GTHP 10-K & 10-Q changes, risk factors and insider trading
Guided Therapeutics Inc. · OTC · Electromedical & Electrotherapeutic Apparatus · CIK 924515 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
New heading “Escalation of geopolitical conflicts in the Middle East could adversely affect our business, financial condition, and results of operations.”
New heading “Risks related to tariffs and international trade policies could adversely affect our business, financial condition, and results of operations.”
Removed heading “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.”
Largest changes
“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. …”see in full comparison
“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.”see in full comparison
“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. …”see in full comparison
“Risks related to tariffs and international trade policies could adversely affect our business, financial condition, and results of operations.”see in full comparison
“Escalation of geopolitical conflicts in the Middle East could adversely affect our business, financial condition, and results of operations.”see in full comparison
“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.”see in full comparison
Full comparison: every changed paragraph (19)
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 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.
Our independent registered public accountants’ report on our consolidated financial statements as of and for the year ended December 31, 2024,2025, 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 $153.7$157.1 million at December 31, 2024, summarized as follows:2025.
As of December 31, 2024,2025, our products have achieved and maintainmaintained 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.
For our products to be marketed and sold in the People’s Republic of China, they must gain approval from the NMPA. We arehave been working with our partner in China, Shandong Yaohua Medical Instrument Corporation,SMI to achieveobtain NMPA approval. In 20222022, device safety compliance testing for device safety was passedcompleted, and in late in 2023 enrollment in the pivotal clinical trial was completed at four hospitals.hospitals Ourwas Chinesecompleted. partner, SMI,SMI filed the application for NMPA approval application on October 16, 2024. On January 6, 2025, SMI informednotified us that the NMPA foundhad accepted the application completeas completed and wascommenced commencing theirits 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.
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.
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.
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. 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:
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 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,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.
As of December 31, 2024,2025, 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 4,528,3056,592,500 shares of our common stock, and thedeferred outstandingcompensation shares of our preferred stockarrangements were convertible into an aggregate of 42,718,4531,890,006 shares of common stock. Also, asAs of that datedate, we also had warrants outstanding that were exercisable for an aggregate of 37,174,46845,165,649 shares of common stock,stock and outstanding vested options outstanding to purchase 2,266,0232,207,341 shares of common stock. The shares of common stock issuable upon conversion or exercise of these securities would have constitutedrepresent approximately 133.1%68.0% of the total number of shares of common stock then issued and outstanding.
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.
Management's Discussion & Analysis (MD&A)
New heading “Promissory Notes”
New heading “Convertible Debt”
New heading “Related Party Debt”
New heading “Summary of our Cash Flows”
Removed heading “Liquidity and Capital Resources”
Largest changes
“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. …”see in full comparison
“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. …”see in full comparison
“The Company’s $1.13 million 10% Senior Unsecured Convertible Debenture, which matured on May 17, 2024, remains in default and continues to accrue interest at the default rate of 18%. Total accrued interest on the debenture was approximately $104,000 as of December 31, 2025, and the balance is classified as short-term debt in default.”see in full comparison
“The Company issued a $160,000 contingently convertible promissory note to Dr. John Imhoff during 2025, of which $150,000 remained outstanding as of December 31, 2025. The note requires monthly payments and may be converted into common stock upon certain events, including payment default.”see in full comparison
“Recent conflicts and heightened geopolitical tensions in the Middle East have contributed to increased uncertainty in global financial markets and may result in volatility in commodity prices, including oil and natural gas, as well as disruptions to international trade routes. Any escalation or expansion of these conflicts could adversely affect global supply chains, increase transportation and energy costs, and create additional regulatory or economic uncertainty. …”see in full comparison
Full comparison: every changed paragraph (76)
Based on writtenexisting agreementspurchase orders and ongoing discussions with SMI,potential we currently holdcustomers and expect to generate additional purchase orders whichpartners, we expect to result in actualpotential sales of approximately $1.5$1.0 million within the next twelve months. We cannot be assured that we will generate all or any of these additional purchase orders, or that existing orders will not be canceled by the distributors or that parts to build product will be available to meet demand, such that existing orders will result in actual sales.sales, in part because demand for LuViva is contingent upon Chinese regulatory approval which has not yet been achieved. Because we have a short history of sales of our products, we cannot confidently predict future sales of our products beyond this time frame and cannot be assured of any particular number of sales. Accordingly, we have not identified any particular trends with regard to sales of our products. In order to increase demand for LuViva, we are focused on three primary markets: the United States, China and Europe. In addition, we have recently received sales orders from Turkey and IndonesiaIndonesia, for which we have received the necessary regulatory approvals and are preparing to fulfill. These orders are expected to result in approximately $500,000$200,000 in revenue for 2025.2026. When combined with sales to our Chinese partner, these constitute what we view as the current demand for our products.
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 February 2026, the status of the FDA application is as follows:
Most sections of the application have been prepared. We are waiting for pathology results from outside pathology experts to complete the results section and submit the application. A short delay (approximately four to six weeks) has resulted from the loss of one of the study’s outside pathologist, 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.
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, 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.
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.
Although SMI no longer holds rights to LuViva in China, SMI and its partners HDMT and YMIC have indicated their willing ness 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.
Following regulatory approval of LuViva in Russia on August 11, 2025, the Company’s distribution partner, Newmars Medical Technologies (“Newmars”), has shifted its focus from smaller Eastern European markets to the Russian market.
In Turkey, we have been in contact with three different medical groups representing over 60 individual hospitals and clinics. We have entered contract discussions for supplying LuViva to the Turkish Ministry of Health (“MOH”). The current plan involves a collaboration with MOH to conduct a clinical study in Turkey to support the use of LuViva for primary screening of cervical cancer as a replacement for the Pap test under the public health system. The MOH has informed us that this could potentially involve significant annual testing volumes if implemented nationwide. The clinical study is expected to involve about 800 patients, take less than six months to complete and will be funded by the MOH. As of December 31, 2025, MOH had approved the study and budget, including paying for LuViva devices and single use cervical guides. Funds totaling $63,000 are expected to be released in 2026 and the study concluded in the first half of 2026.
In the United States, the Company is actively pursuing FDA approval by conducting a clinical trial involving approximately 400 study participants, with the exact number depending in part on the numbers of women in the study both with and without cervical disease. The study protocol was drafted with input from FDA and physicians at the 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 were fully IRB approved. The protocol was also approved by an independent, nationally recognized institutional review board. All four sites have received LuViva devices and have been trained in their use. All four sites have undergone one or more clinical study monitoring visits by the Company’s clinical study monitors. Clinical study monitoring visits are required by FDA to ensure that the study is being conducted under FDA guidelines and in compliance with the study protocol. Findings from the ongoing clinical study monitoring visits include:
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.
Regarding international sales efforts, our focus has been on achieving regulatory approval to sell LuViva in China. Our Chinese partner, SMI, filed the application with NMPA for approval of LuViva as a Class 3 medical device in China on October 16, 2024. The results for the 449 women tested by LuViva were better than required by NMPA with a sensitivity of 83% and a specificity of 54%. There were no adverse events reported during the use of LuViva in the study, adding further evidence as to the safety of the technology. The NMPA application was accepted as complete and is under review. SMI believes NMPA approval could happen within six months, although there can be no assurance that NMPA approval will occur within the projected time frame, or ever.
In Europe, our distribution partners, Newmars Medical Technologies (“Newmars”), is actively pursuing potential customers in Poland, Hungary and Romania, where we have obtained the required approvals to sell our products though Newmars. In addition, an application for approval has been filed in Russia, although current geopolitics presents uncertainty as to the ability to sell and market new medical technology in that country.
In Turkey, we have been in contact with three different medical groups representing over 60 individual hospitals and clinics. We have entered contract discussions for supplying LuViva to the Turkish Ministry of Health and also with a medical device distributor located in Ankara.
In Indonesia, our contracted distributors are in discussions with the local government hospital system of Sulawesi, one of the nation’s most populous islands. During the fourth quarter of 2024, we received an order and full payment for four devices from Indonesia. We expecthave delayed shipment pending final payment for shipping and additional ordersservices forrequested 22by –the 26customer. We expect to ship these devices in 2025.the second quarter of 2026.
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 aan vendorentity 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 is now recognized when control over the goods or services is transferred to the customer. For the Company, revenue is primarily generated from the sale of medical devices and related components, and in certain circumstances may also include service, licensing, or distribution arrangements. 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. In the medical device industry, contracts may include sales agreements with hospitals, clinics, distributors, or international partners.
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. For the Company, performance obligations typically consist of the delivery of medical devices, related disposables or accessories, and in certain arrangements may include installation services, training, technical support, or other post-delivery obligations.
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. Transaction prices for the Company’s products include fixed prices stated in purchase orders or distribution agreements Step 4 – Allocate the transaction price to the performance obligations: If a contract contains multiple performance obligations, the transaction price is allocated to each performance obligation based on the relative standalone selling price of each promised good or service. Standalone selling prices are determined using observable market prices when available or estimated using appropriate pricing methods.
Step 5 – Recognize revenue when (or as) performance obligations are satisfied: Revenue is recognized when control of the promised goods or services transfers to the customer. For product sales, this generally occurs at a point in time when the device is shipped or delivered to the customer in accordance with the contractual shipping terms. Revenue related to services or other ongoing obligations, if any, is recognized over the period in which the services are performed.
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 or Issued to Employee,Employees, Service Providers and Investors: On the date of issuance, the instruments are recorded at their fair value as determined using the Black-Scholes or binomial lattice valuation models.
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. The Company periodically evaluates its inventory for excess, obsolete, or slow-moving items and records an inventory reserve, when necessary, to reduce inventory to its estimated net realizable value. Estimates of net realizable value are based on management’s assessment of forecasted demand, expected selling prices, remaining product life cycles, regulatory approvals, technological changes, and other factors that may affect the recoverability of inventory. As the Company is in the early stages of commercialization of its medical devices and certain products remain subject to regulatory approvals in various jurisdictions, actual demand and market conditions may differ from management’s estimates. Adjustments to inventory reserves are recorded in the period in which such estimates change.
Allowance for Credit Losses: Trade receivables are recorded net of allowances for chargebacks, cash discounts for prompt payment and credit losses. The Company estimates an allowance for expected credit losses by considering factors such as historical experience, credit quality, the age of the accounts receivable balances, and current economic conditions that may affect a customer’s ability to pay. The corresponding expense for the credit loss allowance is reflected in selling, general and administrative expenses. The allowance for credit losses was immaterial as of December 31, 2024 and 2023.
Inventory Valuation: All inventories are stated at lower of cost or net realizable value, with cost determined substantially on a “first-in, first-out” basis. Selling, general, and administrative expenses are not inventoried, but are charged to expense when incurred.
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, 20242025 were $6,940,$766,948, compared to $97,706$6,940 for the year ended December 31, 2023.2024. Cost of goods sold was $195,797 during the year ended December 31, 2025, compared to $4,574 during the year ended December 31, 2024,2024. comparedRevenue in the current period was attributed to $62,382 during the yearshipment endedof Decemberten 31,instrumentation 2023.packages and 49,031 RFID chips to our customers in China. In the prior year, the majority of our2024, revenue was derivedminimal fromand theconsisted saleprimarily of foursales instrumentation packages (“IPs”) to SMI. We currently hold purchase orders with our partner SMI and one other Chinese distributor for approximately $2.45 million inof LuViva devices and disposables. Timing of approval by NMPA is likely a factor in when we will receive these payments, ship our inventory and recognize revenue. As of December 31, 2024, we have a deferred revenue balance of $848,917, which will be recognized as revenue when our products are shipped. We anticipate shipping and therefore recognizing revenue for the majority of these products in 2025, based in part on timing of NMPA approval. .
The increase in revenue was primarily driven by the recognition of $488,766 of revenue in the fourth quarter of 2025 related to amounts previously recorded as deferred revenue under the Company’s arrangement with SMI. During the fourth quarter, SMI breached the agreement and no further performance obligations remained. Accordingly, consistent with ASC 606, the Company recognized the remaining deferred revenue in the current period.
Cost of goods sold consists primarily of direct materials, third-party manufacturing and assembly costs, and shipping and handling. Cost of goods sold for 2025 also included approximately $75,000 of inventory-related charges, consisting of physical inventory count adjustments and write-offs of obsolete inventory, which negatively impacted gross margin and may not be indicative of future results. Gross margin in 2025 reflects limited production volumes, reliance on third-party manufacturers, and the inventory-related charges noted above. While the Company expects its cost structure may improve as production scales, the timing and extent of any such improvement remain uncertain.
As of December 31, 2025, the Company had deferred revenue of $188,552 related to advance customer payments. Certain of these arrangements require additional payments or the satisfaction of contractual conditions, including the receipt of customer-provided components, prior to shipment. Accordingly, the timing of shipment and revenue recognition for these arrangements remains uncertain. The Company also has customer purchase orders for LuViva devices and disposables; however, the timing and fulfillment of these orders, and therefore revenue recognition, are dependent on various factors, including customer requirements, production timing, and regulatory considerations, including the status of approval by the NMPA.
While the Company believes that demand for its products may increase as regulatory approvals are obtained and commercial activities expand, there can be no assurance regarding the level or timing of revenue in 2026, or whether revenue will be greater than that reported for 2025.
Research and Development Expenses: Research and development expenses were $525,650$468,588 and $228,132$525,650 during the years ended December 31, 20242025 and 2023,2024, respectively. The increasedecrease of $297,518,$57,062, or 130.4%,10.9%, was primarily due to a $321,018$62,083 increasedecrease in research and development clinical costs and payroll-related expenses related to clinical trials. This increase was offset by a decrease of $23,500 in fees for patent maintenance and other miscellaneous research and development costs.
Sales and Marketing Expenses: Sales and marketing expenses were $168,511 and $287,016 during the years ended December 31, 2025 and 2024, respectively. The decrease of $118,505, or 41.3%, was primarily due to reductions of $87,412 in salaries and benefits, $26,418 in rent and utilities (due to a decline in allocated rent expense and a decline in ancillary charges from the landlord) and $6,008 of travel costs. Sales and marketing expenses in 2026 are expected to remain limited as the Company continues to focus its efforts on obtaining regulatory approvals in the United States and China. As a result, the Company does not currently expect to incur significant sales and marketing expenses in those markets during 2026. Sales and marketing activities are expected to be primarily concentrated in Turkey, including personnel-related costs, which are currently expected to include approximately $90,000 related to a regional sales resource. The overall level of sales and marketing expense in 2026 will depend on the timing of regulatory approvals and the extent to which commercialization activities expand.
General and Administrative Expense: General and administrative expenses were $2,304,827 and $1,296,537 during the years ended December 31, 2025 and 2024, respectively. The increase of $1,008,290, or 77.8%, was primarily driven by an increase of $866,503 in salaries and benefits, including one-time non-cash charges of $270,389 for warrants and $548,102 for a conversion option, and a $40,000 increase in the Chief Executive Officer’s annual salary effective June 1, 2025, resulting in approximately $23,333 of additional expense in 2025. The increase also reflects higher consulting fees of $96,131, stock-based compensation of $26,419, allocated rent expense of $12,900, and an allowance for credit losses of $6,825.
Sales and Marketing Expenses: Sales and marketing expenses were $287,016 and $268,375 during the years ended December 31, 2024 and 2023, respectively. The increase of $18,641, or 6.9%, was primarily due to $10,981 of additional rent expense allocated to our sales and marketing department. The remaining increase was due to higher travel and payroll-related expenses. Sales and marketing expenses have remained relatively consistent year-over-year due to the fact that our international distribution partners are responsible for sales and marketing expenses in their respective countries and also because our sales team’s pay is not commission-based.
General and Administrative Expense: General and administrative expenses were $1,296,537 and $2,997,424 and during the years ended December 31, 2024 and 2023, respectively. The decrease of $1,700,887, or 56.7%, was primarily driven by a decline of $1,006,320 of expense for consulting fees, which was caused by (1) $827,472 less expense recognized for shares of common stock and warrants issued to Mr. Blumberg, (2) $99,837 less expense for warrants issued to Mr. Grujic and (3) a decline of $13,011 in fees for other outside consultants, attorneys and our auditors. The decrease in our current year general and administrative expenses was also due to a $600,402 decline in payroll and benefits expenses (including payroll taxes), which was primarily caused by a one-time charge of $679,959 recorded for warrants issued in relation to the appointment of Dr. Mark Faupel as the Company’s President and Chief Executive Officer during the prior year period. Additionally, expense for stock options decreased $155,824 in the current period due to (1) a one-time charge of $59,216 in the prior year for the modification of a stock option award and (2) fewer stock option awards vesting in the current period versus the prior. The remaining decrease of $4,341 was driven by a decrease in rent and other miscellaneous expenses in the current period versus the prior.
Interest Expense: Interest expense during the years ended December 31, 20242025 and 20232024 was $380,717$617,205 and $278,350,$380,717, respectively. The increase of $102,367$236,488 (or 36.8%62.1%), was primarily due to anhigher increase inoutstanding debt inbalances theand currentincreased periodamortization versusof thedebt prior.discounts associated with convertible instruments.
Change in Fair Value of Derivative Liability: The change in the fair value of our derivative liability resulted in a lossgain of $18,643$64,747 in the year ended December 31, 2024,2025, versus a gainloss of $5,104$18,643 during the year ended December 31, 2023.2024. The change in the fair value in the current period was attributed to changes in our forecasted stock price. TheIn gainaddition, a greater number of derivative liabilities were recorded in the current year due to theadditional changebifurcated inconversion fairfeatures valueassociated ofwith thenew derivativedebt liability in the year ended December 31, 2023 was due to changes in our stock price.issuances.
Gain (Loss) from Extinguishment of Debt: The gain from extinguishmentforgiveness of debt of $96,294 and $68,622 during the years ended December 31, 20242025 and 20232024, was $68,622 and $196,206, respectively. The decrease of $127,584 or 65.0%,respectively, was due to a lower amountforgiveness of debt forgiven in the current period, as the balances owed tofrom our creditors have declined.creditors.
Loss from Extinguishment of Debt: The $532,864 loss on extinguishment of debt during the year ended December 31, 2025 was primarily attributable to debt-for-equity exchange transactions completed in connection with the Company’s March, August and November 2025 private placement offerings. In these transactions, the Company exchanged an aggregate of $246,246 of outstanding principal and accrued interest for units consisting of common stock and warrants. As a result, the Company recognized a total loss on extinguishment of debt of $532,864, reflecting the excess of the fair value of the equity instruments issued over the carrying value of the debt extinguished.
Other Income: Other income was $163,686 for the year ended December 31, 2025, compared to $17,102 in 2024. The increase was primarily driven by $183,525 recognized pursuant to an agreement with SMI, under which prior payments were applied toward reimbursement of certain expenses incurred by the Company in 2023 and 2024. These amounts were recognized in other income as they represent recoveries of previously incurred costs and do not relate to the transfer of goods or services under ASC 606.
Other income also included $52,400 related to refundable payroll tax credits received under the Employee Retention Credit program. These increases were partially offset by an $84,000 loss on the write-off of a long-term asset.
Other Income: Other income for the years ended December 31, 2024 and 2023 was $18,102 and $39,271, respectively. The decrease of $21,169, or 53.9%, was primarily due to a decrease in write-offs of accounts payable balances that management no longer considered to be valid liabilities in the current year.
Deemed Dividend for Warrant Exchanges: Expense related to deemed dividends was nil and $98,972 for the years ended December 31, 2024 and 2023, respectively. The expense in the prior period was recognized as the excess fair value of warrant instruments exchanged over the fair value of the original warrants.
Preferred Stock Dividends: Expense related to preferred stock dividends ofwas $173,724$149,790 and $170,803$173,724 for the years ended December 31, 20242025 and 2023,2024, respectively,respectively. The decrease was materiallyprimarily consistentattributable overto the twoconversion periods.of preferred shares into common stock during 2025, which reduced the number of outstanding preferred shares subject to dividend accrual.
We have incurred significant losses since our inception. At December 31, 2024,2025, the Company had a negative working capital of approximately $5.0$6.0 million, accumulated deficit of $153.7$157.1 million, and incurred a net loss including preferred and deemed dividends of $2.6$3.35 million for the year then ended. Stockholders’ deficit totaled approximately $4.9$6.0 million at December 31, 2024,2025, 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 maywill 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.
Liquidity
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. Over the next 12 months we expect our burn rate to increase somewhat as we increase headcount, especially for meeting manufacturing demand. In addition, although we have significant inventory, we will need to order additional parts and services for production. Finally, we expect to spend another $300$250 thousand to complete and file our US FDA study.FDA. Thus, we estimate that approximately $2.5$2.3 million will be needed to fund the business over the next 12 months. However, other than completing and filing the US FDA study results, additional expenditures for manufacturing production will be needed only if significant product is ordered and paid for in advance by customers, which is our current policy.
Since our inception, we have raised capital through the public and private sale of debt and equity, funding from collaborative arrangements, and grants. As of December 31, 2024,2025, we had cash of approximately $0.4$63 millionthousand and negative working capital of $4.9$6.0 million. Our outstanding debt obligations include a combination of short- and long-term promissory notes, insurance premium financing, and several convertible notes with varying maturities, interest rates, and terms.
In February 2026, the Company entered into warrant exchange agreements with certain holders of its outstanding warrants, pursuant to which approximately 9,250,000 warrants were exchanged for new warrants with lower exercise prices. In connection with these transactions, approximately 4,825,000 of the newly issued warrants were exercised, resulting in aggregate cash proceeds of approximately $980,000. The remaining approximately 4,425,000 warrants remain outstanding and expire in 2027.
Promissory Notes
As of December 31, 2025, the Company had outstanding promissory notes totaling approximately $105,000, compared to approximately $139,000 as of December 31, 2024. These balances primarily relate to insurance premium financing arrangements and a deferred compensation note. The decrease was primarily due to repayments during the year, including the full repayment of certain short-term promissory notes. The majority of these obligations are classified as current, with approximately $82,000 due within the next twelve months.
Convertible Debt
As of December 31, 2025, the Company had multiple outstanding convertible debt instruments, several of which are in default or contain embedded conversion features that may result in dilution.
What changed in the latest 10-Q
Risk Factors
There have been no material changes from the risk factors previously disclosed in the Company’s most recent Annual Report on Form 10-K as filed with the SEC on March 31, 2026.
No wording changes found in this section.
Full comparison: every changed paragraph (0)
Management's Discussion & Analysis (MD&A)
New heading “COMPARISON OF THE SIX MONTHS ENDED JUNE 30, 2026 AND 2025”
Largest changes
Based on existing purchase orders and ongoing discussions with potential customers and partners, we expect potential sales of approximately $1.0 million within the next twelve months. We cannot be assured that we will generate all or any of these additional purchase orders, or that existing orders will not be canceled by the distributors or that parts to build product will be available to meet demand, such that existing orders will result in actual sales, in part because demand for LuViva is contingent upon Chinese regulatory approval which has not yet been achieved. Because we have a short history of sales of our products, we cannot confidently predict future sales of our products beyond this time frame and cannot be assured of any particular number of sales. Accordingly, we have not identified any particular trends with regard to sales of our products. In order to increase demand for LuViva, we are focused on three primary markets: the United States, China and Europe. In addition, we have recently received sales orders from Turkey and Indonesia, for which we have received the necessary regulatory approvals and are preparing to fulfill.see in full comparisonTheseWeordersanticipatearerecognizingexpectedsalestoofresultapproximately $565 thousand inapproximately2026$200,000wheninwerevenue for 2026. The amount may be lower depending on whether YMIC pays directly for some of the parts due to the origin of manufacture in China. We expect payment once this is resolved. When combined with sales to our Chinese partner,fulfill theseconstituteexistingwhat we view as the current demand for our products.orders.
“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. FDA approval for a Class III medical device includes several steps, and in our case will include review of the clinical study results, a manufacturing inspection and whether a post marketing study will be necessary. The FDA has indicated that it does not need to review modules other than the clinical module that was submitted with the new clinical study results. …”see in full comparison
“Other Income: Other income was $14 thousand and $161 thousand during the six months ended June 30, 2026 and 2025, respectively. Current year other income was due to a refund of a retainer paid to a service provider in a prior year. During the six months ended June 30, 2025, we reached an agreement with SMI to apply their payment of $180 thousand towards reimbursement of certain expenses incurred during the years ended December 31, 2024 and 2023. As a result of this agreement, we recognized $180 thousand of deferred revenue in other income during the prior period. …”see in full comparison
“General and Administrative Expense: General and administrative expenses were $878 thousand and $924 thousand during the six months ended June 30, 2026 and 2025, respectively. The decrease of $46 thousand, or 5.0%, was primarily driven by a decrease of $220 thousand in payroll and benefits (including payroll taxes), largely caused by a one-time charge of $270 thousand for warrants included in a board-approved compensation package for Dr. Faupel during the prior period. Additionally, property tax expense decreased $13 thousand. …”see in full comparison
“General and Administrative Expense: General and administrative expenses were $423 thousand and $658 thousand during the three months ended June 30, 2026 and 2025, respectively. The decrease of $235 thousand, or 35.7%, was primarily driven by a decrease of $261 thousand in payroll and benefits (including payroll taxes), which was largely caused by a one-time charge of $270 thousand for warrants included in a board-approved compensation package for Dr. Faupel during the prior period. Additionally, the Company recognized $30 thousand lower stock option expense during the current period. …”see in full comparison
Full comparison: every changed paragraph (54)
In addition to historical information, this Quarterly Report on Form 10-Q may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which provides a “safe harbor” for forward-looking statements made by us. All statements, other than statements of historical facts, including statements concerning our plans, objectives, goals, beliefs, business strategies, future events, business conditions, results of operations, financial position, business outlook, business trends, and other information, may be forward-looking statements. Words such as “might,” “will,” “may,” “should,” “estimates,” “expects,” “continues,” “contemplates,” “anticipates,” “projects,” “plans,” “potential,” “predicts,” “intends,” “believes,” “forecasts,” “future,” and variations of such words or similar expressions are intended to identify forward-looking statements. The forward-looking statements are not historical facts, and are based upon our current expectations, beliefs, estimates and projections, and various assumptions, many of which, by their nature, are inherently uncertain and beyond our control. Our expectations, beliefs, estimates, and projections are expressed in good faith and we believe there is a reasonable basis for them. However, there can be no assurance that management’s expectations, beliefs, estimates, and projections will occur or can be achieved and actual results may vary materially from what is expressed in or indicated by the forward-looking statements.
On March 25, 2026, the Company established GTHP Turkey, a joint stock company organized under the laws of the Republic of Turkey, as a wholly owned subsidiary. GTHP Turkey is registered with the Istanbul Trade Registry (Trade Registry File No. 1132980) and has issued share capital of TRY 400,000, all of which has been subscribed by the Company. GTHP Turkey has had limited operations to date, and its financial position and results of operations were not material to the Company’s condensed consolidated financial statements as of and for the three and six months ended June 30, 2026.
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 in 1992 as SpectRx, Inc. and, as of MarchJune 31,30, 2026, we have an accumulated deficit of approximately $158.0$158.7 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, described below, 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.
Based on existing purchase orders and ongoing discussions with potential customers and partners, we expect potential sales of approximately $1.0 million within the next twelve months. We cannot be assured that we will generate all or any of these additional purchase orders, or that existing orders will not be canceled by the distributors or that parts to build product will be available to meet demand, such that existing orders will result in actual sales, in part because demand for LuViva is contingent upon Chinese regulatory approval which has not yet been achieved. Because we have a short history of sales of our products, we cannot confidently predict future sales of our products beyond this time frame and cannot be assured of any particular number of sales. Accordingly, we have not identified any particular trends with regard to sales of our products. In order to increase demand for LuViva, we are focused on three primary markets: the United States, China and Europe. In addition, we have recently received sales orders from Turkey and Indonesia, for which we have received the necessary regulatory approvals and are preparing to fulfill. TheseWe ordersanticipate arerecognizing expectedsales toof resultapproximately $565 thousand in approximately2026 $200,000when inwe revenue for 2026. The amount may be lower depending on whether YMIC pays directly for some of the parts due to the origin of manufacture in China. We expect payment once this is resolved. When combined with sales to our Chinese partner,fulfill these constituteexisting what we view as the current demand for our products.orders.
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. FDA approval for a Class III medical device includes several steps, and in our case will include review of the clinical study results, a manufacturing inspection and whether a post marketing study will be necessary. The FDA has indicated that it does not need to review modules other than the clinical module that was submitted with the new clinical study results. In addition, FDA may recommend that an outside panel of experts reviews the application, especially the clinical study results. If it so chooses, FDA can issue an “approvable letter” whereby full marketing approval can be contingent on a manufacturing inspection and/or agreement on a post-marketing protocol. As of August 2026, the status of the FDA application is as follows:
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 April 2026, the status of the FDA application is as follows:
As of December 31, 2025, ourOur 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.
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 the secondthird quarter of 2026, with potential approval in the third or fourth quarter of 2026,2026 or first quarter of 2027, although there is no assurance that this timeline will be met or that NMPA approval of LuViva will be obtained.
In Turkey, we have been in contact with three different medical groups representing over 60 individual hospitals and clinics. We have entered contract discussions for supplying LuViva to the Turkish Ministry of Health (“MOH”). The current plan involves a collaboration with MOH to conduct a clinical study in Turkey to support the use of LuViva for primary screening of cervical cancer as a replacement for the Pap test under the public health system. The MOH has informed us that this could potentially involve significant annual testing volumes if implemented nationwide. The clinical study is expected to involve about 800 patients, take less than six months to complete and will be funded by the MOH. As of December 31, 2025, MOH hadhas approved the study and budget, including paying for LuViva devices and single use cervical guides. Funds totaling approximately $63,000$55 thousand are expected to be released in the secondthird quarter of 2026 and the study concluded in 2026.
COMPARISON OF THE THREE MONTHS ENDED MARCHJUNE 31,30, 2026 AND 2025
Sales Revenue and Cost of Goods Sold: The Company did not recognize any revenue during the three months ended MarchJune 31,30, 20262026, orcompared to $117 thousand of revenue recognized during the three months ended June 30, 2025. Most of our revenue in the prior period was derived from the shipment of 3 instrumentation packages and 49,031 RFID chips.
As of MarchJune 31,30, 2026, the Company had deferred revenue of $188,552,$189 thousand related to advance customer payments. Certain of these arrangements require additional payments or the satisfaction of contractual conditions, including the receipt of customer-provided components, prior to shipment. Accordingly, the timing of shipment and revenue recognition for these arrangements remains uncertain. The Company also has customer purchase orders for LuViva devices and disposables; however, the timing and fulfillment of these orders, and therefore revenue recognition, are dependent on various factors, including customer requirements, production timing, and regulatory considerations, including the status of approval by the NMPA.
Research and Development Expenses: Research and development expenses were $44,511$34 thousand and $74,122$133 thousand during the three months ended MarchJune 31,30, 2026 and 2025, respectively. The decrease of $29,611,$99 thousand, or 40%,74.4%, was primarily due to a $60,450$116 reductionthousand decrease in clinical trial research expenses,costs as we have completed our clinical trials required for FDA approval. The decrease was partially offset by increasesan increase in legal fees of $20,000$12 thousand and an increase in payrollmaterials andcosts $7,025of for$6 professional services and consulting.thousand.
Sales and Marketing Expenses: Sales and marketing expenses were $22,500$23 thousand and $72,993$51 thousand during the three months ended MarchJune 31,30, 2026 and 2025, respectively. The decrease of $50,493,$28 thousand, or 69%,54.9%, was primarily due to a $25 thousand reduction of $41,285 in payroll and benefits and $8,907 in allocated rent expense.expenses.
General and Administrative Expense: General and administrative expenses were $423 thousand and $658 thousand during the three months ended June 30, 2026 and 2025, respectively. The decrease of $235 thousand, or 35.7%, was primarily driven by a decrease of $261 thousand in payroll and benefits (including payroll taxes), which was largely caused by a one-time charge of $270 thousand for warrants included in a board-approved compensation package for Dr. Faupel during the prior period. Additionally, the Company recognized $30 thousand lower stock option expense during the current period. These decreases were offset by an increase of $36 thousand in consulting and professional service fees, a $26 thousand increase in rent expense, and a $4 thousand increase in other miscellaneous expenses.
General and Administrative Expense: General and administrative expenses were $450,673 and $266,920 during the three months ended March 31, 2026 and 2025, respectively. The increase of $183,753, or 69%, was primarily due to increases of $76,380 in attorney's fees incurred in connection with the Company's uplisting to the Canadian stock exchange, $40,644 in stock option expense, $30,875 in rent and utilities (of which a portion reflects rent previously allocated to sales and marketing), $29,918 in payroll and benefits, and $19,355 in professional services and consulting, partially offset by decreases of $10,725 in property taxes and $2,694 in miscellaneous expenses.
Gain on Remeasurement of Deferred Compensation Conversion Liability: During the three months ended MarchJune 31,30, 2026, the Company recognized a gain of $217,062$2 thousand on the remeasurement of the deferred compensation conversion liability related to Dr. Faupel's convertible deferred compensation arrangement. This liability is classified under ASC 718 because settlement into common stock is at the employee's election,election and is carried at fair value with changes recognized each period. As of March 31, 2026, the conversion feature was out-of-the-money relative to the $0.25 conversion price, and accordingly its fair value was estimated using the Black-Scholes option pricing model, reflecting time value rather than intrinsic value. The resulting decrease in fair value from the prior period-end balance generated the gain recognized during the quarter.
Interest Expense: Interest expense was $136 thousand and $157 thousand during the three months ended June 30, 2026 and 2025, respectively. The decrease of $21 thousand, or 13.4%, was primarily due to $50 thousand interest expense recognized in the prior period for a promissory note issued to Flynn Case Living Trust, which was no longer outstanding during the current period. The decrease was offset by an increase of $10 thousand of interest related to the Labrys notes, $10 thousand of interest for the notes issued to GS capital and $8 thousand for the Auctus debt.
Interest Expense: Interest expense was $150,831 and $146,899 during the three months ended March 31, 2026 and 2025, respectively, and remained materially consistent period over period.
Inducement Charges: During the three months ended March 31, 2026, the Company recognized inducement charges of $77,593 related to the issuance of warrants in connection with the conversion of outstanding debt.
Change in fair value of derivative liability: The change in the fair value of derivative liabilities resulted in a gain of $12,847$9 thousand during the three months ended MarchJune 31,30, 2026, compared to a gain of $52,890$30 thousand in the prior-year period. A greater number of derivative liabilities were recorded in the prior year due to additional bifurcated conversion features associated with new debt issuances.
Gain from Forgiveness of Debt: Gain from forgiveness of debt was $3,278nil and $16,291$15 thousand during the three months ended MarchJune 31,30, 2026 and 2025, respectively, and was due to forgiveness of debt from our creditors.
Other Income: Other income was nil and $64 thousand during the three months ended June 30, 2026 and 2025, respectively. Prior year other income was primarily related to $52 thousand of funds received from the Internal Revenue Service related to refundable payroll tax credits under the Employee Retention Credit program.
Loss from Extinguishment of Debt: No loss on extinguishment of debt was recognized during the three months ended March 31, 2026, compared to $31,928 in the prior-year period, which related to the exchange of outstanding debt for equity securities in connection with a private placement completed in March 2025.
Other Income: Other income was $14,588 and $98,090 during the three months ended March 31, 2026 and 2025, respectively. The higher amount in the prior-year period was primarily attributable to an agreement with SMI, under which a $180,000 payment was applied toward reimbursement of certain expenses incurred in prior periods and recognized in other income. This income was partially offset by an $84,000 loss recorded for the write-off of a long-term asset. Other income in the current period primarily relates to a vendor credit issued for amounts incurred in prior periods.
Preferred Stock Dividends: Preferred stock dividend expense was $3,242($1) thousand and $35,559$45 thousand during the three months ended MarchJune 31,30, 2026 and 2025, respectively.respectively, Thea decrease of $32,317$46 thousand. The current period reflects a credit to dividend expense resulting from an adjustment to accrued dividends. The overall decrease was primarily duedriven toby a reduction in outstanding dividend-bearing preferred stock and the cessation of dividend accruals on certain preferred stock series.
Net Loss Attributable to Common Stockholders: Net loss attributable to common stockholders was $1,013,441$604 thousand and $462,742$856 thousand during the three months ended MarchJune 31,30, 2026 and 2025, respectively. The reasons for the increasechange are explained above.
There was no income tax benefit recorded for the three months ended MarchJune 31,30, 2026 or 2025, due to recurring net operating losses.
COMPARISON OF THE SIX MONTHS ENDED JUNE 30, 2026 AND 2025
Sales Revenue and Cost of Goods Sold: The Company did not recognize any revenue during the six months ended June 30, 2026, compared to $117 thousand of revenue recognized during the six months ended June 30, 2025. Most of our revenue in the prior period was derived from the shipment of 3 instrumentation packages and 49,031 RFID chips.
As of June 30, 2026, the Company had deferred revenue of $189 thousand related to advance customer payments. Certain of these arrangements require additional payments or the satisfaction of contractual conditions, including the receipt of customer-provided components, prior to shipment. Accordingly, the timing of shipment and revenue recognition for these arrangements remains uncertain. The Company also has customer purchase orders for LuViva devices and disposables; however, the timing and fulfillment of these orders, and therefore revenue recognition, are dependent on various factors, including customer requirements, production timing, and regulatory considerations, including the status of approval by the NMPA.
While the Company believes that demand for its products may increase as regulatory approvals are obtained and commercial activities expand, there can be no assurance regarding the level or timing of revenue in 2026.
Research and Development Expenses: Research and development expenses were $78 thousand and $207 thousand during the six months ended June 30, 2026 and 2025, respectively. The decrease of $129 thousand, or 62.3%, was primarily due to a $176 thousand decrease in clinical research costs as we have completed our clinical trials required for FDA approval. The decrease was partially offset by an increase in payroll costs of $20 thousand, an increase in professional service fees of $16 thousand and an increase in materials costs of $8 thousand.
Sales and Marketing Expenses: Sales and marketing expenses were $45 thousand and $124 thousand during the six months ended June 30, 2026 and 2025, respectively. The decrease of $79 thousand, or 63.7%, was due to a $66 thousand reduction in payroll and benefits expenses and a $13 thousand reduction in allocated rent expense.
General and Administrative Expense: General and administrative expenses were $878 thousand and $924 thousand during the six months ended June 30, 2026 and 2025, respectively. The decrease of $46 thousand, or 5.0%, was primarily driven by a decrease of $220 thousand in payroll and benefits (including payroll taxes), largely caused by a one-time charge of $270 thousand for warrants included in a board-approved compensation package for Dr. Faupel during the prior period. Additionally, property tax expense decreased $13 thousand. These decreases were offset by a $134 thousand increase in consulting and professional service fees and a $58 thousand increase in rent expense, of which $13 thousand was due to a reallocation of rent expense from sales and marketing to general and administrative expense.
Gain on Remeasurement of Deferred Compensation Conversion Liability: During the six months ended June 30, 2026, the Company recognized a gain of $222 thousand on the remeasurement of the deferred compensation conversion liability related to Dr. Faupel's convertible deferred compensation arrangement. This liability is classified under ASC 718 because settlement into common stock is at the employee's election and is carried at fair value with changes recognized each period.
Interest Expense: Interest expense was $287 thousand and $303 thousand during the six months ended June 30, 2026 and 2025, respectively. The decrease of $16 thousand, or 5.3%, was primarily due to $106 thousand of interest expense recognized in the prior period for a promissory note issued to Flynn Case Living Trust, which was no longer outstanding during the current period. The decrease was partially offset by an increase of $68 thousand of interest related to the convertible notes issued to 1800 Diagonal, Labrys and GS Capital, $15 thousand of interest for the Auctus debt, and $14 thousand of additional interest on the deferred executive compensation notes.
Inducement Charges: During the six months ended June 30, 2026, the Company recognized inducement charges of $78 thousand related to the issuance of warrants in connection with the conversion of outstanding debt.
Change in fair value of derivative liability: The change in the fair value of derivative liabilities resulted in a gain of $22 thousand during the six months ended June 30, 2026, compared to a gain of $83 thousand in the prior-year period. A greater number of derivative liabilities were recorded in the prior year due to additional bifurcated conversion features associated with new debt issuances.
Gain from Forgiveness of Debt: Gain from forgiveness of debt was $3 thousand and $31 thousand during the six months ended June 30, 2026 and 2025, respectively, and was due to forgiveness of debt from our creditors.
Loss from Extinguishment of Debt: No loss on extinguishment of debt was recognized during the six months ended June 30, 2026, compared to $32 thousand in the prior-year period, which related to the exchange of outstanding debt for equity securities in connection with a private placement completed in March 2025.
Other Income: Other income was $14 thousand and $161 thousand during the six months ended June 30, 2026 and 2025, respectively. Current year other income was due to a refund of a retainer paid to a service provider in a prior year. During the six months ended June 30, 2025, we reached an agreement with SMI to apply their payment of $180 thousand towards reimbursement of certain expenses incurred during the years ended December 31, 2024 and 2023. As a result of this agreement, we recognized $180 thousand of deferred revenue in other income during the prior period. Additionally, we recorded other income of $52 thousand in the prior period to account for funds received from the Internal Revenue Service related to refundable payroll tax credits under the Employee Retention Credit program. This income was offset by an $84 thousand loss recorded for the write-off of a long-term asset in the prior period.
Deemed Dividend for Warrant Exchanges: On February 25, 2026, the Company entered into a series of warrant exchange agreements with certain holders of its outstanding warrants originally issued in 2022. As a result of these transactions, approximately 4,425,000 were modified to have their expiration dates extended by one year. The one-year extension of the warrants resulted in incremental fair value of approximately $510 thousand, which was recognized as a deemed dividend recorded as an adjustment to additional paid-in capital.
Preferred Stock Dividends: Preferred stock dividend expense was $2 thousand and $83 thousand during the six months ended June 30, 2026 and 2025, respectively, a decrease of $81 thousand, or 97.6%. The decrease was driven by a reduction in outstanding dividend-bearing preferred stock and the cessation of dividend accruals on certain preferred stock series.
Net Loss Attributable to Common Stockholders: Net loss attributable to common stockholders was $1.6 million and $1.3 million during the six months ended June 30, 2026 and 2025, respectively. The reasons for the change are explained above.
There was no income tax benefit recorded for the six months ended June 30, 2026 or 2025, due to recurring net operating losses.
As of MarchJune 31,30, 2026, the Company had a working capital deficit of approximately $5.1$5.6 million and an accumulated deficit of approximately $158.0$158.7 million. The Company has historically incurred recurring losses from operations and expects such losses to continue as it advances its regulatory approval efforts and commercialization activities. During the threesix months ended MarchJune 31,30, 2026, the Company incurred a net loss attributable to common stockholders of approximately $1.0$1.6 million. The Company’s operating activities continue to require significant cash outflows, primarily related to research and development, general and administrative expenses, and debt servicing obligations.
Operating Activities: Net cash used in operating activities was $616,947$936 thousand during the threesix months ended MarchJune 31,30, 2026, compared to $330,302$500 thousand in the prior-year period. The increase in cash used was primarily due to aan increase in net loss of $500,333$259 thousand after adjustment for non-cash income and unfavorableexpenses. Additionally, changes in working capital,capital primarilyincreased drivennet cash used in operating activities by a$177 decrease in accounts payable and accrued liabilities of $97,111, partially offset by non-cash items including stock-based compensation of $68,316, inducement charges of $77,593, amortization of debt issuance costs and discounts of $47,514, and amortization of the lease right-of-use asset of $22,444, net of a non-cash gain on remeasurement of the deferred compensation conversion liability of $217,062.thousand.
Financing Activities: Net cash provided by financing activities was $922,475$885 thousand during the threesix months ended MarchJune 31,30, 2026, compared to $57,121$297 thousand in the prior-year period. Cash provided by financing activities in the current period was primarily driven by $980,000$980 ofthousand proceeds from warrant exercises and $187,550$295 thousand from the issuance of notes payable, partially offset by $215,119$343 thousand of payments on notes payable, $2,406$2 thousand of payments on notes payable issued to related parties, and $27,550$45 of payments of debt issuance costs. In the prior-year period, financing activities consisted primarily of $204,500$355 thousand from the issuance of notes payable and $205 thousand of proceeds from a private placement offering, partially offset by $147,379$218 thousand of payments on notes payable.payable and $45 thousand payments of debt issuance costs.
Over the next 12 months we expect our burn rate to increase as we increase headcount, especially for meeting manufacturing demand. In addition, although we have significant inventory, we will need to order additional parts and services for production. Finally, we expect to spend another $350,000$275 thousand to complete payments related to our FDA study, although these payments do not impact our schedule for filing the PMA during the second quarter of 2026.study. Thus, we estimate that approximately $2.4 million will be needed to fund the business over the next 12 months. However, other than completing and filing the US FDA study results, additional expenditures for manufacturing production will be needed only if significant product is ordered and paid for in advance by customers, which is our current policy.
Since our inception, we have raised capital through the public and private sale of debt and equity, funding from collaborative arrangements, and grants. As of MarchJune 31,30, 2026, we had cash of approximately $368,886$12 thousand and a working capital deficit of $5.1$5.6 million. Our outstanding debt obligations include a combination of short- and long-term promissory notes, insurance premium financing, and several convertible notes with varying maturities, interest rates, and terms.
As of MarchJune 31,30, 2026, we have a promissory note issued to a former employee with an outstanding principal balance of approximately $41,000.$35 thousand. The note accrues interest at 6% per annum and matures on May 5, 2028. Monthly payments of approximately $2,000$2 thousand are required under the terms of the agreement.
Our convertible debt obligations as of MarchJune 31,30, 2026 include the following:
As of MarchJune 31,30, 2026, we also had multiple outstanding obligations to related parties, including current and former directors and executives:
GTHP insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 0 filings. Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
| Trade date | Insider | Transaction | Shares | Price | Value |
|---|---|---|---|---|---|
| 2026-03-26 | Blumberg Richard P. |
Other | 56,093 | — | — |
| 2026-03-26 | Blumberg Richard P. |
Other | 260 | — | — |
| 2026-03-26 | Blumberg Richard P. |
Other | 352,000 | — | — |
| 2026-03-26 | Blumberg Richard P. |
Other | 19,038 | — | — |
| 2026-03-26 | Blumberg Richard P. |
Other | 88 | — | — |
| 2026-03-26 | Blumberg Richard P. |
Other | 1,040,000 | — | — |
| 2026-02-25 | Blumberg Richard P. |
Option exercise | 1,000,000 | — | — |
Well-known investors holding GTHP (13F)
None of the 59 investors we track reported a position in their latest 13F.