Soligenix, Inc. · NASDAQ:SNGX
Soligenix — Investor Presentation (June 2019)
23 slides from Soligenix's investor presentation, Jun 12, 2019
Slide 1: Rising to the Challenges of Rare Disease Treatment
… 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 Three Phase 3 assets, two with data readout approaching o Cutaneous T-cell lymphoma (SGX301) ‒ Pivotal study in progress; interim analysis complete;
Slide 5: Development Pipeline – Rare Diseases
Development Pipeline – Rare Diseases BioTherapeutics Product Candidates Preclinical Phase 1 Phase 2 Phase 3 Market SGX301 ORPHAN & FAST TRACK DESIGNATION Enrolling; Ph. 3 data 1Q 2020* Cutaneous T-Cell Lymphoma (CTCL) SGX942 FAST TRACK DESIGNATION Enrolling; Ph. 3 data 1H 2020* Oral Mucositis in Hea
Slide 6: Multiple Potential Value Drivers
Multiple Potential Value Drivers 2018 2019 2020 SGX301 Ph. 3 interim 2H: Ph. 3 study 1H: Ph. 3 final 2H: (US) NDA/MAA analysis CTCL complete CTCL data CTCL (1Q) submission CTCL SGX942 * NIH CAP Award Ph. 3 interim 2H: Ph. 3 study 1H: Ph. 3 final 2H: (US) NDA/MAA Oral Mucositis (OM) enrollment comple
Slide 7: Significant Global Market Potential
Significant Global Market Potential $500+ Assumptions(1) 500 $450 Oral Mucositis in Head & Neck Cancer 450 90,000 Patients US 90,000 Patients EU 400 Cutaneous T-Cell Lymphoma 20,000 Patients US 350 $ Millions $300 20,000 Patients EU 300 Pediatric Crohn’s Disease 80,000 Patients US $250 250 80,000 Pa
Slide 8: BioTherapeutics
BioTherapeutics Targeted Approach to Treating Oncology & Inflammation 8
Slide 9: BioTherapeutics Business Segment
BioTherapeutics Business Segment Commercial Targets – Unmet Medical Needs in Oncology and Inflammation BioTherapeutics Product Candidates Preclinical Phase 1 Phase 2 Phase 3 Market SGX301 ORPHAN & FAST TRACK DESIGNATION Enrolling; Ph. 3 data 1Q 2020* Cutaneous T-Cell Lymphoma (CTCL) SGX942 FAST TRAC
Slide 10: Cutaneous T-Cell Lymphoma – Disease Overview
Cutaneous T-Cell Lymphoma – Disease Overview Atypical T-cells in dermis Cutaneous T-cell lymphoma (CTCL) o Rare class of Non-Hodgkin's Lymphoma (NHL) o Malignant T-cells migrate to the skin o Cancer forms patches, lesions or tumors CTCL affects over 40,000 NHL patients worldwide; currently no cu
Slide 11: SGX301 – Synthetic Hypericin
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 No approved front-line therapy for early stage (I-IIA) CTCL (~95% of CTCL patients); unmet medical need Most c
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 Summary of CTCL Lesion Responses to Synthetic Hypericin Ointment Following 6 Weeks of Treatment Responders / Total Percent Responders Hypericin Responders 7/12 58.3% Placebo Responder
Slide 13: SGX301 – Pivotal Phase 3 Clinical Trial
SGX301 – Pivotal Phase 3 Clinical Trial Highly powered, double-blind, placebo-controlled, randomized o Randomized 2 SGX301 (Synthetic Hypericin) : 1 placebo o Actively enrolling ~160 evaluable subjects across ~35 US study sites o Independent interim analysis of ~100 subjects complete – adjustment
Slide 14: Oral Mucositis – Disease Overview
Oral Mucositis – Disease Overview Inflammation causes worsening damage Ref: S. Sonis 2004 Oral mucositis (OM) Secondary infection o Multi-factorial disease linked to a dysregulation of the innate immune system OM affects over 180,000 head & neck (H&N) cancer patients worldwide o $500+ million gl
Slide 15: 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 i
Slide 16: SGX942 – Phase 2 Study Results
SGX942 – Phase 2 Study Results Clinically Meaningful Results demonstrated with 1.5 mg/kg dose versus placebo o Reduction in duration of severe OM, coupled with accelerated tumor clearance, reduced infection rate and improved survival Identified patients at highest risk of developing severe OM (8
Slide 17: SGX942 – Pivotal Phase 3 Clinical Trial
SGX942 – Pivotal Phase 3 Clinical Trial Highly powered, multi-national, double-blind, placebo-controlled, randomized o Head and neck cancer patients receiving chemoradiation therapy including at least 55 Gy fractionated radiation and 80-100 mg/m2 cisplatin every third week o Randomized 1 SGX942 (D
Slide 18: Vaccine/BioDefense
Vaccine/BioDefense Addressing Critical Concerns for Industry and Government 18
Slide 19: Vaccine/BioDefense Business Segment
Vaccine/BioDefense Business Segment Funded by Government – Medical Countermeasures (MCMs) for Civilian and Military Use Vaccines / BioDefense** Product Candidates (FDA Animal Rule) Proof-of-Concept Animal Phase 1 Phase 2/3 Market ThermoVax® (TVax) VACCINE PLATFORM Ebola Vaccine Collaboration; suppor
Slide 20: RiVax – Ricin Toxin Vaccine
RiVax® – Ricin Toxin Vaccine 100 Heat-stable ricin vaccine provided * L a te d e a th n o t d ire c tly 100% protection in a non-human % S u r v iv a l 75 a ttrib u te d to ric in in to x ic a tio n primate aerosol challenge model V a c c in e (N = 1 2 ) (right) 50 S h a m (N = 6 ) Demonstrated safe
Slide 21: Experienced Management and Board of Directors
Experienced Management and Board of Directors • 29 years of experience Keith • 35 years of experience • Discovery Laboratories (COO) Brownlie, CPA • Formerly of Ernst & Young Christopher J. • Acute Therapeutics (Co-Founder) Schaber, PhD President & CEO • Ohmeda Pharmaceuticals • 20 years of experien
Slide 22: In Summary
In Summary Multiple products with fast track and/or orphan designation, each of which holds potential for significant commercial returns Three Phase 3 assets, two with data readout approaching o Cutaneous T-cell lymphoma (SGX301) ‒ Pivotal study in progress; interim analysis complete; final resu
Slide 23: Thank You
Rising to the Challenges of Rare Disease Treatment THANK YOU www.soligenix.com