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
SNGX$0.34+0.5%Stored close · as of Nov 6, 2026
What changed in Risk Factors?
Read the current filingPrevious report: 10-K
Period ended 2024-12-31; filed 2025-03-21.
0001558370-25-003459
Item 1A. Risk factorsCurrent report: 10-K
Period ended 2025-12-31; filed 2026-03-31.
0001104659-26-037701
Item 1A. Risk factorsThe 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 147 previous paragraphs and 169 current paragraphs.
113 unchanged; 25 reworded; 26 added; 1 removed; 8 previous and 5 current paragraphs rearranged.
Tables are not compared: 96 previous and 97 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 (26)
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
Our business strategy includes the potential receipt and monetization of PRVs, but there can be no assurance that we will qualify for, receive or realize value from any such voucher, and changes in the PRV programs or our development plans could materially and adversely affect this aspect of our business.
Current report
From time to time, certain of our product candidates (currently including SuVax™, MarVax™ or combination thereof) may be eligible for a PRV under programs administered by the FDA, including the neglected tropical disease, rare pediatric disease or medical countermeasure PRV programs established under amendments to the Federal Food, Drug and Cosmetic Act. These programs permit a sponsor that obtains FDA approval of a qualifying product to receive a PRV that may be used to obtain priority review for a subsequent marketing application or may be transferred or sold to another sponsor. While PRVs have historically been sold in private transactions for significant amounts, the availability and value of any PRV are subject to substantial uncertainty. Accordingly, even if one or more of our product candidates successfully complete development and receive regulatory approval, we may not qualify for, receive or realize meaningful value from a PRV.
Current report
Eligibility for a PRV depends on numerous statutory and regulatory requirements, and the FDA retains significant discretion in determining whether a particular product satisfies the applicable criteria. For example, a product must generally target a disease that qualifies under the relevant PRV program and must itself satisfy specific eligibility requirements, including, in certain programs, that the product represents a “new chemical entity” or otherwise meets applicable novelty requirements. If our product candidates do not meet these criteria, if the FDA interprets or applies these criteria differently than we expect, or if our development programs are modified in ways that affect eligibility, we may not qualify for a PRV even if the product ultimately receives marketing approval. In addition, the FDA may request or require additional data, analyses or clinical studies that could alter the regulatory pathway or timing of approval in ways that affect PRV eligibility. Certain PRV programs have statutory sunset provisions or limitations that could affect eligibility depending on the timing of regulatory submissions and approvals. For example, the rare pediatric disease PRV program has historically been subject to periodic legislative reauthorization and could expire or otherwise change unless extended by U.S. Congress. Congress has, from time to time, proposed amendments that would narrow eligibility, impose additional conditions or eliminate the program entirely, and similar proposals could be advanced in the future.
Current report
Even if we qualify for and receive a PRV, the timing of receipt would be uncertain and dependent on the timing of regulatory approval of the underlying product candidate. Delays in clinical development, manufacturing, regulatory review or other aspects of the approval process could delay the issuance of any PRV, potentially reducing its strategic or economic value. In addition, the FDA could determine that a product does not meet PRV eligibility criteria at the time of approval, even if we previously believed it would qualify. Further, the FDA has broad authority to rescind or decline to recognize a PRV if it determines that the underlying approval was based on incomplete, inaccurate or subsequently invalidated data, or if the sponsor fails to comply with post approval requirements.
Current report
The market value of PRVs is highly variable and has fluctuated significantly over time as a result of market supply and demand, regulatory developments and the perceived utility of priority review. The number of PRVs available may increase if additional sponsors receive vouchers, which could reduce market demand and depress prices. Conversely, changes in FDA review practices or the perceived advantages of priority review could affect the willingness of potential purchasers to acquire PRVs or the prices they are willing to pay. As a result, even if we obtain a PRV and seek to monetize it through a sale or other transfer, the proceeds we receive, if any, may be significantly lower than historical transaction values or our
Current report
expectations. In addition, PRV transactions are typically complex, privately negotiated arrangements that may require us to make representations, warranties, indemnities or other commitments that could expose us to post closing liabilities.
Current report
In addition, the regulatory and legislative framework governing PRVs could change in ways that adversely affect our ability to obtain or benefit from a voucher. Congress could amend, suspend or terminate PRV programs, modify eligibility requirements, impose additional conditions on issuance or transferability or otherwise limit the availability or value of PRVs. Similarly, the FDA could adopt new guidance, regulations or interpretive positions affecting the eligibility criteria, review process or administration of the PRV programs. Any such changes could occur at any time, including during the development of our vaccine candidates, and could prevent us from qualifying for a PRV or reduce the value of any voucher we may receive. Moreover, changes in user fee legislation or FDA resource allocation could diminish the practical benefits of priority review, thereby reducing the attractiveness of PRVs to potential purchasers.
Current report
Moreover, a PRV may not provide the strategic or financial benefits we anticipate. If we elect to use a PRV to obtain priority review for one of our own future marketing applications, we would be required to pay an additional user fee to the FDA, which in recent years has exceeded several million dollars, and there can be no assurance that priority review would ultimately result in a successful approval or meaningful acceleration of the product’s commercial launch. Alternatively, if we elect to sell or transfer a PRV, we may encounter limited market demand, delays in identifying a buyer or other transaction related risks. The transfer of a PRV must also be reported to the FDA and may be subject to other procedural requirements. We may also be unable to consummate a sale on acceptable terms or within the time frame we anticipate, and any delay or failure to monetize a PRV could adversely affect our liquidity planning.
Current report
Additionally, our ability to obtain, retain or monetize a PRV may depend on factors outside our control, including the actions of collaborators, licensors, contract manufacturers or other third parties involved in the development or regulatory submission for a qualifying product. Any failure by these parties to meet their obligations, maintain compliance with regulatory requirements or provide timely and accurate data could jeopardize PRV eligibility or delay issuance.
Current report
Because the potential receipt and monetization of a PRV may be viewed by investors as a component of our overall business strategy or potential future liquidity, the failure to qualify for, obtain or realize expected value from a PRV could adversely affect market perceptions of our development programs and prospects. Any such outcome could have a material adverse effect on our business, financial condition, results of operations and the market price of our securities. Even if we ultimately receive a PRV, there can be no assurance that it will generate any revenue or strategic benefit or that the PRV programs will continue to exist in their current form at the time we seek to use or monetize a voucher.
Current report
U.S. trade policy remains subject to significant uncertainty following a recent ruling by the U.S. Supreme Court limiting the executive branch’s authority to impose certain tariffs without clear congressional authorization. Although this decision invalidated a number of previously imposed tariffs, it has also created uncertainty regarding the scope of future trade measures and the mechanisms by which they may be implemented. The Administration may seek to impose new or replacement tariffs under alternative statutory authorities, and Congress may consider additional trade legislation. As a result, the timing, scope and structure of future tariffs, export controls or other trade restrictions remain uncertain.
Current report
Escalation of armed conflict and geopolitical instability in the Middle East, including tensions involving Israel, Iran and the United States, could materially disrupt our clinical development activities in general and specifically those relating to SGX945 (dusquetide) for the treatment of BD.
Current report
Ongoing hostilities and escalating tensions in the Middle East may materially and adversely affect our ability to conduct clinical development activities and execute our development strategies in general and specifically for SGX945 (dusquetide) for the treatment of BD. BD has a significant prevalence in countries situated along the historic “Silk Road,” including Turkey, Iran, Japan and China, and we currently anticipate that a meaningful portion of our clinical trial activities, including site selection, patient enrollment and investigator engagement, may occur in jurisdictions in the Middle East and adjacent regions.
Current report
Military conflict, acts of terrorism, civil unrest, political instability, cyberattacks, retaliatory measures or other disruptions in areas in which we conduct clinical trials could impair our ability to initiate, conduct or complete clinical trials on anticipated timelines, if at all. Armed conflict or the threat of further escalation may result in new or continual travel restrictions, border closures, airspace limitations, damage to infrastructure, interruptions in power and telecommunications, and the diversion of medical personnel and hospital resources to emergency or military-related activities. Clinical trial sites located in affected regions may suspend operations, delay patient visits, experience challenges maintaining protocol compliance or be unable to access drug products, laboratory supplies or other essential materials. Patients may also be unwilling or unable to travel to trial sites due to safety concerns, displacement or logistical constraints, which could materially impair patient enrollment and retention, increase protocol deviations and adversely affect the integrity, completeness and regulatory acceptability of our clinical data. If such disruptions occur, we may be required to amend clinical protocols, shift development activities to alternative jurisdictions, add or replace clinical sites, or suspend or terminate affected studies, any of which could result in significant delays, increased costs and uncertainty regarding the timing or outcome of our clinical programs.
Current report
The conflict has also contributed to heightened geopolitical tensions and has the potential to result in additional economic sanctions, export controls and other governmental restrictions. Sanctions or trade restrictions imposed by the government of the United States or other authorities could limit our ability to engage clinical research organizations, investigators, suppliers or other service providers in affected jurisdictions, restrict the cross-border movement of drug products, biological samples or data, or impede the transfer of funds necessary to support clinical operations. Compliance with evolving sanctions regimes and trade controls may require us to implement additional procedures and controls and may cause us to modify, delay or discontinue planned activities in certain jurisdictions. Failure to comply with applicable sanctions or trade restrictions could expose us to civil or criminal penalties and reputational harm.
Current report
In addition, the conflict may contribute to broader macroeconomic and financial market instability, including volatility in global markets, inflationary pressures and supply chain disruptions. These developments could increase the cost of manufacturing, storing and transporting our drug products, disrupt the availability of key materials or services and otherwise increase our operating expenses. Geopolitical instability may also adversely affect the availability of capital for biotechnology companies and contribute to increased volatility in equity markets, which could impair our ability to obtain additional financing on acceptable terms, or at all, and thereby limit our ability to advance our clinical programs.
Current report
Moreover, because BD is geographically concentrated in regions that may be directly or indirectly affected by ongoing hostilities or geopolitical tensions, our clinical development strategy may be inherently more exposed to regional instability than programs focused on diseases with more geographically diversified patient populations. The scope, duration and
Current report
potential escalation of the current conflict remain highly uncertain, including the possibility of broader regional involvement or retaliatory actions by additional state or non-state actors. Any further deterioration in regional security conditions could materially and adversely affect our business, financial condition, results of operations and prospects.
Current report
Our use of generative artificial intelligence tools in our operations may expose us to risks related to confidentiality, accuracy, regulatory compliance and intellectual property ownership or rights.
Current report
We may utilize generative artificial intelligence (“AI”) tools in certain aspects of our operations, including drafting, analysis, administrative functions and other business processes. While these technologies may enhance efficiency, their use involves risks that could adversely affect our business.
Current report
Generative AI platforms are typically operated by third-party providers and may process information through external systems. Although we maintain internal policies governing the use of such tools, there can be no assurance that confidential, proprietary or sensitive information will not be inadvertently disclosed, misused or accessed by unauthorized parties. Any such disclosure could result in reputational harm, competitive disadvantage, regulatory scrutiny or potential legal liability.
Current report
In addition, AI-generated outputs may contain inaccuracies, incomplete information, outdated data or unintended biases. If such outputs are relied upon without appropriate review and validation, they could impair internal decision-making or result in errors in communications or disclosures.
Current report
The legal and regulatory landscape surrounding artificial intelligence technologies is evolving. Future laws, regulations or regulatory interpretations could impose additional requirements or restrictions on the use of AI tools, increase compliance costs or limit our ability to utilize such technologies effectively.
Current report
Further, uncertainty regarding intellectual property ownership or rights associated with AI-generated materials may create additional legal risk. Any failure to appropriately manage the risks associated with our use of generative AI tools could adversely affect our operations, financial condition or results of operations.
Current report
Nasdaq has also proposed amendments to its continued listing standards that would require companies listed on The Nasdaq Capital Market to maintain a minimum market value of at least $5 million. Under the proposed rules, if a company’s market value remains below $5 million for a period of 30 consecutive business days, Nasdaq would issue a Staff Delisting Determination and immediately suspend trading of the company’s securities, without providing a cure or compliance period. In addition, a timely request for a hearing would not stay the suspension of trading, and the hearings panel would have limited authority to grant relief, including being unable to provide additional time to regain compliance. If adopted and applicable to us, these proposed rule changes could materially increase the risk of immediate suspension and delisting during periods of sustained market capitalization decline, which would likely have a material adverse effect on the liquidity and market price of our common stock and our ability to raise additional capital.
Removed paragraphs (1)
Previous report
The U.S. government has recently made statements and taken certain actions that may lead to potential changes to U.S. and international trade policies, including imposing several rounds of tariffs and export control restrictions affecting certain products manufactured in other countries. It is unknown whether and to what extent new tariffs, export controls, or other new laws or regulations will be adopted, or the effect that any such actions would have on us or our business or industry.
Reworded paragraphs (25)
Previous wording
We have experienced significant losses since inception and, at December 31, 2024, had an accumulated deficit of approximately $234.0 million. We expect to incur additional operating losses in the future and expect our cumulative losses to increase. As of December 31, 2024, we had approximately $7.8 million in cash and cash equivalents available, and as
Current wording
We have experienced significant losses since inception and, at December 31, 2025, had an accumulated deficit of approximately $245.1 million. We expect to incur additional operating losses in the future and expect our cumulative losses to increase. As of December 31, 2025, we had approximately $7.9 million in cash and cash equivalents available, and as of March 24, 2026 we had approximately $5.9 million in cash and cash equivalents available. Without additional funding, based on our projected budgetary needs and funding from existing contracts and grants over the next year, we expect to be able to maintain the current level of our operations into the fourth quarter of 2026.
Previous wording
In September 2014, we entered into a contract with the NIH for the development of RiVax® to protect against exposure to ricin toxin that would provide up to $24.7 million of funding in the aggregate over six years if options to extend the contract are exercised by the NIH. In 2017, we were awarded two separate grants from the NIH of approximately $1.5 million each to support our pivotal Phase 3 trials of HyBryte™ for the treatment of CTCL and SGX942 for the treatment of oral mucositis in head and neck cancer. In December 2020, we were awarded Direct to Phase II SBIR grant from NIAID of approximately $1.5 million to support manufacture, formulation (including thermostabilization) and characterization of COVID-19 and EVD vaccine candidates in conjunction with the CoVaccine HT™ adjuvant. Our biodefense grants have an overhead component that allows us an agency-approved percentage over our incurred costs. We estimate that the overhead component associated with our existing contracts and grants will fund some fixed costs for direct employees working on these contracts and grants as well as other administrative costs. As of December 31, 2024, we had approximately $554,000 in awarded grant funding available.
Current wording
In September 2014, we entered into a contract with the NIH for the development of RiVax® to protect against exposure to ricin toxin that would provide up to $24.7 million of funding in the aggregate over six years if options to extend the contract are exercised by the NIH. In 2017, we were awarded two separate grants from the NIH of approximately $1.5 million each to support our pivotal Phase 3 trials of HyBryte™ for the treatment of CTCL and SGX942 for the treatment of oral mucositis in head and neck cancer. In December 2020, we were awarded Direct to Phase II Small Business Innovation Research grant from NIAID of approximately $1.5 million to support manufacture, formulation (including thermostabilization) and characterization of COVID-19 and EBOV disease vaccine candidates in conjunction with the CoVaccine HT™ adjuvant. Our biodefense grants have an overhead component that allows us an agency-approved percentage over our incurred costs. As of December 31, 2025, there was no previously awarded grant funding available.
Previous wording
Our product candidates are positioned for or are currently in clinical trials, and we have not yet generated any significant revenues from sales or licensing of these product candidates. From inception through December 31, 2024, we have expended approximately $124 million developing our current product candidates for pre-clinical research and development and clinical trials. We currently expect to spend approximately $6 million for the year ending December 31, 2025 in connection with the development of our therapeutic and vaccine products, licenses, employment agreements, and consulting agreements, of which approximately $0.1 million is expected to be reimbursed through our existing government grants.
Current wording
Our product candidates are positioned for or are currently in clinical trials, and we have not yet generated any significant revenues from sales or licensing of these product candidates. From inception through December 31, 2025, we have expended approximately $132 million developing our current product candidates for pre-clinical research and development and clinical trials. We currently expect to spend approximately $3.3 million for the year ending December 31, 2026 in connection with the development of our therapeutic and vaccine products, licenses, employment agreements, and consulting agreements. We do not anticipate any contract and grant reimbursements revenue in the next twelve months to offset our research and development expenses.
Previous wording
We have concluded that substantial doubt exists about our ability to continue as a going concern for the 12 months following the issuance of the financial statements included in this Annual Report on Form 10-K. As of December 31, 2024, we had cash and cash equivalents of approximately $7.8 million and current liabilities of approximately $4.8 million. As of the issuance date of these financial statements, we believe that we have sufficient resources available to support our development activities and business operations and timely satisfy our obligations as they come due into the fourth quarter of 2025. We do not have sufficient cash and cash equivalents as of the date of filing this Annual Report on Form 10-K to support our operations for at least the 12 months following the issuance of the financial statements.
Current wording
We have concluded that substantial doubt exists about our ability to continue as a going concern for the 12 months following the issuance of the financial statements included in this Annual Report on Form 10-K. As of December 31, 2025, we had cash and cash equivalents of approximately $7.9 million and current liabilities of approximately $3.7 million. As of the issuance date of these financial statements, we believe that we have sufficient resources available to support our development activities and business operations and timely satisfy our obligations as they come due into the fourth quarter of 2026. We do not have sufficient cash and cash equivalents as of the date of filing this Annual Report on Form 10-K to support our operations for at least the 12 months following the issuance 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 committed at this time. There can be no assurance that we will be successful in obtaining sufficient funding on acceptable terms to fund continuing operations, if at all, identify and enter into any strategic transactions that will provide the capital that we will require, or achieve the other strategies to alleviate the conditions that raise substantial doubt about our ability to continue as a going concern. If none of these alternatives are available, or if available, are not available on satisfactory terms, we will not have sufficient cash resources and liquidity to fund our business operations for at least the 12 months following the date the financial statements are issued. The failure to obtain sufficient capital on acceptable terms when needed may require us to delay, limit, or eliminate the development of business opportunities and our ability to achieve our business objectives and our competitiveness, and our business, financial condition, and results of operations will be materially adversely affected. In addition, market instability, including as a result of geopolitical instability, may reduce our ability to access capital, which could negatively affect our liquidity and ability to continue as a going concern. In addition, the perception that we may not be able to continue as a going concern may cause others to choose not to deal with us due to concerns about our ability to meet our contractual obligations.
Current wording
While the Rodman Sales Agreement is in place, none of the other funding alternatives are currently committed. There can be no assurance that we will be successful in obtaining sufficient funding on acceptable terms to fund continuing operations, if at all, identify and enter into any strategic transactions that will provide the capital that we will require, or achieve the other strategies to alleviate the conditions that raise substantial doubt about our ability to continue as a going concern. If none of these alternatives are available, or if available, are not available on satisfactory terms, we will not have sufficient cash resources and liquidity to fund our business operations for at least the 12 months following the date the financial statements are issued. The failure to obtain sufficient capital on acceptable terms when needed may require us to delay, limit, or eliminate the development of business opportunities and our ability to achieve our business objectives and our competitiveness, and our business, financial condition, and results of operations will be materially adversely affected. In addition, market instability, including as a result of geopolitical instability, may reduce our ability to access capital, which could negatively affect our liquidity and ability to continue as a going concern. In addition, the perception that we may not be able to continue as a going concern may cause others to choose not to deal with us due to concerns about our ability to meet our contractual obligations.
Previous wording
The auditor’s opinion on our audited financial statements for the year ended December 31, 2024 includes an explanatory paragraph stating that we have incurred recurring losses from operations that raise substantial doubt about our ability to continue as a going concern. While we believe that we will be able to obtain the capital we need to continue our operations, there can be no assurances that we will be successful in these efforts or will be able to resolve our liquidity issues or eliminate our operating losses. If we are unable to obtain sufficient funding, we would need to significantly reduce our operating plans and curtail some or all of our development efforts. Accordingly, our business, prospects, financial condition, and results of operations will be materially and adversely affected, and we may be unable to continue as a going concern. If we seek additional financing to fund our business activities in the future and there remains substantial doubt about our ability to continue as a going concern, investors or other financing sources may be unwilling to provide additional funding on commercially reasonable terms or at all.
Current wording
The auditor’s opinion on our audited financial statements for the year ended December 31, 2025 includes an explanatory paragraph stating that we have incurred recurring losses from operations that raise substantial doubt about our ability to continue as a going concern. While we believe that we will be able to obtain the capital we need to continue our operations, there can be no assurance that we will be successful in these efforts or will be able to resolve our liquidity issues or eliminate our operating losses. If we are unable to obtain sufficient funding, we would need to significantly reduce our operating plans and curtail some or all of our development efforts. Accordingly, our business, prospects, financial condition, and results of operations will be materially and adversely affected, and we may be unable to continue as a going concern. If we seek additional financing to fund our business activities in the future and there remains substantial doubt about our ability to continue as a going concern, investors or other financing sources may be unwilling to provide additional funding on commercially reasonable terms or at all.
Previous wording
Additionally, few facilities in the U.S. and internationally have the capability to test animals with ricin, or otherwise assist us in qualifying the requisite animal models. We have to compete with other biodefense companies for access to this limited pool of highly specialized resources. We therefore may not be able to secure contracts to conduct the testing in a predictable timeframe or at all.
Current wording
Additionally, few facilities in the U.S. and internationally have the capability to test animals with ricin, or otherwise assist us in qualifying the requisite animal models. We have to compete with other biodefense companies for access to this limited
Previous wording
The FDA and foreign regulators require manufacturers to register manufacturing facilities. The FDA and foreign regulators also inspect these facilities to confirm compliance with current Good Manufacturing Practice (“cGMP”) or similar requirements that the FDA or foreign regulators establish. We, or our materials suppliers, may face manufacturing or quality control problems causing product production and shipment delays or a situation where we or the supplier may not be able to maintain compliance with the FDA’s cGMP requirements, or those of foreign regulators, necessary to continue manufacturing our drug substance. Any failure to comply with cGMP requirements or other FDA or foreign regulatory requirements could adversely affect our clinical research activities and our ability to market and develop our products.
Current wording
The FDA and foreign regulators require manufacturers to register manufacturing facilities. The FDA and foreign regulators also inspect these facilities to confirm compliance with cGMP or similar requirements that the FDA or foreign regulators establish. We, or our materials suppliers, may face manufacturing or quality control problems causing product production and shipment delays or a situation where we or the supplier may not be able to maintain compliance with the FDA’s cGMP requirements, or those of foreign regulators, necessary to continue manufacturing our drug substance. Any failure to comply with cGMP requirements or other FDA or foreign regulatory requirements could adversely affect our clinical research activities and our ability to market and develop our products.
Previous wording
candidates for specific indications may not yield any commercially viable products. If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through strategic alliance, licensing or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate, or we may allocate internal resources to a product candidate in an area in which it would have been more advantageous to enter into a partnering arrangement.
Current wording
Because we have limited financial and human resources, we are currently focusing on the regulatory approval of certain product candidates. As a result, we may forego or delay pursuit of opportunities with other product candidates or for other indications that later prove to have greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities. Our spending on existing and future product candidates for specific indications may not yield any commercially viable products. If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through strategic alliance, licensing or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate, or we may allocate internal resources to a product candidate in an area in which it would have been more advantageous to enter into a partnering arrangement.
Previous wording
Our product candidates, if successfully developed, will compete with a number of products manufactured and marketed by major pharmaceutical companies, biotechnology companies and manufacturers of generic drugs. Our products may also compete with new products currently under development by others. Physicians, patients, third-party payors and the medical
Current wording
Our product candidates, if successfully developed, will compete with a number of products manufactured and marketed by major pharmaceutical companies, biotechnology companies and manufacturers of generic drugs. Our products may also compete with new products currently under development by others. Physicians, patients, third-party payors and the medical community may not accept and utilize any of our product candidates. If our products do not achieve market acceptance, we will not be able to generate significant revenues or become profitable.
Previous wording
In the U.S., orphan drug designation entitles a party to financial incentives such as opportunities for grant funding towards clinical trial costs, tax advantages, and user-fee waivers. In addition, if a product receives the first FDA approval for the indication for which it has orphan designation, the product is entitled to orphan drug exclusivity, which means the FDA may not approve any other application to market the same drug for the same indication for a period of seven years, except in limited circumstances, such as a showing of clinical superiority over the product with orphan exclusivity or where the manufacturer is unable to assure sufficient product quantity. In the EU, orphan drug designation entitles a party to financial incentives such as reduction of fees or fee waivers and ten years of market exclusivity following drug or biological product approval. This period may be reduced to six years if the orphan drug designation criteria are no longer met, including where it is shown that the product is sufficiently profitable not to justify maintenance of market exclusivity.
Current wording
indication for which it has orphan designation, the product is entitled to orphan drug exclusivity, which means the FDA may not approve any other application to market the same drug for the same indication for a period of seven years, except in limited circumstances, such as a showing of clinical superiority over the product with orphan exclusivity or where the manufacturer is unable to assure sufficient product quantity. In the EU, orphan drug designation entitles a party to financial incentives such as reduction of fees or fee waivers and ten years of market exclusivity following drug or biological product approval. This period may be reduced to six years if the orphan drug designation criteria are no longer met, including where it is shown that the product is sufficiently profitable not to justify maintenance of market exclusivity.
Previous wording
Additionally, the research resulting in certain of our licensed patent rights and technology was funded by the U.S. government. As a result, the government may have certain rights, or march-in rights, to such patent rights and technology. When new technologies are developed with government funding, the government generally obtains certain rights in any resulting patents, including a non-exclusive license authorizing the government to use the invention for non-commercial purposes. The government can exercise its march-in rights if it determines that action is necessary because we fail to
Current wording
Additionally, the research resulting in certain of our licensed patent rights and technology was funded by the U.S. government. As a result, the government may have certain rights, or march-in rights, to such patent rights and technology. When new technologies are developed with government funding, the government generally obtains certain rights in any resulting patents, including a non-exclusive license authorizing the government to use the invention for non-commercial purposes. The government can exercise its march-in rights if it determines that action is necessary because we fail to achieve practical application of the government-funded technology, because action is necessary to alleviate health or safety needs, to meet requirements of federal regulations or to give preference to U.S. industry. In addition, our rights in such inventions may be subject to certain requirements to manufacture products embodying such inventions in the U.S. Any exercise by the government of such rights could harm our competitive position, business, financial condition, results of operations and prospects.
Previous wording
Furthermore, we currently have very limited product development capabilities and no manufacturing, marketing or sales capabilities. For us to research, develop and test our product candidates, we need to contract or partner with outside researchers, in most cases with or through those parties that did the original research and from whom we have licensed the technologies. If products are successfully developed and approved for commercialization, then we will need to enter into additional collaboration and other agreements with third parties to manufacture and market our products. We may not be able to induce the third parties to enter into these agreements, and, even if we are able to do so, the terms of these agreements may not be favorable to us. Our inability to enter into these agreements could delay or preclude the development, manufacture and/or marketing of some of our product candidates or could significantly increase the costs of doing so. In the future, we may grant to our development partners rights to license and commercialize pharmaceutical and related products developed under the agreements with them, and these rights may limit our flexibility in considering alternatives for the commercialization of these products. Furthermore, third-party manufacturers or suppliers may not be able to meet our needs with respect to timing, quantity and quality for the products.
Current wording
Furthermore, we currently have very limited product development capabilities and no manufacturing, marketing or sales capabilities. For us to research, develop and test our product candidates, we need to contract or partner with outside researchers, in most cases with or through those parties that did the original research and from whom we have licensed the technologies. If products are successfully developed and approved for commercialization, then we will need to enter into additional collaboration and other agreements with third parties to manufacture and market our products. We may not be able to induce the third parties to enter into these agreements, and, even if we are able to do so, the terms of these agreements may not be favorable to us. Our inability to enter into these agreements could delay or preclude the development, manufacture and/or marketing of some of our product candidates or could significantly increase the costs of
Previous wording
The biotechnology industry is intensely competitive, subject to rapid change and sensitive to new product introductions or enhancements. Most of our existing competitors have greater financial resources, larger technical staffs, and larger research budgets than we have, as well as greater experience in developing products and conducting clinical trials. Our competition is particularly intense in the gastroenterology and transplant areas and is also intense in the therapeutic area of inflammatory bowel diseases. We face intense competition in the biodefense area from various public and private companies and universities as well as governmental agencies, such as the U.S. Army, which may have their own proprietary technologies that may directly compete with our technologies. In addition, there may be other companies that are currently developing competitive technologies and products or that may in the future develop technologies and products that are comparable or superior to our technologies and products. We may not be able to compete with our existing and future competitors, which could lead to the failure of our business.
Current wording
The biotechnology industry is intensely competitive, subject to rapid change and sensitive to new product introductions or enhancements. Most of our existing competitors have greater financial resources, larger technical staffs, and larger research budgets than we have, as well as greater experience in developing products and conducting clinical trials. Our competition is particularly intense in the gastroenterology and transplant areas and is also intense in the therapeutic area of inflammatory bowel diseases. We face intense competition in the biodefense area from various public and private companies and universities as well as governmental agencies, such as the U.S. Army, which may have their own proprietary technologies that may directly compete with our technologies. In addition, there may be other companies that are currently developing competitive technologies and products or that may in the future develop technologies and products that are comparable or
Previous wording
We currently have 16 employees and we depend upon these employees, in particular Dr. Christopher Schaber, our President and Chief Executive Officer, to manage the day-to-day activities of our business. Because we have such limited personnel, the loss of any of them or our inability to attract and retain other qualified employees in a timely manner would
Current wording
We currently have 14 employees and we depend upon these employees, in particular Dr. Christopher Schaber, our President and Chief Executive Officer, to manage the day-to-day activities of our business. Because we have such limited personnel, the loss of any of them or our inability to attract and retain other qualified employees in a timely manner would likely have a negative impact on our operations. We may be unable to effectively manage and operate our business, and our business may suffer, if we lose the services of our employees.
Previous wording
To the extent that we do not generate sufficient cash from operations, we may need to issue stock or incur indebtedness to finance our plans for growth. Recent turmoil in the credit markets and the potential impact on the liquidity of major financial institutions may have an adverse effect on our ability to fund our business strategy through borrowings, under either existing or newly created instruments in the public or private markets on terms we believe to be reasonable, if at all.
Current wording
To the extent that we do not generate sufficient cash from operations, we may need to issue stock or incur indebtedness to finance our plans for growth. Recent turmoil in the credit markets and the potential impact on the liquidity of major financial
Previous wording
Any unfavorable government policies on international trade, such as export controls, capital controls or tariffs, may increase the cost of manufacturing our product candidates, affect the demand for our drug products (if and once approved), the competitive position of our product candidates, and import or export of raw materials and finished product candidate used in our and our collaborators’ preclinical studies and clinical trials. If any new tariffs, export controls, legislation and/or regulations are implemented, or if existing trade agreements are renegotiated, such changes could have an adverse effect on our business, financial condition and results of operations.
Current wording
Any unfavorable government policies on international trade, including new or replacement tariffs, export controls, capital controls, or other trade barriers, could increase the cost of manufacturing our product candidates, disrupt the import or export of raw materials or finished product candidates used in our and our collaborators’ preclinical studies and clinical trials, and affect the demand for our drug products, if approved. In addition, uncertainty surrounding trade enforcement, potential refund claims related to previously imposed tariffs, and possible renegotiation of trade agreements could create volatility in global supply chains. Any such developments could have an adverse effect on our business, financial condition and results of operations.
Previous wording
not yet sold our 2024 New Jersey NOL carryforwards but may do so in the future. If there is an unfavorable change in the State of New Jersey’s Technology Business Tax Certificate Program (whether as a result of a change in law, policy or otherwise) that terminates the program or eliminates or reduces our ability to use or sell our NOL carryforwards or if we are unable to find a suitable buyer to utilize our New Jersey NOL carryforwards to the extent the NOLs expire before we are able to utilize them against our taxable income, our cash taxes may increase which may have an adverse effect on our financial condition.
Current wording
The State of New Jersey’s Technology Business Tax Certificate Program allows certain high technology and biotechnology companies to sell unused net operating loss (“NOL”) carryforwards to other New Jersey-based corporate taxpayers. We sold 2024 and 2023 New Jersey NOL carryforwards, resulting in the recognition of $506,615 and $409,114 of income tax benefit, net of transaction costs 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. If there is an unfavorable change in the State of New Jersey’s Technology Business Tax Certificate Program (whether as a result of a change in law, policy or otherwise) that terminates the program or eliminates or reduces our ability to use or sell our NOL carryforwards or if we are unable to find a suitable buyer to utilize our New Jersey NOL carryforwards to the extent the NOLs expire before we are able to utilize them against our taxable income, our cash taxes may increase which may have an adverse effect on our financial condition.
Previous wording
In addition to the products for which we have patents or have filed patent applications, we rely upon unpatented proprietary technology and may not be able to meaningfully protect our rights with regard to that unpatented proprietary technology. Furthermore, to the extent that consultants, key employees or other third parties apply technological information developed
Current wording
In addition to the products for which we have patents or have filed patent applications, we rely upon unpatented proprietary technology and may not be able to meaningfully protect our rights with regard to that unpatented proprietary technology. Furthermore, to the extent that consultants, key employees or other third parties apply technological information developed by them or by others to any of our proposed projects, disputes may arise as to the proprietary rights to this information, which may not be resolved in our favor.
Previous wording
Since January 1, 2024, the closing stock price of our common stock has fluctuated between a high of $15.03 per share to a low of $2.00 per share. On March 14, 2025, the last reported sale price of our common stock on The Nasdaq Capital Market was $2.30 per share. The fluctuation in the price of our common stock has sometimes been unrelated or disproportionate to our operating performance. In addition, potential dilutive effects of future sales of shares of common stock and warrants by us, as well as potential sale of common stock by the holders of warrants and options, could have an adverse effect on the market price of our shares.
Current wording
Since January 1, 2025, the closing stock price of our common stock has fluctuated between a high of $4.96 per share to a low of $1.02 per share. On March 24, 2026, the last reported sale price of our common stock on The Nasdaq Capital Market was $1.17 per share. The fluctuation in the price of our common stock has sometimes been unrelated or disproportionate to our operating performance. In addition, potential dilutive effects of future sales of shares of common stock and warrants by us, as well as potential sale of common stock by the holders of warrants and options, could have an adverse effect on the market price of our shares.
Previous wording
We also have an incentive compensation plan for our management, employees and consultants. We have granted, and expect to grant in the future, options to purchase shares of our common stock to our directors, employees and consultants. To the extent that pre-funded warrants, common stock warrants, or options are exercised, our stockholders will experience dilution and our stock price may decrease.
Current wording
We also have an incentive compensation plan for our management, employees and consultants. We have granted, and expect to grant in the future, options to purchase shares of our common stock to our directors, employees and consultants. To the extent that common stock warrants, or options are exercised, our stockholders will experience dilution and our stock price may decrease.
Previous wording
Additionally, the sale, or even the possibility of the sale, of the shares of common stock underlying these pre-funded warrants, common stock warrants, and options could have an adverse effect on the market price for our securities or on our ability to obtain future financing.
Current wording
Additionally, the sale, or even the possibility of the sale, of the shares of common stock underlying these common stock warrants, and options could have an adverse effect on the market price for our securities or on our ability to obtain future financing.
Previous wording
On April 1, 2014, we entered into an option agreement pursuant to which Hy Biopharma granted us an option to purchase certain assets, properties and rights (the “Hypericin Assets”) related to the development of Hy Biopharma’s synthetic hypericin product candidate for the treatment of CTCL, which we refer to as HyBryte™, from Hy Biopharma. In exchange for the option, we paid $50,000 in cash and issued 18 shares of common stock in the aggregate to Hy Biopharma and its assignees. We subsequently exercised the option, and on September 3, 2014, we entered into an asset purchase agreement (the “Asset Purchase Agreement”) with Hy Biopharma, pursuant to which we purchased the Hypericin Assets. Pursuant to the Asset Purchase Agreement, we initially paid $275,000 in cash and issued 771 shares of common stock in the aggregate to Hy Biopharma and its assignees, and the licensors of the license agreement acquired from Hy Biopharma. Also, on September 3, 2014, we entered into a Registration Rights Agreement with Hy Biopharma, pursuant to which we may be required to file a registration statement with the SEC. In March 2020, we issued 8,151 shares of common stock at a value of $5,000,000 (based upon an effective per share price of $614.40 as a result of HyBryte™ demonstrating
Current wording
On April 1, 2014, we entered into an option agreement pursuant to which Hy Biopharma granted us an option to purchase certain assets, properties and rights (the “Hypericin Assets”) related to the development of Hy Biopharma’s synthetic hypericin product candidate for the treatment of CTCL, which we refer to as HyBryte™, from Hy Biopharma. In exchange for the option, we paid $50,000 in cash and issued 18 shares of common stock in the aggregate to Hy Biopharma and its assignees. We subsequently exercised the option, and on September 3, 2014, we entered into an asset purchase agreement (the “Asset Purchase Agreement”) with Hy Biopharma, pursuant to which we purchased the Hypericin Assets. Pursuant to the Asset Purchase Agreement, we initially paid $275,000 in cash and issued 771 shares of common stock in the aggregate to Hy Biopharma and its assignees, and the licensors of the license agreement acquired from Hy Biopharma. Also, on September 3, 2014, we entered into a Registration Rights Agreement with Hy Biopharma, pursuant to which we may be required to file a registration statement with the SEC. In March 2020, we issued 8,151 shares of common stock at a value of $5,000,000 (based upon an effective per share price of $614.40 as a result of HyBryte™ demonstrating statistically significant treatment response in the Phase 3 clinical trial. We will be required to issue up to $5 million worth of our common stock (subject to a cap equal to 19.9% of our issued and outstanding common stock) in the aggregate, if HyBryte™ is approved for the treatment of CTCL by either the FDA or the EMA.
Previous wording
Under our Certificate of Incorporation, our Board of Directors is authorized to issue up to 350,000 shares of preferred stock, of which none are issued and outstanding as of the date of this prospectus. Also, our Board of Directors, without stockholder approval, may determine the price, rights, preferences, privileges and restrictions, including voting rights, of those shares. If our Board of Directors causes shares of preferred stock to be issued, the rights of the holders of our common stock would likely be subordinate to those of preferred holders and therefore could be adversely affected. Our Board of Directors’ ability to determine the terms of preferred stock and to cause its issuance, while providing desirable flexibility in connection with possible acquisitions and other corporate purposes, could have the effect of making it more difficult for a third party to acquire a majority of our outstanding common stock. Preferred shares issued by our Board of Directors could include voting rights or super voting rights, which could shift the ability to control our company to the holders of the preferred stock. Preferred stock could also have conversion rights into shares of our common stock at a discount to the market price of our common stock, which could negatively affect the market for our common stock. In addition, preferred stock would have preference in the event of liquidation of our company, which means that the holders of preferred stock would be entitled to receive the net assets of our company distributed in liquidation before the holders of our common stock receive any distribution of the liquidated assets.
Current wording
Under our Certificate of Incorporation, our Board of Directors is authorized to issue up to 350,000 shares of preferred stock, of which none are issued and outstanding as of the date of this annual report. Also, our Board of Directors, without stockholder approval, may determine the price, rights, preferences, privileges and restrictions, including voting rights, of those shares. If our Board of Directors causes shares of preferred stock to be issued, the rights of the holders of our common stock would likely be subordinate to those of preferred holders and therefore could be adversely affected. Our Board of Directors’ ability to determine the terms of preferred stock and to cause its issuance, while providing desirable flexibility in connection with possible acquisitions and other corporate purposes, could have the effect of making it more difficult for a third party to acquire a majority of our outstanding common stock. Preferred shares issued by our Board of Directors could include voting rights or super voting rights, which could shift the ability to control our company to the holders of the preferred stock. Preferred stock could also have conversion rights into shares of our common stock at a discount to the market price of our common stock, which could negatively affect the market for our common stock. In addition, preferred stock would have preference in the event of liquidation of our company, which means that the holders of preferred stock would be entitled to receive the net assets of our company distributed in liquidation before the holders of our common stock receive any distribution of the liquidated assets.
Rearranged current paragraphs (5)
Current report — wording carried from elsewhere
pool of highly specialized resources. We therefore may not be able to secure contracts to conduct the testing in a predictable timeframe or at all.
Current report — wording carried from elsewhere
In the U.S., orphan drug designation entitles a party to financial incentives such as opportunities for grant funding towards clinical trial costs, tax advantages, and user-fee waivers. In addition, if a product receives the first FDA approval for the
Current report — wording carried from elsewhere
doing so. In the future, we may grant to our development partners rights to license and commercialize pharmaceutical and related products developed under the agreements with them, and these rights may limit our flexibility in considering alternatives for the commercialization of these products. Furthermore, third-party manufacturers or suppliers may not be able to meet our needs with respect to timing, quantity and quality for the products.
Current report — wording carried from elsewhere
superior to our technologies and products. We may not be able to compete with our existing and future competitors, which could lead to the failure of our business.
Current report — wording carried from elsewhere
institutions may have an adverse effect on our ability to fund our business strategy through borrowings, under either existing or newly created instruments in the public or private markets on terms we believe to be reasonable, if at all.
Rearranged previous paragraphs (8)
Previous report — wording carried elsewhere
of March 14, 2025 we had approximately $7.7 million in cash and cash equivalents available. Without additional funding, based on our projected budgetary needs and funding from existing contracts and grants over the next year, we expect to be able to maintain the current level of our operations to the end of 2025.
Previous report — wording carried elsewhere
Because we have limited financial and human resources, we are currently focusing on the regulatory approval of certain product candidates. As a result, we may forego or delay pursuit of opportunities with other product candidates or for other indications that later prove to have greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities. Our spending on existing and future product
Previous report — wording carried elsewhere
community may not accept and utilize any of our product candidates. If our products do not achieve market acceptance, we will not be able to generate significant revenues or become profitable.
Previous report — wording carried elsewhere
achieve practical application of the government-funded technology, because action is necessary to alleviate health or safety needs, to meet requirements of federal regulations or to give preference to U.S. industry. In addition, our rights in such inventions may be subject to certain requirements to manufacture products embodying such inventions in the U.S. Any exercise by the government of such rights could harm our competitive position, business, financial condition, results of operations and prospects.
Previous report — wording carried elsewhere
likely have a negative impact on our operations. We may be unable to effectively manage and operate our business, and our business may suffer, if we lose the services of our employees.
Previous report — wording carried elsewhere
The State of New Jersey’s Technology Business Tax Certificate Program allows certain high technology and biotechnology companies to sell unused net operating loss (“NOL”) carryforwards to other New Jersey-based corporate taxpayers. We sold 2023, 2022 and 2021 New Jersey NOL carryforwards, resulting in the recognition of $409,114 and $1,767,803 of income tax benefit, net of transaction costs during the years ended December 31, 2024 and 2023, respectively. We have
Previous report — wording carried elsewhere
by them or by others to any of our proposed projects, disputes may arise as to the proprietary rights to this information, which may not be resolved in our favor.
Previous report — wording carried elsewhere
statistically significant treatment response in the Phase 3 clinical trial. We will be required to issue up to $5.0 million worth of our common stock (subject to a cap equal to 19.9% of our issued and outstanding common stock) in the aggregate, if HyBryte™ is approved for the treatment of CTCL by either the FDA or the EMA.