Seres Therapeutics, Inc. · NASDAQ:MCRB
Seres Therapeutics — 41st Annual J.P. Morgan Healthcare Conference (January 2023)
24 slides from Seres Therapeutics's conference presentation, January 2023
Slide 1: 41st Annual J.P. Morgan Healthcare Conference
January 2023 41st Annual J.P. Morgan Eric Shaff, President and Healthcare Conference Chief Executive 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 the potential approval and launch of SER-109; the anticipated indication for SER-109; the anticipat
Slide 3: Seres Mission: Transforming the Lives of Patients Worldwide with 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 Disease Eng
Slide 4: Strategic Priorities | Expanding Microbiome Therapeutic Leadership
Strategic Priorities | Expanding Microbiome Therapeutic Leadership • SER-109 BLA submission complete Bring SER-109, potential first- in-class oral microbiome • PDUFA date April 26, 2023 therapeutic, to recurrent CDI • Anticipated launch soon after potential FDA approval patients • Co-commercializati
Slide 5: Corporate Priority is to Advance SER-109 to FDA Approval and Execute Successful Product Launch
Corporate Priority is to Advance SER-109 to FDA Approval and Execute Successful Product Launch INFECTION PROTECTION Preclinical Phase 1b Phase 2b Phase 3 Collaborators 1,2 SER-109 Recurrent C. difficile – ECOSPOR III and ECOSPOR IV studies completed; BLA accepted and priority review underway Bloodst
Slide 6: SER-109 and Recurrent C. difficile Infection
SER-109 and Recurrent C. difficile Infection 6
Slide 7: CDI – Urgent Public Health Threat
CDI – Urgent Public Health Threat Spore-forming, toxin- Symptoms include colitis Acute onset of severe High probability of producing, gram-positive, and severe, watery symptoms leads to recurrence >20%, usually anaerobic bacteria diarrhea with up to 15 hospitalization for within 1-2 weeks after bowe
Slide 8: SER-109 ECOSPOR III Study Results
SER-109 ECOSPOR III Study Results TRIAL DESIGN SER-109 (n = 90) • Multiply recurrent Primary endpoint: Safety C. difficile patients (n=182) C. diff. recurrence, follow-up to • All subjects treated with at up to 8 weeks 24 weeks standard of care antibiotics Approximately Placebo (n = 92) 0 weeks 8 we
Slide 9: SER-109 Phase 3 Results Published in Premier Journals
SER-109 Phase 3 Results Published in Premier Journals RESEARCH LETTER Extended Follow-up of Microbiome Therapeutic SER-109 Through 24 Weeks for Recurrent Clostridioides difficile infection in a Randomized Clinical Trial Survival Function for Time to Recurrence of C. difficile Infection up to 8 Weeks
Slide 10: ECOSPOR III – Favorable Safety Profile Observed
ECOSPOR III – Favorable Safety Profile Observed Adverse Events (AEs) Through 8 Weeks SER-109 (n=90) Placebo (n=92) (Safety Population)2 n (%) 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- Sustained Sustained clinical week follow up: clinical response rate: response rate in patients SER-109 was well tolerated, 91% with first recurrence: consistent with profile observed in ECOSPOR III similar to
Slide 12: Delivering SER-109 to Patients; PDUFA Date April 26, 2023
Delivering SER-109 to Patients; PDUFA Date April 26, 2023 We are here Potential SER-109 BLA submission Priority FDA review approval and launch • BLA submission completed • Accelerated review based Q3 2022; acceptance on Breakthrough Therapy confirmed by FDA Oct. 2022 Designation • PDUFA date April 2
Slide 13: SER-109 May Fill an Important Unmet Need – Prevention of Recurrence
SER-109 May Fill an Important Unmet Need – Prevention of Recurrence • Early and urgent intervention in the cycle of recurrence If approved, SER-109 may can prevent further recurrences serve as appropriate • SER-109 could have a unique place in the treatment foundational therapy for a algorithm, pote
Slide 14: Well Positioned for Commercial Success
Well Positioned for Commercial Success 1 2 3 Highly Favorable Substantial Market Commercial Capabilities, Product Profile, Opportunity Including Manufacturing Pending Approval Preparing for successful SER-109 commercial launch alongside collaborator, Nestlé Health Science 14 Seres press release issu
Slide 15: Seres and Nestlé Health Science Resources and Capabilities to Support SER-109 Launch
Seres and Nestlé Health Science have Full Suite of Resources and Complementary Capabilities to Support SER-109 Launch Market Access and Specialty Product Patient Support Medical Reimbursement Distribution Services Affairs Key Customer Relationships Data and Insights Commercial Infrastructure 15
Slide 16: Focusing on the Most Important Areas at Launch to Set Up SER-109 for Long Term Success
Focusing on the Most Important Areas at Launch to Set Up SER-109 for Long Term Success, if Approved LAND EXPAND First 12 months >12 months • Implement payer policies as quickly as possible to ease access to treatment Patient • Optimize patient support offerings • Access programs to support positive
Slide 17: Well Positioned to Supply Commercial Demand at Launch and Beyond
Well Positioned to Supply Commercial Demand at Launch and Beyond 10+ years of Investment in Technology and Facilities for anaerobic bacterial therapeutics: • In-house GMP Manufacturing and Quality Control • Supported by high-quality CMOs: Recipharm, PCI SER-109 commercial + Bacthera collaboration pr
Slide 18: SER-155 and Infection Protection Franchise
SER-155 and Infection Protection Franchise 18
Slide 19: SER-109 Clinical Data Provide Proof of Concept - Restructuring the Microbiome and Reducing Pathogens
SER-109 Clinical Data Provide Proof of Concept - Restructuring the Microbiome and Reducing Pathogens SER-109 bacteria engraft durably Engraftment reduces proteobacteria* associated with & rapidly to restructure microbiome antimicrobial resistance genes SER-109 Dose Species Engraftment Engrafting Dos
Slide 20: Antimicrobial Resistant Infections - Urgent Public Health Threat
Antimicrobial Resistant Infections - Urgent Public Health Threat Major burden to society Many high-risk patient populations Declared “one of the • Allogeneic HSCT recipients at risk for world’s most urgent bloodstream infections threats” • Additional patients with suppressed $20 billion excess immun
Slide 21: Potential Novel Approach to Address Infection - SER-155 Phase 1b Study Ongoing
Potential Novel Approach to Address Infection - SER-155 Phase 1b Study Ongoing SER-155 Phase 1b study design and objectives Microbiome drug Rationally designed, cultivated product; spore + type vegetative species patients in an open-label ~70 and a randomized, double-blind, placebo-controlled cohort
Slide 22: Maximizing the Opportunity in Infection Protection and AMR
Maximizing the Opportunity in Infection Protection and AMR Broadly Target Antimicrobial Additional Opportunities Resistant • Broad preclinical Infections portfolio • Driving to an additional clinical development Autologous HSCT program in 2023 Cancer Neutropenia • Potentially 2+ Pre-clinical Portfol
Slide 23: Well Positioned to Extend Microbiome Therapeutic Leadership in 2023
Well Positioned to Extend Microbiome Therapeutic Leadership in 2023 Potential SER-109 BLA approval and successful launch for rCDI • BLA submission complete; FDA PDUFA target action date of April 26, 2023 • Working closely with Nestlé to prepare for commercial launch • Producing supply to support com
Slide 24: Continued Microbiome Therapeutic Leadership, Anticipated Compelling Growth and Value Creation
Continued Microbiome Therapeutic Leadership, Anticipated Compelling Growth and Value Creation 2023 2025 • If approved, SER-109 transforming standard Potential SER-109 BLA of care for a broad population of rCDI patients approval and successful launch for rCDI • SER-155 in late-stage clinical developm
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