Seres Therapeutics, Inc. · NASDAQ:MCRB
Seres Therapeutics — Investor Presentation (June 2017)
29 slides from Seres Therapeutics's investor presentation, Jun 12, 2017
Slide 1: Corporate Presentation June 2017
Corporate Presentation June 2017 Exhibit 99.1
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: Seres Investor highlights
Seres Investor highlights Expansive therapeutic opportunity utilizing the microbiome, a highly promising new area of medicine Seres is a leader in microbiome drug development with differentiated capabilities Broad pipeline in infectious, inflammatory and immune, metabolic and liver diseases Experien
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 broad spectrum antibiotics, and resulting gut microbiome dysbiosis, increase risk for C. difficile infection and colonization / infection by multi-drug resistan
Slide 5: Prioritize serious diseases where dysbiosis of the gut microbiome has a causal role
Prioritize serious diseases where dysbiosis of the gut microbiome has a causal role Focused clinical efforts Computational biology Basic microbiome research Microbiology Translational science Clinical development Advanced manufacturing World class, differentiated, microbiome expertise Collaborate wi
Slide 6: Robust microbiome therapeutics pipeline
Robust microbiome therapeutics pipeline SER-109 DISCOVERY EFFORTS PRECLINICAL PHASE 1 PHASE 2 SER-262 SER-287 Inflammatory bowel diseases Primary sclerosing cholangitis, NASH and other liver diseases Immuno-oncology and hematopoietic stem cell transplant SER-301 ACADEMIC COLLABORATOR SER-155 Recurre
Slide 7: Differentiated microbiome R&D platform
Differentiated microbiome R&D platform Computational discovery using human clinical datasets to allow rational design of microbiome drugs in multiple therapeutic areas Vast microbial strain library and commensal bacteria culturing know-how Disease targeted metabolic, immunological, & efficacy screen
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 spore-forming microbes Formulation, Filling, Delivery & Packaging enabling active product delivery cGMP Isolation of spores from complex biological materials Synthetic candidates
Slide 9: Clostridium difficile Infection Overview and R&D Programs
Clostridium difficile Infection Overview and R&D Programs Leading the Microbiome Revolution
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: Disru
Slide 11: Treatment landscape & disease burden
Treatment landscape & disease burden Economic burden as high as $4.8B in U.S. acute-care facilities1 Recurrent CDI episode ~$18K2; >$50K for cycle of recurrences Modality Characteristics Antibiotics Perpetuates microbiome dysbiosis, creating C. difficile infection susceptibility High recurrence rate
Slide 12: Dysbiosis and potential for therapeutic intervention
Dysbiosis and potential for therapeutic intervention Hypothetical patient course Healthy person with intact pathogen resistance High diversity microbiome Use of broad spectrum antibiotics Active C. diff. infection Antibiotic treatment of C. diff. infection Potential for microbiome therapy to reduce
Slide 13: SER-109 Phase 1b and Phase 2 (8-week) study results
SER-109 Phase 1b and Phase 2 (8-week) study results n=59 n=30 n=28 n=15 n=31 n=15 Phase 1b Open Label, Single-Arm (n=30; 4 sites) Phase 2 – Interim results Randomized, Placebo-Controlled (n=89; randomized 2:1; 28 sites) Primary Endpoint CDI recurrence up to 8 weeks defined by: >3 unformed stools ove
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 Clinical Detailed analyses of clinical data Investigation of C. difficile diagnostics Pharmacodynamics / microbiome analyses Investigation of drug activity Chemistry, Manufacturing and Controls (CMC) Drug
Slide 15: SER-109 ECOSPOR III Phase 3 study now underway
Phase 3 SER-109 ECOSPOR III study now underway Seres and FDA agreement on key design elements of a SER-109 Phase 3 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 II
Slide 16: SER-262: Synthetic Ecobiotic therapeutic candidate for primary C. difficile infection
SER-262: Synthetic Ecobiotic® therapeutic candidate for primary C. difficile infection SER-262 strains utilize multiple carbon sources In vitro fermentation Oral, microbiome therapeutic candidate comprising twelve strains of fermented, rationally selected bacterial spores Bacteria species selected b
Slide 17: 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 Primary Objective Safety and tolerability at 24 weeks Relative risk of C. difficile recurrence compared to placebo at up to 8 weeks Secondary Objectives Time to C. difficile recurrence Relative risk of recurrence at up to
Slide 18: Inflammatory Bowel Disease Overview and R&D Programs
Inflammatory Bowel Disease Overview and R&D Programs Leading the Microbiome Revolution
Slide 19: Multiple FMT studies provide proof of concept in ulcerative colitis
Selected references: Paramsothy et al. Lancet, 2017; Moayyedi et al. Gastroenterology, 2015 Multiple FMT studies provide proof of concept for microbiome therapy in ulcerative colitis Subject A, Baseline Subject A, 8-wk post FMT
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 Over half of patients do not respond to biologic therapies Many therapies are immunosuppressive, limiting widespread use SER-287 tar
Slide 21: SER-287 Phase 1b study in ulcerative colitis patients is fully enrolled
SER-287 Phase 1b study in ulcerative colitis patients is fully enrolled Primary Objective Change in composition of intestinal microbiome at 8 weeks Safety and tolerability Secondary Objectives Clinical responses, including complete remission, and endoscopic improvement Change in serum and fecal biom
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 bacte
Slide 23: Additional R&D Opportunities
Additional R&D Opportunities Leading the Microbiome Revolution
Slide 24: SER-155: Synthetic Ecobiotic therapeutic candidate to improve transplantation outcomes
SER-155: Synthetic Ecobiotic® therapeutic candidate to improve transplantation outcomes 1 Khanna et al, Journal of Infectious Disease 2016 2 Jenq, et al, Biology of Blood and Marrow Transplantation 2015, 3 Taur, et al., Blood 2015. 36% 60% 67% Overall Survival HSCT Patient Microbiome Health Correlat
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 patie
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 Families of Applications Nationalized Pending PCT Pending Provisionals SERES PATENT PORTFOLIO 15 9 2 REGULATORY EXCLUSIVITY years for new biological composition 12 years for new drug 10 7 ISSUED US PATENTS + LICENSED IP* Demonstrates rationally designed
Slide 28: Resources to operate through 2018
Resources to operate through 2018 Strong financial position Balance Sheet As of Mar. 31, 2017 Cash, cash equivalents and investments $202 M Income Statement Latest Quarter, as of Mar. 31, 2017 R&D ($20 M) G&A ($9 M) Net loss ($25 M) Common shares outstanding 40.4 M, as of Mar. 31, 2017 SER-109 Phase
Slide 29: Upcoming value-driving milestones
SER-287: Ulcerative Colitis - Phase 1b read-out (H2 2017) SER-262: Primary C. difficile infection - Phase 1b read-out (by early 2018) Advancing new pipeline programs in infectious diseases, inflammatory and immune diseases (including immuno-oncology), metabolic and liver diseases Upcoming value-driv
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