GTHP

New in FY2025

• Any additional funding required may not be available on terms attractive to us, on a timely basis, or at all.
• 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.
• Our management has implemented reductions in operating expenditures and reductions in some development activities.
• As of December 31, 2025 and 2024, our accumulated deficit was approximately $157.1 million and $153.7 million, respectively.
• 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.
• 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.
• 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.
• 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.
• Escalation of geopolitical conflicts in the Middle East could adversely affect our business, financial condition, and results of operations.
• 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.
• 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.
• Risks related to tariffs and international trade policies could adversely affect our business, financial condition, and results of operations.
• 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.
• We have not yet obtained clearance or approval from the U.S.
• 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: · Approximately 480 patients were enrolled, of whom 430 were evaluable for efficacy analysis.
• Both totals satisfy the a priori criteria as set forth in the study protocol. · No adverse events related to the use of LuViva have been reported. · All four clinical study sites adhered to the study protocol and completed required case report forms in accordance with FDA standards. · Close-out activities have been completed at all sites, and all LuViva devices have been retrieved in good working order. · All pathology samples have been diagnosed by at least two independent expert pathologists, as set forth in the study protocol.
• Preliminary analyses of both clinical site pathology diagnoses and the independent expert pathology diagnoses confirm that a significant percentage of disease, i.e., at least 25%, is being missed by the standard of care and that LuViva is able to detect the majority of these missed disease cases, thus providing support for successfully meeting the primary endpoint of the study and by doing so, addressing an important unmet clinical need.
• 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.
• Currently, we hold six active U.S. patents.
• Our outstanding indebtedness, which includes all of our liabilities, was $7.3 million at December 31, 2025.
• 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.

and 7 more.

Gone since FY2024

• Any required additional funding may not be available on terms attractive to us, on a timely basis, or at all.
• 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: Accumulated deficit as of December 31, 2019 $ 139.6 Preferred dividends for the year ended December 31, 2020 0.1 Net loss for the year ended December 31, 2020 0.3 Accumulated deficit as of December 31, 2020 140.0 Preferred dividends for the year ended December 31, 2021 0.4 Net loss for year ended December 31, 2021 2.0 Accumulated deficit as of December 31, 2021 142.4 Preferred dividends for the year ended December 31, 2022 0.6 Net loss for for the year ended December 31, 2022 4.4 Accumulated deficit as of December 31, 2022 $ 147.4 Preferred dividends for the year ended December 31, 2023 0.2 Deemed dividends for warrant exchanges for the year ended December 31, 2023 0.1 Net loss for for the year ended December 31, 2023 3.4 Accumulated deficit as of December 31, 2023 $ 151.1 Preferred dividends for the year ended December 31, 2024 0.2 Net loss for year ended December 31, 2024 2.4 Accumulated deficit as of December 31, 2024 $ 153.7 Our management has implemented reductions in operating expenditures and reductions in some development activities.
• As of December 31, 2024 and 2023, our accumulated deficit was approximately $153.7 million and $151.1 million, respectively.
• 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.
• 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.
• 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.
• 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.
• As of December 31, 2024, we hold six active U.S. patents.
• Our outstanding indebtedness, which includes all of our liabilities, was $6.3 million at December 31, 2024.
• 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.
• In connection with the audits of our financial statements as of and for the years ended December 31, 2024 and 2023, material weaknesses in our internal control over financial reporting were identified and we may identify additional material weaknesses in the future.
• In connection with the preparation and audits of our financial statements as of and for the years ended December 31, 2024 and 2023, material weaknesses (as defined under the Exchange Act and by the auditing standards of the U.S.
• There were no changes to the Company’s internal controls over financial reporting occurred during the year ended December 31, 2024 that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.
• 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.
• 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.