SNGX 10-K & 10-Q changes, risk factors and insider trading
Soligenix, Inc. · Nasdaq · Pharmaceutical Preparations · CIK 812796 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
New heading “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.”
New heading “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.”
New heading “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.”
Largest changes
“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. …”see in full comparison
“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.”see in full comparison
“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. …”see in full comparison
“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.”see in full comparison
Any unfavorable government policies on international trade,see in full comparisonsuchincludingasnew or replacement tariffs, export controls, capitalcontrolscontrols, ortariffs,othermaytrade barriers, could increase the cost of manufacturing our product candidates,affectdisrupt thedemand for our drug products (if and once approved), the competitive position of our product candidates, andimport or export of raw materialsandor finished productcandidatecandidates used in our and our collaborators’ preclinical studies and clinicaltrials.trials,Ifandanyaffectnewthe demand for our drug products, if approved. In addition, uncertainty surrounding trade enforcement, potential refund claims related to previously imposed tariffs,exportandcontrols,possiblelegislationrenegotiationand/or regulations are implemented, or if existingof trade agreementsarecouldrenegotiated,create volatility in global supply chains. Any suchchangesdevelopments could have an adverse effect on our business, financial condition and results of operations.
“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.”see in full comparison
Full comparison: every changed paragraph (41)
We have experienced significant losses since inception and, at December 31, 2024,2025, had an accumulated deficit of approximately $234.0$245.1 million. We expect to incur additional operating losses in the future and expect our cumulative losses to increase. As of December 31, 2024,2025, we had approximately $7.8$7.9 million in cash and cash equivalents available, and as of March 14,24, 20252026 we had approximately $7.7$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 tointo the endfourth quarter of 2025.2026.
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 SBIRSmall Business Innovation Research grant from NIAID of approximately $1.5 million to support manufacture, formulation (including thermostabilization) and characterization of COVID-19 and EVDEBOV 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. 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, 2024,2025, wethere hadwas approximatelyno $554,000 inpreviously awarded grant funding available.
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, 2024,2025, we have expended approximately $124$132 million developing our current product candidates for pre-clinical research and development and clinical trials. We currently expect to spend approximately $6$3.3 million for the year ending December 31, 20252026 in connection with the development of our therapeutic and vaccine products, licenses, employment agreements, and consulting agreements,agreements. ofWe whichdo approximatelynot $0.1anticipate millionany iscontract expectedand grant reimbursements revenue in the next twelve months to be reimbursed throughoffset our existingresearch governmentand grants.development expenses.
To alleviatemitigate the conditions that raise substantial doubt about our ability to continue as a going concern, our plans include securing:
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.
Other thanWhile the AGPRodman Sales Agreement whichis wasin entered into on August 16, 2024,place, none of thesethe other funding alternatives are committedcurrently at this time.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.
The auditor’s opinion on our audited financial statements for the year ended December 31, 20242025 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 assurancesassurance 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.
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.
We do not have extensive experience in marketing or selling pharmaceutical products whether in the U.S. or internationally. To obtain the expertise necessary to successfully market and sell any of our products, the development of our own commercial infrastructure and/or collaborative commercial arrangements and partnerships will be required. Our ability to make that investment and also execute our current operating plan is dependent on numerous factors, including, the performance of third partythird-party collaborators with whom we may contract.
Our products, if approved, may not be commercially viable due to change in health care practice and third partythird-party reimbursement limitations.
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.
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.
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.
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.
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 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.
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.
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.
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.
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.
We may not be able to retain rights licensed to us by third parties to commercialize key products or to develop the third partythird-party relationships we need to develop, manufacture and market our products.
Our research and development processes and/or those of our third partythird-party contractors involve the controlled use of hazardous materials and chemicals. These hazardous chemicals are reagents and solvents typically found in a chemistry laboratory. Our operations also may produce hazardous waste products. Federal, state and local laws and regulations govern the use, manufacture, storage, handling and disposal of hazardous materials. While we attempt to comply with all environmental laws and regulations, including those relating to the outsourcing of the disposal of all hazardous chemicals and waste products, we cannot eliminate the risk of contamination from or discharge of hazardous materials and any resultant injury. In the event of such an accident, we could be held liable for any resulting damages and any liability could materially adversely affect our business, financial condition and results of operations.
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.
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.
Any unfavorable government policies on international trade, suchincluding asnew or replacement tariffs, export controls, capital controlscontrols, or tariffs,other maytrade barriers, could increase the cost of manufacturing our product candidates, affectdisrupt the demand for our drug products (if and once approved), the competitive position of our product candidates, and import or export of raw materials andor finished product candidatecandidates used in our and our collaborators’ preclinical studies and clinical trials.trials, Ifand anyaffect newthe demand for our drug products, if approved. In addition, uncertainty surrounding trade enforcement, potential refund claims related to previously imposed tariffs, exportand controls,possible legislationrenegotiation and/or regulations are implemented, or if existingof trade agreements arecould renegotiated,create volatility in global supply chains. Any such changesdevelopments could have an adverse effect on our business, financial condition and results of operations.
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, 20222024 and 20212023 New Jersey NOL carryforwards, resulting in the recognition of $409,114$506,615 and $1,767,803$409,114 of income tax benefit, net of transaction costs during the years ended December 31, 20242025 and 2023,2024, 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 20242025 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.
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.
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.
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.
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.
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.
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.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.
Management's Discussion & Analysis (MD&A)
Removed heading “Reverse Stock Split”
Largest changes
see in full comparisonOther thanWhile theAGPRodman SalesAgreement,Agreementwhichiswasinentered into on August 16, 2024,place, none ofthesethe other funding alternatives are currently committed. There is no assurance that we willobtainbe successful in securing sufficientfundingfinancing 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.
“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.”see in full comparison
“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. …”see in full comparison
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.see in full comparisonThePursuant2024toAmendment resulted in a substantial modification of the debt forapplicable accountingpurposes,standards,as defined, which is accounted for as an extinguishment. The difference between the fair value, or net carrying amount, of the debt beforeafter the 2024Amendment 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,Amendment, we elected not to account for the amended convertible debtusingunder the fair valueoptionoption.inAccordingly,accordancetherewithwas no further recognition for theapplicable 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 resultimpact ofthis election, we recognized a gain of $260,933 of other income from the changechanges inthefair valueof the convertible debt onin ouraccompanyingfinancial2024 consolidated statement of operations.statements.
In December 2020, we entered into a $20 million convertible debt financing agreement with Pontifax (the “Loan Agreement”)see in full comparison, 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 financingin three tranches,whichwill mature on June 15, 2025 and had anaccrued interestonly period for the first two years withat afixed interestrate 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.AfterPayments of interest only were due for theinterest-onlyfirstperiod,two years and thereafter, the outstanding principal was to be repaid in quarterlypaymentsinstallments,ofas$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.defined.
Full comparison: every changed paragraph (62)
Our Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte™ (a proposed proprietary name of SGX301 or synthetic hypericin sodium), a novel photodynamic therapy, utilizing topical synthetic hypericin activated with safe visible light for the treatment of cutaneous T-cell lymphoma (“CTCL”). With successful completion of the first Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study and agreement from the European Medicines Agency (“EMA”) on the key design components of a confirmatory Phase 3 placebo-controlled study evaluating the safety and efficacy of HyBryte™ in the treatment of CTCL patients with early stageearly-stage disease, we began patient enrollment during December 2024 for the second Phase 3 study called “FLASH2” (Fluorescent Light Activated Synthetic Hypericin 2). We anticipate top-line results in the second half of 2026. Upon successful completion of the Phase 3 FLASH2 study, regulatory approval will be sought to support potential commercialization worldwide.
Development programs in this business segment also include expansion of synthetic hypericin into psoriasis (SGX302) into psoriasis,, and our first-in-class Innate Defense Regulator (“IDR”) technology, and dusquetide (SGX942 and SGX945),dusquetide, for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer (SGX942) and aphthous ulcers in Behçet’s Disease.Disease (“BD”) (SGX945).
Our Public Health Solutions business segment includes development programs for (i) RiVax®, oura ricin toxin vaccine candidatecandidate, and(ii) SGX943, oura therapeutic candidate for antibiotic resistant and emerging infectious diseasedisease, and our(iii) various vaccine programsprograms, including a program targeting filoviruses (such as Marburg virus (“MARV”) and Ebola virus (“EBOV”)) and CiVax™, oura 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.
An outline of ourOur business strategy can be outlined as follows:
In NovemberDecember 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-07,2023-09, SegmentIncome ReportingTaxes (Topic 280740): Improvements to ReportableIncome SegmentTax Disclosures. This update enhances the segment reporting requirements by increasing transparency and decision-usefulness of income tax disclosures, providing investors with additional insightsinformation intoto better assess how an entity’s Chief Operating Decision Maker (“CODM”) evaluates segment performanceoperations and allocatesrelated resources.tax risks and tax planning and operational opportunities affect its tax rate and prospects for future cash flows.
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.
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.
ASU 2023-072023-09 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 2023-072023-09 for the year ended December 31, 2024,2025, and have updated our segmentincome tax disclosures accordingly. The adoption of this standard did not impact the recognition or measurement of our financial statements but resulted in enhanced segment-relatedincome tax related disclosures in the notes to the consolidated financial statements.
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.
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.
Our gross profit forFor the year ended December 31, 20242025, waswe $0had ora 0%net loss of total revenues$11,080,380 as compared to $97,311a ornet 12%loss of total revenues$8,266,576 for the prior year, representing aincreased decreasenet loss of $97,311$2,813,804 or 100%.34%. The decreaseincrease in grossnet profitloss wasis primarily theattributed resultto ofincreases thein conclusionresearch ofand higherdevelopment margin grantscosts associated with the developmentPhase of2a SGX943study andin CiVax™BD, the ongoing second confirmatory Phase 3 CTCL study and a decrease in theother zeroincome marginrelating grantto fortax credits and the HyBryte™change investigatorin initiatedthe study.fair value of debt.
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.
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.
Research and development expenses increased by $1,910,890$2,262,224 or 58%43% to $5,223,589$7,485,813 for year ended December 31, 20242025 as compared to $3,312,699$5,223,589 for the prior year. The increase in research and development spending for the year ended December 31, 20242025 was primarily related to preliminary costs associated with the initiation of our Phase 22a study in Behçet’s DiseaseBD and the ongoing second confirmatory Phase 3 CTCL trial offset by an adjustment of estimated accruals for completed clinical trials.study.
General and administrative expenses decreasedincreased by $266,644$143,755 or 6%,3%, to $4,215,908$4,359,663 for the year ended December 31, 2024,2025, as compared to $4,482,552$4,215,908 for the prior year. This decreaseincrease is primarily relatedattributable to a reductionincreases in legalvarious franchise taxes and consultingstock expenses.related expenses offset by a decrease in professional fees.
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.
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,option. which requires us to record changes in fair value asAs a componentresult, ofwe otherrecognized 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$260,933 of other income from the change in the fair value of the convertible debt onin ourthe accompanying consolidated statements of operations forduring the year ended December 31, 2023.2024. For 2023 and through the 2024 Amendment (described below), theThe fair value of the convertible debt was estimated using the Monte Carlo valuation method.
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.
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.
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.
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.
Total other income for the year ended December 31, 20242025 was $763,807$258,481 as compared to $210,593 of total other expense$763,807 for the prior year, reflecting a decrease of $974,400$505,326 or 463%.66%. The decrease in total other expenseincome was primarily associated 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 increasedecreases in tax credits,credits an increase in other income resulting fromand 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.debt.
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,our 20222024 and 20212023 New Jersey NOL carryforwards resulting in the recognition of income tax benefits, net of transaction costs of $409,114$506,615 and $1,767,803$409,114 during the years ended December 31, 20242025 and 2023,2024, respectively. WeBoth soldamounts ourwere 2023recorded Newas Jersey NOLsreceivables and have recorded a receivable of $409,114 which isare included in prepaid expenses and other current assets on the accompanying consolidated balance sheetsheets for the yearyears ended December 31, 2024.2025 and 2024, respectively. We have not yet sold our 20242025 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.
The Specialized BioTherapeutics business segment had no revenue offor the year ended December 31, 2025 as compared to $119,371 for the year ended December 31, 2024 as compared to $395,124 for the year ended December 31, 2023,2024, representing a decrease of $275,753$119,371 or 70%.100%. The decrease was due to decreasedthe reimbursableconclusion development activity underof the zero-margin grant to supportfor the investigator-initiated study of HyBryte™ forinvestigator expandedinitiated treatment in patients with early-stage CTCL.study.
The Public Health Solutions business segment had no revenues for the years ended years ended December 31, 2025 and 2024, respectively.
RevenuesLoss from operations for the Public Health Solutions business segment for the year ended December 31, 20242025 werewas $0$88,769 as compared to $444,235loss from operations of $254,576 for the year ended December 31, 2023,2024, representing a decrease in loss of $444,235$165,807 or 100%.65%. TheThis decrease in revenuesloss wasis primarilyattributable theto resulta ofreduction thein conclusionresources ofallocated theto grantthis associatedbusiness with the development of SGX943.segment.
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, 20242025 was $4,365,034$6,981,971 as compared to $2,812,303$4,365,034 for the year ended December 31, 2023,2024, representing an increase in loss of $1,552,731$2,616,937 or 55%.60%. This increase in loss is primarily related to preliminary costs associated with the initiation of our Phase 2 study in Behçet’s DiseaseBD and the ongoing second confirmatory Phase 3 CTCL trial offset by an adjustment of estimated accruals for completed clinical trials.study.
As of December 31, 2024,2025, we had cash and cash equivalents of $7,819,514$7,936,153 as compared to $8,446,158$7,819,514 as of December 31, 2023,2024, representing aan decreaseincrease of $626,644$116,639 or 7%.1%. As of December 31, 2024,2025, we had working capital of $3,980,218,$5,149,732, representing an increase of $625,006$1,169,514 as compared to working capital of $3,355,212$3,980,218 for the prior year. The decreaseincrease in cash and cash equivalents was primarily related to net proceeds received from financing activities offset by cash used in operating activities and debtrepayment principalof repaymentsconvertible offset by cash provided by financing activities.debt. The increase in working capital is primarily the result of anet reductionproceeds in outstanding convertible debt resultingreceived from principalfinancing repayments and debt conversionsactivities partially offset by the repayment of convertible debt and cash used in operating activities during the year ended December 31, 2024.2025.
WeBased on our operating budget, current rate of cash outflows, and cash on hand, we believe that we have sufficient resources available to support our development activities andactivities, business operations and to satisfymeet our obligations as they become due throughinto the endfourth quarter of 2025.2026. 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 21,31, 2025.2026. 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 To alleviatemitigate the conditions that raise substantial doubt about our ability to continue as a going concern, our plans include securing:
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.
Other thanWhile the AGPRodman Sales Agreement,Agreement whichis wasin entered into on August 16, 2024,place, none of thesethe other funding alternatives are currently committed. There is no assurance that we will obtainbe successful in securing sufficient fundingfinancing 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.
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.
Reverse Stock Split
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.
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, 20252026 to be approximately $6$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 of approximately $0.1 million to offset research and development expenses in the Specialized BioTherapeutics business segment.
Licenses and Royalties
We have licensing fee commitments of approximately $230,000 as of December 31, 20242025 over the next five years for several licensing agreements with partners and universities. Additionally, we haveare collaborationparty to other agreements which include cash milestone payments, royalties and licenseother agreements,fees payable, which are all contingent upon clinical or commercialization successsuccess. 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, thereThere can be no assurance that clinical or commercialization success will occur.
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.
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.use.
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.
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 followingfor the achievement ofachieving a milestone: underwe the asset purchase agreement, specifically,determine the Phase 3 clinical trial of HyBryte™ beingto 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 asset purchase agreement.
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.
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 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.
Employment Agreements
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.
Debt Financing
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.
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 anaccrued interest only period for the first two years withat 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. AfterPayments of interest only were due for the interest-onlyfirst period,two years and thereafter, the outstanding principal was to be repaid in quarterly paymentsinstallments, ofas $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.defined.
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.
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.
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 alsoadjusted certain payment provisions, and provided for interestan only through June 30, 2024, reduced quarterly principal repaymentsadjustment to $750,000 and eliminated the minimum cash covenant. Further, the 2023 Amendment reduced 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. The remaining terms of the agreement remained unmodified.
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.
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.
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 ofAs a lossresult, onwe extinguishmentrecognized 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$260,933 of other income from the change in the fair value of the convertible debt onin our accompanying consolidated statements of operations forduring the year ended December 31, 2023.2024. For 2023 and through the 2024 Amendment (described below), theThe fair value of the convertible debt was estimated using the Monte Carlo valuation method.
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.
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. ThePursuant 2024to Amendment resulted in a substantial modification of the debt forapplicable accounting purposes,standards, as defined, which is accounted for as an extinguishment. The difference between the fair value, or net carrying amount, of the debt beforeafter 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,Amendment, we elected not to account for the amended convertible debt usingunder the fair value optionoption. inAccordingly, accordancethere withwas no further recognition for 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 resultimpact of this election, we recognized a gain of $260,933 of other income from the changechanges in the fair value of the convertible debt onin our accompanyingfinancial 2024 consolidated statement of operations.statements.
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’sour obligations were released. We did not incur any prepayment penalties for the early repayment.
Contingencies
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.
CARES Act Employee Retention Credit
What changed in the latest 10-Q
Risk Factors
Largest changes
Nasdaq hassee in full comparisonalso proposedadopted amendments to its continued listing standards thatwouldrequire companies listed on The Nasdaq Global Select Market, The Nasdaq Global Market, and The Nasdaq Capital Market to maintain a minimum market value of listed securities (“MVLS”) of at least $5 million. Under theproposedadopted rules, if acompany'scompany’smarket valueMVLS remains below $5 million for a period of 30 consecutive business days, Nasdaqwouldwill issue aStaffstaffDelistingdelistingDeterminationdetermination and immediately suspend trading of thecompany'scompany’s securities, without providing a cure or compliance period. In addition, a timely request for a hearingwouldbefore a Nasdaq Listing Qualifications Hearings Panel will not stay the suspension of trading, and thehearingscompany’spanelsecurities wouldhavegenerallylimitedtrade in the over-the-counter market pending the outcome of any appeal. The Hearings Panel’s authority to grantrelief,reliefincludingonbeingappealunableis narrower than in most other continued listing matters: the Hearings Panel may reverse a delisting determination only if it finds the determination was made in error, or may grant an exception of up toprovide180 days for the company to demonstrate that it satisfies Nasdaq’s initial listing requirements, which are generally more stringent than the continued listing standards from which the company fell out of compliance. The Hearings Panel does not otherwise have discretion to excuse a temporary or good-faith shortfall or to grant additional time to regaincompliance.complianceIfwithadoptedthe ordinary continued listing standards, as it can for most other continued listing deficiencies. Because the Company’s market value is subject to significant fluctuation andapplicablecouldtodeclineus,belowthese$5proposedmillionruleforchangesa sustained period, particularly during periods of adverse clinical, regulatory, or market developments, this new requirement 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 Company’s liquidity and the market price ofourthe Company’s common stock andourits ability to raise additional capital.
“The Nasdaq Listing Rules require listed securities to maintain a minimum bid price of $1.00 per share and, based upon the closing bid price for the last 30 consecutive business days, the Company no longer meets this requirement. The Bid Price Notice indicated that the Company will be provided 180 calendar days, or until December 7, 2026, in which to regain compliance. …”see in full comparison
“On June 10, 2026, the Company received a written notice (the “Bid Price Notice”) from the Listing Qualifications department (the “Nasdaq Staff”) of The Nasdaq Stock Market (“Nasdaq”) indicating that the Company is not in compliance with the $1.00 minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market. …”see in full comparison
“Alternatively, if the Company fails to regain compliance with Rule 5550(a)(2) prior to the expiration of the 180 calendar day period, but meets the continued listing requirement for market value of publicly held shares and all of the other applicable standards for initial listing on The Nasdaq Capital Market, with the exception of the minimum bid price, and provides written notice of its intention to cure the deficiency during the second compliance period by effecting a reverse stock split, if necessary, then the Company may be granted an additional 180 calendar days to regain compliance with …”see in full comparison
see in full comparisonCompanies trading on Nasdaq, such as our company, must be reporting issuers under Section 12 of the Exchange Act, and must meet the listing requirements in order to maintain the listing of common stock on The Nasdaq Capital Market.Additionally, The Nasdaq Capital Market requires listed companies to satisfy at least one of three alternative financial condition standards for continued listing: (i) stockholders' equity of at least $2.5 million, (ii) market value of listed securities of at least $35 million, or (iii) net income from continuing operations of at least $500,000 in the most recently completed fiscal year or in two of the last three fiscal years. As ofMarchJune31,30, 2026, our stockholders' equity was approximately$3.1$6.6 million, and we do not currently satisfy either of the two alternative financial condition standards. Given our history of net losses and theratefluctuationsat whichin our stockholders' equityhas declined—from $5.3 million at December 31, 2025 to $3.1 million at March 31, 2026 and $6.6 million at June 30, 2026—we may be unable to maintain stockholders' equity at or above the $2.5 million minimum absent a significant capital raise or other equity-positive transaction. If our stockholders' equity falls below $2.5 million and we are unable to satisfy an alternative financial condition standard, Nasdaq may notify us that we are not in compliance with its continued listing requirements. There can be no assurance that we will be able to regain compliance if we receive such a notification. If we do not meet these requirements, the market liquidity for our securities could be severely adversely affected by limiting the ability of broker-dealers to sell our securities and the ability of shareholders to sell their securities in the secondary market.
Full comparison: every changed paragraph (7)
If we fail to meet Nasdaq's listing requirements, including the minimum stockholders'bid price requirement, and the minimum stockholders’ equity requirement, we could be removed from The Nasdaq Capital Market, which would limit the ability of broker-dealers to sell our securities and the ability of shareholders to sell their securities in the secondary market and negatively impact our ability to raise capital.
On June 10, 2026, the Company received a written notice (the “Bid Price Notice”) from the Listing Qualifications department (the “Nasdaq Staff”) of The Nasdaq Stock Market (“Nasdaq”) indicating that the Company is not in compliance with the $1.00 minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market. The notification of noncompliance has no immediate effect on the listing or trading of the Company’s common stock on The Nasdaq Capital Market under the symbol “SNGX”, and the Company is currently monitoring the closing bid price of its common stock and evaluating its alternatives, if appropriate, to resolve the deficiency and regain compliance with this rule.
The Nasdaq Listing Rules require listed securities to maintain a minimum bid price of $1.00 per share and, based upon the closing bid price for the last 30 consecutive business days, the Company no longer meets this requirement. The Bid Price Notice indicated that the Company will be provided 180 calendar days, or until December 7, 2026, in which to regain compliance. If at any time during this period the bid price of the Company’s common stock closes at or above $1.00 per share for a minimum of 10 consecutive business days, the Nasdaq Staff will provide the Company with a written confirmation of compliance and the matter will be closed. In the event the Company does not regain compliance with Rule 5550(a)(2) prior to the expiration of the 180 calendar day period, the Nasdaq Staff will provide the Company with written notification that its securities are subject to delisting from The Nasdaq Capital Market. At that time, the Company may appeal the delisting determination to a Nasdaq Listing Qualifications Panel.
Alternatively, if the Company fails to regain compliance with Rule 5550(a)(2) prior to the expiration of the 180 calendar day period, but meets the continued listing requirement for market value of publicly held shares and all of the other applicable standards for initial listing on The Nasdaq Capital Market, with the exception of the minimum bid price, and provides written notice of its intention to cure the deficiency during the second compliance period by effecting a reverse stock split, if necessary, then the Company may be granted an additional 180 calendar days to regain compliance with Rule 5550(a)(2).
Companies trading on Nasdaq, such as our company, must be reporting issuers under Section 12 of the Exchange Act, and must meet the listing requirements in order to maintain the listing of common stock on The Nasdaq Capital Market.Additionally, The Nasdaq Capital Market requires listed companies to satisfy at least one of three alternative financial condition standards for continued listing: (i) stockholders' equity of at least $2.5 million, (ii) market value of listed securities of at least $35 million, or (iii) net income from continuing operations of at least $500,000 in the most recently completed fiscal year or in two of the last three fiscal years. As of MarchJune 31,30, 2026, our stockholders' equity was approximately $3.1$6.6 million, and we do not currently satisfy either of the two alternative financial condition standards. Given our history of net losses and the ratefluctuations at whichin our stockholders' equity has declined—from $5.3 million at December 31, 2025 to $3.1 million at March 31, 2026 and $6.6 million at June 30, 2026—we may be unable to maintain stockholders' equity at or above the $2.5 million minimum absent a significant capital raise or other equity-positive transaction. If our stockholders' equity falls below $2.5 million and we are unable to satisfy an alternative financial condition standard, Nasdaq may notify us that we are not in compliance with its continued listing requirements. There can be no assurance that we will be able to regain compliance if we receive such a notification. If we do not meet these requirements, the market liquidity for our securities could be severely adversely affected by limiting the ability of broker-dealers to sell our securities and the ability of shareholders to sell their securities in the secondary market.
Nasdaq has also proposedadopted amendments to its continued listing standards that would require companies listed on The Nasdaq Global Select Market, The Nasdaq Global Market, and The Nasdaq Capital Market to maintain a minimum market value of listed securities (“MVLS”) of at least $5 million. Under the proposedadopted rules, if a company'scompany’s market valueMVLS remains below $5 million for a period of 30 consecutive business days, Nasdaq wouldwill issue a Staffstaff Delistingdelisting Determinationdetermination and immediately suspend trading of the company'scompany’s securities, without providing a cure or compliance period. In addition, a timely request for a hearing wouldbefore a Nasdaq Listing Qualifications Hearings Panel will not stay the suspension of trading, and the hearingscompany’s panelsecurities would havegenerally limitedtrade in the over-the-counter market pending the outcome of any appeal. The Hearings Panel’s authority to grant relief,relief includingon beingappeal unableis narrower than in most other continued listing matters: the Hearings Panel may reverse a delisting determination only if it finds the determination was made in error, or may grant an exception of up to provide180 days for the company to demonstrate that it satisfies Nasdaq’s initial listing requirements, which are generally more stringent than the continued listing standards from which the company fell out of compliance. The Hearings Panel does not otherwise have discretion to excuse a temporary or good-faith shortfall or to grant additional time to regain compliance.compliance Ifwith adoptedthe ordinary continued listing standards, as it can for most other continued listing deficiencies. Because the Company’s market value is subject to significant fluctuation and applicablecould todecline us,below these$5 proposedmillion rulefor changesa sustained period, particularly during periods of adverse clinical, regulatory, or market developments, this new requirement 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 Company’s liquidity and the market price of ourthe Company’s common stock and ourits ability to raise additional capital.
As of MayJuly 1,31, 2026, we had a number of agreements or obligations that may result in dilution to investors. These include:
Management's Discussion & Analysis (MD&A)
Largest changes
“The Nasdaq Listing Rules require listed securities to maintain a minimum bid price of $1.00 per share and, based upon the closing bid price for the last 30 consecutive business days, we no longer meet this requirement. The Bid Price Notice indicated that we will be provided 180 calendar days, or until December 7, 2026, in which to regain compliance. …”see in full comparison
“In April 2023, we had a Type A meeting with the FDA to clarify and respond to the issues identified in the RTF letter received from the FDA and to seek additional guidance concerning information that the FDA would require for a resubmitted NDA to be deemed acceptable to file, in order to advance HyBryte™ towards marketing approval and U.S. commercialization. …”see in full comparison
“In December 2024, we announced positive clinical results from a comparability study evaluating HyBryte™ versus Valchlor® (mechlorethamine gel) in the treatment of early-stage CTCL. The open-label study has demonstrated continued improvement in HyBryte™ treated patients and their individual lesions even after stopping treatment. The study, which enrolled 10 patients randomized 1:1 with 12 weeks of treatment and 4 weeks of follow-up post-treatment, was previously reported to demonstrate a positive difference in the overall per patient treatment response rate (60% in the HyBryte™ group vs. …”see in full comparison
“In April 2025, we announced positive interim results from the ongoing open-label, IIS evaluating extended HyBryte™ treatment for up to 54 weeks in patients with early-stage CTCL. Following 18 weeks of treatment, 75% of patients achieved "Treatment Success," reinforcing HyBryte™ as a potentially safe and fast-acting therapy for this chronic and underserved cancer. To date, nine patients have been enrolled and treated with HyBryte™ over a time period of up to 54 weeks in the IIS, with all data for the Week 18 timepoint now complete. …”see in full comparison
“In June 2021, we received a Paediatric Investigation Plan (“PIP”) waiver from the EMA for HyBryte™. As part of the regulatory process for the registration of new medicines with the EMA, pharmaceutical companies are required to provide a PIP outlining their strategies for investigation of the new medicinal products in the pediatric population. …”see in full comparison
“In March 2025, we announced a publication describing the preclinical efficacy of CiVax™, a thermostabilized subunit vaccine against SARS-CoV-2. Using custom-developed immunoassays, the combination of a primary adenovirus vaccine (COVID-19 Vaccine AstraZeneca) coupled with a CiVax™ booster was shown to induce broader protection against COVID-19 variants in non-human primates than a 2-shot mRNA series (such as the Moderna vaccine Spikefax® or the Pfizer vaccine Cominarty®) in humans. …”see in full comparison
Full comparison: every changed paragraph (65)
Our Specialized BioTherapeutics business segment is developing synthetic hypericin for the treatment of psoriasis (SGX302), and our first-in-class Innate Defense Regulator technology, dusquetide, for the treatment of inflammatory diseases, including aphthous ulcers in Behçet’s Disease (“BD”) (SGX945) and oral mucositis in head and neck cancer (SGX942). We arewere developing HyBryte™ (a proposed proprietary name of SGX301 or synthetic hypericin sodium), a photodynamic therapy (“PDT”) utilizing topical synthetic hypericin activated with visible light, for the treatment of cutaneous T-cell lymphoma (“CTCL”) in a Phase 3 study called “FLASH2” (Fluorescent Light Activated Synthetic Hypericin 2). The Data Monitoring Committee (“DMC”) completed its interim efficacy analysis of the FLASH2 trial during April 2026, and under the terms of the interim analysis, the study was recommended to halt for futility. WeIn areJune 2026, following a thorough review of the DMC’s recommendation and evaluation of the program’s path forward, our Board of Directors determined that it was in our best interest and the processinterest of analyzingour stockholders to terminate the dataHyBryte™ todevelopment better determine why the study did not meet expectations.program.
Our Public Health Solutions business segment includes development programs for (i) RiVax®, a ricin toxin vaccine candidate, and (ii) 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 (“NIAID”), the Biomedical Advanced Research and Development Authority and the Defense Threat Reduction Agency.
Synthetic hypericin is one of the most efficient known generators of singlet oxygen, the key component for phototherapy. The generation of singlet oxygen induces necrosis and apoptosis in cells. The use of topical synthetic hypericin coupled with directed visible light results in generation of singlet oxygen only at the treated site. We believe that the use of visible light (as opposed to cancer-causing UV light) is a major advance in photodynamic therapy. In a small published Phase 1/2 proof of concept pilot clinical study using synthetic hypericin twice weekly for six weeks, statistically significant efficacy was demonstrated in patients with CTCL (58.3% response, p=0.04) and psoriasis (80% response, p<0.02). Subsequently, a published Phase 3 study in CTCL has further confirmed the biological efficacy of synthetic hypericin (termed HyBryte™ in the context of CTCL). A second Phase 3 clinical trial was recommended to halt for futility at the interim efficacy analysis.analysis Wein willApril analyze2026. In June 2026, following a thorough review of the dataDMC’s recommendation and evaluation of the program’s path forward, our Board of Directors determined that it was in our best interest and the interest of our stockholders to better determine whyterminate the studyHyBryte™ diddevelopment not meet expectations.program.
Following the first Phase 3 study of HyBryte™ for the treatment of CTCL, the FDA and the EMA indicated that they would require a second successful Phase 3 trial to support marketing approval. With agreement from the EMA on the key design components, the confirmatory Phase 3 trial willwas bedesigned as a randomized, double-blind, placebo-controlled, multicenter study treating approximately 80 subjects with early-stage CTCL.CTCL, It will evaluateevaluating the efficacy and safety of HyBryte™ topically applied to CTCL lesions twice weekly for 18 weeks, with each application followed 21 (±3) hours later by the administration of safe, visible light at a wavelength of 500 to 650 nm. All of the patient’s lesions that arewere readily available for exposure to the visible light source willwere to be treated and three to five index lesions of each patient will bewere prospectively identified and indexed for the modified composite assessment of index lesions severity (“mCAILS”) evaluation prior to randomization (baseline). The primary efficacy endpoint willwas to be assessed on the percent of patients in each of the two treatment groups (i.e., HyBryte™ and placebo) achieving a Partial or Complete Response (yes/no) of the treated lesions defined as a ≥ 50% reduction in the total mCAILS score for the three to five index lesions following 18 weeks of treatment compared to the total mCAILS score at baseline. Other secondary measures willwere to assess treatment response (including duration), degree of improvement, time to relapse and safety. Following treatment, all patients willwere to be followed every four weeks for a total of 12 weeks (through Week 30). The Data Monitoring Committee conducted one (1) interim analysis when approximately 60% of the total subjects completed the primary endpoint evaluation. The Data Monitoring Committee completed its interim efficacy analysis of the FLASH2 trial during April 2026, and under the terms of the interim analysis, the study was recommended to halt for futility. WeIn willJune analyze2026, following a thorough review of the dataDMC’s recommendation and evaluation of the program’s path forward, our Board of Directors determined that it was in our best interest and the interest of our stockholders to better determine whyterminate the studyHyBryte™ diddevelopment not meet expectations.program.
In June 2021, we received a Paediatric Investigation Plan (“PIP”) waiver from the EMA for HyBryte™. As part of the regulatory process for the registration of new medicines with the EMA, pharmaceutical companies are required to provide a PIP outlining their strategies for investigation of the new medicinal products in the pediatric population. In some instances, a waiver negating the need for a PIP for certain conditions may be granted by the EMA when development of a medicine for use in children is not feasible or appropriate, as is the case for HyBryte™ in CTCL which is extremely rare in children.
In July 2022, the results of our Phase 3 FLASH study evaluating HyBryte™ for the treatment of CTCL were published in the Journal of the American Medical Association (JAMA) Dermatology.
In July 2022, we received agreement from the FDA on an initial pediatric study plan (“iPSP”) for HyBryte™ for the treatment of CTCL. The agreed iPSP stipulates that we intend to request a full waiver of pediatric studies upon submission of the NDA. Agreement with FDA on an iPSP is one of the regulatory requirements that must be met prior to submitting a NDA.
HyBryte™ has received Orphan Drug designation as well as Fast Track designation from the FDA. The Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders. In addition to providing a seven-year term of market exclusivity for HyBryte™ upon final FDA approval. In addition, Fast Track is a designation that the FDA reserves for a drug intended to treat a serious or life-threatening condition and one that demonstrates the potential to address an unmet medical need for the condition. Fast Track designation is designed to facilitate the development and expedite the review of new drugs. HyBryte™ for the treatment of CTCL also was granted Orphan Drug designation from the EMA Committee for Orphan Medical Products and Promising Innovative Medicine (“PIM”) designation from the MHRA, as well as Innovation Passport under the Innovative Licensing and Access Pathway (“ILAP”) in the UK. The innovation passport designation is the first step in the ILAP process and triggers the MHRA and its partner agencies to create a target development profile to chart out a roadmap for regulatory and development milestones with the goal of early patient access in the UK. Other benefits of ILAP include a 150-day accelerated assessment, rolling review and a continuous benefit risk assessment.
In September 2022, the FDA awarded an Orphan Products Development grant to support the evaluation of HyBryte™ for expanded treatment in patients with early-stage CTCL. The grant, totaling $2.6 million over four years, was awarded to a prestigious academic institution that was a leading enroller in the published positive Phase 3 FLASH study in the treatment of early-stage CTCL.
In December 2022, we submitted the HyBryte™ NDA for the treatment of CTCL with the FDA.
In February 2023, we received a refusal to file (“RTF”) letter from the FDA for the HyBryte™ NDA. Upon preliminary review, the FDA determined that the NDA was not sufficiently complete to permit substantive review.
In April 2023, the United States Adopted Names (“USAN”) Council approved the use of the nonproprietary name of “hypericin sodium” for the novel active ingredient in both HyBryte™ (research name SGX301) for the treatment of CTCL and SGX302 for the treatment of mild-to-moderate psoriasis.
In April 2023, we had a Type A meeting with the FDA to clarify and respond to the issues identified in the RTF letter received from the FDA and to seek additional guidance concerning information that the FDA would require for a resubmitted NDA to be deemed acceptable to file, in order to advance HyBryte™ towards marketing approval and U.S. commercialization. In order to accept an NDA filing for HyBryte™, the FDA is requiring positive results from a second, Phase 3 pivotal study in addition to the Phase 3, randomized, double-blind, placebo-controlled FLASH study previously conducted in this orphan indication. Based on this feedback, we have decided to collaboratively engage in discussions with the FDA in order to define the protocol and evaluate the feasibility of conducting the additional clinical trial.
In May 2023, we were granted a follow-on Type A meeting with the FDA to initiate formal discussions regarding the protocol design of a second, Phase 3 pivotal study evaluating HyBryte™ in the treatment of CTCL in support of potential FDA marketing approval. While discussions have been collaborative, the FDA has expressed a preference for a longer duration comparative study over a placebo-controlled trial. Given the shorter time to potential commercial revenue and the similar trial design to the first FLASH study afforded by the EMA accepted protocol, we determined to initiate the FLASH2 study in support of worldwide potential approval. At the same time, we will continue discussions with the FDA on modifying the development path to adequately address their feedback.
In August 2023, patient enrollment was opened for the investigator-initiated study (“IIS”). IIS is supported by an Orphan Products Development grant of $2.6 million over four years awarded by the FDA to a prestigious academic institution that was a leading enroller in the published positive Phase 3 FLASH study in the treatment of early-stage CTCL. The IIS will evaluate the expanded treatment, including up to 12 months of treatment, with HyBryte™ in patients with early-stage CTCL.
In March 2024, we received agreement from the EMA on the key design components of a confirmatory Phase 3 placebo-controlled study evaluating the safety and efficacy of HyBryte™ in the treatment of CTCL patients with early-stage disease. This confirmatory 18-week study is expected to enroll approximately 80 patients.
In September 2024, the European Patent Office granted the patent entitled "Systems and Methods for Producing Synthetic Hypericin". The newly issued patent's claims are directed to a novel, highly purified form of synthetic hypericin manufactured through a unique proprietary process. Synthetic hypericin is the active pharmaceutical ingredient in HyBryte™, our photodynamic therapy for the treatment of CTCL, set to initiate a confirmatory Phase 3 clinical trial before the end of the year. This new European granted patent (EP3423428) is a related patent to U.S. Pat. No. 10,053,413, previously issued in the U.S. Both patents are expected to expire in 2036, and form part of a larger patent family, including previously granted U.S. patents covering methods of use (U.S. Pat. No. 7,122,518) and methods of synthesis (U.S. Pat. No. 8,629,302), as well as other granted patents throughout the world.
In October 2024, we established a partnership agreement with Sterling Pharma Solutions Limited (“Sterling”) to optimize and implement a commercially viable, scalable production technology for synthetic hypericin. We are currently working to transfer and optimize the manufacturing processes and analytics to enable GMP manufacturing for clinical trials with the intent of establishing a long-term commercial manufacturing collaboration.
In October 2024, the Hong Kong Patent Office granted the patent entitled "Systems and Methods for Producing Synthetic Hypericin". The newly issued patent's claims are directed to a novel, highly purified form of synthetic hypericin manufactured through a unique proprietary process. Synthetic hypericin is the active pharmaceutical ingredient in HyBryte™, our photodynamic therapy for the treatment of CTCL, for which a confirmatory Phase 3 clinical trial has been initiated. This new granted patent (HK1260757) is a related patent to U.S. Pat. Nos. 10,053,413 and 10,526,268, previously issued in the U.S., and is in the same family as another patent granted in Europe. These patents are expected to expire in 2036, and form part of a larger collection of different patent families, including previously granted foreign patents covering liquid formulations and methods of use (EP Pat. No. 2,571,507) and issued U.S. patents for methods of synthesis (U.S. Pat. No. 8,629,302), as well as other granted patents throughout the world.
In December 2024, we announced positive clinical results from a comparability study evaluating HyBryte™ versus Valchlor® (mechlorethamine gel) in the treatment of early-stage CTCL. The open-label study has demonstrated continued improvement in HyBryte™ treated patients and their individual lesions even after stopping treatment. The study, which enrolled 10 patients randomized 1:1 with 12 weeks of treatment and 4 weeks of follow-up post-treatment, was previously reported to demonstrate a positive difference in the overall per patient treatment response rate (60% in the HyBryte™ group vs. 20% in the Valchlor® group) at the end of treatment. After the 4-week follow-up period (Week 16), the majority (3 of 5) of HyBryte™ patients continued to demonstrate improvement with at least a further 10% improvement (absolute difference) at Week 16 relative to the primary outcome measure at Week 12, including one of the HyBryte™ patients achieving a "complete response". In contrast, of the four patients that completed the Valchlor® arm of the study, none achieved this level of improvement by Week 16. For patients, a treatment response was defined as a ≥50% improvement in their cumulative mCAILS score over 3 to 5 lesions. Treatment response was also assessed on individual lesions. There was a similar continued improvement in the lesion responses over time, with the plaque lesions of particular interest given their increasing association with risk of overall disease progression and long-term mortality. At the 12-week (end of treatment) timepoint, the HyBryte™ treated plaque lesions were statistically significantly improved compared to the Valchlor® treated plaques (63%, [10/16] treatment success with HyBryte™ vs. 17%, [2/12] with Valchlor®, p=0.02). By Week 16, the response rates in lesions treated with HyBryte™ were statistically significant responses for all lesions (72% HyBryte™ vs 28% Valchlor®, p=0.02) and specifically for plaque lesions (75% responding plaque lesions with HyBryte™ treatment vs. 17% with Valchlor®, p=0.006) relative to the Valchlor® group. No safety concerns with HyBryte™ were raised during the follow-up period.
In December 2024, we opened patient enrollment for our confirmatory Phase 3 study evaluating HyBryte™ (synthetic hypericin) in the treatment of CTCL with top-line results anticipated in the second half of 2026.
In April 2025, we announced positive interim results from the ongoing open-label, IIS evaluating extended HyBryte™ treatment for up to 54 weeks in patients with early-stage CTCL. Following 18 weeks of treatment, 75% of patients achieved "Treatment Success," reinforcing HyBryte™ as a potentially safe and fast-acting therapy for this chronic and underserved cancer. To date, nine patients have been enrolled and treated with HyBryte™ over a time period of up to 54 weeks in the IIS, with all data for the Week 18 timepoint now complete. Consistent with the Phase 3 trials, Treatment Success is predefined as a greater than or equal to 50% improvement in the cumulative mCAILS score compared to Baseline. Of the eight patients who could be evaluated through Week 18, six (75%) had a Treatment Success. The 18-week treatment window is the same window that is being evaluated in the FLASH2 double-blind, placebo-controlled, randomized study that is currently enrolling patients. This rapid response is a distinct advantage of HyBryte™ therapy, with many other therapies used in CTCL taking up to six to 12 months to generate a clinically meaningful treatment response. Of these eight evaluable patients through Week 18, four have gone on to complete the 54-week treatment with an average maximum improvement in mCAILS score of 85%, with three of the eight evaluable patients achieving a complete response over the course of the study. HyBryte™ appears to be safe and well tolerated in all patients. The trial is sponsored by Ellen Kim, MD, Director, Penn Cutaneous Lymphoma Program, Vice Chair of Clinical Operations, Dermatology Department, and Professor of Dermatology at the Hospital of the University of Pennsylvania who was a leading enroller in the Phase 3 FLASH study for the treatment of early-stage CTCL.
In July 2025, we successfully completed the transfer of the manufacturing process for our synthetic hypericin active ingredient under our partnership agreement with Sterling. The transfer from Europe to the U.S. included the optimization and implementation of a commercially viable, scalable production process for this important active ingredient, which is used in the topical drug product formulations HyBryte™ and SGX302, being developed for the treatment of CTCL and psoriasis, respectively. Together with Sterling, we have enabled current good manufacturing practices (“cGMP”) requirements for clinical trials with the intent of establishing a long-term commercial manufacturing collaboration.
In October 2025, the first Data Monitoring Committee meeting for our confirmatory Phase 3 study evaluating HyBryte™ in the treatment of CTCL concluded that there were no safety concerns with the ongoing Phase 3 study and that HyBryte™ has an acceptable safety profile that remains consistent with the safety data from all prior clinical studies.
In March 2026, a summary of all clinical trials completed to date evaluating HyBryte™ as a treatment for CTCL was published in the peer-reviewed medical journal Expert Opinion on Investigational Drugs.
In March 2026, findings from recent supportive trials with HyBryte™ in the treatment of CTCL were presented at the U.S. Cutaneous Lymphoma Consortium Workshop, preceding the American Academy of Dermatology Annual Meeting.
In April 2026, the results of our comparability study evaluating HyBryte™ versus Valchlor® for the treatment of CTCL were published in Oncology and Therapy.
In April 2026, the Data Monitoring Committee completed its interim efficacy analysis of the FLASH2 trial, and under the terms of the interim analysis, the study was recommended to halt for futility.
In April 2023, the United States Adopted Names (“USAN”) Council approved the use of the nonproprietary name of “hypericin sodium” for the novel active ingredient in SGX302 for the treatment of mild-to-moderate psoriasis.
In September 2024, the European Patent Office granted the patent entitled "Systems and Methods for Producing Synthetic Hypericin". The newly issued patent's claims are directed to a novel, highly purified form of synthetic hypericin manufactured through a unique proprietary process. This new European granted patent (EP3423428) is a related patent to U.S. Pat. No. 10,053,413, previously issued in the U.S. Both patents are expected to expire in 2036, and form part of a larger patent family, including previously granted U.S. patents covering methods of use (U.S. Pat. No. 7,122,518) and methods of synthesis (U.S. Pat. No. 8,629,302), as well as other granted patents throughout the world.
In October 2024, the Hong Kong Patent Office granted the patent entitled "Systems and Methods for Producing Synthetic Hypericin". The newly issued patent's claims are directed to a novel, highly purified form of synthetic hypericin manufactured through a unique proprietary process. Synthetic hypericin is the active pharmaceutical ingredient in SGX302, our photodynamic therapy for the treatment of Psoriasis. This new granted patent (HK1260757) is a related patent to U.S. Pat. Nos. 10,053,413 and 10,526,268, previously issued in the U.S., and is in the same family as another patent granted in Europe. These patents are expected to expire in 2036, and form part of a larger collection of different patent families, including previously granted foreign patents covering liquid formulations and methods of use (EP Pat. No. 2,571,507) and issued U.S. patents for methods of synthesis (U.S. Pat. No. 8,629,302), as well as other granted patents throughout the world.
Based on the positive and previously published Phase 2 results, we conducted a Phase 3 clinical trial referred to as the “DOM–INNATE” (Dusquetide treatment in Oral Mucositis – by modulating INNATE immunity) study.
Based on the positive and previously published Phase 2 results, we conducted a Phase 3 clinical trial referred to as the “DOM–INNATE” (Dusquetide treatment in Oral Mucositis – by modulating INNATE immunity) study. The Phase 3 protocol was a double-blind, randomized, placebo-controlled, multinational trial that sought to enroll approximately 260 subjects with squamous cell carcinoma of the oral cavity and oropharynx who were scheduled to receive a minimum total cumulative radiation dose of 55 Gy fractionated as 2.0-2.2 Gy per day with concomitant cisplatin chemotherapy given as a dose of 80-100 mg/m2 every third week. Subjects were randomized to receive either 1.5 mg/kg SGX942 or placebo given twice a week during and for two weeks following completion of chemoradiation therapy (“CRT”). The primary endpoint for the study was the median duration of SOM, which was assessed by oral examination at each treatment visit and then through six weeks following completion of CRT. Oral mucositis is evaluated using the WHO Grading system. SOM is defined as a WHO Grade of ≥3. Subjects are followed for an additional 12 months after the completion of treatment.
ThermoVax® is a novel method for thermostabilizing vaccines with a variety of adjuvants, resulting in a single vial which can be reconstituted with water for injection immediately prior to use. One of the adjuvants utilized in ThermoVax® is aluminum salts (known colloquially as “Alum”). Alum is the most widely employed adjuvant technology in the vaccine industry.
The value of ThermoVax® lies in its potential ability to eliminate the need for cold chain production, transportation, and storage for Alum-adjuvanted vaccines.storage. This would relieve the high costs of producing and maintaining vaccines under refrigerated conditions. Based on historical reports from WHO and other scientific reports, we believe that a meaningful proportion of vaccine doses globally are wasted due to excursions from required cold chain temperature ranges. This is due to the fact that many vaccines need to be maintained either between 2 and 8 degrees Celsius (“C”), frozen below -20 degrees C, or frozen below -60 degrees C, and even brief excursions from these temperature ranges usually necessitate the destruction of the product or the initiation of costly stability programs specific for the vaccine lots in question. ThermoVax® has the potential to facilitate easier storage and distribution of strategic national stockpile vaccines for ricin exposure in emergency settings.
ThermoVax® development, specifically in the context of an Alum adjuvant,development was supported pursuant to a previous $9.4 million NIAID grant which enabled development of thermo-stable ricin (RiVax®) and anthrax vaccines. Proof-of-concept preclinical studies with ThermoVax® indicate that it is able to produce stable vaccine formulations using adjuvants, protein immunogens, and other components that ordinarily would not withstand long temperature variations exceeding customary refrigerated storage conditions. These studies were conducted with our Alum-adjuvanted ricin toxin vaccine, RiVax® and our Alum-adjuvanted anthrax vaccine. Each vaccine was manufactured under precise lyophilization conditions using excipients that aid in maintaining native protein structure of the key antigen. When RiVax® was kept at 40 degrees C (104 degrees Fahrenheit (“F”)) for up to one year, all of the animals vaccinated with the lyophilized RiVax® vaccine developed potent and high titer neutralizing antibodies. In contrast, animals that were vaccinated with the liquid RiVax® vaccine kept at 40 degrees C did not develop neutralizing antibodies and were not protected against ricin exposure. The ricin A chain is extremely sensitive to temperature and rapidly loses the ability to induce neutralizing antibodies when exposed to temperatures higher than 8 degrees C. When the anthrax vaccine was kept for up to 16 weeks at 70 degrees C, it was able to develop a potent antibody response, unlike the liquid formulation kept at the same temperature. Moreover, we also have demonstrated the compatibility of our thermostabilization technology with other secondary adjuvants such as TLR-4 agonists.
In March 2025, we announced a publication describing the preclinical efficacy of CiVax™, a thermostabilized subunit vaccine against SARS-CoV-2. Using custom-developed immunoassays, the combination of a primary adenovirus vaccine (COVID-19 Vaccine AstraZeneca) coupled with a CiVax™ booster was shown to induce broader protection against COVID-19 variants in non-human primates than a 2-shot mRNA series (such as the Moderna vaccine Spikefax® or the Pfizer vaccine Cominarty®) in humans. In collaboration with Axel Lehrer, PhD, Professor at the Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine, University of Hawaiʻi at Mānoa, the manuscript entitled "Use of a Multiplex Immunoassay Platform to Investigate Multifaceted Antibody Responses in SARS-CoV-2 Vaccinees with and Without Prior Infection", has been published in COVID.
In September 2025, we announced a publication describing the extended stability of filovirus vaccines using our ThermoVax® platform. Bivalent and trivalent vaccines, constructed from antigens against EBOV, SUDVSUDV, and MARV and the CoVaccine HT™ antigen, were formulated in a single vial and subjected to long-term storage at up to 40°C (104°F). After two years of storage, all vaccines were unchanged and had equivalent potency as when initially manufactured. In collaboration with Axel Lehrer, PhD, Professor at the Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine,JABSOM, UH Manoa, the manuscript entitled "Thermostable Bivalent & Trivalent Filovirus Vaccines from Insect Cells: Potency Demonstrated after 3 Months and 2 Years", has been accepted for publication and is available online in Vaccine.
In May 2026, we highlighted that the recent Congo outbreak of BDBV, an Orthoebolavirus, will require new vaccine formulation efforts. In collaboration with Axel Lehrer, PhD, Professor at the Department of Tropical Medicine, Medical Microbiology and Pharmacology, JABSOM, UH Manoa, we have previously developed bivalent and trivalent vaccines, constructed from antigens against EBOV, SUDV, and MARV and the CoVaccine HT™ adjuvant, demonstrating thermostability, immunogenicity and durable efficacy. Previous work in Dr. Lehrer's laboratory has demonstrated platform compatibility of the key BDBV antigen enabling rapid development of a protein-based thermostable subunit vaccine.
In June 2026, we announced that the Coalition for Epidemic Preparedness Innovations (“CEPI”) has publicized a call for proposal for vaccine development for BDBV with applications due June 12, 2026. In collaboration with Axel Lehrer, PhD, Professor at the Department of Tropical Medicine, Medical Microbiology and Pharmacology, JABSOM, UH Manoa, we have previously developed bivalent and trivalent vaccines, constructed from antigens against EBOV, SUDV, and MARV and the CoVaccine HT™ adjuvant, demonstrating thermostability, immunogenicity and durable efficacy in NHPs. This work, combined with previous and ongoing work in Dr. Lehrer's laboratory that has demonstrated platform compatibility of the key BDBV antigen, will form the basis of an application to CEPI enabling rapid development of a protein-based thermostable subunit vaccine for BDBV.
As a vaccine for a neglected tropical disease, an FDA approved SuVax™,SUDV, MarVax™MARV, BDBV or combined vaccine has the potential to qualify for a Tropical Disease Priority Review Voucher (“PRV”). PRVs are transferable and can be sold, with sales in recent years of approximately $200 million. When redeemed, PRVs entitle the user to an accelerated review period of nine months, saving a median of seven months review time as calculated in 2009. However, FDA must be advised 90 days in advance of the use of the PRV and the use of a PRV is associated with an additional user fee (approximately $2.0 million for fiscal year 2026).
In November 2021, an article was published on pre-clinical immunogenicity studies for RiVax® demonstrating enduring protection for at least 12 months post-vaccination. These results, coupled with the previous demonstration of efficacy in mice and NHPs as well as long-term thermostability (at least 1 year at 40 degrees C or 104 degrees F), reinforce the practicality of stockpiling and potentially utilizing the RiVax® vaccine in warfighters and civilian first responders without the complexities that arise for vaccines that require stringent cold chain handling.
In December 2022, we published a paper demonstrating statistically significant correlates of protection predicting survival after lethal aerosolized ricin challenge in non-human primates. The article titled “Serum antibody profiling identifies vaccine-induced correlates of protection against aerosolized ricin toxin in rhesus macaques” was published in the journal npj Vaccines.
Three and Six Months Ended MarchJune 31,30, 2026 Compared to MarchJune 31,30, 2025
For the three months ended June 30, 2026, we had a net loss of $1,987,354 as compared to a net loss of $2,701,976 for the same prior year period, representing decreased net loss of $714,622. This decrease in net loss was primarily due to a decrease in research and development expenses associated with the terminated FLASH2 trial and related HyBryte™ development activities. For the six months ended June 30, 2026, we had a net loss of $4,812,319 as compared to a net loss of $5,653,244 for the same prior year period, representing decreased net loss of $840,925. This decrease in net loss was primarily due to a decrease in research and development expenses associated with the terminated FLASH2 trial and related HyBryte™ development activities, and the completed Phase 2 study in BD.
For the three months ended March 31, 2026, we had a net loss of $2,824,965 as compared to a net loss of $2,951,268 for the same prior year period, representing decreased net loss of $126,303. This decrease in net loss was primarily due to a decrease in operating expenses.
We had no revenue or related costs for the three and six months ended MarchJune 31,30, 2026 and 2025, respectively.
Research and development expenses were $974,091 for the three months ended June 30, 2026 as compared to $1,677,014 for the same period in 2025, representing a decrease of $702,923. The decrease was primarily due to decreases in costs associated with the terminated FLASH2 trial and related HyBryte™ development activities. Research and development expenses were $2,756,391 for the six months ended June 30, 2026 as compared to $3,618,694 for the same period in 2025, representing a decrease of $862,303. The decrease was primarily due to decreases in costs associated with the terminated FLASH2 trial and related HyBryte™ development activities, and the completed Phase 2 study in BD.
Research and development expenses were $1,782,300 for the three months ended March 31, 2026 as compared to $1,941,680 for the same period in 2025, representing a decrease of $159,380. The decrease was primarily due to decreases in costs associated with third-party manufacturing, the completed Phase 2 study in BD and site initiation fees for the second confirmatory Phase 3 CTCL trial, partially offset by an increase in patient fees for the second confirmatory Phase 3 CTCL trial.
General and administrative expenses of $1,102,538$1,125,372 for the three months ended MarchJune 31,30, 2026, as compared to $1,084,828$1,086,865 for the same period in 2025, were relatively flat with a de minimis increase of $17,710.$38,507. General and administrative expenses of $2,227,910 for the six months ended June 30, 2026, as compared to $2,171,693 for the same period in 2025, were relatively flat with a de minimis increase of $56,217.
Interest income, net for the three months ended MarchJune 31,30, 2026 was $61,389$53,598 as compared to $76,028$69,823 for the same period in 2025, representing a decrease of $14,639.$16,225. The decrease is primarily associated with lower cash balances.balances and decreasing interest rates. Interest income, net for the six months ended June 30, 2026 was $114,987 as compared to $145,851 for the same period in 2025, representing a decrease of $30,864. The decrease is primarily associated with lower cash balances and decreasing interest rates.
As of MarchJune 31,30, 2026, we had cash and cash equivalents of $6,029,430$9,811,141 as compared to $7,936,153 as of December 31, 2025, representing aan decreaseincrease of $1,906,723.$1,874,988. As of MarchJune 31,30, 2026, we had working capital of $2,945,938$6,499,947 as compared to working capital of $5,149,732 as of December 31, 2025, representing aan decreaseincrease of $2,203,794.$1,350,215. The decreaseincrease in cash and cash equivalents was primarily related to cash used in operating activities partially offset by proceeds received from at-the-market (“ATM”) sales of shares of our common stock offset by issuance costs and cash used in operating activities during the threesix months ended MarchJune 31,30, 2026.
Based on our operating budget, current rate of cash outflows, and cash on hand, we believe that we have cash runway to support development activities, business operations, and meet our obligations into 2027.the second quarter of 2028. However, as of the date of this filing, we docontinue to explore various strategic alternatives but have not haveconsummated sufficientany cashtransaction andor cashobtained equivalentsany additional program assets to funddevelop operationswhich for at least 12 months following the issuance of these financial statements in this Quarterly Report on Form 10-Q. These factors raiseraises substantial doubt about our ability to continue as a going concern.
In January 2026, we entered into the Rodman Sales Agreement (see Note 4 – Shareholders’ Equity) to sell shares of our common stock from time to time, through ATM sales. The Rodman Sales Agreement providesoriginally provided 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 $0.8 million of potential gross proceeds capacity remaining from the Rodman Sales Agreement as of May 1, 2026 under the prospectus supplement dated January 23, 2026.
In May 2026, we filed a prospectus supplement to increase the maximum aggregate offering amount of the shares of our common stock issuable under the Rodman Sales Agreement by an additional aggregate amount of approximately $3.0 million.
In June 2026, we filed another prospectus supplement (the “Current Prospectus Supplement”) to increase the maximum aggregate offering amount of the shares of our common stock issuable under the Rodman Sales Agreement by an additional aggregate amount of $2.5 million. As of June 30, 2026, we sold approximately $6,234,000 of shares of common stock pursuant to the Rodman Sales Agreement under prior prospectus supplements. From July 1, 2026 through July 31, 2026, we issued 128,000 shares of common stock pursuant to the Rodman Sales Agreement with a weighted average fair value of $0.40 per share. As of July 31, 2026, we have aggregate potential capacity of approximately $2.4 million remaining on our ATM facility under the Current Prospectus Supplement.
Nasdaq Capital Market Listing Requirements
On June 10, 2026, we received a written notice (the “Bid Price Notice”) from the Listing Qualifications department (the “Nasdaq Staff”) of The Nasdaq Stock Market (“Nasdaq”) indicating that we are not in compliance with the $1.00 minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2) for continued listing on the Nasdaq Capital Market. The notification of noncompliance has no immediate effect on the listing or trading of our common stock on The Nasdaq Capital Market under the symbol “SNGX”, and we are currently monitoring the closing bid price of our common stock and evaluating our alternatives, if appropriate, to resolve the deficiency and regain compliance with this rule.
The Nasdaq Listing Rules require listed securities to maintain a minimum bid price of $1.00 per share and, based upon the closing bid price for the last 30 consecutive business days, we no longer meet this requirement. The Bid Price Notice indicated that we will be provided 180 calendar days, or until December 7, 2026, in which to regain compliance. If at any time during this period the bid price of our common stock closes at or above $1.00 per share for a minimum of 10 consecutive business days, the Nasdaq Staff will provide us with a written confirmation of compliance and the matter will be closed. In the event we do not regain compliance with Rule 5550(a)(2) prior to the expiration of the 180 calendar day period, the Nasdaq Staff will provide us with written notification that our securities are subject to delisting from The Nasdaq Capital Market. At that time, we may appeal the delisting determination to a Nasdaq Listing Qualifications Panel.
Alternatively, if we fail to regain compliance with Rule 5550(a)(2) prior to the expiration of the 180 calendar day period, but meet the continued listing requirement for market value of publicly held shares and all of the other applicable standards for initial listing on The Nasdaq Capital Market, with the exception of the minimum bid price, and provide written notice of our intention to cure the deficiency during the second compliance period by effecting a reverse stock split, if necessary, then we may be granted an additional 180 calendar days to regain compliance with Rule 5550(a)(2).
SNGX insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 0 filings. Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
No Form 4 stock transactions in this period.
Well-known investors holding SNGX (13F)
| Investor | Quarter | Shares | Reported value | % of their 13F | Change vs prior quarter |
|---|---|---|---|---|---|
| Citadel Advisors (Ken Griffin) | 2026-06-30 | 209,507 | $83.0K | 0.0% | New position |