GUIDED THERAPEUTICS INC
For the period ended Sep 30, 2025. Filed Nov 13, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 13, 2025
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What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-14.
0001477932-25-005887
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-13.
0001477932-25-008196
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 83 previous paragraphs and 86 current paragraphs.
44 unchanged; 26 reworded; 15 added; 10 removed; 3 previous and 1 current paragraphs rearranged.
Tables are not compared: 4 previous and 4 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (15)
Current report
As of October 31, 2025, SMI had not cured the defaults and had not achieved NMPA approval, resulting in SMI’s loss of rights to sell and market LuViva in China. Guided Therapeutics is currently in discussions with a new partner that works with SMI to assume the responsibilities formerly under the purview of SMI. In addition, during the nine months ended September 30, 2025, we entered into a supply agreement with Hangzhou Dongye Medical Technology Company, Ltd. (“HDMT”), the exclusive provider of gynecology products for 42 hospitals in China, for the purchase of 35 LuViva devices totaling $700,000. As of September 30, 2025, we have received $100,000 in payments and shipped three devices, resulting in the recognition of $60,000 in revenue for the quarter ended September 30, 2025.
Current report
Based on regulatory approval of LuViva in Russia granted on August 11, 2025, our distribution partner, Newmars Medical Technologies (“Newmars”), is shifting its emphasis from smaller East European countries to the larger Russian market,
Current report
Sales and Marketing Expenses: Sales and marketing expenses were $22,500 and $75,850 during the three months ended September 30, 2025 and 2024, respectively. The decrease of $53,350, or 70.3%, was primarily due to reductions of $39,929 in salaries and benefits, $9,474 in allocated rent expense, and $4,439 in travel expenses.
Current report
***General and Administrative Expense:***General and administrative expenses were $361,898 and $374,190 during the three months ended September 30, 2025 and 2024, respectively. The decrease of $12,292, or 3.3%, was primarily driven by a decrease of $23,917 for consulting and professional fees, a decrease of $10,658 for taxes and a decrease of $7,481 for stock option expense. These increases were offset by an increase of $21,211 in salaries & benefits, $7,207 of additional rent expense allocated to general use purposes and a $1,346 increase in other miscellaneous expenses.
Current report
Interest Expense: Interest expense was $129,304 and $107,500 during the three months ended September 30, 2025 and 2024, respectively. The increase of $21,804, or 20.3%, was primarily due to a higher level of outstanding debt.
Current report
Change in fair value of derivative liability: The change in the fair value of our derivative liabilities resulted in a loss of $37,033 and $585 during the three months ended September 30, 2025 and 2024, respectively. The increase in the derivative liability was primarily attributable to accrued interest, which increased the amount subject to conversion features accounted for as derivative liabilities.
Current report
***Preferred Stock Dividends:***Preferred stock dividend expense was $42,837 for the three months ended September 30, 2025, compared to $38,194 in the prior-year period, and was materially consistent between periods.
Current report
RESULTS OF OPERATIONS
Current report
COMPARISON OF THE NINE MONTHS ENDED SEPTEMBER 30, 2025 AND 2024
Current report
Research and Development Expenses: Research and development expenses were $342,359 and $386,417 during the nine months ended September 30, 2025 and 2024, respectively. The decrease of $44,058, or 11.4%, was primarily due to a $29,614 decrease in sponsored research costs, a $10,432 decrease in clinical travel expenses and a decrease of $5,394 in engineering staff salaries.
Current report
Interest Expense: Interest expense was $432,752 and $246,990 during the nine months ended September 30, 2025 and 2024, respectively. The increase of $185,762, or 75.2%, was due to an increase in debt in the current period versus the prior.
Current report
Subsequent to September 30, 2025, the Company received approximately $200,000 in proceeds from an ongoing private placement offering of units consisting of one share of common stock, one three-year warrant exercisable at $0.26 per share, and one four-year warrant exercisable at $0.52 per share, sold at a price of $0.19 per unit. The Company expects to complete the issuance of the related securities during the fourth quarter of 2025, and intends to use the proceeds for general working capital and corporate purposes.
Current report
Net cash used in operating activities was $776,689 for the nine months ended September 30, 2025, compared to $786,783 in the prior-year period, and remained relatively consistent year over year. The change reflects a higher net loss of $213,848 and unfavorable working capital changes of $216,859, offset by higher non-cash adjustments, including increases in stock-based compensation ($219,267), loss on extinguishment of debt ($138,148), and amortization of debt discounts and issuance costs ($117,108). These increases were partially offset by a $46,227 gain from the change in fair value of derivative liabilities compared to a $7,935 loss in the prior period.
Current report
For the nine months ended September 30, 2025, $1,797 of cash used for investing activities was for the purchase of computer equipment.
Current report
Net cash provided by financing activities was $477,832 in the nine months ended September 30, 2025, compared to $390,100 in the prior-year period. The increase of $87,732 was due to $235,900 of additional proceeds from the issuance of notes payable, offset by an increase in debt payments of $74,519, a decrease in proceeds from issuances of equity instruments of $40,499 and an increase in debt issuance costs of $33,150.
Removed paragraphs (10)
Previous report
GTI has contracted to supply LuViva with a separate Chinese medical device distributor, Hangzhou Dongye Medical Technology Company, Ltd. (“HDMT”). The purchase order from HDMT is for 35 LuViva devices and total payments of $700,000 to GTI. Payments of $100,000 have been received and the first three devices are expected to ship this quarter with subsequent devices being shipped over a seven-month period as payments are received.
Previous report
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. Despite this challenge, on August 11, 2025, we were informed by Newmars that full approval to market and sell LuViva in Russia had at last been granted.
Previous report
Sales and Marketing Expenses: Sales and marketing expenses were $50,564 and $69,231 during the three months ended June 30, 2025 and 2024, respectively. The decrease of $18,667, or 27.0%, was primarily due to $10,118 lower salaries and benefits expenses and $5,799 lower rent expense allocated to our sales & marketing department.
Previous report
Interest Expense: Interest expense was $156,549 and $75,372 during the three months ended June 30, 2025 and 2024, respectively. The increase of $81,177, or 107.7%, was primarily due to additional interest expense (including amortization of debt discounts and issuance costs) of $49,912 for the promissory notes issued to Flynn Case Living Trust and $31,131 for the promissory notes issued to Diagonal Lending during the three months ended June 30, 2025.
Previous report
COMPARISON OF THE SIX MONTHS ENDED JUNE 30, 2025 AND 2024
Previous report
Research and Development Expenses: Research and development expenses were $206,810 and $275,119 during the six months ended June 30, 2025 and 2024, respectively. The decrease of $68,309, or 24.8%, was due to a $53,854 decrease in clinical trial costs, a $7,657 decrease in patent management fees, a $7,638 decrease in travel expenses for clinical trials, and a $5,394 decrease in payroll during the six months ended June 30, 2025. These decreases were offset by an increase of $7,271 in consulting fees.
Previous report
Interest Expense: Interest expense was $303,448 and $139,490 during the six months ended June 30, 2025 and 2024, respectively. The increase of $163,958, or 117.5%, was primarily due to additional interest expense (including amortization of debt discounts and issuance costs) of $105,723 for the promissory notes issued to Flynn Case Living Trust, $47,010 for the promissory notes issued to Diagonal Lending during the six months ended June 30, 2025, and $11,225 for other debt instruments.
Previous report
***Preferred Stock Dividends:***Expense related to preferred stock dividends was $83,038 and $87,836 for the six months ended June 30, 2025 and 2024, respectively. The decrease of $4,798, or 5.5%, was due to a decline in the number of preferred shares issued and outstanding.
Previous report
For the six months ended June 30, 2025, we used $498,701 of net cash from operating activities, compared to $314,287 in the prior-year period. The increase in cash used was primarily due to a higher net loss and increased stock-based compensation, partially offset by higher non-cash adjustments such as amortization of debt discounts and favorable working capital changes. Significant non-cash adjustments included $329,552 in stock-based compensation, $135,066 in amortization of debt issuance costs and discounts, and a $31,927 loss on extinguishment of debt. Working capital changes were driven by a $326,882 increase in accounts payable and accrued liabilities and a $149,605 decrease in other current assets, partially offset by a $169,599 decrease in deferred revenue.
Previous report
Net cash provided by financing activities was $297,261 in the six months ended June 30, 2025, compared to no material net financing cashflows in the prior-year period. Financing inflows included $204,500 in proceeds from a private placement offering and $355,250 from new notes payable. These were partially offset by $218,239 in payments on notes payable and $45,250 in related debt issuance costs.
Reworded paragraphs (26)
Previous wording
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 June 30, 2025, we have an accumulated deficit of approximately $155.0 million. To date, we have engaged primarily in research and development efforts and the early stages of marketing our products. We do not have significant experience in manufacturing, marketing or selling our products. We may not be successful in growing sales for our products. Moreover, required regulatory clearances or approvals may not be obtained in a timely manner, or at all. Our products may not ever gain market acceptance and we may not ever generate significant revenues or achieve profitability. The development and commercialization of our products requires substantial development, regulatory, sales and marketing, manufacturing and other expenditures. We expect our operating losses to continue for the foreseeable future as we continue to expend substantial resources to complete commercialization of our products, obtain regulatory clearances or approvals, build our marketing, sales, manufacturing and finance capabilities, and conduct further research and development.
Current wording
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 September 30, 2025, we have an accumulated deficit of approximately $155.8 million. To date, we have engaged primarily in research and development efforts and the early stages of marketing our products. We do not have significant experience in manufacturing, marketing or selling our products. We may not be successful in growing sales for our products. Moreover, required regulatory clearances or approvals may not be obtained in a timely manner, or at all. Our products may not ever gain market acceptance and we may not ever generate significant revenues or achieve profitability. The development and commercialization of our products requires substantial development, regulatory, sales and marketing, manufacturing and other expenditures. We expect our operating losses to continue for the foreseeable future as we continue to expend substantial resources to complete commercialization of our products, obtain regulatory clearances or approvals, build our marketing, sales, manufacturing and finance capabilities, and conduct further research and development.
Previous wording
Based on written agreements and ongoing discussions with SMI, we currently hold and expect to generate additional purchase orders which we expect to result in actual sales of approximately $2.0 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. These orders are expected to result in approximately $200,000 in revenue for 2025. When combined with sales to our Chinese partner, these constitute what we view as the current demand for our products.
Current wording
Based on written agreements and ongoing discussions with SMI and its Chinese partners, we currently hold and expect to generate additional purchase orders which we expect to result in actual 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. These orders are expected to result in approximately $200,000 in revenue for 2025. When combined with sales to our Chinese partner, these constitute what we view as the current demand for our products.
Previous wording
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.
Current wording
We expect the study and data analysis to be completed in 2025. However, there can be no assurance that the study will progress and be completed within the expected timeframe, or ever.
Previous wording
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 has informed us that a mandatory inspection of their manufacturing site has been scheduled for October of 2025, which is consistent with NMPA approval later this year, although there can be no assurance that NMPA approval will occur within the projected time frame, or ever.
Current wording
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 has informed us that a mandatory inspection of their manufacturing site has delayed until of 2026, which is consistent with NMPA approval in the first half of 2026, although there can be no assurance that NMPA approval will occur within the projected time frame, or ever.
Previous wording
As of August 1, 2025, SMI is in contractual default due to late payments totaling $200,000 and failure to provide certain data to the Company as set forth in its agreements with the Company. If the defaults are not cured to the satisfaction of the Company, we have the right to seek additional partners and agreements such as we have with HDMT.
Current wording
As of August 1, 2025, SMI was in contractual default due to late payments totaling $200,000 and failure to provide certain data to the Company as set forth in its agreements with the Company.
Previous wording
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 would potentially involve up to 20 million tests annually in Turkey paid for by the Turkish national healthcare system. The clinical study is expected to involve about 800 patients, take less than six months to complete and will be funded by the MOH.
Current wording
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 would potentially involve up to 20 million tests annually in Turkey paid for by the Turkish national healthcare system. 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 October 31, 2025, MOH had approved the study and budget, including paying for LuViva devices and single use Cervical Guides. Funds are expected to be released in 2025 and the study concluded in the first half of 2026.
Previous wording
In Indonesia, our contracted distributors are in discussions with the local government hospital system of Sulawesi, one of the nation’s most populous islands. During the fourth quarter of 2024, we received an order and full payment for four devices from Indonesia. We expect to ship these devices in the third quarter of this year.
Current wording
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 have delayed shipment pending final payment for shipping and additional services requested by the customer. We expect to ship these devices in the fourth quarter of this year.
Previous wording
Sales Revenue and Cost of Goods Sold: Revenues from the sale of LuViva devices and disposables for the three months ended June 30, 2025 were $117,462, compared to nil for the three months ended June 30, 2024. The majority of our revenue in the current period was derived from the shipment of 3 instrumentation packages and 49,031 RFID chips. Cost of goods sold was $38,212 during the three months ended June 30, 2025, compared to nil during the three months ended June 30, 2024. As of June 30, 2025, we have a deferred revenue balance of $679,318, which will be recognized as revenue when our products are shipped, which is expected to occur in 2025 upon receiving NMPA approval.
Current wording
Sales Revenue and Cost of Goods Sold: Revenue from the sale of LuViva devices and disposables was $60,000 for the three months ended September 30, 2025, compared to none in the prior-year period. The current period revenue was derived from the shipment of three instrumentation packages to Hangzhou Dongye Medical Technology Company, Ltd. (“HDMT”). Cost of goods sold totaled $25,288, of which $22,693 related to the devices shipped to HDMT, with the remainder attributable to inventory adjustments. As of September 30, 2025, we have a deferred revenue balance of $689,318 which will be recognized as revenue upon shipment of devices pending NMPA approval.
Previous wording
Research and Development Expenses:** **Research and development expenses were $132,688 and $221,565 during the three months ended June 30, 2025 and 2024, respectively. The decrease of $88,887, or 40.1%, was primarily due to $81,994 lower costs for sponsored research and $7,509 lower travel costs related to our clinical trials during the three months ended June 30, 2025.
Current wording
Research and Development Expenses: Research and development expenses were $135,549 and $111,298 during the three months ended September 30, 2025 and 2024, respectively. The increase of $24,251, or 21.8%, was primarily due to $24,240 in additional sponsored research costs related to clinical trials.
Previous wording
Gain from Forgiveness of Debt:* *The gain from forgiveness of debt of $15,381 and $16,401 during the three months ended June 30, 2025 and 2024, respectively, was materially consistent period over period and was due to forgiveness of debt from our creditors.
Current wording
Gain from Forgiveness of Debt:* *The gain from forgiveness of debt of $15,118 and $16,145 during the three months ended September 30, 2025 and 2024, respectively, was materially consistent period over period and was due to forgiveness of debt from our creditors.
Previous wording
***Loss from Extinguishment of Debt:***During the six months ended June 30, 2025, we recognized a loss on extinguishment of debt of $31,928 related to exchanges of debt for common stock and warrants.
Current wording
Loss from Extinguishment of Debt*:*During the three months ended September 30, 2025, we recognized a loss on extinguishment of debt of $106,200 related to exchanges of debt for common stock and warrants.
Previous wording
Net Loss: Net loss attributable to common stockholders was $856,477 and $758,180 during the three months ended June 30, 2025 and 2024, respectively. The reasons for the increase in our net loss are outlined above.
Current wording
Net Loss Attributable to Common Stockholders: Net loss attributable to common stockholders was $785,445 and $692,417 during the three months ended September 30, 2025 and 2024, respectively. The change reflects the factors discussed above.
Previous wording
Sales Revenue and Cost of Goods Sold: Revenues from the sale of LuViva devices and disposables for the six months ended June 30, 2025 were $117,462, compared to $5,720 for the six months ended June 30, 2024. The majority of our revenue in the current period was derived from the shipment of 3 instrumentation packages and 49,031 RFID chips. Cost of goods sold was $38,212 during the six months ended June 30, 2025, compared to $1,875 during the six months ended June 30, 2024. As of June 30, 2025, we have a deferred revenue balance of $679,318, which will be recognized as revenue when our products are shipped, which is expected to occur in 2025 upon receiving NMPA approval.
Current wording
Sales Revenue and Cost of Goods Sold: Revenues from the sale of LuViva devices and disposables for the nine months ended September 30, 2025 were $177,462, compared to $5,720 for the nine months ended September 30, 2024. Revenue in the current period was attributed to the shipment of six instrumentation packages and 49,031 RFID chips to our customers in China. Cost of goods sold was $63,500 during the nine months ended September 30, 2025, of which $60,911 related to the devices and RFID chips shipped to China, with the remainder attributable to inventory adjustments. As of September 30, 2025, we have a deferred revenue balance of $689,318 which will be recognized as revenue upon shipment of devices pending NMPA approval.
Previous wording
Sales and Marketing Expenses: Sales and marketing expenses were $123,511 and $141,803 during the six months ended June 30, 2025 and 2024, respectively. The decrease of $18,292, or 12.9%, was primarily due to a decrease of $9,574 in salaries & benefits, a $5,838 decrease in rent expense allocated to our sales & marketing department and a decrease of $2,663 in travel expenses.
Current wording
Sales and Marketing Expenses: Sales and marketing expenses were $146,011 and $217,653 during the nine months ended September 30, 2025 and 2024, respectively. The decrease of $71,642, or 32.9% was primarily due to reductions of $49,503 in salaries & benefits, $15,312 in rent expense (due to a decline in allocated rent expense and a decline in ancillary charges from the landlord), and $7,577 in travel expenses.
Previous wording
General and Administrative Expense:* *General and administrative expenses were $658,112 and $363,989 during the three months ended June 30, 2025 and 2024, respectively. The increase of $294,123, or 80.8%, was primarily driven by an increase of $279,343 in payroll and benefits (including payroll taxes), which was primarily due to a one-time charge of $270,389 for warrants included in a board-approved compensation package for Dr. Faupel during the current period. Additionally, the Company recognized $25,030 of additional stock-based compensation expense during the current period. These increases were offset by a decrease of $10,000 in attorney fees.
Current wording
***General and Administrative Expense:***General and administrative expenses were $1,286,930 and $974,406 during the nine months ended September 30, 2025 and 2024, respectively. The increase of $312,524, or 32.1%, was primarily driven by an increase of $300,672 in payroll & benefits (including payroll taxes), which was primarily due to a one-time charge of $270,389 for warrants included in a board-approved compensation package for Dr. Faupel during the current period. Additionally, the Company recognized $20,009 of additional expense for stock options in the current period versus the prior and $4,464 of additional credit loss expense. These increases were offset by a decrease of $15,658 in taxes.
Previous wording
Change in fair value of derivative liability:** **The change in the fair value of our derivative liability resulted in a gain of $30,370 during the three months ended June 30, 2025 versus a loss of $7,350 during the three months ended June 30, 2024. The change in the fair value was attributed to changes in our forecasted stock price and the expiration of a conversion option.
Current wording
Change in Fair Value of Derivative Liability: The change in the fair value of our derivative liabilities resulted in a gain of $46,227 during the nine months ended September 30, 2025 versus a loss of $7,935 during the nine months ended September 30, 2024. The change in the fair value was attributed to changes in our forecasted stock price. In addition, a greater number of derivative liabilities were recorded in the current year due to additional bifurcated conversion features associated with new debt issuances.
Previous wording
Gain from Forgiveness of Debt:* *The gain from forgiveness of debt of $31,016 and $33,060 during the six months ended June 30, 2025 and 2024, respectively, was materially consistent period over period and was due to forgiveness of debt from our creditors.
Current wording
***Gain from Extinguishment of Debt:***The gain from forgiveness of debt of $46,136 and $49,205 during the nine months ended September 30, 2025 and 2024, respectively, was materially consistent period over period and was due to forgiveness of debt from our creditors.
Previous wording
Other Income: Other income was $161,021 and $12,372 during the six months ended June 30, 2025 and 2024, respectively. During the six months ended June 30, 2025, we reached an agreement with SMI to apply their payment of $180,000 towards reimbursement of certain expenses incurred during the years ended December 31, 2024 and 2023. As a result of this agreement, we recognized $180,000 of deferred revenue in other income during the current period. Additionally, we recorded other income of $52,400 in the current 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 a $84,000 loss recorded for the write-off of a long-term asset in the current period.
Current wording
***Other Income:***Other income was $161,087 and $12,372 during the nine months ended September 30, 2025 and 2024, respectively. During the nine months ended September 30, 2025, we reached an agreement with SMI to apply their payment of $180,000 towards reimbursement of certain expenses incurred during the years ended December 31, 2024 and 2023. As a result of this agreement, we recognized $180,000 of deferred revenue in other income during the current period. Additionally, we recorded other income of $52,400 in the current 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 a $84,000 loss recorded for the write-off of a long-term asset in the current period. Other income in the prior year period primarily reflected an adjustment to a previously recorded liability.
Previous wording
Preferred Stock Dividends:* *Expense related to preferred stock dividends of $45,479 and $48,929 for the three months ended June 30, 2025 and 2024, respectively, was materially consistent over the two periods.
Current wording
***Preferred Stock Dividends:***Expense related to preferred stock dividends of $125,875 and $126,030 for the nine months ended September 30, 2025 and 2024, respectively, was materially consistent over the two periods.
Previous wording
***Net Loss:***Net loss attributable to common stockholders was $1,319,217 and $1,199,452 during the six months ended June 30, 2025 and 2024, respectively. The reasons for the decrease in our net loss are outlined above.
Current wording
Net Loss Attributable to Common Stockholders: Net loss attributable to common stockholders was $2,103,663 and $1,890,970 during the nine months ended September 30, 2025 and 2024, respectively. The change reflects the factors discussed above.
Previous wording
There was no income tax benefit recorded for the three months ended June 30, 2025 or 2024, due to recurring net operating losses.
Current wording
There was no income tax benefit recorded for the nine months ended September 30, 2025 or 2024, due to recurring net operating losses.
Previous wording
We have incurred significant losses since our inception. At June 30, 2025, the Company had negative working capital of approximately $5.6 million, accumulated deficit of $155.0 million, and incurred a net loss including preferred dividends of $1.3 million for the six months then ended. Stockholders’ deficit totaled approximately $5.5 million at June 30, 2025, primarily due to recurring net losses from operations.
Current wording
We have incurred significant losses since our inception. At September 30, 2025, the Company had negative working capital of approximately $5.7 million, accumulated deficit of $155.8 million, and incurred a net loss including preferred dividends of $2.1 million for the nine months then ended. Stockholders’ deficit totaled approximately $5.7 million at September 30, 2025, primarily due to recurring net losses from operations.
Previous wording
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 $425 thousand to complete and file our US FDA study. Thus, we estimate that approximately $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.
Current wording
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 $425 thousand to complete and file our FDA study. Thus, we estimate that approximately $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.
Previous wording
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 June 30, 2025, we had cash of approximately $185 thousand and negative working capital of $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.
Current wording
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 September 30, 2025, we had cash of approximately $87 thousand and negative working capital of $5.7 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.
Previous wording
As of June 30, 2025, we have a long-term note issued to a former employee with a remaining principal balance of $59,162, of which $24,000 is classified as short-term. This note accrues interest at 6% per annum and matures on May 5, 2028. Scheduled monthly payments of $2,000 are being made in accordance with the agreement.
Current wording
As of September 30, 2025, we have a long-term note issued to a former employee with a remaining principal balance of $53,162, of which $24,000 is classified as short-term. This note accrues interest at 6% per annum and matures on May 5, 2028. Scheduled monthly payments of $2,000 are being made in accordance with the agreement.
Previous wording
As a result, our total cash decreased by $185,330 during the six months ended June 30, 2025, compared to a $315,885 decrease during the same period in 2024.
Current wording
As a result, our total cash decreased by $300,654 during the nine months ended September 30, 2025, compared to a $396,683 decrease during the same period in 2024.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
Loss from Extinguishment of Debt:* *During the nine months ended September 30, 2025, we recognized a loss on extinguishment of debt of $138,148 related to exchanges of debt for common stock and warrants.
Rearranged previous paragraphs (3)
Previous report — wording carried elsewhere
Other Income*:*Other income was $63,931 and $11,515 during the three months ended June 30, 2025 and 2024, respectively. The increase was primarily due to $52,400 of funds received from the Internal Revenue Service related to refundable payroll tax credits under the Employee Retention Credit program.
Previous report — wording carried elsewhere
General and Administrative Expense: General and administrative expenses were $925,032 and $600,216 during the six months ended June 30, 2025 and 2024, respectively. The increase of $324,816, or 54.1%, was primarily driven by an increase of $279,461 in payroll and benefits (including payroll taxes), which was primarily due to a one-time charge of $270,389 for warrants included in a board-approved compensation package for Dr. Faupel during the current period. Additionally, the Company recognized $29,490 of additional expense for stock options in the current period versus the prior and $19,510 of additional expense for consultants, attorneys and other third-party service providers. These increases were offset by an overall decline of $3,645 in other general and administrative expenses.
Previous report — wording carried elsewhere
Change in Fair Value of Derivative Liability: The change in the fair value of our derivative liability resulted in a gain of $83,260 during the six months ended June 30, 2025 versus a loss of $7,350 during the six months ended June 30, 2024. The change in the fair value was attributed to changes in our forecasted stock price and the expiration of a conversion option.