Slide 1: Rising to the Challenges of Rare Disease Treatment
OTC QB: 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 Highlights
Company Highlights 3 » Diversified product portfolio in advanced development , targeting rare disease indications in inflammation, oncology and biodefense with $200M+ markets worldwide o Phase 3 clinical program for the treatment of cutaneous T - cell l ymphoma ( SGX301) - Orphan drug and fast track
Slide 4: Rare Disease Pipeline
4 Rare Disease Pipeline Product Candidates Preclinical Phase 1 Phase 2 Phase 3 Market SGX301 Cutaneous T - Cell Lymphoma (CTCL) SGX203 Pediatric Crohn’s Disease** SGX942 Oral Mucositis in Head & Neck Cancer** SGX201 Radiation Enteritis** BioTherapeutics Vaccines / BioDefense ** Product Candidates (F
Slide 5: Multiple Potential Value Drivers
1 H : Ph. 1/2 human safety data 2H : Ph. 1/2 human safety study start 5 Multiple Potential Value Drivers SGX203* ThermoVax ® * 2016 SGX301 2017 RiVax TM * OrbeShield ® * 2018 1H : Ph. 3 start Pediatric Crohn’s SGX942* Ph. 2 long - term data Oral Mucositis * Potential value drivers dependent on conti
Slide 6: Significant WW Market Potential
Significant WW 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 and Neck Cancer 90,000 Patients US 90,000 Patients EU Cutaneous T - Cell Lymphoma 20,000 Patients U
Slide 7: Experienced Management and Board of Directors
Experienced Management and Board of Directors 7 Christopher J. Schaber , PhD President & CEO • 26 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 8: Targeted Approach to Treating Oncology & Inflammation BioTherapeutics
Targeted Approach to Treating Oncology & Inflammation BioTherapeutics 8
Slide 9: BioTherapeutics Business Segment
BioTherapeutics Business Segment Soligenix BioTherapeutics Segment Oncology and Oncology Supportive Care SGX301 (Synthetic Hypericin ) Cutaneous T - Cell Lymphoma SGX942 ( Dusquetide ) Oral Mucositis in Head and Neck Cancer SGX201 (Beclomethasone 17,21 - Dipropionate) Acute Radiation Enteritis Autoi
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 or lesions » CTCL affects over 40 , 000 NHL patients worldwide ; currently no cure » Two main subtyp
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 Six 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 and neck (H&N) cancer patients worldwide » Debilitating side effect of cancer chemotherapy and / or radiotherapy o Triggering in
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 – Preliminary Oral Mucositis Results
SGX942 – Preliminary Oral Mucositis Results 15 » Phase 2 exploratory clinical study o Enrolled H&N cancer patients receiving at least 55 Gy radiation and either weekly (30 - 40mg/m 2 ) or every 3 rd week (80 - 100mg/m 2 ) chemotherapy o Dose escalating: Placebo, 1.5, 3.0 and 6.0 mg/kg administered t
Slide 16: SGX942 – Preliminary Oral Mucositis Results
SGX942 – Preliminary Oral Mucositis Results 16 » Clinically Meaningful Results o 50% decrease in duration of severe OM overall with 67% decrease in patients receiving aggressive chemotherapy (80 - 100 mg/m 2 ) ▪ Consistent with decreased incidence and delay in mean onset of severe OM o Increased inc
Slide 17: Pediatric Crohn's Disease – Disease Overview
17 Pediatric Crohn’s Disease – Disease Overview » Pediatric Crohn’s disease o Chronic inflammatory disorder of the gastrointestinal (GI) 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 Addressing Critical Concerns for Industry and Government
Vaccine/BioDefense 19 Addressing Critical Concerns for Industry and Government
Slide 20: Soligenix Vaccine / BioDefense Segment
20 Soligenix Vaccine / BioDefense Segment* ThermoVax ® Vaccine Heat Stabilization Platform Infectious Disease: HPV and Ebola Vaccines BioDefense : RiVax TM Ricin Vaccine OrbeShield ® (Oral BDP Therapeutic ) Gastrointestinal Acute Radiation Syndrome (GI ARS) SGX943 ( Dusquetide Therapeutic) Melioidos
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 for 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 to BARDA » Categ
Slide 24: Investment Highlights
Investment Highlights 24 » Diversified product portfolio in advanced development , targeting rare disease indications in inflammation, oncology and biodefense with $200M+ markets worldwide o Phase 3 clinical program for the treatment of cutaneous T - cell l ymphoma ( SGX301) - Orphan drug and fast t
Slide 25: Thank You
THANK YOU www.soligenix.com Rising to the Challenges of Rare Disease Treatment