Tivic Health Systems, 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 Condensed Financial Statements (unaudited)
Notes to Unaudited Condensed Financial Statements
(amounts are as indicated)
| 1. | Formation and Business of the Company |
Tivic Health Systems, Inc. (the “Company”) was incorporated in the state of California on* September 22, 2016for the purpose of developing and commercializing non-invasive bioelectronic medicine. In June 2021,the Company was reincorporated as a Delaware corporation and, in November 2021,it completed its initial public offering. In2019,* the Company commercially launched ClearUP, a handheld device for treatment of sinus pain and congestion and the Company'sfirst FDA-regulated product, a business it is in the process of exiting. In2021, the Company also began developing a novel platform directed to vagus nerve stimulation, which has undergone clinical evaluation and optimization studies. In* February 2025,the Company acquired a worldwide exclusive license from Statera Biopharma, Inc. (“Statera”) to the late-stage toll-like receptor5* agonist Entolimod™ for the treatment of Acute Radiation Syndrome (“ARS”). At the same time, the Company acquired an exclusive option to licensefive additional indications and clinical use cases for Entolimod and its immune-optimized derivative, Entolasta™, with buy-out rights to enable use across all indications. In* March 2025,the Company exercised its option to license Entolimod and Entolasta for the treatment of neutropenia,one of the indications covered by the Statera license. With its entrance into the biopharmaceutical market in early2025* and its impending exit from the consumer healthtech business, the Company is a late-stage prescription therapeutics company harnessing the power of the immune system to improve clinical outcomes and save lives. The Company is headquartered in Fremont, California and operates on a decentralized, virtual basis.
| 2. | Summary of Significant Accounting Policies |
Basis of Presentation
The accompanying condensed balance sheet as of* December 31, 2024*, which has been derived from audited financial statements, and the unaudited interim condensed financial statements as of* September 30, 2025*, and for thethree andnine months ended* September 30, 2025* and* September 30, 2024*, have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information. Certain information and note disclosures normally included in annual financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to those rules and regulations. In the opinion of management, all accounting entries and adjustments (including normal, recurring adjustments) considered necessary for a fair presentation of the financial position and the results of operations for the interim periods have been made. Operating results for thethree andnine months ended* September 30, 2025* arenot necessarily indicative of the results that* maybe expected for the fiscal year ending December 31, 2025*.
Going Concern Uncertainty
During thenine months ended* September 30, 2025and2024*, the Company incurred a net loss of $6.0 million and $4.2 million, respectively. At* September 30, 2025*, the Company had an accumulated deficit of $49.6 million. Cash and cash equivalents at* September 30, 2025* were $3.5 million. During thenine months ended* September 30, 2025and2024*, the Company had negative cash flows from operations of $4.7 million and $4.4 million, respectively. The aforementioned factors raise substantial doubt about the Company’s ability to continue as a going concern withinone year from the issuance date of the financial statements. The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The financial statements donot include any adjustments relating to the recoverability and classification of asset amounts or the classification of liabilities that might be necessary should the Company be unable to continue as a going concern withinone year after the date the financial statements are issued.
We expect to incur significant expenses and operating losses for the foreseeable future as we continue the development of, and seek regulatory approval for, our product candidates and technologies. Future capital requirements will depend upon many factors, including, without limitation, progress with developing, manufacturing and marketing our product candidates and technologies; the time and costs involved in obtaining regulatory approvals for our product candidates and technologies; the time and costs involved in preparing, filing, prosecuting, maintaining and enforcing patent claims and other proprietary rights; our ability to execute our strategy to expand our business, including through the closing of potential acquisitions or licenses and integrating new business into our own; our ability to establish collaborative arrangements; completion of any acquisitions or other strategic transactions; marketing activities and competing technological and market developments, including regulatory changes and overall economic conditions in our target markets. We will require substantial additional financing to fund our ongoing clinical trials and operations, and to continue to execute our strategy. These activities, including our planned research and development efforts, will require significant uses of working capital. There can beno assurance that we will obtain regulatory approval of our product candidates or generate sufficient revenue and cash to achieve profitability.
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The Company recognizes it will need to raise additional capital to continue research and development and to fund its planned operations, including to execute on its strategy to expand its business, complete pre-clinical and clinical trials and, if regulatory approval is obtained, commercialize any future products. The Company* mayseek additional funds through equity or debt offerings and/or borrowings under notes payable, lines of credit or other sources. The Company doesnot* know whether additional financing will be available on commercially acceptable terms, or at all, when needed. If adequate funds arenot available or arenot available on commercially acceptable terms, the Company’s ability to fund its operations, support the growth of its business or otherwise respond to competitive pressures could be significantly delayed or limited, which could materially adversely affect its business, financial conditions, or results of operations.
Reverse Stock Split
Effective* March 7, 2025,the Company implemented a reverse stock split of its issued and outstanding shares of common stock, par value $0.0001 per share, at a ratio of1*-for-17. As a result of the reverse stock split, the total number of shares of common stock held by each stockholder of the Company were converted automatically into the number of shares of common stock equal to the number of issued and outstanding shares of common stock held by each such stockholder immediately prior to the reverse stock split divided by 17. The Company issuedone whole share of the post reverse stock split common stock to any stockholder who otherwise would have been entitled to receive a fractional share as a result of the reverse stock split (for a total of 76 shares). As a result, no fractional shares were issued in connection with the reverse stock split andno cash or other consideration was paid in connection with any fractional shares that would otherwise have resulted from the reverse stock split. Also, all options, warrants, preferred stock and other convertible securities of the Company outstanding immediately prior to the reverse stock split were adjusted by dividing the number of shares of common stock into which such options, warrants, preferred stock and other convertible securities were exercisable or convertible by 17 and multiplying the exercise or conversion price thereof by 17, all in accordance with the terms of the plans, agreements or arrangements governing such options, warrants, preferred stock and other convertible securities and subject to rounding pursuant to such terms. There wasno change to the par value or authorized shares, of either the Company’s common stock or preferred stock, as a result of the reverse stock split. All share and per share amounts for the Company’s common stock, as well as the number of shares of common stock issuable upon conversion of outstanding preferred stock and upon exercise of options and warrants outstanding, and conversion/exercise prices thereof, from dates prior to completion of the reverse stock split that are included in this Quarterly Report, including the financial statements and footnotes thereto included herein, have been retroactively restated to give effect to the reverse stock split.
Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of expenses during the reporting period. Actual results could differ materially from those estimates. The Company evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances dictate.
Cash and Cash Equivalents
The Company considers all highly liquid investments with original maturities ofthree months or less at date of purchase to be cash equivalents. As of* September 30, 2025* and* December 31, 2024*, cash and cash equivalents totaled $3.5 million and $2.0 million, respectively.
Accounts Receivable
Trade accounts receivable are recorded at the invoiced amount, net of allowances for credit losses. The allowance for credit losses is based on our assessment of the collectability of accounts. Management regularly reviews the adequacy of the allowance for credit losses by considering the age of each outstanding invoice, each customer’s expected ability to pay, and the collection history with each customer, when applicable, to determine whether a specific allowance is appropriate. Accounts receivable deemed uncollectible are charged against the allowance for credit losses when identified. As of each* September 30, 2025* and* December 31, 2024*, the allowance for credit losses waszero.
Inventory
Inventories are stated at the lower of cost or net realizable value, with cost determined on afirst-in,first-out basis. Inventories are reviewed periodically to identify slow-moving inventory based on anticipated sales activity. As of each* September 30, 2025* and* December 31, 2024*, the reserve for obsolescence was $568 thousand and $338 thousand, respectively.
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Deferred Offering Costs
The Company complies with the requirements of Financial Accounting Standards Board (“FASB”) Accounting Standard Codification (“ASC”)340-10-S99-1. The Company capitalizes incremental legal, professional, accounting, and otherthird-party fees that are directly associated with an equity or debt offering. As of* September 30, 2025*, the balance of deferred offering costs was $211 thousand and consisted of legal and accounting fees paid in connection with the Equity Line of Credit and the Tranched Financing, which are discussed further in Notes11 and10, respectively, below. If the Company consummates an equity offering, the deferred financing costs will be allocated to additional paid-in capital. If the Company consummates a debt offering, the deferred financing costs will be recorded as a discount to the debt. The costs relating to the Equity Line of Credit and the Tranched Financing are reclassified to additional paid in capital on a pro-rata basis when the Company completes offerings.
Business Combination
The Company follows the guidance in ASC805, Business Combinations, for determining the appropriate accounting treatment for asset acquisitions. ASUNo. 2017-01, Clarifying the Definition of a Business, provides an initial fair value screen to determine if substantially all of the fair value of the assets acquired is concentrated in a single asset or group of similar assets. If the initial screening test isnot met, the set is considered a business based on whether there are inputs and substantive processes in place. The accounting treatment is derived based on the results of this analysis and conclusion on an acquisition’s classification of a business combination or an asset acquisition.
If the acquisition is deemed to be a business, the purchase method of accounting is applied. Identifiable assets acquired and liabilities assumed at the acquisition date are recorded at fair value. If the transaction is deemed to be an asset acquisition, the cost accumulation and allocation model is used whereby the assets and liabilities are recorded based on the purchase price and allocated to the individual assets and liabilities based on relative fair values.
Property and Equipment
Property and equipment are recorded at cost net of accumulated depreciation. Depreciation is computed on a straight-line method over the estimated useful lives of the assets, which isthree tofour years. Upon retirement or sale of assets, the cost and related accumulated depreciation are removed from the balance sheet and the resulting gain or loss is reflected in operations. Repairs and maintenance costs that donot improve or extend the lives of the respective assets are charged to operations as incurred.
Impairment of Long-Lived Assets
The Company evaluates its long-lived assets, including property and equipment, for impairment whenever events or changes in circumstances indicate that the carrying amount of these assets* may**not* be recoverable. Recoverability of these assets is measured by comparison of the carrying amount of each asset to the future undiscounted cash flows the asset is expected to generate over its remaining life. When indications of impairment are present and the estimated undiscounted future cash flows from the use of these assets is less than the assets’ carrying value, the related assets will be written down to fair value. There wereno impairments of the Company’s long-lived assets for the periods presented.
Commitments and Contingencies
Liabilities for loss contingencies arising from claims, assessments, litigation, fines, and penalties and other sources are recorded when it is probable that a liability has been incurred and the amount can be reasonably estimated. Legal costs incurred in connection with loss contingencies are expensed as incurred.
Revenue Recognition
The Company recognizes revenue from product sales in accordance with FASB ASC Topic606, Revenue from Contracts with Customers (“Topic606”). The standard applies to all contracts with customers, except contracts that are within scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments.
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Under Topic606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of Topic606, the entity performs the followingfive steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies thefive-step model to contracts when it is probable the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inceptions, once the contract is determined to be within the scope of Topic606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.
The Company sells its products through direct sales and resellers. Revenue is recognized when control of the promised goods is transferred to the customers or the resellers, in an amount that reflects the consideration the Company expects to be entitled to in exchange for those goods. Revenue associated with products holding rights of return is recognized when the Company concludes there isnot a risk of significant revenue reversal in the future periods for the expected consideration in the transaction.
The Company* mayreceive payments at the onset of the contract and before goods have been delivered. In such instances, the Company records a deferred revenue liability. The Company recognizes these contract liabilities as revenue after the revenue criteria are met. As of September 30, 2025* and* December 31, 2024*, the contract liability related to the Company’s deferred revenues was $3 thousand and $2 thousand, respectively, and is included in “Other Accrued Expenses” on the accompanying balance sheets.
The Company relies onthird parties to have procedures in place to detect and prevent credit card fraud, as the Company has exposure to losses from fraudulent charges. The Company records the losses related to chargebacks as incurred.
The Company has also elected to exclude from the measurement of the transaction price sales taxes remitted to governmental authorities.
The table below presents revenue by channel for thethree andnine months ended* September 30, 2025and2024* (in thousands):
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| Product Revenue by Sales Channel | 2025 | 2024 | 2025 | 2024 |
| Product Revenue | ||||
| Direct-to-consumer | $137 | $130 | $277 | $557 |
| Reseller | 24 | 16 | 48 | 110 |
| Returns | (15) | (20) | (23) | (67) |
| Revenue | $146 | $126 | $302 | $600 |
Sales Tax
Sales tax collected from customers and remitted to governmental authorities is accounted for on a net basis and therefore, is excluded from net sales.
Shipping and Handling
Shipping and handling fees paid by customers are recorded in revenue, with the related expenses recorded in cost of sales. Shipping and handling fees paid by customers for thethree andnine months ended* September 30, 2025* were $1 thousand and $2 thousand, respectively. There wereno shipping and handling fees paid by customers for thethree andnine months ended* September 30, 2024*.
Shipping costs for delivery of product to customers in thethree andnine months ended* September 30, 2025* were $8 thousand and $16 thousand, respectively. Shipping costs for delivery of product to customers in thethree andnine months ended* September 30, 2024* were $5 thousand and $28 thousand, respectively.
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Product Warranty
The Company generally offers aone-year limited warranty on its products. The Company has also offered for sale at times a limitedtwo-year warranty. The limitedtwo-year warranty is occasionally provided to customers in connection with promotional sales. The Company estimates the costs associated with the warranty obligation using historical data of warranty claims and costs incurred to satisfy those claims. Estimated warranty costs are expensed to cost of sales.
Returns
The Company estimates a reserve for future product returns based on several factors, including historical returns as a percentage of revenue, an understanding of the reasons for past returns and any other known factors that indicate a return is imminent. Reserves for sales returns are estimated and recorded in the same period as the underlying revenue recognition as a deduction to arrive at net product sales and as a liability classified as “Other Accrued Expenses” on the balance sheet. As of* September 30, 2025* and* December 31, 2024*, the reserve for sales returns was $8 thousand and $10 thousand, respectively.
Research and Development Expenses
Research and development expenses include costs directly attributable to the conduct of research and development programs, including the cost of salaries, payroll taxes, employee benefits, materials, supplies, depreciation on and maintenance of research equipment, the cost of services provided by outside contractors, and the allocable portions of facility costs, such as rent, utilities, insurance, repairs and maintenance, depreciation, and general support services. All costs associated with research and development are expensed as incurred unless there is an alternative future use.
Sales and Marketing Expenses
Sales and marketing expenses are expensed as incurred and consist primarily of personnel costs, merchandising, customer service and targeted online marketing costs, such as display advertising, keyword search campaigns, search engine optimization and social media and offline marketing costs such as television, radio and print advertising. Personnel costs consist of salaries, bonuses, benefits and stock-based compensation expense. Beginning in thesecond quarter of2025, sales and marketing expenses also include personnel and consulting expenses incurred to secure customer awareness of Entolimod’s development. Advertising and other promotional costs to market the Company’s products and services amounted to $140 thousand and $271 thousand for thethree andnine months ended* September 30, 2025*, respectively. Advertising and other promotional costs to market the Company’s products and services were $94 thousand and $415 thousand for thethree andnine months ended* September 30, 2024*, respectively.
Stock-Based Compensation
The Company accounts for stock-based compensation arrangements with employees and non-employee consultants using a fair value method, which requires the recognition of compensation expense for costs related to all stock-based payments, including stock options, restricted stock units and warrants. The fair value method requires the Company to estimate the fair value of stock-based payment awards to employees and non-employees on the date of grant using an option pricing model.
Stock-based compensation costs are based on the fair value of the underlying option calculated using the Black-Scholes option-pricing model and recognized as expense on a straight-line basis over the requisite service period, which is the vesting period. The Company measures equity-based compensation awards granted to non-employees at fair value as the awards vest and recognizes the resulting value as compensation expense at each financial reporting period.
Determining the appropriate fair value model and related assumptions requires judgment, including estimating stock price volatility, expected dividend yield, expected term, risk-free rate of return, and the estimated fair value of the underlying common stock. Due to the lack of company-specific historical and implied volatility data, the Company has based its estimate of expected volatility on the historical volatility of a group of similar publicly traded companies. The historical volatility is calculated based on a period of time commensurate with the expected term assumption. The group of representative companies have characteristics similar to the Company, including stage of product development and focus on the life science industry. Changes to the group are made on an as needed basis to ensure it remains representative of the Company. The Company uses the simplified method, which is the average of the final vesting tranche date and the contractual term, to calculate the expected term for options granted to employees as it doesnot have sufficient historical exercise data to provide a reasonable basis upon which to estimate the expected term. The risk-free interest rate is based on a treasury instrument whose term is consistent with the expected term of the stock options. The Company uses an assumed dividend yield ofzero as the Company has never paid dividends and hasno current plans to pay any dividends on its common stock. The Company accounts for forfeitures as they occur.
Deemed Dividend
The Investor Warrants issued to the Investor in connection with the Tranched Financing contain a provision for the change in exercise price should the Company issue a new Investor Warrant in a subsequent Tranche Closing with an exercise price lower than the exercise price of the Investor Warrant issued earlier. The provision lowers the exercise price to the new Investor Warrant triggering the repricing feature and creates a deemed dividend. The deemed dividend is added to the net income or loss for the period and used in calculating the earnings per share for the period.
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Segment Reporting
Operating segments are identified as components of an enterprise for which separate discrete financial information is available for evaluation by the chief operating decision-maker (“CODM”) in deciding how to allocate resources and assess performance. The Company’s CODM is the Chief Executive Officer, who reviews the Company’s operations and manages its business as asingle operating segment.
Net Loss per Share
Basic earnings (loss) per share is computed using the weighted-average number of shares of common stock outstanding during the period adjusted to add back dividends (declared or cumulative undeclared) applicable to the Series B Preferred Stock. Diluted earnings (loss) per share is computed using the weighted-average number of shares of common stock and the dilutive effect of contingent shares outstanding during the period. Potentially dilutive contingent shares, which primarily consist of stock options issued to employees, directors and consultants, restricted stock units (“RSUs”), warrants issued tothird parties, all of which are accounted for as equity instruments, would be excluded from the diluted earnings per share calculation because their effect is anti-dilutive.
Basic and diluted net income (loss) per share attributable to common stockholders is presented in conformity with thetwo-class method required for participating securities such as our preferred stock. Under thetwo-class method, basic and diluted net income (loss) per share attributable to common stockholders is computed by dividing the basic and diluted net income (loss) attributable to common stockholders by the basic and diluted weighted-average number of shares of common stock outstanding during the period. Diluted net income per share attributable to common stockholders adjusts basic net income per share for the potentially dilutive impact of stock options, RSUs and warrants.
The treasury stock method is used to calculate the potentially dilutive effect of stock options and RSUs. The if-converted method is used to calculate the potentially dilutive effect of shares of the Series A and B Preferred Stock. In both methods, diluted net income (loss) attributable to common stockholders and diluted weighted-average shares outstanding are adjusted to account for the impact of the assumed issuance of potential shares of common stock that are dilutive, subject to dilution sequencing rules.
At* September 30, 2025and2024*, the Company had options to purchase 355,368 and 3,904 shares of common stock outstanding, respectively,79,415 andzero restricted stock units outstanding, respectively, and warrants to purchase 1,055,809 and 707,234 shares of common stock, respectively, that are excluded from the calculation of diluted earnings per share as their effect is anti-dilutive.
The following table shows the calculation of basic and diluted earnings per share for the effect of dividends on the B Preferred Stock, and deemed dividends on warrants, which were outstanding for the periods presented below.
| Three Months Ended · Nine Months Ended | ||||
|---|---|---|---|---|
| September 30, 2025 | September 30, 2025 | |||
| 2025 | 2024 | 2025 | 2024 | |
| (In thousands, except per share amounts) | ||||
| Net loss attributed to Tivic Health Systems, Inc. | $(2,596) | $(1,431) | $(6,029) | $(4,178) |
| Dividends on Series B Preferred Stock | (36) | — | (37) | — |
| Deemed dividends on warrants | (10) | — | (10) | — |
| Net loss attributed to Tivic Health Systems, Inc. | (2,642) | (1,431) | (6,076) | (4,178) |
| Basic and diluted weighted average number of shares outstanding | 1,320,778 | 364,184 | 928,971 | 229,291 |
| Net loss per share - basic and diluted | $(2.00) | $(3.93) | $(6.54) | $(18.22) |
Concentration of Credit Risk and Other Risks and Uncertainties
Financial instruments that potentially subject the Company to significant concentrations of credit risk consist of cash and cash equivalents and accounts receivable. Cash and cash equivalents include a checking account and a money market account held at a single national financial institution in the United States. At times, such deposits* maybe in excess of insured limits. Management believes that the financial institution at which the Company holds its deposits is financially sound, and accordingly, minimal credit risk exists with respect to the financial institution. The Company hasnot* experienced any losses on its deposits of cash and cash equivalents. As of* September 30, 2025* and* December 31, 2024*, the Company had cash and cash equivalents balances exceeding FDIC insured limits by $2.95 million and $1.6 million, respectively.
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The Company extends credit to customers in the normal course of business and performs credit evaluations of its customers. Concentrations of credit risk with respect to accounts receivable exist to the full extent of amounts presented in the financial statements.
During thefirst nine months of2025, the majority, or 85%, of the Company’s sales were to individual customers. In thefirst nine months of2024, the majority, or 82%, of the Company’s sales were to individual consumers. As of* September 30, 2025*, the Company hadone customer whose accounts receivable balance totaled10% or more of the Company’s total accounts receivable (37%) compared withone such customer at* December 31, 2024* (95%).
For each of thethree andnine months ended* September 30, 2025*, the Company hadone customer who individually accounted for10% or more of the Company’s total revenue (16% and 10%, respectively). For each of thethree andnine months ended* September 30, 2024*, the Company hadone customer who individually accounted for10% or more of the Company’s total revenue (13% and 10%, respectively).
The ongoing conflicts between Russia and Ukraine as well as Israel and Hamas, and certain other macroeconomic factors including tariffs, inflation and rising interest rates, have contributed to economic uncertainty. Additionally, events involving limited liquidity, defaults, non-performance or other adverse developments that affect financial institutions or the financial services industry generally, or concerns or rumors about any events of these kinds or other similar risks, have in the past and* may*in the future lead to market-wide liquidity problems. Furthermore, it is possible that U.S. policy changes, including planned or proposed budget cuts at the federal government level, could increase market volatility in the coming months. These factors, amongst other things, could result in further economic uncertainty and volatility in the capital markets in the near term, and could negatively affect our operations. We will continue to monitor material impacts on our business strategies and operating results.
Recently Issued Accounting Pronouncements
In* November 2024,the FASB issued ASU2024*-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic220-40)-Disaggregation of Income Statement Expenses. The guidance applies to all public business entities and becomes effective for annual periods beginning after* December 15, 2026,and interim periods beginning after December 15, 2027.Early adoption is permitted. The guidance requires improved disclosures about expenses, including the types of expenses in commonly presented expense captions (such as cost of sales, SG&A and research and development), which will allow investors to better understand the components of an entity’s expenses. In January 2025,the FASB issued ASU2025*-01 to further clarify the effective date as thefirst annual reporting period beginning after* December 15, 2026,and interim periods within annual reporting periods beginning after December 15, 2027.The Company doesnot* believe that ASU2024-03 will have a material impact on its financial reporting.
Management doesnot believe any other recently issued butnot yet effective accounting pronouncement, if adopted, would have a material effect on the Company’s present or future consolidated financial statements.
| 3. | Financial Instruments and Fair Value Measurements |
The Company’s financial instruments consist of money market funds. The following tables show the Company’s cash equivalents carrying value and fair value at* September 30, 2025* and* December 31, 2024* (in thousands):
| As of September 30, 2025 (unaudited) | |||||
|---|---|---|---|---|---|
| Quoted · Significant | |||||
| Priced in · other · Significant | |||||
| active · observable · unobservable | |||||
| Carrying | Fair | markets | inputs | inputs | |
| Amount | Value | (Level 1) | (Level 2) | (Level 3) | |
| Assets | |||||
| Money market funds | $2,797 | $2,797 | $2,797 | $— | $— |
| Total assets | $2,797 | $2,797 | $2,797 | $— | $— |
| Quoted · Significant | |||||
|---|---|---|---|---|---|
| Priced in · other · Significant | |||||
| active · observable · unobservable | |||||
| Carrying | Fair | markets | inputs | inputs | |
| Amount | Value | (Level 1) | (Level 2) | (Level 3) | |
| Assets | |||||
| Money market funds | $1,819 | $1,819 | $1,819 | $— | $— |
| Total assets | $1,819 | $1,819 | $1,819 | $— | $— |
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Cash equivalents – Cash equivalents of $2.8 million as of* September 30, 2025* and $1.8 million as of* December 31, 2024*, consisted of money market funds. Money market funds are classified as Level1 of the fair value hierarchy because they are valued using quoted market prices in active markets.
Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs.
There have beenno changes to the valuation methodologies utilized by the Company during thenine months ended* September 30, 2025* compared to the year ended* December 31, 2024*. The Company evaluates transfers between levels at the end of each reporting period. There wereno transfers of financial instruments between levels during thenine months ended* September 30, 2025* and the year ended* December 31, 2024*.
| 4. | Prepaid Expenses (in thousands) |
| September 30, | December 31, | |
|---|---|---|
| 2025 | 2024 | |
| (unaudited) | ||
| Prepaid director and officer liability insurance | $44 | $27 |
| Refundable Delaware franchise taxes | — | 133 |
| Other | 223 | 89 |
| Total prepaid expenses and other current assets | $267 | $249 |
| 5. | Inventory, net (in thousands) |
| September 30, | December 31, | |
|---|---|---|
| 2025 | 2024 | |
| (unaudited) | ||
| Raw materials | $458 | $460 |
| Work in process | 5 | 5 |
| Finished goods | 109 | 192 |
| Inventory at cost | 572 | 657 |
| Less reserve for obsolescence | (568) | (338) |
| Inventory, net | $4 | $319 |
| 6. | Property and equipment, net (in thousands) |
| September 30, 2025 | December 31, 2024 | |
|---|---|---|
| Computers and equipment | $24 | $11 |
| Manufacturing tools and dies | — | 148 |
| Total property and equipment | 24 | 159 |
| Less accumulated depreciation | (12) | (40) |
| Property and equipment, net | $12 | $119 |
Depreciation expense waszero and $2 thousand for thethree andnine months ended* September 30, 2025*, respectively. Depreciation expense was $1 thousand and $3 thousand for thethree andnine months ended* September 30, 2024*, respectively. During thethird quarter of2025, we wrote off certain manufacturing molds related to the next generation of ClearUP as weno longer plan to manufacture the product in the future. The net book value of the assets written off was $117 thousand and is included in loss from disposition of property and equipment in the statement of operations.
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| 7. | Statera License Agreement |
On* February 11, 2025,the Company entered into an exclusive license agreement (the “License Agreement”) with Statera, pursuant to which the Company acquired (i) an exclusive worldwide license to the patented Toll-like Receptor5* (“TLR5”) agonist lead program of Statera known as Entolimod (the “Licensed Molecules”) as it relates to the ARS indication (the “Initial Indication”) and (ii) an exclusive option (the “Exclusive Option”) to acquire the exclusive worldwide license to additional indications, including lymphocyte exhaustion, immunosenescence, neutropenia and/or for use as a vaccine adjuvant (the “Subsequent Indications”) and to the optimizedTLR5 agonist follow-on program of Statera known as Entolasta.
Under the terms of the License Agreement, Statera granted the Company an exclusive worldwide license, with the right to grant and authorize sublicenses, under Statera’s patents, trademarks, know-how and other intellectual property, to develop, test, make, have made, use, sell, offer for sale, import and otherwise exploit the product Entolimod as it relates to the Initial Indication during the term of the License Agreement.
As consideration for the License Agreement, the Company agreed to pay Statera a license fee of $1.5 million, consisting of (i) $300 thousand in cash consideration and (ii) $1.2 million in stock consideration, as discussed further in Notes9 and10 below. As additional consideration for the License Agreement, the Company agreed to pay Statera certain royalty payments on net sales for the ARS indication as a single agent, and, if it exercises the Exclusive Option with respect to any Subsequent Indication, net sales for such Subsequent Indications, within certain royalty periods.
The License Agreement further provides the Company with the Exclusive Option to expand the Initial Indications to include the treatment of the Subsequent Indications or to expand the use from a single agent to include uses as vaccine adjuvant, or several or all of them, at any time during the term of the License Agreement, and onone or more occasions, at its discretion. As part of exercise of the Exclusive Option, the license grant would be expanded to include uses of Entolasta, in addition to Entolimod, both for ARS and for the Subsequent Indications for which the Company has exercised its Exclusive Option.
In conjunction with the License Agreement, Statera additionally transferred to the Company the title to approximately fifteen kilograms (15kg) of frozen manufactured Entolimod bulk drug substance and bulk/finished drug product lots and associated quality records associated with their production and applicable verification records (the “Materials”). In connection with this acquisition of ownership of the Materials, the Company will be negotiating a $1 per year lease with an affiliate of Statera for the proper care, storage and handling of the Materials. The Company determined that the fair value associated with the Entolimod lots and associated lease wasnot material to the transaction.
The License Agreement also includes a buyout provision (the “Buyout”) by which the Company maintains the right to acquire from Statera at any time all right, title and interest in and to all technology licensed or otherwise subject to the Exclusive Option under the License Agreement. Should the Company elect to invoke this buyout right, it must provide Statera with a buyout payment equal to (a) the lesser of (i) the aggregate amount of payments due to Statera for achievement of all milestone events (described below), less the amount of payments paid for the achievement ofone or more of such milestone events, and (ii) an amount negotiated in good faith and mutually agreed by the parties in writing as representing the risk adjusted net present value of the aggregate royalties that would have been payable absent such exercise; less (b) the amount of payments paid or payable by the Company to extinguish an existing lien on the licensed technology.
The Company makes certain judgments to determine whether transactions should be accounted for as acquisitions of assets or as business combinations. If it is determined that substantially all of the fair value of gross assets acquired in a transaction is concentrated in a single asset (or a group of similar assets), the transaction is treated as an acquisition of assets. The Company evaluates the inputs, processes, and outputs associated with the acquired set of activities and assets. If the assets in a transaction include an input and a substantive process that together significantly contribute to the ability to create outputs, the transaction is treated as an acquisition of a business. The Company’s assessments concluded that the transactions pursuant to the License Agreement constitute an asset acquisition.
The Company determined the acquisition constituted an acquisition of assets instead of a business combination, as substantially all of the fair value of the gross assets acquired was concentrated in a group of similar identifiable assets, and therefore, the acquisition wasnot considered a business combination. In transactions accounted for as acquisitions of assets,no goodwill is recorded and contingent consideration, such as payments upon achievement of various developmental, regulatory and commercial milestones, generally isnot recognized at the acquisition date. In an asset acquisition, up front payments allocated to in-process research and development (“IPRD”) projects at the acquisition date are expensed unless there is an alternative future use. In addition, product development milestones are expensed upon achievement. As the Company is recording the transaction as an asset acquisition under ASC805, the contingent payments will be recognized upon achievement and at that time will be expensed to in-process research and development, or capitalized, depending on the determination if there is alternative future use of the purchase. Transaction costs of approximately $243 thousand associated with the acquisition were capitalized as part of the acquisition.
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The License Agreement obligates the Company to develop and commercialize the licensed products, at its own cost and expense, inclusive of licensed products with respect to any Subsequent Indications obtained upon exercise of an Exclusive Option. In the development and commercialization process, the Company is obligated to meet certain milestones, and must provide Statera with certain milestone payments, payable in either the form of cash or Company stock (at the sole discretion of the Company), upon accomplishing each milestone as outlined below.
| Event | Payment |
|---|---|
| Validation of current inventory of Materials for distribution and sales | $750,000 |
| Filing of BLA with FDA for Acute Radiation Syndrome | 1,000,000 |
| Total Acute Radiation Syndrome Development Milestones | $1,750,000 |
Upon exercise of an Exclusive Option with respect toone or more Subsequent Indications, the following corresponding applicable milestones and milestone payments (all milestone payments, collectively, the “Milestone Payments”), payable in either cash or Company stock (at the sole discretion of the Company), become obligations of the Company as well:
| Event | Payment |
|---|---|
| File IND and Initiate Phase 2 Clinical Study for Neutropenia | $500,000 |
| Phase III Completion - successfully meets endpoint required to secure FDA approval for treatment of Neutropenia | 750,000 |
| File BLA with FDA and achieve FDA Approval for Neutropenia | 1,500,000 |
| File IND and Initiate Phase 2 study of Lymphocyte Exhaustion | 500,000 |
| Phase III Completion - successfully meets endpoint required by FDA for treatment of Lymphocyte Exhaustion | 750,000 |
| File BLA with FDA and achieve FDA Approval for Lymphocyte Exhaustion | 1,500,000 |
| IND approval and initiation of Phase 3 study as a Vaccine Adjuvant | 500,000 |
| File US BLA with FDA and achieve FDA Approval for use as a Vaccine Adjuvant | 500,000 |
| Total Potential Development Milestones for additional Indications (as applicable) | $6,500,000 |
Pursuant to the License Agreement, in the event that the Company exercises its Exclusive Option with respect toone or more Subsequent Indications, the Company* may*elect, in its sole discretion, to accelerate any of the Milestone Payments in advance of the milestone achievements.
On* March 28, 2025,the Company notified Statera of its election to exercise its Exclusive Option to acquire the exclusive worldwide license to the neutropenia indication for Entolimod under the License Agreement (the “Neutropenia Option”) and to accelerate thefirst* milestone payment of $500 thousand related to the neutropenia indication (the “Neutropenia Milestone Payment”), payable by the Company in connection with the filing of an IND and initiation of a Phase2 clinical study for neutropenia. The Company paid the $500 thousand Neutropenia Milestone Payment paid in Company stock, as discussed further in Notes9 and10 below, and was capitalized as licensed technology.
As a result of the Company’s exercise of the Neutropenia Option, the Company is obligated to develop and commercialize the expanded licensed products related to the neutropenia indication, at its own cost and expense, including to meet those milestones discussed above, and is obligated to pay the milestone payments, other than the Neutropenia Option, upon accomplishing each such milestone.
On* June 18, 2025,the Company entered into an Amended and Restated Exclusive License Agreement (the “A&R License Agreement”) with Statera, which amended certain terms of the License Agreement to, amongst other things, (i) provide that the payment of royalties pursuant to the A&R License Agreement, if any, maybe made by the Company in either cash or securities of the Company, at the discretion of the Company; (ii) increase the approximate amount of the lien held by Avenue Venture Opportunities Fund, L.P. (“Avenue”) to up to $5.6 Million (the “Payoff Amount”); and (iii) provide that, other than the original license fee paid by the Company to Statera in connection with the closing of the license transaction in February 2025*and payment of the Neutropenia Milestone Payment, until such date that the Payoff Amount has been paid in full to Avenue, all subsequent payments due to Statera under the A&R License Agreement shall be paid by the Company as follows:20% of any such payments shall be paid to Statera and 80% of any such payments shall be paid directly to Avenue on behalf of Statera.
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| 8. | Commitments and Contingencies |
Lease
In* June 2024,the Company entered into a short-term rental agreement for office space located in Fremont, California. The Company evaluated the agreement and determined the short-term rental agreement doesnot* meet the criteria for capitalization. Monthly rent payments required are $1 thousand per month and the agreement terminated on* December 1, 2024.After expiration of the initial term, the agreement automatically renewed on a month to month basis and continues until terminated by either party upon30* days’ advance written notice.
Exclusive License Agreement–* Statera BioPharma*
As discussed above in Note7, the Company is obligated to make certain payments to Statera pursuant to the A&R License Agreement, upon the achievement of certain commercialization milestones.
Scorpius Statement of Work
On* May 9, 2025,the Company entered into a Statement of Work (the “Scorpius SOW”) with Scorpius BioManufacturing, Inc. (“Scorpius”), pursuant to which Scorpius will serve as the primary U.S. manufacturer for the Company’s late-stageTLR5* agonist, Entolimod, for the treatment of ARS. Pursuant to the Scorpius SOW, Scorpius will provide the following services, among others: cell line verification, legacy process verification, GMP scale-up production, drug product fill and finish, analytical development and qualification, and upstream and downstream optimization of the process. The Scorpius SOW shall be governed by the Terms and Conditions attached thereto, unless and until a Master Services Agreement is executed by and between the parties in connection with the services contemplated by the Scorpius SOW.
Pursuant to the Scorpius SOW, the Company has agreed to pay Scorpius service fees estimated to be approximately $2.4 million, with a total estimated investment by the Company of approximately $4.1 million, inclusive of additional pass-through costs and expenses, including for consumables and external services. The fees and costs will be payable on a milestone-based invoicing schedule tied to the completion of defined project stages and deliverables, as provided in the Scorpius SOW. Pass-through costs for raw materials, consumables, reagents, shipping, and subcontracted services will be managed by Scorpius on behalf of the Company at cost plus a 15% administrative fee. The Company is required to settle invoices within30 days, with Scorpius reserving the right to impose monthly interest charges of 1% for undisputed amounts unpaid after30 days. The Company will also be responsible for payment of any taxes, fees, duties or charges imposed by any governmental authority in connection with the services provided by Scorpius under the Scorpius SOW, other than on Scorpius’ net income taxes or franchise taxes. The Company estimates the duration of the Scorpius SOW to be approximatelytwo years, with approximately $3.9 million of costs to be incurred in the next12 months. As of* September 30, 2025*, the Company had paid Scorpius a total of $209 thousand in connection with the Scorpius SOW.
Contingencies
From time to time, the Company* mayhave certain contingent liabilities that arise in the ordinary course of its business activities. The Company accrues a liability for such matters when future expenditures are probable and such expenditures can be reasonably estimated. The Company recordedno liabilities for contingent matters as of September 30, 2025*.
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| 9. | Other Accrued Expenses (in thousands) |
| September 30, 2025 | December 31, 2024 | |
|---|---|---|
| Legal and professional fees | $29 | $39 |
| Consulting fees | 30 | — |
| Delaware franchise tax | 73 | — |
| Research study costs | — | 90 |
| Other | 41 | 18 |
| Total other accrued expenses | $173 | $147 |
| 10. | Preferred Stock |
The Company’s board of directors is authorized, without action by its stockholders, to designate and issue up to 10,000,000 shares of preferred stock inone or more series, and to fix the voting rights, designations, powers, preferences, the relative participating, optional or other special rights, if any, and any qualifications, limitations and restrictions thereof, applicable to the shares of any series of preferred stock that they* may*designate in the future.
As of* September 30, 2025*, there were 403 shares of the Company’s Series A Non-Voting Convertible Preferred Stock, par value $0.0001 per share (“Series A Preferred Stock”), and 3,581 shares of the Company’s Series B Non-Voting Convertible Preferred Stock, par value $0.0001 per share (“Series B Preferred Stock”), issued and outstanding. As of* December 31, 2024* there wereno series of preferred stock designated andno shares of preferred stock issued or outstanding.
Series A Preferred Stock
On* February 10, 2025,*in connection with the License Agreement, the Company filed a Certificate of Designation of Preferences, Rights and Limitations of the Series A Non-Voting Convertible Preferred Stock (the “Series A Certificate of Designation”) with the Secretary of State of the State of Delaware, pursuant to which 6,000 shares of the Company’s authorized shares of preferred stock were designated as Series A Preferred Stock. A summary of the powers, preferences, rights, qualifications, limitations and restrictions applicable to the Series A Preferred Stock is set forth below.
Ranking- the Series A Preferred Stock ranks on parity with the Company’s common stock and junior to the Company’s Series B Preferred Stock with respect to dividend rights and rights on the distribution of assets on any voluntary or involuntary liquidation, dissolution or winding up of the affairs of the Company.
Dividend Rights - to the extent that dividends are paid to holders of the Company’s common stock, holders of Series A Preferred Stock shall be entitled to participate in such dividends on an as-if-converted-to-common-stock basis, without regard to the Series A Beneficial Ownership Limitation (as defined below).
Voting Rights - except as otherwise provided by the Series A Certificate of Designation or required by law, the Series A Preferred Stock hasno voting rights. Provided, however, that so long as any shares of Series A Preferred Stock are outstanding, the Company willnot, without the affirmative vote of the holders of a majority of the then-outstanding shares of the Series A Preferred Stock, (i) alter or change adversely the powers, preferences or rights given to the Series A Preferred Stock or alter or amend the Series A Preferred Certificate of Designation, amend or repeal any provision of, or add any provision to, the Company’s amended and restated articles of incorporation, as amended (the “Charter”), or amended and restated bylaws (the “Bylaws”), or file any articles of amendment, certificate of designations, preferences, limitations and relative rights of any series of preferred stock, in each case if any such action would adversely alter or change the preferences, rights, privileges or powers of, or restrictions provided for the benefit of the Series A Preferred Stock, regardless of whether any of the foregoing actions shall be by means of amendment to the Charter or by merger, consolidation, recapitalization, reclassification, conversion or otherwise, (ii) issue further shares of Series A Preferred Stock, or (iii) enter into any agreement with respect to any of the foregoing.
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Conversion- subject to the Series A Beneficial Ownership Limitation, each share of Series A Preferred Stock is convertible into approximately 588 shares of Company common stock (the “Series A Conversion Ratio”), as follows:
| ● | Automatic Conversion - effective as of 5:00 p.m. Eastern time on the third business day after the date that the Company’s stockholders approve the conversion of the Series A Preferred Stock into shares of common stock in accordance with the listing rules of the Nasdaq Stock Market (“Stockholder Approval”), each share of Series A Preferred Stock then outstanding shall automatically convert into a number of shares of common stock equal to the Series A Conversion Ratio, subject to the Series A Beneficial Ownership Limitation. |
The Company received Stockholder Approval at its 2025 Annual Meeting of Stockholders, held on June 30, 2025. As a result, on July 3, 2025, 88 shares of Series A Preferred Stock automatically converted into 51,504 shares of Company common stock.
| ● | Optional Conversion - subject to the Series A Beneficial Ownership Limitation and the automatic conversion (discussed above), each share of Series A Preferred Stock then outstanding shall be convertible, at any time and from time to time following 5:00 p.m. Eastern time on the third business day after the date that the Stockholder Approval is obtained by the Company, at the option of the holder thereof, into a number of shares of common stock equal to the Series A Conversion Ratio. |
Beneficial Ownership Limitation - a holder of Series A Preferred Stock is prohibited from converting shares of Series A Preferred Stock into shares of common stock if, as a result of such conversion, such holder, together with its affiliates, would beneficially own in excess of the applicable beneficial ownership limitation (the “Series A Beneficial Ownership Limitation”). For purposes of the Series A Preferred Stock, the Series A Beneficial Ownership Limitation shall initially be set at 9.9% for each holder and its affiliates and* maybe adjusted at the discretion of the holder to a percentage between 4.9% and 19.9% (butnot* to exceed 19.9%) of the number of shares of common stock outstanding immediately after giving effect to the issuance of shares of common stock pursuant to such conversion.
Redemption Rights - shares of Series A Preferred Stock arenot redeemable.
Liquidation Rights - in the event of the liquidation, dissolution, or winding up of the affairs of the Company, whether voluntary or involuntary, holders of Series A Preferred Stock shall rank on parity with common stockholders as to the distributions of assets.
On* February 11, 2025,*in connection with, and as consideration for the License Agreement, the Company entered into a Securities Purchase Agreement with Statera, pursuant to which the Company issued and sold to Statera an aggregate of (i)55,635 shares of Company common stock and (ii) approximately 360 shares of Series A Preferred Stock for an aggregate price of approximately $1.2 million.
On* March 31, 2025,*in connection with the Company’s exercise of the Neutropenia Option pursuant to the License Agreement and as consideration for the Neutropenia Milestone Payment, the Company entered into a Securities Purchase Agreement with Statera and Avenue, pursuant to which the Company issued to Statera and Avenue an aggregate of $500 thousand shares of Company stock, consisting of 55,704 shares of common stock and approximately 131 shares of Series A Preferred Stock.
On* July 3, 2025,in connection the Company's receipt of Stockholder Approval at its2025* annual meeting of stockholders,88 shares of Series A Preferred Stock automatically converted into 51,504 shares of common stock.
Series B Preferred Stock
On* April 29, 2025,*the Company filed a Certificate of Designation of Preferences, Rights and Limitations of the Series B Non-Voting Convertible Preferred Stock (the “Series B Certificate of Designation”) with the Secretary of State of the State of Delaware in connection with the Tranched Financing. The Series B Certificate of Designation became effective upon filing and designates 8,400 shares of the Company’s preferred stock as Series B Preferred Stock.
Ranking - the Series B Preferred Stock ranks senior to the Company’s common stock and Series A Preferred Stock with respect to dividend rights and rights on the distribution of assets on any voluntary or involuntary liquidation, dissolution or winding up of the affairs of the Company.
Dividend Rights- the holders of outstanding shares of Series B Preferred Stock shall be entitled to cumulative dividends at an annual rate of 10% of the Stated Value (as defined below) per share. Dividends shall accrue from the date of each such Tranche Closing, and for as long as any shares of Series B Preferred Stock remain issued and outstanding and are payable quarterly in arrears. At the Company’s option, dividends on the Series B Preferred Stock* may*be paid in (i) cash, (ii) by adding the amount of dividends payable on such date to the aggregate Stated Value of such holder’s shares of Series B Preferred Stock (“PIK Dividends”), or (iii) any combination of cash and PIK Dividends. The “Stated Value” shall mean $1,000 per share, subject to adjustment in the event of any stock dividend (including PIK Dividends), stock split, combination, recapitalization, or other similar event affecting such shares.
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Voting Rights -except as otherwise provided by the Series B Certificate of Designation or required by law, the Series B Preferred Stock hasno voting rights. Provided, however, that so long as any shares of Series B Preferred Stock are outstanding, the Company willnot, without the affirmative vote of the holders of a majority of the then-outstanding shares of the Series B Preferred Stock, (i) alter or change adversely the powers, preferences or rights given to the Series B Preferred Stock or alter or amend the Series B Certificate of Designation, amend or repeal any provision of, or add any provision to, the Company’s Charter or Bylaws, or file any articles of amendment, certificate of designations, preferences, limitations and relative rights of any series of preferred stock, in each case if any such action would adversely alter or change the preferences, rights, privileges or powers of, or restrictions provided for the benefit of the Series B Preferred Stock, (ii) issue further shares of Series B Preferred Stock, or (iii) enter into any agreement with respect to any of the foregoing.
Conversion - subject to the Series B Beneficial Ownership Limitation, at any time, each holder of Series B Preferred Stock shall have the right, at such holder’s option, to convert any or all of the shares of Series B Preferred Stock held by such holder into fully paid and nonassessable shares of Company common stock. The number of shares of common stock issuable upon conversion of each share of Series B Preferred Stock shall be equal to the quotient obtained by dividing (i) the Stated Value of such share of Series B Preferred Stock plus all accrued and unpaid dividends thereon by (ii) the Series B Conversion Price in effect on the date of conversion. The conversion price (the “Series B Conversion Price”) in effect on any conversion date shall be equal to 90% of the lowest closing volume-weighted average price of the Company’s common stock on the Nasdaq Capital Market for thefive trading days immediately preceding the date of the conversion notice delivered by the holder, subject to adjustment, provided, however, that inno event shall the Series B Conversion Price be lower than $1.294 per share (the “Floor Price”), subject to adjustment.
Beneficial Ownership Limitation - a holder of Series B Preferred Stock is prohibited from converting shares of Series B Preferred Stock into shares of common stock if, as a result of such conversion, such holder, together with its affiliates, would beneficially own in excess of the applicable beneficial ownership limitation (the “Series B Beneficial Ownership Limitation”). For purposes of the Series B Preferred Stock, the Series B Beneficial Ownership Limitation shall initially be set at 4.9% for each holder and its affiliates and* maybe adjusted at the discretion of the holder to a percentage between 4.9% and 19.9% (butnot* to exceed 19.9%) of the number of shares of common stock outstanding immediately after giving effect to the issuance of shares of common stock pursuant to such conversion.
Redemption Rights - the Company* may,at any time and in its sole discretion, request to redeem all or any portion of the outstanding shares of Series B Preferred Stock at a price equal to 115% of the Stated Value plus all accrued and unpaid dividends thereon by providing the holder at least10* days prior written notice, during which10 day period the holder thereof shall have the right to convert such holder’s shares of Series B Preferred Stock into shares of Company common stock. Upon the closing of any equity or equity-linked financing by the Company after the issuance date, the holder shall have the right, butnot the obligation, to require the Company to redeem, out of the proceeds of such financing, up to 25% of the aggregate amount of net proceeds raised in the financing, outstanding shares of Series B Preferred Stock at a per share price equal to the Stated Value, plus all accrued and unpaid dividends thereon, provided that such right shall expire5 days after the holder receives notice from the Company of the consummation of a financing.
Liquidation Rights - in the event of the liquidation, dissolution, or winding up of the Company, whether voluntary or involuntary, the holders of Series B Preferred Stock shall be entitled to receive, prior and in preference to any distribution of any of the assets, funds, or proceeds available for distribution of the Company to the holders of common stock or any other class or series of capital stock ranking junior to the Series B Preferred Stock upon liquidation, by reason of their ownership thereof, an amount per share equal to the greater of (i) the Stated Value plus all accrued and unpaid dividends thereon or (ii) the amount that such holder would receive if such holder converted all of its shares of Series B Preferred Stock into common stock immediately prior to such liquidation, dissolution or winding up.
On* April 29, 2025,*the Company entered into a Securities Purchase Agreement (the “Preferred Purchase Agreement”) with an investor (the “Investor”), pursuant to which, subject to the conditions set forth therein, the Company shall sell to the Investor, and the Investor shall purchase from the Company, up to 8,400 shares of the Company’s Series B Preferred Stock and warrants (“Investor Warrants”) to purchase shares of the Company’s common stock for a total purchase price of up to $8,400,000 (the “Tranched Financing”) in several tranche closings (each, a “Tranche Closing”).
The Preferred Purchase Agreement provides that the Tranched Financing shall be conducted throughsix separate Tranche Closings pursuant to which, subject to satisfaction of the applicable closing conditions set forth in the Preferred Purchase Agreement, the Company shall sell and issue the Investor up to an aggregate of 8,400 shares of Series B Preferred Stock as follows: (i)700 shares of Series B Preferred Stock, for $700,000, in the initial Tranche Closing, which was consummated on* June 25, 2025; (ii)700 shares of Series B Preferred Stock, for $700,000, in thesecond* Tranche Closing, which shall be consummated10 trading days after the initial Tranche Closing; (iii)1,750 shares of Series B Preferred Stock, for $1,750,000, in thethird Tranche Closing, which shall be consummated20 trading days after thesecond Tranche Closing; (iv)1,750 shares of Series B Preferred Stock, for $1,750,000, in thefourth Tranche Closing, which shall be consummated20 trading days after thethird Tranche Closing; (v)1,750 shares of Series B Preferred Stock, for $1,750,000, in thefifth Tranche Closing, which shall be consummated20 trading days after thefourth Tranche Closing; and (vi)1,750 shares of Series B Preferred Stock, for $1,750,000, in the final Tranche Closing, which shall be consummated20 trading days after thefifth Tranche Closing.
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In addition to the shares of Series B Preferred Stock to be sold and issued to the Investor in the Tranched Financing, at each Tranche Closing the Company shall also issue the Investor an Investor Warrant to purchase that number of shares of Company common stock equal to 30% of shares of common stock issuable upon conversion in full of the shares of Series B Preferred Stock issued at the same Tranche Closing. Each Investor Warrant shall be immediately exercisable (subject to certain beneficial ownership limitations), expire five years from the date of issuance, and have an initial exercise price equal to the average closing price of the Company’s common stock during the priorfive trading days preceding each Tranche Closing (as* may*be adjusted for stock dividends, subdivisions, or combinations in the manner described in the Investor Warrant). In the event that Investor Warrants issued to the Investor in a subsequent Tranche Closing have a lower exercise price than the Investor Warrants outstanding as of such later Tranche Closing, immediately after the Tranche Closing the exercise price of all outstanding Investor Warrants held by the Investor shall automatically be reduced to equal such lower exercise price of the Investor Warrants issued in such Tranche Closing.
In the event that the average closing price of the Company’s common stock during the priorthree trading days preceding a Tranche Closing date shallnot be equal to or greater than the Floor Price (as defined below), then the applicable Tranche Closing shall be delayed until such time as the price meets the required threshold for a period offive consecutive trading days. Notwithstanding the foregoing, the Investor has the ability, subject to prior written consent of the Company, to purchase any number of shares of Series B Preferred Stock prior to the dates of the Tranche Closings provided for in the Preferred Purchase Agreement.
The consummation of the transactions contemplated by the Preferred Purchase Agreement is subject to various customary closing conditions. Pursuant to the Preferred Purchase Agreement, subject to certain exceptions, for so long as any shares of Series B Preferred Stock remain outstanding (the “ROFR Period”), the Investor will have a right offirst refusal to with respect to any investment proposed to be made by any other person for each and every future variable rate transaction during the ROFR Period. Additionally, subject to certain exceptions, for so long as the Investor holds any shares of Series B Preferred Stock, Warrants, or shares of common stock issued upon conversion of the Series B Preferred Stock or exercise of the Warrants, the Investor shall have the right to participate in any subsequent financing for up to 20% of such financing. Moreover, for so long as any shares of Series B Preferred Stock remain outstanding, subject to certain exceptions, the Investor shall have the right to require the Company to use 25% of the proceeds received by the Company from any future financing to redeem any shares of Series B Preferred Stock held by the Investor in accordance with the terms of the Series B Certificate of Designation.
The Preferred Purchase Agreement contains customary termination provisions for the Investor under certain limited circumstances and the Preferred Purchase Agreement will automatically terminate if any Tranche Closing hasnot occurred prior to* December 31, 2025.*
Craft Capital Management LLC (“Craft”) acted as placement agent to the Company in connection with the Tranched Financing. As consideration for services rendered by Craft, the Company shall (i) pay Craft a cash fee equal toeight percent (8%) of any such funds received by the Company from the Investor pursuant to the Preferred Purchase Agreement and (ii) issue to Craft that number of warrants to purchase shares of common stock equal in value tosix percent (6%) of any such funds received by the Company from the Investor pursuant to the Preferred Purchase Agreement.
Initial Tranche
On* June 25, 2025,the Company and the Investor held the initial Tranche Closing, pursuant to which the Company received gross proceeds of $700 thousand pursuant to the Preferred Purchase Agreement and issued 700 shares of Series B Preferred Stock to the Investor. In addition to the shares of Series B Preferred Stock, the Company issued Investor Warrants to purchase 61,287 shares of Company common stock with an initial exercise price of $3.85 per share. The Investor Warrants are exercisable immediately and expire on June 25, 2030.On August 21, 2025,in connection with closing of the Third Tranche and pursuant to the Investor Warrants, the exercise price of the Investor Warrants issued to Investor in the Initial Tranche was reduced to $3.372 per share. On September 26, 2025,*in connection with closing of the Fourth Tranche and pursuant to the Investor Warrants, the exercise price of the Investor Warrants issued to the Investor in the Initial Tranche was further reduced to $3.04 per share. The triggering of the anti-dilution clause created a change in valuation of the Investor Warrants issued to the Investor. The valuation resulted in a deemed dividend from the repricing calculation of the 61,287 warrants of $1 thousand.
Additionally, as consideration for placement agent services rendered by Craft in connection therewith, the Company paid Craft $56 thousand at closing of the Initial Tranche and issued warrants to purchase an aggregate of 10,000 shares of Company common stock to the designees of Craft, which warrants have a term offour years from the date of issuance, are exercisable immediately upon issuance, and have an exercise price of $4.20 per share of common stock (equal to 110% of the closing price per share of the Company’s common stock on* June 25, 2025).*Net proceeds to the Company, after deducting placement agent fees and offering expenses paid by the Company, were $585 thousand. The net proceeds were allocated between the Series B Preferred Stock and Investor Warrants issued in the offering based on the relative fair values, which were $455 thousand and $130 thousand, respectively.
Between* July 31, 2025and August 15, 2025,*the Investor converted all 700 Initial Tranche Preferred Shares issued to the Investor in connection with the Initial Tranche Closing into an aggregate of 244,597 shares of common stock.
Second Tranche
On* July 31, 2025,the Company and the Investor held thesecond* Tranche Closing, pursuant to which the Company received gross proceeds of $700 thousand pursuant to the Preferred Purchase Agreement and issued 700 shares of Series B Preferred Stock to the Investor. In addition to the shares of Series B Preferred Stock, the Company issued Investor Warrants to purchase 64,065 shares of Company common stock with an initial exercise price of$3.966 per share. The Investor Warrants are exercisable immediately and expire on* July**31,* 2030. On* August 21, 2025,in connection with closing of the Third Tranche and pursuant to the Investor Warrants, the exercise price of the Investor Warrants issued to the Investor in the Initial Tranche was reduced to $3.372 per share. On September 26, 2025,*in connection with closing of the Fourth Tranche and pursuant to the Investor Warrants, the exercise price of the Investor Warrants issued to the Investor in the Initial Tranche was further reduced to $3.04 per share. The triggering of the anti-dilution clause created a change in valuation of the Investor Warrants issued to the Investor. The valuation resulted in a deemed dividend from the repricing calculation of the 64,065 warrants of $4 thousand.
Additionally, as consideration for placement agent services rendered by Craft in connection therewith, the Company paid Craft $56 thousand at closing of the Initial Tranche and issued warrants to purchase an aggregate of 11,068 shares of Company common stock to the designees of Craft, which warrants have a term offour years from the date of issuance, are exercisable immediately upon issuance, and have an exercise price of $3.795 per share of common stock (equal to 110% of the closing price per share of the Company’s common stock on* July**31,* 2025). Net proceeds to the Company, after deducting placement agent fees and offering expenses paid by the Company, were $625 thousand. The net proceeds were allocated between the Series B Preferred Stock and Investor Warrants issued in the offering based on the relative fair values, which were $499 thousand and $126 thousand, respectively.
Between* August 15, 2025and September 30, 2025,*the Investor converted 615 Second Tranche Preferred Shares issued to the Investor in connection with the Second Tranche Closing into an aggregate of 219,899 shares of common stock.
Third Tranche
On* August 21, 2025,the Company and the Investor held thethird* Tranche Closing, pursuant to which the Company received gross proceeds of $1,750,000 pursuant to the Preferred Purchase Agreement and issued 1,750 shares of Series B Preferred Stock to the Investor. In addition to the shares of Series B Preferred Stock, the Company issued Investor Warrants to purchase 188,842 shares of Company common stock with an initial exercise price of $3.372 per share. On* September 26, 2025,*in connection with closing of the Fourth Tranche and pursuant to the Investor Warrants, the exercise price of the Investor Warrants issued to the Investor in the Initial Tranche was further reduced to $3.04 per share. The triggering of the anti-dilution clause created a change in valuation of the Investor Warrants issued to the Investor. The valuation resulted in a deemed dividend from the repricing calculation of the 188,842 warrants of $5 thousand.
Additionally, as consideration for placement agent services rendered by Craft in connection therewith, the Company paid Craft $140 thousand at closing of the Third Tranche and issued warrants to purchase an aggregate of 29,830 shares of Company common stock to the designees of Craft, which warrants have a term offour years from the date of issuance, are exercisable immediately upon issuance, and have an exercise price of $3.52 per share of common stock (equal to 110% of the closing price per share of the Company’s common stock on* August 21, 2025).*Net proceeds to the Company, after deducting placement agent fees and offering expenses paid by the Company, were $1.6 million. The net proceeds were allocated between the Series B Preferred Stock and Investor Warrants issued in the offering based on the relative fair values, which were $1.3 million and $319 thousand, respectively.
As of* September 30, 2025,*all 1,750 of the Third Tranche Preferred Shares remain outstanding.
Fourth Tranche
On* September 26, 2025,the Company and the Investor held thefourth* Tranche Closing, pursuant to which the Company received gross proceeds of $1,750,000 pursuant to the Preferred Purchase Agreement and issued 1,750 shares of Series B Preferred Stock to the Investor. In addition to the shares of Series B Preferred Stock, the Company issued to the Investor Warrants to purchase 195,793 shares of Company common stock with an initial exercise price of $3.04 per share.
Additionally, as consideration for placement agent services rendered by Craft in connection therewith, the Company paid Craft $140 thousand at closing of the Third Tranche and issued warrants to purchase an aggregate of 32,249 shares of Company common stock to the designees of Craft, which warrants have a term offour years from the date of issuance, are exercisable immediately upon issuance, and have an exercise price of $3.256 per share of common stock (equal to 110% of the closing price per share of the Company’s common stock on* September 26, 2025).*Net proceeds to the Company, after deducting placement agent fees and offering expenses paid by the Company, were $1.6 million. The net proceeds were allocated between the Series B Preferred Stock and Investor Warrants issued in the offering based on the relative fair values, which were $1.2 million and $321 thousand, respectively.
As of* September 30, 2025,*all 1,750 of the Fourth Tranche Preferred Shares remain outstanding.
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| 11. | Common Stock |
At* September 30, 2025* and* December 31, 2024*, there were 1,662,921 and 556,902 shares of Company common stock issued and outstanding, respectively.
Effective* March 7, 2025,the Company implemented a reverse stock split of its issued and outstanding shares of common stock, par value $0.0001 per share, at a ratio of1*-for-17. As a result of the reverse stock split, the total number of shares of common stock held by each stockholder of the Company were converted automatically into the number of shares of common stock equal to the number of issued and outstanding shares of common stock held by each such stockholder immediately prior to the reverse stock split divided by 17. Refer to Note2, Summary of Significant Accounting Policies, for details of the reverse stock split.
On* May 13, 2024,the Company sold 277,059 shares of its common stock, together with Series A warrants (the “Series A Warrants”) to purchase an aggregate of 277,059 shares of common stock and Series B warrants (the “Series B Warrants” and collectively with the Series A Warrants, the “Common Warrants”) to purchase an aggregate of 415,589 shares of common stock, to certain investors in a registered public offering. Each share of common stock was sold together withone Series A Warrant andone and a half Series B Warrants at a combined price of $14.45 per share and Common Warrants, resulting in gross proceeds to the Company of approximately $4 million. Net proceeds to the Company, after deducting placement agent fees and offering expenses paid by the Company, was approximately $3.3 million. The net proceeds were allocated between the common stock and Common Warrants issued in the offering based on the relative fair values, which were $1.4 million and $1.9 million, respectively. Each of the Common Warrants are exercisable immediately upon issuance and have an exercise price of $14.45 per share, subject to certain adjustments. The Series A Warrants will expireone year from the date of issuance and the Series B Warrants will expire five years from the date of issuance. As compensation for services rendered by the placement agent, the Company paid the placement agent a cash fee of 7.0% of the gross proceeds of the offering (amounting to approximately $280 thousand) at closing, as well as $100 thousand for the reimbursement of certain expenses. Additionally, as partial consideration for services rendered in connection with the offering, the Company issued the placement agent registered warrants to purchase an aggregate of 11,083 shares of Company common stock, equal to 4.0% of the aggregate shares of common stock sold in the offering. The placement agent warrants have an initial exercise price of $15.90 per share (equal to 110% of the combined offering price per share and Common Warrants), have a term offive years from the commencement of sales in the offering, and are exercisable commencingsix* months from closing. During thesix months ended* June 30, 2025,a total of 7,524 Series A Warrants were exercised for total proceeds of $109 thousand. On May 13, 2025,*the remaining 269,535 Series A Warrants outstanding as of such date expired pursuant to their terms.
On* September 13, 2024,the Company entered into an Equity Distribution Agreement (the “Distribution Agreement”) with Maxim Group LLC (“Maxim”), pursuant to which the Company mayoffer and sell, from time to time, through or to Maxim, as sales agent or principal, shares of its common stock. The Company will pay Maxim a commission of 3% of the aggregate gross proceeds from each sale of shares pursuant to the Distribution Agreement. The Company also agreed to reimburse Maxim for certain specified fees and expenses of up to $40 thousand, plus an additional $5 thousand for each bringdown, as provided in the Distribution Agreement. The agreement will terminate upon the earlier of (i) the sale of all shares of common stock having an aggregate offering price of $10 million; (ii)twenty-four months from the date of the agreement; (iii) the mutual termination of the agreement uponfifteen* days’ prior written notice; and (iv) as otherwise permitted therein. During the year ended* December 31, 2024*, the Company sold a total of 193,161 shares of its common stock pursuant to the Distribution Agreement for gross proceeds of $1.2 million. The Company paid Maxim $37 thousand in commissions. Net proceeds to the Company, after deducting commissions and offering expenses paid by the Company, was approximately $1.1 million. During thenine months ended* September 30, 2025*, the Company sold an aggregate of 172,700 shares of common stock pursuant to the Distribution Agreement for gross proceeds of $1.8 million and net proceeds of $1.6 million after $53 thousand of commissions paid by the Company to Maxim and $108 thousand of legal and other fees.
On* February 11, 2025,*in connection with, and as consideration for, the License Agreement, the Company entered into a Securities Purchase Agreement with Statera, pursuant to which it issued and sold to Statera an aggregate of (i)55,635 shares of Company common stock and (ii) approximately 360 shares of Series A Preferred Stock for an aggregate price of approximately $1.2 million.
On* March 18, 2025,the Company entered into an Equity Purchase Agreement (the “Purchase Agreement”) with Mast Hill Fund, L.P. (“Mast Hill”), pursuant to which the Company will have the right, butnot* the obligation, to sell to Mast Hill, and Mast Hill will have the obligation to purchase from the Company, up to $25 million shares of the Company’s common stock, at the Company’s sole discretion, over the24 months following the date of execution, subject to the terms of the Purchase Agreement (the “Equity Line of Credit”). As consideration for Mast Hill’s commitment to purchase shares of Company common stock under the Purchase Agreement, the Company issued Mast Hill 29,800 restricted shares of common stock following the execution of the Purchase Agreement (the “Commitment Shares”). During thenine months ended* September 30,*2025, the Company sold and issued an aggregate of 235,792 shares of common stock to Mast Hill pursuant to the Purchase Agreement for gross proceeds of $783 thousand and net proceeds of $741 thousand, after deducting offering costs.
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On* March 31, 2025,*in connection with the Company’s exercise of the Neutropenia Option pursuant to the License Agreement and as consideration for the Neutropenia Milestone Payment, the Company entered into a Securities Purchase Agreement with Statera and Avenue, pursuant to which the Company issued to Statera and Avenue an aggregate of $500 thousand shares of Company stock, consisting of an aggregate of 55,704 shares of common stock and approximately 131 shares of Series A Preferred Stock.
Common stockholders are entitled to dividends if and when declared by the Company’s Board of Directors, subject to the rights of the preferred stockholders. As of* September 30, 2025*, no dividends on common stock had been declared by the Company. At* September 30, 2025* and* December 31, 2024*, the Company had reserved shares of common stock for issuance as follows:
| September 30, | December 31, | |
|---|---|---|
| 2025 | 2024 | |
| Warrants to purchase common stock | 1,055,809 | 707,234 |
| Options issued and outstanding | 355,368 | 8,868 |
| Restricted stock units outstanding | 79,415 | 44,119 |
| Shares available for future incentive plan grants | 79,113 | 5,555 |
| Shares available for the conversion of Series A Preferred Stock | 237,200 | — |
| Shares available for the conversion of Series B Preferred Stock | 2,770,477 | — |
| Total | 4,577,382 | 765,776 |
| 12. | Common Stock Warrants |
Historically, the Company has entered into warrant agreements in connection with certain consulting agreements and equity offerings. In* August 2023,the Company implemented a1*-for-100 reverse stock split pursuant to which, per the terms of the agreements, the number of shares of common stock issuable upon exercise of each of the warrants outstanding at that time was reduced by dividing the quantity outstanding by 100 and the exercise price of each such warrant was multiplied by 100.No other terms of the warrants were changed as a result of the reverse stock split. Additionally, in* March 2025,the Company implemented a1*-for-17 reverse stock split pursuant to which, per the terms of the agreements, the number of shares of common stock issuable upon exercise of each of the warrants outstanding at that time was reduced by dividing the quantity outstanding by 17 and the exercise price of each such warrant was multiplied by 17.No other terms of the warrants were changed as a result of the reverse stock split.
In* July 2021,the Company entered into a consulting agreement, pursuant to which warrants to purchase 30 shares of common stock were granted and warrants to purchase an additional 30 shares of common stock were granted in November 2021.The warrants are exercisable upon issuance, have an exercise price of $1,768.00 per share and have a term offive years. The consulting agreement was effective as of February 2021,had an initial monthly fee of $5 thousand and a term oftwo years. The agreement was amended in Mayof2022* to increase the monthly payment to $7.5 thousand. Currently, the agreement is automatically renewing on a month-to-month basis until terminated by either party. The warrant issuances are indexed to, and settled in, the Company’s own common stock and were classified within stockholders’ equity.
In* November 2021,the Company issued warrants to purchase 102 shares of common stock to designees of ThinkEquity LLC (“ThinkEquity”), the underwriter of the Company’s initial public offering. The warrants maybe exercised at any time on or after May 9, 2022,*have an exercise price of $10,625.00 per share and have a term offive years. The warrant issuances are indexed to and settled in the Company’s own common stock and were classified within stockholders’ equity.
In* February 2023,the Company issued warrants to purchase 589 shares of common stock to designees of ThinkEquity, the underwriter of the underwritten public offering of 11,765 shares of Company common stock that closed in February 2023.The designees paid an aggregate of $0.1 thousand for the warrants. The warrants maybe exercised at any time on or after August 7, 2023,have an exercise price of $531.25 per share, and have a term offour years commencing180* days following the commencement of sales in the offering. The warrant issuances were indexed to and settled in the Company’s own stock and were classified within stockholders’ equity.
In* Julyand August 2023,the Company issued warrants to purchase an aggregate of 2,805 shares of common stock to Maxim, the placement agent for each of thethree* public offerings of the Company’s common stock completed during the period. The warrants are exercisable at any time beginningsix months after the close of the applicable equity offering and expire five years from the commencement of sales under the applicable offering. Of the warrants issued in the offerings,765 are exercisable beginning on* January 11, 2024at a price of $113.20 per share;1,206 are exercisable beginning on January 19, 2024at a price of $81.60 per share; and 781 are exercisable beginning on February 9, 2024*at a price of $83.64 per share.
23
In* May 2024,in connection with the sale of 277,059 shares of common stock, the Company issued Series A Warrants to purchase an aggregate of 277,059 shares of common stock and Series B Warrants to purchase an aggregate of 415,589 shares of common stock to the purchasers of the stock. The warrants are exercisable upon issuance and have an exercise price of $14.45 per share. During thesix* months ended* June 30, 2025,a total of 7,524 Series A Warrants were exercised for total proceeds of $109 thousand. All remaining outstanding Series A Warrants expired on May 13, 2025and the Series B Warrants expire on May 14, 2029.Additionally, the Company issued warrants to purchase 11,083 shares of common stock to Maxim, the placement agent for the public offering of the Company’s securities. The placement agent warrants are exercisable at any time beginningsix* months after the closing date of the equity offering and expire five years from the from the commencement of sales under the offering.
The Company estimated the value of the warrants issued to the placement agent in* May 2024using the Black-Scholes options valuation model. The fair value of the warrants issued in February 2023was $195 thousand and was recognized as issuance costs of the common stock issued in the underwritten public offering and was classified within stockholders’ equity. The fair value of the warrants issued in Julyand August 2023totaled $168 thousand and was recognized as issuance costs of the common stock issued in thethree* offerings during the period and was classified within stockholders’ equity. The fair value of the warrants issued in* May 2024*was $70 thousand and was recognized as issuance costs of the common stock issued in the public offering and was classified within stockholders’ equity as additional paid in capital.
In* June 2025,in connection with the Initial Tranche Closing, the Company issued Investor Warrants to purchase 61,287 shares of common stock. The Investor Warrants are exercisable upon issuance, had an initial exercise price of $3.85 per share and expire on June 25, 2030.On August 21, 2025,in connection with closing of the Third Tranche and pursuant to the Investor Warrants, the exercise price of the Investor Warrants issued in the Initial Tranche was reduced to $3.372 per share. On September 26, 2025,in connection with closing of the Fourth Tranche and pursuant to the Investor Warrants, the exercise price of the Investor Warrants issued in the Initial Tranche was further reduced to $3.04 per share. Additionally, the Company issued warrants to purchase 10,000 shares of common stock to designees of Craft, the placement agent in connection with the Tranched Financing, as partial consideration for services rendered by Craft in connection therewith. The placement agent warrants are exercisable upon issuance, have an exercise price of $4.20 per share and expire on June 25, 2029.*
The Company estimated the value of the placement agent warrants issued to the Craft designees using the Black-Scholes options valuation model. The fair value was $36 thousand and was recognized as issuance costs of the Series B Preferred Stock issued in the offering and was classified within stockholders’ equity as additional paid in capital.
In* July2025,* in connection with the Second Tranche Closing, the Company issued Investor Warrants to purchase 64,065 shares of common stock. The Investor Warrants are exercisable upon issuance, had an initial exercise price of $3.996 per share and expire on* July31,* 2030. On* August 21, 2025,in connection with closing of the Third Tranche and pursuant to the Investor Warrants, the exercise price of the Investor Warrants issued in the Initial Tranche was reduced to $3.372 per share. On September 26, 2025,in connection with closing of the Fourth Tranche and pursuant to the Investor Warrants, the exercise price of the Investor Warrants issued in the Initial Tranche was further reduced to $3.04 per share. Additionally, the Company issued warrants to purchase 11,068 shares of common stock to designees of Craft, the placement agent in connection with the Tranched Financing, as partial consideration for services rendered by Craft in connection therewith. The placement agent warrants are exercisable upon issuance, have an exercise price of $3.795 per share and expire on July**31,* 2029.
The Company estimated the value of the placement agent warrants issued to the Craft designees using the Black-Scholes options valuation model. The fair value was $31 thousand and was recognized as issuance costs of the Series B Preferred Stock issued in the offering and was classified within stockholders’ equity as additional paid in capital.
In* August 2025,in connection with the Third Tranche Closing, the Company issued Investor Warrants to purchase 188,842 shares of common stock. The Investor Warrants are exercisable upon issuance, had an initial exercise price of $3.372 per share and expire on August 21, 2030.On September 26, 2025,in connection with closing of the Fourth Tranche and pursuant to the Investor Warrants, the exercise price of the Investor Warrants issued in the Initial Tranche was further reduced to $3.04 per share. Additionally, the Company issued warrants to purchase 29,830 shares of common stock to designees of Craft, the placement agent in connection with the Tranched Financing, as partial consideration for services rendered by Craft in connection therewith. The placement agent warrants are exercisable upon issuance, have an exercise price of $3.52 per share and expire on August 21, 2029.*
The Company estimated the value of the placement agent warrants issued to the Craft designees using the Black-Scholes options valuation model. The fair value was $77 thousand and was recognized as issuance costs of the Series B Preferred Stock issued in the offering and was classified within stockholders’ equity as additional paid in capital.
In* August 2025,the Company issued warrants to purchase an aggregate of 32,500 shares of common stock totwo* individuals in exchange for investor relations services provided. The warrants are exercisable upon issuance, have an exercise price of $3.64 per share and expire on* August 11, 2029.*The Company estimated the value of the warrants issued to the individuals using the Black-Scholes options valuation model. The fair value was $94 thousand and was classified within stockholders’ equity as additional paid in capital.
In* September 2025,in connection with the Fourth Tranche Closing, the Company issued to the Investor warrants to purchase 195,793 shares of common stock. The warrants are exercisable upon issuance, have an initial exercise price of $3.04 per share and expire on September 26, 2030.Additionally, the Company issued warrants to purchase 32,249 shares of common stock to designees of Craft, the placement agent in connection with the Tranched Financing, as partial consideration for services rendered by Craft in connection therewith. The placement agent warrants are exercisable upon issuance, have an exercise price of $3.256 per share and expire on September 26, 2029.*
The Company estimated the value of the placement agent warrants issued to the Craft designees using the Black-Scholes options valuation model. The fair value was $78 thousand and was recognized as issuance costs of the Series B Preferred Stock issued in the offering and was classified within stockholders’ equity as additional paid in capital.
The fair value of the warrants issued to placement agents in2025 and2024 was estimated on the date of grant using the following assumptions:
| 2025 | 2024 | |||
|---|---|---|---|---|
| Minimum | Maximum | Minimum | Maximum | |
| Expected life (in years) | 4.0 | 5.0 | 5.0 | 5.0 |
| Expected volatility | 126.3% | 187.8% | 118.6% | 118.6% |
| Risk-free interest rate | 3.71% | 3.96% | 4.50% | 4.50% |
| Dividend yield | 0% | 0% | 0% | 0% |
A summary of the Company’s outstanding warrants as of* September 30, 2025* is as follows:
| Class of Shares | Number of Warrant Shares | Exercise Price of Warrants | Expiration Date of Warrants |
|---|---|---|---|
| Common Stock | 30 | $1,768.00 | July 1, 2026 |
| Common Stock | 30 | $1,768.00 | November 15, 2026 |
| Common Stock | 102 | $10,625.00 | November 10, 2026 |
| Common Stock | 589 | $531.25 | August 9, 2027 |
| Common Stock | 765 | $112.20 | July 10, 2028 |
| Common Stock | 1,206 | $81.60 | July 14, 2028 |
| Common Stock | 781 | $83.64 | August 4, 2028 |
| Common Stock | 11,083 | $15.90 | May 9, 2029 |
| Common Stock | 415,589 | $14.45 | May 14, 2029 |
| Common Stock | 61,287 | $3.04 | June 25, 2030 |
| Common Stock | 10,000 | $4.20 | June 25, 2029 |
| Common Stock | 64,065 | $3.04 | July 31, 2030 |
| Common Stock | 11,068 | $3.80 | July 31, 2029 |
| Common Stock | 32,500 | $3.64 | August 11, 2029 |
| Common Stock | 188,842 | $3.04 | August 21, 2030 |
| Common Stock | 29,830 | $3.52 | August 21, 2029 |
| Common Stock | 195,793 | $3.04 | September 26, 2030 |
| Common Stock | 32,249 | $3.26 | September 26, 2029 |
| Total | 1,055,809 | ||
During thenine months ended* September 30, 2025*, a total of 7,524 Series A Warrants were exercised for total proceeds of $109 thousand. There wereno warrant exercises in thenine months ended* September 30, 2024*.
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| 13. | Equity Incentive Plans |
2017 Equity Incentive Plan
In2017, the Company adopted its2017 Equity Incentive Plan (the*“2017* Plan”).
On* November 10, 2021,the2017* Plan terminated and was replaced by the2021 Plan (defined below), and future issuances of incentive instruments will be governed by the2021 Plan. To the extent that outstanding awards under the2017 Plan are forfeited or lapse unexercised, the shares of common stock subject to such awards willno longer be available for future issuance.
2021 Equity Incentive Plan
In2021, the Company adopted the2021 Equity Incentive Plan (the*“2021* Plan”). The plan allows for the issuance of incentive stock options, nonstatutory stock options, restricted stock awards, restricted stock units, stock bonus awards and performance-based awards. Awards granted under the2021 Plan are determined by the Compensation Committee of the Company’s board of directors, who is responsible for administering the2021 Plan. The term for stock options shall beno more thanten years from the date of grant. In the case of an Incentive Stock Option granted to an optionee who, at the time the option is granted, owns stock representing more than10% of the voting power of all classes of stock of the Company or any Parent or Subsidiary, the term of the option shall befive years from the date of grant or such shorter term as* maybe provided in the option Agreement. To the extent outstanding awards under the2021* Plan are forfeited or lapse unexercised, the shares of common stock subject to such awards will be available for future issuance under the2021 Plan. The2021 Plan provides that additional shares will automatically be added to the shares authorized for issuance under the2021 Plan on* January 1of each year. The number of shares added each year will be equal to the lesser of: (i)5.0% of the outstanding shares of the Company’s common stock on December**31st* of the preceding calendar year or (ii) such number of shares determined by the board of directors, in its discretion. On* January 1, 2024,4,312 shares were automatically added to the number of shares authorized for issuance under2021* Plan (an increase equal to5% of the number of the outstanding shares of Company common stock as of* December 31, 2023).*
Amended and Restated2021* Equity Incentive Plan, as amended*
On* August 9, 2024,the Company adopted its Amended and Restated2021* Equity Incentive Plan (the “A&R2021 Plan”), which amended and restated the2021 Plan in full to, amongst other things, increase the number of shares of common stock authorized for issuance thereunder from 5,434 shares to 58,823 shares. The Company’s Board of Directors unanimously approved the adoption of the A&R2021 Plan, subject to stockholder approval, on* June 15, 2024,and the Company’s stockholders approved the A&R2021* Plan at the Company’s2024 Annual Meeting of Stockholders held on* August 9, 2024.On January 1, 2025,27,846 shares were automatically added to the number of shares authorized for issuance under A&R2021* Plan (an increase equal to 5% of the number of the outstanding shares of Company common stock as of* December 31, 2024*).
On* June 30, 2025,following stockholder approval, the Company further amended the A&R2021* Plan to increase the number of shares of common stock authorized for issuance thereunder from 86,669 to 511,669 shares.
As of* September 30, 2025*, there were 79,113 shares of common stock available for issuance under the A&R2021 Plan, as amended.
Stock Options
In the case of an incentive stock option (i) granted to an employee who, at the time of grant of such option, owns stock representing more than 10% of the voting power of all classes of stock of the Company or any parent or subsidiary of the Company, the exercise price shall beno less than 110% of the fair market value per share on the date of grant; (ii) granted to any other employee, the per share exercise price shall beno less than 100% of the fair market value per share on the date of grant. In the case of a non-statutory stock option (i) granted to an employee who, at the time of grant of such option, owns stock representing more than 10% of the voting power of all classes of stock of the Company or any parent or subsidiary of the Company, the exercise price shall beno less than 110% of the fair market value per share on the date of grant; (ii) granted to any other service provider, the per share exercise price shall beno less than 100% of the fair market value per share on the date of grant. Notwithstanding the foregoing, options* may*be granted with a per share exercise price other than as required above pursuant to a merger or other corporate transaction.
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The options* may*include provisions permitting exercise of the option prior to full vesting. Any unvested shares upon termination shall be subject to repurchase by the Company at the original exercise price of the option. Stock options granted under the Company’s equity incentive plans generally vest over four years from the date of grant.
The following table summarizes the stock option award activity for thenine months ended* September 30, 2025*:
| Outstanding | Exercisable | |
|---|---|---|
| January 1, 2025 | 8,868 | 1,935 |
| Granted | 346,500 | — |
| Vested | — | 5,201 |
| Canceled or expired | — | — |
| Exercised | — | — |
| September 30, 2025 | 355,368 | 7,136 |
The weighted-average exercise price as of* September 30, 2025* for stock options outstanding and stock options exercisable was $8.63 and $259.70, respectively. The weighted average remaining contractual life as of* September 30, 2025* for stock options outstanding and stock options exercisable was 9.82 and 8.54 years, respectively. Stock-based compensation expense related to stock options was $91 thousand and $222 thousand for thethree andnine months ended* September 30, 2025*, respectively. Stock-based compensation expense related to stock options was $55 thousand and $160 thousand for thethree andnine months ended* September 30, 2024*, respectively. As of* September 30, 2025*, there was $1.0 million of remaining expense, which is expected to be amortized over 3.46 years.
Restricted Stock Awards
The following table summarizes the restricted stock award activity for thenine months ended* September 30, 2025*:
| Weighted-Average | |||
|---|---|---|---|
| Number of · Grant Date | |||
| Shares · Fair Value Per Share | |||
| January 1, 2025 | 111 | $22.78 | |
| Issuance of restricted common stock | — | $ | - |
| Vested | (111) | $22.78 | |
| Cancelled | — | $ | - |
| September 30, 2025 | — | $ | - |
The fair value of restricted stock awards vested during thethree andnine months ended* September 30, 2025* was $0 and $2 thousand, respectively. The fair value of restricted stock awards vested during thethree andnine months ended* September 30, 2024* was $2 thousand and $5 thousand, respectively. There isno remaining expense to be recognized in connection with restricted stock awards.
Restricted Stock Units
The following table sets forth the status of the Company’s non-vested restricted stock units issued to employees:
| Number of Shares | Weighted- Average Grant-Date Fair Value Per Share | |
|---|---|---|
| Non-vested as of January 1, 2025 | 44,119 | $3.91 |
| Granted | 68,084 | $5.96 |
| Vested | (32,788) | $3.05 |
| Cancelled | — | $— |
| Non-vested as of September 30, 2025 | 79,415 | $5.98 |
The fair value of restricted stock units granted during thethree andnine months ended* September 30, 2025* was $100 thousand and $406 thousand, respectively. There wereno restricted stock units granted during thethree andnine months ended* September 30, 2024*. Stock-based compensation expense related to restricted stock units was $133 thousand and $190 thousand for thethree andnine months ended* September 30, 2025*, respectively. There wasno expense for thethree andnine months ended* September 30, 2024*, asno restricted stock units had been issued. As of* September 30, 2025*, there was $383 thousand of remaining expense, which is expected to be amortized over 3.38 years.
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In* May 2025,the Company’s Board of Directors approved the award of certain bonus payments related to performance in2024,* to be paid in the form of restricted stock units once certain milestones have been achieved. The milestones were achieved and the restricted stock units were issued in thethird quarter.
Total Stock-Based Compensation
Total stock-based compensation recorded in the condensed statements of operations is allocated as follows (in thousands):
| Three Months Ended · Nine Months Ended | ||||
|---|---|---|---|---|
| September 30, | September 30, | |||
| 2025 | 2024 | 2025 | 2024 | |
| Research and development | $58 | $23 | $160 | $68 |
| Sales and marketing | 3 | — | 25 | 1 |
| General and administrative | 77 | 35 | 230 | 97 |
| Total stock-based compensation | $138 | $58 | $415 | $166 |
| 14. | Net Loss per Share |
The Company applies thetwo-class method pursuant to the issuance of our Series B Preferred Stock. Accordingly, the Company’s basic net loss per share attributable to common stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding during the period. Net loss attributable to common stockholders is equal to the Company’s net loss.
The calculation of basic earnings per share requires an allocation of earnings to all securities that participate in dividends with shares of common stock to the extent that each security* may*share in the Company’s earnings. Basic earnings per share are calculated by dividing undistributed earnings allocated to common stock by the weighted average number of shares of common stock.
Diluted earnings per share are calculated using the more dilutive of thetwo-class or if-converted methods. Thetwo-class method uses net income available to common stockholders and assumes conversion of all potential shares other than the participating securities. The if-converted method uses net income and assumes conversion of all potential shares including the participating securities. For the periods where a net loss attributable to common stockholders is present, dilutive securities have been excluded from the calculation of diluted net loss per share attributable to common stockholders as including them would have been anti-dilutive.
| Three Months Ended · Nine Months Ended | ||||
|---|---|---|---|---|
| September 30, | September 30, | |||
| 2025 | 2024 | 2025 | 2024 | |
| (In thousands, except per share amounts) | ||||
| Net loss | $(2,596) | $(1,431) | $(6,029) | $(4,178) |
| Less dividends on Series B Preferred Stock | (36) | — | (37) | — |
| Deemed dividends on warrants | (10) | — | (10) | — |
| Net loss available to common stockholders | (2,642) | (1,431) | (6,076) | (4,178) |
| Weighted average number of shares of common stock outstanding | 1,320,778 | 364,184 | 928,971 | 229,291 |
| Net loss per share - basic | $(2.00) | $(3.93) | $(6.54) | $(18.22) |
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The following outstanding potentially dilutive common stock equivalents have been excluded from the calculation of diluted net loss per share for the periods presented due to their antidilutive effect:
| Nine Months Ended | ||
|---|---|---|
| September 30, | ||
| 2025 | 2024 | |
| Warrants to purchase common stock | 1,055,809 | 707,234 |
| Common stock options issued and outstanding | 355,368 | 3,904 |
| Restricted stock units issued and outstanding | 79,415 | — |
| Series A Preferred Stock | 237,200 | — |
| Series B Preferred Stock | 2,767,387 | — |
| Total | 4,495,179 | 711,138 |
| 15. | Segment Information |
Tivic Health is a late-stage therapeutics company harnessing the power of the immune system to improve clinical outcomes and save lives. Tivic’s biopharma program is focused on advancing itsfirst drug product candidate, Entolimod, into manufacturing, conducting process validation utilizing the output of such manufacturing, and filing the associated Biologics License Application with the FDA, with the intent to sell the biologic compounds either inside or outside of the United States. Tivic’s bioelectronic program has focused on developing non-invasive medical devices that influence biologic functions associated with various diseases and conditions. Tivic has an FDA-approved over-the-counter device, ClearUP, that treats sinus pain and pressure, which it plans to discontinue before the end of the year. Historically, revenue has been derived from sales of the Company’sfirst commercial product, ClearUP. To date, the Company has managed its business activities as asingle operating segment. Tivic’s Chief Executive Officer is the CODM. The CODM utilizes the Company’s long-term plan, which includes product development roadmaps and long-term financial models, as key input to resource allocation. The CODM makes decisions on resource allocation, assesses performance of the business, and monitors budget versus actual results using factors such as gross margin, operating expenses, loss from operations and net loss.
Significant expenses within loss from operations, as well as within net loss, include costs of revenue, research and development, selling and marketing and general and administrative expenses, which are each separately presented on the Company’s Statements of Operations. Other segment items within net loss include interest income and the loss from the disposal of manufacturing molds and dies.
During thethree andnine months ended* September 30, 2025and2024*, all revenue was domestic revenue. To date, the Company hasnot sold its product outside of the United States.
The Company’s long-lived assets consist primarily of computer equipment and the licensed biologics, all of which are located in the United States.
| 16. | Subsequent Events |
On* November 12, 2025,after considering all reasonably available options and a broader strategic reassessment, the Company’s board of directors approved the wind down of the Company’s ClearUP business, which the Company intends to substantially complete prior to the end of the year. In connection with the wind down of the ClearUP business, the Company incurred approximately$347* thousand in charges during the quarter ended* September 30, 2025and expects to incur additional related expenditures in the range of approximately$20* thousand to $50 thousand through the end of the year. Additionally, as a result of its exit from its consumer health business, the Company expects that it will generate minimal tono revenue until such time that it is able to obtain regulatory approval of, and commercialize, its other product candidates. The estimates of the charges and costs that the Company expects to incur, and the timing thereof, as well as its revenue expectations, are subject to a number of assumptions and actual results* maydiffer materially from those described above. In addition, the Company mayincur other charges or cash expendituresnot currently contemplated due to unanticipated events that may*occur as a result of, or in connection with, the wind down of the ClearUP business.
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The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.