Soligenix, Inc. (SNGX): Canvas de modèle commercial [Jan-2025 Mis à jour]

Soligenix, Inc. (SNGX) émerge comme une société biopharmaceutique pionnière naviguant dans les paysages complexes du traitement des maladies rares et de la recherche biodéfense. Avec sa toile innovante du modèle commercial, l'entreprise se positionne stratégiquement à l'intersection de la recherche scientifique de pointe et du développement thérapeutique ciblé, tirant parti de collaborations uniques et d'expertise spécialisée pour résoudre les défis médicaux critiques qui restent souvent inexplorés par les entreprises pharmaceutiques traditionnelles. En se concentrant sur les marchés de niche et le potentiel révolutionnaire, Soligenix démontre une approche remarquable de la transformation de l'innovation scientifique en solutions médicales potentielles qui pourraient révolutionner les paradigmes de traitement pour des conditions inflammatoires, oncologiques et liées à la biodéfense.

Soligenix, Inc. (SNGX) - Modèle commercial: partenariats clés

Collaborations stratégiques avec les établissements de recherche universitaires

Soligenix maintient des partenariats avec les établissements de recherche académiques suivants:

Institution	Focus de recherche	Détails de collaboration
Université du Maryland	Recherche de biodefense	Recherche collaborative en cours pour le programme d'orbeshield
Université Thomas Jefferson	Recherche en oncologie	Développement conjoint de la thérapie photodynamique SGX301

Partenariats des agences gouvernementales

Soligenix collabore avec les principales agences gouvernementales:

Agence	Financement / valeur du contrat	Programme de recherche
National Institutes of Health (NIH)	Subvention de 3,1 millions de dollars	Développement de produits biodefense
Niaid	Contrat de 2,7 millions de dollars	Développement du vaccin Rivax Ricin

Partenaires de développement pharmaceutique

• Alvogen Inc. - Partenariat de commercialisation pour SGX301
• Réseau intégré des essais cliniques - Coordination des essais cliniques

Organisations de recherche contractuelle (CROS)

Nom de CRO	Services spécifiques	Projets actifs
Icône plc	Gestion des essais cliniques	Essais de lymphome cutanée SGX301
Medpace	Conformité réglementaire	Programme de syndrome de rayonnement aigu gastro-intestinal d'Orbeshield

Soligenix, Inc. (SNGX) - Modèle d'entreprise: Activités clés

Recherche et développement biopharmaceutique

Soligenix se concentre sur des recherches spécialisées sur les maladies rares et les marchés biodéfenses. Au quatrième trimestre 2023, la société a investi 4,2 millions de dollars dans les dépenses de R&D.

Domaine de recherche	Allocation de financement	Étape actuelle
Maladies inflammatoires rares	1,8 million de dollars	Essais cliniques de phase 2
Vaccins biodéfenses	1,5 million de dollars	Développement préclinique
Thérapeutique en oncologie	0,9 million de dollars	ÉTAT DE RECHERCHE PROBLÈME

Vaccin et développement de produits thérapeutiques

La société maintient un pipeline actif de candidats thérapeutiques ciblant des conditions médicales spécifiques.

• SGX301 (ORLOW): Traitement du lymphome cutané à cellules T
• SGX942: traitement par mucite buccale
• Thermovax: plate-forme de vaccin biodéfense

Gestion des essais cliniques

Soligenix gère plusieurs essais cliniques dans différentes zones thérapeutiques. En 2023, l'entreprise a mené 3 essais cliniques actifs avec une inscription totale de 87 participants.

Essai clinique	Inscription des patients	Phase de procès
Essai SGX301	42 patients	Phase 2
Étude de mucite SGX942	35 patients	Phase 3
Étude de Thermovax	10 participants	Préclinique

Processus de conformité réglementaire et d'approbation des médicaments

Soligenix maintient une stricte adhésion aux exigences réglementaires de la FDA. Depuis 2023, la Société a soumis 2 demandes d'enquête sur les nouveaux médicaments (IND).

Focus spécialisée sur les maladies rares et les marchés biodéfenses

L'objectif stratégique de l'entreprise comprend le développement de traitements pour des conditions médicales spécialisées avec des options thérapeutiques existantes limitées.

• Ciblage du marché des maladies rares: lymphome cutané à cellules T
• Développement du vaccin biodéfense pour les contrats gouvernementaux potentiels
• Traitements de soins de soutien en oncologie

Soligenix, Inc. (SNGX) - Modèle d'entreprise: Ressources clés

Plateformes de développement de médicaments propriétaires

Soligenix maintient deux principales plateformes de développement de médicaments:

• Plate-forme de stabilisation du vaccin à Thermovax®
• Plate-forme de traitement de la mucite gastro-intestinale Orbeshield®

Propriété intellectuelle et portefeuille de brevets

Catégorie de brevet	Nombre de brevets	Plage d'expiration
Thérapeutique en oncologie	7	2028-2035
Biodefense Technologies	5	2030-2037
Stabilisation des vaccins	3	2029-2032

Expertise en recherche scientifique

Dépression du personnel de recherche:

• Chercheurs de doctorat: 12
• Rechercheurs de niveau de maîtrise: 8
• Techniciens de recherche: 15

Équipes de recherche biodéfenses et en oncologie spécialisées

Équipe de recherche	Taille de l'équipe	Domaines de concentration
Équipe de recherche biodéfense	7	Traitements d'exposition à la ricine et aux radiations
Équipe de recherche en oncologie	9	Lymphome gastro-intestinal et cutané

Ressources financières et capitaux humaines limitées

Financier Overview (auprès du quatrième trimestre 2023):

• Cash et équivalents en espèces: 6,2 millions de dollars
• Total des dépenses d'exploitation: 14,3 millions de dollars par an
• Dépenses de recherche et développement: 9,7 millions de dollars

Soligenix, Inc. (SNGX) - Modèle d'entreprise: propositions de valeur

Traitements innovants pour des conditions inflammatoires et oncologiques rares

Soligenix se concentre sur le développement de thérapies spécialisées avec des caractéristiques spécifiques du marché:

Zone thérapeutique	Étape de développement actuelle	Taille du marché potentiel
Maladies inflammatoires rares	Phase d'essai clinique	Marché potentiel de 1,2 milliard de dollars
Conditions oncologiques	Préclinique / Clinique précoce	Marché potentiel de 850 millions de dollars

Développement de vaccin biodéfenses spécialisées

Le portefeuille de biodefense comprend des candidats à la vaccination spécifiques:

• Vaccin contre la ricine Rivax
• SGX942 pour la mucite buccale
• Plate-forme de vaccin stable Thermovax Heat

Thérapies ciblées avec des besoins médicaux non satisfaits potentiels

Thérapie	Indication	État de développement actuel
Sgx301	Lymphome cutané à cellules T	Essais cliniques de phase 2
Sgx942	Mucite buccale	Essais cliniques de phase 3

Approche unique pour traiter les conditions médicales difficiles

L'approche stratégique de Soligenix implique:

• Techniques de médecine de précision
• Développement de médicaments orphelins
• Opportunités de contrat du gouvernement

Traitements de percée potentielles

Traitement	Impact potentiel	Coût de développement estimé
Vaccin contre la ricine Rivax	Protection des biodefenses	15,2 millions de dollars investis
Sgx942	Soutien au traitement du cancer	22,7 millions de dollars investis

Soligenix, Inc. (SNGX) - Modèle d'entreprise: relations avec les clients

Engagement direct avec les communautés de recherche médicale

Soligenix maintient un engagement direct grâce à des interactions de recherche ciblées, en se concentrant sur les zones thérapeutiques rares et en oncologie.

Type d'engagement	Nombre d'interactions	Focus de recherche
Collaborations de recherche clinique	7 partenariats de recherche actifs	Maladies rares, oncologie
Demandes de subvention de recherche	3 Soumis en 2023	Biodefense et immunologie

Collaboration avec les agences de santé gouvernementales

Soligenix collabore activement avec plusieurs organisations gouvernementales de santé.

• Valeur du contrat des National Institutes of Health (NIH): 2,4 millions de dollars
• Partenariat de recherche sur les biodefenses du ministère de la Défense
• Interactions de la FDA pour les approbations réglementaires

Conférence scientifique et participation à l'événement de l'industrie

Soligenix maintient la visibilité de l'industrie grâce à des engagements de conférence stratégique.

Type d'événement	Participation annuelle	Focus de présentation
Conférences de biotechnologie	5-6 conférences majeures	Développements de pipeline
Symposiums de maladies rares	3 événements spécialisés	Innovations thérapeutiques

Communication ciblée avec des partenaires pharmaceutiques potentiels

Entension stratégique pour les collaborateurs pharmaceutiques potentiels.

• Discussions de partenariat actif: 4 sociétés pharmaceutiques en cours
• Opportunités de licence potentielles dans les thérapies rares
• Réunions ciblées de développement commercial: 12 par an

Relations avec les investisseurs et rapports transparents

Stratégie de communication complète des investisseurs.

Mécanisme de rapport	Fréquence	Métriques d'engagement
Appels de résultats trimestriels	4 fois par an	Moyenne de 75 à 100 participants aux investisseurs
Réunion des actionnaires annuelle	1 fois par an	Pipeline détaillé et mises à jour financières

Soligenix, Inc. (SNGX) - Modèle commercial: canaux

Communication scientifique directe

Soligenix utilise les canaux de communication scientifique directs suivants:

Type de canal	Fréquence	Objectif principal
Publications évaluées par des pairs	4-6 publications par an	Diffusion de la recherche
Soumissions de revues scientifiques	3-5 soumissions par an	Validation de la recherche

Présentations de la conférence médicale

Métriques d'engagement de la conférence:

• Conférences médicales annuelles présentes: 6-8
• Plate-formes de présentation: conférences internationales de biotechnologie
• Fréquence de présentation moyenne: 2-3 par conférence

Canaux de soumission réglementaires

Les canaux de communication réglementaires comprennent:

Agence de réglementation	Méthode de soumission	Fréquence
FDA	Soumissions électroniques	Mises à jour trimestrielles
Ema	Soumissions de plate-forme numérique	Rapports bi-annuels

Réseautage de l'industrie pharmaceutique

Détails du canal de réseautage:

• Conférences de l'industrie: 4-5 par an
• Réunions de partenariat: 8-10 par an
• Plateformes de collaboration: numérique et en personne

Plateformes de relations avec les investisseurs

Canaux de communication des investisseurs:

Plate-forme	Fréquence d'interaction	Atteindre
Appels de résultats trimestriels	4 fois par an	Investisseurs institutionnels
Conférences d'investisseurs	2-3 conférences par an	Investisseurs potentiels
Site Web de relations avec les investisseurs	Mises à jour continues	Communauté des investisseurs mondiaux

Soligenix, Inc. (SNGX) - Modèle d'entreprise: segments de clientèle

Agences de biodefense gouvernementales

Soligenix cible les agences de biodefense du gouvernement américain avec des contre-mesures médicales spécialisées.

Agence	Valeur de contrat potentiel	Domaine de mise au point
Barda	31,5 millions de dollars	Contre-mesures médicales radiologiques / nucléaires
NIH	7,2 millions de dollars	Financement de la recherche biodéfense

Marchés de traitement des maladies rares

Soligenix se concentre sur les segments de traitement des maladies rares spécialisées.

• Taille du marché pédiatrique de la maladie de Crohn: 1,2 milliard de dollars
• Potentiel du marché du lymphome à cellules T cutanés: 850 millions de dollars
• Population estimée des patients pour les maladies rares cibles: 75 000 à 100 000

Institutions de recherche en oncologie

Partenariats de recherche avec des centres d'oncologie spécialisés.

Type d'institution	Valeur de collaboration potentielle	Focus de recherche
Centres de cancer universitaire	2,5 millions de dollars par an	SGX301 Recherche de thérapie photodynamique
Cliniques d'oncologie spécialisées	1,8 million de dollars par an	Traitements cutanés du lymphome à cellules T

Partenaires de développement pharmaceutique

Partenariats stratégiques avec les organisations de développement pharmaceutique.

• Partenariats pharmaceutiques actifs actuels: 3
• Valeur du contrat de partenariat potentiel: 5 à 10 millions de dollars par partenariat
• Les collaborations en phase de développement se sont concentrées sur les maladies rares

Communautés de recherche médicale spécialisées

Engagement ciblé avec des réseaux de recherche médicale spécialisés.

Communauté de recherche	Potentiel de financement	Intérêt de recherche
Réseaux de recherche de maladies rares	4,3 millions de dollars	Développement de médicaments orphelins
Consortiums de recherche en immunologie	3,7 millions de dollars	Traitements inflammatoires

Soligenix, Inc. (SNGX) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice 2023, Soligenix a déclaré des frais de recherche et de développement de 6,1 millions de dollars.

Année	Dépenses de R&D	Pourcentage des dépenses totales
2022	5,8 millions de dollars	62.4%
2023	6,1 millions de dollars	65.2%

Investissements d'essais cliniques

Les dépenses d'essais cliniques pour Soligenix en 2023 ont totalisé environ 3,7 millions de dollars.

• Essais cliniques SGX301 (Oraxol): 1,5 million de dollars
• SGX942 Développement clinique: 2,2 millions de dollars

Coûts de conformité réglementaire

Les dépenses annuelles de conformité réglementaire pour Soligenix se sont élevées à 1,2 million de dollars en 2023.

Acquisition du personnel et des talents scientifiques

Catégorie de personnel	Coût annuel	Nombre d'employés
Personnel scientifique	2,8 millions de dollars	22
Personnel administratif	1,5 million de dollars	12

Maintenance de la propriété intellectuelle

Les coûts de maintenance de la propriété intellectuelle pour 2023 étaient de 450 000 $.

• Dépôt et entretien des brevets: 250 000 $
• Support juridique pour la protection IP: 200 000 $

Coûts opérationnels totaux pour 2023: 13,5 millions de dollars

Soligenix, Inc. (SNGX) - Modèle d'entreprise: Strots de revenus

Subventions de recherche gouvernementale

En 2024, Soligenix a reçu des subventions de recherche gouvernementales provenant de plusieurs sources:

Source de financement	Montant d'octroi	Focus de recherche
National Institutes of Health (NIH)	1,2 million de dollars	Recherche en oncologie
Ministère de la Défense	$850,000	Programmes de biodefense

Licence potentielle de produits thérapeutiques

Licence de revenus potentiel pour les principaux candidats thérapeutiques:

• SGX301 (Beclométhasone orale): valeur de licence potentielle estimée de 15 à 20 millions de dollars
• SGX942 (Dusquetide): fourchette de revenus de licence potentielle de 25 à 30 millions de dollars

Financement de recherche collaborative

Collaboration de recherche actuelle Détails financiers:

Partenaire	Valeur de collaboration	Domaine de recherche
Établissement de recherche universitaire	$750,000	Recherche en oncologie
Partenaire de recherche pharmaceutique	1,1 million de dollars	Développement de biodefense

Ventes de produits pharmaceutiques futures

Potentiel de vente de produits pharmaceutiques projetés:

• SGX301 (lymphome cutané à cellules T): potentiel de vente annuel estimé de 12 à 15 millions de dollars
• SGX942 (mucite buccale): Revenu annuel prévu de 18 à 22 millions de dollars

Payments d'étape provenant de partenariats de recherche

Structure de paiement jalon:

Programme de recherche	Potentiel total des étapes	Paiements de jalon actuels
Développement SGX301	35 millions de dollars	5,2 millions de dollars reçus
Développement SGX942	45 millions de dollars	7,5 millions de dollars reçus

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.