Soligenix, Inc. · NASDAQ:SNGX
Soligenix — Investor Presentation (June 2017)
26 slides from Soligenix's investor presentation, Jun 14, 2017
Slide 1: Rising to the Challenges of Rare Disease Treatment
NASDAQ: SNGX … Rising to the Challenges of Rare Disease Treatment
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 produ
Slide 3: Company Description
Company Description 3 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 BioTherapeutics segment dedicated to the development of products for orphan disease
Slide 4: Investment Highlights
Investment Highlights 4 » Multiple products with fast track and/or orphan designation, each of which holds potential for significant commercial returns » Three Phase 3 assets, one with data readout next year o Cutaneous T - cell lymphoma (SGX301) ‒ Pivotal study in progress with results expected 1H
Slide 5: Development Pipeline – Rare Diseases Product Candidates
5 Development Pipeline – Rare Diseases Product Candidates Preclinical Phase 1 Phase 2 Phase 3 Market SGX301 Cutaneous T - Cell Lymphoma (CTCL) SGX942 Oral Mucositis in Head & Neck Cancer** SGX203 Pediatric Crohn’s Disease** SGX201 Radiation Enteritis** BioTherapeutics Vaccines / BioDefense ** Produc
Slide 6: Multiple Potential Value Drivers
2 H : Ph. 1/2 human safety data 1H : Ph. 1/2 human safety study start 6 Multiple Potential Value Drivers SGX203 * ThermoVax ® * 2017 SGX301 2018 RiVax ® * OrbeShield ® * 2019 2H : Ph. 3 data Pediatric Crohn’s SGX942 * Ph. 3 Start Oral Mucositis * Potential value drivers dependent on continued govern
Slide 7: Significant Global Market Potential
Significant Global Market Potential $300 0 50 100 150 200 $ Millions 250 300 $250 400 350 OrbeShield ® GI Acute Radiation Syndrome SGX301 Cutaneous T - Cell Lymphoma Assumptions (1) Oral Mucositis in Head & Neck Cancer 90,000 Patients US 90,000 Patients EU Cutaneous T - Cell Lymphoma 20,000 Patients
Slide 8: Targeted Approach to Treating Oncology & Inflammation
Targeted Approach to Treating Oncology & Inflammation BioTherapeutics 8
Slide 9: BioTherapeutics Business Segment
BioTherapeutics Business Segment Commercial Targets – Unmet Medical Needs in Oncology and Inflammation 9 BioTherapeutics Product Candidates Preclinical Phase 1 Phase 2 Phase 3 Market SGX301 Cutaneous T - Cell Lymphoma (CTCL) SGX942 Oral Mucositis in Head & Neck Cancer** SGX203 Pediatric Crohn’s Dise
Slide 10: Cutaneous T-Cell Lymphoma – Disease Overview
10 Cutaneous T - Cell Lymphoma – Disease Overview » Cutaneous T - cell lymphoma (CTCL) o R are 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 mi
Slide 11: SGX301 – Synthetic Hypericin
11 SGX301 – Synthetic Hypericin SGX301 is a first - in - class, topical drug applied to CTCL skin lesions followed by activation with safe, visible, fluorescent light to kill malignant T - cells » Affects over 40,000 patients annually worldwide » No approved front - line therapy for early stage (I -
Slide 12: SGX301 – Phase 2 Response Rate
CTCL Patch Pre - Therapy Hypericin Therapy Using Visible Light CTCL Patch Post - Therapy SGX301 – Phase 2 Response Rate 12 Summary of CTCL Lesion Responses to Synthetic Hypericin Ointment Following 6 Weeks of Treatment Responders / Total Percent Responders Hypericin Responders 7/12 58.3% Placebo Res
Slide 13: Oral Mucositis – Disease Overview
13 Oral Mucositis – Disease Overview » Oral mucositis (OM) o Multi - factorial disease linked to a dysregulation of the innate immune system » OM affects over 180,000 head & neck cancer patients worldwide o $500+ million global market potential » Debilitating side effect of cancer chemotherapy and/o
Slide 14: SGX942 – Innate Defense Regulator
14 SGX942 – Innate Defense Regulator SGX942 (dusquetide) is a first - in - class, injectable drug, called an Innate Defense Regulator (IDR), that modulates the body’s innate immune system to reduce inflammation » OM affects over 180,000 H&N cancer patients worldwide » No approved drug for OM in H&N
Slide 15: SGX942 – Oral Mucositis Results
0 10 20 30 Duration of Severe Oral Mucositis Overall Population D u r a t i o n W H O 3 M e d i a n 9 5 % C I ( D a y s ) Placebo N=38 SGX942 1.5mg/kg N=36 18 days 9 days p=0.099 50% 0 20 40 60 Duration of Severe Oral Mucositis Aggressive Chemotherapy D u r a t i o n W H O 3 M e d i a n 9
Slide 16: SGX942 – Oral Mucositis Results
SGX942 – Oral Mucositis Results 16 » Clinically Meaningful Results demonstrated in SGX942 1.5 mg/kg dose group versus placebo one month following completion of chemoradiation in patients at higher risk for severe OM receiving aggressive chemotherapy (80 - 100 mg/m 2 ) o Relative 22% decrease in dura
Slide 17: Pediatric Crohn's Disease – Disease Overview
17 Pediatric Crohn’s Disease – Disease Overview » About pediatric Crohn’s disease o Chronic inflammatory disorder of the gastrointestinal tract o Diarrhea, rectal bleeding and abdominal pain » Resulting in growth failure, malnutrition, pubertal delay and bone demineralization » Over 160,000 children
Slide 18: SGX203 – Beclomethasone Dipropionate
18 SGX203 – Beclomethasone Dipropionate SGX203 is a proprietary oral formulation of immediate and delayed release beclomethasone 17,21 - dipropionate (BDP) tablets to treat GI inflammation with less toxicity than the current standard systemic steroid therapy » 160,000 children/adolescents with Crohn
Slide 19: Vaccine/BioDefense
Vaccine/BioDefense 19 Addressing Critical Concerns for Industry and Government
Slide 20: Vaccine/BioDefense Business Segment
20 Vaccine/BioDefense Business Segment Vaccines / BioDefense ** Product Candidates (FDA Animal Rule) Proof - of - Concept Animal Phase 1 Phase 2/3 Market ThermoVax ® ( TVax ) Heat Stabilization Technology for Vaccines RiVax ® + TVax – Heat Stable Vaccine Ricin Toxin Pre - Exposure OrbeShield ® – The
Slide 21: ThermoVax – Vaccine Thermostability Platform
ThermoVax ® – Vaccine Thermostability Platform 21 ThermoVax ® is a proprietary freeze - drying process that enables vaccines to be stored without refrigeration Demonstrated retained efficacy up to 1 year at 40 ⁰ C (104 ⁰ F) Market Opportunity Development Status » WHO reports about 50% of all vaccine
Slide 22: RiVax – Ricin Toxin Vaccine
22 Heat - stable ricin vaccine provided 100% protection in a non - human primate aerosol challenge model (right) Demonstrated safety in Phase 1 studies Market Opportunity Development Status » Ricin toxin vaccine of rising interest to US due to recent terrorist threats and ease of castor bean procure
Slide 23: OrbeShield – GI Acute Radiation Syndrome
23 Two - tablet BDP system also efficacious in animal models of gastrointestinal acute radiation syndrome (GI ARS) Preliminary proof - of - concept data in canine model of GI ARS (right) Market Opportunity Development Status » Oral BDP is a re - purposed drug of particular importance » Category A co
Slide 24: Experienced Management and Board of Directors
Experienced Management and Board of Directors 24 Christopher J. Schaber, PhD President & CEO • 28 years of experience • Discovery Laboratories (COO) • Acute Therapeutics (Co - Founder) • Ohmeda Pharmaceuticals • The Liposome Company • Wyeth Ayerst Oreola Donini, PhD Chief Scientific Officer • 15 yea
Slide 25: Investment Highlights
25 » Multiple products with fast track and/or orphan designation, each of which holds potential for significant commercial returns » Three Phase 3 assets, one with data readout next year o Cutaneous T - cell lymphoma (SGX301) ‒ Pivotal study in progress with results expected 1H 2018 o Oral mucositis
Slide 26: Thank You
THANK YOU www.soligenix.com Rising to the Challenges of Rare Disease Treatment