Soligenix, Inc. · NASDAQ:SNGX
Soligenix — Investor Presentation (April 2024)
24 slides from Soligenix's investor presentation, Apr 3, 2024
Slide 1: Rising to the Challenges of Rare Disease Treatment
Rising to the Challenges of Rare Disease Treatment NASDAQ: SNGX April 03, 2024
Slide 2: Forward-Looking Statements
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 a
Slide 3: Company Description
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 orphan
Slide 4: Investment Highlights
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™ o
Slide 5: Development Pipeline – Rare Diseases Product Candidates
Development Pipeline – Rare Diseases Product Candidates* Preclinical Phase 1 Phase 2 Phase 3 NDA Review Market HyBryte™ (synthetic hypericin sodium) Cutaneous T-Cell Lymphoma (CTCL) SGX942 (dusquetide) Oral Mucositis in Head & Neck Cancer** SGX203 (beclomethasone dipropionate) Pediatric Crohn’s Dise
Slide 6: Multiple Potential Value Drivers
Multiple Potential Value Drivers 2023 2024 2025 * Potential value drivers dependent on continued government funding and/or other funding sources Green = achieved Blue = data read-out Grey = clinical Orange = regulatory Yellow = nonclinical 6 HyBryte™ * RiVax® * CiVax™ * SuVax™/ MarVax™ * SGX302 * Ph
Slide 7: Total Addressable Global Market
>$250 $1,000 >$200 >$500 $200 $150 $0 $200 $400 $600 $800 $1,000 $1,200 $ Millions Total Addressable Global Market Assumptions(1) Cutaneous T-Cell Lymphoma 30,000 Patients US 38,000 Patients Europe Mild-to-Moderate Psoriasis 3,000,000 Patients US 5,000,000 Patients Europe Behçet’s Disease 18,000 Pat
Slide 8: Specialized BioTherapeutics
Specialized BioTherapeutics Targeted Approach to Treating Oncology & Inflammation 8
Slide 9: Specialized BioTherapeutics Segment Commercial Targets
Specialized BioTherapeutics Segment 9 Commercial Targets – Unmet Medical Needs in Oncology and Inflammation * Anticipated event and timing subject to COVID-19 disruption **Potential value drivers dependent on continued government funding and/or other funding sources Denotes funding in whole or in pa
Slide 10: Cutaneous T-Cell Lymphoma – Disease Overview
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 add
Slide 11: HyBryte™ – Synthetic Hypericin Sodium Ointment + Light Activation
HyBryte™ – Synthetic Hypericin Sodium 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 UV photothe
Slide 12: HyBryte™ – Phase 3 FLASH Study
HyBryte™ – Phase 3 Clinical Trial referred to as the “FLASH” (Fluorescent Light And Synthetic Hypericin) Study ➢ Double-blind, placebo-controlled, randomized o Randomized 2:1 (HyBryte™ [synthetic hypericin 0.25%] : placebo) ➢ Secondary Endpoints o Treatment response (including duration), degree of i
Slide 13: HyBryte™ – Development Status
HyBryte™ – Development Status ➢ Positive Phase 3 FLASH study successfully completed in 2020 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 ➢ Second confirmatory Phase 3 study (FLASH2) of
Slide 14: Comparison of FLASH and FLASH2 Studies
Comparison of FLASH and FLASH2 Studies 14 FLASH FLASH2 ➢ FLASH2 expected to have a high probability of success with larger magnitude of response given the response rate observed after 18 weeks treatment in the first FLASH study (18 weeks, 49%, p<0.0001 vs. Placebo Cycle 1) ➢ FLASH2 will enroll more
Slide 15: Current Treatment Landscape for Early Stage CTCL
➢ Because of chronic nature of early stage CTCL and long-term treatment cycles, clinicians choose therapies with better safety profiles first and foremost ➢ Clinicians see critical need for additional treatment options with fewer side effects ➢ NB UVB and PUVA are not targeted therapies and have ser
Slide 16: HyBryte™ a Significant Commercial Opportunity Addressing a Clear Unmet Need
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 ➢ Chronic nature of early stage CTCL and dissatisfaction with curre
Slide 17: Psoriasis and SGX302 (Synthetic Hypericin)
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 the
Slide 18: HyBryte™ Life Cycle Management
HyBryteTM Life Cycle Management 18 * Total addressable global market HyBryteTM (synthetic hypericin sodium) life cycle management planning includes potential for home and expanded uses * Total addressable global market $250M* >$1B* HyBryteTM Commercial Launch for CTCL Transition to Home Use in treat
Slide 19: Public Health Solutions
Public Health Solutions Addressing Critical Concerns for Industry and Government 19
Slide 20: Public Health Solutions Segment
Public Health Solutions Segment Funded by Government – Medical Countermeasures (MCMs) for Civilian and Military Use With FDA MCM approvals, potential to be awarded: ➢ Up to 3 Priority Review Vouchers (PRVs have sold for ~$100 million) to be used for future programs or sold, and/or ➢ Government Procu
Slide 21: SuVax™ / MarVax™ – Filovirus Vaccine Candidates
SuVax™ / MarVax™ – Filovirus Vaccine Candidates Heat-stable single-vial bivalent SUDV + MARV vaccine provided 100% protection against SUDV and MARV challenge: Published in Vaccine Market Opportunity ➢ Filovirus infections (Zaire ebolavirus, Sudan ebolavirus, Marburg marburgvirus) are deadly; only Za
Slide 22: Experienced Management and Board of Directors
Experienced Management and Board of Directors Christopher J. Schaber, PhD Chairman, President & CEO • 30 years of experience • Discovery Laboratories (COO) • Acute Therapeutics (Co-Founder) • Ohmeda Pharmaceuticals • The Liposome Company • Wyeth Ayerst Richard Straube, MD Chief Medical Officer • 35
Slide 23: In Summary
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
Thank you www.soligenix.com NASDAQ: SNGX 24 Follow us on: facebook.com/soligenix/ twitter.com/Soligenix_Inc linkedin.com/company/soligenix-inc-/ youtube.com/c/SoligenixInc