bioAffinity Technologies, Inc.
For the period ended Sep 30, 2025. Filed Nov 14, 2025.
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Sep 30, 2025 · Filed Nov 14, 2025
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Notes to Unaudited Condensed Consolidated Financial Statements
Notes to Condensed Consolidated Financial Statements
(unaudited)
Note 1. NATURE OF OPERATIONS, ORGANIZATION, AND BASIS OF PRESENTATION
Description of Business
bioAffinity Technologies, Inc., a Delaware corporation (the “Company,” or “bioAffinity Technologies”), addresses the need for noninvasive diagnosis of lung cancer at early stage and other diseases of the lung. bioAffinity Technologies’ proprietary platform uses flow cytometry and automated data analysis built by machine learning, a form of artificial intelligence (“AI”), to preferentially target cancer cell populations and other cell populations indicative of a diseased state. The Company’s first diagnostic test, CyPath® Lung, is a noninvasive test for early detection of lung cancer, the leading cause of cancer-related deaths. CyPath® Lung is offered for sale to physicians by the Company’s subsidiary, Precision Pathology Laboratory Services, LLC (“PPLS”). The Company is developing its flow cytometry platform to address the need to identify patients who can benefit from new and emerging therapies for asthma and chronic obstructive pulmonary disease (COPD) with noninvasive precision diagnostic tests. Research also is advancing the Company’s therapeutic discoveries that could in the future result in broad-spectrum cancer treatments, beginning with treatment delivered topically for squamous cell skin cancer. Commercial operations and product development are conducted in laboratories at PPLS and laboratory space leased at The University of Texas at San Antonio.
Organization
The Company was formed on March 26, 2014, as a Delaware corporation with its corporate offices located in San Antonio, Texas. On June 15, 2016, the Company formed a wholly owned subsidiary, OncoSelect® Therapeutics, LLC, as a Delaware limited liability company. On August 14, 2023, the Company formed a wholly owned subsidiary, PPLS, as a Texas limited liability company, to acquire the assets of Village Oaks Pathology Services, P.A. (“Village Oaks”), a Texas professional association d/b/a Precision Pathology Services, including the clinical pathology laboratory it owned.
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”) and pursuant to the rules and regulations of the SEC for interim financial reporting. The condensed consolidated financial statements are unaudited and in management’s opinion include all adjustments, including normal recurring adjustments and accruals, necessary for a fair presentation of the results for the interim periods presented. The condensed consolidated balance sheet as of December 31, 2024, was derived from the audited consolidated financial statements at that date but does not include all the information and footnotes required by GAAP. Operating results for the periods presented are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2025, or any future period. These unaudited condensed consolidated financial statements should be read in conjunction with the audited annual consolidated financial statements and notes included in the Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 31, 2025 (the “2024 Form 10-K”).
Certain prior period balances have been reclassified to conform to current period presentation. Any reclassifications had an immaterial effect on the Company’s consolidated financial statements and had no effect on prior periods net income or stockholders’ equity.
All share and per-share amounts in the accompanying footnotes have been retroactively adjusted to reflect the Company’s 1-for-30 reverse stock split.
Liquidity and Capital Resources
In accordance with Accounting Standards Update (“ASU”) 2014-15,Presentation of Financial Statements – Going Concern(Subtopic 205-40), the Company has evaluated whether there are conditions and events that raise substantial doubt about the Company’s ability to continue as a going concern for at least one year after the date the condensed consolidated financial statements are issued.
The Company has incurred significant losses and negative cash flows from operations since inception and expects to continue to incur losses and negative cash flows for the foreseeable future. As a result, the Company had an accumulated deficit of approximately $65.4 million at September 30, 2025. The Company’s cash and cash equivalents at September 30, 2025, were approximately $7.7 million. Based on the Company’s current expected level of operating expenditures and the cash and cash equivalents on hand at September 30, 2025, management concludes that there is substantial doubt about the Company’s ability to continue as a going concern for a period of at least twelve (12) months subsequent to the issuance of the accompanying unaudited condensed consolidated financial statements. During the third quarter of 2025, the Company completed various transactions to raise an additional $13.4 million in gross proceeds. Without funding from the proceeds of a capital raise or strategic relationship or grant, management anticipates that the Company’s current cash resources are sufficient to continue operations through May 2026. The Company will need to raise further capital through the sale of additional equity or debt securities or other debt instruments, strategic relationships or grants, or other arrangements to support its future operations, if revenue from operations does not significantly increase. If such funding is not available or not available on terms acceptable to the Company, the Company’s current development plan may be curtailed. Furthermore, an alternative source of funding to the sale of additional equity or debt securities is the exercise of outstanding warrants for which there can be no guarantee. No adjustments have been made to the presented condensed consolidated financial statements as a result of this uncertainty.
Note 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Use of Estimates
The preparation of financial statements in conformity with GAAP in the U.S. requires management to make significant judgments and estimates that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Management bases these significant judgments and estimates on historical experience and other assumptions it believes to be reasonable based upon information presently available. Actual results could differ from those estimates under different assumptions, judgments, or conditions.
Principles of Consolidation
The Company’s consolidated financial statements reflect its financial statements, those of its wholly owned subsidiaries, and certain variable interest entities where the Company is the primary beneficiary. The accompanying consolidated financial statements include all the accounts of the Company, its wholly owned subsidiaries, OncoSelect® Therapeutics, LLC and PPLS, and the variable interest entity, Village Oaks. All significant intercompany balances and transactions have been eliminated.
In determining whether the Company is the primary beneficiary of a variable interest entity, it applies a qualitative approach that determines whether it has both (1) the power to direct the economically significant activities of the entity and (2) the obligation to absorb losses of, or the right to receive benefits from, the entity that could potentially be significant to that entity. The Company continuously assesses whether it is the primary beneficiary of a variable interest entity as changes to existing relationships or future transactions may result in the Company consolidating or deconsolidating one or more of its collaborators or partners.
Cash and Cash Equivalents
For the purpose of the statement of cash flows, the Company considers all highly liquid investments with original maturities of three months or less at the time of purchase to be cash equivalents. Cash equivalents are stated at cost, which approximates market value, because of the short maturity of these instruments.
Concentration of Risk
The Company has significant cash balances at financial institutions which throughout the year regularly exceed the federally insured limit of $250,000. Any loss incurred or a lack of access to such funds could have a significant adverse impact on the Company’s financial condition, results of operations, and cash flow.
Advertising Expense
The Company expenses all advertising costs as incurred. Advertising expense was $273,087 and $232,396 for the nine months ended September 30, 2025 and 2024, respectively, and $101,265 and $101,271 for the three months ended September 30, 2025 and 2024, respectively.
Loss Per Share
Basic loss per share is computed by dividing net loss attributable to common stockholders by the weighted-average number of shares of the Company’s Common Stock outstanding during the period. Diluted loss per share is computed by dividing net loss attributable to common stockholders by the sum of the weighted-average number of shares of Common Stock outstanding during the period and the weighted-average number of dilutive Common Stock equivalents outstanding during the period, using the treasury stock method. Dilutive Common Stock equivalents are comprised of in-the-money stock options, convertible notes payable, unvested restricted stock, and warrants based on the average stock price for each period using the treasury stock method.
The following potentially dilutive securities have been excluded from the computations of weighted-average shares of Common Stock outstanding as of September 30, 2025 and 2024, as they would be anti-dilutive:
| As of September 30, | ||
|---|---|---|
| 2025 | 2024 | |
| Shares underlying options outstanding | 9,055 | 11,243 |
| Shares underlying convertible preferred stock | 101,448 | — |
| Shares underlying warrants outstanding | 1,348,292 | 283,575 |
| Shares underlying unvested restricted stock | 6,805 | 13,843 |
| Anti-dilutive securities | 1,465,600 | 308,661 |
Revenue Recognition
To determine revenue recognition for the arrangements that the Company determines are within the scope of ASC 606,Revenue from Contracts with Customers, the Company performs the following five steps: (1) identify the contract(s) with a customer, (2) identify the performance obligations in the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance obligations in the contract, and (5) recognize revenue when (or as) the entity satisfies a performance obligation.
Post-acquisition of PPLS, additional revenue streams have been consolidated starting September 19, 2023. PPLS generates three sources of revenue: (1) patient service fees, (2) histology service fees, and (3) medical director fees. The Company recognizes as revenue the amount that reflects the consideration to which it expects to be entitled in exchange for goods sold or services rendered primarily upon completion of the testing process (when results are reported) or when services have been rendered.
The Company follows a standard process, which considers historical denial and collection experience and other factors (including the period of time that the receivables have been outstanding), to estimate contractual allowances and implicit price concessions, recording adjustments in the current period as changes in estimates. The process for estimating revenues and the ultimate collection of accounts receivable involves significant judgment and estimation.
| Nine Months Ended September 30, | Three Months Ended September 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| Patient service fees1 | $3,685,397 | $6,259,806 | $1,172,948 | $2,049,851 |
| Histology service fees | 827,944 | 811,914 | 255,586 | 281,861 |
| Medical director fees | 51,171 | 50,136 | 17,274 | 16,943 |
| Department of Defense observational studies | — | 8,654 | — | 1,731 |
| Other revenues | 4,634 | 23,919 | 258 | — |
| Total net revenue | $4,569,146 | $7,154,429 | $1,446,066 | $2,350,386 |
| 1 | Patient services fees include direct billing for CyPath® Lung diagnostic test of approximately $619,000 and $332,000 for the nine months ended September 30, 2025 and 2024, respectively, and $296,000 and $133,000 for the three months ended September 30, 2025 and 2024, respectively. |
Property and Equipment
In accordance with ASC 360-10,Accounting for the Impairment of Long-Lived Assets, the Company periodically reviews the carrying value of its long-lived assets, such as property, equipment, and definite-lived intangible assets, to test whether current events or circumstances indicate that such carrying value may not be recoverable. When evaluating assets for potential impairment, the Company compares the carrying value of the asset to its estimated undiscounted future cash flows. If an asset’s carrying value exceeds such estimated cash flows (undiscounted and with interest charges), the Company records an impairment charge for the difference. The Company did not record any impairment for the three and nine months ended September 30, 2025, or for the fiscal year ended December 31, 2024.
Property and equipment are carried at cost, net of accumulated depreciation. Depreciation is computed using the straight-line method over the estimated useful life of the asset. Amortization of leasehold improvements is computed using the shorter of the lease term or estimated useful life of the asset. Additions and improvements are capitalized, while repairs and maintenance are expensed as incurred. Useful lives of each asset class are as follows:
| Asset Category | Useful Life |
|---|---|
| Computer equipment | 3-5 years |
| Computer software | 3 years |
| Equipment | 3-5 years |
| Furniture and fixtures | 5-7 years |
| Vehicles | 5 years |
| Leasehold improvements | Lesser of lease term or useful life |
Intangible Assets
The Company’s acquisition of PPLS on September 18, 2023, identified goodwill and intangible assets. Goodwill represents the purchase price in excess of fair values assigned to the underlying identifiable net assets of the acquired business. The Company tests goodwill for impairment annually and, therefore, does not record amortization. The intangible assets and their respective useful lives are as follows: trade names and trademarks (18 years) and customer relationships (14 years). Intangible assets, net of accumulated amortization, are summarized as follows as of September 30, 2025, and December 31, 2024:
| September 30, | December 31, | |
|---|---|---|
| 2025 | 2024 | |
| Cost | ||
| Goodwill | $1,404,486 | $1,404,486 |
| Trade names and trademarks | 150,000 | 150,000 |
| Customer relationships | 700,000 | 700,000 |
| Cost | 2,254,486 | 2,254,486 |
| Accumulated amortization | ||
| Trade names and trademarks | (16,944) | (10,694) |
| Customer relationships | (101,667) | (64,167) |
| Accumulated amortization | (118,611) | (74,861) |
| Intangible assets, net | $2,135,875 | $2,179,625 |
The Company incurred amortization of intangible assets of $43,750 for each of the nine months ended September 30, 2025 and 2024, and $14,583 for each of the three months ended September 30, 2025 and 2024.
Recent Accounting Pronouncements
In November 2024, the FASB issued ASU 2024-03,Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses (“ASU 2024-03”), which requires disclosure about the types of costs and expenses included in certain expense captions presented on the income statement. The new disclosure requirements are effective for the Company’s annual periods beginning after December 15, 2026, and interim periods beginning after December 15, 2027, with early adoption permitted. The Company is currently evaluating the impact of this pronouncement on its related disclosures.
Segment Information
The Company is organized intotwo operating segments, Diagnostic Research and Development (“R&D”) and Laboratory Services, whereby its chief operating decision maker (“CODM”) assesses the performance of and allocates resources. The CODM is the Chief Executive Officer. Diagnostic R&D includes research and development and clinical development on diagnostic tests and therapeutic discoveries. Any revenues assigned to Diagnostic R&D are proceeds received from observational studies. Laboratory services include all the operations from Village Oaks and PPLS in addition to sales and marketing costs of CyPath® Lung from bioAffinity Technologies.
| Three months ended September 30, | Nine months ended September 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| Net revenue: | ||||
| Diagnostic R&D | $— | $1,731 | $— | $8,654 |
| Laboratory services | 1,446,066 | 2,348,655 | 4,569,146 | 7,145,775 |
| Total net revenue | 1,446,066 | 2,350,386 | 4,569,146 | 7,154,429 |
| Operating expenses: | ||||
| Diagnostic R&D | (473,900) | (368,202) | (1,420,290) | (1,264,696) |
| Laboratory services | (1,509,795) | (2,150,825) | (5,423,922) | (7,423,109) |
| General corporate activities | (1,755,217) | (1,805,223) | (5,160,479) | (4,473,516) |
| Total operating expenses | (3,738,912) | (4,324,250) | (12,004,691) | (13,161,321) |
| Total operating loss | (2,292,846) | (1,973,864) | (7,435,545) | (6,006,892) |
| Non-operating (expense), net | (2,755,056) | (24,417) | (4,295,882) | (54,392) |
| Net loss before income tax expense | (5,047,902) | (1,998,281) | (11,731,427) | (6,061,284) |
| Income tax expense | (3,182) | (2,559) | (40,861) | (11,650) |
| Net loss | $(5,051,084) | $(2,000,840) | $(11,772,288) | $(6,072,934) |
Research and Development
Research and development costs are charged to expense as incurred. The Company’s research and development expenses consist primarily of expenditures for laboratory operations, preclinical studies, compensation, and consulting costs.
Accrued Research and Development Costs
The Company records accrued liabilities for estimated costs of research and development activities conducted by service providers, which include preclinical studies. The Company records the estimated costs of research and development activities based upon the estimated amount of services provided but not yet invoiced and includes these costs in accrued expenses in the accompanying condensed consolidated balance sheets and within research and development expense in the accompanying condensed consolidated statements of operations.
The Company accrues for these costs based on factors such as estimates of the work completed and in accordance with agreements established with service providers. The Company makes significant judgments and estimates in determining the accrued expenses balance in each reporting period. As actual costs become known, the Company adjusts its accrued liabilities. The Company has not experienced any material differences between accrued costs and actual costs incurred since its inception.
Regulatory Matters
Regulations imposed by federal, state, and local authorities in the U.S. are a significant factor in providing medical care. In the U.S., drugs, biological products, and medical devices are regulated by the Federal Food, Drug, and Cosmetic Act (“FDCA”), which is administered by the Food and Drug Administration (“FDA”) and the Centers for Medicare & Medicaid Services (“CMS”). The Company has not yet obtained marketing authorization from the FDA but is able to market its CyPath® Lung test as a laboratory developed test (“LDT”) sold by our wholly owned subsidiary PPLS, a clinical pathology laboratory accredited by the College of American Pathologists (“CAP”) and certified under the Clinical Laboratory Improvement Amendments (“CLIA”).
Note 3. ACCOUNTS AND OTHER RECEIVABLES, NET
The following is a summary of accounts receivables and other receivables:
| September 30, 2025 | December 31, 2024 | |
|---|---|---|
| Patient service fees | $235,403 | $915,488 |
| Histology service fees | 167,000 | 190,648 |
| Medical director fees | 19,444 | 5,194 |
| Other receivables | 27,143 | 27,874 |
| Total accounts and other receivables, net | $448,990 | $1,139,204 |
Note 4. PREPAID EXPENSES AND OTHER CURRENT ASSETS
Prepaid expenses and other current assets are summarized below:
| September 30, 2025 | December 31, 2024 | |
|---|---|---|
| Prepaid insurance | $224,211 | $248,364 |
| Legal and professional | 45,670 | 27,448 |
| Other | 190,306 | 147,183 |
| Total prepaid expenses and other current assets | $460,187 | $422,995 |
Note 5. PROPERTY AND EQUIPMENT, NET
Property and equipment are summarized below:
| September 30, 2025 | December 31, 2024 | |
|---|---|---|
| Lab equipment | $679,995 | $662,747 |
| Computers and software | 81,433 | 81,433 |
| Leasehold improvements | 32,781 | 19,353 |
| Vehicles | 175,630 | 148,103 |
| Property and equipment, gross | 969,839 | 911,636 |
| Accumulated depreciation | (666,717) | (536,251) |
| Total property and equipment, net | $303,122 | $375,385 |
Depreciation expense was $132,830 and $119,526 for the nine months ended September 30, 2025 and 2024, respectively, and $44,599 and $40,472 for the three months ended September 30, 2025 and 2024, respectively.
Note 6. ACCRUED EXPENSES
Accrued expenses are summarized below:
| September 30, 2025 | December 31, 2024 | |
|---|---|---|
| Compensation | $717,762 | $1,079,839 |
| Legal and professional | 141,714 | 98,477 |
| Clinical | 96,413 | 160,371 |
| Other | 28,658 | 60,035 |
| Total accrued expenses | $984,547 | $1,398,722 |
Note 7. UNEARNED REVENUE
The Company engaged in an observational study of CyPath® Lung with the U.S. Department of Defense (“DOD”). A total of 70 CyPath® Lung units were ordered and shipped. However, in compliance with FASB ASC 606, the performance obligation was complete for only 40 units as of September 30, 2025. The performance obligation is deemed complete after samples have been collected, processed, and analyzed and results communicated to patients. The unearned revenue balance amounted to $24,404 as of September 30, 2025, and December 31, 2024.
During third quarter 2025, the Company engaged with Veteran Administration (“VA”) medical centers to purchase CyPath®Lung tests. A total of 20 tests were ordered and shipped. However, in compliance with FASB ASC 606, the performance obligation was complete for only 4 tests as of September 30, 2025. The performance obligation is deemed complete after samples have been collected, processed, and analyzed and results communicated to patients. The unearned revenue balance amounted to $13,511 as of September 30, 2025.
Note 8. FAIR VALUE MEASUREMENTS
The Company analyzes all financial instruments with features of both liabilities and equity under the FASB accounting standard for such instruments. Under this standard, financial assets and liabilities are classified in their entirety based on the lowest level of input that is significant to the fair value measurement.
The three levels of the hierarchy and the related inputs are as follows:
| Level | Inputs |
| 1 | Unadjusted quoted prices in active markets for identical assets and liabilities; |
| Unadjusted quoted prices in active markets for similar assets and liabilities. | |
| 2 | Unadjusted quoted prices for identical or similar assets or liabilities in markets that are not active; or |
| inputs other than quoted prices that are observable for the asset or liability. | |
| 3 | Unobservable inputs for the asset or liability. |
The estimated fair value of certain financial instruments, including cash and cash equivalents, accounts and other receivables, prepaid and other current assets, accounts payable, accrued expenses, and note payable, are carried at historical cost basis, which approximates their fair values because of the short-term nature of these instruments.
Warrants
The Company issued liability classified warrants in connection with the issuance of the May 2025 warrants. The warrants were liability classified as a result of certain terms in the May 2025 warrant agreement, and the terms were amended during September 2025 to trigger an equity classification on the date of the reverse stock split. The Company uses a Black-Scholes model to estimate the fair value of the warrants. Changes in the fair value of the warrants are recognized in “Change in fair value of warrants issued” for each reporting period in the condensed consolidated statements of operations.
The Company notes there were no liabilities as of September 30, 2025 and December 31, 2024. The Company remeasured the warrant liability three times prior to converting the liability classification to equity classification. The Company initially recorded a warrant liability of $2.9 million as a result of the May 2025 public offering. The Company revalued and recognized an aggregate of $3.8 million in change in fair value of warrants issued before adjusting the warrant liability to equity classified warrants.
Note 9. LEASES
The Company has one operating lease for its real estate and office space for the CAP/CLIA laboratory, as well as multiple finance leases for lab equipment in Texas that were acquired through the September 18, 2023, acquisition. On April 1, 2025, the Company terminated one of the finance leases related to lab equipment due to the Company’s targeted strategic actions announced in March 2025. Additionally, the Company entered into another operating lease on September 1, 2024, with regard to office space. The Company has operating leases consisting of office space with remaining lease terms ranging from 1.8 to 4.9 years as of September 30, 2025. The Company has finance leases consisting of lab equipment with remaining lease terms ranging from approximately 0.6 to 1.3 years as of September 30, 2024, for which the Company has determined that it will use the equipment for a major part of its remaining economic life.
The lease agreements generally do not provide an implicit borrowing rate. Therefore, the Company used a benchmark approach as of the date of inception of the leases to derive an appropriate incremental borrowing rate to discount remaining lease payments. The Company benchmarked itself against other companies of similar credit ratings and comparable quality and derived imputed interest rates ranging from 6.41% to 8.07% for the lease term lengths.
Leases with an initial term of 12 months or less are not recorded on the balance sheet. There are no material residual guarantees associated with any of the Company’s leases, and there are no significant restrictions or covenants included in the Company’s lease agreements. Certain leases include variable payments related to common area maintenance and property taxes, which are billed by the landlord, as is customary with these types of charges for office space. The Company has not entered into any lease arrangements with related parties, and the Company is not the sublessor in any arrangement.
The Company’s existing leases contain escalation clauses and renewal options. The Company has evaluated several factors in assessing whether there is reasonable certainty that the Company will exercise a contractual renewal option. For leases with renewal options that are reasonably certain to be exercised, the Company included the renewal term in the total lease term used in calculating the right-of-use asset and lease liability.
The components of lease expense, which are included in selling, general and administrative expense and depreciation and amortization for the three and nine months ended September 30, 2025 and 2024, are as follows:
| Three months ended September 30, | Nine months ended September 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| Amortization of right-of-use asset - finance lease | $54,177 | $96,243 | $204,597 | $288,729 |
| Interest on lease liabilities - finance lease | 3,227 | 21,533 | 23,718 | 67,318 |
| Operating lease cost | 39,764 | 33,198 | 119,293 | 93,029 |
| Total lease cost | $97,168 | $150,974 | $347,608 | $449,076 |
| Cash paid for amounts included in the measurement of lease liabilities: | ||||
| Operating cash flows from finance leases | $(58,031) | $(91,038) | $(251,272) | $(270,143) |
| Operating cash flows from operating leases | (38,220) | (203) | (94,458) | (1,235) |
| Operating leases: | September 30, 2025 | December 31, 2024 |
|---|---|---|
| Operating lease right-of-use, assets | $367,398 | $463,011 |
| Operating lease liability, current | $136,197 | $127,498 |
| Operating lease liability, non-current | 238,942 | 342,098 |
| Total operating lease liabilities | $375,139 | $469,596 |
| Finance leases: | September 30, 2025 | December 31, 2024 |
|---|---|---|
| Finance lease right-of-use asset, gross | $565,030 | $1,294,168 |
| Accumulated amortization | (451,477) | (513,296) |
| Finance lease right-of-use asset, net | $113,553 | $780,872 |
| Finance lease liability, current portion | $123,757 | $395,301 |
| Finance lease liability, long-term | 1,998 | 444,448 |
| Total finance lease liabilities | $125,755 | $839,749 |
| Weighted-average remaining lease term: | September 30, 2025 | December 31, 2024 |
|---|---|---|
| Operating leases (in years) | 3.22 | 4.21 |
| Finance leases (in years) | 0.64 | 2.39 |
| Weighted-average discount rate: | September 30, 2025 | December 31, 2024 |
|---|---|---|
| Operating leases | 7.32% | 7.41% |
| Finance leases | 7.85% | 8.03% |
Future minimum lease payments under non-cancellable leases as of September 30, 2025, are as follows:
| Operating Leases · Finance Leases | ||
|---|---|---|
| Remaining for 2025 | $39,696 | $61,384 |
| 2026 | 159,282 | 67,425 |
| 2027 | 110,063 | — |
| 2028 | 40,616 | — |
| 2029 | 42,252 | — |
| 2030 and thereafter | 28,919 | — |
| Total undiscounted cash flows | 420,828 | 128,809 |
| Less discounting | (45,689) | (3,054) |
| Present value of lease liabilities | $375,139 | $125,755 |
Note 10. NOTES PAYABLE
Vehicles Notes Payable
On January 10, 2025, the Company entered into a finance agreement to purchase a 2024 Toyota Corolla for $33,517 with a maturity date of January 18, 2031. The loan bears fixed interest at a rate of 11.65% per annum, with monthly payments of $651, which is comprised of principal and interest. This loan is collateralized by the underlying vehicle. The balance of this loan as of September 30, 2025, was $30,840. The current portion of the balance of this loan as of September 30, 2025 was $4,457.
On March 18, 2024, the Company entered into a finance agreement to purchase a 2024 Toyota Corolla for $33,620 with a maturity date of February 18, 2030. The loan bears fixed interest at a rate of 5.99% per annum, with monthly payments of $467, which is comprised of principal and interest. This loan is collateralized by the underlying vehicle. The balance of this loan as of September 30, 2025, and December 31, 2024, was $21,700 and $24,849, respectively. The current portion of the balance of this loan as of September 30, 2025, and December 31, 2024, was $4,425 and $5,603, respectively.
Directors and Officers Insurance Policy – 2025
In September 2025, the Company obtained short-term financing of approximately $127,500 with 10 monthly payments of approximately $13,000 and interest at a 11.64% fixed annual rate for director and officer insurance policies. The current portion of the balance of the Company’s Directors and Insurance short-term financing as of September 30, 2025, was $128,000 and $167,000 as of December 31, 2024, for the 2024 Directors and Officers Insurance Policy.
Note 11. COMMITMENTS AND CONTINGENCIES
Legal Matters
From time to time, the Company is involved in various disputes and litigation matters that arise in the ordinary course of business. To date, the Company has no material pending legal proceedings.
Note 12. COMMON STOCK
Common Stock
The Company has authorized a total of 350,000,000 shares of Common Stock, $0.007 par value per share. On July 22, 2025, the Company received stockholder approval to increase the number of authorized shares of Common Stock from 100,000,000 shares to 350,000,000 shares, and on August 13, 2025, the Company filed an amendment to its Certificate of Incorporation with the Secretary of State of the State of Delaware to effect the increase. The Company has issued 3,473,065 shares of Common Stock, of which 6,805 are unvested restricted stock awards as of September 30, 2025, and 519,155 shares of Common Stock, of which 11,635 are unvested restricted stock awards as of December 31, 2024 adjusted for the 30-1 reverse stock split.
On August 13, 2025, the Company entered into a securities purchase agreement with certain institutional and accredited investors, pursuant to which the Company agreed to issue and sell, in a private placement, (i)990 shares of the Company’s newly designated Series B Convertible Preferred Stock, with a par value $0.001 per share and stated value of $1,000 per share initially convertible into 143,476 shares of the Company’s Common Stock, par value $0.007 per share at an initial conversion price of $6.90 per share and (ii) warrants to purchase up to 223,824 shares of the Company’s Common Stock at an exercise price of $10.56 per share of Common Stock. The investors have converted 290 of the 990 Series B Convertible Preferred Stock in exchange for 42,028 shares of Common Stock as of September 30, 2025.
On September 29, 2025, the Company consummated a best efforts public offering of an aggregate of (i)1,047,694 shares of Common Stock and (ii) pre-funded warrants to purchase up to 874,067 shares of Common Stock in lieu of shares of Common Stock. Each share was sold at a public offering price of $2.50. Each pre-funded warrant was sold at a public offering price of $2.493. The total gross proceeds for the transaction were approximately $4.8 million.
On May 22, 2025, the Company entered into an at-the-market issuance sales agreement (the “ATM Agreement”) with WallachBeth Capital LLC (“WallachBeth”), as sales agent providing for the sale of our common stock from time to time in an “at the market offering” program. The aggregate market value of the shares of Common Stock eligible for sale is currently $5,801,000. The ATM Agreement provides that WallachBeth will receive 3.0% of the gross sales price sold under the ATM Agreement. From May 22, 2025, through September 30, 2025, the Company sold 114,672 shares of Common Stock through the ATM Agreement which accumulated approximately $1.2 million in gross proceeds.
Note 13. STOCK-BASED COMPENSATION
Under the Company’s 2104 Equity Incentive Plan (the “2014 Plan”), the Company is authorized to grant options or restricted stock for up to 66,667 shares of Common Stock. On June 6, 2023, the Company received stockholder approval to increase the number of authorized shares from 38,095 to 66,667, adjusted for the 30-1 reverse split. Options or restricted stock awards may be granted to employees, the Company’s board of directors, and external consultants who provide services to the Company. Options and restricted stock awards granted under the 2014 Plan have vesting schedules with terms of one to three years and become fully exercisable based on specific terms imposed at the date of grant. The 2014 Plan expired at the end of its 10-year term in March 2024. A new 2024 Incentive Compensation Plan (the “2024 Plan”) was approved at the Annual Meeting of Shareholders on June 4, 2024.
The Company has recorded stock-based compensation expense related to the issuance of restricted stock awards in the following line items in the accompanying condensed consolidated statements of operations:
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| Research and development | $— | $30,605 | $12,916 | $87,832 |
| Selling, General and administrative | 67,132 | 155,082 | 592,439 | 667,762 |
| Total stock-based compensation expense | $67,132 | $185,687 | $605,355 | $755,594 |
The following table summarizes stock option activity under the 2014 Plan and 2024 Plan:
| Number of options | Weighted-average exercise price | Weighted-average remaining contractual term (in years) | Aggregate intrinsic value | |
|---|---|---|---|---|
| Outstanding at December 31, 2024 | 9,649 | $207.84 | 4.45 | — |
| Granted | — | — | — | — |
| Exercised | — | — | — | — |
| Forfeited | (594) | 147.28 | — | — |
| Outstanding at September 30, 2025 | 9,055 | $211.82 | 3.90 | — |
| Vested and exercisable at September 30, 2025 | 9,055 | $211.82 | 3.90 | — |
As of September 30, 2025, there wasno unrecognized compensation cost related to non-vested stock options.
The following table summarizes restricted stock award activity under the 2014 Plan and 2024 Plan:
| Number of · As of September 30, 2025 | |||||
|---|---|---|---|---|---|
| restricted stock awards (RSA) | Weighted- average grant price | FMV on grant date | Vested number of RSA | Unvested number of RSA | |
| Balance at December 31, 2024 | 44,107 | $57.08 | $2,517,843 | 39,415 | 4,692 |
| Granted | 8,598 | 24.89 | 214,003 | 5,628 | 2,113 |
| Forfeited | (856) | 24.30 | (20,800) | — | — |
| Balance at September 30, 2025 | 51,849 | $52.28 | $2,711,046 | 45,043 | 6,805 |
During the nine months ended September 30, 2025, the Company issued restricted stock awards (“RSAs”) for 8,598 shares of Common Stock to employees, non-employees, and the board of directors. The shares vest in equal monthly installments over terms of immediately and up tothree years, subject to the employees and non-employees providing continuous service through the vesting date. During the nine months ended September 30, 2025,5,628 shares vested from RSAs granted in 2025, and 6,788 shares vested from RSA’s granted prior to 2025.
Note 14. WARRANTS
The Company’s outstanding Common Stock warrants are equity classified. As of September 30, 2025, and December 31, 2024, the Company had 1,348,292 and 409,937 warrants outstanding to purchase one share of the Company’s Common Stock for each warrant at a weighted average price of $28.44. These warrants expire at various dates through August 2030. During the nine months ended September 30, 2025, a total number of 835,303 warrants were exercised into an equivalent number of shares of Common Stock as compared to 35,558 being exercised during the nine months ended September 30, 2024. During the third quarter of 2025, a total of 63,907 warrants were forfeited through a cashless exercise. The proceeds of the exercised warrants for the nine months ended September 30, 2025, were approximately $4.8 million, compared to proceeds of $1.3 million during the nine months ended September 30, 2024.
On February 25, 2025, the Company entered into a warrant inducement agreement (the “February Inducement Agreement”) with certain holders (the “Holders”) of the Company’s warrants to purchase shares of the Company’s Common Stock, issued in a private placement offering that closed on October 21, 2024 (the “October Warrants”), and a private placement offering that closed on August 5, 2024 (the “August Warrants” and, together with the October Warrants, collectively, the “Existing Warrants”). In consideration of the Holders’ immediate exercise of the Existing Warrants in accordance with the February Inducement Agreement, the Company issued unregistered Common Stock purchase warrants (the “New Warrants”) to purchase an aggregate of up to 97,538 shares of Common Stock (the “New Warrant Shares”) to the Holders of the Existing Warrants, with an exercise price of $25.50.
On May 7, 2025 the Company completed a public offering with warrants (“May 2025 Warrants”) to purchase of 507,812. The May 2025 Warrants have an initial exercise price of $10.56 per share. and are exercisable for a term of five years on a date that is five years after the later of receiving the shareholder The number of shares of our Common Stock issuable upon exercise of the May 2025 Warrant Shares is subject to the following adjustments: (i) a 30% increase in the number of shares of Common Stock that would be issuable upon exercise of the May 2025 Warrants if a reverse stock split is effected prior to the expiration of the May 2025 Warrants (the “Reverse Stock Split Adjustment”), and (ii) subject to Warrant Stockholder Approval (as defined below), a decrease of the exercise price of the May 2025 Warrants, if in a subsequent offering of the Company’s securities the price paid for Common Stock, the exercise price of any options or warrants or the conversion price of any convertible securities issued in such subsequent offering is less than the exercise price immediately prior to such subsequent offering, to an exercise price that is equal to the lowest of the price paid for Common Stock, the exercise price of any options or warrants or the conversion price of any convertible securities issued in such subsequent offering (subject to a floor of $4.50 per share) and an increase in the number of shares of Common Stock underlying the May 2025 Warrants upon such exercise price reset so that the reset exercise price multiplied by the increased number of shares equals the aggregate proceeds that would have resulted from the full exercise of the May 2025 Warrants immediately prior to the reset (the “Anti-Dilution Adjustment”). After the adjustments the Company issued a total of 2,408,908 warrants related to the May 2025 Warrants at an exercise price of $4.50.
On August 13, 2025, the Company entered into a warrant inducement agreement with the holder of a warrant to purchase 15,000 shares of Common Stock originally issued on August 5, 2024, with a current exercise price of $37.50 per share (the “August 2024 Warrant”) and a warrant to purchase 21,667 shares of Common Stock originally issued on October 21, 2024 with a current exercise price of $45.00 per share, pursuant to which the Holder agreed to exercise in cash the Existing Warrants at a reduced exercise price of $6.90 per share, for gross proceeds to the Company of $253,000. As an inducement to such exercise, the Company agreed to issue to the holder unregistered warrants to purchase up to 47,666 shares of the Company’s Common Stock. The new warrants, which have an exercise price of $10.56 per share and will not become exercisable until the Company’s stockholders approve the issuance of shares of Common Stock. Following stockholder approval, the warrants have a term of five years.
On August 13, 2025, the Company entered into a securities purchase agreement with certain institutional and accredited investors, pursuant to which the Company agreed to issue and sell, in a private placement, (i)990 shares of the Company’s newly designated Series B Convertible Preferred Stock, with a par value $0.001 per share and stated value of $1,000 per share initially convertible into 143,476 shares of the Company’s Common Stock, par value $0.007 per share at an initial conversion price of $6.90 per share and (ii) warrants to purchase up to 223,824 shares of the Company’s Common Stock at an exercise price of $10.56 per share of Common Stock.
The following table summarizes the calculated aggregate fair values for the warrants issued in the two August offerings to be equity classified using the Black-Scholes method based on the following assumptions for the Offering:
| Exercise price per share of warrant | $10.56 |
|---|---|
| Fair market closing price per share of Common Stock | $7.66 |
| Volatility | 153% |
| Expected term (years) | 5 |
| Risk-free interest rate | 3.82% |
| Dividend yield | 0% |
The fair value of the warrants using the assumptions above was $143,315 for the inducement warrants and $604,483 for the warrants related to the Series B Convertible Preferred Stock, $113,976 for the change in fair value related to the change in exercise price in the inducement warrants. The fair value of the above warrants was recorded in Additional paid-in capital.
As of September 30, 2025, there were tradeable warrants to purchase up to an aggregate of 53,374 shares of Common Stock outstanding and non-tradeable warrants to purchase an aggregate of up to 90,148 shares of Common Stock outstanding.
| Number of warrants issued | Weighted- average exercise price | Number of warrants exercised | Number of warrants outstanding | |
|---|---|---|---|---|
| Pre-IPO convertible notes | 96,616 | $159.35 | — | 96,616 |
| IPO tradeable | 77,560 | 91.95 | (24,186) | 53,374 |
| IPO non-tradeable | 100,105 | 91.95 | (10,366) | 90,148 |
| Direct offering March 8, 2024 | 53,530 | 37.50 | (35,553) | 17,777 |
| Placement agent direct offering March 8, 2024 | 1,066 | 49.20 | — | 1,066 |
| Inducement/direct offering August 5, 2024 | 58,402 | — | (58,402) | — |
| Placement agent direct offering August 5, 2024 | 1,659 | 45.00 | — | 1,659 |
| Direct offering October 21, 2024 | 88,757 | 17.40 | (59,544) | 29,213 |
| Warrant inducement February 25, 2025 | 97,538 | 25.50 | — | 97,538 |
| Public offering May 7, 2025 | 2,408,908 | 4.50 | (1,719,497) | 689,411 |
| August PIPE/Inducement offering August 13, 2025 | 271,490 | 10.56 | — | 271,490 |
| Balance at September 30, 2025 | 3,255,840 | $28.44 | (1,907,548) | 1,348,292 |
Note 15. SUBSEQUENT EVENTS
In October 2025, the Company entered into definitive agreements for the purchase and sale of 720,000 shares of common stock, par value $0.007 per share, at a purchase price of $2.50 per share in a registered direct offering priced at-the-market under Nasdaq rules. The gross proceeds to the Company from the offering were approximately $1.8 million before deducting placement agent fees and other offering expenses payable by the Company.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.