Soligenix, Inc. · NASDAQ:SNGX
Soligenix — Investor Presentation (July 2023)
23 slides from Soligenix's investor presentation, Jul 15, 2023
Slide 1: Rising to the Challenges of Rare Disease Treatment
Rising to the Challenges of Rare Disease Treatment NASDAQ: SNGX July 15, 2023
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 Actively engaged in FDA
Slide 6: Multiple Potential Value Drivers
6 Multiple Potential Value Drivers 2021** 2022** 2023** EU regulatory – Ph 3 published in 1H: IIS start in CTCL 2H: FDA agreement HyBryte™ * (e.g., PIP/ILAP) JAMA Dermatology ($2.6M FDA grant award)of 2nd Ph 3 study PTX *† Complete option 2H: FDA agreement agreement of Ph 2/3 study Expansion into IN
Slide 7: Total Addressable Global Market
7 Total Addressable Global Market Assumptions(1) $1,200 Cutaneous T-Cell Lymphoma >$1,000 27,000 Patients US $1,000 20,000 Patients EU Mild-to-Moderate Psoriasis 3,000,000 Patients US $800 5,000,000 Patients EU $ Millions Pediatric Crohn’s Disease $600 80,000 Patients US 80,000 Patients EU Behçet's
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 Specialized HyBryte™ (synthetic hypericin sodium) Positive Phase 3 study results; BioTherapeutics Cutaneous T-Cell Lym
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
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 UV photo
Slide 12: HyBryte™ – Phase 3 Clinical Trial
12 HyBryte™ – Phase 3 Clinical Trial referred to as the “FLASH” (Fluorescent Light And Synthetic Hypericin) Study (JAMA Dermatology. Published online July 20, 2022. doi:10.1001/jamadermatol.2022.2749) ➢ Highly powered, double-blind, placebo-controlled, randomized o Randomized 2:1 (HyBryte™ [syntheti
Slide 13: HyBryte™ – Development Status
13 HyBryte™ – Development Status ➢ Successfully completed pivotal Phase 3 FLASH study in 2020 to support potential U.S. marketing approval o Largest double-blind, randomized, placebo-controlled clinical trial ever conducted in CTCL population ➢ HyBryte™ new drug application (NDA) for early-stage CTC
Slide 14: Significant opportunity for improvement to current treatment paradigm in early stage CTCL
14 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 15: HyBryte™ a Significant Commercial Opportunity
15 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 16: Psoriasis and SGX302 (Synthetic Hypericin)
16 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™ but may involve a new formulation o Focused on mi
Slide 17: HyBryte Life Cycle Management
17 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 18: Public Health Solutions
18 Public Health Solutions Addressing Critical Concerns for Industry and Government
Slide 19: Public Health Solutions Segment
19 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 Public Health Solutions** RiVax® + ThermoVax® – Vaccine NIH Contract Awards of $30M to
Slide 20: SuVax™ / MarVax™ – Filovirus Vaccine Candidates
20 SuVax™ / MarVax ™ – Filovirus Vaccine Candidates Heat-stable single-vial bivalent ➢ Filovirus infections (Zaire ebolavirus, SUDV + MARV vaccine provided Sudan ebolavirus, Marburg 100% protection against marburgvirus) are deadly; only Zaire SUDV and MARV challenge strain vaccines are available and
Slide 21: Experienced Management and Board of Directors
21 Experienced Management and Board of Directors • 30 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 22: In Summary
22 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 23: Thank you
23 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