Seres Therapeutics, Inc. · NASDAQ:MCRB
Seres Therapeutics — 39th Annual J.P. Morgan Healthcare Conference (January 2021)
29 slides from Seres Therapeutics's conference presentation, Jan 11, 2021
Slide 1: Seres Therapeutics at 39th Annual J.P. Morgan Healthcare Conference
Seres Therapeutics Eric Shaff, Chief Executive Officer 39th Annual J.P. Morgan Healthcare Conference January 14, 2021 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: Pioneering the development of microbiome therapeutics
Encapsulated consortia of commensal bacteria designed to target multiple disease-relevant pathways simultaneously Pioneering the development of microbiome therapeutics
Slide 4: 2020 landmark success and 2021 priorities
2020 Landmark SER-109 Phase 3 success Clear demonstration of microbiome therapeutics as a new treatment modality 2021 Enrolling SER-109 open label study in support of BLA SER-109 commercial readiness SER-287 Phase 2b data readout Progress earlier stage programs in ulcerative colitis, cancer, and GvH
Slide 5: 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 6: C. difficile Infection Overview and SER-109 Phase 3 study
C. difficile Infection Overview and SER-109 Phase 3 study
Slide 7: Positive ECOSPOR III Phase 3 study readout
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 weeks Toxin testing to ensure inclusion of subjects with a
Slide 8: 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 at
Slide 9: 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 comparable to placebo Overall incidence of patients who experienced AEs during the eight-week study period was sim
Slide 10: Phase 3 mechanism of action data support clinical outcome
Number of engrafting drug species Weeks Post-Dosing Baseline Week 1 Week 2 Week 8 Pharmacokinetics: SER-109 bacteria engrafted rapidly in subjects & significantly greater engraftment was durable at all timepoints post dosing New Study Results Pharmacodynamics: SER-109 administration broadly modulate
Slide 11: SER-109 open-label study enrollment ongoing
FDA has indicated that ECOSPOR III efficacy results should support BLA filing as a single pivotal trial Per FDA, the SER-109 safety database should include at least 300 treated subjects Enrollment is ongoing in a SER-109 open-label study in recurrent CDI patients, including those with a first recurr
Slide 12: 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 13: External stakeholder feedback on SER-109 is resoundingly positive
External stakeholder feedback on SER-109 is resoundingly positive Highly appealing addition to the current armamentarium for rCDI Combination of efficacy and safety profile delivered in a short course oral regimen SER-109 has potential to become the cornerstone of treatment Success is breaking the v
Slide 14: Medical communications strategy and launch infrastructure
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 Identify options for go-to-market model Building Infrastruc
Slide 15: SER-287 and Ulcerative Colitis
SER-287 and Ulcerative Colitis
Slide 16: 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 17: Microbiota transplantation provided clinical proof-of-concept in ulcerative colitis
Published study evaluating microbiota transplantation provided clinical proof-of-concept in ulcerative colitis Note: SER-287 was not involved in this study
Slide 18: Seres' candidates target multiple triggers of ulcerative colitis pathology
Produce immunomodulatory metabolites that improve epithelial barrier integrity IL-10 Inflammatory bacterial antigens Inflammation Germination Decrease cytokine-induced inflammation and modulate T cell populations Reduce the abundance of pro-inflammatory bacteria and epithelial cell inflammation DC,
Slide 19: 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 20: SER-287 Phase 1b study results published January 2021
SER-287 Phase 1b study results published January 2021
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 SER-287 daily treatment arm Placebo pre
Slide 22: 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 23: Phase 1b microbiome biomarker analytics inform pharmacokinetics and pharmacodynamics
SER-287 treatment results in a broad shift in the overall composition of spore & non-spore gut species by 8 weeks post-treatment SER-287 bacteria engrafted in subjects, was durable post-dosing, and was significantly greater in daily dosing arm Henn et al. 2021. Gastroenterology Proportion of subject
Slide 24: Clinical remission associated with changes in microbiome and metabolism
indole taurine arachidonate Concentration log2 fold change from baseline to day 56 Microbially-mediated metabolites that modulate host inflammation & barrier integrity are significantly associated with SER-287 treatment & clinical remission Decrease in pro-inflammatory Enterobacteriaceae bacteria po
Slide 25: 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 26: SER-301, SER-401 and SER-155 programs
SER-301 SER-401 SER-155 Microbiome drug type Rationally designed, fermented product; spore + vegetative species Biologically sourced; composition selected to match I-O therapy responder profile Rationally designed, fermented product; spore + vegetative species Stage Phase 1b Phase 1b Approaching Pha
Slide 27: Novel drug discovery and development platform
Deep understanding of the sweeping role of the microbiome in health: Resistance to pathogens Gut & systemic inflammation Innate & adaptive immunity Regulation of metabolism Novel drug discovery and development platform Option to pursue multiple diseases with high unmet need Highly productive R&D eng
Slide 28: Differentiated CMC capabilities and in-house GMP manufacturing
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 29: Upcoming milestones and cash position
Positive ECOSPOR III Phase 3 study results expected to serve as single study to support BLA; Open-label study enrollment ongoing Metastatic melanoma – Phase 1b ongoing SER-287 SER-109 SER-401 Ulcerative colitis – Phase 2b ongoing; Topline results anticipated H2 ’21 Antibiotic resistant bacterial inf
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