Seres Therapeutics, Inc. · NASDAQ:MCRB
Seres Therapeutics — Jefferies Virtual Healthcare Conference 2021
29 slides from Seres Therapeutics's conference presentation, Jun 1, 2021
Slide 1: Jefferies Virtual Healthcare Conference
Eric Shaff Jefferies Virtual Healthcare Conference Chief Executive Officer June 1, 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: SER-155 IND Clearance
SER-155 IND Clearance Rationally-designed investigational microbiome therapeutic designed prevent mortality in immunocompromised patients due to gastrointestinal infections, bacteremia and GvHD 3
Slide 4: 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 4
Slide 5: 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 anticipate achieving target enrollment in Q3 2021 • Clear demonstration • SER-109 commercial readiness of microbiome therapeutics as a new • SER
Slide 6: 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 7: C. difficile Infection
C. difficile Infection Overview and SER-109 Phase 3 study
Slide 8: Positive ECOSPOR III Phase 3 Study Readout
Positive ECOSPOR III Phase 3 Study Readout SER-109 • Multiply recurrent Primary endpoint: C. difficile patients (n=182) Safety follow-up C. diff. recurrence, to 24 weeks at up to 8 weeks • All subjects treated with standard of care antibiotics Placebo 0 weeks 8 weeks 24 weeks 8
Slide 9: Topline SER-109 Phase 3 Study Efficacy Results
Topline SER-109 Phase 3 Study Efficacy Results PRIMARY EFFICACY ENDPOINT RESULTS: SER-109 Placebo Approximately 88% (N =89) (N =93) p-Value Time point RR (95%CI) (p1/p2) sustained clinical n (%) of n (%) of recurrences recurrences response rate Week 8 11 (12.4) 37 (39.8) 0.32 (0.18-0.58) <0.001 / <0
Slide 10: 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 11: 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 12: 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 ongoing in SER-109 open- label study in recurrent CDI
Slide 13: 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 Leading cause of hospital-acquired infection in the U.S. C. difficile recur • ~ 453K cases of primary CDI with
Slide 14: 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 15: 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 16: SER-287 and Ulcerative Colitis
SER-287 and Ulcerative Colitis
Slide 17: 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 18: SER-287 Phase 1b Ulcerative Colitis Study
SER-287 Phase 1b Ulcerative Colitis Study DAILY 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
Slide 19: 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 20: 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 21: 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 SER-287 bacteria en
Slide 22: SER-287 Phase 1b Study Results Published January 2021
SER-287 Phase 1b Study Results Published January 2021 22
Slide 23: Ongoing SER-287 ECO-RESET Phase 2b Study in Ulcerative Colitis
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 pivotal study, could support 10-week induction period BLA submission • Announced target enr
Slide 24: Additional Pipeline Opportunities
Additional Pipeline Opportunities
Slide 25: 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 IND clearance obtained; plan to Stage Phase 1b initiate Phase 1b Infection, bactere
Slide 26: 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 27: 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 28: 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; Anticipate target enrollment in Q3 2021 SER-287 Ulcerative colitis – Topline clinical results anticipated mid-2021 As of Mar. 31, 2021: SE
Slide 29: Thank You
@» SERES THERAPEUTICS Thank You
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