Soligenix, Inc. · NASDAQ:SNGX
Soligenix — Investor Presentation (January 2013)
25 slides from Soligenix's investor presentation, Jan 10, 2013
Slide 1: Soligenix
(SOLIGENIX OTC QB: SNGX
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," “outlook” and simil
Slide 3: Investment Highlights
Investment Highlights Diverse pipeline with eight (8) potential value drivers in development © Expertise in specialized development areas of Gl, cancer supportive care and biodefense © Innovative products addressing high unmet medical needs © Potential for multiple co-development and/or out-licensin
Slide 4: Development Candidates
Development Candidates Preclinical Phase 1 Phase 2 Phase 3 ‘SGX942 Oral Mucositis in Head and Neck Cancer isexaos [SATE PET HCCDSOTT| Pediatric Crohn's Disease paz cas Radiation Enteritis orBec® Chronic Gastrointestinal (Gl) Graft versus [TORPPANDESIGNATION nn Host Disease (GVHD) Vaccines / BioDefen
Slide 5: Multiple Potential Value Drivers in Coming Months
Multiple Potential Value Drivers in Coming Months a) “4H: Orphan Drug] 2H: P2 startin Oral 2H: P2 data in OM SGX942" Designation Mucositis (OM) $GX203 Drasttack |) | 1H:Pt2staridata | 2H: P2Gstartin | [ 7H: P2data of P2/S | 2H: PS data of P2IS Designation Pediatric Crohn's | Pediatric Crohn's _| | P
Slide 6: Experienced Management and Board of Directors
Experienced Management and Board of Directors Christopher J. Schaber, MS, PhD President & CEO Robert Brey, PhD. Chief Scientific Officer Kevin Horgan, MD Chief Medical Officer Joseph Warusz, CPA, MBA, Acting Chief Financial Officer 23 years of experience Discovery Laboratories (COO) Acute Therapeuti
Slide 7: BioTherapeutics
BioTherapeutics
Slide 8: BioTherapeutics Business Segment
BioTherapeutics Business Segment Our commercial target is inflammation Soligenix eee te Radiation ES — Chronic GI GV! Autoimmune Oral BDP Pediatric Cro (Gl Inflammation) se BioTherapeutics Segment (SOLIGENI
Slide 9: SGX94: Regulating the Innate Defense System
SGX94: Regulating the Innate Defense System First responder to infection and tissue injury Innate Mobilizes anti-infective and tissue healing factors Immunity Mobilizes adaptive immunity May cause excessive inflammatory response Synthetic § amino acid Innate Defense Regulator (IDR) targeting Sequest
Slide 10: Oral Mucositis — Multi-Factorial Disease
Oral Mucositis — Multi-Factorial Disease Debilitating side effect of cancer chemotherapy and / or radiotherapy Massive ulceration of the mouth, tongue, soft palate and oropharynx Results in severe pain, inability to eat, reduced cancer treatment tolerance and significant increases in resource use an
Slide 11: Radiation-Induced Mucositis
Radiation-Induced Mucositis GOLD STANDARD Animal Model of Mucositis related to H&N Cancer + Decreased duration of mucositis by ~50%; + Decreased peak severity from 3.4 to 3.0. 50 i & 40 46% reduction 8 30 P<.001 ao @ 20 g x (10 ie} Vehicle SGX942 Oral Mucositis Induced in Hamsters by Fractionated Ra
Slide 12: Chemo-Induced Mucositis
Chemo-Induced Mucositis PROTECTS against chemotherapy damage PROTECTS ALL mucosal tissue Duration of Severe Oral Mucositis Clinical Endoscopy Score ‘N25: = ° i 5 2 a mn Day 4 Day 7 Cd rs = 315 g : $ 8 10 p<05 a > 2 $ £ B05: a 3 2 z 0. ‘2 00 VEHICLE SGX942 H Vehicle SGX942 Vehicle SGX942 = STUDY DESI
Slide 13: SGX942 for Oral Mucositis
Phase 1 Clinical Trial Market Opportunity Development Plan SGX942 for Oral Mucositis Proprietary composition administered as 4-min IV infusion — short plasma halfife and rapid tissue penetration Phase 1 single and multiple ascending dose, double-blind, placebo-controlled study in 84 healthy voluntee
Slide 14: SGX942 — Other Development Targets
SGX942 — Other Development Targets Multiple targets in infectious disease and biodefense with opportunity for non-dilutive funding to support development Target Indication Potential Application (s)_| ExternalFunding | Summary and Potential Next Steps Vaccine Adjuvant Biodefense; infectious NIH, DoD,
Slide 15: Oral Beclomethasone 17,21-Dipropionate
Oral Beclomethasone 17,21-Dipropionate SGX201, SGX203, orBec® and OrbeShield™ are all independent product opportunities based on our orally administered proprietary formulation technology with beclomethasone 17,21-dipropionate (BDP) Each designed as potent, topically active corticosteroid to treat G
Slide 16: SGX203 for Pediatric Crohn's Disease
SGX203 for Pediatric Crohn’s Disease Two tablet proprietary formulation of immediate and delayed release BDP Designed to block inflammation of Crohn's disease, throughout the Gl tract Positioned as a corticosteroid option with less toxicity than the current standard systemic steroid therapy — predni
Slide 17: SGX201 for Acute Radiation Enteritis
SGX201 for Acute Radiation Enteritis Proprietary time-release formulation of oral BDP Designed to block inflammatory component of radiation enteritis in Gl tract of cancer patients receiving pelvic radiation therapy Phase 1/2 open label, dose-ranging study completed in 16 subjects across five center
Slide 18: Vaccine/BioDefense
Vaccine/BioDefense oo Addressing Critical Concerns for Industry and Government SOLIGENIX
Slide 19: Vaccine/BioDefense Business Model
Vaccine/BioDefense Business Model Infectious Disease Vaccines. ThermoVax™ Heat Stabilization Platform BioDefense Vaccines RiVax™ Ricin Vaccine Soligenix Vaccine / BioDefense Biodefense Vaccines Division VeloThrax™ Anthrax Vaccine * Funded by Government Gastrointestinal Acute Radiation Syndrome (GIAR
Slide 20: ThermoVax - Vaccine Thermostability Platform
ThermoVax™ - Vaccine Thermostability Platform Overview Market Opportunity Development Plan Dried vaccine with desirable physical and immunogenic properties Improved stability and shelf-life at temperatures exceeding 40°C Positive Proof of Concept achieved — 4 months stability data with no degradatio
Slide 21: RiVax - Ricin Toxin Vaccine Overview
Overview Market Opportunity Development Plan RiVax™— Ricin Toxin Vaccine Produced as aluminum-adsorbed vaccine Effectiveness observed against all routes of toxin exposure Non-human primate pilot efficacy studies demonstrated induction of neutralizing antibodies and protection against aerosol exposur
Slide 22: OrbeShield for GI ARS Overview
Overview Market Opportunity Development OrbeShield™ for GI ARS Proprietary two tablet immediate and delayed release BDP formulation Multiple commercial scale cGMP batches manufactured with long-term controlled room temperature stability Statistically significant survival post radiation exposure vers
Slide 23: Significant WW Market Potential
Significant WW Market Potential Oral Mucositis in H&N Cancer {90,000 Patients US 90,000 Patients EU Pediatric Crohn's Disease 80,000 Patients US 80,000 Patients EU Acute Radiation Enteritis 50,000 Patients US 50,000 Patients EU Chronic GI GVHD Treatment 6,000 Patients US 6,000 Patients EU $ Millions
Slide 24: Investment Highlights
Investment Highlights Diverse pipeline with eight (8) potential value drivers in development © Expertise in specialized development areas of Gl, cancer supportive care and biodefense © Innovative products addressing high unmet medical needs © Potential for multiple co-development and/or out-licensin
Slide 25: Thank You
, * | THANK YOU