Seres Therapeutics, Inc. · NASDAQ:MCRB
Seres Therapeutics — Corporate Update (April 2023)
28 slides from Seres Therapeutics's corporate update, Apr 27, 2023
Slide 1: VOWST FDA Approval Conference Call
April 27, 2023 VOWSTTM FDA Approval Conference Call
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 the availability of VOWST product supply, the degree of market adoption and penetration, the results
Slide 3: Agenda & Speakers
Agenda & Speakers Introductory remarks Financial considerations Eric Shaff David Arkowitz President and Chief Executive Officer, Chief Financial Officer and Head of Business Development, Seres Therapeutics Seres Therapeutics VOWST supporting data and profile Seres’ path forward in infection Lisa von
Slide 4: VOWST is the first and only FDA-approved orally administered microbiota-based therapeutic
VOWST is the first and only FDA-approved orally administered microbiota- based therapeutic VOWST is indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age or older following antibacterial treatment for recurrent CDI (rCDI) Seres is pioneering a
Slide 5: Co-commercializing VOWST in the United States with 50/50 profit sharing
Co-commercializing VOWST in the United States with 50/50 profit sharing per July 2021 agreement, extending our global strategic collaboration Seres Therapeutics, Inc. © 2023 5
Slide 6: VOWST supporting data and profile
VOWST supporting data and profile Lisa von Moltke, M.D. Chief Medical Officer, Seres Therapeutics Seres Therapeutics, Inc. © 2023 6
Slide 7: C. difficile infections are an urgent public health threat
C. DIFFICILE INFECTIONS ARE AN URGENT PUBLIC HEALTH THREAT Spore-forming, toxin- Symptoms include colitis Acute onset of severe High probability of producing, gram-positive, and severe, watery symptoms leads to recurrence >20%, usually anaerobic bacteria diarrhea with up to 15 hospitalization for wi
Slide 8: Patients facing recurrent C. difficile infections may require microbiome restoration
PATIENTS FACING RECURRENT C. DIFFICILE INFECTIONS MAY REQUIRE MICROBIOME RESTORATION ~156,000 Initial clinical response Episodes placing patients with with antibiotics alone disrupted microbiomes into the recurrent cycle Antibiotics Recurrent ~459,000 Recurrence cycle of CDI Disruption Patients with
Slide 9: VOWST Prescribing Information
VOWST PRESCRIBING INFORMATION Highlights of Prescribing Information Indication VOWST is indicated to prevent the recurrence of statement Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibiotic treatment for recurrent CDI (rCDI). Limitations of use VOWST
Slide 10: ECOSPOR III data: 88% of subjects recurrence-free at 8 weeks
ECOSPOR III DATA: VOWST REDUCED CDI RECURRENCES WITH 88% OF SUBJECTS RECURRENCE-FREE AT 8 WEEKS Significant reduction in recurrences at week 8; sustained at 24 weeks VOWST 100 75 Probability Probability (%) (%) 50 Placebo 25 0 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 Time Time to to CDI CDI rec
Slide 11: ECOSPOR III data: VOWST was well-tolerated
ECOSPOR III DATA: VOWST WAS WELL-TOLERATED Adverse Events (AEs) Through 8 Weeks VOWST (n=90) Placebo (n=92) (Safety Population)2 n (%) n (%) Any adverse event 84 (93) 84 (91) Adverse event related or possibly related to VOWST or placebo 46 (51) 48 (52) Serious adverse event3 7 (8) 15 (16) Adverse ev
Slide 12: ECOSPOR III data: VOWST was well-tolerated (adverse reactions)
ECOSPOR III DATA: VOWST WAS WELL-TOLERATED VOWST (n=90) Placebo (n=92) Adverse Reactions Within 8 Weeks % % Solicited* Abdominal distension 31.1 29.3 Fatigue 22.2 21.7 Constipation 14.4 10.9 Chills 11.1 7.6 Unsolicited Diarrhea 10.0 4.3 Source: VOWST Package Insert * Solicited adverse events were re
Slide 13: ECOSPOR IV data: VOWST was well-tolerated
ECOSPOR IV DATA: VOWST WAS WELL-TOLERATED • Overall safety profile through 24-week follow-up showed that VOWST was well tolerated, consistent with the safety profile observed in ECOSPOR III ECOSPOR IV summary • Phase 3, open-label, single- • Overall, 141 (53.6%) subjects experienced a total of 476 a
Slide 14: ECOSPOR IV data on prevention of recurrence
VOWST ECOSPOR IV DATA ON PREVENTION OF RECURRENCE: LOW NUMBER OF RECURRENCES AT 8 WEEKS Time Interval After Completion of Therapy n (%) 8 Weeks (up to Day 58) (n=263) Number of Subjects with CDI Recurrence 23 (8.7) Prevention of CDI Recurrence at 8 Weeks 240 (91.3) Number of Subjects with Clinical B
Slide 15: VOWST commercial opportunity
VOWST commercial opportunity Terri Young, Ph.D. Chief Commercial and Strategy Officer, Seres Therapeutics Seres Therapeutics, Inc. © 2023 15
Slide 16: VOWST is highly anticipated by healthcare professionals
VOWST IS HIGHLY ANTICIPATED BY HEALTHCARE PROFESSIONALS HCP intent to prescribe VOWST “ Recurrent C. difficile infection is a highly debilitating and life-threatening disease, and antibiotics alone do not address the 22% underlying cause of rCDI, dysbiosis of the gut Definitely will microbiome. The
Slide 17: HCP enthusiasm driven by desire to prevent recurrences
HCP ENTHUSIASM FOR VOWST DRIVEN BY DESIRE TO PREVENT RECURRENCES AND LIMITATIONS OF CURRENT OPTIONS Top 5 rCDI Treatment Goals Top 5 Unmet Needs % Ranked in Top 3 % Ranked in Top 3 Prevention of Preventing subsequent recurrences 59% 66% • Prevention of recurrences is recurrences seen as a top treatm
Slide 18: Expect HCP use of VOWST to broaden with product experience
EXPECT HCP USE OF VOWST TO BROADEN WITH PRODUCT EXPERIENCE Expected initial patient types Broadened use after experience The first patient I'd give it to would be somebody who probably This idea is what we're looking for. I has it from being on prolonged antibiotics, doesn't have a lot of guess this
Slide 19: Combined field teams to cover highest potential rCDI prescribers
COMBINED FIELD TEAMS TO COVER HIGHEST POTENTIAL RCDI PRESCRIBERS Prioritize top volume and early adopting HCPs w/150 person GI sales force • GI sales force covers 85% of GI practices for current inline Nestle product • Average 10 years industry experience & 5 years in GI • Drove ZENPEP® acceleration
Slide 20: Engaging with key commercial and Medicare Part D plans
ENGAGING WITH KEY COMMERCIAL AND MEDICARE PART D PLANS TO INITIATE BROAD COVERAGE Path to coverage for VOWST Payer mix Up to Launch + 12 months Launch + 18 months Payers utilize NTMBs* to limit Medicare coverage demand begins 37% Medicare 54% Commercial Launch + 12 months 6% Medicaid VOWST Medicaid
Slide 21: VOWST delivers compelling value proposition and broad patient access
VOWST DELIVERS COMPELLING VALUE PROPOSITION AND WE ARE COMMITTED TO BROAD PATIENT ACCESS Uniquely addresses #1 unmet need of preventing Addresses costly burden of rCDI: $43,000 cost / recurrence, with robust efficacy and an established patient1 safety profile with an orally administered regimen Inno
Slide 22: Laying the foundations to transform standard of care
LAYING THE FOUNDATIONS TO ULTIMATELY TRANSFORM STANDARD OF CARE AND ACHIEVE POTENTIAL Initial focus Expanded focus • Increase HCP awareness and trial of • Drive repeat use among higher- an entirely new modality volume HCPs • Provide positive experience • Increase reach to lower-volume HCPs • Enhance
Slide 23: Financial considerations
Financial considerations David Arkowitz Chief Financial Officer and Head of Business Development, Seres Therapeutics Seres Therapeutics, Inc. © 2023 23
Slide 24: 3/31/2023 pro-forma cash balance: $282 million
Seres is well positioned to bring VOWST to patients and advance our pipeline 3/31/2023 cash balance: $107 million $125 million milestone due Secured up to $250 million debt facility; to Seres with approval $110 million funded at closing Replaces existing debt facility 3/31/2023 pro-forma cash balanc
Slide 25: Seres' path forward in infection
Seres’ path forward in infection Eric Shaff President and Chief Executive Officer, Seres Therapeutics Seres Therapeutics, Inc. © 2023 25
Slide 26: SER-155 Phase 1b Study Ongoing With Data Available in May 2023
Potential Novel Approach to Address Infection - SER-155 Phase 1b Study Ongoing With Data Available in May 2023 SER-155 Phase 1b study design and objectives Microbiome drug Rationally designed, cultivated product; spore + type vegetative species patients in an open-label Phase 1b – Cohort 2 enrollmen
Slide 27: Maximizing the Opportunity in Infection Protection and AMR
Maximizing the Opportunity in Infection Protection and AMR Broadly Target Antimicrobial Additional Opportunities Resistant • Broad preclinical Infections portfolio • Driving to an additional clinical development Autologous HSCT program in 2023 Cancer Neutropenia • Potentially 2+ Pre-clinical Portfol
Slide 28: Q&A
Q&A Seres Therapeutics, Inc. © 2023 28