Seres Therapeutics, Inc. · NASDAQ:MCRB
Seres Therapeutics — J.P. Morgan Conference 2025
34 slides from Seres Therapeutics's conference presentation, Jan 13, 2025
Slide 1: J.P. Morgan Conference Seres Therapeutics Investor Presentation
Exhibit 99.1 J.P. Morgan Conference Seres Therapeutics Investor Presentation January 16, 2025
Slide 2: Disclaimers: Forward Looking Statements
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 • Accelerate SER-155
Slide 4: Validated therapeutic modality and platform: VOWST as first-ever oral live microbiome therapeutic
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 88% FDA approved (April 2023) 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 Sources: Ley et al. (2006) Cell; Qin et al. (2010) Nature Seres
Slide 7: Disrupted gastrointestinal microbiome is mechanistically linked to infections and disease
Disrupted gastrointestinal microbiome is mechanistically linked to infections and disease Disrupted & Disease Susceptible Not Disrupted Impacted Biology & Disease Relevance Pathogen or “undesirable” microbe abundance Increased pathogen abundance, in combination with impaired barrier integrity Lost e
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 PD PK bacterial strains Optimized to target Engraftment Restructure Change in Change Disrupted Microbiome multiple of drug microbiome microbiome in host with functional disease-relevant strains composi
Slide 9: Well tolerated safety profile reducing development risk
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 adv
Slide 10: Initial focus preventing infections in allo-HSCT; potential is broad
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- Lower microbiome diversity post Micr
Slide 11: Near-term focus on SER-155 as anchor biotherapeutic program
Near-term focus on SER-155 as anchor biotherapeutic program; achieved Breakthrough and Fast Track designations Lead Indication & Therapeutic Potential Additional Program Development Stage Objectives Indications Allogeneic HSCT: provides clinical Phase 1b Reduce incidence of • Autologous HSCT proof o
Slide 12: Allo-HSCT regimen can result in life-threatening complications
Allo-HSCT regimen can result in life-threatening complications Allo-HSCT treatment regimen • Only ~60% survival 3 years post- Chemotherapy Allo-HSCT Increased risk of infection, GvHD Anti-infectives infusion transplant • Significant immune compromise • ~10% transplant mortality for adults in first 1
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% • ~50% of infections are
Slide 14: Standards of care to prevent bloodstream infections are poor and decreasing in efficacy
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 design in adult allo-HSCT recipients
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: no treatment-related SAEs
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: 77% relative risk reduction in bacterial BSIs
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 / antimycotics through Day 100
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 / 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 Pharmacokinetics: strain engraftment robust and as expected
SER-155 Pharmacokinetics: Primary objective achieved - drug bacteria strain engraftment was robust and as expected • The majority of SER-155 strains engrafted and were durable through chemotherapy exposure • Engraftment decreased but was detectable post- neutrophil recovery, suggesting sustained eng
Slide 22: SER-155 Pharmacodynamics: multiple measures in Ph1b study
SER-155 Pharmacodynamics: the Ph1b study included multiple measures of drug pharmacodynamics SER-155 Mechanism of Action Preclinical Measurements on Ph1b clinical study Optimization Targets Genomic measurements of pathogen abundance in Inhibit Pathogens or gastrointestinal tract, including dominatio
Slide 23: SER-155 Pharmacodynamics (pathogen domination)
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 1, 2 negative clinical outcomes • Observed path
Slide 24: US HCPs seek significant reduction of infection risk without compromising safety
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 • Reduce systemic antibiotic use that is contributing to risi
Slide 25: HCPs see SER-155 as potentially transformative
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 26: US payers confirm high unmet clinical need for infection prophylaxis
New Data US payers confirm high unmet clinical need for infection prophylaxis in allo- HSCT recipients and robust profile of SER-155 Clinical Burden Rating • High perceived clinical burden of BSIs within the allo-HSCT patient population is driven by high frequency of occurrences and poor associated
Slide 27: 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 • Overall cost of allo-HSCT is high solid organ transplant populations) (~$400K US year 1 allo-HSCT costs) • Transplant-related complications (e.g.,
Slide 28: 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 29: Indication expansion: potential 10x addressable population
Indication expansion: potential 10x addressable population Broader leukemia & Allo-HSCT Autologous HSCT lymphoma population* WW annual ~40,000 ~60,000 ~500,000 diagnoses or transplants US annual ~9,300 ~13,500 ~87,000 diagnoses or initial focus transplants Unmet needs Prevent mortality and Prevent m
Slide 30: Accelerating SER-155 clinical development with positive Ph1b outcomes
Accelerating SER-155 clinical development with positive Ph1b outcomes Aim to accelerate SER-155 development in allo-HSCT • Potential to follow successful precedent from VOWST development with single registrational study for efficacy Seeking SER-155 Engage with FDA on advancement of SER-155 allo- str
Slide 31: 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 32: 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 33: Maximizing opportunity of live biotherapeutics going forward
Maximizing opportunity of live biotherapeutics going forward • Prevent life-threatening bacterial infections, including antimicrobial resistant infections in additional populations Additional • Treat immune-related diseases (e.g., IBD, GvHD, checkpoint Opportunities colitis) • Infections in Chronic
Slide 34: Summary and path forward
Summary and path forward SER-155 Phase 1b placebo-controlled clinical efficacy data further support Seres’ strategy • Developing a pipeline of Pipeline aims to bring transformative medicines to a wider set of patients, led by SER-155 while • novel live biotherapeutics in advancing SER-147 areas of h