Seres Therapeutics, Inc. · NASDAQ:MCRB
Seres Therapeutics — Investor Presentation (April 2022)
22 slides from Seres Therapeutics's investor presentation, Apr 6, 2022
Slide 1: Corporate Overview April 2022
Corporate Overview April 2022 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, the potential approval of SER-109 and its status as a first-in-class therapeutic, the timing of a BLA filing, the market for
Slide 3: Pioneering the Development of Microbiome Therapeutics
Pioneering the Development of Microbiome Therapeutics Encapsulated consortia of commensal bacteria designed to target multiple disease-relevant pathways simultaneously Seres’ mission: To transform the lives of patients worldwide with revolutionary microbiome therapeutics Deliver clinical benefit Ser
Slide 4: Strategic Priorities
Strategic Priorities Bring first-in-class microbiome therapeutic to patients with SER-109 BLA approval and successful launch for recurrent CDI Maximize opportunities in Infection Protection, based on proven mechanism of SER-109 Optimize plans for continued development in UC based on SER-287 and SER-
Slide 5: Expanding Microbiome Therapeutic Leadership in 2022+
Expanding Microbiome Therapeutic Leadership in 2022+ SER-109 BLA filing in mid-2022; potential to transform management of recurrent C. difficile infection Preparing for commercial launch in collaboration with Nestlé Health Science Build on SER-109 by expanding into additional opportunities in Infect
Slide 6: Broad Opportunities for Microbiome Therapeutics
Broad Opportunities for Microbiome Therapeutics Collaboration with Nestlé Health Science, announced Jan. 11, 2016, regarding C. difficile and IBD programs for markets outside of North America SER-109 co-commercialization agreement for North America with Nestlé Health Science announced July 1, 2021 S
Slide 7: Strategic Priorities
Strategic Priorities Bring first-in-class microbiome therapeutic to patients with SER-109 BLA approval and successful launch for recurrent CDI Maximize opportunities in Infection Protection, based on proven mechanism of SER-109 Optimize plans for continued development in UC based on SER-287 and SER-
Slide 8: 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 episodes
Slide 9: Approximately 88% sustained clinical response rate
Approximately 88% sustained clinical response rate Response rate far exceeded FDA predefined threshold for single pivotal trial Time point SER-109 (N =89) Placebo (N =93) Relative risk (95%CI) p-value (p1/p2) n (%) of recurrences n (%) of recurrences Week 8 11 (12.4) 37 (39.8) 0.32 (0.18-0.58) <0.00
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 comparable to placebo Overall incidence of patients who experienced AEs was similar between SER-109 and placebo ar
Slide 11: Phase 3 Data Published in New England Journal of Medicine
Phase 3 Data Published in New England Journal of Medicine SER-109
Slide 12: On Track for BLA Submission in Mid-2022
On Track for BLA Submission in Mid-2022 SER-109 Open-label safety study Enrollment completed in September Study has 24-week follow-up period Study includes first and multiply recurrent patients BLA submission BLA submission mid-2022 after study completion Expanded access program ongoing across multi
Slide 13: Well-Positioned to Meet Commercial Demand At Launch and Beyond
Well-Positioned to Meet Commercial Demand At Launch and Beyond SER-109 SER-109 commercial supply See Seres and Bacthera collaboration press release issued Nov. 10, 2021 + Seres In-house GMP manufacturing and quality control Joint venture between Chr. Hansen and Lonza with offices in Switzerland and
Slide 14: SER-109 is Potential First and Best-in-class Microbiome Therapeutic
SER-109 is Potential First and Best-in-class Microbiome Therapeutic to Transform Care for Patients with rCDI 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 short
Slide 15: Seres, Nestlé Health Science Co-Commercialization Agreement - Preparation for Launch
Seres, Nestlé Health Science SER-109 Co-Commercialization License Agreement for North America - Preparation for Launch Broadly engage KOL audience leveraging Seres and NHSc Medical Affairs teams Develop and deploy payer value proposition with NHSc payer account teams Scaling Market Education Efforts
Slide 16: Strategic Priorities
Strategic Priorities Bring first-in-class microbiome therapeutic to patients with SER-109 BLA approval and successful launch for recurrent CDI Maximize opportunities in Infection Protection, based on proven mechanism of SER-109 Optimize plans for continued development in UC based on SER-287 and SER-
Slide 17: SER-109 Provides Proof of Concept - Restructuring the Microbiome
SER-109 Provides Proof of Concept - Restructuring the Microbiome and Reducing Pathogens SER-109 bacteria engraft durably & rapidly to restructure microbiome N = 182 patients enrolled; figure shows data for 143 patients at baseline Feuerstadt P NEJM 2022; 386:220-9 Seres Therapeutics, Inc. © 2022 SER
Slide 18: Antimicrobial Resistant Infections Are an Urgent Public Health Threat
Antimicrobial Resistant Infections Are an Urgent Public Health Threat Limited innovation despite substantial and growing impact Declared “one of the world’s most urgent threats” $20 billion excess direct healthcare costs 35,000 deaths per year in the US Major burden to society Many high risk patient
Slide 19: SER-155
SER-155 Microbiome drug type Rationally designed, cultivated product; spore + vegetative species Stage Phase 1b - enrollment ongoing Indication Infection, bacteremia & GvHD in HSCT for cancer Collaborations SER-155 Phase 1b Study Ongoing Phase 1b study design and objectives ~70 patients in an open-l
Slide 20: Maximizing the Opportunity in Infection Protection and AMR
Seres Therapeutics, Inc. © 2022 Maximizing the Opportunity in Infection Protection and AMR SER-109 rCDI SER-155 BSI & GvHD in allogeneic HSCT recipients Broad preclinical portfolio Driving to an additional clinical development program in 2023 Potentially up to 3 additional programs within 3 years Ri
Slide 21: Strategic Priorities
Strategic Priorities Bring first-in-class microbiome therapeutic to patients with SER-109 BLA approval and successful launch for recurrent CDI Maximize opportunities in Infection Protection, based on proven mechanism of SER-109 Optimize plans for continued development in UC based on SER-287 and SER-
Slide 22: Well-Capitalized to Extend Microbiome Therapeutic Leadership
SER-155: Phase 1b initiated and first patient enrolled Preclinical programs ongoing Well-Capitalized to Extend Microbiome Therapeutic Leadership As of Dec. 31, 2021: $291M in cash, cash equivalents and short and long-term investments Opportunities in Infection Protection Continued development in UC
Seres Therapeutics — Investor Presentation (April 2022) on 6ix