GUIDED THERAPEUTICS INC
For the period ended Dec 31, 2025. Filed Mar 31, 2026.
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A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2025 · Filed Mar 31, 2026
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What changed in Risk Factors?
Read the current filingPrevious report: 10-K
Period ended 2024-12-31; filed 2025-03-31.
0001477932-25-002200
Item 1A. Risk FactorsCurrent report: 10-K
Period ended 2025-12-31; filed 2026-03-31.
0001477932-26-001723
Item 1A. Risk FactorsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 98 previous paragraphs and 104 current paragraphs.
85 unchanged; 10 reworded; 9 added; 3 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 5 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (9)
Current report
Although SMI no longer holds rights to LuViva in China, SMI and its partners HDMT and YMIC have indicated their willingness to continue assisting with the NMPA approval process. We are not obligated to grant long-term distribution or manufacturing rights in China to any of these parties. Both HDMT and YMIC continue to place product orders with us, as described above.
Current report
NMPA approval requires a successful manufacturing inspection. Current indications suggest that YMIC may be the entity to achieve this, as they are approved by the Chinese government to manufacture Class III medical devices. Based on current expectations, a manufacturing inspection could occur in May 2026, with potential approval in the third quarter of 2026, although there is no assurance that this timeline will be met or that NMPA approval of LuViva will be obtained.
Current report
Escalation of geopolitical conflicts in the Middle East could adversely affect our business, financial condition, and results of operations.
Current report
Recent conflicts and heightened tensions in the Middle East have increased geopolitical uncertainty and contributed to volatility in global financial markets and commodity prices, particularly oil and natural gas. The extent and duration of these conflicts, including the potential for broader regional escalation, remain uncertain. Any escalation or expansion of these conflicts could result in disruptions to global trade routes, additional economic sanctions, or other geopolitical responses by the United States and other countries. These developments may adversely affect global supply chains, increase transportation and energy costs, and contribute to inflationary pressures.
Current report
Such conditions could increase our operating costs and disrupt the availability of materials, components, or services necessary to manufacture and distribute our products. As a result, continued instability in the region could have a material adverse effect on our business, financial condition, and results of operations.
Current report
Risks related to tariffs and international trade policies could adversely affect our business, financial condition, and results of operations.
Current report
Tariffs imposed and/or publicly contemplated by the U.S. government, particularly as to China, create significant uncertainty with respect to future tax and trade regulations and the potential competitive effects of such actions. The countries in which our products will be manufactured or imported may from time to time impose additional quotas, duties, tariffs or other restrictions on our imports or adversely modify existing restrictions. It is unclear what the U.S. administration or foreign governments specifically will or will not do with respect to tariffs, tax policies, or other international trade agreements, regulations and policies. A trade war, other governmental action related to tariffs or international trade agreements, changes in U.S. social, political, regulatory and economic conditions or in laws and policies governing foreign trade, manufacturing, development and investment in the territories and countries where we manufacture and sell products or any resulting negative sentiments towards the United States could materially adversely affect the Company’s business, financial condition, operating results and cash flows.
Current report
We have not yet obtained clearance or approval from the U.S. FDA. However, we have completed patient enrollment in the clinical trial required to support an application for FDA approval to market and sell LuViva in the United States. As of March 25, 2026, the status of the FDA application is as follows:
Current report
Most sections of the application have been prepared. A short delay (approximately four to six weeks) has resulted from the loss of one of the study’s outside pathologists, who has since been replaced. We currently expect to submit the application to the FDA in the second quarter of 2026. However, there can be no assurance that the analysis and submission will be completed within the expected timeframe or that the results will support regulatory clearance or approval.
Removed paragraphs (3)
Previous report
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.
Previous report
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.
Previous report
Currently, we have not obtained clearance or approval from the U.S. FDA, however we have agreed with the U.S. FDA on the clinical trial protocol and have initiated a clinical trial protocol involving approximately 400 study participants. As of March 1, 2025, approximately 320 patients have been enrolled and tested, which represents approximately eighty percent of the 400 anticipated patients needed to complete the study. Based on current and expected enrollment rates, we expect the study to be completed in 2025, depending in part by how many women are diagnosed with cervical disease. However, there can be no assurance that the study will progress and be completed within the expected timeframe, or ever.
Reworded paragraphs (10)
Previous wording
Additional debt or equity financing will be required for us to continue as a going concern. We may seek to obtain additional funds for the financing of our cervical cancer detection business through additional debt or equity financings and/or new collaborative arrangements. Management believes that additional financing, if obtainable, will be sufficient to support planned operations only for a limited period. Management has implemented operating actions to reduce cash requirements. Any required additional funding may not be available on terms attractive to us, on a timely basis, or at all. We currently hold $1.13 million of senior unsecured convertible debentures that are in default, which may further hinder our ability to obtain additional debt funding. If we cannot obtain additional funds or achieve profitability, we may not be able to continue as a going concern.
Current wording
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 additional funding required may not be available on terms attractive to us, on a timely basis, or at all. We currently hold $1.13 million of senior unsecured convertible debentures that are in default, which may further hinder our ability to obtain additional debt funding. If we cannot obtain additional funds or achieve profitability, we may not be able to continue as a going concern.
Previous wording
Our independent registered public accountants’ report on our consolidated financial statements as of and for the year ended December 31, 2024, indicates that there is substantial doubt about our ability to continue as a going concern, because we have suffered recurring losses from operations and had an accumulated deficit of $153.7 million at December 31, 2024, summarized as follows:
Current wording
Our independent registered public accountants’ report on our consolidated financial statements as of and for the year ended December 31, 2025, 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 $157.1 million at December 31, 2025.
Previous wording
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, 2024 and 2023, our accumulated deficit was approximately $153.7 million and $151.1 million, respectively.
Current wording
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, 2025 and 2024, our accumulated deficit was approximately $157.1 million and $153.7 million, respectively.
Previous wording
As of December 31, 2024, our products have achieved and maintain both ISO 13485:2016 certification and the CE Mark through our contract manufacturer, Newmars Technologies.
Current wording
As of December 31, 2025, our products have achieved and maintained both ISO 13485:2016 certification and the CE Mark through our contract manufacturer, Newmars Technologies. However, because of our focus on countries that do not require the CE Mark, it is uncertain whether we will maintain the CE Mark for the short term, as standards are continually evolving.
Previous wording
For our products to be marketed and sold in the People’s Republic of China, they must gain approval from the NMPA. 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, filed the application for NMPA approval on October 16, 2024. On January 6, 2025, SMI informed us that NMPA found the application complete and was commencing their review. In the same communication, SMI believed that NMPA approval could occur in the second quarter of 2025, although there is no certainty that NMPA approval will occur within this timeframe.
Current wording
For our products to be marketed and sold in the People’s Republic of China, they must gain approval from the NMPA. We have been working with SMI to obtain NMPA approval. In 2022, device safety compliance testing was completed, and in late 2023 enrollment in the pivotal clinical trial at four hospitals was completed. SMI filed the NMPA approval application on October 16, 2024. On January 6, 2025, SMI notified us that the NMPA had accepted the application as completed and commenced its review.
Previous wording
As of December 31, 2024, we hold six active U.S. patents. In addition, we have filed for, or have rights to, one U.S. patent (including those under license) that is still pending. There are additional international patents and pending applications. One or more of the patents we hold directly or license from third parties, including those for our cervical cancer detection products, may be successfully challenged, invalidated or circumvented, or we may otherwise be unable to rely on these patents. These risks are also present for the process we use or will use for manufacturing our products. In addition, our competitors, many of whom have substantial resources and have made substantial investments in competing technologies, may apply for and obtain patents that prevent, limit or interfere with our ability to make, use and sell our products, either in the United States or in international markets.
Current wording
Currently, we hold six active U.S. patents. In addition, we have filed for, or have rights to, one U.S. patent (including those under license) that is still pending. There are additional international patents and pending applications. One or more of the patents we hold directly or license from third parties, including those for our cervical cancer detection products, may be successfully challenged, invalidated or circumvented, or we may otherwise be unable to rely on these patents. These risks are also present for the process we use or will use for manufacturing our products. In addition, our competitors, many of whom have substantial resources and have made substantial investments in competing technologies, may apply for and obtain patents that prevent, limit or interfere with our ability to make, use and sell our products, either in the United States or in international markets.
Previous wording
Our outstanding indebtedness, which includes all of our liabilities, was $6.3 million at December 31, 2024. The terms of our indebtedness could have negative consequences to us, such as:
Current wording
Our outstanding indebtedness, which includes all of our liabilities, was $7.3 million at December 31, 2025. The terms of our indebtedness could have negative consequences to us, such as:
Previous wording
Our certificate of incorporation authorizes our board of directors to issue up to 5.0 million shares of preferred stock of which 6,857 were outstanding as of December 31, 2024. Our undesignated shares of preferred stock may be issued in one or more series, the terms of which may be determined by the board without further stockholder action. These terms may include, among other terms, voting rights, including the right to vote as a series on particular matters, preferences as to liquidation and dividends, repurchase rights, conversion rights, redemption rights and sinking fund provisions. The issuance of any preferred stock could diminish the rights of holders of our common stock, and therefore could reduce the value of our common stock. In addition, specific rights granted to future holders of preferred stock could be used to restrict our ability to merge with or sell assets to a third party. The ability of our board to issue preferred stock could make it more difficult, delay, discourage, prevent or make it more costly to acquire or effect a change in control, which in turn could prevent our stockholders from recognizing a gain in the event that a favorable offer is extended and could materially and negatively affect the market price of our common stock.
Current wording
Our certificate of incorporation authorizes our board of directors to issue up to 5.0 million shares of preferred stock of which 2,185.25 were outstanding as of December 31, 2025. 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.
Previous wording
As of December 31, 2024, our outstanding convertible debt was convertible into an aggregate of 4,528,305 shares of our common stock, and the outstanding shares of our preferred stock were convertible into an aggregate of 42,718,453 shares of common stock. Also, as of that date we had warrants outstanding that were exercisable for an aggregate of 37,174,468 shares of common stock, and outstanding vested options to purchase 2,266,023 shares of common stock. The shares of common stock issuable upon conversion or exercise of these securities would have constituted approximately 133.1% of the total number of shares of common stock then issued and outstanding.
Current wording
As of December 31, 2025, our outstanding convertible debt and accrued interest were convertible into an aggregate of 2,754,246 shares of our common stock, our outstanding preferred stock was convertible into an aggregate of 6,592,500 shares of common stock, and deferred compensation arrangements were convertible into an aggregate of 1,890,006 shares of common stock. As of that date, we also had warrants outstanding exercisable for an aggregate of 45,165,649 shares of common stock and vested options outstanding to purchase 2,207,341 shares of common stock. The shares issuable upon conversion or exercise of these securities would represent approximately 68.0% of the total shares of common stock then issued and outstanding.
Previous wording
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.
Current wording
Under the terms of a portion of our convertible debt, the conversion price fluctuates with the 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 will increase, and may result in the issuance of a significant number of additional shares of our common stock.