Seres Therapeutics, Inc. · NASDAQ:MCRB
Seres Therapeutics — Investor Presentation (November 2020)
36 slides from Seres Therapeutics's investor presentation, Nov 20, 2020
Slide 1: Seres Therapeutics Overview November 2020
Seres Therapeutics Overview November 2020 Exhibit 99.1
Slide 2: 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 ability of our clinical tr
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
Slide 4: Seres is developing a novel drug modality that modulates the gut microbiome
Formulated for oral delivery using current Good Manufacturing Practices (cGMP) Consortia capture breadth of biological & functional diversity Mechanisms includes microbial engraftment in GI tract to restructure the microbiome Designed to target inflammatory & immunological disease pathways simultane
Slide 5: Industry-leading, in-house research engine for drug discovery, development & manufacturing
End-to-End GMP Manufacturing Lead Optimization & Bioprocess Hit-to-Lead Identification Clinical sample biorepository Microbiome Biomarker Discovery Consortia Design Pharmacological Properties Validation Oral formulation Proprietary genomic & metabolomic analytics World-class collaborations Broad str
Slide 6: Broad opportunities for microbiome therapeutics
1. Collaboration with Nestlé Health Science, announced Jan. 11, 2016, regarding C. difficile and IBD programs for markets outside of North America 2. Collaboration with University of Texas MD Anderson Cancer Center and the Parker Institute for Cancer Immunotherapy, announced Nov. 14, 2017, regarding
Slide 7: C. difficile Infection Overview and SER-109 Phase 3 study
C. difficile Infection Overview and SER-109 Phase 3 study
Slide 8: Positive ECOSPOR III Phase 3 study read-out
August 2020: Positive ECOSPOR III Phase 3 study read-out Primary endpoint: C. diff. recurrence, at up to 8 weeks SER-109 (n = 90) Multiply recurrent C. difficile patients (n=182) All subjects treated with standard of care antibiotics Placebo (n = 92) 0 weeks 8 weeks 24 weeks Safety follow-up to 24 w
Slide 9: Topline SER-109 Phase 3 study efficacy results
Topline SER-109 Phase 3 study efficacy results Time point SER-109 (N =90) Placebo (N =92) RR (95%CI) p-Value (p1/p2) n (%) n (%) Week 8 10 (11.1) 38 (41.3) 0.27 (0.15, 0.51) <0.001 / <0.001 Highly statistically significant 30.2% absolute reduction in the rate of CDI recurrence compared to placebo Nu
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 simila
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. ~ 453K cases of primary CDI within the U.S. each year ~ 170K episode
Slide 12: FMT safety concerns highlight the need for 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 manufactur
Slide 13: SER-109 open label study enrollment ongoing to support expanded safety database
SER-109 open label study enrollment ongoing to support expanded safety database Seres is currently enrolling recurrent CDI patients in an open label study to expand the SER-109 safety database, supporting a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) In Novembe
Slide 14: Amplifying efforts for market preparation and launch
Amplifying efforts for market preparation and launch Medical communications strategy KOL mapping Develop and deploy payer value proposition Scaling Market Education Efforts Enhancing Understanding of Commercial Opportunity Deeper patient journey analysis Pricing analysis Customer segmentation Identi
Slide 15: SER-109: Investigational, spore-based therapeutic for 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: Investigational, spore-based therapeutic designed to break the cycle of recurrent C. difficile infection Oral formulation Spores are resis
Slide 16: SER-287 and Ulcerative Colitis
SER-287 and Ulcerative Colitis
Slide 17: 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 States Only ~1/3 achieve remiss
Slide 18: The dysbiotic microbiome may be a trigger of inflammation in ulcerative colitis
Steroids Thiopurines / MTX Anti-TNFs JAK Inhibitors Anti IL12/23 Microbiome Anti-Integrins S1P1 Agonists Gut Lumen Lamina Propria Blood vessel Gut Epithelium Microbiome therapeutics may drive therapeutic benefit May address drivers of inflammation, barrier integrity, innate immune activation, and ad
Slide 19: Published study provided clinical proof-of-concept in ulcerative colitis
Published study regarding microbiota transplantation provided clinical proof-of-concept in ulcerative colitis Note: SER-287 was not involved in this study
Slide 20: SER-287 Phase 1b ulcerative colitis study
DAILY Primary Objectives Safety and tolerability Change in composition of intestinal microbiome at 8 weeks (n=11) (n=15) (n=15) (n=17) Placebo pre-treatment for 6 days 58 mild-to-moderate ulcerative colitis patients Placebo once daily for 8 weeks Vancomycin pre-treatment for 6 days SER-287 once dail
Slide 21: Phase 1b study results – clinical remission improvement in daily arm
Remission = Total Modified Mayo score ≤ 2 AND endoscopic subscore ≤ 1 Note: Missing data treated as failure; statistical significance not found in SER-287 weekly arms Phase 1b study results – Statistically significant clinical remission improvement observed in Vanco/SER-287 daily treatment arm Place
Slide 22: 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 bleeding and ulceration Post-treatment day 64 endoscopy
Slide 23: SER-287 Phase 1b safety results 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 likely re
Slide 24: SER-287 bacteria engrafted and was durable to four weeks after dosing
Phase 1b study results – SER-287 bacteria engrafted in subjects and was durable to four weeks after dosing Significant engraftment observed starting one week post-dosing Engraftment is significantly higher in arms with vancomycin pre-conditioning Engraftment in vancomycin arms is dose-dependent; sig
Slide 25: SER-287 Phase 1b study results published
SER-287 Phase 1b study results published
Slide 26: Ongoing SER-287 ECO-RESET Phase 2b study
Ongoing SER-287 ECO-RESET Phase 2b study in patients with mild-to-moderate active ulcerative colitis 10-week induction period Pbo pre-treat Mild to moderate UC patients with active disease N=201 Vanco pre-treat Vanco pre-treat Placebo SER-287 daily high dose SER-287 daily high dose followed by step
Slide 27: Earlier stage development programs: SER-401, SER-301, SER-155
Earlier stage development programs: SER-401, SER-301, SER-155
Slide 28: SER-301: Next-generation 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 immune p
Slide 29: SER-301: Ongoing Phase 1b in mild-to-moderate ulcerative colitis
SER-301: Ongoing Phase 1b in adults with mild-to-moderate ulcerative colitis Screening Induction Treatment (daily dosing) Safety Period Pre- Cond. 10 weeks 16 weeks * * endoscopy, pre- and post-treatment 6d Cohort 1, Open Label (15 subjects, SER-301) SER-301 after pre-conditioning Cohort 2, Placebo-
Slide 30: SER-401: Immuno-oncology microbiome signature in melanoma responders
Gopalakrishnan et al, Science 2017 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 SER-401: Immuno-oncology - Microbiome signature in melanoma patient responder to anti-P
Slide 31: SER-401: Ongoing Phase 1b study
Patients with metastatic melanoma treated with anti-PD-1 (nivolumab) SER-401; biologically sourced product to match microbiome signature of anti-PD-1 responders (n=20) Placebo (n=10) Day -14 Day -7 Day +7 Day 0 Day +14 Day +28 Day +56 Biospecimens: SER-401 / Placebo Day +84 Blood Stool Biopsy SER-40
Slide 32: SER-155: Fermented microbiome therapeutic for infection, bacteremia & GvHD
Decreases infection by antibiotic resistant bacteria in the gastrointestinal tract that lead to bacteremia Enhances epithelial barrier integrity to prevent bacterial translocation to the blood stream Modulates local and systemic immunomodulatory responses to decrease graft versus host disease Collab
Slide 33: SER-109 success validates our microbiome therapeutic approach
SER-109 success validates our microbiome therapeutic approach, presenting opportunity in multiple additional areas Deep understanding of the broad role of the microbiome in health: Resistance to pathogens Gut & systemic inflammation Innate & adaptive immunity Regulation of metabolism Novel drug disc
Slide 34: Differentiated CMC capabilities producing fermented products
Differentiated CMC capabilities producing rationally designed fermented products Potential best-in-class clinical profile based on species specific properties Fermented approach enables efficient and highly scalable manufacturing process to serve large markets Cell banking & inoculum Drug substance
Slide 35: Broad IP portfolio and regulatory exclusivity
Broad IP portfolio and regulatory exclusivity PROJECTED BIOSIMILAR REGULATORY EXCLUSIVITY years for new biological composition 12 Have obtained issued patents in the US, demonstrating that rationally designed ecologies of spores and microbes are patentable Portfolio includes composition of matter an
Slide 36: Seres is well positioned to advance its pipeline
Seres is well positioned to harness core microbiome capabilities to advance its pipeline Positive ECOSPOR III Phase 3 study results expected to serve as single study to support BLA Metastatic melanoma – Phase 1b ongoing SER-287 SER-109 SER-401 Ulcerative colitis – Phase 2b ongoing Antibiotic resista
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