Soligenix (SNGX) investor relations material

Strategic focus and pipeline overview

• Focuses on rare diseases with unmet medical needs, targeting oncology, inflammation, and public health threats.

• Pipeline includes late-stage assets with fast track and orphan designations, aiming for ~$2B in global annual sales.

• Two main segments: Specialized BioTherapeutics (orphan diseases, oncology, inflammation) and Public Health Solutions (vaccines for ricin, filoviruses, COVID-19).

• Multiple products in advanced clinical stages, including HyBryte for CTCL, SGX302 for psoriasis, and SGX945 for Behçet's Disease.

• Non-dilutive government funding and collaborations support R&D and operations.

Clinical development highlights

• HyBryte achieved positive, statistically significant results in Phase 3 for CTCL; confirmatory Phase 3 ongoing with interim analysis expected in 2Q2026.

• SGX302 for mild-to-moderate psoriasis showed clinical success in Phase 2a with both ointment and gel formulations.

• SGX945 demonstrated biological efficacy and safety in Phase 2a for Behçet's Disease, matching or exceeding approved comparator outcomes.

• Public Health Solutions segment advancing vaccines for ricin, Ebola, Marburg, and COVID-19, with significant NIH funding and potential for Priority Review Vouchers.

• Product candidates benefit from orphan and fast track designations, expediting regulatory pathways.

Market opportunities and commercialization

• HyBryte targets a $250M global market for CTCL, addressing a clear unmet need with rapid, safe, and effective treatment.

• SGX302 addresses a >$1B market for mild-to-moderate psoriasis, focusing on patients underserved by current therapies.

• SGX945 targets a $200M+ market for Behçet's Disease, offering improved efficacy over existing treatments.

• Public Health Solutions products positioned for government procurement and stockpile contracts, with PRV potential.

• Commercial strategy includes targeted sales force and partnerships for device integration and expanded indications.