Soligenix, Inc. (SNGX): Business Model Canvas [Dec-2025 Updated]

You're digging into the mechanics of a late-stage biopharma, Soligenix, Inc., whose business model is a fascinating mix of rare disease focus and heavy reliance on US Government funding, which is a key differentiator. Honestly, when you see their Q3 2025 cash position at about $10.5 million covering significant R&D costs like the $1.6 million spent that quarter, you realize the near-term success hinges on advancing their lead asset, HyBryte™, while managing those government contracts. This canvas breaks down exactly how they plan to transition from grant-funded R&D to future product sales, which they project could exceed $90 million annually for HyBryte™ post-approval; check out the nine building blocks that define their path from clinical trials to potential commercialization.

Soligenix, Inc. (SNGX) - Canvas Business Model: Key Partnerships

You're looking at the external relationships Soligenix, Inc. relies on to push its late-stage pipeline forward, especially given their current cash position. These aren't just vendor relationships; they are critical dependencies for clinical execution and non-dilutive funding.

US Government Agencies (NIAID, BARDA, DTRA) for Vaccine Funding

The Public Health Solutions segment, which includes vaccine candidates like RiVax®, is heavily reliant on government support. Soligenix, Inc. explicitly states that this business segment has been supported with grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agency (DTRA), and the Biomedical Advanced Research and Development Authority (BARDA). To give you a sense of the variability, Soligenix, Inc. reported revenues of only $0.1 million for the full year ended December 31, 2024, which they noted was impacted by the timing of government grant funding supporting SGX943 development. This highlights that non-dilutive funding is lumpy, not a steady revenue stream.

The company's strategy, as of late 2025, involves continuing to evaluate strategic options, including seeking additional government grants, even while holding approximately $10.5 million in cash as of September 30, 2025, which provides runway through 2026.

Daavlin for Exclusive Supply of the HyBryte™ Companion Light Device

For the Specialized BioTherapeutics segment, specifically the HyBryte™ photodynamic therapy for cutaneous T-cell lymphoma (CTCL), Soligenix, Inc. has an exclusive Supply, Distribution and Services Agreement with Daavlin. This partnership, signed back in January 2021, secures the light device component necessary for the therapy. While the initial agreement is in place, the financial terms regarding per-unit cost or volume commitments for 2025 aren't public, but the existence of this exclusive deal is integral to the commercialization strategy upon regulatory approval.

Clinical Research Organizations (CROs) Managing Global Trials

Advancing the HyBryte™ confirmatory Phase 3 FLASH2 study, which involves an enrollment of 80 patients, requires significant external support from third parties, which includes CROs and contract manufacturers. You can see this spending reflected directly in the operating expenses. For instance, Research and Development expenses were $1.6 million for the quarter ended September 30, 2025, an increase from $1.0 million in the same period in 2024, primarily due to costs associated with the Phase 3 CTCL trial and increases in third-party contract manufacturing. This trend of increased external trial spending was also evident earlier in the year; R&D expenses for Q1 2025 were $2.2 million.

Here's a quick look at the scale of R&D spending tied to these external clinical and manufacturing partners:

Period End Date	R&D Expenses (USD)	Primary Driver Mentioned
September 30, 2025 (Q3)	$1.6 million	Second confirmatory Phase 3 CTCL trial and third party contract manufacturing
June 30, 2025 (Q2)	$1.7 million	Phase 2a Behçet's Disease study, second confirmatory Phase 3 CTCL trial, and third party manufacturing
March 31, 2025 (Q1)	$2.2 million	Phase 2 Behçet's Disease study, second confirmatory Phase 3 CTCL trial, and third party manufacturing

Academic and Investigator-Initiated Study (IIS) Collaborators

Academic collaborations, often structured as Investigator-Initiated Studies (IIS), provide crucial, independent data validation. Soligenix, Inc. reported positive outcomes from an open-label, investigator-initiated study evaluating extended HyBryte™ treatment for up to 12 months in early-stage CTCL patients, announced in January 2025. The design of the ongoing confirmatory Phase 3 FLASH2 study also builds on a recent successful comparative study and an ongoing investigator-initiated study (protocol # RW-HPN-MF-01). These studies are key to de-risking the path to regulatory submission, even if they don't directly generate revenue.

• The HyBryte™ Phase 3 trial enrollment update was anticipated in 4Q2025.
• Interim efficacy analysis for the HyBryte™ Phase 3 study is targeted for 1H2026.
• The FDA previously supported a study with a $2.6 million Orphan Products Development Grant, illustrating the value of government-backed academic/investigator research.

Finance: draft 13-week cash view by Friday.

Soligenix, Inc. (SNGX) - Canvas Business Model: Key Activities

You're looking at the core engine driving Soligenix, Inc. (SNGX) right now-the hands-on work needed to push their late-stage assets toward the finish line and keep the pipeline moving. This is where the capital goes and where the near-term value inflection points are set.

Conducting confirmatory Phase 3 trial for HyBryte™ (SGX301) in CTCL

The primary focus is the confirmatory Phase 3 FLASH2 study for HyBryte™ in cutaneous T-cell lymphoma (CTCL). This is an 80 patient, double-blind, placebo-controlled trial. As of November 19, 2025, Soligenix, Inc. announced the completion of planned enrollment for the interim analysis, hitting 50 patients. The expected overall blinded study response rate for the trial design was 25% (based on a 40% response in the HyBryte™ arm versus 10% for placebo through 18 weeks). However, for patients who completed the treatment phase to date, the overall blinded study response rate observed was 48%. The first Data Monitoring Committee (DMC) meeting concluded on October 7, 2025, confirming no safety concerns with an acceptable safety profile. The planned interim analysis is scheduled for the second quarter of 2026, with topline results anticipated in the second half of 2026.

Key trial milestones include:

• Trial size: 80 patients total.
• Interim analysis enrollment reached: 50 patients as of November 19, 2025.
• Interim analysis date: Q2 2026.
• Topline results expected: H2 2026.

Research and development (R&D) for rare disease pipeline expansion

Soligenix, Inc. is actively managing R&D costs while advancing other rare disease candidates. Research and development expenses for the quarter ended September 30, 2025, totaled $1.6 million. For the six months ended June 30, 2025, R&D expenses surged to $3.6 million. The pipeline expansion efforts include moving SGX302 (synthetic hypericin) into psoriasis, with top-line results from the Phase 2a study anticipated in the second half of 2025. Furthermore, SGX945 (dusquetide) for Behçet's Disease saw its Phase 2a study costs reflected in R&D spending, and it received Orphan Drug Designation from the FDA on August 18, 2025.

Here's a look at the recent R&D expenditure:

Period End Date	Research and Development Expenses
September 30, 2025 (Q3)	$1.6 million
June 30, 2025 (Q2)	$1.7 million
Six Months Ended June 30, 2025	$3.6 million
Year Ended December 31, 2024	$5.2 million

Securing regulatory approvals (e.g., FDA, EMA) for lead candidates

Regulatory management involves navigating different requirements for the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). The EMA agreed on the design for the confirmatory Phase 3 FLASH2 study. HyBryte™ already holds Orphan Drug Designation from the FDA and Orphan Designation from the EMA. For U.S. approval, the FDA prefers a 'longer duration comparative study,' which presents a potential need for a distinct third Phase 3 trial. Successful completion of the second Phase 3 study is the prerequisite for seeking worldwide regulatory approvals.

Regulatory status highlights:

• HyBryte™: FDA Orphan Drug Designation; EMA Orphan Designation.
• SGX945: FDA Orphan Drug Designation for Behçet's Disease (granted August 18, 2025).
• EMA: Agreed on the FLASH2 protocol.

Managing government contracts for Public Health Solutions segment

The Public Health Solutions segment relies on non-dilutive government funding for its vaccine programs, including RiVax® (ricin toxin vaccine), filovirus vaccines, and CiVax™ (COVID-19 vaccine), leveraging the ThermoVax® platform. Funding sources include the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agency (DTRA), and the Biomedical Advanced Research and Development Authority (BARDA). Revenue from these sources is variable; for the year ended December 31, 2024, revenues were $0.1 million, down from $0.8 million the prior year, due to grant timing fluctuations. As of September 30, 2025, the company reported $10.5 million in cash, which management stated provides sufficient operating runway through 2026, while continuing to evaluate strategic options including government grants.

Government funding activity context:

• Funding agencies include NIAID, DTRA, and BARDA.
• Revenue for FY 2024 from grants/contracts: $0.1 million.
• Cash runway projected through 2026 based on $10.5 million cash on hand at September 30, 2025.

Finance: draft Q4 2025 cash flow projection by next Tuesday.

Soligenix, Inc. (SNGX) - Canvas Business Model: Key Resources

You're looking at the core assets Soligenix, Inc. (SNGX) is banking on as of late 2025. These are the tangible and intellectual properties that underpin their entire operation.

Financially, the company held cash and equivalents of approximately $10.53 million as of September 30, 2025. Honestly, management stated this cash position provides sufficient operating runway through 2026, which is a key near-term resource for funding ongoing trials.

The ThermoVax® heat stabilization platform technology for vaccines is a significant intangible asset. This proprietary method allows vaccines to be lyophilized (freeze-dried) and remain stable at ambient temperatures, specifically up to 40°C/104°F for extended periods. For instance, bivalent and trivalent ebolavirus vaccines stabilized with ThermoVax® retained full potency for two years under these conditions. This technology has supported vaccine development programs targeting filoviruses and SARS-CoV-2 (CiVax™).

The Specialized BioTherapeutics segment is anchored by the HyBryte™ asset. Here's a quick look at the pipeline resources:

Asset/Technology	Indication/Application	Development Stage/Key Metric
Proprietary HyBryte™ (SGX301)	Cutaneous T-cell Lymphoma (CTCL)	Confirmatory Phase 3 (FLASH2) study ongoing; Top-line results anticipated H2 2026.
HyBryte™ (SGX301) Investigator-Initiated Study	CTCL	Reported 75% treatment success rate after 18 weeks of continuous treatment.
SGX945 (Dusquetide)	Behçet's Disease	Received FDA Orphan Drug Designation; Phase 2a results reviewed.
ThermoVax® Platform	Vaccine Stabilization (e.g., Filovirus, CiVax™)	Enables stability at 40°C/104°F; Supported by funding from NIAID, DTRA, and BARDA.

The intellectual property estate is bolstered by specific regulatory advantages granted to its lead candidates:

• Orphan Drug Designation for HyBryte™ (SGX301) from the FDA and EMA.
• Fast Track designation from the FDA for HyBryte™ (SGX301).
• Orphan Drug Designation for SGX945 (dusquetide) for Behçet's Disease from the FDA, providing seven years of U.S. market exclusivity upon approval.

The HyBryte™ asset, which is synthetic hypericin sodium, is a novel photodynamic therapy using safe visible light for activation. The confirmatory Phase 3 FLASH2 study is designed to satisfy remaining requirements for a global submission package. The first Data Monitoring Committee review for FLASH2 confirmed no safety concerns, maintaining a consistent safety profile across trials.

For SGX945, the Orphan Drug Designation is significant because Behçet's Disease affects up to 18,000 people in the U.S. Dusquetide, the active ingredient, is classified as an innate defense regulator (IDR) peptide. The company is also developing SGX942, which uses the same IDR technology, for oral mucositis in head and neck cancer.

Soligenix, Inc. (SNGX) - Canvas Business Model: Value Propositions

You're looking at the core things Soligenix, Inc. offers that solve customer problems or create gains for them. For a late-stage biopharma company like Soligenix, Inc., the value is tied directly to the clinical and regulatory progress of its pipeline assets, which is where the numbers really matter.

Novel, non-invasive photodynamic therapy (HyBryte™) for early-stage CTCL

The primary value here is offering a treatment for early-stage Cutaneous T-Cell Lymphoma (CTCL) that is non-invasive. This therapy, HyBryte™ (synthetic hypericin), is in a confirmatory Phase 3 study, known as FLASH2, which is designed to enroll approximately $\mathbf{80}$ subjects. Soligenix, Inc. announced in November $\mathbf{2025}$ that they completed the planned enrollment of $\mathbf{50}$ patients needed for the interim analysis. The company anticipates providing top-line results in the second half of $\mathbf{2026}$.

The clinical data supports the value proposition:

• Response rate of $\mathbf{75\%}$ after $\mathbf{18}$ weeks in an ongoing investigator-initiated study.
• The FLASH2 study's current overall blinded study response rate is $\mathbf{48\%}$ to date.
• The study design is based on an anticipated overall blinded study response rate of $\mathbf{25\%}$ (based on $\mathbf{40\%}$ in the HyBryte™ arm versus $\mathbf{10\%}$ in the placebo arm through $\mathbf{18}$ weeks).
• The previous Phase 3 FLASH trial enrolled $\mathbf{169}$ patients ($\mathbf{166}$ evaluable).

Safe, visible light treatment with a favorable safety profile

The safety profile is a key differentiator, especially for a rare disease therapy. The value is confirmed by regulatory committee review. Soligenix, Inc. announced in October $\mathbf{2025}$ that the first Data Monitoring Committee (DMC) meeting for the confirmatory Phase 3 FLASH2 study concluded there were $\mathbf{no}$ safety concerns, with HyBryte™ demonstrating an acceptable safety profile consistent with all prior clinical studies. Furthermore, $\mathbf{66\%}$ of patients elected to continue with the optional third treatment cycle focused on safety/compassionate use in the prior trial structure. The treatment utilizes $\mathbf{safe}$ visible light, which is a core component of its non-invasive nature.

Heat-stable vaccines (RiVax®, CiVax™) for biodefense and emerging infectious diseases

The value proposition for the Public Health Solutions segment centers on the proprietary ThermoVax® platform, which imparts heat stability, reducing the need for cold-chain logistics. This segment is supported by government grant and contract funding from the National Institute. The pipeline includes RiVax®, the ricin toxin vaccine candidate, and CiVax™, the vaccine candidate for COVID-19 (SARS-CoV-2). In March $\mathbf{2025}$, Soligenix, Inc. announced a publication describing the preclinical efficacy of CiVax™. Also, in September $\mathbf{2025}$, a publication detailed the extended stability of ebolavirus vaccines using the ThermoVax® platform.

First-in-class innate defense regulator (IDR) technology (SGX945) for inflammatory diseases

This technology targets inflammatory diseases with first-in-class potential. The company has multiple IDR candidates in development, including SGX945 for Behçet's Disease, SGX942 for oral mucositis in head and neck cancer, and SGX302 for mild-to-moderate psoriasis. The value for SGX945 was bolstered in August $\mathbf{2025}$ when the FDA granted it Orphan Drug designation for Behçet's Disease following positive Phase 2a results. The company also announced that SGX945 provides $\mathbf{7}$ years of U.S. Market Exclusivity upon FDA Approval. Top-line results for SGX945 (Behçet's) and SGX302 (psoriasis) were anticipated in the second half of $\mathbf{2025}$ (as per the March $\mathbf{2025}$ update).

Here's a quick look at the financial context underpinning these development values as of late $\mathbf{2025}$:

Metric	Value/Date	Context
Cash Position (as of Sept 30, 2025)	\$10.5 million	Sufficient operating runway through 2026.
R&D Expenses (Q3 2025)	\$1.6 million	Compared to \$1.0 million in Q3 2024.
R&D Expenses (6 Months Ended June 30, 2025)	\$3.6 million	A 130% year-over-year surge.
Net Loss (Q3 2025)	\$2.5 million (or (\$0.58) per share)	Compared to \$1.7 million in Q3 2024.
HyBryte™ Phase 3 Trial Size (FLASH2)	80 subjects	Interim analysis planned after 50 patients enrolled.

The company's ability to fund these value-driving milestones is currently supported by that $\mathbf{\$10.5}$ million cash balance as of September $\mathbf{30}$, $\mathbf{2025}$.

Soligenix, Inc. (SNGX) - Canvas Business Model: Customer Relationships

You're developing therapies for rare diseases, so your customer relationships aren't about mass-market acquisition; they're about deep, specialized engagement with very specific patient populations and the experts who treat them. For Soligenix, Inc. (SNGX), this means a high-touch, almost personal approach to clinical development and future commercialization.

High-touch support for rare disease patient communities

Soligenix, Inc. focuses on rare diseases, where the patient community is small but highly engaged, especially since over 30 million Americans are affected by a rare disease, according to the National Institutes of Health. The relationship here is built on providing hope where there's an unmet medical need, particularly for conditions like cutaneous T-cell lymphoma (CTCL). The company's lead asset, HyBryte™, is positioned to potentially be the first FDA-approved photodynamic therapy for CTCL. This requires close coordination with the few centers treating these patients.

The ongoing investigator-initiated study (IIS) for HyBryte™ at the University of Pennsylvania, supported by an FDA Orphan Products Development grant totaling $2.6 million over four years, serves as a key touchpoint, demonstrating real-world use and gathering extended patient data up to 54 weeks. The early success seen in this study, with a 75% 'Treatment Success' rate after 18 weeks, directly informs and validates the relationship with the patient advocates and treating physicians.

Here's a snapshot of the clinical relationship data supporting the HyBryte™ development:

Metric	Value/Status	Context/Timeframe
Total FLASH2 Trial Patients	80	Confirmatory Phase 3 Trial
Patients Enrolled for Interim Analysis	50	Completed November 19, 2025
Anticipated Blinded Response Rate (Placebo Arm)	10%	Design Assumption
Observed Overall Blinded Response Rate (to date)	48%	In FLASH2 Trial
IIS Treatment Success Rate	75%	At 18 Weeks of Continuous Treatment
Expected Peak U.S. Annual Sales (HyBryte™ Estimate)	Exceeding $90 million	Future Commercialization

Direct engagement with key opinion leaders (KOLs) and Medical Advisory Boards

Engaging KOLs is critical for clinical strategy and future adoption. Soligenix, Inc. actively manages its advisory structure to guide development, especially for its rare disease assets.

• The United States (U.S.) Medical Advisory Board (MAB) for CTCL was updated on October 14, 2025.
• The European Medical Advisory Board for CTCL was expanded on September 30, 2025, in preparation for European health authority interactions.
• Dr. Ellen Kim, MD, a leading enroller in the prior FLASH study, serves as the Principal Investigator for the confirmatory Phase 3 FLASH2 study.
• The company also appointed former White House Economic Adviser Tomas J. Philipson, PhD, as a Strategic Advisor on September 23, 2025, to contribute business and government affairs expertise.

Formal contract management with US government agencies

Government funding and contracts form a key, non-dilutive relationship for Soligenix, Inc., particularly for its vaccine platform technology, ThermoVax®. This funding helps offset Research and Development expenses, which were $1.6 million for the quarter ended September 30, 2025.

The company's vaccine business segment has received grant and contract funding from several key agencies:

• National Institute of Allergy and Infectious Diseases (NIAID)
• Defense Threat Reduction Agency (DTRA)
• Biomedical Advanced Research and Development Authority (BARDA)

Revenue from government grants and contracts supporting development for SGX943, CiVax™, and HyBryte™ was $0.8 million for the year ended December 31, 2024. The cash runway, supported by these efforts and a recent offering, is expected to extend through 2026, with approximately $10.5 million in cash as of September 30, 2025.

Clinical trial site management and investigator relations

Managing the relationship with clinical trial sites is central to hitting key development timelines. The successful completion of enrollment for the 80-patient FLASH2 trial on November 19, 2025, is a direct measure of effective site management. The interim efficacy analysis for this trial is targeted for the first half of 2026, with topline results anticipated in the second half of 2026.

For the SGX945 program (dusquetide) for Behçet's Disease, the company achieved the study objective of demonstrating biological efficacy in its Phase 2a proof of concept study, announced on July 31, 2025. Furthermore, SGX945 received Orphan Drug Designation from the FDA on August 18, 2025, a direct result of positive investigator data and subsequent regulatory interaction.

Finance: review Q4 2025 cash burn projection against the $10.5 million cash on hand as of September 30, 2025, by next Tuesday.

Soligenix, Inc. (SNGX) - Canvas Business Model: Channels

You're looking at how Soligenix, Inc. (SNGX) plans to get its specialized therapies and vaccines to the people who need them, which is a critical step as they move closer to potential approvals. Since a dedicated commercial infrastructure isn't fully built out yet, the channels rely on partnerships and existing government frameworks.

Specialized direct sales force (planned post-approval for HyBryte™)

A specialized direct sales force for HyBryte™ (SGX301) is definitely planned, but it's contingent on receiving regulatory approvals following the completion of the confirmatory Phase 3 FLASH2 study. Right now, the company is focused on hitting that next clinical milestone, which is an enrollment update later this year, with top-line results anticipated in the second half of 2026. To fund the operations leading up to and through this period, Soligenix, Inc. reported approximately $10.5 million in cash as of September 30, 2025, which provides an operating runway through 2026. They are actively evaluating strategic options, including partnerships, to better position for this commercial launch phase. Honestly, until approval is secured, the sales channel remains theoretical, but the market potential is clear.

Here's a quick look at the market opportunity that this planned sales force would target:

Metric	Value/Estimate (Late 2025)
Peak U.S. Annual Sales Projection (HyBryte™)	Exceed $90 million
Total Addressable Worldwide CTCL Market	Greater than $250 million annually
Total Pipeline Global Opportunities Projection	Surpassing $2 billion

Daavlin's established phototherapy distribution network for the light device

For HyBryte™, which is a photodynamic therapy, the light device is a necessary companion product. Soligenix, Inc. secured this channel via an exclusive Supply, Distribution and Services Agreement with Daavlin, signed back in January 2021. Daavlin brings a significant existing footprint to the table, boasting a 40-year history of innovation in phototherapy. They use an extensive line of products and services to reach health care providers and patients globally for treating photoresponsive skin disorders. This existing network is integral to the regulatory and commercial strategy for SGX301, meaning Soligenix, Inc. doesn't have to build the hardware distribution from scratch.

Government procurement channels (e.g., Strategic National Stockpile) for vaccines

The Public Health Solutions business segment, which includes vaccine candidates like RiVax® (ricin toxin), filovirus, and CiVax™ (COVID-19), leverages established government funding and procurement pathways. This segment has historically been supported by non-dilutive government grants and contract funding. You can expect these channels to be key for future procurement, potentially including the Strategic National Stockpile (SNS), based on past support from these agencies:

• National Institute of Allergy and Infectious Diseases (NIAID)
• Defense Threat Reduction Agency (DTRA)
• Biomedical Advanced Research and Development Authority (BARDA)

The use of the ThermoVax® heat stabilization platform is a major factor supporting this government interest, as it addresses stability concerns for these countermeasures.

Clinical trial sites for current product access

While not a commercial channel in the traditional sense, clinical trial sites are the current access point for patients to receive investigational products like HyBryte™. These sites are crucial for generating the data needed for future market access. The ongoing investigator-initiated study (IIS) for extended HyBryte™ treatment is sponsored by a leading center in the field.

• Investigator-Initiated Study (IIS) Principal Investigator: Ellen Kim, MD, at the Hospital of the University of Pennsylvania.
• Confirmatory Phase 3 FLASH2 trial enrollment: The study is designed for 80 patients.
• Interim analysis trigger: Enrollment completion of 50 patients was announced on November 19, 2025.

These sites are where the real-world performance data, like the 75% success rate at 18 weeks seen in the IIS, is being generated. Finance: draft 13-week cash view by Friday.

Soligenix, Inc. (SNGX) - Canvas Business Model: Customer Segments

You're looking at the specific groups Soligenix, Inc. targets with its specialized biotherapeutics and public health solutions as of late 2025. This isn't about the whole market; it's about the precise patient and institutional groups driving their current strategy.

Patients with Rare Dermatologic Cancers, Specifically Early-Stage CTCL

This segment is the primary focus for HyBryte™ (SGX301). The customer base is defined by the clinical trial enrollment targets and demonstrated efficacy in prior studies. The ongoing confirmatory Phase 3 FLASH2 study is enrolling approximately 80 patients with early-stage cutaneous T-cell lymphoma (CTCL). The preceding Phase 3 FLASH trial evaluated 169 patients. Data from an investigator-initiated study (IIS) shows strong response rates, with over 80% (5/6) of patients achieving treatment success after 18 weeks of therapy in that trial. This IIS is supported by a $2.6 million grant from the FDA.

Dermatologists and Oncologists Who Treat CTCL Patients

These are the prescribers and clinical decision-makers. They are influenced by the speed and depth of response seen in trials. For example, the Phase 3 FLASH study showed over 70% of patients achieving treatment success. The company actively updates its U.S. Medical Advisory Board (MAB) for CTCL to provide strategic guidance as they advance the Phase 3 development.

US Government and Biodefense Agencies (NIAID, BARDA, DTRA)

This segment funds the Public Health Solutions business, specifically vaccine candidates like RiVax™. This funding stream is critical, as the company reported approximately $10.5 million in cash as of September 30, 2025, which provides operating runway through 2026, partly supported by these non-dilutive sources. Past government support is substantial:

• The GI ARS program has been supported by contract awards from BARDA and NIAID totaling approximately $33 million.
• Exercised funds for the GI ARS program include $7 million from NIAID and $11 million from BARDA.
• A past NIAID contract for RiVax™ development was valued up to $24.7 million.

Patients with Other Rare Inflammatory Diseases (e.g., Behçet's Disease)

This segment is targeted by SGX945 (dusquetide). Behçet's Disease (BD) is an orphan disease with an estimated global market value of $200 million. The patient population includes approximately 18,000 known cases in the U.S. and 50,000 in Europe, with as many as 1 million people worldwide living with BD. Soligenix, Inc. completed a Phase 2a proof-of-concept clinical trial for SGX945 in BD, expecting top-line results in Q3 2025. The active ingredient received Orphan Drug Designation from the FDA in August 2025.

Here's a quick look at the market context for these rare disease segments:

Disease/Product Focus	Metric Type	Value/Amount
CTCL (HyBryte™)	FLASH2 Trial Enrollment	80 Patients
CTCL (HyBryte™)	FLASH Trial Evaluated Patients	166 Patients
Behçet's Disease (SGX945)	Estimated Global Market Value	$200 million
Behçet's Disease (SGX945)	Estimated US Cases	18,000 Cases
Behçet's Disease (SGX945)	Estimated Worldwide Cases	1 million People
Biodefense (OrbeShield™)	Exercised BARDA Funding (to date)	$11 million
Company Financials (As of Q3 2025)	Cash Position	$10.5 million

The R&D expenses for Q3 2025 were $1.6 million, primarily due to costs associated with the second confirmatory Phase 3 CTCL trial. The net loss for that quarter was $2.53 million.

Soligenix, Inc. (SNGX) - Canvas Business Model: Cost Structure

You're looking at the cost side of Soligenix, Inc.'s operations as of late 2025. For a late-stage biopharma company, the cost structure is heavily weighted toward getting that late-stage asset across the finish line. Honestly, the burn rate is what you need to watch most closely.

The biggest driver of expenditure is definitely Research and Development (R&D). For the quarter ended September 30, 2025, Soligenix, Inc. reported R&D expenses totaling $1.6 million. This was up from $1.0 million in the same period in 2024. That increase tells you the clinical engine is running hot, which is expected when you're in a confirmatory Phase 3 trial.

Here's a quick look at the key operating expenses for that third quarter:

Expense Category	Q3 2025 Amount (USD)	Context
Research and Development (R&D)	$1.6 million	Driven by Phase 3 CTCL trial and manufacturing
General and Administrative (G&A)	$1.0 million	Overhead, professional expenses
Total Operating Expenses	$2.58 million	Sum of R&D and G&A plus other minor costs

The R&D spend isn't just lab work; it directly reflects significant external commitments. The increase in R&D was primarily due to costs associated with the second confirmatory Phase 3 CTCL trial, which is a major cash outlay, and increases in third-party contract manufacturing needed for trial supply.

Your cost structure components are pretty standard for this stage, but they are all tied to the pipeline's progress. You can expect these costs to remain high until key data readouts.

• High Research and Development (R&D) expenses, totaling $1.6 million in Q3 2025.
• Significant costs for third-party contract manufacturing and clinical trial operations, specifically the Phase 3 CTCL study.
• General and administrative (G&A) overhead, approximately $1.0 million in Q3 2025.
• Ongoing regulatory filing and intellectual property maintenance costs are baked into the operating expenses, though not itemized separately in the top-line figures.

Remember, with approximately $10.5 million in cash at September 30, 2025, the company is funding these costs from its balance sheet, projecting runway through 2026. That runway is directly dependent on keeping these operating expenses in check relative to the cash position.

Finance: draft 13-week cash view by Friday.

Soligenix, Inc. (SNGX) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Soligenix, Inc. (SNGX) as of late 2025, and honestly, it's a story of non-commercial revenue funding development right now, with big potential on the horizon. The current financial reality shows that product sales aren't the income driver yet.

Government grants and contracts for vaccine development are the primary current source supporting a segment of the business. This funding has historically come from several key U.S. government entities. Soligenix, Inc. has received government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agency (DTRA), and the Biomedical Advanced Research and Development Authority (BARDA) to support its vaccine programs. To be fair, the company reported no revenue for the quarter ended September 30, 2025, and annual revenue for the fiscal year ended December 31, 2024, was only $0.1 million.

Future product sales of HyBryte™ (SGX301) post-regulatory approval represent the major commercial upside. The company expects peak annual net sales of HyBryte™ in the U.S. to exceed $90 million. This is based on the ongoing development of HyBryte™ for cutaneous T-cell lymphoma (CTCL), where top-line results from the confirmatory Phase 3 study are anticipated in the second half of 2026.

Potential licensing or partnership fees from strategic transactions are a critical component of the near-term financial strategy, especially given the current cash position. As of September 30, 2025, Soligenix, Inc. held approximately $10.5 million in cash, which provides an operating runway through 2026. The company explicitly continues to evaluate all strategic options, including partnership and merger and acquisition opportunities, to advance its late-stage pipeline.

The potential value of the pipeline drives the expected future revenue streams from both product sales and potential deals. Here's a quick look at the market opportunities that underpin these projections:

Product/Indication	Estimated Worldwide Annual Market Opportunity
HyBryte™ (CTCL)	Greater than $250 million
SGX302 (Psoriasis)	Estimated to exceed $1 billion annually
SGX945 (Behçet's Disease)	Approximately $200 million annually
Total Pipeline Potential	Over $2 billion

The revenue structure is clearly weighted toward future commercialization, but the current funding mechanism relies on non-dilutive government support and cash management. You can see the focus on hitting those upcoming milestones:

• HyBryte™ (SGX301) confirmatory Phase 3 enrollment update expected in late 2025.
• Top-line Phase 2a results for SGX302 in psoriasis before year-end 2025.
• Phase 2a proof of concept results for SGX945 in Behçet's Disease in 3Q 2025.

If onboarding takes longer than anticipated for the Phase 3 trial, the timing for the $90 million peak sales projection definitely shifts. Finance: draft 13-week cash view by Friday.