Seres Therapeutics, Inc. · NASDAQ:MCRB
Seres Therapeutics — Jefferies Virtual Healthcare Conference 2020
33 slides from Seres Therapeutics's conference presentation, Jun 3, 2020
Slide 1: Seres Therapeutics Overview
Seres Therapeutics Overview Jefferies Virtual Healthcare Conference June 3, 2020 Eric Shaff, Chief Executive Officer
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 or c
Slide 3: Seres Therapeutics Overview
Seres Therapeutics Overview Leader in microbiome drug development with differentiated drug discovery, Platform manufacturing and clinical capabilities Focus Prioritized pipeline in C. difficile infection, ulcerative colitis, oncology • SER-109 for C. difficile infection; Phase 3 top-line data in mid
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 drug discovery, development & manufacturing platforms
Industry-leading, in-house drug discovery, development & manufacturing platforms Disease Target Hit-to-Lead Lead Optimization End-to-End GMP Identification Identification & Bioprocess Manufacturing Microbiome Pharmacological Consortia Design Oral formulation Biomarker Discovery Properties Validation
Slide 6: Promising microbiome therapeutic pipeline
Promising microbiome therapeutic pipeline Preclinical Phase 1b Phase 2b Phase 3 Collaborators SER-109 Recurrent C. difficile Phase 3 Study Infectious Disease Infection, Bacteremia & GvHD in HSCT for cancer SER-155 (Rationally-designed, fermented) Inflammatory Ulcerative colitis Phase 2b Study SER-28
Slide 7: C. difficile Infection
C. difficile Infection Overview and SER-109 Phase 3 study
Slide 8: C. difficile infection overview and market opportunity
C. difficile infection overview and 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 episodes per
Slide 9: C. difficile pathogenesis is a two-hit process
C. difficile pathogenesis is a two-hit process: Disruption and Exposure Leading risk factor for C. difficile infection - exposure to antibiotics, which disrupt the microbiome Disruption of C. difficile Exposure to gut microbiome infection C. difficile spores 9 McGovern Clin Infect Dis 2020; Theriot
Slide 10: Current treatment options for C. difficile are suboptimal
Current treatment options for C. difficile are suboptimal Primary C. difficile infection: • Vancomycin or fidaxomicin associated with rapid recurrence in 25% within 1 to 3 weeks of antibiotic completion Multiply recurrent disease: • Treatment options are limited with high rates of recurrence: 42-74%
Slide 11: 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 manuf
Slide 12: 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 Scientific Rationale Oral Formulation • Spore-forming Firmicute • Spores are resistant to gastric bacteria prevent C. difficile acid, facilitating oral delivery to germination and
Slide 13: ECOSPOR III Phase 3: Top-line results expected in mid-2020
ECOSPOR III Phase 3: Top-line results expected in mid-2020 SER-109 (n = 94) • Multiply recurrent Primary endpoint: Safety C. difficile patients C. diff. recurrence, follow-up to • All subjects treated with at up to 8 weeks 24 weeks standard of care antibiotics Placebo (n = 94) 0 weeks 8 weeks 24 wee
Slide 14: Looking ahead to ECOSPOR-III study results
Looking ahead to ECOSPOR-III study results Seeking to demonstrate efficacy and safety in patients with true C. difficile infection • Clinically compelling data with statistically significant delta between placebo and SER-109 • Safety and tolerability consistent with Ph1 and Ph2 trials With favorable
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 in Vanco/SER-287 daily arm
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 and was durable
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: Microbiome signature of remission strongly correlated with metabolite shifts
Microbiome signature of remission strongly correlated with metabolite shifts in patients administered SER-287 • Strong correlation between signature species and stool metabolites that predict clinical remission • Metabolomic signature of clinical remission represents diverse functional pathways • Ma
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 clinical stage development programs: SER-401, SER-301, SER-155
Earlier clinical 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: Rationally designed fermented products (SER-301, SER-155) may provide important advantages
Rationally designed fermented products (SER-301, SER-155) may provide important advantages 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 proper
Slide 30: 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 31: 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 32: Broad IP portfolio and regulatory exclusivity
Broad IP portfolio and regulatory exclusivity PATENT PORTFOLIO OF OWNED & LICENSED PATENTS AND APPLICATIONS* • Obtained issued patents in the US, demonstrating that rationally designed ecologies of spores and microbes are patentable 21 Families of Applications • Portfolio includes composition of mat
Slide 33: Significant value drivers anticipated
Significant value drivers anticipated Recurrent C. difficile infection – Phase 3 enrollment complete; SER-109 top-line data in mid 2020 Ulcerative colitis – Phase 2b study ongoing; ~60% enrolled as of SER-287 March 30, 2020; study design modifications are under evaluation SER-401 Metastatic melanoma
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