Soligenix, Inc. · NASDAQ:SNGX
Soligenix — Investor Presentation (May 2022)
25 slides from Soligenix's investor presentation, May 16, 2022
Slide 1: Rising to the Challenges of Rare Disease Treatment
Rising to the Challenges of Rare Disease Treatment NASDAQ: SNGX May 16, 2022
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 Market Specialized HyBryte™ (SGX301 or synthetic hypericin) Positive Phase 3 results; BioTherapeutics Cutaneous T-Cell Lymphoma (CTCL) ORPHAN & FAST TRACK DESIGNATION NDA in preparation SGX942 (dusquetide)
Slide 6: Multiple Potential Value Drivers
6 Multiple Potential Value Drivers 2021** 2022** 2023** EU regulatory – 1H: Publication of 2H: (US) NDA 1H: (EU) MAA 2H: (US) NDA HyBryte™ * (e.g., PIP/ILAP) Ph 3 FLASH study submission CTCL submission CTCL approval CTCL Expansion into 1H: Clinical 2H: Initiate Ph 2a 2H: Ph 2a SGX302 * Psoriasis pro
Slide 7: Total Addressable Global Market
7 Total Addressable Global Market $1,200 Assumptions(1) > $1,000 Cutaneous T-Cell Lymphoma $1,000 27,000 Patients US 20,000 Patients EU Mild-to-Moderate Psoriasis $800 3,000,000 Patients US $ Millions 5,000,000 Patients EU $600 Pediatric Crohn’s Disease 80,000 Patients US 80,000 Patients EU $400 RiV
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 Market Specialized BioTherapeutics HyBryte™ (SGX301 or synthetic hypericin) ORPHAN & FAST TRACK DESIGNATION Positive Phase 3 results; Cu
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 Ointment + Light Activation, First-in-Class
HyBryte™ – Synthetic Hypericin Ointment 11 + 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 phototherapy
Slide 12: HyBryte – Pivotal Phase 3 Clinical Trial
12 HyBryte™ – Pivotal Phase 3 Clinical Trial ➢ Highly powered, double-blind, placebo-controlled, randomized o Randomized 2:1 (HyBryte™ [synthetic hypericin 0.25%] : placebo) HyBryte™ Placebo o Cycle 1 complete: Primary Endpoint (response rate) Cycle 1: statistically significant (p=0.04) 118 subjects
Slide 13: Phototherapy a mainstay treatment of early stage CTCL
Phototherapy a mainstay treatment of 13 early stage CTCL HyBryte™ Treatment Regimen ➢ Treating dermatologists are experienced administering phototherapy ➢ Approximately 80% of community dermatology practices have light units available ➢ 100% of the ~50 US CTCL clinics currently administer UV phototh
Slide 14: Dermatologist KOLs play pivotal role in treatment of early stage CTCL
Dermatologist KOLs play pivotal role in 14 treatment of early stage CTCL ➢ Most CTCL patients who go to a Key Opinion Leader (KOL) for diagnosis will remain with that KOL for their care and treatment ➢ For those that return to their referring physician (typically for logistical reasons or travel dis
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: Advantages to commercializing CTCL in the US
16 Advantages to commercializing CTCL in the US: smaller sales force and market access support ➢ A concentrated prescriber base ➢ Payers are likely to cover the drug allows for an efficient sales force and light treatment if shown to be footprint safe and efficacious o Planned launch focused on high
Slide 17: HyBryte a Significant Near Term Commercial Opportunity
17 HyBryte™ a Significant Near Term 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 di
Slide 18: HyBryte Life Cycle Management
18 HyBryteTM Life Cycle Management HyBryteTM (synthetic hypericin) 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 anticipated
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 Public Health Product Candidates (FDA Animal Rule)* Proof-of-Concept IND Phase 1 Phase 2/3 Market Solutions** RiVax® + ThermoVax® – Vaccine NIH Contract Awards of $30M to date; ORPH
Slide 21: RiVax – Ricin Toxin Vaccine Candidate
21 RiVax® – Ricin Toxin Vaccine Candidate ➢ Ricin toxin vaccine of rising Heat-stable ricin vaccine provided interest to US and other countries 100% protection in a non-human primate due to recent terrorist threats and (NHP) aerosol challenge model ease of castor bean procurement and ricin productio
Slide 22: CiVax – COVID-19 Vaccine Candidate
22 CiVax™ – COVID-19 Vaccine Candidate Spike protein and CoVaccine HT™ ➢ Worldwide vaccination response still adjuvant demonstrated (here): insufficient ➢ Compatible as booster for other ✓ Balanced antibody response (including Th1) vaccines ✓ Broad and strong neutralizing antibody Market ➢ Rapid dis
Slide 23: Experienced Management and Board of Directors
23 Experienced Management and Board of Directors • 30 years of experience • 25 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 24: In Summary
24 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 25: Thank you
25 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