Soligenix, Inc. · NASDAQ:SNGX
Soligenix — Investor Presentation (May 2025)
24 slides from Soligenix's investor presentation, May 1, 2025
Slide 1: Rising to the Challenges of Rare Disease Treatment
Rising to the Challenges of Rare Disease Treatment NASDAQ: SNGX May 1, 2025
Slide 2: Forward-Looking Statements
2 Forward-Looking Statements This presentation contains forward-looking statements. All statements other than statements of historical facts contained in this presentation, including statements regarding our future results of operations and financial position, business strategy, prospective products
Slide 3: Company Description
3 Company Description Soligenix, Inc. is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need Two areas of focus: A Specialized BioTherapeutics segment dedicated to the development of products for orph
Slide 4: Investment Highlights
4 Investment Highlights Robust pipeline consisting of multiple fast track and/or orphan designated products, with potential for significant commercial returns of ~$2B in global annual sales Late clinical-stage assets, one with successful Phase 3 data readout o Cutaneous T-cell lymphoma (HyBryte™
Slide 5: Development Pipeline – Rare Diseases
5 Development Pipeline – Rare Diseases Product Candidates Preclinical Phase 1 Phase 2 Phase 3 NDA Review Market Specialized HyBryte™ (synthetic hypericin sodium) Positive Phase 3 study results; BioTherapeutics Cutaneous T-Cell Lymphoma (CTCL) ORPHAN & FAST TRACK DESIGNATION 2nd Phase 3 study activel
Slide 6: Multiple Potential Value Drivers
6 Multiple Potential Value Drivers 2023 2024 2025 HyBryteTM* EMA/FDA meetings EMA Ph 3 study Initiate 2nd IIS study status 2H: Ph 3 enrollment 2nd Ph 3 study design agreement Ph 3 study update status update Ph 2a clinical study Ph 2a expanded Ph 2a contd. 2H: Ph 2a extended SGX302* expansion/results
Slide 7: Total Addressable Global Market
7 Total Addressable Global Market Assumptions(1) $1,200 Cutaneous T-Cell Lymphoma >$1,000 30,000 Patients US $1,000 38,000 Patients Europe Mild-to-Moderate Psoriasis 3,000,000 Patients US $800 5,000,000 Patients Europe $ Millions Behçet’s Disease $600 18,000 Patients US >$500 50,000 Patients Europe
Slide 8: Specialized BioTherapeutics
8 Specialized BioTherapeutics Targeted Approach to Treating Oncology & Inflammation
Slide 9: Specialized BioTherapeutics Segment
9 Specialized BioTherapeutics Segment Commercial Targets – Unmet Medical Needs in Oncology and Inflammation Product Candidates Preclinical Phase 1 Phase 2 Phase 3 NDA Review Market HyBryte™ (synthetic hypericin sodium) Positive Phase 3 study results; Cutaneous T-Cell Lymphoma (CTCL) ORPHAN & FAST TR
Slide 10: Cutaneous T-Cell Lymphoma – Disease Overview
10 Cutaneous T-Cell Lymphoma – Disease Overview Cutaneous T-cell lymphoma (CTCL) o Rare class of Non-Hodgkin's Lymphoma (NHL) o Malignant T-cells migrate to the skin o Cancer forms patches, lesions or tumors CTCL affects over 40,000 NHL patients worldwide; currently no cure o $250 million total
Slide 11: HyBryte™ – Synthetic Hypericin Sodium Ointment + Light Activation
HyBryte™ – Synthetic Hypericin Sodium 11 Ointment + Light Activation, First-in-Class Treatment safe and well-tolerated o Minimal reported adverse events ‒ Other CTCL treatments characterized by acute and chronic side effects o Uses visible fluorescent light ‒ Not carcinogenic unlike other photothe
Slide 12: HyBryte™ – Phase 3 Clinical Trial
HyBryte™ – Phase 3 Clinical Trial 12 referred to as the “FLASH” (Fluorescent Light And Synthetic Hypericin) Study (JAMA Dermatology. Published online July 20, 2022. doi:10.1001/jamadermatol.2022.2749) Double-blind, placebo-controlled, randomized o Randomized 2:1 (HyBryte™ [synthetic hypericin 0.25
Slide 13: HyBryte™ – Development Status
13 HyBryte™ – Development Status Positive Phase 3 FLASH study successfully completed o Largest double-blind, randomized, placebo-controlled clinical trial ever conducted in CTCL o FDA and EMA require a second confirmatory Phase 3 clinical trial HyBryteTM Recent supportive studies continue to con
Slide 14: Comparison of FLASH and FLASH2 Studies
14 Comparison of FLASH and FLASH2 Studies FLASH FLASH2 Cycle 1: Weeks 1-8 HyBryte™ Placebo HyBryte™ Placebo (Blinded) 118 subjects; 3 lesions 51 subjects; 3 lesions ~40 subjects; 3-5 lesions ~40 subjects; 3-5 lesions Treatment 2×/week for 6 weeks (+ 2 week rest prior to assessment) Treatment Primary
Slide 15: Significant opportunity for improvement to current treatment paradigm in early stage CTCL
15 Significant opportunity for improvement to current treatment paradigm in early stage CTCL Early Stage CTCL Treatment Paradigm Current Treatment Landscape Because of chronic nature of early stage CTCL and long-term treatment cycles, clinicians choose Empiric Tx therapies with better safety Topic
Slide 16: HyBryte™ a Significant Commercial Opportunity Addressing a Clear Unmet Need
16 HyBryte™ a Significant Commercial Opportunity Addressing a Clear Unmet Need Clinicians see need for additional treatment options with fewer side effects Most patients cycle through several treatments over course of their disease Unmet Need Chronic nature of early stage CTCL and dissatisfact
Slide 17: Psoriasis and SGX302 (Synthetic Hypericin)
17 Psoriasis and SGX302 (Synthetic Hypericin) Caused by dysregulated T-cells o Affects 60-125 Million people worldwide o Affects 8 Million people in the US SGX302 – visible light activated photodynamic therapy o Same active ingredient as HyBryte™ o Focused on mild-moderate patients, especially t
Slide 18: HyBryte Life Cycle Management
18 HyBryteTM Life Cycle Management HyBryteTM (synthetic hypericin sodium) life cycle management >$1B* planning includes potential for home and expanded uses Expansion into new disease indications such as psoriasis Transition to Home Use in treatment of CTCL HyBryteTM Commercial Launch for CTCL $250M
Slide 19: Public Health Solutions
19 Public Health Solutions Addressing Critical Concerns for Industry and Government
Slide 20: Public Health Solutions Segment
20 Public Health Solutions Segment Funded by Government – Medical Countermeasures (MCMs) for Civilian and Military Use Product Candidates (FDA Animal Rule)* Proof-of-Concept IND Phase 1 Phase 2/3 BLA Review Market RiVax® + ThermoVax® – Vaccine ORPHAN & FAST TRACK DESIGNATION NIH Contract Awards of $
Slide 21: SuVax™ / MarVax™ – Filovirus Vaccine Candidates
21 SuVax™ / MarVax™ – Filovirus Vaccine Candidates Heat-stable single-vial bivalent Filovirus infections (Zaire ebolavirus, Sudan SUDV + MARV vaccine provided ebolavirus, Marburg marburgvirus) are deadly; only Zaire strain vaccines are available and 100% protection against requires ≤ -60°C shippin
Slide 22: Experienced Management and Board of Directors
22 Experienced Management and Board of Directors • 35 years of experience • 30 years of experience Gregg Lapointe, Christopher J. • Discovery Laboratories (COO) • Cerium Pharmaceuticals (CEO) CPA, MBA Schaber, PhD • Acute Therapeutics (Co-Founder) • Formerly of Sigma-Tau Pharmaceuticals, Chairman, •
Slide 23: In Summary
23 In Summary Robust pipeline consisting of multiple fast track and/or orphan designated products, with potential for significant commercial returns of ~$2B in global annual sales Late clinical-stage assets, one with successful Phase 3 data readout o Cutaneous T-cell lymphoma (HyBryte™ or SGX301
Slide 24: Thank you
24 Thank you Follow us on: facebook.com/soligenix/ youtube.com/c/SoligenixInc twitter.com/Soligenix_Inc linkedin.com/company/soligenix-inc-/ www.soligenix.com NASDAQ: SNGX