Soligenix, Inc. · NASDAQ:SNGX
Soligenix — Investor Presentation (January 2015)
30 slides from Soligenix's investor presentation, Jan 7, 2015
Slide 1: Soligenix Corporate Presentation
(GOLIGENIX OTC QB: SNGX
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 products a
Slide 3: Company Highlights
Company Highlights Diversified product portfolio in advanced clinical development, targeting indications with $200M+ markets worldwide © Phase 3 program for the treatment of cutaneous T-cell lymphoma (SGX301) + Orphan drug and fast track designations © Phase 3 program for the treatment of pediatric
Slide 4: Development Candidates
Development Candidates BioTherapeutics SGX301 Saar couns Su Uymmhowsa (CTCTT ‘ORPHAN/FAST TRACK DESIGNATION Ph. 3 data 2H 2016 SOxss2 FAST TRACK DESIGNATION Ph. 2 data 1H 2015" Oral Mucositis in Head & Neck Cancer ote ORPHANIFAST TRACK DESIGNATION Pediatric Crohn's Disease™* Ph. 3 data 1H 2017" SGX2
Slide 5: Multiple Potential Value Drivers
Multiple Potential Value Drivers SE) SGX942 SGX203* SGX201* oresnicia™ (TBE SOLIGENI. 4H: Ph. 3 start in CTCL, 4H: FDA clearance Ph. 3 study 2H: Ph. 1/2 human safety study start 1H: Preclinical study start * Potential value drivers dependent on continued government funding and/or other funding sourc
Slide 6: Experienced Management and Board of Directors
Experienced Management and Board of Directors Christopher J ‘Schaber, MSc, i) President & CEO Richard Straube, MD Chief Medical Offi Oreola Doni PhD Rasappa Arumugham, PhD VP, Biopharm Development Joseph Warusz, CPA, MBA VP & Acting Chief Financial Officer 25 years of experience Discovery Laboratori
Slide 7: BioTherapeutics
BioTherapeutics ™ \ & Targeted Approach to Treating Oncology & Inflammation SOLIGENIX
Slide 8: BioTherapeutics Business Segment
BioTherapeutics Business Segment Commercial targets — unmet medical needs in oncology and inflammation Oncology portive Care ral BDP Acute Radiation (8¢x201) Enteritis
Slide 9: SGX301 — Synthetic Hypericin
SGX301 — Synthetic Hypericin First-in-class, represents new treatment paradigm — safe, visible light activates topical SGX301 (synthetic hypericin) to treat disease Hypericin is one of the most powerful photosensitizers in nature Established mechanism - Generation of singlet oxygen and apoptosis Pat
Slide 10: Cutaneous T-Cell Lymphoma (CTCL)
Cutaneous T-Cell Lymphoma (CTCL) Class of Non-Hodgkin's Lymphoma (NHL) Caused by a mutation of T-cells Most NHLs are B-cell related Malignant, skin-trafficking T-cells are recruited to the upper dermis and epidermis (by virtue of expression of high levels of the chemokine receptor CCR4) Overview Two
Slide 11: SGX301 for CTCL
Phase 1&2 Clinical Trials Market Opportunity Development Plan SGX301 for CTCL First-in-class, proprietary composition represents new treatment paradigm — visible light with topical synthetic hypericin (skin-directed therapy) Phase 1 study in healthy volunteers demonstrated safety and tolerability Ph
Slide 12: SGX301 — Phase 2 Response Rate
SGX301 — Phase 2 Response Rate Summary of CTCL Lesion Responses to Synthetic Hyp Following Six Weeks of Treatment Ointment Responders/Total* Percent Responders* All Hypericin Responders 7/12 Hypericin 0.25% Dose 5/9° Hypericin 0.1% Dose 5/12 Placebo Responder 1/12 Note: No serious adverse events oth
Slide 13: Clinical Efficacy
Clinical Efficacy Before and After - SGX301 and Visible Light CTCL Patch Hypericin Therapy Pre-Therapy Using Visible Light ii (GOLIGENIX
Slide 14: SGX94: Regulating the Innate Defense System
SGX94: Regulating the Innate Defense System Innate Immunity First-in- Class Innate Defense Regulator Robust Preclinical Package First responder to infection and tissue injury Mobilizes anti-infective and tissue healing factors Mobilizes adaptive immunity May cause excessive inflammatory response Syn
Slide 15: 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 16: 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 ° a 2 40 46% reduction ro 2 5g 30 P< 001 8 a eg 20 & a 2 10 ie} Vehicle SGX942 Oral Mucositis Induced in Hamsters by Fracti
Slide 17: Chemo-Induced Mucositis
Chemo-Induced Mucositis PROTECTS against chemotherapy damage PROTECTS ALL mucosal tissue Duration of Severe Oral Mucositis Clinical Endoscopy Score R 25 = 2 g 20 Day 4 Day 7 3 2 ———— ic 53% reduction 5 £ 3 154 2 2 $ 3 10. a a 3 ¢ 305 2 3 z & x = 0.0 VEHICLE SGX942 q Vehicle SGX942 Vehicle SGX942 = O
Slide 18: 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 half-life, rapid tissue penetration and prolonged pharmacodynamic impact Phase 1 single and multiple ascending dose, double-blind, placebo-con
Slide 19: 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 Targetindications | PotentialApplications | PotentialFunding | Summary and Potential Next Steps Melioidosis Biodefense — Category B; NIH
Slide 20: Oral Beclomethasone 17,21-Dipropionate
Oral Beclomethasone 17,21-Dipropionate SGX201, SGX203 and OrbeShield™ are all independent product opportunities based on our orally administered proprietary formulation technology with beclomethasone 17,21-dipropionate (BDP) Each enables potent, topical corticosteroid effectto treat GI inflammation
Slide 21: SGX203 for Pediatric Crohn's Disease
SGX203 for Pediatric Crohn’s Disease Two tablet proprietary formulation of immediate and delayedrelease BDP Oleniew Designed to treat inflammation throughout the Gl tract Positioned as a corticosteroid option with less toxicity than the current standard systemic steroid therapy — prednisone Over 160
Slide 22: Vaccine/BioDefense
Vaccine/BioDefense Tt Addressing Critical Concerns for Industry and Government SOLIGENIX
Slide 23: Vaccine/BioDefense Business Segment
Vaccine/BioDefense Business Segment Infectious Di Vaccines Stabilization Platform ligenix joDefens: Vaccine / BioDefense Gngere® Vaccines VeloThrax™ Anthrax Vaccine * Funded by Government (GI ARS) Melioidosis (GOLIGENI
Slide 24: 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 (POC) — 1 year stability data with no degradation Pre
Slide 25: RiVax — Ricin Toxin Vaccine
Overview Market Opportunity Development Plan RiVax™ — Ricin Toxin Vaccine Produced as aluminum-adsorbed vaccine Efficacy against all routes of toxin exposure Statistically significant (p < 0.002) survival versus controls in non-human primate (NHP) lethal ricin toxin aerosol exposure model Induction
Slide 26: OrbeShield for GI ARS
Overview Market Opportunity Development OrbeShield™ for GI ARS Proprietary two tablet immediate and delayedrelease BDP formulation Multiple commercial scale cGMP batches manufactured with long-term controlled room temperature stability Statistically significant survival post radiation exposure versu
Slide 27: SGX101 for Melioidosis
Overview Market Opportunity Development Plan SGX101 for Melioidosis Melioidosisis caused by Burkholderia pseudomallei (Bps) Frequently resistant to antibiotic treatment High mortality and relapse rate, despite prolonged therapy Exclusive Channel Collaboration with Intrexon Corporation Development of
Slide 28: Significant WW Market Potential
Significant WW Market Potential $500+ $ Millions SGX942 _ SGX301 Oral Cutaneous Mucositis T-Cell Lymphoma SOLIGENIX SGX203 Pediatric Crohn's Disease SGx201 ‘Acute Ra Enteritis $500 Assumptions Syndrome Oral Mucositis in H&N Cancer 20,000 Patients US 90,000 Patients EU 20,000 Patients US 20,000 Patie
Slide 29: Investment Highlights
Investment Highlights Diversified product portfolio in advanced clinical development, targeting indications with $200M+ markets worldwide © Phase 3 program for the treatment of cutaneous T-cell lymphoma (SGX301) + Orphan drug and fast track designations © Phase 3 program for the treatment of pediatr
Slide 30: Thank You
THANK YOU