UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

☒[X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(Dd) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, ~~2017~~2020

☐[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ___________ to ___________

Commission file number: 001-33635

~~TAXUS~~GENE BIOTHERAPEUTICS ~~CARDIUM PHARMACEUTICALS GROUP~~ INC.

(Exact name of registrant as specified in its charter)

Delaware	27-0075787
(State ofincorporation)	(IRS Employer Identification No.)
State or other jurisdiction of incorporation or organization	IRS Employer Identification No.
11568 Sorrento Valley Rd, Suite #14 San Diego, California 92121	(858) 436-1000
11230 Sorrento Valley Rd, Suite 220 San Diego, California 92121	(858) 414-1477
(Address of principal executive offices)	(Registrant’s telephone number)
Address of principal executive offices	(Registrant’s telephone number)

~~Indicate~~Securities registered byunder ~~check mark whether the registrant (1) has filed all reports required to be filed by~~ Section 13 ~~or 15~~12(db) of the ~~Securities~~ Exchange Act of 1934 during the preceding 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 and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes ☐ No ☒None

Indicate by check mark 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 preceding 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 [X]

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer ☐[ ] Accelerated filer ☐[ ] Non-accelerated filer ☐[ ~~(Do~~] ~~not check if a small reporting company)~~ Smaller reporting company ☒[X] Emerging ~~growth~~Growth ~~company~~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 is a shell company (as defined in Rule 12b-2 of the Exchange Act.): . Yes [ ☐ ] No ☒ [X]

As of ~~July~~August 28, ~~2017~~2021, ~~the registrant had 14~~64,~~373~~931,~~544~~888 shares of our common stock were outstanding.

TABLE OF CONTENTS

		Page	~~Page~~
EXPLANATORY NOTE		3	1
SPECIAL NOTE ABOUT FORWARD-LOOKING STATEMENTS		3	1
PART 1 FINANCIAL INFORMATION		5
Item 1.	Financial Statements (Unaudited)	5
	Condensed Consolidated Balance Sheets	5	3
	Condensed Consolidated Statements of Operations	6	4
	Condensed Consolidated Statements of Cash Flows	7	5
	Notes to Condensed Consolidated Financial Statements		6
	Condensed Consolidated Statement of Stockholders Equity	8
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations		13
	Notes to Condensed Consolidated Financial Statements	9
Item 3.	Quantitative and Qualitative Disclosures About Market Risk		21
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	20
Item 4.	Controls and Procedures		21
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	23
PART II OTHER INFORMATION
Item 4.	Controls and Procedures	24
Item 1.	Legal Proceedings		22
PART II OTHER INFORMATION		25
Item 1A.	Risk Factors		22
Item 1.	Legal Proceedings	25
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds		31
Item 1A.	Risk Factors	25
Item 3	Defaults Upon Senior Securities		31
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	25
Item 4.	Mine Safety Disclosures		31
Item 3	Defaults Upon Senior Securities	25
Item 5.	Other Information		31
Item 4.	Mine Safety Disclosures	25
Item 6.	Exhibits		32
Item 5.	Other Information	25
SIGNATURES			33
Item 6.	Exhibits	26
SIGNATURES		27

-2-

EXPLANATORY NOTE

~~Unless~~Due to ~~the~~financial ~~context~~hardship, ~~requires~~we ~~otherwise,~~were ~~all~~unable ~~references~~to insecure ~~this~~auditor review or audit of our financial statements and suspended regular reporting of our financial results of operations following our quarterly report tofor the ~~“Company,”~~period ~~“Taxus~~ended ~~Cardium~~March 31,” ~~“Cardium~~2017. On May 22,” ~~“we~~2020,” ~~“our~~after the period covered by this report,” we secured a $1.7 million financing arrangement and ~~“us”~~have ~~refer~~used a portion of those proceeds to ~~Taxus~~complete ~~Cardium~~the ~~Pharmaceuticals~~financial statements ~~Group~~and ~~Inc~~disclosures in this report. ~~and,~~See asNote ~~applicable,~~7—Subsequent ~~our~~Events in the footnotes to the consolidated ~~subsidiaries:~~financial ~~Angionetics,~~statements and ~~Inc~~elsewhere in this report. ~~(“Angionetics’),~~We ~~Activation~~filed ~~Therapeutics~~a comprehensive Annual Report on Form 10-K for the period ended December 31, ~~Inc.~~2019 (the “~~Activation~~2019 Annual ~~Therapeutics~~Report”), with expanded disclosures for the fiscal years ended December 31, 2018 and ~~LifeAgain~~2017, ~~Insurance~~and ~~Solutions~~the quarterly period ended March 31, ~~Inc.~~June ~~(“LifeAgain”)~~30, and September 30 during 2019, 2018 and 2017.

~~Due~~The filing toof ~~financial~~this ~~hardship,~~report wewill ~~were~~not ~~unable~~result toin ~~secure~~us ~~the~~becoming ~~necessary~~“current” ~~accounting~~in ~~review~~our ~~and~~reporting ~~audit~~requirements ofunder ~~our~~the ~~financial~~Securities ~~statements~~Exchange Act ~~and~~of ~~suspended~~1934. ~~filing~~It ofis our ~~regular~~intention ~~quarterly~~to ~~and~~become ~~annual~~current, ~~reports~~and ~~following~~we ~~our~~are ~~Quarterly~~preparing ~~Report~~quarterly onreports ~~Form 10-Q~~ for the ~~period~~periods ended June 30, ~~2015. We~~2020 ~~have~~and ~~subsequently~~September 30, ~~filed~~2020, ~~our~~and ~~Quarterly Report on Form 10-Q~~ for the annual reporting period ended ~~September~~December 3031, ~~2015,~~2020. ~~our~~In ~~Annual~~addition, ~~Report~~to onbecome ~~Form~~current ~~10-K~~we ~~for~~also ~~the~~plan ~~year~~to ~~ended~~file ~~December 31, 2015,~~ our ~~Quarterly~~quarterly reports ~~Report on Form 10-Q~~ for the ~~period~~periods ended March 31, ~~2016,~~2021 ~~our~~and ~~Quarterly Report on Form 10-Q for the period ended~~ June 30, ~~2016~~2021. ~~and~~Once ~~our~~we ~~Quarterly~~do ~~Report~~become oncurrent, ~~Form~~we ~~10-Q~~will ~~for~~continue ~~the~~to ~~period~~be ~~ended~~precluded ~~September~~from the ~~30,~~use ~~2016. It~~of iscertain ~~our~~abbreviated ~~intention~~registration tostatements ~~become~~and ~~current~~forms, inwhich ~~our~~are ~~reporting~~predicated ~~obligations~~on ~~under~~timely ~~the~~filing ~~Securities~~all ~~Exchange~~required ~~Act~~reports ofover ~~1934,~~the prior as12-month ~~amended~~period.

All references in this report to the “Company,” “Gene Biotherapeutics,” “Gene Bio,” “we,” “our,” and “us” refer to Gene Biotherapeutics Inc., and its consolidated subsidiaries Angionetics, Inc. and Activation Therapeutics, Inc.

SPECIAL NOTE ABOUT FORWARD-LOOKING STATEMENTS

~~Certain statements in this~~ This report, ~~including~~contains ~~information incorporated by reference, are “~~forward-looking statements” ~~within~~that ~~the~~reflect ~~meaning~~our ofcurrent ~~Section~~expectations ~~27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934,~~ and ~~the~~views ~~Private Securities Litigation Reform Act~~ of ~~1995. Forward-looking statements reflect current views about~~ future events ~~and financial performance based on certain assumptions~~. ~~They~~These ~~include~~forward-looking ~~opinions, forecasts, intentions, plans, goals, projections, guidance, expectations, beliefs or other~~ statements can ~~that~~also ~~are~~be ~~not~~identified ~~statements~~by ofwords ~~historical fact. Words~~ such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “believes,” “anticipates,” “intends,” “estimates,” “approximates,” “predicts,” or “projects,” or ~~the negative or other variation of such words, and~~ similar ~~expressions may identify a statement as a forward-looking statement~~terms. Any statements that refer to projections of our future financial performance, anticipated growth and trends in our business, our goals, strategies, focus and plans, and other characterizations of future events or circumstances, including statements expressing general optimism about future operating results and the development of our products, are forward-looking statements. Forward-looking statements in this report may include statements about:

•● our ability to ~~fund~~contract ~~operations~~with third-party suppliers and ~~business~~manufacturers ~~plans~~and their ability to perform adequately, particularly with respect to the timely production and delivery of our Generx product candidate; ● our ability and the ability of third parties with whom we contract to successfully manufacture our commercial products at scale, as well as drug substances, delivery vehicles, development candidates, and investigational medicines for preclinical and clinical use; ● the scope of protection we are able to establish and maintain for intellectual property rights covering our commercial products, investigational medicines and technology; ● the initiation, timing, progress, results, and cost of our research and development programs and our current and future preclinical studies and clinical trials, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available, and our research and development programs; ● the ultimate impact of the current coronavirus pandemic, or the COVID-19 pandemic, or any ~~funding~~other health epidemic, on our business, manufacturing, clinical trials, research programs, supply chain, regulatory review, healthcare systems or ~~corporate~~the global economy as a whole; ● risks related to the direct or indirect impact of the COVID-19 pandemic or any future large-scale adverse health event, such as the scope and duration of the outbreak, government actions and restrictive measures implemented in response, material delays in diagnoses, initiation or continuation of treatment for diseases that may be addressed by our development ~~transactions~~candidates weand investigational medicines, or in patient enrollment in clinical trials, potential clinical trials, regulatory review or supply chain disruptions, and other potential impacts to our business, the effectiveness or timeliness of steps taken by us to mitigate the impact of the pandemic, and our ability to execute business continuity plans to address disruptions caused by the COVID-19 pandemic or future large-scale adverse health event; ● our anticipated next steps for our development candidates and investigational medicines that may ~~pursue~~be slowed down due to the impact of the COVID-19 pandemic; ● our ability to identify research priorities and apply a risk-mitigated strategy to efficiently discover and develop development candidates and investigational medicines, including by applying learnings from one program to our other programs and from one modality to our other modalities; ● the ability and willingness of our third-party strategic collaborators to continue research and development activities relating to our development candidates and investigational medicines; ● our ability to obtain and maintain regulatory approval of our investigational medicines; ● our ability to successfully commercialize any future products, if approved; ● the pricing and reimbursement of our investigational medicines, if approved; ● the implementation of our business model, and strategic plans for our business, investigational medicines, and technology; ● estimates of our future expenses, revenues, capital requirements, and our needs for additional financing;

~~• planned development pathways and potential commercialization activities or opportunities;~~-3-

•● the ~~timing~~potential benefits of strategic collaboration agreements, ~~conduct~~our ability to enter into strategic collaborations or arrangements, and ~~outcome~~our ofability ~~discussions~~to attract collaborators with development, regulatory, ~~agencies~~and commercialization expertise; ● future agreements with third parties in connection with the commercialization of our investigational medicines, ~~regulatory~~if ~~submissions~~approved; ● the size and ~~clinical~~growth ~~trials,~~potential ~~including~~of the ~~timing~~markets for ~~completion~~our investigational medicines, and our ability to serve those markets; ● our financial performance; ● the rate and degree of ~~clinical~~market ~~studies~~acceptance of our investigational medicines; ● regulatory developments in the United States and foreign countries; ● our ability to produce our products or investigational medicines with advantages in turnaround times or manufacturing cost; ● the success of competing therapies that are or may become available; ● our ability to attract and retain key scientific or management personnel; ● the impact of laws and regulations; ● developments relating to our competitors and our industry; and ● other risks and uncertainties discussed in this Form 10-Q.

•Caution should ~~our~~be ~~beliefs~~taken not to place undue reliance on any such forward-looking statements. Forward-looking statements are subject to certain events, risks, and ~~opinions~~uncertainties ~~about~~that ~~the~~may ~~anticipated~~be ~~results~~outside of our ~~clinical~~control ~~studies~~that could cause actual results to differ materially from those expressed in or implied by the forward-looking statements. These factors include, among others, the risks described under Part II, Item 1A “Risk Factors” and ~~trials~~elsewhere in this report, as well as in other reports and documents we file with the ~~safety~~United States Securities and Exchange ~~efficacy~~Commission (the “SEC”). The forward-looking statements in this report speak only as of ~~our~~the ~~products~~date ~~and~~of ~~product~~this ~~candidates;~~report. We do not undertake to update or revise any forward-looking statements in the report, except as required by law.

•This report also contains, or may contain, estimates, projections and other information concerning our ~~ability~~industry, our business, and the markets for our products, including data regarding the estimated size of those markets and their projected growth rates. Information that is based on estimates, forecasts, projections, or similar methodologies is inherently subject to ~~generate~~uncertainties ~~revenues~~and actual events or circumstances may differ materially from events and circumstances reflected in this information. Unless otherwise expressly stated, we obtained these industry, business, market and ~~raise~~other ~~sufficient~~data ~~financing~~from reports, ~~maintain~~research ~~stock~~surveys, ~~price~~studies and ~~valuation~~similar data prepared by third parties, industry and togeneral ~~regain~~publications, ~~the~~government ~~listing~~data ofand ~~our~~similar ~~common~~sources. ~~stock~~In onsome acases, ~~national~~we ~~exchange;~~do not expressly refer to the sources from which these data are derived.

• our ability to enter into acceptable relationships with one or more contract manufacturers or other service providers, and the ability of such contract manufacturers or other service providers to manufacture biologics, devices, other key products or components, or to provide other services, of an acceptable quality on a timely and cost-effective basis;Additional Information

•Additional information about the Company is available from our ~~ability~~website, towww.genebiotherapeutics.com, ~~enter~~including ~~into~~the ~~acceptable~~investor ~~relationships~~relations ~~with~~section. ~~one~~In addition, orspecific ~~more~~information ~~development~~about orour ~~commercialization~~planned ~~partners~~FDA-cleared, toGenerx ~~advance~~[Ad5FGF-4] ~~the~~AFFIRM ~~commercialization~~Phase of3 ~~new~~clinical ~~products~~study ~~and~~is ~~product~~available ~~candidates~~from ~~and~~our ~~the~~website www.myrefractoryangina.com. ~~timing~~We ofencourage ~~any~~investors ~~product~~to ~~launches;~~visit these websites as information is frequently undated and information is shared.

~~• our growth, expansion and acquisition strategies, the success of such strategies, and the benefits we believe can be derived from such strategies;~~-4-

•GENE BIOTHERAPEUTICS ~~our ability to pursue and effectively develop new product opportunities and acquisitions and to obtain value from such product opportunities and acquisitions;~~INC.

• the protection expected from our intellectual property rights and those of others, including actual or potential competitors;

• the outcome of litigation matters;

• the anticipated activities of our personnel, consultants and collaborators;

• expectations concerning our operations outside the United States;

• future economic and political conditions;

• overall industry and market performance;

• the impact of new accounting standards;

• management’s goals and plans for future operations; and

• other assumptions described in this report underlying or relating to any forward-looking statements.

The forward-looking statements in this report speak only as of the date of this report and caution should be taken not to place undue reliance on any such forward-looking statements. Forward-looking statements are subject to certain events, risks, and uncertainties that may be outside of our control that could cause actual results to differ materially from those expressed in or implied by the forward-looking statements. These factors include, among others, the risks described under Item 1A and elsewhere in this report, as well as in other reports and documents we file with the United States Securities and Exchange Commission (the “SEC”).

TAXUS CARDIUM PHARMACEUTICALS GROUP, INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets

(unaudited)

	March 31,			December 31,
	2017			2016
	2020			2019
Assets
Current assets:
Cash and cash equivalents	$	~~176~~2,~~367~~926		$	~~930,397~~400
Prepaid expenses and other assets		39111,~~204~~988			1032,~~426~~395
Total current assets		~~215~~114,~~571~~914			~~940~~32,~~823~~795
Property and equipment, net		~~146~~2,~~590~~219			~~158~~2,~~227~~640
Other long term assets		11,767			11,767
Other long term		12,541
Total assets	$	~~373~~129,~~928~~674		$	135,~~110,817~~435
Liabilities and Stockholders’ Deficit
Current liabilities:
Accounts payable	$	1,~~605~~040,~~532~~045		$	1967,~~672,932~~126
Accrued liabilities		12,~~658~~890,~~610~~440			12,~~670~~796,~~340~~689
Advances from officer		1,047,851			1,050,327
Note Payable		281,976			273,749
Total current liabilities		4,311,993			4,393,599
Advances from officer		690,050			725,425
Deferred rent		6,887			6,887
Total current liabilities		4,902,511			4,762,989
Total liabilities		4,318,880			4,400,486
Notes payable-long term		245,740			122,209
Total liabilities		5,148,251			4,885,198
Commitments and contingencies
Stockholders’ deficit:
Taxus Cardium Pharmaceuticals Group, Inc. Series A Convertible Preferred stock, $0.0001 par value; 40,000,000 shares authorized; issued and outstanding 829 at March 31, 2017 and 928 at December 31, 2016, with liquidation preferences of $1,000		—			—
Common stock, $0.0001 par value; 200,000,000 shares authorized; issued and Outstanding 14,273,544 at March 31, 2017 and 13,723,544 at December 31, 2016		1,427			1,373
Common stock issuable		600,000			600,000
Additional paid-in capital		113,710,577			113,710,631
Series A Convertible Preferred stock, $0.0001 par value; 40,000,000 shares authorized; issued and outstanding 790 March 31, 2020 and 790 at December 31, 2019
Accumulated deficit		(118,030,066	)		(117,449,942	)
Common stock, $0.0001 par value; 200,000,000 shares authorized; issued and outstanding 14,489,399 at March 31, 2020 and 14,489,399 at December 31, 2019, respectively		1,449			1,449
Total controlling interest		(3,718,062	)		(3,137,938	)
Additional paid-in capital		114,020,581			114,020,581
Non-controlling interest		(226,890	)		(151,731	)
Accumulated deficit		(119,062,053	)		(118,912,290	)
Total stockholders’ deficit		(3,944,952	)		(3,289,669	)
Total controlling interest		(4,440,023	)		(4,290,260	)
Total liabilities and stockholders’ deficit	$	373,928		$	1,110,817
Non-controlling interest		(578,554	)		(559,503	)
Total stockholders’ deficit		(5,018,577	)		(4,849,763	)
Total liabilities and stockholders’ deficit	$	129,674		$	35,435

See accompanying notes, which are an integral part of these condensed consolidated financial statements.

3-5-

~~TAXUS~~GENE BIOTHERAPEUTICS ~~CARDIUM PHARMACEUTICALS GROUP~~ INC. ~~AND SUBSIDIARIES~~

Condensed Consolidated Statements of Operations

(unaudited)

	Three Months Ended March 31,
	2017			2016
	2020			2019
Operating expenses
Research and development	$	~~130~~46,~~762~~605		$	8363,~~333~~379
Selling, general and administrative		~~521~~106,~~218~~278			~~340~~179,~~669~~599
Total operating expenses		~~651~~152,~~980~~883			~~424~~242,~~002~~978
Loss from operations		(~~651~~152,~~980~~883	)		(~~424~~242,~~002~~978	)
Other expenses		3,303			2,573
Other expenses:
Net loss	$	(655,283	)	$	(426,575	)
Interest expense		(15,931	)		(10,129	)
Net loss attributable to the non-controlling interest		(75,159	)		—
Net loss	$	(168,814	)	$	(253,107	)
Net loss attributable to the controlling interest	$	(580,124	)	$	(426,575	)
Net loss attributable to the non-controlling interest		(19,051	)		(26,736	)
Net loss attributable to the controlling interest	$	(149,763	)	$	(226,369	)
Net loss attributable to controlling interest per share:
Basic and diluted	$	(0.0401	)	$	(0.0302	)
Weighted average common shares outstanding		14,~~045~~489,~~264~~399			1314,~~187~~473,~~544~~967

See accompanying notes, which are an integral part of these condensed consolidated financial statements.

4-6-

~~TAXUS~~GENE BIOTHERAPEUTICS ~~CARDIUM PHARMACEUTICALS GROUP,~~ INC. ~~AND SUBSIDIARIES~~

Condensed Consolidated Statements of Cash Flows

(unaudited)

	Three Months Ended March 31,
	2017			2016
	2020			2019
Cash Flows From Operating Activities
Cash Flows from Operating Activities
Net loss	$	(655,283	)	$	(426,575	)
Net (Income) loss	$	(168,814	)	$	(253,107	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation		~~13,502~~421			315,~~263~~942
Stock-based compensation		—			25,530
Deferred rent amortization					(2,722	)
Changes in operating assets and liabilities
Prepaid expenses and other assets		(2879,~~778~~594	)		—5,305
Accounts payable		(67,400	)		(28,843	)
Deposits and other long-term assets		(12,541	)
Accrued liabilities		(11,730	)		173,726
Accounts payable		72,920			8,863
Net cash used in operating activities		(749,689	)		(252,899	)
Accrued liabilities		93,751			185,375
Cash Flows From Investing Activities
Net cash used in operating activities		(93,857	)		(40,344	)
Purchase of property and equipment		(1,865	)		—
Cash Flows from Financing Activities
Net cash used in investing activities		(1,865	)		—
Proceeds (Payments) from officer’s loan		(35,375	)		(45,503	)
Cash Flows From Financing Activities
Increase in notes payable		131,758			8,137
Cash advance from (repayments of advance to) officer		(2,476	)		100,627
Net cash provided by financing activities		96,383			(37,366	)
Proceeds from preferred stock issuable		—			250,000
Net increase (decrease) in cash		2,526			(77,710	)
Net cash provided by (used in) financing activities		(2,476	)		350,627
Cash and cash equivalents at beginning of period		400			82,115
Net increase (decrease) in cash		(754,030	)		97,728
Cash and cash equivalents at end of period	$	2,926		$	4,405
Cash and cash equivalents at beginning of period		930,397			21,547
Cash and cash equivalents at end of period	$	176,367		$	119,275
Supplemental Disclosures of Cash Flow Information:
Cash paid for interest	$	14,~~957~~173		$	21,~~573~~991
Cash paid for taxes	$	—		$	—

See accompanying notes, which are an integral part of these condensed consolidated financial statements.

5-7-

~~TAXUS~~GENE BIOTHERAPEUTICS ~~CARDIUM PHARMACEUTICALS GROUP,~~ INC. AND SUBSIDIARIES

Condensed Consolidated Statements Of Stockholders (Deficit)/Equity

March 31, 2020

	Controlling Interest
	Common Stock				Series A Convertible Preferred Stock				Common Stock Issuable		Additional Paid-In- Capital		Controlling Interest Deficit			Non- Controlling Interest			Deficit Total
	Shares		Amount		Shares		Amount
Balance—December 31, 2019		14,489,399	$	1,449		790		—	$	600,000	$	114,020,581	$	(118,912,290	)	$	(559,503	)	$	(4,849,763	)
Issuance of common stock on conversion of preferred stock		0		0		0		—				0					—			—
Non-controlling interest								—									(19,051	)		(19,051	)
Net income														(149,763	)					(149763	)
Balance—March 31, 2020		14,489,399	$	1,449		790	$	—	$	600,000	$	114,020,581	$	(119,062,053	)	$	(578,554	)	$	(5,018,577	)

-8-

GENE BIOTHERAPEUTICS INC., AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Note 1—. Organization and Liquidity

Organization

~~Taxus~~Gene Biotherapeutics ~~Cardium~~Inc. (the “Company”) was initially incorporated in Delaware in December 2003. WeThe ~~are~~Company anis ~~operating company that manages~~ a ~~medical technologies portfolio of equity~~late-~~based~~stage biotechnology ~~and~~company ~~potential royalty-driven investments as follows: (1) Angionetics, currently a majority-owned subsidiary~~ focused on the ~~late-stage~~ clinical ~~development~~ and commercialization of ~~Generx™, an~~ angiogenic gene therapy ~~product~~biotherapeutics ~~candidate designed~~ for ~~medical~~strategic niche ~~revascularization~~markets, primarily for the ~~potential~~ treatment of ~~patients~~cardiovascular ~~with~~disease. ~~myocardial~~The ~~ischemia~~technology ~~and~~platform ~~refractory~~is ~~angina~~designed ~~due~~ to ~~advanced~~biologically ~~coronary~~activate ~~artery~~the human ~~disease;~~body’s ~~(2)~~innate ~~Activation~~angiogenic ~~Therapeutics,~~healing aprocess ~~wholly~~to ~~owned~~stimulate ~~subsidiary focused on~~ the ~~development~~growth ~~and commercialization~~ of ~~the~~microvascular ~~Excellagen®~~networks ~~technology platform, an FDA-cleared flowable dermal matrix~~ for ~~advanced~~patients ~~wound~~with ~~care~~ischemic ~~that we believe has broad potential applications as a delivery platform for small molecule drugs~~cardiovascular, cerebral, ~~proteins~~ and ~~biologics;~~other ~~(3) LifeAgain a wholly-owned subsidiary that has developed an advanced~~ medical ~~data~~conditions ~~analytics (ADAPT®) technology platform focused on developing new~~ and ~~innovative products for the life insurance and healthcare sectors; and (4) a minority investment in Healthy Brands Collective~~diseases, aas ~~functional~~well ~~food~~as ~~and~~for ~~nutraceutical~~advanced ~~company~~tissue ~~which~~engineering ~~acquired the Company’s To Go Brands® business~~applications.

~~Our~~The Company’s current business is focused exclusively on the ~~acquisition and strategic~~ development of ~~product~~Generx, ~~opportunities~~an orangiogenic ~~businesses~~gene ~~having~~therapy ~~the~~product ~~potential~~candidate, initially totargeted ~~address~~for ~~significant~~patients ~~unmet~~with ~~medical~~refractory ~~needs,~~angina ~~and~~due ~~having definable pathways~~ to ~~commercialization.~~advanced ~~Our~~coronary ~~business~~artery ~~model~~disease isand ~~designed~~other toforms ~~create~~of ischemic aheart ~~portfolio~~disease ofincluding ~~opportunities~~congestive ~~for~~heart ~~success~~failure, ~~avoiding~~through ~~reliance~~our on85% ~~any~~owned ~~single~~subsidiary ~~technology~~Angionetics ~~platform or product type~~Inc. The WeCompany ~~focus~~does onnot ~~late-stage~~currently ~~product~~have ~~development~~any ~~bridging~~other ~~the~~products ~~critical~~or ~~gap~~other ~~between promising new technologies and~~ product opportunities that are ready for commercialization. As our product opportunities and businesses are advanced and corresponding valuations established, we intend to consider various corporate development transactions designed to place our product candidates ~~into larger organizations or with partners having existing commercialization, sales~~ and ~~marketing~~has ~~resources,~~not ~~and~~generated aany ~~need~~revenues from operations for ~~innovative~~the ~~products.~~three-month ~~Such~~period ~~transactions~~ended ~~could~~March ~~involve the sale~~31, ~~partnering or other monetization of particular product opportunities or businesses~~2020.

In May 2020, after the period covered by this report, we entered into a Preferred Stock Purchase Agreement with Nostrum Pharmaceuticals, LLC (“Nostrum”), selling Nostrum 1,700,000 shares of our newly authorized Series B Convertible Preferred Stock in exchange for $1.7 million. In addition, to further support the operations of the Company for the period May 2021 through July 2021, subsequent to this reporting period, Nostrum invested an additional $292,000, into the Company. Nostrum is the parent company of Nostrum Laboratories, Inc., a privately held pharmaceutical company engaged in the formulation, commercialization, marketing and sale of specialty pharmaceutical products and controlled release, orally administered, branded and generic drug products. We have used the proceeds from the sale of the Series B Convertible Preferred Stock to fund working capital requirements in preparation for conducting the U.S. FDA-approved Phase 3 clinical trial for our Generx product candidate. We believe that Nostrum’s assets and experience in the formulation and commercialization of pharmaceutical products will facilitate the administration and completion of the Phase 3 clinical trial for Generx on a cost-effective basis. Refer to the Subsequent Section for further discussion.

Liquidity and Going Concern

As of March 31, ~~2017~~2020, wethe Company had ~~approximately~~ $0.2,926 ~~million~~ in cash and cash equivalents. ~~Our~~The Company’s working capital deficit atas ~~March~~of March 31, ~~2017~~2020 was ~~approximately~~ $4.1,787,597 ~~million. We~~and ~~have~~the Company has incurred recurring losses and ashas ~~of March 31, 2017, we have~~ an accumulated deficit of $~~118~~119,062,053.0 ~~million.~~ During the ~~quarters~~three-month period ended March 31, ~~2017 and 2016~~2020, wethe Company used ~~$749,689~~approximately ~~and~~ $~~252~~93,~~899~~857 of cash in our operating activities. The Company also began restructuring efforts with its vendors in 2019, resulting in the forgiveness of approximately $1.66 million in vendor payables and additional forgiveness of approximately $68,000 in the quarter ending June 30, 2020.

WeOn April ~~anticipate~~10, ~~that~~2020, ~~negative~~after ~~cash~~the ~~flows~~period ~~from~~covered ~~operations~~by ~~will~~this ~~continue~~report, we transferred our residual rights in Excellagen to Shanxi Taxus Pharmaceuticals Co. Ltd. in exchange for the ~~foreseeable~~release ~~future.~~of Weany ~~have~~rights ~~yet~~or toclaims ~~generate~~in ~~positive~~ownership interest ~~cash~~in ~~flows~~Gene ~~from~~Biotherapeutics. ~~operations~~As a result, ~~and~~we ~~are~~no ~~essentially~~longer ~~dependent~~have onan ~~equity~~interest ~~and~~in ~~debt~~Excellagen, ~~funding~~other tothan ~~finance~~the ~~our~~right ~~operations. We~~to ~~currently~~receive doroyalty ~~not~~payments from ~~have~~Olaregen ~~any~~totaling ~~unused~~up ~~credit~~to ~~facilities.~~$3,350,000, Asbased ~~long~~on asmonthly ~~any~~net ~~shares~~sales of ~~our~~Excellagen ~~Series~~worldwide, Aexcluding ~~Convertible~~Greater ~~Preferred~~China, ~~Stock~~the ~~are~~Russian ~~outstanding~~Federation, and wecountries ~~have~~in the Commonwealth of Independent States. In connection with this transaction, Shanxi agreed ~~that~~to weapply ~~will~~previously ~~not~~funded $600,000 ~~without~~subscription ~~the~~payment ~~consent~~in ofexchange for the ~~holders~~rights ofto ~~two-thirds~~Excellagen ofin the ~~Series~~Greater AChina, ~~Convertible~~the ~~Preferred~~Russian ~~Stock,~~Federation ~~incur~~and ~~indebtedness~~countries ~~other~~in the ~~than~~Commonwealth ~~specified~~of ~~“Permitted~~Independent ~~Indebtedness”~~States, ~~incur~~and Shanxi released any ~~liens~~future ~~other~~rights ~~than~~or ~~specified~~claims ~~“Permitted~~against ~~Liens”~~us.

~~Our~~On April ~~history~~10, of2020, ~~recurring~~after ~~losses~~the period covered by this report, our Angionetics, Inc. subsidiary entered into a Distribution and ~~uncertainties~~License Agreement with Shanxi (as toamended, ~~whether~~the ~~our~~“Shanxi ~~operations~~License ~~will~~Agreement”), ~~become~~granting ~~profitable~~Shanxi ~~raises~~certain ~~substantial~~license ~~doubt~~rights ~~about~~with respect to our ~~ability~~Generx product tocandidate. ~~continue~~The asdistribution aand ~~going~~license ~~concern~~rights commence only after we obtain U.S. ~~Our~~FDA ~~consolidated~~approval ~~financial~~for ~~statements~~marketing doand ~~not~~sale of Generx in the United States. The license rights include (a) a non-exclusive right to manufacture Generx products in China, and (b) an exclusive right to market and sell Generx products in Singapore, Macau, Hong Kong, Taiwan, any ~~adjustments~~other ~~related~~municipality other than mainland China where Chinese (Mandarin or Cantonese) is the common language, the Russian Federation, and the Commonwealth of Independent States (i.e., Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Moldova, Tajikistan, Turkmenistan, and Uzbekistan). The Shanxi License Agreement provides for a royalty ranging from 5% up to 10% based on the ~~recoverability~~level of ~~assets~~annual ornet ~~classifications~~sales of ~~liabilities~~the ~~that~~Generx ~~might~~product besold ~~necessary~~by ~~should~~Shanxi wein bethe ~~unable~~licensed territory. Refer to ~~continue~~the asSubsequent Events section for a ~~going~~further ~~concern~~discussion on this matter.

The Company ~~accompanying~~anticipates ~~consolidated~~that ~~financial~~negative ~~statements~~cash ~~have~~flows ~~been~~from ~~prepared~~operations inwill ~~conformity~~continue ~~with~~for Uthe foreseeable future.S. ~~GAAP,~~We ~~which~~have ~~contemplates~~yet ~~our~~to ~~continuation~~generate positive ascash aflows ~~going~~from ~~concern~~operations and we are essentially dependent on external funding sources to support the ~~realization~~Company’s ofresearch, ~~assets~~development and ~~satisfaction~~commercialization activities. The Company’s history of ~~liabilities~~recurring inlosses ~~the~~and uncertainties ~~normal~~as ~~course~~to ofwhether ~~business~~operations will become profitable raises substantial doubt about its ability to continue as a going concern for atthe ~~least~~next ~~one~~twelve ~~year~~months from the date of issuance of these ~~consolidated~~ financial statements. ~~Our~~We ~~ability~~do tonot ~~continue~~have ~~our~~any ~~operations~~unused iscredit ~~dependent~~facilities. onWe intend ~~the~~to ~~execution~~pursue sources of ~~management~~working capital from non-dilutive funding channels to support the Company’s ~~plans,~~operations ~~which~~that could include, but ~~the~~not ~~raising~~be oflimited ~~capital~~to, ~~through~~(1) ~~the~~up ~~equity~~to ~~and/or~~$3.350 ~~debt~~million ~~markets,~~from ~~until~~potential ~~such~~royalties ~~time~~from ~~that~~commercial ~~funds~~sales ~~provided~~of byExcellagen® ~~operations~~from ~~are~~certain ~~sufficient~~geographic regions, toincluding ~~fund~~the ~~working~~United ~~capital~~States; ~~requirements.~~(2) ~~The~~Federal ~~consolidated~~government ~~financial~~sponsored ~~statements~~research ~~contained~~grants; in(3) ~~this~~agreements ~~report~~and doarrangements ~~not~~covering ~~include~~distributor and ~~any~~strategic ~~adjustments~~partnerships ~~related~~and todrug royalty agreements based on the ~~recoverability~~commercial sale of ~~assets~~Generx orfollowing ~~classifications~~the ofsuccessful ~~liabilities~~completion ~~that~~of the ~~might~~planned beFDA-cleared, ~~necessary~~Phase ~~should~~3 weAFFIRM beclinical ~~unable~~study toand ~~continue~~FDA asregistration ain ~~going~~the ~~concern~~U.S., Ifand weadditional ~~were~~registrations ~~not~~ to ~~continue~~market asand asell Generx ~~going~~in ~~concern,~~other wecountries ~~would~~internationally. ~~likely~~At ~~not~~the beappropriate ~~able~~time, towith ~~realize~~favorable ~~our~~market ~~assets~~conditions, atand ~~values~~an ~~comparable~~appropriate toenterprise value reflective of the ~~carrying~~Company’s ~~value~~clinical orstatus and the ~~fair~~Generx ~~value~~[Ad5FGF-4] ~~estimates~~economic ~~reflected~~potential, inwe could also consider the ~~balances~~sale ~~set~~of ~~out~~equity and debt securities in ~~the~~a ~~consolidated~~privately ~~financial~~negotiated ~~statements~~structured transactions or public capital market offerings.

We intend to secure additional working capital through sales of equity and debt securities to finance our operations, or the sale of certain equity interests in our businesses, technology platforms, products or product candidates and licensing agreements covering the marketing and sale of Excellagen and Generx in certain geographic markets and regions.-9-

OnThe accompanying ~~June~~consolidated 7,financial ~~2016,~~statements ~~Taxus~~have ~~Cardium~~been ~~and~~prepared ~~Angionetics~~in ~~entered~~conformity ~~into~~with aU.S. ~~Share~~GAAP, ~~Purchase~~which ~~Agreement~~contemplates ~~with~~our ancontinuation ~~entity~~as a ~~affiliated~~going ~~with~~concern ~~Huapont~~and ~~Life~~the ~~Sciences~~realization ~~Co.~~of ~~Ltd,~~assets aand ~~China-based~~satisfaction ~~pharmaceutical~~of ~~and~~liabilities ~~active~~in ~~pharmaceutical~~the ~~ingredient~~normal ~~company~~course ~~(“Huapont”)~~of business. ~~Pursuant~~The Company’s ability to ~~the~~continue ~~Share~~operations ~~Purchase~~is ~~Agreement,~~dependent ~~Angionetics~~on ~~agreed~~the toexecution ~~sell~~of ~~600~~management’s plans,~~000,~~ ~~shares~~which include the raising of ~~its~~additional ~~newly~~capital through ~~authorized~~the ~~Series~~equity Aand/or ~~Convertible~~debt ~~Preferred~~markets, ~~Stock~~until ~~(the~~such ~~“Shares”)~~time that funds provided by operations are sufficient to fund working capital requirements. Without additional capital the ~~Huapont~~Company ~~affiliate~~will innot ~~exchange~~have sufficient resources for $3research,~~000,000~~ inproduct ~~cash.~~development ~~The~~and ~~agreement~~sales ~~called~~and ~~for~~marketing ~~the~~efforts to ~~investment~~bring ~~from~~Generx ~~the~~to ~~Huapont~~commercialization. ~~affiliate~~The toconsolidated befinancial ~~made~~statements contained in ~~two~~this ~~tranches—~~report do not include any adjustments related to the ~~closing~~recoverability of ~~the~~assets ~~initial~~or ~~tranche~~classifications of ~~200,000~~liabilities ~~Shares~~that ~~for~~might ~~$1,000,000~~be ~~shortly~~necessary ~~following~~should the Company be unable to continue as a going concern.

6Impact of Coronavirus Outbreak

~~execution~~On January of30, ~~the~~2020, ~~agreement and~~ the ~~closing~~World ofHealth ~~the~~Organization ~~second~~(“WHO”) ~~tranche~~announced ofa ~~400,000~~global ~~Shares~~health ~~for~~emergency ~~$2,000,000~~because ~~was~~of ~~conditioned upon Angionetics securing FDA clearance to initiate~~ a new ~~U.S.-based~~strain ~~Phase~~of 3coronavirus originating ~~clinical~~in ~~study~~Wuhan, China (the ~~AFFIRM~~“COVID-19 ~~study~~outbreak”) toand ~~evaluate~~ the ~~safety~~risks ~~and~~to ~~definitive efficacy of~~ the ~~GenerxTM~~international ~~[Ad5FGF-4]~~community ~~product~~as ~~candidate for~~ the ~~treatment~~virus ofspreads ~~patients~~globally beyond ~~with~~its ~~ischemic~~point ~~heart~~of ~~disease and refractory angina~~origin. ~~The~~In ~~closings~~March ~~took place~~2020, ~~and~~ the ~~Shares~~WHO ~~were~~classified ~~issued,~~the onCOVID-19 ~~July~~outbreak 5as a pandemic, ~~2016~~based ~~and~~on ~~September~~the ~~28,~~rapid ~~2016,~~increase ~~respectively~~in exposure globally.

OnThe Company ~~April~~did 4,not ~~2015~~experience wesubstantial ~~entered~~effects ~~into~~from athe ~~term~~COVID- ~~sheet~~19 ~~with~~outbreak ~~Shenzhen~~on ~~Qianhai~~its ~~Taxus,~~operations ~~whereby~~for wethe ~~proposed~~period toended ~~sell~~March ~~Shenzhen~~31, ~~Qianhai~~2020. The ~~Taxus~~full ~~600,000~~impact ~~shares~~ of ~~common~~the ~~stock~~COVID-19 inoutbreak ~~our~~continues ~~Angionetics~~to ~~subsidiary~~evolve inas ~~exchange~~of ~~for~~the ~~$3.0~~date ~~million~~of inthis ~~cash~~report. ~~The~~As ~~$3.0~~such, ~~million~~it ~~was~~is touncertain beas ~~paid~~to inthe ~~tranches~~full magnitude that ~~were~~the topandemic bewill ~~completed~~have byon ~~May~~the ~~31,~~Company’s ~~2015.~~financial ~~Shenzhen~~condition, ~~Qianhai~~liquidity, ~~Taxus~~and ~~paid~~future ~~$600,000~~results of ~~the~~operations. ~~financing,~~Management ~~which~~is ~~was~~actively monitoring ~~recorded~~the asimpact ~~common~~of ~~stock~~the ~~issuable.~~global ~~Since~~situation ~~Shenzhen~~on ~~Qianhai~~its ~~Taxus~~financial ~~did~~condition, ~~not~~liquidity, ~~complete~~operations, ~~this~~suppliers, ~~transaction~~industry, ~~instead~~and ~~Huapont~~workforce. Given ~~agreed~~the todaily ~~fund~~evolution of the ~~investment.~~COVID-19 ~~Shenzhen~~outbreak ~~Qianhai~~and ~~Taxus~~the isglobal ~~eligible~~responses to ~~apply~~curb ~~this~~its ~~amount~~spread, ~~toward~~ the ~~purchase~~Company ofis ~~common~~not ~~stock~~able ofto estimate the effects ~~Company~~of orthe ~~its~~COVID-19 ~~subsuduaries~~outbreak ~~based~~ on ~~terms~~its ~~and~~results ~~conditions approved by the Company’s Board~~ of ~~Directors.~~operations, ~~This~~financial ~~contribution~~condition, isor ~~committed~~liquidity ~~and~~on ~~not~~its ~~refundable~~future ~~to Shenzhen Qianhai Taxus~~operations.

Note 2—Summary of Significant Accounting Policies

Basis of Presentation

The accompanying ~~condensed~~ consolidated financial statements ~~contained in this report~~ have been prepared in accordance with ~~GAAP for interim financial statements and with Form 10-Q and Article 10 of Regulation~~ U.S-X. ~~Accordingly, they do not contain all information and footnotes required by~~ GAAP for annual financial statements. In the opinion of our management, the accompanying unaudited condensed consolidated financial statements contain all the adjustments necessary (consisting only of normal recurring accruals) to present the financial position of the Company as of March 31, 2017 and the ~~results~~rules ~~of operations~~ and ~~cash~~regulations ~~flows for the period presented. The results~~ of ~~operations for~~ the ~~three~~Securities and ~~months~~Exchange ~~ended~~Commission ~~March 31, 2017 are not necessarily indicative of the operating results for the full fiscal year or any future period~~(“SEC”).

These condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and related notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016. Our accounting policies are described in the Notes to Consolidated Financial Statements in our Annual Report on Form 10-K for the year ended December 31, 2016, and updated, as necessary, in this Quarterly Report on Form 10-Q.

Estimates

The preparation of condensed consolidated financial statements in conformity with U.S. 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 of the financial statements and the reported amounts of revenues and expenses during the reporting period.

The most significant estimates impacting the financial statements contained in this report include valuing options and warrants using option pricing models. These significant accounting estimates or assumptions bear the risk of change due to the fact that there are uncertainties attached to these estimates or assumptions, and certain estimates or assumptions are difficult to measure or value

Investments

We adjust the carrying amount of our investments for any impairments that might occur due to other-than-temporary impairment (“OTTI”) declines. We consider the need for impairment if and when indicators of other than temporary declines in value are present. Management evaluates investments for OTTI declines on at least a quarterly basis, and more frequently when economic or market conditions warrant such an evaluation.

Fair Value of Financial Instruments

The carrying amounts of cash and cash equivalents, ~~advances~~accounts ~~from~~receivable, ~~related~~inventories, ~~party~~accounts payable, and ~~accounts~~accrued ~~payable~~liabilities approximate fair value due to the short -term maturities of these instruments.

Use of Estimates and assumptions and critical accounting estimates and assumptions.

The preparation of financial statements in conformity with U.S. 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 of the financial statements and the reported amounts of revenues and expenses during the reporting period.

Actual results could differ from these estimates. Management’s estimates and assumptions are reviewed regularly, and the effects of revisions are reflected in the consolidated financial statements in the periods they are determined to be necessary.

Principles of Consolidation

The consolidated financial statements include the accounts of ~~Taxus~~Gene ~~Cardium~~Biotherapeutics ~~Pharmaceuticals Group,~~ Inc., and its consolidated subsidiaries, Angionetics Inc., Activation Therapeutics, Inc. and LifeAgain Insurance Solutions, Inc. All significant inter-company transactions and balances have been eliminated in consolidation.

7The profit and losses of Angionetics are allocated among the controlling interest and the non-controlling interest in the same proportions as their ownership interests.

~~Controlling~~ Cash and ~~Non-Controlling~~Cash ~~Interest~~Equivalents

AsThe Company aconsiders ~~result~~all ofhighly ~~the~~liquid ~~issuance~~investments ofwith ~~200,000~~maturities ~~shares~~ of ~~Angionetics~~three ~~Series~~months Aor ~~Convertible~~less ~~Preferred~~when ~~Stock~~purchased onto ~~July~~be 5,cash ~~2016, the investor acquired a non-controlling interest of 5~~equivalents.~~6% of the voting interests of Angionetics for the purchase price of $1,000,000 (See Note 5 – Stockholders’ Equity – Preferred Stock – Angionetics Series A Convertible Preferred Stock.)~~

~~As a result of the issuance of 400,000 shares of Angionetics Series A Convertible Preferred Stock on September 28, 2016, the same investor acquired an additional non~~-controlling interest, which brought them to 15.0% of the aggregate voting interests of Angionetics, for an additional purchase price of $2,000,000 (See Note 5 – Stockholders’ Equity – Preferred Stock – Angionetics Series A Convertible Preferred Stock.)10-

~~The profits and losses~~ Concentration of ~~Angionetics~~Credit ~~are allocated among the controlling interest and the non-controlling interest in the same proportions as their ownership interests.~~Risk

Financial instruments that potentially subject us to significant concentrations of credit risk consist of cash and cash equivalents. At times, our cash and cash equivalents may be uninsured or in deposit accounts that exceed the Federal Deposit Insurance Corporation (“FDIC”) insurance limits. As of March 31, 2020, the Company had no cash and cash equivalent balances in excess of the federally insured limit of $250,000. The Company has not experienced any losses in such accounts and believes it is not exposed to significant risk on its cash balances due to the financial position of the depository institution in which those deposits are held.

Property and Equipment, net

Property and equipment are stated at cost and include equipment, installation costs and materials less accumulated depreciation and amortization. Depreciation is calculated on a straight-line basis over the estimated useful lives of the assets. Estimated useful lives of the assets range from 3 to 5 years. Leasehold improvements are amortized over the lesser of the useful lives or the term of the respective lease.

Expenditures for maintenance and repairs, which do not extend the useful life of the assets, are charged to expense as incurred. Gains or losses on disposal of property and equipment are reflected in general and administrative expenses in the statement of operations.

Impairment of Long-Lived Assets

The Company assesses its property and equipment for potential impairment when there is a change in circumstances that indicates carrying values of assets may not be recoverable. Such long-lived assts are deemed to be impaired when the undiscounted cash flows expected to be generated by the asset (or asset group) are less than the asset’s carrying amount. Any required impairment loss would be measured as the amount by which the asset’s carrying value exceeds its fair value and would be recorded as a reduction in the carrying value of the related asset and a charge to operating expense. The Company recognized no impairment losses during any of the periods presented in these financial statements.

Preferred Stock

WeThe Company ~~apply~~applies the accounting standards for distinguishing liabilities from equity when determining the classification and measurement of ~~our~~its preferred stock. Shares that are subject to mandatory redemption, (if any,) are classified as liability instruments and are measured at fair value. WeThe ~~classify~~Company classifies conditionally redeemable preferred shares, which includes preferred shares that feature redemption rights that are either within the control of the holder or subject to redemption upon the occurrence of uncertain events not solely within our control, as temporary equity. At all other times, preferred shares are classified as stockholders’ equity.

Revenue Recognition

The Company’s products have not reached commercialization, accordingly revenue from product sales have not been recognized. For arrangements that include sales-based royalties, the Company recognizes revenue based on an assessment of the probability of achievement. There is considerable judgement involved in determining whether it is probable that royalties will be collected. At the end of each subsequent reporting period, the Company reevaluates the probability of achievement and if necessary, adjusts the estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenues and earnings in the period of adjustment. To date, the Company has not recognized revenue from product sales or for royalties.

Research and Development

~~In accordance with Accounting Standard Codification (“ASC”) Topic 730 “~~Research and ~~Development”, research and~~ development ~~costs~~expenditures, which are ~~expensed~~charged asto ~~incurred.~~operations ~~Research~~in ~~and~~the ~~development~~period ~~expenses consist of purchased technology~~incurred, ~~purchased~~include ~~research~~costs ~~and development rights and outside services for research and development activities~~ associated with ~~product~~the design, development., testing Inand ~~accordance~~enhancement ~~with~~of ~~ASC~~products, ~~Topic~~regulatory ~~730~~fees, the ~~cost to~~ purchase ~~such~~of ~~technology~~laboratory supplies, and ~~research~~pre-clinical and ~~development~~clinical ~~rights~~studies ~~are~~as ~~required~~well as tosalaries beand ~~charged~~benefits ~~to expense if there is currently no alternative future use~~ for ~~this~~research ~~technology~~ and, ~~therefore,~~development ~~no separate economic value~~employees.

Income Taxes

Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, and operating ~~loss~~losses and tax credit ~~carryforwards~~carry forwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income(loss) in the years in which those temporary differences are expected to be recovered or settled. Due ~~The~~to ~~effect~~the onCompany’s ~~deferred~~history ~~tax assets and liabilities~~ of losses, a ~~change~~full invaluation ~~tax~~allowance ~~rates~~was is recognized inagainst ~~operations in~~ the ~~period enacted. A valuation allowance is provided when it is more likely than not that a portion or all of a~~ deferred tax ~~asset will not be realized. The ultimate realization of deferred tax~~ assets ~~is dependent upon the generation~~ as of ~~future~~December ~~taxable income and the reversal of deferred tax liabilities during the period in which related temporary differences become deductible~~31,2020. The ~~benefit of tax positions taken or expected to be taken in the~~ Company’s ~~income~~expects ~~tax~~that ~~returns~~it ~~are~~will ~~recognized~~continue ~~in the consolidated financial statements if such positions are more likely than not~~ to beexperience ~~sustained~~operating ~~upon examination~~losses.

The portion of the benefit associated with tax positions taken that exceed the amount measured as described above should be reflected as a liability for uncertain tax benefits in the accompanying balance sheet along with any associated interest and penalties that would be payable to the taxing authorities upon examination.-11-

The Company’s policy is to recognize interest and penalties related to income tax matters in income tax expense. For the three-month period ended March 31, 2020, the Company has not recorded any interest or penalties related to income tax matters. The Company does not foresee any material changes in unrecognized tax benefits within the next twelve months.

When tax returns are filed, there may be uncertainty about the merits of positions taken or the amount of the position that would be ultimately sustained. The benefit of a tax position is recognized in the financial statements in the period during which, based on all available evidence, management believes it is more likely than not that the position will be sustained upon examination, including the resolution of appeals or litigation processes, if any. Tax positions taken are not offset or aggregated with other positions.

Tax positions that meet the more likely than not recognition threshold are measured at the largest amount of tax benefit that is more than 50 percent likely of being realized upon settlement with the applicable taxing authority. The portion of the benefit associated with tax positions taken that exceed the amount measured as described above should be reflected as a liability for uncertain tax benefits in the accompanying balance sheet along with any associated interest and penalties that would be payable to the taxing authorities upon examination. The Company believes our tax positions are all more likely than not to be upheld upon examination. As such, the Company has not recorded a liability for uncertain tax benefits.

Under the provision of ASC 740-10, the Company recognizes the impact of a tax position in its financial statements if the position is more likely than not to be sustained upon examination based on the technical merits of the position. For the year period ended March 31, 2020, the Company had no material unrecognized tax benefits, and based on the information currently available, no significant changes in unrecognized tax benefits are expected in the next twelve months

As of the tax year ending December 31,2019 the Company has net operating loss carryforwards for federal income tax purposes of approximately $91.4 million and net operating loss carryforwards for state income tax purposes of approximately $52.5 million. The net operating losses begin to expire in 2023 for federal income purposes and in 2028 for state income tax purposes. The federal net operating loss carryover includes $258,000 of net operating losses generated in 2018 and later. Federal net operating losses generated from 2018 onwards carryover indefinitely and may generally be used to offset up to 80% of future taxable income. The Company also has R&D tax credits available for federal and state purposes of $1.8 million and $1.9 million, respectively. The federal R&D credits will begin to expire December 31, 2035.

The ultimate realization of deferred tax assets depends on the generation of future taxable income during the periods in which those net operating losses are available. The Company considers projected future taxable income and tax planning strategies in making their assessment. At present, the Company does not have a sufficient history of income to conclude that it is more-likely-than-not that the Company will be able to realize all of our tax benefits in the near future and therefore the Company has established a valuation allowance for the full value of the deferred tax asset.

In December 2017, the Tax Cuts and Jobs Act (the “2017 Act) was enacted. The 2017 Tax Act includes a number of changes to existing U.S. tax laws that impact the Company, most notably a reduction of the U.S. corporate income tax rate from 34 percent to 21 percent for tax years beginning after December 31, 2017. In 2017, the Company recorded provisional amounts for certain enactment-date effects of the act by applying the guidance in Staff Accounting Bulletin No. 118 (“SAB 118”). In 2018 and 2017, the Company recorded $0 net tax expense related to the enactment-date effects of the Act related to the remeasurement of deferred tax assets and liabilities.

As of December 31, 2018, the Company completed its accounting for all of the enactment-date income tax effects of the Act and no adjustments were made to the provisional amounts recorded on December 31, 2017.

As of December 31, 2017, the Company remeasured certain deferred tax assets and liabilities based on the rates at which they were expected to reverse in the future (which was generally 21%), by recording a provisional amount of $14.5 million, which was fully offset by valuation allowance. Upon further analysis of certain aspects of the Act and refinement of our calculations during the 12 months ended December 31, 2018, the Company determined that no adjustment was necessary to our provisional amount.

Pursuant to the Internal Revenue Code (“IRC”) of 1986, as amended, specifically IRC Section 382 and 383, the Company’s ability to use net operating loss and R&D tax credit carryforwards (“tax attribute carries forwards”) to offset future taxable income is limited if we experience a cumulative change in ownership of more than 50% within a three-year testing period. The Company had an ownership change on May 22, 2020 as result of the Nostrum investment. Accordingly for periods subsequent to May 22, 2020, the annual utilization of the net operating losses that are carried forward are expected to be limited. Further, the Company’s deferred tax assets associated with such tax attributes are expected to be significantly reduced upon realization of the ownership change within the meaning of IRC 382. The Company incurred an operating loss for the period ended March 31, 2020 and expects to have operating losses and federal and state tax losses for the full year December 31, 2020.

Common Stock Purchase Warrants

WeThe Company ~~account~~accounts for the issuance of common stock purchase warrants issued in connection with capital financing transactions ~~in accordance with the provisions of ASC Topic 815 “Derivatives and Hedging”~~. ~~Based~~The ~~upon~~Company classifies ~~the provisions of ASC Topic 815, we classify~~ as equity any contracts that (i) require physical settlement or net-share settlement or (ii) give ~~the~~us ~~Company~~ a choice of net-cash settlement or settlement in ~~its~~our own shares (physical settlement or net-share settlement). WeThe ~~classify~~Company classifies as assets or liabilities any contracts that (i) require net-cash settlement (including a requirement to net-cash settle the contract if an event occurs and if that event is outside ~~the control~~ of ~~the~~our ~~Company~~control), or (ii) gives the counterparty a choice of net-cash settlement or settlement in shares (physical settlement or net-share settlement).

Earnings (Loss) Per Common Share

~~We compute~~ Basic earnings (loss) per common share, inis ~~accordance~~computed ~~with~~by ~~ASC~~dividing ~~Topic~~net ~~260~~income ~~“Earnings~~or ~~per~~loss ~~Share”,~~by ~~which~~the ~~requires~~weighted ~~dual~~average ~~presentation~~number of ~~basic~~common ~~and~~shares ~~diluted~~outstanding during ~~earnings~~the ~~per share~~period. ~~Basic~~ Diluted earnings (loss) per common share is computed by dividing ~~earnings~~net ~~(loss)~~income ~~attributable~~or toloss ~~the controlling interest~~ by the weighted average number of common shares outstanding, plus the issuance of common shares, if dilutive, that could result from the exercise of outstanding ~~during~~stock options and warrants. These potentially dilutive securities were not included in the calculation of loss attributable to the controlling interest per common share for the three-month period. ~~Diluted~~ended March 31, 2020, because their effect would be anti-dilutive.

8As of March 31, 2020, there were potentially dilutive securities issued and outstanding which consisted of Series A Convertible Preferred Stock, that were convertible into 4,388,889 share of Common Stock, and there were stock options and warrants to acquire up to 14,811,333 shares of the Company’s Common Stock.

earnings (loss) per common share is computed by dividing earnings (loss) attributable to the controlling interest by the weighted average number of common shares outstanding, plus the issuance of common shares, if dilutive, that could result from the exercise of outstanding stock options and warrants. As of March 31, 2017 and 2016, potentially dilutive securities consist of preferred stock convertible into 4,604,674 and 3,468,804 shares of common stock, respectively and outstanding stock options and warrants to acquire 12,116,334 and 7,442,598 shares of common stock, respectively.

These potentially dilutive securities were not included in the calculation of loss attributable to the controlling interest per common share for the three month periods ended March 31, 2017 and 2016 because their effect would be anti-dilutive.

Stock-Based Compensation

~~Stock-based~~The Company ~~compensation~~recognizes ~~expense~~the isfair ~~recognized~~value onof aall ~~straight~~share-~~line~~based ~~basis~~payment ~~over~~awards in the ~~requisite~~Statement ~~service~~of ~~period~~Operations ofover the ~~award,~~requisite ~~which~~vesting period isfor ~~generally~~each ~~the~~expected ~~vesting~~volatility, expected term, ofand ~~the~~risk-free ~~award~~interest rate.

~~Total~~The Company ~~stock-based~~estimated ~~compensation~~the ~~expense~~fair ~~included~~value inof ~~the~~an ~~condensed~~option ~~consolidated~~award ~~statements~~on the date of ~~operations~~grant ~~was~~using ~~allocated~~the toBlack–Scholes ~~research~~option ~~and~~valuation model. The Black–Scholes option valuation model requires the development of assumptions that are input into the model. These assumptions are the expected stock volatility, the risk–free interest rate, the option’s expected life, the dividend yield on the underlying stock and ~~general~~the expected forfeiture rate. Expected volatility is calculated based on the historical volatility of our common stock over the expected option life and ~~administrative~~other ~~expenses~~appropriate factors. Risk–free interest rates are calculated based on continuously compounded risk–free rates for the appropriate term. The dividend yield is assumed to be zero as ~~follows:~~the Company has never paid or declared any cash dividends on its common stock and does not intend to pay dividends on its common stock in the foreseeable future. The expected forfeiture rate is estimated based on historical experience.

	For the Three Months Ended March 31,
	2017		2016
	(unaudited)
Research and development	$	—	$	—
General and administrative		—		25,530
Total stock-based compensation	$	—	$	25,530

Determining the appropriate fair value model and calculating the fair value of equity–based payment awards require the input of the subjective assumptions described above. The assumptions used in calculating the fair value of equity–based payment awards represent management’s best estimates, which involve inherent uncertainties and the application of management’s judgment. As a result, if factors change and the Company uses different assumptions, equity–based compensation could be materially different in the future. In addition, the Company is required to estimate the expected forfeiture rate and recognize expense only for those shares expected to vest. If the actual forfeiture rate is materially different from the estimates, the equity–based compensation could be significantly different from what the Company has recorded in the current period.

~~Note 3—Accrued Liabilities~~-12-

~~Accrued~~Recent Accounting ~~liabilities consisted of the following:~~Pronouncements

	March 31, 2017 (unaudited)		December 31, 2016 (unaudited)
Payroll and benefits	$	1,000,399	$	982,482
Other		658,211		687,858
Total	$	1,658,610	$	1,670,340

In February 2016, the FASB issued Accounting Standards Update (“ASU”) 2016-02, Leases. Under this new guidance, at the commencement date, lessees will be required to recognize (i) a lease liability, which is a lessee’s obligation to make lease payments arising from a lease, measured on a discounted basis and (ii) a right -of-use asset, which is an asset that represents the lessee’s right to use, or control the use of, a specified asset for the lease term. This guidance is not applicable for leases with a term of 12 months or less. The Company adopted the new guidance effective January 1, 2020. There was no material impact on the Company’s financial statements for the current period ending March 31,2020.

Note 4 3—~~Advances~~Property ~~From~~and ~~Related Party - Officer~~Equipment

~~Officers of the Company occasionally incur or advance expenses on behalf of the Company, which are subsequently reimbursed to the officers along with any associated costs. As of March 31, 2017~~ Property and ~~December 31,~~equipment ~~2016,~~consisted ~~$1,047,851 and $1,050,327, respectively, in net Company expenses incurred in the ordinary course~~ of ~~business have been paid by or with cash advanced by~~ the Company’s Chief Executive Officer. During the three month period ended March 31, 2017, $2,476 was repaid. During the three month period ended March 31, 2017, $0 in net expenses were paid by or with cash advanced by our Chief Executive Officer. following:

Note 5—Stockholders’ Equity

	March 31,			December 31,
	2020			2019
Computer and telecommunication equipment	$	12,902		$	12,902
Office equipment		5,871			5,871
Office furniture and equipment		7,396			7,396
Leasehold improvements		177,436			177,436
		203,605			203,605
Accumulated depreciation and amortization		(201,386	)		(200,965	)
Property and equipment, net	$	2,219		$	2,640

Depreciation and amortization of property and equipment totaled $421.

Note 4—Accrued Liabilities

Accrued Liabilities consisted of the following:

	March 31,		December 31,
	2020		2019
Payroll and benefits	$	2,761,467	$	2,657,717
Other		128,973		138,973
Total	$	2,890,440	$	2,796,690

Note 5—Advances from Related Party-Officer

As of March 31, 2020, and December 31, 2019, $690,050 and $725,425 respectively, was owed to the Company’s Chief Executive Officer for cash advances made to the Company to fund working capital requirements incurred in the ordinary course of business. These advances are non-interest bearing with no fixed terms of repayment. During the period ended March 31, 2020, the Company repaid $35,375. Subsequent to the reporting period, effective in June, 2020, the Company is repaying the loan in equal monthly installments of $20,000.

Note 6—Commitments and Contingencies

Lease Commitments

In June 2016, the Company entered into a thirty-eight-month lease agreement to lease office space commencing on September 30, 2016. The approximate base monthly rent in the first, second and third years is $3,500, $3,700, and $3,800, respectively. The base monthly rent in the final two months of the agreement is $3,900. The total base rent over the lease term equals $139,800. The lease was extended until July 31, 2020, on a month-to-month basis.

On July 8, 2020, the Company entered into a twenty-nine-month lease for approximately 3,039 square feet of office space in San Diego, California commencing on August 1, 2020. The monthly base rent is $6,685 and increases by three percent (3%) on each anniversary of the Commencement Date.

Contingent Liability

During the year ended December 31, 2019, the Company entered into various restructuring efforts including the restructuring of certain payables with its vendors to pay certain amounts due contingent on the receipt of FDA approval on Generx or contingent on the FDA approval and commercial sales of Generx. Since it is not determinable when and if Generx will receive FDA approval and the Company will achieve commercial sales, the Company has reflected these re-negotiated amounts due as contingent liabilities where it is not determinable when and if the amounts will ultimately be paid. The total liabilities payable by the Company in the event of FDA approval is $172,449 and an additional amount totaling $225,000 is payable when commercial sales cumulatively reach $100 million for Generx. Since the Company does not know if FDA approval will be received for the Generx product, it is not determinable if and when this payment will be made by the Company. Accordingly, these amounts have been reported as a contingent liability and have not been included in accounts payable and accrued liabilities.

-13-

Deferred Compensation

As of March 31, 2020, we had an outstanding balance in accrued but unpaid salaries and benefits for current and former employees totaling $2,926,717. In January 2020, all affected current and former employees agreed to defer their compensation, less applicable tax withholdings, upon the earliest to occur of (a) the FDA’s approval of Generx for marketing and sale in the U.S.; (b) the EMA approval of Generx for marketing and sale in the European Union and the United Kingdom; (c) the sale of Generx to an independent third party for an aggregate value equal to or greater than $35,000,000; (d) our entry into a strategic partnership that would facilitate a capital contribution equal to or greater than $35,000,000 for the purpose of supporting the clinical and commercial development of Generx; (e) our successful completion of a public or private equity offering for the issuance of its common stock equal to $35,000,000; or (f) at such other time, as our board of directors determines that we have the financial ability to make such payments without jeopardizing our ability to operate as a going concern.

License Fees

Technology License Agreements

As of October 2019, the outstanding and unpaid amount due and payable under the UC License Agreement totaled $1,006,709. As part of the Company’s restructuring efforts, the Company and the University of California reached a settlement agreement in the amount of $172,449, payable as $100,000 in quarterly cash payments of $8,333 over a 36 month-month period, with the first payment commencing on June 15, 2020, and an additional lump sum payment of $72,449 payable upon FDA approval of Generx.

As of November 2019, the Company and the New York University reached an agreement to settle total amounts due under this agreement for $400,000 payable as follows: (1) $75,000 in six quarterly payments of $12,500 commencing June 15, 2020, with additional contingent payments due as follows (2) $100,000 payable upon FDA approval to market and sell Generx; and (3) an additional amount totaling $225,000 when commercial sales cumulatively reach $100 million for Generx.

The Company has not reflected the contingent amounts payable of $397,449 in the Consolidated Balance Sheet as the payable is contingent on FDA approval and commercialization of the product. Since it is not determinable when and if FDA approval will be received, it is not determinable if and when this payment will be made by the Company. Accordingly, these amounts have been reported as a contingent liability. As a result of these settlements, the agreements are deemed terminated and no further amounts and royalties are payable by the Company.

Legal Proceedings

In the course of our business, the Company is routinely involved in proceedings such as disputes involving goods or services provided by various third parties, which the Company does not consider likely to be material to the technology we develop or license, or the products we develop for commercialization, but which can result in costs and diversions of resources to pursue and resolve.

Note 7—Stockholders’ Equity

Common Stock

On In April 4, 2015, wethe ~~entered~~Company entered into a term sheet with Shenzhen Qianhai Taxus Capital Management Co., Ltd. (“Shenzhen Qianhai Taxus”), a company affiliated with Shanxi Taxus Pharmaceuticals Co. Ltd., whereby wethe Company proposed to sell Shenzhen Qianhai Taxus 600,000 shares of common stock in our Angionetics subsidiary in exchange for $3.0 million in cash. The $3.0 million was to be paid in tranches that were to be completed by May 31, 2015. Shenzhen Qianhai Taxus paid $600,000 of the financing, which was recorded as common stock issuable. Shenzhen Qianhai Taxus did not complete this transaction. This subscription iswas committed and not refundable to Shenzhen Qianhai Taxus. Shenzhen Qianhai Taxus iswas eligible to apply this amount toward the purchase of common stock of the Company or its subsidiaries based on terms and conditions approved by the Company’s Board of Directors.

In April 2020, in connection with the Change of Control and restructuring efforts executed pursuant to the Preferred Stock Purchase Agreement, the Company entered into a Reaffirmation and Ratification Agreement with Shenzhen Qianhai Taxus (the “Ratification Agreement”) confirming that the Company terminated all prior agreements with Shenzhen Qianhai Taxus and entered into a mutual release of claims, which canceled the rights for the issuance of common shares. Refer to subsequent event note.

Shenzhen Qianhai Taxus previously held approximately 24% of the Company shares as of March 31, 2020 and the chairman of Shenzhen Qianhai Taxus was also on the Board of Directors and Chairman of the Board of the Company. Following completion of the transaction with Nostrum, which included the issuance of the Series B Convertible Preferred Stock, the Chairman resigned from the Company’s Board of Directors. After the Nostrum Series B Preferred stock investment and excluding Nostrum’s Series A Preferred Stock investment and pending Series B Preferred issuances Shenzhen Qianhai Taxus and Nostrum own 1.6% and 70% of the voting common stock respectively as of August 28,2021.

Preferred Stock

~~Taxus Cardium~~ Series A ~~Convertible~~ Preferred Stock Exchange and Redemption Agreement with Sabby Healthcare Volatility Master Fund, Ltd.

On In April 4, 2013, wethe ~~entered~~Company entered into a securities purchase agreement with Sabby Healthcare Volatility Master Fund, Ltd. (“Sabby”), ~~pursuant~~ to ~~which~~purchase weup ~~sold~~to 4,012 shares of our newly authorized Series A Convertible Preferred Stock (the “Preferred Stock”) for maximum proceeds of $4.0 million. The Preferred Stock was convertible into shares of our common stock at an initial conversion price of $0.6437 per share. The conversion price is subject to downward adjustment if the Company issues common stock or common stock equivalents at a price less than the then effective conversion price. Sabby is limited to hold no more than 10% of Gene Biotherapeutics’ issued and outstanding common stock at any time. As long as the Preferred Stock is outstanding, the Company has also agreed not to incur specified indebtedness without the consent of the holders of the Preferred Stock. These factors may restrict our ability to raise capital through equity or debt offerings in the future.

9-14-

~~Stock”)~~In July ~~for~~2015, ~~$4.0~~the ~~million.~~Company ~~The~~entered ~~Preferred~~into ~~Stock~~an ~~was~~Exchange ~~convertible~~and ~~into~~Redemption Agreement with Sabby relating to the 1,176 shares of ~~our~~Preferred ~~common~~Stock ~~stock~~that remained outstanding at anthat ~~initial~~time. Under the terms of the Exchange and Redemption Agreement, the Company agreed to reduce the conversion price of the Preferred Stock to $0.~~6437~~30 per share. The ~~conversion~~Agreement ~~price~~grants Gene isBiotherapeutics ~~subject~~(1) a right to ~~downward~~redeem ~~adjustment~~any ifor weall ~~issue~~of ~~common~~the ~~stock~~outstanding orPreferred ~~common~~Stock ~~stock~~for ~~equivalents~~its stated value (approximately $1,000 per share) at any time during a ~~price~~120-day ~~less~~period ~~than~~after the ~~then~~date ~~effective~~of ~~conversion~~the ~~price. Sabby~~Agreement, isand ~~limited~~(2) toincreases ~~hold~~the nolimitation ~~more~~on ~~than~~certain ~~10%~~indebtedness contained in the Certificate of ~~Taxus~~Designation ~~Cardium’s~~for ~~issued~~the ~~and~~Preferred ~~outstanding~~Stock ~~common~~to ~~stock~~allow atGene ~~any~~Biotherapeutics ~~time~~to borrow up to $250,000. As ~~long~~The asCompany entered into the Agreement to increase our options for retiring the outstanding Preferred Stock isand ~~outstanding,~~financing weour ~~have~~continued ~~also~~business operations. ~~agreed~~As ~~not~~a toresult ~~incur~~of ~~specified~~the ~~indebtedness~~effective ~~without~~conversion price changing from $0.64 to $0.30 per share, the ~~consent~~1,176 shares of ~~the~~Preferred ~~holders~~Stock outstanding at that time were convertible to 3,918,667 shares of Gene Biotherapeutics common stock, an additional 2,092,350 shares compared to before the ~~Preferred~~conversion ~~Stock~~price change. ~~These~~As ~~factors~~of ~~may~~March ~~restrict~~31, ~~our~~2020, ~~ability~~and December 31, 2019, there were 790 Preferred Stock outstanding. Refer to ~~raise~~the ~~capital~~Subsequent ~~through~~Events ~~equity~~section orfor ~~debt~~further ~~offerings~~discussion inon the ~~future~~Series A Preferred Stock.

OnSeries A ~~July 22, 2015, we entered into an Exchange and Redemption Agreement with Sabby relating to the 1,176 outstanding shares of~~ Preferred Stock ~~that~~Purchase ~~remained outstanding at that time. Under the terms of the Exchange and Redemption~~ Agreement, weBetween ~~agreed~~Nostrum ~~to reduce the conversion price of the Preferred Stock to $0.30 per share from $0.64 per share in exchange for a limited redemption right (which has now expired)~~ and anSabby ~~increase in the limitation on certain indebtedness.~~

OnIn May ~~September 23~~2020, ~~2016,~~subsequent weto ~~entered~~this ~~into~~reporting aperiod, ~~second~~concurrent ~~Exchange and Redemption Agreement~~ with ~~Sabby~~the ~~covering~~sale of the ~~1,000~~Series ~~shares~~B of Preferred Stock, ~~outstanding~~Nostrum atacquired ~~the~~220 ~~time.~~shares of ~~Under~~ the ~~terms~~Company’s ofSeries ~~the~~A ~~Exchange~~Preferred ~~and~~Stock ~~Redemption~~from ~~Agreement,~~Sabby ~~Taxus~~Master ~~Cardium~~Healthcare Ltd. and agreed to ~~reduce~~purchase the ~~conversion~~remaining ~~price~~570 ~~at which Sabby can convert~~ shares of Series A Convertible Preferred Stock tothat ~~common~~are ~~shares~~outstanding toand anheld ~~effective~~by ~~price of $0~~Sabby.18 ~~per~~As ~~share. The Exchange and Redemption Agreement granted Taxus Cardium~~ a ~~right~~result toof ~~redeem~~the ~~any~~issuance ~~or all~~ of the ~~outstanding~~Series B Convertible Preferred Stock, ~~for~~each ~~its~~share ~~Stated~~of ~~Value~~our ~~(approximately~~Series ~~$1,000~~A ~~per~~Convertible ~~share)~~Preferred atStock ~~any~~became ~~time~~convertible ~~after~~into ~~the~~88,496 ~~date~~shares of ~~the~~our ~~Agreement~~Common ~~until~~Stock ~~November~~which totaled 2950,442,489 ~~2016. As~~shares ~~a result~~ of ~~the~~Common ~~conversion~~Stock. ~~price~~The ~~changing~~Certificate ~~from~~of ~~$0.30~~Designation toof ~~$0.18 per share~~Preferences, ~~the~~Rights ~~1,000~~and ~~shares~~Limitations of Series A Convertible Preferred Stock ~~outstanding~~restricts ~~are~~Nostrum ~~convertible~~from toconverting ~~5,554,667~~any ~~shares~~Series ofA ~~Taxus~~Preferred ~~Cardium~~Stock ~~common~~if ~~stock,~~Nostrum anwould ~~additional~~beneficially ~~2,221,867~~own ~~compared~~a tonumber ~~before~~of ~~the~~shares ~~conversion~~of Common ~~price~~Stock ~~change.~~in Atexcess ~~March~~of ~~31,~~9.99% ~~2017,~~of ~~there~~the ~~were 829~~ shares of ~~Preferred~~Common Stock then issued and outstanding. AAs ~~hypothetical~~a ~~conversion~~result of ~~all~~its ownership of the ~~outstanding~~Series B Convertible Preferred Stock, asNostrum ofis ~~March~~currently ~~31,~~limited ~~2017~~in ~~into~~its ~~4,604,674~~entirety from converting any shares of ~~common~~Series ~~stock~~A ~~would~~Convertible ~~increase~~Preferred Stock. ~~the~~The ~~common~~Series ~~stock~~A ~~outstanding~~Convertible ~~from~~Preferred ~~14,273,544~~Stock ~~shares~~has asno ofvoting ~~March~~rights ~~31,~~on ~~2017,~~general tocorporate 18matters,~~878,218,~~ anprovided ~~increase~~that ofthe ~~32.3%. As~~Series aA ~~result~~Convertible Preferred ofStock ~~such~~contain ~~holder~~customary ~~entering~~protective ~~into~~provisions. ~~the~~As ~~Agreement,~~of ~~for~~April ~~which~~28, ~~the~~2021, ~~fair~~Sabby ~~value~~converted all of ~~preferred~~its ~~stock~~remaining ~~before~~570 ~~and~~shares ~~after~~of ~~the~~Series A ~~modification~~Convertible ~~was~~Preferred aStock ~~substantially~~into ~~different~~50,442,489 ~~the~~shares ~~modification~~of ~~was~~Common ~~accounted~~and ~~for~~no asfurther anshares ~~extinguishment. Consequently,~~of wethe ~~recorded~~Series aA ~~deemed~~Convertible ~~dividend,~~Preferred ~~during~~Stock ~~the~~were purchased ~~quarter~~by ~~ended~~Nostrum. ~~September~~As ~~30,~~a ~~2016~~result, ~~totaling~~Nostrum ~~$782,879~~did innot ~~the~~acquire ~~2016~~any ~~statement~~further shares of ~~operations~~the inSeries ~~arriving~~A atConvertible ~~net~~Preferred ~~loss~~beyond totheir ~~common~~initial 220 ~~shareholders~~share acquisition.

~~Angionetics~~ Series B A Convertible Preferred Stock Purchase Agreement with Nostrum

OnIn May ~~June 7~~2020, ~~2016,~~subsequent ~~Taxus~~to ~~Cardium~~this ~~and~~reporting ~~Angionetics~~period we entered into a ~~Share~~Preferred Stock Purchase Agreement with ~~Pineworld~~Nostrum ~~Capital Limited an entity affiliated with Huapont Life Sciences Co. Ltd~~Pharmaceuticals, ~~a China-based pharmaceutical, and active pharmaceutical ingredient company~~ LLC (“~~Huapont~~Nostrum”)~~. Pursuant to the Share Purchase Agreement~~, ~~Angionetics~~selling ~~agreed~~Nostrum ~~to sell 600~~1,~~000~~700,000 shares of ~~its~~our newly authorized Series AB Convertible Preferred Stock ~~(the “Shares”) to the Huapont affiliate~~ in exchange for $~~3,000,000 in cash~~1. ~~The~~7 ~~Shares represent an initial 15% equity interest in Angionetics, resulting in a post-money valuation of $20.0~~ million ~~for Angionetics~~, ~~subject~~that toare ~~certain~~convertible ~~anti-dilution~~into ~~protection described below. The investment from the Huapont affiliate was made in two tranches. The closing of the initial tranche of 200~~150,~~000 Shares for $1~~442,~~000,000~~478 ~~occurred~~shares ~~on July 5, 2016. The closing~~ of the ~~second~~Company’s ~~tranche~~Common ~~of 400,000 Shares for $2,000,000 was conditioned upon Angionetics securing FDA clearance to initiate a new U~~Stock.~~S.-based~~ ~~Phase~~Set 3forth ~~clinical~~below ~~study~~are (the ~~AFFIRM~~specific ~~study) to evaluate the safety and definitive efficacy~~ details of the ~~Generx®~~ ~~[Ad5FGF-4]~~terms ~~product candidate for the treatment of patients with ischemic heart disease~~ and ~~refractory~~conditions ~~angina. On September 28, 2016, following FDA clearance~~ of the ~~Phase~~Series 3B ~~AFFIRM~~Convertible ~~study,~~Preferred ~~Angionetics received $2,000,000 from the closing of the second tranche~~Stock.

~~The~~Amendment to ~~Angionetics~~Certificate ~~Shares~~of ~~have~~Incorporation and Amendment to Bylaws Covering the ~~following~~Series ~~rights,~~B ~~privileges~~Convertible ~~and~~Preferred ~~preferences:~~Stock

•On May ~~Dividends.~~21, ~~Holders~~2020, the Company amended their Certificate of Incorporation with the ~~Shares~~filing ~~are~~of ~~entitled~~a Certificate of Designation to ~~receive~~establish ~~dividends~~the rights, asprivileges, ~~when~~ and ifpreferences ~~declared~~of bya ~~the~~new ~~Angionetics~~class ~~board~~ of ~~directors~~our onpreferred ~~the~~stock ~~Angionetics~~designated ~~common~~Series ~~stock,~~B onConvertible anPreferred ~~as-converted~~Stock ~~basis~~(“Series B Preferred Stock”). The Series B Preferred has the following material terms and provisions:

~~• Liquidation~~Dividends. Each Inshare ~~the~~of ~~event~~our ofSeries aB ~~liquidation~~Convertible ofPreferred ~~Angionetics,~~Stock ~~including~~is aentitled ~~change~~to ofreceive ~~control~~dividends ~~transaction~~when, ~~holders~~as, and if dividends are paid on shares of ~~the~~our ~~Shares~~Common Stock. Dividends are ~~entitled~~payable toon beeach ~~paid~~share of Series B Convertible Preferred Stock on an “as-converted” basis, in the same amount ~~equal~~and toform ~~their~~as ~~investment~~dividends ~~amount~~actually ~~before~~paid ~~any~~on ~~payment~~shares isof ~~made~~our toCommon ~~Taxus~~Stock. ~~Cardium~~The orCompany ~~any~~has ~~other~~never ~~holders~~paid dividends on shares of ~~Angionetics~~our common stock and the Company does not intend to do so for the foreseeable future.

• Voting Rights. ~~The~~Each ~~Shares~~share ~~generally~~of ~~vote~~our ~~with~~Series B Convertible Preferred Stock will have the ~~Angionetics~~same ~~common~~voting ~~stock~~rights as ashares ~~single~~of ~~class~~our onCommon Stock, on an “as-converted” basis., ~~Holders~~and ofwill ~~the~~vote ~~Shares~~on ~~also~~all ~~have~~matters ~~certain~~with ~~special~~the ~~voting~~Common ~~rights~~Stock as a ~~separate~~single class. ~~including~~In ~~(a)~~addition, the ~~right~~Series toB Convertible ~~appoint~~Preferred aStock ~~member~~has tovoting ~~the~~rights ~~Angionetics~~that ~~board~~require the approval of ~~directors,~~a ~~(b)~~majority of the ~~right~~outstanding toshares ~~approve~~of Series B Convertible Preferred Stock for any ~~increase~~action to: (1) alter or ~~decrease~~change inadversely the ~~number~~powers, ofpreferences ~~authorized~~or ~~shares~~rights ofgiven to the ~~Shares~~shares orof ~~the~~our ~~common~~Series B ~~stock,~~Convertible ~~any~~Preferred ~~merger~~Stock or ~~acquisition~~alter ~~involving~~or ~~Angionetics~~amend its Certificate of Designation, ~~any~~(2) ~~liquidation~~authorize or ~~winding~~create upany class of ~~Angionetics,~~shares ~~any~~ranking ~~increase~~as to individends, ~~the~~redemption ~~number~~or distribution of ~~directors~~assets ~~and~~upon ~~any~~liquidation ~~dividend~~senior to, or ~~distribution,~~otherwise ~~and~~pari ~~(c)~~passu with, the ~~right~~shares toof ~~approve~~our ~~any~~Series B ~~amendment~~Convertible toPreferred ~~the~~Stock, ~~Angionetics~~(3) ~~certificate~~amend our Certificate of ~~incorporation~~Incorporation or other charter documents in aany manner that adversely affects any ~~the~~ rights of the ~~Shares.~~holders ~~The~~of ~~voting~~our ~~rights~~Series ~~under~~B ~~(a)~~Convertible ~~and~~Preferred Stock, (b4) ~~terminate~~increase ifthe ~~Huapont~~number ~~does~~of ~~not~~authorized ~~complete~~shares ~~the~~of ~~second~~our ~~closing~~Series ~~under~~B ~~the~~Convertible Preferred ~~share~~Stock, ~~purchase~~or (5) enter into any agreement with respect to any of the foregoing.

• Conversion. The Shares are convertible into shares of Angionetics common stock at any time at the holder’s election. The Shares automatically convert into common stock upon the closing of a firm commitment underwritten public offering of Angionetics common stock. The Shares are initially convertible on a one to one basis into Angionetics common stock. The Shares are subject to anti-~~dilution protection, such that in the event of a firm commitment underwritten public offering or a change in control each Share will be convertible into a pro rata portion of~~ 15~~% of the outstanding Angionetics common stock at the time of the public offering or change in control.~~-

10Conversion. The shares of our Series B Convertible Preferred Stock are convertible at any time at the option of the holder into shares of our Common Stock at a ratio determined by dividing the Stated Value of such share of Series B Preferred Stock by the conversion price of $0.0113 per share of Common Stock. Accordingly, each share of our Series B Convertible Preferred Stock is initially convertible into 88.5 shares of our Common Stock. The conversion price is subject to adjustment in the case of share splits, share dividends, combinations of shares and similar recapitalization transactions. In addition, if the Company sells shares of Common Stock or Common Stock equivalents at a price less than the current conversion price, the conversion price of the Series B Convertible Preferred Stock will be reduced to equal eighty percent (80%) of the price at which such Common Stock or Common Stock equivalents are sold.

Liquidation. The ~~Angionetics~~ Series AB Convertible Preferred Stock ishas ~~classified as permanent equity, since the triggering of~~ a liquidation ~~event~~preference. toUpon ~~sell,~~any ~~merge~~liquidation, dissolution or ~~consolidate~~winding ~~Angionetics,~~up orof toour ~~sell~~company, after ~~all~~payment or ~~substantially~~provision ~~all~~for payment of ~~its~~our ~~assets~~debts (aand ~~“change~~other inliabilities ~~control”)~~and isbefore ~~solely~~any ~~within~~distribution ~~Taxus~~or ~~Cardium’s~~payment ~~control. The~~is ~~Certificate~~made ofto ~~Designation for~~ the ~~Series~~holders of Aour ~~Convertible~~common ~~Preferred~~stock ~~Stock~~or ~~does~~any ~~not~~junior ~~provide~~securities, the holders of our Series AB Convertible Preferred Stock ~~the~~will ~~right~~first tobe ~~initiate~~entitled ~~such~~to abe ~~change~~paid an inamount ~~control,~~equal ~~through~~to ~~special~~$1.00 ~~voting~~per ~~privileges, majority~~share ~~representation~~plus onany ~~the~~other ~~Angionetics~~fees, ~~board~~liquidated ofdamages ~~directors,~~ or ~~other~~dividends ~~rights. In~~then ~~the~~owing, ~~absence~~before ofour ~~special~~remaining ~~provisions~~assets inwill be ~~the~~distributed ~~Certificate~~among ~~of Designation, Delaware law requires~~ the ~~approval~~holders of the ~~full~~other ~~Angionetics~~classes ~~board~~or series of ~~directors~~shares toof ~~initiate~~our acapital ~~change~~stock in ~~control~~accordance ~~transaction~~with our Certificate of Incorporation.

~~Also~~In May 2020, ~~given~~ the ~~Preferred~~Board ~~holders~~amended ~~have acquired a 15% equity position in Angionetics on and as a converted Common Stock basis, and given~~ the ~~Preferred~~Company’s ~~Stock~~bylaws ~~holders~~to ~~have~~eliminate ~~immediate substantive rights of~~ the ~~Common~~classified ~~shareholders,~~Board. ~~the~~Directors ~~equity~~will ~~investment~~serve inone-year ~~Angionetcis~~terms ~~was~~until ~~recorded as noncontrolling interest. A noncontrolling interest is~~ the next ~~portion~~annual meeting of ~~equity~~stockholders ~~(net assets) in a subsidiary not attributable, directly~~ or ~~indirectly,~~until totheir asuccessors ~~parent.~~are ~~The~~duly ~~noncontrolling~~elected ~~interest~~and ~~in a subsidiary is part of the equity of the consolidated group~~qualified.

Stock Options and Other Equity Compensation Plans

WeThe Company ~~have~~had an equity incentive plan that was established in 2005 under which 283,058 shares of ~~the~~our ~~Company’s~~ common stock ~~were~~was reserved for issuance to employees, non-employee directors and consultants ~~of the Company~~. The 2005 Equity Incentive Plan expired on October 20, 2015, ten years after its adoption, and wethe ~~are~~Company is no longer able to issue ~~shares~~share or awards under that plan. All options or other awards issued under the 2005 Equity Incentive ~~Plan~~plan prior to its expiration remain outstanding in accordance with their terms. At March 31,2020, there are no shares outstanding and available for future issuance under the option plan.

AtThere were ~~March~~no ~~31,~~stock ~~2017~~options, warrant under the ~~following~~Equity ~~shares~~Incentive ~~were~~plan ~~subject~~and no warrant issued outside of the plan to ~~option~~employees ~~awards~~and consultants during the three-month period ended March 31, 2020. The total number of options and warrants outstanding ~~under~~and ~~the~~exercisable were ~~2005~~14,811,333 ~~Equity~~as ~~Incentive~~of ~~Plan:~~March 31, 2020 with a weighted average exercise price of $0.62 per share, and a weighted average remaining life of 4.42.

Plan	Shares Outstanding			Shares Available for Issuance
	Number of Options			Weighted Average Exercise Price		Weighted Average Remaining Contractual Life (in years)
2005 Equity Incentive Plan		17,000			—
Balance outstanding, January 1, 2017		12,116,334		$	0.62		7.67
Granted		—			—		—
Exercised		—			—		—
Cancelled (unvested)		—			—		—
Expired (vested)		(5,001	)		0.62		—
Balance outstanding, December 31, 2017		12,111,333			0.62		6.67
Granted		—			—		—
Exercised		—			—		—
Cancelled (unvested)		—			—		—
Expired (vested)		—			—		—
Balance outstanding, December 31, 2018		12,111,333		$	0.62		5.67
Granted		—			—		—
Exercised		—			—		—
Cancelled (unvested)		—			—		—
Expired (vested)		—			—		—
Balance outstanding, December 31, 2019		12,111,333		$	0.62		4.67
Balance exercisable, December 31, 2019		12,111,333		$	0.62		4.67
Balance exercisable, March 31, 2020		12,111,333		$	0.62		4.42

The Company ~~following~~calculates isthe afair ~~summary~~value of stock options using the Black-Scholes option-pricing model. In determining the expected term, the Company separate groups of employees that have historically exhibited similar behavior with regard to option exercises and ~~warrant~~post-vesting cancellations. ~~activity~~The ~~under~~option-pricing model requires the ~~2005~~input ~~Equity~~of ~~Incentive~~subjective ~~Plan~~assumptions, such as ~~well~~those asincluded in the ~~warrants~~table ~~issued~~above. ~~outside~~The volatility rates are based principally on our historical stock prices and expectations of the ~~plan~~future volatility of its common stock. The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant. The total expense to ~~employees~~be ~~and~~recorded in ~~directors~~future periods will depend on several variables, ~~during~~including the ~~three~~number ~~months~~of ~~ended~~share-based awards and expected vesting. As of March 31, 2020, ~~2017:~~there was a $0, intrinsic value to the outstanding and exercisable options and warrants, respectively.

	Number of Options or Warrants		Weighted Average Exercise Price		Weighted Average Remaining Contractual Life (in years)
Balance outstanding, December 31, 2016		12,116,334	$	0.73		7.67
Granted		—		—		—
Cancelled (unvested)		—		—		—
Expired (vested)		—		—		—
Balance outstanding, March 31, 2017		12,116,334	$	0.73		7.37
Balance exercisable, March 31, 2017		12,110,469	$	0.73		7.37

-16-

~~As of March 31, 2017, there was no intrinsic value to the outstanding and exercisable options and warrants as their exercise price exceeded the market price of our common stock.~~Warrants

~~Note~~In October ~~6—Commitments~~2017, the Company issued 1,000,000 fully vested Common Stock warrants to Landmark, in exchange for economic monetization and business ~~Contingencies~~mobilization services for the Company. The warrants are exercisable at any time from October 9, 2017 (initial exercise date) and on or prior to the close of business on the 10-year anniversary from the initial exercise date, October 8, 2027, at an exercise price of $0.25 per share. The warrants had a fair value of $0.15 per share and the Company has recognized $150,000 as consulting costs in the statement of operations during the fourth quarter ended December 31, 2017.

In November 2017, the Company issued 700,000 fully vested Common Stock warrants to a consultant for ongoing scientific and business consulting services. The warrants are exercisable at any time from November 14, 2017 (the grant date) for a period up to 10 years at an exercise price of $0.25 per share. The warrants had a fair value of $0.11 per share, determined using the Black-Scholes valuation model, and the Company has recognized $79,222 as consulting costs in the statement of operations during the further quarter ended December 31, 2017.

In April 2018, the Company issued an additional 1,000,000 fully vested Common Stock warrants to Landmark as final consideration paid upon completion of the 6-month Agreement. The Common Stock warrants are exercisable at any time from April 23, 2018 (initial exercise date) and on or prior to the close of business on the 10-year anniversary from the initial exercise date, April 22, 2028, at an exercise price of $0.25 per share. The warrants had a fair value of $0.08 per share, determined using the Black-Scholes valuation model. The Company recognized approximately $80,000, representing the aggregate fair value of the warrants as consulting expenses in the statement of operations during the second quarter ended June 30, 2018.

The Company calculates the fair value of stock options using the Black-Scholes option-pricing model which approximates a binomial lattice model. In determining the expected term, the Company separate groups of employees that have historically exhibited similar behavior regarding option exercises and post-vesting cancellations. The option-pricing model requires the input of subjective assumptions, such as those included in the table below. The volatility rates are based principally on our historical stock prices and expectations of the future volatility of its Common Stock. The risk-free interest rate is based on the U.S. Treasury Yield curve in effect at the time of grant. The total expense to be recorded in future periods will depend on several variables, including the number of share-based awards and expected vesting.

The following table summarizes warrants that we granted during the year ended December 31, 2017 and 2018:

Grant Date	Quantity Issued		Expected Life (Years)		Strike Price		Volatility			Dividend Yield			Risk-Free Interest Rate			Grant Date Fair Value Per Warrant		Aggregate Fair Value
04/23/2018		1,000,000		10.0	$	0.25		126.00	%		0	%		2.47	%	$	0.08	$	80,000
11/14/2017		700,000		10.0	$	0.25		116.47	%		0	%		2.33	%	$	0.11		79,222
10/09/2017		1,000,000		10.0	$	0.25		115.00	%		0	%		2.47	%	$	0.16		150,000

The Company did not grant any warrants after 2018 and had total warrants issued and outstanding to third party consultants of 2,700,000 as of March 31, 2020.

-17-

Note 8—Subsequent Events

The following significant events took place after the period covered by this report:

Matters Relating to Our Relationship with Shanxi Taxus Pharmaceuticals Inc. and Affiliated Entities

In April 2020, the Company entered into a Reaffirmation and Ratification Agreement with Shanxi Taxus Pharmaceuticals Co., Ltd. (“Shanxi”). Shanxi has previously paid a subscription of $600,000 to acquire shares of our Common Stock or shares of capital stock in our Angionetics Inc. subsidiary. In exchange for the cancellation of the $600,000 stock subscription agreement the Company entered into the two agreements described below and terminated all prior agreements with Shanxi and entered into a mutual release of claims.

Generx Product

In April 2020, Angionetics, Inc. entered into a Distribution and License Agreement with Shanxi, as amended by the First Amendment to Distribution and License Agreement dated April 14, 2020 (as amended, the “Shanxi License Agreement”), granting Shanxi certain license rights with respect to our Generx product candidate. The distribution and license rights commence only after the Company obtains U.S. FDA approval for marketing and sale of Generx in the United States. The license rights include (a) a non-exclusive right to manufacture Generx products in China, and (b) an exclusive right to market and sell Generx products in Singapore, Macau, Hong Kong, Taiwan, any other municipality other than mainland China where Chinese (Mandarin or Cantonese) is the common language, the Russian Federation and the Commonwealth of Independent States (i.e., Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Moldova, Tajikistan, Turkmenistan, and Uzbekistan). The Shanxi License Agreement provides for a royalty ranging from 5% up to 10% based on the level of annual net sales of the Generx product sold by Shanxi in the licensed territory.

Excellagen Product

In April 2020, subsequent to the date of this report, the Company’s Activation Therapeutics, Inc. subsidiary entered into the Shanxi Assignment Agreement pursuant to which the Company transferred all of its license rights to manufacture, use, market and sell Excellagen in China to Shanxi. The Company also assigned to Shanxi a Chinese patent that the Company received on Excellagen. As a result, the Company no longer has an interest in Excellagen, other than the right to the royalty payments from Olaregen.

-18-

Nostrum Financing

On May 22, 2020, subsequent to the date of this report, the Company entered into a Preferred Stock Purchase Agreement (the “Agreement”) with Nostrum Pharmaceuticals, LLC, a Delaware limited liability company (“Nostrum”) pursuant to which the Company sold Nostrum 1,700,000 shares of newly designated Series B Preferred Stock, for a total cash consideration of $1.7 million. Series B Preferred Stock is convertible into shares of our common stock at an initial conversion ratio of $.0113 shares of Series B Preferred Stock for each share of common stock or 150,442,478 shares of the Company’s Common Stock. We have used the proceeds from the sale of the Series B Convertible Preferred Stock to fund working capital requirements in preparation for conducting a Phase 3 clinical trial in the U.S. for our Generx product candidate. We believe that Nostrum’s assets and experience in the formulation and commercialization of pharmaceutical products will facilitate the administration and completion of the Phase 3 clinical trial for Generx on a cost-effective basis. Nostrum is the parent of Nostrum Laboratories, Inc., a privately held pharmaceutical company engaged in the formulation and commercialization of specialty pharmaceutical products and controlled release, orally administered branded and generic drug products.

Concurrently with the sale of the Series B Preferred Stock, Nostrum acquired 220 shares of the Company’s Series A Preferred Stock from Sabby Master Healthcare Ltd. and agreed to purchase the remaining 570 shares of Series A Convertible Preferred Stock that are outstanding and held by Sabby. As a result of the issuance of the Series B Convertible Preferred Stock, each share of our Series A Convertible Preferred Stock became convertible into 88,496 shares of our Common Stock. The Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock restricts Nostrum from converting any Series A Preferred Stock if Nostrum would beneficially own a number of shares of Common Stock in excess of 9.99% of the shares of Common Stock then issued and outstanding. As a result of its ownership of the Series B Convertible Preferred Stock, Nostrum is currently limited in its entirety from converting any shares of Series A Convertible Preferred Stock. The Series A Convertible Preferred Stock has no voting rights on general corporate matters, provided that the Series A Convertible Preferred Stock contain customary protective provisions.

As of April 28, 2021, Sabby converted all of its remaining 570 shares of Series A Convertible Preferred Stock into 50,442,489 shares of Common and no further shares of the Series A Convertible Preferred Stock were purchased by Nostrum. As a result, Nostrum did not acquire any further shares of the Series A Convertible Preferred beyond their initial 220 share acquisition

For the period May 2021 through July 2021, Nostrum provided an additional $292,000 in cash funding to support the operations of the Company to execute on our current business plan and seek alternative sources of non-dilutive capital to fund the Company’s research, development and commercialization activities for our lead product Generx [Ad5FGF-4]. The Company will issue an additional 292,000 of Series B Preferred Stock in exchange for the additional funding from Nostrum.

Office Lease

OnIn July ~~June 23~~2020, ~~2016,~~the weCompany entered into a ~~thirty~~twenty-~~eight~~ nine-month lease ~~agreement~~for approximately ~~to lease office space commencing on September 30~~3,039 ~~2016. The~~square ~~approximate~~feet ~~base~~of ~~monthly~~office ~~rent~~space in ~~the~~San ~~first~~Diego, ~~second~~California ~~and~~commencing ~~third~~on ~~years~~August ~~is $3~~1,~~500,~~ ~~$3,700, and $3,800 respectively~~2020. The ~~base~~ monthly base rent inis ~~the~~$6,685 and ~~final~~increases ~~two~~by ~~months~~three ofpercent ~~the agreement is $~~(3~~,900.~~%) ~~The~~on ~~total~~each ~~base~~anniversary ~~rent~~of ~~over~~ the ~~lease~~Commencement ~~term equals $139,800~~Date.

InRetirement of ~~the~~Members ~~course~~ of ~~our~~the ~~business,~~Board weof ~~are~~Directors ~~routinely~~& ~~involved~~Bylaw inAmendment ~~proceedings such as disputes involving goods or services provided by various third parties, which we do not consider likely~~ to beChange ~~material to~~ the ~~technology~~Term ~~we develop or license, or the products we develop for commercialization, but which can result in costs and diversions of resources to pursue and resolve.~~ Period

11On May 22, 2020, Andrew Leitch, John Wallace, Jiayue Zhang and Wei-Wei Zhang resigned as members of the Company’s Board of Directors. The resignations were required under the terms of the Series B Preferred Stock Purchase Agreement. On May 22, 2020, at the request of Nostrum, James Grainer and Kaushik K. Vyas were appointed to the Company’s Board of Directors and James L. Grainer was appointed to serve as Chairman of the Board. In addition, on May 22, 2020, the Board amended the Company’s bylaws to eliminate the classified Board. Directors will serve one-year terms until the next annual meeting of stockholders or until their successors are duly elected and qualified.

InFuji Film October 2014, BioRASI LLC (“BioRASI”) filed a complaint in Broward County, Florida, seeking payments of approximately $0.5 million allegedly owed for services that BioRASI provided in connection with the Company’s clinical trial conducted in the Russian Federation. In June of 2015, BioRASI amended the complaint to include as plaintiffs additional parties affiliated with BioRASI including Vendevia Group, LLC, Biosciences Research Ltd., and Progressive Scientific Bioresearch, Ltd. We are defending the action and have filed counterclaims. Although at March 31, 2017, the probable outcome of this matter cannot be determined, we believe that we have supportable defenses and any negative decision, if any, is expected to be insignificant. Accordingly, we have not recorded any provisions related to this matter.Agreement

~~Note~~In March ~~7—Subsequent~~2021, ~~Events~~the Company entered into an agreement with FUJIFILM Diosynth Biotechnologies (“FDB”) to manufacture the Generx [Ad5FGF-4] angiogenic gene therapy product candidate for Phase 3 clinical evaluation for the treatment of refractory angina due to late-stage coronary artery disease. Manufacturing operations will be conducted at FDB’s facilities in College Station, Texas where FDB will perform technology transfer and process development activities for Phase 3 clinical and commercial-scale GMP manufacturing of Generx.

~~We have evaluated events that occurred subsequent to March 31, 2017 and through the date the condensed consolidated financial statements were issued.~~-19-

Notice of Allowance on Patent Application Covering Excellagen®

On June 7, 2017, the Company’s wholly-owned subsidiary, Activation Therapeutics, received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for a new patent application (U.S. Application No. 13/648,255) entitled “Flowable Formulations for Tissue Repair and Regeneration.” The patent application includes claims covering methods to utilize formulations encompassing Excellagen [2.6%] as a topically applied flowable fibrillar collagen matrix for wound repair by promoting localized release of platelet derived growth factors and providing an in situ microstructural scaffold for cell migration.

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion and analysis isare intended to help you understand our financial condition and results of operations for the three -month period ended March 31, ~~2017~~2020. You should read the following discussion and analysis together with our ~~unaudited~~audited ~~condensed~~ consolidated financial statements and the notes to the ~~condensed~~ consolidated financial statements included under Part I, Item 1 in this report,. asStatements ~~well~~in as the ~~risk~~following ~~factors~~discussion that ~~and~~are ~~other~~not ~~information~~historical ~~included~~ in ~~Part~~nature ~~II,~~are ~~Item 1A~~forward looking statements, inand ~~our~~inherently ~~annual~~subject ~~report~~to onrisk. ~~Form~~Our ~~10-K~~future ~~for~~financial ~~our~~condition ~~year~~and results ~~ended~~of ~~December 31,~~operations ~~2016~~will (vary from our ~~“2016~~historical ~~Annual~~financial ~~Report”),~~condition and ~~other~~results ~~reports~~of ~~and~~operations ~~documents~~described webelow ~~file~~based ~~with~~on a variety of factors. You should carefully review the ~~United~~risks ~~States~~described ~~Securities~~under Part II, Item 1A and ~~Exchange~~elsewhere ~~Commission~~in ~~(“SEC”).~~this ~~Our~~report, which identify certain important factors that could cause our future financial condition and results of operations ~~will~~to vary from our historical ~~financial~~operations ~~condition~~ and from ~~results~~our ofcurrent ~~operations~~expectations ~~described~~of ~~below~~future results.

Overview

~~The~~We are ~~following~~a ~~overview~~clinical ~~does~~stage ~~not~~biotechnology ~~address~~company ~~all~~focused ofon the ~~matters~~clinical ~~covered~~and incommercialization ~~the other sections~~ of ~~this~~angiogenic ~~Item 2~~gene ortherapy ~~other~~biotherapeutics for ~~items~~strategic inniche ~~this~~markets, ~~report~~primarily orfor ~~contain~~the ~~all~~treatment of ~~the~~cardiovascular ~~information~~disease. ~~that~~Our ~~may~~technology beplatform ~~important~~is designed to ~~our~~biologically activate ~~stockholders~~the orhuman ~~the~~body’s ~~investing~~innate ~~public.~~angiogenic ~~This~~healing ~~overview~~process ~~should~~to bestimulate ~~read~~the ingrowth ~~conjunction~~of microvascular networks for patients with ischemic ~~the~~cardiovascular, cerebral, and other ~~sections~~medical ofconditions ~~this~~and ~~Item 2~~diseases, as well as for advanced tissue engineering applications. Historically we have developed FDA registered and ~~this~~sold ~~report~~various medical devices, products and product candidates.

WeIn May ~~are~~2020, anafter ~~operating~~the ~~company~~period ~~that~~covered ~~manages~~by athis ~~medical~~report, ~~technologies~~we ~~portfolio~~entered into ofa ~~equity-based~~Preferred ~~and~~Stock ~~potential~~Purchase ~~royalty-driven~~Agreement ~~investments~~with asNostrum ~~follows:~~ Pharmaceuticals, LLC (1“Nostrum”) ~~Angionetics~~, ~~currently~~selling aNostrum ~~majority-owned~~1,700,000 shares ~~subsidiary~~of ~~focused~~our onnewly ~~the~~authorized ~~late-stage~~Series ~~clinical~~B ~~development~~Convertible ~~and~~Preferred ~~commercialization~~Stock ofin ~~Generx™,~~exchange anfor ~~angiogenic~~$1.7 ~~gene~~million. ~~therapy~~In ~~product~~addition, ~~candidate~~to ~~designed~~further ~~for~~support ~~medical~~the operations ~~revascularization~~of the Company for the ~~potential~~period ~~treatment~~May of2021 ~~patients~~through ~~with~~June ~~myocardial~~2021, ~~ischemia~~subsequent ~~and~~to ~~refractory~~this ~~angina~~reporting ~~due~~period, toNostrum ~~advanced~~invested an ~~coronary~~additional ~~artery~~$292,000, ~~disease;~~and ~~(2)~~the ~~Activation~~Company ~~Therapeutics,~~will aissue ~~wholly~~and ~~owned~~additional ~~subsidiary~~$292,00 ~~focused~~of onSeries ~~the~~B ~~development~~Preferred ~~and~~Stock. ~~commercialization~~Nostrum ofis the ~~Excellagen®~~parent ~~technology~~company of ~~platform~~Nostrum Laboratories, anInc., ~~FDA-cleared~~a ~~flowable~~privately ~~dermal~~held ~~matrix~~pharmaceutical ~~for~~company ~~advanced~~engaged ~~wound~~in ~~care~~the ~~that~~formulation, wecommercialization. ~~believe~~Marketing ~~has~~and sale ~~broad~~of ~~potential~~specialty ~~applications~~pharmaceutical asproducts aand ~~delivery~~controlled ~~platform~~release, ~~for~~orally ~~small molecule drugs~~administered, ~~proteins~~branded and ~~biologics;~~generic ~~(3)~~drug ~~LifeAgain~~products. aWe ~~wholly-owned~~will use ~~subsidiary~~the ~~that~~proceeds ~~has~~from ~~developed~~the ansale ~~advanced~~of ~~medical~~the ~~data~~Series ~~analytics~~B ~~(ADAPT®)~~Convertible ~~technology~~Preferred ~~platform~~Stock ~~focused~~to onfund ~~developing~~working ~~new~~capital ~~and~~requirements ~~innovative~~in ~~products~~preparation for conducting the ~~life~~U.S. ~~insurance~~FDA-approved ~~and~~Phase ~~healthcare~~3 ~~sectors;~~clinical ~~and~~trial ~~(4)~~for aour ~~minority~~Generx ~~investment~~product incandidate. ~~Healthy~~We ~~Brands~~believe ~~Collective,~~that aNostrum’s ~~functional~~assets ~~food~~and experience in the formulation and ~~nutraceutical~~commercialization ~~company~~of ~~which~~pharmaceutical ~~acquired~~products will facilitate the ~~Company’s~~administration Toand Gocompletion ~~Brands®~~of ~~business~~the Phase 3 clinical trial for Generx on a cost-effective basis.

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• Continue Angionetics’ development and commercialization of Generx™, an angiogenic, gene-based biotherapeutic designed for the treatment patients who have late-stage coronary artery disease and refractory angina and other ischemic heart disorders and medical conditions, including support in the funding and operation of the AFFIRM U.S.-based Phase 3 clinical trial.

• Monetize Activation Therapeutics’ FDA-cleared pharmaceutically formulated collagen commercial wound care product Excellagen® through either a sale of Activation Therapeutics or its assets or the establishment of strategic partnership for the sale and distribution of Excellagen in selected U.S.-based vertical market channels.

• Leverage Excellagen’s advanced regenerative medicine delivery platform by identifying innovative product extensions for tissue regeneration based on stem cells (including exosomes), biologics, peptides and/or small molecule drugs for future development and commercialization with one or more strategic partners.

• Identify a new insurance partner and seek opportunities for the application LifeAgain’s Medical analytics to commercialize “Survivable risk” term life insurance for cancer survivors or others with medical conditions who are currently considered uninsurable based on traditional under writing standards as well as other forms of survivable risk programs.

• With the successful monetization of current business interests, we plan to redeploy capital strategically to acquire and develop new and innovative medicine product candidates and create shareholder value.

We have yet to generate positive cash flows from operations, and are dependent on equity and debt funding to finance our operations. We intend to raise capital to finance the operations of Angionetics through a sale of equity in that entity. Alternatively, we are seeking to raise sufficient capital to finance our operations through the sale of equity or assets in our investments in Activation Therapeutics, LifeAgain and Healthy Brands Collective. If we fail to complete a financing or conclude such a transaction in a timely manner, we will not generate sufficient cash flows to cover our operating expenses. Our history of recurring losses and uncertainties as to whether our operations will become profitable raise substantial doubt about our ability to continue as a going concern. The consolidated financial statements contained in this report do not include any adjustments related to the recoverability of assets or classifications of liabilities that might be necessary should we be unable to continue as a going concern.

Recent highlights of our operating activities include the following:

Angionetics Inc. (Generx™)

Angionetics is a majority-owned subsidiary established to hold our Generx™ angiogenic gene therapy product candidate.

Generx™ has been under clinical development for over a decade, under the continual oversight of our highly experienced management team. Our management and consulting team have been responsible for the development of Generx from the initial scientific discoveries by researchers at the University of California, San Diego, through the first in-man U.S.-based clinical studies and late stage clinical studies, the acquisition of the Generx development program by Schering AG following the successful completion of a five-year strategic partnership, and the re-acquisition of the Generx development program by Taxus Cardium after Schering AG was acquired by Bayer Healthcare. Collectively, Angionetics’ small and highly focused management team has over 100 years of experience in the fields of gene therapy, cardiovascular product development and biologics.

On September 9, 2016, the U.S. FDA Center for Biologics Evaluation and Research (CBER) cleared Angionetics’ AFFIRM Phase 3 clinical study protocol, thus allowing Angionetics to proceed with late-stage clinical evaluation of GenerxTM. The AFFIRM study patient population and trial design are based on Ad5FGF-4 responder data from the four prior FDA-cleared clinical studies. The primary efficacy endpoint is improvement in exercise treadmill test (ETT) duration in GenerxTM -treated patients compared to a placebo control group. Enrolled patients must have refractory angina, documented clinical evidence of myocardial ischemia, clinically significant limitation of physical activity due to angina, and angina-limited ETT duration of 3-7 minutes.

On February 3, 2017, Angionetics received notice that the FDA has granted Fast Track designation for the Phase 3 clinical investigation of Generx [Ad5FGF-4] cardiovascular angiogenic gene therapy as a one-time treatment for improving exercise tolerance in patients who have angina that is refractory to standard medical therapy and not amenable to conventional revascularization procedures (coronary artery bypass surgery and percutaneous coronary intervention and stents). Under the FDA Modernization Act of 1997, designation as a Fast Track product means that FDA will take actions, as appropriate, to expedite the development and review of a biologics license application (BLA) for product approval. The FDA’s Fast Track process is designed to facilitate clinical and commercial development and expedite the review of new drugs and biologics that are intended to treat serious conditions that demonstrate the potential to address an unmet medical need.

After over two decades of basic, pre-clinical and clinical research in the field of gene therapy by universities, research institutes, as well as pharmaceutical and biotechnology companies worldwide, Angionetics’ Generx represents one of only a few cardiovascular DNA-based therapeutic product candidates to successfully advance into late-stage, U.S. Phase 3 clinical study. Our primary business focus is securing the additional capital that we will need to finance the completion of the AFFIRM study. We estimate that we will need an additional $25 to $50 million in additional capital to complete that study. We plan to secure that capital through the sale of additional equity or debt securities in that entity. There are no agreements or arrangement for any additional financing in place at this time.

The Generx™ Product Candidate:

Generx™ is a disease-modifying, precision medicine that is designed to improve cardiac perfusion (blood flow) in patients with chronic myocardial ischemia and refractory angina due to advanced coronary artery disease. In our clinical studies, enhanced cardiac perfusion is expected to improve exercise capacity, reduce the frequency of angina (chest pain) attacks and correspondingly reduce the need for certain anti-anginal drugs, and improve overall cardiovascular disease status. Generx has been designed to improve perfusion by promoting the formation of functional coronary collateral blood vessels within the heart. This process, termed “medical revascularization,” represents a fundamentally new mechanism of action that involves the stimulation of the formation of new biological structures in the heart, through arteriogenesis (enlargement of existing arterioles) and angiogenesis (formation on new capillary vessels), as opposed to currently available pharmacologic therapies which only address the symptoms of angina.

The Generx product candidate is designed to easily fit within the current practice of medicine, as a ready-to-use, one-time treatment, which is administered by interventional cardiologists using standard cardiac balloon catheters, during an approximately one-hour, out-patient, angiogram-like procedure conducted on a non-acute basis, in a hospital or medical center catheter lab setting. Interim study results demonstrate effectiveness similar to that of bypass surgery or stents, but in a significantly less costly and less invasive procedure.

Addressable Market:

Patients experiencing “refractory angina”--chronic and disabling stable angina despite conventional forms of treatment represent a significant and rapidly growing, “no option” patient population. According to the 2016 American Heart Association report, there are approximately 15.5 million Americans with coronary artery disease, 50% of whom have symptomatic angina pectoris. Many of these patients (1) have coronary artery disease that is not limited or localized to large vessels, (2) continue to experience angina after coronary artery bypass surgery (CABG) or percutaneous coronary interventions (PCI), and/or (3) are not suitable candidates for surgical interventions. Based on a study from the Cleveland Clinic [Mukherjee et al., Am J Cardiol. 1999; 84:598-600], it is estimated that approximately 12% of patients with angina due to coronary artery disease are considered not suitable for CABG or PCI.

For many patients, there are few treatment options for refractory angina, and currently available alternative therapies do not directly address the reversible, stress-induced perfusion defects responsible for refractory angina. We believe that the Generx angiogenic gene therapy product candidate represents a new and innovative biological tool for the interventional cardiologist and potentially a breakthrough therapy for this very substantial unmet market segment, and for multiple small and orphan medical indications that currently have no specific therapeutic products.

We estimate that there are approximately 1.0 million patients in the U.S. with refractory angina who may benefit from Generx angiogenic gene therapy, and that the potential addressable market is estimated to range from $3.0 billion in the U.S. and up to $20.0 billion worldwide.

Generx Clinical Studies and FDA developments:

The Generx FDA regulatory dossier represents one of the most extensive and advanced DNA-based clinical data platforms ever compiled. Generx has been evaluated as a treatment for patients with refractory angina in four prior FDA-cleared, multi-center, randomized and placebo-controlled clinical studies (AGENT 1-4, Phase 1/2 to Phase 2b/3) and one small international study (ASPIRE). The combined AGENT studies have enrolled over 650 patients at over 100 medical centers in the U.S. and Western Europe, and have generated over 2,500 patient years of safety data.

In these multiple prior clinical studies, the Generx product candidate appeared safe and well-tolerated, and has generated preliminary findings of efficacy in men and women, in measures of cardiac perfusion, cardiac performance, and angina status, including: (1) significant improvement in exercise duration by Exercise Treadmill Testing (ETT); (2) significant improvement in cardiac perfusion as assessed by SPECT imaging, with observed improvements comparable in magnitude to those seen with coronary artery bypass surgery (CABG) and angioplasty with the use of stents (PCI); (3) significant and durable improvement in physical exertion capacity, as assessed by functional classification of angina out to 12 months post-treatment; (4) improvement in angina status, as assessed by documented reduction in angina episodes and nitroglycerin usage; and (5) significant reduction in incidence of worsening angina.

Generx Technology Platform:

The Generx™ [Ad5FGF-4] angiogenic gene therapy product candidate requires three key elements: a myocardial delivery vector; a therapeutic transgene; and methods of gene delivery. Generx is biologically engineered using an E1-region deleted, replication deficient adenovirus serotype 5 vector to deliver the 621 base pair gene encoding human fibroblast growth factor-4 (FGF-4) under the control of a modified cytomegalovirus (CMV) promoter. Adenovirus is the most well-characterized and widely used gene therapy vector in human clinical studies, and has cGMP manufacturing and testing standards established by the FDA. The Generx FGF-4 transgene has been engineered to include a signal peptide, which enables effective secretion from cells that express the protein (such as cardiac myocytes). Our preclinical studies have shown that therapeutic efficacy is significantly increased by the presence of such a signal sequence in the growth factor DNA construct. [Gao et al., Hum Gene Ther. 2005; 16:1058-64] The CMV promoter is capable of driving high levels of transgene protein expression in transfected cells for up to 3 weeks. This short-term expression is ideal for tissue regeneration clinical applications requiring generation of new biological structures, including promotion of new vessel growth in the heart.

Identifying the optimal route of administration and delivery parameters for Generx angiogenic gene therapy, such as infusion volume, flow rate, vector concentration and dose, are critical to achieving safe and effective levels of vector uptake and FGF-4 transgene expression. We have developed clinically feasible protocols that fit within current medical practice and that are designed to yield reproducible results and reduce inter-patient variability. Generx is administered by an interventional cardiologist into the coronary arteries under transient ischemic conditions through the use of a standard balloon catheter. Generx is distributed into the microvascular pathways of the heart, and transfects cardiac cells by binding to cell surface coxsackievirus-adenovirus receptors (CAR). CAR receptors are found throughout the heart, and our research indicates that the binding of Generx to CAR receptors is enhanced by the induction of transient ischemia and the use of agents like nitroglycerin to boost cell permeability during administration.

The transfected heart cells then express and release FGF-4 protein, which promotes the growth of new blood vessels and increased blood flow to ischemic heart tissue. Recent Company-sponsored research studies have demonstrated that FGF appears to be a key angiogenic regulatory protein that stimulates the release and action of other angiogenic factors, including vascular endothelial growth factors (VEGF), platelet-derived growth factors (PDGF), and hepatocyte growth factor (HGF), to orchestrate and promote the growth of a functional collateral network in ischemic cardiac tissue. The evidence shows that FGF-4 expressed by Ad5FGF-4 has the capacity to enlarge pre-existing collateral arterioles (arteriogenesis) and to form new capillary vessels (angiogenesis) when driven by cardiac hemodynamic-impairment and ischemic stimuli. These studies have further demonstrated a synergistic interaction between FGF-4 expressed by Ad5FGF-4, and endogenous vascular endothelial growth factor (VEGF) in the promotion of neo-vessel formation, with evidence that FGF controls angiogenesis upstream of VEGF.

Commercialization Developments:

Angionetics has continued to refine and advance Generx clinical and commercial development, summarized as follows:

• New Pre-Clinical Research on Ad5 Receptor. The Company and its research collaborators at Emory University completed in vivo preclinical studies demonstrating that intracoronary Ad5-based gene delivery under conditions of transient ischemia enhances transgene expression in the heart by over two orders of magnitude (>100 fold), as compared to prior intracoronary delivery methods, likely due to ischemia-driven up regulation of the cardiac Coxsackievirus-Adenovirus Receptor (CAR) and enhanced Ad5-mediated gene transfer.

• New Delivery Techniques & Higher Dose Level. The completion of further international clinical research confirmed recent innovations covering the use of a balloon catheter and transient ischemia during Generx delivery to improve efficacy responses by leveraging pre-conditioning cardiac physiology and our enhanced understanding of cell surface receptor-mediated uptake. This clinical study also confirmed the safety and efficacy of a new higher single dose level of Ad5FGF-4. Both the new catheter delivery techniques and higher dose level have been integrated into the recently FDA-cleared U.S.-based Phase 3 AFFIRM clinical study protocol.

• New Fundamental Research on FGF Signaling. Company-sponsored research studies have demonstrated that fibroblast growth factor (FGF) appears to be a key angiogenic regulatory protein that stimulates the release and action of other angiogenic factors, including vascular endothelial growth factors (VEGF), platelet-derived growth factors (PDGF), and hepatocyte growth factor (HGF), to orchestrate and promote the growth of cardiac microvasculature (a functional collateral network) in ischemic cardiac tissue.

• New Clinical Data Analytics to Identify Generx Responders. Angionetics has completed an advanced analysis of patient data from prior clinical studies to characterize male and female patient responders and those who are expected to have the highest likelihood to benefit from Generx angiogenic gene therapy. Data from a pilot International study which employed the new transient-ischemia Generx delivery protocol, identified statistically significant improvement in myocardial perfusion, as measured using SPECT myocardial perfusion imaging in patients treated with a single dose of Generx compared to control, which was consistent and confirmatory of findings from a prior FDA-cleared Phase 2 study. In addition to myocardial ischemia, likely responders have been characterized as having significant limitation of functional/exercise capacity due to angina.

• New Simplified Handling Process for Generx. Angionetics has pioneered application of the Becton Dickinson PhaSeal Closed System Transfer Device for DNA-based products to simplify the handling of Generx within the medical center and hospital pharmacy and interventional cardiology catheter labs, and has integrated use of the PhaSeal system into the FDA-cleared Generx AFFIRM Phase 3 clinical study protocol.

Angionetics is committed to applying our first-mover scientific and clinical development leadership position in the field of angiogenic gene therapy for the treatment of patients with a variety of cardiovascular conditions which are related by insufficient cardiac perfusion. The core elements of our long-term strategy for Angionetics include:

• Secure the requisite funding and successfully complete the clinical development and commercialization Generx in the United States as a novel, first-in-class therapy for patients with myocardial ischemia and refractory angina.

• Initiate additional Phase 2 or Phase 4 (post-marketing) clinical studies to expand the Generx product labeling for use for other medical indications related to cardiac perfusion dysfunction that could include ischemic heart failure, Cardiac Syndrome X, and certain other orphan medical indications such as Prinzmetal’s and inversa anginas.

• Establish a Generx patient registry and conduct additional clinical studies to evaluate the safety and clinical efficacy of repeat dosing of Generx in patients as their coronary artery disease advances causing additional perfusion defects.

• Initiate additional studies to assess the potential long-term prognostic benefits of patients receiving angiogenic therapy through medical revascularization.

• Following U.S. registration, initiate the registration process to market and sell Generx in China with our current strategic partner, and consider registration in other prioritized regional markets.

• Commercialize Generx in the U.S. using an internal, highly-targeted interventional cardiology-focused sales force, or enter into strategic partnerships in the U.S. and internationally.

• Strategically deploy capital to develop our portfolio of Generx product candidates and create shareholder value through the worldwide commercialization of our Generx portfolio and royalty agreements.

Activation Therapeutics Inc. (Excellagen®)

Activation Therapeutics is a wholly-owned subsidiary established to hold and manage our assets related to the Excellagen® product and technology platform.

We are looking to monetize Excellagen through the sale of Activation Therapeutics or the technology. Alternatively, we have sought strategic partners to market and sell Excellagen in the United States and elsewhere through multiple marketing channels. We have been in discussions with parties expressing interest in purchasing the business, however, as of the date of this report, such discussions have not resulted in a completed monetization or strategic partnering transaction. We cannot guarantee that it will accept an offer to purchase the Excellagen business or that any such bona fide offer will be made on acceptable terms and conditions.

Without a strategic partner, we do not plan to build inventory or establish an internal marketing and sales force to directly support the commercialization of Excellagen.

Excellagen® Dermal Wound Matrix:

Excellagen has been engineered to activate and promote wound healing through the growth of granulation tissue. Excellagen is a flowable homogenate of highly purified bovine dermal collagen (Type I) in its native 3-dimensional fibrillar configuration.

Excellagen was cleared by FDA via the 510(k) pathway on October 3, 2011 (K110318) for the treatment of chronic dermal wounds including partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) and draining wounds. Excellagen has been classified for reimbursement purposes by the U.S. Centers for Medicare and Medicaid Services as a unique “skin substitute”-- a designation which is consistent with other forms of skin substitutes including living skin equivalents Dermagraft® and Apligraf® and human dermal and amnion placental tissue-based products including Graftjacket® and EpiFix®.

The Excellagen manufacturing process includes steps by which purified full-length Type I collagen molecules are reassembled into collagen’s native, staggered fibrillar configuration. Scanning electron microscopy has demonstrated Excellagen’s 3-dimensional scaffold structure and histological analysis of Excellagen-treated dermal wounds demonstrates efficient infiltration with fibroblasts, and development of patent blood vessels. Excellagen activates human platelets resulting in release of platelet-derived growth factor (PDGF). Excellagen’s ability to activate platelets is functional/biological evidence of its 3-dimensional fibrillar structure, as it has been demonstrated that this structure (as opposed to monomeric or denatured collagen) is required for effective platelet activation.

Excellagen is a cost-effective, easy to use, professional product that is conveniently packaged in prefilled, syringes with accessory flexible applicator tips. Excellagen is topically applied in a thin layer directly to the entire wound surface, providing a structural scaffold for cellular infiltration and wound granulation. The flowable format allows immediate, intimate contact with the entire wound surface, including highly contoured wounds, and can also be easily applied to areas of undermining or tunneling. The wound is first prepared by performing sharp debridement using standard methods to remove debris and necrotic tissue, and then Excellagen should be applied in the presence of a small influx of blood. Application of Excellagen in the presence of a small influx of blood cells and platelets likely contributes to its support of a favorable wound healing environment by triggering immediate, localized release of PDGF and other platelet-derived growth factors and cytokines, providing wound healing cues to the responsive cells exposed by debridement. After application, the treated wound is overlaid with a non-adherent dressing. The treated wound (including non-adherent dressing) is left undisturbed for one week to allow Excellagen to promote new granulation tissue growth. If the wound is not completely healed, Excellagen may be reapplied weekly.

Excellagen Clinical Studies and FDA approval:

Excellagen was studied in a multi-center, randomized, controlled, double-blinded Phase 2b study in patients with diagnosed diabetes (Type I or II) with non-healing ulcers of the lower extremity (with no bone or tendon exposed) that had failed prior therapy, that were present for at least 6 weeks, and were documented to be non-healing (≤ 30% decrease in ulcer area) during a 2-week run-in period under standard of care treatment (debridement, daily saline-moistened gauze, and off-loading). The study control included the conventional Standard of Care or “SOC”; daily saline-moistened gauze dressing changes, offloading, and sharp debridement. Excellagen was applied only once (day 1) or twice (day 1 and week 4), with offloading and weekly outer dressing changes.

After the 12 week study period, 45% percent of the patients treated with Excellagen (n=31) achieved complete wound closure. This was a 45% relative improvement over wounds treated with SOC therapy alone (n=16; 31% closure incidence). There was a 68% relative improvement with Excellagen for wounds achieving 90-100% area reduction during the 12-week evaluation period. In other words, 74% of wounds receiving only one or two applications of Excellagen achieved ≥90% area reduction compared with only 44% of patients receiving daily SOC. The improvement seen with Excellagen compared to SOC was even more dramatic for larger wounds. For wounds that were larger than three centimeters squared, 33% of wounds treated only once or twice with Excellagen achieved complete wound closure at 12 weeks whereas none of the SOC-treated wounds closed.

In the clinical study, Excellagen was applied to wounds only once or twice (with the second application four weeks after the first). Excellagen’s FDA clearance and the instructions for use suggest weekly application such that the accelerated healing and granulation tissue development observed in the Phase 2b study can be sustained, potentially further enhancing and accelerating the healing response. This schedule of weekly application has been followed in post-marketing use with positive reports of rapid, robust granulation tissue formation in chronic diabetic foot ulcers and pressure ulcers that have failed prior therapies.

Excellazome™ Advanced Wound Care Biologics Research:

We believe that Excellagen also represents a unique platform technology for the delivery of biologics for use in regenerative medicine applications. Prior research by Taxus Cardium and its collaborators has demonstrated biocompatibility and functionality of viral-based gene therapies and stem cell biologics when delivered in Excellagen. In addition to DNA- and stem cell-based biologics, Excellagen provides a potential enabling delivery platform for numerous therapeutic product classes, including small molecule drugs, peptides and anti-microbials.

Activation Therapeutics is developing plans to undertake research and preclinical studies to evaluate the toxicology and mechanism of action with respect to the use of Excellagen as a delivery platform for secreted extracellular vesicles (“Exosomes”), which carry factors that stimulate and augment wound healing. Exosomes are small (30-100 nm diameter), cell-derived, lipid bilayer-encapsulated vesicles that are naturally secreted by most cell types. Exosomes are found in, and can be isolated from, almost all bodily fluids and the media of cultured cells. Exosome contents include lipids, proteins, nucleic acids, and soluble factors. First identified in 1983, only in recent years has the therapeutic potential of exosomes been recognized and investigated. They are now known to play a vital role in intercellular communication by delivering their contents to recipient cells, and triggering biologic responses. In addition, exosomes are key secretory products of mesenchymal stem cells (MSC), and recently published preclinical research studies have demonstrated that MSC-derived exosomes can stimulate proliferation and migration of dermal fibroblasts, enhance angiogenesis, and accelerate wound healing in a diabetic mouse model. We believe that Excellagen could be a valuable delivery platform for exosomes in wound healing applications, by facilitating delivery and potentially augmenting the biological response to exosomes.

Based on this new and exciting field of research, we currently plan to retain the exclusive rights to develop, market and sell an advanced biologic product extension utilizing Excellagen as a delivery platform for exosomes ( Excellazome ), to stimulate and augment wound healing beyond levels already observed with our Excellagen dermal matrix product. Advancing the Excellazome biologic product concept to clinical and commercial readiness will require additional process engineering by exosome manufacturers to establish reproducible and scalable procedures that generate well-characterized end products that meet current Good Manufacturing Practices (cGMP) quality standards.

LifeAgain Insurance Solutions, Inc.

Our LifeAgain subsidiary has developed an advanced medical data analytics (ADAPT®) technology platform focused on developing new and innovative products for the life insurance and healthcare sectors. Our initial product offering was Blue Metric term life, an insurance program for men with prostate cancer. LifeAgain established a relationship with Symetra Financial Corporation to provide the insurance policies to men in the United States, based on actuarial information developed with our ADAPT technology.

On April 4, 2015, we entered into a license agreement with Shenzhen Qianhi Taxus Industry Capital Management Co., Ltd., a company affiliated with Shanxi Taxus Pharamaceuticals Co. Ltd., for the license of LifeAgain’s ADAPT technology to develop and commercialize survivable risk life insurance products in Greater China. No products were commercialized or sold based on that license during the year ended December 31, 2015.

On August 11, 2015, Symetra Financial Corporation announced that it entered into a definitive merger agreement with Sumitomo Life Insurance Company pursuant to which Sumitomo Life will acquire all of the outstanding shares of Symetra. Following the transaction, Symetra advised us that it was discontinuing its partnership with LifeAgain. As a result, we are not currently offering the Blue Metric term life product.

LifeAgain plans to continue to seek opportunities for the application of its ADAPT medical analytics platform to commercialize “survivable risk” term life insurance for cancer survivors or others with medical conditions who are currently considered uninsurable based on traditional underwriting standards as well as other forms of survivable risk programs.

Healthy Brands Collective.

On November 15, 2013, we sold the assets of our To Go Brands subsidiary to Healthy Brands Collective® in exchange for shares of preferred stock representing approximately 4% of Healthy Brand Collective’s fully-diluted common stock. Healthy Brands Collective® is the trading name for Cellnique Corporation, a privately-held company that has acquired a portfolio of eight independent brand product platforms (prior to To Go Brands) including Cell-nique® , Cherrybrook Kitchen®, Yumnuts®, Living Harvest/Tempt®, Bites of Bliss®, High Country Kombucha® drinks and Organics European Gourmet Bakery™ (formerly Dr. Oetker) natural and organic baking mixes.

At the time of the transaction, Healthy Brands Collective had announced plans for an initial public offering. Healthy Brands Collective has not completed any liquidity event. During 2015 we took additional impairment writeoffs against our investment in Healthy Brands Collective, fully reserving our investment. We are looking for opportunities to monetize our investment in Health Brands Collective, but do not have any arrangements or agreements in place at this time.

Critical Accounting Policies and Estimates

Our condensed consolidated financial statements included ~~under Item 1~~ in this report and in our Annual Report on Form 10-K have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”). The preparation of our financial statements in accordance with U.S. GAAP requires that we make estimates and assumptions that affect the amounts reported in our financial statements and their accompanying notes.

We have identified certain policies that we believe are important to the portrayal of our financial condition and results of operations, including obsolescence reserve for inventory, valuation of equity instruments, and impairment of long-lived assets. These significant accounting Accounting estimates or assumptions ~~bear the risk of change due to the fact that there~~ are ~~uncertainties~~inherently ~~attached~~subject to ~~these estimates or assumptions~~change, and certain estimates or assumptions are difficult to measure or value. We base our estimates on our historical experience, industry standards, and various other assumptions that we believe are reasonable under the circumstances. Actual results could differ from these estimates under different assumptions or conditions. AnIf ~~adverse~~results ~~effect~~differ onmaterially from our ~~financial condition~~estimates, ~~changes~~we inwill ~~financial~~make ~~condition,~~adjustments ~~and~~to ~~results~~our offinancial ~~operations~~statements ~~could~~prospectively ~~occur~~as ifwe ~~circumstances~~become ~~change~~aware ~~that~~of ~~alter~~ the ~~various~~necessity ~~assumptions~~for oran ~~conditions used in such estimates or assumptions~~adjustment.

We believe ~~record~~that ~~reserves~~the ~~for~~following ~~inventories~~accounting ~~that~~policies ~~are~~involve ~~obsolete~~the ormost ~~exceed~~complex ~~anticipated~~judgments ~~demand~~concerning orassumptions ~~carried~~and atestimates anwith ~~amount~~the ~~that~~greatest potential ~~exceeds~~impact ~~market.~~on Inour ~~establishing~~consolidated ~~such~~financial ~~reserves~~statements. Therefore, ~~management~~we ~~considers~~consider ~~historical~~these ~~sales~~to ofbe ~~identical~~our critical accounting policies and~~/or~~ ~~similar~~estimates. For ~~goods~~further information on all of our significant accounting policies, ~~product~~see ~~development~~the ~~plans~~notes ~~and~~to ~~expected~~our ~~market~~consolidated ~~demand~~financial statements included in the Annual Report on Form 10-K of 2019.

~~We calculate the value of equity compensation expense associated with the issuance of warrants and stock options using the Black~~-Scholes Option which approximates a binomial lattice model. Determining the appropriate fair value model and calculating the fair value of equity–based payment awards requires the input of a number of subjective assumptions including the expected stock volatility, the risk–free interest rate, the options expected life, the dividend yield on the underlying stock. The assumptions used in calculating the fair value of equity–based payment awards represent management’s best estimates, which involve inherent uncertainties and the application of management’s judgment. As a result, if factors change and the Company uses different assumptions, equity–based compensation could be materially different in the future. In addition, the Company is required to estimate the expected forfeiture rate and recognize expense only for those shares expected to vest. If actual forfeiture rate is materially different from the estimates, the equity–based compensation could be significantly different from what the Company has recorded in the current period. If we were to undervalue our derivative liabilities or stock–based compensation expense we would understate the expense recognized in our consolidated statements of operation. Conversely if we were to overvalue our warrant and stock–based compensation expenses we would overstate the expense recognized in our consolidated statements of operations.21-

Our other significant accounting policies are described in the notes to our condensed consolidated financial statements.

Results of Operations

For the Three Months Ended March 31, ~~2017~~2020, compared to the Three Months Ended March 31, ~~2016~~2019

~~Research~~The following ~~and~~tables ~~development~~sets ~~expenses~~forth our results of operations for the three-month ~~months~~period ended March 31, ~~2017 were $130~~2020,~~762~~ ~~compared~~and ~~to $83~~2019,~~333~~ ~~for~~and the ~~same~~relative dollar ~~period~~and inpercentage ~~2016.~~change ~~The~~between ~~increase of $47,429 was~~ the ~~result~~two ~~of a $1,427 increase in clinical trial expenses and a $46,002 increase in personnel related costs~~periods.

	Period Ended March 31,						Change (2020 to 2019)
	2020			2019			($)			%
Operating Expenses:
Research and development	$	46,605		$	63,379			(16,774	)		(26.5	)%
Selling, general and administrative		106,278			179,599			(73,321	)		(40.8	)%
Total Operating Expenses		152,883			242,978			(90,095	)		(37.1	)%
Income (Loss) from Operations		(152,883	)		(242,978	)		90,095			(37.1	)%
Other Income (Expense):
Interest Expense		(15,931	)		(10,129	)		(5,802	)		57.3	%
Total Other Income (Expense)		(15,931	)		(10,129	)		(5,802	)		57.3	%
Net Income (Loss)		(168,814	)		(253,107	)		84,293			(33.3	)%
Net (Loss) attributable to the non-controlling interest		(19,051	)		(26,738	)		7,686			(28.7	)%
Net Income (Loss) attributable to the controlling interest		(149,763	)		(226,369	)		76,607			(33.8	)%

~~Selling, general~~ Research and ~~administrative~~development expenses, for the three-month ~~months~~period ended March 31, ~~2017~~2020 ~~were~~compared ~~$521~~to 2019,~~218~~ ~~compared~~decreased toby $~~340~~16,~~669~~774 ~~for~~or ~~the~~26.5% ~~same~~mainly ~~period~~due to a reduction in ~~2016.~~employee ~~The~~salary ~~increase~~and benefits expense of $~~180~~4,~~549~~274 ~~was~~as the ~~result~~Company discontinued payment of abenefits. ~~$25~~In addition,~~530~~ ~~decrease~~the incollaboration for ~~stock-based~~research ~~compensation~~activities ~~offset~~with byNew aYork ~~$33,945~~University ~~increase~~was interminated ~~personnel~~decreasing research and ~~related~~development ~~costs,~~fees anby ~~increase of~~ $~~125~~12,~~954~~500 per quarter. The reduction in ~~professional~~expenses ~~services~~is ~~expense,~~consistent awith ~~$20,701~~the ~~increase~~Company’s inrestructuring ~~travel~~plan ~~related~~to ~~expenses,~~focus aon ~~$13,740~~the ~~increase~~development inof ~~investor~~Generx, ~~relations~~the ~~expenses~~sale of non-core products and an ~~$11,739~~overall ~~increase~~reduction in ~~other~~expenses ~~selling,~~while ~~general~~management focused company resources on raising capital to provide the resources to advance the development and ~~administration~~commercialization ~~related~~of ~~expenses~~Generx.

~~Interest~~Selling, general ~~expense~~and administrative expenses decreased, for the ~~three~~period ~~months~~ ended March 31, ~~2017~~2020 ~~was~~by $173,~~957~~321 or 40.8% compared to ~~$2,573~~2019 ~~for~~mainly due ~~the~~to ~~same~~a ~~period~~reduction in ~~2016.~~employee ~~The~~salary ~~decrease~~and benefits of $~~616~~56,875. In addition, there was a decrease in the ~~result~~office expenses of ~~interest~~$14,899 ~~charges~~mainly due ~~for~~to ~~expenditures~~a ~~made~~reduction onin ~~our~~depreciation ~~credit~~expense ~~card~~as assets became fully depreciated and an overall reduction of $1,547 in ~~2017~~other miscellaneous expenses as the company focused time and resources on raising capital.

~~Net~~Interest expenses ~~loss~~increased for the ~~three~~period ~~months~~ ended March 31, ~~2017~~2020 ~~was~~by $~~655~~5,~~283~~802 ~~(including~~compared ~~$75,159 attributable~~ to ~~the~~2019 ~~non-controlling~~primarily ~~interest~~as ~~and $0 of stock-based compensation) compared to~~ a ~~net~~result ~~loss~~ of ~~$426,575~~an ~~(including~~increase ~~$25,530~~in ~~of stock-based compensation) for~~ the ~~same~~total notes ~~period~~payable of ~~2016. The increase of~~ $~~228~~240,~~708~~000 ~~was~~received ~~primarily~~from ~~due~~Nostrum ~~to increases~~ in ~~operating~~September ~~expenses~~2019 asand ~~described~~January ~~above~~2020, ~~and~~which ~~changes~~bears ininterest ~~operating~~at ~~assets~~6% ~~and liabilities~~per annum.

Liquidity and Capital Resources

AsThe following oftable ~~March~~summarizes ~~31,~~our ~~2017,~~liquidity ~~we had approximately $0.2 million in cash~~ and ~~cash equivalents. Our~~ working capital ~~deficit~~position at March 31, ~~2017~~2020 ~~was~~and ~~approximately $4.1 million.~~2019:

Net cash used in operating activities was $749,689 for the three months ended March 31, 2017 compared to $252,899 for the three months ended March 31, 2016. The increase of $496,790 in net cash used in operating activities was due primarily to an increase in our net loss plus changes in operating assets and liabilities.

	March 31,
	2020			2019
Cash and Cash Equivalents	$	2,926		$	4,405
Other Current Assets		111,988			13,660
Accounts Payable		1,040,045			1,866,814
Other Current Liabilities		3,862,466			4,078,121
Working Capital		(4,787,597	)		(5,926,870	)

Net cash used in investing activities for the three months ended March 31, 2017 was $1,865 compared to no cash used in investing activities for the same period in 2016. The increase of $1,865 was related to property and equipment purchases associated with our move into our new office space. At March 31, 2017, we did not have any significant capital expenditure requirements.-22-

~~Net cash used in financing activities was $(2,476) for~~ Following the ~~three~~period ~~months~~covered ~~ended March 31, 2017 compared to net cash provided~~ by ~~financing~~this activities of $350,627 for the same period in 2016. For the three month period ended March 31, 2017, we repaid our Chief Executive Officer $2,476 of advances made for ordinary Company expenses. For the three month period ended March 31, 2016 the $350,627 net cash received from financing activities included a $250,000 payment from a Huapont affiliate for shares of Series A Convertible preferred stock in Angionetics and $100,627 net cash advances received from our Chief Executive Officer to cover ordinary Company expenses. report:

We anticipate that negative cash flows from operations will continue for the foreseeable future. We do not have any unused credit facilities. We intend to secure additional working capital through sales of additional equity and debt securities to finance our operations. As long as any shares of our Preferred Stock are outstanding, we have agreed that we will not, without the consent of the holders of two-thirds of the Series A Convertible Preferred Stock, incur indebtedness other than specified “Permitted Indebtedness”, or incur any liens other than specified “Permitted Liens”.

	●	The Company entered into a number of agreements with vendors to restructure amounts payable, reducing the outstanding balance of accounts payable.

	●	In May 2020, the Company secured $1.7 million financing from the sale of our newly authorized Series B Convertible Preferred Stock to Nostrum. We will use the proceeds from the sale of the Series B Convertible Preferred Stock to fund working capital requirements in preparation for conducting a Phase 3 clinical trial in the U.S. for our Generx product candidate.

OnThe following ~~June~~table 7,summarizes ~~2016,~~our ~~Taxus Cardium and Angionetics entered into a Share Purchase Agreement with Pineworld Capital Limited an entity affiliated with Huapont Life Sciences Co. Ltd~~operating, ~~a China-based pharmaceutical and active pharmaceutical ingredient company (“Huapont”). Huapont is focused on the research and development of new and innovative healthcare products~~investing, and ~~the~~financing ~~manufacture,~~activities ~~marketing~~for and sale of leading pharmaceutical products, active pharmaceutical ingredients (known as APIs) and a portfolio of safe and effective agricultural herbicides (including NC16, NC34, NC36, NC125, NC201) serving the ~~agricultural business throughout the U.S. and South American markets. Huapont’s pharmaceutical business includes dermatology products, cardiovascular products, anti~~three-~~tuberculosis~~month ~~agents,~~period ~~autoimmune-related~~ended ~~products~~March ~~and oncology-related products. Huapont’s API business involves the production and sale of bulk pharmaceutical chemicals~~31, ~~pharmaceutical intermediates and preparations of Western medicines~~2020, ~~with current annual revenues of approximately $1.1 billion,~~ and approximately 7,100 employees operating throughout mainland China. Huapont is listed on the Shenzhen Stock Exchange (002004.SZ) and trades at a current market capitalization of approximately $3.0 billion.2019:

In connection with this agreement, Angionetics sold 600,000 shares of its newly authorized Series A Convertible Preferred Stock (the “Shares”) to the Huapont affiliate in exchange for $3,000,000 in cash. The Shares represent an initial 15% equity interest in Angionetics, resulting in a post-money valuation of $20.0 million for Angionetics, subject to certain anti-dilution protection.

	Period ended March 31,
	2020			2019
Net cash generated from (used in) operating activities	$	(93,857	)	$	(40,344	)
Net cash used in investing activities		—			—
Net cash generated from/(used in) financing activities		96,383			(37,366	)
Net increase/(decrease) in cash and cash equivalents		2,526			(77,710	)

The increase ~~agreement called for the investment from the Huapont affiliate to be made in two tranches—the closing~~ of ~~the initial tranche of 200,000 Shares for~~ $153,~~000,000~~513 ~~shortly~~in ~~following~~net ~~the~~cash ~~execution~~used ofin ~~the~~operating ~~agreement~~activities ~~and the closing of the second tranche of 400,000 Shares for $2,000,000~~ was ~~conditioned~~primarily ~~upon~~due ~~Angionetics securing FDA clearance~~ to ~~initiate~~legal acosts ~~new~~paid ~~U.S.-based~~in ~~Phase~~connection ~~3 clinical study (the AFFIRM study) to evaluate the safety and definitive efficacy of the GenerxTM [Ad5FGF-4] product candidate for the treatment of patients~~ with ~~ischemic~~May ~~heart~~2020 Nostrum ~~disease and refractory angina~~financing. ~~The~~ ~~closings~~These ~~took~~legal ~~place,~~costs ~~and the Shares~~ were ~~issued,~~capitalized onas ~~July~~a 5,prepaid ~~2016~~asset ~~and~~until ~~September 28, 2016, respectively~~closing.

20We had no net cash used in investing activities for the three months ended March 31, 2020, and 2019. On March 31, 2020 we did not have any significant capital expenditure requirements.

~~Angionetics~~The increase ~~will~~of ~~require~~$133,749 ~~substantial~~in ~~additional~~net ~~capital~~cash toprovided ~~complete~~by ~~the~~financing ~~Phase~~activities 3was ~~AFFIRM~~primarily ~~study. We~~due ~~estimate~~to ~~that~~the weNostrum ~~will~~financing ~~need~~in anJanuary ~~additional~~2020 ~~$25~~of to $50120,000 and ~~million~~accrued inand ~~additional~~unpaid ~~capital~~interest toon ~~complete~~notes ~~that~~payable ~~study. We~~of ~~plan~~approximately to$15,931, ~~secure~~which ~~that~~was ~~capital~~offset ~~through~~by the ~~sale~~payments ofmade ~~additional~~to ~~equity~~loans orfrom ~~debt~~officer of ~~securities~~approximately ~~in that entity~~$35,375. ~~There are no agreements or arrangement for any additional financing in place at this time.~~

The Company anticipates that negative cash flows from operations will continue for the foreseeable future. We have yet to generate positive cash flows from operations, and we are essentially dependent on ~~equity~~external funding sources to support the Company’s research, development and ~~debt~~commercialization ~~funding~~activities. toWe ~~finance~~do ~~our~~not ~~operations~~have any unused credit facilities. We intend to ~~raise~~pursue ~~capital~~sources toof ~~finance~~working ~~the~~capital ~~operations~~from ofnon-dilutive funding ~~Angionetics~~channels ~~through~~to asupport ~~sale~~the ofCompany’s ~~equity~~operations in that ~~entity. Alternatively~~could include, webut ~~are~~not ~~seeking~~be limited to, ~~raise~~(1) ~~sufficient~~up ~~capital~~ to ~~finance~~$3.350 ~~our~~million ~~operations~~from ~~through~~potential royalties ~~the~~from ~~sale~~commercial sales of ~~equity~~Excellagen® orfrom ~~assets~~certain ingeographic ~~our~~regions, ~~investments~~including inthe ~~Activation~~United ~~Therapeutics,~~States; ~~LifeAgain~~(2) ~~and~~Federal ~~Healthy~~government sponsored ~~Brands~~research ~~Collective. If~~grants; we(3) ~~fail~~agreements toand ~~complete~~arrangements acovering ~~financing~~distributor orand ~~conclude~~strategic ~~such~~partnerships aand ~~transaction~~drug inroyalty aagreements based ~~timely~~on ~~manner,~~the wecommercial ~~will~~sale ~~not~~of ~~generate~~Generx ~~sufficient~~following ~~cash~~the ~~flows~~successful tocompletion ~~cover~~of ~~our~~the ~~operating~~planned ~~expenses.~~FDA-cleared, ~~Our~~Phase ~~history~~3 ofAFFIRM ~~recurring~~clinical ~~losses~~ study and ~~uncertainties~~FDA asregistration toin ~~whether~~the ~~our~~U.S., ~~operations~~and ~~will~~additional ~~become~~registrations ~~profitable~~to ~~raise~~market ~~substantial~~and ~~doubt~~sell ~~about~~Generx ~~our~~in ~~ability~~other tocountries ~~continue~~internationally. asAt aan ~~going~~appropriate time, ~~concern.~~with ~~The~~favorable ~~consolidated~~market ~~financial~~conditions, ~~statements~~and ~~contained~~an inappropriate ~~this~~enterprise ~~report~~value doreflective ~~not~~of ~~include~~the ~~any~~Company’s ~~adjustments~~clinical ~~related~~status toand the Generx ~~recoverability~~[Ad5FGF-4] ofeconomic ~~assets~~potential, orwe ~~classifications~~could also consider the sale of ~~liabilities~~equity ~~that~~and ~~might~~debt besecurities ~~necessary~~in ~~should~~a wevariety beprivately ~~unable~~negotiated structured totransactions ~~continue~~or aspublic acapital ~~going~~market ~~concern~~offerings.

Off-Balance Sheet Arrangements

As of March 31, ~~2017~~2020, wethe Company did not have any significant off-balance sheet debt nor did we have any transactions, arrangements, obligations (including contingent obligations) or other relationships with any unconsolidated entities or other persons that have or are reasonably likely to have a material current or future effect on financial condition, changes in financial condition, results of operations, liquidity, capital expenditures, capital resources, or significant components of revenue or expenses material to investors.

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

As a smaller reporting company, we are not required to provide the information required by this item.

-23-

ITEM 4. CONTROLS AND PROCEDURES

WeDisclosure Controls ~~maintain disclosure controls~~ and procedures that are designed to provide reasonable assurance that material information is: (i) gathered and communicated to our management, including our principal executive and financial officers, on a timely basis; and (ii) recorded, processed, summarized, reported and filed with the SEC as required under the Securities Exchange Act of 1934, as amended.Procedures

~~Our~~We maintain ~~management,~~certain ~~with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our~~ disclosure controls and procedures asthat ofare ~~March~~designed ~~31,~~to ~~2017.~~provide ~~Based~~reasonable onassurance ~~this evaluation, management concluded~~ that ~~our~~information ~~disclosure~~required ~~controls~~to ~~were~~be disclosed ~~not~~in ~~effective~~the ~~for~~reports ~~their~~that ~~intended~~we ~~purposes~~submit ~~described~~or ~~above~~file aswith athe ~~result~~SEC ofunder athe ~~material~~Securities ~~weakness~~Exchange inAct ~~our~~of ~~internal~~1934 ~~control over financial reporting. A material weakness~~ is a(1) ~~deficiency~~recorded, orprocessed ~~combination~~summarized and ofreported ~~deficiencies,~~within inthe ~~internal~~time ~~control~~periods ~~over~~specified ~~financial~~in ~~reporting,~~the ~~such~~SEC ~~that~~rules ~~there~~and isforms aand ~~reasonable~~(2) ~~possibility~~accumulated ~~that~~and acommunicated ~~material~~to ~~misstatement~~our ofmanagement, including our ~~annual~~Chief orExecutive ~~interim~~Officer ~~consolidated financial statements will not be prevented or detected~~ and ~~corrected~~Chief onFinancial ~~a timely basis. For the year ended December 31~~Officer, ~~2016,~~as weappropriate ~~noted~~to ~~the~~allow ~~following~~timely ~~material~~discussions ~~weaknesses~~regarding inrequired ~~the operation of our internal controls as follows:~~disclosure.

•Our management, Wewith ~~did~~the ~~not~~participation ~~maintain~~of aour ~~sufficient~~Chief ~~complement~~Executive ofOfficer ~~personnel~~and ~~with~~Chief Financial Officer, evaluated the ~~appropriate~~effectiveness ~~level~~of our disclosure controls and procedures as of ~~accounting~~March ~~knowledge~~31, ~~experience~~2020. ~~and~~Based ~~training~~on inthis ~~the~~evaluation, ~~application~~management concluded that our disclosure controls were not effective for their intended purposes described above as a result of ~~GAAP~~a ~~commensurate~~material ~~with~~weakness in our internal control over financial reporting. ~~requirements;~~A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim consolidated financial statements will not be prevented or detected and corrected on a timely basis. For the year ended December 31, 2019, we noted the following material weaknesses in the operation of our internal controls as follows:

•● We did not maintain a sufficient complement of personnel with the appropriate level of accounting knowledge, experience, and training in the application of GAAP commensurate with our financial reporting requirements; and ● We did not maintain a sufficient complement of personnel to permit the segregation of duties among personnel with access to the Company’s accounting and information systems and controls.

Our management does not believe that the material weakness in internal controls has resulted in any inaccuracy or misstatement in the financial statements included in this report. We plan to remediate these material weaknesses by hiring additional qualified accounting personnel when the Company has the financial resources to support those expenses. However, these material weaknesses continued to exist during the quarterly period ended March 31, ~~2017~~2020.

~~There~~Changes in ~~were~~Internal noControl ~~changes to our internal control~~ over ~~financial~~Financial ~~reporting during the quarterly period ended March 31, 2017 that have materially affected, or that are reasonably likely to materially affect, our internal control over financial reporting.~~Reporting

21There were no changes to our internal control over financial reporting during the quarterly period ended March 31, 2020 that have materially affected, or that are reasonably likely to materially affect, our internal control over financial reporting.

-24-

PART II – OTHER INFORMATION

ITEM 1. LEGAL PROCEEDINGS

In the course of our business, we ~~are~~may ~~routinely~~become involved in proceedings such as disputes involving goods or services provided by various third parties, ~~which~~intellectual weproperty doinfringement ~~not~~claims, ~~consider~~and ~~likely~~employment todisputes. beWe ~~material~~are tonot ~~the~~currently ~~technology~~a weparty ~~develop~~to orany ~~license,~~legal orproceedings ~~the products~~ that we ~~develop~~believe ~~for~~would ~~commercialization,~~reasonably ~~but~~be ~~which~~expected ~~can~~to ~~result~~have ina ~~costs~~material ~~and~~effect ~~diversions~~on ofour ~~resources~~financial ~~to pursue and resolve~~position.

In October 2014, BioRASI LLC (“BioRASI”) filed a complaint in Broward County, Florida, seeking payments of approximately $0.5 million allegedly owed for services that BioRASI provided in connection with the Company’s clinical trial conducted in the Russian Federation. In June of 2015, BioRASI amended the complaint to include as plaintiffs additional parties affiliated with BioRASI including Vendevia Group, LLC, Biosciences Research Ltd., and Progressive Scientific Bioresearch, Ltd. We are defending the action and have filed counterclaims. Although at March 31, 2017, the probable outcome of this matter cannot be determined, we believe that we have supportable defenses and any negative decision, if any, is expected to be insignificant. Accordingly, we have not recorded any provisions related to this matter.

ITEM 1 A. RISK FACTORS

~~You~~Our business, ~~should~~financial ~~carefully~~condition ~~review~~ and ~~consider~~operating ~~the~~results ~~risks~~can ~~described~~be ~~below,~~affected asby ~~well~~a asnumber ~~the~~of ~~other~~factors, ~~information~~including inbut ~~this~~not ~~report~~limited ~~and~~to those described in ~~other~~our ~~reports~~annual ~~and~~report ~~documents~~on weForm ~~file~~10-K ~~with~~for the ~~SEC~~year ~~when~~ended ~~evaluating~~December ~~our~~31, ~~business~~2019 ~~and~~under ~~future prospects. The risks and uncertainties described below are not~~ the ~~only~~heading ~~ones~~“Risk ~~we face~~Factors”. ~~Additional~~The ~~risks~~occurrence ~~and~~of any ~~uncertainties,~~one ~~not presently known to us,~~ or ~~that~~more ~~we currently perceive as immaterial or remote, may also occur. If any~~ of ~~the~~those ~~following~~factors ~~risks~~could orcause ~~any~~our ~~additional~~actual ~~risks~~financial and ~~uncertainties~~operating ~~actually~~results ~~occur,~~to ~~our~~vary ~~business~~materially ~~could~~from bepast ~~materially~~or ~~harmed,~~from ~~and~~expected future ~~our~~ financial condition, ~~results of operations~~ and ~~future~~operating ~~growth prospects could be materially and adversely affected~~results. InThere ~~that~~have ~~event,~~been ~~the~~no ~~market~~material ~~price~~changes ofto our ~~common~~risk ~~stock~~factors ~~could~~since ~~decline and you could lose all or a portion of~~ the ~~value~~filing of ~~your investment in~~ our ~~stock.~~2019 Annual ~~You should not draw any inference as to the magnitude of any particular risk from its position in the following discussion~~Report.

~~Risks~~The risk ~~Related~~factors included in our 2019 Annual Report and our other filings with the SEC are not the only ones we face. Additional risks and uncertainties, not presently known to ~~Our~~us, ~~Business~~or that we currently perceive as immaterial or remote, may also occur. If any of the following risks or any additional risks and ~~Industry~~uncertainties actually occur, our business could be materially harmed, and our financial condition, results of operations and future growth prospects could be materially and adversely affected.

We need substantial additional capital to develop our products and for our operations in the near term. If we are unable to obtain such funds when needed, we may have to delay, scale back or terminate our product development or our business.

Conducting the costly and time consuming research, pre-clinical and clinical testing necessary to obtain regulatory approvals and bring our products to market will require a commitment of substantial funds in excess of our current capital. The audit opinion accompanying our consolidated financial statements for the year ended December 31, 2016 included an explanatory paragraph indicating substantial doubt about our ability to continue as a going concern.

We expect capital outlays and operating expenditures for Angionetics to increase over the next several years as it works to advance Generx through late stage clinical trials, secure regulatory approval, begin to commercialization. Angionetics will need to raise additional capital to, among other things:

• Fund the completion of its U.S.-based Phase 3 AFFIRM clinical trial for Generx;

• Fund additional clinical trials and preclinical trials for GenerxTM as requested or required by regulatory agencies;

• Fund clinical trials and preclinical trials for GenerxTM in new indications;

• Sustain commercialization of GenerxTM or any other new product candidate;

• Develop manufacturing capabilities, if any;

• Increase sales and marketing efforts to drive market adoption and address competitive developments;

• Finance general and administrative expenses;

• Maintain, expand and protect its intellectual property portfolio;

• Add operational, financial and management information systems; and

• Hire additional clinical, quality, scientific, and general and administrative personnel.

Our future capital requirements will depend on many factors, including, among others: the progress of our current and new product development programs; the progress, scope and results of our pre-clinical and clinical testing; the time and cost involved in obtaining regulatory approvals; the cost of manufacturing our products and product candidates; the cost of prosecuting, enforcing and defending against patent claims and other intellectual property rights; competing technological and market developments; and our ability to establish and maintain collaborative and other arrangements with third parties to assist in potentially bringing our products to market and/or to monetize the economic value of our product portfolio.

We cannot be certain that additional financing will be available on acceptable terms, or at all. If we are unable to obtain additional capital on acceptable terms when needed, we may need to take actions that adversely affect our business, our stock price and our ability to achieve cash flow in the future, including possibly surrendering our rights to some technologies or product opportunities, delaying our clinical trials or curtailing or ceasing operations.

If we raise capital through the sale of equity securities it may result in substantial dilution to our existing stockholders.

To the extent we raise additional capital through the sale of equity securities or we issue securities in connection with another transaction, the ownership position of existing stockholders could be substantially diluted. Anti-dilution adjustments to our securities currently outstanding would cause further dilution. If additional funds are raised through the issuance of preferred stock or debt securities, these securities are likely to have rights, preferences and privileges senior to our common stock and may involve significant fees, interest expense, restrictive covenants and the granting of security interests in our assets.

In order to raise capital to fund the development of our GenerxTM product candidate we have sold shares in our Angionetics subsidiary. Our management did this because it believed that it could raise capital at a better valuation, and with less dilution to existing stockholders, than if it were to sell shares of Taxus Cardium. If Angionetics continues to issue additional equity securities to third party investors, as is currently planned, it will dilute the interest of Taxus Cardium, and consequently our stockholders in Angionetics and the GenerxTM product candidate.

We have incurred losses since our inception in December 2003 and expect to incur significant net losses in the foreseeable future and may never become profitable.

We have sustained operating losses to date and will likely continue to sustain losses as we seek to develop our products and product candidates. We expect these losses to be substantial because of the significant amounts we expect to spend on development activities and clinical trials for our product candidates. As of March 31, 2017, our accumulated deficit was approximately $118 million, and our cash and cash equivalents were approximately $0.2 million. To date, we have generated very limited revenues and a large portion of our expenses are fixed, including expenses related to facilities, equipment, contractual commitments and personnel. As a result, we expect our net losses from operations to continue for at least the next few years.

Whether we will generate additional revenues and become profitable will depend largely on our ability, alone or with potential collaborators, to efficiently and successfully complete the development of our product candidates, successfully complete pre-clinical and clinical tests, obtain necessary regulatory approvals, and manufacture and market our products. There can be no assurance that any such events will occur or that we will ever become profitable. Even if we do achieve profitability, we cannot predict the level of such profitability. If we sustain losses over an extended period of time, we may be unable to continue our business.

There is a high rate of failure for drug candidates proceeding through clinical trials.

Generally, there is a high rate of failure for drug candidates proceeding through clinical trials. We may suffer significant setbacks in clinical trials, even after receiving promising results in earlier trials. Further, even if we view the results of a clinical trial to be positive, the FDA or other regulatory authorities may disagree with our interpretation of the data. In the event that Angionetics obtains negative results from the AFFIRM Phase 3 clinical study or receives poor clinical results for other product candidates, or the FDA chooses to block progress of the trials, or does not approve our Biologics License Application for Generx, Angionetics may not be able to generate sufficient revenue or obtain financing to continue operations. In such event, our ability to execute on our current business plan will be materially impaired, our reputation in the industry and in the investment community would likely be significantly damaged, and the price of our stock would likely decrease significantly.

Our technologies and product candidates may have unacceptable side effects that could delay or prevent product approval.

Side effects of therapeutic technologies can be serious and life threatening. While we are not presently aware of any side effects from the use of GenerxTM, possible serious side effects of gene transfer include viral or gene product toxicity resulting in inflammation or other injury to the heart or other parts of the body. The development or worsening of cancer in a patient could potentially be a perceived or actual side effect of gene therapy technologies. Furthermore, there is a possibility of side effects or decreased effectiveness associated with an immune response toward any viral vector or gene used in gene therapy. The possibility of such response may increase if there is a need to deliver the viral vector more than once.

If GenerxTM or any of our product candidates are found, prior to or after any approval for commercial sale, to cause serious or unexpected side effects, a number of potentially significant negative consequences could result, including:

• We may voluntarily interrupt, delay or halt clinical trials or regulatory authorities may require that we interrupt, delay interrupt, delay or halt clinical trials;

• Regulatory authorities may deny regulatory approval of our product candidates;

• Regulatory authorities may withdraw their approval of the product or impose restrictions on distribution in the form of a risk evaluation and mitigation strategy, or REMS;

• Regulatory authorities may require the addition of labeling statements, such as warnings or contraindications or limitations on the indications for use;

• We may be required to change the way the product is administered or conduct additional clinical trials;

• We could be sued and held liable for harm caused to patients; or

• Our reputation may suffer.

If we elect or are forced to suspend or terminate any planned clinical trial of GenerxTM or any other of our product candidates, the commercial prospects for that product will be harmed and our ability to generate product revenue from that product may be delayed or eliminated. Furthermore, any of these events could prevent us or our partners from achieving or maintaining market acceptance of the affected product and could substantially increase the costs of commercializing our product candidates and impair our ability to generate revenue from the commercialization of these products.

We rely on third party clinical research organizations to manage our clinical trials. Consequently we have less control over the conduct of the clinical trials and may experience delays or errors in our clinical trials that could adversely affect our business, financial results and commercial prospects.

To obtain regulatory approvals for new products, we must, among other things, initiate and successfully complete multiple clinical trials demonstrating to the satisfaction of the FDA or other regulatory authority that our product candidates are sufficiently safe and effective for a particular indication. We rely on third party clinical research organizations to assist us in designing, administering and assessing the results of those trials. We are dependent upon them to timely and accurately perform their services. We have experienced, and in the future may experience, delays in our clinical trials. Our development costs will increase and our business may be negatively impacted, if we experience delays in testing or approvals or if we need to perform more or larger clinical trials than planned, for reasons such as the following:

• the FDA or other health regulatory authorities, or institutional review boards, do not approve a clinical study protocol or place a clinical study on hold;

• suitable patients do not enroll in a clinical study in sufficient numbers or at the expected rate, or data is adversely affected by trial conduct or patient drop out;

• patients experience serious adverse events, including adverse side effects of our drug candidate or device;

• patients die during a clinical study for a variety of reasons that may or may not be related to our product candidates, including the advanced stage of their disease and medical problems;

• patients in the placebo or untreated control group exhibit greater than expected improvements or fewer than expected adverse events;

• third-party clinical investigators do not perform the clinical studies on the anticipated schedule or consistent with the clinical study protocol and good clinical practices, or other third-party organizations do not perform data collection and analysis in a timely or accurate manner;

• service providers, collaborators or co-sponsors do not adequately perform their obligations in relation to the clinical study or cause the study to be delayed or terminated;

• regulatory inspections of manufacturing facilities, which may, among other things, require us or a co-sponsor to undertake corrective action or suspend the clinical studies;

• the interim results of the clinical study are inconclusive or negative;

• the clinical study, although approved and completed, generates data that is not considered by the FDA or others to be sufficient to demonstrate safety and efficacy; or

• changes in governmental regulations or administrative actions affect the conduct of the clinical trial or the interpretation of its results.

Significant delays may adversely affect our financial results and the commercial prospects for our product candidates and delay our ability to become profitable. If third party organizations do not accurately collect and assess the trial data, we may discontinue development of viable product candidates or continue allocating resources to the development and marketing of product candidates that are not efficacious. Either outcome could result in significant financial harm to our company and damage to our reputation.

If we are unable to enter into successful sales, marketing and distribution agreements with third parties, we may not be able to successfully commercialize our products.

We rely on collaborations or other arrangements with third parties to sell, market and distribute our products. Under these arrangements third parties would be largely responsible for the timing and extent of sales and marketing efforts, they may not dedicate sufficient resources to our product opportunities, and our ability to cause them to devote additional resources or to otherwise promote sales of our products may be limited. In addition, to the extent that we enter into licensing, distributorship, co-promotion, co-marketing or other collaborative arrangements, our product revenues are likely to be lower than if we directly marketed and sold our products on a direct basis.

We have entered into agreements with third parties to market our Excellagen® product and to date have not been successful in generating material sales. We have also entered into agreements with third parties to market our GenerxTM product in certain territories if approved by relevant regulatory authorities, but there can be no assurance that the efforts of such third parties will meet our expectations or result in any significant product sales.

Even if approved for marketing, our product candidates may fail to gain market acceptance.

Our ongoing business and future depends on the success of our technologies and product candidates. Gene-based therapy, like our GenerxTM product candidate, is a new and rapidly evolving medical approach that has any not been shown to be effective on a widespread basis. Biotechnology and pharmaceutical companies have successfully developed and commercialized only a limited number of biologic-based products to date and no gene therapy has yet been successfully commercialized. Our product candidates, and the technology underlying them, are new and unproven and there is no guarantee that health care providers or patients will be interested in our products even if they are approved for use.

Our success will depend in part on our ability to demonstrate sufficient clinical benefits, reliability, safety and cost effectiveness of our product candidates and technology relative to other approaches, as well as on our ability to continue to develop our product candidates to respond to competitive and technological changes.

If the market does not accept our products or product candidates, when and if we are able to commercialize them, then we may never become profitable. It is difficult to predict the future growth of our business, if any, and the size of the market for our product candidates because the market and technology are continually evolving. There can be no assurance that our technologies and product candidates will prove superior to technologies and products that may currently be available or may become available in the future or that our technologies or research and development activities will result in any commercially profitable products.

We will rely on third parties to manufacture our products and product candidates. There can be no guarantee that we can obtain sufficient and acceptable quantities of our product candidates on acceptable terms, which may delay or impair our ability to develop, test and market such products.

Our business strategy relies on third parties to manufacture and produce our products and product candidates and the catheters used to deliver the products in accordance with Good Manufacturing Practices established by the FDA and other regulators. These third party manufacturers are subject to extensive government regulation and must receive FDA approval before they can produce clinical material or commercial product.

Our products and product candidates may be in competition with other products for access to these facilities and may be subject to delays in manufacture if our contract manufacturers give other products greater priority than our products. These third parties also may not deliver sufficient quantities of our products, manufacture our products in accordance with specifications, or comply with applicable government regulations. Successful large-scale manufacturing of gene-based therapy products has been accomplished by very few companies, and significant process development changes may be necessary before commercializing and manufacturing any of our biologic product candidates. Additionally, if the manufactured products fail to perform as specified, our business and reputation could be severely impacted.

If any manufacturing agreement is terminated or any third party service provider or collaborator experiences a significant problem that could delay or interrupt the supply of product to us, there are very few contract manufacturers who currently have the capability to produce our product candidates. There can be no assurance that manufacturers on whom we depend will be able to successfully produce our products or product candidates on acceptable terms, or on a timely or cost-effective basis, or in accordance with our product specifications and applicable FDA or other governmental regulations. We must have sufficient and acceptable quantities of our product materials to conduct our clinical trials and to market our product candidates, if and when such products have been approved by the FDA for marketing. If we are unable to obtain sufficient and acceptable quantities of our product material, we may be required to delay the clinical testing and marketing of our products, which would negatively impact our business.

We may pursue acquisitions of other companies or product rights that, if not successful, could adversely affect our business, financial condition and results of operations.

As part of our business strategy, we may pursue acquisitions of other companies, technologies or products. Acquisitions of businesses or product rights involve numerous risks, including:

• our limited experience in evaluating businesses and product opportunities and completing acquisitions;

• the use of any existing cash reserves or the need to obtain additional financing to pay for all or a portion of the purchase price of such acquisitions and to support the ongoing operations of the businesses acquired;

• the potential need to issue convertible debt, equity securities, stock options and stock purchase warrants to complete an acquisition, which would dilute our stockholders and could adversely affect the market price of our common stock;

• potential difficulties related to integrating the technology, products, personnel and operations of the acquired company;

• requirements of significant capital infusions in circumstances under which the acquired business, its products and/or technologies may not generate sufficient revenue or any revenue to offset acquisition costs or ongoing expenses;

• entering markets in which we have no or limited prior direct experience and where competitors have stronger market or intellectual property positions;

• disruptions to our ongoing business, diversion of resources, increases in our expenses and distraction of management’s attention from the normal daily operations of our business;

• the potential to negatively impact our results of operations because an acquisition may require us to incur large one-time charges to earnings, amortize or write down amounts related to goodwill and other intangible assets, or incur or assume substantial debt or liabilities, or cause adverse tax consequences, substantial depreciation or deferred compensation charges;

• an uncertain sales and earnings stream, or greater than expected liabilities and expenses, associated with the acquired company, product or product rights;

• failure to operate effectively and efficiently as a combined organization utilizing common information and communication systems, operating procedures, financial controls and human resources practices;

• potential loss of key employees of the acquired company; and

• disruptions to our relationships with existing collaborators who could be competitive with the acquired business.

There can be no assurance that transactions that we may pursue will ultimately prove successful. If we pursue an acquisition but are not successful in completing it, or if we complete an acquisition but are not successful in integrating the acquired company’s employees, products or operations successfully, our business, financial condition or results of operations could be harmed.

We face intense and increasing competition and must cope with rapid technological change, which may adversely affect our financial condition and/or our ability to successfully commercialize and/or market our products and product candidates.

Our competitors and potential competitors include large pharmaceutical and medical device companies and more established biotechnology companies. These companies have significantly greater financial and other resources and greater expertise than us in research and development, manufacturing, pre-clinical and clinical testing, obtaining regulatory approvals and marketing. This may make it easier for them to respond more quickly than us to new or changing opportunities, technologies or market needs. Our larger competitors may be able to devote greater resources to research and development, marketing, distribution and other activities that could provide them with a competitive advantage. Many of these competitors operate large, well-funded research and development programs and have significant products approved or in development. Small companies may also prove to be significant competitors, particularly through collaborative arrangements with large pharmaceutical companies or through acquisition or development of intellectual property rights. Our potential competitors also include academic institutions, governmental agencies and other public and private research organizations that conduct research, seek patent protection and establish collaborative arrangements for product and clinical development and marketing.

Our industry is characterized by extensive research and development, rapid technological change, frequent innovations and new product introductions, and evolving industry standards. Existing products and therapies to treat vascular and cardiovascular disease, including drugs and surgical procedures, as well as competitive approaches to wound healing and tissue repair, will compete directly or indirectly with the products that we are seeking to develop and market. In addition, our competitors may develop more effective or more affordable products, or achieve earlier patent protection or product commercialization and market penetration than us. As these competitors develop their technologies, they may develop proprietary positions that prevent us from successfully commercializing our future products. To be successful, we must be able to adapt to rapidly changing technologies by continually enhancing our products and introducing new products. If we are unable to adapt, products and technologies developed by our competitors may render our products and product candidates uneconomical or obsolete, and we may not be successful in marketing our products and product candidates against competitors. We may never be able to capture and maintain the market share necessary for growth and profitability and there is no guarantee we will be able to compete successfully against current or future competitors.

Changes and reforms in the health care system or reimbursement policies may adversely affect the sale of our products and future products or our ability to obtain an adequate level of reimbursement or acceptable prices for our products or future products.

Our ability to earn sufficient returns on our products and future products will depend in part on the extent to which reimbursement for our products and related treatments will be available from government health administration authorities, private health coverage insurers, managed care organizations and other third-party payers. If we fail to obtain appropriate reimbursement, it could prevent us from successfully commercializing and marketing our products and future products.

There have been and will continue to be efforts by governmental and third-party payers to contain or reduce the costs of health care through various means, including limiting coverage and the level of reimbursement. We expect that there will continue to be a number of legislative proposals to implement government controls and other reforms to limit coverage and reimbursement. Additionally, third-party payers, including Medicare, are increasingly challenging the price of medical products and services and are limiting the reimbursement levels offered to consumers for these medical products and services. If purchasers or users of our products or future products are not able to obtain adequate reimbursement from third-party payers for the cost of using the products, they may forego or reduce their use. Significant uncertainty exists as to the reimbursement status of newly approved health care products, including gene therapy and other therapeutic products and devices, and whether adequate third-party coverage will be available. The announcement or considerations of these proposals or reforms could impair our ability to raise capital and negatively affect our business.

If we are unable to attract and retain key personnel and advisors, it may adversely affect our ability to obtain financing, pursue collaborations or develop or market our products or product candidates.

Our future success depends on our ability to attract, retain and motivate highly qualified management and scientific and regulatory personnel and advisors. We currently rely on Christopher J. Reinhard, our Chairman of the Board, Chief Executive Officer, President and Treasurer, as our sole executive officer. The loss of Mr. Reinhards’ services would significantly disrupt our operations. We do not maintain any key man life insurance on our executive officers.

To pursue our business strategy, we will need to hire or otherwise engage qualified scientific personnel and managers, including personnel with expertise in clinical trials, government regulation, manufacturing, marketing and other areas. Competition for qualified personnel is intense among companies, academic institutions and other organizations. If we are unable to attract and retain key personnel and advisors, it may negatively affect our ability to successfully develop, test, commercialize and market our products and product candidates.

We will use hazardous and biological materials in our business. Any claims relating to improper handling, storage or disposal of these materials could be time consuming and costly.

Our products and processes involve the controlled storage, use and disposal of certain hazardous and biological materials and waste products. We and our suppliers and other collaborators are subject to federal, state and local regulations governing the use, manufacture, storage, handling and disposal of materials and waste products. Even if we and these suppliers and collaborators comply with the standards prescribed by law and regulation, the risk of accidental contamination or injury from hazardous materials cannot be completely eliminated. In the event of an accident, we could be held liable for any damages that result, and any liability could exceed the limits or fall outside the coverage of any insurance we may obtain and exceed our financial resources. We may not be able to maintain insurance on acceptable terms, or at all. We may incur significant costs to comply with current or future environmental laws and regulations.

To the extent that we enter markets outside the United States, our business will be subject to political, economic, legal and social risks in those markets, which could adversely affect our business.

There are significant regulatory and legal barriers in markets outside the United States that we must overcome to the extent we enter or attempt to enter markets in countries other than the United States. We will be subject to the burden of complying with a wide variety of national and local laws, including multiple and possibly overlapping and conflicting laws. We also may experience difficulties adapting to new cultures, business customs and legal systems. Any sales and operations outside the United States would be subject to political, economic and social uncertainties including, among others:

• changes and limits in import and export controls;

• increases in custom duties and tariffs;

• changes in currency exchange rates;

• economic and political instability;

• changes in government regulations and laws;

• absence in some jurisdictions of effective laws to protect our intellectual property rights; and

• currency transfer and other restrictions and regulations that may limit our ability to sell certain products or repatriate profits to the United States.

Any changes related to these and other factors could adversely affect any business operations that we conduct outside the United States.

Risks Related to Our Intellectual Property and Potential Litigation

If we do not obtain protection for our respective intellectual property rights, our competitors may be able to take advantage of our research and development efforts to develop competing products.

Our success, competitive position and future revenues depends in part on our ability to obtain and maintain patent protection for products, methods, processes and other technologies, to preserve trade secrets, to prevent third parties from infringing on their intellectual proprietary rights and to operate without infringing the proprietary rights of third parties.

The patent process is subject to numerous risks and uncertainties, and there can be no assurance that we will be successful in protecting our products by obtaining and defending patents. These risks and uncertainties include but are not limited to the following:

• Patents may not be granted from patent applications.

• Patents that have issued or will issue may be challenged, invalidated, or circumvented, or otherwise may not provide any competitive advantage.

• Countries other than the United States may have less restrictive patent laws than those upheld by United States courts, allowing foreign competitors the ability to exploit these laws to create, develop, and market competing products.

• Competitors, many of which have substantially greater resources than and many of which have made significant investments in competing technologies, may seek, or may already have obtained, patents that will limit, interfere with, or eliminate their ability to make, use, and sell our potential products either in the United States or in international markets.

• There may be significant pressure on the United States government and other international governmental bodies to limit the scope of patent protection both inside and outside the United States for treatments that prove successful as a matter of public policy regarding worldwide health concerns.

In addition, the U.S. Patent and Trademark Office and patent offices in other jurisdictions have often required that patent applications concerning pharmaceutical and/or biotechnology-related inventions be limited or narrowed substantially to cover only the specific innovations exemplified in the patent application, thereby limiting the scope of protection against competitive challenges. Thus, even if our subsidiaries are able to obtain patents, the patents may be substantially narrower than anticipated.

In addition to patents, we also rely on trade secrets and proprietary know-how. Although we take measures to protect this information by entering into confidentiality and inventions agreements with employees, scientific advisors, consultants, and collaborators, we cannot provide any assurances that these agreements will not be breached, that we will be able to protect ourselves from the harmful effects of disclosure if they are breached, or that trade secrets will not otherwise become known or be independently discovered by competitors. If any of these events occurs, we otherwise lose protection for their trade secrets or proprietary know-how, the value of this information may be greatly reduced.

Intellectual property and trade secrets protection are important to the success of our business and prospects, and there is a substantial risk that such protections will prove inadequate.

We may be subject to costly claims, and, if we are unsuccessful in resolving conflicts regarding patent rights, we may be prevented from developing, commercializing or marketing our products and/ or product candidates.

There has been, and will likely continue to be, substantial litigation regarding patent and other intellectual property rights in the biotechnology industry.

As more potentially competing patent applications are filed, and as more patents are actually issued, in the fields of gene therapy, biologics, collagen-based products, wound healing and tissue repair, adenoviral vectors or in other fields in which we may become involved and with respect to component methods or compositions that we may employ, the risk increases that we or our licensors may be subjected to litigation or other proceedings that claim damages or seek to stop our manufacturing, marketing, product development or commercialization efforts. Litigation may be necessary to enforce our or our licensors’ proprietary rights or to determine the enforceability, scope and validity of the proprietary rights of others. If we become involved in litigation, it could be costly and divert our efforts and resources. In addition, if any of our competitors file patent applications in the United States claiming

technology also invented by us or our licensors, we may need to participate in interference proceedings held by the U.S. Patent and Trademark Office to determine priority of invention and the right to a patent for the technology. Like litigation, interference proceedings can be lengthy and often result in substantial costs and diversion of resources.

If we are unsuccessful in defending against any adverse claims, we could be compelled to seek licenses from one or more third parties who could be direct or indirect competitors and who might not make licenses available on terms that we find commercially reasonable or at all. In addition, such proceedings, even if decided in our favor, involve lengthy processes, are subject to appeals, and typically result in substantial costs and diversion of resources.

Even if such patent applications or patents are ultimately proven to be invalid, unenforceable or non-infringed, such proceedings are generally expensive and time consuming and could consume a significant portion of our resources and substantially impair our marketing and product development efforts.

We may not have adequate protection for our unpatented proprietary information, which could adversely affect our competitive position.

We also rely on trade secrets, know-how, continuing technological innovations and licensing opportunities to develop and maintain our competitive position. However, others may independently develop substantially equivalent proprietary information and techniques or otherwise gain access to our trade secrets or disclose our technology. To protect our trade secrets, we may enter into confidentiality agreements with employees, consultants and potential collaborators. However, these agreements may not provide meaningful protection of our trade secrets or adequate remedies in the event of unauthorized use or disclosure of such information. Likewise, our trade secrets or know-how may become known through other means or be independently discovered by our competitors. Any of these events could prevent us from developing or commercializing our product candidates.

We face the risk of product liability claims, which could adversely affect our business and financial condition.

Our sales and marketing will expose us to product liability risks that are inherent in the testing, manufacturing and marketing of biotechnology and medical device products. Failure to obtain or maintain sufficient product liability insurance or otherwise protect against product liability claims could prevent or delay the commercialization or marketing of our products or product candidates or expose us to substantial liabilities and diversions of resources, all of which can negatively impact our business. Regardless of the merit or eventual outcome, product liability claims may result in withdrawal of product candidates from clinical trials, costs of litigation, damage to our reputation, substantial monetary awards to plaintiffs and decreased demand for products.

Product liability may result from harm to patients using our products, such as a complication that was either not communicated as a potential side effect or was more extreme than communicated. We will require all patients enrolled in our clinical trials to sign consents, which explain various risks involved with participating in the trial. However, patient consents provide only a limited level of protection, and it may be alleged that the consent did not address or did not adequately address a risk that the patient suffered from. Additionally, we will generally be required to indemnify the clinical product manufacturers, clinical trial centers, medical professionals and other parties conducting related activities in connection with losses they may incur through their involvement in the clinical trials. We may not be able to obtain or maintain product liability insurance on acceptable terms or with adequate coverage against potential liabilities.

Risks Related to Our Capital Structure

The conversion of our Series A Convertible Preferred Stock will result in substantial dilution to holders of our common stock.

On April 4, 2013, we agreed to issue 4,012 shares of our newly authorized Series A Convertible Preferred Stock (the “Preferred Stock”) to Sabby Healthcare Volatility Master Fund, Ltd. (“Sabby”) for $4.0 million in cash. The Preferred Stock is convertible into shares of our common stock. The Preferred Stock had an initial conversion price of $0.6437 per share. In addition, the conversion price is subject to downward adjustment if we issue common stock or common stock equivalents at a price less than the then effective conversion price. As long as the Preferred Stock is outstanding, we have also agreed not to incur specified indebtedness without the consent of the holders of the Preferred Stock. These factors may restrict our ability to raise capital through equity or debt offerings in the future.

On July 22, 2015, we entered into an Exchange and Redemption Agreement with Sabby pursuant to which we agreed to reduce the conversion price on the Preferred Stock to $0.30 per share. The Exchange and Redemption Agreement granted us a right to redeem any or all of the outstanding Preferred Stock for its Stated Value (approximately $1,000 per share) at any time during a 120 day period after the date of the agreement, and permanently increased the limitation on indebtedness contained in the Certificate of Designation for the Preferred Stock to allow us to borrow up to $250,000. As a result of the effective conversion price changing from $0.64 to $0.30 per share, the 1,176 shares of Preferred Stock outstanding at July 22, 2015 became convertible into 3,918,667 shares of our common stock, an additional 2,092,350 compared to before the conversion price change.

On September 23, 2016, we entered into a second Exchange and Redemption Agreement with Sabby covering the 1,000 shares of Preferred Stock outstanding at that time. Under the terms of the Exchange and Redemption Agreement, we agreed to reduce the conversion price to $0.18 per share. The Exchange and Redemption Agreement granted us a right to redeem any or all of the outstanding Preferred Stock for its Stated Value (approximately $1,000 per share) at any time until November 29, 2016. We entered into the agreement to increase our options for retiring the outstanding Preferred Stock and financing our continued business operations. As a result of the conversion price changing from $0.30 to $0.18 per share, the 1,000 shares of Series A Convertible Preferred Stock outstanding became convertible to 5,554,667 shares of our common stock, an additional 2,221,867 compared to before the conversion price change. At March 31, 2017, there were 829 shares of Preferred Stock outstanding. A hypothetical conversion of all of the outstanding Preferred Stock as of March 31, 2017 into 4,604,674 shares of common stock would increase the common stock outstanding from 14,273,544 shares as of March 31, 2017, to 18,878,218, an increase of 32.3%.

As a result of such holder entering into the Agreement, for which the fair value of preferred stock before and after the modification was a substantially different, the modification was accounted for as an extinguishment. Consequently, we recorded a deemed dividend totaling $782,879 in the statement of operations in arriving at net loss to common shareholders.

Our outstanding warrants (stock options and warrants to employees and directors) have anti-dilution protection and, if exercised, will significantly dilute the ownership interest of existing stockholders.

At March 31, 2017, we had an aggregate of 12,116,334 stock options and warrants outstanding at exercise prices ranging from $0.19 to $55.00. The exercise of some or all of our outstanding warrants would significantly dilute the ownership interests of existing stockholders. Any sales in the public market of the common stock issuable upon such exercise could adversely affect prevailing market prices of our common stock.

Our outstanding warrants have anti-dilution protection. On September 23, 2016, we entered into a second Exchange and Redemption Agreement with Sabby covering the 1,000 shares of Preferred Stock outstanding at the time. Under the terms of the Exchange and Redemption Agreement, Taxus Cardium agreed to reduce the conversion price at which Sabby can convert shares of Preferred Stock to common shares from $0.30 to an effective price of $0.18 per share. As a result of this reduction of the conversion price of the preferred stock, the Company was also required to issue an additional 4,823,736 of warrants, to such warrant holders (current and former employees), in accordance with the original terms of their agreements. The fair value of these issuances was recorded as compensation expense.

Additional sales of Taxus Cardium equity securities or derivative securities will result in additional shares of common stock being issuable under the outstanding warrants.

The price of our common stock is expected to be volatile and an investment in our common stock could decline substantially in value.

In light of our small size, limited resources, and dependence on relatively few products or product candidates, our stock price is expected to be highly volatile and can be subject to substantial drops, with or even in the absence of news affecting our business. The following factors, in addition to the other risk factors described in this report, may have a significant impact on the market price of our common stock, some of which are beyond our control:

• changes in the economic performance and/or market valuations of other biotechnology and medical device companies;

• changes in economic conditions in the United States and worldwide;

• anticipated or unanticipated changes in financial condition, operating results or the perceived value of our business;

• anticipated or unanticipated changes that affect our ability to list our common stock on a national exchange;

• developments concerning any research and development, clinical trials, manufacturing, and marketing efforts or collaborations;

• our announcement of significant acquisitions, strategic collaborations, joint ventures or capital commitments;

• announcements of technological innovations;

• new products that we or our competitors offer;

• the initiation, conduct and/or outcome of intellectual property and/or litigation matters;

• changes in financial or other estimates by securities analysts or other reviewers or evaluators of our business;

• regulatory developments in the United States and other countries;

• additions or departures of key personnel;

• sales or other transactions involving our common stock; and

• global unrest, terrorist activities, and economic and other external factors.

The market prices of securities of smaller biotechnology and medical device companies have experienced dramatic fluctuations that often have been unrelated or disproportionate to the operating results of these companies. Continued market fluctuations could result in extreme volatility in the price of the common stock, which could cause a decline in the value of the common stock. Price volatility may be increased if the trading volume of our common stock remains limited or declines.

Our company could be difficult to acquire due to anti-takeover provisions in our charter, our stockholder rights plan and Delaware law.

Our bylaws provide for a staggered board of directors and for advance shareholder notice for actions to be taken at meetings of stockholders. In addition, our board of directors has adopted a stockholder rights plan in which preferred stock purchase rights were distributed as a dividend. These provisions may make it more difficult for stockholders to take corporate actions and may have the effect of delaying or preventing a change in control. These provisions also could deter or prevent transactions that stockholders deem to be in their interests.

In addition, we are subject to the anti- takeover provisions of Section 203 of the Delaware General Corporation Law. Subject to specified exceptions, this section provides that a corporation may not engage in any business combination with any interested stockholder during the three-year period following the time that such stockholder becomes an interested stockholder. This provision could have the effect of delaying or preventing a change of control of our company. The foregoing factors could reduce the price that investors or an acquirer might be willing to pay in the future for shares of our common stock.

We have never paid cash dividends on our capital stock and we do not anticipate paying dividends in the foreseeable future.

We have never paid cash dividends on any of our classes of capital stock to date, and we currently intend to retain our future earnings, if any, to fund the development and growth of our business. Our outstanding Preferred Stock prohibits us from paying any dividends without the consent of the holders of the preferred stock. In addition any future debt or credit facility we obtain also may preclude or limit our ability to pay any dividends. As a result, capital appreciation, if any, of our common stock will be your sole source of potential gain for the foreseeable future.

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

None.

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

None.

ITEM 4. MINE SAFETY DISCLOSURES

Not applicable.

ITEM 5. OTHER INFORMATION

None.

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ITEM 6. EXHIBITS

The following exhibit index shows those exhibits filed with this report and those incorporated by reference:

EXHIBIT INDEX

ExhibitNumber	Description	Incorporated By Reference To
Exhibit Number	Description	Incorporated By Reference To
4.1	Form of Warrant Agreement issued to directors and officers in February 2014.	Exhibit 4.1 of our Form 10-Q, filed with the Commission on May 15, 2014.
3.4	Certificate of Designation for Series B Convertible Preferred Stock	Exhibit 3.1 of our Current Report on Form 8-K, filed with the SEC on May 28, 2020.
4.2	Certificate of Designation of Series A Convertible Preferred Stock of Angionetics Inc.	Exhibit 99.1 of our Current Report on Form 8-K filed with the Commission on July 11, 2016.
10.1	Asset Purchase Agreement dated July 15, 2018 between Activation Therapeutics, Inc. and Olaregen Therapeutix, Inc. for the sale of Excellagen.	Exhibit 10.5 of our Form 10-K, filed with the SEC on April 23, 2021
10.1	Securities Purchase Agreement dated February 21, 2014 between the registrant and Shanxi Taxus Pharmaceuticals Co., Ltd.	Exhibit 10.2 of our Current Report on Form 8-K filed with the Commission on March 4, 2014.
10.2	Reaffirmation and Ratification Agreement dated April 10, 2020 between the registrant and Shanxi Taxus Pharmaceuticals Co. Ltd.	Exhibit 10.2 of our Current Report on Form 8-K filed with the SEC on May 28, 2020
10.2	Exchange Redemption Agreement dated July 22, 2015 between the registrant and Sabby Healthcare Volatility Master Fund, Ltd.	Exhibit 10.1 of our Current Report on Form 8-K filed with the Commission on July 23, 2015.
10.3	Distribution and License Agreement Dated April 10, 2020 between Angionetics, Inc. and Shanxi Taxus Pharmaceuticals Co., Ltd.	Exhibit 10.3 of our Current Report on Form 8-K filed with the SEC on May 28, 2020
10.3	Contribution Agreement dated June 6, 2016 between the registrant and Angionetics Inc.	Exhibit 10.2 of our Current Report on Form 8-K filed with the Commission on July 11, 2016.
10.4	Amendment No. 1 to Distribution and License Agreement dated April 14, 2020 between Angionetics, Inc. and Shanxi Taxus Pharmaceuticals Co., Ltd.	Exhibit 10.4 of our Current Report on Form 8-K filed with the SEC on May 28, 2020
10.4	Services Agreement dated June 6, 2016 between the registrant and Angionetics Inc.	Exhibit 10.3 of our Current Report on Form 8-K filed with the Commission on July 11, 2016.
10.5	License and Patent Assignment Agreement dated April 10, 2020 between Activation Therapeutics, Inc. and Shanxi Taxus Pharmaceuticals Co., Ltd.	Exhibit 10.5 of our Current Report on Form 8-K filed with the SEC on May 28, 2020
10.5	Share Purchase Agreement dated June 7, 2016 among the registrant , Angionetics Inc. and Pineworld Capital Limited	Exhibit 10.1 of our Current Report on Form 8-K filed with the Commission on July 11, 2016.
10.6	Preferred Stock Purchase Agreement dated May 22, 2020 between the registrant and Nostrum Pharmaceuticals LLC for the purchase of Series B Convertible Preferred Stock.	Exhibit 10.1 of our Current Report on Form 8-K filed with the SEC on May 28, 2020
10.6	Distribution and License Agreement dated June 7, 2016 between Angionetics Inc. and Pineworld Capital Limited	Exhibit 10.1 of our Current Report on Form 8-K filed with the Commission on July 11, 2016.
31.1	Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002	Filed herewith
10.7	Exchange Redemption Agreement dated September 23, 2016 between the registrant and Sabby Healthcare Volatility Master Fund, Ltd.	Exhibit 10.1 of our Current Report on Form 8-K filed with the Commission on September 23, 2016.
31.2	Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002	Filed herewith
31.1	Rule 13a-14(a)/15d-14(a) Certification of Chief Executive Officer	Filed herewith.
32	Section 1350 Certification of Chief Executive Officer and Chief Financial Officer	Filed herewith
31.2	Rule 13a-14(a)/15d-14(a) Certification of Chief Financial Officer	Filed herewith.
101	Inline XBRL document Set for the financial statements and accompanying notes in Part I, Item 1 “Financial Statements” of this Quarterly Report on Form 10-Q.	Filed herewith
32	Section 1350 Certification	Filed herewith.
101	The following financial statements and footnotes from the Taxus Cardium Pharmaceuticals Group, Inc. Quarterly Report on Form 10-Q for the quarter ended March 31, 2017 formatted in eXtensible Business Reporting Language (XBRL): (i) Condensed Consolidated Balance Sheets; (ii) Condensed Consolidated Statements of Operations; (iii) Condensed Consolidated Statements of Cash Flows; and (iv) the Notes to Condensed Consolidated Financial Statements.	Filed herewith.

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SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, ~~Taxus~~Gene ~~Cardium Pharmaceuticals Group~~Biotherapeutics, Inc., the registrant, has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

Date: July 28, 2017
Date: September 3, 2021
		TAXUS CARDIUM PHARMACEUTICALS GROUP, INC.
	GENE BIOTHERAPEUTICS, INC.
	By:	~~By:~~/s/ CHRISTOPHER J. REINHARD	~~/s/ CHRISTOPHER J. REINHARD~~
		Christopher J. Reinhard,	~~Christopher J. Reinhard,~~
			Chief Executive Officer (Principal Executive and Accounting Officer)
		Chief Executive Officer (Principal Executive Officer)
	By:	/s/ JAMES L. GRAINER
		James L. Grainer,
		Chief Financial Officer (Principal Accounting Officer)

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