Seres Therapeutics, Inc. · NASDAQ:MCRB
Seres Therapeutics — Oppenheimer Fall Healthcare Summit 2020
34 slides from Seres Therapeutics's conference presentation, Sep 23, 2020
Slide 1: Seres Therapeutics Overview
Seres Therapeutics Overview Eric Shaff, Chief Executive Officer Oppenheimer Fall Healthcare Summit September 23, 2020
Slide 2: Forward looking statements
Forward looking statements Some of the statements in this presentation constitute “forward looking statements” under the Private Securities Litigation Reform Act of 1995, including, but not limited to, our development plans, the promise and potential impact of any of our microbiome therapeutics, the
Slide 3: SER-109 Phase 3 success highlights that the time for microbiome therapeutics is now
SER-109 Phase 3 success highlights that the time for microbiome therapeutics is now Seres’ mission: To transform the lives of patients worldwide with revolutionary microbiome therapeutics 3
Slide 4: Seres is developing a novel drug modality that modulates the gut microbiome
Seres is developing a novel drug modality that modulates the gut microbiome Ecobiotic® microbiome therapeutics are encapsulated consortia of commensal bacteria with specific pharmacologic properties Formulated for Designed to oral delivery using target inflammatory current Good & immunological Manuf
Slide 5: Industry-leading, in-house research engine for drug discovery, development & manufacturing
Industry-leading, in-house research engine for drug discovery, development & manufacturing Disease Target Hit-to-Lead Lead Optimization End-to-End GMP Identification Identification & Bioprocess Manufacturing Microbiome Pharmacological Consortia Design Oral formulation Biomarker Discovery Properties
Slide 6: Broad opportunities for microbiome therapeutics
Broad opportunities for microbiome therapeutics Preclinical Phase 1b Phase 2b Phase 3 Collaborators SER-109 Recurrent C. difficile Phase 3 Infectious Disease Infection, Bacteremia & GvHD in HSCT for cancer SER-155 (Rationally-designed, fermented) Inflammatory SER-287 Ulcerative colitis Phase 2b Ulce
Slide 7: C. difficile Infection
C. difficile Infection Overview and SER-109 Phase 3 study
Slide 8: August 2020: Positive ECOSPOR III Phase 3 study read-out
August 2020: Positive ECOSPOR III Phase 3 study read-out SER-109 (n = 90) • Multiply recurrent Primary endpoint: Safety C. difficile patients (n=182) C. diff. recurrence, follow-up to • All subjects treated with at up to 8 weeks 24 weeks standard of care antibiotics Placebo (n = 92) 0 weeks 8 weeks
Slide 9: Topline SER-109 Phase 3 study efficacy results
Topline SER-109 Phase 3 study efficacy results Primary efficacy endpoint results: SER-109 Placebo (N =90) (N =92) p-Value Time point RR (95%CI) (p1/p2) n (%) n (%) Week 8 10 (11.1) 38 (41.3) 0.27 (0.15, 0.51) <0.001 / <0.001 • Sustained clinical response rate (i.e., percentage of patients who remain
Slide 10: Favorable safety profile observed in Phase 3
Favorable safety profile observed in Phase 3 • SER-109 was well tolerated, with no treatment-related serious adverse events (SAEs) observed in the active arm, and an adverse event profile similar to placebo • Overall incidence of patients who experienced AEs during the eight-week study period was si
Slide 11: Substantial recurrent C. difficile infection market opportunity
Substantial recurrent C. difficile infection market opportunity Infectious disease caused by toxin-producing bacteria, resulting in diarrhea, abdominal pain, fever and nausea Leading cause of hospital-acquired infection in the U.S. o ~ 453K cases of primary CDI within the U.S. each year o ~ 170K epi
Slide 12: FMT safety concerns highlight the need for improved, FDA-approved treatment options
FMT safety concerns highlight the need for improved, FDA-approved treatment options for C. difficile infection • In contrast to FMT, SER-109 is comprised of a highly purified consortia of spore-based bacteria manufactured under GMP conditions to ensure product quality and consistency • Unique manufa
Slide 13: Amplifying efforts for market preparation and launch
Amplifying efforts for market preparation and launch • Medical communications strategy Scaling Market Education Efforts • KOL mapping • Develop and deploy payer value proposition • Deeper patient journey analysis Enhancing Understanding • Pricing analysis of Commercial Opportunity • Customer segment
Slide 14: SER-109: Investigational, spore-based therapeutic designed to break the cycle of recurrent C. difficile infection
SER-109: Investigational, spore-based therapeutic designed to break the cycle of recurrent C. difficile infection Strong clinical & scientific data • Dramatic reduction in CDI recurrence rate • Spore-forming Firmicute bacteria prevent C. difficile germination and growth SER-109 Oral formulation • Sp
Slide 15: SER-287 and Ulcerative Colitis
SER-287 and Ulcerative Colitis
Slide 16: Ulcerative colitis overview
Ulcerative colitis overview Serious chronic condition characterized by inflammation of the colon and rectum resulting in abdominal pain, bowel urgency and diarrhea Significant need for improved therapies - Many drugs are immunosuppressive, limiting use to more severe patients ~700K in the United Sta
Slide 17: The dysbiotic microbiome may be a trigger of inflammation in ulcerative colitis
The dysbiotic microbiome may be a trigger of inflammation in ulcerative colitis Gut Lumen Microbiome therapeutics may drive Microbiome therapeutic benefit • May address drivers of inflammation, barrier integrity, innate immune activation, and adaptive immune education and cell Gut Epithelium traffic
Slide 18: Published study regarding microbiota transplantation provided clinical proof-of-concept in ulcerative colitis
Published study regarding microbiota transplantation provided clinical proof-of-concept in ulcerative colitis 30% P= 0.027 27% 25% 20% 15% 10% 8% 5% 0% Steroid-free clinical remission and endoscopic remission or response Microbiota transplant Placebo 18 Note: SER-287 was not involved in this study
Slide 19: SER-287 Phase 1b ulcerative colitis study
SER-287 Phase 1b ulcerative colitis study Placebo pre-treatment for 6 Placebo once daily for 8 (n=11) days DAILY weeks Primary Vancomycin pre-treatment SER-287 once daily for 8 Objectives (n=15) for 6 days weeks • Safety and 58 mild-to- tolerability moderate ulcerative WEEKLY • Change in colitis pat
Slide 20: Phase 1b study results – Statistically significant clinical remission improvement
Phase 1b study results – Statistically significant clinical remission improvement observed in Vanco/SER-287 daily treatment arm 40.0% (6/15) 40% achieving remission 30% p = 0.0237 % patients 17.7% 20% 13.3% (3/17) (2/15) 10% 0.0% (0/11) 0% Placebo Vancomycin Placebo Vancomycin pretreatment / pretrea
Slide 21: Illustrative endoscopy improvement — Vanco/SER-287 daily treatment
Illustrative endoscopy improvement — Vanco/SER-287 daily treatment Pre-treatment endoscopy showing the sigmoid colon with spontaneous Post-treatment day 64 endoscopy bleeding and ulceration 21
Slide 22: SER-287 Phase 1b safety results show safety profile comparable to placebo
SER-287 Phase 1b safety results show safety profile comparable to placebo • SER-287 daily arm demonstrated a similar safety profile to placebo • No serious drug-related adverse events • Reduced gastrointestinal adverse events provide an independent assessment of efficacy as the GI adverse events lik
Slide 23: Phase 1b study results – SER-287 bacteria engrafted in subjects
Phase 1b study results – SER-287 bacteria engrafted in subjects and was durable to four weeks after dosing Henn et al. (in review) ● Significant engraftment observed starting one week post-dosing ● Engraftment is significantly higher in arms with vancomycin pre-conditioning ● Engraftment in vancomyc
Slide 24: SER-287 Phase 1b study results published
SER-287 Phase 1b study results published 24
Slide 25: Ongoing SER-287 ECO-RESET Phase 2b study in mild-to-moderate active ulcerative colitis
Ongoing SER-287 ECO-RESET Phase 2b study in patients with mild-to-moderate active ulcerative colitis 10-week induction period Pbo pre- Placebo treat Mild to moderate 26-week Vanco UC patients with exploratory pre- SER-287 daily high dose active disease maintenance treat N=201 follow-up Vanco SER-287
Slide 26: Earlier stage development programs: SER-401, SER-301, SER-155
Earlier stage development programs: SER-401, SER-301, SER-155
Slide 27: Immuno-oncology - Microbiome signature in melanoma patient responder to anti-PD-1
Immuno-oncology - Microbiome signature in melanoma patient responder to anti-PD-1 • SER-401 composition driven by bacteria consistent with responder profile • All spore formers that leverage deep Seres expertise in the biology and manufacturing of these organisms 27 Gopalakrishnan et al, Science 201
Slide 28: Ongoing SER-401 Phase 1b study
Ongoing SER-401 Phase 1b study Study Objectives SER-401; biologically sourced product to match microbiome Primary endpoint = safety and tolerability signature of anti-PD-1 responders (n=20) All patients = CT scans with RECIST week 12 Secondary endpoints = engraftment, response and correlative studie
Slide 29: SER-301: Next-generation, rationally designed fermented microbiome therapeutic candidate for ulcerative colitis
SER-301: Next-generation, rationally designed fermented microbiome therapeutic candidate for ulcerative colitis • Reduces induction of pro-inflammatory activity • Improves epithelial barrier integrity & TNF-α driven inflammation in IECs • Modulates UC-relevant anti-inflammatory, innate & adaptive im
Slide 30: SER-155: Rationally-designed, fermented microbiome therapeutic candidate for infection, bacteremia & GvHD
SER-155: Rationally-designed, fermented microbiome therapeutic candidate for infection, bacteremia & GvHD • Decreases infection by antibiotic resistant Catalyzes changes in the microbiome & bacteria in the gastrointestinal tract that lead microbe-derived metabolites to prevent to bacteremia bacterem
Slide 31: SER-109 success validates our microbiome therapeutic approach, presenting opportunity in multiple additional areas
SER-109 success validates our microbiome therapeutic approach, presenting opportunity in multiple additional areas Highly productive R&D engine pursing multiple promising potential opportunities Infectious (e.g. Antibiotic resistant infections) • Deep understanding of the broad Inflammatory (e.g. Cr
Slide 32: Differentiated CMC capabilities producing rationally designed fermented products
Differentiated CMC capabilities producing rationally designed fermented products Seres in-house GMP manufacturing and quality control capabilities Cell banking & inoculum Drug substance Drug product Quality control • Potential best-in-class clinical profile based on species specific properties • Fer
Slide 33: Broad IP portfolio and regulatory exclusivity
Broad IP portfolio and regulatory exclusivity PATENT PORTFOLIO OF OWNED & LICENSED PATENTS AND APPLICATIONS* • Have obtained issued patents in the US, demonstrating that rationally designed ecologies of spores and 21 Families of Applications microbes are patentable • Portfolio includes composition o
Slide 34: Seres is well positioned to harness core microbiome capabilities and advance pipeline
Seres is well positioned to harness core microbiome capabilities advance pipeline Positive ECOSPOR III Phase 3 study results expected to serve as SER-109 single study to support BLA; Plan to meet with FDA to discuss filing SER-287 Ulcerative colitis – Phase 2b study ongoing SER-401 Metastatic melano
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