Seres Therapeutics, Inc. · NASDAQ:MCRB
Seres Therapeutics — 31st Annual Oppenheimer Healthcare Conference (March 2021)
31 slides from Seres Therapeutics's conference presentation, Mar 16, 2021
Slide 1: 31st Annual Oppenheimer Healthcare Conference
Eric Shaff 31st Annual Oppenheimer Healthcare Conference Chief Executive Officer March 16, 2021
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, including, but not limited to, our development plans, the promise and potential impact of any of our microbiome therapeutics, the
Slide 3: Pioneering the Development of Microbiome Therapeutics
Pioneering the Development of Microbiome Therapeutics Encapsulated consortia of commensal bacteria designed to target multiple disease- relevant pathways simultaneously 3
Slide 4: Building on microbiome therapeutic leadership position
Building on microbiome therapeutic leadership position • Landmark SER-109 • Enrolling SER-109 open label study in support of BLA 2020 Phase 3 success 2021 • SER-109 commercial readiness • Clear demonstration of microbiome • SER-287 Phase 2b clinical data readout mid-2021 therapeutics as a new • Adva
Slide 5: Broad Opportunities for Microbiome Therapeutics
Broad Opportunities for Microbiome Therapeutics INFECTIOUS DISEASE Preclinical Phase 1b Phase 2b Phase 3 Collaborators 1 SER-109 Recurrent C. difficile – Open label safety study enrollment ongoing SER-155 Antibiotic resistant bacterial infections, bacteremia, & GvHD (Rationally-designed, cultivated)
Slide 6: C. difficile Infection
C. difficile Infection Overview and SER-109 Phase 3 study
Slide 7: Positive ECOSPOR III Phase 3 Study Readout
Positive ECOSPOR III Phase 3 Study Readout SER-109 • Multiply recurrent C. difficile patients (n=182) Primary endpoint: Safety follow-up C. diff. recurrence, to 24 weeks • All subjects treated with at up to 8 weeks standard of care antibiotics Placebo 0 weeks 8 weeks 24 weeks Toxin testing to ensure
Slide 8: Topline SER-109 Phase 3 Study Efficacy Results
Topline SER-109 Phase 3 Study Efficacy Results PRIMARY EFFICACY ENDPOINT RESULTS: SER-109 Placebo p-Value Approximately 88% Time point (N =89) (N =93) RR (95%CI) (p1/p2) sustained clinical n (%) n (%) response rate Week 8 11 (12.4) 37 (39.8) 0.32 (0.18-0.58) <0.001 / <0.001 (percentage of patients w
Slide 9: Favorable Safety Profile Observed in Phase 3
Favorable Safety Profile Observed in Phase 3 • SER-109 was well tolerated, with no treatment-related serious adverse events (SAEs) observed in the active arm, and an adverse event profile comparable to placebo • Overall incidence of patients who experienced AEs during the eight-week study period was
Slide 10: Phase 3 Mechanism of Action Data Support Clinical Outcome
Phase 3 Mechanism of Action Data Support Clinical Outcome Pharmacokinetics: Pharmacodynamics: SER-109 bacteria engrafted rapidly in SER-109 administration broadly modulated the gut microbiome subjects & significantly greater engraftment and rapidly shifted metabolic landscape of the gut significantl
Slide 11: SER-109 Open-label Study Enrollment Ongoing
SER-109 Open-label Study Enrollment Ongoing • FDA has indicated that ECOSPOR III efficacy results should support BLA filing as a single pivotal trial • Per FDA, the SER-109 safety database should include at least 300 treated subjects • Enrollment is ongoing in a SER-109 open-label study in recurrent
Slide 12: Substantial Recurrent C. difficile Infection Market Opportunity
Substantial Recurrent C. difficile Infection Market Opportunity Infectious disease caused by toxin-producing bacteria, resulting in diarrhea, abdominal pain, fever and nausea 25% of primary C. Leading cause of hospital-acquired infection in the U.S. difficile recur • ~ 453K cases of primary CDI with
Slide 13: SER-109 is Potential First and Best-in-class Microbiome Therapeutic
SER-109 is Potential First and Best-in-class Microbiome Therapeutic to Transform Care for Patients with rCDI High HCP Likelihood to Prescribe % of MDs • External stakeholder feedback on Definitely will not 22% SER-109 is resoundingly positive 28% High payer value perception: Probably will not – High
Slide 14: Amplifying Efforts for Market Preparation and Launch
Amplifying Efforts for Market Preparation and Launch Scaling Market • Medical communications strategy Education Efforts • KOL mapping • Develop and deploy payer value proposition Enhancing • Deeper patient journey analysis Understanding of • Pricing analysis • Customer segmentation Commercial Opport
Slide 15: SER-287 and Ulcerative Colitis
SER-287 and Ulcerative Colitis
Slide 16: Ulcerative Colitis Overview
Ulcerative Colitis Overview • Serious chronic condition ~700K characterized by inflammation of the colon and rectum resulting in abdominal pain, bowel urgency in the United States and diarrhea • Significant need for improved therapies - Many drugs are Only 1/3 achieve remission immunosuppressive, li
Slide 17: Published Study Provides Clinical Proof-of-concept in Ulcerative Colitis
Published Study Provides Clinical Proof-of-concept in Ulcerative Colitis 30% 27% 25% 20% Multidonor intensive faecal p = 0.027 microbiota transplantation 15% for active ulcerative colitis: a randomized placebo- 10% 8% controlled trial 5% Sudershan Paramsothy, Michael A Kamm, Nadeem O Kaakoush, Aliss
Slide 18: Seres' Therapeutic Candidates have Potential to Target Multiple Triggers of Ulcerative Colitis Pathology
Seres’ Therapeutic Candidates have Potential to Target Multiple Triggers of Ulcerative Colitis Pathology Drug Bacteria Pro-inflammatory Bacteria Reduce the abundance of pro-inflammatory bacteria and epithelial cell inflammation Produce immunomodulatory metabolites that improve epithelial barrier int
Slide 19: SER-287 Phase 1b Ulcerative Colitis Study
SER-287 Phase 1b Ulcerative Colitis Study Placebo pre-treatment for Placebo once daily for (n=11) 6 days 8 weeks Vancomycin pre-treatment for SER-287 once daily for DAILY (n=15) 6 days 8 weeks Primary Objectives 58 mild-to- • Safety and tolerability moderate • Change in composition ulcerative coliti
Slide 20: Phase 1b Study Results – Statistically Significant Improvement in Clinical Remission
Phase 1b Study Results – Statistically Significant Improvement in Clinical Remission Observed in SER-287 Daily Treatment Arm 40.0% (6/15) 40% achieving remission 30% % patients p = 0.0237 17.7% 20% (3/17) 13.3% (2/15) 10% 0.0% (0/11) 0% Placebo pretreatment Vancomycin Placebo pretreatment / Vancomyc
Slide 21: SER-287 Phase 1b Safety Profile Comparable to Placebo
SER-287 Phase 1b Safety Profile Comparable to Placebo • SER-287 daily arm demonstrated a similar safety profile to placebo • No serious drug-related adverse events • Reduced gastrointestinal adverse events provide an independent assessment of efficacy as the GI adverse events likely reflect ulcerati
Slide 22: Phase 1b – High Resolution Microbiome Biomarker Analytics
Phase 1b – High Resolution Microbiome SER-287 treatment results in a broad shift in the Biomarker Analytics overall composition of spore & non-spore gut species by 8 weeks post-treatment Placebo/ Placebo/ Vancomycin/ Vancomycin/ Placebo SER-287 weekly SER-287 weekly SER-287 daily , Other spore-forme
Slide 23: Clinical Remission Significantly Associated with Changes in Microbiome and Metabolism
Clinical Remission Significantly Associated with Changes in Microbiome and Microbe-associated Metabolism Decrease in pro-inflammatory Enterobacteriaceae Microbially-mediated metabolites that modulate host inflammation bacteria post-treatment is associated with & barrier integrity are significantly a
Slide 24: SER-287 Phase 1b Study Results Published January 2021
SER-287 Phase 1b Study Results Published January 2021 24
Slide 25: Ongoing SER-287 ECO-RESET Phase 2b Study
Ongoing SER-287 ECO-RESET Phase 2b Study in Patients with Mild-to-moderate Active Ulcerative Colitis • FDA Fast Track designation • FDA feedback: Phase 2b study results, in conjunction with data from a second 10-week induction period pivotal study, could support BLA submission Pbo • Announced target
Slide 26: Additional Pipeline Opportunities
Additional Pipeline Opportunities
Slide 27: Earlier Stage Clinical Development Programs
Earlier Stage Clinical Development Programs SER-301 SER-155 Rationally designed, cultivated Rationally designed, cultivated Microbiome drug type product; spore + vegetative species product; spore + vegetative species Stage Phase 1b Approaching Phase 1b Infection, bacteremia & GvHD in Indication Mild
Slide 28: Opportunity for Microbiome Therapeutics in Additional Therapeutic Areas
Opportunity for Microbiome Therapeutics in Additional Therapeutic Areas Highly productive R&D engine pursuing multiple promising potential opportunities Infectious (e.g. Antibiotic-resistant infections) Inflammatory (e.g. Crohn’s, RA) • Deep understanding of the sweeping role of the microbiome in he
Slide 29: Differentiated CMC Capabilities
Differentiated CMC Capabilities SERES IN-HOUSE GMP MANUFACTURING AND QUALITY CONTROL CAPABILITIES Cell banking & inoculum Drug substance Drug product Quality control • Potential best-in-class clinical profile based on species specific properties • Cultivated approach enables efficient and highly sca
Slide 30: Well capitalized to Extend Microbiome Therapeutic Leadership
Well capitalized to Extend Microbiome Therapeutic Leadership Positive ECOSPOR III Phase 3 study results expected to serve as SER-109 single study to support BLA; Open-label study enrollment ongoing SER-287 Ulcerative colitis – Topline clinical results anticipated mid-2021 As of Dec. 31, 2020: SER-30
Slide 31: Thank You
@» SERES THERAPEUTICS Thank You
Seres Therapeutics — 31st Annual Oppenheimer Healthcare Conference (March 2021) on 6ix