Seres Therapeutics, Inc. · NASDAQ:MCRB
Seres Therapeutics — 41st Annual J.P. Morgan Healthcare Conference 2023
24 slides from Seres Therapeutics's conference presentation, Jan 9, 2023
Slide 1: 41st Annual J.P. Morgan Healthcare Conference
41st Annual J.P. Morgan Healthcare Conference January 2023 Eric Shaff, President and Chief Executive Officer Exhibit 99.1
Slide 2: 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 the potential approval and launch of SER-109; the anticipated indication for SER-109; the anticipated supply of SER-109; the p
Slide 3: Seres Mission: Revolutionary Microbiome Therapeutics
Seres Mission: Transforming the Lives of Patients Worldwide with Revolutionary Microbiome Therapeutics Encapsulated consortia of commensal bacteria designed to target multiple disease-relevant pathways simultaneously Bacterial Consortia Orally-formulated, using current Good Manufacturing Practices (
Slide 4: Strategic Priorities
Strategic Priorities | Expanding Microbiome Therapeutic Leadership Bring SER-109, potential first-in-class oral microbiome therapeutic, to recurrent CDI patients Maximize opportunities in Infection Protection Continue research to inform further development in ulcerative colitis and immune modulation
Slide 5: Corporate Priority is to Advance SER-109 to FDA Approval and Launch
Corporate Priority is to Advance SER-109 to FDA Approval and Execute Successful Product Launch Collaboration with Nestlé Health Science, announced Jan. 11, 2016, regarding C. difficile and IBD programs for markets outside of North America. SER-109 co-commercialization agreement for North America wit
Slide 6: SER-109 and Recurrent C. difficile Infection
SER-109 and Recurrent C. difficile Infection
Slide 7: CDI – Urgent Public Health Threat
CDI – Urgent Public Health Threat High probability of recurrence >20%, usually within 1-2 weeks after completion of antibiotic therapy Symptoms include colitis and severe, watery diarrhea with up to 15 bowel movements a day Spore-forming, toxin-producing, gram-positive, anaerobic bacteria 1. Centers
Slide 8: SER-109 ECOSPOR III Study Results
Time point SER-109 (N =89) Placebo (N =93) Relative risk (95%CI) p-value (p1/p2) n (%) of recurrences n (%) of recurrences Week 8 11 (12.4) 37 (39.8) 0.32 (0.18-0.58) <0.001 / <0.001 TRIAL DESIGN SER-109 ECOSPOR III Study Results Primary endpoint: C. diff. recurrence, at up to 8 weeks SER-109 (n = 9
Slide 9: SER-109 Phase 3 Results Published in Premier Journals
SER-109 Phase 3 Results Published in Premier Journals January 20, 2022 Extended Follow-up of Microbiome Therapeutic SER-109 Through 24 Weeks for Recurrent Clostridioides difficile infection in a Randomized Clinical Trial RESEARCH LETTER Survival Function for Time to Clostridioides difficile Infectio
Slide 10: ECOSPOR III – Favorable Safety Profile Observed
ECOSPOR III – Favorable Safety Profile Observed Adverse Events (AEs) Through 8 Weeks (Safety Population)2 SER-109 (n=90) n (%) Placebo (n=92) n (%) Any adverse event 84 (93) 84 (91) Adverse event related or possibly related to SER-109 or placebo 46 (51) 48 (52) Serious adverse event3 7 (8) 15 (16) A
Slide 11: ECOSPOR IV Study Results Extend ECOSPOR III Data
ECOSPOR IV Study (n=263) Results Extend ECOSPOR III Data Overall safety profile through 24-week follow up: SER-109 was well tolerated, consistent with profile observed in ECOSPOR III Seres believes that based on disease pathophysiology and overall Phase 3 results, SER-109 may provide clinical benefi
Slide 12: Delivering SER-109 to Patients; PDUFA Date April 26, 2023
Delivering SER-109 to Patients; PDUFA Date April 26, 2023 BLA submission Priority FDA review Accelerated review based on Breakthrough Therapy Designation Orphan Drug Designation BLA submission completed Q3 2022; acceptance confirmed by FDA Oct. 2022 Expanded access program ongoing across multiple US
Slide 13: SER-109 May Fill an Important Unmet Need
SER-109 May Fill an Important Unmet Need – Prevention of Recurrence Early and urgent intervention in the cycle of recurrence can prevent further recurrences SER-109 could have a unique place in the treatment algorithm, potentially transforming standard of care: Reducing the need for antibiotic taper
Slide 14: Well Positioned for Commercial Success
Well Positioned for Commercial Success Highly Favorable Product Profile, Pending Approval Substantial Market Opportunity Commercial Capabilities, Including Manufacturing 1 2 3 Preparing for successful SER-109 commercial launch alongside collaborator, Nestlé Health Science Seres press release issued
Slide 15: Seres and Nestlé Health Science Resources and Capabilities for Launch
Seres and Nestlé Health Science have Full Suite of Resources and Complementary Capabilities to Support SER-109 Launch Market Access and Reimbursement Specialty Product Distribution Patient Support Services Medical Affairs Data and Insights Commercial Infrastructure Key Customer Relationships
Slide 16: Focusing on the Most Important Areas at Launch
Focusing on the Most Important Areas at Launch to Set Up SER-109 for Long Term Success if Approved Patient Access Product Choice LAND First 12 months EXPAND >12 months Implement payer policies as quickly as possible to ease access to treatment Access programs to support positive early experience Ens
Slide 17: Well Positioned to Supply Commercial Demand at Launch and Beyond
Well Positioned to Supply Commercial Demand at Launch and Beyond SER-109 commercial supply Note: Seres and Bacthera collaboration press release issued Nov. 10, 2021 + 10+ years of Investment in Technology and Facilities for anaerobic bacterial therapeutics: In-house GMP Manufacturing and Quality Con
Slide 18: SER-155 and Infection Protection Franchise
SER-155 and Infection Protection Franchise
Slide 19: SER-109 Clinical Data Provide Proof of Concept
SER-109 Clinical Data Provide Proof of Concept -Restructuring the Microbiome and Reducing Pathogens SER-109 bacteria engraft durably & rapidly to restructure microbiome N = 182 patients enrolled; figure shows data for 143 patients at baseline Feuerstadt P NEJM 2022; 386:220-9 SER-109 Dose Species En
Slide 20: Antimicrobial Resistant Infections - Urgent Public Health Threat
Antimicrobial Resistant Infections - Urgent Public Health Threat Limited innovation despite substantial and growing impact Declared “one of the world’s most urgent threats” $20 billion excess direct healthcare costs 35,000 deaths per year in US Major burden to society Many high-risk patient populati
Slide 21: SER-155 Phase 1b Study Ongoing
SER-155 Microbiome drug type Rationally designed, cultivated product; spore + vegetative species Stage Phase 1b - study ongoing Indication Infection, bacteremia & GvHD in HSCT for cancer Lead Collaborator Potential Novel Approach to Address Infection - SER-155 Phase 1b Study Ongoing Phase 1b study d
Slide 22: Maximizing the Opportunity in Infection Protection and AMR
SER-109 rCDI SER-155 BSI & GvHD in allogeneic HSCT recipients Broad preclinical portfolio Driving to an additional clinical development program in 2023 Potentially 2+ additional programs within 3 years SER-155: Therapeutic adjacency to SER-109 Phase 1b study ongoing – to advance to cohort 2 Addition
Slide 23: Well Positioned to Extend Microbiome Therapeutic Leadership in 2023
SER-155 Phase 1b ongoing; initial safety and pharmacological data in early 2023 Preclinical programs ongoing with potential to address large immunocompromised patient populations Well Positioned to Extend Microbiome Therapeutic Leadership in 2023 Opportunities in Infection Protection Continued resea
Slide 24: Continued Microbiome Therapeutic Leadership and Value Creation
Continued Microbiome Therapeutic Leadership, Anticipated Compelling Growth and Value Creation Advancing opportunities in Infection Protection and other therapeutic areas Potential SER-109 BLA approval and successful launch for rCDI If approved, SER-109 transforming standard of care for a broad popul
Seres Therapeutics — 41st Annual J.P. Morgan Healthcare Conference 2023 on 6ix