SOLIGENIX, INC.
For the period ended Dec 31, 2025. Filed Mar 31, 2026.
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A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2025 · Filed Mar 31, 2026
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What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-K
Period ended 2024-12-31; filed 2025-03-21.
0001558370-25-003459
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations8. Financial Statements and Supplementary DataCurrent report: 10-K
Period ended 2025-12-31; filed 2026-03-31.
0001104659-26-037701
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations8. Financial Statements and Supplementary DataThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 79 previous paragraphs and 78 current paragraphs.
29 unchanged; 32 reworded; 14 added; 17 removed; 1 previous and 3 current paragraphs rearranged.
Tables are not compared: 28 previous and 25 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (14)
Current report
Our business strategy can be outlined as follows:
Current report
In December 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-09,Income Taxes (Topic 740): Improvements to Income Tax Disclosures. This update enhances the transparency and decision-usefulness of income tax disclosures, providing investors with additional information to better assess how an entity’s operations and related tax risks and tax planning and operational opportunities affect its tax rate and prospects for future cash flows.
Current report
The standard requires public entities to disclose additional disaggregation of information in the effective tax rate reconciliation, including specified categories. Additionally, entities must provide separate disclosure of significant reconciling items and expanded disclosure of income taxes paid by jurisdiction.
Current report
The Public Health Solutions business segment had no revenues for the years ended years ended December 31, 2025 and 2024, respectively.
Current report
Loss from operations for the Public Health Solutions business segment for the year ended December 31, 2025 was $88,769 as compared to loss from operations of $254,576 for the year ended December 31, 2024, representing a decrease in loss of $165,807 or 65%. This decrease in loss is attributable to a reduction in resources allocated to this business segment.
Current report
In January 2026, we entered into the Rodman Sales Agreement (See Note 12 in the accompanying consolidated financial statements – Subsequent Events). The Rodman Sales Agreement provides for the offer and sale of shares of common stock having aggregate potential gross proceeds of up to approximately $3.5 million. We have up to approximately $3.2 million of potential gross proceeds capacity remaining from the Rodman Sales Agreement as of March 24, 2026 under the prospectus supplement dated January 23, 2026.
Current report
Additionally, macroeconomic and geopolitical uncertainties may further restrict access to capital, exacerbating liquidity challenges. Furthermore, concerns regarding our ability to continue as a going concern could negatively impact relationships with business partners, vendors, and other stakeholders.
Current report
Licenses and Royalties
Current report
Pursuant to an agreement with Hy Biopharma, we are obligated to pay Hy Biopharma a success-oriented milestone of $5 million in the event FDA approval is attained. Such payment will be payable in our restricted securities provided such number of shares does not exceed 19.9% ownership of our outstanding stock. As of December 31, 2025, no other milestone or royalty payments have been paid or accrued.
Current report
Leases
Current report
BioTherapeutics and Public Health Solutions), operate from this space. Pursuant to an amendment in May 2025, the lease has been extended through October 2028. The current monthly rent is $11,625 through October 2026 and increases to $11,883 in November 2026 and to $12,142 in November 2027 where it remains until expiration.
Current report
Employment Agreements
Current report
Debt Financing
Current report
Upon the closing of this transaction, we borrowed an initial amount of $10 million and made no further borrowings through the term of the agreement.
Removed paragraphs (17)
Previous report
An outline of our business strategy follows:
Previous report
In November 2023, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2023-07,Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. This update enhances the segment reporting requirements by increasing transparency and providing investors with additional insights into how an entity’s Chief Operating Decision Maker (“CODM”) evaluates segment performance and allocates resources.
Previous report
The standard requires public entities to disclose significant segment expenses that are regularly reviewed by the CODM and included in the reported measure of segment profit or loss. Additionally, entities must provide a reconciliation of total segment amounts to consolidated financial statements, as well as enhanced qualitative disclosures regarding the methodology used to identify reportable segments and assess performance. The update applies to all public entities, including those with a single reportable segment, and expands segment disclosures in interim financial statements.
Previous report
In October 2024, we entered into an amendment (the “2024 Amendment”) to the convertible debt financing agreement with Pontifax, as amended. The 2024 Amendment resulted in a substantial modification of the debt for accounting purposes, as defined, which is accounted for as an extinguishment. The difference between the fair value, or net carrying amount, of the debt before the 2024 Amendment and upon reacquisition was diminimus. Accordingly, no gain or loss was recognized related to the extinguishment related to the 2024 Amendment. Furthermore, as the 2024 Amendment resulted in a substantial modification, as defined, we elected not to account for the convertible debt using the fair value option in accordance with the applicable guidance. We determined the embedded conversion feature, after the 2024 Amendment, does not require bifurcation and therefore the convertible debt, as amended, has been recorded as a single liability classified instrument in accordance with ASU 2020-06. As a result of this election, we recognized a gain of $260,933 of other income from the change in the fair value of the convertible debt on our accompanying 2024 consolidated statement of operations.
Previous report
with the reduction in interest resulting from the repayment of a portion of the convertible debt principal balance, higher interest income earned on cash balances, an increase in tax credits, an increase in other income resulting from the change in the fair value of the convertible debt and approximately $394,000 of a loss on extinguishment of debt resulting from an amendment to the original convertible debt loan agreement was recognized in 2023.
Previous report
Revenues for the Public Health Solutions business segment for the year ended December 31, 2024 were $0 as compared to $444,235 for the year ended December 31, 2023, representing a decrease of $444,235 or 100%. The decrease in revenues was primarily the result of the conclusion of the grant associated with the development of SGX943.
Previous report
price of the Existing Warrants from $6.40 per share to $6.00 per share and (ii) issued new warrants (“New Warrants”) to the Holders to purchase a number of shares of common stock equal to 150% of the number of shares of common stock issued upon exercise of the Holders’ Existing Warrants. Pursuant to the Inducement Agreement, the Holders agreed to exercise for cash their Existing Warrants to purchase up to 703,125 shares of our common stock at a reduced exercise price of $6.00 per share on July 9, 2024, the date of the Inducement Agreement, until 1:30 p.m., Eastern Time. The total gross proceeds to us was approximately $4.2 million from the exercise of the Existing Warrants before deducting financial advisory fees and other expenses;
Previous report
Reverse Stock Split
Previous report
On June 5, 2024, we completed a reverse stock split of our issued and outstanding shares of common stock at a ratio of one-for-sixteen, whereby every sixteen shares of our issued and outstanding common stock were automatically combined into one issued and outstanding share of common stock without any change in the par value per share. No fractional shares were issued as a result of the reverse stock split. Any fractional shares that would otherwise have resulted from the reverse stock split were rounded up to the next whole number. Our common stock began trading on The Nasdaq Capital Market on a reverse split basis at the market opening on June 6, 2024. All share and per share data have been restated to reflect this reverse stock split.
Previous report
Provided the final success-oriented milestone is attained, we will be required to make a payment of up to $5 million, if and when achieved. The potential future payment will be payable in our common stock, not to exceed 19.9% of our outstanding stock.
Previous report
Upon the closing of this transaction, we borrowed the first tranche of $10 million. We did not utilize our option to draw the second or third tranche of $5 million each, which expired on December 15, 2021 and March 15, 2022, respectively.
Previous report
Contingencies
Previous report
We follow subtopic 450-20 of the FASB Accounting Standards Codification to report accounting for contingencies. Certain conditions may exist as of the date the financial statements are issued, which may result in a loss to us but which will only be resolved when one or more future events occur or fail to occur. We assess such contingent liabilities, and such assessment inherently involves an exercise of judgment. A liability is only recorded if management determines that it is both probable and reasonably estimable.
Previous report
CARES Act Employee Retention Credit
Previous report
The Coronavirus Aid, Relief, and Economic Security Act provides for an employee retention credit (“CARES ERC”), which is a refundable tax credit equal to 70% of qualified wages paid to employees during a quarter, capped at $10,000 of qualified wages per employee.
Previous report
We qualified for the CARES ERC for qualified wages through September 30, 2021. We have submitted filings for refunds of the CARES ERC but cannot reasonably estimate when or if we will receive any or all of the requested refunds. We have elected to follow subtopic 450-30 of the FASB Accounting Standards Codification and to account for the CARES ERC only when all uncertainties regarding realization have been resolved. For the years ended December 31, 2024 and 2023, we
Previous report
received refunds of approximately $313,000 and $121,000, respectively. The refunds were recorded as other income on our accompanying consolidated statements of operations for the years ended December 31, 2024 and 2023, respectively.
Reworded paragraphs (32)
Previous wording
Development programs in this business segment also include expansion of synthetic hypericin (SGX302) into psoriasis, and our first-in-class Innate Defense Regulator (“IDR”) technology, and dusquetide (SGX942 and SGX945), for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer and aphthous ulcers in Behçet’s Disease.
Current wording
Development programs in this business segment also include expansion of synthetic hypericin into psoriasis (SGX302), and our first-in-class Innate Defense Regulator technology, dusquetide, for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer (SGX942) and aphthous ulcers in Behçet’s Disease (“BD”) (SGX945).
Previous wording
Our Public Health Solutions business segment includes development programs for RiVax®, our ricin toxin vaccine candidate and SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease and our vaccine programs targeting filoviruses (such as Marburg and Ebola) and CiVax™, our vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®. To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases, the Biomedical Advanced Research and Development Authority and the Defense Threat Reduction Agency.
Current wording
Our Public Health Solutions business segment includes development programs for (i) RiVax®, a ricin toxin vaccine candidate, (ii) SGX943, a therapeutic candidate for antibiotic resistant and emerging infectious disease, and (iii) various vaccine programs, including a program targeting filoviruses (such as Marburg virus (“MARV”) and Ebola virus (“EBOV”)) and CiVax™, a vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®. To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases, the Biomedical Advanced Research and Development Authority and the Defense Threat Reduction Agency.
Previous wording
As part of the process of preparing our financial statements, we are required to estimate our accrued research and development expenses. This process involves reviewing open contract and purchase orders, communicating with our
Current wording
As part of the process of preparing our financial statements, we are required to estimate our accrued research and development expenses. This process involves reviewing open contract and purchase orders, communicating with our personnel to identify services that have been performed on our behalf and estimating the level of service performed and the
Previous wording
personnel to identify services that have been performed on our behalf and estimating the level of service performed and the associated costs incurred for the services when we have not yet been invoiced or otherwise notified of the actual costs. The majority of our service providers invoice us in arrears for services performed, on a pre-determined schedule or when contractual milestones are met; however, some require advance payments. We make estimates of our accrued expenses as of each balance sheet date in our financial statements based on facts and circumstances known to us at that time. Examples of estimated accrued research and development expenses include fees paid to:
Current wording
associated costs incurred for the services when we have not yet been invoiced or otherwise notified of the actual costs. The majority of our service providers invoice us in arrears for services performed, on a pre-determined schedule or when contractual milestones are met; however, some require advance payments. We make estimates of our accrued expenses as of each balance sheet date in our financial statements based on facts and circumstances known to us at that time. Examples of estimated accrued research and development expenses include fees paid to:
Previous wording
ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. We have adopted ASU 2023-07 for the year ended December 31, 2024, and have updated our segment disclosures accordingly. The adoption of this standard did not impact the recognition or measurement of our financial statements but resulted in enhanced segment-related disclosures in the notes to the consolidated financial statements.
Current wording
ASU 2023-09 is effective for fiscal years beginning after December 15, 2024. We have adopted ASU 2023-09 for the year ended December 31, 2025, and have updated our income tax disclosures accordingly. The adoption of this standard did not impact the recognition or measurement of our financial statements but resulted in enhanced income tax related disclosures in the notes to the consolidated financial statements.
Previous wording
For the year ended December 31, 2024, we had a net loss of $8,266,576 as compared to a net loss of $6,140,730 for the prior year, representing increased net loss of $2,125,846 or 35%. The increase in net loss is primarily attributed to decreases in gross profit and income tax benefits as well as an increase in operating expenses, offset by increases in interest income, tax credits and the change in the fair value of debt. For the year ended December 31, 2024, we had revenues of $119,371 as compared to $839,359 for the prior year, representing a decrease of $719,988 or 86%. The decrease in revenues was primarily a result of the conclusion of higher margin grants associated with the development of SGX943 and CiVax™ and a decrease in revenue associated with the zero margin grant for the HyBryte™ investigator initiated study.
Current wording
For the year ended December 31, 2025, we had a net loss of $11,080,380 as compared to a net loss of $8,266,576 for the prior year, representing increased net loss of $2,813,804 or 34%. The increase in net loss is primarily attributed to increases in research and development costs associated with the Phase 2a study in BD, the ongoing second confirmatory Phase 3 CTCL study and a decrease in other income relating to tax credits and the change in the fair value of debt.
Previous wording
Our gross profit for the year ended December 31, 2024 was $0 or 0% of total revenues as compared to $97,311 or 12% of total revenues for the prior year, representing a decrease of $97,311 or 100%. The decrease in gross profit was primarily the result of the conclusion of higher margin grants associated with the development of SGX943 and CiVax™ and a decrease in the zero margin grant for the HyBryte™ investigator initiated study.
Current wording
For the year ended December 31, 2025, we had no revenues as compared to revenues of $119,371 for the prior year, representing a decrease of $119,371 or 100%. The decrease in revenues was primarily a result of the conclusion of the zero-margin grant for the HyBryte™ investigator initiated study.
Previous wording
We incurred costs related to contract and grant revenues in the year ended December 31, 2024 and 2023 of $119,371 and $742,048, respectively, representing a decrease of $622,677 or 84%. The decrease in costs was primarily the result of the conclusion of higher margin grants associated with the development of SGX943 and CiVax™ and a decrease in the zero margin grant for the HyBryte™ investigator initiated study.
Current wording
For the year ended December 31, 2025, we had no costs related to contract and grant revenues as compared to costs of $119,371 for the prior year, representing a decrease of $119,371 or 100%. The decrease in costs was primarily a result of the conclusion of the zero-margin grant for the HyBryte™ investigator initiated study.
Previous wording
Research and development expenses increased by $1,910,890 or 58% to $5,223,589 for year ended December 31, 2024 as compared to $3,312,699 for the prior year. The increase in research and development spending for the year ended December 31, 2024 was primarily related to preliminary costs associated with the initiation of our Phase 2 study in Behçet’s Disease and the second confirmatory Phase 3 CTCL trial offset by an adjustment of estimated accruals for completed clinical trials.
Current wording
Research and development expenses increased by $2,262,224 or 43% to $7,485,813 for year ended December 31, 2025 as compared to $5,223,589 for the prior year. The increase in research and development spending for the year ended December 31, 2025 was primarily related to costs associated with the Phase 2a study in BD and the ongoing second confirmatory Phase 3 CTCL study.
Previous wording
General and administrative expenses decreased by $266,644 or 6%, to $4,215,908 for the year ended December 31, 2024, as compared to $4,482,552 for the prior year. This decrease is primarily related to a reduction in legal and consulting expenses.
Current wording
General and administrative expenses increased by $143,755 or 3%, to $4,359,663 for the year ended December 31, 2025, as compared to $4,215,908 for the prior year. This increase is primarily attributable to increases in various franchise taxes and stock related expenses offset by a decrease in professional fees.
Previous wording
The 2023 Amendment resulted in the extinguishment of the original convertible debt for accounting purposes. We elected to account for the amended convertible debt using the fair value option. The fair value of the convertible debt on the date of the amendment was approximately $3,304,000, which resulted in the recognition of a loss on extinguishment of approximately $394,000 on our accompanying consolidated statements of operations for the year ended December 31, 2023. The fair value of the convertible debt as of December 31, 2023 was approximately $3,260,934, which resulted in the recognition of $43,066 of other income from the change in the fair value of the convertible debt on our accompanying consolidated statements of operations for the year ended December 31, 2023. For 2023 and through the 2024 Amendment (described below), the fair value of the convertible debt was estimated using the Monte Carlo valuation method.
Current wording
The 2023 Amendment resulted in the extinguishment of the original convertible debt for accounting purposes. We elected to account for the amended convertible debt using the fair value option. As a result, we recognized $260,933 of other income from the change in the fair value of the convertible debt in the accompanying consolidated statements of operations during the year ended December 31, 2024. The fair value of the convertible debt was estimated using the Monte Carlo valuation method.
Previous wording
On January 3, 2024, Pontifax delivered a conversion notice to us electing to convert a portion of the remaining principal balance into shares of our common stock. Upon conversion, we issued 9,139 shares of our common stock at $10.88 per share, reducing the remaining principal balance by $99,416.
Current wording
During the year ended December 31, 2024, Pontifax delivered to us notices of conversion electing to convert a portion of the then outstanding principal balance into shares of our common stock. Accordingly, we issued 36,790 shares of our common stock resulting in a reduction of the outstanding principal balance totaling $254,256.
Previous wording
In October 2024, we entered into an amendment (the “2024 Amendment”) to the Loan Agreement, as amended. The 2024 Amendment reduced the conversion price with respect to the remaining principal amount outstanding to (i) $3.81 for the first 501,648 shares of our common stock issuable upon conversion and (ii) $4.23 with respect to all shares of our common stock issuable upon conversion thereafter. The remaining terms of the agreement remained in effect with minimal, non-material modifications to those terms. The 2024 Amendment resulted in a substantial modification of the debt for accounting purposes, as defined, which is accounted for as an extinguishment. The difference between the fair value, or net carrying amount, of the debt before the 2024 Amendment and upon reacquisition was diminimus. Accordingly, no gain or loss was recognized related to the extinguishment related to the 2024 Amendment. Furthermore, as the 2024 Amendment resulted in a substantial modification, as defined, we elected not to account for the convertible debt using the fair value option in accordance with the applicable guidance. We determined the embedded conversion feature, after the 2024 Amendment, does not require bifurcation and therefore the convertible debt, as amended, has been recorded as a single liability classified instrument in accordance with ASU 2020-06. As a result of this election, we recognized a gain of $260,933 of other income from the change in the fair value of the convertible debt on our accompanying 2024 consolidated statement of operations.
Current wording
In October 2024, we entered into an amendment (the “2024 Amendment”) to the Loan Agreement, as amended. The 2024 Amendment reduced the conversion price with respect to the remaining principal amount outstanding to (i) $3.81 for the first 501,648 shares of our common stock issuable upon conversion and (ii) $4.23 with respect to all shares of our common stock issuable upon conversion thereafter. The remaining terms of the agreement remained in effect with minimal, non-material modifications to those terms. Pursuant to applicable accounting standards, after the 2024 Amendment, we elected not to account for the amended convertible debt under the fair value option. Accordingly, there was no further recognition for the impact of changes in fair value in our financial statements.
Previous wording
In February 2025, we fully repaid all outstanding obligations and terminated the Loan Agreement. As a result, all related liens and security interests securing the Company’s obligations were released. We did not incur any prepayment penalties for the early repayment.
Current wording
In February 2025, we fully repaid all outstanding obligations and terminated the Loan Agreement. As a result, all related liens and security interests securing our obligations were released. We did not incur any prepayment penalties for the early repayment.
Previous wording
Total other income for the year ended December 31, 2024 was $763,807 as compared to $210,593 of total other expense for the prior year, reflecting a decrease of $974,400 or 463%. The decrease in total other expense was primarily associated
Current wording
Total other income for the year ended December 31, 2025 was $258,481 as compared to $763,807 for the prior year, reflecting a decrease of $505,326 or 66%. The decrease in total other income was primarily associated with decreases in tax credits and the change in the fair value of debt.
Previous wording
The State of New Jersey’s Technology Business Tax Certificate Program allows certain high technology and biotechnology companies to sell unused NOL carryforwards to other New Jersey-based corporate taxpayers. We sold 2023, 2022 and 2021 New Jersey NOL carryforwards resulting in the recognition of income tax benefits, net of transaction costs of $409,114 and $1,767,803 during the years ended December 31, 2024 and 2023, respectively. We sold our 2023 New Jersey NOLs and have recorded a receivable of $409,114 which is included in prepaid expenses and other current assets on the accompanying consolidated balance sheet for the year ended December 31, 2024. We have not yet sold our 2024 New Jersey NOL carryforwards but may do so in the future. We will continue to explore opportunities to sell unused NOL carryforwards for the year ended December 31, 2024. However, there can be no assurance as to the continuation or magnitude of this program in future years.
Current wording
The State of New Jersey’s Technology Business Tax Certificate Program allows certain high technology and biotechnology companies to sell unused NOL carryforwards to other New Jersey-based corporate taxpayers. We sold our 2024 and 2023 New Jersey NOL carryforwards resulting in the recognition of income tax benefits, net of transaction costs of $506,615 and $409,114 during the years ended December 31, 2025 and 2024, respectively. Both amounts were recorded as receivables and are included in prepaid expenses and other current assets on the accompanying consolidated balance sheets for the years ended December 31, 2025 and 2024, respectively. We have not yet sold our 2025 New Jersey NOL carryforwards but may do so in the future. However, there can be no assurance as to the continuation or magnitude of this program in future years.
Previous wording
The Specialized BioTherapeutics business segment had revenue of $119,371 for the year ended December 31, 2024 as compared to $395,124 for the year ended December 31, 2023, representing a decrease of $275,753 or 70%. The decrease was due to decreased reimbursable development activity under the grant to support the investigator-initiated study of HyBryte™ for expanded treatment in patients with early-stage CTCL.
Current wording
The Specialized BioTherapeutics business segment had no revenue for the year ended December 31, 2025 as compared to $119,371 for the year ended December 31, 2024, representing a decrease of $119,371 or 100%. The decrease was due to the conclusion of the zero-margin grant for the HyBryte™ investigator initiated study.
Previous wording
Loss from operations for the Public Health Solutions business segment for the year ended December 31, 2024 was $254,576 as compared to loss from operations of $36,531 for the year ended December 31, 2023, representing an increase in loss of $218,045 or 597%. The loss for the year ended December 31, 2024 is attributable to additional expenses incurred due to the expiration of grants and contracts. Loss from operations for the Specialized BioTherapeutics business segment for the year ended December 31, 2024 was $4,365,034 as compared to $2,812,303 for the year ended December 31, 2023, representing an increase in loss of $1,552,731 or 55%. This increase in loss is primarily related to preliminary costs associated with the initiation of our Phase 2 study in Behçet’s Disease and the second confirmatory Phase 3 CTCL trial offset by an adjustment of estimated accruals for completed clinical trials.
Current wording
Loss from operations for the Specialized BioTherapeutics business segment for the year ended December 31, 2025 was $6,981,971 as compared to $4,365,034 for the year ended December 31, 2024, representing an increase in loss of $2,616,937 or 60%. This increase in loss is primarily related to costs associated with the Phase 2 study in BD and the ongoing second confirmatory Phase 3 CTCL study.
Previous wording
As of December 31, 2024, we had cash and cash equivalents of $7,819,514 as compared to $8,446,158 as of December 31, 2023, representing a decrease of $626,644 or 7%. As of December 31, 2024, we had working capital of $3,980,218, representing an increase of $625,006 as compared to working capital of $3,355,212 for the prior year. The decrease in cash and cash equivalents was primarily related to cash used in operating activities and debt principal repayments offset by cash provided by financing activities. The increase in working capital is primarily the result of a reduction in outstanding convertible debt resulting from principal repayments and debt conversions partially offset by cash used in operating activities during the year ended December 31, 2024.
Current wording
As of December 31, 2025, we had cash and cash equivalents of $7,936,153 as compared to $7,819,514 as of December 31, 2024, representing an increase of $116,639 or 1%. As of December 31, 2025, we had working capital of $5,149,732, representing an increase of $1,169,514 as compared to working capital of $3,980,218 for the prior year. The increase in cash and cash equivalents was primarily related to net proceeds received from financing activities offset by cash used in operating activities and repayment of convertible debt. The increase in working capital is primarily the result of net proceeds received from financing activities partially offset by the repayment of convertible debt and cash used in operating activities during the year ended December 31, 2025.
Previous wording
We believe that we have sufficient resources available to support our development activities and business operations and to satisfy our obligations as they become due through the end of 2025. However, as of the date of filing this Annual Report on Form 10-K, we do not have sufficient cash and cash equivalents to support our operations for at least 12 months following the issuance of our financial statements on March 21, 2025. As a result, these conditions raise substantial doubt about our ability to continue as a going concern through 12 months after the issuance date of the financial statements
Current wording
Based on our operating budget, current rate of cash outflows, and cash on hand, we believe we have sufficient resources available to support our development activities, business operations and meet our obligations as they become due into the fourth quarter of 2026. However, as of the date of filing this Annual Report on Form 10-K, we do not have sufficient cash and cash equivalents to support our operations for at least 12 months following the issuance of our financial statements on March 31, 2026. As a result, these conditions raise substantial doubt about our ability to continue as a going concern through 12 months after the issuance date of the financial statements
Previous wording
To alleviate the conditions that raise substantial doubt about our ability to continue as a going concern, our plans include securing:
Current wording
To mitigate the conditions that raise substantial doubt about our ability to continue as a going concern, our plans include securing:
Previous wording
Other than the AGP Sales Agreement, which was entered into on August 16, 2024, none of these alternatives are currently committed. There is no assurance that we will obtain sufficient funding on acceptable terms, if at all, to continue operations, enter into strategic transactions that provide the necessary capital, or implement other strategies to mitigate the substantial doubt about our ability to continue as a going concern. If these alternatives are unavailable or not secured on satisfactory terms, we will not have sufficient cash resources or liquidity to fund our operations for at least 12 months after the financial statements are issued. Failure to obtain adequate capital when needed may force us to delay, reduce, or eliminate business development efforts, negatively impacting our ability to achieve our objectives, remain competitive, and maintain our financial condition and operating results. Additionally, market instability, including geopolitical factors, may limit our access to capital, further straining our liquidity and ability to continue as a going concern. The perception of financial instability may also deter potential business partners due to concerns about our ability to fulfill contractual obligations.
Current wording
While the Rodman Sales Agreement is in place, none of the other funding alternatives are currently committed. There is no assurance that we will be successful in securing sufficient financing on acceptable terms, if at all, to continue operations, enter into strategic transactions that provide the necessary capital, or implement other strategies to mitigate the substantial doubt about our ability to continue as a going concern. If these alternatives are unavailable or not secured on satisfactory terms, we will not have sufficient cash resources or liquidity to fund our operations for at least 12 months after the financial statements are issued. Failure to obtain adequate capital when needed may force us to delay, reduce, or eliminate business development efforts, negatively impacting our ability to achieve our objectives, remain competitive, and maintain our financial condition and operating results.
Previous wording
Under our budget and based upon our existing product development agreements and license agreements pursuant to letters of intent and option agreements, we expect our total research and development expenditures for the year ending December 31, 2025 to be approximately $6 million before any contract or grant reimbursements, of which approximately all relates to the Specialized BioTherapeutics business segment. We anticipate grant reimbursements for the same period of approximately $0.1 million to offset research and development expenses in the Specialized BioTherapeutics business segment.
Current wording
Under our budget and based upon our existing product development agreements and license agreements pursuant to letters of intent and option agreements, we expect our total research and development expenditures for the year ending December 31, 2026 to be approximately $3.3 million before any contract or grant reimbursements, of which approximately all relates to the Specialized BioTherapeutics business segment. We do not anticipate any grant reimbursements for the same period to offset research and development expenses in the Specialized BioTherapeutics business segment.
Previous wording
We have licensing fee commitments of approximately $230,000 as of December 31, 2024 over the next five years for several licensing agreements with partners and universities. Additionally, we have collaboration and license agreements, which upon clinical or commercialization success may require the payment of milestones of up to approximately $13.2 million, royalties on net sales of covered products ranging from 2% to 3%, sub-license IND milestones on covered products of up to approximately $200,000, sub-license income royalties on covered products up to 15% and sub-license global net sales royalties on covered products ranging from 1.5% to 2.5%, if and when achieved. However, there can be no assurance that clinical or commercialization success will occur.
Current wording
We have licensing fee commitments of approximately $230,000 as of December 31, 2025 over the next five years for several licensing agreements with partners and universities. Additionally, we are party to other agreements which include cash milestone payments, royalties and other fees payable, which are all contingent upon clinical or commercialization success. There can be no assurance that clinical or commercialization success will occur.
Previous wording
In September 2014, we entered into an asset purchase agreement with Hy Biopharma pursuant to which we acquired certain intangible assets, properties and rights of Hy Biopharma related to the development of Hy BioPharma’s synthetic hypericin product. As consideration for the assets acquired, we initially paid $275,000 in cash and issued 771 shares of common stock with a fair value based upon our stock price on the date of grant of $3.75 million. These amounts were charged to research and development expense during the third quarter of 2014 as the assets will be used in our research and development activities and do not have alternative future use pursuant to generally accepted accounting principles in the U.S.
Current wording
In September 2014, we entered into an asset purchase agreement with Hy Biopharma pursuant to which we acquired certain intangible assets, properties and rights of Hy Biopharma related to the development of Hy BioPharma’s synthetic hypericin product. As consideration for the assets acquired, we initially paid $275,000 in cash and issued 771 shares of common stock with a fair value based upon our stock price on the date of grant of $3.75 million. These amounts were charged to research and development expense during the third quarter of 2014 as the assets will be used in our research and development activities and do not have alternative future use.
Previous wording
In March 2020, we filed a prospectus supplement covering the offer and sale of up to 8,151 shares of our common stock, which were issued to Hy Biopharma. We were required to issue the shares to Hy Biopharma as payment following the achievement of a milestone under the asset purchase agreement, specifically, the Phase 3 clinical trial of HyBryte™ being successful in the treatment of CTCL. The number of shares of our common stock issued to Hy Biopharma was calculated using an effective price of $614.40 per share, based upon a formula set forth in the asset purchase agreement.
Current wording
In March 2020, we filed a prospectus supplement covering the offer and sale of up to 8,151 shares of our common stock, which were issued to Hy Biopharma as payment for achieving a milestone: we determine the Phase 3 clinical trial of HyBryte™ to be successful in the treatment of CTCL. The number of shares of our common stock issued to Hy Biopharma was calculated using an effective price of $614.40 per share, based upon a formula set forth in the purchase agreement.
Previous wording
We currently lease approximately 6,200 square feet of office space at 29 Emmons Drive, Suite B-10 in Princeton, New Jersey. This office space currently serves as our corporate headquarters, and both of our business segments (Specialized BioTherapeutics and Public Health Solutions), operate from this space. Pursuant to the lease which expires October 2025, the current rent is $11,625 per month. Our office space is sufficient for our current needs.
Current wording
We currently lease approximately 6,200 square feet of office space at 29 Emmons Drive, Suite B-10 in Princeton, New Jersey. This office space currently serves as our corporate headquarters, and both of our business segments (Specialized
Previous wording
In January 2020, our Board of Directors authorized an amendment to Dr. Schaber’s employment agreement to increase the number of shares of common stock from 21 to 2,084, issuable to Dr. Schaber immediately prior to the completion of a transaction, or series or a combination of related transactions, negotiated by our Board of Directors whereby, directly or indirectly, a majority of our capital stock or a majority of our assets are transferred from us and/or our stockholders to a third party.
Current wording
In May 2025, we entered into an amendment to Dr. Schaber’s employment agreement to increase the number of shares of common stock, from 2,084 to 200,000, issuable to Dr. Schaber immediately prior to the completion of a transaction, or series or a combination of related transactions, negotiated by our Board of Directors whereby, directly or indirectly, a majority of our capital stock or a majority of our assets are transferred from us and/or our stockholders to a third party.
Previous wording
In December 2020, we entered into a $20 million convertible debt financing agreement with Pontifax (the “Loan Agreement”), the healthcare-dedicated venture and debt fund of the Pontifax life science funds. Under the terms of the Loan Agreement, we had access to up to $20 million in convertible debt financing in three tranches, which will mature on June 15, 2025 and had an interest only period for the first two years with a fixed interest rate of 8.47% on borrowed amounts and an interest rate of 1% on amounts available but not borrowed as an unused line of credit fee. After the interest-only period, the outstanding principal was to be repaid in quarterly payments of $1 million each commencing in the first quarter of 2023. The agreement is secured by a lien covering substantially all of our assets, other than intellectual property.
Current wording
In December 2020, we entered into a $20 million convertible debt financing agreement with Pontifax (the “Loan Agreement”). Under the terms of the Loan Agreement, we had access to up to $20 million in convertible debt financing which accrued interest at a rate of 8.47% on borrowed amounts and an interest rate of 1% on amounts available but not borrowed as an unused line of credit fee. Payments of interest only were due for the first two years and thereafter, the outstanding principal was to be repaid in quarterly installments, as defined.
Previous wording
In April 2023, we entered into an amendment to the Loan Agreement (the “2023 Amendment”). The 2023 Amendment called for the immediate payment of $5 million of the outstanding principal balance and any accrued interest, waived any prepayment charge in connection with the repayment of this amount and resulted in an outstanding principal balance of $3 million. The 2023 Amendment also provided for interest only through June 30, 2024, reduced quarterly principal repayments to $750,000 and eliminated the minimum cash covenant. Further, the 2023 Amendment reduced the conversion price with respect to the remaining principal amount to (i) 90% of the closing price of our common stock on the day before the delivery of a conversion notice with respect to the first 36,790 shares of our common stock issuable upon conversion and to (ii)
Current wording
In April 2023, we entered into an amendment to the Loan Agreement (the “2023 Amendment”). The 2023 Amendment called for the immediate payment of $5 million of the outstanding principal balance and any accrued interest, waived any prepayment charge in connection with the repayment of this amount and resulted in an outstanding principal balance of $3 million. The 2023 Amendment adjusted certain payment provisions, and provided for an adjustment to the conversion price provisions with respect to the remaining principal amount to (i) 90% of the closing price of our common stock on the day before the delivery of a conversion notice with respect to the first 36,790 shares of our common stock issuable upon conversion and to (ii) $27.20 with respect to all shares of our common stock issuable upon conversion thereafter.
Previous wording
In April 2023, we entered into an amendment (the “2023 Amendment”) to the convertible debt financing agreement with Pontifax Medison Finance (“Pontifax”) (see Note 5 – Debt). The 2023 Amendment resulted in the extinguishment of the original convertible debt for accounting purposes. We elected to account for the amended convertible debt using the fair value option, which requires us to record changes in fair value as a component of other income or expense. The fair value of the convertible debt on the date of the amendment was approximately $3,304,000, which resulted in the recognition of a loss on extinguishment of approximately $394,000 on our accompanying consolidated statements of operations during the year ended December 31, 2023. The fair value of the convertible debt as of December 31, 2023 was approximately $3,260,934, which resulted in the recognition of $43,066 of other income from the change in the fair value of the convertible debt on our accompanying consolidated statements of operations for the year ended December 31, 2023. For 2023 and through the 2024 Amendment (described below), the fair value of the convertible debt was estimated using the Monte Carlo valuation method.
Current wording
The 2023 Amendment resulted in the extinguishment of the original convertible debt for accounting purposes. We elected to account for the amended convertible debt using the fair value option. As a result, we recognized $260,933 of other income from the change in the fair value of the convertible debt in our accompanying consolidated statements of operations during the year ended December 31, 2024. The fair value of the convertible debt was estimated using the Monte Carlo valuation method.
Previous wording
On April 15, 2024, Pontifax delivered a conversion notice to us electing to convert a portion of the remaining principal balance into shares of our common stock. Upon conversion, we issued 27,651 shares of our common stock at $5.60 per share, reducing the remaining principal balance by $154,840.
Current wording
During the first half of 2024, Pontifax delivered to us notices of conversion electing to convert a portion of the then outstanding principal balance into shares of our common stock. Accordingly, we issued 36,790 shares of our common stock resulting in a reduction of the outstanding principal balance totaling $254,256.
Rearranged current paragraphs (3)
Current report — wording carried from elsewhere
In April 2023, we entered into an amendment (the “2023 Amendment”) to the convertible debt financing agreement with Pontifax Medison Finance (“Pontifax”) (see Note 5 in the accompanying consolidated financial statements – Debt). The 2023 Amendment called for the immediate payment of $5 million of the outstanding principal balance and any accrued interest, waived any prepayment charge in connection with the repayment of this amount and resulted in an outstanding principal balance of $3 million. The 2023 Amendment adjusted certain payment provisions, and provided for an adjustment to the conversion price provisions with respect to the remaining principal amount to (i) 90% of the closing price of our common stock on the day before the delivery of a conversion notice with respect to the first 36,790 shares of our common stock issuable upon conversion and to (ii) $27.20 with respect to all shares of our common stock issuable upon conversion thereafter.
Current report — wording carried from elsewhere
In October 2024, we entered into an amendment (the “2024 Amendment”) to the Loan Agreement, as amended. The 2024 Amendment reduced the conversion price with respect to the remaining principal amount outstanding to (i) $3.81 for the first 501,648 shares of our common stock issuable upon conversion and (ii) $4.23 with respect to all shares of our common stock issuable upon conversion thereafter. The remaining terms of the agreement remained in effect with minimal, non-material modifications to those terms. Pursuant to applicable accounting standards, after the 2024 Amendment, we elected not to account for the amended convertible debt under the fair value option. Accordingly, there was no further recognition for the impact of changes in fair value in our financial statements.
Current report — wording carried from elsewhere
In February 2025, we fully repaid all outstanding obligations and terminated the Loan Agreement. As a result, all related liens and security interests securing our obligations were released. We did not incur any prepayment penalties for the early repayment.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
$27.20 with respect to all shares of our common stock issuable upon conversion thereafter. The remaining terms of the agreement remained unmodified.