Seres Therapeutics, Inc. · NASDAQ:MCRB
Seres Therapeutics — Investor Presentation (August 2020)
34 slides from Seres Therapeutics's investor presentation, Aug 10, 2020
Slide 1: Seres Therapeutics Overview: SER-109 ECOSPOR III top-line study results
Seres Therapeutics Overview SER-109 ECOSPOR III top-line study results August 10, 2020 Exhibit 99.1
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, potential approval of SER-109 by the FDA, the potential number of patients
Slide 3: Seres Mission
Seres Mission To transform the lives of patients worldwide with revolutionary microbiome therapeutics
Slide 4: SER-109 ECOSPOR III Phase 3 Top-line Study Results – Recurrent C. Difficile Infection
SER-109 ECOSPOR III Phase 3 Top-line Study Results – Recurrent C. Difficile Infection
Slide 5: SER-109: First Ever Positive Pivotal Study For Targeted Microbiome Therapeutic Candidate
SER-109: First Ever Positive Pivotal Study For Targeted Microbiome Therapeutic Candidate Primary endpoint met with substantial efficacy benefit observed Favorable safety profile observed We believe study can serve as efficacy basis for BLA submission Highly stat. sig. reduction in CDI recurrence rat
Slide 6: ECOSPOR III Phase 3 Study design
ECOSPOR III Phase 3 Study 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(1) Toxin testing to ensure
Slide 7: SER-109 Phase 3 Topline Efficacy Results
SER-109 Phase 3 Topline Efficacy Results Demonstrate Statistically Significant Delta Between SER-109 And Placebo SER-109 (n= 90) Placebo (n= 92) RR (95%CI) p-Value (p1/p2) n (%) n (%) Recurrence At 8 Weeks 10 (11.1) 38 (41.3) 0.27 (0.15, 0.51) <0.001 / <0.001 Primary efficacy endpoint results Highly
Slide 8: ECOSPOR III Safety Results Display Favorable Safety Profile (1/2)
ECOSPOR III Safety Results Display Favorable Safety Profile (1/2) MedDRA Preferred Term Number (%) of Subjects SER-109 (n= 90) Placebo (n= 92) At least one TEAE 83 (92.2) 84 (91.3) Flatulence 63 (70.0) 70 (76.1) Fatigue 53 (58.9) 58 (63.0) Abdominal pain 46 (51.1) 56 (60.9) Abdominal distension 49 (
Slide 9: ECOSPOR III Safety Results Display Favorable Safety Profile (2/2)
ECOSPOR III Safety Results Display Favorable Safety Profile (2/2) SER-109 (n= 90) n (%)* Placebo (n= 92) n (%)* Any TEAE 83 (92.2) 84 (91.3) TEAEs Resulting in Premature Discontinuation through Week 8 0 2 (2.2) Treatment Related/Possibly Related TEAEs 46 (51.1) 48 (52.2) Treatment Emergent AESIs 1 (
Slide 10: Patient Demographics
Patient Demographics Characteristic SER-109 (n =90) Placebo (n =92) Total (n=182) Age (yrs) mean ± SD 65.8 ± 16.39 65.3 ± 16.75 65.5 ± 16.53 < 65 40 (44.4) 39 (42.4) 79 (43.4) >= 65 50 (55.6) 53 (57.6) 103 (56.6) Prior Antibiotic Regimen, n (%) vancomycin 65 (72.2) 68 (73.9) 133 (73.1) fidaxomicin 2
Slide 11: SER-109: Investigational, Spore-based Therapeutic Designed To Break The Cycle Of Recurrent CDI
SER-109: Investigational, Spore-based Therapeutic Designed To Break The Cycle Of Recurrent C. Difficile Infection Strong clinical & scientific data Significant reduction in CDI recurrence rate observed in Phase 3 trial Spore-forming Firmicute bacteria prevent C. difficile germination and growth Oral
Slide 12: Substantial Recurrent C. Difficile Infection Market Opportunity
Substantial Recurrent C. Difficile Infection Market Opportunity Infectious disease 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 episodes per year (100K episodes of first r
Slide 13: Current CDI Treatment Options Are Suboptimal
Current CDI Treatment Options Are Suboptimal Primary C. difficile infection: Recurrence in 25% of patients within 1 to 3 weeks of antibiotic completion Bezlotoxumab recommended only for those at high-risk for recurrence Recurrent infection: Retreatment with same drugs: lower efficacy observed Unappr
Slide 14: 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 15: Broad Opportunities For Microbiome Therapeutic Candidates
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 16: SER-109 Data Validate Our Microbiome Therapeutic Approach
SER-109 Data Validate 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 field-leading
Slide 17: SER-287 and Ulcerative Colitis
SER-287 and Ulcerative Colitis
Slide 18: 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 19: The Dysbiotic Microbiome May Be A Trigger Of Inflammation In Ulcerative Colitis
Microbiome therapeutics may drive therapeutic benefit May address drivers of inflammation, barrier integrity, innate immune activation, and adaptive immune education and cell trafficking Effector molecules may include short chain fatty acids, secondary bile acids, tryptophan metabolites, and TLR lig
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 Placebo once daily for 8 weeks Vancomycin pre-treatment for 6 days SER-287 once daily for 8 weeks Placebo pre-treatment for 6 days S
Slide 21: Phase 1b Study Results – Statistically Significant Clinical Remission Improvement
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 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 likely re
Slide 24: 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 Significant engraftment observed starting one week post-dosing Engraftment was significantly higher in arms with vancomycin pre-conditioning Engraftment in vancomycin arms was dose-dependent; s
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: 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
Gopalakrishnan et al, Science 2017 SER-401 composition driven by bacteria consistent with responder profile Comprised entirely of spore formers; leverages Seres’ deep expertise in biology and manufacturing Immuno-oncology - Microbiome Signature In Melanoma Patient Responder To Anti-pd-1
Slide 28: Ongoing SER-401 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 Ongoin
Slide 29: SER-301: Next-generation Fermented Microbiome Therapeutic Candidate For Ulcerative Colitis
SER-301: Next-generation, Rationally Designed Fermented Microbiome Therapeutic Candidate For Ulcerative Colitis Reduce induction of pro-inflammatory activity Improve epithelial barrier integrity & TNF-α driven inflammation in IECs Modulate UC-relevant anti-inflammatory, innate & adaptive immune path
Slide 30: SER-155: Fermented microbiome therapeutic candidate for infection, bacteremia & GvHD
SER-155: Rationally-designed, fermented microbiome therapeutic candidate for infection, bacteremia & GvHD Decrease infection by antibiotic resistant bacteria in the gastrointestinal tract that lead to bacteremia Enhance epithelial barrier integrity to prevent bacterial translocation to the blood str
Slide 31: Differentiated CMC Capabilities
Differentiated CMC Capabilities Cell banking & inoculum Drug substance Drug product Quality control Seres in-house GMP manufacturing and quality control capabilities Specialized, dedicated facilities addressing FDA and EMA guidance on manufacturing with spore-forming organisms Integrated manufacturi
Slide 32: End-to-End GMP Manufacturing
End-to-End GMP Manufacturing Lead Optimization & Bioprocess Hit-to-Lead Identification In-house Research Engine Enable Efficient Early Discovery Through Manufacturing Clinical sample biorepository Microbiome Biomarker Discovery Consortia Design Pharmacological Properties Validation Orally-delivered
Slide 33: Broad IP portfolio and potential for regulatory exclusivity
Broad IP portfolio and potential for regulatory exclusivity POTENTIAL 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 compositio
Slide 34: Seres: The Leading Microbiome Company
Seres: The Leading Microbiome Company Scientifically-based, targeted discovery platform Platform SER-109 Positive ECOSPOR III Phase 3 study results expected to serve as efficacy basis to support BLA; plan to meet with FDA to discuss filing SER-287 for Ulcerative colitis in Phase 2b SER-401 for Metas
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