Seres Therapeutics, Inc. · NASDAQ:MCRB
Seres Therapeutics — Q3 2024 Earnings Presentation
30 slides from Seres Therapeutics's earnings presentation, Nov 13, 2024
Slide 1: Seres Therapeutics Investor Presentation
Seres Therapeutics Investor Presentation November 13, 2024 Exhibit 99.2
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 Validated platform with VOWST® clinical and regulatory success Asset sale strengthens balance sheet, expected to extend runway into Q4 ‘25 Wholly-owned cultivated pipeline: SER-155, SER-147, beyond Fa
Slide 4: Validated platform: VOWST first FDA-approved oral live microbiome therapeutic
Validated platform: Seres pioneered the development and FDA approval of VOWST as the first-ever oral live microbiome therapeutic FDA approved (April 2023) to prevent the recurrence of C. difficile infection in adults Approximately 88% sustained clinical response rate (C. diff. recurrence, at up to 8
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 VOWST asset purchase agreement provided infusion of capital and supports SER-155 development Asset sale extends operational runway into Q4 2025 Retires de
Slide 6: Near-term focus on SER-155 as anchor biotherapeutic program
Near-term focus on SER-155 as anchor biotherapeutic program Program Lead Indication & Development Stage Therapeutic Objectives Potential Additional Indications SER-155 Allogeneic HSCT: Phase 1b Cohort 2 (placebo controlled) data announced Sept. ‘24 Reduce incidence of serious bacterial infections (e
Slide 7: Potential to treat a range of vulnerable patient populations
Potential to treat a range of vulnerable patient populations Seres Therapeutics, Inc. © 2024 Blood cancers (including HSCT, CAR-T) Solid organ transplant ICU & long-term care patients Chronic liver disease Target population characteristics Potential to prevent bacterial infections and immune-related
Slide 8: GI microbiome functional disruption leads to disease susceptibility
GI microbiome functional disruption leads to disease susceptibility Functionally disrupted Healthy GI Microbiome: Commensal microbes Pathogenic microbes Seres Therapeutics, Inc. © 2024 Pathogen domination Lost barrier & mucosal integrity Unfavorable immune responses IMPACTED BIOLOGY
Slide 9: Seres' biotherapeutics designed to restore functionality and health
Seres’ biotherapeutics designed to restore functionality and health Formulated for oral administration Bacteria selected based on desired functional properties Cultivated in Seres labs from master cell banks Bacteria engraft and restructure GI microbiome, restoring critical biology Pathogen inhibiti
Slide 10: Well tolerated safety profile, reducing development risk
Seres’ biotherapeutics and pipeline candidates are expected to have well tolerated safety profile, reducing development risk Sources: Nanayakkara et al, CA Cancer J Clin 2021; Penack et al, Blood Adv 2020; Zheng et al, Infect Dis Ther 2021 Seres Therapeutics, Inc. © 2024 Based on GI bacteria natural
Slide 11: Allo-HSCT regimen can result in potentially life-threatening complications
Allo-HSCT regimen can result in potentially life-threatening complications Only ~60% survival 3 years post-transplant Significant immune compromise ~10% transplant mortality for adults in first 100 days post-transplant Infections are leading cause of death in first 100 days post-transplant for adult
Slide 12: Bloodstream infections are a leading cause of death post-transplant
Bloodstream infections (BSI) are a leading cause of death and an escalating problem post-transplant 32-55% BSI incidence reported in the literature BSI risk escalating due to recent adoption of post-transplant cyclophosphamide (PTCy) for GvHD prophylaxis ~50% of infections believed to be gut-seeded
Slide 13: 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 SER-155 COHORT 1 Open-label (n=15 enrolled) COHORT 2 Placebo-controlled 1:1 (n=45 enrolled) SER-155 Placebo results reported May 2023 results announced Sept. 2024 Primary Endpoints: Safety and tolerabil
Slide 14: Patient Safety: SER-155 well tolerated with no treatment-related SAEs
Patient Safety: Cohort 2 SER-155 was generally well tolerated with no treatment-related SAEs Seres Therapeutics, Inc. © 2024 Treatment-emergent adverse events (TEAEs) 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% grea
Slide 15: Efficacy: 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 Seres Therapeutics, Inc. © 2024 Bloodstream infections Significant decrease in bacterial bloodstream infections in SER-155-treated subjects vs. pl
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 Seres Therapeutics, Inc. © 2024 Bloodstream infections from Day 0 to Day 100 (# patients) SER-155 n=20 n (%) Placebo n=14 n (%) Subjects with confirmed BSI 2 (10.0%) 6 (42.9%) 95% confidence in
Slide 17: Cumulative exposure to systemic antibacterials / antimycotics
Cumulative exposure to systemic antibacterials / antimycotics through HSCT Day 100: Lower incidence in SER-155 treated subjects vs. placebo Seres Therapeutics, Inc. © 2024 Cumulative Antibacterial or Antimycotic Exposure (HSCT Days) SER-155 n=20 n (SD) Placebo n=14 n (SD) Mean (SD) 9.2 (5.44) 21.1 (
Slide 18: 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 Seres Therapeutics, Inc. © 2024 Cumulative Antibacterial or Antimycotic Exposure Rate SER-155 n=20 Rate (SD) Placebo n=14 Rate (SD) Mean (SD) 0.090 (0.0530
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 Seres Therapeutics, Inc. © 2024 The majority of SER-155 strains were present at start of HSCT conditioning and durable through chemotherapy exposure Engraftment decreased but was dete
Slide 20: Pathogen Domination: lower prevalence in SER-155 cohort
Pathogen Domination: Prevalence in SER-155 Cohort 2 was substantially lower relative to Historical Control Cohort Seres Therapeutics, Inc. © 2024 SER-155 was designed to reduce pathogen domination that has been associated with risk of BSIs and other negative clinical outcomes1 Observed pathogen domi
Slide 21: Allo-HSCT patient journey and key providers
Key providers Key procedures Blood tests Bone marrow biopsy Lumbar puncture Chromosome and genetic analysis Donor matching considerations begin Induction chemotherapy Consolidation and maintenance to maintain remission Transplant for eligible patients Conditioning regiments Prophylactic regimens to
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) $605M ‘23 WW sales Reduces CMV infection in allo-HSCT recipients Lowers mortality rate Overall cost of allo-HSCT
Slide 23: 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 Primary Value Driver for SER-155 Reducing the risk of HSCT-related complications, thus ensuring successful engraftment and long-term health of the patient 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 Sources: CIBMTR; HRSA; Passweg et al, BMT 2021; IQVIA; Broder et al, Am Drug Health Benefits 2017; Perales et al, Biol Blood Marrow Transplant 2017 CMS.gov; Merck SEC filings High unmet need to
Slide 25: Accelerating SER-155 clinical development with positive Ph1b outcomes
Accelerating SER-155 clinical development with positive Ph1b outcomes Seeking SER-155 strategic partnership to accelerate next study in allo-HSCT and expand to multiple target populations Aim to accelerate SER-155 development in allo-HSCT Potential to follow successful precedent from VOWST developme
Slide 26: Anticipated SER-155 expansion in biologically adjacent populations
Anticipated SER-155 expansion in biologically adjacent populations Seres Therapeutics, Inc. © 2024 Sources: CIBMTR; Passweg et al, BMT 2021; US Organ Procurement & Transplantation Network; International Registry in Organ Donation and Transplantation; US National Cancer Institute SEER Program; Americ
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 Sources: GBD 2017 Cirrhosis Collaborators, Lancet Gastroenterology & Hepatology 2020; United Nations world population data; Trebicka et al, J Hepatol 2020; Seres preclinical da
Slide 28: Manufacturing platform delivers defined consortia in oral formulation
Manufacturing platform delivers defined consortia in oral formulation using cost-effective production Novel formulations enabling consistent drug product composition, drug stability for distribution, and targeted drug delivery Quality systems to ensure product quality and stability, extending prior
Slide 29: Maximizing opportunity going forward
Maximizing opportunity going forward SER-155 Allo-HSCT: Engaging with FDA to accelerate; filed for Breakthrough Therapy and Qualified Infectious Disease Product designations Evaluate in additional populations with high risk of serious bacterial infections Prevent life-threatening infections in addit
Slide 30: Summary and path forward
Summary and path forward SER-155 Phase 1b placebo-controlled clinical results promising SER-155 administration associated with 77% relative risk reduction for bloodstream infections SER-155 administration associated with significant reduction in systemic antibiotic exposure and lower incidence of fe