Guided Therapeutics Inc 10-K for FY2023
Guided Therapeutics Inc (GTHP)
About this 10-K
Guided Therapeutics Inc filed this 10-K on March 28, 2024, covering the fiscal year ended December 31, 2023 (FY2023).
Headline figures
Fiscal year ended December 31, 2023, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Revenue
- $98K
- up 653.8% from $13K a year earlier
- Net loss
- $3.49M
- compared with a net loss of $4.34M a year earlier
- Diluted EPS
- -$0.07
- compared with -$0.15 a year earlier
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
For the fiscal year ended
Commission File No.
(Exact Name of Registrant as Specified in Its Charter) |
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(State or other jurisdiction of incorporation or organization) |
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(Address of principal executive offices, including zip code)
Registrant’s telephone number, including area code: (
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 ☐
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 ☐
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:
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).
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 | ☐ |
☒ | Smaller reporting company | ||
Emerging growth company |
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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
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 (the last business day of the registrant’s most recently completed second fiscal quarter), was: $
As of March 28, 2024, the registrant had
GUIDED THERAPEUTICS, INC. |
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ANNUAL REPORT ON FORM 10-K |
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TABLE OF CONTENTS |
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Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations |
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Item 7A. Quantitative and Qualitative Disclosures About Market Risk |
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Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure |
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Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections |
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Item 10. Directors, Executive Officers and Corporate Governance |
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Item 13. Certain relationships and related transactions and director independence |
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Item 16. Form 10-K Summary |
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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; |
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| · | 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; |
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| · | the extent to which certain debt holders may call the notes to be paid; |
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| · | the effectiveness and ultimate market acceptance of our products and our ability to generate sufficient sales revenues to sustain our growth and strategy plans; |
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| · | whether our products in development will prove safe, feasible and effective; |
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| · | whether and when we or any potential strategic partners will obtain required regulatory approvals in the markets in which we plan to operate; |
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| · | 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; |
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| · | the lack of immediate alternate sources of supply for some critical components of our products; |
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| · | our ability to establish and protect the proprietary information on which we base our products, including our patent and intellectual property position; |
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| · | the impact of the conflict between Russia and Ukraine on economic conditions in general and on our business and operations; |
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| · | the need to fully develop the marketing, distribution, customer service and technical support and other functions critical to the success of our product lines; |
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| · | the dependence on potential strategic partners or outside investors for funding, development assistance, clinical trials, distribution and marketing of some of our products; and |
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| · | 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.
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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 604,000 new cases in 2020, an increase of 34,000 cases from 2018. 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 342,000 women died from cervical cancer, with 89% 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 - $310 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, leading online medical service providers, the cost of a colposcopy examination with biopsy in the United States is currently $1,300 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.
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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, we have sold 148 LuViva devices and approximately 78,400 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. |
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| · | Regulatory approvals have been granted covering over 40 countries, with most of these covered by our CE Mark. |
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| · | We have legitimate pathways for securing marketing approvals in the two largest medical markets – the US and China, within a 1-2 year period. |
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| · | 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. |
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| · | 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. |
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| · | Seek Chinese FDA approval working with our existing partner in China, Shandong Medical Instrumentation Co. Ltd. |
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| · | Pursue regulatory approval in Russia and work with our partner in Central and Eastern Europe, Newmars Technology, Inc. to generate sales in Europe. |
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| · | 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 27, 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 $8.4 million in research and development expenses, net of about $927,000 reimbursed through collaborative arrangements and government grants. Research and development costs were approximately $0.2 and $0.1 million in the years ended December 31, 2023 and 2022, 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, we have 41 granted 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 | 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 | 7/15/14 | 7/14/31 |
9,561,003 | Method and Apparatus For Rapid Detection and Diagnosis of Tissue Abnormalities | US | 2/7/17 | 3/5/34 |
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 | 3/10/15 | 3/10/29 |
D746475 | Mobile Cart and Hand Held Unit for Diagnostics or Measurement | US | 12/29/15 | 12/29/29 |
The Company has applied for two additional US patents, although there is no assurance that these patents 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, we had four regular employees and two 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. |
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| · | Class II device: Further control is required to ensure the safety and effectiveness of the device. |
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| · | 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 clinical trials to commence.
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. We agreed with the FDA on the study protocol during the second quarter of 2021 and have begun enrollment of subjects in the clinical study. To date, approximately 100 patients have been enrolled and tested. We expect the study to be completed in 2024, however there can be no assurance that it will progress within our expected timeframe.
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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. 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, 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 $151.1 million at December 31, 2023, summarized as follows:
Accumulated deficit as of December 31, 2019 |
| $ | 139.6 |
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Preferred dividends for the year ended December 31, 2020 |
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| 0.1 |
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Net loss for the year ended December 31, 2020 |
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| 0.3 |
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Accumulated deficit as of December 31, 2020 |
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| 140.0 |
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Preferred dividends for the year ended December 31, 2021 |
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| 0.4 |
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Net loss for year ended December 31, 2021 |
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| 2.0 |
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Accumulated deficit as of December 31, 2021 |
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| 142.4 |
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Preferred dividends for the year ended December 31, 2022 |
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| 0.6 |
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Net loss for the year ended December 31, 2022 |
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| 4.4 |
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Accumulated deficit as of December 31, 2022 |
| $ | 147.4 |
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Preferred dividends for the year ended December 31, 2023 |
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| 0.2 |
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Deemed dividends for warrant exchanges for the year ended December 31, 2023 |
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| 0.1 |
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Net loss for the year ended December 31, 2023 |
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| 3.4 |
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Accumulated deficit as of December 31, 2023 |
| $ | 151.1 |
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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 and 2022, our accumulated deficit was approximately $151.1 million and $147.4 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.
In 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, 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 the clinical trial data to be filed with NMPA in the first quarter of 2024.
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; |
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| · | unexpected or unfavorable changes in foreign laws, regulatory requirements and related interpretations; |
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| · | difficulty of effective enforcement of contractual provisions in local jurisdictions; |
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| · | inadequate intellectual property protection in foreign countries; |
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| · | 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; |
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| · | trade sanctions imposed by the United States or other governments with jurisdictional authority over our business operations; |
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| · | the effects of applicable and potentially adverse foreign tax law changes; |
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| · | significant adverse changes in foreign currency exchange rates; |
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| · | longer accounts receivable cycles; |
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| · | managing a geographically dispersed workforce; and |
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| · | compliance with the U.S. Foreign Corrupt Practices Act, or FCPA, and the Office of Foreign Assets Control regulations, particularly in emerging markets. |
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| · | whether and when we or any potential strategic partners will obtain required regulatory approvals in the markets in which we plan to operate; and |
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| · | 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; |
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| · | the U.S. FDA will act favorably or quickly on these submissions; |
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| · | we will not be required to submit additional information or perform additional clinical studies; or |
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| · | 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.
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; |
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| · | difficulties in penetrating markets in which our competitors’ products may be more established; |
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| · | reduced or no protection for intellectual property rights in some countries; |
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| · | export restrictions, trade regulations and foreign tax laws; |
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| · | fluctuating foreign currency exchange rates; |
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| · | foreign certification and regulatory clearance or approval requirements; |
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| · | difficulties in developing effective marketing campaigns for unfamiliar, foreign countries; |
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| · | customs clearance and shipping delays; |
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| · | political and economic instability; and |
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| · | 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, we have been issued, 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 (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 $5.5 million at December 31, 2023. 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; |
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| · | the amount of our interest expense may increase if we are unable to make payments when due; |
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| · | our vendors or employees may, and some have, instituted proceedings to collect on amounts owed them; |
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| · | 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 |
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| · | 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 were outstanding as of December 31, 2023. 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 and 2022, 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 and 2022, 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 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, our outstanding convertible debt was convertible into an aggregate of 2,809,278 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 19,020,513 shares of common stock. Also, as of that date we had warrants outstanding that were exercisable for an aggregate of 28,584,580 shares, and outstanding options to purchase 2,338,636 shares. The shares of common stock issuable upon conversion or exercise of these securities would have constituted approximately 97.5% 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. 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. 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
Item 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
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 13, 2024 was 159.
The high and low common stock share prices for the first quarter of 2024 and calendar years 2023 and 2022, as reported by the OTCQB, were as set forth in the following table:
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| 2023 |
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| 2022 |
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| Low |
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| High |
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| Low |
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| High |
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| Low |
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First Quarter* |
| $ | 0.19 |
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| $ | 0.13 |
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| $ | 0.36 |
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| $ | 0.20 |
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| $ | 0.70 |
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| $ | 0.46 |
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Second Quarter |
| $ | - |
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| $ | - |
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| $ | 0.28 |
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| $ | 0.11 |
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| $ | 0.73 |
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| $ | 0.38 |
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Third Quarter |
| $ | - |
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| $ | - |
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| $ | 0.28 |
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| $ | 0.11 |
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| $ | 0.59 |
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| $ | 0.40 |
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Fourth Quarter |
| $ | - |
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| $ | - |
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| $ | 0.19 |
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| $ | 0.13 |
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| $ | 0.48 |
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| $ | 0.23 |
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*Through March 13, 2024 |
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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:
Plan Description |
| Number of securities to be issued upon exercise of outstanding options |
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| Weighted-average exercise price of outstanding options |
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| Number of securities available for future issuance under equity compensation plans |
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2018 Equity Incentive Plan |
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| 2,338,636 |
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| $ | 0.41 |
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| 3,659,411 |
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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
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 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 we have an accumulated deficit of approximately $151.1 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 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 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, including an amended agreement executed on February 17, 2024, we currently hold and expect to generate additional purchase orders for approximately $4.4 million in LuViva devices and disposables and expect those purchase orders to result in actual sales of $1.5 to $2.5 million throughout in 2024, representing what we view as current demand for our products. 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 the United States, the Company is actively pursuing FDA approval by initiating 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 protocol was drafted with input from FDA and at least 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 fully IRB approved. All four sites have received LuViva devices and have been trained on their use. One 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 Company 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 clinical study monitoring visits include:
| 1) | There have not been any adverse events reported related to the use of LuViva. |
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| 2) | All three monitored clinical study sites are adhering to the study protocol and are completing the necessary case report forms according to FDA standards. |
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| 3) | Enrollment rates predictably slowed down over the Thanksgiving and Christmas holidays but have increased during 2024. |
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| 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, however there can be no assurance that the study will progress within the expected timeline.
Regarding international sales efforts, our focus has been on achieving regulatory approval to sell LuViva in China. Our Chinese partner, SMI, has reported to us that as of December 2023, all study subjects needed for Chinese National Medical Products Administration (NMPA) approval have been enrolled and tested. There have been no reports of any adverse events from the study associated with the LuViva device. SMI believes that they can file the clinical report with NMPA during the second quarter of 2024 and that approval could occur in 2024, although there can be no assurance that NMPA filing and approval will be completed within the projected time frames.
In Europe, our distribution partners, Newmars Medical Technologies (“Newmars”), reported that sales efforts have restarted after delays caused by Covid-19. They are now actively pursuing potential customers in Poland, Hungary and Romania.
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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 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 valuation model.
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Allowance for Accounts Receivable: The Company reviews all outstanding accounts receivable for collectability on a quarterly basis. An allowance for credit losses is recorded for any amounts deemed uncollectable. The allowance is adjusted based on our assessment of the ability of our distributors to make required payments and our review of the financial condition of our distributors.
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 and 2022
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 were $97,706, compared to $13,459 for the year ended December 31, 2022. Cost of goods sold was $62,382 during the year ended December 31, 2023, compared to $80,656 during the year ended December 31, 2022. The decrease of $18,274 in cost of goods sold was primarily caused by a $33,573 increase in the inventory reserve during 2022 and a larger amount of inventory write-offs, which resulted in a negative gross margin during 2022. While we currently hold purchase orders with our partner SMI for approximately $4.4 million in LuViva devices and disposables, supply chain issues due to COVID-19 have caused delays in our ability to procure the circuit boards that are needed to ship our products. As of December 31, 2023, we have deferred revenue balance of $424,225, which will be recognized as revenue when our products are shipped. We anticipate recognizing revenue for these shipments in 2024.
Research and Development Expenses: Research and development expenses were $228,132 and $76,892 during the years ended December 31, 2023 and 2022, respectively. The increase of $128,676, or 167.3%, was primarily due to an increase in research and development clinical costs and payroll-related expenses related to clinical trials.
Sales and Marketing Expenses: Sales and marketing expenses were $268,375 and $181,024 during the years ended December 31, 2023 and 2022, respectively. The increase of $87,351, or 48.3%, was primarily due to higher travel and payroll-related expenses.
General and Administrative Expense: General and administrative expenses were $2,997,424 and $3,007,148 during the years ended December 31, 2023 and 2022, respectively. The decrease of $9,724, or 0.3%, was due to a decrease of $858,591 of consulting, attorney and other professional fees (attributed to lower fees incurred for SEC filings), a $21,650 decrease in bad debt expense, and a $5,580 decrease in other miscellaneous operating expenses. These decreases were offset by an $812,764 increase in payroll and benefits expense and a $60,333 increase in expense related to stock options during 2023. The increase in payroll and benefits was primarily driven by $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 year. The increase in stock option expense was primarily driven by $59,216 of additional expense due to the modification of a stock option award.
Interest Expense: Interest expense during the years ended December 31, 2023 and 2022 was $278,350 and $582,174, respectively. The decrease of $303,824 (or 52.2%), was due to a decrease in debt, which is a result of the Company’s concerted efforts to reduce debt through payoffs and exchanges of debt for equity.
Interest Income: Interest income was $6,119 and nil during the years ended December 31, 2023 and 2022, respectively. During 2023, the Company opened a Preferred Deposit Business account which earned interest on the cash deposited.
Change in Fair Value of Derivative Liability: The gain due to the change in fair value of the derivative liability was $5,104 and $26,785 during the years ended December 31, 2023 and 2022, respectively. The change in the fair value of the derivative liability was due to changes to our stock price during the period and a reduction in the principal amount of debt owed.
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 and 2022 was $39,271 and $16,551, respectively. The increase of $22,720, or 137.3%, was primarily due to an increase 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 $98,972 and nil for the years ended December 31, 2023 and 2022, respectively. The expense in the current 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 $170,803 and $631,356 during the years ended December 31, 2023 and 2022, respectively. The decrease of $460,553 (or 72.9%) was primarily due to payment of a one-time, non-recurring 15% dividend to the Series F and Series F-2 Preferred shareholders which was paid via issuance of common stock in the first quarter of 2022. 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 $3,759,032 and $4,972,174 during the years ended December 31, 2023 and 2022, respectively. The reasons for the fluctuation are outlined above.
There was no income tax benefit recorded for 2023 or 2022, 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, the Company had a negative working capital of approximately $3.4 million, accumulated deficit of $151.1 million, and incurred a net loss including preferred and deemed dividends of $3.8 million for the year then ended. Stockholders’ deficit totaled approximately $3.8 million at December 31, 2023, 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. We anticipate we will require approximately $1.8 million to $2.2 million of funds to operate our business over the next twelve months, including approximately $0.6 million of funds to complete our ongoing clinical studies.
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, we had cash of approximately $0.59 million and negative working capital of $3.4 million.
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
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.
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 |
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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 and 2022, 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 and 2022, 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 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. 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. |
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| · | 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. |
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| · | We performed sensitivity analyses of significant assumptions to evaluate the changes in the fair value that would result from changes in these assumptions. |
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| · | With the assistance of our valuation specialists, we evaluated management’s valuation methodology, including the selection of the pricing model. |
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| · | 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. |
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| · | 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. |
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| · | We assessed whether the disclosures in the consolidated financial statements are complete and accurate. |
We have served as the Company’s auditor since 2007.
March 28, 2024
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GUIDED THERAPEUTICS, INC. AND SUBSIDIARY |
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CONSOLIDATED BALANCE SHEETS |
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(in thousands) |
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| December 31, |
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| December 31, |
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| 2023 |
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| 2022 |
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ASSETS |
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Current Assets: |
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Cash and cash equivalents |
| $ |
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| $ |
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Accounts receivable, net of allowance for credit losses of $ |
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Inventory, net of reserves of $ |
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Other current assets |
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Total current assets |
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Non-Current Assets: |
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Property and equipment, net |
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Operating lease right-of-use asset, net of amortization |
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Other assets |
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Total non-current assets |
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TOTAL ASSETS |
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| $ |
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LIABILITIES AND STOCKHOLDERS’ DEFICIT | ||||||||
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Current Liabilities: |
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Accounts payable |
| $ |
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| $ |
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Accounts payable, related parties |
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Accrued liabilities |
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Deferred revenue |
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Current portion of lease liability |
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Current portion of long-term debt |
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Current portion of long-term debt, related parties |
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Short-term notes payable |
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Short-term notes payable, related parties |
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Short-term convertible debt |
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Total current liabilities |
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Long-Term Liabilities |
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Long-term lease liability |
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Derivative liability |
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Long-term convertible debt |
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Long-term debt, related parties |
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Total long-term liabilities |
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Total liabilities |
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COMMITMENTS AND CONTINGENCIES (Note 7) |
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STOCKHOLDERS’ DEFICIT: |
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Series C convertible preferred stock, $ |
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Series C1 convertible preferred stock, $ |
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Series C2 convertible preferred stock, $ |
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Series D convertible preferred stock, $ |
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Series E convertible preferred stock, $ |
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Series F convertible preferred stock, $ |
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Series F-2 convertible preferred stock, $ |
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Common stock, $ |
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Additional paid-in capital |
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Treasury stock at cost |
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Accumulated deficit |
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Total stockholders’ deficit |
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TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT |
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| $ |
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The accompanying notes are an integral part of these consolidated statements.
| 36 |
| Table of Contents |
GUIDED THERAPEUTICS, INC. AND SUBSIDIARY | ||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||
(in thousands) | ||||||||
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| Years Ended |
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Sales - devices and disposables |
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Cost of goods sold |
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Gross profit (loss) |
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Operating expenses: |
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Research and development |
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Sales and marketing |
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General and administrative |
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Total operating expenses |
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Loss from operations |
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Other income (expense) |
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Interest expense |
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Interest income |
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Change in fair value of derivative liability |
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Gain (Loss) from extinguishment of debt |
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Other income |
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Total other income (expense) |
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Loss before income taxes |
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Provision for income taxes |
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Net loss |
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Deemed dividend for warrant exchanges |
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Preferred stock dividends |
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NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS |
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NET LOSS PER SHARE ATTRIBUTABLE TO COMMON STOCKHOLDERS |
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Basic |
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Diluted |
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Weighted average shares outstanding |
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Basic |
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Diluted |
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The accompanying notes are an integral part of these consolidated statements.
| 37 |
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GUIDED THERAPEUTICS, INC. AND SUBSIDIARY |
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT |
FOR THE YEAR ENDED DECEMBER 31, 2023 |
(in thousands) |
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| Preferred Stock Series C |
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| Preferred Stock Series C1 |
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| Preferred Stock Series D |
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| Amount |
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| Amount |
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Balance at December 31, 2022 |
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Common stock warrants exercised |
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| - |
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Issuance of common stock for payment of Series D preferred dividends |
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| - |
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| - |
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| - |
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Issuance of common stock for payment of Series E preferred dividends |
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| - |
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| - |
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| - |
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Issuance of common stock for payment of Series F preferred dividends |
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| - |
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| - |
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| - |
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| - |
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Issuance of common stock for payment of Series F-2 preferred dividends |
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| - |
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| - |
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| - |
|
|
|
|
|
| - |
|
|
|
| ||||
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 |
|
| - |
|
| $ |
|
|
|
|
| $ |
|
|
|
|
| $ |
|
|
|
|
| $ |
| |||||||
| 38 |
| 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 |
|
|
|
| $ |
|
|
|
|
| $ |
|
|
| - |
|
| $ |
| |||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
|
|
| $ |
|
|
|
|
| $ |
|
|
| - |
|
| $ |
| |||||
| 39 |
| Table of Contents |
|
|
|
| Additional |
|
|
|
|
|
|
|
| ||||||||||||
|
| Common Stock |
|
| Paid-In |
|
| Treasury |
|
| Accumulated |
|
|
| ||||||||||
|
| Shares |
|
| Amount |
|
| Capital |
|
| Stock |
|
| Deficit |
|
| Total |
| ||||||
Balance at December 31, 2022 |
|
|
|
| $ |
|
| $ |
|
| $ | ( | ) |
| $ | ( | ) |
| $ | ( | ) | |||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
|
|
| $ |
|
| $ |
|
| $ | ( | ) |
| $ | ( | ) |
| $ | ( | ) | |||
The accompanying notes are an integral part of these consolidated statements.
| 40 |
| 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 |
|
| - |
|
| $ |
|
|
|
|
| $ |
|
|
|
|
| $ |
|
|
|
|
| $ |
| |||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| ( | ) |
|
| ( | ) |
|
| - |
|
|
|
| |||
Conversion of Series D preferred stock to common stock |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
| ( | ) | |||
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 |
|
| - |
|
| $ |
|
|
|
|
| $ |
|
|
|
|
| $ |
|
|
|
|
| $ |
| |||||||
| 41 |
| Table of Contents |
|
| Preferred Stock |
|
| Preferred Stock |
|
| Preferred Stock |
| |||||||||||||||
|
| Series E |
|
| Series F |
|
| Series F-2 |
| |||||||||||||||
|
| Shares |
|
| Amount |
|
| Shares |
|
| Amount |
|
| Shares |
|
| Amount |
| ||||||
Balance at December 31, 2021 |
|
|
|
| $ |
|
|
|
|
| $ |
|
|
|
|
| $ |
| ||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| |||
Conversion of Series D preferred stock to common stock |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| |||
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 |
|
|
|
| $ |
|
|
|
|
| $ |
|
|
| - |
|
| $ |
| |||||
| 42 |
| Table of Contents |
|
| Common Stock |
|
| Additional Paid-In |
|
| Treasury |
|
| Accumulated |
|
|
| ||||||||||
|
| Shares |
|
| Amount |
|
| Capital |
|
| Stock |
|
| Deficit |
|
| Total |
| ||||||
Balance at December 31, 2021 |
|
|
|
| $ |
|
| $ |
|
| $ | ( | ) |
| $ | ( | ) |
| $ | ( | ) | |||
Common stock warrants exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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| ||||||
| Issuances of common stock to investors |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
| Issuances of warrants to investors |
|
| - |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||
| Issuance of common stock for payment of Series D preferred dividends |
|
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|
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|
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|
|
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| ||||||
| Issuance of common stock for payment of Series E preferred dividends |
|
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|
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|
|
|
|
|
|
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| ||||||
| Issuance of common stock for payment of Series F preferred dividends |
|
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|
|
|
|
|
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|
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|
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|
|
|
| ||||||
| Issuance of common stock for payment of Series F-2 preferred dividends |
|
|
|
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|
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| ||||||
| Issuance of common stock for payment of interest |
|
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|
|
|
|
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|
|
|
|
|
|
|
|
|
| ||||||
| 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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
| Conversion of Series D preferred stock to common stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
| 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 |
|
|
|
| $ |
|
| $ |
|
| $ | ( | ) |
| $ | ( | ) |
| $ | ( | ) | |||
The accompanying notes are an integral part of these consolidated financial statements.
| 43 |
| 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 |
| $ | ( | ) |
| $ | ( | ) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
Bad debt expense |
|
|
|
|
|
| ||
Inventory reserve |
|
|
|
|
|
| ||
Depreciation |
|
|
|
|
|
| ||
Amortization of debt issuance costs and discounts |
|
|
|
|
|
| ||
Stock-based compensation |
|
|
|
|
|
| ||
Change in fair value of derivative liability |
|
| ( | ) |
|
| ( | ) |
Amortization of lease right-of-use-asset |
|
|
|
|
|
| ||
Loss on extinguishment of debt |
|
|
|
|
|
| ||
Gain from forgiveness of debt |
|
| ( | ) |
|
| ( | ) |
Other non-cash expenses |
|
|
|
|
|
| ||
Change in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
| ( | ) |
|
|
| |
Inventory |
|
| ( | ) |
|
| ( | ) |
Other current assets |
|
|
|
|
|
| ||
Accounts payable and accrued liabilities |
|
|
|
|
| |||
Lease liabilities |
|
| ( | ) |
|
| ( | ) |
Deferred revenue |
|
| ( | ) |
|
|
| |
NET CASH USED IN OPERATING ACTIVITIES |
|
| ( | ) |
|
| ( | ) |
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING ACTIVITIES: |
|
|
|
|
|
|
|
|
Purchase of property and equipment |
|
|
|
|
| ( | ) | |
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
Proceeds from warrant exercises |
|
|
|
|
|
| ||
Payments made on notes payable |
|
| ( | ) |
|
| ( | ) |
Proceeds from issuance of common stock, net of costs |
|
|
|
|
|
| ||
Proceeds from issuance of warrants, net of costs |
|
|
|
|
|
| ||
NET CASH PROVIDED BY (USED IN) FINANCING ACTIVITIES |
|
|
|
|
|
| ||
| 44 |
| Table of Contents |
NET CHANGE IN CASH |
|
| ( | ) |
|
|
| |
|
|
|
|
|
|
|
|
|
Cash at beginning of period |
|
|
|
|
|
| ||
|
|
|
|
|
|
|
|
|
CASH AT END OF PERIOD |
| $ |
|
| $ |
| ||
|
|
|
|
|
|
|
|
|
SUPPLEMENTAL DISCLOSURE FOR OPERATING ACTIVITIES: |
|
|
|
|
|
|
|
|
Cash paid for interest |
| $ |
|
| $ |
| ||
|
|
|
|
|
|
|
|
|
SUPPLEMENTAL DISCLOSURE FOR NON-CASH INVESTING AND FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
Dividends on preferred stock |
| $ |
|
| $ |
| ||
Deemed dividends for warrant exchanges |
| $ |
|
| $ |
| ||
Settlement of interest through common stock issuance |
| $ |
|
| $ |
| ||
Settlement of dividends through common stock issuance |
| $ |
|
| $ |
| ||
Settlement of previously accrued professional fees through common stock issuance |
| $ |
|
| $ |
| ||
Conversion of Series C-2 preferred shares into common stock |
| $ |
|
| $ |
| ||
Conversion of Series D preferred shares into common stock |
| $ |
|
| $ |
| ||
Conversion of Series E preferred shares into common stock |
| $ |
|
| $ |
| ||
Conversion of Series F preferred shares into common stock |
| $ |
|
| $ |
| ||
Conversion of Series F-2 preferred shares into common stock |
| $ |
|
| $ |
| ||
Directors and Officers insurance obtained with financing |
| $ |
|
| $ |
|
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, it had an accumulated deficit of approximately $151.1 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 Company 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.
| 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, the Company had a negative working capital of approximately $
During the year ended December 31, 2023, the Company received $
2. SIGNIFICANT ACCOUNTING POLICIES
Use of Estimates
Recent Accounting Standard (“ASU”) to Be Adopted in a Future Period
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
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. As of December 31, 2023 and 2022, our inventories were as follows:
|
| (in thousands) |
| |||||
|
| December 31, |
|
| December 31, |
| ||
|
| 2023 |
|
| 2022 |
| ||
|
|
|
|
|
|
| ||
Raw materials |
| $ |
|
| $ |
| ||
Work-in-progress |
|
|
|
|
|
| ||
Finished goods |
|
|
|
|
|
| ||
Inventory reserve |
|
| ( | ) |
|
| ( | ) |
|
|
|
|
|
|
|
|
|
Total inventory |
| $ |
|
| $ |
| ||
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 of operations. Expenditures for repairs and maintenance are expensed as incurred. Property and equipment are summarized as follows at December 31, 2023 and 2022:
|
| (in thousands) |
| |||||
|
| December 31, |
|
| December 31, |
| ||
|
| 2023 |
|
| 2022 |
| ||
|
|
|
|
|
|
| ||
Equipment |
| $ |
|
| $ |
| ||
Software |
|
|
|
|
|
| ||
Furniture and fixtures |
|
|
|
|
|
| ||
Leasehold improvements |
|
|
|
|
|
| ||
|
|
|
|
|
|
|
|
|
Subtotal |
|
|
|
|
|
| ||
Less accumulated depreciation |
|
| ( | ) |
|
| ( | ) |
Property, equipment and leasehold improvements, net |
| $ |
|
| $ |
| ||
During the year ended December 31, 2023, we disposed of approximately $
| 48 |
| 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 to approximately $
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, “Commitments and Contingencies”.
Accrued Liabilities
Accrued liabilities as of December 31, 2023 and 2022 are summarized as follows:
|
| (in thousands) |
| |||||
|
| December 31, 2023 |
|
| December 31, 2022 |
| ||
|
|
|
|
|
|
| ||
Compensation |
| $ |
|
| $ |
| ||
Professional fees |
|
|
|
|
|
| ||
Interest |
|
|
|
|
|
| ||
Vacation |
|
|
|
|
|
| ||
Preferred dividends |
|
|
|
|
|
| ||
Stock subscription payable |
|
|
|
|
|
| ||
Other accrued expenses |
|
|
|
|
|
| ||
|
|
|
|
|
|
|
|
|
Total |
| $ |
|
| $ |
| ||
| 49 |
| Table of Contents |
Stock Subscription Payable
Cash received from investors for 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 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 Company’s 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.
| 50 |
| Table of Contents |
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 $
Significant 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 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, the Company had approximately $
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
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.
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 common shares 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.
| 51 |
| Table of Contents |
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.
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 VALUE OF FINANCIAL INSTRUMENTS
The guidance for fair value measurements, ASC 820, Fair Value Measurements and Disclosures, establishes the authoritative definition of fair value, sets out a framework for measuring fair value, and outlines the required disclosures regarding fair value measurements. Fair value is the price that would be received to sell an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants at the measurement date. The Company uses a three-tier fair value hierarchy based upon observable and non-observable inputs as follow:
| · | Level 1–Quoted market prices in active markets for identical assets and liabilities; |
|
|
|
| · | Level 2–Inputs, other than level 1 inputs, either directly or indirectly observable; and |
|
|
|
| · | Level 3–Unobservable inputs developed using internal estimates and assumptions (there is little or no market date) which reflect those that market participants would use. |
The Company records its derivative activities at fair value. There were no derivative liabilities recorded as of December 31, 2023. As of December 31, 2022, we had one derivative liability associated with the bifurcated conversion option of a loan due to Auctus Funds, LLC (“Auctus”) in the amount of $
| 52 |
| Table of Contents |
The following tables present the fair value of those liabilities measured on a recurring basis as of December 31, 2022:
|
| 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 |
|
|
|
|
|
|
|
| ( | ) |
|
| ( | ) | ||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total long-term liabilities at fair value |
| $ |
|
| $ |
|
| $ | ( | ) |
| $ | ( | ) | ||
The following is a summary of changes to Level 3 instruments during the year ended December 31, 2023:
|
| (in thousands) |
| |
|
|
|
| |
Balance at December 31, 2022 |
| $ | ( | ) |
Change in fair value during the period |
|
|
| |
|
|
|
|
|
Balance at December 31, 2023 |
| $ |
| |
4. STOCKHOLDERS’ DEFICIT
Sales of Securities – 2022
During the year ended December 31, 2022, the Company entered into certain Securities Purchase Agreements (the “Agreement”) with certain accredited investors (the “Investors”), including Richard Blumberg, Michael James and John Imhoff, each a member of the Company’s Board of Directors, pursuant to which the Company issued
After payment of all fees and expenses relating to the transaction, the Company received net proceeds of approximately $
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Common Stock
The Company has authorized
During the years ended December 31, 2023 and 2022 the Company issued 5,509,386 and 34,922,132 shares of common stock, respectively, as summarized in the following tables:
|
| Number of Shares |
| |
|
|
|
| |
Issuances of common stock to investors |
|
|
| |
Issuances of common stock for warrants exercised |
|
|
| |
Issuances of common stock to Auctus for Exchange Agreement |
|
|
| |
Issuances of common stock for payment of Series D Preferred dividends |
|
|
| |
Issuances of common stock for payment of Series E Preferred dividends |
|
|
| |
Issuances of common stock for payment of Series F Preferred dividends |
|
|
| |
Issuances of common stock for payment of Series F-2 Preferred dividends |
|
|
| |
Issuances of common stock for payment of interest |
|
|
| |
Issuances of common stock for Series F one-time 15% dividend |
|
|
| |
Issuances of common stock for Series F-2 one-time 15% dividend |
|
|
| |
Conversion of Series C-2 Preferred stock to common stock |
|
|
| |
Conversion of Series D Preferred stock to common stock |
|
|
| |
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 |
|
|
| |
Total common stock issued during the year ended December 31, 2022 |
|
| 34,922,132 |
|
|
|
|
|
|
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 |
|
|
| |
Issuance of common stock for payment of interest |
|
|
| |
Issuance of common stock to consultants |
|
|
| |
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 |
|
|
| |
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 |
|
|
| |
Common shares issued during the year ended December 31, 2022 |
|
|
| |
Shares outstanding at December 31, 2022 |
|
|
| |
Common shares issued during the year ended December 31, 2023 |
|
|
| |
Shares outstanding at December 31, 2023 |
|
|
| |
Preferred Stock
The Company has authorized
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| Table of Contents |
Series C Convertible Preferred Stock
The board designated
Holders of the Series C Preferred Stock are entitled to quarterly cumulative dividends at an annual rate of
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 $
Series C1 Convertible Preferred Stock
The board designated
At December 31, 2023 and 2022, there were
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
At December 31, 2023 and 2022, there were
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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 ($
During the year ended December 31, 2022, the Company issued
Series D Convertible Preferred Stock
The board designated
Each share of Series D Preferred is convertible, at any time for a period of
During the year ended December 31, 2023, the Company issued
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
During the year ended December 31, 2022, the Company issued (1)
As of December 31, 2023 and 2022, the Company had accrued dividends for Series D preferred shares of $
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Series E Convertible Preferred Stock
The board designated
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 ended December 31, 2023, the Company issued (1)
During the year ended December 31, 2022, the Company issued (1)
As of December 31, 2023 and 2022, the Company had accrued dividends of $
Series F Convertible Preferred Stock
The board designated
Each share of Series F Preferred Stock is convertible, at any time for a period of
During the year ended December 31, 2023, the Company issued 200,000 shares of common stock for the conversion of 50 shares of Series F Convertible Preferred Stock and 233,308 shares of common stock for payment of annual Series F Convertible Preferred Stock dividends.
During the year ended December 31, 2022, the Company issued
As of December 31, 2023 and 2022, the Company had accrued dividends of $
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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
Each share of Series F-2 Preferred Stock is convertible, at any time for a period of
During the year ended December 31, 2023, the Company issued 60,000 shares of common stock for the conversion of 15 shares of Series F-2 Preferred Stock and 120,284 shares of common stock for payment of annual Series F-2 Preferred Stock dividends.
During the year ended December 31, 2022, the Company issued
As of December 31, 2023 and 2022, the Company had accrued dividends of $
Series G Convertible Preferred Stock
During January 2021, the board designated
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| Table of Contents |
Warrants
The following table summarizes transactions involving the Company’s outstanding warrants to purchase common stock for the years ended December 31, 2023 and 2022:
|
| Warrants (Underlying Shares) |
|
| Weighted-Average Exercise Price Per Share |
| ||
|
|
|
|
|
|
| ||
Outstanding, December 31, 2021 |
|
|
|
| $ |
| ||
Warrants issued |
|
|
|
| $ |
| ||
Warrants cancelled/expired |
|
| ( | ) |
| $ |
| |
Warrants exchanged |
|
| ( | ) |
| $ |
| |
Warrants exercised |
|
| ( | ) |
| $ |
| |
|
|
|
|
|
|
|
|
|
Outstanding, December 31, 2022 |
|
|
|
| $ |
| ||
|
|
|
|
|
|
|
|
|
Warrants issued |
|
|
|
| $ |
| ||
Warrants cancelled/expired |
|
| ( | ) |
| $ |
| |
Warrants exchanged |
|
| ( | ) |
| $ |
| |
Warrants exercised |
|
| ( | ) |
| $ |
| |
Outstanding, December 31, 2023 |
|
|
|
| $ |
| ||
Warrant Transactions – 2023
On May 14, 2023, the Compensation Committee of the Company’s Board of Directors approved the issuance of
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,
During the year ended December 31, 2023, the Company issued
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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
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
Management estimated the fair value of the warrants issued during the year ended December 31, 2023 utilizing the Black-Scholes Option Pricing model with the following weighted-average assumptions:
Expected term |
|
| ||
Volatility |
|
| % | |
Risk-free interest rate |
|
| % | |
Dividend yield |
|
| % | |
Warrant Transactions – 2022
During the year ended December 31, 2022, the Company issued
During the year ended December 31, 2022, the Company exchanged
During the year ended December 31, 2022, the Company issued
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:
Expected term |
|
| ||
Volatility |
|
| % | |
Risk-free interest rate |
|
| % | |
Dividend yield |
|
| % | |
During the year ended December 31, 2022, the Company issued
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5. STOCK OPTIONS
The new Stock Plan (the “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 board of directors, but incentive stock options were granted at an exercise price equal to the fair market value of the Company’s common stock as of the grant date. Options historically granted have generally become exercisable over four years and expire ten years from the date of grant. The plan provides for stock options to be granted up to
On February 10, 2023, the Company granted
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
On March 7, 2023, the Company granted
Management estimated the fair value of the stock options granted during the year ended December 31, 2023 utilizing the Black-Scholes Option Pricing model with the following weighted-average assumptions:
Expected term (years) |
|
| ||
Volatility |
|
| % | |
Risk-free interest rate |
|
| % | |
Dividend yield |
|
| % | |
During the years ended December 31, 2023 and 2022, the Company recognized expense for stock options of $
|
| 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 |
|
|
|
| $ |
|
|
| $ |
| ||||
Options exercisable as of December 31, 2022 |
|
|
|
| $ |
|
|
| $ |
| ||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options outstanding as of January 1, 2023 |
|
|
|
|
|
|
|
|
|
|
| |||
Options granted |
|
|
|
| $ |
|
|
|
|
|
|
| ||
Options forfeited |
|
| ( | ) |
| $ | 0.31 |
|
|
|
|
|
|
|
Options outstanding as of December 31, 2023 |
|
|
|
| $ |
|
|
| $ |
| ||||
Options exercisable as of December 31, 2023 |
|
|
|
| $ |
|
|
| $ |
| ||||
The aggregate intrinsic value is calculated as the difference between the Company’s closing stock price as of December 31, 2023 and the exercise price, multiplied by the number of options. As of December 31, 2023, there was $
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| Table of Contents |
6. LITIGATION AND CLAIMS
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 $
|
| (in thousands) |
| |||||
|
| December 31, 2023 |
|
| December 31, 2022 |
| ||
Operating lease right-of-use assets |
| $ |
|
| $ |
| ||
Operating lease liabilities |
| $ |
|
| $ |
| ||
The table below presents the maturities of operating lease liabilities as of December 31, 2023:
|
| (in thousands) |
| |
|
| Operating Leases |
| |
2024 |
|
|
| |
2025 |
|
|
| |
2026 |
|
|
| |
Total future lease payments |
|
|
| |
Less: discount |
|
| ( | ) |
Total lease liabilities |
| $ |
| |
| 62 |
| Table of Contents |
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, |
| |||||
|
| 2023 |
|
| 2022 |
| ||
Weighted average remaining lease term (years) |
|
|
|
|
|
| ||
Weighted average discount rate |
|
| % |
|
| % | ||
Related Party Contracts
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. Shenghuo was already the Company’s exclusive distributor in China, Macau and Hong Kong, and the license extended to manufacturing in those countries as well. 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
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 $
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
During the year ended December 31, 2023, the Company entered into an agreement with Mr. Blumberg to exchange
During the year ended December 31, 2023, the Company entered into an agreement with Mr. Blumberg to exchange
| 63 |
| Table of Contents |
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:
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 $
Expected term (years) |
|
|
| |
Volatility |
|
| % | |
Risk-free interest rate |
|
| % | |
Dividend yield |
|
| % |
During the years ended December 31, 2023 and 2022, the Company issued
During the years ended December 31, 2023 and 2022, the Company issued
During the year ended December 31, 2021,
Expected term (years) |
|
|
| |
Volatility |
|
| % | |
Risk-free interest rate |
|
| % | |
Dividend yield |
|
| % |
Expense recorded for the warrants was nil and $
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 $
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) |
|
|
| |
Volatility |
|
| % | |
Risk-free interest rate |
|
| % | |
Dividend yield |
|
| % |
The Company recognized expense of $
The Company estimated the fair value of the second tranche warrants using the Binomial Lattice model with the following assumptions:
Expected term (years) |
|
|
| |
Volatility |
|
| % | |
Risk-free interest rate |
|
| % | |
Dividend yield |
|
| % |
| 64 |
| Table of Contents |
The Company estimated the fair value of the third tranche warrants using the Binomial Lattice model with the following assumptions:
Expected term (years) |
|
|
| |
Volatility |
|
| % | |
Risk-free interest rate |
|
| % | |
Dividend yield |
|
| % |
The Company recognized expense for the second and third tranches of warrants of $
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 $
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 and March 27, 2024, the Company entered into additional amended agreements with SMI, which are described in Note 13, “Subsequent Events.”
Contingencies
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.
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8. SHORT-TERM NOTES PAYABLE
On July 4, 2023, the Company entered into a premium finance agreement to finance its insurance policies totaling $
On July 4, 2022, the Company entered into a premium finance agreement to finance its insurance policies totaling $
During 2019, the Company issued promissory notes to Mr. Cartwright totaling $
The following table summarizes short-term notes payable, including notes held by related parties (in thousands):
|
| December 31, 2023 |
|
| December 31, 2022 |
| ||
Dr. Cartwright |
| $ |
|
| $ |
| ||
Premium Finance (insurance) |
|
|
|
|
|
| ||
Short-term notes payable |
| $ |
|
| $ |
| ||
As of December 31, 2023 and 2022, short-term notes payable due to related parties was nil and $
9. CONVERTIBLE DEBT
Auctus Convertible Note
On December 17, 2019, the Company entered into a securities purchase agreement and convertible note with Auctus. The convertible note issued to Auctus was for a total of $
| 66 |
| Table of Contents |
On 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 debt, including an early prepayment penalty of $
The total outstanding balance of the convertible note was $
As a result of the Exchange Agreement, the Company recorded a loss on extinguishment of debt of $
10% Senior Unsecured Convertible Debenture
On May 17, 2021, the Company issued
At December 31, 2023 and 2022, the balance due on the 10% Senior Unsecured Convertible Debenture was $
|
| December 31, 2023 |
|
| December 31, 2022 |
| ||
10% Senior Unsecured Convertible Debentures |
| $ |
|
| $ |
| ||
Unamortized debt issuance costs |
|
| ( | ) |
|
| ( | ) |
Debt Discount |
|
| ( | ) |
|
| ( | ) |
Senior Unsecured Convertible Debenture |
| $ |
|
| $ |
| ||
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.
10. LONG-TERM DEBT
Long-term Debt – Related Parties
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 $
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 $
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.
| 67 |
| Table of Contents |
The table below summarizes the outstanding balance of long-term debt owed to Dr. Faupel and Dr. Cartwright:
For Dr. Faupel: |
|
|
| |
|
|
|
| |
Salary |
| $ |
| |
Bonus |
|
|
| |
Vacation |
|
|
| |
Interest on compensation |
|
|
| |
Loans to Company |
|
|
| |
Interest on loans |
|
|
| |
Total outstanding prior to exchange |
|
|
| |
|
|
|
|
|
Amount forgiven in prior years |
|
| ( | ) |
Amount exchanged for Series F-2 Preferred Stock |
|
| ( | ) |
Total interest accrued through December 31, 2022 |
|
|
| |
Balance outstanding at December 31, 2022 |
| $ |
| |
|
|
|
|
|
Interest accrued during the year ended December 31, 2023 |
|
|
| |
Balance outstanding at December 31, 2023 |
| $ |
| |
| 68 |
| Table of Contents |
For Dr. Cartwright |
|
|
| |
|
|
|
| |
Salary |
| $ |
| |
Bonus |
|
|
| |
Loans to Company |
|
|
| |
Interest on loans |
|
|
| |
Total outstanding prior to exchange |
|
|
| |
|
|
|
|
|
Amount forgiven in prior years |
|
| ( | ) |
Amount exchanged for Series F-2 Preferred Stock |
|
| ( | ) |
Total interest accrued through December 31, 2022 |
|
|
| |
Balance outstanding at December 31, 2022 |
| $ |
| |
|
|
|
|
|
Payments on outstanding debt |
|
| ( | ) |
Interest accrued during the year ended December 31, 2023 |
|
|
| |
Balance outstanding at December 31, 2023 |
| $ |
| |
On March 22, 2021, the Company entered into an exchange agreement with Richard Fowler. As of December 31, 2020, the Company owed Mr. Fowler $
During year ended December 31, 2023, Mr. Fowler forgave $
Future debt obligations at December 31, 2023 for debt owed to related parties is as follows:
Year |
| Amount (thousands) |
| |
2024 |
|
|
| |
2025 |
|
|
| |
2026 |
|
|
| |
Total |
| $ |
| |
As of December 31, 2023, $
| 69 |
| Table of Contents |
6% Unsecured Promissory Note
On July 9, 2020, we entered into an exchange agreement with Mr. Bill Wells, a former employee.
As of December 31, 2023 and 2022, the outstanding principal balance on the note was nil and $
| 70 |
| Table of Contents |
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
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 |
| ||
|
|
|
|
|
|
| ||
Net loss |
|
| ( | ) |
|
| ( | ) |
Basic weighted average number of shares outstanding |
|
|
|
|
|
| ||
Net loss per share (basic) |
|
| ( | ) |
|
| ( | ) |
Diluted weighted average number of shares outstanding |
|
|
|
|
|
| ||
Net loss per share (diluted) |
|
| ( | ) |
|
| ( | ) |
| 71 |
| Table of Contents |
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.
12. INCOME TAXES
The Company has incurred net operating losses (“NOLs”) since inception. As of December 31, 2023, the company had NOL carryforwards available through 2038 of approximately $
| 72 |
| Table of Contents |
Components of deferred taxes are as follows at December 31, 2023 and 2022 (in thousands):
|
| December 31, |
| |||||
|
| 2023 |
|
| 2022 |
| ||
Deferred tax assets: |
|
|
|
|
|
| ||
Warrants |
| $ | |
|
|
| |
|
Accrued executive compensation |
| $ |
|
| $ |
| ||
Reserves and other |
|
|
|
|
|
| ||
Stock options |
|
|
|
|
|
| ||
Net operating loss carryforwards |
|
|
|
|
|
| ||
Total deferred tax assets: |
|
|
|
|
|
| ||
Valuation allowance |
|
| ( | ) |
|
| ( | ) |
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, 2023 and 2022:
|
| 2023 |
|
| 2022 |
| ||
Statutory federal tax rate |
|
| % |
|
| % | ||
State taxes, net of federal benefit |
|
| % |
|
| % | ||
Nondeductible expenses |
|
| - |
|
|
| - |
|
Valuation allowance |
|
| - | % |
|
| - | % |
Effective tax rate |
|
| % |
|
| % | ||
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, 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, 2023.
The Company 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.
The total provision for income taxes as of December 31, 2023 and 2022 was as follows:
|
| 2023 |
|
| 2022 |
| ||
Current |
| $ |
|
| $ |
| ||
Deferred |
|
|
|
|
|
| ||
Deferred provision (credit) |
|
|
|
|
| ( | ) | |
Change in valuation allowance |
|
| ( | ) |
|
|
| |
Total provision for income taxes |
| $ |
|
| $ |
| ||
In 2023 and 2022, our effective tax rate differed from the U.S. federal statutory rate due to the valuation allowance over our deferred tax assets.
13. SUBSEQUENT EVENTS
SMI Fourth Amendment and Standstill Agreement
On February 17, 2024, the Company entered into a fourth amendment to the agreement with SMI. Under the terms of the amended agreement, SMI also agreed to pay the Company $
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,
On March 27, 2024, the parties entered into a Standstill Agreement (the “Standstill Agreement”).
Jones Day Amended Exchange Agreement
On January 6, 2020, we entered into an exchange agreement with Jones Day.
During the year ended December 31, 2023, the S-1 was declared effective and the Company also entered into an amended agreement with Jones Day to extend the due date of the $
Subsequent to December 31, 2023, the Company and Jones Day entered into an Amended Exchange Agreement,
Common Stock and Warrants Issued
Subsequent to December 31, 2023, the Company issued
Subsequent to December 31, 2023, the Company issued
Subsequent to December 31, 2023, we issued
| 73 |
| 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, 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, 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.
There were no changes to the Company’s internal controls over financial reporting occurred during the year ended December 31, 2023 that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.
| 74 |
| Table of Contents |
Item 9B. OTHER INFORMATION
None.
Item 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
Not applicable.
| 75 |
| 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 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.
Michael C. James has served as a member of our Board of Directors since March 2007 and as Chairman of the Board since October 2013. Mr. James is a founder of Edible Garden AG Incorporated and served as Chief Financial Officer and a director from March 2020 until January 2024. Mr. James previously served as Chief Financial Officer of Unrivaled Brands, Inc. (formerly Terra Tech) from February 2012 to March 2020. In addition to this role, Mr. James served as the Chief Executive Officer and Chief Financial Officer of Inergetics, Inc. from June 2012 until January 2016. Previously, Mr. James served as Chief Executive Officer of Nestor,the Inc. (“Nestor”), where he successfully completed a financial restructuring of Nestor prior to its sale in September 2009 from the Receiver’s Estate in Superior Court of the State of Rhode Island. He also served on Nestor’s Board of Directors from 2006 to 2009. Mr. James was the Managing Partner of Kuekenhof Capital Management, LLC, a private investment management company, from 1999 to 2015. During his career, Mr. James has served as a Partner at Moore Capital Management, Inc., a premiere private investment management company; Chief Financial and Administrative Officer at Buffalo Partners, L.P., a private investment management company; and Treasurer and Chief Financial Officer of National Discount Brokers. Mr. James began his career in 1980 as a staff accountant with EisnerAmper, LLP. Mr. James is a retired CPA. Mr. James received a B.S. degree in Accounting from Fairleigh Dickinson University in 1980.
Mr. James has experience both in the areas of company finance and accounting, which is invaluable to us during financial audits and offerings. Mr. James has extensive experience in the management of both small and large companies and his entrepreneurial background is relevant as we develop as a company.
Richard P. Blumberg was appointed to the Board of Directors on November 10, 2016 and resigned on March 27, 2019, but was reappointed on September 1, 2020. Mr. Blumberg has been a long-time investor in the Company. Since 1978, Mr. Blumberg has been a Principal at Webster, Mrak & Blumberg, a medical-legal and class action labor litigation firm. He is also currently a Managing Member of K2 Medical, LLC formerly known as Shenghuo Medical, LLC (“Shenghuo”), a company with licensing rights in several Asian countries for the Company’s LuViva Advanced Cervical Scan, and is a Managing Member of Elysian Medical, LLC, a company with world-wide rights for certain breast cancer detection technology. He served from 2004 to 2007 as Chief Executive Officer of Energy Logics, a wind power company that developed projects in Alberta, Canada and Montana. Mr. Blumberg holds a B.S. in Electrical Engineering and Computer Science from the University of Illinois and received a J. D. from Stanford University. He also brings extensive experience as a venture capitalist specializing in high-tech and life science companies.
| 76 |
| Table of Contents |
John E. Imhoff, M.D. has served as a member of our Board of Directors since April 2006. Dr. Imhoff is an ophthalmic surgeon who specializes in cataract and refractive surgery. He is one of our principal stockholders and invests in many other private and public companies. He has a B.S. in Industrial Engineering from Oklahoma State University, an M.D. from the University of Oklahoma and completed his ophthalmic residency at the Dean A. McGee Eye Institute. He has worked as an ophthalmic surgeon and owner of Southeast Eye Center since 1983.
Dr. Imhoff has experience in clinical trials and in other technical aspects of a medical device company. His background in industrial engineering is especially helpful to us, especially as Dr. Imhoff can combine this knowledge with clinical applications. His experience in the investment community is invaluable to a public company often undertaking capital raising efforts.
Alan Grujic was appointed to serve as a member of our Board of Directors in March 2023. Mr. Grujic earned a bachelor’s degree in electrical engineering from the University of Toronto and an MBA with a concentration in finance from the University of British Columbia. After commencing his engineering career at CAMI Automotive (Ingersoll, Ontario), Mr. Grujic began a new career in international finance where he was promoted to Director at TD Bank from 1994 to 2002. While in this role, he was stationed in various cities including Toronto, London, and Tokyo. In 2002, Mr. Grujic co-founded and was a managing partner of Infinium Securities, a company which was a large participant in the U.S. and European financial markets, and, at times, was the top equity trader in Canada. In 2012, Mr. Grujic founded Galiam Capital, a hedge fund that raised most of its capital from several large financial institutions. This fund was the largest new quantitative fund launch in 2012. Most recently, Mr. Grujic served as Managing Partner and Chief Executive Officer of All of Us Financial, which he sold to a large publicly listed fintech company in 2021.
Section 16(a) Beneficial Ownership Reporting Compliance
Section 16(a) of the Securities Exchange Act of 1934, as amended, requires our directors and executive officers and persons who beneficially own more than 10% of a registered class of our equity securities to file reports of ownership and reports of changes in ownership with the Securities and Exchange Commission. These persons are required by regulations of the Securities and Exchange Commission to furnish us with copies of all Section 16(a) forms they file.
Based solely on our review of the copies of these forms received by us, we believe that, with respect to fiscal year 2023, our officers and directors were in compliance with all applicable filing requirements.
Code of Ethics
We have adopted a code of ethics that applies to all of our directors, officers and employees. To obtain a copy without charge, contact our Corporate Secretary, Guided Therapeutics, Inc., 5835 Peachtree Corners East, Suite B, Peachtree Corners, Georgia 30092. If we amend our code of ethics, other than a technical, administrative or non-substantive amendment, or we grant any waiver, including any implicit waiver, from a provision of the code that applies to our principal executive officer, principal financial officer, principal accounting officer or controller, we will disclose the nature of the amendment or waiver on our website, www.guidedinc.com,within the “Investor Relations” section. Also, we may elect to disclose the amendment or waiver in a report on Form 8-K filed with the Securities and Exchange Commission.
| 77 |
| Table of Contents |
Risk Oversight
Our board as a whole has responsibility for risk oversight, with reviews of certain areas being conducted by the relevant board committees that report on their deliberations to the full board, as further described below. Given the small size of the board, the board feels that this structure for risk oversight is appropriate (except for those risks that require risk oversight by independent directors only). The audit committee is specifically charged with discussing risk management (primarily financial and internal control risk) and receives regular reports from management and independent auditors on risks related to, among others, our financial controls and reporting. Mr. James is the Chairman, while Dr. Imhoff and Mr. Blumberg are members of the audit committee. The compensation committee reviews risks related to compensation and makes recommendations to the board with respect to whether the Company’s compensation policies are properly aligned to discourage inappropriate risk-taking and is regularly advised by management. Dr. Imhoff is the Chairman, while Mr. James and Mr. Blumberg are members of the compensation committee. The Company’s management regularly communicates with the board to discuss important risks for their review and oversight, including regulatory risk, and risks stemming from periodic litigation or other legal matters in which we are involved.
Material Changes to Security Holders Nomination Procedure
There has been no material change to the procedures by which security holders may recommend nominees to the registrant’s board of directors since the last disclosure.
Item 11. EXECUTIVE COMPENSATION
Summary Compensation Table
The following table lists specified compensation we paid or accrued during each of the fiscal years ended December 31, 2023 and 2022 to the Chief Executive Officer and the Chief Operating Officer, collectively referred to as the “named executive officers,” in 2023. On March 3, 2023, Dr. Gene Cartwright notified the Board of Directors the Company of his intent to retire from his position as President and Chief Executive Officer of the Company and as a member of the Board. Mark Faupel was appointed by the Corporation’s Board as President and Chief Executive Officer on March 10, 2023.
During 2023, the Compensation Committee of the Board of Directors approved a salary for Mr. Faupel of $200 thousand per annum, beginning May 1, 2023, to be accrued until such time as the Corporation’s Board of Directors determines funds are available to pay Mr. Faupel. Any salary not paid by May 1, 2024 will accrue 6.0% (six percent) annual interest starting on that date and will accrue until the remaining unpaid salary is fully paid off.
The below tables reflect the updated roles and total compensation paid to the named executive officers for the years ended December 31, 2023 and 2022:
Name and Principal Position |
| Year |
| Salary ($) |
|
|
|
|
| Option and Warrant Awards ($) |
|
|
|
|
| Other ($) (3) |
|
|
|
|
| Total ($) |
| |||||||
Mark Faupel, Ph.D. - Chief Executive Officer, President, Acting Chief Financial Officer, Director and Former Chief Operating Officer |
| 2023 |
|
| 137,333 |
|
|
| (1) |
|
| 732,580 |
|
|
| (3) |
|
| 19,389 |
|
|
| (5) |
|
| 889,302 |
| |||
|
| 2022 |
|
| 12,000 |
|
|
| (1) |
|
| - |
|
|
|
|
|
|
| 34,912 |
|
|
| (5) |
|
| 46,912 |
| ||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gene S. Cartwright, Ph.D. - Former Chief Executive Officer, President, Acting Chief Financial Officer and Director |
| 2023 |
|
| 2,000 |
|
|
| (2) |
|
| 59,216 |
|
|
| (4) |
|
| - |
|
|
|
|
|
|
| 61,216 |
| ||
|
| 2022 |
|
| 12,000 |
|
|
| (2) |
|
| - |
|
|
|
|
|
|
| - |
|
|
|
|
|
|
| 12,000 |
| |
| (1) | From January - April 2023, Dr. Faupel was owed $1,000 per month in compensation. Beginning May 2023, Dr. Faupel is owed $16,667 per month as compensation. Mr. Faupel was paid $57,883 during 2023, the remaining balance of his compensation has been deferred. |
|
|
|
| (2) | During 2022 and in January 2023, Mr. Cartwright was owed $1,000 per month in compensation, which has been deferred and is unpaid. |
| 78 |
| Table of Contents |
| (3) | On February 10, 2023, the Company granted 200,000 stock options to Mr. Faupel. The stock options, which have an exercise price 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 May 14, 2023, the Compensation Committee of the Company’s Board of Directors approved the issuance of 4,000,000 common stock warrants to Mr. Faupel, upon his appointment to the Company’s Board as President and Chief Executive Officer. The warrants, which have a strike price of $0.25, are fully vested and will expire on May 13, 2028. |
|
|
|
| (4) | On February 10, 2023, the Company granted 200,000 stock options to Mr. Cartwright, which had an exercise price of $0.2629 and an expiration date of February 9, 2033. One fourth of the stock options vested immediately, while the remaining options were forfeited upon Mr. Cartwright’s retirement in March of 2023. 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. The amount presented above is equal to the excess of management's estimate of the fair value of the modified awards over the original awards. |
|
|
|
| (5) | Other compensation is related to the Company health insurance plan. |
Outstanding Equity Awards to Officers at December 31, 2023
Name and Principal Position |
| Number of Securities Underlying Vested Options and Warrants |
|
| Number of Securities Underlying Unvested Options |
|
| Weighted-Average Exercise Price |
|
| Weighted-Average Expiration Date | ||||
Mark Faupel, Ph.D. - Chief Executive Officer, President, Acting Chief Financial Officer, Director and Former Chief Operating Officer |
|
| 4,486,364 |
|
|
| 113,636 |
|
|
| 0.27 |
|
| 10/04/28 | |
| 79 |
| Table of Contents |
Outstanding Equity Awards to Directors at December 31, 2023
Name and Principal Position |
| Number of Securities Underlying Vested Options |
|
| Number of Securities Underlying Unvested Options |
|
| Weighted-Average Exercise Price |
|
| Weighted-Average Expiration Date | ||||
Michael C. James, Chairman and Director |
|
| 93,182 |
|
|
| 56,818 |
|
|
| 0.34 |
|
| 03/31/32 | |
John E. Imhoff, M.D., Director |
|
| 93,182 |
|
|
| 56,818 |
|
|
| 0.49 |
|
| 03/31/32 | |
Alan Grujic, Director |
|
| 40,909 |
|
|
| 59,091 |
|
|
| 0.27 |
|
| 03/06/33 | |
Item 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
The following table lists information regarding the beneficial ownership of our equity securities as of March 13, 2024 by (1) each person whom we know to beneficially own more than 5% of the outstanding shares of our common stock, (2) each director, (3) each officer named in the summary compensation table below, and (4) all directors and executive officers as a group. Unless otherwise indicated, the address of each officer and director is 5835 Peachtree Corners East, Suite B, Peachtree Corners, Georgia 30092.
|
| Common Stock Beneficially Owned (2) |
|
| Series C2 Preferred Stock (5) |
| ||||||||||
Name and Address of Beneficial Owner (1) |
| Number of Shares |
|
| Percentage |
|
| Number of Shares |
|
| Percentage |
| ||||
Blumberg, Richard (10) |
|
| 13,089,359 |
|
|
| 21.07 | % |
|
| - |
|
|
| - |
|
Grujic, Alan (11) |
|
| 2,138,551 |
|
|
| 3.78 | % |
|
| - |
|
|
| - |
|
Faupel, Mark (12) |
|
| 5,862,155 |
|
|
| 9.66 | % |
|
| 299.25 |
|
|
| 11.08 | % |
Imhoff, John (13) |
|
| 12,016,338 |
|
|
| 19.41 | % |
|
| 2,400.75 |
|
|
| 88.92 | % |
James, Michael (14) |
|
| 462,773 |
|
| * |
|
|
| - |
|
|
| - |
| |
DRG Services, LLC (15) |
|
| 3,000,000 |
|
|
| 5.26 | % |
|
| - |
|
|
| - |
|
Grimm, Frederick (16) |
|
| 3,498,320 |
|
|
| 6.14 | % |
|
| - |
|
|
| - |
|
K2 Medical LLC (17) |
|
| 2,374,370 |
|
|
| 4.18 | % |
|
| - |
|
|
| - |
|
Auctus (18) |
|
| 13,760,911 |
|
|
| 21.49 | % |
|
| - |
|
|
| - |
|
GPB Holdings (19) |
|
| 9,135,152 |
|
|
| 16.61 | % |
|
| - |
|
|
| - |
|
All directors and executive officers as a group (5 persons) (20) |
|
| 33,569,176 |
|
|
| 43.78 | % |
|
| 2,700.00 |
|
|
| 100.00 | % |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Series D Preferred Stock (6) |
|
| Series E Preferred Stock (7) |
| ||||||||||
Name and Address of Beneficial Owner (1) |
| Number of Shares |
|
| Percentage |
|
| Number of Shares |
|
| Percentage |
| ||||
Blumberg, Richard (10) |
|
| - |
|
|
| - |
|
|
| 233 |
|
|
| 26.39 | % |
Grujic, Alan (11) |
|
| - |
|
|
| - |
|
|
| 50 |
|
|
| 5.66 | % |
Faupel, Mark (12) |
|
| 38 |
|
|
| 8.68 | % |
|
| - |
|
|
| - |
|
Imhoff, John (13) |
|
| 300 |
|
|
| 68.49 | % |
|
| - |
|
|
| - |
|
James, Michael (14) |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
DRG Services, LLC (15) |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
Grimm, Frederick (16) |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
K2 Medical LLC (17) |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
Auctus (18) |
|
| - |
|
|
| - |
|
|
| 105 |
|
|
| 11.89 | % |
GPB Holdings (19) |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
All directors and executive officers as a group (5 persons) (20) |
|
| 338 |
|
|
| 77.17 | % |
|
| 283 |
|
|
| 32.05 | % |
|
| Series F Preferred Stock (8) |
|
| Series F-2 Preferred Stock (9) |
| ||||||||||
Name and Address of Beneficial Owner (1) |
| Number of Shares |
|
| Percentage |
|
| Number of Shares |
|
| Percentage |
| ||||
Blumberg, Richard (10) |
|
| 260 |
|
|
| 25.84 | % |
|
| 88 |
|
|
| 16.92 | % |
Grujic, Alan (11) |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
Faupel, Mark (12) |
|
| - |
|
|
| - |
|
|
| 97 |
|
|
| 18.65 | % |
Imhoff, John (13) |
|
| 10 |
|
| * |
|
|
| - |
|
|
| - |
| |
James, Michael (14) |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
DRG Services, LLC (15) |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
Grimm, Frederick (16) |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
K2 Medical LLC (17) |
|
| 440 |
|
|
| 43.74 | % |
|
| - |
|
|
| - |
|
Auctus (18) |
|
| 200 |
|
|
| 19.88 | % |
|
| - |
|
|
| - |
|
GPB Holdings (19) |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
All directors and executive officers as a group (5 persons) (20) |
|
| 270 |
|
|
| 26.84 | % |
|
| 185 |
|
|
| 35.58 | % |
(*) | Less than 1%. |
(1) | Except as otherwise indicated in the footnotes to this table and pursuant to applicable community property laws, the persons named in the table have sole voting and investment power with respect to all shares of common stock. |
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(2) | Percentage ownership is based on 55,005,299 shares of common stock outstanding as of March 13, 2024. Beneficial ownership is determined in accordance with the rules of the SEC, based on factors that include voting and investment power with respect to shares. Shares of common stock subject to convertible securities convertible or exercisable within 60 days after the record date, are deemed outstanding for purposes of computing the percentage ownership of the person holding those securities but are not deemed outstanding for purposes of computing the percentage ownership of any other person. Note that certain of our outstanding securities, including certain warrants and the shares of Series C1 preferred stock held by the persons listed in this table, have anti-dilution “ratchet” or “price-protection” provisions that, when triggered, will increase the number of shares of common stock underlying such securities. Subject to customary exceptions, these provisions are triggered anytime we issue shares of common stock to third parties at a price lower than the then-current conversion price or exercise price of the subject securities. As a result, the beneficial ownership reported in this table is only as of the date presented, and the beneficial ownership amounts of the persons in this table may increase on a future date, even though such persons have not actually acquired any additional shares of common stock. |
(3) | As of March 13, 2024, there were 286 shares of Series C preferred stock outstanding, and each such share was convertible into approximately 2,000 shares of common stock. |
(4) | As of March 13, 2024, there were 1,049.25 shares of Series C1 preferred stock outstanding, and each such share was convertible into approximately 2,000 shares of common stock. |
(5) | As of March 13, 2024, there were 2,700 shares of Series C2 preferred stock outstanding, and each such share was convertible into approximately 2,000 shares of common stock. |
(6) | As of March 13, 2024, there were 438 shares of Series D preferred stock outstanding, and each such share was convertible into approximately 3,000 shares of common stock. |
(7) | As of March 13, 2024, there were 883 shares of Series E preferred stock outstanding, and each such share was convertible into approximately 2,000 shares of common stock. |
(8) | As of March 13, 2024, there were 1,006 shares of Series F preferred stock outstanding, and each such share was convertible into approximately 4,000 shares of common stock. |
(9) | As of March 13, 2024, there were 520 shares of Series F-2 preferred stock outstanding, and each such share was convertible into approximately 4,000 shares of common stock. |
(10) | Beneficial ownership includes 5,965,359 shares of common stock directly held, 4,700,000 shares issuable upon exercise of warrants, 932,000 shares issuable upon conversion of 233 shares of Series E preferred stock, 1,040,000 shares issuable upon conversion of 260 shares of Series F preferred stock, 352,000 shares issuable upon conversion of 88 shares of Series F-2 preferred stock, and 100,000 shares issuable upon exercise of stock options. |
(11) | Beneficial ownership includes 538,551 shares of common stock directly held, 1,800,000 shares issuable upon exercise of warrants, 200,000 shares issuable upon conversion of 50 shares of Series E preferred stock and 100,000 shares issuable upon exercise of stock options. |
(12) | Beneficial ownership includes 161,655 shares of common stock directly held, 598,500 shares issuable upon conversion of 299.25 shares of Series C-2 preferred stock, 114,000 shares issuable upon conversion of 38 shares of Series D preferred stock, 388,000 shares issuable upon conversion of 97 shares of Series F-2 preferred stock and 600,000 shares issuable upon exercise of stock options. |
(13) | Beneficial ownership includes 5,124,838 shares of common stock directly held, 1,000,000 shares issuable upon exercise of warrants, 4,801,500 shares issuable upon conversion of 2,400.75 shares of Series C-2 preferred stock, 900,000 shares issuable upon conversion of 300 shares of Series D preferred stock, 40,000 shares issuable upon conversion of 10 shares of Series F preferred stock and 150,000 shares issuable upon exercise of stock options. |
(14) | Beneficial ownership includes 112,773 shares of common stock directly held, 200,000 shares issuable upon exercise of warrants and 150,000 shares issuable upon exercise of stock options. |
(15) | Beneficial ownership includes 1,000,000 shares of common stock directly held and 2,000,000 shares issuable upon exercise of warrants. |
(16) | Beneficial ownership includes 1,498,320 shares of common stock directly held and 2,000,000 shares issuable upon exercise of warrants. |
(17) | Beneficial ownership includes 614,370 shares of common stock directly held and 1,760,000 shares issuable upon conversion of 440 shares of Series F preferred stock. |
(18) | Beneficial ownership includes 4,083,217 shares of common stock directly held, 7,800,000 shares issuable upon exercise of warrants, 420,000 shares issuable upon conversion of 105 shares of Series E preferred stock, 800,000 shares issuable upon conversion of 200 shares of Series F preferred stock and 657,694 shares issuable upon conversion of debt. |
(19) | Beneficial ownership includes 9,135,152 shares of common stock directly held. |
(20) | Includes the beneficial ownership of Richard Blumberg (10), Alan Grujic (11), Mark Faupel (12), John Imhoff (13) and Michael James (14). |
Item 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
Our board recognizes that related party transactions present a heightened risk of conflicts of interest. The audit committee has the authority to review and approve all related party transactions involving our directors or executive officers.
Under the policy, when management becomes aware of a related person transaction, management reports the transaction to the audit committee and requests approval or ratification of the transaction. Generally, the audit committee will approve only related party transactions that are on terms comparable to those that could be obtained in arm’s length dealings with an unrelated third person. The audit committee will report to the full board all related person transactions presented to it. Based on the definition of independence of the NASDAQ Stock Market, the board has determined that Mr. James and Dr. Imhoff are independent directors.
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.
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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.
The table below summarizes the outstanding balance of long-term debt owed to Dr. Faupel and Dr. Cartwright:
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. 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 |
|
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%.
During year ended December 31, 2023, Mr. Fowler forgave $69,274 of the outstanding balance of deferred compensation and, as of December 31, 2023, may forgive up to $129,336 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. 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 amount owed on the note was $82,985 and $119,814, respectively.
Promotional Agreement - Blumberg & Bowles Consulting, LLC (“BB”)
On January 22, 2020, the Company entered into a promotional agreement with Blumberg & Bowles Consulting, LLC (“BB”), which is partially owned by Mr. Blumberg (a related party), 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 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, respectively. Unrecognized consulting expense to be recognized under this agreement was nil as of December 31, 2023. As of December 31, 2023, 2,500,000 of the warrants had been issued, of which 1,750,000 were issued to Mr. Blumberg and 750,000 were issued to non-related parties.
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Consulting Agreement - Richard Blumberg
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 and 2022, the Company issued 1.8 million and nil warrants pursuant to the agreement and recognized $740,517 and $393,893 of expense for the warrants issued to Mr. Blumberg, respectively. Total unrecognized expense for the warrants was nil as of December 31, 2023.
During the years ended December 31, 2023 and 2022, the Company issued 800,000 and nil shares of common stock and recognized $104,844 and $166,667 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 the year ended December 31, 2021, the consulting agreement was amended to clarify that $350,000 is not intended to be debt and will not be required to be repaid in cash. The Company confirmed an obligation to provide Mr. Blumberg with 950,000 fully transferrable warrants, which had an expiration date of January 1, 2024 an exercise price of $0.25. Issuance of the warrants owed to Mr. Blumberg for his services was predicated on the Company receiving funding receipts of $1,000,000, whether from a financing, series of financing, or gross sales. The amended agreement clarified that the warrants issued to Mr. Blumberg are compensation for services which involve investor relations, marketing services and assisting the Company with obtaining financing. During the year ended December 31, 2022, the Company obtained the requisite funding receipts. Expense recorded for the warrants was nil and $307,457 during the years ended December 31, 2023 and 2022, respectively. The unrecognized expense to be recognized for the warrants was nil as of December 31, 2023.
Warrant Exchanges – Richard Blumberg
During the year ended December 31, 2023, the Company entered into an agreement with Richard Blumberg, pursuant to which Mr. Blumberg agreed to exchange 875,000 common stock warrants with a strike price of $0.25 for 831,250 common stock warrants with a strike price of $0.20. During the year ended December 31, 2023, the Company received approximately $166,250 from Mr. Blumberg for the exercise of the 831,250 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 $55,740.
During the year ended December 31, 2023, the Company entered into agreements with Richard Blumberg (a Director of the Company) and Lee Bowles (a partial owner of Blumberg & Bowles Consulting, LLC, of which Richard Blumberg is also a partial owner), 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.
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Consulting Agreement – Alan Grujic
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 recognized expense of $364,800 for the first tranche warrants during the year ended December 31, 2022. Unrecognized expense related to the first tranche warrants was nil as of December 31, 2022.
The Company recognized expense for the second and third tranches of warrants of $141,079 and $60,229 during the years ended December 31, 2023 and 2022, respectively. Unrecognized expense for the second and third tranche warrants was $41,242 as of December 31, 2023.
Policies and Procedures for Related Party Transactions
All future transactions between us and our officers, directors or five percent stockholders, and respective affiliates will be on terms no less favorable than could be obtained from unaffiliated third parties and will be approved by a majority of our independent directors who do not have an interest in the transactions and who had access, at our expense, to our legal counsel or independent legal counsel.
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Indemnification of Officers and Directors
Our Amended and Restated Certificate of Incorporation and amended and restated bylaws, provide that we will indemnify each of our directors and officers to the fullest extent permitted by the DGCL. Further, we intend to enter into indemnification agreements with each of our directors and officers, and we intend to purchase a policy of directors’ and officers’ liability insurance that insures our directors and officers against the cost of defense, settlement or payment of a judgment under certain circumstances. For further information, see “Elimination of Monetary Liability for Officers and Directors.”
To the best of our knowledge, during the past two fiscal years, other than as set forth above, there were no material transactions, or series of similar transactions, or any currently proposed transactions, or series of similar transactions, to which we were or are to be a party, in which the amount involved exceeds the lesser of (A) $120,000 or (B) one percent of our average total assets at year-end for the last two completed fiscal years, and in which any director or executive officer, or any security holder who is known by us to own of record or beneficially more than 5% of any class of our common stock, or any member of the immediate family of any of the foregoing persons, has an interest (other than compensation to our officers and directors in the ordinary course of business).
Item 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
UHY LLP is our current independent registered public accounting firm. We were billed by UHY LLP approximately $177,595 and $238,372 during the fiscal years ended December 31, 2023 and 2022, respectively, for professional services, which include fees associated with the annual audit of financial statements, as well as the 10-K annual report, review of our quarterly reports, and other SEC filings.
|
| 2022 |
|
| 2023 |
| ||
Audit Fees |
| $ | 157,500 |
|
| $ | 152,500 |
|
Audit-Related Fees |
|
| 13,500 |
|
|
| 76,527 |
|
Tax Fees |
|
| 6,595 |
|
|
| 9,345 |
|
All Other Fees |
|
| - |
|
|
| - |
|
Total Fees |
| $ | 177,595 |
|
| $ | 238,372 |
|
Audit Committee Pre-Approval Policy and Permissible Non-Audit Services of Independent Registered Public Accounting Firm
Our Audit Committee pre-approves all audit and permissible non-audit services provided by our independent registered public accounting firm. These services may include audit services, audit-related services, tax services and other services. Pre-approval is generally provided for up to one year, and any pre-approval is detailed as to the particular service or category of services and is generally subject to a specific budget. Our independent registered public accounting firm and management are required to periodically report to the Audit Committee regarding the extent of services provided by the independent registered public accounting firm in accordance with the pre-approval, and the fees for the services performed to date. The Audit Committee may also pre-approve particular services on a case-by-case basis.
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PART IV
Item 15. Exhibits and Financial Statement Schedules
The consolidated financial statements included in Item 8 of this report are filed as part of this report.
The exhibits listed below are filed as part hereof, or incorporated by reference into, this Report. All documents referenced below were filed pursuant to the Securities and Exchange Act of 1934 by Guided Therapeutics, Inc. (f/k/a SpectRx, Inc.), file number 0-22179, unless otherwise indicated.
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| Certification of the Principal Executive Officer and Principal Financial Officer | |
101.1* | Interactive Data File |
*Filed herewith
| 90 |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
GUIDED THERAPEUTICS, INC. | ||
| ||
By: | /s/ Mark Faupel | |
Mark Faupel | ||
President, Chief Executive Officer, Chief Operating Officer and Acting Chief Financial Officer | ||
Date: March 28, 2024
| 91 |
EXHIBIT 23.1
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We hereby consent to the incorporation by reference in the Registration Statement on Form S-8 (No. 333-178261) of Guided Therapeutics, Inc. and Subsidiary of our report dated March 28, 2024, relating to the consolidated financial statements, which appears in this Form 10-K for the year ended December 31, 2023.
| /s/ UHY LLP |
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| Sterling Heights, Michigan |
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| March 28, 2024 |
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EXHIBIT 31
Rule 13a-14(a)/15(d)-14(a) Certifications
I, Mark Faupel, certify that:
| 1. | I have reviewed this annual report on Form 10-K of Guided Therapeutics, Inc.; |
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| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
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| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
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| 4. | The registrant and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f) for the registrant and have: |
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| (a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
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| (b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, 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; |
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| (c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
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| (d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant ‘s internal control over financial reporting. |
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| 5. | I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): | |
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| (a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
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| (b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
| Date: March 28, 2024 | /s/ Mark Faupel |
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| Mark Faupel |
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| President, Chief Executive Officer, Chief Operating Officer and Acting Chief Financial Officer |
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EXHIBIT 32.1
SECTION 1350 CERTIFICATION
In connection with the Annual Report of Guided Therapeutics, Inc. (the “Company”) on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Mark Faupel, Chief Executive Officer, Acting Chief Financial Officer, Chief Operating Officer, President and Director, certify, pursuant to 18 U.S.C. Sec. 1350, as adopted pursuant to Sec 906 of the Sarbanes-Oxley Act of 2002, that, to the best of my knowledge:
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| (1) | the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
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| (2) | the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
Date: March 28, 2024
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| /s/ Mark Faupel |
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| Name: Mark Faupel |
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| Title: President, Chief Executive Officer, Chief Operating Officer and Acting Chief Financial Officer |
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