Seres Therapeutics, Inc. · NASDAQ:MCRB
Seres Therapeutics — JMP Securities Life Science Conference 2021
18 slides from Seres Therapeutics's conference presentation, Jun 17, 2021
Slide 1: JMP Securities Life Science Conference: SER-109 poised to transform standard of care for patients with rCDI
JMP Securities Life Science SER-109: poised to transform Conference standard of care for patients JMP Securities Life Science Conference June 17, 2021 with rCDI Terri Young, Ph.D. EVP, Chief Commercial and Strategy Officer
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 or c
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 anticipate achieving target enrollment in Q3 2021 • Clear demonstration • SER-109 commercial readiness of microbiome therapeutics as a new • SER
Slide 5: C. difficile Infection is a Toxin-mediated Disease Leading to Inflammatory Colitis
C. difficile Infection is a Toxin-mediated Disease Leading to Inflammatory Colitis Hallmark of this bacterial disease is diarrhea C. difficile bacteria • Can be severe with 10-15 bowel movements in a day Severe disease Other symptoms: • Nausea, abdominal cramping • Low grade fever • Fatigue, weight
Slide 6: C. difficile Infection is Associated with Significantly Lower Quality of Life
C. difficile Infection is Associated with Significantly Lower Quality of Life 43.2 Vitality 43.9 Severe burden on patients 50.1 • Poor quality of life and loss of General Health 40.2* 41.7* productivity due to disabling diarrhea 49.4 39.6* Physical Functioning 44.5* 50.8 SF-36v2 Health Domain I have
Slide 7: Burden of C. difficile Infection on Healthcare Systems
Burden of C. difficile Infection on Healthcare Systems ESTIMATED BURDEN OF C. DIFF INFECTION CASES: 462,100 (95% CI 428,600 to 495,600) 224,000 20,500 Greater incidence in patients ≥65 years hospitalizations in-hospital deaths than all other age groups combined ADVERSE IMPACT ON SHORT AND LONG-TERM
Slide 8: Current Treatment Options are Suboptimal
Current Treatment Options are Suboptimal Primary C. difficile infection: • Vancomycin or fidaxomicin associated with rapid recurrence in 25% within 1 to 3 weeks of antibiotic completion due to original strain Risk factors: age >65 years, female gender, hospitalization Bezlotoxumab for those at high-
Slide 9: FMT Safety Concerns Amplified by High-profile FDA Alerts
FMT Safety Concerns Amplified by High-profile FDA Alerts Drug-Resistant E. coli Transmission of drug- Bacteremia Transmitted by Using the Fecal Microbiota Transplant resistant bacteria discovered universe of during clinical use microbes in stool brings unintended consequences Safety Alert Regarding
Slide 10: Positive ECOSPOR III Phase 3 Study Readout
Positive ECOSPOR III Phase 3 Study Readout SER-109 • Multiply recurrent C. difficile patients Primary endpoint: Safety follow-up (n=182) C. diff. recurrence, to 24 weeks at up to 8 weeks • All subjects treated with standard of care Placebo antibiotics 0 weeks 8 weeks 24 weeks Toxin testing to ensure
Slide 11: 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 12: 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 13: 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 14: 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 15: Broad SER-109 Commercial Potential in the U.S. and Globally
Broad SER-109 Commercial Potential in the U.S. and Globally C. difficile infection market (U.S.) 32K 3+ Recurrent Cases Potential SER-109 addressable 38K population of ~170K annual (40% of 1st recurrence cases (U.S.) will recur a 2nd time) 2nd Recurrent Cases 100K (14%-21% of primary recurrence 1st
Slide 16: 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 22% not SER-109 is resoundingly positive 28% Probably will High payer value perception: not – High
Slide 17: 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 18: Thank You
@» SERES THERAPEUTICS ._- Thank You
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