Seres Therapeutics, Inc. · NASDAQ:MCRB
Seres Therapeutics — Investor Presentation (December 2024)
30 slides from Seres Therapeutics's investor presentation, Dec 9, 2024
Slide 1: Seres Therapeutics Investor Presentation December 9, 2024
Seres Therapeutics Investor Presentation December 9, 2024
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 Favorable Phase 1b Blockbuster opportunity Expansive potential • Validated platform with clinical data in SER- • Accelerate SER-155 • Current focus of preventing VOWST® clinical and 155 allo-HSCT deve
Slide 4: Validated platform: Seres pioneered the development and FDA approval of VOWST
Validated 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) to prevent the recurrence of 88% sustained clinical response rate (C. d
Slide 5: VOWST asset sale completed September 30, 2024: transformational for Seres
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: Near-term focus on SER-155 as anchor biotherapeutic program
Near-term focus on SER-155 as anchor biotherapeutic program Lead Indication & Therapeutic Potential Additional Program Development Stage Objectives Indications Allogeneic HSCT: Reduce incidence of Phase 1b • Autologous HSCT serious bacterial infections provides clinical validation SER-155 Cohort 2 (
Slide 7: Potential to treat a range of vulnerable patient populations
Potential to treat a range of vulnerable patient populations Potential to prevent bacterial infections and Target population characteristics immune-related disease Prevent life-threatening infections (current focus) GI microbiome Immune • Blood cancers (including HSCT, CAR-T) functional suppression
Slide 8: GI microbiome functional disruption leads to disease susceptibility
GI microbiome functional disruption leads to disease susceptibility GI Microbiome: Healthy Functionally disrupted IMPACTED BIOLOGY • Pathogen domination • Lost barrier & mucosal integrity • Unfavorable immune responses Commensal microbes Pathogenic microbes 8 Seres Therapeutics, Inc. © 2024
Slide 9: Seres' biotherapeutics designed to restore functionality and health
Seres’ biotherapeutics designed to restore functionality and health Bacteria engraft and restructure GI microbiome, restoring critical biology Formulated for oral administration Cultivated in Pathogen inhibition Seres labs from master cell banks Bacteria selected based on desired functional properti
Slide 10: Seres' biotherapeutics expected to have 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 11: Allo-HSCT regimen can result in potentially life-threatening complications
Allo-HSCT regimen can result in potentially life-threatening complications • Investigational live oral biotherapeutic cultivated from clonal master cell banks SER-155 • Designed to prevent GI-derived bacterial bloodstream infections (BSIs) and other pathogen-associated complications Allo-HSCT treatm
Slide 12: Bloodstream infections (BSI) are a leading cause of death post-transplant
Bloodstream infections (BSI) are a leading cause of death and an escalating problem post-transplant TBD • 32-55% BSI incidence reported in the Bacterial BSI in first 30 days Incidence literature post-HSCT • BSI risk escalating due to recent 50% adoption of post-transplant 40% cyclophosphamide (PTCy)
Slide 13: 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 Endpoi
Slide 14: Patient Safety: Cohort 2 SER-155 was generally well tolerated
Patient Safety: Cohort 2 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),
Slide 15: Efficacy: significant reduction in bacterial BSIs and systemic antibiotic exposure
Efficacy: SER-155 administration favorable with significant* reduction in both bacterial BSIs and systemic antibiotic exposure; lower febrile neutropenia Significant decrease in bacterial bloodstream infections in SER-155-treated Bloodstream infections subjects vs. placebo Numerically lower incidenc
Slide 16: 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 17: 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 18: Cumulative exposure rate to systemic antibacterials / antimycotics through Day 100
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 19: SER-155 Strain Engraftment: Primary objective achieved
SER-155 Strain Engraftment: Primary objective achieved - drug bacteria strain engraftment was robust and as expected • The majority of SER-155 strains were present at start of HSCT conditioning and durable through chemotherapy exposure • Engraftment decreased but was detectable post- neutrophil reco
Slide 20: Pathogen Domination: Prevalence lower relative to Historical Control Cohort
Pathogen Domination: Prevalence in SER-155 Cohort 2 was substantially lower relative to Historical Control Cohort • SER-155 was designed to reduce pathogen domination that has been associated with risk of BSIs and other negative clinical outcomes1 • Observed pathogen domination events were low in th
Slide 21: Key procedures
Hematologist-oncologist leads care team and sets protocol for treating allo- HSCT patients Hematopoietic stem cell transplant Diagnosis Pre-transplant treatment (HSCT) Hematologist-oncologist Hematologist-oncologist Hematologist-oncologist (heme-onc) leads diagnosis makes treatment decisions makes t
Slide 22: 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) • Transplant-related complications (e.g.,
Slide 23: HCPs see SER-155 as a potentially transformative means to eliminate complications
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 24: SER-155 has blockbuster commercial potential
SER-155 has blockbuster commercial potential, driven by poor standard of care and a robust SER-155 profile ✓ High unmet need to prevent frequent and serious infections ✓ ~40K annual transplants worldwide; 3% annual growth from aging population and transplant success rates ✓ Costly procedure (~$400K
Slide 25: 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- HSC
Slide 26: Anticipated SER-155 expansion in biologically adjacent populations
Anticipated SER-155 expansion in biologically adjacent populations Transplants / diagnoses per year Population (US + EU) Autologous HSCT ~30K Blood cancers with high neutropenia rates ~190K (acute myeloid leukemia, multiple myeloma, B cell non-Hodgkin’s lymphomas) Potential to initiate multiple clin
Slide 27: 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 28: 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 29: Maximizing opportunity going forward
Maximizing opportunity going forward Prevent life-threatening infections in additional populations Additional Treat immune-related diseases (e.g., IBD, GvHD, checkpoint Opportunities colitis, radiation enteritis) Chronic liver disease: Progressing towards IND readiness SER-147 Indication expansion (
Slide 30: 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 novel live biotherapeutics in • advancing SER-147 Pipeline aims to bring transformative medicines to a wider set of patients, led by SER-155 while areas of h
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