Seres Therapeutics, Inc. · NASDAQ:MCRB
Seres Therapeutics — Cowen and Company 37th Annual Health Care Conference (March 2017)
29 slides from Seres Therapeutics's conference presentation, Mar 8, 2017
Slide 1: Cowen and Company 37th Annual Health Care Conference
Cowen and Company 37th Annual Health Care Conference Roger J. Pomerantz, M.D. President, Chief Executive Officer and Chairman Leading the Microbiome Revolution March 8, 2017 1
Slide 2: Forward looking statements
Forward looking statements Some of the statements in this presentation constitute “forward looking statements” under the Private Securities Litigation Reform Act of 1995. Such statements are subject to factors, risks and uncertainties (such as those detailed in the Company’s periodic filings with th
Slide 3: Investor highlights
Investor highlights Expansive therapeutic opportunity utilizing the Opportunity microbiome, a highly promising new area of medicine Seres is a leader in microbiome drug development Platform with differentiated capabilities Broad pipeline in infectious, inflammatory and Pipeline immune, metabolic and
Slide 4: The microbiome is essential to human health
The microbiome is essential to human health Infectious Disease • A diverse microbiome resists colonization by exogenous pathogens • Exposure to spectrum antibiotics, and resulting gut microbiome dysbiosis, increase risk for C. difficile infection and colonization / infection by multi-drug resistant
Slide 5: Business strategy
Business strategy World class, Focused clinical Research in new differentiated, efforts therapeutic areas microbiome expertise • Prioritize serious • Computational • Collaborate with diseases where biology leading academic dysbiosis of the gut • Basic microbiome centers to advance microbiome has a r
Slide 6: Robust microbiome therapeutics pipeline
Robust microbiome therapeutics pipeline PRECLINICAL PHASE 1 PHASE 2 SER-109 Recurrent C. difficile SER-262 Primary C. difficile SER-287 Ulcerative Colitis SER-301 Inflammatory Bowel Disease (IBD) Prevention of infection and GVHD following SER-155 hematologic stem cell or solid organ transplant Synth
Slide 7: Differentiated microbiome R&D platform
Differentiated microbiome R&D platform Computational In silico discovery using human derivation of clinical datasets to ‘backbone’ allow rational design of functional microbiome drugs in microbial multiple therapeutic ecologies Microbial Functional areas networks pathways Vast microbial strain libra
Slide 8: CMC platform enables manufacture of cGMP-compliant, oral, microbiome therapeutic candidates
CMC platform enables manufacture of cGMP-compliant, oral, microbiome therapeutic candidates Fermentation of anaerobic and cGMP Isolation of spores from complex spore-forming microbes biological materials Synthetic Biologically candidates a sourced a Novel germination, cultivation, and Formulation, F
Slide 9: Clostridium difficile Infection
Clostridium difficile Infection Overview and R&D Programs Leading the Microbiome Revolution 9
Slide 10: C. difficile infection overview
C. difficile infection overview • Infectious disease caused by toxin producing anaerobic, spore-forming bacteria, resulting in diarrhea, abdominal pain, fever, and nausea • Leading cause of hospital-acquired infection in the US; approximately 29,000 deaths/year • Infection caused by two-hit process:
Slide 11: Treatment landscape & disease burden
Treatment landscape & disease burden Modality Characteristics • Perpetuates microbiome dysbiosis, creating C. difficile Antibiotics infection susceptibility • High recurrence rates, especially in recurrent cases • Invasive procedures (colonoscopy or NG-tube) Fecal Transplant • Potential for transmis
Slide 12: Dysbiosis and potential for therapeutic intervention
Dysbiosis and potential for therapeutic intervention Hypothetical patient course High diversity microbiome Antibiotic Potential for mediated microbiome therapy microbiome diversity C. diff. bacterial & dysbiosis to increase cytotoxin levels Gastrointestinal bacterial diversity in the colon Antibioti
Slide 13: SER-109 Phase 1b and Phase 2 (8-week) study results
SER-109 Phase 1b and Phase 2 (8-week) study results Phase 1b Phase 2 – Interim results Open Label, Single-Arm Randomized, Placebo-Controlled (n=30; 4 sites) (n=89; randomized 2:1; 28 sites) Primary CDI recurrence up to 8 weeks defined CDI recurrence up to 8 weeks defined by: ≥3 Endpoint by: >3 unfor
Slide 14: SER-109 Phase 2 study post read-out analyses and findings
SER-109 Phase 2 study post read-out analyses and findings SER-109 analyses Key issues addressed • Detailed analyses of clinical data Clinical • Investigation of C. difficile diagnostics Pharmacodynamics / • Investigation of drug activity microbiome analyses • Drug product distribution and handling C
Slide 15: Further SER-109 clinical development
Further SER-109 clinical development • FDA discussions regarding a new SER-109 clinical study in progress • Anticipate completion of FDA dialogue in the near future 15
Slide 16: SER-262: Synthetic Ecobiotic drug candidate for primary C. difficile infection
SER-262: Synthetic Ecobiotic® drug candidate for primary C. difficile infection • Oral, microbiome therapeutic candidate comprising twelve strains of fermented, rationally selected bacterial spores • Bacteria species selected based on analysis of SER-109 Phase 1b microbiome data, biological and phyl
Slide 17: SER-262 Phase 1b to provide insight into efficacy and safety in primary C. difficile infection
SER-262 Phase 1b to provide insight into efficacy and safety in patients with primary C. difficile infection Arm A: Tx with 104 spores (n=10); placebo (n=2) Primary Objective • Safety and tolerability at 24 weeks Arm B: Tx with 105 spores (n=10); placebo (n=2) • Relative risk of C. difficile 60 pati
Slide 18: Inflammatory Bowel Disease
Inflammatory Bowel Disease Overview and R&D Programs Leading the Microbiome Revolution 18
Slide 19: Multiple FMT studies provide proof of concept for microbiome therapy in ulcerative colitis
Multiple FMT studies provide proof of concept for microbiome therapy in ulcerative colitis Subject A, Subject A, Baseline 8-wk post FMT 19 Selected references: Paramsothy et al. Lancet, 2017; Moayyedi et al. Gastroenterology, 2015
Slide 20: SER-287 Inflammatory Bowel Disease (IBD) opportunity
SER-287 Inflammatory Bowel Disease (IBD) opportunity Significant unmet need for improved therapies for IBD • Large US population: ~700K ulcerative colitis, ~700K Crohn’s • Only~30% of patients respond to currently approved therapies • Many therapies are immunosuppressive, limiting widespread use SER
Slide 21: SER-287 Phase 1b to provide insight into efficacy and mechanism in UC patients
SER-287 Phase 1b to provide insight into efficacy and mechanism in UC patients Arm A (n=15): Placebo pre- Primary Objective treatment / SER-287 once • Change in composition of intestinal weekly dosing for 8 weeks microbiome at 8 weeks • Safety and tolerability Arm B (n=10): Placebo pre- 55 mild- tre
Slide 22: SER-301: Synthetic Ecobiotic therapeutic candidate for inflammatory bowel disease
SER-301: Synthetic Ecobiotic® therapeutic candidate for inflammatory bowel disease • Follow-on therapeutic candidate to SER-287 in preclinical development for inflammatory bowel disease • Oral, microbiome therapeutic candidate comprising fermented, rationally selected bacteria • Selection of SER-301
Slide 23: Additional R&D Opportunities
Additional R&D Opportunities Leading the Microbiome Revolution 23
Slide 24: SER-155: To improve hematopoietic stem cell transplantation outcomes
SER-155: To improve hematopoietic stem cell transplantation outcomes Microbiome Profile Correlates with • Designed Ecobiotic® drug candidate GvHD Mortality Risk2 SER-155 for prevention of allogeneic HSCT Overview associated infection and Graft vs. Host Disease (GvHD) • HSCT conditioning results in P
Slide 25: Immuno-oncology microbiome therapeutic opportunity
Immuno-oncology microbiome therapeutic opportunity Therapeutic Objectives • To improve efficacy: Modulate immune response, improve clinical response to therapeutic checkpoint inhibitors • To improve safety: Reduce anti-CTLA4 induced colitis by providing microbial ecologies correlated with improved p
Slide 26: Collaborations with leading institutes to advance R&D progress
Collaborations with leading institutes to advance R&D progress Target Indication Academic Collaboration Inflammatory Bowel Disease Immuno-oncology Therapeutics Hematopoietic Stem Cell Transplantation Primary Sclerosing Cholangitis, NASH and Other Liver Diseases Obesity and Metabolic Syndrome Rare ge
Slide 27: Broad IP portfolio and regulatory exclusivity
Broad IP portfolio and regulatory exclusivity 7 ISSUED US PATENTS + LICENSED IP* • Demonstrates rationally designed ecologies of spores and microbes are patentable • Composition of matter and method claims • Claims related to SER-109/CDI & colitis lead candidates through 2033 SERES PATENT PORTFOLIO
Slide 28: Upcoming value-driving milestones
Upcoming value-driving milestones SER-109: Completion of FDA dialogue regarding future development SER-109: Initiation of further clinical development SER-287: Ulcerative Colitis - Phase 1b read-out (2017) SER-262: Primary C. difficile infection - Phase 1b read-out (2017) Advancing new pipeline prog
Slide 29: Thank you
Thank you Leading the Microbiome Revolution
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