Annual Report for Fiscal Year Ending December 31, 2025 (Form 10-K)

Management's Discussion and Analysis of Financial Condition and Results of Operations.

The following discussion and analysis is related to our financial condition and results of operations for the two years ended December 31, 2025. This information should be read in conjunction with our consolidated financial statements and related notes thereto beginning on F-1 of this Form 10-K. Please also see "Special Note Regarding Forward Looking Statements and Summary Risk Factors" in ITEM 1. Business.

RESULTS OF OPERATIONS

Year ended December 31, 2025, versus year ended December 31, 2024

Our net loss was approximately $13,958,000 and $17,320,000 for the years ended December 31, 2025, and 2024, respectively, representing a decrease in net loss of approximately $3,362,000 or 19% when compared to the same period in 2024. This decrease in net loss for the year ended December 31, 2025, was primarily due to the following:

	●	a decrease in general and administrative expenses of $6,014,000;
	●	a decrease in research and development expenses of $2,273,000;
	●	an increase on gain from investments of $110,000;
	●	an increase in the change in fair value of warrants of $186,000;
	●	a decrease in loss from sale of income tax operating losses of $1,604,000.

These improvements were offset by:

	●	Losses recognized from warrant issuance of $3,977,000;
	●	a decrease in interest/other income of $2,009,000;
	●	an increase in issuance costs of $433,000;
	●	an increase in interest expense of $227,000;
	●	an increase in production costs of $97,000;
	●	a decrease in revenue of $82,000.

Net loss per share was $ (8.62) and $ (30.92) for the years ended December 31, 2025, and 2024, respectively. The weighted average number of shares of our common stock outstanding as of December 31, 2025, was 1,618,617 as compared to 560,169 as of December 31, 2024.

Revenues

Revenues from our Ampligen® Cost Recovery Program were $88,000 and $170,000 for the years ended December 31, 2025, and 2024, representing a decrease of $82,000 which is primarily related to the fluctuation of patient participation.

Interest and other income

Interest and other income was $3,183,000 and $5,192,000 for the years ended December 31, 2025, and 2024, respectively. Other income for the year ended December 31, 2025, was primarily attributable to an agreement reached with a vendor surrounding disputed legal fees. The agreement related to a liability classified as accounts payable of $4,916,000 and stipulated that $3,041,000 of previously billed fees would be forgiven in exchange for payments totaling $1,875,000. The forgiven fees were classified as other income in 2025. Primary components of other income for the year ended December 31, 2024, included D&O insurance proceeds of $4,250,000 and a vendor credit of $657,000. None of the above-mentioned items are considered recurring.

Production Costs

For the years ended December 31,2025 and 2024, production costs were approximately $128,000 and $31,000, respectively, reflecting an increase of $97,000 in the current period. This increase was primarily due to the increase in production costs incurred for the manufacturing of Ampligen.

Research and Development Costs

For the year ended December 31, 2025, research and development ("R&D") expenses totaled approximately $3,924,000, compared to $6,197,000 in the prior year, representing a decrease of approximately $2,273,000. This reduction was primarily driven by a $1,290,000 decrease in company sponsored clinical trial expenses, a $1,920,000 reduction in salaries and consultant fees, a $163,000 decrease in rent and office expenses, and $18,000 net in other cost reductions. This is offset by an increase in patent and trademark expenses of $1,053,000 together with a $65,000 increase in IT expenses.

General and Administrative Expenses

For the years ended December 31, 2025, and 2024, general and administrative ("G&A") expenses were approximately $7,700,000 and $13,714,000, respectively, reflecting a decrease of approximately $6,014,000. This reduction was primarily driven by a $4,384,000 decrease in legal, financial and consulting fees, which were higher in the prior year due to expenses incurred in response to stockholder nomination litigation issues. Also contributing to, the reduction was a decrease of $544,000 in stock comp expenses, a decrease of $469,000 of investment banker fees, a $448,000 decrease in salaries, a $236,000 decrease in public relation expenses, a $195,000 decrease in director fees, a $37,000 decrease in insurance expenses, a $27,000 decrease in office supplies and expenses, and an $18,000 decrease in travel expenses, which is offset by an increase in rent expense of $46,000, taxes and license fees of $160,000, an increase in SEC filing fees of $115,000, and $23,000 of increases in other expenses.

Gain (loss) on Investments

For the years ended December 31, 2025, and 2024, gain (loss) on investments was approximately 17,000 and ($93,000), respectively, reflecting an increase in investment gain of approximately $110,000. This gain was primarily driven by changes in the fair value of equity investments.

Warrant issuances

On July 30, 2025, we announced the closing of a public offering of an aggregate of 2,000,000 shares of our common stock (or pre-funded warrants in lieu thereof), Class E warrants to purchase up to 2,000,000 shares of common stock, and Class F warrants to purchase up to 2,000,000 shares of common stock, at a combined public offering price of $4.00 per share (or $3.999 per pre-funded warrant) and accompanying warrants. The warrants were issued with an exercise price of $4.00 per share and were exercisable immediately upon issuance. The Class E warrants will expire on the fifth anniversary of the original issuance date, and the Class F warrants will expire on the eighteen-month anniversary of the original issuance date. Gross proceeds, before deducting placement agent fees and offering expenses, were approximately $8,000,000. Maxim Group LLC acted as sole placement agent in connection with this offering.

Based on a review of the Class E and F warrants, it was determined that the warrants met the liability criteria described in Accounting Standards Codification 480. Accordingly, as the warrants might require us to issue additional stock under certain circumstances, a loss was recognized and the resulting computed value was classified as a liability on our balance sheet at December 31, 2025.

Gain (loss) from sale of income tax operating losses

In the prior year, we recognized a ($1,604,000) impact related to the sale of our net operating losses (NOLs) under the New Jersey Technology Business Tax Certificate Transfer Program. This decline was primarily due to our company reaching the program's lifetime cap of $20,000,000 in cumulative NOL sales. Accordingly, as of December 31, 2025, we had no remaining net operating loss carryforwards available for future sales.

Liquidity and Capital Resources

Cash used in operating activities for the year ended December 31, 2025, was approximately $10,957,000 compared with approximately $14,888,000 for the same period in 2024, a decrease of $3,931,000. Net cash used in operating activities for the year ended December 31, 2025, was impacted by a net loss of approximately $13,958,000, an improvement from a net loss of approximately $17,320,000 in 2024. This reduction was largely driven by a $4,385,000 decrease in legal, financial and consulting fees, which were higher in the prior year due to expenses incurred in response to stockholder nomination litigation issues. Non- cash operating activity adjustments were $3,879,000 for the year ended December 31, 2025, compared with $2,136,000 for the year ended December 31, 2024. In 2025, $1,138,000 of patents and trademarks expired or were abandoned compared with $48,000 in the prior year. Additionally, during the year ended December 31, 2025, the Company recognized a gain of $3,041,000 from the settlement of disputed legal fees and a loss of $4,411,000 from the issuance of class E and F warrants. During the year ended December 31, 2024, significant non-cash operating activity adjustments included $686,000 of equity based compensation, compared with $60,000 during the year ended December 31, 2025.

Changes in cash flows from operating activities related to changes in assets and liabilities were ($878,000) and $296,000 for the years ended December 31, 2025, and 2024, respectively. During the year ended December 31, 2024, the Company received $1,184,000 from the sale of New Jersey operating losses. In the prior year, we recognized proceeds from the sale of our net operating losses (NOLs) under the New Jersey Technology Business Tax Certificate Transfer Program. In 2024 the Company reached the program's lifetime cap of $20,000,000 in cumulative NOL sales. Accordingly, as of December 31, 2025, we had no remaining net operating loss carryforwards available for future sales.

Cash provided by investing activities was $1,853,000 in 2025 and $4,706,000 in 2024, reflecting a $2,853,000 year-over-year decrease. The primary driver of this decrease was $2,322,000 in proceeds from the sale of marketable securities in 2025, compared with $5,623,000 in 2024.

Cash provided by financing activities totaled $10,388,000 in 2025, compared with $6,444,000 in 2024, reflecting a $3,944,000 year-over-year increase. This increase was primarily driven by the proceeds of $7,314,000 from the issuance of warrants compared with $3,303,000 from warrant transactions during the year ended December 31, 2024.

Our principal source of liquidity is our cash and cash equivalents, marketable securities, and proceeds from financing activities to provide the necessary funding to meet our obligations as they become due. As noted above, as of December 31, 2025, we had approximately $3,047,000 in cash, cash equivalents and marketable securities, inclusive of approximately $62,000 in marketable securities, representing a decrease of approximately $930,000 from December 31, 2024.

We continued to report losses from operations as of December 31, 2025, and have a working capital deficit. These conditions raise substantial doubt regarding our ability to continue as a going concern for a period of at least one year from the date of the issuance of these consolidated financial statements. See Note 1 to our audited Consolidated Financial Statements. Please see "Risk Factors - We have a history of losses, expect to continue to incur losses in the near term and may not achieve or sustain profitability in the future, and as a result, there is a substantial doubt about our ability to continue as a going concern."

The accompanying audited consolidated financial statements have been prepared assuming that we will continue as a going concern. On December 31, 2025, our current liabilities exceeded our current assets by $2,929,000 which further raises doubt about our ability to continue as a going concern. Additionally, at December 31, 2025, our stockholders' equity was below the minimum requirements for continued listing on the NYSE American. However, please see "Class E and Class F Warrant Reclassification" in Item 1. Business above.

At December 31, 2024, Management evaluated the conditions, and the significance of those conditions related to our ability to meet our obligations and noted a working capital deficit of $5,359,000. It was determined that the primary cause of the working capital deficit was related to an accounts payable balance of approximately $6,400,000. This balance included approximately $4,900,000 of legal fees related to litigation. During 2025 we successfully negotiated with the law firm to reduce prior billings. These negotiations resulted in a favorable outcome which partially mitigated the working capital deficit in 2025.

On March 6, 2026, we completed a rights offering (the "2026 Rights Offering") to our stockholders and to holders of certain of our outstanding options and warrants that had the right to participate in the 2026 Rights Offering as of February 10, 2026, the record date. In the Rights Offering we issued non-transferable subscription rights to purchase 1,842 Units. Each Unit consists of one share of Series G Convertible Preferred Stock (the "G Preferred") and 2,000 warrants to purchase common stock (the "G Warrants"). Each share of G Preferred is convertible, at the option of the holder at any time, into a number of shares of our common stock equal to the quotient of the stated value of the Preferred Stock ($1,000) divided by $1.00, the conversion price. Each G Warrant is exercisable for one share of our common stock at an exercise price of $1.00 per share from March 6, 2026, the date of issuance, through its expiration five years from the date of issuance. Although the 2026 Rights Offering closed after Fiscal year end December 31, 2025, it raised approximately $1,800,000 in gross proceeds.

On September 6, 2024, an amendment to an agreement dated April 7, 2022, was executed by us and Amarex clarifying and changing the nature of the remaining execution fee of $725,437. The amendment allowed that the remainder would not be exclusive to the agreement dated on April 7, 2022, that the nature of the payment changed from an execution fee to a fully refundable deposit, and that it could be applied to any invoice upon mutual agreement of the parties, removed the threshold contingencies, and if such invoices were not sufficient to exhaust the balance, that the refund would be refunded in cash. Due to the changes brought about by the amendment, the nature of the payment changed to deposit status. At December 31, 2025, we had an outstanding deposit of approximately $205,000, which may be used to offset future clinical research expenditures. This deposit is listed as a non-current asset on the balance sheet but could provide working capital if the timing of expenditures are realized within the next 12 months.

We entered into an amendment to a Promissory Note with our lender on March 10, 2026. The maturity date for the Note was extended until June 30, 2026. Other than the maturity date extension, there were no other changes to the agreement.

As a research and development company, we are conducting research necessary to bring our product, Ampligen, to market. As such, we primarily rely on financing activities to provide the necessary funding to meet our obligations as they become due. AIM has a long and demonstrated history of success in these efforts, however, there is no assurance that we will be successful in attaining the necessary funding in the future.

Potential Delisting from the NYSE American.

On December 11, 2024, we received an official notice of noncompliance with the NYSE American's continued listing requirements. This includes the need for us to have stockholders' equity of $6,000,000 or more. The NYSE American's review showed that we were not in compliance with that requirement. As required, we submitted a plan (the "Plan") to the NYSE American illustrating how we can regain compliance by June 11, 2026. The Plan includes a number of ways to raise capital. The NYSE American accepted our Plan on February 26, 2025. If we are not able to regain compliance by June 11, 2026, our common stock may be delisted from the NYSE American. As of December 31, 2025, our stockholders' deficit was approximately ($9,783,000). We must increase our stockholders' equity to be at least $6,000,000 to regain compliance with this rule. If we are not able to raise sufficient capital as set forth in the Plan or by other means, we may be unable to regain compliance with the NYSE American's listing standards, and our securities could be subject to delisting. In the event that the price of our Common Stock drops to $0.10 per share, our Common Stock will automatically be delisted from the NYSE American. However, please see "Class E and Class F Warrant Reclassification" in Item 1. Business above.

On April 30, 2025, the Company held a special meeting of stockholders and authorized the Company's Board of Directors to effect a reverse split at its discretion on a basis of up to one for 100 outstanding shares of Common Stock. On May 29, 2025, the Board authorized the Reverse Split and on June 10, 2025, the Company filed an amendment to its Articles of Incorporation effecting a reverse split of its outstanding shares of Common Stock on a one for 100 basis (the "Reverse Split"). Stockholders were given cash in lieu of any fractional shares on a post-split basis.

On June 11, 2025, the Company was notified by the Exchange that the Company had regained compliance with Section 1003(f)(v) of the Exchange's Company Guide (low selling price) and that trading in the Company's Common Stock was reinstated on the Exchange on June 17, 2025.

We are committed to a focused business plan oriented toward finding senior co-development partners with the capital and expertise needed to commercialize the many potential therapeutic aspects of our experimental drugs and our FDA approved drug Alferon N Injection.

The development of our products requires the commitment of substantial resources to conduct time-consuming research, preclinical development, and clinical trials that are necessary to bring pharmaceutical products to market. We believe, based on our current financial condition, that we do not have adequate funds to meet our anticipated operational cash needs and fund current clinical trials. At present we do not generate any material revenues from operations, and we do not anticipate doing so in the near future. We will need to obtain additional funding in the future to continue operations and for new studies and/or if current studies do not yield positive results, require unanticipated changes and/or additional studies.

Today, some six years after COVID-19 first appeared, the world has a number of vaccines and therapeutics. Our quest to prove the antiviral activities of Ampligen continues. If Ampligen has the broad-spectrum antiviral properties that we believe that it has, it could be a very valuable tool in treating variants of existing viral diseases, including COVID-19, or novel ones that arise in the future. Unlike most developing therapeutics which attack the virus, Ampligen works differently. We believe that it activates antiviral immune system pathways that fight not just a particular virus or viral variant, but other similar viruses as well.

At present we do not generate any material revenues from operations, and we do not anticipate doing so in the near future. We will need to obtain additional funding in the future for new studies and/or if current studies do not yield positive results, require unanticipated changes and/or additional studies. If we are unable to commercialize and sell Ampligen and/or recommence material sales of Alferon N Injection, our operations, financial position and liquidity may be adversely impacted, and additional financing may be required. There can be no assurances that, if needed, we will be able to raise adequate funds or enter into licensing, partnering or other arrangements to advance our business goals. We may seek to access the public equity market whenever conditions are favorable, even if we do not have an immediate need for additional capital at that time. We are unable to estimate the amount, timing or nature of future sales of outstanding common stock or instruments convertible into or exercisable for our common stock. Any additional funding may result in significant dilution and could involve the issuance of securities with rights, which are senior to those of existing stockholders. See Part I, Item 1A - "Risk Factors; We will require additional financing which may not be available".

Atlas Equity Line of Credit (Equity Purchase Agreement)

On March 28, 2024, we entered into a purchase agreement (the "Purchase Agreement") and a registration rights agreement (the "Registration Rights Agreement") with Atlas Sciences, LLC, a Utah limited liability company ("Atlas"), pursuant to which Atlas committed to purchase up to $15,000,000 of our common stock. As of February 2025, the Purchase Agreement was no longer in effect.

As of December 31, 2025, a total of 30,829 shares had been issued pursuant to the purchase agreement for a total of approximately $398,000 after clearing costs. There were no shares issued subsequent to December 31, 2025.

Securities Purchase Agreement

May 2024 Securities Purchase Agreement

On May 31, 2024, we entered into a Securities Purchase Agreement (the "Purchase Agreement") to complete an offering (the "Transactions") with a single accredited investor (the "Purchaser"), pursuant to which, on June 3, 2024, we issued to the Purchaser, (i) in a registered direct offering, 56,410 shares of our common stock (the "Shares"), par value $0.001 per share ("common stock") and (ii) in a concurrent private placement, we issued to the Purchaser Class A common warrants to purchase an aggregate of up to 56,410 shares of our common stock (the "A Warrants") at an exercise price of $36.30 per share and Class B common warrants to purchase an aggregate of up to 56,410 shares of our common stock (the "B "Warrants" and, along with the A Warrants, the "Common Warrants") at an exercise price of $36.30 per share. The A Warrants and B Warrants are not exercisable for six months after the issuance date and expire, respectively, five years and six months and twenty-four months after the issuance date. The Common Warrants and the shares of common stock are issuable upon the exercise of such warrants are offered pursuant to an exemption from the registration requirements of the Securities Act provided in Section 4(a)(2) of the Securities Act and Rule 506(b) promulgated thereunder.

The Shares were offered by us pursuant to a shelf registration statement on Form S-3 (File No. 333-262280), which was declared effective on February 4, 2022.

Pursuant to the terms of the Purchase Agreement, subject to certain exceptions, we could not issue any equity securities for 60 days following the issuance date, provided that we were able to utilize our at-the-market offering program with the Placement Agent after 30 days. Additionally, we cannot enter into a variable rate transaction (other than the ATM program with the Placement Agent) for 120 days after the issuance date. In addition, our executive officers and each of our directors have entered into lock-up agreements with us pursuant to which each of them has agreed not to, for a period of 90 days from the closing of the Transactions, offer, sell, transfer or otherwise dispose of our securities, subject to certain exceptions.

The exercise price of the Common Warrants, and the number of Common Warrant Shares, are subject to adjustment in the event of any stock dividend or split, reverse stock split, recapitalization, reorganization or similar transaction, as described in the Common Warrants. If a Fundamental Transaction (as defined in the Common Warrants) occurs, then the successor entity will succeed to, and be substituted for us, and may exercise every right and power that we may exercise and will assume all of our obligations under the Common Warrants with the same effect as if such successor entity had been named in the warrant itself. Common Warrant Holders will have additional rights defined in the Common Warrants. The Common Warrants are exercisable on a "cashless" basis only if there is not a current registration statement permitting public resale. In this regard, we filed a registration statement to register the resale of the Common Warrant Shares providing for the resale of the Shares issued and issuable upon exercise of the Common Warrants. That registration statement was declared effective by the SEC on July 11, 2024. We have agreed to use commercially reasonable efforts to cause such registration statement to keep such registration statement effective at all times until no Purchaser owns any Warrants or Warrant Shares issuable upon exercise thereof.

Maxim Group LLC acted as the placement agent (the "Placement Agent") on a "commercially reasonable best efforts" basis, in connection with the Transactions pursuant to the Placement Agency Agreement, dated May 31, 2024 (the "Placement Agency Agreement"), by and between us and the Placement Agent. Pursuant to the Placement Agency Agreement, the Placement Agent was paid a cash fee of 8% of the aggregate gross proceeds paid to us for the securities sold in the Transactions and reimbursement of certain out-of-pocket expenses.

We evaluated the Common Warrants under the guidance of ASC 480 - Distinguishing Liabilities from Equity and determined that they were in scope under the guidance as freestanding financial instruments but did not meet the criteria for liability classification and are classified as equity within the consolidated financial statements. Proceeds allocated to such warrants totaled approximately $2,500,000. For the year ended December 31, 2025, no Common Warrants were exercised, and all remain outstanding on December 31, 2025, related to this agreement.

September 2024 Securities Purchase Agreement

On September 30, 2024, we entered into a Purchase Agreement with the Selling Stockholder as Purchaser, pursuant to which we issued to the Selling Stockholder, (i) in a registered direct offering, 46,530 shares of our common stock ("Shares") and (ii) in the concurrent Private Placement, Class C and Class D Warrants, each to purchase an aggregate of up to 46,530 Shares (the "Common Warrant Shares") each with an exercise price of $28.00. The Class C and Class D Warrants together, hereinafter the "Common Warrants". The purchase price for Shares in the registered direct offering was $28.00 per Share.

We received aggregate gross proceeds from the Transactions of approximately $1,260,000, before deducting fees to the Placement Agent and other estimated offering expenses payable by us. The Shares were offered by us pursuant to a shelf registration statement on Form S-3 (File No. 333-262280), which was declared effective on February 4, 2022. The Common Warrants and the Common Warrant Shares issued in the Private Placement were not registered under the Securities Act. Rather the Common Warrants and the Common Warrant Shares were issued pursuant to the exemption from registration provided in Section 4(a)(2) under the Securities Act and Rule 506(b) promulgated thereunder. The Class C Warrants and the Class D Warrants are not exercisable until December 3, 2024, and will expire, respectively, twenty-four months and five years and six months after that date.

We evaluated the Common Warrants under the guidance of ASC 480 - Distinguishing Liabilities from Equity and determined that they were in scope under the guidance as freestanding financial instruments but did not meet the criteria for liability classification and are classified as equity within the consolidated financial statements. Proceeds allocated to such warrants totaled approximately $2,500,000. For the year ended December 31, 2025, no Common Warrants were exercised, and all remain outstanding on December 31, 2025, related to this agreement.

Public Offering on a Registration Statement on Form S-1

On July 31, 2025, we announced the closing of our public offering of an aggregate of 2,000,000 shares of our common stock (or pre-funded warrants in lieu thereof), Class E warrants to purchase up to 2,000,000 shares of common stock, and Class F warrants to purchase up to 2,000,000 shares of common stock, at a combined public offering price of $4.00 per share (or $3.999 per pre-funded warrant) and accompanying warrants. The warrants had an exercise price of $4.00 per share and were exercisable immediately upon issuance. The Class E warrants will expire on the fifth anniversary of the original issuance date, and the Class F warrants will expire on the eighteen-month anniversary of the original issuance date. Gross proceeds, before deducting placement agent fees and offering expenses, were approximately $8,000,000. Maxim Group LLC acted as sole placement agent in connection with this offering.

As of March 25, 2026, the adjusted exercise price of the Class E and Class F warrants was $1.439 per share, and the adjusted number of outstanding and unexercised Class E and Class F warrants was to purchase 5,078,619 and 4,760,610 shares of common stock, respectively.

Based on review of the Class E and F Warrants, it was determined that the warrants met the liability criteria as described in Accounting Standards Codification 480. As such, a loss was recognized and the resulting computed value was classified as a liability on the Company's balance sheet at December 31, 2025 as the warrants might require the Company to issue additional stock under certain circumstances. While the warrants met the technical requirements of the accounting standard, the ultimate redemption of the warrants will not require any cash expenditure or transfer of assets by the Company. Any warrant exercises would result in additional cash and equity to the Company because the Company has a sufficient number of authorized and unissued shares available to satisfy the warrant exercises in shares. Subsequent to the year ended December 31, 2025, these warrants will be re-evaluated to determine if they should be reclassified to equity from liability. Please see "Class E and Class F Warrant Reclassification in Item 1. Business above.

As discussed above, on March 6, 2026, we completed a rights offering to our stockholders and to holders of certain of our outstanding options and warrants that had the right to participate in the rights offering as of February 10, 2026, the record date. It raised approximately $1,800,000 in gross proceeds.

NYSE American Continued Listing Requirements

To maintain our listing on the NYSE American (the "Exchange"), among other things, we are required to maintain Stockholders Equity of $6,000,000 or we may receive a warning or a delisting notice.

If the common stock ultimately were to be delisted for any reason, it could negatively impact us by (i) reducing the liquidity and market price of our common stock; (ii) reducing the number of investors willing to hold or acquire the common stock, which could negatively impact our ability to raise equity financing; (iii) limiting our ability to use a registration statement to offer and sell freely tradable securities, thereby preventing us from accessing the public capital markets; and (iv) impairing our ability to provide equity incentives to our employees.

Possible Sources of Funding

Universal Shelf Registration Statement and At-The-Market Offering with Maxim

On April 1, 2025, we entered into a new sales agreement (the "Sales Agreement") with Maxim Group LLC ("Maxim") pursuant to which we may issue and sell up to an aggregate of $3,000,000 shares of our common stock from time to time through Maxim acting as agent. Under the terms of the Sales Agreement, in no event will we, inter alia, issue or sell through the Sales Agreement such number or dollar amount of shares of common stock that would exceed the number or dollar amount of shares of common stock permitted to be sold under Form S-3 (including General Instruction I.B.6 thereof, if applicable).

Pursuant to the Sales Agreement, we will pay Maxim in cash, upon each sale of the common stock pursuant to the sales agreement, a commission in an amount equal to 3.0% of the aggregate gross proceeds from each sale of common stock. Because there is no minimum offering amount required as a condition to this offering, the actual total public offering amount, commissions and proceeds to us, if any, are not determinable at this time. We have agreed, under certain circumstances, to reimburse a portion of Maxim's expenses, including legal fees up to a maximum of $50,000, and $5,000 on a quarterly basis thereafter.

The shares under the sales agreement will only be offered after a prospectus related to such offering is filed with the SEC. If and when the shares are offered, they will be offered pursuant to a shelf registration statement on Form S-3 (File No. 333-286319), which was declared effective on July 3, 2025.

During the year ended December 31, 2025, we sold 155,874 shares under the ATM Sales Agreement for total gross proceeds of approximately $225,362, which includes a 3.0% fee to Maxim of $6,761. Subsequent to December 31, 2025, the Company has sold 2,025,292 shares under the ATM Sales Agreement for total gross proceeds of approximately $2,063,396, which includes a 3.0% fee to Maxim of approximately $61,901.

Certain Relationships and Related Transactions

Refer to PART III, ITEM 13 - "Certain Relationships and Related Transactions, and Director Independence.

New Accounting Pronouncements

Refer to "Note 2(h) - Recent Accounting Standards and Pronouncements" under Notes to Consolidated Financial Statements.

Critical Accounting Estimates

Our significant accounting estimates are described in the Notes to Consolidated Financial Statements. The significant accounting estimates that we believe are most critical to aid in fully understanding our reported financial results are the following:

Long-Lived Assets

We assess long-lived assets for impairment when events or changes in circumstances indicate that the carrying value of the assets or the asset grouping may not be recoverable. Factors that the Company considers in deciding when to perform an impairment review include significant decreases in the market price of a long-lived asset or group, a significant adverse change in the extent or manner in which a long-lived asset (asset group) is being used or its physical condition, a significant adverse change in legal factors or in the business climate that could affect the value of a long-lived asset (asset group, including an adverse action or assessment by a regulator, an accumulation of costs significantly in excess of the amount originally expected for the acquisition or construction of a long-lived asset (asset group), a current period operating or cash flow loss combined with a history of operating or cash flow losses or projection or forecast that demonstrates continuing losses associated with the use of a long-lived asset (asset group) or a current expectation that, more likely than not, a long-lived asset (asset group) will be sold or otherwise disposed of significantly before the end of its previously estimated useful life.

When assessing for impairment, we measure the recoverability of assets that it will continue to use in its operations by comparing the carrying value of the asset grouping to our estimate of the related total future undiscounted net cash flows. If an asset grouping's carrying value is not recoverable through the related undiscounted cash flows, the asset grouping is considered to be impaired.

We measure the impairment by comparing the difference between the asset grouping's carrying value and its fair value. Long-lived assets are considered a non-financial asset and are recorded at fair value only if an impairment charge is recognized. Impairments are determined for groups of assets related to the lowest level of identifiable independent cash flows. The Company makes subjective judgments in determining the independent cash flows that can be related to specific asset groupings. In addition, as the Company reviews its manufacturing process and other manufacturing planning decisions, if the useful lives of assets are shorter than the Company had originally estimated, it accelerates the rate of depreciation over the assets' new, shorter useful lives.

Research & Development (R&D) Expenses

We expense R&D costs as incurred. However, we estimate and accrue costs related to clinical trials, third-party contract research organizations (CRO's), manufacturing development, and preclinical studies based on services performed. Material changes in assumptions could significantly impact R&D expenses in any given period.

Stock-Based Compensation

We grant stock options, the valuation of which requires significant judgement. To estimate their fair value, we use the Black-Scholes-Merton pricing model, which involves assumptions about stock volatility, expected option life, and risk-free interest rates. Changes in estimated volatility or expected option life could have a material impact on stock-based compensation expenses.