Soligenix, Inc. · NASDAQ:SNGX
Soligenix — Investor Presentation (September 2020)
36 slides from Soligenix's investor presentation, Sep 10, 2020
Slide 1: COVID-19 Landscape and Applications
COVID - 19 Landscape and Applications 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 produ
Slide 3: Agenda
Agenda » Corporate overview Dr. Christopher Schaber, President & CEO, Soligenix » COVID - 19 and vaccine overview Dr. Axel Lehrer, Associate Professor, University of Hawaii » CiVax program overview Dr. Oreola Donini, CSO, Soligenix » Dusquetide in COVID - 19 Dr. Oreola Donini » COVID - 19 vaccine ma
Slide 4: Christopher Schaber, PhD, Chairman, President & CEO
Christopher Schaber, PhD » Chairman, President & CEO » 30 years of broad R&D and operational experience across pharmaceutical and biotech industry o Discovery Laboratories (COO) o Acute Therapeutics (Co - Founder) o Ohmeda Pharmaceuticals o The Liposome Company o Wyeth Ayerst » Detailed bio at: http
Slide 5: 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 Specialized BioTherapeutics segment dedicated to the development of products for orph
Slide 6: Development Pipeline – Rare Diseases
Development Pipeline – Rare Diseases Product Candidates Preclinical Phase 1 Phase 2 Phase 3 Market SGX301 Cutaneous T - Cell Lymphoma (CTCL) SGX942 Oral Mucositis in Head & Neck Cancer SGX203 Pediatric Crohn’s Disease** SGX201 Radiation Enteritis** Specialized BioTherapeutics Public Health Solutions
Slide 7: Axel Lehrer, PhD, Associate Professor
Axel Lehrer, PhD » Associate Professor, Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine, University of Hawaiʻi at Mānoa » 18 years of experience in vaccine research and development o Previous research in vaccine R&D with filoviruses (e.g., Ebo
Slide 8: COVID-19: Disease Background
COVID - 19: Disease Background » Respiratory illness caused by SARS - CoV - 2 virus o Droplet transmission is believed to be the major mode of transmission in enclosed spaces o Spike protein (trimeric glycoprotein on viral surface) is key to viral entry, utilizing the human ACE2 receptor, which is p
Slide 9: COVID-19: Treatment Background
COVID - 19: Treatment Background » Treatment options focused on “severe” disease o Remdesivir shown to decrease length of hospital stay, but not to increase survival (yet) ▪ Anti - viral treatment administered IV and likely primarily targets systemic viral circulation o Dexamethasone may decrease mo
Slide 10: COVID-19: Vaccine Background
COVID - 19: Vaccine Background » Many vaccines in development – utilizing different vaccine platforms o Different platforms may be used to target different patient populations ▪ Mainly driven by safety profile o Different platforms have different logistical requirements ▪ Storage/distribution requir
Slide 11: Vaccine Platforms
Vaccine Platforms » Development Platforms: o Conventional (live attenuated, inactivated virus) o Subunit (conventional or recombinant) o Recombinant (genetic expression of antigen): ▪ Viral vectors (replicated limited or incompetent) – Adenovirus, chimp adenovirus, VSV, measles virus etc. ▪ RNA ▪ DN
Slide 12: Immune Response
Immune Response » Different platforms modulate different immune responses » For COVID - 19, emphasis has been placed on: o Total antibody response ▪ Can be raised by isolated pieces of the virus (e.g., pieces of protein) ▪ Antibodies to Receptor - binding domain are believed to inhibit viral entry o
Slide 13: Immune Response
Immune Response 13 From: Barrett, AD (2008). Nature Biotechnology 26, 525 - 526 Journal of Clinical and Experimental Hepatology DOI: (10.1016/j.jceh.202 0.06.003) » Live - attenuated vaccine ( LA) » Inactivated vaccine ( IA) » DNA vaccine ( DNA) » RNA vaccine (RNA ) » Viral vector replicating vaccin
Slide 14: Vaccine Candidates
Vaccine Candidates 14 From: Barrett, AD (2008). Nature Biotechnology 26, 525 - 526 Platform Pre - clinical Phase I Phase II Phase III Inactivated 9 2 ? 3 live attenuated 4 protein subunits 61 5 4 ? VLP 14 1 DNA 12 4 ? RNA 21 2 2 ? 2 ? non - replicating viral vector 20 1 3 ? 1 replicating viral vecto
Slide 15: Oreola Donini, PhD, SVP & Chief Scientific Officer
Oreola Donini, PhD » Senior Vice - President & Chief Scientific Officer » 20 years industry experience o Inimex Pharmaceuticals o ESSA Pharma, Inc. o Kinetek Pharmaceuticals » Focused preclinical and early clinical development o Lead programs in early manufacturing, GLP toxicology and pharmacology o
Slide 16: Anti-viral Glycoprotein Vaccine Platform
Anti - viral Glycoprotein Vaccine Platform 16 » Antibody and cell - mediated responses preferred » Viral antigens are often multimeric viral surface glycoproteins » Platform developed in collaboration with University of Hawaii o Insect cell expression system to produce multimeric proteins with stabl
Slide 17: Soligenix: Anti-Viral Protein Vaccines
Soligenix: Anti - Viral Protein Vaccines » Gold standard vaccine platform for safety o Equally applicable to older populations and immunocompromised populations, allowing widest possible application » Antigen production o Stably transformed insect S2 expression system produces stable glycosylation c
Slide 18: CoVaccine HT – Nanoemulsion adjuvant
CoVaccine HT™ – Nanoemulsion adjuvant 18 » Safety demonstrated in Phase 1 and Phase 2 clinical studies in a non - infectious disease context o MTD 10 mg/dose » Nonclinical efficacy data in the context of viral vaccines (e.g., EBOV, SUDV, MARV, Zika, Tick borne encephalitis) o Broad applicability to
Slide 19: TriFiloVax – Ebola and Marburg Vaccines
TriFiloVax – Ebola and Marburg Vaccines CoVaccine - adjuvanted filovirus vaccine provided 100 % protection in a non - human primate challenge model with Marburg marburgvirus Market Opportunity » Filovirus infections ( Sudan virus, Marburg virus and Ebola virus ) are deadly; only Ebola vaccine is app
Slide 20: Glycoprotein Platform for COVID-19
Glycoprotein Platform for COVID - 19 20 Parameter Filovirus Coronavirus Surface glycoprotein antigen x (GP) x (Spike) Multimeric glycoprotein structure x (trimer+) x (trimer) Humoral + cell mediated adjuvancy likely required x x Cell construct for S2 expression system x x Formulation conditions iden
Slide 21: CiVax Benefits
CiVax™ Benefits 21 » CoVaccine shown to elicit Th1 balanced humoral and cell mediated immunity with prototype Spike S1 protein antigen in Th2 - biased mice, yielding neutralizing antibodies of similar levels to convalescent plasma. Strong antibody response within 14 days of the first vaccination » P
Slide 22: CiVax Competitive Profile
CiVax™ Competitive Profile 22 Parameter / Platform Protein (Soligenix / UH) * Protein (NovaVax) rVSV chAd (AstraZeneca) Ad26 (Janssen) RNA (Moderna/ BioNtech) Ambient storage x ? × × × × Immune compromised populations? x x × × × ? Repeat vaccination possible? x x × Limited Limited x Single dose regi
Slide 23: WHO Target Product Profile (TPP)
WHO Target Product Profile (TPP) 23 WHO Preferred Characteristic CiVax™ TPP Thermostability (higher temperature preferred) x No contra - indications x Rapid onset of immunity x Single dose regimen (minimal: no more than 2) x Durability of at least 1 year (minimal: At least 6 months) ? Non - parenter
Slide 24: CiVax – COVID-19 Vaccine Candidate
CiVax™ – COVID - 19 Vaccine Candidate Proof of concept study with S1 Spike protein and CoVaccine HT™ adjuvant with rapid and potent onset of immunogenicity Market Opportunity » Pandemic response will require many different vaccines to produce adequate coverage worldwide » Rapid distribution enabled
Slide 25: CiVax – Proof of Concept Study
CiVax™ – Proof of Concept Study 25 » Selective response » Th1 bias preferred for COVID - 19 vaccines o Th1 response demonstrated (IgG2a and IgG2b subtype responses) in BALB/c ( Th2 - biased ) mice with the use of CoVaccine o Superior response to alhydrogel (alum) – shows strong Th2 bias Isotype Char
Slide 26: CiVax – Proof of Concept Study
CiVax™ – Proof of Concept Study 26 » Strong neutralizing antibody responses o PRNT90 = 1620 o As good as post - convalescent plasma » Enhanced cell mediated immunity o IFN response indicative of Th1 - biased T - cell memory response » Actively exploring the p ossibility for single dose formulation C
Slide 27: CiVax – Proprietary Antigen
CiVax™ – Proprietary Antigen 27 » Expression of full spike protein with mutation to lock the pre - fusion configuration » Immunoaffinity chromatography ensures proper / recognizable protein antigen » Immunogenicity as early as 7 days post - dose o CoVaccine improves kinetics and magnitude of respons
Slide 28: CiVax – Proprietary Antigen
CiVax™ – Proprietary Antigen » Strong Th1 response in adjuvanted vaccine after 2 nd dose o IgG2a and IgG2b represent the Th1 response o Study conducted in Swiss Webster mice (outbred) 28
Slide 29: CiVax – Proprietary Antigen
CiVax™ – Proprietary Antigen » Strong cell mediated immune response after 2 nd dose o Preliminary data show high amount of cells secreting IFN - representing recall memory response of splenic T - cells 29
Slide 30: Dusquetide – Potential Therapeutic in COVID-19
Dusquetide – Potential Therapeutic in COVID - 19 30 » Dusquetide (active ingredient in SGX942 for oral mucositis) has been shown to control the inflammatory response to infection while enhancing the anti - infective and tissue healing pathways » Potential to provide benefit in preventing progression
Slide 31: Daniel Ring, MBA, VP Business Development and Strategic Planning
Daniel Ring, MBA » Vice President, Business Development and Strategic Planning » 22 years industry experience, o Business development experience includes work with large (e.g., Merck & Co.) and small companies o Experience with growing commercial operations (e.g., Exela Pharma Sciences LLC) » Detail
Slide 32: COVID-19 Vaccine Market Potential
COVID - 19 Vaccine Market Potential 32 Sources: *Goldman Sachs research note July 29, 2020, assumes 50% vaccination rate and two does at $19.50 / dose. § Market Insights report. ± CDC Potential Value » Global COVID - 19 vaccine market is estimated to be worth approximately $23 Billion* o Current ent
Slide 33: First Generation Vaccines vs. Second Generation CiVax
First Generation Vaccines vs. Second Generation CiVax™ » First generation vaccines utilize more novel and less understood technologies o Potential to introduce additional regulatory risk and may limit repeat use o “Tried and True” protein subunit vaccine has established regulatory and safety precede
Slide 34: Christopher Schaber, PhD, Chairman, President & CEO
Christopher Schaber, PhD » Chairman, President & CEO » 30 years of broad R&D and operational experience across pharmaceutical and biotech industry o Discovery Laboratories (COO) o Acute Therapeutics (Co - Founder) o Ohmeda Pharmaceuticals o The Liposome Company o Wyeth Ayerst » Detailed bio at: http
Slide 35: In Summary
In Summary » Multiple products with fast track and/or orphan designation, each of which holds potential for significant commercial returns » Phase 3 assets with data readout approaching o Cutaneous T - cell lymphoma (SGX301) – Positive statistically significant final results achieved ; follow - up o
Slide 36: Question & Answer Session
Question & Answer Session NASDAQ: SNGX