Seres Therapeutics, Inc. · NASDAQ:MCRB
Seres Therapeutics — Corporate Update (September 2024)
46 slides from Seres Therapeutics's corporate update, Sep 12, 2024
Slide 1: SER-155 Phase 1b Readout
Exhibit 99.1 SER-155 Phase 1b Readout September 12, 2024
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: Disclaimers: Important Information About the Transaction
Disclaimers Important Information About the Transaction and Where to Find it In connection with the proposed transaction involving Seres Therapeutics, Inc. (“Seres”) and Société des Produits Nestlé S.A. (“SPN”), Seres filed a definitive proxy statement with the Securities and Exchange Commission (th
Slide 4: SER-155 is designed to reduce life-threatening complications of allo-HSCT
SER-155 is designed to reduce life-threatening complications of allo-HSCT • 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 treatme
Slide 5: 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 Endpoi
Slide 6: Cohort patient disposition
Cohort 2 patient disposition ITT Safety mITT-1 SER-155 n = 23 n = 21 n = 20 -2 randomized untreated -1 consent withdrawal mITT-1 population studied for efficacy Safety mITT-1 ITT Placebo n = 19 n = 14 n = 22 -3 randomized untreated -3 disease progression -1 transplant delay -1 consent withdrawal ITT
Slide 7: Cohort demographics: Representative of the allo-HSCT population
Cohort 2 demographics: Representative of the allo-HSCT population • Median age: 63 years Demographics • Gender: 50% male, 50% female • Ethnicity: 88% white • Most common diagnosis: acute myeloid leukemia (AML): 38% Cancer Diagnosis • Other common diagnoses: acute lymphocytic leukemia (ALL), myelodys
Slide 8: Patient Safety: SER-155 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 9: Efficacy: reduction in bacterial BSIs and 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 10: 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 11: Febrile neutropenia from HSCT Day 0 to Day 100
Febrile neutropenia from HSCT Day 0 to Day 100: Lower incidence in SER-155 treated subjects vs. placebo Febrile neutropenia from Day 0 to SER-155 Placebo Day 100 n=20 n=14 (# patients) n (%) n (%) Subjects with FN 13 (65.0) 11 (78.6) 95% confidence interval (40.8, 84.6) (49.2, 95.3) mITT-1 populatio
Slide 12: 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 Cumulative Antibacterial or SER-155 Placebo Antimycotic Exposure n=20 n=14 (HSCT Days) n (%) n (%) Mean (SD) 9.2 (5.44) 21.1 (20.31) Median 9.0 14.0 Min, Max 0,
Slide 13: 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 (% of days) n (%) n (%) Mean (SD) 0.090 (0.0530) 0.305 (0.2898) Median 0.08
Slide 14: SER-155 Strain Engraftment
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 15: Pathogen Domination: 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 1 clinical outcomes 2 • In Cohort 2, the ability to detect pathogen dom
Slide 16: Summary and Next Steps
Summary and Next Steps Seres to engage with FDA on advancement Phase 1 results support Seres’ strategy to of SER-155 allo-HSCT program pursue SER-155 and other live biotherapeutics for prevention of serious bacterial infections • Intend to evaluate SER-155 in additional patient • Seek Breakthrough T
Slide 17: Exhibit 99.3 Seres Therapeutics
Exhibit 99.3 Seres Therapeutics Investor Presentation September 12, 2024
Slide 18: 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 19: Disclaimers: Important Information About the Transaction
Disclaimers Important Information About the Transaction and Where to Find it In connection with the proposed transaction involving Seres Therapeutics, Inc. (“Seres”) and Société des Produits Nestlé S.A. (“SPN”), Seres filed a definitive proxy statement with the Securities and Exchange Commission (th
Slide 20: September 2024: SER-155 Phase 1b Cohort 2 study results
September 2024: SER-155 Phase 1b placebo-controlled Cohort 2 study results in allo-HSCT • Phase 1b study in adults undergoing allogeneic hematopoietic stem cell transplant (allo-HSCT) to assess SER-155 safety and pharmacology, with additional endpoints such as incidence of bacterial bloodstream infe
Slide 21: 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 clinical data in SER- • Validated platform with • Accelerate SER-155 • SER-147 designed to ® 155 allo-HSCT VOWST clinical and development
Slide 22: Validated platform: 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 88% FDA approved (April 2023) sustained clinical response rate to prevent the recurrence of (C. d
Slide 23: VOWST asset sale a transformational transaction for Seres
VOWST asset sale a transformational transaction for Seres 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 at closing provides infusion of capital and $60M prepaid sales-based
Slide 24: 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 25: 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 Seres Therapeutics, Inc. © 2024 9
Slide 26: 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 Barrier
Slide 27: Well tolerated safety profile reducing development risk
Seres’ biotherapeutics and pipeline candidates 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 adverse events ✓Wel
Slide 28: Near-term focus on SER-155 and SER-147
Near-term focus on SER-155 and SER-147 with potential to address expansive therapeutic opportunities Lead Indication & Therapeutic Potential Additional Program Development Stage Objectives Indications Allogeneic HSCT: • Autologous HSCT Reduce incidence of Phase 1b • CAR-T serious bacterial infection
Slide 29: SER-155 is designed to reduce life-threatening complications of allo-HSCT
SER-155 is designed to reduce life-threatening complications of allo-HSCT • 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 treatme
Slide 30: 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 Endpoi
Slide 31: Patient Safety: SER-155 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 32: Efficacy: reduction in bacterial BSIs and 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 33: 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 34: 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 Cumulative Antibacterial or SER-155 Placebo Antimycotic Exposure n=20 n=14 (HSCT Days) n (%) n (%) Mean (SD) 9.2 (5.44) 21.1 (20.31) Median 9.0 14.0 Min, Max 0,
Slide 35: 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 (% of days) n (%) n (%) Mean (SD) 0.090 (0.0530) 0.305 (0.2898) Median 0.08
Slide 36: SER-155 Strain Engraftment
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 37: Pathogen Domination: 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 1 and other negative clinical outcomes 2 • In Cohort 2, the ability to detect pathogen dom
Slide 38: 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 39: SER-155 allo-HSCT commercial opportunity is meaningful
SER-155 allo-HSCT commercial opportunity is meaningful Serious bacterial infections are frequent, creating a strong medical ✓ rationale for prophylaxis to prevent infections and complications ~40K transplants per year worldwide ✓ Very high overall cost of allo-HSCT and related cost of ✓ complication
Slide 40: 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 Potential global SER-155 Engage with FDA on advancement of SER-155 allo- development and HSCT program commerciali
Slide 41: 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) Solid organ transplant ~65K (liver,
Slide 42: SER-147 in development to prevent infections in chronic liver disease
SER-147 in development 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 t
Slide 43: End-to-end capabilities for live biotherapeutics discovery and development
End-to-end capabilities & expertise for discovery and development of bacterial live biotherapeutics GI microbiome biomarker & drug Clinical translation target identification & patient subpopulation insights Proven discovery, Lead candidate design, Proprietary know-how on clinical screening, optimiza
Slide 44: 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 45: 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: Anticipate IND ready in H2 '25 SER-147 Indication expansion (e.g
Slide 46: Summary and path forward
Summary and path forward Successful VOWST development validates using live biotherapeutics to prevent life-threatening • infections Developing a pipeline of SER-155 Phase 1b placebo-controlled clinical efficacy data further support Seres’ strategy novel live biotherapeutics in • areas of high unmet
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