Seres Therapeutics, Inc. · NASDAQ:MCRB
Seres Therapeutics — Q1 2025 Earnings Presentation
35 slides from Seres Therapeutics's earnings presentation, May 7, 2025
Slide 1: Seres Therapeutics Investor Presentation
Seres Therapeutics Investor Presentation May 2025
Slide 2: Disclaimers
Disclaimers Forward Looking Statements This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this communication that do not relate to matters of historical fact should be considered forward-looki
Slide 3: Transforming patient outcomes using proprietary consortia of live biotherapeutics
Transforming patient outcomes using proprietary consortia of live biotherapeutics Strong Foundation Positive SER-155 Phase Blockbuster SER-155 Expansive Platform 1b Data in Allo-HSCT Opportunity Potential • Validated platform highlighted by VOWST® • 77% relative risk reduction • Initial SER-155 deve
Slide 4: Dramatic clinical benefit
Validated therapeutic modality and platform: Seres pioneered the development and FDA approval of VOWST as the first-ever oral live microbiome therapeutic DRAMATIC CLINICAL BENEFIT – Preventing infection recurrence Approximately FDA approved (April 2023) 88% to prevent the recurrence of sustained cli
Slide 5: VOWST asset sale completed September 30, 2024
VOWST asset sale completed September 30, 2024: transformational for Seres – provides resources to support SER-155 advancement KEY FINANCIAL TERMS $100M upfront payment to Seres, less ~$20M in net obligations due to an affiliate of SPN* • VOWST asset purchase agreement $15M equity investment by SPN a
Slide 6: The gut microbiome has substantial untapped therapeutic potential
The gut microbiome has substantial untapped therapeutic potential to both prevent and treat diseases The genetic content of the microbes living within and on your body is at least 100-fold greater than that contained in the human genome 6 Seres Therapeutics, Inc. © 2025 Sources: Ley et al. (2006) Ce
Slide 7: Disrupted gastrointestinal microbiome is mechanistically linked to infections and disease
Disrupted gastrointestinal microbiome is mechanistically linked to infections and disease Disrupted & Not Disrupted Disease Susceptible Impacted Biology & Disease Relevance Pathogen or “undesirable” microbe abundance Increased pathogen abundance, in combination with Lost epithelial barrier & impaire
Slide 8: Consortia of live commensal bacteria can be used as therapeutics
Consortia of live commensal bacteria can be used as therapeutics Live Biotherapeutics Consortia of PK PD bacterial strains Optimized to target Disrupted Microbiome Engraftment Restructure Change in Change multiple with functional of drug microbiome microbiome in host disease-relevant deficiencies st
Slide 9: Well tolerated safety profile
Seres’ biotherapeutics and pipeline candidates are expected to have well tolerated safety profile, reducing development risk ✓ Based on GI bacteria naturally found in healthy humans, and not associated with disease ✓ VOWST product profile includes well tolerated safety without drug-related serious a
Slide 10: Seres' initial focus is preventing infections in allo-HSCT
Seres’ initial focus is preventing infections in allo-HSCT; potential is broad Allo-HSCT Autologous HSCT Chronic Liver Disease Survival by microbiome diversity Survival by microbiome diversity Survival by microbiome diversity Lower microbiome diversity post allo- HSCT is associated with increased Lo
Slide 11: Near-term focus on SER-155 as anchor biotherapeutic program
Near-term focus on SER-155 as anchor biotherapeutic program; constructive FDA engagement on path forward in addition to Breakthrough and Fast Track designations Lead Indication & Therapeutic Potential Additional Program Development Stage Objectives Indications provides clinical Allogeneic HSCT: Phas
Slide 12: Allo-HSCT regimen can result in infectious consequences
Allo-HSCT regimen can result in infectious consequences and increased mortality Allo-HSCT treatment regimen Treatment consequences Chemotherapy Allo-HSCT • Only ~60% survival 3 years post- Increased risk of infection, GvHD Anti-infectives infusion transplant in US and EU • Significant immune comprom
Slide 13: Bloodstream infections are a leading cause of death post-transplant
Bloodstream infections (BSIs) are a leading cause of death post-transplant and are increasing in incidence Bacterial BSI in first 30 days • BSI risk increasing due to recent adoption post-HSCT Incidence of post-transplant cyclophosphamide (PTCy) 50% for GvHD prophylaxis 40% • BSI prevalence high des
Slide 14: Standards of care to prevent bloodstream infections are poor
Standards of care to prevent bloodstream infections in allo-HSCT patients are poor and decreasing in efficacy Joint ASCO* and IDSA EBMT guidelines and Infectious Disease recommendation Working Party recommendations • Fluoroquinolones (FQ) recommended • 2022 Workshop recommends move to for antibacter
Slide 15: SER-155 Phase 1b study evaluated safety, pharmacology, and efficacy
SER-155 Phase 1b study evaluated safety, pharmacology, and efficacy in adult allo- HSCT recipients COHORT 1 COHORT 2 Open-label (n=15 enrolled) Placebo-controlled 1:1 (n=45 enrolled) SER-155 SER-155 Placebo results reported May 2023 results announced Sept. 2024 Primary Endpoints: Key Secondary Endpo
Slide 16: SER-155 Safety
SER-155 Safety: SER-155 was generally well tolerated with no treatment-related SAEs • All but one subject in the placebo arm experienced at least 1 TEAE • Most common for SER-155 treated subjects (≥50% and with Δ ≥5% greater than placebo): Treatment-emergent diarrhea (86% vs. 74% placebo), nausea (6
Slide 17: SER-155 Efficacy
SER-155 Efficacy: SER-155 associated with 77% relative risk reduction in bacterial BSIs and reduction in systemic antibiotic exposure Significant decrease in bacterial bloodstream infections in SER-155-treated subjects vs. Bloodstream infections placebo with 77% relative risk reduction Significantly
Slide 18: Bloodstream infections from HSCT Day 0 to Day 100
Bloodstream infections from HSCT Day 0 to Day 100: Lower incidence in SER-155 treated subjects vs. placebo Bloodstream infections from Day 0 SER-155 Placebo to Day 100 n=20 n=14 (# patients) n (%) n (%) Subjects with confirmed BSI 2 (10.0%) 6 (42.9%) 95% confidence interval (1.2, 31.7) (17.7, 71.1)
Slide 19: Cumulative exposure to systemic antibacterials and antimycotics
Cumulative exposure to systemic antibacterials / antimycotics through HSCT Day 100: Lower incidence in SER-155 treated subjects vs. placebo Cumulative Antibacterial or SER-155 Placebo Antimycotic Exposure n=20 n=14 (HSCT Days) n (SD) n (SD) Mean (SD) 9.2 (5.44) 21.1 (20.31) Median 9.0 14.0 Min, Max
Slide 20: Cumulative exposure rate to systemic antibacterials and antimycotics
Cumulative exposure rate to systemic antibacterials / antimycotics through HSCT Day 100: Lower incidence in SER-155 treated subjects vs. placebo Cumulative Antibacterial or SER-155 Placebo Antimycotic Exposure Rate n=20 n=14 Rate (SD) Rate (SD) Mean (SD) 0.090 (0.0530) 0.305 (0.2898) Median 0.089 0.
Slide 21: SER-155 Pharmacodynamics
SER-155 Pharmacodynamics: the Phase 1b study included multiple measures of drug pharmacodynamics SER-155 Mechanism of Action Preclinical Clinical Support Measurements on Targets Optimization for MoA Ph1b clinical study Genomic measurements of pathogen Inhibit Pathogens or abundance in gastrointestin
Slide 22: Pathogen domination prevalence in SER-155 Cohort 2
SER-155 Pharmacodynamics (pathogen domination): prevalence in SER-155 Cohort 2 was substantially lower relative to Historical Control Cohort • Pathogen domination (i.e., relative abundance in the GI ≥30%) has been associated with risk of BSIs and other negative clinical outcomes1, 2 • Observed patho
Slide 23: Epibarrier exploratory translational biomarker results
Clinical: Epibarrier exploratory translational biomarker results support intended mechanisms of action and clinical safety and efficacy results Repair & Protect Intestinal Epithelial Barrier Integrity p = 0.0006 Fecal Albumin (ng/ML) Following SER-155 treatment course 1 (“post-155 T1”), fecal albumi
Slide 24: Anti-inflammatory translational biomarker results
Clinical: Anti-inflammatory translational biomarker results support intended mechanisms of action and clinical safety and efficacy results Neutrophil Biomarker Post-155 T1 HCT Day 0 Modulate / Regulate Immune recovery Responses and Function 155 < PBO 155 < PBO IFN-γ p<0.1 p<0.05 155 < PBO TNF-α p<0.
Slide 25: Profile of SER-155
US HCPs seek significant reduction of infection risk without compromising patient safety and would incorporate such a therapeutic into standard of care • Reduce incidence of bloodstream infections: target 20% BSI rate vs. current 40% rate Profile of SER-155 Efficacy • Reduce systemic antibiotic use
Slide 26: HCPs see SER-155 as a potentially transformative means
HCPs see SER-155 as a potentially transformative means to eliminate complications that get in the way of achieving transplant success Reducing the risk of HSCT-related complications, thus ensuring successful engraftment Primary Value Driver for and long-term health of the patient SER-155 A relative
Slide 27: US payers confirm high unmet clinical need
US payers confirm high unmet clinical need for infection prophylaxis in allo- HSCT recipients and robust profile of SER-155 • High perceived clinical burden of BSIs within the allo-HSCT patient population is Clinical Burden Rating driven by high frequency of occurrences and poor associated outcomes
Slide 28: Viral prophylaxis provides precedent in medically vulnerable patients
Viral prophylaxis provides precedent in medically vulnerable patients Prevymis - increasingly used for viral infection prophylaxis (e.g., allo-HSCT and solid organ transplant populations) • Overall cost of allo-HSCT is high (~$400K US year 1 allo-HSCT costs) $785M ‘24 • Transplant-related complicati
Slide 29: SER-155 has blockbuster commercial potential
SER-155 has blockbuster commercial potential, driven by a robust SER-155 profile and substantial unmet needs in allo-HSCT and additional groups ✓ High unmet need to prevent frequent and serious infections ✓ ~40K annual transplants worldwide; 3% annual growth from aging population and transplant succ
Slide 30: Indication expansion: potential 10x addressable population
Indication expansion: potential 10x addressable population Broader leukemia & Allo-HSCT Autologous HSCT lymphoma population* WW annual diagnoses or ~40,000 ~60,000 ~500,000 transplants US annual diagnoses or ~9,300 ~13,500 ~87,000 transplants initial focus Unmet needs Prevent mortality and Prevent m
Slide 31: Accelerating SER-155 clinical development based on positive Ph1b outcomes
Accelerating SER-155 clinical development based on positive Ph1b outcomes Constructive engagement with FDA on advancement of SER-155 allo-HSCT program • Received Breakthrough Therapy designation in December 2024 Seeking SER-155 • FDA recommended next study be a Phase 2 • Finalizing Phase 2 protocol
Slide 32: Advancing SER-147 to prevent infections in chronic liver disease patients
Advancing SER-147 to prevent infections in chronic liver disease patients Substantial unmet need Promising preclinical data SER-147 is an investigational live oral biotherapeutic designed to reduce pathogens 0.5M 2.1M causing gut-seeded SBP and BSIs in liver disease patients Declining E. coli titers
Slide 33: Manufacturing platform delivers defined consortia in oral formulation
Manufacturing platform delivers defined consortia in oral formulation using cost-effective production Strain isolation and characterization pipeline to rapidly identify cGMP- suitable medium components Highly intensive strain bioprocessing leveraging flexible, single-use manufacturing technology for
Slide 34: Maximizing opportunity of live biotherapeutics going forward
Maximizing opportunity of live biotherapeutics going forward • Prevent life-threatening bacterial infections, including Additional antimicrobial resistant infections in additional populations Opportunities • Treat immune-related diseases (e.g., IBD, UC, Crohn’s) • Infections in Chronic liver disease
Slide 35: Summary and path forward
Summary and path forward Developing a pipeline of • SER-155 Phase 1b placebo-controlled clinical efficacy data support Seres’ strategy novel live biotherapeutics • Pipeline aims to bring transformative medicines to a wider set of patients, led by SER-155 while in areas with large advancing SER-147 c