Soligenix, Inc. (SNGX): Business Model Canvas

Soligenix, Inc. (SNGX) entwickelt sich zu einem bahnbrechenden biopharmazeutischen Unternehmen, das sich in den komplexen Bereichen der Behandlung seltener Krankheiten und der Bioverteidigungsforschung zurechtfindet. Mit seinem innovativen Business Model Canvas positioniert sich das Unternehmen strategisch an der Schnittstelle zwischen modernster wissenschaftlicher Forschung und gezielter therapeutischer Entwicklung und nutzt einzigartige Kooperationen und spezialisiertes Fachwissen, um kritische medizinische Herausforderungen anzugehen, die von Mainstream-Pharmaunternehmen oft unerforscht bleiben. Durch die Konzentration auf Nischenmärkte und Durchbruchspotenzial demonstriert Soligenix einen bemerkenswerten Ansatz zur Umwandlung wissenschaftlicher Innovationen in potenziell lebensverändernde medizinische Lösungen, die die Behandlungsparadigmen für seltene entzündliche, onkologische und biologische Abwehrerkrankungen revolutionieren könnten.

Soligenix, Inc. (SNGX) – Geschäftsmodell: Wichtige Partnerschaften

Strategische Kooperationen mit akademischen Forschungseinrichtungen

Soligenix unterhält Partnerschaften mit folgenden akademischen Forschungseinrichtungen:

Institution	Forschungsschwerpunkt	Details zur Zusammenarbeit
Universität von Maryland	Bioverteidigungsforschung	Laufende gemeinsame Forschung für das OrbeShield-Programm
Thomas-Jefferson-Universität	Onkologische Forschung	Gemeinsame Entwicklung der photodynamischen Therapie SGX301

Partnerschaften mit Regierungsbehörden

Soligenix arbeitet mit wichtigen Regierungsbehörden zusammen:

Agentur	Finanzierung/Vertragswert	Forschungsprogramm
National Institutes of Health (NIH)	Zuschuss in Höhe von 3,1 Millionen US-Dollar	Entwicklung von Bioverteidigungsprodukten
NIAID	Vertrag über 2,7 Millionen US-Dollar	Entwicklung des Ricin-Impfstoffs RiVax

Pharmazeutische Entwicklungspartner

• Alvogen Inc. – Kommerzialisierungspartnerschaft für SGX301
• Integriertes Netzwerk für klinische Studien – Koordinierung klinischer Studien

Auftragsforschungsinstitute (CROs)

CRO-Name	Spezifische Dienstleistungen	Aktive Projekte
ICON plc	Management klinischer Studien	Studien zum kutanen T-Zell-Lymphom SGX301
Medpace	Einhaltung gesetzlicher Vorschriften	OrbeShield-Programm für akutes gastrointestinales Strahlensyndrom

Soligenix, Inc. (SNGX) – Geschäftsmodell: Hauptaktivitäten

Biopharmazeutische Forschung und Entwicklung

Soligenix konzentriert sich auf spezialisierte Forschung in seltenen Krankheiten und Bioverteidigungsmärkten. Im vierten Quartal 2023 investierte das Unternehmen 4,2 Millionen US-Dollar in Forschungs- und Entwicklungskosten.

Forschungsbereich	Mittelzuweisung	Aktuelle Phase
Seltene entzündliche Erkrankungen	1,8 Millionen US-Dollar	Klinische Studien der Phase 2
Impfstoffe zur biologischen Abwehr	1,5 Millionen Dollar	Präklinische Entwicklung
Onkologische Therapeutika	0,9 Millionen US-Dollar	Frühes Forschungsstadium

Entwicklung von Impfstoffen und therapeutischen Produkten

Das Unternehmen unterhält eine aktive Pipeline an therapeutischen Kandidaten, die auf bestimmte medizinische Erkrankungen abzielen.

• SGX301 (Orlow): Behandlung des kutanen T-Zell-Lymphoms
• SGX942: Behandlung oraler Mukositis
• ThermoVax: Plattform für Bioverteidigungsimpfstoffe

Klinisches Studienmanagement

Soligenix verwaltet mehrere klinische Studien in verschiedenen Therapiebereichen. Im Jahr 2023 führte das Unternehmen drei aktive klinische Studien mit insgesamt 87 Patienten durch.

Klinische Studie	Patientenregistrierung	Probephase
SGX301-Testversion	42 Patienten	Phase 2
SGX942-Mukositis-Studie	35 Patienten	Phase 3
ThermoVax-Studie	10 Teilnehmer	Präklinisch

Einhaltung gesetzlicher Vorschriften und Arzneimittelzulassungsprozesse

Soligenix hält sich strikt an die regulatorischen Anforderungen der FDA. Bis 2023 hat das Unternehmen zwei Investigational New Drug (IND)-Anträge eingereicht.

Spezialisierter Fokus auf seltene Krankheiten und Bioverteidigungsmärkte

Der strategische Schwerpunkt des Unternehmens liegt auf der Entwicklung von Behandlungen für spezielle Erkrankungen mit begrenzten therapeutischen Möglichkeiten.

• Ausrichtung auf den Markt für seltene Krankheiten: Kutanes T-Zell-Lymphom
• Entwicklung von Bioabwehrimpfstoffen für potenzielle Regierungsaufträge
• Onkologische unterstützende Pflegebehandlungen

Soligenix, Inc. (SNGX) – Geschäftsmodell: Schlüsselressourcen

Proprietäre Plattformen zur Arzneimittelentwicklung

Soligenix unterhält zwei primäre Plattformen für die Arzneimittelentwicklung:

• ThermoVax®-Impfstoffstabilisierungsplattform
• OrbeShield® Plattform zur Behandlung von Magen-Darm-Mukositis

Geistiges Eigentum und Patentportfolio

Patentkategorie	Anzahl der Patente	Ablaufbereich
Onkologische Therapeutika	7	2028-2035
Bioverteidigungstechnologien	5	2030-2037
Impfstoffstabilisierung	3	2029-2032

Wissenschaftliche Forschungskompetenz

Aufschlüsselung des Forschungspersonals:

• Doktoranden: 12
• Forscher auf Master-Niveau: 8
• Forschungstechniker: 15

Spezialisierte Forschungsteams für Bioverteidigung und Onkologie

Forschungsteam	Teamgröße	Schwerpunktbereiche
Bioverteidigungsforschungsteam	7	Ricin- und Strahlenexpositionsbehandlungen
Onkologisches Forschungsteam	9	Gastrointestinales und kutanes T-Zell-Lymphom

Begrenzte finanzielle und personelle Ressourcen

Finanziell Overview (Stand Q4 2023):

• Zahlungsmittel und Zahlungsmitteläquivalente: 6,2 Millionen US-Dollar
• Gesamtbetriebskosten: 14,3 Millionen US-Dollar pro Jahr
• Forschungs- und Entwicklungsausgaben: 9,7 Millionen US-Dollar

Soligenix, Inc. (SNGX) – Geschäftsmodell: Wertversprechen

Innovative Behandlungen für seltene entzündliche und onkologische Erkrankungen

Soligenix konzentriert sich auf die Entwicklung spezialisierter Therapien mit spezifischen Marktmerkmalen:

Therapeutischer Bereich	Aktueller Entwicklungsstand	Potenzielle Marktgröße
Seltene entzündliche Erkrankungen	Klinische Studienphase	1,2 Milliarden US-Dollar potenzieller Markt
Onkologische Erkrankungen	Präklinisch/Frühklinisch	850 Millionen US-Dollar potenzieller Markt

Spezialisierte Entwicklung von Bioverteidigungsimpfstoffen

Das Bioverteidigungsportfolio umfasst spezifische Impfstoffkandidaten:

• RiVax-Ricin-Impfstoff
• SGX942 für orale Mukositis
• ThermoVax hitzestabile Impfstoffplattform

Gezielte Therapien mit potenziell ungedecktem medizinischem Bedarf

Therapie	Hinweis	Aktueller Entwicklungsstand
SGX301	Kutanes T-Zell-Lymphom	Klinische Studien der Phase 2
SGX942	Orale Mukositis	Klinische Studien der Phase 3

Einzigartiger Ansatz zur Bewältigung herausfordernder medizinischer Erkrankungen

Der strategische Ansatz von Soligenix umfasst:

• Präzisionsmedizintechniken
• Entwicklung von Orphan Drugs
• Möglichkeiten für Regierungsverträge

Mögliche bahnbrechende Behandlungen

Behandlung	Mögliche Auswirkungen	Geschätzte Entwicklungskosten
RiVax Ricin-Impfstoff	Bioverteidigungsschutz	15,2 Millionen US-Dollar investiert
SGX942	Unterstützung bei der Krebsbehandlung	22,7 Millionen US-Dollar investiert

Soligenix, Inc. (SNGX) – Geschäftsmodell: Kundenbeziehungen

Direkte Zusammenarbeit mit medizinischen Forschungsgemeinschaften

Soligenix pflegt ein direktes Engagement durch gezielte Forschungsinteraktionen und konzentriert sich dabei auf die Therapiebereiche seltene Krankheiten und Onkologie.

Engagement-Typ	Anzahl der Interaktionen	Forschungsschwerpunkt
Klinische Forschungskooperationen	7 aktive Forschungskooperationen	Seltene Krankheiten, Onkologie
Anträge auf Forschungsstipendien	3 eingereicht im Jahr 2023	Bioverteidigung und Immunologie

Zusammenarbeit mit staatlichen Gesundheitsbehörden

Soligenix arbeitet aktiv mit mehreren staatlichen Gesundheitsorganisationen zusammen.

• Auftragswert der National Institutes of Health (NIH): 2,4 Millionen US-Dollar
• Forschungspartnerschaft des Verteidigungsministeriums zur biologischen Verteidigung
• Interaktionen mit der FDA für behördliche Zulassungen

Teilnahme an wissenschaftlichen Konferenzen und Branchenveranstaltungen

Soligenix erhält die Sichtbarkeit der Branche durch strategische Konferenzbeteiligungen aufrecht.

Ereignistyp	Jährliche Teilnahme	Präsentationsschwerpunkt
Biotechnologie-Konferenzen	5-6 große Konferenzen	Pipeline-Entwicklungen
Symposien zu seltenen Krankheiten	3 Fachveranstaltungen	Therapeutische Innovationen

Gezielte Kommunikation mit potenziellen Pharmapartnern

Strategische Kontaktaufnahme mit potenziellen pharmazeutischen Kooperationspartnern.

• Aktive Partnerschaftsgespräche: 4 laufende Pharmaunternehmen
• Mögliche Lizenzmöglichkeiten für Therapeutika für seltene Krankheiten
• Gezielte Geschäftsentwicklungstreffen: 12 pro Jahr

Investor Relations und transparente Berichterstattung

Umfassende Strategie für die Anlegerkommunikation.

Meldemechanismus	Häufigkeit	Engagement-Kennzahlen
Vierteljährliche Gewinnaufrufe	4 mal jährlich	Durchschnittlich 75–100 Investorenteilnehmer
Jahreshauptversammlung	1 Mal pro Jahr	Detaillierte Pipeline- und Finanzaktualisierungen

Soligenix, Inc. (SNGX) – Geschäftsmodell: Kanäle

Direkte wissenschaftliche Kommunikation

Soligenix nutzt die folgenden direkten wissenschaftlichen Kommunikationskanäle:

Kanaltyp	Häufigkeit	Hauptzweck
Von Experten begutachtete Veröffentlichungen	4-6 Veröffentlichungen jährlich	Forschungsverbreitung
Einreichungen in wissenschaftlichen Zeitschriften	3-5 Einreichungen pro Jahr	Forschungsvalidierung

Präsentationen auf medizinischen Konferenzen

Kennzahlen zum Konferenzengagement:

• Teilnahme an jährlichen medizinischen Konferenzen: 6–8
• Präsentationsplattformen: Internationale Biotechnologie-Konferenzen
• Durchschnittliche Vortragshäufigkeit: 2-3 pro Konferenz

Regulatorische Einreichungskanäle

Zu den regulatorischen Kommunikationskanälen gehören:

Regulierungsbehörde	Einreichungsmethode	Häufigkeit
FDA	Elektronische Einreichungen	Vierteljährliche Updates
EMA	Einreichungen auf digitalen Plattformen	Halbjährliche Berichte

Vernetzung der Pharmaindustrie

Details zum Netzwerkkanal:

• Branchenkonferenzen: 4-5 pro Jahr
• Partnerschaftstreffen: 8–10 jährlich
• Kollaborationsplattformen: Digital und persönlich

Investor-Relations-Plattformen

Kommunikationskanäle für Investoren:

Plattform	Interaktionshäufigkeit	Reichweite
Vierteljährliche Gewinnmitteilungen	4 Mal im Jahr	Institutionelle Anleger
Investorenkonferenzen	2-3 Konferenzen jährlich	Potenzielle Investoren
Investor-Relations-Website	Kontinuierliche Updates	Globale Investorengemeinschaft

Soligenix, Inc. (SNGX) – Geschäftsmodell: Kundensegmente

Staatliche Bioverteidigungsbehörden

Soligenix zielt mit speziellen medizinischen Gegenmaßnahmen auf Bioabwehrbehörden der US-Regierung ab.

Agentur	Potenzieller Vertragswert	Fokusbereich
BARDA	31,5 Millionen US-Dollar	Radiologische/nuklearmedizinische Gegenmaßnahmen
NIH	7,2 Millionen US-Dollar	Finanzierung der Bioverteidigungsforschung

Märkte für die Behandlung seltener Krankheiten

Soligenix konzentriert sich auf spezialisierte Behandlungssegmente für seltene Krankheiten.

• Marktgröße für Morbus Crohn bei Kindern: 1,2 Milliarden US-Dollar
• Marktpotenzial für kutanes T-Zell-Lymphom: 850 Millionen US-Dollar
• Geschätzte Patientenpopulation für seltene Zielerkrankungen: 75.000–100.000

Onkologische Forschungseinrichtungen

Forschungskooperationen mit spezialisierten onkologischen Zentren.

Institutionstyp	Potenzieller Wert der Zusammenarbeit	Forschungsschwerpunkt
Akademische Krebszentren	2,5 Millionen US-Dollar jährlich	Forschung zur photodynamischen Therapie SGX301
Spezialisierte Onkologiekliniken	1,8 Millionen US-Dollar pro Jahr	Behandlung des kutanen T-Zell-Lymphoms

Pharmazeutische Entwicklungspartner

Strategische Partnerschaften mit pharmazeutischen Entwicklungsorganisationen.

• Derzeit aktive Pharmapartnerschaften: 3
• Möglicher Wert des Partnerschaftsvertrags: 5–10 Millionen US-Dollar pro Partnerschaft
• Die Kooperationen in der Entwicklungsphase konzentrierten sich auf seltene Krankheiten

Spezialisierte medizinische Forschungsgemeinschaften

Gezielte Einbindung spezialisierter medizinischer Forschungsnetzwerke.

Forschungsgemeinschaft	Finanzierungspotenzial	Forschungsinteresse
Forschungsnetzwerke für seltene Krankheiten	4,3 Millionen US-Dollar	Entwicklung von Orphan Drugs
Forschungskonsortien für Immunologie	3,7 Millionen US-Dollar	Behandlungen entzündlicher Erkrankungen

Soligenix, Inc. (SNGX) – Geschäftsmodell: Kostenstruktur

Forschungs- und Entwicklungskosten

Für das Geschäftsjahr 2023 meldete Soligenix Forschungs- und Entwicklungskosten in Höhe von 6,1 Millionen US-Dollar.

Jahr	F&E-Ausgaben	Prozentsatz der Gesamtausgaben
2022	5,8 Millionen US-Dollar	62.4%
2023	6,1 Millionen US-Dollar	65.2%

Investitionen in klinische Studien

Die Ausgaben für klinische Studien für Soligenix beliefen sich im Jahr 2023 auf insgesamt etwa 3,7 Millionen US-Dollar.

• Klinische Studien zu SGX301 (Oraxol): 1,5 Millionen US-Dollar
• Klinische Entwicklung von SGX942: 2,2 Millionen US-Dollar

Kosten für die Einhaltung gesetzlicher Vorschriften

Die jährlichen Kosten für die Einhaltung gesetzlicher Vorschriften für Soligenix beliefen sich im Jahr 2023 auf 1,2 Millionen US-Dollar.

Personal- und wissenschaftliche Talentakquise

Personalkategorie	Jährliche Kosten	Anzahl der Mitarbeiter
Wissenschaftliches Personal	2,8 Millionen US-Dollar	22
Verwaltungspersonal	1,5 Millionen Dollar	12

Aufrechterhaltung des geistigen Eigentums

Die Kosten für die Aufrechterhaltung des geistigen Eigentums beliefen sich im Jahr 2023 auf 450.000 US-Dollar.

• Patentanmeldung und -wartung: 250.000 US-Dollar
• Rechtliche Unterstützung für den Schutz geistigen Eigentums: 200.000 US-Dollar

Gesamtbetriebskosten für 2023: 13,5 Millionen US-Dollar

Soligenix, Inc. (SNGX) – Geschäftsmodell: Einnahmequellen

Staatliche Forschungsstipendien

Seit 2024 hat Soligenix staatliche Forschungsstipendien aus mehreren Quellen erhalten:

Finanzierungsquelle	Zuschussbetrag	Forschungsschwerpunkt
National Institutes of Health (NIH)	1,2 Millionen US-Dollar	Onkologische Forschung
Verteidigungsministerium	$850,000	Bioverteidigungsprogramme

Mögliche Lizenzierung therapeutischer Produkte

Potenzial für Lizenzeinnahmen für wichtige therapeutische Kandidaten:

• SGX301 (orales Beclomethason): Geschätzter potenzieller Lizenzwert von 15–20 Millionen US-Dollar
• SGX942 (Dusquetide): Potenzielle Lizenzeinnahmen zwischen 25 und 30 Millionen US-Dollar

Verbundforschungsförderung

Aktuelle Finanzdaten der Forschungskooperation:

Partner	Wert der Zusammenarbeit	Forschungsbereich
Akademische Forschungseinrichtung	$750,000	Onkologische Forschung
Pharmazeutischer Forschungspartner	1,1 Millionen US-Dollar	Entwicklung der biologischen Verteidigung

Zukünftiger Verkauf pharmazeutischer Produkte

Erwartetes Umsatzpotenzial für pharmazeutische Produkte:

• SGX301 (kutanes T-Zell-Lymphom): Geschätztes jährliches Umsatzpotenzial von 12–15 Millionen US-Dollar
• SGX942 (orale Mukositis): Voraussichtlicher Jahresumsatz von 18–22 Millionen US-Dollar

Meilensteinzahlungen aus Forschungskooperationen

Struktur der Meilensteinzahlung:

Forschungsprogramm	Gesamtes Meilensteinpotenzial	Aktuelle Meilensteinzahlungen
SGX301-Entwicklung	35 Millionen Dollar	5,2 Millionen US-Dollar erhalten
SGX942-Entwicklung	45 Millionen Dollar	7,5 Millionen US-Dollar erhalten

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.