Seres Therapeutics, Inc. · NASDAQ:MCRB
Seres Therapeutics — Stifel 2017 Healthcare Conference
36 slides from Seres Therapeutics's conference presentation, Nov 14, 2017
Slide 1: Stifel 2017 Healthcare Conference
Stifel 2017 Healthcare Conference Roger J. Pomerantz, M.D. President, Chief Executive Officer and Chairman November 14, 2017 L e ad i n g t h e M i c ro b i o me R e vo l u t i o n
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: Collaboration announced to advance microbiome therapeutic development for immuno-oncology
Collaboration announced to advance microbiome therapeutic development for immuno-oncology 3
Slide 4: Seres Investor highlights
Seres Investor highlights Phase 3 stage company developing microbiome-based Opportunity therapeutics, a highly promising new area of medicine Leader in microbiome drug development Platform with differentiated capabilities, field leading CMC and demonstrated GMP quality, and supportive clinical data
Slide 5: 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 broad spectrum antibiotics, and resulting gut microbiome dysbiosis, increase risk for C. difficile infection and colonization / infection by multi-drug resi
Slide 6: 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 7: Robust microbiome therapeutics pipeline
Robust microbiome therapeutics pipeline PRECLINICAL PHASE 1b PHASE 2 PHASE 3 SER-109 Recurrent C. difficile Positive top-line SER-287 Ulcerative colitis Phase 1b results SER-262 Primary C. difficile SER-301 Inflammatory Bowel Disease (IBD) Immuno-oncology – in combination with anti- SER-401 PD-(L)1
Slide 8: 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 9: 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 10: Clostridium difficile Infection
Clostridium difficile Infection Overview and R&D Programs Leading the Microbiome Revolution 10
Slide 11: 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 • Multiply recurrent C. difficile inf
Slide 12: 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 • Typically invasive procedure (colonoscopy or NG-tube) High Unmet Fecal Transplant • Po
Slide 13: 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 GI tract Antibi
Slide 14: 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 15: 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 16: Phase 3 SER-109 ECOSPOR III study underway
Phase 3 SER-109 ECOSPOR III study underway • Based on FDA feedback, ECOSPOR III designated as a Phase 3 study • The ECOSPOR III Phase 3 study is the first pivotal trial in the emerging field of oral microbiome therapeutics • ECOSPOR III to utilize a SER-109 dose approximately 10-fold higher than the
Slide 17: SER-262: Synthetic Ecobiotic therapeutic candidate for primary C. difficile infection
SER-262: Synthetic Ecobiotic® therapeutic 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 a
Slide 18: SER-262 Phase 1b dosing study in patients with primary C. difficile infection
SER-262 Phase 1b dosing study in patients with primary C. difficile infection Cohort A: Tx with 104 spores (n=10); placebo (n=2); single dose Primary Objective • Safety and tolerability at 24 weeks Cohort B: Tx with 105 spores (n=10); placebo (n=2); single dose • Relative risk of C. difficile recurr
Slide 19: Inflammatory Bowel Disease
Inflammatory Bowel Disease Overview and R&D Programs Leading the Microbiome Revolution 19
Slide 20: 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 Selected references: Paramsothy et al. Lancet, 2017; Moayyedi et al. Gastroenterology, 2015; 20 Review article: Costello et al. Alimentary Pharmacology & Therapeuti
Slide 21: SER-287 Phase 1b Ulcerative Colitis study
SER-287 Phase 1b Ulcerative Colitis study Arm A: Placebo pre-treatment / Placebo once daily for 8 weeks (n=11) 58 mild- Arm B: Vancomycin pre-treatment / SER-287 moderate once daily dosing for 8 weeks (n=15) UC patients failing standard of Arm C: Placebo pre-treatment / SER-287 care* once weekly dos
Slide 22: SER-287 Phase 1b study endpoints
SER-287 Phase 1b study endpoints Primary Objectives • Safety and tolerability • Change in composition of intestinal microbiome at 8 weeks * Secondary Objectives • Clinical remission, endoscopic improvement, and response through measure of the total modified Mayo Score • Change in serum and fecal bio
Slide 23: SER-287 Phase 1b efficacy analyses
SER-287 Phase 1b efficacy analyses Two prespecified Intent-to-Treat (ITT) statistical methods were used to analyze SER-287 Phase 1b efficacy outcomes: Patients Intent-to-Treat statistical analyses analyzed Limited to observed data Initial • All patients with post-treatment endoscopy results were inc
Slide 24: Efficacy analysis: Limited to observed data
Initial top-line reported results Efficacy analysis: Limited to observed data Endpoint Intent-to-Treat Population: Limited to Observed Data Vancomycin / SER-287 Placebo / SER-287 Vancomycin / SER-287 Placebo / Placebo daily weekly weekly (N = 10) (%) (N = 15) (%) (N = 14) (%) (N = 14) (%) Clinical R
Slide 25: Efficacy analysis: All subjects, missing data counted as failure
Efficacy analysis: All subjects, missing data counted as failure Endpoint Intent-to-Treat Population: All Subjects, Missing Data Counted as Failure Vancomycin / SER-287 Placebo / SER-287 Vancomycin / SER-287 Placebo / Placebo daily weekly weekly (N = 11) (%) (N = 15) (%) (N = 15) (%) (N = 17) (%) Cl
Slide 26: Definitions of clinical efficacy endpoints
Definitions of clinical efficacy endpoints Endpoint Protocol Definition New FDA Definition (2016)* Stool Frequency subscore =0, Total Modified Mayo Score <=2 and Rectal Bleeding subscore=0 and Clinical Remission an endoscopic subscore of 0 or 1 Endoscopic subscore = 0 or 1 (modified) on Mayo Score E
Slide 27: Efficacy analysis: Limited to observed data (Per FDA definition from 2016 guidance)
Efficacy analysis: Limited to observed data (Per FDA definition from 2016 guidance) Endpoint Intent-to-Treat Population: Limited to Observed Data Vancomycin / SER-287 Placebo / SER-287 Vancomycin / SER-287 Placebo / Placebo daily weekly weekly (N = 10) (%) (N = 15) (%) (N = 14) (%) (N = 14) (%) Clin
Slide 28: Efficacy analysis: All subjects, missing data counted as failure (Per FDA definition)
Efficacy analysis: All subjects, missing data counted as failure (Per FDA definition from 2016 guidance) Endpoint Intent-to-Treat Population: All Subjects, Missing Data Counted as Failure Vancomycin / SER-287 Placebo / SER-287 Vancomycin / SER-287 Placebo / Placebo daily weekly weekly (N = 11) (%) (
Slide 29: SER-287 safety and tolerability profile very favorable
SER-287 safety and tolerability profile very favorable • No drug related serious adverse events associated with SER-287 • Lower rate of GI related adverse events in SER-287 daily arm provides supportive evidence of SER-287 benefit on symptoms seen in Ulcerative Colitis System Organ Class Safety Popu
Slide 30: 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 31: Additional Pipeline Programs
Additional Pipeline Programs Leading the Microbiome Revolution 31
Slide 32: SER-155: Synthetic Ecobiotic therapeutic candidate to improve transplantation outcomes
SER-155: Synthetic Ecobiotic® therapeutic candidate to improve transplantation outcomes HSCT Patient Microbiome Health Correlates with Overall Mortality Risk3 • Synthetically-derived Ecobiotic® therapeutic candidate to improve outcomes in patients receiving Overall Survival 67% allogeneic hematopoie
Slide 33: Collaboration to advance immuno-oncology microbiome therapeutic into clinical development
Collaboration to advance immuno-oncology microbiome therapeutic into clinical development • Research by MD Anderson collaborators indicates specific microbiome signatures may impact response to Responders anti-PD-1 (e.g., KEYTRUDA®) immunotherapy • Seres has received an option to license foundationa
Slide 34: Immuno-oncology microbiome development next steps
Immuno-oncology microbiome development next steps • Collaboration to initiate a randomized, placebo-controlled clinical study at MD Anderson, sponsored by the Parker Institute, in patients with advanced metastatic melanoma • Clinical trial to evaluate impact of anti-PD-1 checkpoint inhibitor with ad
Slide 35: 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, including option to license foundational IP from MD Anderson related to the use of bacteria i
Slide 36: Well positioned for success: Resources to operate through 2018
Well positioned for success SER-109: Multiply recurrent C. difficile infection – Phase 3 ongoing SER-287: Ulcerative colitis – Microbiome Data (early 2018); FDA feedback (2018) SER-262: Primary C. difficile infection - Phase 1b read-out (early 2018) Advancing new pipeline programs in infectious dise
Seres Therapeutics — Stifel 2017 Healthcare Conference on 6ix