Soligenix, Inc. · NASDAQ:SNGX
Soligenix — Investor Presentation (July 2013)
26 slides from Soligenix's investor presentation, Jul 12, 2013
Slide 1: Soligenix
((SOLIGENIX OTC QB: SNGX
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation and the comments of our management related thereto 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,
Slide 3: Company Highlights
Company Highlights • Diverse pipeline with nine (9) potential value drivers in development o Innovative products addressing high unmet medical needs o Experienced management and Board of Directors o Expertise in specialized development areas of GI, cancer supportive care and biodefense o Potential f
Slide 4: Development Candidates
Development Candidates BioTherapeutics Preclinical Phase 1 Phase 2 Phase 3 SGX942 FAST TRACK DESIGNATION Ph. 2 data 2H 2014* Oral Mucositis in Head & Neck Cancer SGX203 Pediatric Crohn’s Disease ORPHAN/FAST TRACK DESIGNATION Ph. 2/3 data 2H 2014* SGX201 FAST TRACK DESIGNATION Ph. 2b start 1H 2014* R
Slide 5: Multiple Potential Value Drivers
Multiple Potential Value Drivers 2012 2013 2014 1H: Oral Mucositis 2H: P2 start in OM 2H: P2 data in OM SGX942* (OM) IND Clearance 2H: Fast Track 1H: P1/2 start/data 2H: P2/3 start in 1H: P2 of P2/3 2H: P2/3 data of SGX203 Designation Pediatric Crohn’s Pediatric Crohn’s Pediatric Crohn’s Pediatric C
Slide 6: Experienced Management and Board of Directors
Experienced Management and Board of Directors • 23 years of experience • Discovery Laboratories (COO) Christopher J. Schaber, MS, PhD • Acute Therapeutics (Co-Founder) Keith Brownlie, • 35 years of experience President & CEO • Ohmeda PPD CPA • Ernst & Young • The Liposome Company • Wyeth Ayerst • 20
Slide 7: BioTherapeutics
BioTherapeutics Targeted Approach to Treating Inflammation 7
Slide 8: BioTherapeutics Business Segment
BioTherapeutics Business Segment Our commercial target is inflammation Oral Mucositis in SGX942 Head & Neck Cancer Supportive Cancer Care Acute Radiation Enteritis Oral BDP Soligenix (orBec®, SGX201) BioTherapeutics Chronic GI GVHD Segment Autoimmune Oral BDP Pediatric Crohn’s (GI Inflammation) (SGX
Slide 9: SGX94: Regulating the Innate Defense System
SGX94: Regulating the Innate Defense System • First responder to infection and tissue injury Innate o Mobilizes anti-infective and tissue healing factors Immunity o Mobilizes adaptive immunity o May cause excessive inflammatory response • Synthetic 5 amino acid Innate Defense Regulator (IDR) targeti
Slide 10: Oral Mucositis – Multi-Factorial Disease
Oral Mucositis – Multi-Factorial Disease • Debilitating side effect of cancer chemotherapy and / or radiotherapy o Massive ulceration of the mouth, tongue, soft palate and oropharynx Mucositis o Results in severe pain, inability to eat, reduced cancer treatment tolerance and significant increases in
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 % Days Score of >/= 3 P < .001 Oral Mucositis Induced in Hamsters by Fractionated Radiation – GOLD STANDARD • On study days 0,
Slide 12: Chemo-Induced Mucositis
Chemo-Induced Mucositis PROTECTS against chemotherapy damage PROTECTS ALL mucosal tissue Duration of Severe Oral Mucositis Clinical Endoscopy Score %Animals Days with a Score ≥ 3 25 M ean Endoscopy Colitis Score (+/-SEM ) Day 4 Day 7 2.0 20 53% reduction 1.5 15 p<.001 10 1.0 p<.05 5 0.5 0 0.0 VEHICL
Slide 13: SGX942 for Oral Mucositis
SGX942 for Oral Mucositis • Proprietary composition administered as 4-min IV infusion – short plasma half-life and rapid tissue penetration • Phase 1 single and multiple ascending dose, double-blind, placebo-controlled study Phase 1 in 84 healthy volunteers o Safe and well tolerated Clinical Trial o
Slide 14: SGX942 – Other Development Targets
SGX942 – Other Development Targets Multiple potential targets in infectious disease and biodefense with opportunity for non-dilutive funding to support development Target Indication Potential Application (s) Potential Funding Summary and Potential Next Steps Vaccine Adjuvant Biodefense; infectious N
Slide 15: Oral Beclomethasone 17,21-Dipropionate
Oral Beclomethasone 17,21-Dipropionate • SGX201, SGX203, orBec® and OrbeShieldTM are all independent product opportunities based on our orally administered proprietary formulation technology with beclomethasone 17,21-dipropionate (BDP) o Each enables potent, topical corticosteroid effect to treat GI
Slide 16: SGX203 for Pediatric Crohn's Disease
SGX203 for Pediatric Crohn’s Disease • Two tablet proprietary formulation of immediate and delayed release BDP Overview o Designed to treat inflammation throughout the GI tract o Positioned as a corticosteroid option with less toxicity than the current standard systemic steroid therapy – prednisone
Slide 17: SGX201 for Acute Radiation Enteritis
SGX201 for Acute Radiation Enteritis • Proprietary time-release formulation of oral BDP o Designed to block inflammatory component of radiation enteritis in GI tract of cancer patients receiving pelvic radiation therapy • Phase 1/2 open label, dose-ranging study completed in 16 subjects across five
Slide 18: Vaccine/BioDefense
Vaccine/BioDefense Addressing Critical Concerns for Industry and Government 18
Slide 19: Vaccine/BioDefense Business Segment
Vaccine/BioDefense Business Segment Infectious Disease Vaccines ThermoVaxTM Heat Stabilization Platform BioDefense Vaccines RiVaxTM Ricin Vaccine BioDefense Vaccines Soligenix Vaccine / BioDefense VeloThraxTM Division Anthrax Vaccine OrbeShieldTM Gastrointestinal Acute * Funded by Government (Oral B
Slide 20: ThermoVax – Vaccine Thermostability Platform
ThermoVaxTM – Vaccine Thermostability Platform • Dried vaccine with desirable physical and immunogenic properties • Improved stability and shelf-life at temperatures exceeding 40ºC o Positive Proof of Concept achieved – 6 months stability data with no degradation • Preservation of native protein str
Slide 21: RiVax – Ricin Toxin Vaccine
RiVaxTM – Ricin Toxin Vaccine • Produced as aluminum-adsorbed vaccine o Effectiveness observed against all routes of toxin exposure • Non-human primate pilot efficacy studies demonstrated induction of Overview neutralizing antibodies and protection against aerosol exposure • Phase 1 studies demonstr
Slide 22: OrbeShield for GI ARS
OrbeShieldTM for GI ARS • Proprietary two tablet immediate and delayed release BDP formulation o Multiple commercial scale cGMP batches manufactured with long-term controlled room temperature stability Overview • Statistically significant survival post radiation exposure versus controls in canine mo
Slide 23: SGX101 for Melioidosis
SGX101 for Melioidosis • Melioidosis is caused by Burkholderia pseudomallei (Bps) o Frequently resistant to antibiotic treatment o High mortality and relapse rate, despite prolonged therapy • Exclusive Channel Collaboration with Intrexon Corporation o Development of human monoclonal antibody (mAb) t
Slide 24: Significant WW Market Potential
Significant WW Market Potential $500+ $500 Assumptions(1) 500 Oral Mucositis in H&N Cancer $450 450 90,000 Patients US 90,000 Patients EU 400 Pediatric Crohn’s Disease 80,000 Patients US 350 $ Millions 80,000 Patients EU $300 Acute Radiation Enteritis in 300 Colorectal cancer 50,000 Patients US 250
Slide 25: Investment Highlights
Investment Highlights • Diverse pipeline with nine (9) potential value drivers in development o Innovative products addressing high unmet medical needs o Experienced management and Board of Directors o Expertise in specialized development areas of GI, cancer supportive care and biodefense o Potentia
Slide 26: Thank You
THANK YOU www.soligenix.com