UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-K

☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended December 31, ~~2023~~2024

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

Commission File No. 0-22179

GUIDED THERAPEUTICS, INC.

(Exact Name of Registrant as Specified in Its Charter)

Delaware		58-2029543
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

5835 Peachtree Corners East, Suite B

Peachtree Corners, Georgia 30092

(Address of principal executive offices, including zip code)

Registrant’s telephone number, including area code: (770) 242-8723

Securities registered pursuant to Section 12(b) of the Act: None

Securities registered pursuant to Section 12(g) of the Act: Common Stock, $0.001 Par Value

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

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

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 ☐

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

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

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

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

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

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

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

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

The aggregate market value of the voting and non-voting common equity held by non-affiliates computed by reference to the price at which the common equity was last sold on June 30, ~~2023~~2024 (the last business day of the registrant’s most recently completed second fiscal quarter), was: $113,~~477~~717,~~380~~645.

As of March 2818, ~~2024~~2025, the registrant had 5577,~~613~~967,~~449~~594 shares of Common Stock, $0.001 par value per share, outstanding.

GUIDED THERAPEUTICS, INC.
ANNUAL REPORT ON FORM 10-K
TABLE OF CONTENTS
		Page
Part I		4
	Item 1. Business	4
	Item 1A. Risk Factors	12
	Item 1B. Unresolved Staff Comments	24
	Item 1C. Cybersecurity	24
	Item 2. Properties	24
	Item 3. Legal Proceedings	24
	Item 4. Mine Safety Disclosures	24
PART II		25
	Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	25
	Item 6. Reserved	26
	Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations	26
	Item 7A. Quantitative and Qualitative Disclosures About Market Risk	31
	Item 8. Financial Statements and Supplementary Data	32
	Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure	74
	Item 9A. Controls and Procedures	74
	Item 9B. Other Information	75
	Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections	75
PART III		76
	Item 10. Directors, Executive Officers and Corporate Governance	76
	Item 11. Executive Compensation	78
	Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	80
	Item 13. Certain relationships and related transactions and director independence	81
	Item 14. Principal Accountant Fees and Services	85
PART IV		86
	Item 15. Exhibits and Financial Statement Schedules	86
	Item 16. Form 10-K Summary
SIGNATURES		91

GUIDED THERAPEUTICS, INC.

ANNUAL REPORT ON FORM 10-K

TABLE OF CONTENTS

PART I
	Item 1. Business	4
	Item 1A. Risk Factors	12
	Item 1B. Unresolved Staff Comments	24
	Item 1C. Cybersecurity	24
	Item 2. Properties	24
	Item 3. Legal Proceedings	24
	Item 4. Mine Safety Disclosures	24
PART II
	Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	25
	Item 6. Reserved	26
	Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations	26
	Item 7A. Quantitative and Qualitative Disclosures About Market Risk	31
	Item 8. Financial Statements and Supplementary Data	32
	Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure	33
	Item 9A. Controls and Procedures	33
	Item 9B. Other Information	33
	Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections	33
PART III
	Item 10. Directors, Executive Officers and Corporate Governance	34
	Item 11. Executive Compensation	36
	Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	37
	Item 13. Certain relationships and related transactions and director independence	39
	Item 14. Principal Accountant Fees and Services	42
PART IV
	Item 15. Exhibits and Financial Statement Schedules	43
	Item 16. Form 10-K Summary	47
SIGNATURES		48

Table of Contents

When we use the terms “Guided,” “Guided Therapeutics, “we,” “us,” or “our,” we are referring to Guided Therapeutics, Inc. and its subsidiaries, unless the context otherwise requires.

Cautionary Statement Regarding Forward-Looking Statements

This Annual Report on Form 10-K includes certain statements that are not historical facts that may be deemed to be “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and the United States Private Securities Litigation Reform Act of 1995~~, and “forward-looking information” within the meaning of applicable Canadian securities legislation~~. We use words such as “anticipate,” “continue,” “likely,” “estimate,” “expect,” “may,” “will,” “projection,” “should,” “believe,” “potential,” “could,” or similar words suggesting future outcomes (including negative and grammatical variations) to identify forward-looking statements. These statements include statements regarding the following, among other things:

	·	access to sufficient debt or equity capital to meet our operating and financial needs;

	·	the extent of dilution of the holdings of our existing stockholders upon the issuance, conversion or exercise of securities issued as part of our capital raising efforts;

	·	the extent to which certain debt holders may call the notes to be paid;

	·	the effectiveness and ultimate market acceptance of our products and our ability to generate sufficient sales revenues to sustain our growth and strategy plans;

	·	whether our products in development will prove safe, feasible and effective;

	·	whether and when we or any potential strategic partners will obtain required regulatory approvals in the markets in which we plan to operate;

	·	our need to achieve manufacturing scale-up in a timely manner, and our need to provide for the efficient manufacturing of sufficient quantities of our products;

	·	the lack of immediate alternate sources of supply for some critical components of our products;

	·	our ability to establish and protect the proprietary information on which we base our products, including our patent and intellectual property position;

	·	the impact of the conflict between Russia and Ukraine on economic conditions in general and on our business and operations;

	·	the need to fully develop the marketing, distribution, customer service and technical support and other functions critical to the success of our product lines;

	·	the dependence on potential strategic partners or outside investors for funding, development assistance, clinical trials, distribution and marketing of some of our products; and

	·	other risks and uncertainties described from time to time in our reports filed with the SEC.

These forward-looking statements reflect our management’s beliefs and views with respect to future events and are based on estimates and assumptions as of the date of this filing and are subject to risks and uncertainties. We discuss many of these risks in greater detail under “Risk Factors.” Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward-looking statements.

Forward-looking statements speak only as of the date the statements are made. We assume no obligation to update forward-looking statements to reflect actual results, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If we update one or more forward-looking statements, no inference should be drawn that we will make additional updates with respect thereto or with respect to other forward-looking statements.

Table of Contents

PART I

Item 1. Business

Overview

We are a medical technology company focused on developing innovative medical devices that have the potential to improve healthcare. Our primary focus is the sales and marketing of our LuViva® Advanced Cervical Scan non-invasive cervical cancer detection device. The underlying technology of LuViva primarily relates to the use of biophotonics for the non-invasive detection of cancers. LuViva is designed to identify cervical cancers and precancers painlessly, non-invasively and at the point of care by scanning the cervix with light, then analyzing the reflected and fluorescent light.

LuViva is designed to provide a less invasive and painless alternative to conventional tests for cervical cancer screening and detection. Additionally, LuViva is designed to improve patient well-being not only because it eliminates pain, but also because it is convenient to use and provides rapid results at the point of care. We focus on two primary applications for LuViva: first, as a cancer screening tool in the developing world, where infrastructure to support traditional cancer-screening methods is limited or non-existent, and second, as a triage following traditional screening in the developed world, where a high number of false positive results cause a high rate of unnecessary and ultimately costly follow-up tests.

Screening for cervical cancer represents one of the most significant demands on the practice of diagnostic medicine. As cervical cancer is linked to a sexually transmitted disease—the human papillomavirus (HPV)—every woman essentially becomes “at risk” for cervical cancer simply after becoming sexually active. In the developing world, there are approximately 2.0 billion women aged 15 and older who are potentially eligible for screening with LuViva. Guidelines for screening intervals vary across the world, but U.S. guidelines call for screening every three years. Traditionally, the Pap smear screening test, or Pap test, is the primary cervical cancer screening methodology in the developed world. However, in developing countries, cancer screening using Pap tests is expensive and requires infrastructure and skill not currently existing, and not likely to be developed in the near future, in these countries.

We believe LuViva is the answer to the developing world’s cervical cancer screening needs. Screening for cervical cancer in the developing world often requires working directly with foreign governments or non-governmental agencies (NGOs). By partnering with governments or NGOs, we can provide immediate access to cervical cancer detection to large segments of a nation’s population as part of national or regional governmental healthcare programs, eliminating the need to develop expensive and resource-intensive infrastructures.

In the developed world, we believe LuViva offers a more accurate and ultimately cost-effective triage medical device, to be used once a traditional Pap test or HPV test indicates the possibility of cervical cancer. Due to the high number of false positive results from Pap tests, traditional follow-on tests entail increased medical treatment costs. We believe these costs can be minimized by utilizing LuViva as a triage to determine whether and to what degree follow-on tests are warranted.

We believe our non-invasive cervical cancer detection technology can be applied to the early detection of other cancers as well. For example, we have developed prototypes and conducted limited clinical studies using our biophotonic technology for the detection of esophageal cancer. We believe that skin cancer detection is also a promising target for our biophotonic technology, but currently we are focused primarily on the large-scale commercialization of LuViva.

Corporate History

We are a Delaware corporation, originally incorporated in 1992 under the name “SpectRx, Inc.” On February 22, 2008, we changed our name to Guided Therapeutics, Inc. At the same time, we renamed our wholly-owned subsidiary, InterScan, which originally had been incorporated as “Guided Therapeutics, Inc.”

Our principal executive and operations facility is located at 5835 Peachtree Corners East, Suite B, Peachtree Corners, Georgia 30092, and our telephone number is (770) 242-8723.

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Our Potential Market

The Developing World

According to the most recent data published by the World Health Organization (WHO), cervical cancer is the fourth most frequent cancer in women worldwide, with an estimated ~~604~~660,000 new cases in ~~2020~~2022, an increase of 3456,000 cases from ~~2018~~2020. For women living in less developed regions, however, cervical cancer is the second most common cancer, and 9 out of 10 women who die from cervical cancer reside in low- and middle-income countries. In 2022, GLOBOCAN, the international cancer tracking agency, estimated that approximately ~~342~~349,000 women died from cervical cancer, with ~~89%~~the majority of these deaths occurring in low- and middle-income countries.

As noted by the WHO, in developed countries, programs are in place that enable women to get screened, making most pre-cancerous lesions identifiable at stages when they can easily be treated. Early treatment prevents up to 80% of cervical cancers in these countries. In developing countries, however, limited access to effective screening means that the disease is often not identified until it is further advanced and symptoms develop. In addition, prospects for treatment of such late-stage disease may be poor, resulting in a higher rate of death from cervical cancer in these countries.

We believe that the greatest need and market opportunity for LuViva lies in screening for cervical cancer in developing countries where the infrastructure for traditional screening may be limited or non-existent.

In addition to private care markets, we are actively working with distributors in the following countries to implement government-sponsored screening programs: Turkey, Indonesia and several countries in Central and Eastern Europe. The number of screening candidates in those countries is approximately 155 million.

The Developed World

The Pap test, which involves a sample of cervical tissue being placed on a slide and observed in a laboratory, is currently the most common form of cervical cancer screening. Since the introduction of screening and diagnostic methods, the number of cervical cancer deaths in the developed world has declined dramatically, due mainly to the increased use of the Pap test. However, the Pap test has a wide variation in sensitivity, which is the ability to detect the disease, and specificity, which is the ability to exclude false positives. Currently, about 50 million Pap tests are given annually in the United States and, combined with a pelvic exam as the standard of care, have an average price in the range of approximately $~~150~~125 - $~~310~~375 per exam.

After a Pap test returns a positive result for cervical cancer, accepted protocol calls for a visual examination of the cervix using a colposcope, usually followed by a biopsy, or tissue sampling, at one or more locations on the cervix. This method looks for visual changes attributable to cancer. There are about two million colposcope examinations annually in the United States and Europe. According to ~~industry reports by~~ MD Save ~~and Costhelper Health~~, a leading online medical service ~~providers~~provider, the average cost of a colposcopy examination with biopsy in the United States is currently $13,300 ~~or more, if performed in a hospital~~.

In 2019 and 2020, the American Society for Colposcopy and Cervical Pathology published new cervical cancer management guidelines based on patient risk profiles and test results. The guidelines resulted in a complex algorithm that indicates whether woman has at least a 4% chance of developing a precancerous or cancerous condition of the cervix within a 2-year period. If so, she is referred to colposcopy and biopsy. This more conservative management approach may result in more women being referred to colposcopy and biopsy.

Given this landscape, we believe that there is a material need and market opportunity for LuViva as a triage device in the developed world where LuViva represents a more cost-effective method of verifying a positive Pap test than the alternatives.

Table of Contents

The LuViva Advanced Cervical Scan

LuViva is designed to identify cervical cancers and precancers painlessly, non-invasively and at the point of care by scanning the cervix with light, then analyzing the light reflected from the cervix. The information presented by the light would be used to indicate the likelihood of cervical cancer or precancers. Our product, in addition to detecting the structural changes attributed to cervical cancer, is also designed to detect the biochemical changes that precede the development of visual lesions. In this way, cervical cancer may be detected earlier in its development, which should increase the chances of effective treatment. In addition to the device itself, operation of LuViva requires employment of our single-use, disposable calibration and alignment cervical guide.

To date, thousands of women in multiple international clinical settings have been tested with LuViva. As a result, more than 25 papers and presentations have been published regarding LuViva in a clinical setting, including at the International Federation of Gynecology and Obstetrics Congress in London in 2015 and at the Indonesian National Obstetrics and Gynecology (POGI) Meeting in Solo in 2016.

Internationally, we contract with country-specific or regional distributors. We believe that the international market will be significantly larger than the U.S. market due to the international demand for cervical cancer screening. We have executed formal distribution agreements covering over 40 countries, some of which have expired. We still have active contracts in place for countries including China and Southeast Asia (including Indonesia), Central & Eastern Europe and Russia. In addition to the US, China and Eastern/Central Europe we intend to focus on other markets where we have or previously had regulatory approvals, such as those in the European Union, India and certain Persian Gulf countries, such as Saudi Arabia. The ongoing conflict in Ukraine may delay filing and approval to market in Russia.

We have previously obtained regulatory approval to sell LuViva in Europe under our Edition 3 CE Mark. Additionally, LuViva has also previously obtained marketing approval from Health Canada, COFEPRIS in Mexico, Ministry of Health in Kenya, which have all expired. In addition, in 2018, we were approved for sales and marketing in India. We currently are seeking regulatory approval to market LuViva in the United States but have not yet received approval from the U.S. Food and Drug Administration (FDA). As of December 31, ~~2023~~2024, we have sold 148 LuViva devices and approximately 78,~~400~~950 single-use-disposable cervical guides to international distributors. In order to effect these sales, we have a sales team of three people and work through country and region specific medical device distributors.

Our Strengths

Currently, we are the only commercial stage company with a biophotonic technology that potentially addresses a large primary screening market and a potential R&D pipeline that could improve the early detection of numerous cancers that afflict men and women. Key strengths include:

· The engineering and production risks have been largely addressed as we have sold 148 working systems worldwide. · Regulatory approvals have been granted covering over 40 countries~~, with most of these covered by our CE Mark~~. · We have legitimate pathways for securing marketing approvals in the two largest medical markets – the US and China, within a 1-2 year period. · The clinical results of our technology have been published in leading peer-reviewed journals by world famous, thought leading physicians.

Our Business Strategy

Our near-term goals are to accomplish the following over the next two years by pursuing the following strategies:

· Seek US FDA approval by completing a clinical trial. · Contingent upon FDA approval, discuss opportunities to partner with a larger U.S. based company for distribution in the U.S. At the same time, we intend to build a small, dedicated sales force based near major metropolitan centers and focused on generating sales at large centralized Ob-Gyn practices. · Seek Chinese FDA approval working with our existing partner in China, Shandong Medical Instrumentation Co. Ltd. · Pursue regulatory approval in Russia and work with our partner in Central and Eastern Europe, Newmars Technology, Inc. to generate sales in central and eastern Europe. · Continue to selectively support sales through our distributors in large countries such as Indonesia.

While we plan to pursue regulatory approval in Russia, the ongoing conflict in Ukraine may delay filing and approval to market. It does not affect any existing contracts with our distribution partner for Eastern Europe and Russia as they are focused more on countries less affected by the conflict in Ukraine.

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Manufacturing, Sales and Distribution

We manufacture the key subsystems of LuViva at our Georgia facility and final manufacturing is done at our contract manufacturing site in Hungary by NTI. Many of the specialized parts of LuViva are custom made for us by third-party manufacturers. We adhere to ISO 13485:2003 quality standards in our manufacturing processes. Our single-use cervical guides are manufactured by a vendor that specializes in injection molding of plastic medical products. On January 22, 2017, we entered into a license agreement with Shandong Yaohua Medical Instrument Corporation (“SMI”), as amended on March 28, 2017, pursuant to which we granted SMI an exclusive global license to manufacture the LuViva device and related disposables (subject to a carve-out for manufacturing in Turkey). On December 18, 2018, we entered into a co-development agreement with Newmars Technologies, Inc. (“NTI”), whereby NTI will perform final assembly of the LuViva device for its contracted distribution countries in Eastern Europe and Russia at its ISO 13485 facility in Hungary. This additional carve out has been agreed to by SMI. The Company has entered into several additional amendments with SMI, the latest of which was executed on ~~March~~October 2721, 2024.

We rely on distributors to sell our products. Distributors can be country exclusive or cover multiple countries in a region. We manage these distributors, provide them marketing materials and train them to demonstrate and operate LuViva. We seek distributors that have experience in gynecology and in introducing new technology into their assigned territories. Currently, we rely on SMI in distributing our products in the People’s Republic of China, Macau, Hong Kong and Taiwan; we rely on NTI in distributing our products in Eastern Europe and Russia.

~~During the year ended December 31, 2023, we sold 5 instrumentation packages and various parts and raw materials, resulting in $107 thousand of gross revenue before returns and allowances.~~ We have only limited experience in the production planning, quality system management, facility development, and production scaling that will be needed to bring production to increased sustained commercial levels. We will likely need to develop additional expertise to successfully manufacture, market, and distribute future products or applications of our technology for other cancers.

Research, Development and Engineering

We have been engaged primarily in the research, development and testing of our LuViva non-invasive cervical cancer detection product and our core biophotonic technology. Since 2013, we have incurred approximately $8.49 million in research and development expenses, net of about $927,000 reimbursed through collaborative arrangements and government grants. Research and development costs were approximately $0.25 and $0.12 million in the years ended December 31, ~~2023~~2024 and ~~2022~~2023, respectively.

Since 2013, we have focused our research and development and our engineering resources almost exclusively on development of our biophotonic technology, with only limited support of other programs funded through government contracts or third-party funding. Because our research and clinical development programs for other cancers are at a very early stage, substantial additional research and development and clinical trials will be necessary before we can produce commercial prototypes of other cancer detection products.

Several of the components used in LuViva currently are available from only one supplier, and substitutes for these components could not be obtained easily or would require substantial modifications to our products.

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Patents

We have pursued a course of developing and acquiring patents and patent rights and licensing technology. Our success depends in large part on our ability to establish and maintain the proprietary nature of our technology through the patent process and to license from other’s patents and patent applications necessary to develop our products. As of December 31, ~~2023~~2024, we have 41six ~~granted~~active ~~U.S. and foreign~~ patents~~, collectively, relating to our biophotonic cancer detection technology that were developed in-house and are owned by the Company~~. ~~Seven (7) patents are still currently active and 34 have since expired.~~ Currently, we do not own third party patents, nor do we make any outside payments for patents.

Patents can be extended up to an additional five (5) years. However, patent term extension under the Hatch-Waxman Act does not occur automatically and the patent owner must file an application with the USPTO requesting term extension within 60 days of obtaining FDA marketing approval.\

Patent No.	Title	Country	Grant Date	Expiration Date
7,174,927	Vacuum Source For Harvesting Substances	US	2/13/07	9/3/24
8,644,912	System and Method For Determining Tissue Characteristics	US	2/4/2014	8/22/2031
8,644,912	Method and Apparatus For Determining Tissue Characteristics	US	2/4/14	8/22/31
8,781,560	Method and Apparatus For Rapid Detection and Diagnosis of Tissue Abnormalities	US	7/15/2014	7/14/2031
8,781,560	Method and Apparatus For Rapid Detection and Diagnosis of Tissue Abnormalities	US	7/15/14	7/14/31
9,561,003	Method and Apparatus For Rapid Detection and Diagnosis of Tissue Abnormalities	US	2/7/2017	3/5/2034
9,561,003	Method and Apparatus For Rapid Detection and Diagnosis of Tissue Abnormalities	US	2/7/17	3/5/34
D714453	Hand Held Unit for Diagnostics or Measurement	US	9/30/2014	9/30/2028
D714453	Mobile Cart and Hand Held Unit for Diagnostics of Measurement	US	9/30/14	9/30/28
D724199	Medical Diagnostic Stand Off Tube	US	3/10/2015	3/10/2029
D724199	Medical Diagnostic Stand Off Tube	US	3/10/15	3/10/29
D746475	Mobile Cart and Hand Held Unit for Diagnostics or Measurement	US	12/29/2015	12/29/2029
D746475	Mobile Cart and Hand Held Unit for Diagnostics or Measurement	US	12/29/15	12/29/29

The Company has applied for ~~two~~one additional US ~~patents~~patent, although there is no assurance that ~~these~~the ~~patents~~patent will be granted. The Company’s strategy is to continue improving its products and filing new patents to protect those improvements.

In the United States, additional years of patent protection may be added (on a case-by-case basis) beyond the standard patent terms under the 1984 Drug Price Competition and Patent Term Restoration Act, also known as the Hatch-Waxman Act. The Hatch-Waxman act includes Section 156, which provides for the extension of the term of a granted patent (PTE) under certain circumstances. The intent behind Section 156 is to extend patent life to compensate patent holders for patent term lost while developing their product and awaiting FDA approval. The Company’s patents qualify under Section 156 because LuViva has not yet been commercialized in the United States and it is being regulated by FDA as a Class III Medical Device.

Employees and Consultants

As of December 31, ~~2023~~2024, we had four regular employees and ~~two~~three consultants to provide services to us on a full- or part-time basis. No employees are covered by collective bargaining agreements, and we believe we maintain good relations with our employees.

Our ability to operate successfully and manage our potential future growth depends in significant part upon the continued service of key scientific, technical, managerial and finance personnel, and our ability to attract and retain additional highly qualified personnel in these fields. In addition, if we are able to successfully develop and commercialize our products, we likely will need to hire additional scientific, technical, marketing, managerial and finance personnel. We face intense competition for qualified personnel in these areas, many of whom are often subject to competing employment offers. The loss of key personnel or our inability to hire and retain additional qualified personnel in the future could have a material adverse effect on our business, financial condition and results of operations.

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Competition

The medical device industry in general and the markets for cervical cancer detection in particular, are intensely competitive. If successful in our product development, we will compete with other providers of cervical cancer detection and prevention products.

Current cervical cancer screening and diagnostic tests, primarily the Pap test, HPV test, and colposcopy, are well established and pervasive. Improvements and new technologies for cervical cancer detection and prevention, such as Thin-Prep from Hologic and HPV testing from Qiagen, have led to other new competitors. In addition, there are other companies attempting to develop products using forms of biophotonic technologies in cervical cancer detection, such as Spectrascience, which has a very limited U.S. FDA approval to market its device for detection of cervical cancers but has not yet entered the market. The approval limits use of the Spectrascience device only after a colposcopy, as an adjunct. In addition to the Spectrascience device, there are other technologies that are seeking to enter the market as adjuncts to colposcopy, including devices from Dysis and Zedco. While these technologies are not direct competitors to LuViva, modifications to them or other new technologies will require us to develop devices that are more accurate, easier to use or less costly to administer so that our products have a competitive advantage.

In April 2014, the U.S. FDA approved the use of the Roche cobas HPV test as a primary screener for cervical cancer. Using a sample of cervical cells, the cobas HPV test detects DNA from 14 high-risk HPV types. The test specifically identifies HPV 16 and HPV 18, while concurrently detecting 12 other types of high-risk HPVs. This could make HPV testing a competitor to the Pap test. However, due to its lower specificity, we believe that screening with HPV will increase the number of false positive results if widely adopted.

In June 2006, the U.S. FDA approved the HPV vaccine Gardasil from drug maker Merck. Gardasil is a prophylactic HPV vaccine, meaning that it is designed to prevent the initial establishment of HPV infections. For maximum efficacy, it is recommended that girls receive the vaccine prior to becoming sexually active. Since Gardasil will not block infection with all of the HPV types that can cause cervical cancer, the vaccine should not be considered a substitute for routine Pap tests. On October 16, 2009, GlaxoSmithKline PLC was granted approval in the United States for a similar preventive HPV vaccine, known as Cervarix. Due to the ~~limited availability and~~ lack of 100% protection against all potentially cancer-causing strains of HPV, we believe that the vaccines will have a limited impact on the cervical cancer screening and diagnostic market for many years.

Government Regulation

The medical devices that we manufacture are subject to regulation by numerous regulatory bodies, including the Chinese ~~FDA (recently renamed the Chinese~~ National Medical Product Administration (“NMPA”)), the U.S. FDA, and comparable international regulatory agencies. These agencies require manufacturers of medical devices to comply with applicable laws and regulations governing the development, testing, manufacturing, labeling, marketing and distribution of medical devices. Devices are generally subject to varying levels of regulatory control, the most comprehensive of which requires that a clinical evaluation program be conducted before a device receives approval for commercial distribution.

In the European Union, medical devices are required to comply with the Medical Devices Directive and obtain CE Mark certification in order to market medical devices. The CE Mark certification, granted following approval from an independent “Notified Body,” is an international symbol of adherence to quality assurance standards and compliance with applicable European Medical Devices Directives. From 2017 through 2019, we were unable to pay the annual registration fees to maintain our ISO 13485:2003 certification and our CE Mark. On December 21, 2018 we executed agreement with Newmars, described above, for final assembly of LuViva at their ISO 13485:2016 accredited facility. This allowed LuViva to be granted a CE Mark through the facility at Newmars, which was achieved in 2021, and both the ISO and CE Mark accreditations for LuViva are currently active. Thus, LuViva can be marketed in the European Union and other countries that honor the CE Mark.

China has a regulatory regime similar to that of the European Union, but due to interaction with the U.S. regulatory regime, the NMPA also shares some similarities with its U.S. counterpart. Devices are classified by the NMPA’s Center for Medical Device Evaluation (CMDE) into three categories based on medical risk, with the level of regulatory oversight determined by degree of risk and invasiveness. CMDE’s device classifications and definitions are as follows:

	·	Class I device: The safety and effectiveness of the device can be ensured through routine administration.

	·	Class II device: Further control is required to ensure the safety and effectiveness of the device.

	·	Class III device: The device is implanted into the human body; used for life support or sustenance; or poses potential risk to the human body, and thus must be strictly controlled in respect to safety and effectiveness.

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Based on the above definitions and several discussions with regulatory consultants and potential partners, we believe that LuViva is most likely to be classified as a Class II device, however, this is not certain and the NMPA may determine that LuViva requires a Class III registration. Class III registrations are granted by the national NMPA office while Class I and II registrations occur at the provincial level. Typically, registration granted at the provincial level allows a medical device to be marketed in all of China’s provinces.

While Class I devices usually do not require clinical trial data from Chinese patients and Class III devices almost always do, Class II medical devices sometimes do and sometimes do not require Chinese clinical trials, and this determination may depend on the claim for the device and quality of clinical trials conducted outside of China. If clinical trials conducted in China are required, they usually are less burdensome for Class II devices than Class III devices.

NMPA labs also conduct electrical, mechanical and electromagnetic emission safety testing for medical devices similar to those required for the CE Mark. As is the case with the U.S. FDA, manufacturers in China undergo periodic inspections and must comply with international quality standards such as ISO 13485 for medical devices. As part of our agreement with SMI, SMI will underwrite the cost of securing approval of LuViva with the NMPA. SMI has informed us in writing that LuViva has passed electrical, mechanical and electromagnetic emission safety testing for medical devices, which ~~allows~~allowed clinical trials to commence. SMI filed the application for NMPA approval on October 16, 2024. On January 6, 2025, SMI informed us that NMPA found the application complete and was commencing their review. In the same communication, SMI believed that NMPA approval could occur in the second quarter of 2025, although there is no certainty that NMPA approval will occur within this timeframe.

In the United States, permission to distribute a new device generally can be met in one of two ways. The first process requires that a pre-market notification (510(k) Submission) be made to the U.S. FDA to demonstrate that the device is as safe and effective as, or substantially equivalent to, a legally marketed device that is not subject to premarket approval (PMA). A legally marketed device is a device that (1) was legally marketed prior to May 28, 1976, (2) has been reclassified from Class III to Class II or I, or (3) has been found to be substantially equivalent to another legally marketed device following a 510(k) Submission. The legally marketed device to which equivalence is drawn is known as the “predicate” device. Applicants must submit descriptive data and, when necessary, performance data to establish that the device is substantially equivalent to a predicate device. In some instances, data from human clinical studies must also be submitted in support of a 510(k) Submission. If so, the data must be collected in a manner that conforms with specific requirements in accordance with federal regulations. The U.S. FDA must issue an order finding substantial equivalence before commercial distribution can occur. Changes to existing devices covered by a 510(k) Submission which do not significantly affect safety or effectiveness can generally be made by us without additional 510(k) Submissions.

The second process requires that an application for premarket approval (PMA) be made to the U.S. FDA to demonstrate that the device is safe and effective for its intended use as manufactured. This approval process applies to most Class III devices, including LuViva. In this case, two steps of U.S. FDA approval are generally required before marketing in the United States can begin. First, investigational device exemption (IDE) regulations must be complied with in connection with any human clinical investigation of the device in the United States. Second, the U.S. FDA must review the PMA application, which contains, among other things, clinical information acquired under the IDE. The U.S. FDA will approve the PMA application if it finds that there is a reasonable assurance that the device is safe and effective for its intended purpose.

We completed enrollment in our U.S. FDA pivotal trial of LuViva in 2008 and, after the U.S. FDA requested two-years of follow-up data for patients enrolled in the study, the U.S. FDA accepted our completed PMA application on November 18, 2010, effective September 23, 2010, for substantive review. On March 7, 2011, we announced that the U.S. FDA had inspected two clinical trial sites and audited our clinical trial data base systems as part of its review process and raised no formal compliance issues. On January 20, 2012, we announced our intent to seek an independent panel review of our PMA application after receiving a “not-approvable” letter from the U.S. FDA. On November 14, 2012 we filed an amended PMA with the U.S. FDA. On September 6, 2013, we received a letter from the U.S. FDA with additional questions and met with the U.S. FDA on May 8, 2014 to discuss our response. On July 25, 2014, we announced that we had responded to the U.S. FDA’s most recent questions.

We received a “not-approvable” letter from the U.S. FDA on May 15, 2015. We had a follow up meeting with the U.S. FDA to discuss a path forward on November 30, 2015, at which we agreed to submit a detailed clinical protocol for U.S. FDA review so that additional studies can be completed. We held a follow up teleconference with FDA on January 28, 2020 and filed a pre-submission document to the Agency on February 17, 2020 that summarized the clinical protocol to be submitted for FDA review. WeIn ~~agreed~~the second quarter of 2021, we reached basic agreement with the FDA on ~~the~~a study protocol ~~during~~that ~~the~~would ~~second~~require ~~quarter~~approximately of400 ~~2021~~women ~~and~~to ~~have~~be ~~begun~~tested. During ~~enrollment~~2022, ofFDA ~~subjects~~asked infor ~~the~~a ~~clinical~~few additional clarifications which we resolved, allowing for the study to begin in 2023. To date, approximately ~~100~~320 patients have been enrolled and tested. We expect the study to be completed in ~~2024~~2025, however there can be no assurance that it will progress within our expected timeframe or that the results will be positive.

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We remain committed to obtaining U.S. FDA approval as a priority. At the same time, we have narrowed our international focus to concentrate on markets with large screening populations, and where we currently have or are actively seeking regulatory approvals, such as China, the European Union and Indonesia. We believe the commercial opportunities are large and the clinical need is significant in these select international markets.

The process of obtaining clearance to market products is costly and time-consuming in virtually all of the major markets in which we sell, or expect to sell, our products and may delay the marketing and sale of our products. Countries around the world have recently adopted more stringent regulatory requirements, which are expected to add to the delays and uncertainties associated with new product releases, as well as the clinical and regulatory costs of supporting those releases. No assurance can be given that our products will be approved on a timely basis in any particular jurisdiction, if at all. In addition, regulations regarding the development, manufacture and sale of medical devices are subject to future change. We cannot predict what impact, if any, those changes might have on our business. Failure to comply with regulatory requirements could have a material adverse effect on our business, financial condition and results of operations.

Noncompliance with applicable requirements can result in import detentions, fines, civil penalties, injunctions, suspensions or losses of regulatory approvals or clearances, recall or seizure of products, operating restrictions, denial of export applications, governmental prohibitions on entering into supply contracts, and criminal prosecution. Failure to obtain regulatory approvals or the restriction, suspension or revocation of regulatory approvals or clearances, as well as any other failure to comply with regulatory requirements, would have a material adverse effect on our business, financial condition and results of operations.

Regulatory approvals and clearances, if granted, may include significant labeling limitations and limitations on the indicated uses for which the product may be marketed. In addition, to obtain regulatory approvals and clearances, the U.S. FDA and some foreign regulatory authorities impose numerous other requirements with which medical device manufacturers must comply. U.S. FDA enforcement policy strictly prohibits the marketing of approved medical devices for unapproved uses. Any products we manufacture or distribute under U.S. FDA clearances or approvals are subject to pervasive and continuing regulation by the U.S. FDA. The U.S. FDA also requires us to provide it with information on death and serious injuries alleged to have been associated with the use of our products, as well as any malfunctions that would likely cause or contribute to death or serious injury.

The U.S. FDA requires us to register as a medical device manufacturer and list our products. We are also subject to inspections by the U.S. FDA and state agencies acting under contract with the U.S. FDA to confirm compliance with good manufacturing practice. These regulations require that we manufacture our products and maintain documents in a prescribed manner with respect to manufacturing, testing, quality assurance and quality control activities. The U.S. FDA also has promulgated final regulatory changes to these regulations that require, among other things, design controls and maintenance of service records. These changes will increase the cost of complying with good manufacturing practice requirements.

Distributors of medical devices may also be required to comply with other foreign regulatory agencies, and we or our distributors have in the past received marketing approval for LuViva from Health Canada, COFEPRIS in Mexico, the Ministry of Health in Kenya, and the Singapore Health Sciences Authority. However, most of these approvals have expired and would need to be updated in order sell LuViva in those countries. The time required to obtain these foreign approvals to market our products may be longer or shorter than that required in China or the United States, and requirements for those approvals may differ from those required by the NMPA or the U.S. FDA.

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We are also subject to a variety of other controls that affect our business. Labeling and promotional activities are subject to scrutiny by the U.S. FDA and, in some instances, by the U.S. Federal Trade Commission. The U.S. FDA actively enforces regulations prohibiting marketing of products for unapproved users. We are also subject, as are our products, to a variety of state and local laws and regulations in those states and localities where our products are or will be marketed. Any applicable state or local regulations may hinder our ability to market our products in those regions. Manufacturers are also subject to numerous federal, state and local laws relating to matters such as safe working conditions, manufacturing practices, environmental protection, fire hazard control and disposal of hazardous or potentially hazardous substances. We may be required to incur significant costs to comply with these laws and regulations now or in the future. These laws or regulations may have a material adverse effect on our ability to do business.

Although our marketing and distribution partners around the world assist in the regulatory approval process, ultimately, we are responsible for obtaining and maintaining regulatory approvals for our products. The inability or failure to comply with the varying regulations or the imposition of new regulations would materially adversely affect our business, financial condition and results of operations.

Item 1A. RISK FACTORS

A purchase of our securities involves a high degree of risk. Our business or operating or financial condition could be harmed due to any of the following risks. Accordingly, investors should carefully consider these risks in making a decision as to whether to purchase, sell or hold our securities. In addition, investors should note that the risks described below are not the only risks facing us. Additional risks not presently known to us, or risks that do not seem significant today, may impair our business operations in the future. You should carefully consider the risks described below, as well as the other information contained in this Annual Report on Form 10-K and the documents incorporated by reference herein, before making a decision to invest in our securities.

We will be required to raise additional funds. There is no assurance that such funds can be raised on terms that we would find acceptable, on a timely basis, or at all.

Additional debt or equity financing will be required for us to continue as a going concern. We may seek to obtain additional funds for the financing of our cervical cancer detection business through additional debt or equity financings and/or new collaborative arrangements. Management believes that additional financing, if obtainable, will be sufficient to support planned operations only for a limited period. Management has implemented operating actions to reduce cash requirements. Any required additional funding may not be available on terms attractive to us, on a timely basis, or at all. We currently hold $1.13 million of senior unsecured convertible debentures that are in default, which may further hinder our ability to obtain additional debt funding. If we cannot obtain additional funds or achieve profitability, we may not be able to continue as a going concern.

Because we must obtain additional funds through financing transactions or through new collaborative arrangements in order to grow the revenues of our cervical cancer detection product line, there exists substantial doubt about our ability to continue as a going concern. There can be no assurance that we will be able to raise the funds necessary to fund our operations. If we do not secure additional funding when needed, we will be unable to conduct all of our product development efforts as planned, which may cause us to alter our business plan in relation to the development of our products. Even if we obtain additional funding, we will need to achieve profitability thereafter.

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Our independent registered public accountants’ report on our consolidated financial statements as of and for the year ended December 31, ~~2023~~2024, indicates that there is substantial doubt about our ability to continue as a going concern, because we have suffered recurring losses from operations and had an accumulated deficit of $~~151~~153.17 million at December 31, ~~2023~~2024, summarized as follows:

Accumulated deficit as of December 31, 2019	$	139.6
Preferred dividends for the year ended December 31, 2020		0.1
Net loss for the year ended December 31, 2020		0.3
Accumulated deficit as of December 31, 2020		140.0
Preferred dividends for the year ended December 31, 2021		0.4
Net loss for year ended December 31, 2021		2.0
Accumulated deficit as of December 31, 2021		142.4
Preferred dividends for the year ended December 31, 2022		0.6
Net loss for the year ended December 31, 2022		4.4
Net loss for for the year ended December 31, 2022		4.4
Accumulated deficit as of December 31, 2022	$	147.4
Preferred dividends for the year ended December 31, 2023		0.2
Deemed dividends for warrant exchanges for the year ended December 31, 2023		0.1
Net loss for the year ended December 31, 2023		3.4
Net loss for for the year ended December 31, 2023		3.4
Accumulated deficit as of December 31, 2023	$	151.1
Preferred dividends for the year ended December 31, 2024		0.2
Net loss for year ended December 31, 2024		2.4
Accumulated deficit as of December 31, 2024	$	153.7

Our management has implemented reductions in operating expenditures and reductions in some development activities. We have determined to make cervical cancer detection the focus of our business. We are managing the development of our other programs only when funds are made available to us via grants or contracts with government entities or strategic partners. However, there can be no assurance that we will be able to successfully implement or continue these plans.

If we cannot obtain additional funds when needed, we will not be able to implement our business plan.

We require substantial additional capital to develop our products, including completing product testing and clinical trials, obtaining all required regulatory approvals and clearances, beginning and scaling up manufacturing, and marketing our products. We have historically financed our operations though the public and private sale of debt and equity, funding from collaborative arrangements, and grants. Any failure to achieve adequate funding in a timely fashion would delay our development programs and could lead to abandonment of our business plan. To the extent we cannot obtain additional funding, our ability to continue to manufacture and sell our current products, or develop and introduce new products to market, will be limited. Further, financing our operations through the public or private sale of debt or equity may involve restrictive covenants or other provisions that could limit how we conduct our business or finance our operations. Financing our operations through collaborative arrangements generally means that the obligations of the collaborative partner to fund our expenditures are largely discretionary and depend on a number of factors, including our ability to meet specified milestones in the development and testing of the relevant product. We may not be able to obtain an acceptable collaboration partner, and even if we do, we may not be able to meet these milestones, or the collaborative partner may not continue to fund our expenditures.

We have a history of losses, and we expect losses to continue.

We have never been profitable and we have had operating losses since our inception. We expect our operating losses to continue as we continue to expend substantial resources to complete commercialization of our products, obtain regulatory clearances or approvals; build our marketing, sales, manufacturing and finance capabilities, and conduct further research and development. The further development and commercialization of our products will require substantial development, regulatory, sales and marketing, manufacturing and other expenditures. We have only generated limited revenues from product sales. As of December 31, ~~2023~~2024 and ~~2022~~2023, our accumulated deficit was approximately $~~151~~153.17 million and $~~147~~151.41 million, respectively.

Our ability to sell our products is controlled by government regulations, and we may not be able to obtain any necessary clearances or approvals.

The design, manufacturing, labeling, distribution and marketing of medical device products are subject to extensive and rigorous government regulation in most of the markets in which we sell, or plan to sell, our products, which can be expensive and uncertain and can cause lengthy delays before we can begin selling our products in those markets.

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In foreign countries, including European countries, we are subject to government regulation, which could delay or prevent our ability to sell our products in those jurisdictions.

InFor ~~order for~~ us to market our products in Europe and some other international jurisdictions, we and our distributors and agents must obtain required regulatory registrations or approvals. We must also comply with extensive regulations regarding safety, efficacy and quality in those jurisdictions. We may not be able to obtain the required regulatory registrations or approvals, or we may be required to incur significant costs in obtaining or maintaining any regulatory registrations or approvals we receive. Delays in obtaining any registrations or approvals required for marketing our products, failure to receive these registrations or approvals, or future loss of previously obtained registrations or approvals would limit our ability to sell our products internationally. For example, international regulatory bodies have adopted various regulations governing product standards, packaging requirements, labeling requirements, import restrictions, tariff regulations, duties and tax requirements. These regulations vary from country to country. In order to sell our products in Europe, in 2018 we had to undergo an inspection and re-file for ISO 13485:2016 and the CE Mark, which is an international symbol of quality and compliance with applicable European medical device directives. Failure to maintain ISO 13485:2016 certification or CE mark certification or other international regulatory approvals would prevent us from selling in some countries in the European Union.

As of December 31, ~~2023~~2024, our products have achieved and maintain both ISO 13485:2016 certification and the CE Mark through our contract manufacturer, Newmars Technologies.

For our products to be marketed and sold in the People’s Republic of China, they must gain approval from the NMPA~~, formerly known as the Chinese Food and Drug Administration~~. We are working with our partner in China, Shandong Yaohua Medical Instrument Corporation, to achieve NMPA approval. In 2022 compliance testing for device safety was passed and late in 2023 enrollment in the pivotal clinical trial was completed at four hospitals. Our Chinese partner, SMI, ~~expects~~filed the ~~clinical~~application ~~trial~~for ~~data~~NMPA toapproval beon ~~filed~~October ~~with~~16, 2024. On January 6, 2025, SMI informed us that NMPA found the application complete and was commencing their review. In the same communication, SMI believed that NMPA approval could occur in the ~~first~~second quarter of ~~2024~~2025, although there is no certainty that NMPA approval will occur within this timeframe.

Our business is subject to the risks of international operations.

Our business and financial results could be adversely affected due to a variety of factors, including:

	·	changes in a specific country or region’s political and cultural climate or economic condition, including change in governmental regime;

	·	unexpected or unfavorable changes in foreign laws, regulatory requirements and related interpretations;

	·	difficulty of effective enforcement of contractual provisions in local jurisdictions;

	·	inadequate intellectual property protection in foreign countries;

	·	trade protection measures, import or export licensing requirements such as Export Administration Regulations promulgated by the U.S. Department of Commerce and fines, penalties or suspension or revocation of export privileges;

	·	trade sanctions imposed by the United States or other governments with jurisdictional authority over our business operations;

	·	the effects of applicable and potentially adverse foreign tax law changes;

	·	significant adverse changes in foreign currency exchange rates;

	·	longer accounts receivable cycles;

	·	managing a geographically dispersed workforce; and

	·	compliance with the U.S. Foreign Corrupt Practices Act, or FCPA, and the Office of Foreign Assets Control regulations, particularly in emerging markets.

	·	whether and when we or any potential strategic partners will obtain required regulatory approvals in the markets in which we plan to operate; and

	·	the impact of the conflict between Russia and Ukraine on economic conditions in general and on our business and operations.

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In foreign countries, particularly in those with developing economies, certain business practices may exist that are prohibited by laws and regulations applicable to us, such as the U.S. Foreign Corrupt Practices Act, the U.K. Bribery Act and other anti-corruption laws. Although our policies and procedures require compliance with these laws and are designed to facilitate compliance with these laws, our employees, contractors and agents may take actions in violation of applicable laws or our policies. Any such violation, even if prohibited by our policies, could have a material adverse effect on our business and reputation.

Our international businesses must comply with applicable laws such as the U.S. Foreign Corrupt Practices Act. Failure to maintain compliance with or adapt to changes in any of the aforementioned requirements could result in fines, penalties or regulatory actions that could have an adverse impact on our business, results of operations and financial condition.

While we plan to pursue regulatory approval in Russia, the ongoing conflict in Ukraine may delay filing and approval to market in Russia. It is unclear how long any delays may last due to the uncertainty of the situation both in Ukraine and Russia.

The conflict in Ukraine, which has already had an impact on financial markets, could result in additional repercussions in our operating business, including delays in obtaining regulatory approval to market our products in Russia. The future impact of the conflict is highly uncertain and cannot be predicted, and we cannot provide any assurance that the conflict will not have a material adverse impact on our operations or future results or filings with regulatory health authorities.

Russia’s invasion of Ukraine, and sanctions brought by the United States and other countries against Russia, have caused disruptions in many business sectors outside of the medical sector and have resulted in significant market disruptions and increased volatility in the price of certain commodities, including oil and natural gas.

On February 24, 2022, Russia launched a large-scale invasion of Ukraine. The extent and duration of the military action, resulting sanctions and future market disruptions in the region are impossible to predict, but could be significant and may have a severe adverse effect on the region. Among other things, the conflict has resulted in increased volatility in the markets for certain securities and commodities, including oil and natural gas, and other sectors.

The United States and other countries and certain international organizations have imposed broad-ranging economic sanctions on Russia and certain Russian individuals, banking entities and corporations as a response to Russia’s invasion of Ukraine. Actual and threatened responses to Russia’s invasion, as well as a rapid peaceful resolution to the conflict, may impact the markets for certain commodities, such as oil and natural gas, and may have collateral impacts, including increased volatility, and cause disruptions to availability of certain commodities, commodity and futures prices and the supply chain globally. At this time, the situation is rapidly evolving and may evolve in a way that could have a negative impact on our operations and financial position in the future.

In the United States, our products would be subject to regulation by the U.S. FDA, which could prevent us from selling our products domestically.

In order for us to market our products in the United States, we must obtain clearance or approval from the U.S. Food and Drug Administration, or U.S. FDA. We cannot be sure that:

	·	we, or any collaborative partner, will make timely filings with the U.S. FDA;

	·	the U.S. FDA will act favorably or quickly on these submissions;

	·	we will not be required to submit additional information or perform additional clinical studies; or

	·	we will not face other significant difficulties and costs necessary to obtain U.S. FDA clearance or approval.

It can take several years from initial filing of a PMA application and require the submission of extensive supporting data and clinical information. The U.S. FDA may impose strict labeling or other requirements as a condition of its clearance or approval, any of which could limit our ability to market our products domestically. Further, if we wish to modify a product after U.S. FDA approval of a PMA application, including changes in indications or other modifications that could affect safety and efficacy, additional clearances or approvals will be required from the U.S. FDA. Any request by the U.S. FDA for additional data, or any requirement by the U.S. FDA that we conduct additional clinical studies, could result in a significant delay in bringing our products to market domestically and require substantial additional research and other expenditures. Similarly, any labeling or other conditions or restrictions imposed by the U.S. FDA could hinder our ability to effectively market our products domestically. Further, there may be new U.S. FDA policies or changes in U.S. FDA policies that could be adverse to us.

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Currently, we have not obtained clearance or approval from the U.S. FDA, however we have agreed with the U.S. FDA on the clinical trial protocol and have initiated a clinical trial protocol involving approximately 400 study participants. As of March 1, 2025, approximately 320 patients have been enrolled and tested, which represents approximately eighty percent of the 400 anticipated patients needed to complete the study. Based on current and expected enrollment rates, we expect the study to be completed in 2025, depending in part by how many women are diagnosed with cervical disease. However, there can be no assurance that the study will progress and be completed within the expected timeframe, or ever.

Even if we obtain clearance or approval to sell our products, we are subject to ongoing requirements and inspections that could lead to the restriction, suspension or revocation of our clearance.

We, as well as any potential collaborative partners, will be required to adhere to applicable regulations in the markets in which we operate and sell our products, regarding good manufacturing practice, which include testing, control, and documentation requirements. Ongoing compliance with good manufacturing practice and other applicable regulatory requirements will be strictly enforced applicable regulatory agencies. Failure to comply with these regulatory requirements could result in, among other things, warning letters, fines, injunctions, civil penalties, recall or seizure of products, total or partial suspension of production, failure to obtain premarket clearance or premarket approval for devices, withdrawal of approvals previously obtained, and criminal prosecution. The restriction, suspension or revocation of regulatory approvals or any other failure to comply with regulatory requirements would limit our ability to operate and could increase our costs.

We depend on a limited number of distributors and any reduction, delay or cancellation of an order from these distributors or the loss of any of these distributors could cause our revenue to decline.

Each year we have had one or a few distributors that have accounted for substantially all of our limited revenues. As a result, the termination of a purchase order with any one of these distributors may result in the loss of substantially all of our revenues. We are constantly working to develop new relationships with existing or new distributors, but despite these efforts we may not be successful at generating new orders to maintain similar revenues as current purchase orders are filled. In addition, since a significant portion of our revenues is derived from a relatively few distributors, any financial difficulties experienced by any one of these distributors, or any delay in receiving payments from any one of these distributors, could have a material adverse effect on our business, results of operations, financial condition and cash flows.

To successfully market and sell our products internationally, we must address many issues with which we have limited experience.

All of our sales of LuViva to date have been to distributors outside of the United States. We expect that substantially all of our business will continue to come from sales in foreign markets, through increased penetration in countries where we currently sell LuViva, combined with expansion into new international markets. However, international sales are subject to a number of risks, including:

	·	difficulties in staffing and managing international operations;

	·	difficulties in penetrating markets in which our competitors’ products may be more established;

	·	reduced or no protection for intellectual property rights in some countries;

	·	export restrictions, trade regulations and foreign tax laws;

	·	fluctuating foreign currency exchange rates;

	·	foreign certification and regulatory clearance or approval requirements;

	·	difficulties in developing effective marketing campaigns for unfamiliar, foreign countries;

	·	customs clearance and shipping delays;

	·	political and economic instability; and

	·	preference for locally produced products.

If one or more of these risks were realized, it could require us to dedicate significant resources to remedy the situation, and even if we are able to find a solution, our revenues may still decline.

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To market and sell LuViva internationally, we depend on distributors and they may not be successful.

We currently depend almost exclusively on third-party distributors to sell and service LuViva internationally and to train our international distributors, and if these distributors terminate their relationships with us or under-perform, we may be unable to maintain or increase our level of international revenue. We will also need to engage additional international distributors to grow our business and expand the territories in which we sell LuViva. Distributors may not commit the necessary resources to market, sell and service LuViva to the level of our expectations. If current or future distributors do not perform adequately, or if we are unable to engage distributors in particular geographic areas, our revenue from international operations will be adversely affected.

Our success largely depends on our ability to maintain and protect the proprietary information on which we base our products.

Our success depends in large part upon our ability to maintain and protect the proprietary nature of our technology through the patent process, as well as our ability to license from others patents and patent applications necessary to develop our products. If any of our patents are successfully challenged, invalidated or circumvented, or our right or ability to manufacture our products was to be limited, our ability to continue to manufacture and market our products could be adversely affected. In addition to patents, we rely on trade secrets and proprietary know-how, which we seek to protect, in part, through confidentiality and proprietary information agreements. The other parties to these agreements may breach these provisions, and we may not have adequate remedies for any breach. Additionally, our trade secrets could otherwise become known to or be independently developed by competitors.

As of December 31, ~~2023~~2024, we ~~have~~hold ~~been~~six ~~issued,~~active ~~or have rights to, 27~~ U.S. patents ~~(including those under license)~~. In addition, we have filed for, or have rights to, one U.S. ~~patents~~patent (including those under license) that is still pending. There are additional international patents and pending applications. One or more of the patents we hold directly or license from third parties, including those for our cervical cancer detection products, may be successfully challenged, invalidated or circumvented, or we may otherwise be unable to rely on these patents. These risks are also present for the process we use or will use for manufacturing our products. In addition, our competitors, many of whom have substantial resources and have made substantial investments in competing technologies, may apply for and obtain patents that prevent, limit or interfere with our ability to make, use and sell our products, either in the United States or in international markets.

The medical device industry has been characterized by extensive litigation regarding patents and other intellectual property rights. In addition, the U.S. Patent and Trademark Office, or USPTO, may institute interference proceedings. The defense and prosecution of intellectual property suits, USPTO proceedings and related legal and administrative proceedings are both costly and time consuming. Moreover, we may need to litigate to enforce our patents, to protect our trade secrets or know-how, or to determine the enforceability, scope and validity of the proprietary rights of others. Any litigation or interference proceedings involving us may require us to incur substantial legal and other fees and expenses and may require some of our employees to devote all or a substantial portion of their time to the proceedings. An adverse determination in the proceedings could subject us to significant liabilities to third parties, require us to seek licenses from third parties or prevent us from selling our products in some or all markets. We may not be able to reach a satisfactory settlement of any dispute by licensing necessary patents or other intellectual property. Even if we reached a settlement, the settlement process may be expensive and time consuming, and the terms of the settlement may require us to pay substantial royalties. An adverse determination in a judicial or administrative proceeding or the failure to obtain a necessary license could prevent us from manufacturing and selling our products.

We may not be able to generate sufficient sales revenues to sustain our growth and strategy plans.

Our cervical cancer diagnostic activities have been financed to date through a combination of government grants, strategic partners and direct investment. Growing revenues for this product is the main focus of our business. In order to effectively market the cervical cancer detection product, additional capital will be needed.

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Additional product lines involve the modification of the cervical cancer detection technology for use in other cancers. These product lines are only in the earliest stages of research and development and are currently not projected to reach market for several years. Our goal is to receive enough funding from government grants and contracts, as well as payments from strategic partners, to fund development of these product lines without diverting funds or other necessary resources from the cervical cancer program.

Because our products, which use different technology or apply technology in different ways than other medical devices, are or will be new to the market, we may not be successful in launching our products and our operations and growth would be adversely affected.

Our products are based on new methods of cancer detection. If our products do not achieve significant market acceptance, our sales will be limited and our financial condition may suffer. Physicians and individuals may not recommend or use our products unless they determine that these products are an attractive alternative to current tests that have a long history of safe and effective use. To date, our products have been used by only a limited number of people, and few independent studies regarding our products have been published. The lack of independent studies limits the ability of doctors or consumers to compare our products to conventional products.

If we are unable to compete effectively in the highly competitive medical device industry, our future growth and operating results will suffer.

The medical device industry in general and the markets in which we expect to offer products in particular, are intensely competitive. Many of our competitors have substantially greater financial, research, technical, manufacturing, marketing and distribution resources than we do and have greater name recognition and lengthier operating histories in the health care industry. We may not be able to effectively compete against these and other competitors. A number of competitors are currently marketing traditional laboratory-based tests for cervical cancer screening and diagnosis. These tests are widely accepted in the health care industry and have a long history of accurate and effective use. Further, if our products are not available at competitive prices, health care administrators who are subject to increasing pressures to reduce costs may not elect to purchase them. Also, a number of companies have announced that they are developing, or have introduced, products that permit non-invasive and less invasive cancer detection. Accordingly, competition in this area is expected to increase.

Furthermore, our competitors may succeed in developing, either before or after the development and commercialization of our products, devices and technologies that permit more efficient, less expensive non-invasive and less invasive cancer detection. It is also possible that one or more pharmaceutical or other health care companies will develop therapeutic drugs, treatments or other products that will substantially reduce the prevalence of cancers or otherwise render our products obsolete.

We have limited manufacturing experience, which could limit our growth.

We do not have manufacturing experience that would enable us to make products in the volumes that would be necessary for us to achieve significant commercial sales, and we rely upon our suppliers. In addition, we may not be able to establish and maintain reliable, efficient, full-scale manufacturing at commercially reasonable costs in a timely fashion. Difficulties we encounter in manufacturing scale-up, or our failure to implement and maintain our manufacturing facilities in accordance with good manufacturing practice regulations, international quality standards or other regulatory requirements, could result in a delay or termination of production. In the past, we have had substantial difficulties in establishing and maintaining manufacturing for our products and those difficulties impacted our ability to increase sales. Companies often encounter difficulties in scaling up production, including problems involving production yield, quality control and assurance, and shortages of qualified personnel.

Since we rely on sole source suppliers for several of the components used in our products, any failure of those suppliers to perform would hurt our operations.

Several of the components used in our products are available from only one supplier, and substitutes for these components could not be obtained easily or would require substantial modifications to our products. Any significant problem experienced by one of our sole source suppliers may result in a delay or interruption in the supply of components to us until that supplier cures the problem or an alternative source of the component is located and qualified. Any delay or interruption would likely lead to a delay or interruption in our manufacturing operations. For our products that require premarket approval, the inclusion of substitute components could require us to qualify the new supplier with the appropriate government regulatory authorities. Alternatively, for our products that qualify for premarket notification, the substitute components must meet our product specifications.

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Because we operate in an industry with significant product liability risk, and we have not specifically insured against this risk, we may be subject to substantial claims against our products.

The development, manufacture and sale of medical products entail significant risks of product liability claims. We currently have no product liability insurance coverage beyond that provided by our general liability insurance. Accordingly, we may not be adequately protected from any liabilities, including any adverse judgments or settlements, we might incur in connection with the development, clinical testing, manufacture and sale of our products. A successful product liability claim or series of claims brought against us that result in an adverse judgment against or settlement by us in excess of any insurance coverage could seriously harm our financial condition or reputation. In addition, product liability insurance is expensive and may not be available to us on acceptable terms, if at all.

The availability of third-party reimbursement for our products is uncertain, which may limit consumer use and the market for our products.

In the United States and elsewhere, sales of medical products are dependent, in part, on the ability of consumers of these products to obtain reimbursement for all or a portion of their cost from third-party payors, such as government and private insurance plans. Any inability of patients, hospitals, physicians and other users of our products to obtain sufficient reimbursement from third-party payors for our products, or adverse changes in relevant governmental policies or the policies of private third-party payors regarding reimbursement for these products, could limit our ability to sell our products on a competitive basis. We are unable to predict what changes will be made in the reimbursement methods used by third-party health care payors. Moreover, third-party payors are increasingly challenging the prices charged for medical products and services, and some health care providers are gradually adopting a managed care system in which the providers contract to provide comprehensive health care services for a fixed cost per person. Patients, hospitals and physicians may not be able to justify the use of our products by the attendant cost savings and clinical benefits that we believe will be derived from the use of our products, and therefore may not be able to obtain third-party reimbursement.

Reimbursement and health care payment systems in international markets vary significantly by country and include both government-sponsored health care and private insurance. We may not be able to obtain approvals for reimbursement from these international third-party payors in a timely manner, if at all. Any failure to receive international reimbursement approvals could have an adverse effect on market acceptance of our products in the international markets in which approvals are sought.

We have a substantial amount of indebtedness, which may adversely affect our cash flow and our ability to operate our business.

Our outstanding indebtedness, which includes all of our liabilities, was $56.53 million at December 31, ~~2023~~2024. The terms of our indebtedness could have negative consequences to us, such as:

	·	we may be unable to obtain additional financing to fund working capital, operating losses, capital expenditures or acquisitions on terms acceptable to us, or at all;

	·	the amount of our interest expense may increase if we are unable to make payments when due;

	·	our vendors or employees may, and some have, instituted proceedings to collect on amounts owed them;

	·	we have to use a substantial portion of our cash flows from operations to repay our indebtedness, including ordinary course accounts payable and accrued payroll liabilities, which reduces the amount of money we have for future operations, working capital, inventory, expansion, or general corporate or other business activities; and

	·	we may be unable to refinance our indebtedness on terms acceptable to us, or at all.

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Our ability to meet our expenses and debt obligations will depend on our future performance, which will be affected by financial, business, economic, regulatory and other factors. We will be unable to control many of these factors, such as economic conditions. We cannot be certain that our earnings will be sufficient to allow us to pay the principal and interest on our debt and meet any other obligations. If we do not have enough money to service our debt, we may be required, but unable, to refinance all or part of our existing debt, sell assets, borrow money or raise equity on terms acceptable to us, if at all.

Our success depends on our ability to attract and retain scientific, technical, managerial and finance personnel.

Our ability to operate successfully and manage our future growth depends in significant part upon the continued service of key scientific, technical, managerial and finance personnel, as well as our ability to attract and retain additional highly qualified personnel in these fields. We may not be able to attract and retain key employees when necessary, which would limit our operations and growth. In addition, if we are able to successfully develop and commercialize our products, we will need to hire additional scientific, technical, marketing, managerial and finance personnel. We face intense competition for qualified personnel in these areas, many of whom are often subject to competing employment offers.

Certain provisions of our certificate of incorporation that authorize the issuance of additional shares of preferred stock may make it more difficult for a third party to effect a change in control.

Our certificate of incorporation authorizes our board of directors to issue up to 5.0 million shares of preferred stock of which 6,~~882~~857 were outstanding as of December 31, ~~2023~~2024. Our undesignated shares of preferred stock may be issued in one or more series, the terms of which may be determined by the board without further stockholder action. These terms may include, among other terms, voting rights, including the right to vote as a series on particular matters, preferences as to liquidation and dividends, repurchase rights, conversion rights, redemption rights and sinking fund provisions. The issuance of any preferred stock could diminish the rights of holders of our common stock, and therefore could reduce the value of our common stock. In addition, specific rights granted to future holders of preferred stock could be used to restrict our ability to merge with or sell assets to a third party. The ability of our board to issue preferred stock could make it more difficult, delay, discourage, prevent or make it more costly to acquire or effect a change in control, which in turn could prevent our stockholders from recognizing a gain in the event that a favorable offer is extended and could materially and negatively affect the market price of our common stock.

Risks Related to Our Securities

The market prices for our common stock are volatile and will fluctuate.

The market price for our common stock may be volatile and subject to wide fluctuations in response to numerous factors, many of which are beyond our control, including the following: (i) actual or anticipated fluctuations in our quarterly financial results; (ii) recommendations by securities research analysts; (iii) changes in the economic performance or market valuations of other issuers that investors deem comparable to ours; (iv) addition or departure of our executive officers or members of our Board and other key personnel; (v) release or expiration of lock-up or other transfer restrictions on outstanding common stock; (vi) sales or perceived sales of additional common stock; (vii) liquidity of the common stock; (viii) significant acquisitions or business combinations, strategic partnerships, joint ventures or capital commitments by or involving us or our competitors; and (ix) news reports relating to trends, concerns, technological or competitive developments, regulatory changes and other related issues in our industry or target markets. Financial markets often experience significant price and volume fluctuations that affect the market prices of equity securities of public entities and that are, in many cases, unrelated to the operating performance, underlying asset values or prospects of such entities. Accordingly, the market price of our common stock may decline even if our operating results, underlying asset values or prospects have not changed. Additionally, these factors, as well as other related factors, may cause decreases in asset values that are deemed to be other than temporary, which may result in impairment losses. As well, certain institutional investors may base their investment decisions on consideration of our environmental, governance and social practices and performance against such institutions’ respective investment guidelines and criteria, and failure to meet such criteria may result in limited or no investment in our common stock by those institutions, which could materially adversely affect the trading price of our common stock. There can be no assurance that continuing fluctuations in price and volume will not occur. If such increased levels of volatility and market turmoil continue for a protracted period of time, our operations could be materially adversely impacted and the trading price of our common stock may be materially adversely affected.

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There is a limited market for our securities.

Our common stock is listed on the OTC Markets. There can be no assurance that an active and liquid market for the common stock will develop or be maintained on the applicable stock exchanges, and an investor may find it difficult to resell any of our securities.

Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our technologies.

We may seek additional capital through a combination of private and public equity offerings, debt financings, strategic partnerships and alliances and licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, existing ownership interests will be diluted and the terms of such financings may include liquidation or other preferences that adversely affect the rights of existing stockholders. Debt financings may be coupled with an equity component, such as warrants to purchase shares, which could also result in dilution of our existing stockholders’ ownership. The incurrence of indebtedness would result in increased fixed payment obligations and could also result in certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business and may result in liens being placed on our assets and intellectual property. If we were to default on such indebtedness, we could lose such assets and intellectual property. If we raise additional funds through strategic partnerships and alliances and licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies or grant licenses on terms that are not favorable to us.

Future offerings of debt or equity securities may rank senior to common stock.

If we decide to issue debt or equity securities in the future ranking senior to our common stock or otherwise incur additional indebtedness, it is possible that these securities or indebtedness will be governed by an indenture or other instrument containing covenants restricting our operating flexibility and limiting our ability to pay dividends to stockholders. Additionally, any convertible or exchangeable securities that we issue in the future may have rights, preferences and privileges, including with respect to dividends, more favorable than those of common stock and may result in dilution to stockholders. Because our decision to issue debt or equity securities in any future offering or otherwise incur indebtedness will depend on market conditions and other factors beyond our control, we cannot predict or estimate the amount, timing or nature of our future offerings or financings, any of which could reduce the market price of our common stock and dilute their value.

Common stockholders are subordinated to our lenders.

In the event of bankruptcy, liquidation or reorganization, any holders of our debt and our trade creditors will generally be entitled to payment of their claims from our assets before any assets are made available for distribution to us or our stockholders. The common stock is effectively subordinated to our debt and other obligations.

Future sales of common stock by officers and directors may negatively impact the market price for our common stock.

Subject to compliance with applicable securities laws, our directors and officers and their affiliates may sell some or all of their common stock in the future. No prediction can be made as to the effect, if any, such future sales of common stock may have on the market price of the common stock prevailing from time to time. However, the future sale of a substantial number of common stock by our directors and officers and their affiliates, or the perception that such sales could occur, could adversely affect prevailing market prices for our common stock.

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We do not currently pay dividends on our common stock and have no intention to pay dividends on our common stock for the foreseeable future.

No dividends on our common stock have been paid by us to date. We do not intend to declare or pay any cash dividends in the foreseeable future. Payment of any future dividends will be at the discretion of our Board, after taking into account a multitude of factors appropriate in the circumstances, including our operating results, financial condition and current and anticipated cash needs. In addition, the terms of any future debt or credit facility may preclude us from paying any dividends unless certain consents are obtained, and certain conditions are met.

In connection with the audits of our financial statements as of and for the years ended December 31, ~~2023~~2024 and ~~2022~~2023, material weaknesses in our internal control over financial reporting were identified and we may identify additional material weaknesses in the future.

In connection with the preparation and audits of our financial statements as of and for the years ended December 31, ~~2023~~2024 and ~~2022~~2023, material weaknesses (as defined under the Exchange Act and by the auditing standards of the U.S. Public Company Accounting Oversight Board, or “PCAOB”) were identified in our internal control over financial reporting. A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual financial statements will not be prevented or detected on a timely basis. The material weaknesses identified arose from a lack of resources to properly research and account for complex transactions and a lack of oversight and approval by the Board of Directors and Audit Committee, including formally documented approval of significant transactions, including related party transactions.

There were no changes to the Company’s internal controls over financial reporting occurred during the year ended December 31, ~~2023~~2024 that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.

In light of the identified material weaknesses, it is possible that, had we performed a formal assessment of our internal control over financial reporting or had our independent registered public accounting firm performed an audit of our internal control over financial reporting in accordance with PCAOB standards, additional control deficiencies may have been identified.

We have begun taking measures, and plan to continue to take measures, to remediate these material weaknesses. However, the implementation of these measures may not fully address these material weaknesses in our internal control over financial reporting, and, if so, we would not be able to conclude that they have been fully remedied. Our failure to correct these material weaknesses or our failure to discover and address any other control deficiencies could result in inaccuracies in our financial statements and could also impair our ability to comply with applicable financial reporting requirements and make related regulatory filings on a timely basis. As a result, our business, financial condition, results of operations and prospects, as well as the trading price of our common stock, may be materially and adversely affected.

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Anti-takeover provisions in our Amended and Restated Certificate of Incorporation and By-laws may reduce the likelihood of a potential change of control, or make it more difficult for our stockholders to replace management.

Certain provisions of our Amended and Restated Certificate of Incorporation and By-laws could have the effect of making it more difficult for our stockholders to replace management at a time when a substantial number of stockholders might favor a change in management. These provisions include authorizing the board of directors to fill vacant directorships or increase the size of its board of directors.

Furthermore, our board of directors has the authority to issue up to 5.0 million shares of preferred stock in one or more series and to determine the rights and preferences of the shares of any such series without stockholder approval. Any series of preferred stock is likely to be senior to the common stock with respect to dividends, liquidation rights and, possibly, voting rights. The board’s ability to issue preferred stock may have the effect of discouraging unsolicited acquisition proposals, thus adversely affecting the market price of our common stock.

If securities or industry analysts publish inaccurate or unfavorable research about our business, our share price and trading volume may decline.

The trading market for our common stock depends in part on the research and reports that securities or industry analysts publish about us or our business. If one or more analysts downgrade our shares or publish inaccurate or unfavorable research about our business, our shares price may decline. If one or more of these analysts cease coverage of our company or fail to publish reports on us regularly, demand for our shares may decrease, which may cause our shares price and trading volume to decline.

The number of shares of our common stock issuable upon the conversion of our outstanding convertible debt and preferred stock or exercise of outstanding warrants and options is substantial.

As of December 31, ~~2023~~2024, our outstanding convertible debt was convertible into an aggregate of 24,~~809~~528,~~278~~305 shares of our common stock, and the outstanding shares of our ~~Series C, Series C1, Series C2, Series D, Series E, Series F and Series F-2~~ preferred stock were convertible into an aggregate of 1942,~~020~~718,~~513~~453 shares of common stock. Also, as of that date we had warrants outstanding that were exercisable for an aggregate of 2837,~~584~~174,~~580~~468 shares of common stock, and outstanding vested options to purchase 2,~~338~~266,~~636~~023 shares of common stock. The shares of common stock issuable upon conversion or exercise of these securities would have constituted approximately 97133.51% of the total number of shares of common stock then issued and outstanding.

Further, under the terms of our convertible debt and preferred stock, as well as certain of our outstanding warrants, the conversion price or exercise price, as the case may be, could be adjusted downward, causing substantial dilution.

Adjustments to the conversion price of some of our convertible debt and preferred stock, and the exercise price for certain of our warrants, will dilute the ownership interests of our existing stockholders.

Under the terms of a portion of our convertible debt, the conversion price fluctuates with the market price of our common stock. Additionally, under the terms of our Series C preferred stock, any dividends we choose to pay in shares of our common stock will be calculated based on the then-current market price of our common stock. Accordingly, if the market price of our common stock decreases, the number of shares of our common stock issuable upon conversion of the convertible debt or upon payment of dividends on our outstanding Series C preferred stock will increase, and may result in the issuance of a significant number of additional shares of our common stock.

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Under the terms of some of our preferred stock and certain of our convertible notes and outstanding warrants, the conversion price or exercise price will be lowered if we issue common stock at a per share price below the then-conversion price or then-exercise price for those securities. Reductions in the conversion price or exercise price would result in the issuance of a significant number of additional shares of our common stock upon conversion or exercise, which would result in dilution in the value of the shares of our outstanding common stock and the voting power represented thereby.

Our need to raise additional capital in the near future or to use our equity securities for payments could have a dilutive effect on your investment.

In order to continue operations, we will need to raise additional capital. We may attempt to raise capital through the public or private sale of our common stock or securities convertible into or exercisable for our common stock. In addition, from time to time we have issued our common stock or warrants in lieu of cash payments. If we sell additional shares of our common stock or other equity securities, or issue such securities in respect of other claims or indebtedness, such sales or issuances will further dilute the percentage of our equity that you own. Depending upon the price per share of securities that we sell or issue in the future, if any, your interest in us could be further diluted by any adjustments to the number of shares and the applicable exercise price required pursuant to the terms of the agreements under which we previously issued convertible securities.

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

Item 1B. UNRESOLVED STAFF COMMENTS

None.

Item 1C. CYBERSECURITY

Cybersecurity is an area of increasing concern to management and our investors. ByThere ~~design, our device and software (LuViva)~~ are ~~not~~two ~~connected~~main toareas ~~the~~involving ~~internet.~~personal ~~Patient~~data ~~results~~that ~~cannot~~we bepay ~~saved~~particular toattention ~~the device and must first be downloaded~~ to: a1) ~~flash~~Patient ~~drive~~data ~~and~~of ~~then~~women ~~transferred~~enrolled toin ~~another computer or cloud-based system to be saved. The design of~~ our ~~product~~clinical ~~limits~~trials ~~our~~or ~~exposure~~commercially toby ~~the~~overseas ~~compliance~~partners ~~requirements~~and of2) ~~NIST 800-171. Our~~ Company ~~generally keeps all~~ employee ~~personally identifiable~~ information ~~with our payroll service provider. Each year the provider furnishes us with their SOC report which includes their cybersecurity policies and procedures.~~,

By design, our device and software (LuViva) are not connected to the internet. Patient results cannot be saved to the device and must first be downloaded to a flash drive and then transferred to another computer or cloud-based system to be saved. The design of our product limits our exposure to the compliance requirements of NIST 800-171.

Regarding employee information, our Company generally keeps all employee personally identifiable information with our payroll service provider. Each year the provider furnishes us with their SOC report which includes their cybersecurity policies and procedures.

The board of directors, as a whole, has oversight responsibility for our strategic and operational risks, while we engage consultants who are responsible for day-to-day assessment and management of cybersecurity risks and who report regularly to the board of directors. We have previously experienced cybersecurity incidents, from time to time. These incidents have not materially affected our business strategy, results of operations or financial condition. We are not currently aware of any cybersecurity incidents that would have a material effect on our business strategy, results of operations or financial condition. Nevertheless, there is always a risk that a phishing attempt, ransomware or other attack by a bad actor could have a material adverse effect on our financial position or results of operations. Based on information currently available, management does not believe that there is a reasonably likely risk of these issues, nevertheless the possibility of one occurring cannot be completely ruled out.

Item 2. PROPERTIES

Our corporate offices, which also comprise our administrative, research and development, marketing and production facilities, are located at 5835 Peachtree Corners East, Suite B, Peachtree Corners, Georgia 30092, where we lease approximately 12,835 square feet under a lease that expires in May 2026.

Item 3. LEGAL PROCEEDINGS

Although we may, from time to time, be involved in various legal claims arising out of our operations in the normal course of business, we are not currently subject to any claims or actions that we believe would have a material adverse effect on our financial position or results of operations.

Item 4. MINE SAFETY DISCLOSURE

Not applicable.

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PART II

Market for Common Stock; Holders

Our common stock is listed on the OTCQB under the ticker symbol “GTHP.” The number of record holders of our common stock at March 1318, ~~2024~~2025 was ~~159~~155.

The high and low common stock share prices for the first quarter of ~~2024~~2025 and calendar years ~~2023~~2024 and ~~2022~~2023, as reported by the OTCQB, were as set forth in the following table:

	2024				2023				2022
	2025				2024				2023
	High		Low		High		Low		High		Low
First Quarter*	$	0.1916	$	0.1308	$	0.3619	$	0.2012	$	0.7036	$	0.4620
Second Quarter	$	-	$	-	$	0.2816	$	0.1106	$	0.7328	$	0.3811
Third Quarter	$	-	$	-	$	0.2819	$	0.1108	$	0.5928	$	0.4011
Fourth Quarter	$	-	$	-	$	0.1920	$	0.1312	$	0.4819	$	0.2313
*Through March 13, 2024

*Through March 18, 2025

Dividend Policy

We have not paid any dividends on our common stock since our inception and do not intend to pay any dividends in the foreseeable future.

Securities Authorized for Issuance Under Equity Compensation Plans

All the securities we have provided our employees, directors and consultants have been issued under our stock option plans, which are approved by our stockholders. We have issued common stock to other individuals that are not employees or directors, in lieu of cash payments, that are not part of any plan approved by our stockholders.

Securities authorized for issuance under equity compensation plans as of December 31, ~~2023~~2024:

Plan Description	Number of securities to be issued upon exercise of outstanding options		Weighted-average exercise price of outstanding options		Number of securities available for future issuance under equity compensation plans
2018 Equity Incentive Plan		2,~~338~~383,636	$	0.4139		3116,~~659,411~~364
Equity compensation not approved by security holders		500,000	$	0.12		-
TOTAL		2,883,636	$	0.35		116,364

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Item 6. [RESERVED]

Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITIONS AND RESULTS OF OPERATIONS

The following discussion should be read in conjunction with our financial statements and related notes in Part II, Item 8. The following discussion contains forward-looking statements that involve risks, uncertainties and assumptions that could cause actual results to differ materially from management’s expectations. You should review the “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” sections of this Annual Report for a discussion of the important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements described in the following discussion and analysis.

Because such statements include risks and uncertainties, many of which are beyond our control, actual results may differ materially from those expressed or implied by such forward-looking statements. The forward-looking statements speak only as of the date on which they are made, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they are made.

Overview

LuViva provides a less invasive and painless alternative to conventional tests for cervical cancer screening and detection. Additionally, LuViva improves patient well-being not only because it eliminates pain, but also because it is convenient to use and provides rapid results at the point of care. We focus on two primary applications for LuViva: first, as a cancer screening tool in the developing world, where infrastructure to support traditional cancer-screening methods is limited or non-existent, and second, as a triage following traditional screening in the developed world, where a high number of false positive results cause a high rate of unnecessary and ultimately costly follow-up tests.

We are a Delaware corporation, originally incorporated in 1992 under the name “SpectRx, Inc.” and, on February 22, 2008, changed our name to Guided Therapeutics, Inc. At the same time, we renamed our wholly owned subsidiary, InterScan, which originally had been incorporated as “Guided Therapeutics.”

Since our inception, we have raised capital through the public and private sale of debt and equity, funding from collaborative arrangements, and grants.

Our prospects must be considered in light of the substantial risks, expenses and difficulties encountered by entrants into the medical device industry. This industry is characterized by an increasing number of participants, intense competition and a high failure rate. We have experienced operating losses since our inception and, as of December 31, ~~2023~~2024 we have an accumulated deficit of approximately $~~151~~153.17 million. To date, we have engaged primarily in research and development efforts and the early stages of marketing our products. We do not have significant experience in manufacturing, marketing or selling our products. We may not be successful in growing sales for our products. Moreover, required regulatory clearances or approvals may not be obtained in a timely manner, or at all. Our products may not ever gain market acceptance and we may not ever generate significant revenues or achieve profitability. The development and commercialization of our products requires substantial development, regulatory, sales and marketing, manufacturing and other expenditures. We expect our operating losses to continue for the foreseeable future as we continue to expend substantial resources to complete commercialization of our products, obtain regulatory clearances or approvals, build our marketing, sales, manufacturing and finance capabilities, and conduct further research and development.

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Our product revenues to date have been limited. In ~~2022~~2024 and 2023, ~~the majority of~~ our revenues were from the sale of components of our LuViva devices and disposables. We expect that the majority of our revenue in ~~2024~~2025 will be derived from revenue from the sale of LuViva devices and disposables.

Current Demand for LuViva

Based on written agreements and ongoing discussions with ~~our distributors~~SMI, ~~including an amended agreement executed on February 17, 2024,~~ we currently hold and expect to generate additional purchase orders ~~for~~which ~~approximately~~we ~~$4.4 million in LuViva devices and disposables and~~ expect ~~those purchase orders~~ to result in actual sales of approximately $1.5 ~~to $2.5~~ million ~~throughout~~within inthe ~~2024,~~next ~~representing~~twelve ~~what we view as current demand for our products~~months. We cannot be assured that we will generate all or any of these additional purchase orders, or that existing orders will not be canceled by the distributors or that parts to build product will be available to meet demand, such that existing orders will result in actual sales. Because we have a short history of sales of our products, we cannot confidently predict future sales of our products beyond this time frame and cannot be assured of any particular number of sales. Accordingly, we have not identified any particular trends with regard to sales of our products. In order to increase demand for LuViva, we are focused on three primary markets: the United States, China and Europe. In addition, we have recently received sales orders from Turkey and Indonesia which we are preparing to fulfill. These orders are expected to result in approximately $500,000 in revenue for 2025. When combined with sales to our Chinese partner, these constitute what we view as the current demand for our products.

In the United States, the Company is actively pursuing FDA approval by ~~initiating~~conducting a clinical trial ~~protocol~~ involving approximately 400 study participants, with the exact number depending in part on the numbers of women in the study both with and without cervical disease. The study protocol was drafted with input from FDA and physicians at ~~least~~the ~~two prestigious~~ clinical centers that are participating in the study. In 2023, FDA completed its review of the protocol and had no further recommendations or questions. Also in 2023, four clinical sites agreed to participate in the study and all four of the study sites ~~are~~were fully IRB approved. The protocol was also approved by an independent, nationally recognized institutional review board. All four sites have received LuViva devices and have been trained onin their use. ~~One~~All ~~site unexpectedly needed additional approvals from the local hospital that is contributing subjects to the study, but that approval was recently granted. Three of the~~ four sites have undergone one or more clinical study monitoring visits by the Company’s clinical study monitors. Clinical study monitoring visits are required by FDA to ensure that the study is being conducted under FDA guidelines and in compliance with the study protocol. Findings from the ~~initial~~ongoing clinical study monitoring visits include:

1). As of March 1, 2025, approximately 320 patients have been enrolled and tested, which represents approximately eighty percent of the 400 anticipated patients needed to complete the study. 2. There have not been any adverse events reported related to the use of LuViva. 2)3. All ~~three~~four monitored clinical study sites are adhering to the study protocol and are completing the necessary case report forms according to FDA standards. ~~3) Enrollment rates predictably slowed down over the Thanksgiving and Christmas holidays but have increased during 2024. 4) Approximately 100 patients have been enrolled and tested.~~

Based on current and expected enrollment rates, we expect the study to be completed in ~~2024~~2025, ~~however~~depending in part by how many women are diagnosed with cervical disease. However, there can be no assurance that the study will progress and be completed within the expected ~~timeline~~timeframe, or ever.

Regarding international sales efforts, our focus has been on achieving regulatory approval to sell LuViva in China. Our Chinese partner, SMI, ~~has~~filed ~~reported~~the toapplication uswith ~~that~~NMPA asfor approval of ~~December~~LuViva ~~2023,~~as ~~all~~a ~~study~~Class ~~subjects~~3 ~~needed~~medical ~~for~~device ~~Chinese~~in ~~National~~China ~~Medical~~on ~~Products~~October ~~Administration~~16, ~~(NMPA)~~2024. ~~approval~~The ~~have~~results ~~been~~for ~~enrolled~~the ~~and~~449 women tested. ~~There~~by ~~have~~LuViva ~~been~~were nobetter ~~reports~~than required by NMPA with a sensitivity of ~~any~~83% and a specificity of 54%. There were no adverse events ~~from~~reported during the ~~study~~use ~~associated~~of ~~with~~LuViva in the ~~LuViva~~study, ~~device.~~adding ~~SMI~~further ~~believes~~evidence ~~that~~as ~~they~~to ~~can~~the ~~file~~safety of the ~~clinical~~technology. ~~report~~The ~~with~~ NMPA ~~during~~application ~~the~~was ~~second~~accepted ~~quarter~~as ofcomplete ~~2024~~ and ~~that~~is under review. SMI believes NMPA approval could ~~occur~~happen inwithin ~~2024~~six months, although there can be no assurance that NMPA ~~filing and~~ approval will beoccur ~~completed~~ within the projected time ~~frames~~frame, or ever.

In Europe, our distribution partners, Newmars Medical Technologies (“Newmars”), ~~reported~~is ~~that~~actively ~~sales~~pursuing ~~efforts~~potential customers in Poland, Hungary and Romania, where we have ~~restarted~~obtained ~~after~~the ~~delays~~required ~~caused~~approvals byto ~~Covid-19~~sell our products though Newmars. ~~They~~In ~~are~~addition, ~~now~~an ~~actively~~application ~~pursuing~~for ~~potential~~approval ~~customers~~has been filed in ~~Poland~~Russia, ~~Hungary~~although current geopolitics presents uncertainty as to the ability to sell and ~~Romania~~market new medical technology in that country.

In Turkey, we have been in contact with three different medical groups representing over 60 individual hospitals and clinics. We have entered contract discussions for supplying LuViva to the Turkish Ministry of Health and also with a medical device distributor located in Ankara.

In Indonesia, our contracted distributors are in discussions with the local government hospital system of Sulawesi, one of the nation’s most populous islands. During the fourth quarter of 2024, we received an order and full payment for four devices from Indonesia. We expect additional orders for 22 – 26 devices in 2025.

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Critical Accounting Policies

Our material accounting policies, which we believe are the most critical to investors’ understanding of our financial results and condition, are discussed below. Because we are still early in our enterprise development, the number of these policies requiring explanation is limited. As we begin to generate increased revenue from different sources, we expect that the number of applicable policies and complexity of the judgments required will increase.

Revenue Recognition: ASC 606, Revenue from Contracts with Customers establishes a single and comprehensive framework which sets out how much revenue is to be recognized, and when. The core principle is that a vendor should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the vendor expects to be entitled in exchange for those goods or services. Revenue ~~will~~is now be recognized ~~by a vendor~~ when control over the goods or services is transferred to the customer. The application of the core principle in ASC 606 is carried out in five steps:

Step 1 – Identify the contract with a customer: a contract is defined as an agreement (including oral and implied), between two or more parties that creates enforceable rights and obligations and sets out the criteria for each of those rights and obligations. The contract needs to have commercial substance and it is probable that the entity will collect the consideration to which it will be entitled.

Step 2 – Identify the performance obligations in the contract: a performance obligation in a contract is a promise (including implicit) to transfer a good or service to the customer. Each performance obligation should be capable of being distinct and is separately identifiable in the contract.

Step 3 – Determine the transaction price: transaction price is the amount of consideration that the entity can be entitled to, in exchange for transferring the promised goods and services to a customer, excluding amounts collected on behalf of third parties.

Step 4 – Allocate the transaction price to the performance obligations in the contract: for a contract that has more than one performance obligation, the entity will allocate the transaction price to each performance obligation separately, in exchange for satisfying each performance obligation. The acceptable methods of allocating the transaction price include adjusted market assessment approach, expected cost plus a margin approach, and the residual approach (in limited circumstances). Discounts given should be allocated proportionately to all performance obligations unless certain criteria are met and reallocation of changes in standalone selling prices after inception is not permitted.

Step 5 – Recognize revenue as and when the entity satisfies a performance obligation: the entity should recognize revenue at a point in time, except if it meets any of the three criteria, which will require recognition of revenue over time: the entity’s performance creates or enhances an asset controlled by the customer, the customer simultaneously receives and consumes the benefit of the entity’s performance as the entity performs, and the entity does not create an asset that has an alternative use to the entity and the entity has the right to be paid for performance to date.

Valuation of Deferred Taxes: We account for income taxes in accordance with the liability method. Under the liability method, we recognize deferred assets and liabilities based upon anticipated future tax consequences attributable to differences between financial statement carrying amounts of assets and liabilities and their respective tax bases. We establish a valuation allowance to the extent that it is more likely than not that deferred tax assets will not be utilized against future taxable income.

Valuation of Equity Instruments Granted to Employee, Service Providers and Investors: On the date of issuance, the instruments are recorded at their fair value as determined using the Black-Scholes or binomial lattice valuation ~~model~~models.

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Allowance for ~~Accounts~~Credit ~~Receivable~~Losses: ~~The~~Trade ~~Company~~receivables ~~reviews~~are ~~all~~recorded ~~outstanding~~net ~~accounts~~of ~~receivable~~allowances for ~~collectability~~chargebacks, oncash adiscounts ~~quarterly~~for ~~basis~~prompt payment and credit losses. AnThe Company estimates an allowance for expected credit losses isby ~~recorded~~considering ~~for~~factors ~~any~~such ~~amounts~~as ~~deemed~~historical ~~uncollectable.~~experience, ~~The~~credit ~~allowance~~quality, isthe ~~adjusted~~age ~~based~~of onthe ~~our~~accounts ~~assessment~~receivable ofbalances, ~~the~~and ~~ability~~current ofeconomic ~~our~~conditions ~~distributors~~that may affect a customer’s ability to ~~make~~pay. ~~required~~The ~~payments~~corresponding expense for the credit loss allowance is reflected in selling, general and ~~our~~administrative ~~review~~expenses. ofThe ~~the~~allowance ~~financial~~for ~~condition~~credit losses was immaterial as of ~~our~~December ~~distributors~~31, 2024 and 2023.

Inventory Valuation: All inventories are stated at lower of cost or net realizable value, with cost determined substantially on a “first-in, first-out” basis. Selling, general, and administrative expenses are not inventoried, but are charged to expense when incurred.

RESULTS OF OPERATIONS

COMPARISON OF ~~2023~~2024 ~~and~~AND ~~2022~~2023

Sales Revenue, Cost of Goods Sold and Gross Profit from Devices and Disposables: Revenues from the sale of LuViva devices and disposables for the year ended December 31, ~~2023~~2024 were $976,~~706~~940, compared to $1397,~~459~~706 for the year ended December 31, ~~2022~~2023. Cost of goods sold was $624,~~382~~574 during the year ended December 31, ~~2023~~2024, compared to $8062,~~656~~382 during the year ended December 31, ~~2022~~2023. ~~The~~In ~~decrease~~the ofprior ~~$18~~year,~~274~~ inthe ~~cost~~majority of ~~goods~~our ~~sold~~revenue was ~~primarily~~derived ~~caused~~from ~~by a $33,573 increase in~~ the ~~inventory~~sale ~~reserve during 2022 and a larger amount~~ of ~~inventory~~four ~~write-offs,~~instrumentation ~~which~~packages ~~resulted~~(“IPs”) into ~~a negative gross margin during 2022~~SMI. ~~While~~We we currently hold purchase orders with our partner SMI and one other Chinese distributor for approximately $42.445 million in LuViva devices and disposables~~, supply~~. ~~chain~~Timing ~~issues~~of ~~due~~approval toby ~~COVID-19~~NMPA ~~have~~is ~~caused~~likely ~~delays~~a factor in ~~our~~when ~~ability~~we towill ~~procure~~receive ~~the~~these ~~circuit~~payments, ~~boards~~ship ~~that~~our ~~are~~inventory ~~needed~~and torecognize ~~ship our products~~revenue. As of December 31, ~~2023~~2024, we have a deferred revenue balance of $~~424~~848,~~225~~917, which will be recognized as revenue when our products are shipped. We anticipate shipping and therefore recognizing revenue for the majority of these ~~shipments~~products in ~~2024~~2025, based in part on timing of NMPA approval. .

Research and Development Expenses: Research and development expenses were $~~228~~525,~~132~~650 and $76228,~~892~~132 during the years ended December 31, ~~2023~~2024 and ~~2022~~2023, respectively. The increase of $~~128~~297,~~676~~518, or ~~167~~130.34%, was primarily due to ana $321,018 increase in research and development clinical costs and payroll-related expenses related to clinical trials. This increase was offset by a decrease of $23,500 in fees for patent maintenance and other miscellaneous research and development costs.

Sales and Marketing Expenses: Sales and marketing expenses were $~~268~~287,~~375~~016 and $~~181~~268,~~024~~375 during the years ended December 31, ~~2023~~2024 and ~~2022~~2023, respectively. The increase of $8718,~~351~~641, or 486.39%, was primarily due to $10,981 of additional rent expense allocated to our sales and marketing department. The remaining increase was due to higher travel and payroll-related expenses. Sales and marketing expenses have remained relatively consistent year-over-year due to the fact that our international distribution partners are responsible for sales and marketing expenses in their respective countries and also because our sales team’s pay is not commission-based.

General and Administrative Expense: General and administrative expenses were $21,~~997~~296,~~424~~537 and $32,~~007~~997,~~148~~424 and during the years ended December 31, ~~2023~~2024 and ~~2022~~2023, respectively. The decrease of $91,~~724~~700,887, or 056.37%, was ~~due~~primarily todriven by a ~~decrease~~decline of $~~858~~1,~~591~~006,320 of expense for consulting fees, ~~attorney~~which ~~and~~was ~~other~~caused ~~professional~~by ~~fees~~ (~~attributed~~1) to$827,472 ~~lower~~less ~~fees~~expense ~~incurred~~recognized for ~~SEC~~shares ~~filings),~~of acommon ~~$21,650~~stock ~~decrease~~and inwarrants ~~bad~~issued ~~debt~~to ~~expense~~Mr. Blumberg, ~~and~~(2) a $599,~~580~~837 ~~decrease~~less inexpense ~~other~~for ~~miscellaneous~~warrants ~~operating~~issued ~~expenses~~to Mr. ~~These~~Grujic ~~decreases~~and ~~were~~(3) ~~offset~~a bydecline anof $~~812~~13,~~764~~011 ~~increase~~ in ~~payroll~~fees ~~and~~for ~~benefits~~other ~~expense~~outside consultants, attorneys and aour ~~$60,333~~auditors. ~~increase~~The decrease in ~~expense~~our ~~related~~current toyear ~~stock~~general ~~options~~and ~~during~~administrative ~~2023.~~expenses ~~The~~was ~~increase~~also due to a $600,402 decline in payroll and benefits expenses (including payroll taxes), which was primarily ~~driven~~caused by a one-time charge of $679,959 ~~of additional expense~~ recorded for warrants issued in relation to the appointment of Dr. Mark Faupel as the Company’s President and Chief Executive Officer during the ~~current~~prior year period. ~~The~~ ~~increase~~Additionally, inexpense for stock ~~option~~options ~~expense~~decreased ~~was~~$155,824 ~~primarily~~in ~~driven~~the bycurrent period due to (1) a one-time charge of $59,216 ofin ~~additional~~the ~~expense~~prior ~~due~~year tofor the modification of a stock option award and (2) fewer stock option awards vesting in the current period versus the prior. The remaining decrease of $4,341 was driven by a decrease in rent and other miscellaneous expenses in the current period versus the prior.

Interest Expense: Interest expense during the years ended December 31, ~~2023~~2024 and ~~2022~~2023 was $~~278~~380,~~350~~717 and $~~582~~278,~~174~~350, respectively. The ~~decrease~~increase of $~~303~~102,~~824~~367 (or 5236.28%), was due to aan ~~decrease~~increase in debt, ~~which~~in isthe acurrent ~~result~~period ofversus the ~~Company’s concerted efforts to reduce debt through payoffs and exchanges of debt for equity~~prior.

~~Interest~~Change ~~Income~~in Fair Value of Derivative Liability: ~~Interest~~The ~~income~~change ~~was~~in the fair value of our derivative liability resulted in a loss of $618,~~119~~643 ~~and~~in ~~nil~~the year ended December 31, 2024, versus a gain of $5,104 during the ~~years~~year ended December 31, 2023. ~~and~~The ~~2022,~~change ~~respectively.~~in ~~During~~the ~~2023,~~fair value in the ~~Company~~current ~~opened~~period awas ~~Preferred~~attributed ~~Deposit~~to ~~Business~~changes ~~account~~in ~~which~~our ~~earned~~forecasted ~~interest~~stock onprice. The gain due to the ~~cash~~change ~~deposited.~~in fair value of the derivative liability in the year ended December 31, 2023 was due to changes in our stock price.

~~Change~~Gain in(Loss) ~~Fair~~from ~~Value~~Extinguishment of ~~Derivative Liability~~Debt: The gain ~~due~~from toextinguishment ~~the change in fair value~~ of ~~the~~debt ~~derivative liability was $5,104 and $26,785~~ during the years ended December 31, 2024 and 2023 was $68,622 and ~~2022~~$196,206, respectively. The ~~change~~decrease ~~in the fair value~~ of ~~the~~$127,584 ~~derivative~~or ~~liability~~65.0%, was due to ~~changes~~a tolower ~~our~~amount ~~stock~~of ~~price~~debt ~~during~~forgiven in the current period, ~~and~~as athe ~~reduction~~balances inowed ~~the~~to ~~principal~~our ~~amount~~creditors ofhave ~~debt owed~~declined.

Gain (Loss) from Extinguishment of Debt: The gain from extinguishment of debt during the year ended December 31, 2023 was $196,206, compared to a loss on extinguishment of debt of $468,719 during the year ended December 31, 2022. The gain recognized in the current year was due to forgiveness of debt. The loss recognized in the prior year was primarily due to the Auctus Exchange Agreement, which resulted in a loss on extinguishment of $626,776. The loss in the prior year was partially offset by forgiveness of debt.

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Other Income: Other income for the years ended December 31, ~~2023~~2024 and ~~2022~~2023 was $3918,~~271~~102 and $1639,~~551~~271, respectively. The ~~increase~~decrease of $2221,~~720~~169, or ~~137~~53.39%, was primarily due to ana ~~increase~~decrease in write-offs of accounts payable, balances that management no longer considered to be valid liabilities, in the current year.

Deemed Dividend for Warrant Exchanges: Expense related to deemed dividends was nil and $98,972 ~~and nil~~ for the years ended December 31, ~~2023~~2024 and ~~2022~~2023, respectively. The expense in the ~~current~~prior period was recognized as the excess fair value of warrant instruments exchanged over the fair value of the original warrants.

Preferred Stock Dividends: Expense related to preferred stock dividends ~~was~~of $~~170~~173,~~803~~724 and $~~631~~170,~~356~~803 ~~during~~for the years ended December 31, ~~2023~~2024 and ~~2022~~2023, respectively~~. The decrease of $460~~,~~553~~ ~~(or 72.9%)~~ was ~~primarily~~materially ~~due~~consistent toover ~~payment of a one-time, non-recurring 15% dividend to~~ the ~~Series~~two ~~F and Series F-2 Preferred shareholders which was paid via issuance of common stock in the first quarter of 2022~~periods. ~~The decrease was also driven by a lower amount of outstanding preferred stock due to conversions of preferred shares into shares of common stock.~~

Net Loss: Net loss attributable to common stockholders was $32,~~759~~590,~~032~~848 and $43,~~972~~759,~~174~~032 during the years ended December 31, ~~2023~~2024 and ~~2022~~2023, respectively. The reasons for the ~~fluctuation~~decrease are ~~outlined~~explained above.

There was no income tax benefit recorded for ~~2023~~2024 or ~~2022~~2023, due to recurring net operating losses and the full valuation allowance recognized against our deferred tax assets.

LIQUIDITY AND CAPITAL RESOURCES

Going Concern Considerations

We have incurred significant losses since our inception. At December 31, ~~2023~~2024, the Company had a negative working capital of approximately $35.40 million, accumulated deficit of $~~151~~153.17 million, and incurred a net loss including preferred and deemed dividends of $32.86 million for the year then ended. Stockholders’ deficit totaled approximately $34.89 million at December 31, ~~2023~~2024, primarily due to recurring net losses from operations. We expect our capital expenses and operational expenses to increase in the future due to increased sales and marketing expenses, operational costs, and general and administrative costs. Therefore, we believe our operating losses will continue or even increase at least through the near term.

The Company may need to continue to raise capital in order to provide funding for its operations and FDA/NMPA approval process. If sufficient capital cannot be raised, the Company will continue its plans of curtailing operations by reducing discretionary spending and staffing levels and attempting to operate by only pursuing activities for which it has external financial support. However, there can be no assurance that such external financial support will be sufficient to maintain even limited operations or that the Company will be able to raise additional funds on acceptable terms, or at all. In such a case, the Company might be required to enter into unfavorable agreements or, if that is not possible, be unable to continue operations, and to the extent practicable, liquidate and/or file for bankruptcy protection.

There is no assurance that we will ever be profitable or that debt or equity financing will be available to us in the amounts, on terms, and at times deemed acceptable to us, if at all. The issuance of additional equity or equity- linked securities by us could result in significant dilution in the equity interests of our current stockholders. Obtaining commercial loans, assuming those loans would be available, would increase our liabilities and future cash commitments and may involve agreements that include covenants limiting or restricting our ability to take specific actions such as incurring additional debt, expending capital, or declaring dividends, or which impose financial covenants on us that limit our ability to achieve our business objectives. If we are unable to obtain financing in the amounts and on terms deemed acceptable to us, we may be unable to continue our business as planned and as a result may be required to scale back or cease operations, which could cause our stockholders to lose some or all of their investment in us. The financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result should we be unable to continue as a going concern.

Liquidity and Capital Resources

The Company’s primary liquidity requirements are for working capital, funding clinical studies, and other costs associated with achieving regulatory approval to sell our products. Although income taxes are not currently a significant use of funds, after the benefits of our net operating loss carryforwards are fully recognized, they could become a material use of funds, depending on our future profitability and future tax rates. WeOver ~~anticipate~~the next 12 months we expect our burn rate to increase somewhat as we increase headcount, especially for meeting manufacturing demand. In addition, although we have significant inventory, we will ~~require~~need ~~approximately~~to $1order additional parts and services for production.8 Finally, ~~million~~we expect to spend another $2300 thousand to complete and file our US FDA study. Thus, we estimate that approximately $2.5 million ofwill ~~funds~~be needed to ~~operate~~fund ~~our~~the business over the next ~~twelve~~12 months. However, ~~including~~other ~~approximately~~than ~~$0.6~~completing ~~million~~and offiling ~~funds~~the toUS ~~complete~~FDA ~~our~~study ~~ongoing~~results, ~~clinical~~additional ~~studies~~expenditures for manufacturing production will be needed only if significant product is ordered and paid for in advance by customers, which is our current policy.

Since our inception, we have raised capital through the public and private sale of debt and equity, funding from collaborative arrangements, and grants. As of December 31, ~~2023~~2024, we had cash of approximately $0.594 million and negative working capital of $3.4.9 million.

Our major cash flows for the year ended December 31, 2024 consisted of cash used for operating activities of $1.12 million and net cash provided by financing activities of $916 thousand, which was primarily attributed to $835 thousand of proceeds from the issuance of common stock and warrants in private placement offerings.

Our major cash flows for the year ended December 31, 2023 consisted of cash used for operating activities of $1.75 million and net cash provided by financing activities of $24 thousand, which was attributed to proceeds from warrant exercises, less payments made on notes payable.

Our major cash flows for the year ended December 31, 2022 consisted of cash used for operating activities of $1.48 million and net cash provided by financing activities of $3.18 million, which was primarily attributed to $3.19 million of proceeds from issuances of common stock and warrants.

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Contingencies

Tariffs imposed and/or publicly contemplated by the U.S. government in the first quarter of 2025, particularly as to China, create significant uncertainty with respect to future tax and trade regulations and the potential competitive effects of such actions. The countries in which our products will be manufactured or imported may from time to time impose additional quotas, duties, tariffs or other restrictions on our imports or adversely modify existing restrictions. It is unclear what the U.S. administration or foreign governments specifically will or will not do with respect to tariffs, tax policies, or other international trade agreements, regulations and policies. A trade war, other governmental action related to tariffs or international trade agreements, changes in U.S. social, political, regulatory and economic conditions or in laws and policies governing foreign trade, manufacturing, development and investment in the territories and countries where we manufacture and sell products or any resulting negative sentiments towards the United States could materially adversely affect the Company’s business, financial condition, operating results and cash flows.

Off-Balance Sheet Arrangements

We have no material off-balance sheet arrangements, no special purpose entities, and no activities that include non-exchange-traded contracts accounted for at fair value.

Item 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Not applicable.

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Item 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

GUIDED THERAPEUTICS, INC. ~~INDEX TO CONSOLIDATED FINANCIAL STATEMENTS~~

	Page
Report of Independent Registered Public Accounting Firm (PCAOB ID - 1195)		33
Consolidated Balance Sheets as of December 31, 2023 and 2022		35
Consolidated Statements of Operations for the Years ended December 31, 2023 and 2022		37
Consolidated Statements of Stockholders’ Deficit for the Years ended December 31, 2023 and 2022		38
Consolidated Statements of Cash Flows for the Years ended December 31, 2023 and 2022		44
Notes to the Consolidated Financial Statements		46

INDEX TO CONSOLIDATED FINANCIAL STATEMENTS

		Page
Report of Independent Registered Public Accounting Firm (PCAOB ID 1195)		F-1
Consolidated Balance Sheets as of December 31, 2024 and 2023		F-3
Consolidated Statements of Operations for the Years ended December 31, 2024 and 2023		F-4
Consolidated Statements of Stockholders' Deficit for the Years ended December 31, 2024 and 2023		F-5
Consolidated Statements of Cash Flows for the Years ended December 31, 2024 and 2023		F-10
Notes to the Consolidated Financial Statements		F-11

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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Board of Directors and Stockholders of

Guided Therapeutics, Inc.

Opinion on the Financial Statements

We have audited the accompanying consolidated balance sheets of Guided Therapeutics, Inc. and Subsidiary (the “Company”) as of December 31, ~~2023~~2024 and ~~2022~~2023, and the related consolidated statements of operations, stockholders’ deficit, and cash flows for the years then ended, and the related notes (collectively, the “consolidated financial statements”). In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of the Company as of December 31, ~~2023~~2024 and ~~2022~~2023, and the results of its operations and its cash flows for the years then ended, in conformity with accounting principles generally accepted in the United States of America (“US GAAP”).

Substantial Doubt about the Company’s Ability to Continue as a Going Concern

The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the consolidated financial statements, the Company has recurring losses from operations, limited cash flow, and an accumulated deficit. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. Management's plans in regard to these matters are also described in Note 1. The consolidated financial statements do not include any adjustment that might result from the outcome of this uncertainty. Our opinion is not modified with respect to this matter.

Basis for Opinion

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

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

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

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To the Board of Directors and Stockholders of

Guided Therapeutics, Inc.

Page Two

Critical Audit Matter

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

Stock-Based Compensation

~~The~~As described in Note 2 of the consolidated financial statements, the Company issues stock options and warrants to officers, employees and service providers of the Company. The fair value of these equity instruments is determined as of the grant date using either the Black-Scholes or binomial option pricing models and is recorded as Stock-Based Compensation on the consolidated statements of stockholders’ deficit and within general and administrative expense on the consolidated statements of operations. The selection of the valuation methodology and assumptions utilized in the models are based, in part, upon assumptions for which management is required to use judgment, particularly the risk-free interest rate, volatility, and expected term.

We identified management’s judgments and assumptions used in the valuation of the warrants and stock options as a critical audit matter because of the significant judgments made by management to determine the grant date fair values. This required a high degree of auditor judgment and an increased extent of effort, including the need to involve our valuation specialists, when performing audit procedures to evaluate the reasonableness of management’s valuation methodology and related assumptions.

How the Critical Audit Matter was Addressed

The primary procedures we performed to address this critical audit matter included the following:

	·	We obtained and inspected the underlying agreements and management’s valuation analyses, including supporting schedules.

	·	We agreed inputs used in the models to the a) underlying agreement such as the number of options or warrants and b) observable third party inputs, such as Company’s stock price as of the grant date and the risk-free interest rate.

	·	We performed sensitivity analyses of significant assumptions to evaluate the changes in the fair value that would result from changes in these assumptions.

	·	With the assistance of our valuation specialists, we evaluated management’s valuation methodology, including the selection of the pricing model.

	·	With the assistance of our valuation specialists, we evaluated the reasonableness of management’s assumptions and the source of the information underlying those assumptions, including the risk-free interest rate, volatility and expected term.

	·	With the assistance of our valuation specialists, we assessed whether management’s calculations of the fair values were applied in accordance with the selected methodology, including testing the mathematical accuracy of the valuation analyses.

	·	We assessed whether the disclosures in the consolidated financial statements are complete and accurate.

We have served as the Company’s auditor since 2007.

/s/ UHY LLP

Sterling Heights, Michigan

March 2831, ~~2024~~2025

34F-2 Table of Contents

GUIDED THERAPEUTICS, INC. AND SUBSIDIARY
CONSOLIDATED BALANCE SHEETS
(in thousands)
	December 31,		December 31,
	2023		2022
ASSETS
Current Assets:
Cash and cash equivalents	$	591	$	2,313
Accounts receivable, net of allowance for credit losses of $2 and $48 at December 31, 2023 and 2022, respectively.		7		6
Inventory, net of reserves of $818 at December 31, 2023 and 2022.		632		548
Other current assets		163		137
Total current assets		1,393		3,004
Non-Current Assets:
Property and equipment, net		32		42
Operating lease right-of-use asset, net of amortization		227		303
Other assets		17		17
Total non-current assets		276		362
TOTAL ASSETS	$	1,669	$	3,366
LIABILITIES AND STOCKHOLDERS’ DEFICIT
Current Liabilities:
Accounts payable	$	1,991	$	2,186
Accounts payable, related parties		32		39
Accrued liabilities		970		1,247
Deferred revenue		424		509
Current portion of lease liability		91		79
Current portion of long-term debt		-		17
Current portion of long-term debt, related parties		39		504
Short-term notes payable		59		57
Short-term notes payable, related parties		-		1
Short-term convertible debt		1,203		230
Total current liabilities		4,809		4,869
Long-Term Liabilities
Long-term lease liability		155		246
Derivative liability		-		5
Long-term convertible debt		-		1,046
Long-term debt, related parties		511		83
Total long-term liabilities		666		1,380
Total liabilities		5,475		6,249

GUIDED THERAPEUTICS, INC. AND SUBSIDIARY

35CONSOLIDATED ~~Table~~BALANCE ~~of Contents~~SHEETS

COMMITMENTS AND CONTINGENCIES (Note 7)
STOCKHOLDERS’ DEFICIT:
Series C convertible preferred stock, $0.001 par value; 9.0 shares authorized, 0.3 shares issued and outstanding as of December 31, 2023 and 2022. Liquidation preference of $286 at December 31, 2023 and 2022.		105			105
Series C1 convertible preferred stock, $0.001 par value; 20.3 shares authorized, 1.0 shares issued and outstanding as of December 31, 2023 and 2022. Liquidation preference of $1,049 at December 31, 2023 and 2022.		170			170
Series C2 convertible preferred stock, $0.001 par value; 5,000 shares authorized, 2.7 shares issued and outstanding as of December 31, 2023 and 2022. Liquidation preference of $2,700 at December 31, 2023 and 2022.		439			439
Series D convertible preferred stock, $0.001 par value; 6.0 shares authorized, 0.4 shares issued and outstanding as of December 31, 2023 and 2022. Liquidation preference of $438 at December 31, 2023 and 2022.		159			159
Series E convertible preferred stock, $0.001 par value; 5.0 shares authorized, 0.9 shares issued and outstanding as of December 2023 and 2022. Liquidation preference of $883 and $888 at December 31, 2023 and 2022, respectively.		834			839
Series F convertible preferred stock, $0.001 par value; 1.5 shares authorized, 1.1 shares issued and outstanding as of December 31, 2023 and 2022. Liquidation preference of $1,006 and $1,056 at December 31, 2023 and 2022, respectively.		838			880
Series F-2 convertible preferred stock, $0.001 par value; 5.0 shares authorized, 0.5 shares issued and outstanding as of December 31, 2023 and 2022. Liquidation preference of $520 and $535 at December 31, 2023 and 2022, respectively.		475			489
Common stock, $0.001 par value; 500,000 shares authorized, 54,105 and 48,596 shares issued and outstanding as of December 31, 2023 and 2022, respectively.		3,441			3,437
Additional paid-in capital		140,983			138,090
Treasury stock at cost		(132	)		(132	)
Accumulated deficit		(151,118	)		(147,359	)
Total stockholders’ deficit		(3,806	)		(2,883	)
TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT	$	1,669		$	3,366

(in thousands)

	December 31,			December 31,
	2024			2023
ASSETS

Current Assets:
Cash and cash equivalents	$	388		$	591
Accounts receivable, net of allowance for doubtful accounts of $0.5 and $2 at December 31, 2024 and 2023, respectively.		3			7
Inventory, net of reserves of $818 at December 31, 2024 and 2023.		633			632
Other current assets		173			163
Total current assets		1,197			1,393

Non-Current Assets:
Property and equipment, net		23			32
Operating lease right-of-use asset, net of amortization		141			227
Other assets		17			17
Total non-current assets		181			276

TOTAL ASSETS	$	1,378		$	1,669

LIABILITIES AND STOCKHOLDERS’ DEFICIT

Current Liabilities:
Accounts Payable	$	2,094		$	1,991
Accounts payable, related parties		36			32
Accrued liabilities		1,011			1,068
Deferred revenue		849			424
Current portion of lease liability		106			91
Short-term notes payable due to related parties		70			-
Current portion of long-term debt, related parties		532			39
Short-term notes payable		92			59
Short-term convertible debt, net of discounts		117			1,105
Short-term convertible debt in default		1,130			-
Derivative liability at fair value		118			-
Total current liabilities		6,155			4,809

Long-Term Liabilities
Long-term lease liability		49			155
Long-term notes payable		47			-
Long-term convertible notes payable, net of discounts		14			-
Long-term debt, related parties		2			511
Total long-term liabilities		112			666

Total liabilities		6,267			5,475

STOCKHOLDERS’ DEFICIT:

Series C convertible preferred stock, $.001 par value; 9.0 shares authorized, 0.3 shares issued and outstanding as of December 31, 2024 and 2023. Liquidation preference of $286 at December 31, 2024 and 2023.		105			105
Series C1 convertible preferred stock, $.001 par value; 20.3 shares authorized, 1.0 shares issued and outstanding as of December 31, 2024 and 2023. Liquidation preference of $1,049 at December 31, 2024 and 2023.		170			170
Series C2 convertible preferred stock, $.001 par value; 5,000 shares authorized, 2.7 shares issued and outstanding as of December 31, 2024 and 2023. Liquidation preference of $2,700 at December 31, 2024 and 2023.		439			439
Series D convertible preferred stock, $.001 par value; 6.0 shares authorized, 0.4 shares issued and outstanding as of December 31, 2024 and 2023. Liquidation preference of $438 at December 31, 2024 and 2023.		159			159
Series E convertible preferred stock, $.001 par value; 5.0 shares authorized, 0.9 shares issued and outstanding as of December 2024 and 2023. Liquidation preference of $883 at December 31, 2024 and 2023.		834			834
Series F convertible preferred stock, $.001 par value; 1.5 shares authorized, 1.0 and 1.1 shares issued and outstanding as of December 31, 2024 and 2023, respectively. Liquidation preference of $981 and $1,006 at December 31, 2024 and 2023, respectively.		817			838
Series F-2 convertible preferred stock, $.001 par value; 5.0 shares authorized, 0.5 shares issued and outstanding as of December 31, 2024 and 2023. Liquidation preference of $520 at December 31, 2024 and 2023.		475			475
Common stock, $.001 par value; 500,000 shares authorized, 65,131 and 54,105 shares issued and outstanding as of December 31, 2024 and 2023, respectively.		3,452			3,441
Additional paid-in capital		142,501			140,983
Treasury stock at cost		(132	)		(132	)
Accumulated deficit		(153,709	)		(151,118	)

Total stockholders’ deficit		(4,889	)		(3,806	)

TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT	$	1,378		$	1,669

The accompanying notes are an integral part of these consolidated statements.

36F-3 Table of Contents

GUIDED THERAPEUTICS, INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands)
	Years Ended
	December 31,
	2023			2022
Sales - devices and disposables	$	98		$	13
Cost of goods sold		62			81
Gross profit (loss)		36			(68	)
Operating expenses:
Research and development		228			77
Sales and marketing		268			181
General and administrative		2,997			3,007
Total operating expenses		3,493			3,265
Loss from operations		(3,457	)		(3,333	)
Other income (expense)
Interest expense		(278	)		(582	)
Interest income		6			-
Change in fair value of derivative liability		5			27
Gain (Loss) from extinguishment of debt		196			(469	)
Other income		39			16
Total other income (expense)		(32	)		(1,008	)
Loss before income taxes		(3,489	)		(4,341	)
Provision for income taxes		-			-
Net loss		(3,489	)		(4,341	)
Deemed dividend for warrant exchanges		(99	)		-
Preferred stock dividends		(171	)		(631	)
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS	$	(3,759	)	$	(4,972	)
NET LOSS PER SHARE ATTRIBUTABLE TO COMMON STOCKHOLDERS
Basic	$	(0.07	)	$	(0.15	)
Diluted	$	(0.07	)	$	(0.15	)
Weighted average shares outstanding
Basic		51,131			32,505
Diluted		51,131			32,505

GUIDED THERAPEUTICS, INC. AND SUBSIDIARY

CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands)

	Years Ended
	December 31,
	2024			2023

Sales - devices and disposables	$	7		$	98
Cost of goods sold		5			62
Gross profit		2			36

Operating expenses:
Research and development		526			228
Sales and marketing		287			268
General and administrative		1,297			2,997
Total operating expenses		2,110			3,493

Loss from operations		(2,108	)		(3,457	)

Other income (expense)
Interest expense		(381	)		(278	)
Interest income		3			6
Change in fair value of derivative liability		(18	)		5
Gain from extinguishment of debt		69			196
Other income		18			39
Total other income (expense)		(309	)		(32	)

Loss before income taxes		(2,417	)		(3,489	)
Provision for income taxes		-			-

Net loss		(2,417	)		(3,489	)
Deemed dividend for warrant exchanges		-			(99	)
Preferred stock dividends		(174	)		(171	)

NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS	$	(2,591	)	$	(3,759	)

NET LOSS PER SHARE ATTRIBUTABLE TO COMMON STOCKHOLDERS
Basic	$	(0.05	)	$	(0.07	)
Diluted	$	(0.05	)	$	(0.07	)

Weighted average shares outstanding
Basic		57,339			51,131
Diluted		57,339			51,131

The accompanying notes are an integral part of these consolidated statements.

37F-4 Table of Contents

GUIDED THERAPEUTICS, INC. AND SUBSIDIARY ~~CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT FOR THE YEAR ENDED DECEMBER 31, 2023 (in thousands)~~

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT

FOR THE YEAR ENDED DECEMBER 31, 2024

(in thousands)

	Preferred Stock				Preferred Stock				Preferred Stock				Preferred Stock
	Series C				Series C1				Series C2				Series D
	Shares		Amount		Shares		Amount		Shares		Amount		Shares		Amount
Balance at December 31, 2023		-	$	105		1	$	170		2	$	439		1	$	159
Issuance of common stock and warrants in private placement offerings, net of expenses		-		-		-		-		-		-		-		-
Issuance of common stock for payment of Series D preferred dividends		-		-		-		-		-		-		-		-
Issuance of common stock for payment of Series E preferred dividends		-		-		-		-		-		-		-		-
Issuance of common stock for payment of Series F preferred dividends		-		-		-		-		-		-		-		-
Issuance of common stock for payment of Series F-2 preferred dividends		-		-		-		-		-		-		-		-
Issuance of common stock for payment of interest		-		-		-		-		-		-		-		-
Conversion of Series F preferred stock to common stock		-		-		-		-		-		-		-		-
Settlement of previously accrued professional fees through common stock issuance		-		-		-		-		-		-		-		-
Issuance of warrants with debt		-		-		-		-		-		-		-		-
Stock-based compensation		-		-		-		-		-		-		-		-
Accrued preferred dividends		-		-		-		-		-		-		-		-
Net loss		-		-		-		-		-		-		-		-
Balance at December 31, 2024		-	$	105		1	$	170		2	$	439		1	$	159

	Preferred Stock				Preferred Stock					Preferred Stock
	Series E				Series F					Series F2
	Shares		Amount		Shares		Amount			Shares		Amount
Balance at December 31, 2023		1	$	834		1	$	838			-	$	475
Issuance of common stock and warrants in private placement offerings, net of expenses		-		-		-		-			-		-
Issuance of common stock for payment of Series D preferred dividends		-		-		-		-			-		-
Issuance of common stock for payment of Series E preferred dividends		-		-		-		-			-		-
Issuance of common stock for payment of Series F preferred dividends		-		-		-		-			-		-
Issuance of common stock for payment of Series F-2 preferred dividends		-		-		-		-			-		-
Issuance of common stock for payment of interest		-		-		-		-			-		-
Conversion of Series F preferred stock to common stock		-		-		-		(21	)		-		-
Settlement of previously accrued professional fees through common stock issuance		-		-		-		-			-		-
Issuance of warrants with debt		-		-		-		-			-		-
Stock-based compensation		-		-		-		-			-		-
Accrued preferred dividends		-		-		-		-			-		-
Net loss		-		-		-		-			-		-
Balance at December 31, 2024		1	$	834		1	$	817			-	$	475

F-5

Table of Contents

					Additional
	Common Stock				Paid-In		Treasury			Accumulated
	Shares		Amount		Capital		Stock			Deficit			Total
Balance at December 31, 2023		54,105	$	3,441	$	140,983	$	(132	)	$	(151,118	)	$	(3,806	)
Issuance of common stock and warrants in private placement offerings, net of expenses		7,448		7		828		-			-			835
Issuance of common stock for payment of Series D preferred dividends		249		-		31		-			-			31
Issuance of common stock for payment of Series E preferred dividends		625		1		62		-			-			63
Issuance of common stock for payment of Series F preferred dividends		451		1		55		-			-			56
Issuance of common stock for payment of Series F-2 preferred dividends		236		-		27		-			-			27
Issuance of common stock for payment of interest		1,117		1		125		-			-			126
Conversion of Series F preferred stock to common stock		100		-		21		-			-			-
Settlement of previously accrued professional fees through common stock issuance		800		1		113		-			-			114
Issuance of warrants with debt		-		-		136		-			-			136
Stock-based compensation		-		-		120		-			-			120
Accrued preferred dividends		-		-		-		-			(174	)		(174	)
Net loss		-		-		-		-			(2,417	)		(2,417	)
Balance at December 31, 2024		65,131	$	3,452	$	142,501	$	(132	)	$	(153,709	)	$	(4,889	)

F-6

Table of Contents

GUIDED THERAPEUTICS, INC. AND SUBSIDIARY

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT

FOR THE YEAR ENDED DECEMBER 31, 2023

(in thousands)

	Preferred Stock Series C				Preferred Stock Series C1				Preferred Stock Series C2				Preferred Stock Series D
	Shares		Amount		Shares		Amount		Shares		Amount		Shares		Amount
Balance at December 31, 2022		-	$	105		1	$	170		2	$	439		1	$	159

Common stock warrants exercised		-		-		-		-		-		-		-		-
Issuance of common stock for payment of Series D preferred dividends		-		-		-		-		-		-		-		-
Issuance of common stock for payment of Series E preferred dividends		-		-		-		-		-		-		-		-
Issuance of common stock for payment of Series F preferred dividends		-		-		-		-		-		-		-		-
Issuance of common stock for payment of Series F-2 preferred dividends		-		-		-		-		-		-		-		-
Conversion of Series E preferred stock to common stock		-		-		-		-		-		-		-		-
Conversion of Series F preferred stock to common stock		-		-		-		-		-		-		-		-
Conversion of Series F-2 preferred stock to common stock		-		-		-		-		-		-		-		-
Issuance of common stock for payment of interest		-		-		-		-		-		-		-		-
Settlement of previously accrued professional fees through common stock issuance		-		-		-		-		-		-		-		-
Stock-based compensation		-		-		-		-		-		-		-		-
Impact of warrant exchanges		-		-		-		-		-		-		-		-
Accrued preferred dividends		-		-		-		-		-		-		-		-
Net loss		-		-		-		-		-		-		-		-

Balance at December 31, 2023		-	$	105		1	$	170		2	$	439		1	$	159

38F-7 Table of Contents

	Preferred Stock Series E					Preferred Stock Series F					Preferred Stock Series F2
	Shares		Amount			Shares		Amount			Shares		Amount
Balance at December 31, 2022		1	$	839			1	$	880			-	$	489

Common stock warrants exercised		-		-			-		-			-		-
Issuance of common stock for payment of Series D preferred dividends		-		-			-		-			-		-
Issuance of common stock for payment of Series E preferred dividends		-		-			-		-			-		-
Issuance of common stock for payment of Series F preferred dividends		-		-			-		-			-		-
Issuance of common stock for payment of Series F-2 preferred dividends		-		-			-		-			-		-
Conversion of Series E preferred stock to common stock		-		(5	)		-		-			-		-
Conversion of Series F preferred stock to common stock		-		-			-		(42	)		-		-
Conversion of Series F-2 preferred stock to common stock		-		-			-		-			-		(14	)
Issuance of common stock for payment of interest		-		-			-		-			-		-
Settlement of previously accrued professional fees through common stock issuance		-		-			-		-			-		-
Stock-based compensation		-		-			-		-			-		-
Impact of warrant exchanges		-		-			-		-			-		-
Accrued preferred dividends		-		-			-		-			-		-
Net loss		-		-			-		-			-		-

Balance at December 31, 2023		1	$	834			1	$	838			-	$	475

39F-8 Table of Contents

					Additional
	Common Stock				Paid-In			Treasury			Accumulated
	Shares		Amount		Capital			Stock			Deficit			Total
Balance at December 31, 2022		48,596	$	3,437	$	138,090		$	(132	)	$	(147,359	)	$	(2,883	)
Common stock warrants exercised		3,~~129~~128		3		469			-			-			472
Issuance of common stock for payment of Series D preferred dividends		~~152~~151		-		30			-			-			30
Issuance of common stock for payment of Series E preferred dividends		~~379~~378		-		61			-			-			61
Issuance of common stock for payment of Series F preferred dividends		233		-		53			-			-			53
Issuance of common stock for payment of Series F-2 preferred dividends		121		-		29			-			-			29
Conversion of Series E preferred stock to common stock		20		-		5			-			-			-
Conversion of Series F preferred stock to common stock		200		-		42			-			-			-
Conversion of Series F-2 preferred stock to common stock		60		-		14			-			-			-
Issuance of common stock for payment of interest		418		-		119			-			-			119
Settlement of previously accrued professional fees through common stock issuance		800		1		167			-			-			168
Stock-based compensation		-		-		1,806			-			-			1,806
Impact of warrant exchanges		-		-		99			-			(99	)		-
Accrued preferred dividends		-		-		(1	)		-			(171	)		(172	)
Net loss		-		-		-			-			(3,489	)		(3,489	)
Balance at December 31, 2023		54,~~106~~105	$	3,441	$	140,983		$	(132	)	$	(151,118	)	$	(3,806	)

The accompanying notes are an integral part of these consolidated statements.

40F-9 Table of Contents

GUIDED THERAPEUTICS, INC. AND SUBSIDIARY ~~CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT FOR THE YEAR ENDED DECEMBER 31, 2022 (in thousands)~~

	Preferred Stock				Preferred Stock				Preferred Stock						Preferred Stock
	Series C				Series C1				Series C2						Series D
	Shares		Amount		Shares		Amount		Shares			Amount			Shares		Amount
Balance at December 31, 2021		-	$	105		1	$	170		3		$	531			1	$	276
Common stock warrants exercised		-		-		-		-		-			-			-		-
Issuances of common stock to investors		-		-		-		-		-			-			-		-
Issuances of warrants to investors		-		-		-		-		-			-			-		-
Issuance of common stock for payment of Series D preferred dividends		-		-		-		-		-			-			-		-
Issuance of common stock for payment of Series E preferred dividends		-		-		-		-		-			-			-		-
Issuance of common stock for payment of Series F preferred dividends		-		-		-		-		-			-			-		-
Issuance of common stock for payment of Series F-2 preferred dividends		-		-		-		-		-			-			-		-
Issuance of common stock for payment of interest		-		-		-		-		-			-			-		-
Issuance of common stock for Series F and Series F-2 one-time 15% dividends		-		-		-		-		-			-			-		-
Conversion of Series C-2 preferred stock to common stock		-		-		-		-		(1	)		(92	)		-		-
Conversion of Series D preferred stock to common stock		-		-		-		-		-			-			-		(117	)
Conversion of Series E preferred stock to common stock		-		-		-		-		-			-			-		-
Conversion of Series F preferred stock to common stock		-		-		-		-		-			-			-		-
Conversion of Series F-2 preferred stock to common stock		-		-		-		-		-			-			-		-
Stock-based compensation		-		-		-		-		-			-			-		-
Issuances of warrants to consultants		-		-		-		-		-			-			-		-
Impact of Auctus exchange		-		-		-		-		-			-			-		-
Accrued preferred dividends		-		-		-		-		-			-			-		-
Net loss		-		-		-		-		-			-			-		-
Balance at December 31, 2022		-	$	105		1	$	170		2		$	439			1	$	159

CONSOLIDATED STATEMENTS OF CASH FLOWS

41(in ~~Table of Contents~~thousands)

	Preferred Stock						Preferred Stock					Preferred Stock
	Year Ended
	Series E						Series F					Series F-2
	December 31,
	Shares			Amount			Shares		Amount			Shares			Amount
	2024			2023
Balance at December 31, 2021		2		$	1,639			1	$	1,187			3		$	2,963
CASH FLOWS FROM OPERATING ACTIVITIES:
Common stock warrants exercised		-			-			-		-			-			-
Net loss	$	(2,417	)	$	(3,489	)
Issuances of common stock to investors		-			-			-		-			-			-
Adjustments to reconcile net loss to net cash used in operating activities:
Issuances of warrants to investors		-			-			-		-			-			-
Bad debt expense		-			2
Issuance of common stock for payment of Series D preferred dividends		-			-			-		-			-			-
Depreciation		9			9
Issuance of common stock for payment of Series E preferred dividends		-			-			-		-			-			-
Amortization of debt issuance costs and discounts		93			130
Issuance of common stock for payment of Series F preferred dividends		-			-			-		-			-			-
Amortization of beneficial conversion feature		17			-
Issuance of common stock for payment of Series F-2 preferred dividends		-			-			-		-			-			-
Stock-based compensation		120			1,806
Issuance of common stock for payment of interest		-			-			-		-			-			-
Change in fair value of derivative liability		18			(5	)
Issuance of common stock for Series F and Series F-2 one-time 15% dividends		-			-			-		-			-			-
Amortization of lease right-of-use-asset		86			76
Conversion of Series C-2 preferred stock to common stock		-			-			-		-			-			-
Gain from forgiveness of debt		(69	)		(196	)
Conversion of Series D preferred stock to common stock		-			-			-		-			-			-
Other non-cash expenses		21			26
Conversion of Series E preferred stock to common stock		(1	)		(800	)		-		-			-			-
Change in operating assets and liabilities:
Conversion of Series F preferred stock to common stock		-			-			-		(307	)		-			-
Accounts receivable		6			(3	)
Conversion of Series F-2 preferred stock to common stock		-			-			-		-			(3	)		(2,474	)
Inventory		(1	)		(84	)
Stock-based compensation		-			-			-		-			-			-
Other current assets		120			103
Issuances of warrants to consultants		-			-			-		-			-			-
Accounts payable and accrued liabilities		545			43
Impact of Auctus exchange		-			-			-		-			-			-
Lease liabilities		(92	)		(79	)
Accrued preferred dividends		-			-			-		-			-			-
Deferred revenue		425			(85	)
Net loss		-			-			-		-			-			-
NET CASH USED IN OPERATING ACTIVITIES		(1,119	)		(1,746	)
Balance at December 31, 2022		1		$	839			1	$	880			-		$	489
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from the issuance of notes payable		512			-
Proceeds from the issuance of notes payable issued to related parties		75			-
Payments made on notes payable		(438	)		(412	)
Payments made on notes payable issued to related parties		(39	)		-
Payments of debt issuance costs		(29	)		-
Proceeds from issuance of common stock and warrants in private placement offerings		835			-
Proceeds from warrant exercises		-			436
NET CASH PROVIDED BY FINANCING ACTIVITIES		916			24
NET CHANGE IN CASH		(203	)		(1,722	)
Cash at beginning of period		591			2,313
CASH AT END OF PERIOD	$	388		$	591
SUPPLEMENTAL DISCLOSURE FOR OPERATING ACTIVITIES:
Cash paid for interest	$	51		$	107
SUPPLEMENTAL DISCLOSURE FOR NON-CASH INVESTING AND FINANCING ACTIVITIES:
Dividends on preferred stock	$	174		$	171
Deemed dividends for warrant exchanges	$	-		$	99
Warrants issued with debt	$	136		$	-
Fair value of beneficial conversion features	$	100		$	-
Settlement of interest through common stock issuance	$	126		$	119
Settlement of dividends through common stock issuance	$	177		$	173
Settlement of previously accrued professional fees through common stock issuance	$	114		$	168
Accrued payroll liability exchanged for promissory note	$	87		$	-
Directors and Officers Insurance obtained with Financing	$	130		$	129
Conversion of Series E preferred shares into common stock	$	-		$	5
Conversion of Series F preferred shares into common stock	$	21		$	42
Conversion of Series F-2 preferred shares into common stock	$	-		$	14

42 Table of Contents

	Common Stock				AdditionalPaid-In		Treasury			Accumulated
	Shares		Amount		Capital		Stock			Deficit			Total
Balance at December 31, 2021		13,673	$	3,403	$	126,800	$	(132	)	$	(142,387	)	$	(5,445	)
Common stock warrants exercised		5,128		5		841		-			-			846
Issuances of common stock to investors		6,712		7		1,422		-			-			1,429
Issuances of warrants to investors		-		-		1,795		-			-			1,795
Issuance of common stock for payment of Series D preferred dividends		82		-		47		-			-			47
Issuance of common stock for payment of Series E preferred dividends		181		-		102		-			-			102
Issuance of common stock for payment of Series F preferred dividends		162		-		107		-			-			107
Issuance of common stock for payment of Series F-2 preferred dividends		114		-		75		-			-			75
Issuance of common stock for payment of interest		242		-		150		-			-			150
Issuance of common stock for Series F and Series F-2 one-time 15% dividends		624		1		399		-			-			400
Conversion of Series C-2 preferred stock to common stock		1,125		1		91		-			-			-
Conversion of Series D preferred stock to common stock		975		1		116		-			-			-
Conversion of Series E preferred stock to common stock		3,390		3		797		-			-			-
Conversion of Series F preferred stock to common stock		1,480		1		306		-			-			-
Conversion of Series F-2 preferred stock to common stock		10,808		11		2,463		-			-			-
Stock-based compensation		-		-		176		-			-			176
Issuances of warrants to consultants		-		-		1,204		-			-			1,204
Impact of Auctus exchange		3,900		4		1,199		-			-			1,203
Accrued preferred dividends		-		-		-		-			(631	)		(631	)
Net loss		-		-		-		-			(4,341	)		(4,341	)
Balance at December 31, 2022		48,596	$	3,437	$	138,090	$	(132	)	$	(147,359	)	$	(2,883	)

The accompanying notes are an integral part of these consolidated financial statements.

43F-10 Table of Contents

GUIDED THERAPEUTICS, INC. AND SUBSIDIARY CONSOLIDATED STATEMENTS OF CASH FLOWS (in thousands)

	Year Ended
	December 31,
	2023			2022
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$	(3,489	)	$	(4,341	)
Adjustments to reconcile net loss to net cash used in operating activities:
Bad debt expense		2			23
Inventory reserve		-			81
Depreciation		9			4
Amortization of debt issuance costs and discounts		130			143
Stock-based compensation		1,806			1,381
Change in fair value of derivative liability		(5	)		(27	)
Amortization of lease right-of-use-asset		76			68
Loss on extinguishment of debt		-			655
Gain from forgiveness of debt		(196	)		(186	)
Other non-cash expenses		26			172
Change in operating assets and liabilities:
Accounts receivable		(3	)		16
Inventory		(84	)		(58	)
Other current assets		103			363
Accounts payable and accrued liabilities		43			122
Lease liabilities		(79	)		(67	)
Deferred revenue		(85	)		172
NET CASH USED IN OPERATING ACTIVITIES		(1,746	)		(1,479	)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of property and equipment		-			(31	)
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from warrant exercises		436			532
Payments made on notes payable		(412	)		(540	)
Proceeds from issuance of common stock, net of costs		-			1,392
Proceeds from issuance of warrants, net of costs		-			1,796
NET CASH PROVIDED BY (USED IN) FINANCING ACTIVITIES		24			3,180

44 Table of Contents

NET CHANGE IN CASH		(1,722	)		1,670
Cash at beginning of period		2,313			643
CASH AT END OF PERIOD	$	591		$	2,313
SUPPLEMENTAL DISCLOSURE FOR OPERATING ACTIVITIES:
Cash paid for interest	$	107		$	149
SUPPLEMENTAL DISCLOSURE FOR NON-CASH INVESTING AND FINANCING ACTIVITIES:
Dividends on preferred stock	$	171		$	631
Deemed dividends for warrant exchanges	$	99		$	-
Settlement of interest through common stock issuance	$	119		$	151
Settlement of dividends through common stock issuance	$	173		$	730
Settlement of previously accrued professional fees through common stock issuance	$	168		$	-
Conversion of Series C-2 preferred shares into common stock	$	-		$	92
Conversion of Series D preferred shares into common stock	$	-		$	118
Conversion of Series E preferred shares into common stock	$	5		$	800
Conversion of Series F preferred shares into common stock	$	42		$	308
Conversion of Series F-2 preferred shares into common stock	$	14		$	2,473
Directors and Officers insurance obtained with financing	$	129		$	124

The accompanying notes are an integral part of these consolidated financial statements.

45 Table of Contents

GUIDED THERAPEUTICS, INC. AND SUBSIDIARY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

1. ORGANIZATION, BACKGROUND, AND BASIS OF PRESENTATION

Guided Therapeutics, Inc. (formerly SpectRx, Inc.), together with its wholly owned subsidiary, InterScan, Inc. (formerly Guided Therapeutics, Inc.), collectively referred to herein as the “Company”, is a medical technology company focused on developing innovative medical devices that have the potential to improve healthcare. The Company’s primary focus is the continued commercialization of its LuViva non-invasive cervical cancer detection device and extension of its cancer detection technology into other cancers, including esophageal. The Company’s technology, including products in research and development, primarily relates to biophotonics technology for the non-invasive detection of cancers.

Basis of Presentation

The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America, or U.S. GAAP. All intercompany transactions and balances have been eliminated in consolidation. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation of the Company as of December 31, 2023 and 2022, and the consolidated results of operations and cash flows for the years ended December 31, 2023 and 2022 have been included.

The Company’s prospects must be considered in light of the substantial risks, expenses and difficulties encountered by entrants into the medical device industry. This industry is characterized by an increasing number of participants, intense competition and a high failure rate. The Company has experienced net losses since its inception and, as of December 31, ~~2023~~2024, it had an accumulated deficit of approximately $~~151~~153.17 million. To date, the Company has engaged primarily in research and development efforts and the early stages of marketing its products. The Company may not be successful in growing sales for its products. Moreover, required regulatory clearances or approvals may not be obtained in a timely manner, or at all. The Company’s products may not ever gain market acceptance and the Company may not ever generate significant revenues or achieve profitability. The development and commercialization of the Company’s products requires substantial development, regulatory, sales and marketing, manufacturing and other expenditures. The Company expects operating losses to continue for the foreseeable future as it continues to expend substantial resources to complete development of its products, obtain regulatory clearances or approvals, build its marketing, sales, manufacturing and finance capabilities, and conduct further research and development.

~~The~~F-11 ~~Company~~Table ~~is not organized by multiple operating segments for the purpose~~ of making operating decisions or assessing performance. Accordingly, the Company operates in one reportable operating segment. The Company’s principal decision maker is the Chief Executive Officer and acting Chief Financial Officer. Management believes that its business operates as one reportable segment because: a) the Company measures profit and loss as a whole; b) the principal decision makers do not review information based on any operating segment; c) the Company does not maintain discrete financial information on any specific segment; d) the Company has not chosen to organize its business around different products and services, and e) the Company has not chosen to organize its business around geographic areas.Contents

46 Table of Contents

Going Concern

The Company’s consolidated financial statements have been prepared and presented on a basis assuming it will continue as a going concern. The factors below raise substantial doubt about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might be necessary from the outcome of this uncertainty.

At December 31, ~~2023~~2024, the Company had a negative working capital of approximately $35.4 0 million, accumulated deficit of $~~151~~153.17 million, and incurred a net loss including preferred ~~and deemed~~ dividends of $32.8 5 million for the year then ended. Stockholders’ deficit totaled approximately $34.8 9 million at December 31, ~~2023~~2024, primarily due to recurring net losses from operations.

During the year ended December 31, 2024, the Company raised $0.8 million of proceeds from the sale of common stock and warrants in private placement offerings. During the year ended December 31, 2023, the Company received $~~436 thousand~~0.4 million of proceeds from warrant exercises. The Company will need to continue to raise capital in order to provide funding for its operations and FDA/NMPA approval process. If sufficient capital cannot be raised, the Company will continue its plans of curtailing operations by reducing discretionary spending and staffing levels and attempting to operate by only pursuing activities for which it has external financial support. However, there can be no assurance that such external financial support will be sufficient to maintain even limited operations or that the Company will be able to raise additional funds on acceptable terms, or at all. In such a case, the Company might be required to enter into unfavorable agreements or, if that is not possible, be unable to continue operations, and to the extent practicable, liquidate and/or file for bankruptcy protection.

Reclassifications

Certain prior period amounts have been reclassified to conform to the current period presentation. These reclassifications did not affect net loss, revenues or stockholders’ equity.

2. SIGNIFICANT ACCOUNTING POLICIES

Use of Estimates

~~Recent~~The ~~Accounting~~preparation ~~Standard~~of ~~(“ASU”)~~financial tostatements Bein ~~Adopted~~conformity with accounting principles generally accepted in athe ~~Future~~United ~~Period~~States 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 those estimates. Significant areas where estimates are used include the inventory valuation, valuation of share-based compensation and the valuation of the convertible note payable derivative liability. Management bases its estimates on historical experience and on various other assumptions believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results could differ from those estimates, and such differences could be material to the Company’s financial statements.

Recently Implemented Accounting Pronouncements

In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which requires public entities to disclose information about their reportable segments’ significant expenses and other segment items on an interim and annual basis. Public entities with a single reportable segment are required to apply the disclosure requirements in ASU 2023-07, as well as all existing segment disclosures and reconciliation requirements in ASC 280, “Segment Reporting” on an interim and annual basis. ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and for interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The Company adopted this guidance effective January 1, 2024 retrospectively to all periods presented in financial statements. Adoption of this guidance did not have a material impact on our financial statement disclosures.

Accounting Standard to Be Adopted in a Future Period

In December 2023, the FASB issued ASU No. 2023-09, Improvements to Income Tax Disclosures (Topic 740). The ASU requires disaggregated information about a reporting entity’s effective tax rate reconciliation as well as additional information on income taxes paid. The ASU is effective on a prospective basis for annual periods beginning after December 15, 2024. Early adoption is permitted. This ASU will result in the required additional disclosures being included in our consolidated financial statements, once adopted. We are currently evaluating the provisions of this ASU and expect to adopt them for the year ending December 31, 2025.

In November 2024, the FASB issued ASU No. 2024-03 “Income Statement – Reporting Comprehensive Income – Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses.” This ASU requires public business entities to disclose, for interim and annual reporting periods, additional information about certain income statement expense categories. The requirements are effective for fiscal years beginning after December 15, 2026, and for interim periods beginning after December 15, 2027. Entities are permitted to apply either the prospective or retrospective transition methods. The Company is currently evaluating the impact that the adoption of this ASU will have on its consolidated financial statements.

Cash Equivalents

The Company considers all highly liquid investments with an original maturity of three months or less when purchased to be a cash equivalent.

Accounts Receivable

47 Table of Contents

Concentrations of Credit Risk

The Company maintains a cash balance in a financial institution that is insured by the Federal Deposit Insurance Corporation up to certain federal limitations. At times, the Company’s cash balance exceeds these federal limitations. The amount in excess of insured limitations was $137,770 and $156,112 as of December 31, 2024 and December 31, 2023, respectively.

F-12

Table of Contents

Inventory Valuation

All inventories are stated at the lower of cost or net realizable value, with cost determined substantially on a “first-in, first-out” basis. Selling, general, and administrative expenses are not inventoried, but are charged to expense when incurred. AsInventories consisted of the following as of December 31, ~~2023~~2024 and ~~2022~~December 31, ~~our inventories were as follows~~2023:

	(in thousands)
	December 31,			December 31,
	2023			2022
	2024			2023
Raw materials	$	1,~~360~~362		$	1,~~260~~360
Work-in-progress		46			6846
Finished goods		4443			3844
Inventory reserve		(818	)		(818	)
Total inventory	$	~~632~~633		$	~~548~~632

The company periodically reviews the value of items in inventory and provides write-downs or write-offs of inventory based on its assessment of market conditions. Write-downs and write-offs are charged to cost of goods sold.

Property and Equipment

Property and equipment are recorded at cost. Depreciation is computed using the straight-line method over estimated useful lives of three to seven years. ~~Leasehold improvements are amortized at the shorter of the useful life of the asset or the remaining lease term.~~ Depreciation and amortization expense are included in general and administrative expense on the ~~statement~~statements of operations. Expenditures for repairs and maintenance are expensed as incurred. Property and equipment ~~are~~consisted ~~summarized~~of asthe ~~follows~~following atas of December 31, ~~2023~~2024 and ~~2022~~2023:

	(in thousands)
	December 31,			December 31,
	2023			2022
	2024			2023
Equipment	$	951		$	~~1,083~~951
Software		634			~~656~~634
Furniture and fixtures		17			4117
Leasehold improvements		12			12
Subtotal		1,614			1,~~792~~614
Less accumulated depreciation		(1,~~582~~591	)		(1,~~750~~582	)
Property, equipment and leasehold improvements, net	$	32		$	42
	$	23		$	32

During the year ended December 31, 2023, we disposed of approximately $177,685 of fixed assets that were fully depreciated, resulting in no gain or loss on disposal recognized during the year then ended. Depreciation expense related to property and equipment for the years ended December 31, ~~2023~~2024 and ~~2022~~2023 was not material.

48F-13 Table of Contents

Debt Issuance Costs

Debt issuance costs are capitalized and amortized over the term of the associated debt. Debt issuance costs are presented in the balance sheet as a direct deduction from the carrying amount of the debt liability consistent with the debt discount.

Patent Costs (Principally Legal Fees)

Costs incurred in filing, prosecuting, and maintaining patents are recurring, and expensed as incurred. Maintaining patents are expensed as incurred as the Company has not yet received U.S. FDA approval and recovery of these costs is uncertain. Such costs ~~aggregated~~were ~~to approximately~~ $3011,~~500~~377 and $530,~~400~~505 ~~during~~for the years ended December 31, ~~2023~~2024 and ~~2022~~2023, respectively.

Leases

A lease provides the lessee the right to control the use of an identified asset for a period of time in exchange for consideration. Right-of-use assets represent the Company’s right to use an underlying asset for the lease term and operating lease liabilities represent the Company’s obligation to make lease payments arising from the lease. The Company determines if an arrangement is a lease at inception. Right-of-use assets and lease liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term.

Where an operating lease contains extension options that the Company is reasonably certain to exercise, the extension period is included in the calculation of the right-of-use assets and lease liabilities.

The discount rate used to determine the commencement date present value of lease payments is the interest rate implicit in the lease, or when that is not readily determinable, the Company utilizes its secured borrowing rate. Right-of-use assets include any lease payments required to be made prior to commencement and exclude lease incentives. Both right-of-use assets and lease liabilities exclude variable payments not based on an index or rate, which are treated as period costs. The Company’s lease agreements do not contain significant residual value guarantees, restrictions or covenants. See Note 7,6 – “Commitments and Contingencies”. ”

Accrued Liabilities

Accrued liabilities as of December 31, ~~2023~~2024 and ~~2022~~2023 are summarized as follows:

	(in thousands)
	December 31, 2023		December 31, 2022
	December 31, 2024		December 31, 2023
Compensation	$	~~401~~424	$	~~444~~401
Professional fees		~~216~~81		~~285~~216
Interest		90243		~~189~~188
Vacation		2726		4127
Preferred dividends		~~228~~227		~~231~~228
Stock subscription payable		-		36
Other accrued expenses		10		8
Other accrued expenses		8		21
Total	$	1,011	$	1,068
Total	$	970	$	1,247

49F-14 Table of Contents

Stock Subscription Payable

Cash received from investors for shares of common stock ~~shares~~ that have not yet been issued is recorded as a liability, which is presented within Accrued Liabilities on the consolidated balance sheet.

Revenue Recognition

ASC 606, Revenue from Contracts with Customers, establishes a single and comprehensive framework which sets out how much revenue is to be recognized, and when. The core principle is that a vendor should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the vendor expects to be entitled in exchange for those goods or services. Revenue will ~~now~~is be recognized ~~by a vendor~~ when control over the goods or services is transferred to the customer. In contrast, revenue-based revenue recognition around an analysis of the transfer of risks and rewards; this now forms one of a number of criteria that are assessed in determining whether control has been transferred. The application of the core principle in ASC 606 is carried out in five steps:

	·	Step 1 – Identify the contract with a customer: a contract is defined as an agreement (including oral and implied), between two or more parties, that creates enforceable rights and obligations and sets out the criteria for each of those rights and obligations. The contract needs to have commercial substance and it is probable that the entity will collect the consideration to which it will be entitled.

	·	Step 2 – Identify the performance obligations in the contract: a performance obligation in a contract is a promise (including implicit) to transfer a good or service to the customer. Each performance obligation should be capable of being distinct and is separately identifiable in the contract.

	·	Step 3 – Determine the transaction price: transaction price is the amount of consideration that the entity can be entitled to, in exchange for transferring the promised goods and services to a customer, excluding amounts collected on behalf of third parties.

	·	Step 4 – Allocate the transaction price to the performance obligations in the contract: for a contract that has more than one performance obligation, the entity will allocate the transaction price to each performance obligation separately, in exchange for satisfying each performance obligation. The acceptable methods of allocating the transaction price include adjusted market assessment approach, expected cost plus a margin approach, and the residual approach in limited circumstances. Discounts given should be allocated proportionately to all performance obligations unless certain criteria are met and reallocation of changes in standalone selling prices after inception is not permitted.

	·	Step 5 – Recognize revenue as and when the entity satisfies a performance obligation: the entity should recognize revenue at a point in time, except if it meets any of the three criteria, which will require recognition of revenue over time: the entity’s performance creates or enhances an asset controlled by the customer, the customer simultaneously receives and consumes the benefit of the entity’s performance as the entity performs, and the entity does not create an asset that has an alternative use to the entity and the entity has the right to be paid for performance to date.

~~The~~F-15 ~~Company’s~~Table ~~revenues do not require significant estimates or judgments and are recognized when control~~ of the promised goods or services is transferred to the Company’s customers in an amount that reflects the consideration the Company expects to be entitled to in exchange for those goods or services. The Company does not offer returns, discounts, loyalty programs or other sales incentive programs that are material to revenue recognition. The Company is not party to contracts that include multiple performance obligations or material variable consideration.Contents

50The ~~Table~~Company’s revenues do not require significant estimates or judgments and are recognized when control of ~~Contents~~the promised goods or services is transferred to the Company’s customers, which occurs at a point in time, most frequently upon shipment of the product or receipt of the product, depending on shipment terms. Revenue is measured as the amount that reflects the consideration the Company expects to be entitled to in exchange for those goods or services. The Company does not offer returns, discounts, loyalty programs or other sales incentive programs that are material to revenue recognition. The Company is not party to contracts that include multiple performance obligations or material variable consideration.

Contract Balances

The Company defers payments received as revenue until earned based on the related contracts and applying ASC 606 as required. Deferred revenue totaled $~~424~~848,~~225~~917, $~~509~~424,~~101~~225, and $~~337~~509,~~315~~ 101 as of December 31, ~~2023~~2024, ~~2022~~December 31, 2023 and ~~2021~~December 31, 2022, respectively.

Trade receivables are recorded net of allowances for chargebacks, cash discounts for prompt payment and credit losses. The Company estimates an allowance for expected credit losses by considering factors such as historical experience, credit quality, the age of the accounts receivable balances, and current economic conditions that may affect a customer’s ability to pay. The corresponding expense for the credit loss allowance is reflected in selling, general and administrative expenses. The credit loss allowance was immaterial as of December 31, 2024 and December 31, 2023.

Significant Customers

As of December 31, 2024, trade receivables of $2,669 (net of the allowance for credit losses of $586) were attributed to one customer. As of December 31, 2023, trade receivables of $7,442 (net of the allowance for credit losses of $1,500) were attributed to two customers.

Research and Development

Research and development expenses consist of expenditures for research conducted by the Company and payments made under contracts with consultants or other outside parties and costs associated with internal and contracted clinical trials. All research and development costs are expensed as incurred.

Income Taxes

The provision for income taxes is determined in accordance with ASC 740, “Income Taxes”. The Company provides for income taxes based on enacted tax law and statutory tax rates at which items of income and expense are expected to be settled in our income tax return. Certain items of revenue and expense are reported for Federal income tax purposes in different periods than for financial reporting purposes, thereby resulting in deferred income taxes. Deferred taxes are also recognized for operating losses that are available to offset future taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized.

The Company has filed its ~~2022~~2023 federal and state corporate tax returns. Although the Company has been experiencing recurring losses, it is obligated to file tax returns for compliance with IRS regulations and that of applicable state jurisdictions. At December 31, ~~2023~~2024, the Company had approximately $6663.4 9 million of net operating losses carryforward available, $2.9 million ~~This~~of which will expire on December 31, 2026. The remaining net operating loss will be eligible to be carried forward for tax purposes at federal and applicable states level. A full valuation allowance has been recorded related to the deferred tax assets ~~generated from the net operating losses~~.

The Company recognizes uncertain tax positions based on a benefit recognition model. Provided that the tax position is deemed more likely than not of being sustained, the Company recognizes the largest amount of tax benefit that is greater than 50.0% likely of being ultimately realized upon settlement. The tax position is derecognized when it is no longer more likely than not of being sustained. The Company classifies income tax related interest and penalties as interest expense and selling, general and administrative expense, respectively, on the consolidated statements of operations.

Warrants

The Company has issued warrants, which allow the warrant holder to purchase one share of stock at a specified price for a specified period of time. The Company records equity instruments including warrants based on the fair value at the date of issue. The fair value of warrants ~~classified as equity instruments at the date of issuance~~ is estimated using the Black-Scholes or binomial option pricing models on the date of issuance.

Stock Based Compensation

The Company accounts for its stock-based awards in accordance with ASC Subtopic 718, “Compensation – Stock Compensation”, which requires fair value measurement on the grant date and recognition of compensation expense for all stock-based payment awards made to employees and directors. The Company determines the fair value of stock options using the Black-Scholes model. The fair value of restricted stock awards is based upon the quoted market price of the shares of common ~~shares~~stock on the date of grant. The fair value of stock-based awards is expensed over the requisite service periods of the awards. The Company accounts for forfeitures of stock-based awards as they occur.

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The Black-Scholes option pricing model requires the input of certain assumptions that require the Company’s judgment, including the expected term and the expected stock price volatility of the underlying stock. The assumptions used in calculating the fair value of stock-based compensation represent management’s best estimates, but these estimates involve inherent uncertainties and the application of judgment. As a result, if factors change resulting in the use of different assumptions, stock-based compensation expense could be materially different in the future.

During the year ended December 31, 2024, the Company recognized $80,155 of expense for stock options and $41,242 of expense for warrants issued to a director. Additionally, during the year ended December 31, 2024, the Company accrued $17,889 of expense for common stock owed to a director, pursuant to his consulting agreement. During the year ended December 31, 2023, the Company recognized $235,980 of expense related to stock options and $1,570,877 of expense for common stock and warrants issued to consultants and directors. Additionally, during the year ended December 31, 2023, the Company accrued $104,844 of expense for common stock owed to a director, pursuant to his consulting agreement.

F-16

Table of Contents

Derivatives

The Company reviews the terms of convertible debt issued to determine whether there are embedded derivative instruments, including embedded conversion options, which are required to be bifurcated and accounted for separately as derivative financial instruments. In circumstances where the host instrument contains more than one embedded derivative instrument, including the conversion option, that is required to be bifurcated, the bifurcated derivative instruments are accounted for as a single, compound derivative instrument.

Bifurcated embedded derivatives are initially recorded at fair value and are then revalued at each reporting date with changes in the fair value reported as non-operating income or expense. When the equity or convertible debt instruments contain embedded derivative instruments that are to be bifurcated and accounted for as liabilities, the total proceeds received are first allocated to the fair value of all the bifurcated derivative instruments. The remaining proceeds, if any, are then allocated to the host instruments themselves, usually resulting in those instruments being recorded at a discount from their face value. The discount from the face value of the convertible debt, together with the stated interest on the instrument, is amortized over the life of the instrument through periodic charges to interest expense.

3.Fair ~~FAIR~~Value ~~VALUE OF FINANCIAL INSTRUMENTS~~Measurements

~~The guidance for fair value measurements,~~ ASC 820, “Fair Value Measurements and Disclosures,” ~~establishes~~clarifies ~~the~~that ~~authoritative definition of~~ fair value, ~~sets~~is ~~out~~an aexit ~~framework for measuring fair value~~price, ~~and~~representing ~~outlines~~ the ~~required~~amount ~~disclosures regarding fair value measurements. Fair value is the price~~ that would be received to sell an asset or paid to transfer a liability (in an ~~exit~~orderly ~~price)~~transaction inbetween ~~the~~market ~~principal~~participants. orFair ~~most~~value ~~advantageous~~is a market-based ~~for~~measurement ~~the~~that ~~asset~~should orbe ~~liability~~determined inbased anupon ~~orderly~~assumptions ~~transaction~~that ~~between~~ market participants atwould ~~the~~use ~~measurement~~in ~~date~~pricing an asset or liability. ~~The~~As ~~Company~~a ~~uses~~basis for considering such assumptions, ASC 820 establishes a three-tier fair value hierarchy, ~~based~~which ~~upon~~prioritizes ~~observable~~the ~~and~~inputs ~~non-observable~~used ~~inputs~~in measuring fair value as ~~follow~~follows:

· Level 1–: Quoted ~~market~~ prices for identical assets or liabilities in active markets ~~for~~that ~~identical~~the ~~assets~~Company ~~and~~can ~~liabilities;~~access at the measurement date. · Level 2~~–Inputs,~~: Significant other observable inputs other than level 1 ~~inputs,~~prices ~~either~~such ~~directly~~as orquoted ~~indirectly~~prices ~~observable;~~for ~~and~~similar ·assets ~~Level~~or ~~3–Unobservable~~liabilities, ~~inputs~~quoted ~~developed~~prices ~~using~~in ~~internal~~markets ~~estimates~~that ~~and~~are ~~assumptions~~not ~~(there~~active isor ~~little~~other inputs that are observable or nocan be corroborated by observable market ~~date)~~data. ~~which~~· Level 3: Significant unobservable inputs that reflect ~~those~~the Company’s judgment about the assumptions that market participants would use in pricing an asset or liability.

~~The~~An ~~Company~~asset ~~records~~or ~~its~~liability’s ~~derivative activities at~~ fair value. ~~There~~measurement ~~were~~level nowithin ~~derivative~~the ~~liabilities~~fair ~~recorded~~value ashierarchy ofis ~~December~~based ~~31,~~on ~~2023.~~the Aslowest level of ~~December~~any ~~31,~~input ~~2022,~~that weis ~~had~~significant ~~one~~to ~~derivative liability associated with~~ the ~~bifurcated~~fair ~~conversion~~value ~~option~~measurement. ofValuation atechniques ~~loan~~used ~~due~~need to ~~Auctus~~maximize ~~Funds, LLC (“Auctus”) in~~ the ~~amount~~use of ~~$326,016.~~observable ~~There~~inputs ~~was~~and nominimize ~~movement of instruments between fair value hierarchy tiers during~~ the ~~years~~use ~~ended~~of ~~December~~unobservable ~~31, 2023 or 2022~~inputs.

52Assets ~~Table~~and liabilities measured at fair value are based on one or more of ~~Contents~~the following three valuation techniques noted in ASC 820:

~~The~~· ~~following~~Market ~~tables~~approach: ~~present~~Prices ~~the~~and ~~fair~~other ~~value~~relevant ofinformation ~~those~~generated by market transactions involving identical or comparable assets or liabilities. ~~measured~~· onCost aapproach: ~~recurring~~Amount ~~basis~~that aswould be required to replace the service capacity of ~~December~~an ~~31,~~asset ~~2022~~(replacement cost). · Income approach: Techniques to convert future amounts to a single present value amount

	Fair Value at December 31, 2022 (in thousands)
	Level 1		Level 2		Level 3			Total
Derivative liability/bifurcated conversion option in connection with Auctus $326,016 loan on December 17, 2019		-		-		(5	)		(5	)
Total long-term liabilities at fair value	$	-	$	-	$	(5	)	$	(5	)

The Company believes its valuation methods are appropriate and consistent with other market participants, however the use of different methodologies or assumptions to determine the fair value of certain financial instruments could result in a different fair value measurement at the reporting date.

~~The~~F-17 ~~following~~Table ~~is a summary~~ of ~~changes to Level 3 instruments during the year ended December 31, 2023:~~Contents

	(in thousands)
Balance at December 31, 2022	$	(5	)
Change in fair value during the period		5
Balance at December 31, 2023	$	-

3. STOCKHOLDERS’ DEFICIT

4.2024 ~~STOCKHOLDERS’~~Private ~~DEFICIT~~Placement Offerings

~~Sales~~On ofSeptember 23, 2024, the Company entered into a Securities –Purchase ~~2022~~ Agreement (the “September Purchase Agreement”) with certain institutional investors, including John Imhoff a member of the Company’s Board of Directors, for the purpose of raising $300,000 in gross proceeds for the Company. Pursuant to the terms of the September Purchase Agreement, the Company agreed to sell, in a private placement offering, an aggregate of 3,333,335 units, each unit consisting of one share of common stock and one warrant to purchase up to 3,333,335 shares of common stock (the “September Warrants”). The purchase price per unit was $0.09. The September Warrants were immediately exercisable upon issuance, expire four years following the issuance date and have an exercise price of $0.12 per share.

~~During~~On ~~the year ended~~ December 3118, ~~2022~~2024, the Company entered into ~~certain~~a Securities Purchase ~~Agreements~~Agreement (the “December Purchase Agreement”) with certain ~~accredited~~institutional investors ~~(the “Investors”)~~, including ~~Richard Blumberg, Michael James and~~ John Imhoff, ~~each~~ a member of the Company’s Board of Directors, ~~pursuant~~for tothe ~~which~~purpose of raising $535,000 in gross proceeds for the Company. ~~issued 6,711,540 shares~~Pursuant to the terms of ~~its~~the ~~common~~December ~~stock~~Purchase Agreement, ~~four~~the ~~year~~Company ~~warrants~~agreed to ~~purchase~~sell, in a private placement offering, an aggregate of 6 4,~~711~~115,~~540 shares~~386 ofunits, ~~Common~~each ~~Stock~~unit atconsisting ~~$0.50 per~~of one share of common stock and 6one warrant to purchase up to 4,~~711~~115,~~540~~386 shares of ~~Common~~common ~~Stock~~stock at(the “December Warrants”). The purchase price per unit was $0.~~65 per~~13. ~~share~~The ~~(the~~December “Warrants”) ~~for~~were animmediately ~~aggregate~~exercisable ~~purchase~~upon issuance, expire four years following the issuance date and have an exercise price of $~~3,355,270 (the~~0.18 ~~“Transaction”)~~per share.

~~After~~F-18 ~~payment~~Table of all fees and expenses relating to the transaction, the Company received net proceeds of approximately $3.2 million. The primary use of proceeds was to fund the completion and filing of clinical study data needed for FDA approval of the Company’s LuViva Advanced Cervical Scan. The proceeds were also used to support international distribution partners to grow sales and for general and administrative expenses.Contents

53 Table of Contents

Common Stock

The Company has authorized 500,000,000 shares of common stock with $0.001 par value. As of December 31, ~~2023~~2024 and ~~2022~~December 31, 542023,~~105~~ 65,~~101~~130,623 and 4854,~~595~~105,~~715~~101 shares of common ~~shares~~stock were issued and outstanding, respectively.

During the years ended December 31, ~~2023~~2024 and ~~2022~~2023, the Company issued 511,~~509~~025,~~386~~522 and 345,~~922~~509,~~132~~386 shares of common stock, respectively, as summarized in the following tables:

	Number of Shares
Issuances of common stock to investors		6,711,540
Issuances of common stock for warrants exercised		5,127,923
Issuances of common stock to Auctus for Exchange Agreement		3,900,000
Issuances of common stock for payment of Series D Preferred dividends		81,973
Issuances of common stock for payment of Series E Preferred dividends		179,858
Issuances of common stock for payment of Series F Preferred dividends		163,214
Issuances of common stock for payment of Series F-2 Preferred dividends		114,304
Issuances of common stock for payment of interest		241,914
Issuances of common stock for Series F one-time 15% dividend		255,401
Issuances of common stock for Series F-2 one-time 15% dividend		368,505
Conversion of Series C-2 Preferred stock to common stock		1,124,500
Conversion of Series D Preferred stock to common stock		975,000
Conversion of Series E Preferred stock to common stock		3,390,000
Conversion of Series F Preferred stock to common stock		1,480,000
Conversion of Series F-2 Preferred stock to common stock		10,808,000
Total common stock issued during the year ended December 31, 2022		34,922,132
Common stock warrants exercised		3,128,274
Issuance of common stock for payment of Series D preferred dividends		151,347
Issuance of common stock for payment of Series E preferred dividends		378,294
Issuance of common stock for payment of Series F preferred dividends		233,308
Issuance of common stock for payment of Series F-2 preferred dividends		120,284
Issuance of common stock for payment of interest		417,879
Issuance of common stock to consultants		800,000
Conversion of Series E preferred stock to common stock		20,000
Conversion of Series F preferred stock to common stock		200,000
Conversion of Series F-2 preferred stock to common stock		60,000
Total common stock issued during the year ended December 31, 2023		5,509,386
Summary table of common stock transactions:
Shares outstanding at December 31, 2021		13,673,583
Common shares issued during the year ended December 31, 2022		34,922,132
Shares outstanding at December 31, 2022		48,595,715
Common shares issued during the year ended December 31, 2023		5,509,386
Shares outstanding at December 31, 2023		54,105,101

	Number of Shares

Issuance of common stock in private placement offerings		7,448,721
Issuance of common stock for payment of Series D preferred dividends		248,858
Issuance of common stock for payment of Series E preferred dividends		625,511
Issuance of common stock for payment of Series F preferred dividends		450,179
Issuance of common stock for payment of Series F-2 preferred dividends		235,544
Conversion of Series F preferred stock to common stock		100,000
Issuance of common stock for payment of interest		1,116,709
Issuance of common stock to consultants		800,000
Total common stock issued during the year ended December 31, 2024		11,025,522

Summary table of common stock transactions:
Shares outstanding at December 31, 2022		48,595,715
Common shares issued during the year ended December 31, 2023		5,509,386
Shares outstanding at December 31, 2023		54,105,101
Common shares issued during the year ended December 31, 2024		11,025,522
Shares outstanding at December 31, 2024		65,130,623

Preferred Stock

The Company has authorized 5,000,000 shares of preferred stock with a $0.001 par value. The board of directors has the authority to issue these shares and to set dividends, voting and conversion rights, redemption provisions, liquidation preferences, and other rights and restrictions.

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Series C Convertible Preferred Stock

The board designated 9,000 shares of preferred stock as Series C Convertible Preferred Stock, (the “Series C Preferred Stock”). Pursuant to the Series C certificate of designations, shares of Series C Preferred Stock are convertible into common stock by their holder at any time and may be mandatorily convertible upon the achievement of specified average trading prices for the Company’s common stock. At December 31, ~~2023~~2024 and ~~December 31~~2023, ~~2022,~~ there were 286 shares outstanding with a conversion price of $0.5013 per share, ~~such that each share of Series C Preferred Stock would convert into approximately 2,000 shares of the Company’s common stock; for a total of 572,000 shares,~~ subject to customary adjustments, including for any accrued but unpaid dividends and pursuant to certain anti-dilution provisions, as set forth in the Series C certificate of designations. The conversion price will automatically adjust downward to 80% of the then-current market price of the Company’s common stock 15 trading days after any reverse stock split of the Company’s common stock, and 5 trading days after any conversions of the Company’s outstanding convertible debt.

Holders of the Series C Preferred Stock are entitled to quarterly cumulative dividends at an annual rate of 12.0% until 42 months after the original issuance date (the “Dividend End Date”), payable in cash or, subject to certain conditions, the Company’s common stock. Unpaid accrued dividends were $120,120 as of December 31, ~~2023~~2024 and ~~2022~~2023. Upon conversion of the Series C Preferred Stock prior to the Dividend End Date, the Company will also pay to the converting holder a “make-whole payment” equal to the number of unpaid dividends through the Dividend End Date on the converted shares. At December 31, ~~2023~~2024 and ~~2022~~2023, the “make-whole payment” for a converted share of Series C Preferred Stock would convert to 200 shares of the Company’s common stock.

The Series C Preferred Stock generally has no voting rights except as required by Delaware law. Upon the Company’s liquidation or sale to or merger with another corporation, each share will be entitled to a liquidation preference of $1,000, plus any accrued but unpaid dividends.

Series C1 Convertible Preferred Stock

The board designated 20,250 shares of preferred stock as Series C1 Preferred Stock, of which 1,049.25 shares were issued and outstanding at December 31, ~~2023~~2024 and ~~2022~~2023. The C1 Convertible Preferred Stock has a conversion price of $0.13 per share.

AtThe ~~December~~Series ~~31,~~C1 ~~2023~~Preferred ~~and~~Stock ~~2022,~~has ~~there~~terms ~~were~~that ~~1,049.25~~are ~~shares~~substantially ~~outstanding~~the ~~with~~same aas ~~conversion~~the ~~price~~Series ofC ~~$0.50~~Preferred ~~per share~~Stock, ~~such~~except that ~~each~~the ~~share of~~ Series C1 Preferred Stock ~~would~~does ~~convert~~not ~~into~~pay ~~approximately~~dividends ~~2,000~~(unless ~~shares~~and ofto the ~~Company’s~~extent declared on the common stock) or at-the-market “make-whole payments” and, ~~for~~while ait ~~total~~has some of 2the same anti-dilution protections afforded the Series C Preferred Stock,~~098,500~~ ~~common~~it ~~shares~~does not automatically reset in connection with a reverse stock split or conversion of our outstanding convertible debt.

The Series C1 Preferred Stock has terms that are substantially the same as the Series C Preferred Stock, except that the Series C1 Preferred Stock does not pay dividends (unless and to the extent declared on the common stock) or at-the-market “make-whole payments” and, while it has the same anti-dilution protections afforded the Series C preferred stock, it does not automatically reset in connection with a reverse stock split or conversion of our outstanding convertible debt.

Series C2 Convertible Preferred Stock

On August 31, 2018, the Company entered into agreements with certain holders of the Company’s Series C1 Convertible Preferred Stock, including the chairman of the Company’s board of directors, the former Chief Operating Officer (now the Chief Executive Officer) and a director of the Company pursuant to which those holders separately agreed to exchange each share of the Series C1 Preferred Stock held for one (1) share of the Company’s newly created Series C2 Convertible Preferred Stock. In total, for 3,262.25 shares of Series C1 Convertible Preferred Stock to be surrendered, the Company issued 3,262.25 shares of Series C2 Convertible Preferred Stock. At December 31, 2024 and December 31, 2023, there were 2,700 shares outstanding, each with a conversion price of $0.13 per share.

At December 31, 2023 and 2022, there were 2,700 shares outstanding, each with a conversion price of $0.50 per share, such that each share of Series C preferred stock would convert into approximately 2,000 shares of the Company’s common stock; for a total of 5,400,000 common shares.

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The terms of the Series C2 Convertible Preferred Stock are substantially the same as the Series C1 shares, except that (i) shares of Series C1 Convertible Preferred Stock were not convertible into the Company’s common stock by their holder for a period of 180 days following the date of the filing of the Certificate of Designation (the “Lock-Up Period”); (ii) the Series C2 Convertible Preferred Stock has the right to vote as a single class with the Company’s common stock on an as-converted basis, notwithstanding the Lock-Up Period; and (iii) the Series C2 Convertible Preferred Stock will automatically convert into that number of securities sold in the next Qualified Financing (as defined in the Exchange Agreement) determined by dividing the stated value ($1,000 per share) of such share of Series C2 Preferred Stock by the purchase price of the securities sold in the Qualified Financing.

~~During~~F-20 ~~the~~Table ~~year ended December 31, 2022, the Company issued 1,124,500 common stock shares for the conversion~~ of 562.25 shares of Series C2 Preferred stock. As of December 31, 2023 and 2022, 2,700 shares of Series C2 Convertible Preferred stock remained outstanding with a conversion price of $0.50 per share, such that each share of Series C2 Convertible Preferred Stock would convert into approximately 2,000 shares of the Company’s common stock, for a total of 5,400,000 common shares.Contents

Series D Convertible Preferred Stock

The board designated 6,000 shares of preferred stock as Series D Preferred Stock, 438 of which remained outstanding as of December 31, ~~2023~~2024 and ~~2022~~December 31, 2023. On January 8, 2021, the Company entered into a Stock Purchase Agreement with certain accredited investors (“the Series D Investors”) pursuant to all obligations under the Series D Certificate of Designation. The Series D Investors included the Chief Executive Officer, Chief Operating Officer (now the Chief Executive Officer) and a director of the Company. In total, for $763,000 the Company issued 763 shares of Series D Preferred Stock, 1,526,000 shares of common stock, 1,526,000 common stock warrants exercisable at $0.25, and 1,526,000 common stock warrants, exercisable at $0.75. ~~Each Series D Preferred Stock is convertible into 3,000 shares of common stock.~~ The Series D Preferred Stock have cumulative dividends at the rate per share of 10% per annum. Each share of Series D Preferred Stock has a par value of $0.001 per share and a stated value equal to $750.

Each share of Series D Preferred is convertible, at any time for a period of 5 years after issuance, into that number of shares of Common Stock, determined by dividing the Stated Value by $0.25, subject to certain adjustments set forth in the Series D Certificate of Designation (the “Series D Conversion Price”). The conversion of Series D Preferred is subject to a 4.99% beneficial ownership limitation, which may be increased to 9.99% at the election of the holder of the Series D Preferred. If the average of the VWAPs (as defined in the Series D Certificate of Designation) for any consecutive 5 trading day period (“Measurement Period”) exceeds 200% of the then Series D Conversion Price and the average daily trading volume of the Common Stock on the primary trading market exceeds 1,000 shares per trading day during the Measurement Period (subject to adjustments), the Company may redeem the then outstanding Series D Preferred, for cash in an amount equal to aggregate ~~stated~~Stated ~~value~~Value then outstanding plus accrued but unpaid dividends. During the years ended December 31, 2024, and 2023 the Company issued 248,858 and 151,347 shares of common stock for payment of accrued Series D Preferred Stock dividends, respectively. As of December 31, 2024 and 2023, the Company had accrued dividends for the Series D Preferred Stock of $8,360.

~~During~~F-21 ~~the~~Table ~~year ended December 31, 2023, the Company issued 151,347 shares~~ of ~~common stock for payment of Series D Preferred Stock dividends.~~ Contents

During the year ended December 31, 2022, the Company entered into various agreements with Series D Preferred shareholders, pursuant to which each holder separately agreed to exchange their Series D Preferred shares into the Company’s common shares (in accordance with their existing Series D Preferred Share Agreements). In addition, the holders agreed to exchange 650,000 common stock warrants with a strike price of $0.25 for 650,000 warrants with a strike price of $0.20, which were required to be immediately exercised. The Company received $130,000 from the holders for exercises of the aforementioned warrants.

During the year ended December 31, 2022, the Company issued (1) 975,000 common stock shares for the conversion of 325 shares of Series D Preferred Stock, and (2) 81,973 shares of common stock for the payment of accrued Series D Preferred Stock dividends.

As of December 31, 2023 and 2022, the Company had accrued dividends for Series D preferred shares of $8,360 and $8,213, respectively.

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Series E Convertible Preferred Stock

The ~~board~~Board designated 5,000 shares of preferred stock as Series E Preferred Stock, 883 ~~and 888~~ of which remained outstanding as of December 31, ~~2023~~2024 and ~~2022, respectively~~2023. ~~Each~~During ~~share~~year ofended ~~Series~~December E31, ~~Preferred is convertible~~2020, atthe ~~any~~Company ~~time~~entered ~~for~~into a ~~period of 5 years after issuance, into that number of shares of Common~~ Stock, ~~determined~~Purchase byAgreement ~~dividing~~with ~~the Stated Value by $0.25, subject to~~ certain ~~adjustments~~accredited ~~set~~investors ~~forth in the Series E Certificate of Designation~~ (“the “Series E ~~Conversion Price~~Investors”). ~~The~~pursuant ~~conversion of Series E Preferred is subject~~ to ~~a 4.99%~~all ~~beneficial~~obligations ~~ownership~~under ~~limitation, which may be increased to 9.99% at~~ the ~~election of the holder of the~~ Series E ~~Preferred. If the average of the VWAPs (as defined in the Series E~~ Certificate of Designation). ~~for~~In ~~any~~total, ~~consecutive~~for ~~5 trading day period (“Measurement Period”) exceeds 200% of the then Series E Conversion Price and the average daily trading volume of the Common Stock on the primary trading market exceeds~~ $1,736,000 ~~shares~~ ~~per trading day during~~ the ~~Measurement Period (subject to adjustments), the~~ Company ~~may~~issued ~~redeem the then outstanding Series E Preferred~~1,736 ~~for~~shares ~~cash in an amount equal to aggregate Stated Value then outstanding plus accrued but unpaid dividends. Each share~~ of Series E Preferred Stock ~~has a par value of $0~~.~~001 per~~ ~~share~~The ~~and a~~ stated value ~~equal~~and toliquidation ~~$1,000,~~preference ~~subject~~on to the ~~increase~~Series ~~set~~E ~~forth~~Preferred inStock ~~its~~is ~~Certificate of Designation~~$1,736.

Each ~~holder~~share of Series E Preferred is convertible, at any time for a period of 5 years after issuance, into that number of shares of Common Stock, isdetermined ~~entitled~~by dividing the Stated Value by $0.25, subject to ~~receive~~certain ~~cumulative~~adjustments ~~dividends~~set forth in the Series E Certificate of 8Designation (the “Series E Conversion Price”). The conversion of Series E Preferred is subject to a 4.99% ~~per~~beneficial ~~annum~~ownership limitation, ~~payable~~which ~~annually~~may inbe ~~cash~~increased ~~or,~~to 9.99% at the ~~option~~election of the holder of the Series E Preferred. If the average of the VWAPs (as defined in the Series E Certificate of Designation) for any consecutive 5 trading day period (“Measurement Period”) exceeds 200% of the then Series E Conversion Price and the average daily trading volume of the Common Stock on the primary trading market exceeds 1,000 shares per trading day during the Measurement Period (subject to adjustments), the Company may redeem the then outstanding Series E Preferred, ~~shares~~for cash in an amount equal to aggregate Stated Value then outstanding plus accrued but unpaid dividends. Each share of ~~common~~Series ~~stock~~E Preferred Stock has a par value of $0.001 per share and a stated value equal to $1,000, subject to the increase set forth in its Certificate of Designation.

Each holder of Series E Preferred Stock is entitled to receive cumulative dividends of 8% per annum, payable annually in cash or, at the option of the Company, shares of common stock. During the ~~year~~years ended December 31, 2024 and 2023, the Company issued ~~(1)~~625,511 and 378,294 shares of common stock for payment of accrued Series E Preferred Stock dividends, respectively. During the year ended December 31, 2023, the Company issued 20,000 shares of common stock for the conversion of 5 shares of Series E Convertible Preferred Stock. As of December 31, 2024 and ~~(2)~~ ~~378~~2023,~~294 shares~~ ofthe ~~common~~Company ~~stock~~had ~~for~~accrued ~~payment~~dividends of $30,272 for the Series E Preferred Stock ~~dividends~~.

During the year ended December 31, 2022, the Company issued (1) 3,390,000 common stock shares for the conversion of 847.5 shares of Series E Convertible Preferred Stock, and (2) 179,858 common stock shares for the payment of Series E Preferred Stock dividends.

As of December 31, 2023 and 2022, the Company had accrued dividends of $30,272 and $30,414 for the Series E Preferred Stock, respectively.

Series F Convertible Preferred Stock

The ~~board~~Board designated 1,500 shares of preferred stock as Series F Preferred Stock, 981 and 1,006 ~~and 1,056~~ of which ~~were~~remained ~~issued and~~ outstanding as of December 31, ~~2023~~2024 and ~~2022~~2023, respectively. During 2021, the Company entered into a Stock Purchase Agreement with certain accredited investors (“the Series F Investors”). In total, for $1,436,000 the Company issued 1,436 shares of Series F ~~Convertible~~ Preferred Stock. ~~Each Series F Preferred share is convertible into 4,000 shares of common stock.~~ The Series F ~~Convertible~~ Preferred Stock is entitled to cumulative dividends at the rate per share of 6% per annum. The stated value on the Series F ~~Convertible~~ Preferred Stock is $1,000.

Each share of Series F Preferred Stock is convertible, at any time for a period of 5 years after issuance, into that number of shares of Common Stock, determined by dividing the Stated Value by $0.25, subject to certain adjustments set forth in the Series F Certificate of Designation (the “Series F Conversion Price”). The conversion of Series F Preferred Stock is subject to a 4.99% beneficial ownership limitation, which may be increased to 9.99% at the election of the holder. If the average of the VWAPs (as defined in the Series F Certificate of Designation) for any consecutive 5 trading day period (“Measurement Period”) exceeds 200% of the then Series F Conversion Price and the average daily trading volume of the Common Stock on the primary trading market exceeds 1,000 shares per trading day during the Measurement Period (subject to adjustments), the Company may redeem the then outstanding Series F Preferred, for cash in an amount equal to aggregate stated value then outstanding plus accrued but unpaid dividends.

During the ~~year~~years ended December 31, 2024 and 2023, the Company issued ~~200~~ 450,179 and 233,308 shares of common stock for the payment of annual Series F Preferred Stock dividends, respectively. During the year ended December 31, 2024, the Company issued 100,000 shares of common stock for the conversion of 50 shares of Series F Convertible Preferred Stock. ~~and 233~~During the year ended December 31,~~308~~ 2023, the Company issued 200,000 shares of common stock for ~~payment~~the conversion of ~~annual~~50 shares of Series F Convertible Preferred Stock. As of December 31, 2024 and 2023, the Company had accrued dividends. for Series F preferred shares of $44,799 and $46,108, respectively.

~~During the year ended December 31, 2022, the Company issued 1,480,000 shares of common stock for the conversion of 370 shares of Series~~ F Preferred stock and 163,214 shares of common stock for the payment of annual Series F Preferred Stock dividends. During the year ended December 31, 2022, the Company also issued 255,401 shares of common stock for the payment of a one-~~time,~~22 ~~non-recurring~~Table ~~15% dividend to the Series F Preferred shareholders (as required by the Series F Certificate~~ of ~~Designation, in the event the Company did not uplist to the NASDAQ stock exchange or file its clinical data intended for FDA approval of LuViva by December 31, 2021).~~ Contents

As of December 31, 2023 and 2022, the Company had accrued dividends of $46,108 and $48,400 for the Series F Convertible Preferred Stock, respectively.

57 Table of Contents

Series F-2 Convertible Preferred Stock

The Company was oversubscribed for its Series F Preferred Stock, resulting in the requirement to file an additional Certificate of Designation for Series F-2 Preferred Stock with substantially the same terms as the Series F Preferred Stock. The Board designated 3,500 shares of preferred stock as Series F-2 Preferred Stock, 520 ~~and 535~~ of which were issued and outstanding as of December 31, ~~2023~~2024 and ~~2022, respectively~~2023. During 2021, the Company entered into a Stock Purchase Agreement with certain accredited investors. In total, for $678,000 the Company issued 678 shares of Series F-2 Preferred Stock. In addition, the Company exchanged outstanding debt of $2,559,000 for 2,559 shares of Series F-2 Preferred Stock. ~~Each Series F-2 Preferred share is convertible into 4,000 shares of common stock.~~ The Series F-2 Preferred Stock will have cumulative dividends at the rate per share of 6% per annum. The stated value on the Series F-2 Preferred Stock is $1,000.

Each share of Series F-2 Preferred Stock is convertible, at any time for a period of 5 years after issuance, into that number of shares of Common Stock, determined by dividing the Stated Value by $0.25, subject to certain adjustments set forth in the Series F-2 Certificate of Designation (the “Series F-2 Conversion Price”). The conversion of Series F-2 Preferred is subject to a 4.99% beneficial ownership limitation, which may be increased to 9.99% at the election of the holder. If the average of the VWAPs (as defined in the Series F-2 Certificate of Designation) for any consecutive 5 trading day period (“Measurement Period”) exceeds 200% of the then Series F-2 Conversion Price and the average daily trading volume of the Common Stock on the primary trading market exceeds 1,000 shares per trading day during the Measurement Period (subject to adjustments), the Company may redeem the then outstanding Series F-2 Preferred Stock, for cash in an amount equal to aggregate Stated Value then outstanding plus accrued but unpaid dividends.

During the ~~year~~years ended December 31, 2024 and 2023, the Company issued 60 235,~~000~~ 544 and 120,284 shares of common stock for the ~~conversion~~payment of 15annual ~~shares of~~ Series F-2 Preferred Stock ~~and~~dividends, respectively. During the year ended December 31, 2023, the Company issued ~~120~~60,~~284~~000 shares of common stock for ~~payment~~the conversion of ~~annual~~15 shares of Series F-2 Preferred Stock. As of December 31, 2024 and 2023, the Company had accrued dividends. for Series F-2 preferred shares of $23,518 and $23,579, respectively.

During the year ended December 31, 2022, the Company issued 10,808,000 shares of common stock for the conversion of 2,702 shares of Series F-2 Preferred stock and 114,304 shares of common stock for the payment of annual Series F-2 Preferred Stock dividends. During the year ended December 31, 2022, the Company also issued 368,505 shares of common stock for the payment of a one-time, non-recurring 15% dividend to the Series F-2 Preferred shareholders (as required by the Series F-2 Certificate of Designation, in the event the Company did not uplist to the NASDAQ stock exchange or file its clinical data intended for FDA approval of LuViva by December 31, 2021).

As of December 31, 2023 and 2022, the Company had accrued dividends of $23,579 and $24,267 for the Series F-2 Convertible Preferred Stock, respectively.

Series G Convertible Preferred Stock

During January 2021, the board designated 1,000 shares of preferred stock as Series G Convertible Preferred Stock, none of which remained outstanding as of December 31, ~~2023~~2024 and ~~2022~~2023. The Series G Convertible Preferred Stock had a mandatory redemption feature and was fully redeemed prior to January 1, 2022.

58 Table of Contents

Warrants

The following table summarizes transactions involving the Company’s outstanding warrants to purchase common stock for the ~~years~~year ended December 31, ~~2023~~2024 and ~~2022~~2023:

	Warrants (Underlying Shares)			Weighted-Average Exercise Price Per Share
Outstanding, December 31, 2021		27,669,634		$	0.29
Warrants issued		24,223,080		$	0.54
Warrants cancelled/expired		(4,450,866	)	$	0.54
Warrants exchanged		(8,775,000	)	$	0.19
Warrants exercised		(3,079,868	)	$	0.17
Outstanding, December 31, 2022		35,586,980		$	0.46
Warrants issued		8,782,730		$	0.22
Warrants cancelled/expired		(9,545,200	)	$	0.30
Warrants exchanged		(3,257,200	)	$	0.25
Warrants exercised		(2,982,730	)	$	0.15
Outstanding, December 31, 2023		28,584,580		$	0.50
Warrants issued		10,151,388		$	0.19
Warrants cancelled/expired		(1,561,500	)	$	0.44
Outstanding, December 31, 2024		37,174,468		$	0.42

~~Warrant~~F-23 ~~Transactions~~Table –of ~~2023~~Contents

OnWarrants ~~May~~Issued ~~14,~~in 2023, the Compensation Committee of the Company’s Board of Directors approved the issuance of 4,000,000 common stock warrants to Mark Faupel, upon his appointment to the Company’s Board as President and Chief Executive Officer on March 10, 2023. The warrants, which have a strike price of $0.25, are fully vested and will expire on May 13, 2028. During the year ended December 31, 2023, the Company recorded approximately $679,959 of stock-based compensation expense attributed to the warrants.2024

OnDuring ~~May 14, 2023,~~ the ~~Compensation~~year ~~Committee~~ended ofDecember ~~the Company’s Board of Directors also approved the issuance of 4~~31,~~000,000~~ ~~common stock warrants to Mark Faupel~~2024, ~~2,500,000 of~~ ~~which will be vested upon receipt by~~ the ~~Corporation~~Company ~~of an Approval Letter from the U.S. Food and Drug Administration for the LuViva Advanced Cervical Scan and~~issued 1,~~500~~800,000 ofwarrants ~~which~~to ~~will~~Richard ~~be vested upon receipt by the Corporation of an Approval Letter or equivalent from the Chinese National Medical Products Administration for the LuViva Advanced Cervical Scan. The warrants~~Blumberg, ~~which have~~ a ~~strike~~related ~~price of $0.40~~party, ~~will~~pursuant ~~expire~~to ~~five years after they are exercisable with~~ a ~~maximum~~consulting ~~term of 10 years from issuance~~agreement. AsSee ofNote ~~December 31~~6, “Commitments ~~2023, the Company has concluded it is not probable that the performance conditions related to the warrants will be achieved,~~ and ~~as a result~~Contingencies” ~~no compensation~~for ~~expense~~additional ~~related to the warrants has been recorded~~information.

During the year ended December 31, ~~2023~~2024, the Company issued 1 827,~~800~~667 warrants in conjunction with the issuances of notes payable totaling $350,000 ~~warrants~~ to ~~Richard~~unaffiliated ~~Blumberg~~third parties and 75,000 awarrants ~~related~~in ~~party~~conjunction with issuances of $75,000 ~~pursuant~~of tonotes apayable ~~consulting~~to ~~agreement~~board members. See Note 7, “~~Commitments~~Notes Payable” and ~~Contingencies~~Note 9, “Related Party Debt” for additional ~~information~~details on the warrants issued with debt.

59During ~~Table~~the year ended December 31, 2024, the Company issued 3,333,335 warrants in connection with the private placement offering that closed on September 23, 2024, 1,666,677 of ~~Contents~~which were issued to one of our board members, a related party. Management estimated the fair value of the warrants utilizing the Black-Scholes Option Pricing model with the following assumptions before allocating the total proceeds from the offering to the common stock and warrants issued:

During the year ended December 31, 2023, the Company entered into various agreements with holders of the Company’s $0.25 strike price warrants (including Richard Blumberg, a related party), pursuant to which each holder separately agreed to exchange 1,025,000 common stock warrants with a strike price of $0.25 for 973,750 common stock warrants with a strike price of $0.20. During the year ended December 31, 2023, the Company received approximately $194,750 from the holders for the exercise of the 973,750 warrants. The Company measured the effect of the exchange as the excess of fair value of the exchanged instruments over the fair value of the original instruments and recorded a deemed dividend of approximately $65,296.

Expected term (years)	4.0
Volatility	397.3	%
Risk-free interest rate	3.5	%
Dividend yield	0.0	%

During the year ended December 31, 2024, the Company issued 4,115,386 warrants in connection with the private placement offering that closed on December 18, 2024, 1,615,385 of which were issued to one of our board members, a related party. Management estimated the fair value of the warrants utilizing the Black-Scholes Option Pricing model with the following assumptions before allocating the total proceeds from the offering to the common stock and warrants issued:

Expected term (years)	4.0
Volatility	396.6	%
Risk-free interest rate	4.4	%
Dividend yield	0.0	%

Warrants Issued in 2023

On May 14, 2023, the Compensation Committee of the Company’s Board of Directors approved the issuance of 4,000,000 common stock warrants to Mark Faupel, upon his appointment to the Company’s Board as President and Chief Executive Officer on March 10, 2023. The warrants, which have a strike price of $0.25, were fully vested on the issuance date and will expire on May 13, 2028. During the year ended December 31, 2023, the Company recorded approximately $679,959 of stock-based compensation expense attributed to the warrants.

On May 14, 2023, the Compensation Committee of the Company’s Board of Directors also approved the issuance of 4,000,000 common stock warrants to Mark Faupel, 2,500,000 of which will be vested upon receipt by the Corporation of an Approval Letter from the U.S. Food and Drug Administration for the LuViva Advanced Cervical Scan and 1,500,000 of which will be vested upon receipt by the Corporation of an Approval Letter or equivalent from the Chinese National Medical Products Administration for the LuViva Advanced Cervical Scan. The warrants, which have a strike price of $0.40, will expire five years after they are exercisable with a maximum term of 10 years from issuance. As of December 31, 2024, the Company has concluded it is not probable that the performance conditions related to the warrants will be achieved, and as a result no compensation expense related to the warrants has been recorded.

During the year ended December 31, 2023, the Company issued 1,800,000 warrants to Richard Blumberg, a related party, pursuant to a consulting agreement. See Note 6, “Commitments and Contingencies” for additional information.

During the year ended December, 2023, the Company entered into various agreements with holders of the Company’s $0.25 strike price warrants, pursuant to which each holder separately agreed to exchange 1,025,000 common stock warrants with a strike price of $0.25 for 973,750 common stock warrants with a strike price of $0.20. The Company received approximately $194,750 from the holders for the exercise of the 973,750 warrants. The Company measured the effect of the exchange as the excess of fair value of the exchanged instruments over the fair value of the original instruments and recorded a deemed dividend of approximately $65,296.

During the year ended December 31, 2023, the Company entered into agreements with Richard Blumberg (a Director of the Company) and Lee Bowles who were holders of 2,232,200 common stock warrants with a strike price of $0.25. The parties agreed to exchange their warrants for 2,008,980 common stock warrants with a strike price of $0.12 and a contractual term of 5 days. During November 2023, the Company received approximately $241,078 from the holders and issued 2,008,980 common shares upon exercise of the warrants. The Company measured the effect of the exchange as the excess of fair value of the exchanged instruments over the fair value of the original instruments and recorded a deemed dividend of approximately $33,676.

~~Management~~During ~~estimated~~ the ~~fair~~year ~~value~~ended ofDecember ~~the~~31, ~~warrants~~2023, ~~issued~~management ~~during~~estimated the ~~year~~fair ~~ended~~value ~~December~~of ~~31,~~the ~~2023~~warrants issued utilizing the Black-Scholes Option Pricing model with the following weighted-average assumptions:

Expected term	2.9 Years
Expected term (years)		2.9
Volatility		241.2	%
Risk-free interest rate		3.3	%
Dividend yield		0.0	%

~~Warrant~~F-24 ~~Transactions~~Table –of ~~2022~~Contents

~~During~~4. ~~the~~STOCK year ended December 31, 2022, the Company issued 13,423,080 warrants to investors (see “Sales of Securities - 2022” above); the proceeds from which were assigned to the warrants on an allocated fair-value basis.OPTIONS

~~During~~The Company’s Stock Plan (the ~~year~~“Plan”) ~~ended~~allows ~~December~~for 31the issuance of incentive stock options, ~~2022~~nonqualified stock options, and stock purchase rights. The exercise price of options was determined by the Company’s ~~exchanged 8,775,000 warrants~~board ~~for 7~~of directors,~~800,000 newly~~ ~~issued~~but ~~warrants~~incentive instock ~~accordance~~options ~~with~~were granted at an ~~exchange~~exercise ~~agreement~~price ~~with~~equal ~~Auctus~~to the fair market value of the Company’s common stock as of the grant date. ~~See~~Options ~~Note~~historically 9granted have generally become exercisable over four years and expire ten years from the date of grant. The aggregate number of common shares that may be issued or reserved pursuant to stock option or other awards under the plan may not exceed 2,500,000 ~~“Auctus~~common ~~Convertible~~shares. ~~Debt”~~ As of December 31, 2024, shares available for ~~details~~issuance under the Plan were 116,364.

~~During~~The ~~the~~following ~~year~~tables ~~ended~~summarize ~~December 31, 2022,~~ the Company’s ~~issued 3,000,000 warrants~~stock tooption ~~consultants~~activity asand ~~consideration~~related ~~for~~information ~~performing services. The expense~~ for ~~such~~the ~~warrants~~years ~~will~~ended beDecember ~~recognized~~31, on2024 aand ~~pro-rata basis over the term of their respective agreements.~~2023:

Management estimated the fair value of the warrants issued during the year ended December 31, 2022 utilizing the Black-Scholes Option Pricing model with the following weighted-average assumptions:

	Number of Shares			Weighted-Average Exercise Price Per Share		Weighted-Average Remaining Contractual Life	Aggregate Intrinsic Value of In-the-Money Options (in thousands)

Options outstanding as of December 31, 2022		1,500,000		$	0.49	7.5 years	$	-
Options granted		1,025,000		$	0.26
Options forfeited		(186,364	)	$	0.31
Options outstanding as of December 31, 2023		2,338,636		$	0.41	6.5 years	$	-
Options exercisable as of December 31, 2023		1,811,364		$	0.45	5.9 years	$	-
Options granted		545,000		$	0.12
Options outstanding as of December 31, 2024		2,883,636		$	0.35	6.3 years	$	16,350
Options exercisable as of December 31, 2024		2,266,023		$	0.40	5.6 years	$	5,202

Expected term	3.8 Years
Volatility		148.4	%
Risk-free interest rate		3.6	%
Dividend yield		0.0	%

The aggregate intrinsic value is calculated as the difference between the Company’s closing stock price as of December 31, 2024 and the exercise price, multiplied by the number of options. As of December 31, 2024, there was $109,496 of unrecognized stock-based compensation expense. Such costs are expected to be recognized over a weighted average period of approximately 1.7 years. The weighted-average fair value of awards granted was $0.12 and $0.26 during the years ended December 31, 2024 and 2023, respectively.

~~During~~The ~~the~~Company ~~year~~recognizes ~~ended~~compensation ~~December~~expense ~~31,~~for ~~2022,~~stock ~~the~~option ~~Company~~awards ~~issued 5,127,923 common~~on ~~shares~~a ~~for~~straight-line ~~warrants~~basis ~~exercised, 2,193,599 of~~over ~~which~~the ~~were~~applicable ~~for~~service ~~warrants~~period ~~exercised~~of ~~prior~~the toaward. ~~December~~During ~~31,~~the ~~2021.~~years Asended of December 31, ~~2022~~2024 and 2023, the Company ~~had~~recognized ~~received~~expense ~~approximately $36,386 of proceeds~~ for ~~the~~stock ~~exercise~~options of ~~145~~$80,~~544~~155 and ~~warrants~~$235, ~~which was included in Accrued Liabilities as of December 31~~980, ~~2022 pending issuance of the common shares~~respectively.

602024 ~~Table~~Stock ofOption ~~Contents~~Activity

5On July 9, 2024, the Company granted 45,000 stock options to employees under the Plan and 500,000 stock options to executives and directors of the Company outside of the Plan. ~~STOCK~~The ~~OPTIONS~~stock options, which have exercise prices of $0.12, will expire on July 8, 2034. One fourth of the stock options vested immediately, while the remaining options will vest over a period of 33 months, beginning on October 9, 2024.

The ~~new~~Black-Scholes ~~Stock~~option ~~Plan~~pricing ~~(the~~model ~~“Plan”) allows for the issuance of incentive stock options, nonqualified stock options,~~ and ~~stock purchase rights. The exercise price of options was determined by~~ the ~~Company’s~~following ~~board~~weighted-average ofassumptions ~~directors, but incentive stock options~~ were ~~granted~~used ~~at an exercise price equal~~ to estimate the fair ~~market~~ value of ~~the~~awards ~~Company’s common stock as of the grant date. Options historically~~ granted ~~have~~during ~~generally become exercisable over four years and expire ten years from~~ the ~~date~~year ofended ~~grant.~~December ~~The~~31, ~~plan provides for stock options to be granted up to 10% of the outstanding common stock shares.~~2024:

Expected term (years)	6.1
Volatility	797.4	%
Risk-free interest rate	4.2	%
Dividend yield	-

2023 Stock Option Activity

On February 10, 2023, the Company granted 925,000 stock options to employees, executives and directors of the Company. The stock options, which have exercise prices of $0.2629, will expire on February 9, 2033. One fourth of the stock options vested immediately, while the remaining options will vest over a period of 33 months, beginning on May 10, 2023.

On March 3, 2023, Dr. Gene Cartwright retired from his position as President and Chief Executive Officer of the Company and as a member of the Board. Upon his departure, Mr. Cartwright forfeited 186,364 unvested stock options. On May 2, 2023, the Company’s Board of Directors approved an extension of the expiration date of Mr. Cartwright’s vested options to June 1, 2025. Management measured the modified stock option award using the Black-Scholes option pricing model and recorded expense of $59,216 during the ~~year~~nine months ended ~~December~~September 3130, 2023, representing the excess fair value of the modified award over the original award. Management estimated the fair value of the modified award using the Black-Scholes option pricing model and the following assumptions:

On March 7, 2023, the Company granted 100,000 stock options, which have exercise prices of $0.27 and will expire on March 6, 2033, to Alan Grujic, upon appointing him to the Board of Directors. One fourth of the stock options vested immediately, while the remaining options will vest over a period of 33 months, beginning on June 7, 2023.

~~Management~~The ~~estimated~~Black-Scholes ~~the~~option ~~fair~~pricing ~~value~~model ofand the ~~stock~~following ~~options~~weighted-average ~~granted~~assumptions ~~during~~were ~~the~~used ~~year~~to ~~ended~~estimate ~~December~~the ~~31,~~fair ~~2023~~value ~~utilizing~~of ~~the~~awards ~~Black-Scholes~~granted ~~Option~~during ~~Pricing~~the ~~model~~year ~~with~~ended ~~the~~December ~~following~~31, ~~weighted-average assumptions~~2023:

Expected term (years)	~~10 years~~	10.0
Volatility		366.4	%
Risk-free interest rate		3.8	%
Dividend yield		~~0.0~~-	%

~~During~~F-25 ~~the~~Table ~~years ended December 31, 2023 and 2022, the Company recognized expense for stock options~~ of $235,980 and $175,647, respectively. There was no stock option activity during the year ended December 31, 2022. The following table summarizes the Company’s stock option activity and related information for the years ended December 31, 2023 and 2022: Contents

	Number of Shares			Weighted-Average Exercise Price Per Share		Weighted-Average Remaining Contractual Life	Aggregate Intrinsic Value of In-the-Money Options (in thousands)
Options outstanding as of December 31, 2022		1,500,000		$	0.49	7.5 years	$	-
Options exercisable as of December 31, 2022		1,318,091		$	0.49	7.5 years	$	-
Options outstanding as of January 1, 2023		1,500,000			0.49	7.5 years
Options granted		1,025,000		$	0.26
Options forfeited		(186,364	)	$	0.31
Options outstanding as of December 31, 2023		2,338,636		$	0.41	6.5 years	$	-
Options exercisable as of December 31, 2023		1,867,614		$	0.44	5.9 years	$	-

5. LITIGATION AND CLAIMS

~~The~~From ~~aggregate~~time ~~intrinsic~~to ~~value~~time, isthe ~~calculated~~Company asmay ~~the~~be ~~difference~~involved ~~between~~in ~~the~~various ~~Company’s~~legal ~~closing~~proceedings ~~stock~~and ~~price~~claims asarising ofin ~~December~~the ~~31,~~ordinary ~~2023~~course ~~and~~of ~~the~~business. ~~exercise~~Management ~~price,~~believes ~~multiplied~~that by the ~~number~~dispositions of ~~options.~~these Asmatters, ofindividually ~~December~~or ~~31,~~in ~~2023~~aggregate, ~~there~~are ~~was~~not ~~$124,251~~expected ~~total~~to ~~unrecognized~~have ~~stock-based~~a ~~compensation~~material ~~expense.~~adverse ~~Such~~effect ~~costs~~on ~~are~~the ~~expected~~Company’s tofinancial becondition. ~~recognized~~However, ~~over~~depending aon ~~period~~the ofamount ~~approximately~~and ~~2.25~~timing ~~years.~~of ~~The~~such ~~weighted-average~~disposition, ~~fair~~an ~~value~~unfavorable resolution of ~~awards~~some ~~granted~~or ~~was~~all ~~$0.26~~of ~~and~~these ~~nil~~matters ~~during~~could materially affect the ~~years~~future ~~December~~results ~~31,~~of ~~2023~~operations ~~and~~or ~~2022,~~cash ~~respectively.~~flows in a particular year.

61As ~~Table~~ of ~~Contents~~December 31, 2024, and 2023, there was no accrual recorded for any potential losses related to pending litigation.

6. ~~LITIGATION~~COMMITMENTS AND ~~CLAIMS~~ CONTINGENCIES

From time to time, the Company may be involved in various legal proceedings and claims arising in the ordinary course of business. Management believes that the dispositions of these matters, individually or in the aggregate, are not expected to have a material adverse effect on the Company’s financial condition. However, depending on the amount and timing of such disposition, an unfavorable resolution of some or all of these matters could materially affect the future results of operations or cash flows in a particular year.

As of December 31, 2023 and 2022, there was no accrual recorded for any potential losses related to pending litigation.

7. COMMITMENTS AND CONTINGENCIES

Operating Leases

Our corporate offices, which also comprise our administrative, research and development, marketing and production facilities, are located on a 12,835 square foot leased property. Total operating lease cost recognized for this lease was $109,404 for the years ended December 31, ~~2023~~2024 and ~~2022~~2023. The below table presents total operating lease right-of-use assets and lease liabilities as of December 31, ~~2023~~2024 and ~~2022~~2023:

	(in thousands)
	December 31, 2023		December 31, 2022
	December 31, 2024		December 31, 2023
Operating lease right-of-use assets	$	~~227~~141	$	~~303~~227
Operating lease liabilities	$	~~246~~155	$	~~325~~246

The table below presents the maturities of operating lease liabilities as of December 31, ~~2023~~2024:

	(in thousands)
	OperatingLeases
	Operating
2024		115
	Leases
2025		118
2026		50
Total future lease payments		~~283~~168
Less: discount		(3713	)
Total lease liabilities	$	~~246~~155

62The ~~Table~~table below presents the weighted-average remaining lease term and discount rate used in the calculation of ~~Contents~~operating lease right-of-use assets and lease liabilities as of December 31, 2024 and December 31, 2023

The table below presents the weighted-average remaining lease term and discount rate used in the calculation of operating lease right-of-use assets and lease liabilities:

	Year Ended December 31,
	2024			2023
Weighted average remaining lease term (years)		1.4			2.4
Weighted average discount rate		11.4	%		11.4	%

	Year Ended December 31,
	2023			2022
Weighted average remaining lease term (years)		2.4			3.4
Weighted average discount rate		11.4	%		11.4	%

Related Party Contracts

OnDuring ~~June 5, 2016,~~ the ~~Company~~year ~~entered~~ended ~~into~~December ~~a license agreement with Shenghuo Medical~~31, ~~LLC pursuant to which the Company granted Shenghuo an exclusive license to manufacture~~2024, ~~sell and distribute LuViva in Taiwan, Brunei Darussalam, Cambodia, Laos, Myanmar, Philippines, Singapore, Thailand, and Vietnam. Shenghuo was already~~ the Company’s ~~exclusive~~issued ~~distributor~~promissory innotes ~~China,~~totaling ~~Macau and Hong Kong~~$75,000 ~~and the license extended~~ to ~~manufacturing~~members ~~in those countries as well. Under the terms~~ of the ~~license~~Board ~~agreement, once Shenghuo was capable~~ of ~~manufacturing LuViva in accordance with ISO 13485 for medical devices, Shenghuo would pay the Company a royalty equal to $2~~Directors.00 ~~or 20%~~See ofNote ~~the distributor price (subject to a discount under certain circumstances)~~9, ~~whichever~~“Related isParty ~~higher,~~Debt” per disposable distributed within Shenghuo’s exclusive territories. In connection with the license grant, Shenghuo was to underwrite the cost of securing approval of LuViva with Chinese Food and Drug Administration. At its option, Shenghuo also would provide up to $1.0 million in furtherance of the Company’s efforts to secure regulatory approval for ~~LuViva~~additional ~~from the U~~details.S. Food and Drug Administration, in exchange for the right to receive payments equal to 2% of the Company’s future sales in the United States, up to an aggregate of $4.0 million. Pursuant to the license agreement, Shenghuo had the option to have a designee appointed to the Company’s board of directors (current director Richard Blumberg is the designee).

On June 5, 2016, the Company entered into a license agreement with Shenghuo Medical, LLC pursuant to which the Company granted Shenghuo an exclusive license to manufacture, sell and distribute LuViva in Taiwan, Brunei Darussalam, Cambodia, Laos, Myanmar, Philippines, Singapore, Thailand, and Vietnam. Under the terms of the license agreement, once Shenghuo was capable of manufacturing LuViva in accordance with ISO 13485 for medical devices, Shenghuo would pay the Company a royalty equal to $2.00 or 20% of the distributor price (subject to a discount under certain circumstances), whichever is higher, per disposable distributed within Shenghuo’s exclusive territories. Pursuant to the license agreement, Shenghuo had the option to have a designee appointed to the Company’s board of directors (current director Richard Blumberg is the designee).

F-26

Table of Contents

On September 6, 2016, the Company entered into a royalty agreement with one of its directors, John Imhoff, and another stockholder, Dolores Maloof, pursuant to which the Company sold to them a royalty of future sales of single-use cervical guides for LuViva. Under the terms of the royalty agreement, and for consideration of $50,000, the Company will pay them an aggregate perpetual royalty initially equal to $0.10, and from and after October 2, 2016, equal to $0.20, for each cervical guide that the Company sells (or that is sold by a third party pursuant to a licensing arrangement with the Company).

On January 22, 2020, the Company entered into a promotional agreement with a related party, which is partially owned by Mr. Blumberg, to provide investor and public relations services for a period of two years. As compensation for these services, the Company agreed to issue a total of 5,000,000 warrants, broken into four tranches of 1,250,000. The warrants have a strike price of $0.25 and ~~are~~were subject to vesting based upon the close of the Series D offering and a minimum share price based on the 30-day VWAP. If the minimum share price per the terms of the agreement is not achieved, the warrants will expire three years after the scheduled issuance date. The warrants were valued using the Black Scholes model on the grant date of January 22, 2020. As ~~a result~~ of ~~this agreement, the Company recognized nil and $79,444 of consulting expense during the years ended~~ December 31, ~~2023 and 2022~~2024, ~~respectively.~~unrecognized ~~Unrecognized~~ consulting expense toassociated bewith ~~recognized~~the ~~under this~~ agreement was nil ~~as of December 31, 2023. As of December 31, 2023,~~ and 2,500,000 of the warrants ~~had~~have been issued, of which 1,750,000 were issued to Mr. Blumberg and 750,000 were issued to non-related parties.

During the year ended December 31, 2023, the Company entered into an agreement with Mr. Blumberg to exchange 875,000 of ~~the~~his outstanding warrants for 831,250 warrants with a strike price of $0.20, which were exercised during the first quarter of 2023.

During the year ended December 31, 2023, the Company entered into anagreements ~~agreement~~ with Mr. Blumberg toand ~~exchange~~Lee Bowles, who were holders of ~~875~~2,~~000~~232,200 common stock warrants with a strike price of ~~the~~$0.25. ~~outstanding~~The parties agreed to exchange their warrants for ~~787~~2,~~500~~008,980 common stock warrants with a strike price of $0.12 and a contractual term of 5 days. During November 2023, ~~which~~the ~~were~~Company ~~exercised~~received ~~during~~approximately $241,078 from the ~~fourth~~holders ~~quarter~~and issued 2,008,980 common shares upon exercise of ~~2023~~the warrants. The Company measured the effect of the exchange as the excess of fair value of the exchanged instruments over the fair value of the original instruments and recorded a deemed dividend of approximately $33,676.

63On ~~Table~~March 10, 2021, the Company entered into a consulting agreement with Richard Blumberg. As a result of ~~Contents~~the consulting agreement Mr. Blumberg provided a non-refundable payment of $350,000 to the Company in exchange for the following: (1) 3,600,000 3-year warrants with exercise prices ranging from $0.30 - $0.60, and (2) 1,600,000 common stock shares. On September 30, 2021, the Company and Mr. Blumberg entered into an amended agreement, pursuant to which issuance of the warrants and common shares became predicated on Mr. Blumberg’s assistance in helping the Company obtaining financing or a series of financings resulting in minimum receipts of at least $1.0 million. Upon receipt of the funds, the Company agreed to issue the common shares and warrants owed to Mr. Blumberg in four equal tranches, to be issued every six months, beginning six months after the financing transaction. On November 11, 2022, the Company and Mr. Blumberg entered into an amended agreement, upon which the exercise prices of the warrants were changed to $0.30. The Company estimated the fair value of the modified warrants using the Black-Scholes option pricing model and the following assumptions:

On March 10, 2021, the Company entered into a consulting agreement with Richard Blumberg. As a result of the consulting agreement Mr. Blumberg provided $350,000 to the Company in exchange for the following: (1) 3,600,000 3-year warrants with exercise prices ranging from $0.30 - $0.60, and (2) 1,600,000 common stock shares. On September 30, 2021, the Company and Mr. Blumberg entered into an amended agreement, pursuant to which issuance of the warrants and common shares became predicated on the Company obtaining financing or a series of financings resulting in minimum receipts of at least $1.0 million. Upon receipt of the funds, the Company agreed to issue the common shares and warrants owed to Mr. Blumberg in four equal tranches, to be issued every six months, beginning six months after the financing transaction.

On November 11, 2022, the Company and Mr. Blumberg entered into an amended agreement, upon which the exercise prices of the warrants were changed to $0.30. The Company estimated the fair value of the modified warrants using the Black-Scholes option pricing model and the following assumptions:

Expected term (years)	3.0
Volatility	108.7	%
Risk-free interest rate	4.3	%
Dividend yield	0.0	%

During the years ended December 31, ~~2023~~2024 and ~~2022~~2023, the Company issued 1.8,800,000 warrants ~~million~~to ~~and~~Mr. ~~nil~~Blumberg ~~warrants~~ pursuant to the agreement, and recognized ~~$740,517~~expense ~~and $393,893~~ of ~~expense~~nil ~~for~~and ~~the warrants issued to Mr. Blumberg~~$740, 517, respectively. Total unrecognized expense for the warrants was nil as of December 31, ~~2023~~2024.

During the years ended December 31, ~~2023~~2024 and ~~2022~~2023, the Company issued 800,000 ~~and nil~~ shares of common stock and recognized $~~104~~17,~~844~~ 889 and $~~166~~104,~~667~~844 of expense for the shares of common stock issued and due to Mr. Blumberg, respectively. ~~As not all of the shares had been issued as of December 31, 2023, the Company estimated the total amount of expense using the closing price of the Company’s stock as of December 31, 2023.~~

~~During~~On ~~the~~August ~~year ended December 31~~24, ~~2021~~2022, the ~~consulting~~Company entered into an agreement ~~was~~with ~~amended~~Ironstone toCapital ~~clarify~~Corp. ~~that~~and ~~$350,000~~Alan isGrujic ~~not~~(the ~~intended~~“Advisory Group”) whereby the Advisory Group agreed to beperform ~~debt~~marketing and ~~will~~investor ~~not~~relations beservices ~~required~~over toa beterm ~~repaid~~of intwelve ~~cash.~~months, ~~The~~commencing ~~Company~~on ~~confirmed~~the anclosing ~~obligation~~of toa ~~provide~~financing ~~Mr.~~of ~~Blumberg~~at ~~with~~least ~~950,000~~$2.5 ~~fully~~million. ~~transferrable~~In ~~warrants,~~consideration ~~which~~for ~~will~~these ~~expire~~services, onthe ~~January~~Company 1issued 800,000 warrants ~~2024~~(“first ~~and~~tranche ~~have~~warrants”) with an exercise price of $0.2550 to Mr. ~~Issuance~~Grujic, which were due within 10 business days of closing the ~~warrants~~financing ~~owed~~transaction to(the ~~Mr.~~“Transaction”) ~~Blumberg~~that ~~for~~took ~~his~~place ~~services~~in ~~was~~September ~~predicated~~2022. onIn the event the Company’s ~~receiving~~20 ~~funding~~trading ~~receipts~~day ofvariable weighted average price (“VWAP”) exceeds $1.00 within one year of the closing of the financing,~~000~~ the Company would have issued 600,000, warrants ~~whether~~(“second ~~from~~tranche awarrants”) ~~financing,~~with ~~series~~an exercise price of ~~financing,~~$0.75 to orMr. ~~gross~~Grujic. ~~sales~~In the event the Company’s 20 trading day VWAP exceeds $1.50 within ~~The~~two ~~amended~~years ~~agreement~~of ~~clarified~~the ~~that~~closing of the financing, the Company will issue an additional 600,000 warrants ~~issued~~(“third tranche warrants”) to Mr. ~~Blumberg~~Grujic. ~~are~~Once ~~compensation~~issued, ~~for~~the ~~services~~warrants ~~which~~vest ~~involve~~immediately ~~investor~~and ~~relations,~~will ~~marketing~~expire ~~services~~two ~~and~~years ~~assisting~~from the date of issuance. If the Company’s U.S. clinical study is not completed and filed with ~~obtaining~~the ~~financing~~U.S. ~~During~~FDA or if the ~~year~~Chinese ~~ended~~NMPA ~~December~~approval ~~31,~~is ~~2022~~not granted by each due date for reaching each respective pricing milestone, then the ~~Company~~due ~~obtained~~date ~~the~~for ~~requisite~~reaching ~~funding~~each ~~receipts~~milestone ~~and~~shall ~~estimated~~be ~~the~~extended ~~fair~~by ~~value~~six months. As of December 31, 2024, the ~~warrants~~deadline ~~using~~to achieve the ~~Black-Scholes~~stock ~~option~~price ~~pricing~~of ~~model~~$1.50 has ~~with~~passed and the ~~following~~second ~~assumptions:~~and third tranche of warrants will therefore not be issued.

Expected term (years)	1.3
Volatility	164.6	%
Risk-free interest rate	4.1	%
Dividend yield	0.0	%

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Table of Contents

~~Expense~~Pursuant ~~recorded~~to ~~for~~the agreement, the ~~warrants~~Company ~~was~~also ~~nil~~agreed ~~and~~to pay the Advisory Group $~~307~~2,~~457~~000 ~~during~~per month for 12 months, starting the ~~years~~month ~~ended~~after ~~December~~the 31closing of the Transaction. Subsequently, ~~2023~~the ~~and~~agreement ~~2022~~was amended to extend the term of the agreement to September of 2024. On November 1, ~~respectively~~2024, the Company entered into a new consulting agreement with Ironstone Capital Corp., ~~The~~pursuant ~~unrecognized~~to ~~expense~~which the Company agreed to bepay ~~recognized~~$2,500 per month for ~~the~~continued ~~warrants~~advisory ~~was~~and ~~nil~~consulting asservices, offor ~~December~~a ~~31,~~term ~~2023~~of six months.

On August 24, 2022, the Company entered into an agreement with Ironstone Capital Corp. and Alan Grujic (the “Advisory Group”) whereby the Advisory Group agreed to perform marketing and investor relations services over a term of twelve months, commencing on the closing of a financing of at least $2.5 million. In consideration for these services, the Company issued 800,000 warrants (“first tranche warrants”) with an exercise price of $0.50 to Mr. Grujic, which were due within 10 business days of closing the financing transaction (the “Transaction”) that took place in September 2022. In the event the Company’s 20 trading day variable weighted average price (“VWAP”) exceeds $1.00 within one year of the closing of the financing, the Company would have issued 600,000 warrants (“second tranche warrants”) with an exercise price of $0.75 to Mr. Grujic. In the event the Company’s 20 trading day VWAP exceeds $1.50 within two years of the closing of the financing, the Company will issue an additional 600,000 warrants (“third tranche warrants”) to Mr. Grujic. Once issued, the warrants vest immediately and will expire two years from the date of issuance. If the Company’s U.S. clinical study is not completed and filed with the U.S. FDA or if the Chinese NMPA (formerly Chinese FDA) approval is not granted by each due date for reaching each respective pricing milestone, then the due date for reaching each milestone shall be extended by six months. Pursuant to the agreement, the Company also agreed to pay the Advisory Group $2,000 per month for 12 months, starting the month after the closing of the Transaction. Subsequently, the agreement was amended to extend the term of the agreement to September of 2024.

The Company estimated the fair value of the first tranche warrants issued in September 2022 using the Black-Scholes option pricing model with the following assumptions:

Expected term (years)	2.0
Volatility	173.0	%
Risk-free interest rate	3.4	%
Dividend yield	0.0	%

~~The~~Expense ~~Company~~related ~~recognized~~to ~~expense of $364,800 for~~ the first tranche of warrants ~~during~~was ~~the~~recognized ~~year~~in ~~ended~~prior ~~December 31, 2022~~years. Unrecognized expense related to the first tranche warrants was nil as of December 31, ~~2022~~2024.

The Company estimated the fair value of the second tranche warrants using the Binomial Lattice model with the following assumptions:

Expected term (years)	1.0
Volatility	144.4	%
Risk-free interest rate	3.6	%
Dividend yield	0.0	%

64The ~~Table~~Company recognized expense for the second tranche of ~~Contents~~warrants of nil and $79,216 during the years ended December 31, 2024 and 2023, respectively. Unrecognized expense for the second tranche of warrants was nil as of December 31, 2024.

The Company estimated the fair value of the third tranche warrants using the Binomial Lattice model with the following assumptions:

Expected term (years)	2.0
Volatility	172.1	%
Risk-free interest rate	3.6	%
Dividend yield	0.0	%

The Company recognized expense for the ~~second and~~ third ~~tranches~~tranche of warrants of $~~141~~41,~~079~~242 and $6061,~~229~~863 during the years ended December 31, ~~2023~~2024 and ~~2022~~2023, respectively. Unrecognized expense for the ~~second and~~ third tranche of warrants was ~~$41,242~~nil as of December 31, ~~2023~~2024.

Other Commitments

On July 24, 2019, the Company agreed to grant Shandong Yaohua Medical Instrument Corporation (“SMI”) (1) exclusive manufacturing rights, excepting the disposable cervical guides for the Republic of Turkey, and the final assembly rights for Hungary, and (2) exclusive distribution and sales for LuViva in jurisdictions, subject to the terms and conditions described below.

First, SMI shall complete the payment for parts, per the purchase order, for five additional LuViva devices. Second, in consideration for the $885,144 that the Company received, SMI will receive 12,147 shares of common stock. Third, SMI shall honor all existing purchase orders it has executed to date with the Company, in order to maintain jurisdiction sales and distribution rights. If SMI needs to purchase cervical guides, then it will do so at a cost including labor, plus ten percent markup. The Company will provide 200 cervical guides at no cost for the clinical trials. Fourth, the Company and SMI will make best efforts to sell devices after CFDA approval. With an initial estimate of year one sales of 200 LuViva devices; year two sales of 500 LuViva devices; year three sales of 1,000 LuViva devices; and year four sales of 1,250 LuViva devices. Fifth, SMI shall pay for entire costs of securing approval of LuViva with the Chinese FDA. Sixth, SMI shall arrange, at its sole cost, for a manufacturer in China to build tooling to support manufacturing. In addition, SMI retains the right to manufacture for China, Hong Kong, Macau and Taiwan, where SMI has distribution and sales rights. For each singleF-~~use~~28 ~~cervical~~Table ~~guide sold by SMI in the jurisdictions, SMI shall transfer funds to escrow agent at a rate~~ of $1.90 per device chip. If within 18 months of the license’s effective date, SMI fails to achieve commercialization of LuViva in China, SMI shall no longer have any rights to manufacture, distribute or sell LuViva. Commercialization is defined as: filing an application with the Chinese FDA for the approval of LuViva; any assembly or manufacture of the devices or disposables that begins in China; and purchase of at least 10 devices and disposables for clinical evaluations and regulatory use and or sales in the jurisdictions.Contents

OnFirst, ~~August~~SMI 12shall complete the payment for parts, ~~2021~~per the purchase order, for five additional LuViva devices. Second, in consideration for the $885,144 that the Company received, SMI will receive 12,147 shares of common stock. Third, SMI shall honor all existing purchase orders it has executed anto ~~amendment~~date with the Company, in order to ~~its~~maintain ~~agreement~~jurisdiction ~~with~~sales and distribution rights. If SMI needs to purchase cervical guides, then it will do so at a cost including labor, plus ten percent markup. ~~Under~~The ~~the~~Company ~~terms~~will ofprovide 200 cervical guides at no cost for the ~~amended~~clinical ~~agreement~~trials. Fourth, the ~~parties~~Company ~~agreed~~and ~~that~~SMI ifwill bymake ~~October~~best 30efforts to sell devices after NMPA approval. With an initial estimate of year one sales of 200 LuViva devices; year two sales of 500 LuViva devices; year three sales of 1,000 ~~2022~~LuViva devices; and year four sales of 1,250 LuViva devices. Fifth, SMI ~~fails~~shall topay ~~achieve~~for ~~commercialization~~entire costs of securing approval of LuViva inwith ~~China~~the Chinese FDA. Sixth, SMI shall noarrange, ~~longer~~at ~~have~~its ~~any~~sole ~~rights~~cost, for a manufacturer in China to ~~manufacture,~~build ~~distribute~~tooling orto ~~sell~~support ~~LuViva~~manufacturing. OnIn ~~March~~addition, 3SMI retains the right to manufacture for China, ~~2023~~Hong Kong, ~~the~~Macau ~~Company~~and ~~entered~~Taiwan, ~~into~~where aSMI ~~third~~has ~~amendment~~distribution ~~with~~and sales rights. For each single-use cervical guide sold by SMI ~~pursuant~~in the jurisdictions, SMI shall transfer funds to ~~which~~escrow ~~the~~agent ~~Company~~at ~~extended~~a rate of $1.90 per device chip. If within 18 months of the ~~deadline~~license’s ~~for~~effective date, SMI fails to achieve commercialization of LuViva in China, toSMI ~~April~~shall 30no longer have any rights to manufacture, ~~2024~~distribute or sell LuViva. OnCommercialization ~~February~~is ~~17,~~defined ~~2024~~as: ~~and~~filing ~~March~~an ~~27,~~application ~~2024,~~with the ~~Company entered~~Chinese ~~into~~FDA ~~additional~~for ~~amended~~the ~~agreements~~approval ~~with~~of ~~SMI,~~LuViva; ~~which~~any ~~are~~assembly ~~described~~or manufacture of the devices or disposables that begins in ~~Note~~China; ~~13,~~and ~~“Subsequent~~purchase ~~Events.”~~of at least 10 devices and disposables for clinical evaluations and regulatory use and or sales in the jurisdictions.

On August 12, 2021, the Company executed an amendment to its agreement with SMI. Under the terms of the amended agreement, the parties agreed that if by October 30, 2022, SMI fails to achieve commercialization of LuViva in China, SMI shall no longer have any rights to manufacture, distribute or sell LuViva. On March 3, 2023, the Company entered into a third amendment with SMI pursuant to which the Company extended the deadline for SMI to achieve commercialization of LuViva in China to April 30, 2024.

On February 17, 2024, the Company entered into a fourth amendment to the agreement with SMI. Under the terms of the amended agreement, SMI agreed to pay the Company $531,100 on or prior to March 15, 2024. On March 18, 2024, SMI, through SMI’s authorized distribution partner, initiated a wire payment of $330,000 in partial satisfaction of $531,100 owed to the Company. The payment was received by the Company on March 20, 2024. As the full payment was not received by March 15, 2024, the Company had the right to terminate the agreement with two weeks’ notice to SMI, however the Company did not exercise this option.

The amended agreement also provides for a timeline for the Company to deliver inventory during 2024, including LuViva devices and components, as well as approximately 1,640,000 RFID chips. In consideration, SMI agreed to pay a total of $4.4 million during 2024, including the payment due on March 15, 2024.

On March 27, 2024, the parties entered into a Standstill Agreement (the “Standstill Agreement”). The parties agreed that SMI will make a nonrefundable payment of $100,000 to the Company prior to March 31, 2024. In exchange, the Company will not initiate any legal proceedings, including but not limited to filing a lawsuit, obtaining a judgement, or enforcing any security interest, as related to the March shortfall in payments of $201,100, until April 30, 2024. Upon paying $100,000, SMI will have the option to extend the Standstill Agreement until June 15, 2024 by making a nonrefundable payment to the Company of $150,000. One additional payment of $150,000 may be made to extend the standstill rights until July 30, 2024, if mutually agreed upon. If SMI is unable to make the payments pursuant to the Standstill Agreement, the Company agreed to seek loans on behalf of SMI to cover the payments. SMI agreed to reimburse the Company for these loans along with all expenses associated with them within three months of the loans being issued as long as the loans are used solely for (1) parts for LuViva devices to be used by SMI for marketing and promotional activities, or (2) labor or consulting fees connected to providing parts, assemblies of devices or disposables to SMI. Additionally, SMI confirmed its commitment to make payments to GTI of at least $4.0 million during 2024 and as part of this commitment will make payments of $200,000 and $500,000 by the end of May 2024 and July 2024, respectively, to ensure that the program commercialization proceeds according to schedule.

On April 26, 2024, the parties extended the Standstill Agreement (“Standstill Extension”) until July 30, 2024, contingent on payments from SMI totaling $770,000 on or before July 30, 2024. In addition, because SMI did not make its scheduled payment of $100,000 on or before March 31, 2024, the Company can place a 25% surcharge on the cost of goods and services already paid for by SMI. Additionally, the Standstill Extension reduced the number of RFID chips the Company committed to shipping by 240,000 and reduced the total amount due from SMI in 2024 by $247,545. The other terms from the Amendment and Standstill Agreement remained intact.

On October 21, 2024, the Company executed an agreement with SMI (the “Agreement”), which supersedes all previous agreements, other than existing purchase orders (except those as modified and summarized below). Pursuant to the Agreement, the Company plans to execute a purchase agreement with a distributor of SMI for 35 base units, connected, aligned, calibrated and tested (“Completed Instrumentation Packages”). SMI, to obtain the license for global manufacturing rights and exclusive distribution of LuViva within certain jurisdictions, agreed to:

	1.	Meet an established schedule for minimum sales of the product in China.
	2.	Establish a manufacturing capability for the manufacture of LuViva and its accessories including the single use disposable Cervical Guide “Disposables” or “Accessories”).
	3.	Apply for NMPA approval for LuViva no later than October 30, 2024. Said application was filed by SMI with NMPA on October 16, 2024.

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Table of Contents

Under the terms of the agreement, the Handheld Unit and Base Unit constitute an Instrumentation Package or “IP”. An IP and mobile cart with a monitor constitute a fully functional LuViva device ready for sale. SMI will be responsible for the manufacture of the mobile carts that house the IPs and the display monitor. All active purchase orders will be revised to include 100 IPs to be provided by the Company to SMI and/or its distribution partners to meet expected demand for the end of 2024 and 2025, as summarized below:

	1.	Forty-seven (47) of the 100 IPs will be provided by the Company to SMI, at an approximate price of $1,351,250; The number of IPs may be reduced if the full payment is delayed beyond the end of 2024.
	2.	Thirty-five (35) of the 100 IPs will be provided by the Company to SMI or to one of SMI’s distributors, at a total price of $700,000.
	3.	Eighteen (18) of the 100 IPs will be provided to SMI at no additional charge, beyond what has already been paid by SMI.

To meet demand for the remainder of 2024 and for the first half of 2025, SMI agreed to purchase a minimum of 500,000 RFID chips, at prices ranging between $1.00 and $1.40 per chip. To meet demand for the second half of 2025, SMI agreed to purchase an additional 100 IPs and 1,000,000 RFID chips, at prices ranging between $1.00 and $1.40 per chip. SMI agreed to pay a minimum of $400,000 to the Company prior to December 31, 2024, to cover additional components, devices and costs incurred by the Company. On January 3, 2025, after confirming with SMI that no payment was forthcoming, the Company notified SMI in writing that the failure to make this payment constituted a breach of the October 21, 2024 Agreement. A second non-monetary breach also was identified in the Company’s correspondence to SMI. SMI informed the Company that it intended to cure the monetary breach and the Company agreed to negotiate a partial settlement by April 1, 2025.

Beginning in 2026 and extending into 2030, to preserve its licensing rights, SMI shall be committed to the minimum LuViva Cervical Guide Radio Frequency Identification Chips and Royalty Sales (“RFID Chips”) of the single-use Cervical Guide Chip, at a sale price to SMI at $1.00, as specified in the table below:

Year	Cumulative Number of Devices Placed or Sold		Cumulative Resulting Minimum Tests		Cumulative Minimum Cervical Guide Royalty Payments to GTI
2026		300		1,440,000	$	1,440,000
2027		400		5,040,000	$	4,480,000
2028	1500			15,840,000	$	15,840,000
2029	3000			37,440,000	$	37,440,000
2030	4000			66,240,000	$	66,240,000

If by April 30, 2025, SMI fails to achieve commercialization of LuViva in China, SMI shall no longer have any rights to manufacture, distribute or sell LuViva.

Contingencies

65Tariffs imposed ~~Table~~and/or publicly contemplated by the U.S. government in the first quarter of ~~Contents~~2025, particularly as to China, create significant uncertainty with respect to future tax and trade regulations and the potential competitive effects of such actions. The countries in which our products will be manufactured or imported may from time to time impose additional quotas, duties, tariffs or other restrictions on our imports or adversely modify existing restrictions. It is unclear what the U.S. administration or foreign governments specifically will or will not do with respect to tariffs, tax policies, or other international trade agreements, regulations and policies. A trade war, other governmental action related to tariffs or international trade agreements, changes in U.S. social, political, regulatory and economic conditions or in laws and policies governing foreign trade, manufacturing, development and investment in the territories and countries where we manufacture and sell products or any resulting negative sentiments towards the United States could materially adversely affect the Company’s business, financial condition, operating results and cash flows.

~~8. SHORT~~F-~~TERM~~30 ~~NOTES~~Table ~~PAYABLE~~of Contents

On July 4, 2023, the Company entered into a premium finance agreement to finance its insurance policies totaling $129,073. Monthly payments of $12,041 are due on the note, including interest incurred at a rate of 7.~~9%.~~ ~~The~~NOTES ~~note, which matures on May 4, 2024, had an outstanding balance of 59,422 as of December 31, 2023.~~PAYABLE

OnShort-term ~~July~~Promissory 4, 2022, the Company entered into a premium finance agreement to finance its insurance policies totaling $123,889. Monthly payments of $11,409 were due on the note, including interest incurred at a rate of 5.0%. The note, which matured on May 4, 2023, had an outstanding balance of nil and $56,569 as of December 31, 2023 and 2022, respectively. Notes

~~During~~On ~~2019~~June 28, 2024, the Company issued a promissory ~~notes~~note totaling $100,000 to ~~Mr.~~an ~~Cartwright~~unaffiliated ~~totaling~~third ~~$45,829~~party. The ~~notes~~promissory ~~were~~note ~~initially~~matures ~~issued~~on ~~with~~January ~~0% interest~~1, ~~however~~2025 and will accrue total interest ~~increased~~of ~~to 6~~$10,000.0% ~~interest~~Monthly 90payments ~~days~~of ~~after~~$20,000 are due on the ~~Company~~note, ~~received~~beginning $August 1,~~000~~ 2024 until December 1,~~000 in~~ ~~financing~~2024, ~~proceeds~~while the interest payment is due on or before January 1, 2025. As of December 31, ~~2023~~2024, the ~~notes~~remaining amount due was nil. The holder of the promissory note also received 100,000 common stock purchase warrants, which will have ~~been~~an ~~repaid~~exercise inprice ~~full~~of $0.25 and will expire on July 1, 2028. The warrants, which had an estimated fair value of $11,998, were recorded based on the relative fair value as a discount on the note payable. The Company estimated the fair value of the warrants using the Black-Scholes option pricing model with the following assumptions:

The following table summarizes short-term notes payable, including notes held by related parties (in thousands):

Expected term (years)	4.0
Volatility	389.2	%
Risk-free interest rate	4.4	%
Dividend yield	0.0	%

	December 31, 2023		December 31, 2022
Dr. Cartwright	$	-	$	1
Premium Finance (insurance)		59		57
Short-term notes payable	$	59	$	58

On July 23, 2024, the Company issued a promissory note totaling $50,000 to an unaffiliated third party. The promissory note matures on February 1, 2025 and will accrue total interest of $5,000. Monthly payments of $10,000 are due on the note, beginning September 1, 2024 until January 1, 2025, while the interest payment is due on or before February 1, 2025. As of December 31, 2024, the remaining amount due of $10,000 is presented in “Short-term notes payable” within the consolidated balance sheet. The holder of the promissory note also received 60,000 common stock purchase warrants, which have an exercise price of $0.25 and will expire on August 1, 2028. The warrants, which had an estimated fair value of $6,329, were recorded based on the relative fair value as a discount on the note payable. The Company estimated the fair value of the warrants using the Black-Scholes option pricing model with the following assumptions:

As of December 31, 2023 and 2022, short-term notes payable due to related parties was nil and $619, respectively.

Expected term (years)	4.0
Volatility	397.3	%
Risk-free interest rate	3.9	%
Dividend yield	0.0	%

9.Long-term ~~CONVERTIBLE~~Promissory ~~DEBT~~Notes

On April 15, 2024, the Company entered into an exchange agreement with a former employee, whereby the former employee agreed to exchange outstanding amounts due to him for deferred compensation in the amount of $81,768 for an $87,162 promissory note dated April 15, 2024. Beginning on May 5, 2024, monthly payments of $2,000 are due on the note until its maturity date. The promissory note, which accrues interest at a rate of 6.0% per annum, matures on May 5, 2028. The total principal balance of the promissory note was $71,162 as of December 31, 2024, of which $24,000 is included in “Short-term notes payable” on the consolidated balance sheets and $47,162 is included in “Long-term notes payable.”

Insurance Policy Financing

On July 4, 2024, the Company entered into a premium finance agreement to finance its insurance policies totaling $129,556. Monthly payments of $12,025 are due on the note, including interest incurred at a rate of 8.8%. The note, which matures on May 4, 2025, had an outstanding balance of $59,255 as of December 31, 2024.

On July 4, 2023, the Company entered into a premium finance agreement to finance its insurance policies totaling $129,073. Monthly payments of $12,041 were due on the note, including interest incurred at a rate of 7.9%. The note, which matured on May 4, 2024, had an outstanding balance of nil and $59,422 as of December 31, 2024 and December 31, 2023, respectively.

F-31

Table of Contents

The following tables summarize notes payable (in thousands):

	Notes Payable (in thousands)

	December 31, 2024			December 31, 2023
Short-term promissory notes	$	10		$	-
Deferred compensation note		71			-
Insurance policy financing		59			59
Debt discount		(1	)		-
Total		139			59

Less: Current portion of notes payable		(92	)		(59	)
Total long-term notes payable	$	47		$	-

Future debt obligations at December 31, 2024 for notes payable are as follows:

Year	Amount (thousands)
2025		92
2026		24
2027		23
Total	$	139

8. CONVERTIBLE DEBT

10% Senior Unsecured Convertible Debentures

On May 17, 2021, the Company issued 10% Senior Unsecured convertible debentures to investors, which matured on May 17, 2024 (the “Maturity Date”). The Company subscribed $1,130,000 of the $1,000 convertible debentures. The terms of the debentures are as follows: 1) the principal amount of some or all of the convertible debentures and accrued interest are convertible into shares of common stock at the holder’s option, at a price of $0.50 per common stock share (the “conversion price”), subject to adjustment in certain events, at any time prior to maturity date; 2) upon successful uplist to a U.S. National Exchange, the note will automatically convert into the uplisting financing; 3) each debenture unit included 1,000 common stock warrants with an exercise price of $0.80 and an expiration date of May 17, 2023; 4) if a Change of Control (as defined in the Convertible Debenture Certificate) occurs prior to the Maturity Date, unless the holder elects in writing to convert the Convertible Debentures into shares of common stock, the Company will repay in cash upon the closing of such Change of Control all outstanding principal and accrued interest under each Convertible Debenture plus a Change of Control premium equal to an additional 3% of the outstanding principal sum under such Convertible Debenture. Prior to the closing of an Change of Control, in lieu of repayment as set forth in the preceding sentence, the holder has the right to elect in writing to convert, effective immediately prior to the effective date of such Change of Control, all outstanding principal and accrued Interest under the Convertible Debentures into shares of common stock at the Conversion Price; 5) Subject to a holder’s option of electing conversion prior to the Redemption Date (as such term is defined below), on or after the date that is 24 months from the Closing Date if the daily volume weighted average trading price of the shares of common stock is $1.50 per share of common stock or more for each trading day over a 30 consecutive trading day period, the Company may, at any time (the “Redemption Date”), at its option, redeem all, or any portion of the Convertible Debentures for either: (i) a cash payment (in the form of a certified cheque or bank draft) that is equal to all outstanding principal and accrued interest under each Convertible Debenture up to the Redemption Date; or (ii) by issuing and delivering shares of common stock to the holders of Convertible Debentures at a deemed price of $0.50 per share of common stock that is equal to all outstanding principal and accrued interest under each Convertible Debenture up to the Redemption Date, or any combination of (i) or (ii), upon not less than 30 days and not more than 60 days prior written notice in the manner provided in the Debenture Certificate, to the holder of Convertible Debentures.

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At December 31, 2024 and December 31, 2023, the balance due on the 10% Senior Unsecured Convertible Debentures was $1,130,000 and total accrued interest was $103,960 and $58,494, respectively. After the May 17, 2024 maturity date, the debt went into default and the interest rate increased to the default rate of 18.0%. The bond payable discount and unamortized debt issuance costs as of December 31, 2024 and December 31, 2023 are presented below (in thousands):

	December 31, 2024		December 31, 2023
10% Senior Unsecured Convertible Debentures	$	1,130	$	1,130
Unamortized debt issuance costs		-		(12	)
Debt discount		-		(38	)
Senior Unsecured Convertible Debenture	$	1,130	$	1,080

As of December 31, 2024, the balance of the Senior Unsecured Convertible Debentures is included in “Short-term convertible debt in default” within the consolidated balance sheets. As of December 31, 2023, the balance of the Senior Unsecured Convertible Debentures is included in “Short-term convertible notes payable” within the consolidated balance sheets.

Convertible Promissory Notes

The following table summarizes convertible promissory notes outstanding as of December 31, 2024 and 2023:

	December 31, 2024			December 31, 2023
Convertible promissory notes	$	330		$	25
Unamortized debt issuance costs		(3	)		-
Debt discount		(196	)		-
Convertible promissory notes	$	131		$	25

1800 Diagonal Lending LLC Notes

On July 22, 2024, the Company entered into a securities purchase agreement and contingently convertible note with 1800 Diagonal Lending LLC (“Diagonal Lending”). The convertible note issued to Diagonal Lending had a total principal balance of $62,100 and an original issue discount of $8,100. The note, which will accrue total interest of $8,694, will mature on May 30, 2025. A payment of $35,397 is due on the note on January 30, 2025. The remaining balance due, including accrued interest, will be paid in monthly payments of $8,849 from February 28, 2025 through May 30, 2025. The note may be prepaid at any time with no prepayment penalty. Any amount of principal or interest on the note which is not paid when due will bear interest at the rate of the lessor of 22.0% or the maximum permitted by law. The Company may not sell, lease, or otherwise dispose of any significant portion of its assets outside of the ordinary course of business without the express permission of Diagonal Lending. In the event of default, the note will become immediately due and payable in an amount equal to 150.0% times the sum of the then outstanding principal, accrued interest and default interest.

On June 11, 2024, the Company entered into a securities purchase agreement and contingently convertible note with Diagonal Lending (together with the July 22, 2024 note, the “Notes”). The convertible note issued to Diagonal Lending had a total principal balance of $100,050 and an original issue discount of $13,050. The note, which will accrue total interest of $14,007, will mature on April 15, 2025. A payment of $57,029 was due on the note on December 15, 2024. The remaining balance due, including accrued interest, will be paid in monthly payments of $14,257 from January 15, 2025 through April 15, 2025. The note may be prepaid within 120 days of issuance for a discount of 2.0 -3.0 % of the principal and accrued interest due. Any amount of principal or interest on the note which is not paid when due will bear interest at the rate of the lessor of 22% or the maximum permitted by law. The Company may not sell, lease, or otherwise dispose of any significant portion of its assets outside of the ordinary course of business without the express permission of Diagonal Lending. In the event of default, the note will become immediately due and payable in an amount equal to 150.0% times the sum of the then outstanding principal, accrued interest and default interest.

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Table of Contents

In the event of default, the unpaid portion of the Notes and accrued interest is convertible into shares of common stock at a conversion rate equal to the variable conversion price. The variable conversion price is equal to the lowest closing price of our common stock during the ten days prior to the conversion date multiplied by 65.0%. The Company assessed the embedded conversion features and determined that they are not considered clearly and closely related to the host notes, and therefore meet the definition of derivatives. Therefore, these embedded conversion features are required to be bifurcated from the note and accounted for separately as a derivative liability. The Company estimated the fair value of the derivative liabilities on the issuance dates of the Notes and recorded them as discounts that net against the convertible notes. The Company is required to remeasure the derivative liabilities to their then fair values at each subsequent balance sheet date, through an adjustment to current earnings (see Note 11 for further details on the Company’s fair value measurement).

At December 31, 2024, the balance due on the Notes was $115,681 and is presented net of total unamortized debt discounts and debt issuance costs of $16,423 within “Short-term convertible debt, net of discounts” on the consolidated balance sheet. Total accrued interest as of December 31, 2024 was $7,518.

Flynn D. Case Living Trust Convertible Note

On October 10, 2024, the Company issued a promissory note totaling $200,000 to Flynn D. Case Living Trust, an unaffiliated third party (the “Holder”). The promissory note had a maturity date of October 10, 2025 and accrued interest at a rate of 12.0% per annum. Monthly payments of $20,000 were due on the note, beginning November 30, 2024 until August 31, 2025, while the interest payment was due on or before October 10, 2025. If not repaid by the maturity date, the unpaid balance of the note accrued interest at a rate of 16.0% per annum. With the Holder’s permission, the promissory note may be prepaid in full or in part without penalty or premium. The Holder also received 667,667 common stock purchase warrants, which have an exercise price of $0.25 and will expire on October 9, 2028. The warrants, which had an estimated fair value of $109,356, were recorded based on relative fair value as a discount on the note payable. The Company estimated the fair value of the warrants using the Black-Scholes option pricing model with the following assumptions:

Expected term (years)	4.0
Volatility	398.8	%
Risk-free interest rate	3.9	%
Dividend yield	0.0	%

On December 5, 2024, the Company amended the payment terms of the convertible promissory note. In accordance with the amended agreement, payments of $75,000 plus accrued interest will be due on June 4, 2025 and December 4, 2025. The note will mature on June 4, 2026, upon which a final payment of $50,000 plus all accrued interest will be due. The Holder will have an option to convert the principal and accrued interest due on each payment date to common stock at the following conversion prices:

	·	$75,000 plus interest accrued through June 4, 2025 may be converted at a price equal to the lower of $0.25 or a 25.0% discount on the average 10-day VWAP of the common stock immediately prior to the conversion date;

	·	$75,000 plus interest accrued through December 4, 2025 may be converted at a price equal to the lower of $0.50 or a 20.0% discount on the average of the 10-day VWAP of the common stock immediately prior to the conversion date; and

	·	$50,000 plus interest accrued through June 4, 2026 may be converted at a price equal to the lower of $0.75 or a 15.0% discount on the average of the 10-day VWAP of the common stock immediately prior to the conversion date.

The Company assessed the embedded conversion features and determined that they are not considered clearly and closely related to the host note and therefore meet the definition of derivatives. Therefore, these embedded conversion features are required to be bifurcated from the note and accounted for separately as a derivative liability. The Company estimated the fair value of the derivative liabilities on the date the amendment was executed and recorded them as discounts that net against the convertible note. The Company is required to remeasure the derivative liabilities to their then fair values at each subsequent balance sheet date, through an adjustment to current earnings (see Note 11 for further details on the Company’s fair value measurement).

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Table of Contents

At December 31, 2024, the balance due on the convertible promissory note was $200,000 and is presented net of total unamortized debt discounts of $183,176, of which $2,583 is included in “Short-term convertible debt, net of discounts” and $14,241 is included in “Long-term convertible debt, net of discounts” on the consolidated balance sheets. Total accrued interest as of December 31, 2024 was $1,733.

Auctus Convertible Note

On December 17, 2019, the Company entered into a securities purchase agreement and convertible note with Auctus Fund, LLC (“Auctus’). The convertible note issued to Auctus was for a total of $2.4 million. The note may not have been prepaid in whole or in part except as otherwise explicitly allowed. Any amount of principal or interest on the note which was not paid when due shall bore interest at the rate of the lessor of 24% or the maximum permitted by law (the “default interest”). The variable conversion prices equaled the lesser of: (i) the lowest trading price on the issue date, and (ii) the variable conversion price. The variable conversion price was 95% multiplied by the market price (the market price means the average of the five lowest trading prices during the period beginning on the issue date and ending on the maturity date), minus $0.04 per share, provided however that in no event could the variable conversion price be less than $0.15. If an event of default under this note occurred and/or the note was not extinguished in its entirety prior to December 17, 2020, the $0.15 price floor no longer applied.

66On ~~Table~~September 1, 2022, the Company agreed to exchange certain debt and equity owned by Auctus pursuant to an Exchange Agreement between the Company and Auctus (the “Exchange Agreement”). Immediately prior to the Exchange Agreement, Auctus held $1,228,183 of ~~Contents~~debt, including an early prepayment penalty of $350,000, default premiums of $281,256, and $91,555 in interest payable. Auctus agreed to reduce the amount owed to $710,911 and to revert the May 27, 2020 note to its original term. Additionally, Auctus agreed to exchange 8,775,000 warrants that were priced between $0.15 and $0.20 and the $350,000 prepayment penalty for 3,900,000 shares of common stock, warrants to purchase 3,900,000 shares of common stock at $0.50 per share and warrants to purchase 3,900,000 shares of common stock at $0.65 per share (the “Exchange”). As a result of the Exchange Agreement, Auctus forgave a default penalty of $225,444. Following the Exchange and Repayment, the Company will make payments to Auctus in four installments, over an 18-month period. During 2024, Auctus agreed to apply the payments to the principal portion of the debt before applying the funds to the accrued interest. As a result, management has reclassified a portion of the current and prior period outstanding debt to the accrued interest.

OnThe ~~September~~total 1,outstanding ~~2022,~~balance ~~the~~of ~~Company agreed to exchange certain debt and equity owned by Auctus pursuant to an Exchange Agreement between~~ the ~~Company~~convertible ~~and~~note ~~Auctus~~was ~~(the “Exchange Agreement”). Immediately prior to the Exchange Agreement~~$15,000 ~~Auctus~~and ~~held~~ $125,~~228,183 of~~000 ~~debt,~~as ~~including an early prepayment penalty~~ of ~~$350~~December 31,~~000,~~ ~~default~~2024 ~~premiums~~and ofDecember ~~$281~~31,~~256,~~ ~~and $91~~2023,~~555 in~~ ~~interest payable~~respectively. ~~Auctus~~The ~~agreed~~balances toare ~~reduce~~included ~~the~~within ~~amount~~“Short-term ~~owed~~convertible todebt” ~~$710,911 and~~on ~~to revert~~ the ~~May~~consolidated ~~27,~~balance ~~2020~~sheets. ~~note~~Total toaccrued ~~its~~interest ~~original~~on ~~term.~~the ~~Additionally,~~ Auctus ~~agreed~~convertible tonote ~~exchange 8,775,000 warrants~~was ~~that were priced between~~ $~~0.15~~116,412 and $~~0.20 and the $350~~121,~~000 prepayment~~995 ~~penalty~~as ~~for 3,900,000 shares~~ of ~~common~~December ~~stock~~31, ~~warrants~~2024 ~~to purchase 3,900,000 shares of common stock at $0.50 per share~~ and ~~warrants~~December ~~to purchase 3~~31,~~900,000 shares~~ ~~of common stock at $0.65 per share (the “Exchange”). As a result of the Exchange Agreement~~2023, ~~Auctus forgave a default penalty of $225,444~~respectively. ~~Following the Exchange and Repayment, the Company will make payments to Auctus in four installments, over an 18-month period.~~

~~The total outstanding balance of the convertible note was $123,039 and $326,016 as of December 31, 2023 and 2022, respectively~~9. RELATED AsPARTY of December 31, 2023, the balance is included within “Short-term convertible debt” on the consolidated balance sheet. As of December 31, 2022, $230,482 is included within “Short-term convertible debt” and $95,534 is included within “Long-term convertible debt” on the consolidated balance sheet.DEBT

AsShort-Term aNotes ~~result~~Payable ofDue ~~the~~to ~~Exchange~~Related ~~Agreement, the Company recorded a loss on extinguishment of debt of $626,776 during the year ended December 31, 2022.~~ Parties

10During the year ended December 31, 2024, the Company issued promissory notes totaling $75,000 to members of the Board of Directors. The promissory notes mature in the third quarter of 2025, at which time the principal and accrued interest payments are due in full. The promissory notes accrue interest at a rate of 9.0%. ~~Senior~~The ~~Unsecured~~holders ~~Convertible~~of ~~Debenture~~the promissory notes also received 75,000 common stock purchase warrants, which have exercise prices of $0.25 and will expire four years after issuance. The warrants, which had an estimated fair value of $8,800, were recorded as a discount on the notes payable. The Company estimated the fair value of the warrants using the Black-Scholes option pricing model with the following weighted-average assumptions:

On May 17, 2021, the Company issued 10% Senior Unsecured convertible debentures to investors, which mature on May 17, 2024 (the “Maturity Date”). The Company subscribed $1,130,000 of the $1,000 convertible debentures. The terms of the debentures are as follows: 1) the principal amount of some or all of the convertible debentures and accrued interest are convertible into shares of common stock at the holder’s option, at a price of $0.50 per common stock share (the “conversion price”), subject to adjustment in certain events, at any time prior to maturity date; 2) upon successful uplist to a U.S. National Exchange, the note will automatically convert into the uplisting financing; 3) each debenture unit included 1,000 common stock warrants with an exercise price of $0.80 and an expiration date of May 17, 2023; 4) if a Change of Control (as defined in the Convertible Debenture Certificate) occurs prior to the Maturity Date, unless the holder elects in writing to convert the Convertible Debentures into shares of common stock, the Company will repay in cash upon the closing of such Change of Control all outstanding principal and accrued interest under each Convertible Debenture plus a Change of Control premium equal to an additional 3% of the outstanding principal sum under such Convertible Debenture. Prior to the closing of an Change of Control, in lieu of repayment as set forth in the preceding sentence, the holder has the right to elect in writing to convert, effective immediately prior to the effective date of such Change of Control, all outstanding principal and accrued Interest under the Convertible Debentures into shares of common stock at the Conversion Price; 5) Subject to a holder’s option of electing conversion prior to the Redemption Date (as such term is defined below), on or after the date that is 24 months from the Closing Date if the daily volume weighted average trading price of the shares of common stock is $1.50 per share of common stock or more for each trading day over a 30 consecutive trading day period, the Company may, at any time (the “Redemption Date”), at its option, redeem all, or any portion of the Convertible Debentures for either: (i) a cash payment (in the form of a certified cheque or bank draft) that is equal to all outstanding principal and accrued interest under each Convertible Debenture up to the Redemption Date; or (ii) by issuing and delivering shares of common stock to the holders of Convertible Debentures at a deemed price of $0.50 per share of common stock that is equal to all outstanding principal and accrued interest under each Convertible Debenture up to the Redemption Date, or any combination of (i) or (ii), upon not less than 30 days and not more than 60 days prior written notice in the manner provided in the Debenture Certificate, to the holder of Convertible Debentures.

Expected term (years)	4.0
Volatility	397.1	%
Risk-free interest rate	3.9	%
Dividend yield	0.0	%

AtF-35 ~~December~~Table 31, 2023 and 2022, the balance due on the 10% Senior Unsecured Convertible Debenture was $1,130,000 and total accrued interest was $58,494. The bond payable discount and unamortized debt issuance costs as of ~~December 31, 2023 and 2022 are presented below (in thousands):~~Contents

	December 31, 2023			December 31, 2022
10% Senior Unsecured Convertible Debentures	$	1,130		$	1,130
Unamortized debt issuance costs		(12	)		(40	)
Debt Discount		(38	)		(140	)
Senior Unsecured Convertible Debenture	$	1,080		$	950

Total accrued interest on the promissory notes was $2,817 as of December 31, 2024. The outstanding principal and associated debt discounts as of December 31, 2024 and December 31, 2023 are presented below (in thousands):

As of December 31, 2023, the balance of the Senior Unsecured Convertible Debenture is included in “Short-term convertible debt” within the consolidated balance sheet. As of December 31, 2022, the balance of the Senior Unsecured Convertible Debenture is included in “Long-term convertible debt” within the consolidated balance sheet.

	December 31, 2024			December 31, 2023
Short-term promissory notes	$	75		$	-
Debt discount		(5	)		-
Short-term notes payable due to related parties	$	70		$	-

~~10.~~Current ~~LONG~~Portion of Long-~~TERM~~Term ~~DEBT~~Debt, Related Parties

~~Long-term~~On ~~Debt~~July –14, ~~Related~~2018, ~~Parties~~the Company entered into an exchange agreement with Dr. Faupel, whereby Dr. Faupel agreed to exchange outstanding amounts due to him for loans, interest, bonus, salary and vacation pay in the amount of $660,895 for a $207,111 promissory note dated September 4, 2018. On July 20, 2018, the Company entered into an exchange agreement with Dr. Cartwright, whereby Dr. Cartwright agreed to exchange outstanding amounts due to him for loans, interest, bonus, salary and vacation pay in the amount of $1,621,499 for a $319,000 promissory note dated September 4, 2018 that incurs interest at a rate of 6.0% per annum.

On July 14, 2018, the Company entered into an exchange agreement with Dr. Faupel, whereby Dr. Faupel agreed to exchange outstanding amounts due to him for loans, interest, bonus, salary and vacation pay in the amount of $660,895 for a $207,111 promissory note dated September 4, 2018. On July 20, 2018, the Company entered into an exchange agreement with Dr. Cartwright, whereby Dr. Cartwright agreed to exchange outstanding amounts due to him for loans, interest, bonus, salary and vacation pay in the amount of $1,621,499 for a $319,000 promissory note dated September 4, 2018 that incurs interest at a rate of 6% per annum.

On July 24, 2019, Dr. Faupel and Mr. Cartwright agreed to an addendum to the debt restructuring exchange agreement. Pursuant to this modification Dr. Faupel and Mr. Cartwright agreed to extend the note to be due in full on the third anniversary of that agreement.

On February 19, 2021, the Company entered into new promissory notes replacing the original notes from September 4, 2018, with Mark Faupel and Gene Cartwright. For Dr. Cartwright the principal amount on the new note was $267,085, the maturity date was February 18, 2023, and the interest rate was 6.0%. For Dr. Faupel the principal amount on the new note was $153,178, the maturity date was February 18, 2023, and the interest rate was 6.0%. Additionally, the Company exchanged $100,000 and $85,000 of the balances owed to Dr. Cartwright and Dr. Faupel for 100 and 85 shares of Series F-2 Preferred Stock, respectively.

On February 18, 2023, the Company amended the terms of the promissory notes held by Mark Faupel and Gene Cartwright. Under the terms of the new agreements, the promissory notes will mature on February 18, 2025.

67F-36 Table of Contents

The ~~table~~tables below ~~summarizes~~summarize the outstanding balance of ~~long-term~~ debt owed to Dr. Faupel and Dr. Cartwright (in thousands):

For Dr. Faupel:
Salary	$	134
Bonus		20
Vacation		95
Interest on compensation		67
Loans to Company		196
Interest on loans		149
Total outstanding prior to exchange		661
Amount forgiven in prior years		(454	)
Amount exchanged for Series F-2 Preferred Stock		(85	)
Total interest accrued through December 31, 2022		48
Balance outstanding at December 31, 2022	$	170
Interest accrued during the year ended December 31, 2023		9
Balance outstanding at December 31, 2023	$	179

For Dr. Faupel:

68 Table of Contents

Salary	$	134
Bonus		20
Vacation		95
Interest on compensation		67
Loans to Company		196
Interest on loans		149
Total outstanding prior to exchange		661

Amount forgiven in prior years		(454	)
Amount exchanged for Series F-2 Preferred Stock		(85	)
Total interest accrued through December 31, 2022		48
Balance outstanding at December 31, 2022	$	170

Interest accrued during the year ended December 31, 2023		9
Balance outstanding at December 31, 2023	$	179

Interest accrued during the year ended December 31, 2024		10
Balance outstanding at December 31, 2024	$	189

For Dr. Cartwright
Salary	$	337
Bonus		675
Loans to Company		528
Interest on loans		81
Total outstanding prior to exchange		1,621
Amount forgiven in prior years		(1,302	)
Amount exchanged for Series F-2 Preferred Stock		(100	)
Total interest accrued through December 31, 2022		78
Balance outstanding at December 31, 2022	$	297
Payments on outstanding debt		(25	)
Interest accrued during the year ended December 31, 2023		15
Balance outstanding at December 31, 2023	$	287

For Dr. Cartwright

On March 22, 2021, the Company entered into an exchange agreement with Richard Fowler. As of December 31, 2020, the Company owed Mr. Fowler $546,214 ($412,624 in deferred salary and $133,590 in accrued interest). The Company exchanged $50,000 of the amount owed of $546,214 for 50 shares of Series F-2 Preferred Stock (convertible into 200,000 shares of common stock), and a $150,000 unsecured note. The note accrues interest at the rate of 6% (18% in the event of default) beginning on March 22, 2022 and is payable in monthly installments of $3,580 for four years, with the first payment due on March 15, 2022. The effective interest rate of the note is 6.18%.

Salary	$	337
Bonus		675
Loans to Company		528
Interest on loans		81
Total outstanding prior to exchange		1,621

Amount forgiven in prior years		(1,302	)
Amount exchanged for Series F-2 Preferred Stock		(100	)
Total interest accrued through December 31, 2022		78
Balance outstanding at December 31, 2022	$	297

Payments on outstanding debt		(25	)
Interest accrued during the year ended December 31, 2023		15
Balance outstanding at December 31, 2023	$	287

Interest accrued during the year ended December 31, 2024		15
Balance outstanding at December 31, 2024	$	302

~~During~~On ~~year~~March ~~ended December 31~~22, ~~2023~~2021, ~~Mr.~~the ~~Fowler~~Company ~~forgave~~entered ~~$69,274~~into ofan ~~the~~exchange ~~outstanding~~agreement ~~balance~~with ofRichard ~~deferred~~Fowler. ~~compensation~~As ~~and, as~~ of December 31, ~~2023~~2020, ~~may~~the ~~forgive~~Company upowed toMr. Fowler $~~129~~546,~~336~~214 of($412,624 in ~~the~~deferred ~~remaining~~salary ~~deferred~~and ~~compensation~~$133,590 in ifaccrued ~~the~~interest). The Company ~~complies~~exchanged ~~with~~$50,000 of the ~~repayment~~amount ~~plan~~owed ~~described~~of ~~above.~~$546,214 for 50 shares ~~The~~of ~~reductions~~Series inF-2 ~~the~~Preferred ~~outstanding~~Stock ~~balance~~(convertible ~~met~~into 200,000 shares ~~the~~of ~~criteria~~common ~~for~~stock), ~~troubled~~and ~~debt~~a $150,000 unsecured note. The ~~basic~~note ~~criteria~~accrues ~~are~~interest ~~that~~at the ~~borrower~~rate isof ~~troubled,~~6.0% i(18.~~e.,~~0% ~~they~~in ~~are~~the ~~having~~event ~~financial~~of ~~difficulties,~~default) ~~and~~beginning aon ~~concession~~March is22, ~~granted~~2022 byand ~~the~~is ~~creditor.~~payable Asin ofmonthly ~~December~~installments 31of $3,600 for ~~2023~~four ~~and 2022~~years, with the ~~outstanding~~first ~~principal~~payment ~~amount~~due ~~owed~~ on ~~the~~March ~~note~~15, ~~was~~2022. ~~$82,945~~The ~~and~~effective ~~$119,814,~~interest ~~respectively.~~rate of the note is 6.18%.

~~Future~~During ~~debt~~the ~~obligations~~years atended December 31, 2024 and 2023, Mr. Fowler forgave $65,095 and $69,274 of the outstanding balance of deferred compensation, respectively. As of December 31, 2024, Mr. Fowler may forgive up to $64,240 of the remaining deferred compensation if the Company complies with the repayment plan described above. The reductions in the outstanding balance met the criteria for troubled debt and were recorded as a gain. The basic criteria are that the borrower is troubled, i.e., they are having financial difficulties, and a concession is granted by the creditor. As of December 31, 2024, the outstanding principal amount owed toon the note was $43,895, of which $41,489 is included in “Current portion of long-term debt, related parties” and $2,406 is asincluded ~~follows:~~in “Long-term debt, related parties.” As of December 31, 2023, the outstanding principal amount owed on the note was $82,945, of which $39,090 is included in “Current portion of long-term debt, related parties” and $43,855 is included in “Long-term debt, related parties.”

Year	Amount (thousands)
2024		39
2025		508
2026		3
Total	$	550

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Table of Contents

AsFuture ~~of December 31, 2023, $39,090 of the~~ debt ~~owed~~obligations toat ~~related parties is included in “Current portion of long-term debt, related parties” and $510,470 is included in “Long-term debt, related parties” within the consolidated balance sheet. As of~~ December 31, ~~2022,~~2024 ~~the~~for ~~outstanding~~ debt owed isto ~~included in “Long-term debt,~~ related parties” ~~within~~is ~~the~~as ~~consolidated balance sheet.~~follows:

69 Table of Contents

Year	Amount (thousands)
2025		607
2026		2
Total	$	609

6%10. INCOME ~~Unsecured~~(LOSS) ~~Promissory~~PER ~~Note~~SHARE OF COMMON STOCK

On July 9, 2020, we entered into an exchange agreement with Mr. Bill Wells, a former employee. In lieu of agreeing to dismiss approximately half of what was owed to him, or $220,000, Mr. Wells received the following: (i) cash payment totaling $20,000; (ii) an unsecured promissory note in the amount of $90,000, to be executed within 30 days of completing new financing(s) totaling at least $3.0 million and (iii) 66,000 common stock options that vest at a rate of 3,667 per month and have a $0.49 exercise price (if two consecutive payments in (ii) are not made the stock options will be canceled and a cash payment will be required). Pursuant to the agreement, Mr. Wells agreed that the total amount forgiven of $110,000 shall be prorated according to the amount paid to him.

During the year ended December 31, 2021, the Company closed a financing round that exceeded the $3.0 million threshold and issued an unsecured promissory note in the amount of $97,052 to Mr. Wells. The note, for which monthly installment payments of $5,000 are due, matures 18 months after the issuance date and incurs interest at a rate of 6.0% per annum. During the years ended December 31, 2023 and 2022, the Company made principal payments of $17,052 and $80,000 to Mr. Wells, respectively. As a result of these payments, Mr. Wells forgave equivalent amounts of the remaining amount of compensation. The reductions in the outstanding balance met the criteria for troubled debt. The basic criteria are that the borrower is troubled, i.e., they are having financial difficulties, and a concession is granted by the creditor.

As of December 31, 2023 and 2022, the outstanding principal balance on the note was nil and $17,052, respectively. As of December 31, 2022, the balance is included in “Current portion of long-term debt” within the consolidated balance sheet. As of December 31, 2023 and 2022, accrued interest on the note was nil and $5,139, respectively.

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11. INCOME (LOSS) PER COMMON SHARE

Basic net income (loss) per share attributable to common stockholders, amounts are computed by dividing the net income (loss) plus preferred stock dividends and deemed dividends on preferred stock by the weighted average number of shares outstanding during the year.

Diluted net income (loss) per share attributable to common stockholders amounts are computed by dividing the net income (loss) plus preferred stock dividends, deemed dividends on preferred stock, after-tax interest on convertible debt and convertible dividends by the weighted average number of shares outstanding during the year, plus Series C, Series C-1, Series C-2, Series D, Series E, Series F and Series F-2 convertible preferred stock, convertible debt, convertible preferred dividends, ~~and~~ warrants ~~convertible into common stock shares. For the years ended December 31, 2023~~ and ~~2022, all~~ stock options, convertible ~~preferred stock, convertible debt and warrants were anti-dilutive and excluded from the computation of diluted (loss) per share. At December 31, 2023 and 2022, these instruments were convertible~~ into ~~52,752,994 and 59,980,134~~ common ~~shares~~stock ~~and were excluded from the computation of diluted earnings per share, respectively~~shares.

During a period of net loss, basic and diluted earnings per share are the same as the assumed exercise of warrants and the conversion of convertible debt and preferred stock are anti-dilutive. For the year ended December 31, 2024 and 2023, all stock options, convertible preferred stock, convertible debt and warrants were anti-dilutive and were therefore excluded from the computation of diluted loss per share. At December 31, 2024 and 2023, these instruments were convertible into 86,687,248 and 76,550,947 common shares, respectively.

The following table sets forth pertinent data relating to the computation of basic and diluted net loss per share attributable to common shareholders (in thousands, except for per-share data):

	December 31,
	2023			2022
	2024			2023
Net loss		(32,~~759~~591	)		(43,~~972~~759	)
Basic weighted average number of shares outstanding		5157,~~131~~339			3251,~~505~~131
Net loss per share (basic)		(0.0705	)		(0.1507	)
Diluted weighted average number of shares outstanding		5157,~~131~~339			3251,~~505~~131
Net loss per share (diluted)		(0.0705	)		(0.1507	)

71F-38 Table of Contents

~~During a~~11. ~~period~~FAIR ofVALUE ~~net loss, basic and diluted earnings per share are the same as the assumed exercise of warrants and the conversion of convertible debt and preferred stock are anti-dilutive.~~MEASUREMENTS

The convertible notes payable derivative liabilities are considered Level 3 measurements, due to the significant unobservable inputs in the valuation, which are based on a forecast of the Company’s future stock performance and, as the note payable is contingently convertible upon an event of default, management’s estimate of the likelihood and timing of conversion.

Based on the terms and provisions of the convertible notes payable, management built a pricing simulation that predicts the Company’s future stock prices using historical volatility. Our model is designed to utilize the Company’s best estimates of the timing and likelihood of a conversion of the notes payable to calculate the variable conversion price as of the future conversion date.

The key inputs to the valuation model that was utilized to estimate the fair value of the bifurcated conversion option included:

	·	The forecasted future stock prices were determined using historical stock prices and the Company’s equity volatility.
	·	The expected conversion price was determined using the forecast and the contractual terms of the convertible note agreements.
	·	The probability and timing of potential conversions are based on management’s best estimate of the future settlements of the convertible notes.

The following table presents the fair value of the bifurcated conversion options as of December 31, 2024:

	Fair Value at December 31, 2024 (in thousands)
	Level 1		Level 2		Level 3		Total

Derivative liability/bifurcated conversion options in connection with convertible promissory notes	$	-	$	-	$	118	$	118

Total short-term liabilities at fair value	$	-	$	-	$	118	$	118

Derivative financial instruments and changes thereto recorded in the years ended December 31, 2024 and 2023 are presented below:

	Year Ended December 31,
	2024		2023

Fair value, beginning of period	$	-	$	(5	)
Inception of derivative liability		100		-
Change in fair value of beneficial conversion features		18		5

Fair value, end of period	$	118	$	-

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12. INCOME TAXES

The Company has incurred net operating losses (“NOLs”) since inception. As of December 31, ~~2023~~2024, the company had NOL carryforwards available through 2038 of approximately $6548.56 million to offset its future income tax liability. The company has recorded deferred tax assets but reserved against, due to uncertainties related to utilization of NOLs as well as calculation of effective tax rate. Utilization of existing NOL carryforwards may be limited in future years based on significant ownership changes. The ~~company~~Company is in the process of analyzing their NOL and has not determined if the ~~company~~Company has had any change of control issues that could limit the future use of NOL. NOL carryforwards that were generated after 2017 of approximately $1315.13 million may only be used to offset 80% of taxable income and are carried forward indefinitely.

72Components ~~Table~~ of ~~Contents~~deferred taxes are as follows at December 31, 2024 and 2023 (in thousands):

Components of deferred taxes are as follows at December 31, 2023 and 2022 (in thousands):

	December 31,
	2024			2023
Deferred tax assets:
Warrants	$	861		$	851
Accrued executive compensation		277			253
Reserves and other		205			221
Stock options		257			237
Net operating loss carryforwards		15,965			16,396
Total deferred tax assets:		17,565			17,958
Valuation allowance		(17,565	)		(17,958	)
Net deferred tax assets	$	-		$	-

	December 31,
	2023			2022
Deferred tax assets:
Warrants	$	851			-
Accrued executive compensation	$	253		$	259
Reserves and other		221			237
Stock options		237			178
Net operating loss carryforwards		16,374			16,390
Total deferred tax assets:		17,936			17,064
Valuation allowance		(17,936	)		(17,064	)
Net deferred tax assets	$	-		$	-

The following is a summary of the items that caused recorded income taxes to differ from taxes computed using the statutory federal income tax rate for the years ended December 31, 2024 and 2023:

The following is a summary of the items that caused recorded income taxes to differ from taxes computed using the statutory federal income tax rate for the years ended December 31, 2023 and 2022:

	2024			2023
Statutory federal tax rate		21	%		21	%
State taxes, net of federal benefit		4	%		4	%
Nondeductible expenses		-			-
Valuation allowance		-25	%		-25	%
Effective tax rate		0	%		0	%

	2023			2022
Statutory federal tax rate		21	%		21	%
State taxes, net of federal benefit		4	%		4	%
Nondeductible expenses		-			-
Valuation allowance		-25	%		-25	%
Effective tax rate		0	%		0	%

The Company applies the applicable authoritative guidance which prescribes a comprehensive model for the manner in which a company should recognize, measure, present and disclose in its financial statements all material uncertain tax positions that the Company has taken or expects to take on a tax return. As of December 31, 2024 and 2023, the Company has no uncertain tax positions. There are no uncertain tax positions for which it is reasonably possible that the total amounts of unrecognized tax benefits will significantly increase or decrease within twelve months from December 31, 2024.

The Company ~~applies~~files ~~the~~federal ~~applicable~~income ~~authoritative~~tax ~~guidance~~returns ~~which~~and ~~prescribes~~income atax ~~comprehensive~~returns ~~model for the manner~~ in ~~which~~various astate ~~company should recognize, measure, present and disclose in its financial statements all material uncertain~~ tax ~~positions~~jurisdictions ~~that~~with ~~the~~varying ~~Company~~statutes ~~has~~of ~~taken or expects to take on a tax return~~limitations. AsThe ~~of December 31, 2023, the~~ Company has nofiled ~~uncertain~~its ~~tax~~2023 ~~positions.~~federal ~~There~~and ~~are~~state nocorporate ~~uncertain~~ tax ~~positions for which it is reasonably possible that the total amounts of unrecognized tax benefits will significantly increase or decrease within twelve months from December 31, 2023~~returns.

~~The~~F-40 ~~Company~~Table ~~files federal income tax returns and income tax returns in various state tax jurisdictions with varying statutes~~ of ~~limitations. The Company has filed its 2022 federal and state corporate tax returns.~~Contents

The total provision for income taxes as of December 31, ~~2023~~2024 and ~~2022~~2023 was as follows:

	2023			2022
	2024			2023
Current	$	-		$	-
Deferred		-			-
Deferred provision (credit)		~~872~~(392	)		~~(617~~872	)
Change in valuation allowance		~~(872~~392	)		~~617~~(872	)
Total provision for income taxes	$	-		$	-

In ~~2023~~2024 and ~~2022~~2023, our effective tax rate differed from the U.S. federal statutory rate due to the valuation allowance over our deferred tax assets.

13. SEGMENT ~~SUBSEQUENT EVENTS~~REPORTING

OnThe ~~February~~Company ~~17,~~is ~~2024,~~not ~~the~~organized ~~Company~~by ~~entered~~multiple ~~into~~operating asegments ~~fourth~~for ~~amendment~~the topurpose ~~the~~of ~~agreement~~making ~~with~~operating ~~SMI~~decisions or assessing performance. ~~Under~~Accordingly, the ~~terms~~Company ofoperates ~~the~~in ~~amended~~one ~~agreement,~~reportable ~~SMI~~operating ~~also~~segment. ~~agreed~~The toCompany’s ~~pay~~principal decision maker is the ~~Company~~Chief ~~$531,100 on~~Executive orOfficer ~~prior~~and toacting ~~March~~Chief ~~15,~~Financial ~~2024~~Officer. OnManagement ~~March~~believes ~~18,~~that ~~2024,~~its ~~SMI,~~business ~~through~~operates ~~SMI’s~~as ~~authorized~~one ~~distribution~~reportable ~~partner,~~segment ~~initiated~~because: a) ~~wire~~the ~~payment~~Company ofmeasures ~~$330,000~~profit inand ~~partial~~loss ~~satisfaction~~as ofa ~~$531,100~~whole; ~~owed~~b) to the ~~Company.~~principal ~~The~~decision ~~payment~~maker ~~was~~does ~~received~~not byreview information based on any operating segment; c) the Company does not maintain discrete financial information on ~~March~~any ~~20,~~specific ~~2024.~~segment; Asd) the ~~full~~Company ~~payment~~has ~~was~~ not ~~received~~chosen byto ~~March~~organize ~~15,~~its ~~2024~~business around different products and services, and e) the Company ~~had~~has ~~the~~not ~~right~~chosen to ~~terminate~~organize its business around geographic areas. Since the ~~agreement~~Company ~~with~~operates ~~two~~as ~~weeks’~~one ~~notice~~operating tosegment, ~~SMI~~financial segment information, ~~however~~including ~~the~~profit ~~Company~~or ~~did~~loss ~~not~~and ~~exercise~~asset ~~this~~information, ~~option~~can be found in the consolidated financial statements.

~~The amended agreement also provides for a timeline for the Company to deliver inventory during 2024, including LuViva devices and components, as well as approximately~~14. ~~1,640,000~~SUBSEQUENT ~~RFID chips. In consideration, SMI agreed to pay a total of $4.4 million during 2024, including the payments due on March 15, 2024.~~EVENTS

OnPrivate ~~March~~Placement 27, 2024, the parties entered into a Standstill Agreement (the “Standstill Agreement”). The parties agreed that SMI will make a nonrefundable payment of $100,000 to the Company prior to March 31, 2024. In exchange, the Company will not initiate any legal proceedings, including but not limited to filing a lawsuit, obtaining a judgement, or enforcing any security interest, as related to the March shortfall in payments of $201,100, until April 30, 2024. Upon paying $100,000, SMI will have the option to extend the Standstill Agreement until June 15, 2024 by making a nonrefundable payment to the Company of $150,000. One additional payment of $150,000 may be made to extend the standstill rights until July 30, 2024, if mutually agreed upon. If SMI is unable to make the payments pursuant to the Standstill Agreement, the Company agreed to seek loans on behalf of SMI to cover the payments. SMI agreed to reimburse the Company for these loans along with all expenses associated with them within three months of the loans being issued as long as the loans are used solely for (1) parts for LuViva devices to be used by SMI for marketing and promotional activities, or (2) labor or consulting fees connected to providing parts, assemblies of devices or disposables to SMI. Additionally, SMI confirmed its commitment to make payments to GTI of at least $4.0 million during 2024 and as part of this commitment will make payments of $200,000 and $500,000 by the end of May 2024 and July 2024, respectively, to ensure that the program commercialization proceeds according to schedule. Offering

~~Jones~~On ~~Day~~March ~~Amended~~18, ~~Exchange~~2025, the Company entered into a Securities Purchase Agreement (the “March Purchase Agreement”) with certain institutional investors, including John Imhoff and Michael James, members of the Company’s Board of Directors, for the purpose of raising $257,102 in gross proceeds for the Company. Pursuant to the terms of the March Purchase Agreement, the Company agreed to sell, in a private placement offering, an aggregate of 2,571,023 units, each unit consisting of one share of common stock and one warrant to purchase up to 2,571,023 shares of common stock (the “March Warrants”). The purchase price per unit was $0.10. The March Warrants were immediately exercisable upon issuance, expire four years following the issuance date and have an exercise price of $0.13 per share.

OnIn ~~January~~connection 6,with ~~2020~~the March Purchase Agreement, wethe Company entered into an exchange agreement with ~~Jones Day~~Dr. ~~Upon execution of the agreement~~Imhoff, ~~Jones~~whereby ~~Day~~Dr. Imhoff agreed to exchange ~~$1,744,768 of payables outstanding for: (1)~~ a $~~175~~25,000 ~~cash payment, (2) an unsecured promissory~~ note inpayable ~~the~~and ~~amount~~accrued interest of $~~550~~1,~~000~~307 ~~(the~~for ~~“13-Month Note”)~~263,069 ~~due~~units 13as ~~months~~described ~~form~~above. ~~the date of issuance~~Additionally, ~~that~~the ~~may~~Company beentered ~~called~~into ~~at any time prior to maturity upon a payment of $150,000; and (3)~~ an ~~unsecured~~exchange ~~promissory~~agreement ~~note~~ with aMr. ~~principal amount of $444~~James,~~768~~ ~~(the~~whereby ~~“Five-Year Note”), bearing an annualized interest rate of 6~~Mr.0% ~~and~~James ~~due in four equal annual installments beginning on the second anniversary of the date of issuance. The parties~~ agreed ~~that~~to ~~the~~ exchange ~~would~~a ~~be executed once the~~ $~~175~~25,000 ~~cash~~note ~~payment~~payable ~~was made, on or before the date the Securities~~ and ~~Exchange~~accrued ~~Commission~~interest ~~(the~~of ~~“SEC”) declared effective a registration statement on Form S-~~$1,295 ~~(the~~for ~~“S-1”)~~262,945 ~~the~~units ~~Company~~as ~~filed~~described ~~to register certain securities in connection with an offering~~above.

~~During the year ended December 31, 2023, the S~~C-1 ~~was declared effective~~ and the Company also entered into an amended agreement with Jones Day to extend the due date of the $175,000 payment (and thus the execution date of the exchange agreement) to March 31, 2024. The Company agreed to pay an additional $25,000 as part of the final payment of the FiveC-~~Year~~2 ~~Note~~Preferred inStock ~~exchange for extending the due date of the $175,000 payment until March 31, 2024.~~Exchanges

~~Subsequent~~On toMarch ~~December 31~~3, ~~2023~~2025, the Company ~~and Jones Day~~ entered into anexchange ~~Amended~~agreements ~~Exchange~~with ~~Agreement,~~certain ~~pursuant~~accredited ~~to which the $175~~investors,~~000~~ ~~payment~~including ~~will~~Mark beFaupel ~~paid~~and inJohn ~~three~~Imhoff, ~~quarterly~~members ~~installments~~ of ~~$25,000,~~the ~~beginning~~Company’s onboard ~~March 31, 2024 and two quarterly installments~~ of ~~$50~~directors,~~000~~ ~~beginning~~to ~~December~~exchange ~~31,~~675 ~~2024.~~shares ~~Upon final payment~~ of ~~the~~Series ~~$175,000, the 13~~C-~~Month~~1 ~~Note~~Preferred ~~and~~Stock ~~Five-Year Notes will be issued~~ and ~~will~~2,700 ~~have~~shares ~~the~~of ~~same~~Series ~~terms~~C-2 asPreferred ~~described~~stock ininto ~~the~~6,750,000 ~~original~~shares ~~agreement. Any payment not made in full by its due date shall bear interest at the annualized rate~~ of ~~12.0%~~common ~~on the unpaid amount~~stock.

Common Stock ~~and Warrants~~ Issued

Subsequent to December 31, ~~2023~~2024, the Company issued ~~900~~ (1) 2,258,690 common shares to Dr. Imhoff for the conversion of 286 Series C Preferred shares, (2) 1,350,000 ~~3-year~~ ~~warrants~~common ~~with~~shares to an ~~exercise~~accredited ~~price~~investor for the conversion of ~~$0.30 and~~ 675 Series C-1 Preferred shares, (3) 5,400,000 common shares to ~~Richard~~Dr. ~~Blumberg,~~Faupel aand ~~related party~~Dr. ~~The~~Imhoff ~~securities~~for ~~were~~the ~~issued~~conversion inof ~~accordance~~2,700 ~~with~~Series aC-2 ~~consulting~~Preferred ~~agreement~~shares ~~the~~, ~~Company~~(4) ~~entered~~1,050,000 ~~into~~common onshares ~~March~~to ~~10,~~Dr. ~~2021~~Imhoff and ~~subsequently~~an ~~amended~~accredited oninvestor ~~September~~for ~~30,~~the ~~2021~~conversion of 350 Series D Preferred shares and ~~November~~(5) 11100,000 ~~2022.~~shares for the conversion of 25 Series F-2 Preferred shares.

Subsequent to December 31, ~~2023~~2024, the Company issued ~~54,494 and~~ 52(1) 51,~~332~~555 shares of common stock for ~~Series~~the Dpayment ~~and~~of Series ED Preferred Stock dividends, ~~respectively.~~(2) ~~Additionally~~48,668 for the ~~Company~~payment ~~issued~~of ~~444,621~~Series E Preferred Stock dividends and ~~163~~(3) 7,~~529~~035 shares of common stock for ~~Series~~the Fpayment ~~and~~of Series F-2 Preferred Stock dividends~~, respectively~~.

Other Subsequent ~~to December 31, 2023, we issued 393,372 shares of common stock for the payment of interest.~~Events

73On ~~Table~~March 7, 2025, the Company amended the terms of ~~Contents~~the promissory note held by Mark Faupel. Under the terms of the new agreement, the promissory note will mature on February 18, 2026.

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Table of Contents

Item 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

None.

Item 9A. CONTROLS AND PROCEDURES

We maintain a set of disclosure controls and procedures designed to ensure that information required to be disclosed by us in reports that we file or submit under the Securities Exchange Act of 1934, as amended (the “Exchange Act”) is recorded, processed, summarized, and reported, within the time periods specified in Securities and Exchange Commission (“Commission”) rules and forms. We carried out an evaluation under the supervision and with the participation of our management, including the Chief Executive Officer/Acting Chief Financial Officer, Gene Cartwright, of the effectiveness of its disclosure controls and procedures. Based on that evaluation, the Chief Executive Officer/Acting Chief Financial Officer has concluded that our disclosure controls and procedures were ineffective as of December 31, ~~2023~~2024, due to the existence of material weaknesses in our internal control over financial reporting, described below, that we have yet to fully remediate.

Management’s Annual Report on Internal Control over Financial Reporting

Our management, including our Chief Executive Officer/Acting Chief Financial Officer, is responsible for establishing and maintaining adequate internal control over our financial reporting. Internal control over financial reporting is a process designed by, or under the supervision of, our Chief Executive Officer/Chief Financial Officer and implemented by our board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles and includes those policies and procedures that: (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of our assets; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorization of our management and directors; and (ii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on the financial statements. Because of their inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

Under the supervision and with the participation of our management, including our Principal Executive Officer/Principal Financial Officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting based on the 2013 version of the Internal Control – Integrated Framework, issued by the Committee of Sponsoring Organizations of the Treadway Commission.

Based on our evaluation, our management concluded that our internal control over financial reporting was ineffective as of December 31, ~~2023~~2024, due to the existence of the material weaknesses described below:

	1)	The Company lacks the resources to properly research and account for complex transactions.

	2)	There is a lack of oversight and approval by the Board of Directors and Audit Committee, including formally documented approval of significant transactions, including related party transactions.

This annual report does not include an attestation report of our independent registered public accounting firm regarding internal control over financial reporting. Management’s report was not subject to attestation by our independent registered public accounting firm pursuant to rules of the Commission that permit non-accelerated filers to provide only the management’s report in their annual reports on Form 10-K.

74 Table of Contents

Item 9B. OTHER INFORMATION

None.

Item 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS

Not applicable.

7533 Table of Contents

PART III

Item 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

Our executive officers are elected by and serve at the discretion of our board of directors. The following table lists information about our directors and executive officers:

Name	Age	Position with Guided Therapeutics
Mark Faupel, Ph.D.	68	Chief Executive Officer, President, Acting Chief Financial Officer, Chief Operating Officer and Director
Michael C. James	65	Chairman and Director
Richard P. Blumberg	67	Director
John E. Imhoff, M.D.	74	Director
Alan Grujic	56	Director

Mark Faupel, Ph.D., rejoined us as Chief Operating Officer and director on December 8, 2016. On March 7, 2023, the Board appointed Dr. Mark Faupel to replace Mr. Cartwright as the Company’s President and Chief Executive Officer, effective as of March 6, 2023. He previously served on our board of directors through 2013 and has more than 30 years of experience in developing non-invasive alternatives to surgical biopsies and blood tests, especially in the area of cancer screening and diagnostics. Dr. Faupel was one of our co-founders and also served as our Chief Executive Officer from May 2007 through 2013. Prior thereto was our Chief Technical Officer from April 2001 to May 2007. Dr. Faupel has served as a National Institutes of Health reviewer, is the inventor on 26 U.S. patents and has authored numerous scientific publications and presentations, appearing in such peer-reviewed journals as The Lancet. Dr. Faupel earned his Ph.D. in neuroanatomy and physiology from the University of Georgia. Dr. Faupel is also a shareholder of Shenghuo Medical, LLC.

Filing Compare · GUIDED THERAPEUTICS INC