Soligenix, Inc. · NASDAQ:SNGX
Soligenix — Investor Presentation (September 2017)
25 slides from Soligenix's investor presentation, Sep 29, 2017
Slide 1: Rising to the Challenges of Rare Disease Treatment
(GOLIGENIX ... Rising to the Challenges of Rare Disease Treatment NASDAQ: 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 Description
Company Description 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 diseases an
Slide 4: Investment Highlights
Investment Highlights Multiple products with fast track and/or orphan designation, each of which holds potential for significant commercial returns Vv » Three Phase 3 assets, one with data readout next year o Cutaneous T-cell lymphoma (SGX301) — Pivotal study in progress with results expected 2H 201
Slide 5: Development Pipeline — Rare Diseases
Development Pipeline — Rare Diseases BioTherapeutics ‘SGX301 N ‘ Cutaneous T-Cell Lymphoma (CTCL) ORPHAN & FAST TRACK DESIGNATION. Enrolling; Ph. 3 data 2H 2018" ‘SGxo42 oa Oral Mucositis in Heed & Neck Canc FAST TRACK DESIGNATION Enrolling; Ph. 3 data 1H 2019" $GX203 TUTORPUAN WAST TRACK DESIENATIO
Slide 6: Multiple Potential Value Drivers
Multiple Potential Value Drivers SGX301 SGX942* SGX203 * 4H: Ph. 3 start Pediatric Crohn's 12 human’ safety study start RiVax®* Groen = achieved Blue = data read-out Orange = regulatory * Potential value drivers dependent on continued government funding andior other funding sources
Slide 7: Significant Global Market Potential
Significant Global Market Potential $500+ Assumptions) 500 + Oral Mucositis in Head & Neck 450 4 Cancer 90,000 Patients US 400 4 90,000 Pationts EU w 3504 20,000 Patients US c 20,000 Patients EU © 3004 Pediatric Crohn’s Disease = 80,000 Patients US t= 2504 80,000 Patients EU = ‘Acute Radiation Enter
Slide 8: BioTherapeutics
BioTherapeutics SOLIGENIX :
Slide 9: BioTherapeutics Business Segment
BioTherapeutics Business Segment Commercial Targets — Unmet Medical Needs in Oncology and Inflammation BioTherapeutics 8@X203 (UU GFPHAN EI FASTTRACRDESIENATIONSTN> Pn. 3 cata 2H 2019" Pediatric Crohn's Disease** s@x201 [DUFASTHRAERBESTGNATIONND Positive phase 172 data Radiation Enteritis" “Anticipa
Slide 10: Cutaneous T-Cell Lymphoma — Disease Overview
Cutaneous T-Cell Lymphoma — Disease Overview * xs) Atypical T-cells S| in dermis Cutaneous T-cell lymphoma (CTCL) Rare class of Non-Hodgkin's Lymphoma (NHL) Malignant T-cells migrate to the skin Cancer forms patches, lesions or tumors CTCL affects over 40,000 NHL patients worldwide; currently no cur
Slide 11: SGX301 — Synthetic Hypericin
SGX301 — Synthetic Hypericin $GX301 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 No approved front-line therapy for early stage (I-I[A) CTCL (~95% of CTCL patients); unmet medical need Most commo
Slide 12: SGX301 — Phase 2 Response Rate
SGX301 — Phase 2 Response Rate CTCL Patch Hypericin Therapy CTCL Patch Pre-Therapy Using Visible Light Post -Therapy Lesion Responses to Synth Following 6 Weeks of Treatment 71] Responders / Total Percent Responders Hypericin Responders 72 58.3% Placebo Responder 412 8.3% Note: No serious adverse ev
Slide 13: Oral Mucositis — Disease Overview
Oral Mucositis — Disease Overview - PA . > Oral mucositis (OM) ” Secondery infection > Multi-factorial disease linked to a dysregulation of the innate immune system » OM affects over 180,000 head & neck (H&N) cancer patients worldwide $500+ million global market potential » Debilitating side effect
Slide 14: SGX942 — Innate Defense Regulator
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 No approved drug for OM in H&N cancer; unmet medical need Market Only approved drug for OM is pa
Slide 15: SGX942 — Oral Mucositis Results
Duration WHORS SGX942 — Oral Mucositis Results » Clinically Meaningful Results demonstrated in the 1.5 mg/kg dose group versus placebo at one month following completion of chemoradiation therapy o Primary Endpoint — Decrease in the duration of severe OM o Primary endpoint outcome consistent with mul
Slide 16: SGX942 — Oral Mucositis Results
SGX942 — Oral Mucositis Results » 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?) o Relative 22% decrease in duration of
Slide 17: Pediatric Crohn's Disease — Disease Overview
Pediatric Crohn’s Disease — Disease Overview Normal mucosa under endoscopy About pediatric Crohn's disease Chronic inflammatory disorder of the gastrointestinal tract Diarrhea, rectal bleeding and abdominal pain Resulting in growth failure, malnutrition, pubertal delay and bone demineralization Over
Slide 18: SGX203 — Beclomethasone Dipropionate
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 No approved drug for mild-to-moderate; unmet m
Slide 19: Vaccine/BioDefense
Vaccine/BioDefense i Addressing Critical Concerns for Industry and Government SOLIGENIX
Slide 20: Vaccine/BioDefense Business Segment
Vaccine/BioDefense Business Segment Funded by Government — Medical Countermeasures (MCMs) for Civilian and Military Use Vaccines / BioDefense** ‘ThermoVax® (TVax) Ebola Vaccine Collaboration; supported by Heat Stabilization Technology for Vaccines NIH Grant Subaward of $700,000 RiVax® + TVax— Heat S
Slide 21: ThermoVax® — Vaccine Thermostability Platform
ThermoVax® — Vaccine Thermostability Platform > ThermoVax® is a proprietary @ 100 freeze-drying process that ° \ © 40°C ThermoVax Positive results: enables vaccines to be stored 2 | \-* 40°¢ original Ricin without refrigeration 3 Anthrax E HPV £ an Ebola ze Demonstrated retained efficacy up to 1 yea
Slide 22: RiVax® — Ricin Toxin Vaccine
RiVax®— Ricin Toxin Vaccine Heat-stable ricin vaccine provided 100% protection in a non-human primate aerosol challenge model (right) Demonstrated safety in Phase 1 Studies % Survival 100+ “Late death not directly 75 attrbuted to ricin intoxication ‘Vaccine (N=12) © sham (N=6) p<0.0001 ° 5 10 15 Day
Slide 23: Experienced Management and Board of Directors
Experienced Management and Board of Directors Christopher J Schaber, PhD President & CEO Oreola Donini, PhD Chief Scientific Officer Karen Krumeich Chief Financial Offic 28 years of experience Discovery Laboratories (COO) Acute Therapeutics (Co-Founder) Ohmeda Pharmaceuticals The Liposome Company Wy
Slide 24: In Summary
In Summary Multiple products with fast track and/or orphan designation, each of which holds potential for significant commercial returns Vv » Three Phase 3 assets, one with data readout next year o Cutaneous T-cell lymphoma (SGX301) — Pivotal study in progress with results expected 2H 2018 o Oral mu
Slide 25: Rising to the Challenges of Rare Disease Treatment
eee challenges of Rare Disease Treatment ay f : ) www.soligenix.com