04/15/2026 | Press release | Distributed by Public on 04/15/2026 14:31
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Management's Discussion and Analysis of Financial Condition and Results of Operations ("MD&A") is designed to provide a reader of Petros' consolidated financial statements with a narrative from the perspective of management on the Company's financial condition, results of operations, liquidity and certain other factors that may affect future results. In certain instances, parenthetical references are made to relevant sections of the Notes to Consolidated Financial Statements to direct the reader to a further detailed discussion. This section should be read in conjunction with the Consolidated Financial Statements and Supplementary Data included in this Annual Report on Form 10-K. This MD&A contains forward-looking statements reflecting Petros' current expectations, whose actual outcomes involve risks and uncertainties. Actual results and the timing of events may differ materially from those stated in or implied by these forward-looking statements due to a number of factors, including those discussed in the sections entitled "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" contained in this Annual Report on Form 10-K.
Overview
Petros was incorporated in Delaware on May 14, 2020, for the purpose of effecting the transactions contemplated by that certain Agreement and Plan of Merger, dated as of May 17, 2020 (as amended, the "Merger Agreement"), by and between Petros, Neurotrope, Inc., a Nevada corporation ("Neurotrope"), Metuchen Pharmaceuticals LLC, a Delaware limited liability company ("Metuchen"), and certain subsidiaries of Petros and Neurotrope. Prior to June 2025, Petros consisted of wholly owned subsidiaries: Metuchen, Neurotrope, Timm Medical Technologies, Inc. ("Timm Medical"), and Pos-T-Vac, LLC ("PTV" and, collectively with Metuchen and Timm Medical, the "Subsidiaries"). The Company has historically been engaged in the commercialization and development of Stendra®, a U.S. Food and Drug Administration ("FDA") approved PDE-5 inhibitor prescription medication for the treatment of erectile dysfunction ("ED"), which the Company licensed from Vivus, Inc. ("Vivus"). Petros also historically marketed its own line of ED products in the form of vacuum erection device products ("VEDs") through its previous subsidiaries, Timm Medical and PTV, including VEDs marketed as "Osbon ErecAid" and "PosTVac."
In December 2024, the Company determined to discontinue sales of Stendra® to wholesalers. Beginning in March 2025, the Company is no longer engaged in the commercialization, development or sales of Stendra®. In addition, on June 16, 2025, in accordance with California state law, the Company effected an assignment (the "Assignment") of all of the business, assets, properties, contractual rights, goodwill, going concern value, rights and claims ("Assets") of Metuchen, including Metuchen's wholly-owned subsidiaries, Timm Medical and PTV and each of their respective Assets (collectively, the "ABC Assets"), for the benefit of creditors to a special purpose vehicle that is managed by a third-party fiduciary (the "Assignee") such that, as of June 16, 2025, the Assignee succeeded to all of each Subsidiary's right, title and interest in and to the respective ABC Assets. Upon the completion of the Assignment, the Assignee obtained sole control over the ABC Assets and each Subsidiary no longer operates its business or controls the liquidation or distribution of its assets or the resolution of claims. The Assignment is a judicial insolvency procedure, which was commenced by each Subsidiary entering a contractual assignment for the benefit of creditors on June 16, 2025, that effectuates the assignment, grant, conveyance, transfer, and setting over to the Assignee, in trust, of all of the ABC Assets. Accordingly, the Company is no longer engaged in the marketing or selling of VEDs following the completion of the Assignment. Today, the Company is working towards the goal of becoming a leading innovator in the emerging self-care market driving expanded access to key nonprescription pharmaceuticals as Over-the-Counter ("OTC") and nonprescription drug products with additional condition for nonprescription use ("ACNU Products") treatment options.
Petros is pursuing the development of a proprietary integrated technology solutions platform (the "platform") containing two components (i) SaaS, designed to assist pharmaceutical companies in operationalizing and commercializing an Rx-to-OTC switch as an element in the development of an ACNU Product, and (ii) a potential Software as a Medical Device ("SaMD") component, which must comply with FDA governance and approval and is expected to be a consumer interface that guides the consumer in navigating appropriate self-selection or deselection, through the acquisition process of the OTC product. The Company has been working towards the development of the platform, which is currently in early development stages and is being designed to serve as a retail or online interface, with clinically established algorithmic logic qualifying the intended consumer-patient for purchase and use of an ACNU Product, while reducing subjectivity to the least possible degree and maximizing objective qualifiers to the greatest possible degree.
We believe our platform will be anchored in recent FDA adopted rules, such as the FDA's Nonprescription Drug Product with an Additional Condition for Nonprescription Use rule ("ACNU Rule"), intended to increase options to develop and market nonprescription drug products; Trusted Exchange Framework and Common Agreement ("TEFCA"), a nationwide framework for health information sharing; and Qualified Health Information Networks, which are sponsored by the FDA and the Department of Health and Human Services.
The Company's Business
The Company has historically been engaged in the commercialization and development of Stendra®. In December 2024, the Company determined to discontinue sales of Stendra® to wholesalers to mitigate the risk of returns associated with expired or near-expired prescription medication due to Stendra® having less than a six-month shelf life. In addition, as of March 2025, the Company is no longer engaged in the commercialization, development or sales of Stendra® and is no longer engaged in the marketing or selling of VEDs. Today, the Company is working towards the goal of becoming a leading innovator in the emerging self-care market driving expanded access to key nonprescription pharmaceuticals as Over-the-Counter ("OTC") and nonprescription drug products with additional condition for nonprescription use ("ACNU Products") treatment options.
Going Concern
Petros has experienced net losses and negative cash flows from operations since our inception. As of December 31, 2025, the Company had cash of approximately $5.1 million, working capital of $2.9 million, an accumulated deficit of approximately $111.3 million and used cash in operations during the twelve months ended December 31, 2025, of approximately $4.7 million.
The Company does not currently have sufficient available liquidity to fund its operations for at least the next 12 months. These conditions and events raise substantial doubt about the Company's ability to continue as a going concern within one year after the date that these consolidated financial statements are issued. The accompanying consolidated financial statements do not include any adjustments that might result from these uncertainties. The consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result should the Company be unable to continue as a going concern.
In response to these conditions and events, the Company is evaluating various financing strategies to obtain sufficient additional liquidity to meet its operating, debt service and capital requirements for the next twelve months following the date of our consolidated financial statements included in this annual report. The potential sources of financing that the Company is evaluating include one or any combination of secured or unsecured debt, convertible debt and equity in both public and private offerings. The Company also plans to finance near-term operations by exploring additional ways to raise capital and increasing cash flows from operations. There is no assurance the Company will manage to raise additional capital or otherwise increase cash flows, if required or that the Company will have sufficient cash to develop its platform, even after the proceeds raised in this offering.
Vivus Settlement Agreement, Promissory Note and the Security Agreement
On January 18, 2022, Petros (through its wholly-owned subsidiary) and Vivus entered into a Settlement Agreement (the "Vivus Settlement Agreement") related to the minimum purchase requirements under the Vivus Supply Agreement in 2018, 2019 and 2020 and certain reimbursement rights asserted by a third-party retailer in connection with quantities of the Company's Stendra® product that were delivered to the third-party retailer and later returned. In connection with the Vivus Settlement Agreement, Petros retained approximately $7.3 million of API inventory (representing the 2018 and 2019 minimum purchase requirements) out of approximately $12.4 million due under the Vivus Supply Agreement, in conjunction with forgiveness of approximately $4.25 million of current liabilities relating to returned goods and minimum purchase commitments. In exchange for the API and reduction of current liabilities, Petros executed an interest-bearing promissory note (the "Note") in favor of Vivus in the principal amount of $10,201,758. The parties also entered into a Security Agreement to secure Petros' obligations under the Note. The Company recorded the impact of this transaction, including the gain in the first quarter of 2022.
Under the terms of the Note, the principal amount of $10,201,758 was payable in consecutive quarterly installments beginning on April 1, 2022, through January 1, 2027. Interest on the principal amount accrued at a rate of 6% per year, Pursuant to the Security Agreement, dated January 18, 2022, the Company granted to Vivus a continuing security interest in all of its Stendra® API and products and its rights under the License Agreement (the "Security Agreement"). The Security Agreement contains customary events of default. For the years ended December 31, 2025, and December 31, 2024, the Company paid Vivus $0.0 million and $1.0 million, respectively under the Note.
On October 1, 2024, we failed to make the payment due pursuant to the Note and related Security Agreement in the amount of $0.5 million, constituting an Event of Default (as defined in the Note) under the Note and Security Agreement. The outstanding principal amount on the Note, plus accrued and unpaid interest thereon, was $7,574,824 as of December 31, 2024. As a result of an event of default under the Settlement Agreement and the Security Agreement existing and continuing by virtue of our failure to pay the Installment (as defined in the Note) that was due October 1, 2024 (the "Vivus Event of Default"), all the obligations under the Settlement Agreement and the Security Agreement (the "Obligations") became immediately due and payable on the date of the Foreclosure Notice (as defined below).
Pursuant to the Security Agreement, Vivus held a security interest against the Collateral (as defined herein). On December 10, 2024, pursuant to a Notice of Proposal to Accept Pledged Collateral in Partial Satisfaction of Indebtedness Pursuant to Uniform Commercial Code Section 9-620 (the "Foreclosure Notice"), Vivus proposed to accept all the Collateral (save and except the Specified License Agreement (as defined in the Security Agreement); collectively, the "Foreclosed Collateral") in partial satisfaction of the Obligations. Vivus further proposed in the Foreclosure Notice that its acceptance of the Foreclosed Collateral would only constitute satisfaction of $2,000,000 worth of the Obligations and would not include any other amounts outstanding under the Note, the Settlement Agreement, or the Security Agreement, including but not limited to (i) all interest accrued or at any time accruing thereon and (ii) all other sums recoverable by Vivus from Metuchen by virtue of the Obligations. On December 13, 2024, Metuchen accepted and agreed to the Foreclosure Notice.
In connection with the Foreclosure Notice, Metuchen and Vivus entered into that certain termination agreement, dated as of March 31, 2025, pursuant to which, the parties mutually agreed to terminate the Vivus License Agreement, effective as of March 31, 2025 (the "Vivus Termination Agreement"), subject to the survival of certain provisions as set forth therein. As a result of the Vivus Termination Agreement, Metuchen no longer has any right in or to Vivus Technology (as defined in the Vivus License Agreement in the United States of America and its territories and possessions, including Puerto Rico and U.S. military bases abroad, Canada, South America and India (the "Licensed Territory") and Metuchen agreed to immediately cease the development, manufacturing and commercialization of Stendra® in the Licensed Territory. Metuchen further agreed to assign any trademarks incorporating the mark "Stendra®" to Vivus, subject to certain exceptions as set forth therein. In furtherance of the Foreclosure Notice, and pursuant to the Termination Agreement, Metuchen agreed to transfer all completed inventory of Stendra® and all substantially manufactured inventory of Stendra® on hand to Vivus at Metuchen's sole expense within 30 days of the date of the Vivus Termination Agreement.
Metuchen ABC
On March 31, 2025, the Board determined and approved that it is advisable and in the best interests of the Company and the Company's stockholders to effect the Assignment. In accordance with California state law, on June 16, 2025, the Company assigned all of its right, title, interest in, and custody and control of each Subsidiary's property to the Assignee, such that, as of June 16, 2025, the Assignee succeeded to all of each Subsidiary's right, title and interest in and to the respective ABC Assets. Upon the completion of the Assignment, the Assignee obtained sole control over the ABC Assets and each Subsidiary no longer operates its business or controls the liquidation or distribution of its assets or the resolution of claims. The Assignment is a judicial insolvency procedure, which was commenced by each Subsidiary entering a contractual assignment for the benefit of creditors on June 16, 2025, that effectuates the assignment, grant, conveyance, transfer, and setting over to the Assignee, in trust, of all of the ABC Assets. The Assignee liquidated the property through an auction sale and distributed the proceeds to the Subsidiaries' creditors according to their respective priorities at law to satisfy the Subsidiaries' obligations, in accordance with the rules and regulations of the State of California.
Reverse Stock Split
On April 29, 2025, the Company filed a Certificate of Amendment to the Company's Amended and Restated Certificate of Incorporation with the Secretary of State of Delaware to effect a 1-for-25 reverse stock split of the shares of the Company's Common Stock, either issued and outstanding or held by the Company as treasury stock, effective as of 4:05 p.m. (New York time) on April 30, 2025 (the "Reverse Stock Split") and began trading on a Reverse Stock Split-adjusted basis on Nasdaq on May 1, 2025. All share amounts have been retroactively adjusted for the Reverse Stock Split.
Nasdaq Listing Requirements
On May 15, 2024, the Company received notice from the Listing Qualifications Staff of Nasdaq (the "Staff") indicating that, based upon the closing bid price of the Company's Common Stock for the 30 consecutive business day period between April 3, 2024, through May 14, 2024, the Company did not meet the minimum bid price of $1.00 per share required for continued listing on the Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2) (the "Rule"). The letter also indicated that the Company was provided with a compliance period until November 11, 2024, in which to regain compliance pursuant to Nasdaq Listing Rule 5810(c)(3)(A).
On November 12, 2024, the Company received notice from the Staff granting the Company's request for a 180-day extension to regain compliance with the Rule, or, until May 12, 2025 (the "Compliance Period"). In order to regain compliance with Nasdaq's minimum bid price requirement, the Company's Common Stock must maintain a minimum closing bid price of $1.00 for at least ten consecutive business days during the Compliance Period. On May 6, 2025, the Company addressed these concerns before a Nasdaq Hearings Panel (the "Panel").
On March 26, 2025, the Company received a letter (the "March 2025 Letter") from the Staff notifying the Company that the Company's Common Stock had a closing bid price of $0.10 or less for ten consecutive trading days, and, accordingly, the Company is subject to the provisions contemplated under Nasdaq Listing Rule 5810(c)(3)(A)(iii) (the "Low Bid Price Listing Rule") which the Company addressed before the Panel.
On April 8, 2025, Nasdaq notified the Company that it did not comply with the $2.5 million minimum stockholders' equity requirement, as set forth in Nasdaq Listing Rule 5550(b)(1). Pursuant to Nasdaq Listing Rule 5810(d), this deficiency became an additional basis for delisting, and as such, the Company addressed these concerns before the Panel on May 6, 2025.
On April 28, 2025, the Company received a letter from the Staff indicating that the Staff had public interest concerns regarding the Company's public offering of securities that closed on February 19, 2025, which serves as an additional basis for delisting the Company's securities pursuant to Nasdaq Listing Rule 5810(d) (the "Matter") and the Company addressed these concerns before the Panel on May 6, 2025.
On May 20, 2025, the Company received a letter (the "Letter") from the Panel indicating that the Panel has determined to delist the Company's securities from Nasdaq as a result of the foregoing. Pursuant to the Letter, the Panel determined to deny the Company's request to continue its listing on Nasdaq and the Company's Common Stock was suspended at the open of trading on May 22, 2025. Following the suspension of trading on Nasdaq, the Company's Common Stock continues trade publicly on the OTC Markets under its existing symbol "PTPI" beginning on May 22, 2025.
On November 3, 2025, Nasdaq notified the Company that, on November 7, 2025, it would announce the delisting of the Company's Common Stock. Since July 1, 2025, the Company's Common Stock has been trading on the OTCID® Basic Market (the "OTCID") under the symbol "PTPI." Nasdaq filed a Form 25 with the SEC on November 7, 2025, to complete the delisting in accordance with Rule 12d2-2 promulgated under the Exchange Act. The delisting became effective ten days after the date the Form 25 was filed.
Critical Accounting Estimates
The preparation of the consolidated financial statements requires us to make assumptions, estimates and judgments that affect the reported amounts of assets and liabilities, the disclosures of contingent assets and liabilities as of the date of the consolidated financial statements, and the reported amounts of revenues and expenses during the reporting periods. Certain of our more critical accounting policies require the application of significant judgment by management in selecting the appropriate assumptions for calculating financial estimates. By their nature, these judgments are subject to an inherent degree of uncertainty. On an ongoing basis, we evaluate our judgments, including but not limited to those related to income taxes, litigation, and contingencies. We use historical experience and other assumptions as the basis for our judgments and making these estimates. Because future events and their effects cannot be determined with precision, actual results could differ significantly from these estimates. Any changes in those estimates will be reflected in our consolidated financial statements as they occur. The Company did not have any critical accounting estimates for the year ended December 31, 2025.
Revenue Recognition
The Company does not expect to generate revenue unless and until we successfully complete development of our products and/or services and obtain required regulatory approvals, enter into commercial arrangements, or otherwise commence revenue-generating operations. There can be no assurance as to when, or if, we will generate revenue. Accordingly, no revenue has been recognized for any period presented in this Annual Report on Form 10-K.
Results of Operations
Years ended December 31, 2025, and December 31, 2024
The following table sets forth a summary of our statements of operations for the years ended December 31, 2025, and 2024:
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For the Year Ended |
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December 31, |
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2025 |
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2024 |
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Operating expenses: |
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Selling, general and administrative |
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4,641,350 |
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4,626,943 |
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Total operating expenses |
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4,641,350 |
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4,626,943 |
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Loss from operations |
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(4,641,350) |
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(4,626,943) |
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Other income (expense): |
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Warrant issuance costs |
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(10,420,982) |
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- |
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Change in fair value of derivative liability |
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- |
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3,550,000 |
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Change in fair value of warrant liability |
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10,305,357 |
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- |
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Interest income |
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256,933 |
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371,769 |
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Total other income |
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141,308 |
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3,921,769 |
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Loss before income taxes |
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(4,500,042) |
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(705,174) |
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Provision for income taxes |
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- |
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- |
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Loss from continuing operations, net of tax |
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(4,500,042) |
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(705,174) |
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Gain from assignment of subsidiaries and Vivus settlement |
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6,973,302 |
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- |
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Loss from discontinued operations, net of tax |
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(559,665) |
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(13,613,616) |
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Net Income (loss) |
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$ |
1,913,595 |
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$ |
(14,318,790) |
Operating Expenses
Selling, general and administrative expenses for the years ended December 31, 2025, and December 31, 2024, were $4,641,350 and $4,626,943, respectively. Selling, general and administrative expenses include administrative and corporate expenses.
Selling, general and administrative expenses increased by $14,407 or 0.3% during the year ended December 31, 2025, compared to the year ended December 31, 2024. Increased selling general and administrative expenses were primarily driven by increased professional service fees of $113,223, increased stock-based compensation expense of $107,419, and increased payroll and benefits expenses of $41,088, partially offset by decreased franchise taxes of $200,824 and decreased other operating expenses of $46,499.
Warrant Issuance Costs
Warrant issuance costs for the years ended December 31, 2025, and December 31, 2024, were $10,420,982 and $0, respectively. The warrant issuance costs of $10.4 million were associated with the February 2025 Public Offering (as defined herein).
Change in Fair Value of Derivative Liability
For the years ended December 31, 2025, and December 31, 2024, the Company recorded gains of $0.0 million and $3.6 million, respectively, for the change in fair value of the derivative liability. The gain in 2024 is related to the decrease in the fair value of a derivative liability established for certain bifurcated features of the Series A Preferred Stock issued in the July 2023 Private Placement.
Change in Fair Value of Warrant Liability
For the years ended December 31, 2025, and December 31, 2024, the Company recorded a gain of approximately $10.3 million and $0.0 million, respectively, for the change in fair value of the warrant liability. The gain in 2025 is related to the decrease in fair value of the Series Warrants issued in the Public Offering.
Interest Income
Interest income for the years ended December 31, 2025, and December 31, 2024, was $256,933 and $371,769, respectively. Petros invested its cash in money market securities during 2025 and 2024.
Gain from assignment of subsidiaries and Vivus settlement
For the years ended December 31, 2025, and December 31, 2024, the Company recorded a gain of $7.0 million and $0.0 million, respectively, for the disposal of assets and the settlement with Vivus. The gain in 2025 is related to the assignment of the net liabilities of the Subsidiaries on June 15, 2025.
Loss on Discontinued Operations
For the years ended December 31, 2025, and December 31, 2024, the Company recorded losses of $0.6 million and $13.6 million, respectively, from discontinued operations.
Liquidity and Capital Resources
General
Cash and cash equivalents totaled $5,136,722 at December 31, 2025, compared to $1,718,645 at December 31, 2024.
We have experienced net losses and negative cash flows from operations since our inception. As of December 31, 2025, we had cash of $5.1 million, working capital of $2.9 million, and an accumulated deficit of $111.3 million. Our plans include, or may include, utilizing our cash and cash equivalents on hand, as well as exploring additional ways to raise capital in addition to increasing cash flows from operations.
To date, our principal sources of capital used to fund our operations have been the revenues from product sales, private sales, registered offerings and private placements of equity securities. The Company does not currently have sufficient available liquidity to fund its operations for at least the next 12 months. These conditions and events raise substantial doubt about the Company's ability to continue as a going concern within one year after the date that these audited annual consolidated financial statements are issued. For further information, see the section titled "Going Concern" above.
Metuchen ABC
On March 31, 2025, the Board determined and approved that it is advisable and in the best interests of the Company and the Company's stockholders to effect the Assignment. In accordance with California state law, on June 16, 2025, the Company assigned all of its right, title, interest in, and custody and control of each Subsidiary's property to the Assignee, such that, as of June 16, 2025, the Assignee succeeded to all of each Subsidiary's right, title and interest in and to the respective ABC Assets. Upon the completion of the Assignment, the Assignee obtained sole control over the ABC Assets and each Subsidiary no longer operates its business or controls the liquidation or distribution of its assets or the resolution of claims. The Assignment is a judicial insolvency procedure, which was commenced by each Subsidiary entering a contractual assignment for the benefit of creditors on June 16, 2025, that effectuates the assignment, grant, conveyance, transfer, and setting over to the Assignee, in trust, of all of the ABC Assets. The Assignee liquidated the property through
an auction sale and distributed the proceeds to the Subsidiaries' creditors according to their respective priorities at law to satisfy the Subsidiaries' obligations, in accordance with the rules and regulations of the State of California. If any proceeds remain and costs associated with the liquidation process have been satisfied, any remaining proceeds will be distributed to the Subsidiaries' equity holder, which is the Company.
February 2025 Equity Financing
On February 17, 2025, the Company entered into a securities purchase agreement (the "Purchase Agreement") with certain institutional and accredited investors (collectively, the "Investors") for the issuance and sale, in a best efforts public offering (the "Public Offering"), of (i) 558,000 units (the "Units"), each Unit consisting of one share (the "Shares") of the Company's Common Stock, one Series A Warrant (the "Series A Warrants") to purchase 0.25 share of Common Stock (the "Series A Warrant Shares") and one Series B Warrant (the "Series B Warrants," and together with the Series A Warrants, the "Series Warrants") to purchase one shares of Common Stock (the "Series B Warrant Shares" and, together with the Series A Warrant Shares, the "Series Warrant Shares") and (ii) 1,042,000 pre-funded units (the "Pre-Funded Units"), each Pre-Funded Unit consisting of one pre-funded warrant (the "Pre-Funded Warrants") to purchase one share of Common Stock (the "Pre-Funded Warrant Shares"), one Series A Warrant and one Series B Warrant. The public offering price was $6.00 per Unit and $5.9975 per Pre-Funded Unit. The Offering closed on February 19, 2025. The initial exercise price of each of the Series A Warrants and the Series B Warrants was $12.00 per share of Common Stock, which was subsequently adjusted as set forth herein. The aggregate gross proceeds from the Offering were approximately $9.6 million before deducting estimated offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes.
In connection with the Company's Reverse Stock Split, the exercise price of the Series B Warrants was adjusted to $0.4883 per share and the number of shares of Common Stock issuable upon exercise of the Series B Warrants was adjusted to 13,105,802 shares pursuant to the full ratchet anti-dilution provisions contained in the Series Warrants. As the Series B Warrants were classified as liabilities upon issuance, the changes in fair value as a result of these adjustments were recognized in earnings during the year ended December 31, 2025.
During April 2025, the Company modified the Series A Warrants to adjust the exercise price to $0.36625 per 0.25 share, and the number of Series A Warrants to 13,105,802 which are exercisable into 3,276,451 shares of Common Stock (the "Series A Warrant Modification"). As a result of the Series A Warrant Modification, the Company recognized the change in the fair value of the Series A Warrants as a deemed dividend in the amount of approximately $3.03 million during the year ended December 31, 2025.
The Company valued the deemed dividend in connection with the Series A Warrant Modification as the difference between: (a) the modified fair value of the Series A Warrants in the amount of approximately $3.31 million and (b) the fair value of the original award prior to the modification of approximately $0.34 million. The fair value of the Series A Warrants before the Series A Warrant Modification was estimated utilizing the Black Scholes model and the following key inputs and assumptions: the number of the Series A Warrants totaling 1,600,000; the exercise price of $3.00 per 0.25 share; dividend yield of 0%; remaining term of 4.95 years; equity volatility of 129%; and a risk-free interest rate of 3.7%. The fair value of the Series A Warrants after the effect of the Series A Warrant Modification was estimated utilizing the Black Scholes model and the following key inputs and assumptions: the number of the Series A Warrants totaling 13,105,802; the exercise price of $0.36625 per 0.25 share; dividend yield of 0%; remaining term of 4.95 years; equity volatility of 129%; and a risk-free interest rate of 3.7%.
The exercisability of the Series Warrants was subject to receipt of such stockholder approval was required by the applicable rules and regulations of the Nasdaq Capital Market LLC, including, but not limited to, with respect to (i) the issuance of all of the shares of Common Stock issuable upon exercise the Series Warrants in accordance with their terms (including adjustment provisions set forth therein), and (ii) to consent to any adjustment to the exercise price or number of shares of Common Stock underlying the Series Warrants in the event of a Share Combination Event and Dilutive Issuance, each as defined in the Series Warrants (collectively, the "Warrant Stockholder Approval"). The Company agreed to use its reasonable best efforts to obtain such approval within 60 days from the closing of the Offering, and agreed to cause an additional stockholder meeting to be held every 90 days thereafter until such Warrant Stockholder Approval is obtained. The Series B Warrants specifically can be settled by way of an alternative cashless exercise after stockholder approval is obtained, in which the Series B Warrant holders can receive three times the number of shares of Common Stock that would be issuable under a cash exercise. The Warrant Stockholder Approval was obtained at the Company's special meeting of stockholders held on April 10, 2025. Subsequent to March 31, 2025, and pursuant to the terms of the Series Warrants, upon receipt of the Warrant Stockholder Approval, the Floor Price (as defined in the Series Warrants) was adjusted to $1.465 per share.
The Series B Warrants became exercisable beginning on the first trading day following the date of Warrant Stockholder Approval (the "Initial Exercise Date."). Holders of the Series B Warrants may effect an "alternative cashless exercise" at any time while the Series B Warrants are outstanding following the Initial Exercise Date. Under the alternative cashless exercise option, a holder of a Series B Warrant has the right to receive an aggregate number of shares equal to the product of (i) the aggregate number of shares of Common Stock that would be issuable upon a cash rather than a cashless exercise of the Series B Warrant and (ii) 3.0.
Subject to certain limitations described in the Pre-Funded Warrants, the Pre-Funded Warrants were immediately exercisable and could have been exercised at a nominal consideration of $0.0001 per share any time until all of the Pre-Funded Warrants were exercised in full. A holder did not have the right to exercise any portion of the Series Warrants or the Pre-Funded Warrants if the holder (together with its affiliates) would have beneficially owned in excess of 4.99% or 9.99%, respectively (or at the election of the holder of the Series Warrants, 9.99%) of the number of shares of Common Stock outstanding immediately after having given effect to the exercise, as such percentage ownership was determined in accordance with the terms of the Series Warrants or the Pre-Funded Warrants, respectively. However, upon notice from the holder to the Company, the holder could have increased the beneficial ownership limitation pursuant to the Series Warrants, which may not have exceeded 9.99% of the number of shares of Common Stock outstanding immediately after having given effect to the exercise, as such percentage ownership was determined in accordance with the terms of the Series Warrants, provided that any increase in the beneficial ownership limitation would not have taken effect until 61 days following notice to the Company.
In connection with the Public Offering, (i) the conversion price of the Series A Preferred Stock was adjusted to $6.00 per share pursuant to the full ratchet anti-dilution provisions contained in the Certificate of Designations and, (ii) the exercise price of the Warrants was adjusted to $6.00 per share and the number of shares of Common Stock issuable upon exercise of the Warrants was adjusted proportionally to 2,700,000 shares pursuant to the full ratchet anti-dilution provisions contained in the Warrants (the "Public Offering Warrant Adjustment"). In connection with the Company's 1-for-25 Reverse Stock Split and pursuant to the share combination event adjustment provisions in the Series A Certificate of Designations, the conversion price of the Series A Preferred Stock was further adjusted to $0.1269.
During April 2025, the Company modified the Warrants to adjust the exercise price to $0.1269 per share and the number of shares of Common Stock issuable upon exercise of the Warrants to 127,659,584 shares (the "April 2025 Modification").
As a result of the Public Offering Warrant Adjustment and the April 2025 Modification, the Company recognized the change in the fair value of the Warrants as a deemed dividend in the amount of approximately $41.6 million during the year ended December 31, 2025. The Company valued the deemed dividend in connection with the Public Offering Warrant Adjustment as the difference between: (a) the modified fair value of the Warrants in the amount of approximately $9.1 million and (b) the fair value of the original award prior to the modification of approximately $0.7 million. The fair value of the Warrants before the effect of the Public Offering Warrant Adjustment was estimated utilizing the Black Scholes model using the following key inputs and assumptions: the number of shares issuable upon exercise of the Warrants totaling 288,000 shares; the exercise price of $56.25 per share; dividend yield of 0%; %; remaining term of 3.40 years; equity volatility of 165.0%; and a risk-free interest rate of 4.3%. The fair value of the Warrants after the effect of the Public Offering Warrant Adjustment was estimated utilizing the Black Scholes model and the following key inputs and assumptions: the number of shares issuable upon exercise of the Warrants totaling 2,700,000 shares; the exercise price of $6.00 per share; dividend yield of 0%; remaining term of 3.40 years; equity volatility of 165.0%; and a risk-free interest rate of 4.3%. The Company valued the deemed dividend in connection with the April 2025 Modification as the difference between: (a) the modified fair value of the Warrants in the amount of approximately $33.6 million and (b) the fair value of the original award prior to the modification of approximately $0.5 million. The fair value of the Warrants before the effect of the April 2025 Modification was estimated utilizing the Black Scholes model using the following key inputs and assumptions: the number of shares issuable upon exercise of the Warrants totaling 2,700,000 shares; the exercise price of $6.00 per share; dividend yield of 0%; remaining term of 3.20 years; equity volatility of 140.0%; and a risk-free interest rate of 3.6%. The fair value of the Warrants after the effect of the April 2025 Modification was estimated utilizing the Black Scholes model and the following key inputs and assumptions: the number of shares issuable upon exercise of the Warrants totaling 127,659,584 shares; the exercise price of $0.1269 per share; dividend yield of 0%; remaining term of 3.20 years; equity volatility of 140.0%; and a risk-free interest rate of 3.6%.
Dawson James Securities, Inc. ("Dawson") acted as the Company's exclusive placement agent in connection with the Public Offering, pursuant to that certain engagement letter, dated as of January 24, 2025, between the Company and Dawson (the "Engagement Letter"). Pursuant to the Engagement Letter, the Company agreed to pay Dawson a cash fee equal to 8.0% of the aggregate gross proceeds of the Public Offering and reimbursed certain expenses and legal fees.
The aggregate gross proceeds from the Public Offering were approximately $9.6 million before deducting estimated offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes.
The Company assessed the Pre-Funded Warrants and Series A Warrants under ASC 480 and ASC 815 and determined that the Pre-Funded and Series A Warrants met the requirements to be classified in stockholders' equity. However, as discussed in the following paragraph, as the fair value of the Series B Warrants exceeded the proceeds received from the Public Offering, and thus the Pre-Funded Warrants and Series A Warrants were recorded at their residual fair value of $0 upon issuance.
Transaction costs incurred attributable to the Series B Warrants of approximately $10.4 million were expensed immediately upon issuance, of which approximately $1.1 million represents cash broker and legal fees, and approximately $9.3 million represents the excess of the issuance date fair value of the Series B Warrants over cash proceeds.
July 2023 Private Placement
On July 13, 2023, we entered into the Purchase Agreement with certain accredited investors (the "Investors"), pursuant to which we agreed to sell in a private placement to the Investors (i) an aggregate of 15,000 shares of our newly-designated Series A Preferred Stock initially convertible into up to 266,667 shares of our Common Stock (ii) Warrants to acquire up to an aggregate of 266,667 shares of Common Stock.
Series A Preferred Stock
The terms of the Series A Preferred Stock are as set forth in the form of Certificate of Designations. The Series A Preferred Stock is convertible into shares of Common Stock (the "Conversion Shares") at the election of the holder at any time at an initial conversion price of $56.25 (the "Conversion Price"). The Conversion Price is subject to customary adjustments for stock dividends, stock splits, reclassifications and the like, and subject to price-based adjustment in the event of any issuances of Common Stock, or securities convertible, exercisable or exchangeable for Common Stock, at a price below the then-applicable Conversion Price (subject to certain exceptions).
Pursuant to the Certificate of Designations and prior to the November 2024 Certificate of Amendment (as defined below) and the January 2025 Certificate of Amendment (as defined below), we were initially required to redeem the Series A Preferred Stock in 13 equal monthly installments, which commenced on November 1, 2023.
On November 13, 2024, the Company entered into an Amendment Agreement with the Required Holders (as defined in the Certificate of Designations), pursuant to which, the Required Holders agreed to (i) amend the Certificate of Designations, by filing a Certificate of Amendment with the Secretary of State of the State of Delaware (the "November 2024 Certificate of Amendment"), (ii) defer any payment amounts that have accrued and that are unpaid as of November 13, 2024, pursuant to the Certificate of Designations, to January 15, 2025, and (iii) waive any breach or violation of the Purchase Agreement, the Certificate of Designations, or the Warrants resulting from the Company's failure to pay such outstanding amounts (the "November 2024 Certificate of Amendment"). The November 2024 Certificate of Amendment amends the Certificate of Designations to, (i) extend the maturity date to January 15, 2025, (ii) modify the schedule of Installment Dates (as defined in the Certificate of Designations), and (iii) adds an additional restrictive covenant to the Certificate of Designations requiring the Company from November 13, 2024 until January 15, 2025, to maintain unencumbered, unrestricted cash and cash equivalents on hand in amount equal to at least $1,500,000. The November 2024 Certificate of Amendment was filed with the Secretary of State of the State of Delaware, effective as of November 13, 2024.
On January 23, 2025, the Company entered into an Amendment Agreement with the Required Holders (as defined in the Certificate of Designations), pursuant to which, the Required Holders agreed to (i) amend the Certificate of Designations of the Company's Series A Preferred Stock by filing a Certificate of Amendment to the Certificate of Designations (the "January 2025 Certificate of Amendment") with the Secretary of State of the State of Delaware, (ii) defer any payment amounts that have accrued and that are unpaid as of January 23, 2025, pursuant to the Certificate of Designations, to February 15, 2025, and (iii) waive any breach or violation of the Purchase Agreement, the Certificate of Designations, or the Warrants resulting from the Company's failure to pay such outstanding amounts. The January 2025 Certificate of Amendment amends the Certificate of Designations to, (i) extend the maturity date to February 15, 2025, (ii) modify the schedule of Installment Dates (as defined in the Certificate of Designations), (iii) amends the restrictive covenant to the Certificate of Designations requiring the Company from January 15, 2025 until February 15, 2025, to maintain unencumbered, unrestricted cash and cash equivalents on hand in amount equal to at least $500,000, and (iv) amends the restrictive covenant relating to
the change in nature of the Company's business, such that such covenant does not apply to the Company's change in sales strategy related to the Company's Stendra® avanafil and product development strategy as it relates to the development and commercialization of a proprietary platform focused on prescription medication to over-the-counter switch solutions. The January 2025 Certificate of Amendment was filed with the Secretary of State of the State of Delaware, effective as of January 24, 2025.
On March 30, 2025, the Company entered into an Amendment Agreement (the "March 2025 Amendment Agreement") with the Required Holders (as defined in the Certificate of Designations), pursuant to which, the Required Holders agreed to (i) amend the Certificate of Designations of the Company's Series A Preferred Stock by filing a Certificate of Amendment to the Certificate of Designations (the "March 2025 Certificate of Amendment") with the Secretary of State of the State of Delaware, (ii) defer any payment amounts that have accrued and that are unpaid as of the date of the March 2025 Amendment Agreement, pursuant to the Certificate of Designations, to July 15, 2025, and (iii) waive any breach or violation of the Purchase Agreement, the Certificate of Designations, or the Warrants resulting from the Company's failure to pay such outstanding amounts. The March 2025 Certificate of Amendment amends the Certificate of Designations to, (i) extend the maturity date to July 15, 2025, and (ii) modify the schedule of Installment Dates (as defined in the Certificate of Designations). The March 2025 Certificate of Amendment was filed with the Secretary of State of the State of Delaware, effective as of March 31, 2025.
The amortization payments due upon redemptions are payable, at our election, in cash at 107% of the Installment Redemption Amount (as defined in the Certificate of Designations), or subject to certain limitations, in shares of Common Stock valued at the lower of (i) the Conversion Price then in effect and (ii) the greater of (A) 80% of the average of the three lowest closing prices of the Common Stock during the thirty trading day period immediately prior to the date the amortization payment is due or (B) $9.90 or such lower amount as permitted, from time to time, by the Nasdaq Stock Market, subject to adjustment for stock splits, stock dividends, stock combinations, recapitalizations or other similar events.
The holders of the Series A Preferred Stock are entitled to dividends of 8% per annum, compounded monthly, which are payable, at our option, in cash or shares of Common Stock, or in a combination thereof, in accordance with the terms of the Certificate of Designations. Upon the occurrence and during the continuance of a Triggering Event (as defined in the Certificate of Designations), the Series A Preferred Stock will accrue dividends at the rate of 15% per annum. In connection with a Triggering Event, each holder of Series A Preferred Stock will be able to require us to redeem in cash any or all of the holder's Series A Preferred Stock at a premium set forth in the Certificate of Designations. Upon conversion or redemption, the holders of the Series A Preferred Stock are also entitled to receive a dividend make-whole payment.
The event of default under the Settlement Agreement and the Security Agreement with Vivus existing and continuing by virtue of Metuchen's failure to pay the Installment (as defined in the Promissory Note) that was due October 1, 2024, constitutes a Triggering Event pursuant to the terms of the Certificate of Designations. As a result, the dividend rate of the Series A Preferred Stock was automatically increased to 15% per annum beginning on October 1, 2024.
During the year ended December 31, 2024, the Company experienced an Equity Conditions Failure in which the Company's average stock price during the Installment Conversion Price Measuring Period (as defined in the Certificate of Designations) corresponding to the September 1, 2024, and October 1, 2024, and November 1, 2024, installments (the "Affected Installments") was below the Floor Price (as defined in the Certificate of Designations) (the "Floor Price Condition"). As a result of the Floor Price Condition, the Company is required to redeem the Affected Installments as well as any previously deferred installment amounts at a 125% premium. Accordingly, the Company recorded an additional liability for penalty premiums totaling $697,504 (the "ECF Premiums") as of December 31, 2024, related to the Floor Price Condition, which is included in Accrued Series A Convertible Preferred payments payable on the accompanying consolidated balance sheet, and a corresponding reduction in additional paid-in capital for the year ended December 31, 2024, which was recognized as a deemed dividend.
On October 11, 2024, the Company entered into an Amendment Agreement with the Required Holders (as defined in the Certificate of Designations) pursuant to which, the Required Holders agreed to amend the Certificate of Designations of the Company's Series A Preferred Stock, by filing a Certificate of Amendment with the Secretary of State of the State of Delaware ("October 2024 Certificate of Amendment"). The October 2024 Certificate of Amendment amends the Certificate of Designations to, among other things, provide that, except as required by applicable law, the holders of the Series A Preferred Stock will be entitled to vote with holders of the Common Stock on an as converted basis based on the Stated Value (as defined in the Certificate of Designations) of preferred shares held and the conversion price in effect, subject to certain beneficial ownership limitations. The October 2024 Certificate of Amendment was filed with the Secretary of State of the State of Delaware, effective as of October 11, 2024.
During the year ended December 31, 2024, the Company recorded a gain of $3,550,000 related to the change in fair value of the derivative liability related to the bifurcated embedded derivative within the Series A Preferred Stock which is recorded in other income (expense) on the Consolidated Statement of Operations and reflects a derivative liability of $0 at December 31, 2024, as the Company had redeemed, converted, or accrued for redemption all Series A Preferred Shares as of December 31, 2024.
As of December 31, 2024, the Company has notified the investors of its intention to redeem the remaining installments due in cash and recorded a liability of $1,909,496 representing the cash payable to investors which includes $853,185 of the stated value of the Series A Preferred Shares, $314,998 of accrued dividends payable, and $741,313 for the cash premiums (inclusive of the ECF Premiums) which was recognized as a deemed dividend. During the year ended December 31, 2024, the Company has redeemed an aggregate 10,022 Series A Preferred Shares for cash of $6,234,087 and issued 283,070 shares of Common Stock, elected pursuant to the terms of the Certificate of Designations, worth $6,791,325 in relief of the accrued Series A Preferred Stock payments payable. During the year ended December 31, 2024, the Company recognized $2,308,122 of preferred dividends.
During the year ended December 31, 2025, the Company issued 1,031,638 shares of Common Stock to settle $476,444 of the accrued Series A Preferred Stock payments payable. Additionally, during the year ended December 31, 2025, the Company made cash payments totaling $224,249 in settlement of the accrued Series A Preferred Stock payments payable. During the year ended December 31, 2025, the Company recognized additional Series A Preferred Stock dividends totaling $973,984.
As of December 31, 2025, we have redeemed, converted or accrued for redemption all 15,000 shares of Series A Preferred Stock.
We are subject to certain affirmative and negative covenants regarding the incurrence of indebtedness, the existence of liens, the repayment of indebtedness, the payment of cash in respect of dividends (other than dividends pursuant to the Certificate of Designations), distributions or redemptions, and the transfer of assets, among other matters.
There is no established public trading market for the Series A Preferred Stock and we do not intend to list the Series A Preferred Stock on any national securities exchange or nationally recognized trading system.
Warrants
The Warrants became exercisable for shares of Common Stock (the "Warrant Shares") immediately upon issuance, at an initial exercise price of $56.25 per share (the "Exercise Price") and expire five years from the date of issuance. The Exercise Price is subject to customary adjustments for stock dividends, stock splits, reclassifications and the like, and subject to price-based adjustment, on a "full ratchet" basis, in the event of any issuances of Common Stock, or securities convertible, exercisable or exchangeable for Common Stock, at a price below the then-applicable Exercise Price (subject to certain exceptions). Upon any such price-based adjustment, the number of Warrant Shares issuable upon exercise of the Warrants will be increased proportionately. There is no established public trading market for the Warrants and we do not intend to list the Warrants on any national securities exchange or nationally recognized trading system.
On March 21, 2024, we entered into the Waiver and Amendment with the Investors in the Private Placement, effective as of December 31, 2023. The Waiver and Amendment, among other things, amended certain terms of the Warrants relating to the rights of the holders of the Warrants to provide that, in the event of a Fundamental Transaction (as defined in the Warrants) that is not within our control, including not approved by our Board of Directors, the holder of a Warrant shall only be entitled to receive from the Company or any successor entity the same type or form of consideration (and in the same proportion), at the Black Scholes Value of the unexercised portion of such Warrant, that is being offered and paid to the holders of our Common Stock in connection with the Fundamental Transaction.
Registration Rights
In connection with the Private Placement, we entered into a Registration Rights Agreement with the Investors (the "Registration Rights Agreement"), pursuant to which we agreed to file a resale registration statement (the "Registration Statement") with the SEC to register for resale 200% of the Conversion Shares and the Warrant Shares promptly following the Closing Date (as defined in the Purchase Agreement), but in no event later than 30 calendar days after the effective date of the Registration Rights Agreement, and to have such Registration Statement declared effective by the Effectiveness Date (as defined in the Registration Rights Agreement). We filed a registration statement on Form S-3 covering such securities, which registration statement, as amended, was declared effective on September 18, 2023. Under the Registration Rights Agreement, we are obligated to pay certain liquidated damages to the investors if we fail to maintain the effectiveness of the Registration Statement.
We will require additional financing to further develop and market our products, fund operations, and otherwise implement our business strategy at amounts relatively consistent with the expenditure levels disclosed above. We are exploring additional ways to raise capital, but we cannot assure you that we will be able to raise capital. Our failure to raise capital as and when needed would have a material adverse impact on our financial condition, our ability to meet our obligations, and our ability to pursue our business strategies. We expect to seek additional funds through a variety of sources, which may include additional public or private equity or debt financings, collaborative, or other arrangements with corporate sources, or through other sources of financing.
We are focused on expanding our service offering through internal development, collaborations, and through strategic acquisitions. We are continually evaluating potential asset acquisitions and business combinations. To finance such acquisitions, we might raise additional equity capital, incur additional debt, or both.
Cash Flows
The following table summarizes our cash flows from continuing operations for the years ended December 31, 2025, and 2024:
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For the Years Ended |
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December 31, |
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2025 |
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2024 |
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Net cash used in operating activities |
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$ |
(4,743,381) |
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$ |
(4,054,565) |
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Net cash used in investing activities |
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- |
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- |
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Net cash provided by/(used in) financing activities |
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8,161,458 |
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(6,234,087) |
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Net increase (decrease) in cash - continuing operations |
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$ |
3,418,077 |
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$ |
(10,288,652) |
Cash Flows Used in Operating Activities
Net cash used in operating activities for the year ended December 31, 2025, was $4,743,381, which primarily reflected our net loss of $1,422,333, which was inclusive of a loss from discontinued operations of $559,665, in addition to noncash adjustments to reconcile net loss to net cash used in operating activities of $6,553,043 consisting of the change in the fair value of the warrant liability, noncash warrant expense, and the gain on the assignment of the Subsidiaries and Vivus settlement, and changes in operating assets and liabilities of $172,336 largely driven by accounts payable and accrued expenses related to professional fees and employee bonuses and equity issuance fees.
Net cash used in operating activities for the year ended December 31, 2024, was $4,054,565, which primarily reflected our net loss of $14,318,790, which was inclusive of a loss from discontinued operations of $13,613,616 in addition to noncash adjustments to reconcile net loss to net cash used in operating activities of $3,082,785 consisting of the change in the fair value of the derivative liability, and changes in operating assets and liabilities of $266,606 largely driven by accounts payable and accrued expenses related to professional fees and employee bonuses and equity issuance fees.
Cash Flows Used in Investing Activities
Net cash used in investing activities for the year ended December 31, 2025, was $0.
Net cash used in investing activities for the year ended December 31, 2024, was $0.
Cash Flows Provided by/Used in Financing Activities
Net cash provided by financing activities was $8,161,458 for the year ended December 31, 2025, consisting of proceeds from the Public Offering, and the payment for the redemption of Series A Preferred Stock.
Net cash used in financing activities was $6,234,087 for the year ended December 31, 2024, consisting of redemptions of Series A Preferred Stock.
Contingencies
Certain conditions may exist as of the date the consolidated financial statements are issued, which may result in a loss to the Company, but which will only be resolved when one or more future events occur or fail to occur. The Company's management, in consultation with its legal counsel as appropriate, assesses such contingent liabilities, and such assessment inherently involves an exercise of judgment. In assessing loss contingencies related to legal proceedings that are pending against the Company or unasserted claims that may result in such proceedings, the Company, in consultation with legal counsel, evaluates the perceived merits of any legal proceedings or unasserted claims, as well as the perceived merits of the amount of relief sought or expected to be sought therein. If the assessment of a contingency indicates it is probable that a material loss has been incurred and the amount of the liability can be estimated, then the estimated liability would be accrued in the Company's consolidated financial statements. If the assessment indicates a potentially material loss contingency is not probable, but is reasonably possible, or is probable, but cannot be estimated, then the nature of the contingent liability, together with an estimate of the range of possible loss, if determinable and material, would be disclosed. Loss contingencies considered remote are generally not disclosed unless they involve guarantees, in which case the guarantees would be disclosed.