimal prior experience; and ~~continuing~~we ~~after~~may ~~announcement~~experience decreases in earnings as a result of ~~acquisition~~non-cash ~~plans~~impairment charges.

~~Acquisitions~~We ~~may~~cannot ~~also~~ensure ~~cause~~that any usacquisition, ~~to:~~partnership or joint venture we make will not have a material adverse effect on our business, financial condition and results of operations.

· Issue common stock that would dilute our current shareholders’ percentage ownership; · Use a substantial portion of our cash resources or incur debt; · Significantly increase our interest expense, leverage and debt service requirements if we incur additional debt to pay for an acquisition; · Assume liabilities; · Record goodwill and nonamortizable intangible assets that are subject to impairment testing on a regular basis and potential periodic impairment charges; · Incur amortization expenses related to certain intangible assets; · Incur tax expenses related to the effect of acquisitions on our intercompany research and development cost sharing arrangement and legal structure; · Incur large and immediate write-offs and restructuring and other related expenses; and · Become subject to intellectual property or other litigation.24

~~Mergers~~Table ~~and acquisitions are inherently risky and subject to many factors outside~~ of our control, and no assurance can be given that our previous or future acquisitions will be successful and will not materially adversely affect our business, operating results, or financial condition. Failure to manage and successfully integrate acquisitions could materially harm our business and operating results. Prior acquisitions could result in a wide range of outcomes, from successful introduction of new products and technologies to a failure to do so. Even when an acquired company has already developed and marketed products, there can be no assurance that product enhancements will be made in a timely fashion or that pre-acquisition due diligence will have identified all possible issues that might arise with respect to such products.Contents

~~From~~Risks ~~time~~Relating to ~~time, we have~~Our ~~made~~Company acquisitions that resulted in charges in an individual quarter. These charges may occur in any particular quarter, resulting in variability in our quarterly earnings. In addition, our effective tax rate for future periods is uncertain and ~~could be impacted by mergers and acquisitions. Risks related to new product development also apply to acquisitions.~~Industry

22Our future success will largely depend on the success of our drug candidates, which development will require significant capital resources and years of preclinical and clinical development effort.

~~Table~~We currently have no drug products on the market, and none of ~~Contents~~our drug development projects / pipeline drug candidates has reached preclinical development or clinical trial status. Our business depends almost entirely on the successful clinical development, regulatory approval and commercialization of our pipeline drug candidates. Investors need to be aware that substantial additional investments including preclinical and clinical development and regulatory approval efforts will be required before we are permitted to market and commercialize our pipeline drug candidates, if ever. It may be several years before we can commence clinical trials, if ever. Any clinical trial will be subject to extensive and rigorous review and regulation by numerous government authorities in the United States, the European Union, and other jurisdictions where we intend, if approved, to market our pipeline drug candidates. Before obtaining regulatory approvals for any of our pipeline drug candidates, we must demonstrate through preclinical testing and clinical trials that the pipeline drug candidate is safe and effective for its specific application. This process can take many years and may include post- marketing studies and surveillance, which would require the expenditure of substantial resources. Of the large number of drugs in development for approval in the United States, European Union (and the rest of the world), only a small percentage will successfully complete the FDA regulatory approval process or be granted authorization to be marketed in the European Commission or the other competent authorities in the European Union (“EU”) Member States, or the rest of the world. Accordingly, even if we obtain the sufficient financing to fund our planned research, development and clinical programs, we cannot assure you that any of our pipeline drug candidates will be successfully developed or commercialized.

~~Acquisitions,~~We may ~~joint~~be unable to formulate or scale-up any or all of our pipeline drug candidates. There is no guarantee that any of the pipeline ~~ventures~~drug candidates will be or are able to be manufactured or produced in a manner to meet the FDA’s (or any other ~~strategic~~international ~~transactions~~regulatory agency’s) ~~create~~criteria for ~~certain~~product ~~risks~~stability, content uniformity and ~~may~~all ~~adversely~~other ~~affect~~criteria necessary for ~~our~~product ~~business,~~approval ~~financial~~in ~~condition~~the orUnited ~~results~~States and other markets. Any of our pipeline drug candidates may fail to achieve their specified endpoints ~~operations~~in clinical trials.

~~Acquisitions~~Furthermore, ~~partnerships~~ ~~and~~pipeline ~~joint~~drug ~~ventures~~candidates ~~are~~may ~~part~~not ofbe approved ~~our~~even ~~growth~~if ~~strategy.~~they Weachieve ~~evaluate~~their ~~and~~specified ~~expect~~endpoints in ~~the~~clinical trials. The ~~future~~FDA to(or ~~evaluate~~any ~~potential~~other ~~strategic~~international ~~acquisitions~~regulatory agency) may disagree with our trial design and our interpretation of, ~~and~~data ~~partnerships~~from clinical trials, or ~~joint~~may ~~ventures~~change ~~with,~~the requirements ~~complementary~~for ~~businesses,~~approval even ~~services~~after orit ~~technologies~~has reviewed and commented on the design for our clinical trials. WeThe FDA may ~~not~~also beapprove ~~successful~~a indrug ~~identifying~~for fewer ~~acquisition,~~or ~~partnership~~more ~~and~~limited ~~joint~~indications ~~venture~~than ~~targets.~~we ~~In addition~~request, weor may ~~not~~grant beapproval ~~able~~contingent toon ~~successfully~~the performance of costly ~~finance~~post-approval orclinical ~~integrate~~trials ~~any~~(i.e., ~~businesses~~Phase IV trials). In addition, ~~services~~ orthe ~~technologies~~FDA may not approve the labeling claims that we ~~acquire~~believe are necessary or ~~with~~desirable ~~which~~for wethe ~~form~~successful acommercialization ~~partnership~~of orour ~~joint~~pipeline ~~venture~~drug candidates.

WeIf ~~may~~we ~~not~~are beunable ~~able~~ to ~~identify~~expand ~~suitable~~our ~~acquisition~~pipeline ~~candidates~~and orobtain ~~complete~~regulatory ~~acquisitions~~approval infor ~~the future, which could adversely affect~~ our ~~future~~pipeline ~~growth;~~drug orcandidates ~~businesses that~~within the timelines we ~~acquire~~anticipate, ~~may~~we will not ~~perform~~be asable ~~well~~to asexecute ~~expected~~our orbusiness ~~may~~strategy beeffectively and ~~more~~our ~~difficult~~ability ~~or expensive~~ to ~~integrate~~substantially grow our ~~and~~revenues ~~manage~~will ~~than~~be ~~expected~~limited, which ~~could~~ ~~adversely~~would have ~~affect~~a ~~our~~material ~~business~~adverse ~~and~~impact ~~results~~on ofour ~~operations.~~long-term ~~In addition~~business, ~~the~~results ~~process~~ of ~~integrating these acquisitions may disrupt~~operations, ~~our~~financial ~~business~~condition, and ~~divert our resources~~prospects.

InOur drug ~~addition~~development projects, ~~acquisitions~~if ~~outside~~approved, ~~our~~may ~~current operating~~be ~~jurisdictions~~unable ~~often~~to ~~involve~~achieve ~~additional~~the orexpected market ~~increased~~acceptance ~~risks~~and, ~~including~~consequently, limit ~~for~~our ~~example:~~ability to generate revenue.

·Even ~~managing~~when ~~geographically~~drug ~~separated~~development is ~~organizations~~successful and regulatory approval has been obtained, ~~systems~~our ability to generate significant revenue depends on the acceptance of our (then) approved medicines by physicians, prescribers and ~~facilities;~~patients. ·We ~~integrating~~cannot ~~personnel~~assure you ~~with~~that ~~diverse~~any ~~business~~of ~~backgrounds~~our pipeline drug candidates will achieve the expected market acceptance and ~~organizational~~revenue, ~~cultures;~~if ·and ~~complying~~when ~~with~~we ~~foreign~~obtain the regulatory approvals. ~~requirements;~~The ·market ~~fluctuations~~acceptance inof ~~exchange~~any ~~rates;~~drug ·depends ~~enforcement~~on a number of factors, including the indication statement and ~~protection~~warnings approved by regulatory authorities for the drug label, continued demonstration of ~~intellectual~~efficacy ~~property~~and safety in ~~some~~commercial ~~foreign~~use, ~~countries;~~physicians’ ·/ ~~difficulty~~prescribers ~~entering~~willingness ~~new~~to ~~foreign~~prescribe ~~markets~~the drug, ~~due~~reimbursement tofrom third-party payers such as government health care systems and insurance companies, ~~among~~the ~~other~~price ~~things~~of the drug, ~~customer~~the nature of ~~acceptance~~any post-approval risk management plans mandated by regulatory authorities, competition, and ~~business~~marketing ~~knowledge~~and distribution support. Any factors preventing or limiting the market acceptance of ~~these~~our ~~new~~drugs ~~markets;~~could ~~and~~have ·a material ~~general~~adverse ~~economic~~effect on our business, results of operations and ~~political~~financial ~~conditions~~condition.

These risks may arise for a number of reasons: we may not be able to find suitable businesses to acquire at affordable valuations or on other acceptable terms; we may face competition for acquisitions from other potential acquirers; we may need to borrow money or sell equity or debt securities to the public to finance acquisitions and the terms of these financings may be adverse to us; changes in accounting, tax, securities or other regulations could increase the difficulty or cost for us to complete acquisitions; we may incur unforeseen obligations or liabilities in connection with acquisitions; we may need to devote unanticipated financial and management resources to an acquired business; we may not realize expected operating efficiencies or product integration benefits from an acquisition; we could enter markets where we have minimal prior experience; and we may experience decreases in earnings as a result of non-cash impairment charges.25

WeTable ~~cannot ensure that any acquisition, partnership or joint venture we make will not have a material adverse effect on our business, financial condition and results~~ of ~~operations.~~Contents

23Results of preclinical studies and earlier clinical trials are not necessarily predictive indicators of future results.

~~Table~~Any positive results from future preclinical testing of ~~Contents~~our pipeline drug candidates and potential future clinical trials may not necessarily be predictive of the results from Phase 1, Phase 2 or Phase 3 clinical trials. In addition, our interpretation of results derived from clinical data or our conclusions based on our preclinical data may prove inaccurate. Frequently, pharmaceutical and biotechnology companies have suffered significant setbacks in clinical trials after achieving positive results in preclinical testing and early phase clinical trials, and we cannot be certain that we will not face similar setbacks. These setbacks may be caused by the fact that preclinical and clinical data can be susceptible to varying interpretations and analyses. Furthermore, certain pipeline drug candidates may perform satisfactorily in preclinical studies and clinical trials, but nonetheless fail to obtain FDA approval, a marketing authorization granted by the European Commission, or appropriate approvals by the appropriate medicines regulatory authorities in other countries. If we fail to produce positive results in our clinical trials for our pipeline drug candidates, the development timeline and regulatory approval and commercialization prospects for them and as a result our business and financial prospects, would be materially adversely affected.

~~Risks~~The regulatory ~~Relating~~approval toprocesses ~~Our Company~~with the FDA, the EMA and ~~Industry~~other comparable foreign regulatory authorities is lengthy and inherently unpredictable.

~~Our~~We ~~future~~are ~~success~~not ~~will~~permitted ~~largely~~to ~~depend~~market onour drug candidates as medicines in the ~~success~~United States or the European Union or other countries until we receive approval of a New Drug Application (“NDA”) from the FDA or a Marketing Authorization Application (“MAA”) from the European Commission, respectively, or in any foreign countries until we receive the approval from the regulatory authorities of such countries. Prior to submitting an NDA to the FDA or an MAA to the EMA for approval of our drug candidates, ~~which~~we ~~development~~ will ~~require~~need ~~significant~~to have completed our preclinical studies and clinical trials. Successfully completing any ~~capital~~clinical ~~resources~~program and ~~years~~obtaining approval of ~~preclinical~~an NDA or MAA is a complex, lengthy, expensive and ~~clinical~~uncertain ~~development~~process, ~~effort.~~and the FDA or EMA (or other country medicines regulatory body) may delay, limit or deny approval of pipeline drug candidates for many reasons, including, among others, because:

We• ~~currently~~an ~~have~~inability noto ~~drug products~~demonstrate onthat ~~the~~our ~~market,~~pipeline ~~and~~drug ~~none~~candidates ofare ~~our~~safe ~~drug~~and ~~development~~effective ~~projects~~in /treating ~~pipeline~~patients ~~drug candidates has~~to ~~reached~~the ~~preclinical~~satisfaction ~~development~~of orthe ~~clinical~~FDA ~~trial~~or ~~status.~~EMA ~~Our~~(or ~~business~~any ~~depends~~other ~~almost entirely~~country’s onmedicine ~~the successful clinical development,~~ regulatory ~~approval~~body); ~~and~~• ~~commercialization~~results of ~~our~~clinical ~~pipeline~~trials ~~drug~~that ~~candidates.~~may ~~Investors~~not ~~need to~~meet ~~be aware that~~the ~~substantial~~level ~~additional~~of ~~investments~~statistical ~~including~~or ~~preclinical and~~ clinical ~~development~~significance ~~and regulatory approval efforts will be~~ required ~~before~~by wethe ~~are~~FDA ~~permitted~~or toEMA ~~market~~(or ~~and~~any ~~commercialize~~other ~~our~~country’s ~~pipeline drug candidates,~~medicine ifregulatory ~~ever.~~body); It• ~~may~~disagreements bewith ~~several years~~the ~~before~~FDA weor ~~can~~EMA ~~commence~~(or ~~clinical~~any ~~trials,~~other ifcountry’s ~~ever. Any~~medicine ~~clinical~~regulatory ~~trial will~~body) bewith ~~subject~~respect to ~~extensive and rigorous review and regulation by numerous government authorities in~~ the ~~United~~number, ~~States~~design, ~~the European Union~~size, ~~and~~conduct ~~other~~or ~~jurisdictions where we~~implementation ~~intend,~~of ifclinical ~~approved,~~trials; to• ~~market~~requirements ~~our~~by ~~pipeline~~the ~~drug~~FDA ~~candidates.~~and ~~Before~~EMA ~~obtaining~~(or ~~regulatory approvals for~~ any ~~of our pipeline~~other ~~drug~~country’s ~~candidates,~~medicine weregulatory ~~must~~body) ~~demonstrate~~to ~~through~~conduct ~~preclinical~~additional ~~testing and~~ clinical trials; ~~that the~~• ~~pipeline~~disapproval ~~drug~~by ~~candidate is~~the ~~safe~~FDA ~~and~~or ~~effective~~EMA ~~for~~or ~~its~~other ~~specific~~applicable ~~application.~~foreign ~~This~~regulatory ~~process~~authorities ~~can~~of ~~take~~certain ~~many~~formulations, ~~years~~labeling ~~and~~or ~~may~~specifications ~~include~~of ~~post- marketing studies~~pipeline ~~and~~drug ~~surveillance,~~candidates; ~~which~~• ~~would~~findings ~~require~~by the ~~expenditure~~FDA ofor ~~substantial~~EMA ~~resources. Of~~(or ~~the~~any ~~large~~other ~~number~~country’s ofmedicine ~~drugs~~regulatory inbody) ~~development for~~that ~~approval in~~ the ~~United~~data ~~States,~~from ~~European~~preclinical ~~Union~~studies (and ~~the~~clinical ~~rest~~trials ofare ~~the~~insufficient; ~~world),~~• ~~only a small percentage will successfully complete~~ the FDA ~~regulatory approval process~~ or beEMA ~~granted authorization to be marketed in the European Commission~~ (or ~~the~~any other ~~competent authorities~~country’s inmedicine ~~the~~regulatory ~~European Union (“EU”~~body) ~~Member~~may ~~States,~~disagree orwith the ~~rest of~~ ~~the~~interpretation ~~world.~~of ~~Accordingly,~~data ~~even~~from ifpreclinical westudies ~~obtain~~and ~~the~~clinical ~~sufficient financing~~trials; toand ~~fund~~• ~~our~~the ~~planned research~~FDA, ~~development and clinical~~European ~~programs,~~Commission weor ~~cannot~~EMA ~~assure~~or ~~you~~other ~~that~~applicable ~~any~~foreign ofregulatory ~~our~~agencies ~~pipeline~~may ~~drug~~change ~~candidates will~~their beapproval ~~successfully~~policies ~~developed~~ or ~~commercialized~~adopt new regulations.

WeAny ~~may be unable to formulate or scale-up any or all~~ of ~~our~~these ~~pipeline~~factors, ~~drug~~many ~~candidates. There is no guarantee that any~~ of ~~the~~which ~~pipeline drug candidates will be or~~ are ~~able~~beyond toour ~~be manufactured or produced in a manner to meet the FDA’s (or any other international regulatory agency’s) criteria for product stability~~control, ~~content~~could ~~uniformity~~increase ~~and all other criteria~~development ~~necessary~~time ~~for product approval in the United States~~ and ~~other~~/ ~~markets.~~or costs or ~~Any~~jeopardize of our ~~pipeline~~ability ~~drug candidates may fail~~ to ~~achieve~~obtain ~~their~~regulatory ~~specified~~approval ~~endpoints~~for inour ~~clinical~~drug ~~trials~~candidates.

Furthermore, pipeline drug candidates may not be approved even if they achieve their specified endpoints in clinical trials. The FDA (or any other international regulatory agency) may disagree with our trial design and our interpretation of data from clinical trials, or may change the requirements for approval even after it has reviewed and commented on the design for our clinical trials. The FDA may also approve a drug for fewer or more limited indications than we request, or may grant approval contingent on the performance of costly post-approval clinical trials (i.e., Phase IV trials). In addition, the FDA may not approve the labeling claims that we believe are necessary or desirable for the successful commercialization of our pipeline drug candidates.26

IfTable we are unable to expand our pipeline and obtain regulatory approval for our pipeline drug candidates within the timelines we anticipate, we will not be able to execute our business strategy effectively and our ability to substantially grow our revenues will be limited, which would have a material adverse impact on our long-term business, results of ~~operations, financial condition, and prospects.~~Contents

~~Our~~We ~~drug~~may ~~development~~apply ~~projects,~~for iforphan ~~approved,~~drug ~~may~~status begranted by ~~unable to achieve~~ the ~~expected~~FDA ~~market~~and ~~acceptance~~/ ~~and,~~or ~~consequently,~~EMA for ~~limit~~some of our ~~ability~~drug tocandidates ~~generate~~for ~~revenue~~the treatment of rare diseases.

~~Even~~Regulatory authorities ~~when~~in ~~drug~~some ~~development is~~jurisdictions, ~~successful~~including ~~and~~the ~~regulatory~~United ~~approval~~States ~~has~~and ~~been~~the ~~obtained~~European Union, ~~our~~may designate ~~ability to generate~~drugs ~~significant~~for ~~revenue~~relatively ~~depends~~small onpatient ~~the~~populations ~~acceptance~~as oforphan ~~our~~drugs. ~~(then)~~The ~~approved~~FDA ~~medicines~~may bygrant ~~physicians, prescribers~~Orphan ~~and~~Drug ~~patients.~~Designation We(ODD) ~~cannot~~to ~~assure you~~drugs ~~that~~intended ~~any~~to treat ofa ~~our~~rare ~~pipeline~~disease ~~drug~~or ~~candidates~~condition ~~will~~that ~~achieve~~affects ~~the~~fewer ~~expected~~than ~~market~~200,000 ~~acceptance~~individuals ~~and~~annually ~~revenue,~~in ifthe ~~and~~United ~~when~~States. weIn ~~obtain~~ the ~~regulatory~~ European ~~approvals.~~Union, ~~The~~the ~~market~~EMA’s ~~acceptance~~Committee offor ~~any~~Orphan ~~drug~~Medicinal ~~depends~~Products ongrants aorphan ~~number~~drug designation ofto ~~factors,~~promote ~~including~~ the ~~indication statement and warnings approved~~ development byof ~~regulatory~~drugs ~~authorities~~that are intended for the ~~drug label~~diagnosis, ~~continued demonstration~~prevention or treatment of ~~efficacy~~life-threatening ~~and~~or ~~safety~~chronically debilitating conditions inaffecting ~~commercial~~not ~~use,~~more ~~physicians’~~than /5 ~~prescribers~~in ~~willingness~~10,000 topersons ~~prescribe~~in the ~~drug,~~ ~~reimbursement~~European ~~from~~Union. ~~third-party~~Additionally, ~~payers~~ such asdesignation ~~government~~is ~~health~~granted ~~care~~for ~~systems~~drugs ~~and~~intended ~~insurance~~for ~~companies~~the diagnosis, ~~the~~prevention ~~price~~or treatment of ~~the~~a ~~drug~~life-threatening, ~~the~~seriously ~~nature~~debilitating or ofserious ~~any~~and ~~post-approval risk~~chronic ~~management~~condition ~~plans~~and ~~mandated~~when, bywithout ~~regulatory authorities~~incentives, ~~competition, and~~it ~~marketing~~is ~~and distribution~~unlikely ~~support.~~that ~~Any~~sales ~~factors~~of ~~preventing~~the ordrug ~~limiting~~in the ~~market~~European ~~acceptance~~Union ofwould ~~our~~be ~~drugs could have a~~sufficient ~~material~~to ~~adverse~~justify ~~effect~~the onnecessary ~~our~~investment ~~business,~~in ~~results~~developing ofthe ~~operations and financial condition~~drug.

24In the USA, orphan drug designation entitles a party to financial incentives, such as opportunities for grant funding towards clinical trial costs, tax credits for certain research and user fee waivers under certain circumstances. In addition, if a drug receives the first FDA approval for the drug and indication for which it has orphan drug designation, the drug is entitled to seven years of market exclusivity, which means the FDA may not approve any other application for the same drug for the same indication for a period of seven years, except in limited circumstances, such as a showing of clinical superiority over the drug with orphan drug exclusivity. Orphan drug exclusivity does not prevent the FDA from approving a different drug for the same disease or condition, or the same drug for a different disease or condition.

~~Table~~In the European Union, orphan drug designation also entitles a party to financial incentives such as reduction of ~~Contents~~fees or fee waivers and ten years of market exclusivity following drug approval. This period may be reduced to six years if the orphan drug designation criteria are no longer met, including where it is shown that the drug is sufficiently profitable so that market exclusivity is no longer justified.

~~Results~~Whilst the company may wish to apply for ODDs for some or all of ~~preclinical~~its ~~studies~~pipeline ~~and~~drug ~~earlier~~candidates, ~~clinical~~there ~~trials~~is ~~are~~no ~~not~~guarantee ~~necessarily~~that ~~predictive~~FDA ~~indicators~~ or EMA (or any other international regulatory body) will grant an ODD for any of ~~future~~the ~~results~~company’s pipeline drug candidates.

~~Any~~Our ~~positive results from future preclinical testing of our pipeline~~ drug candidates ~~and potential future clinical trials~~ may ~~not~~ ~~necessarily~~become besubject predictive of the results from Phase 1, Phase 2 or Phase 3 clinical trials. In addition, our interpretation of results derived from clinical data or our conclusions based on our preclinical data may prove inaccurate. Frequently, pharmaceutical and biotechnology companies have suffered significant setbacks in clinical trials after achieving positive results in preclinical testing and early phase clinical trials, and we cannot be certain that we will not face similar setbacks. These setbacks may be caused by the fact that preclinical and clinical data can be susceptible to ~~varying interpretations and analyses. Furthermore, certain pipeline~~controlled ~~drug~~substance ~~candidates~~laws ~~may perform satisfactorily in preclinical studies~~ and ~~clinical~~regulations ~~trials, but nonetheless fail to obtain FDA approval, a marketing authorization granted by the European Commission, or appropriate approvals by the appropriate medicines regulatory authorities~~ in ~~other countries. If we fail to produce positive results in our clinical trials for our pipeline drug candidates,~~ the ~~development timeline and regulatory approval and commercialization prospects for them and as a result our business and financial prospects, would be materially adversely affected~~U.S.

~~The~~While cannabis and some cannabinoids ~~regulatory~~are ~~approval~~controlled ~~processes~~substances ~~with~~under the ~~FDA,~~CSA in the ~~EMA~~United States, we plan to initially focus our drug development projects using cannabinoids and other ~~comparable~~molecules ~~foreign~~that ~~regulatory~~are ~~authorities~~produced from a variety of sources: (1) isproduced ~~lengthy~~via chemical synthesis and ~~inherently~~/ ~~unpredictable~~or (2) produced biosynthetically and / or (3) produced via botanical means.

WeA ~~are~~number ~~not permitted to market our drug candidates~~of ascannabinoid-containing medicines in, ~~the~~such ~~United States~~as ~~or the European Union or other countries until~~Marinol® ~~we receive approval of a New Drug Application (“NDA”) from the FDA~~ or ~~a Marketing Authorization Application~~ Syndros® (~~“MAA”)~~containing ~~from the European Commission~~dronabinol), ~~respectively,~~ or ~~in any foreign countries until we receive the approval~~Epidiolex® ~~from the regulatory~~(containing ~~authorities~~botanically-derived ofcannabidiol) ~~such countries. Prior to submitting an NDA to the FDA~~ or ~~an MAA to the EMA for~~Cesamet® ~~approval~~(containing ~~of our drug candidates we will need to~~ nabilone) have ~~completed~~been ~~our~~approved ~~preclinical~~by ~~studies and clinical trials. Successfully completing any clinical program and obtaining approval of an NDA or MAA is a complex, lengthy, expensive and uncertain process, and~~ the FDA ~~or EMA (or other country medicines regulatory body) may delay, limit or deny approval of pipeline drug candidates~~ for ~~many~~various ~~reasons, including, among others, because:~~indications.

•In anthe ~~inability~~USA, towhile cannabis-derived cannabinoids ~~demonstrate~~with ~~that~~a ~~our~~THC ~~pipeline~~content ~~drug~~greater ~~candidates~~than ~~are~~0.3%, ~~safe~~– ~~and~~during ~~effective~~development in- ~~treating~~are ~~patients~~categorized toas ~~the~~Schedule ~~satisfaction~~I ofsubstances under the CSA, the ~~FDA~~scheduling orchanges ~~EMA~~once ~~(or~~a ~~any~~medicine ~~other~~has ~~country’s~~been ~~medicine~~approved ~~regulatory~~by ~~body);~~the FDA.

•Marinol®, a ~~results~~capsule offormulation ~~clinical~~which ~~trials~~contains ~~that~~synthetic tetrahydrocannabinol, ~~may~~or ~~not~~THC when formulated is ~~meet~~a ~~the~~Schedule ~~level~~III medicine. Syndros® (which also ofcontains ~~statistical~~synthetic orTHC, ~~clinical~~dronabinol) ~~significance~~is ~~required~~a byliquid ~~the~~formulation ~~FDA~~as oris ~~EMA~~classified ~~(or~~as ~~any~~Schedule ~~other country’s medicine regulatory body);~~II.

•Epidiolex® was initially ~~disagreements~~a ~~with~~Schedule ~~the~~V ~~FDA~~medicine orwhen ~~EMA~~it ~~(or~~was ~~any~~introduced ~~other~~in ~~country’s~~2018, ~~medicine~~but ~~regulatory~~was ~~body)~~descheduled ~~with~~by ~~respect to~~ the ~~number,~~DEA ~~design,~~in ~~size,~~2020. ~~conduct~~It orwas ~~implementation~~completely ofde-scheduled on ~~clinical~~April ~~trials;~~06, 2020.

•It is ~~requirements~~our byintention ~~the~~to ~~FDA~~produce pipeline drug candidates via synthetic, and ~~EMA~~/ (or biosynthetic and / ~~any~~or ~~other~~botanical means, ~~country’s~~which may ~~medicine~~produce ~~regulatory~~complex ~~body)~~mixtures toand ~~conduct~~/or ~~additional~~extracts or ~~clinical~~purified ~~trials;~~drug substance as API.

~~• disapproval by the FDA or EMA or other applicable foreign regulatory authorities of certain formulations, labeling or specifications of pipeline drug candidates;~~27

•Table ~~findings~~of ~~by the FDA or EMA (or any other country’s medicine regulatory body) that the data from preclinical studies and clinical trials are insufficient;~~Contents

•Depending upon the ~~FDA~~content of orour ~~EMA~~selected API(s), and their subsequent controlled drug status in the USA, and if the company conducts preclinical studies or ~~any~~clinical ~~other~~trials in ~~country’s~~the ~~medicine~~United ~~regulatory~~States, ~~body~~we will become subject to the Controlled Substances Act (CSA) ~~may~~laws ~~disagree~~and ~~with~~regulation in addition to FDA regulations. If the ~~interpretation~~Company ofdecides ~~data~~to proceed ~~from~~with ~~preclinical~~APIs ~~studies~~which are controlled drugs, it will evaluate where it is best to conduct its research and ~~clinical~~preclinical and clinical trials;. ~~and~~This may or may not be the USA.

•Nevertheless, our finished drug products may contain controlled substances as defined in the ~~FDA~~CSA. Pipeline drug candidates which contain controlled substances are subject to a high degree of regulation under the CSA, ~~European~~which establishes, ~~Commission~~among other things, certain registration, manufacturing quotas, security, recordkeeping, reporting, import, export and other requirements administered by the Drug Enforcement Agency (DEA). The DEA classifies controlled substances into five schedules: Schedule I, II, III, IV or ~~EMA~~V substances. Schedule I substances, by definition, have a high potential for abuse, have no currently “accepted medical use” in the United States, lack accepted safety for use under medical supervision, and may not be prescribed, marketed or ~~other~~sold ~~applicable~~in ~~foreign~~the ~~regulatory~~United ~~agencies~~States. Pharmaceutical products approved for use in the United States may be ~~change~~listed as ~~their~~Schedule ~~approval~~II, ~~policies~~III, IV or ~~adopt~~V, with Schedule II substances considered to present the highest potential for abuse or dependence and Schedule V substances the lowest relative risk of abuse among such substances. Schedule I and II drugs are subject to the strictest controls under the CSA, including manufacturing and procurement quotas, security requirements and criteria for importation. In addition, dispensing of Schedule II drugs is further restricted. For example, they may not be refilled without a new ~~regulations~~prescription.

~~Any~~While cannabis and some of ~~these~~its ~~factors~~derivatives and certain cannabinoids are Schedule I controlled substances, ~~many~~drugs approved for ofmedical ~~which~~use ~~are~~in ~~beyond~~the ~~our~~United ~~control~~States that contain cannabis, ~~could~~cannabis ~~increase~~extracts or ~~development~~certain cannabinoids must be ~~time~~placed ~~and~~in /Schedules II - V, or unscheduled, since approval ~~costs~~by the FDA satisfies the “accepted medical use” requirement. If, and when orany ~~jeopardize~~of our ~~ability~~pipeline todrug ~~obtain~~candidates ~~regulatory~~receive FDA approval, for those that are considered controlled substances under the CSA, the DEA will make a scheduling determination and place it in a schedule other than Schedule I for it to be prescribed for patients in the United States. If approved by the FDA, depending upon the products potential for abuse amongst other factors, the finished dosage forms of any of our pipeline drug candidates may be listed by the DEA as a Schedule II-V controlled substance. Consequently, their manufacture, importation, exportation, domestic distribution, storage, sale, and legitimate use may be subject to a significant degree of regulation by the DEA (in the USA) and the corresponding competent authorities around the world.

25The scheduling process may take one or more years beyond FDA approval in the USA, thereby significantly delaying the launch of our drugs / medicines. However, the DEA must issue a temporary order scheduling the drug within 90 days after the FDA approves the drug and the DEA receives a scientific and medical evaluation and scheduling recommendation from the Department of Health and Human Services. Furthermore, if the FDA, DEA or any foreign regulatory authority determines that any of our drugs may have potential for abuse, it may require us to generate more clinical data than that which is currently anticipated, which could increase the cost and/or delay the launch of our drugs / medicines or APIs (or food or cosmetic ingredients outside of the USA).

~~Table~~Clinical trials of ~~Contents~~cannabinoid-based drug candidates are novel with very limited or non-existing history; we face a significant risk that the trials will not result in commercially viable drugs and treatments.

WeAt present, there is only ~~may~~a ~~apply~~very limited documented clinical trial history from which we can derive any scientific conclusions for ~~orphan~~our drug ~~status~~pipeline ~~granted by~~candidates, or prove that our present assumptions for the ~~FDA~~ current and /planned orresearch ~~EMA~~are scientifically compelling. ~~for~~The ~~some~~API content of ~~our~~the ~~drug~~Investigational ~~candidates~~Medicinal ~~for~~Products (IMPs) can vary from one IMP to another – hence it is not necessarily possible to extrapolate results from studies with one product and predict efficacy of safety with another product containing a similar API a different source. Whilst the ~~treatment~~principal cannabinoid component may be similar, the APIs may differ in terms of ~~rare~~minor ~~diseases~~cannabinoid content, impurity profiles or degradant profiles. While we are encouraged by the results of clinical trials by others (where they exist), there can be no assurance that any preclinical study or clinical trial will result in producing results which will lead to commercially viable drugs or treatments.

Regulatory authorities in some jurisdictions, including the United States and the European Union, may designate drugs for relatively small patient populations as orphan drugs. The FDA may grant Orphan Drug Designation (ODD) to drugs intended to treat a rare disease or condition that affects fewer than 200,000 individuals annually in the United States. In the European Union, the EMA’s Committee for Orphan Medicinal Products grants orphan drug designation to promote the development of drugs that are intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions affecting not more than 5 in 10,000 persons in the European Union. Additionally, such designation is granted for drugs intended for the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition and when, without incentives, it is unlikely that sales of the drug in the European Union would be sufficient to justify the necessary investment in developing the drug.28

InTable the USA, orphan drug designation entitles a party to financial incentives, such as opportunities for grant funding towards clinical trial costs, tax credits for certain research and user fee waivers under certain circumstances. In addition, if a drug receives the first FDA approval for the drug and indication for which it has orphan drug designation, the drug is entitled to seven years of market exclusivity, which means the FDA may not approve any other application for the same drug for the same indication for a period of seven years, except in limited circumstances, such as a showing of clinical superiority over the drug with orphan drug exclusivity. Orphan drug exclusivity does not prevent the FDA from approving a different drug for the same disease or condition, or the same drug for a different disease or condition.Contents

InClinical ~~the~~trials ~~European~~are ~~Union~~expensive, ~~orphan~~time ~~drug~~consuming ~~designation~~and ~~also~~difficult ~~entitles a party~~ to ~~financial~~design ~~incentives~~and ~~such~~implement. We, as ~~reduction~~well ofas ~~fees~~the orregulatory ~~fee~~authorities ~~waivers~~may ~~and~~suspend, ~~ten~~delay ~~years~~or ofterminate ~~market~~our ~~exclusivity~~clinical ~~following~~trials ~~drug~~at ~~approval.~~any ~~This~~time, ~~period~~ may berequire ~~reduced~~us, tofor ~~six~~various ~~years~~reasons, ~~if the~~to ~~orphan~~conduct ~~drug~~additional ~~designation~~clinical ~~criteria~~trials, ~~are~~or may norequire ~~longer~~a ~~met,~~particular ~~including~~clinical ~~where~~trial itto iscontinue ~~shown~~for ~~that~~a ~~the~~longer ~~drug is~~duration ~~sufficiently~~than ~~profitable~~originally ~~so that~~planned, ~~market~~including, ~~exclusivity~~among ~~is no longer justified.~~others:

~~Whilst~~• ~~the~~lack ~~company~~of ~~may~~effectiveness ~~wish to apply for ODDs for some or all~~ of ~~its~~any ~~pipeline drug candidates~~API, ~~there~~formulation ~~is no guarantee that FDA~~ or ~~EMA~~delivery ~~(or~~system ~~any~~during ~~other~~clinical ~~international regulatory body) will grant an ODD for any of the company’s pipeline drug candidates.~~trials;

~~Our drug~~• ~~candidates~~discovery ~~may~~of ~~become~~serious ~~subject~~or tounexpected ~~controlled substance~~toxicities ~~laws~~or ~~and~~side ~~regulations~~effects inexperienced ~~the~~by ~~U.S.~~trial participants or other safety issues;

~~While~~• ~~cannabis~~slower ~~and~~than ~~some~~expected ~~cannabinoids are~~rates ~~controlled substances under the CSA in the United States, we plan to initially focus our drug development projects using cannabinoids and other molecules that are produced from a variety~~ of ~~sources:~~subject ~~(1) produced~~recruitment ~~via chemical synthesis~~ and /enrollment orrates ~~(2)~~in ~~produced~~clinical ~~biosynthetically and / or (3) produced via botanical means.~~trials;

~~A number~~• ~~of cannabinoid-containing~~delays ~~medicines,~~or ~~such~~inability asin ~~Marinol® or Syndros® (containing dronabinol),~~manufacturing or ~~Epidiolex® (containing botanically~~obtaining sufficient quantities of GMP-~~derived~~grade ~~cannabidiol)~~materials orfor ~~Cesamet® (containing nabilone) have~~use ~~been~~in ~~approved~~clinical bytrials ~~the~~due ~~FDA~~to ~~for~~regulatory ~~various~~and ~~indications.~~manufacturing constraints;

In• ~~the~~delays ~~USA,~~in ~~while cannabis-derived cannabinoids~~obtaining ~~with~~regulatory authorization to commence a ~~THC~~trial, ~~content~~including ~~greater~~Institutional ~~than~~Review ~~0.3%,~~Board –(“IRB”) ~~during~~approvals ~~development~~or -DEA ~~are~~approvals, ~~categorized~~licenses asrequired ~~Schedule~~for Iobtaining ~~substances under the~~and ~~CSA~~using cannabis , ~~the~~cannabis-derived ~~scheduling~~cannabinoid ~~changes~~or ~~once~~cannabinoid-like asubstances ~~medicine~~for ~~has~~research, ~~been~~either ~~approved~~before byor ~~the~~after ~~FDA.~~a trial is commenced;

~~Marinol®, a~~• ~~capsule~~unfavorable ~~formulation~~results ~~which~~from ~~contains~~ongoing ~~synthetic tetrahydrocannabinol,~~pre-clinical orstudies ~~THC when formulated is~~and aclinical ~~Schedule III medicine. Syndros® (which also contains synthetic THC, dronabinol) is a liquid formulation as is classified as Schedule II.~~trials;

~~Epidiolex® was initially~~• apatients ~~Schedule~~or Vinvestigators ~~medicine~~failing ~~when~~to itcomply ~~was~~with ~~introduced~~clinical intrial ~~2018, but was descheduled by the DEA in 2020. It was completely de-scheduled on April 06, 2020.~~protocols;

~~It is~~• ~~our~~patients ~~intention~~failing to ~~produce~~return ~~pipeline~~for ~~drug~~post-treatment ~~candidates~~follow-up ~~via synthetic,~~at ~~and~~the /expected ~~or biosynthetic and / or botanical means, which may produce complex mixtures and /or extracts or purified drug substance as API.~~rate;

26• sites participating in an ongoing clinical trial withdraw, requiring us to engage new sites;

~~Table~~• ofthird-party ~~Contents~~clinical investigators decline to participate in our clinical trials, do not perform the clinical trials on the anticipated schedule, or act in ways inconsistent with the established investigator agreement, clinical trial protocol, good clinical practices, and other IRB requirements;

~~Depending~~• ~~upon~~third-party ~~the~~entities ~~content of~~do ~~our~~not ~~selected~~perform ~~API(s),~~data collection and ~~their~~analysis ~~subsequent controlled drug status~~ in ~~the~~a ~~USA,~~timely ~~and if the company conducts preclinical studies~~ or ~~clinical~~accurate ~~trials in~~manner the United States, we will become subject to the Controlled Substances Act (CSA) laws and regulation in addition to FDA regulations. If the Company decides to proceed with APIs which are controlled drugs, it will evaluate where it is best to conduct its research and preclinical and clinical trials. This may or ~~may~~at ~~not~~all; ~~be the USA.~~or

~~Nevertheless,~~• ~~our~~regulatory ~~finished drug~~inspections ~~products~~of ~~may~~our ~~contain~~clinical ~~controlled~~trials ~~substances~~require asus ~~defined in the CSA. Pipeline drug candidates which contain controlled substances are subject~~ to aundertake ~~high~~corrective ~~degree~~action of regulation under the CSA, which establishes, among other things, certain registration, manufacturing quotas, security, recordkeeping, reporting, import, export and other requirements administered by the Drug Enforcement Agency (DEA). The DEA classifies controlled substances into five schedules: Schedule I, II, III, IV or Vsuspend substances. Schedule I substances, by definition, have a high potential for abuse, have no currently “accepted medical use” in the United States, lack accepted safety for use under medical supervision, and may not be prescribed, marketed or ~~sold~~terminate inour ~~the~~clinical ~~United States~~trials. Pharmaceutical products approved for use in the United States may be listed as Schedule II, III, IV or V, with Schedule II substances considered to present the highest potential for abuse or dependence and Schedule V substances the lowest relative risk of abuse among such substances. Schedule I and II drugs are subject to the strictest controls under the CSA, including manufacturing and procurement quotas, security requirements and criteria for importation. In addition, dispensing of Schedule II drugs is further restricted. For example, they may not be refilled without a new prescription.

~~While~~Any ~~cannabis and some~~ of ~~its derivatives and certain cannabinoids are Schedule I controlled substances, drugs approved for medical use in~~ the ~~United~~foregoing ~~States~~could ~~that~~have contain cannabis, cannabis extracts or certain cannabinoids must be placed in Schedules II - V, or unscheduled, since approval by the FDA satisfies the “accepted medical use” requirement. If, and when any of our pipeline drug candidates receive FDA approval, for those that are considered controlled substances under the CSA, the DEA will make a ~~scheduling~~material ~~determination~~adverse ~~and~~effect ~~place~~on it in a schedule other than Schedule I for it to be prescribed for patients in the United States. If approved by the FDA, depending upon the products potential for abuse amongst other factors, the finished dosage forms of any of our ~~pipeline drug candidates may be listed by the DEA as a Schedule II-V controlled substance. Consequently~~business, ~~their~~ ~~manufacture,~~results ~~importation, exportation, domestic distribution, storage, sale, and legitimate use may be subject to a significant degree~~ of ~~regulation~~operations ~~by the DEA (in the USA)~~ and ~~the~~financial ~~corresponding competent authorities around the world~~condition.

The ~~scheduling process may~~ ~~take one or more years beyond~~ FDA ~~approval~~ inhas ~~the~~not ~~USA, thereby~~approved ~~significantly~~any ~~delaying the~~complex ~~launch~~botanically-derived ~~of our drugs / medicines. However, the DEA must issue a temporary order scheduling the~~ cannabinoid drug ~~within~~as ~~90 days after the FDA approves the drug and the DEA receives~~ a ~~scientific~~safe and ~~medical evaluation~~effective ~~and~~drug ~~scheduling~~for ~~recommendation from the Department of Health and Human Services. Furthermore, if the FDA, DEA or~~ any foreign regulatory authority determines that any of our drugs may have potential for abuse, it may require us to generate more clinical data than that which is currently anticipated, which could increase the cost and/or delay the launch of our drugs / medicines or APIs (or food or cosmetic ingredients outside of the USA)indication.

~~Clinical~~To ~~trials~~date, ofthe ~~cannabinoid-based~~FDA ~~drug~~has ~~candidates~~not ~~are~~approved ~~novel~~any ~~with~~complex ~~very~~botanical ~~limited~~cannabinoid ormedicine ~~non-existing~~as safe and effective for any ~~history;~~indication. It wehas ~~face~~however approved a ~~significant~~cannabinoid medicine containing a highly purified cannabinoid (CBD) medicine (Epidiolex®) ~~risk~~for a limited number of indications. However, the FDA is aware that there is considerable interest in the use of complex ~~trials~~botanical ~~will~~medicines (e.g. Sativex® - which is not ~~result~~approved in ~~commercially~~the ~~viable~~USA, ~~drugs~~but ~~and~~is ~~treatments~~approved in some other countries) or purified cannabinoids (e.g. Epidiolex®) or synthesized cannabinoid medicines (e.g. Marinol®) to attempt to treat a number of medical conditions.

At present, there is only a very limited documented clinical trial history from which we can derive any scientific conclusions for our drug pipeline candidates, or prove that our present assumptions for the current and planned research are scientifically compelling. The API content of the Investigational Medicinal Products (IMPs) can vary from one IMP to another – hence it is not necessarily possible to extrapolate results from studies with one product and predict efficacy of safety with another product containing a similar API a different source. Whilst the principal cannabinoid component may be similar, the APIs may differ in terms of minor cannabinoid content, impurity profiles or degradant profiles. While we are encouraged by the results of clinical trials by others (where they exist), there can be no assurance that any preclinical study or clinical trial will result in producing results which will lead to commercially viable drugs or treatments.29

27Table of Contents

~~Table~~Before conducting testing in humans of ~~Contents~~a drug that has not been approved by the FDA, we will need to submit an investigational new drug (“IND”) application to the FDA (or a Clinical Trial Authorization (CTA) to the EMA). Failure to comply with applicable U.S. requirements may subject a company to a variety of administrative or judicial sanctions, such as the FDA’s refusal to approve pending NDAs, warning letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, civil penalties and criminal prosecution. Failure to comply with similarly applicable regulatory requirements in other countries may also subject a company to a variety of administrative or judicial sanctions within their country.

~~Clinical trials are expensive, time consuming and difficult to design and implement.~~ We~~, as well as the regulatory authorities~~ ~~may~~face ~~suspend,~~a ~~delay or terminate our clinical~~potentially ~~trials~~highly atcompetitive any time, may require us, for various reasons, to conduct additional clinical trials, or may require a particular clinical trial to continue for a longer duration than originally planned, including, among others:market.

•Demand for ~~lack~~cannabinoid-containing or ofcannabis-based ~~effectiveness~~medicines will likely be dependent on a number of ~~any~~social, political and ~~API~~economic factors that are beyond our control. While we believe that there will be a demand for such drugs, ~~formulation~~and that the demand will grow, there is no assurance that such demand will happen, that we will benefit from any demand or ~~delivery~~that ~~system~~our ~~during~~business, ~~clinical~~in ~~trials;~~fact, will ever generate revenues from our drug development programs or become profitable.

•The ~~discovery~~emerging ofmarkets ~~serious~~for cannabinoid-containing or ~~unexpected~~cannabis-derived ~~toxicities~~medicines orand ~~side~~medical ~~effects~~research ~~experienced~~and development is and will likely remain competitive. The development and commercialization of drugs / medicines is highly competitive. We compete with a variety of multinational pharmaceutical companies and specialized biotechnology companies, as well as products and processes being developed by ~~trial~~universities ~~participants~~and other research institutions. Many of our competitors have developed, are developing, or will develop drugs and processes which may be competitive with our drug candidates. Competitive therapeutic treatments include those that have already been approved by medicines regulators and accepted by the medical community and any new treatments that may enter the market. For some of our drug development programs / areas of therapeutic interest, other ~~safety~~treatment ~~issues;~~options are currently available, under development, and may become commercially available in the future. If any of our pipeline drug candidates is approved for the diseases and conditions we are currently pursuing, they may compete with a range of medicines / therapeutic treatments that are either in development, will be developed in the future or currently marketed.

•We are ~~slower~~aware ~~than~~of ~~expected~~many ~~rates~~companies ofthat ~~subject~~are ~~recruitment~~engaged in cannabinoid-derived drug development activities. In addition, other U.S.-based and ~~enrollment~~foreign-based companies ~~rates~~are in ~~clinical~~early ~~trials;~~stage discovery and preclinical development utilizing the cannabinoids CBD and/or THC.

•Established companies ~~delays~~may orhave ~~inability~~a incompetitive ~~manufacturing~~advantage orover ~~obtaining~~us ~~sufficient~~due ~~quantities~~to their size and experiences, financial resources, and institutional networks. Many of ~~GMP-grade~~our ~~materials~~competitors ~~for~~may ~~use~~have insignificantly greater ~~clinical~~financial, ~~trials~~technical ~~due~~and human resources than we do. Due to these factors, our competitors may have an advantage in marketing their approved drugs and may obtain regulatory approval of their drug candidates before we are able to, which may limit our ability to develop or commercialize our drug candidates. Our competitors may also develop ingredients and ~~manufacturing~~/ ~~constraints;~~or drugs / medicines that are safer, more effective, more widely used and less expensive than ours. These advantages could materially impact our ability to develop and, if approved, commercialize our pipeline drug candidates successfully. Furthermore, some of these competitors may make acquisitions or establish collaborative relationships among themselves or with third parties to increase their ability to rapidly gain market share.

•Our pipeline ~~delays~~drug incandidates ~~obtaining~~may ~~regulatory~~compete ~~authorization~~with toother ~~commence~~cannabinoid aor ~~trial~~cannabis-based drugs, ~~including~~in ~~Institutional~~addition ~~Review~~to ~~Board~~competing ~~(“IRB”)~~with ~~approvals~~state-licensed medical orand ~~DEA~~recreational ~~approvals~~marijuana, ~~licenses~~in ~~required~~markets where the recreational and/or medical use of marijuana is legal. There is continuing support in the USA for ~~obtaining~~further state legalization of marijuana. In markets where recreational and/or ~~using~~medical ~~cannabis~~marijuana is not legal, ~~cannabis~~our pipeline drug candidates, once approved by regulators, may compete with marijuana or marijuana-~~derived~~based ~~cannabinoid~~products purchased in the illegal drug market. This may or may not affect the commercial price that we may be able to achieve for our cannabinoid-~~like~~containing ~~substances~~or ~~for~~other non-cannabinoid-containing regulatory-approved ~~research~~medicines, ~~either~~should ~~before~~they orbe ~~after~~approved aby ~~trial~~the ~~is commenced;~~FDA.

•Moreover, as ~~unfavorable~~generic ~~results~~versions ~~from~~of ~~ongoing~~drug ~~pre-clinical~~products ~~studies~~enter the market, the price for such medicines may be expected to decline rapidly and substantially. ~~clinical~~Even ~~trials;~~if we are the first to obtain FDA approval of one of our pipeline drug candidates, the future potential approval of generics could adversely affect the price we are able to charge and the profitability of our product(s) will likely decline.

~~• patients or investigators failing to comply with clinical trial protocols;~~30

•Table ~~patients~~of ~~failing to return for post-treatment follow-up at the expected rate;~~Contents

•Mergers and ~~sites~~acquisitions ~~participating~~in the pharmaceutical and biotechnology industries may result in anmore ~~ongoing~~resources ~~clinical~~being concentrated among ~~trial~~a ~~withdraw,~~smaller ~~requiring~~number usof our competitors. Smaller and other early-stage companies may also prove to be significant ~~engage~~competitors, ~~new~~particularly ~~sites;~~through collaborative arrangements with large and established companies.

•These companies ~~third-party~~may ~~clinical~~compete ~~investigators~~with ~~decline~~us ~~to participate~~ in ~~our~~recruiting ~~clinical~~and ~~trials~~retaining qualified scientific, domanagement ~~not~~and ~~perform~~commercial personnel, utilizing ~~the~~contract ~~clinical~~manufacturing ~~trials~~facilities or oncontract ~~the~~research ~~anticipated~~organizations ~~schedule~~(CROs), or ~~act~~establishing inclinical ~~ways~~trial ~~inconsistent~~sites ~~with~~and ~~the~~subject ~~established~~registration ~~investigator~~for ~~agreement,~~ clinical ~~trial protocol~~trials, ~~good~~as ~~clinical~~well ~~practices,~~as ~~and~~in ~~other~~acquiring ~~IRB~~technologies ~~requirements;~~complementary to our research projects.

•Our failure ~~third-party~~to ~~entities~~comply dowith ~~not~~existing ~~perform~~and ~~data~~potential ~~collection~~future laws and ~~analysis~~regulations inrelating ato ~~timely~~drug development orcould harm ~~accurate~~our ~~manner~~plan orof ~~at all; or~~operations.

•Our ~~regulatory~~business ~~inspections~~is, and will be, subject to wide-ranging existing federal and state laws and regulations and other governmental bodies in each of the countries we may develop and/or market our ~~clinical~~pipeline ~~trials~~drug ~~require~~candidates. usWe tomust ~~undertake~~comply ~~corrective~~with ~~action~~all orregulatory requirements ~~suspend~~if orwe ~~terminate~~expect ~~our~~to ~~clinical~~be ~~trials~~successful.

~~Any~~If any of our cannabinoid-containing or cannabis-based or cannabinoid-like-containing pipeline drug candidates are controlled substances and are approved in the ~~foregoing~~United ~~could~~States, ~~have~~they awill ~~material~~be ~~adverse~~subject ~~effect~~to onongoing regulatory requirements including federal and state requirements. As a result, we and our ~~business~~contractors, collaborators and/or joint venture ~~results~~partners must continue to expend time, money and effort in all areas of ~~operations~~regulatory compliance, including, if applicable, manufacturing, production, quality control and ~~financial~~assurance, ~~condition~~preclinical research and development and, of upmost importance, clinical trials. We will also be required to report certain adverse reactions and production problems, if any and applicable, to the FDA and other regulatory agencies, and to comply with advertising and promotion requirements for our cannabinoid-containing and or cannabinoid-like-containing drug candidates.

~~The~~Any ~~FDA~~failure ~~has~~to ~~not~~comply ~~approved~~with ~~any~~ongoing ~~complex~~regulatory ~~botanically~~or controlled drug requirements may significantly and adversely affect our ability to conduct clinical trials which are prerequisites to our ability to commercialize our cannabinoid-~~derived~~based and or cannabinoid-like drugs ~~drug~~and asrelated treatments. aIf ~~safe~~regulatory ~~and~~sanctions ~~effective~~are ~~drug~~applied or if regulatory approval, once obtained, is for any ~~indication~~reason suspended or withdrawn, the value of our business and our operating results could be materially adversely affected.

ToOur ~~date,~~failure ~~the FDA has not approved any complex botanical cannabinoid medicine as safe and effective for any~~to ~~indication. It~~be ~~has~~able ~~however~~to approved a cannabinoid medicine containing a highly purified cannabinoid (CBD) medicine (Epidiolex®) for a limited number of indications. However, the FDA is aware that there is considerable interest in the use of complex botanical medicines (e.g. Sativex® out- ~~which~~license ~~is not approved in the USA, but is approved in~~ some ~~other countries)~~ or ~~purified~~ ~~cannabinoids~~all ~~(e.g.~~of ~~Epidiolex®)~~our orpipeline ~~synthesized~~drug ~~cannabinoid medicines (e.g. Marinol®) to attempt to~~candidates ~~treat~~could harm aour ~~number~~plan of ~~medical conditions~~operations.

~~Before~~The ~~conducting~~cost ~~testing in humans~~ of a drug ~~that~~development is ~~has~~high ~~not~~and ~~been~~the ~~approved~~attrition byrate ~~the~~of ~~FDA,~~new wedrug ~~will~~pipeline ~~need~~candidates tois ~~submit~~also ~~an investigational new~~high ~~drug~~during ~~(“IND”)~~the ~~application~~drug todevelopment ~~the~~process. ~~FDA~~In ~~(or~~order ato ~~Clinical~~help ~~Trial~~fund the ~~Authorization~~development ~~(CTA)~~of tosome ~~the~~of ~~EMA).~~our ~~Failure~~pipeline todrug ~~comply~~candidates, ~~with~~the ~~applicable U.S. requirements~~company may ~~subject~~ awish ~~company~~/ need to aout-license ~~variety~~some of ~~administrative~~its ~~or judicial~~assets ~~sanctions,~~to other (big) ~~such~~pharmaceutical asor ~~the~~biotechnology ~~FDA’s~~companies. ~~refusal~~The toaim ~~approve~~of ~~pending NDAs,~~such ~~warning~~out-licensing ~~letters,~~would ~~product~~be ~~recalls, product~~generate ~~seizures,~~funds ~~total or~~for ~~partial~~the ~~suspension~~company ofwhich ~~production~~may ortake ~~distribution, injunctions,~~the form ~~fines,~~of ~~civil~~up-front ~~penalties~~payments and ~~criminal~~/ ~~prosecution.~~or ~~Failure~~milestone topayments ~~comply with~~and ~~similarly~~/ ~~applicable~~or ~~regulatory requirements in~~royalties. ~~other~~Such ~~countries~~decisions ~~may~~will ~~also~~be ~~subject~~taken on a ~~company~~case-by-case tobasis, aas ~~variety~~the ofopportunity arises ~~administrative~~ or ~~judicial~~is ~~sanctions within their country~~required.

28There is no guarantee that the company will generate pipeline drug candidates which are suitable for out-licensing. In addition, even if the company does produce pipeline drug candidates that are suitable for out-licensing there is no guarantee that the company will be successful in being able to identify potential licensees and successfully negotiate such out-licensing agreements, on agreeable terms if and when required. Any failure to secure such out-licensing agreements may materially affect our ability to finance or develop and / or commercialize one or more of our pipeline drug candidates. Any such failure may materially adversely affect our business.

~~Table of Contents~~31

~~We face~~Table aof ~~potentially highly competitive market.~~Contents

~~Demand~~Our ~~for~~failure ~~cannabinoid-containing or~~to ~~cannabis-based medicines will likely~~ be ~~dependent~~able onto aenter ~~number~~Research ~~of social, political~~ and ~~economic~~Development ~~factors~~(R ~~that~~& ~~are~~D) ~~beyond~~Collaboration ~~our~~Agreements ~~control.~~or ~~While~~Joint weVenture ~~believe that~~(JV) ~~there~~Agreements ~~will be a demand~~ for ~~such~~some ~~drugs, and that the~~or ~~demand~~all ~~will~~of ~~grow, there is no assurance that such demand will happen, that we will benefit from any demand or that~~ our ~~business,~~pipeline indrug ~~fact, will~~candidates ~~ever~~could ~~generate~~harm ~~revenues from~~ our ~~drug~~plan ~~development~~of ~~programs or become profitable.~~operations

~~The~~As ~~emerging~~mentioned ~~markets~~above, ~~for~~the cost ~~cannabinoid-containing~~of ordrug ~~cannabis-derived~~development ~~medicines~~ and ~~medical~~manufacturing ~~research~~is ~~and development~~high. ~~is and~~In ~~will~~order ~~likely~~to ~~remain~~help ~~competitive.~~fund ~~The~~the development ~~and~~ ~~commercialization~~ of ~~drugs~~some /of ~~medicines~~our isingredients ~~highly~~and ~~competitive.~~pipeline Wedrug ~~compete~~candidates, ~~with~~the acompany ~~variety~~may ofwish ~~multinational~~to ~~pharmaceutical~~enter ~~companies~~into Research and ~~specialized~~Development ~~biotechnology~~Collaboration ~~companies,~~Agreements asor ~~well~~Joint Venture asAgreements with ~~products~~other ~~and~~(big) ~~processes~~pharmaceutical ~~being developed~~or bybiotechnology ~~universities~~companies ~~and~~to ~~other~~help research ~~institutions.~~ ~~Many~~and ofdevelop ~~our~~some ~~competitors~~of ~~have~~its ~~developed,~~assets ~~are~~and ~~developing,~~for orthose ~~will~~companies ~~develop~~pay ~~drugs~~for ~~and~~some ~~processes which~~or ~~may be~~all ~~competitive~~of ~~with our~~the ~~drug~~associated ~~candidates~~R & D costs. ~~Competitive therapeutic~~The ~~treatments~~aim ~~include~~of ~~those~~such ~~that~~Collaboration ~~have~~or ~~already~~JV ~~been approved~~agreements would be byto ~~medicines~~offset ~~regulators~~some ~~and~~of ~~accepted~~the bycompany’s R & D costs. Depending upon the ~~medical~~outcome ~~community and~~of ~~any~~such ~~new~~R ~~treatments~~& ~~that~~D or JV Agreements, it may ~~enter~~lead to the opportunity ~~market.~~to ~~For~~out ~~some~~license one or more of ~~our~~ ~~drug~~the ~~development~~assets ~~programs~~investigated /under ~~areas~~the ofCollaboration ~~therapeutic~~Agreement ~~interest,~~to ~~other~~the ~~treatment~~same ~~options~~other ~~are currently~~(big) pharmaceutical ~~available,~~or ~~under~~biotechnology ~~development,~~company ~~and~~who may ~~become~~be ~~commercially~~our ~~available in~~R ~~the~~&D ~~future~~Collaboration / JV partner. If ~~any~~successful, ofthis ~~our~~may ~~pipeline drug candidates~~generate isfunds ~~approved~~ for the ~~diseases~~company ~~and~~which may ~~conditions~~take wethe ~~are currently~~form ~~pursuing,~~of ~~they~~up-front ~~may~~payments ~~compete~~and ~~with~~/ aor ~~range~~milestone ofpayments ~~medicines~~ and / ~~therapeutic~~or ~~treatments~~royalties. ~~that~~Such ~~are~~decisions ~~either~~will inbe ~~development,~~taken ~~will~~on bea ~~developed~~case-by-case basis, inas the ~~future~~opportunity arises or ~~currently~~is ~~marketed~~required.

WeThere is no guarantee that ~~are~~the ~~aware~~company ofwill ~~many~~generate ~~companies~~pipeline ~~that~~drug candidates which are ~~engaged~~suitable infor ~~cannabinoid-derived~~R ~~drug~~& ~~development~~D ~~activities~~Collaborations or JV Agreements. In addition, ~~other~~ even ~~U.S.-based~~if ~~and~~the ~~foreign-based companies~~company does produce pipeline drug candidates that are suitable for such collaborations or JVs, there is no guarantee that the company will be successful in ~~early~~being ~~stage~~able ~~discovery~~to identify potential R & D collaboration partners or JV partners and ~~preclinical~~successfully negotiate ~~development~~such ~~utilizing~~collaboration or JV agreements, on agreeable terms if and when required. Depending upon the ~~cannabinoids~~ ~~CBD~~financial status of the company, any failure to secure such collaboration or JV agreements may materially affect our ability to finance or develop and / or ~~THC~~commercialize one or more of our pipeline drug candidates. Any such failure may materially adversely affect our business.

~~Established companies~~The ~~may~~introduction ~~have~~of anew ~~competitive advantage over us due to their size and experiences~~businesses, ~~financial resources, and~~ ~~institutional~~products, ~~networks. Many of our competitors may have significantly greater financial~~services, ~~technical~~ and ~~human resources than we do. Due to these factors~~technologies, our ~~competitors~~activities ~~may have an advantage~~ in ~~marketing~~certain ~~their~~jurisdictions, ~~approved~~or ~~drugs~~other ~~and~~actions ~~may obtain regulatory approval of their drug candidates before~~ we ~~are~~take ~~able to, which~~ may ~~limit~~subject ~~our~~us ~~ability~~ to ~~develop~~additional orlaws and ~~commercialize~~regulations. ~~our~~The ~~drug~~costs ~~candidates. Our~~of ~~competitors~~compliance ~~may~~with ~~also~~these ~~develop~~laws ~~ingredients~~ and /regulations orare ~~drugs~~high /and ~~medicines that~~ are ~~safer, more effective,~~likely ~~more~~to ~~widely~~increase ~~used~~in ~~and~~the ~~less expensive than ours~~future. ~~These~~Any ~~advantages~~failure on ~~could materially impact~~ our ~~ability~~part to ~~develop and,~~comply ifwith ~~approved,~~laws ~~commercialize~~and ~~our~~regulations ~~pipeline~~can ~~drug~~result ~~candidates~~in ~~successfully.~~negative ~~Furthermore,~~publicity ~~some~~and diversion of ~~these competitors may~~management ~~make~~time ~~acquisitions~~and oreffort ~~establish~~and ~~collaborative~~may ~~relationships~~subject us ~~among themselves or with third parties~~ to ~~increase~~significant ~~their~~liabilities ~~ability to~~and ~~rapidly~~other ~~gain market share~~penalties.

~~Our pipeline~~We ~~drug~~could ~~candidates~~be ~~may compete with other cannabinoid or cannabis-based drugs, in addition~~ subject to ~~competing with state-licensed medical and recreational marijuana~~litigation, inallegations ~~markets where the recreational and/~~or ~~medical~~other ~~use of marijuana is~~ legal. ~~There is continuing support in the USA for further state legalization of marijuana~~claims. In markets where recreational and/or medical marijuana is not legal, our pipeline drug candidates, once approved by regulators, may compete with marijuana or marijuana-based products purchased in the illegal drug market. This may or may not affect the commercial price that we may be able to achieve for our cannabinoid-containing or other non-cannabinoid-containing regulatory-approved medicines, should they be approved by the FDA.

~~Moreover,~~Our assets or our business asactivities ~~generic~~may ~~versions~~be ofsubject ~~drug~~to ~~products~~disputes ~~enter~~that ~~the~~may ~~market, the~~result ~~price~~in ~~for~~litigation ~~such~~or ~~medicines~~other legal claims. We may be ~~expected~~subject to ~~decline~~allegations ~~rapidly~~through ~~and~~press, ~~substantially~~social media, the courts or other mediums that may or may not be founded. ~~Even~~We ifmay webe ~~are~~required ~~the~~to ~~first~~respond to ~~obtain~~or ~~FDA~~defend ~~approval~~against ofthese ~~one~~claims and/or ofallegations, which will divert resources away from our ~~pipeline~~principal ~~drug candidates, the~~business. ~~future~~There ~~potential~~can ~~approval~~be no assurance that our defense of ~~generics~~such ~~could~~claims and/or ~~adversely affect~~allegations ~~the~~would ~~price~~be successful, and we ~~are~~may ~~able~~be required to ~~charge~~make ~~and~~material ~~the~~settlements. ~~profitability~~This ofcould have a material adverse effect on our ~~product(s)~~business ~~will~~prospects, ~~likely~~results ~~decline~~of operations, cash flows, financial condition and corporate reputation.

~~Mergers and~~Item ~~acquisitions in the pharmaceutical and biotechnology industries may result in more resources being concentrated among a smaller number of our competitors~~1B. ~~Smaller~~Unresolved ~~and~~Staff ~~other early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies.~~Comments

~~These companies~~This ~~may~~information ~~compete~~is ~~with~~not ~~us in recruiting and retaining qualified scientific, management and commercial personnel,~~required ~~utilizing contract manufacturing facilities or contract research organizations (CROs), or establishing clinical trial sites and subject registration~~ for ~~clinical~~smaller ~~trials,~~reporting ~~as well as in acquiring technologies complementary to our research projects~~companies.

29Item 1C. Cybersecurity

~~Table~~We rely on our information technology to operate our business. As such, we have policies and processes designed to protect our information technology systems, some of ~~Contents~~which are managed by third parties, and resolve issues in a timely manner in the event of a cybersecurity threat or incident.

~~Our~~We have designed our business ~~failure~~applications and hosting services to ~~comply~~minimize ~~with~~the ~~existing~~impact ~~and~~that ~~potential~~cybersecurity ~~future~~incidents ~~laws~~could have on our business and ~~regulations~~have ~~relating~~identified back-up systems where appropriate. We seek to ~~drug development~~further ~~could~~mitigate cybersecurity risks through a combination of monitoring and detection activities, ~~harm~~use of anti-malware applications, employee training, quality audits and communication and reporting structures, among other processes. We engage a third-party consultant to assist us with our ~~plan~~cybersecurity risk management framework, including the monitoring and detection of ~~operations~~cybersecurity threats and responding to any cybersecurity threats or incidents. Our third-party consultant team is managed by our Chief Financial Officer who reports to the audit committee or board, as appropriate.

Our business is, and will be, subject to wide-ranging existing federal and state laws and regulations and other governmental bodies in each of the countries we may develop and/or market our pipeline drug candidates. We must comply with all regulatory requirements if we expect to be successful.32

~~If any~~Table of our cannabinoid-containing or cannabis-based or cannabinoid-like-containing pipeline drug candidates are controlled substances and are approved in the United States, they will be subject to ongoing regulatory requirements including federal and state requirements. As a result, we and our contractors, collaborators and/or joint venture partners must continue to expend time, money and effort in all areas of regulatory compliance, including, if applicable, manufacturing, production, quality control and assurance, preclinical research and development and, of upmost importance, clinical trials. We will also be required to report certain adverse reactions and production problems, if any and applicable, to the FDA and other regulatory agencies, and to comply with advertising and promotion requirements for our cannabinoid-containing and or cannabinoid-like-containing drug candidates.Contents

~~Any failure~~As toof ~~comply~~March ~~with~~31, ~~ongoing~~2024, ~~regulatory~~we have ornot ~~controlled~~identified ~~drug~~any ~~requirements~~indication ~~may~~of ~~significantly and~~a ~~adversely~~cybersecurity ~~affect our ability~~incident tothat ~~conduct~~would ~~clinical~~have ~~trials~~a ~~which~~material ~~are~~impact ~~prerequisites~~on to our ~~ability~~business ~~to commercialize our cannabinoid-based~~ and orconsolidated ~~cannabinoid-like~~financial ~~drugs and related treatments~~statements. If regulatory sanctions are applied or if regulatory approval, once obtained, is for any reason suspended or withdrawn, the value of our business and our operating results could be materially adversely affected.

~~Our failure~~Item ~~to be able to out-license some or all of our pipeline drug candidates could harm our plan of operations~~2. Properties

~~The~~We ~~cost~~do ofnot ~~drug~~own ~~development is~~any ~~high~~real ~~and~~property. ~~the~~We ~~attrition~~maintain ~~rate~~our ofcorporate offices ~~new~~at ~~drug~~47 ~~pipeline~~Hamilton ~~candidates~~Square isBirkenhead ~~also~~Merseyside ~~high~~CH41 ~~during~~5AR ~~the~~United ~~drug development process~~Kingdom. InOne ~~order to help fund the development~~ of ~~some of our pipeline drug candidates,~~ the company ~~may~~directors ~~wish~~has /a ~~need~~beneficial toownership ~~out-license some of its assets to other (big)~~in ~~pharmaceutical or biotechnology companies. The aim of such out-licensing would be generate funds for~~ the ~~company~~property, which ~~may~~is ~~take~~leased ~~the form of up-front payments and / or milestone payments and / or royalties. Such decisions will be taken~~ on a“arm’s ~~case-by-case~~length” ~~basis, as the opportunity arises or is required~~terms.

~~There~~Item ~~is no guarantee that the company will generate pipeline drug candidates which are suitable for out-licensing~~3. ~~In addition, even if the company does produce~~ ~~pipeline~~Legal drug candidates that are suitable for out-licensing there is no guarantee that the company will be successful in being able to identify potential licensees and successfully negotiate such out-licensing agreements, on agreeable terms if and when required. Any failure to secure such out-licensing agreements may materially affect our ability to finance or develop and / or commercialize one or more of our pipeline drug candidates. Any such failure may materially adversely affect our business.Proceedings

~~Our failure~~We toare benot ~~able~~a party to ~~enter~~any ~~Research~~pending ~~and~~legal ~~Development~~proceeding. We (Rare &not D)aware ~~Collaboration~~of ~~Agreements~~any orpending ~~Joint~~legal ~~Venture~~proceeding ~~(JV)~~to ~~Agreements~~which ~~for~~any ~~some~~of our officers, directors, or ~~all~~ any beneficial holders of 5% or more of our voting ~~pipeline~~securities ~~drug~~are ~~candidates~~adverse ~~could~~to ~~harm~~us ~~our~~or ~~plan~~have ofa ~~operations~~material interest adverse to us.

As mentioned above, the cost of drug development and manufacturing is high. In order to help fund the development of some of our ingredients and pipeline drug candidates, the company may wish to enter into Research and Development Collaboration Agreements or Joint Venture Agreements with other (big) pharmaceutical or biotechnology companies to help research and develop some of its assets and for those companies pay for some or all of the associated R & D costs. The aim of such Collaboration or JV agreements would be to offset some of the company’s R & D costs. Depending upon the outcome of such R & D or JV Agreements, it may lead to the opportunity to outlicense one or more of the assets investigated under the Collaboration Agreement to the same other (big) pharmaceutical or biotechnology company who may be our R &D Collaboration / JV partner. If successful, this may generate funds for the company which may take the form of up-front payments and / or milestone payments and / or royalties. Such decisions will be taken on a case-by-case basis, as the opportunity arises or is required.

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There is no guarantee that the company will generate pipeline drug candidates which are suitable for R & D Collaborations or JV Agreements. In addition, even if the company does produce pipeline drug candidates that are suitable for such collaborations or JVs, there is no guarantee that the company will be successful in being able to identify potential R & D collaboration partners or JV partners and successfully negotiate such collaboration or JV agreements, on agreeable terms if and when required. Depending upon the financial status of the company, any failure to secure such collaboration or JV agreements may materially affect our ability to finance or develop and / or commercialize one or more of our pipeline drug candidates. Any such failure may materially adversely affect our business.

The introduction of new businesses, products, services, and technologies, our activities in certain jurisdictions, or other actions we take may subject us to additional laws and regulations. The costs of compliance with these laws and regulations are high and are likely to increase in the future. Any failure on our part to comply with laws and regulations can result in negative publicity and diversion of management time and effort and may subject us to significant liabilities and other penalties.

We could be subject to litigation, allegations or other legal claims.

Our assets or our business activities may be subject to disputes that may result in litigation or other legal claims. We may be subject to allegations through press, social media, the courts or other mediums that may or may not be founded. We may be required to respond to or defend against these claims and/or allegations, which will divert resources away from our principal business. There can be no assurance that our defense of such claims and/or allegations would be successful, and we may be required to make material settlements. This could have a material adverse effect on our business prospects, results of operations, cash flows, financial condition and corporate reputation.

Item 2. Properties

We do not own any real property. We maintain our corporate offices at 47 Hamilton Square Birkenhead Merseyside CH41 5AR United Kingdom. One of the company directors has a beneficial ownership in the property, which is leased on “arm’s length” terms.

Item 3. Legal Proceedings

We are not a party to any pending legal proceeding. We are not aware of any pending legal proceeding to which any of our officers, directors, or any beneficial holders of 5% or more of our voting securities are adverse to us or have a material interest adverse to us.

Item 4. Mine Safety Disclosures

Not applicable.

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PART II

Item 5. Market for Registrant’s Common Equity and Related Stockholder Matters and Issuer Purchases of Equity Securities

Market Information

Our common stock is quoted under the symbol “ABTI” on the OTC Pink operated by OTC Markets Group, Inc.

There is currently no active trading market for our securities. There is no assurance that a regular trading market will develop, or if developed, that it will be sustained. Therefore, a shareholder may be unable to resell his securities in our company.

Penny Stock

The Securities Exchange Commission (“SEC”) has adopted rules that regulate broker-dealer practices in connection with transactions in penny stocks. Penny stocks are generally equity securities with a price of less than $5.00, other than securities registered on certain national securities exchanges or quoted on the NASDAQ system, provided that current price and volume information with respect to transactions in such securities is provided by the exchange or system. The penny stock rules require a broker-dealer, prior to a transaction in a penny stock, to deliver a standardized risk disclosure document prepared by the Commission, that: (a) contains a description of the nature and level of risk in the market for penny stocks in both public offerings and secondary trading;(b) contains a description of the broker's or dealer's duties to the customer and of the rights and remedies available to the customer with respect to a violation to such duties or other requirements of Securities' laws; (c) contains a brief, clear, narrative description of a dealer market, including bid and ask prices for penny stocks and the significance of the spread between the bid and ask price;(d) contains a toll-free telephone number for inquiries on disciplinary actions;(e) defines significant terms in the disclosure document or in the conduct of trading in penny stocks; and;(f) contains such other information and is in such form, including language, type, size and format, as the Commission shall require by rule or regulation.

The broker-dealer also must provide, prior to effecting any transaction in a penny stock, the customer with; (a) bid and offer quotations for the penny stock;(b) the compensation of the broker-dealer and its salesperson in the transaction;(c) the number of shares to which such bid and ask prices apply, or other comparable information relating to the depth and liquidity of the market for such stock; and (d) a monthly account statements showing the market value of each penny stock held in the customer's account.

In addition, the penny stock rules require that prior to a transaction in a penny stock not otherwise exempt from those rules; the broker-dealer must make a special written determination that the penny stock is a suitable investment for the purchaser and receive the purchaser's written acknowledgment of the receipt of a risk disclosure statement, a written agreement to transactions involving penny stocks, and a signed and dated copy of a written suitability statement.

These disclosure requirements may have the effect of reducing the trading activity in the secondary market for our stock if it becomes subject to these penny stock rules. Therefore, because our common stock is subject to the penny stock rules, stockholders may have difficulty selling those securities.

Holders of Our Common Stock

Currently, we have approximately ~~140~~ 139 holders of record of our common stock. ~~On June 06, 2023, the company reclaimed 44,064,000 shares into Treasury.~~

Exercise of Warrants

On 13th June 2023, EMC2 Capital LLC exercised their 15,000,000 Warrants on a cashless basis.

Stock Option Grants

To date, we have not granted any stock options.

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Dividends

There are no restrictions in our articles of incorporation or bylaws that prevent us from declaring dividends. The Nevada Revised Statutes, however, do prohibit us from declaring dividends where after giving effect to the distribution of the dividend:

we would not be able to pay our debts as they become due in the usual course of business, or;

	2.	our total assets would be less than the sum of our total liabilities plus the amount that would be needed to satisfy the rights of shareholders who have preferential rights superior to those receiving the distribution.

We have not declared any dividends and we do not plan to declare any dividends in the foreseeable future.

Recent Sales of Unregistered Securities

On October 29, 2021, the Company issued 7,500,000 shares of stock in exchange for services provided by EMC2 Capital LLC. The shares were issued at fair value of the date of exchange, or $2,399,250.

As pursuant to the asset purchase agreement dated November 9, 2021, the Company acquired certain intellectual property rights of C2 Wellness Corp. In exchanges for the assets acquired, the Company issued 24,000,000 shares of common stock valued at $0.50 per share. The intellectual property rights acquired are recorded as intangible assets as of December 31, 2021 for $12,000,000.

On December 21, 2021, the company issued 520,000 shares of stock in exchange for $130,000 of cash consideration.

On February 8, 2022, the company issued 333,333 shares to an investor for an investment of $50,000 (at a price of $0.15 per share).

On or about March 3, 2022, the Company issued 16,000,000 shares of stock for services under a consulting agreement.

On April 5, 2022, the company issued 384,615 shares to an investor for an investment of $50,000 (at a price of $0.13 per share).

On April 29, 2022, the Company issued 1,500,000 shares for services under a consultancy agreement at $0.214 per share, or $321,000.

On May 2, 2022, the Company issued 280,000 shares to an investor relating to a subscription agreement for an investment of £100,000 Sterling (or $136,721) at $0.50 per share, or $140,000.

On May 4, 2022, we issued 2,250,000 shares of our common stock to our director, Mr. Michael Hunter Land, pursuant to his employment agreement dated October 18, 2021 and board decision to award him shares for his performance.

On August 1, 2022, the Company signed loan agreements with note holders for the sum of $75,000. A total of 2,250,000 shares were issued to the note holders in connection with loan agreements. These loans were repaid in full by December 23, 2022.

On June 6, 2023, the Company reclaimed 44,064,000 shares into Treasury.

On June 13, 2023, we issued 13,500,000 shares of common stock to EMC2 Capital LLC following the exercise of their 15,000,000 Warrants issued in August 2021.

On June 13, 2023, we issued 476,000 shares of common stock to Alison Rose Burgess as settlement of a £125,000 Sterling loan under the terms and conditions of the loan dated 21 September 2021.

On June 13, 2023, we issued 5,000,000 shares of common stock to Alinova Biosciences Ltd as part payment of consideration for the acquisition of intellectual property.

June 13, 2023, we issued 5,999,900 shares of common stock to Long Eight Limited as part payment of consideration for services received by Green Ocean Administration Limited.

June 13, 2023, we issued 10,088,100 shares of common stock to Warren Law Group to be held in escrow as potential part payment for services received from Bridgeway Capital Partners LLC, Bridgeway Capital Partners II LLC and Entoro Securities LLC.

On June 14, 2023, we issued 9,000,000 shares of common stock to our Directors as payment for their services as Directors.

These securities were issued pursuant to Section 4(a)(2) of the Securities Act and/or Rule 506 promulgated thereunder. The holders represented their intention to acquire the securities for investment only and not with a view towards distribution. The investors were given adequate information about us to make an informed investment decision. We did not engage in any general solicitation or advertising. We directed our transfer agent to issue the stock certificates with the appropriate restrictive legend affixed to the restricted stock. 35

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On September 8, 2023, the Company entered into an Agreement to Return Assets and Shares with C2 Wellness Corp. As part of the agreement, the company received 29,015,996 shares of ABTI stock and returned all assets related to the acquisition, resulting in a write-off of $12,000,000 in intangibles.

On October 16, 2023, TPR Global Limited, Equipped 4 Holdings Limited and Phytotherapeutix Holdings Ltd converted a total of $2.35m USD of debt in the Company into common shares at a price of $0.004 per share.

On December 21, 2023, we issued 8,360,306 shares as payment for services under a consultancy agreement at a price of $0.0036 per share.

On December 21, 2023, we issued 8,770,695 shares to Guy Webber as payment in lieu of payment of three months’ salary under his employment agreement at a price of $0.0036 per share.

Securities Authorized for Issuance under Equity Compensation Plans

We did not issue any securities under any equity compensation plan as of March 31, ~~2023~~2024.

Item 6. [RESERVED]

Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations ~~Forward-Looking Statements~~

This Annual Report on Form 10-K contains forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995. Certain statements, other than purely historical information, including estimates, projections, statements relating to our business plans, objectives, and expected operating results, and the assumptions upon which those statements are based, are “forward-looking statements.” These forward-looking statements generally are identified by the words “believes,” “project,” “expects,” “anticipates,” “estimates,” “intends,” “strategy,” “plan,” “may,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions. Forward-~~looking~~Looking statements are based on current expectations and assumptions that are subject to risks and uncertainties which may cause actual results to differ materially from the forward-looking statements. Our ability to predict results or the actual effect of future plans or strategies is inherently uncertain. Factors which could have a material adverse effect on our operations and future prospects on a consolidated basis include but are not limited to: changes in economic conditions, global pandemics, legislative/regulatory changes, availability of capital, interest rates, competition, and generally accepted accounting principles. These risks and uncertainties should also be considered in evaluating forward-looking statements and undue reliance should not be placed on such statements.Statements

~~Results~~This Annual Report on Form 10-K contains forward-looking statements, within the meaning of ~~Operations~~the Private Securities Litigation Reform Act of 1995. Certain statements, other than purely historical ~~for~~information, including estimates, projections, statements relating to our business plans, objectives, and expected operating results, and the ~~Years~~assumptions ~~Ended~~upon ~~March~~which 31those statements are based, ~~2023~~are “forward-looking statements.” These forward-looking statements generally are identified by the words “believes,” “project,” “expects,” “anticipates,” “estimates,” “intends,” “strategy,” “plan,” “may,” “will,” “would,” “will be,” “will continue,” “will likely result,” and ~~2022~~similar expressions. Forward-looking statements are based on current expectations and assumptions that are subject to risks and uncertainties which may cause actual results to differ materially from the forward-looking statements. Our ability to predict results or the actual effect of future plans or strategies is inherently uncertain. Factors which could have a material adverse effect on our operations and future prospects on a consolidated basis include but are not limited to: changes in economic conditions, global pandemics, legislative/regulatory changes, availability of capital, interest rates, competition, and generally accepted accounting principles. These risks and uncertainties should also be considered in evaluating forward-looking statements and undue reliance should not be placed on such statements.

WeTermination ~~have~~of ~~generated no revenue~~Relationship ~~since~~with ~~inception,~~Bright ~~and~~Green ~~we do not anticipate earning revenue until such time that we are able to market and sell our ingredients and / or products / medicines.~~Corporation

WeOn ~~incurred~~August ~~operating~~26, ~~expenses~~2022, we entered into a letter of $1intent (the “LOI”) dated August 25,~~896~~ 2022 with Bright Green Corporation (“Bright Green”),~~981~~ ~~and~~a $6Delaware corporation,~~471,134~~ with a binding provision for Bright Green to acquire a 25% interest (the ~~years~~“Share ~~ended~~Purchase”) ~~March~~in ~~31,~~our ~~2023~~company ~~and~~from existing ~~2022~~shareholders in exchange for $4,000,000 ~~respectively~~(the “Purchase Price”). ~~Our~~The ~~operating~~LOI ~~expenses~~also ~~for~~had ~~the~~a ~~year~~non-binding ~~ended~~option ~~March~~for Bright ~~31,~~Green ~~2023~~to ~~were~~acquire ~~mainly~~all of our outstanding capital stock. A Share Purchase Agreement was executed on October 3, 2022 and the ~~result~~Purchase Price for 25% of ~~$443~~the company stock,~~073~~ insold ~~consulting~~by ~~fees,~~three affiliate shareholders was $~~363,944~~4m inUS ~~professional~~dollars. ~~fees~~However, ~~$347,362~~the inshareholder ~~directors’~~affiliates ~~fees~~only ~~and~~ever ~~expenses,~~received a total of $~~179~~2,~~940~~350,000 inUSD ~~legal~~of ~~fees~~the ~~and $140~~4,~~409~~000,000 inUSD ~~salaries~~of stock sold. The non-binding option has expired for Bright Green to acquire our company and ~~wages~~the parties were not able to reach a new agreement. ~~Our~~As ~~operating~~a ~~expenses~~result, we terminated discussions with Bright Green for a potential acquisition, and Mr. Rafih departed the ~~year~~Board ~~ended~~of Directors on October 16, 2023. On March 3112, ~~2022~~2024, ~~were~~our ~~mainly~~company, Bright Green and the ~~result~~selling shareholders reached an agreement for Bright Green Corporation to return 83,226,814 shares of $3our common stock to the three shareholders (Equipped4 Holdings Limited (“Equipped”),~~155~~ Phytotherapeutix Holdings Ltd. (“Phyto”),~~593~~ and TPR Global Limited (“TPR”)) who had initially sold the shares to Bright Green. This was in ~~consulting~~exchange ~~fees,~~for settlement of the $21,~~432~~650,~~210~~000 inremaining ~~professional~~balance ~~fees,~~for ~~$341~~the shares as per the Share Purchase Agreement between the parties executed on October 03,~~286~~ in2022. ~~research~~Equipped, Phyto, and ~~development,~~TPR ~~$133~~each had returned to them approximately 27,~~036~~742,271 inshares ~~accounting~~of ~~and~~Alterola ~~audit~~common stock. The shares were transferred back on ~~fees~~June 3, 2024 and, ~~$194~~as a result of this agreement,~~643~~ inBright ~~salaries~~Green ~~and~~is ~~wages~~no longer a shareholder in our company.

If we are able to obtain financing, we expect that our operational expenses will increase significantly for the balance of the fiscal year ended March 31, 2024 and beyond. This would be the result of increased research and development expenses associated with our product candidates, the development of those candidates in compliance with regulatory processes, laws and regulations, increased payroll as we take on more help, as well as the expenses associated with our reporting obligations with the Securities and Exchange Commission.36

WeTable ~~recorded a net loss~~ of ~~$1,742,457~~ ~~and $6,471,134 for the years ended March 31, 2023 and 2022, respectively.~~Contents

AsAppointment aof ~~relatively~~Chief ~~recently~~Financial formed pharmaceutical company, the company has limited operations to date, and expects to have reoccurring losses, as is typical with companies in the pharmaceutical industry, for the foreseeable future. As explained above, the company intends to raise capital and ramp up its efforts to bring its product candidates to market. This will require significant capital, product development to continue and complete and momentum on those product candidates through the regulatory process. There are no assurances that we will be able to generate revenues and achieve profitable operations. Officer

34On October 10, 2023, we appointed Mr. Nathan Thompson as our Chief Financial Officer, Secretary and Director.

~~Table~~Sale of ~~Contents~~Assets acquired from C2 Wellness Corp.

~~Liquidity~~In November 2021, we acquired assets and ~~Capital~~IP from C2 Wellness Corporation. The consideration paid was 24,000,000 ABTI shares. On September 08, 2023, we agreed to sell ~~Resources~~the same assets and IP to C2 Wellness Corporation for a total of 29,015,993 of our shares.

AsAcquisition of ~~March~~IP ~~31, 2023, we~~from ~~had~~Alinova ~~$237,184~~Biosciences in current assets, consisting mostly of a deferred tax credit, and current liabilities of $2,127,807. We had a working capital deficit of $1,890,623 as compared with a working capital deficit of $1,630,685 as of December 31, 2022.Limited

WeOn ~~used~~April ~~cash for operating activities of $1~~18,~~039,792~~ ~~for the year ended March 31,~~ 2023, aswe ~~compared with cash provided of $44,344 for the year ended 2022. Our negative~~acquired ~~operating cash flow for 2023 was mainly~~ the ~~result~~interests of aAlinova ~~net~~Biosciences ~~loss,~~Ltd ~~net changes~~ in ~~operating~~the ~~assets~~IP ~~and~~pertaining ~~liabilities~~to ~~and~~the ~~deferred~~patent ~~tax~~Family ~~credit offset by shares issued for services~~PTX0001. ~~Our~~We ~~positive~~paid ~~operating~~the ~~cash~~following ~~flow~~consideration for ~~2022 was~~ the transaction: ~~result~~£35,000 ~~net~~Sterling ~~changes in operating assets~~ and ~~liabilities offset~~5,000,000 byABTI ~~our net loss~~shares.

WeConversion ~~used cash for investing activities~~ of ~~$139,799~~EMC2 ~~for the year ended March 31, 2023, as compared with no cash used in investing activities for the year ended 2022,~~Capital ~~for~~LLC ~~investments in intellectual property from C2 Wellness Corp. on December 2, 2021.~~Warrants

~~Financing~~On ~~activities~~June ~~provided $1~~13,~~212~~ 2023,~~159~~ ~~for~~EMC2 ~~the~~Capital LLC, ~~year~~exercised ~~ended~~its ~~March 31~~15, ~~2023~~000,000 ~~mainly~~warrants asthat awere ~~result~~issued ofto ~~related~~it ~~party~~on ~~loans~~August 11, as2021. ~~compared~~The ~~with~~exercise ~~$9,669~~was ~~used~~performed ~~for~~on ~~the~~a ~~year~~cashless ~~ended 2022~~basis, ~~mainly~~resulting in asour ~~result~~issuing of13,500,000 ~~repayments~~ABTI ~~of related party loans~~shares.

AsConversion ~~part~~ of ~~the~~Debt ~~SPA, executed on October 03, 2022, the shareholder affiliates, through their respective companies, have committed~~ to ~~enter into loan agreements with~~ ~~our company to provide up to $4,000,000 USD of working capital, subject to the terms and conditions of the SPA dated October 2022 being fulfilled.~~Equity

~~Based~~On ~~upon~~June ~~our current financial condition~~13, we do not have sufficient cash to operate our business at the current level for the next 12 months. We intend to fund operations through short-term or long-term debt and/or equity financing arrangements2023, ~~however~~an ~~this may be insufficient to fund expenditures or other~~investor ~~cash~~converted ~~requirements.~~her ~~If and when Bright Green completes the acquisition of Alterola~~£125,000 weSterling ~~anticipate~~loan ~~that~~into ~~Alterola and / or its subsidiaries will have sufficient cash therefrom. Without it, we plan to seek additional financing in a private~~ equity ~~offering~~as toper ~~secure funding for operations. There can be no assurance that we will be successful in raising additional funding. If we are not able to secure additional funding,~~ the ~~implementation~~Loan ofAgreement ~~our~~signed ~~business plan will be impaired. There can be no assurance that such additional financing will be available to us~~ on ~~acceptable~~September ~~terms~~21, ~~or at all~~2021.

~~Off~~Results ~~Balance~~of ~~Sheet~~Operations for ~~Arrangements~~the Years Ended March 31, 2024 and 2023

AsWe ofhave ~~March~~generated ~~31,~~no ~~2023~~revenue since inception, and we ~~had~~ nodo ~~off~~not ~~balance~~anticipate ~~sheet~~earning ~~arrangements~~revenue until such time that we are able to market and sell our ingredients and / or products / medicines.

~~Going~~We ~~Concern~~incurred operating expenses of $2,108,318 and $2,032,846 for the years ended March 31, 2024 and 2023, respectively. Our operating expenses for the year ended March 31, 2024 were mainly the result of $994,051 in consulting fees, $288,904 in professional fees, $251,999 in general and administrative expense, $227,575 in directors’ fees and expenses, $118,257 in accounting and audit fees and $124,924 in salaries and wages. Our operating expenses for the year ended March 31, 2023 were mainly the result of $546,903 in directors’ fees and expenses, $442,354 in consulting fees, $363,944 in professional fees, $181,805 in research and development, $179,846 in legal fees, $131,664 in salaries and wages and $118,611 in accounting and audit fees.

~~Our~~We ~~financial~~had ~~statements were~~other ~~prepared~~expenses ~~assuming we will continue as a going concern which contemplates the realization~~ of ~~assets and satisfaction of liabilities~~ in$266,061 for the ~~normal~~year ~~course~~ended ofMarch ~~business.~~31, ~~We have negative working capital of $1~~2024,~~890,623~~ ~~and~~as ~~have~~compared ~~incurred~~with ~~losses~~other ~~since~~expenses ~~inception~~ of $938,~~576,247. We~~340 ~~expect~~for ~~to incur further losses in~~ the ~~development~~year ofended ~~our~~March ~~business~~31, ~~and have been dependent on funding operations from inception~~2023. ~~These conditions~~Our ~~raise~~other ~~substantial doubt about our ability to continue as a going concern. Management’s plans include continuing to finance~~expense ~~operations~~for ~~through~~ the ~~private~~year orended ~~public~~March ~~placement~~31, of2024 ~~debt~~is ~~and/or~~largely ~~equity securities and~~ the ~~reduction~~result of ~~expenditures.~~an ~~However,~~impairment noexpense ~~assurance can~~and beour ~~given~~other atexpense ~~this~~for ~~time~~the asyear toended ~~whether~~March we31, ~~will be able to achieve these objectives. The financial statements do not include any adjustment~~2024 ~~relating~~was to the ~~recoverability~~result ~~and classification~~ of ~~recorded asset amounts or the amounts and classification of liabilities that might be necessary should we be unable to continue as~~ a ~~going~~loss ~~concern~~on currency.

~~Recently~~If ~~Issued~~we ~~Accounting~~are able to obtain ~~Pronouncements~~financing, we expect that our operational expenses will increase significantly for the balance of the fiscal year ended March 31, 2025 and beyond. This would be the result of increased research and development expenses associated with our product candidates, the development of those candidates in compliance with regulatory processes, laws and regulations, increased payroll as we take on more help, as well as the expenses associated with our reporting obligations with the Securities and Exchange Commission.

We dorecorded ~~not~~a ~~expect~~net ~~the~~loss ~~adoption~~ of $2,374,379 ~~recently~~and ~~issued~~$2,071,186 ~~accounting~~for ~~pronouncements~~the toyears ~~have~~ended aMarch ~~significant~~31, ~~impact~~2024 onand ~~our results of operation~~2023, ~~financial position or cash flow~~respectively.

3537

Table of Contents

~~Item~~As 7Aa relatively recently formed pharmaceutical company, the company has limited operations to date, and expects to have reoccurring losses, as is typical with companies in the pharmaceutical industry, for the foreseeable future. ~~Quantitative~~As explained above, the company intends to raise capital and ramp up its efforts to bring its product candidates to market. This will require significant capital, product development to continue and ~~Qualitative~~complete and ~~Disclosures~~momentum ~~About~~on ~~Market~~those ~~Risk~~product candidates through the regulatory process. There are no assurances that we will be able to generate revenues and achieve profitable operations.

ALiquidity ~~smaller~~and ~~reporting company~~Capital ~~is not required to provide the information required by this Item.~~Resources

~~Item~~As of March 31, 2024, we 8.had ~~Financial~~$3,663 ~~Statements~~in current assets and ~~Supplementary~~current ~~Data~~ liabilities of $1,333,264. We had a working capital deficit of $1,329,601 as compared with a working capital deficit of $2,084,015 as of March 31, 2023.

~~Index~~We toused ~~Financial~~cash for operating ~~Statements~~activities ~~Required~~of by$1,447,088 ~~Article~~for 8the year ended March 31, 2024, as compared with cash used for operating activities of ~~Regulation~~$1,307,324 ~~S-X:~~for ~~Audited~~the year ~~Financial~~ended ~~Statements:~~March 31, 2023. Our negative operating cash flow for 2024 and 2023 was mainly the result of a net loss, net changes in operating assets and liabilities offset by shares issued for services.

F-1	Report of Independent Registered Public Accounting Firm
F-2	Consolidated Balance Sheets as of March 31, 2023 and 2022 (Audited);
F-3	Statements of Operations for the years ended March 31, 2023 and 2022 (Audited);
F-4	Statement of Stockholders’ Deficit from inception to March 31, 2023 (Audited);
F-5	Consolidated Statements of Cash Flows for the years ended March 31, 2023 and 2022 (Audited);
F-6	Notes to Consolidated Financial Statements (Audited)

Financing activities provided $1,468,856 for the year ended March 31, 2024, mainly as a result of related party loans and share issuances for conversions, as compared with $1,199,073 provided for the year ended March 31, 2023, mainly as a result of related party loans.

36As part of the SPA, executed on October 03, 2022, the shareholder affiliates, through their respective companies, committed to loan monies to the company to provide up to $4,000,000 USD of working capital.

~~Table~~Based upon our current financial condition, we do not have sufficient cash to operate our business at the current level for the next 12 months. We intend to fund operations through short-term or long-term debt and/or equity financing arrangements, however this may be insufficient to fund expenditures or other cash requirements. We plan to seek additional financing in a private equity offering to secure funding for operations. There can be no assurance that we will be successful in raising additional funding. If we are not able to secure additional funding, the implementation of ~~Contents~~our business plan will be impaired. There can be no assurance that such additional financing will be available to us on acceptable terms or at all.

~~Gries~~Off &Balance ~~Associates,~~Sheet ~~LLC Certified Public Accountants 501 S. Cherry Street, Suite 1100 Denver, Colorado 80246~~Arrangements

~~REPORT~~As OFof ~~INDEPENDENT~~March 31, 2024, we ~~REGISTERED~~had ~~PUBLIC~~no ~~ACCOUNTING~~off-balance ~~FIRM~~sheet arrangements.

ToGoing ~~the Board of Directors and Stockholders Alterola Biotech, Inc.~~Concern

~~Opinion~~Our financial statements were prepared assuming we will continue as a going concern which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. We have negative working capital of $1,329,601 and have incurred losses since inception of $12,416,075. We expect to incur further losses in the development of our business and have been dependent on funding operations from inception. These conditions raise substantial doubt about our ability to continue as a going concern. Management’s plans include continuing to finance operations through the private or public placement of debt and/or equity ~~Financial~~securities ~~Statements~~and the reduction of expenditures. However, no assurance can be given at this time as to whether we will be able to achieve these objectives. The financial statements do not include any adjustment relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should we be unable to continue as a going concern.

We have audited the accompanying balance sheets of Alterola Biotech, Inc. (the Company), which comprise the balance sheet as of March 31, 2023 and March 31, 2022 and the related statements of Operations, Changes in Stockholder’s Equity, and Cash Flows for the years then ended, and the related notes to the financial statements. In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of March 31, 2023 and 2022, respectively, and the results of its operations and its cash flows for each of the years then ended, in conformity with accounting principles generally accepted in the United States of America.38

~~Basis for~~Table ~~Opinion~~of Contents

~~These~~Recently ~~financial~~Issued statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting ~~Oversight Board (United~~ Sates) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.Pronouncements

We ~~conducted~~do ~~our audits~~not inexpect ~~accordance with~~ the ~~standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable~~adoption ~~assurance about whether the financial statements are free~~ of ~~material~~recently ~~misstatement,~~issued ~~whether~~accounting ~~due~~pronouncements to ~~error or fraud. The Company is not required to~~ have, ~~nor~~a ~~were~~significant weimpact ~~engaged~~on ~~to perform, an audit of its internal control over financial reporting. As part of~~ our ~~audits~~results ~~we were required to obtain an understanding~~ of ~~internal~~operation, ~~control over~~ financial ~~reporting~~position ~~but~~or ~~not~~cash ~~for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting~~flow. ~~Accordingly, we express no such opinion.~~

~~Our~~Item ~~audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks~~7A. ~~Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures~~Quantitative ~~in the financial statements. Our audits also included evaluation of the accounting principles used~~ and ~~significant~~Qualitative ~~estimates~~Disclosures ~~made~~About ~~by management,~~Market ~~as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.~~Risk

~~Going~~A ~~Concern~~smaller reporting company ~~Uncertainty~~is not required to provide the information required by this Item.

~~The~~Item ~~accompanying financial statements have been prepared assuming that the Company will continue as a going concern~~8. AsFinancial ~~discussed~~Statements ~~in note 7 to the financial statements, the Company has negative working capital of $ 1,889,903, has incurred losses since inception of $9,576,247,~~ and ~~has~~Supplementary ~~not received any revenues~~Data These factors create an uncertainty as to the Company’s ability to continue as a going concern. Management’s plans in regard to these matters are also described in note 7. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

~~Critical~~Index to Financial ~~Audit~~Statements ~~Matter~~Required by Article 8 of Regulation S-X: Audited Financial Statements:

The critical audit matter communicated below is a matter arising from the current-period audit of the financial statements that was communicated or required to be communicated to the audit committee and that (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgements. The communication of critical audit matters does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the disclosures to which it relates.

	F-1	Report of Independent Registered Public Accounting Firm
	F-2	Consolidated Balance Sheets as of March 31, 2024 and 2023;
	F-3	Statements of Operations for the years ended March 31, 2024 and 2023;
	F-4	Statement of Stockholders’ Deficit for the years ended March 31, 2024 and 2023;
	F-5	Consolidated Statements of Cash Flows for the years ended March 31, 2024 and 2023;
	F-6	Notes to Consolidated Financial Statements

~~Intangible Assets~~39

~~Critical Audit~~Table ~~Matter~~of ~~Description~~Contents

~~On November~~Report ~~9, 2021, the Company entered into an agreement with C2 Wellness Corporation for acquisition~~ of ~~technology~~Independent ~~platforms~~Registered ~~and~~Public ~~associated intellectual~~Accounting ~~property.~~Firm

~~The transaction~~To ~~was closed by providing 24,000,000 million shares of~~ the ~~company~~Board ~~to the prior owners~~ of C2Directors ~~Wellness Corporation, who stayed on~~ and ~~are working as consultants for the company. At the date of acquisition, the price per share of the company shares was $0.50, and~~ ~~the~~Stockholders ~~value~~ of ~~the~~Alterola ~~intangible~~Biotech ~~asset identified was $12,000,000~~Inc. The Company tests impairment by either performing a qualitative evaluation or a quantitative test, at least annually, or more frequently if an indication of impairment exists. Managements Quantitative Intangible Assets impairment testing is performed in the fourth quarter of the fiscal year by comparing the estimated fair value of the associated reporting unit as of March 31 to it carrying value. Fair value is estimated using a discounted cash flow model.

~~Significant judgment~~Opinion ison ~~exercised by~~ the ~~Company~~Financial ~~in determining the accounting policies related to these Intangible Assets impairment assumptions, including the following:~~Statements

·We ~~Estimated~~have ~~revenue~~audited ~~growth~~the ~~rate~~accompanying ~~for~~balance ~~the~~sheets of ~~projection~~Alterola ~~period~~Biotech ·Inc. ~~Estimation~~(the ofCompany) ~~operating~~as ~~cash~~of ~~flows~~March ~~based~~31, on2024 ~~forecasted~~and ~~figures~~2023, ~~for~~and the ~~impairment~~related ~~model~~statements ·of ~~Review~~operations, ofstockholders’ ~~the~~deficit, and ~~assets~~cash ~~acquired~~flows asfor ~~part~~each of the ~~transaction.~~years ·in ~~Review~~the ofperiods ~~any~~ended ~~possible~~in ~~projected~~March ~~revenues~~31, or2024 ~~development~~and ofMarch ~~assets~~31, ~~for~~2023, ~~future~~and ~~periods. · Discussion with~~ the ~~development~~related ~~team~~notes ~~related~~(collectively referred to ~~timeline~~as ~~for~~the ~~possible~~financial ~~production~~statements).

~~Given these~~In ~~factors~~our opinion, the ~~related~~financial ~~audit~~statements ~~effort~~present fairly, in ~~evaluation~~all ~~management’s~~material ~~judgements~~respects, inthe ~~determining~~financial ~~Intangible~~position ~~Assets~~of ~~value~~the ~~was~~Company ~~extensive~~as of March 31, 2024 and 2023, and the results of its operations and ~~required~~its acash ~~high~~flows ~~degree~~for each of ~~auditor~~the ~~judgement~~years in the period ended March 31, 2024 and March 31, 2023, in conformity with accounting principles generally accepted in the United States of America.

~~How the~~Explanatory ~~Critical~~Paragraph ~~Audit~~– ~~Matter Was Addressed in the Audit~~Restatement

~~Our principal~~As ~~audit~~discussed ~~procedures~~in ~~related~~Note 2 to the ~~Company’s~~financial ~~Intangible~~statements, the ~~Assets~~2023 ~~impairment~~financial ~~evaluation~~statements ~~included~~have ~~the~~been ~~following:~~restated to correct misstatements.

·Consideration ~~Reviewed Qualitative items for Intangible Assets impairment, determining if there was a need to perform Quantitative assessment. · Recalculated the Quantitative assessment~~ of the ~~Intangible~~Company’s ~~Assets~~Ability to ~~calculation,~~Continue ~~including~~as a ~~reasonableness~~Going test of the discount rate and projected growth rate. · Reviewing projections to comparable companies, ensuring reasonableness of the rates used. · Verified no impairment noted based on recalculations performed.Concern

~~Shares~~The accompanying financial statements have been ~~issued~~prepared ~~for~~assuming ~~services~~that the Company will continue as a going concern. As discussed in Note 1 to the financial statements, the Company has suffered recurring losses from operations and has a net capital deficiency that raises substantial doubt about its ability to continue as a going concern. Management's plans in regard to these matters are also described in Note 1. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

~~Critical Audit~~Basis ~~Matter~~for ~~Description~~Opinion

~~At various~~These ~~points~~financial ~~throughout~~statements are the ~~year,~~responsibility of the Company’s ~~issued~~management. ~~stock~~Our inresponsibility ~~exchange~~is ~~for~~to ~~services~~express ~~provided~~an ~~from~~opinion ~~EMC2~~on ~~Capital~~the ~~and~~Company’s ~~REB~~financial ~~Consulting. As~~statements ~~part~~based ofon ~~the~~our audits. ~~issuance~~We ofare ~~shares,~~a ~~the~~public ~~Company~~accounting ~~valued~~firm registered with the ~~shares~~Public atCompany ~~what~~Accounting ~~was~~Oversight ~~considered~~Board ~~fair~~(United ~~value~~States) as(PCAOB) ofand ~~the~~are required ~~date~~to ofbe ~~the~~independent ~~issuance.~~with ~~The company~~respect ~~considered~~to the ~~fair~~Company ~~value~~in ataccordance with the ~~date~~U.S. offederal ~~issuance~~securities tolaws beand the ~~share~~applicable ~~price~~rules and regulations of the ~~Company~~Securities onand ~~the~~Exchange ~~date~~Commission ofand ~~issuance~~the PCAOB.

~~How~~We conducted our audits in accordance with the standards of the ~~Critical~~PCAOB. ~~Audit~~Those ~~Matter~~standards ~~Was~~require ~~Addressed~~that inwe plan and perform the ~~Audit~~audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.

Our audits included performing procedures to assess ~~principal~~the ~~audit~~risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures ~~related~~that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the ~~Company’s~~amounts ~~stock~~and ~~issued~~disclosures ~~for~~in ~~services~~the financial statements. Our audits also included evaluating the ~~following:~~accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.

·Critical ~~Confirmed~~Audit the issuance of shares with the transfer agent to verify the shares were released to the identified parties. · Reviewed the share value as of the date of issuance and performed recalculation of the valuation. · Verified the expense recorded was properly included on the statement of operations in the appropriate expense category.Matters

~~Emphasis~~The critical audit matters communicated below are matters arising from the current period audit of ~~Matters-Risks~~the financial statements that were communicated or required to be communicated to the audit committee and ~~Uncertainties~~that: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.

~~The Company is not able to predict the ultimate impact that COVID -19 will have on its business~~I. ~~However,~~Going if the current economic conditions continue, the pandemic could have an adverse impact on the economies and financial markets of many countries, including the geographical area in which the Company plans to operate.Concern

WeCritical ~~have~~Audit ~~served~~Matter ~~as the Company’s auditor since 2021. Denver, Colorado July 7, 2023 PCAOB# 6778~~Description

~~blaze@griesandassociates~~As described in Note 1, the Company’s has negative working capital, has incurred losses since inception and has not received revenues from sales of products or services.~~com~~ The principal funding for its operations depends on the funding from related parties. These factors create substantial doubt about the Company’s ability to continue as a going concern. The financial statements do not include any adjustment that might be necessary if the Company is unable to continue as a going concern. operations are mainly funded with debt financing, which is dependent upon many external factors and may be difficult to raise when required. The Company may not have sufficient cash to fund its operations, and therefore, will require additional funding, which if not raised, may result in the delay, postponement or curtailment of some or all of its activities. Management’s plans include selling its equity securities and obtaining debt financing to fund its capital requirement and ongoing operations; however, there can be no assurance the Company will be successful in these efforts.

~~400~~We ~~South~~identified the Company’s ability ~~Colorado~~to ~~Blvd,~~continue ~~Suite~~as ~~870,~~a ~~Denver,~~going ~~Colorado~~concern ~~80246~~as a critical audit matter because auditing the Company’s going concern assessment is complex and involves a high degree of auditor judgment to assess the reasonableness of the planned financing actions and other assumptions used in the Company’s going concern analysis.

~~(O)720-464-2875 (M)773-255-5631~~Audit ~~(F)720-222-5846~~Response

~~F-1~~We responded to this matter by performing procedures over management’s assessment of the Company’s ability to continue as a going concern. Our audit work in relation to this included, but was not restricted to, the following:

~~Table~~· ofWe ~~Contents~~inquired with management whether there is substantial doubt regarding the Company’s ability to continue as a going concern;

~~PART I~~· -We ~~FINANCIAL~~inquired ~~INFORMATION~~and evaluated management’s plan for future actions, including subsequent events, and whether the outcome of these plans is likely to improve the situation and assessed the feasibility of the plan;

~~ALTEROLA BIOTECH,~~· ~~INC~~We reviewed the related financial statement disclosure in the notes to the financial statements to ensure they are adequate.

~~AUDITED CONSOLIDATED~~II. ~~BALANCE~~Foreign ~~SHEETS~~Currency Translation

ASThe consolidated financial statements are presented OFin ~~MARCH~~US 31Dollars. The transactions of the foreign subsidiaries where US dollars are not the functional currency are originally recorded on its local currency (GBP) and translated at year end per reporting purposes, ~~2023~~in ~~AND~~accordance ~~MARCH~~with 31the Accounting Standards Codification (“ASC”) Topic 830 Foreign Currency Transaction issued by the Financial Accounting Standards Board (“FASB”). According to Topic 830, all ~~2022~~ assets and liabilities are translated at the exchange rate on the balance sheet date, stockholders’ equity is translated at historical rates and statement of operations items are translated at the weighted average exchange rate for the period. The resulting translation adjustments are reported under other comprehensive income (loss) in accordance with ASC Topic 220, Comprehensive Income. Gains and losses resulting from the translations of foreign currency transactions and balances are reflected in the statement of operations and comprehensive income (loss).

	March 31, 2023			March 31, 2022
ASSETS
Current Assets
Bank	$	8,890		$	63,816
Funds in attorney trust account		—			12,409
VAT receivable		37,953			50,686
Deferred tax asset		189,355			—
Inventories		986			1,050
Total current assets		237,184			127,961
Intangible assets		12,139,779			12,000,000
TOTAL ASSETS	$	12,376,963		$	12,127,961
LIABILITIES AND STOCKHOLDERS’ DEFICIT
Current Liabilities
Accounts payable	$	611,805		$	542,510
Accrued expenses		254,864			396,486
Loan payable, related party		1,260,434			98,470
Total Current Liabilities		2,127,103			1,037,465
Convertible Note Payable		154,313			164,220
Total Liabilities		2,281,416			1,201,685
Stockholders’ Equity (Deficit)
Preferred Stock, $.001 par value, 10,000,000 shares authorized, -0- shares issued and outstanding		—			—
Common Stock, $.001 par value, 2,000,000,000 shares authorized, 807,047,948 and 802,633,333 shares issued and outstanding, respectively		807,048			802,633
Additional paid-in capital		18,927,919			18,079,554
Accumulated deficit		(9,576,247	)		(7,970,510	)
Foreign currency translation adjustment		(63,173	)		14,599
Total Stockholders’ Equity (Deficit)		10,095,547			10,926,276
TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT	$	12,376,963		$	12,127,961

We identified the Company’s calculation of the foreign currency translation as a critical audit matter because it has a moderate level of complexity and involves additional effort from the auditor to assess the reasonableness of the Company’s analysis.

~~See accompanying~~Audit ~~notes to financial statements.~~Response

~~F-2~~We responded to this matter by performing procedures over management’s conversion of balances.

~~Table~~· ofWe ~~Contents~~reconciled the trial balances in local currency from the subsidiaries to the general ledgers at year end.

~~ALTEROLA~~· ~~BIOTECH~~We recalculated the conversion balances in US dollars per reporting purposes by verifying that the assets and liabilities were converted using the year end exchange rate, ~~INC~~the equity was converted using the historical rates and the results were converted using the average exchange rate form the year.

~~AUDITED CONSOLIDATED~~· ~~STATEMENT~~We OFverified ~~OPERATIONS~~that the difference in the trial balance after applying different conversion rates was booked as currency translation adjustment in the Other Comprehensive Income.

~~FOR THE~~/s/ ~~YEARS~~Green ~~ENDED~~Growth ~~MARCH 31, 2023 AND 2022~~CPAs

	Year Ended March 31, 2023			Year Ended March 31, 2022
REVENUES	$	—		$	—
OPERATING EXPENSES
Accounting and audit fees		106,893			133,036
Professional fees		363,944			2,432,210
Research and development		46,422			341,286
Legal fees		179,940			38,248
Directors fees and expenses		347,362			82,913
Consulting fees		443,073			3,155,593
Salaries and wages		140,409			194,693
General and administrative expenses		68,938			93,206
TOTAL OPERATING EXPENSES		1,896,981			6,471,134
LOSS FROM OPERATIONS		(1,896,981	)		(6,471,134	)
OTHER INCOME (EXPENSE)
Miscellaneous sale		—			—
TOTAL OTHER INCOME (EXPENSE)		—			—
PROVISION FOR INCOME TAXES		(154,524	)		—
NET LOSS		(1,742,457	)		(6,471,134	)
NET LOSS PER SHARE: BASIC AND DILUTED	$	(0.00	)	$	(0.00	)
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING: BASIC AND DILUTED		806,332,740			769,967,671

July 17, 2024

~~See accompanying~~We ~~notes~~have toserved ~~financial~~as ~~statements~~the Company’s auditor since 2023.

~~F-3~~Los Angeles, California

~~Table~~PCAOB ofID ~~Contents~~Number 6580

~~ALTEROLA BIOTECH, INC.~~F-1

~~AUDITED CONSOLIDATED~~Table ~~STATEMENT~~of ~~OF STOCKHOLDERS’ EQUITY (DEFICIT)~~Contents

~~FOR THE~~ALTEROLA ~~PERIOD FROM JANUARY 7~~BIOTECH, ~~2021 (INCEPTION) TO MARCH 31, 2023~~ INC.

	Common stock
	Shares		Amount		Additional paid in capital			Accumulated other comprehensive income ( loss)			Deficit			Total
Balance, January 7, 2021(inception)		100	$	136		—		$	—		$	—		$	136
Related party interest forgiven		—		—		1,544			—			—			1,544
Recapitalization on reverse merger		754,279,900		754,144		(1,544	)		—			(1,156,343	)		(403,743	)
Change in foreign currency		—		—		—			(14,023	)		—			(14,023	)
Net loss for the period ended March 31, 2021		—		—		—			—			(343,033	)		(343,033	)
Balance, March 31, 2021		754,280,000	$	754,280		—		$	(14,023	)	$	(1,499,376	)	$	(759,119	)
Change in foreign currency		—		—		—			28,622			—			28,622
Shares issued for cash		853,333		853		367,804			—			—			368,657
C2 Wellness Acquisition		24,000,000		24,000		11,976,000			—			—			12,000,000
Shares related to S-1 Registration		7,500,000		7,500		2,391,750			—			—			2,399,250
Shares issued for REB Consulting		16,000,000		16,000		3,344,000			—			—			3,360,000
Net loss for the period ended March 31, 2022		—		—		—			—			(6,471,134	)		(6,471,134	)
Balance, March 31, 2022		802,633,333	$	802,633		18,079,554		$	14,599	)	$	(7,970,510	)	$	10,926,276
Change in foreign currency		—		—		—			(77,772	)		—			(77,772	)
Shares issued for cash		280,000		280		—			—			136,721			137,001
Shares issued for cash		384,615		385		49,615			—			—			50,0000
Shares issued for services		1,500,000		1,500		319,500			—			—			321,000
Shares issued for services		2,250,000		2,250		479,250			—			—			481,500
Net loss for the period ended March 31, 2023		—		—		—			—			(1,742,457	)		(1,742,457	)
Balance, March 31, 2023		807,047,948	$	807,048		18,927,919		$	(63,173	)	$	(9,576,247	)	$	10,095,547

AUDITED CONSOLIDATED BALANCE SHEETS

~~See~~AS ~~accompanying~~OF ~~notes~~MARCH to31, ~~financial~~2024 ~~statements.~~ AND MARCH 31, 2023

F-4

	March 31, 2024			March 31, 2023 (as restated)
ASSETS
Current Assets
Bank	$	2,654		$	8,899
VAT receivable		—			36,426
Deferred tax asset		—			—
Inventories		1,009			990

Total Current Assets		3,663			46,315

Intangible assets		—			12,000,000

TOTAL ASSETS	$	3,663		$	12,046,315

LIABILITIES AND STOCKHOLDERS’ DEFICIT

Current Liabilities
Accounts payable	$	825,210		$	613,729
Accrued expenses		362,451			259,960
Loan payable, related party		145,603			1,256,641
Total Current Liabilities		1,333,264			2,130,330

Convertible Note Payable		—			154,841

Total Liabilities		1,333,264			2,285,171

Stockholders’ Equity (Deficit)
Preferred Stock, $.001 par value, 10,000,000 shares authorized, -0- shares issued and outstanding		—			—
Common Stock, $.001 par value, 2,000,000,000 shares authorized, 1,382,662,952 and 807,047,948 shares issued and outstanding, respectively		1,382,644			807,048
Additional paid-in capital		9,663,970			18,927,919
Accumulated deficit		(12,416,075	)		(10,041,696	)
Foreign currency translation adjustment		39,860			67,873
Total Stockholders’ Equity (Deficit)		(1,329,601	)		9,761,144

TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT	$	3,663		$	12,046,315

~~Table~~See ofaccompanying ~~Contents~~notes to financial statements.

~~ALTEROLA BIOTECH, INC.~~F-2

~~AUDITED CONSOLIDATED~~Table ~~STATEMENT~~of ~~OF CASH FLOWS~~Contents

~~FOR~~ ~~THE~~ALTEROLA ~~YEARS ENDED MARCH 31~~BIOTECH, ~~2023 AND 2022~~ INC.

	Year Ended March 31, 2023			Year Ended March 31, 2022
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss for the period	$	(1,742,457	)	$	(6,471,134	)
Adjustments to reconcile net loss to net cash flows used in operating activities
Shares issued for services		802,500			5,759,250
Deferred tax asset		(189,535	)		—
Non cash currency adjustments		136,721			—
Changes in assets and liabilities:
Funds in attorney trust		12,409			(12,409	)
Inventory		—			(1,050	)
VAT receivable		12,733			(50,686	)
Deferred tax asset		12,409			2,500
Accounts payable		69,295			444,131
Accrued liabilities		(141,638	)		376,242
Net Cash (Used by)/Provided by Operating Activities		(1,039,792	)		44,344
CASH FLOWS FROM INVESTING ACTIVITIES
Investment in intellectual property		(139,799	)		—
Net Cash Used by Investing Activities		(139,799	)		—
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from share issuance		50,295			368,657
Loan from related parties		1,164,964			(542,545	)
Convertible debt issuance		—			164,220
Net Cash Provided by/Used by Financing Activities		1,212,159			(9,669	)
Net change in cash		32,689			34,675
Foreign currency change		(87,615	)		28,622
Cash and cash equivalents, beginning of period		63,816			519
Cash and cash equivalents, end of period	$	8,890		$	63,816
SUPPLEMENTAL CASH FLOW INFORMATION
Interest paid	$	—			—
Income taxes paid	$	—			—
NON-CASH INVESTING AND FINANCING INFORMATION

AUDITED CONSOLIDATED STATEMENT OF OPERATIONS

~~See accompanying~~FOR ~~notes~~THE toYEARS ~~financial~~ENDED ~~statements.~~MARCH 31, 2024 AND 2023

F-5


	Year Ended March 31, 2024			Year Ended March 31, 2023 (as restated)

REVENUES	$	—			—

OPERATING EXPENSES
Accounting and audit fees		118,257			118,611
Professional fees		288,904			363,944
Research and development		28,770			181,805
Legal fees		73,838			179,846
Directors fees and expenses		227,575			546,903
Consulting fees		994,051			442,354
Salaries and wages		124,924			131,664
General and administrative expenses		251,999			67,719
TOTAL OPERATING EXPENSES		2,108,318			2,032,846

LOSS FROM OPERATIONS		(2,108,318	)		(2,032,846	)

OTHER INCOME (EXPENSE)
Impairment losses of intangible assets		(392,278	)		—
Impairment losses of deferred tax asset		(39,567	)		(20,484	)
Gain on forgiveness of debt		138,137			—
Foreign exchange influences		27,647			(17,856	)
TOTAL OTHER INCOME (EXPENSE)		(266,061	)		(38,340	)

PROVISION FOR INCOME TAXES		—			—

NET LOSS		(2,374,379	)		(2,071,186	)

NET LOSS PER SHARE: BASIC AND DILUTED	$	(0.00	)	$	(0.00	)

WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING: BASIC AND DILUTED		1,051,629,613			807,047,948
NET LOSS		(2,374,379	)		(2,071,186	)

Foreign translation adjustment		(28,013	)		53,274
Comprehensive Loss		(2,402,392	)		(2,017,912	)

~~Table~~See ofaccompanying ~~Contents~~notes to financial statements.

~~ALTEROLA BIOTECH, INC.~~F-3

~~NOTES TO~~Table ~~THE~~of ~~AUDITED CONSOLIDATED FINANCIAL STATEMENTS~~Contents

~~MARCH 31,~~ALTEROLA ~~2023~~BIOTECH INC.

~~NOTE 1~~AUDITED –CONSOLIDATED ~~NATURE~~STATEMENT OF ~~BUSINESS~~STOCKHOLDERS’ DEFICIT FOR THE YEARS ENDED MARCH 31, 2024 AND MARCH 31, 2023 (as restated)

After formation, the Company was in the business of mineral exploration. On May 3, 2010, the Company sold its mineral exploration business and entered into an Intellectual Property Assignment Agreement (“IP Agreement”) with Soren Nielsen pursuant to which Mr. Nielsen transferred his right, title and interest in all intellectual property relating to certain chewing gum compositions having appetite suppressant activity (the “IP”) to the Company for the issuance of 55,000,000 shares of the Company’s common stock.


	Common Stock						Treasury Shares
	$0.001 Par Value						$0.001 Par Value
	Shares			Amount			Shares			Amount			Additional Paid-in Capital			Stock Subscription			OCI			Accumulated (Deficit)			Total Stockholders' Equity (deficit)
BALANCES, March 31, 2022		802,633,333		$	802,633			—		$	—			17,942,833		$	136,721		$	14,599		$	(7,970,510	)	$	10,926,276

Change in foreign currency		—			—			—			—			—			—			53,274			—			53,274
Shares issued for cash		384,615			385			—			—			49,615			—			—			—			50,000
Shares issued for subscription of cash		280,000			280			—			—			136,721			(136,721	)		—			—			280
Shares issued for services		1,500,000			1,500			—			—			319,500			—			—			—			321,000
Shares issued for services		2,250,000			2,250			—			—			479,250			—			—			—			481,500
Net loss for the period ended March 31, 2023		—			—			—			—			—			—						(2,071,186	)		(2,071,186)
Balances March 31, 2023		807,047,948			807,048			—			—			18,927,919			—			67,873			(10,041,696	)		9,761,144
Shares reclaimed into Treasury shares		(44,064,000	)		(44,064	)		44,064,000		$	44,064			—			—			—			—			—
Shares issued for settlement of debt		476,000			476			(476,000	)		(476	)		157,339			—			—			—			157,339
Shares issued for exercise of warrants		13,500,000			13,500			(13,500,000	)		(13,500	)		—			—			—			—			—
Shares issued for acquisition of Alinova Biosciences		5,000,000			5,000			(5,000,000	)		(5,000	)		295,000			—			—			—			295,000
Shares issued for services		16,088,000			16,088			(16,088,000	)		(16,088	)		305,652			—			—			—			305,652
Shares issued for services - Directors		9,000,000			9,000			(9,000,000	)		(9,000	)		171,000			—			—			—			171,000
Shares reclaimed from asset acquisition cancellation		(24,000,000	)		(24,000	)		24,000,000			24,000			(12,000,000	)		—			—			—			(12,000,000)
Additional shares reclaimed from asset acquisition cancellation		(5,015,996	)		(5,016	)		5,015,996			5,016			—			—			—			—			—
Shares issued for conversion of debt		587,499,996			587,500			(29,015,996	)		(29,016	)		1,762,500			—			—			—			2,320,984
Shares issued for services		8,360,306			8,360			—			—			21,737			—			—			—			30,097
Shares issued for services - management		8,770,695			8,771			—			—			22,804			—			—			—			31,575
Change in foreign currency		—			—			—			—			—			—			(28,013	)		—			(28,013)

Net loss for the period		—			—			—			—			—			—			—			(2,374,379	)		(2,374,379)
BALANCES, March 31, 2024		1,382,662,949			1,382,663			—			—			9,663,951			—			39,860			(12,416,075	)		(1,329,601)

~~Following the~~See ~~acquisition~~accompanying ofnotes ~~the IP the Company changed its business direction~~ to ~~pursue~~financial the development of chewing gums for the delivery of Nutraceutical/functional ingredients for applications such as appetite suppressant, cholesterol suppressant, vitamin delivery, antioxidant delivery and motion sickness suppressantstatements.

On January 19, 2021, the Company entered into an Stock Purchase Agreement (the “Agreement”) with ABTI Pharma Limited, a company registered in England and Wales (“ABTI Pharma”), pursuant to which the Company agreed to acquire all of the outstanding shares of capital stock of ABTI Pharma from its shareholders in exchange for 600,000,000 shares of the Company pro rata to the ABTI Pharma shareholders. The shares were issued on January 29, 2021 in anticipation of the closing and the parties to the transaction agreed in a May 24, 2021 amendment to close upon the ABTI Pharma Limited Shares being transferred to the Company, which was to occur upon the filing by the Company of its outstanding December 31, 2020 quarterly report on Form 10F-~~Q, which was filed on May 28, 2021 with the Securities and Exchange Commission. The transaction closed on May 28, 2021.~~4

~~The transaction~~Table is being accounted for as a reverse acquisition and recapitalization. ABTI Pharma is the acquirer for accounting purposes and the Company is the issuer. The historical financial statements presented are the financial statements of ~~ABTI. The Agreement was treated as a recapitalization and not as a business combination; at the date of the acquisition, the net liabilities of the legal acquirer, Alterola, were $389,721.~~Contents

~~As a~~ALTEROLA ~~consequence the company is now developing cannabinoid~~BIOTECH, cannabinoid-like, and non-cannabinoid pharmaceutical active pharmaceutical ingredients (APIs), pharmaceutical medicines made from cannabinoids, cannabinoid-like, and non-cannabinoid APIs and will seek European novel food approval of certain ingredients and products INC.~~In addition, the company plans to develop such bulk ingredients for supply into the cosmetic sector.~~

~~NOTE 2~~AUDITED –CONSOLIDATED ~~SUMMARY~~STATEMENT OF ~~SIGNIFICANT~~CASH ~~ACCOUNTING POLICIES~~FLOWS

~~Basis~~FOR ofYEARS ~~Presentation~~ENDED MARCH 31, 2024 AND MARCH 31, 2023

The accompanying consolidated financial statements were prepared in accordance with accounting principles generally accepted in the United State of America (GAAP accounting) and include the accounts of Alterola and its wholly owned subsidiaries ABTI Pharma, Phytotherapeutix Ltd, and Ferven Ltd. All material intercompany transactions and balances have been eliminated.


	Year Ended March 31, 2024			Year Ended March 31, 2023 (as restated)
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss for the period	$	(2,374,379	)	$	(2,071,186	)
Adjustments to reconcile net loss to net cash flows used in operating activities
Shares issued for services		538,324			802,500
Changes in assets and liabilities:
Funds in attorney trust		—			12,414
Inventory		(19	)		60
VAT receivable		65,110			14,260
Accounts payable		221,385			71,219
Accrued liabilities		102,491			(136,531	)
Net Cash Used in Operating Activities		(1,447,088	)		(1,307,264	)

CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from share issuance		—			50,281
Loan from related parties		1,468,856			1,148,792
Net Cash Provided by Financing Activities		1,468,856			1,199,073

Net change in cash		21,768			(108,191	)

Foreign currency change		(28,013	)		53,274

Cash and cash equivalents, beginning of period		8,899			63,816
Cash and cash equivalents, end of period	$	2,654		$	8,899

SUPPLEMENTAL CASH FLOW INFORMATION

NON-CASH INVESTING AND FINANCING INFORMATION
Return of intangible assets	$	12,000,000		$	—
Impairment of deferred tax asset	$	39,567		$	20,484
Shares issued for Allinova acquisition	$	300,000		$	—
Impairment of intangible assets	$	392,278		$	—
Non-cash intangible additions	$	92,278		$	—
Shares issued for forgiveness of debt	$	157,339		$	—
Gain on debt conversion	$	138,163		$	—
Shares issued for conversion of debt	$	2,320,984		$	—

~~The Company~~See ~~had~~accompanying anotes ~~September 30 fiscal year end. Subsequent~~ to ~~the~~financial ~~Agreement with ABTI Pharma, the Company has changed its year end from September 30 to March 31~~statements.

~~Use of Estimates~~F-5

~~The preparation~~Table of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date the financial statements and the reported amount of revenues and expenses during the reporting period. Actual results could differ from those estimates.Contents

~~Cash~~ALTEROLA ~~and~~BIOTECH, ~~Equivalents~~INC.

~~For~~NOTES ~~purposes~~TO ofTHE ~~the~~UNAUDITED ~~statement~~CONSOIDATED ofFINANCIAL ~~cash flows, the Company considers highly liquid financial instruments purchased with a maturity of three months or less to be cash equivalents.~~STATEMENTS

~~F-6~~MARCH 31, 2024

~~Table~~NOTE 1– ofNATURE ~~Contents~~OF BUSINESS

~~ALTEROLA~~After ~~BIOTECH~~formation, ~~INC~~the Company was in the business of mineral exploration. On May 3, 2010, the Company sold its mineral exploration business and entered into an Intellectual Property Assignment Agreement (“IP Agreement”) with Soren Nielsen pursuant to which Mr. Nielsen transferred his right, title and interest in all intellectual property relating to certain chewing gum compositions having appetite suppressant activity (the “IP”) to the Company for the issuance of 55,000,000 shares of the Company’s common stock.

~~NOTES~~Following TOthe ~~THE~~acquisition ~~AUDITED~~of ~~CONSOLIDATEDED~~the ~~FINANCIAL~~IP ~~STATEMENTS~~the Company changed its business direction to pursue the development of chewing gums for the delivery of Nutraceutical/functional ingredients for applications such as appetite suppressant, cholesterol suppressant, vitamin delivery, antioxidant delivery and motion sickness suppressant.

~~MARCH~~On January 19, 2021, the Company entered into an Stock Purchase Agreement (the “Agreement”) with ABTI Pharma Limited, a company registered in England and Wales (“ABTI Pharma”), pursuant to which the Company agreed to acquire all of the outstanding shares of capital stock of ABTI Pharma from its shareholders in exchange for 600,000,000 shares of the Company pro rata to the ABTI Pharma shareholders. The shares were issued on January 29, 2021 in anticipation of the closing and the parties to the transaction agreed in a March 24, 2021 amendment to close upon the ABTI Pharma Limited Shares being transferred to the Company, which was to occur upon the filing by the Company of its outstanding December 31, ~~2023~~2020 quarterly report on Form 10-Q, which was filed on May 28, 2021 with the Securities and Exchange Commission. The transaction closed on May 28, 2021.

~~NOTE~~The 2transaction –is ~~SUMMARY~~being OFaccounted ~~SIGNIFICANT~~for ~~ACCOUNTING~~as ~~POLICIES~~a ~~(CONTINUED)~~reverse acquisition and recapitalization. ABTI Pharma is the acquirer for accounting purposes and the Company is the issuer. The historical financial statements presented are the financial statements of ABTI. The Agreement was treated as a recapitalization and not as a business combination; at the date of the acquisition, the net liabilities of the legal acquirer, Alterola, were $389,721.

~~Funds~~The inbusiness ~~attorney~~plan ~~trust~~of ~~account~~the company is no longer focused on a chewing gum delivery system but was re-focused on the development of cannabinoid, cannabinoid-like, and non-cannabinoid pharmaceutical active pharmaceutical ingredients (APIs), pharmaceutical medicines made from cannabinoid, cannabinoid-like, and non-cannabinoid APIs and European novel food approval of cannabinoid-based, cannabinoid-like and non-cannabinoid ingredients and products .In addition, the company plans to develop such bulk ingredients for supply into the cosmetic sector.

~~The~~On ~~company~~December ~~has~~2, a2021, ~~fully~~the ~~operational~~Company USclosed ~~Dollar~~an ~~($)~~Asset ~~and~~Purchase aAgreement ~~Sterling bank account in~~ (the ~~United~~“Purchase ~~Kingdom~~Agreement”) with ~~HSBC.~~C2 ~~Amounts~~Wellness ~~due~~Corp., ~~from~~a ~~attorney~~Wyoming ~~represents~~corporation, ~~fund~~and ~~held~~Dr. onG. ~~behalf~~Sridhar ofPrasad (together, the ~~Company~~“Seller”) inand ~~trust~~acquired bycertain ~~its~~IP ~~legal~~assets ~~counsel.~~(the “Assets”) from Seller, which include:

~~Fair Value~~• ofNovel ~~Financial~~cannabinoid ~~Instruments~~molecules and their associated intellectual property; • Novel cannabinoid pro-drugs, and their associated intellectual property; • Novel proprietary cannabinoid formulations, designed to target lymphatic delivery, and their associated intellectual property; • Novel proprietary nano-encapsulated cannabinoid formulations, in self-dissolving polymers, and their associated intellectual property; and • Cannabinoids and cannabinoid pro-drug formulations for topical ocular delivery, and their associated intellectual property.

~~Alterola’s~~In ~~financial~~exchange ~~instruments~~for ~~consist~~the Assets, the Company issued to Seller shares of ~~cash~~common ~~and~~stock. ~~equivalents,~~On ~~accrued~~September ~~expenses~~8, ~~accrued~~2023, ~~interest~~the Company and ~~notes~~Seller ~~payable.~~entered ~~The~~into an ~~carrying~~Agreement ~~amount~~to ofsell ~~these financial~~the ~~instruments~~assets, ~~approximates~~such ~~fair~~that ~~value~~the ~~(“FV”)~~Company ~~due~~sold ~~either~~the assets back to ~~length~~the ofSeller ~~maturity~~and orthe ~~interest~~Seller ~~rates~~paid ~~that~~29,015,993 ~~approximate~~shares of ABTI ~~prevailing~~common ~~market~~stock ~~rates~~to ~~unless~~the ~~otherwise~~Company. ~~disclosed~~The inassets ~~these~~were ~~financial~~sold ~~statements~~to the Seller in September 2023.

FV is defined as the price that would be received upon sale of an asset or paid upon transfer of a liability in an orderly transaction between market participants at the measurement date and in the principal or most advantageous market for that asset or liability. The FV should be calculated based on assumptions that market participants would use in pricing the asset or liability, not on assumptions specific to the entity. In addition, the FV of liabilities should include consideration of nonF-~~performance risk including our own credit risk.~~6

~~In addition~~Table to defining FV, the disclosure requirements around FV establish a FV hierarchy for valuation inputs which is expanded. The hierarchy prioritizes the inputs into three levels based on the extent to which inputs used in measuring FV are observable in the market. Each FV measurement is reported in one of ~~the three levels which is determined by the lowest level input that is significant to the FV measurement in its entirety. These levels are:~~Contents

~~Level~~As 1of –April ~~inputs~~18, ~~are~~2023, ~~based~~we ~~upon~~acquired ~~unadjusted~~intellectual ~~quoted~~property ~~prices~~from ~~for~~Alinova ~~identical~~Biosciences ~~instruments~~Ltd. ~~traded~~We acquired Alinova’s joint interest in ~~active~~the ~~markets~~patent family of PTX 0001. We paid 35,000 Sterling in cash and 5,000,000 shares of ABTI Stock.

~~Level~~LIQUIDITY 2& –GOING inputs are based upon significant observable inputs other than quoted prices included in Level 1, such as quoted prices for identical or similar instruments in markets that are not active, and model-based valuation techniques for which all significant assumptions are observable in the market or can be corroborated by observable market data for substantially the full term of the assets or liabilities.CONCERN

~~Level~~Alterola 3has –negative ~~inputs~~working ~~are~~capital ~~generally~~of ~~unobservable~~$1,329,601, and has ~~typically~~incurred ~~reflect~~losses ~~management’s~~since ~~estimates~~inception of ~~assumptions~~$12,416,075, ~~that~~and ~~market~~has ~~participants~~not received revenues from sales of products or services. These factors ~~would~~create ~~use~~substantial indoubt ~~pricing~~about the ~~asset~~Company’s orability ~~liability~~to continue as a going concern. The FVfinancial ~~are~~statements ~~therefore~~do ~~determined~~not ~~using~~include any ~~model-based~~adjustment ~~techniques~~ that ~~include~~might ~~option~~be ~~pricing models,~~necessary ~~discounted~~if ~~cash~~the ~~flow~~Company ~~models,~~is ~~and~~unable ~~similar~~to ~~techniques~~continue as a going concern.

The ~~carrying~~ability ~~value~~ of ~~the~~Alterola ~~Company’s~~to ~~financial~~continue ~~assets~~as ~~and~~a ~~liabilities~~going ~~which~~concern ~~consist~~is ofdependent ~~cash,~~on ~~accounts~~the ~~payable~~Company ~~and~~generating ~~accrued~~cash ~~liabilities, and~~from ~~notes~~the ~~payable~~sale ~~are~~of ~~valued~~its ~~using~~common ~~level~~stock 1and/or obtaining ~~inputs.~~debt ~~The~~financing ~~Company~~and ~~believes~~attaining ~~that~~future ~~the~~profitable ~~recorded~~operations. ~~values~~Management’s ~~approximate~~plans ~~their~~include FVselling ~~due~~its toequity ~~the~~securities ~~short~~and ~~maturity~~obtaining ofdebt ~~such~~financing ~~instruments.~~to ~~Unless~~fund ~~otherwise~~its ~~noted,~~capital itrequirement isand ~~management’s~~ongoing ~~opinion~~operations; ~~that~~however, ~~the~~there ~~Company~~can isbe ~~not~~no ~~exposed~~assurance tothe ~~significant~~Company will ~~interest,~~be ~~exchange~~successful orin ~~credit risks arising from~~ these ~~financial instruments~~efforts.

~~Income~~NOTE ~~Taxes~~2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Income taxes are computed using the asset and liability method. Under the asset and liability method, deferred income tax assets and liabilities are determined based on the differences between the financial reporting and tax bases of assets and liabilities and are measured using the currently enacted tax rates and laws. A valuation allowance is provided for the amount of deferred tax assets that, based on available evidence, are not expected to be realized.Restatement

~~F-7~~During the year ended March 31, 2024, the Company identified that the deferred tax asset and capitalized intangible costs recorded during the year ended March 31, 2023 should have been removed from the balance sheet. Additionally, the company reperformed their cumulative translation adjustment summary and recorded adjustments related to this. The company recorded entries and the impact of these entries was as follows:

~~Table~~ NOTE 2 of- ~~Contents~~SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Restatement Summary (Details)

ALTEROLA BIOTECH, INC.

	3/31/2023 (as restated)			3/31/2023			Differences
Assets		12,046,315			12,376,963			(330,648	)
Liabilities		2,285,171			2,281,416			3,755
Equity		9,761,144			10,095,547			(334,403	)
CTA		67,873			(63,173	)		131,046
Result of the year		(2,071,186	)		(1,742,457	)		(328,729	)

NOTES TO THE AUDITED CONSOLIDATED FINANCIAL STATEMENTS

	3/31/2023 (as restated)			3/31/2023			Differences
Net cash provided by operating activities		(1,307,264	)		(1,039,792	)		(267,472	)
Net cash used by investing activities		—			(139,799	)		139,799
Net cash provided by financing activities		1,199,073			1,212,159			(13,086	)
Net change in cash		(108,191	)		32,689			(140,880	)

~~MARCH~~Basis ~~31,~~of ~~2023~~Presentation

~~NOTE~~The 2accompanying –consolidated ~~SUMMARY~~financial OFstatements ~~SIGNIFICANT~~were ~~ACCOUNTING~~prepared ~~POLICIES~~in accordance with accounting principles generally accepted in the United State of America (~~CONTINUED~~GAAP accounting) and include the accounts of Alterola and its wholly owned subsidiaries ABTI Pharma, Phytotherapeutix Ltd, and Ferven Ltd. All material intercompany transactions and balances have been eliminated.

~~Foreign~~The Company had a September 30 fiscal year end. Subsequent ~~Currency~~to ~~Translation~~the Agreement with ABTI Pharma , the Company has changed its year end from September 30 to March 31 effective July 13, 2021

~~The~~Use financial statements are presented in US Dollars. Transactions with foreign subsidiaries where US dollars are not the functional currency will be recorded in accordance with Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 830 Foreign Currency Transaction. According to Topic 830, all assets and liabilities are translated at the exchange rate on the balance sheet date, stockholders’ equity is translated at historical rates and statement of operations items are translated at the weighted average exchange rate for the period. The resulting translation adjustments are reported under other comprehensive income (loss) in accordance with ASC Topic 220, Comprehensive Income . Gains and losses resulting from the translations of foreign currency transactions and balances are reflected in the statement of operations and comprehensive income (loss )Estimates

~~Revenue~~The ~~Recognition~~preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date the financial statements and the reported amount of revenues and expenses during the reporting period. Actual results could differ from those estimates.

On January 1, 2018, the Company adopted ASC Topic 606, Revenue from Contracts with Customers ("ASC 606"), using the modified retrospective method applied to those contracts which were not completed as of January 1, 2018. Results for reporting periods beginning after January 1, 2018 are presented under ASC 606, while prior period amounts are not adjusted and continue to be reported in accordance with our historic accounting under ASC 605. As of and for the year ended March 31, 2022, the financial statements were not materially impacted as a result of the application of Topic 606 compared to Topic 605.F-7

~~Loss Per~~Table ~~Common~~of ~~Share~~Contents

~~Basic~~ALTEROLA loss per share is calculated using the weighted-average number of common shares outstanding during each reporting period. Diluted loss per share includes potentially dilutive securities such as outstanding options and warrantsBIOTECH, ~~using various methods such as the treasury stock or modified treasury stock method in the determination of dilutive shares outstanding during each reporting period~~INC. ~~The Company does not have any potentially dilutive instruments.~~

~~Stock-Based~~NOTES ~~Compensation~~TO THE UNAUDITED CONSOLIDATEDEDFINANCIAL STATEMENTS

~~Stock-based~~MARCH ~~compensation is accounted for at FV in accordance with ASC Topic 718. To date~~31, ~~the Company has not adopted a stock option plan and has not granted any stock options~~2024

~~Research~~NOTE ~~and~~2 ~~development~~– SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)

~~We engage in a variety of research and development~~Cash ~~activities to develop our technologies~~ and work toward development of a saleable product. When it is determined that the research and development products we are creating have reached a point where saleable products are possible, these amounts are capitalized. As of March 31, 2023 and 2022 there are no capitalized research and development costs.Equivalents

~~The~~For purposes ~~research~~of ~~and~~the ~~development~~statement ~~costs~~of ~~incurred~~cash byflows, the Company considers highly liquid financial instruments purchased with a maturity of three ~~company~~months ~~relate~~or less to ~~the~~be ~~following:~~cash equivalents.

~~Licenses for patent and know-how (Nano 4 M)- this~~Fair ~~relates~~Value ~~to the company’s formulation~~ of ~~Active~~Financial ~~Pharmaceutical Ingredients ( API) for its lead pharmaceutical programs.~~Instruments

~~The company~~Alterola’s financial ~~research~~instruments ~~into~~consist ~~production~~ of ~~cannabinoids by~~cash ~~biosynthesis~~and ~~(as~~equivalents, ~~opposed~~accrued toexpenses, ~~botanical~~accrued ~~production~~interest byand ~~growing~~notes ~~plants)~~payable. ~~has~~The ~~been~~carrying ~~carried~~amount ~~out~~of bythese financial ~~3rd~~instruments ~~party~~approximates ~~contractors.~~fair ~~The~~value ~~company has~~(“FV”) ~~genetically~~due ~~modified~~either anto ~~organism~~length toof ~~produce~~maturity ~~cannabinoids~~or byinterest ~~fermentation~~rates ~~(similar~~that toapproximate prevailing ~~methodology~~market ~~used~~rates ~~for~~unless ~~the~~otherwise ~~production~~disclosed ofin ~~antibiotics)~~these financial statements.

~~Similarly~~FV is ~~3rd~~defined ~~party~~as ~~contractors~~the ~~have~~price ~~been~~that would be received upon sale of an asset or paid upon transfer of a liability in an orderly transaction between ~~used~~market toparticipants ~~synthesize~~at ~~both~~the ~~novel~~measurement date and ~~natural~~in ~~molecules~~the ~~their~~principal ~~pharmaceutical~~or ~~development~~most ~~programs~~advantageous market for that asset or liability. The FV should be calculated based on assumptions that market participants would use in pricing the asset or liability, not on assumptions specific to the entity. In addition, the FV of liabilities should include consideration of non-performance risk including our own credit risk.

~~Payment~~In addition to defining FV, the disclosure requirements around FV establish a FV hierarchy for valuation inputs which is expanded. The hierarchy prioritizes the inputs into three levels based on the extent to which inputs used in measuring FV are observable in the market. Each FV measurement is reported in one of ~~ongoing~~the IPthree ~~costs~~levels ~~associated~~which ~~with~~is determined by the ~~programs~~lowest level input that is significant to the FV measurement ~~listed~~in ~~above~~its entirety. These levels are:

~~Other~~Level ~~Intangible~~1 ~~Assets~~– inputs are based upon unadjusted quoted prices for identical instruments traded in active markets.

WeLevel ~~have~~2 ~~recorded~~– ~~the~~inputs ~~assets~~are ~~acquired~~based asupon ~~part~~significant ofobservable ~~the~~inputs C2other ~~Wellness~~than ~~acquisition~~quoted asprices ~~indefinite~~included ~~lived~~in ~~Intangible~~Level ~~assets.~~1, ~~Indefinite~~such ~~life~~as ~~intangible assets~~quoted ~~recorded~~prices ~~are~~for identical ~~not~~or ~~amortized~~similar ~~and,~~instruments asin amarkets ~~result,~~that are ~~assessed~~not ~~for~~active, ~~impairment~~and atmodel-based ~~least~~valuation ~~annually,~~techniques ~~using~~for ~~either~~which aall ~~qualitative~~significant ~~or quantitative~~assumptions ~~process.~~are Weobservable ~~performed~~in ~~this~~the ~~annual~~market ~~assessment~~or ascan ofbe ~~March~~corroborated ~~31,~~by ~~2023,~~observable ~~noting~~market nodata ~~factors~~for ~~indicating~~substantially ~~possible~~the ~~impairment~~full term of ~~intangible~~the assets ~~recognized~~ or liabilities.

FLevel 3 – inputs are generally unobservable and typically reflect management’s estimates of assumptions that market participants would use in pricing the asset or liability. The FV are therefore determined using model-8based techniques that include option pricing models, discounted cash flow models, and similar techniques.

~~Table~~The carrying value of ~~Contents~~the Company’s financial assets and liabilities which consist of cash, accounts payable and accrued liabilities, and notes payable are valued using level 1 inputs. The Company believes that the recorded values approximate their FV due to the short maturity of such instruments. Unless otherwise noted, it is management’s opinion that the Company is not exposed to significant interest, exchange or credit risks arising from these financial instruments.

~~ALTEROLA~~Income ~~BIOTECH, INC.~~Taxes

~~NOTES~~Income TOtaxes ~~THE~~are ~~AUDITED~~computed ~~CONSOLIDATED~~using ~~FINANCIAL~~the ~~STATEMENTS~~asset and liability method. Under the asset and liability method, deferred income tax assets and liabilities are determined based on the differences between the financial reporting and tax bases of assets and liabilities and are measured using the currently enacted tax rates and laws. A valuation allowance is provided for the amount of deferred tax assets that, based on available evidence, are not expected to be realized.

~~MARCH 31, 2023~~F-8

~~Risks and~~Table ~~Uncertainties~~of Contents

OnALTEROLA ~~January 30~~BIOTECH, ~~2020, the World Health Organization declared the coronavirus outbreak a “Public Health Emergency of International Concern” and on March 10, 2020, declared it to be a pandemic~~INC. Actions taken around the world to help mitigate the spread of the coronavirus include restrictions on travel, and quarantines in certain areas, and forced closures for certain types of public places and business. The Coronavirus and actions taken to mitigate it have had and are expected to have an adverse impact on the economies and financial markets of many countries, including the geographical area in which the Company plans to operate.”

~~Recent~~NOTES ~~Accounting~~TO ~~Pronouncements~~THE UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS

~~Alterola~~MARCH ~~does not expect the adoption of recently issued accounting pronouncements to have a significant impact on the Company’s results of operations~~31, ~~financial position or cash flow.~~2024

NOTE 32 – ~~ACCRUED~~SUMMARY ~~EXPENSES~~OF SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)

~~Accrued~~Foreign ~~expenses~~Currency ~~consisted~~Translation ~~of the following at March 31, 2023 and March 31, 2022~~

	March 31, 2023		March 31, 2022
Audit fees	$	15,000	$	32,687
Accounting		7,407		26,275
Research and development		9,433		326,080
General and administrative		115,821		—
Legal fees and transfer agent		107,203		11,444
Total Accrued Expenses	$	254,864	$	396,486

The financial statements are presented in US Dollars. Transactions with foreign subsidiaries where US dollars are not the functional currency will be recorded in accordance with Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 830 Foreign Currency Transaction. According to Topic 830, all assets and liabilities are translated at the exchange rate on the balance sheet date, stockholders’ equity is translated at historical rates and statement of operations items are translated at the weighted average exchange rate for the period. The resulting translation adjustments are reported under other comprehensive income (loss) in accordance with ASC Topic 220, Comprehensive Income . Gains and losses resulting from the translations of foreign currency transactions and balances are reflected in the statement of operations and comprehensive income (loss )

~~NOTE~~Revenue ~~4 – CAPITAL STOCK~~Recognition

~~The~~On January 1, 2018, the Company ~~has~~adopted 2ASC Topic 606,~~000~~ Revenue from Contracts with Customers ("ASC 606"),~~000,000~~ ~~shares~~using the modified retrospective method applied to those contracts which were not completed as of $January 1, 2018.~~001~~ ~~par~~Results ~~value~~for ~~common~~reporting ~~stock~~periods beginning ~~authorized~~after ~~and~~January 101,~~000~~ 2018 are presented under ASC 606,~~000~~ ~~shares~~while ofprior $period amounts are not adjusted and continue to be reported in accordance with our historic accounting under ASC 605.~~001~~ ~~par~~As ~~value~~of ~~preferred~~and ~~stock~~for the year ended March 31, 2022, the financial statements were ~~authorized~~not materially impacted as a result of the application of Topic 606 compared to Topic 605.

OnLoss ~~August~~Per 1,Common ~~2022, the Company issued 2,250,000 shares to note holders in connection with loan agreements. See Note 5. These loans were repaid in full by December 23, 2022.~~ Share

OnBasic ~~May~~loss 4,per ~~2022,~~share is calculated using the ~~Company~~weighted-average ~~issued~~number ~~2,250,000~~of common shares tooutstanding aduring ~~director~~each reporting period. Diluted loss per share includes potentially dilutive securities such as ~~part~~outstanding ofoptions and warrants, using various methods such as the ~~employment~~treasury stock ~~contract~~or atmodified $0treasury stock method in the determination of dilutive shares outstanding during each reporting period.~~214~~ ~~per~~The ~~share,~~Company does ornot ~~$481,500~~have any potentially dilutive instruments.

OnStock-Based ~~April 29, 2022, the Company issued 1,500,000 shares for services under a consultancy agreement at $0.214 per share, or $321,000.~~Compensation

OnStock-based ~~April~~compensation 5,is ~~2022,~~accounted ~~the~~for ~~company~~at ~~issued~~FV ~~384,615~~in ~~shares~~accordance towith anASC ~~investor~~Topic ~~for~~718. anTo ~~investment~~date, ofthe ~~$50,000~~Company ~~(at~~has not adopted a ~~price~~stock ofoption ~~$0.13~~plan ~~per~~and ~~share).~~has not granted any stock options

OnResearch orand ~~about March 3, 2022, the Company issued 16,000,000 shares of stock for services under a consulting agreement. The shares were issued at fair value the date of the exchange, or $3,360,000.~~development

AsWe ~~pursuant~~engage toin ~~the~~a ~~asset~~variety ~~purchase~~of ~~agreement~~research ~~dated~~and ~~November~~development 9,activities ~~2021,~~to ~~the~~develop ~~Company~~our ~~acquired~~technologies ~~certain~~and ~~intellectual~~work ~~property~~toward ~~rights~~development of C2a ~~Wellness Corp~~saleable product. When Init ~~exchanges~~is ~~for~~determined that the ~~assets~~research ~~acquired,~~and ~~the~~development ~~Company~~products ~~issued~~we ~~24,000,000~~are ~~shares~~creating ofhave ~~common~~reached ~~stock~~a ~~valued~~point atwhere ~~$0.50~~saleable ~~per~~products ~~share.~~are ~~The intellectual~~possible, ~~property~~these ~~rights~~amounts ~~acquired~~ are ~~recorded~~capitalized. asAs ~~intangible~~of ~~assets~~March as31, of2024 ~~December~~and March 31 ,2023 ~~2021~~there ~~for~~are ~~$12,000,000~~no capitalized research and development costs.

~~F-9~~The research and development costs incurred by the company relate to the following:

Table of Contents

	•	Licenses for patent and know-how (Nano 4 M) - this relates to the company’s formulation of Active Pharmaceutical Ingredients ( API) for its lead pharmaceutical programs.
	•	Protein Technologies Ltd – this relates to the company’s research into production of cannabinoids by biosynthesis (as opposed to botanical production by growing plants). The company has genetically modified an organism to produce cannabinoids by fermentation ( similar to methodology used for the production of antibiotics)

~~ALTEROLA BIOTECH, INC.~~F-9

~~NOTES TO~~Table ~~THE~~of ~~AUDITED CONSOLIDATED FINANCIAL STATEMENTS~~Contents

~~MARCH~~ALTEROLA 31BIOTECH, ~~2023~~INC.

~~On October 29, 2021, the Company issued 7,500,000 shares of stock in exchange~~NOTES ~~for~~TO ~~services~~THE ~~provided~~UNAUDITED ~~byEMC2~~CONSOLIDATED ~~Capital.~~FINANCIAL ~~The shares were issued at fair value of the date of exchange, or $2,399,250.~~STATEMENTS

~~During September 2021, the Company received an investment for £100,000~~MARCH ~~Sterling (or $137~~31,~~721)~~ ~~in exchange for a subscription for 280,000 shares. On May 2, 2022, the Company issued the 280,000 shares to the investor.~~2024

OnNOTE ~~August~~2 ~~11,~~– ~~2021,~~SUMMARY ~~the~~OF ~~Company~~SIGNIFICANT ~~issued~~ACCOUNTING ~~15,000,000~~POLICIES ~~warrants to purchase common stock at $0.64 per share. The warrants were issued with a 5 year term. The warrants exercise price includes a declining scale with the stock price.~~(CONTINUED)

~~As of March 31, 2023, the warrants were exercisable at $0.001 per share~~Research and ~~the~~development ~~total potential impact on the financial statements of the exercise of the warrants was approximately $15,000 dollars.~~(continued)

~~The Company~~• ~~has~~Apex ~~807,047,948~~Molecular ~~and~~Ltd.- ~~802,633,333~~the ~~shares~~company has a number of ~~common~~pharmaceutical ~~stock~~development ~~issued~~programs using both novel and ~~outstanding~~natural asmolecules. ofThe ~~March~~Company ~~31,~~employs ~~2023~~third ~~and~~party ~~March~~chemistry ~~31,~~/ ~~2022~~contract, ~~respectively~~manufacturing companies such as Apex Molecular Ltd. ~~There~~ ~~are~~to nosynthesize ~~shares~~and purify these compounds for their pharmaceutical development programs. • Acquisition of ~~preferred~~intellectual ~~stock~~property ~~issued~~from ~~and~~Alinova ~~outstanding~~Biosciences asLtd. • Continued patent prosecution and internationalization of ~~March~~company ~~31,~~intellectual ~~2023~~property. • Staff costs and ~~March~~consultancy ~~31,~~costs ~~2022~~relating to R & D.

~~NOTE~~Other 5Intangible ~~– NOTES PAYABLE~~Assets

OnWe ~~August~~have 1,recorded ~~2022,~~the assets acquired as part of the ~~Company~~C2 ~~issued~~Wellness aacquisition ~~note~~and ~~payable~~Alinova ~~for~~acquisition 90as ~~days~~indefinite ~~bearing~~lived ~~zero~~Intangible ~~interest~~assets. Indefinite ~~for~~life ~~the~~intangible ~~term~~assets ofrecorded ~~the~~are ~~note~~not amortized and, as a result, are assessed for ~~cash~~impairment ~~received~~at byleast ~~the~~annually, using either ~~Company~~a onqualitative ~~June~~or ~~29,~~quantitative ~~2022~~process. ~~and~~The ~~July~~C2 ~~18,~~Wellness ~~2022~~asset ~~totaling~~that ~~$75,000.~~was Asacquired ~~part~~was ofsubsequently ~~the~~re-sold ~~note~~as ~~the~~discussed ~~Company~~above. ~~committed~~We ~~delivery~~performed this annual assessment as of 2March 31,~~250~~ 2024,~~000~~ ~~shares to~~noting ~~the~~impairment ~~note~~factors ~~holders.~~indicating ~~The~~possible ~~loans~~impairment ~~totaling~~of ~~$75,000~~intangible ~~were~~assets ~~repaid~~recognized and inrecorded ~~full~~impairment byof ~~December 23~~$392, ~~2022~~278.

~~NOTE~~Risks 6and ~~– RELATED PARTY TRANSACTIONS~~Uncertainties

~~Alterola~~On ~~leases~~January ~~office~~30, ~~space~~2020, ~~from~~the World Health Organization declared the coronavirus outbreak a ~~director~~“Public atHealth Emergency of International Concern” and on March 10, 2020, declared it to be a pandemic. Actions taken around the world to help mitigate the spread of the coronavirus include restrictions on travel, and quarantines in certain areas, and forced closures for certain types of public places and business. The Coronavirus and actions taken to mitigate it have had an ~~independently~~adverse ~~determined~~impact ~~commercial~~on ~~rate~~the economies and financial markets of many countries, including the geographical area in which the Company plans to operate.

~~During~~We ~~the~~may ~~period~~be ~~ended~~impacted ~~March~~by 31business interruptions resulting from pandemics and public health emergencies, ~~2023~~including those related to geopolitical actions, including war and terrorism or natural disasters including earthquakes, typhoons, floods, and fires. An outbreak of infectious disease, a ~~shareholder~~pandemic ~~made~~or ~~advances~~a tosimilar public health threat or a fear of any of the ~~company~~foregoing, tocould ~~fund~~adversely impact us by causing operating, manufacturing ~~expenses~~supply inchain, ~~the~~clinical ~~amount~~trial ofand $1project development delays and disruptions,~~260~~ labour shortages,~~434.~~ ~~These~~travel and shipping disruption ~~advances~~and ~~are~~shutdowns ~~non~~(including –as ~~interest~~a ~~bearing~~result of government regulation and ~~have~~prevention nomeasures). ~~specified~~It ~~terms~~is unknown whether and how we may be affected if such an epidemic persists for an extended period of ~~repayment~~time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results, and financial condition.

~~NOTE~~Recent 7Accounting ~~– LIQUIDITY & GOING CONCERN~~Pronouncements

Alterola ~~has~~does ~~negative working capital of $1,890,623 has incurred losses since inception of $9,576,247, and has~~ not ~~received~~expect ~~revenues~~the ~~from~~adoption ~~sales~~ of ~~products~~recently orissued ~~services.~~accounting ~~These~~pronouncements ~~factors~~to ~~create~~have ~~substantial~~a ~~doubt~~significant ~~about~~impact on the Company’s ~~ability~~results of tooperations, ~~continue as a going concern. The~~ financial ~~statements~~position door ~~not~~cash ~~include any adjustment that might be necessary if the Company is unable to continue as a going concern~~flow.

~~The ability~~NOTE of3 ~~Alterola~~– toINTANGIBLE continue as a going concern is dependent on the Company generating cash from the sale of its common stock and/or obtaining debt financing and attaining future profitable operations. Management’s plans include selling its equity securities and obtaining debt financing to fund its capital requirement and ongoing operations; however, there can be no assurance the Company will be successful in these efforts.ASSETS

~~NOTE~~As part of the C2 Wellness acquisition, the company 8recognized –$12,000,000 ~~SUBSEQUENT~~in ~~EVENTS~~intangibles as discussed in Note 1. During fiscal year ended March 31, 2023, there were certain costs associated with the C2 Wellness intangibles that were capitalized, resulting in a balance of $12,139,779. During the year ended March 31, 2024, it was determined that these costs should have been expensed as research and development costs and not capitalized as part of the initial balance recorded. This correction was made and is reflected in the restatement footnote as indicated above.

~~In accordance~~NOTE ~~with~~4 ~~ASC~~– ~~Topic~~DEFERRED ~~855-10,~~TAX the Company analyzed its operations subsequent to March 31, 2023 to the date these financial statements were issued, and determined it does not have any material subsequent events to disclose in these financial statements.ASSET

~~F-10~~As of the year ended March 31, 2023, the Company had recorded $189,355 in deferred tax assets as reported. During the year ended March 31, 2024, the Company identified that this balance should have been fully impaired with the unlikelihood of net income during FY 2024. As a result, this balance was fully written off for the year ended March 31, 2023 as mentioned in the restatement footnote above.

~~Table~~NOTE 5 of– ~~Contents~~ACCOUNTS PAYABLE

~~Item~~Accounts 9.payable ~~Changes~~consisted Inof ~~and~~the ~~Disagreements~~following ~~with~~at ~~Accountants~~March on31, ~~Accounting~~2024 and ~~Financial~~ ~~Disclosure~~March 31, 2023:

None.

	March 31, 2024		March 31, 2023
Accounting and audit	$	181,955	$	149,613
Legal fees and transfer agent		85,627		59,565
Research and development		409,904		337,893
General and administrative		147,724		66,658
Total Accrued Expenses	$	825,210	$	613,729

~~Item 9A. Controls and Procedures Disclosure Controls and Procedures~~F-10

~~As required~~Table ~~by Rule 13a-15 under the Securities Exchange Act~~ of 1934, we have carried out an evaluation of the effectiveness of our disclosure controls and procedures as of the end of the period covered by this annual report, being March 31, 2023. This evaluation was carried out under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer.Contents

~~Disclosure~~ALTEROLA controls and procedures are controls and other procedures that are designed to ensure that information required to be disclosed in our reports filed or submitted under the Securities Exchange Act of 1934 is recordedBIOTECH, ~~processed, summarized and reported, within the time periods specified in the Securities and Exchange Commission’s rules and forms~~INC. Disclosure controls and procedures include controls and procedures designed to ensure that information required to be disclosed in our company’s reports filed under the Securities Exchange Act of 1934 is accumulated and communicated to management, including our Chief Executive Officer and Chief Financial Officer, to allow timely decisions regarding required disclosure.

~~Based~~NOTES ~~upon~~TO ~~that~~THE ~~evaluation,~~UNAUDITED ~~including~~CONSOLIDATED ~~our~~FINANCIAL ~~Chief Executive Officer and Chief Financial Officer, we have concluded that our disclosure controls and procedures were ineffective as of the end of the period covered by this annual report.~~STATEMENTS

~~Management’s~~MARCH ~~Report~~31, ~~on Internal Control over Financial Reporting~~2024

~~Our~~NOTE ~~management~~6 is– ~~responsible~~ACCRUED for establishing and maintaining adequate internal control over financial reporting (as defined in Rule 13a-15(f) under the Securities Exchange Act of 1934). Management has assessed the effectiveness of our internal control over financial reporting as of March 31, 2023 based on criteria established in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission. As a result of this assessment, management concluded that, as of March 31, 2023, our internal control over financial reporting was not effective. Our management identified the following material weaknesses in our internal control over financial reporting, which are indicative of many small companies with small staff: (i) inadequate segregation of duties and effective risk assessment; and (ii) insufficient written policies and procedures for accounting and financial reporting with respect to the requirements and application of both US GAAP and SEC guidelines.EXPENSES

WeAccrued ~~plan~~expenses toconsisted ~~take steps to enhance and improve the design~~ of ~~our internal control over financial reporting. During~~ the ~~period covered by this annual report on Form 10-K, we have not been able to remediate the material weaknesses identified above. To remediate such weaknesses, we hope to implement the~~ following ~~changes~~at ~~during our fiscal year ending~~ March 31, 2024: ~~(i) appoint additional qualified personnel to address inadequate segregation of duties~~ and ~~ineffective~~March risk management; and (ii) adopt sufficient written policies and procedures for accounting and financial reporting. The remediation efforts set out in (i) and (ii) are largely dependent upon our securing additional financing to cover the costs of implementing the changes required. If we are unsuccessful in securing such funds31, ~~remediation efforts may be adversely affected in a material manner.~~2023:

This annual report does not include an attestation report of our registered public accounting firm regarding internal control over financial reporting. Management’s report was not subject to attestation by our registered public accounting firm pursuant to an exemption for non-accelerated filers set forth in Section 989G of the Dodd-Frank Wall Street Reform and Consumer Protection Act.

	March 31, 2024		March 31, 2023
Accounting and Audit	$	49,468	$	15,000
Research and development		—		9,432
General and administrative		89,508		128,325
Legal fees and transfer agent		223,475		107,203
Total Accrued Expenses	$	362,451	$	259,960

~~Remediation~~NOTE of7 ~~Material~~– ~~Weakness~~CAPITAL STOCK

WeThe ~~are~~Company ~~unable~~has to2,000,000,000 ~~remedy~~shares ~~our~~of ~~controls~~$0.001 ~~related~~par tovalue ~~the~~common ~~inadequate~~stock ~~segregation~~authorized ~~of duties~~ and ~~ineffective~~10,000,000 ~~risk~~shares ~~management~~of ~~until we receive financing to hire additional employees~~$0.001 Wepar ~~recently~~value ~~hired~~preferred ~~an outsourced controller to improve the controls for accounting and financial reporting~~stock authorized.

37On August 11, 2021, the Company issued 15,000,000 warrants to purchase common stock at $0.64 per share. The warrants were issued with a 5 year term. The warrants exercise price includes a declining scale with the stock price. As of December 31, 2022, the warrants were exercisable at $0.001 per share and the total potential impact on the financial statements of the exercise of the warrants was approximately $1 million dollars. The warrants were exercised on June 13, 2023 (see below). The total potential impact on the financial statements of the exercise of the warrants was approximately $13,500.

~~Table~~During September of2021, ~~Contents~~the Company received an investment for £100,000 Sterling (or $136,721) in exchange for a subscription for 280,000 shares. On May 2, 2022, the Company issued 280,000 shares to the investor.

~~Limitations~~On October on29, 2021, the ~~Effectiveness~~Company issued 7,500,000 shares of ~~Internal~~stock in exchange for services provided byEMC2 Capital. The shares were issued ~~Controls~~at fair value of the date of exchange, or $2,399,250.

~~Our management, including our Chief Executive Officer~~As ~~and~~pursuant ~~our~~to ~~Chief~~the ~~Financial~~asset ~~Officer,~~purchase ~~does~~agreement ~~not~~dated ~~expect~~November ~~that our disclosure controls and procedures or our internal control over financial reporting are or will be capable of preventing or detecting all errors or all fraud. Any control system~~9, ~~no matter how well designed and operated~~2021, ~~can~~the ~~provide~~Company ~~only~~acquired ~~reasonable,~~certain ~~not~~intellectual ~~absolute,~~property ~~assurance~~rights ~~that~~of ~~the~~C2 ~~control system’s~~Wellness ~~objectives will be met~~Corp. ~~The~~In ~~design~~exchanges offor ~~a control system must reflect~~ the ~~fact~~assets ~~that there are resource constraints~~acquired, ~~and~~ the ~~benefits~~Company ofissued ~~controls must be considered relative to their costs. Further~~24, ~~because of the inherent limitations in all control systems~~000,000 noshares ~~evaluation~~ of ~~controls~~common ~~can~~stock ~~provide~~valued ~~absolute~~at ~~assurance that misstatements, due to error or fraud will not occur or that all control issues and instances of fraud, if any, within the company have been detected~~$0.50 ~~These~~per ~~inherent limitations include the realities that judgments in decision- making can be faulty and that breakdowns may occur because of simple error or mistake~~share. ~~Controls can also be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of controls.~~ The ~~design of~~intellectual ~~any~~property ~~system~~rights ofacquired ~~controls~~are isrecorded ~~based~~as inintangible ~~part~~assets onas ~~certain assumptions about the likelihood~~ of ~~future~~December ~~events~~31, ~~and~~ ~~there~~2021 ~~can~~for ~~be no assurance that any design will succeed in achieving its stated goals under all potential future conditions~~$12,000,000. ~~Projections of any evaluation of controls effectiveness to future periods are subject to risk.~~

~~Item~~On ~~9B.~~December ~~Other~~21, ~~Information~~2021, the company issued 520,000 shares of stock in exchange for $130,000 of cash consideration.

~~None~~On February 8, 2022, the company issued 333,333 shares to an investor for an investment of $50,000 (at a price of $0.15 per share).

~~Item~~On 9Cor about March 3, 2022, the Company issued 16,000,000 shares of stock for services under a consulting agreement. ~~Disclosure~~The ~~Regarding~~shares ~~Foreign~~were ~~Jurisdictions~~issued at ~~that~~fair ~~Prevent~~value ~~Inspections~~the date of the exchange, or $3,360,000.

~~None~~On April 5, 2022, the company issued 384,615 shares to an investor for an investment of $50,000 (at a price of $0.13 per share).

~~PART III~~F-11

~~Item~~Table ~~10.~~of ~~Directors, Executive Officers and Corporate Governance~~Contents

~~The~~ALTEROLA ~~following information sets forth the names~~BIOTECH, ~~ages, and positions of our current directors and executive officers~~INC.

Name	Age		Positions and Offices Held
Timothy Rogers		60	Chairman, CFO and Director
David Hitchcock		60	Chief Executive Officer and Director
Colin Stott		57	Chief Operating Officer and Director
Dominic Schiller		59	Chief Intellectual Property Officer and Director
Hunter Land		39	Director
Daniel Reshef		72	Director
Ning Qu		55	Director
Terry Rafih		66	Director

NOTES TO THE UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS

~~Set forth below~~MARCH is31, ~~a brief description of the background and business experience of each of our current executive officers and directors.~~2024

~~Timothy Paul Rogers -~~NOTE ~~Chairman~~7 – ~~CFO~~CAPITAL -STOCK ~~Director - Age 60~~(continued)

~~Timothy. Rogers is an international~~On ~~business~~April ~~leader with 35 years’ experience in global sales and marketing~~29, ~~specifically launching products from an intellectual property platform. Mr. Rogers is multi-lingual~~2022, ~~and has been involved with start-ups in Singapore, South East Asia, Africa, Australia,~~ the ~~United States,~~Company ~~Canada~~issued ~~and Europe in the pharmaceutical~~1, ~~agriculture~~500,000 ~~essential~~shares ~~oil,~~for ~~biocide, oil and gas and cosmetic sectors. He has gained success from a number of industry disturbing products and~~ services, ~~leading~~under in particular, to being part of the team taking control of Alterola. Trained as an accountant, he is known for his finance connections, his complex business interests across the globe and specifically in Africa, ranging from mining, agriculture and controlled substances and linking them all to a ~~focused~~consultancy ~~coffee~~agreement ~~based~~at ~~social equity program for economic empowerment of African agricultural workers~~$0.214 Heper ~~is known for his closeness to a number of African politicians and business leaders~~share, ~~and~~or his co-operation with these 21st century African entrepreneurs is with the aim to establish a new foreign investment policy in Africa to use the vast resource of that continent to benefit the most disadvantaged in society. Tim has lived and worked in UK$321, ~~Ireland, France, Australia, U~~000.~~S.A and Thailand for the past 40 years and has conducted business in over 40 countries across the world physically visiting each one personally.~~

38On May 2, 2022, the Company issued 280,000 shares to an investor relating to a subscription agreement for an investment of £100,000 Sterling (or $136,721) at $0.50 per share, or $140,000.

~~Table~~On May 4, 2022, we issued 2,250,000 shares of ~~Contents~~our common stock to our director, Mr. Michael Hunter Land, pursuant to his employment agreement dated October 18, 2021 and board decision to award him shares for his performance.

HeOn August ~~currently~~1, ~~serves~~2022, asthe ~~a Director~~Company ofissued ~~Novagean~~2,250,000 ~~International~~shares ~~Limited.~~to anote ~~medical~~holders ~~device~~in ~~and~~connection ~~therapeutic~~with ~~diagnostic~~loan ~~manufacturer~~agreements. ~~and~~See ~~clinical~~Note ~~research~~6. ~~company~~These ~~based~~loans were repaid in ~~China~~full ~~and~~by ~~Galway~~December ~~Ireland~~23, 2022.

InOn June ~~recent~~6, ~~years~~2023, ~~Mr.~~the ~~Rogers has~~Company ~~focused~~reclaimed ~~his~~44,064,000 ~~time~~shares ~~building~~into ~~a multi-sector agro-pharma drug development business in Africa which includes controlled substances~~Treasury.

~~Mr.~~On June ~~Rogers~~13, ~~earned~~2023, ~~diplomas including~~we ~~Business~~issued ~~Studies~~13,500,000 ~~from~~shares ~~Birkenhead~~of ~~Technical~~common ~~College,~~stock ~~and~~to ~~Animation~~EMC2 atCapital LLC following the ~~Fisher~~cashless ~~School~~exercise of ~~English~~their 15,000,000 Warrants issued in ~~Paris,~~August ~~France~~2021.

~~David~~On June ~~Hitchcock~~13, 2023, we issued 476,000 shares of common stock to Alison Rose Burgess as settlement of a £125,000 Sterling loan under –the ~~CEO~~terms –and ~~Director~~conditions -of ~~Age~~the 60loan dated 21 September 2021.

~~David~~On June ~~Hitchcock~~13, ~~OBE~~ ~~has~~2023, ~~worked~~we inissued ~~the~~5,000,000 ~~City~~shares of ~~London~~common ~~for~~stock ~~nearly 30 years, most recently in companies he co-founded~~ to ~~facilitate~~Alinova ~~equity~~Biosciences ~~investment~~Ltd ~~into UK~~as ~~Small~~part ~~and~~payment ~~Medium~~of ~~Enterprises~~consideration ~~(SMEs).~~for ~~His experience concentrated particularly in~~ the ~~UK Life Sciences and Precision Engineering Sectors~~acquisition including listings onto the London Stock Exchange. David and his team bought several high precision engineering companies from administration, turning them round and creating over 200 jobs in Wales and the West of ~~England~~intellectual ~~including a standalone apprentice training centre~~property.

~~David spent 21~~June ~~years~~13, in2023, ~~Investment~~we ~~Banking~~issued ~~with~~5,999,900 10shares ~~years as a Managing Director at JPMorgan and Head~~ of ~~Investor~~common ~~Client~~stock ~~Management.~~to ~~David~~Long ~~and~~Eight ~~his~~Limited team managed the bank’s most senior client relationships with its most important institutional asset managers and hedge funds in the UK and EMEA. He began his City career in Equities at Goldman Sachs in 1992. Before entering the City David served as apart ~~British~~payment ~~Army Officer with The Sixth (Queen Elizabeth’s Own) Gurkha Rifles. He is a Graduate~~ of ~~The~~consideration ~~Royal~~for ~~Military~~services ~~Academy,~~received ~~Sandhurst~~by Green ~~and~~Ocean ~~Pembroke~~Administration ~~College, Cambridge~~Limited.

~~David~~June 13, ~~has~~2023, ~~lectured at~~we ~~The~~issued ~~Royal~~10,088,100 ~~College~~shares of ~~Defence~~common ~~Studies~~stock ~~and~~to ~~the~~Warren ~~Master~~Law ofGroup ~~Finance~~to ~~Course~~be atheld ~~the~~in ~~Judge~~escrow ~~Business~~as ~~School,~~potential ~~Cambridge~~part ~~University. He~~payment isfor services areceived ~~Trustee~~from ofBridgeway ~~several~~Capital ~~educational~~Partners LLC, Bridgeway Capital Partners II LLC and ~~military~~Entoro ~~charities~~Securities LLC.

~~Dominic~~On June ~~Schiller~~14, ~~– Director~~2023, –we IPissued ~~Counsel~~9,000,000 ~~Age~~shares 59of common stock to our Directors as payment for their services as Directors.

~~Mr. Schiller is a Chartered~~On ~~and~~September ~~European~~8, ~~Patent~~2023, ~~Attorney~~the ~~with~~Company ~~over~~entered 30into ~~years~~an ofAgreement ~~experience,~~to ~~largely~~Return inAssets ~~the~~and ~~pharmaceutical,~~Shares ~~botanical~~with ~~and~~C2 ~~nutraceutical~~Wellness ~~industries~~Corp. He isAs ~~the~~part ~~founder and CEO~~ of ~~Equipped~~the ~~4 Holdings Limited~~agreement, the ~~parent~~ company received 29,015,993 shares of ~~Equipped~~ABTI 4stock (~~IP) Limited~~24,000,000 anshares ~~Intellectual~~originally ~~Property~~issued ~~law practice~~and 5,015,996 ~~specializing~~shares inadditionally ~~building~~issued) ~~patent~~and sold ~~portfolios~~all ~~for~~assets ~~biotech~~related ~~companies~~to the acquisition, ~~most~~resulting ~~notably~~in GWa ~~Pharmaceuticals~~write-off ~~and~~of ~~Compass~~$12,000,000 ~~Pathways~~in intangibles.

~~A pioneer in innovative pharmaceutical~~On ~~sectors,~~October ~~Mr. Schiller successfully secured some of the earliest and most prominent cannabinoid related patents for GW Pharma~~16, ~~helping them establish an IP portfolio comprising claims directed to plants~~2023, ~~plant~~the ~~extracts,~~Company ~~extraction~~issued ~~technology~~587, ~~pharmaceutical formulations~~499, ~~drug~~996 ~~delivery~~shares ~~and~~in ~~the~~exchange ~~therapeutic~~of ~~uses~~forgiveness of ~~cannabinoids,~~debt asof ~~well~~approximately ~~as plant variety rights~~$2.35 Hemillion ~~was also the patent attorney behind Compass~~outstanding. ~~Pathways,~~The aexchange ~~mental~~resulted ~~health~~in ~~care company, where he drafted and prosecuted to grant, patents relating to~~ a ~~psilocybin~~loss ~~polymorph,~~on ~~formulations and~~exchange ~~their~~of ~~medical use to treat drug resistant depression. For Phynova~~$406, ~~a natural products company, he has secured patents for Chinese herbal products, products with Food Approvals~~575.

~~Mr. Schiller serves as a~~On ~~director~~December ~~and/or~~21, ~~advisor~~2023, tothe ~~The~~Company ~~Life~~issued ~~Sciences Division (an investment bank)~~17,131,001 ~~and~~shares ~~plays~~in anexchange ~~active~~for ~~management~~services ~~role~~provided for athe ~~number~~company offor ~~companies which~~the heperiod ~~helped~~ended ~~found. He is also an inventor on two key GW Pharmaceutical patents relating to “The use of cannabinoids in the treatment~~December of31, ~~epilepsy”~~2023, ~~and~~valued ~~“The~~at ~~use~~$61,672 ofat ~~cannabinoids in~~ the ~~treatment~~date of ~~mental disorders~~issuance.”

~~Mr.~~During the ~~Schiller~~year ~~holds a~~ended ~~combined~~March ~~honors~~31, ~~degree~~2024, inthe ~~Biochemistry~~company ~~and~~reviewed ~~Genetics~~the ~~from~~cumulative ~~Leeds~~translation ~~University~~adjustment recorded on the financial statements and ~~earned~~made corrections ~~his~~to ~~MBA~~the ~~from~~amount ~~Liverpool~~recorded ~~University~~for the year ended March 31, 2023 as discussed in the restatement footnote above. The updated number was recorded as $67,873.

39The Company had 1,382,662,952 and 807,047,948 shares of common stock issued and outstanding as of March 31, 2024 and March 31, 2024, respectively. There are no shares of preferred stock issued and outstanding as of March 31, 2024 and March 31, 2024.

~~Table of Contents~~F-12

~~Colin~~Table ~~Stott~~of ~~– Chief Operating Officer and Director - Age 57~~Contents

~~Mr Stott is an experienced~~ALTEROLA ~~preclinical and clinical research professional with more than 30 years’ experience in the experience in preclinical & clinical development~~BIOTECH, across a range of therapeutic indications, with specific expertise in the development of botanical medicines, particularly cannabinoid / cannabis-based medicines He is a veteran of the cannabis / cannabinoid medicines industry, with more than 20 years’ experience in the sectorINC. He was Director of Research and Development Operations at GW Pharmaceuticals (now Jazz Pharmaceuticals) from 2001 until May 2017, and was closely involved in the development and approval of Sativex®, GW’s first licensed cannabis-based product, and the more recently NDA-approved cannabinoid (CBD) medicine for treatment-resistant epilepsy, Epidiolex®. He was also a key individual in the development of GW’s discovery and development pipeline, until 2017. As Scientific Affairs Director, he was part of the Medical Affairs team responsible for the preparation for launch of Epidyolex® in the international region (ex-US). Colin has a BSc (Hons) in Medicinal and Pharmaceutical Chemistry (Loughborough University of Technology) and a Diploma in Clinical Science (University of Wales).

~~From November 2020~~NOTES –TO ~~present,~~THE ~~Mr.~~UNAUDITED ~~Stott~~CONSOLIDATED ~~has~~FINANCIAL been Founder and Chief Executive Officer of Phytotherapeutix Holdings Ltd. From April 2019 – present, Mr. Stott has been Founder and Chief Executive Officer of Phytotherapeutix Ltd. From July 1, 2019 – December 1, 2020, he served as Chief Operating Officer for Alinova Biosciences Ltd. From June 1, 2017 – May 31, 2019, he served as Scientific Affairs Director, International Division for GW Pharmaceuticals plc. From January 2001 – May 31, 2017, he was R & D Operations Director for GW Pharmaceuticals plc.STATEMENTS

~~He is an inventor~~MARCH ~~on more than 20 patents in the cannabinoid medicines sector~~31, ~~and has more than 25 publications.~~2024

~~Hunter~~NOTE 8 ~~Land~~ –~~- Director~~ -NOTES ~~Age 39~~PAYABLE

~~Hunter Land has~~On ~~over~~September 1921, ~~years~~2021, ofthe ~~R&D~~Company ~~expertise~~entered ~~across~~into 15a ~~different~~convertible ~~indications,~~note asagreement ~~well~~with asan 10outside ~~years~~party ~~of cannabinoid-focused research~~for $171,863. AsThe ~~an expert~~convertible innote ~~the~~agreement ~~field~~was offor 90 ~~cannabinoid science~~days, hewith ~~has~~an ~~developed~~interest afee ~~pipeline~~ of ~~discovery work on over 20 novel cannabinoids and terpenes~~$13,680. ~~Previously, Hunter~~The ~~acted~~conversion asoption ~~the~~would ~~Sr.~~be ~~Scientific~~at ~~Director,~~90 ~~Director of Cannabinoid Research~~days, ~~and~~with ~~scientific~~share ~~spokesperson~~ conversion at ~~Canopy Growth Corporation~~. ~~Most~~50 ~~notably~~cents, ~~Hunter~~with ~~co-established~~an ~~R&D~~issuance ~~for~~of ~~GW Pharmaceuticals within the US~~340,000 ~~where he authored multiple protocols in refractory epilepsy (Dravet Syndrome and Lennox-Gastaut Syndrome)~~shares, ~~Multiple~~valued ~~Sclerosis,~~at ~~pain~~$428,400 ~~and~~at ~~led~~ the ~~clinical~~date ~~development~~ of ~~Epidiolex® (FDA approved prescription CBD). Hunter acts as~~ the Srloan. ~~Scientific~~Additionally, ~~Advisor~~there ~~for~~was ~~the~~a ~~National~~share ~~Hockey~~bonus ~~League Alumni Association in conjunction with NEEKA~~issued ~~Brain~~of ~~Health~~136,000 ashares, ~~board~~valued ~~member~~at ~~of Veterinary Cannabis Society~~$171,000 ~~and~~as ~~lectures~~of at the ~~University~~date of ~~Wisconsin~~the loan. HeThe ~~has~~note ~~been~~was aconverted ~~featured~~for ~~speaker at~~stock ~~over~~on 50June ~~scientific conferences~~13, a2023 ~~named~~for ~~inventor on 6 patent applications~~476,000 ~~and has over 20 publications~~shares.

Conversion of the debt is at a discount rate of ~~Dr.~~60% of ~~Daniel~~the ~~Reshef -~~published ~~Director~~share –price, ~~Age~~with 72a valuation floor of $1.37 per share.

~~Dr.~~On August ~~Daniel~~1, ~~Reshef is~~2022, anthe ~~Executive~~Company ~~Director~~issued ~~with~~a ~~substantial~~note ~~clinical~~payable ~~experience~~for ~~and~~90 ~~demonstrated~~days ~~history~~bearing ofzero ~~strategic~~interest ~~work~~for inthe term of the ~~pharmaceuticals~~note, ~~industry.~~for cash received by the ~~Skilled~~Company inon ~~Immuno-Oncology,~~June ~~Oncology~~29, ~~Biomarkers,~~2022 ~~Epidemiology,~~and ~~Vaccines,~~July ~~Ophthalmology~~18, ~~and~~2022 ~~Clinical~~totaling ~~Pharmacology~~$75,000. heAs ispart ~~Board~~of ~~certified in~~the ~~Ophthalmology.~~note ~~Dan~~the ~~has~~Company ~~extensive~~committed ~~experience~~delivery inof ~~clinical~~2, ~~industry~~250,000 ~~and~~shares ~~public~~to the ~~health~~noteholders. ~~settings,~~The ~~technical~~loans ~~skills~~totaling $75,000 ~~project~~were ~~management and~~repaid ~~data~~in ~~quality~~full by December 23, 2022.

~~Dr.~~On June ~~Reshef~~13, ~~worked at Roche~~2023, ~~Genentech~~ ~~and~~we ~~served~~issued as476,000 ~~Therapeutic~~shares ~~Area~~of ~~Lead~~common –stock ~~Immuno-~~to ~~Oncology~~Alison atRose aBurgess ~~leading~~as ~~pharmaceutical~~settlement ~~company.~~of ~~Dan~~a ~~has~~£125,000 ~~also~~Sterling ~~been~~loan ~~successfully~~under ~~involved in numerous entrepreneurial ventures in~~ the ~~past~~terms 20and ~~years.~~conditions Heof ~~has been active in diverse areas such as~~ the ~~hotel~~loan ~~industry,~~dated ~~technology start-~~September ~~ups~~21, ~~Customer Relations Management (CRM), innovative novel energy sources, blockchain, cryptocurrencies and Forex~~2021. ~~Dr. Reshef earned his MPH & PhD in Epidemiology from Johns Hopkins University.~~

~~Prof.~~NOTE 9 ~~Dr.~~– ~~Ning~~RELATED ~~Qu – Age~~PARTY 55TRANSACTIONS

~~Ning Qu was born in China~~Alterola

Filing Compare · ALTEROLA BIOTECH INC.