Soligenix (SNGX) investor relations material

Strategic focus and pipeline overview

• Focuses on rare diseases with unmet medical needs through two segments: Specialized BioTherapeutics (oncology and inflammation) and Public Health Solutions (vaccines and therapeutics for infectious diseases and bioterror threats).

• Pipeline includes multiple fast track and orphan designated products, targeting a potential $2B in global annual sales.

• Late-stage clinical assets include HyBryte for cutaneous T-cell lymphoma (CTCL), SGX302 for psoriasis, and SGX945 for Behçet's Disease.

• Public Health Solutions segment develops vaccines for ricin, filoviruses (Ebola, Marburg), and COVID-19, supported by significant NIH funding.

Clinical development and market opportunities

• HyBryte demonstrated statistically significant efficacy and safety in Phase 3 CTCL trials, with a second confirmatory Phase 3 ongoing and global market potential over $250M.

• SGX302 targets mild-to-moderate psoriasis, showing positive results in Phase 1/2 and 2a studies, with a market opportunity exceeding $1B.

• SGX945 showed biological efficacy in Phase 2a for Behçet's Disease, with a market potential over $200M.

• Public Health Solutions products have received over $30M in NIH contracts and may qualify for up to three Priority Review Vouchers.

Commercialization and competitive positioning

• HyBryte offers rapid, safe, and effective treatment for CTCL, addressing a clear unmet need with minimal side effects and potential for home use.

• Clinicians express strong interest in prescribing HyBryte due to its efficacy and safety profile.

• Commercial strategy includes a targeted sales force and partnerships for device integration, aiming for efficient market penetration.

• Life cycle management plans include expanding HyBryte into new indications and transitioning to home use.