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SOLIGENIX, INC.

For the period ended Sep 30, 2026. Filed Nov 6, 2026.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Sep 30, 2026 · Filed Nov 6, 2026

SNGX$0.34+0.5%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2026-06-30; filed 2026-08-07.

0001104659-26-092681

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2026-09-30; filed 2026-11-06.

0001104659-26-123855

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 169 previous paragraphs and 158 current paragraphs.

118 unchanged; 28 reworded; 7 added; 17 removed; 6 previous and 5 current paragraphs rearranged.

Tables are not compared: 34 previous and 33 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (7)

Current report

We record accruals for clinical trial and other research and development costs based on estimates of services received and efforts expended under contracts with contract research organizations, clinical sites and other vendors, using information such as patient enrollment, site activity and vendor reports. If actual costs differ from

Current report

our estimates, we adjust the accruals in the period in which the differences become known, including for wind-down costs associated with the terminated FLASH2 trial.

Current report

Interest income, net for the three months ended September 30, 2026 was $78,651 as compared to $52,351 for the same period in 2025, representing an increase of $26,300. The increase is attributed to higher cash balances during the three months ended September 30, 2026. Interest income, net of $193,638 for the nine months ended September 30, 2026, as compared to $198,202 for the same period in 2025, was relatively flat with a de minimis decrease of $4,564 attributable to decreasing interest rates.

Current report

We recognized a gain on extinguishment of vendor liabilities of $179,913 and $238,356 for the three and nine months ended September 30, 2026, respectively, resulting from the settlement of vendor liabilities for less than their carrying amounts.

Current report

At our 2026 Annual Meeting of Stockholders, our stockholders approved the grant to our Board of Directors of discretionary authority to implement a reverse stock split of our outstanding common stock at a ratio in the range of 1-for-2 to 1-for-20, which authority may be used to regain compliance with the minimum bid price requirement if the Board determines it to be in the best interests of the Company and its stockholders.

Current report

We intend to seek an additional 180-day compliance period if our common stock does not regain compliance with the minimum bid price requirement.
Removed paragraphs (17)

Previous report

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 in April 2026. In June 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 interest of our stockholders to terminate the HyBryte™ development program.

Previous report

HyBryte™ is a PDT that utilizes safe visible light for activation. The active ingredient in HyBryte™ is synthetic hypericin, a photosensitizer which is topically applied to skin lesions and then activated by visible fluorescent light 16 to 24 hours later.

Previous report

Based on the positive and previously published Phase 1/2 results, we initiated our Phase 3 clinical study of HyBryte™ for the treatment of CTCL during December 2015 and completed the trial in 2020. This trial, referred to as the “FLASH” (Fluorescent Light Activated Synthetic Hypericin) study, aimed to evaluate the response to HyBryte™ as a skin directed therapy to treat early-stage CTCL. We completed the study with approximately 35 CTCL centers across the U.S. participating in this trial. The Phase 3 protocol was a highly powered, double-blind, randomized, placebo-controlled, multicenter trial that enrolled 169 subjects (166 evaluable). The trial consisted of three treatment cycles, each of eight weeks duration. Treatments were administered twice weekly for the first six weeks and treatment response was determined at the end of the eighth week. In the first treatment cycle, approximately 66% of subjects received HyBryte™ and 33% received placebo treatment of their index lesions. In the second cycle, all subjects received HyBryte™ treatment of their index lesions, and in the third cycle, all subjects received HyBryte™ treatment of all of their lesions. The majority of subjects enrolled elected to continue into the third optional, open-label cycle of the study. Subjects were followed for an additional six months after their last evaluation visit. The primary efficacy endpoint was assessed on the percentage of patients in each of the two treatment groups (i.e., HyBryte™ and placebo) achieving a partial or complete response of the treated lesions, defined as a ≥ 50% reduction in the total Composite Assessment of Index Lesion Disease Severity (“CAILS”) score for three index lesions at the Cycle 1 evaluation visit (Week 8) compared to the total CAILS score at baseline. Secondary endpoints for the trial included the duration of responses, the extent of the regression of the tumors, and the safety of the treatment. We continue to work closely with the Cutaneous Lymphoma Foundation, as well as the National Organization for Rare Disorders.

Previous report

Over the course of 2020, the Phase 3 FLASH study data was announced. The study enrolled 169 patients (166 evaluable) randomized 2:1 to receive either HyBryte™ (116 patients) or placebo (50 patients) and demonstrated a statistically significant treatment response (p=0.04) in the CAILS primary endpoint assessment at 8 weeks for Cycle 1. A total of 16% of the patients receiving HyBryte™ achieved at least a 50% reduction in their index lesions compared to only 4% of patients in the placebo group at 8 weeks. HyBryte™ treatment in the first cycle was safe and well tolerated.

Previous report

Analysis of the second open-label treatment cycle (Cycle 2) showed that continued treatment with HyBryte™ twice weekly for an additional 6 weeks (12 weeks total) increased the positive response rate to 40% (p<0.0001 compared to placebo and p<0.0001 compared to 6-weeks treatment). The response rate in patients receiving a total of 12 weeks of treatment increased two and a half-fold. Treatment responses were assessed at Week 8 (after 6 weeks of treatment) and at Week 16 (after 12 weeks of treatment). A positive response was defined as an improvement of at least 50% in the CAILS score for the three index lesions evaluated in both Cycles 1 and 2. The data continued to indicate that HyBryte™ was safe and well tolerated.

Previous report

The optional third open-label treatment cycle (Cycle 3) focused on safety and all patients could elect to receive HyBryte™ treatment of all their lesions for an additional 6 weeks or up to 18 weeks in total. Of note, 66% of

Previous report

patients elected to continue with this optional safety cycle of the study. Of the subset of patients that received HyBryte™ throughout all three cycles of treatment (18 weeks), 49% of them demonstrated a treatment response (p=0.046 vs. patients completing 12 weeks of HyBryte™ treatment in Cycle 2; p<0.0001 vs. patients receiving placebo in Cycle 1). Moreover, in a subset of patients evaluated in this cycle, it was demonstrated that HyBryte™ is not systemically available, consistent with the general safety of this topical product observed to date. At the end of Cycle 3, HyBryte™ continued to be well tolerated despite extended and increased use of the product to treat multiple lesions.

Previous report

In addition, continued analysis of results from the protocol mandated efficacy cycles (Cycles 1 and 2) of the study revealed that 12 weeks of treatment (Cycle 2) with HyBryte™ is equally effective on both patch (response 37%, p=0.0009) and plaque (response 42%, p<0.0001) lesions when compared to Cycle 1 placebo lesion responses, further demonstrating the unique benefits of the more deeply penetrating visible light activation of hypericin.

Previous report

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 was designed as a randomized, double-blind, placebo-controlled, multicenter study treating approximately 80 subjects with early-stage CTCL, evaluating 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 were readily available for exposure to the visible light source were to be treated and three to five index lesions of each patient were prospectively identified and indexed for the modified composite assessment of index lesions severity (“mCAILS”) evaluation prior to randomization (baseline). The primary efficacy endpoint was 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 were to assess treatment response (including duration), degree of improvement, time to relapse and safety. Following treatment, all patients were 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. In June 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 interest of our stockholders to terminate the HyBryte™ development program.

Previous report

CTCL is a class of non-Hodgkin’s lymphoma (“NHL”), a type of cancer of the white blood cells that are an integral part of the immune system. CTCL is caused by an expansion of malignant T-cell lymphocytes (involved in cell-mediated immunity) normally programmed to migrate to the skin causing various lesions to appear that may change shape as the disease progresses, typically beginning as a rash and eventually forming plaques and tumors. Mycosis fungoides (“MF”) is the most common form of CTCL. It generally presents with skin involvement only, manifested as scaly, erythematous patches. Advanced disease with diffuse lymph node and visceral organ involvement is usually associated with a poorer response rate to standard therapies. A relatively uncommon sub-group of CTCL patients present with extensive skin involvement and circulating malignant cerebriform T-cells, referred to as Sézary syndrome. These patients have substantially graver prognoses (expected five-year survival rate of 24%), than those with MF (expected five-year survival rate of 88%).

Previous report

CTCL mortality is related to stage of disease, with median survival generally ranging from about 12 years in the early stages to only 2.5 years when the disease has advanced. There is currently no FDA-approved drug for front-line treatment of early-stage CTCL. Treatment of early-stage disease generally involves skin-directed therapies. One of the most common unapproved therapies used for early-stage disease is oral 5 or 8-methoxypsoralen (“Psoralen”) given with ultraviolet A (“UVA”) light, referred to as PUVA, which is approved

Previous report

for dermatological conditions such as disabling psoriasis not adequately responsive to other forms of therapy, idiopathic vitiligo and skin manifestations of CTCL in persons who have not been responsive to other forms of treatment. Psoralen is a mutagenic chemical that interferes with DNA causing mutations and other malignancies. Moreover, UVA is a carcinogenic light source that when combined with the Psoralen, results in serious adverse effects including secondary skin cancers; therefore, the FDA requires a Black Box warning for PUVA.

Previous report

CTCL constitutes a rare group of NHLs, occurring in about 4% of the more than 1.7 million individuals living with the disease in the United States and Europe (European Union and United Kingdom). It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of CTCL that it affects approximately 31,000 individuals in the U.S. (based on SEER data, with approximately 3,200 new cases seen annually) and approximately 38,000 individuals in Europe (based on ECIS prevalence estimates, with approximately 3,800 new cases annually). We estimate, based upon review of historic published studies and reports and an interpolation of data on the incidence of CTCL, that it affects over 20,000 individuals in the U.S., with approximately 2,800 new cases seen annually.

Previous report

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.

Previous report

Interest income, net for the three months ended June 30, 2026 was $53,598 as compared to $69,823 for the same period in 2025, representing a decrease of $16,225. The decrease is primarily associated with lower cash 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.
Reworded paragraphs (28)

Previous wording

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 were 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. In June 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 interest of our stockholders to terminate the HyBryte™ development program.

Current wording

We were 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. In June 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 interest of our stockholders to terminate the HyBryte™ development program, and we have undertaken an orderly wind-down of the FLASH2 trial and related activities.

Previous wording

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”)). 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

Current wording

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”)). The development of our vaccine programs incorporates

Previous wording

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

Current wording

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.

Previous wording

In June 2022, we received FDA IND clearance for our Phase 2a clinical trial (protocol number HPN-PSR-01) titled, "Phase 2 Study Evaluating SGX302 in the Treatment of Mild-to-Moderate Psoriasis." In December 2022, we initiated patient enrollment for the Phase 2a study (protocol number HPN-PSR-01) evaluating SGX302 in the treatment of mild-to-moderate psoriasis. The Phase 2a clinical trial (protocol number HPN-PSR-01) will target enrollment of up to 42 patients ages 18 years or older with mild to moderate, stable psoriasis covering 2 to 30% of the body. In both Parts A and B, all patients will apply the study drug twice per week and activate the drug with visible light 24 ± 6 hours later using the supplied visible light devices and according to the manufacturer's instructions. Patients will undergo treatments for a total of 18 weeks and, on completion, will be followed for a four-week follow-up period in which patients will not receive other psoriasis treatments. In Part A, five to ten patients will be assigned open-label SGX302 (0.25% hypericin) at the time of enrollment. Once the tolerability and response to SGX302 has been established, Part B of the protocol will commence. In Part B, patients will be randomized to double-blind treatment groups at a ratio 1:1 of active drug to placebo ointment. Active dermatologic assessment of treated lesions for adverse events will be performed immediately before and during light treatments. Patients will be assessed for overall disease status through four weeks of follow-up. Efficacy endpoints will include the extent of lesion clearance and patient reported quality of life indices. Routine safety data also will be collected.

Current wording

In June 2022, we received FDA IND clearance for our Phase 2a clinical trial (protocol number HPN-PSR-01) titled, "Phase 2 Study Evaluating SGX302 in the Treatment of Mild-to-Moderate Psoriasis." In December 2022, we initiated patient enrollment for the Phase 2a study (protocol number HPN-PSR-01) evaluating SGX302 in the treatment of mild-to-moderate psoriasis. The Phase 2a clinical trial (protocol number HPN-PSR-01) will target enrollment of up to 42 patients ages 18 years or older with mild to moderate, stable psoriasis covering 2 to 30% of the body. In both Parts A and B, all patients will apply the study drug twice per week and activate the drug with visible light 24 ± 6 hours later using the supplied visible light devices and according to the manufacturer's instructions. Patients will undergo treatments for a total of 18 weeks and, on completion, will be followed for a four-week follow-up period in which patients will not receive other psoriasis treatments. In Part A, five to ten patients will be assigned open-label SGX302 (0.25% hypericin) at the time of enrollment. Once the tolerability and response to SGX302 has been established, Part B of the protocol will commence. In Part B, patients will be randomized to double-blind treatment groups at a ratio 1:1 of active drug to placebo ointment. Active dermatologic assessment of treated lesions for adverse events will be performed immediately before

Previous wording

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.

Current wording

In April 2023, the United States Adopted Names 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.

Previous wording

Dusquetide has demonstrated efficacy in numerous animal disease models including mucositis, oncology, colitis, skin infection and other bacterial infections and has been evaluated in a double-blind, placebo-controlled Phase 1 clinical trial in 84 healthy volunteers with both single ascending dose and multiple ascending dose components. Dusquetide was shown to have a good safety profile and be well-tolerated in all dose groups when administered by IV over 7 days and was consistent with safety results seen in pre-clinical studies. We believe that market opportunities for dusquetide include, but are not limited to, oral and gastrointestinal mucositis, oncology (e.g., breast cancer), acute Gram-positive bacterial infections (e.g., methicillin resistant

Current wording

Dusquetide has demonstrated efficacy in numerous animal disease models including mucositis, oncology, colitis, skin infection and other bacterial infections and has been evaluated in a double-blind, placebo-controlled Phase 1 clinical trial in 84 healthy volunteers with both single ascending dose and multiple ascending dose components. Dusquetide was shown to have a good safety profile and be well-tolerated in all dose groups when administered by IV over 7 days and was consistent with safety results seen in pre-clinical studies. We believe that market opportunities for dusquetide include, but are not limited to, oral and gastrointestinal mucositis, oncology (e.g., breast cancer), acute Gram-positive bacterial infections (e.g., methicillin resistant Staphylococcus aureus), acute Gram-negative infections (e.g., acinetobacter, melioidosis), and acute radiation syndrome.

Previous wording

We estimate the potential worldwide market for SGX945 is in excess of $200 million for the treatment of aphthous ulcers in BD. This potential market information is a forward-looking statement, and investors are urged not to place undue reliance on this statement. While we have determined this potential market size based

Current wording

We estimate the potential worldwide market for SGX945 is in excess of $200 million for the treatment of aphthous ulcers in BD. This potential market information is a forward-looking statement, and investors are urged not to place undue reliance on this statement. While we have determined this potential market size based on assumptions that we believe are reasonable, there are a number of factors that could cause our expectations to change or not be realized.

Previous wording

Following analysis of the full dataset, including the 12-month long-term follow-up safety data in late 2021, we held a meeting with the MHRA to review the study results and to obtain further clarity on the future of the oral mucositis development program. The meeting was informative with the outcome being that based on the SGX942 biologic activity observed and the consistency in response between the Phase 2 and Phase 3 trials, the Phase 3 DOM-INNATE study could serve as the first of two Phase 3 studies required to support potential marketing authorization, assuming the second Phase 3 clinical trial achieves the required level of statistical significance in its primary endpoint. With the benefit of a robust preclinical and clinical data package for SGX942, we now will analyze the data to design a second Phase 3 study and will look to identify a potential partner(s) to continue this development program.

Current wording

Following analysis of the full dataset, including the 12-month long-term follow-up safety data in late 2021, we held a meeting with the MHRA to review the study results and to obtain further clarity on the future of the oral mucositis development program. The meeting was informative with the outcome being that based on the SGX942 biologic activity observed and the consistency in response between the Phase 2 and Phase 3 trials,

Previous wording

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.

Current wording

The value of ThermoVax® lies in its potential ability to eliminate the need for cold chain production, transportation, and 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.

Previous wording

In March 2020, we entered into a research collaboration with Axel Lehrer, PhD of the Department of Tropical Medicine, Medical Microbiology and Pharmacology, JABSOM, UH Manoa to further expand the filovirus collaboration to investigation of potential coronavirus vaccines, including for SARS-CoV-2 (causing COVID-19). This research collaboration will utilize the technology platform developed in the search for filovirus vaccines and will use well-defined surface glycoprotein(s) from one or more coronaviruses, which are expected to be protective for COVID-19.

Current wording

In March 2020, we entered into a research collaboration with Axel Lehrer, PhD of the Department of Tropical Medicine, Medical Microbiology and Pharmacology, JABSOM, UH Manoa to further expand the filovirus collaboration to investigation of potential coronavirus vaccines, including for SARS-CoV2 (causing COVID-19). This research collaboration will utilize the technology platform developed in the search for filovirus vaccines and will use well-defined surface glycoprotein(s) from one or more coronaviruses, which are expected to be protective for COVID-19.

Previous wording

During April 2020, we obtained an exclusive worldwide license for CoVaccine HT™, a novel vaccine adjuvant, from SERB Pharmaceuticals (formerly BTG Specialty Pharmaceuticals, a division of Boston Scientific Corporation) (“SERB”), for the fields of coronavirus infection (including SARS-CoV-2, the cause of COVID-19), and pandemic flu. CoVaccine HT™ is a novel adjuvant, which has been shown to enhance both cell-mediated and antibody-mediated immunity. We and our collaborators, including UH Manoa and Dr. Axel Lehrer, have successfully demonstrated the utility of CoVaccine HT™ in the development of our heat stable filovirus vaccine program, with vaccine candidates against EBOV and MARV disease. Given this previous success, CoVaccine HT™ will potentially be an important component of our vaccine technology platform currently being assessed for use against coronaviruses including SARS-CoV-2, the cause of COVID-19. The license agreement was executed between us and SERB, which owns the CoVaccine HT™ intellectual property.

Current wording

During April 2020, we obtained an exclusive worldwide license for CoVaccine HT™, a novel vaccine adjuvant, from SERB Pharmaceuticals (formerly BTG Specialty Pharmaceuticals, a division of Boston Scientific Corporation) (“SERB”), for the fields of coronavirus infection (including SARS-CoV2, the cause of COVID-19), and pandemic flu. CoVaccine HT™ is a novel adjuvant, which has been shown to enhance both cell-mediated and antibody-mediated immunity. We and our collaborators, including UH Manoa and Dr. Axel Lehrer, have successfully demonstrated the utility of CoVaccine HT™ in the development of our heat stable filovirus vaccine program, with vaccine candidates against EBOV and MARV disease. Given this previous success, CoVaccine HT™ will potentially be an important component of our vaccine technology platform currently being assessed for use against coronaviruses including SARS-CoV2, the cause of COVID-19. The license agreement was executed between us and SERB, which owns the CoVaccine HT™ intellectual property.

Previous wording

In September 2023, positive data demonstrated two-year stability of thermostabilized bivalent and trivalent filovirus vaccine candidates at temperatures of 40 degrees C (104 degrees F) when formulated in a single vial, needing reconstitution only with sterile water immediately prior to use. This important milestone is part of an ongoing collaboration with UH Manoa, demonstrating the successful presentation of one or more antigen(s) within the same formulation while maintaining full potency and thermostability. It further demonstrates the broad

Current wording

In September 2023, positive data demonstrated two-year stability of thermostabilized bivalent and trivalent filovirus vaccine candidates at temperatures of 40 degrees C (104 degrees F) when formulated in a single vial, needing reconstitution only with sterile water immediately prior to use. This important milestone is part of an ongoing collaboration with UH Manoa, demonstrating the successful presentation of one or more antigen(s) within the same formulation while maintaining full potency and thermostability. It further demonstrates the broad applicability of the heat stable vaccine platform, and its potential role in the U.S. government's initiative for pandemic preparedness.

Previous wording

As a vaccine for a neglected tropical disease, an FDA approved SUDV, 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).

Current wording

As a vaccine for a neglected tropical disease, an FDA approved SUDV, MARV, BDBV or combined vaccine has the potential to qualify for a tropical disease PRV.

Previous wording

RiVax® has been granted Orphan Drug designation as well as Fast Track designation by the FDA for the prevention of ricin intoxication. In addition, RiVax® has also been granted Orphan Drug designation in the European Union (“EU”) from the EMA Committee for Orphan Medical Products.

Current wording

RiVax® has been granted Orphan Drug designation as well as Fast Track designation by the FDA for the prevention of ricin intoxication. In addition, RiVax® has also been granted Orphan Drug designation in the European Union from the EMA Committee for Orphan Medical Products.

Previous wording

Our management’s discussion and analysis of our financial condition and results of operations are based upon the accompanying condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the U.S. (“GAAP”). The preparation of our financial statements and related disclosures requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, costs and expenses, and the disclosure of contingent assets and liabilities. Actual results may differ from these estimates under different assumptions or conditions.

Current wording

Our management’s discussion and analysis of our financial condition and results of operations are based upon the accompanying condensed consolidated financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles. The preparation of our financial statements and related disclosures requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, costs and expenses, and the disclosure of contingent assets and liabilities. Actual results may differ from these estimates under different assumptions or conditions.

Previous wording

Three and Six Months Ended June 30, 2026 Compared to June 30, 2025

Current wording

Three and Nine Months Ended September 30, 2026 Compared to September 30, 2025

Previous wording

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.

Current wording

For the three months ended September 30, 2026, we had a net loss of $1,117,525 as compared to a net loss of $2,530,947 for the same prior year period, representing decreased net loss of $1,413,422. 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 a gain on extinguishment of vendor liabilities. For the nine months ended September 30, 2026, we had a net loss of $5,929,844 as compared to a net loss of $8,184,191 for the same prior year period, representing decreased net loss of $2,254,347. 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, the completed Phase 2 study in BD, and a gain on extinguishment of vendor liabilities.

Previous wording

We had no revenue for the three and six months ended June 30, 2026 and 2025, respectively.

Current wording

We had no revenue for the three and nine months ended September 30, 2026 and 2025, respectively.

Previous wording

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.

Current wording

Research and development expenses were $357,012 for the three months ended September 30, 2026 as compared to $1,583,879 for the same period in 2025, representing a decrease of $1,226,867. 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 $3,113,403 for the nine months ended September 30, 2026 as compared to $5,202,573 for the same period in 2025, representing a decrease of $2,089,170. 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.

Previous wording

General and administrative expenses of $1,125,372 for the three months ended June 30, 2026, as compared to $1,086,865 for the same period in 2025, were relatively flat with a de minimis increase of $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.

Current wording

General and administrative expenses of $1,018,758 for the three months ended September 30, 2026, as compared to $996,604 for the same period in 2025, were relatively flat with a de minimis increase of $22,154. General and administrative expenses of $3,246,668 for the nine months ended September 30, 2026, as compared to $3,168,297 for the same period in 2025, were relatively flat with a de minimis increase of $78,371.

Previous wording

As of June 30, 2026, we had cash and cash equivalents of $9,811,141 as compared to $7,936,153 as of December 31, 2025, representing an increase of $1,874,988. As of June 30, 2026, we had working capital of $6,499,947 as compared to working capital of $5,149,732 as of December 31, 2025, representing an increase of $1,350,215. The increase in cash and cash equivalents was primarily related to cash 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 six months ended June 30, 2026.

Current wording

As of September 30, 2026, we had cash and cash equivalents of $9,023,510 as compared to $7,936,153 as of December 31, 2025, representing an increase of $1,087,357. As of September 30, 2026, we had working capital of $6,107,837 as compared to working capital of $5,149,732 as of December 31, 2025, representing an increase of $958,105. The increase in cash and cash equivalents was primarily related to cash 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 nine months ended September 30, 2026.

Previous wording

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.

Current wording

As of September 30, 2026, we sold approximately $6,234,000 of shares of common stock pursuant to the Rodman Sales Agreement under prior prospectus supplements and approximately $667,000 of shares of common stock pursuant to the Rodman Sales Agreement under the Current Prospectus Supplement for total gross sales of approximately $6,901,000. After deducting sales commissions and other fees of approximately $219,000, we received proceeds of approximately $6,682,000, before other offering costs. The amount by which these deductions exceed the 3% commission payable to Rodman under the Rodman Sales Agreement consists of other fees and not commissions. From October 1, 2026 through October 30, 2026, we did not issue any shares of common stock pursuant to the Rodman Sales Agreement. As of October 30, 2026, we have aggregate potential capacity of approximately $1.8 million remaining on our ATM facility under the Current Prospectus Supplement.

Previous wording

Under our budget and based upon our existing product development agreements and license agreements, we expect our total research and development expenditures for the next 12 months to be approximately $1.6 million, all of which relates to the Specialized BioTherapeutics business segment. We do not anticipate any contract and grant reimbursements revenue in the next 12 months to offset research and development expenses in the Specialized BioTherapeutics business segment.

Current wording

Under our budget and based upon our existing product development agreements and license agreements, we expect our total research and development expenditures for the next 12 months to be approximately $1.6 million, the substantial majority of which relates to the Specialized BioTherapeutics business segment. We do not anticipate any contract and grant reimbursements revenue in the next 12 months to offset research and development expenses in the Specialized BioTherapeutics business segment.

Previous wording

The table below details our costs for research and development by program for the six months ended June 30, 2026 and 2025:

Current wording

The table below details our costs for research and development by program for the nine months ended September 30, 2026 and 2025:

Previous wording

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 June 30, 2026, no other milestone or royalty payments have been paid or accrued.

Current wording

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 of HyBryte™ 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. Following the termination of the HyBryte™ development program in June 2026, the likelihood of this milestone being triggered has been substantially reduced; however, the obligation remains in effect. As of September 30, 2026, no other milestone or royalty payments have been paid or accrued.

Previous wording

Pursuant to an amendment in May 2025, our office lease has been extended through October 2028. The current monthly rent is $11,625 through October 2026 and increases to $11,883 in November 2026 and to $12,142 in November 2027 where it remains until expiration.

Current wording

Pursuant to an amendment in May 2025, our office lease has been extended through October 2028. The 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.

Previous wording

As previously disclosed, Richard C. Straube, MD, retired from his employment as our Chief Medical Officer and Senior Vice President effective August 12, 2025 and entered into a one-year consulting agreement (the “Consulting Agreement”), pursuant to which Dr. Straube served as our Consulting Chief Medical Officer effective August 16, 2025. Under the Consulting Agreement, Dr. Straube served as an independent contractor and received an hourly consulting fee of $1,000 per hour for up to ten hours per month of consulting work.

Current wording

As previously disclosed, Richard C. Straube, MD, retired from his employment as our Chief Medical Officer and Senior Vice President effective August 12, 2025 and entered into a one-year consulting agreement (the “Straube Consulting Agreement”), pursuant to which Dr. Straube served as our Consulting Chief Medical Officer effective August 16, 2025. Under the Straube Consulting Agreement, Dr. Straube served as an independent contractor and received an hourly consulting fee of $1,000 per hour for up to ten hours per month of consulting work.

Previous wording

On June 11, 2026, in connection with our decision to terminate the HyBryte™ development program, Dr. Straube ceased serving as our Consulting Chief Medical Officer. We have agreed that Dr. Straube will continue to be available to consult with us on an as-needed, hourly basis. In the interim, Dr. Straube’s responsibilities will be transitioned to Dr. Christopher Pullion, our Medical Director.

Current wording

On June 11, 2026, in connection with our decision to terminate the HyBryte™ development program, Dr. Straube ceased serving as our Consulting Chief Medical Officer, and his responsibilities were transitioned on an interim basis to Dr. Christopher Pullion, our Medical Director.
Rearranged current paragraphs (5)

Current report — wording carried from elsewhere

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).

Current report — wording carried from elsewhere

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.

Current report — wording carried from elsewhere

and during light treatments. Patients will be assessed for overall disease status through four weeks of follow-up. Efficacy endpoints will include the extent of lesion clearance and patient reported quality of life indices. Routine safety data also will be collected.

Current report — wording carried from elsewhere

the Phase 3 DOM-INNATE study could serve as the first of two Phase 3 studies required to support potential marketing authorization, assuming the second Phase 3 clinical trial achieves the required level of statistical significance in its primary endpoint. With the benefit of a robust preclinical and clinical data package for SGX942, we will consider designing a second Phase 3 study and will look to identify a potential partner(s) to continue this development program.

Current report — wording carried from elsewhere

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.
Rearranged previous paragraphs (6)

Previous report — wording carried elsewhere

and Infectious Diseases (“NIAID”), the Biomedical Advanced Research and Development Authority and the Defense Threat Reduction Agency.

Previous report — wording carried elsewhere

Staphylococcus aureus (“MRSA”)), acute Gram-negative infections (e.g., acinetobacter, melioidosis), and acute radiation syndrome.

Previous report — wording carried elsewhere

on assumptions that we believe are reasonable, there are a number of factors that could cause our expectations to change or not be realized.

Previous report — wording carried elsewhere

The value of ThermoVax® lies in its potential ability to eliminate the need for cold chain production, transportation, and 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

Previous report — wording carried elsewhere

applicability of the heat stable vaccine platform, and its potential role in the U.S. government's initiative for pandemic preparedness.

Previous report — wording carried elsewhere

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