Clinical Development and Regulatory Designations - SER-155 demonstrated a 77% relative risk reduction in bloodstream infections (BSIs) compared to placebo in the Phase 1b study, with significant reductions in systemic antibiotic exposure and febrile neutropenia incidence[33]. - The FDA granted Breakthrough Therapy designation to SER-155 for the reduction of BSIs in patients 18 years and older undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT) in December 2024[33]. - The company plans to submit a draft protocol for the next SER-155 study to the FDA in Q2 2025, incorporating feedback from the FDA on the development strategy[24]. - SER-155, an investigational oral live biotherapeutic, is designed to reduce bacterial bloodstream infections (BSIs) in patients undergoing allo-HSCT, with Fast Track Designation received in December 2023 and Breakthrough Therapy designation granted in December 2024[64][65]. - In the Phase 1b study of SER-155, the incidence of BSIs was significantly lower in the treatment group (10%) compared to the placebo group (42.9%), representing a relative risk reduction of approximately 77%[70]. - SER-155 administration resulted in a mean reduction of antibiotic treatment duration from 21.1 days in the placebo group to 9.2 days in the SER-155 group[70]. - The company continues to explore the therapeutic mechanisms of SER-155, including promoting intestinal epithelial barrier integrity and reducing systemic inflammatory responses[75]. - The company aims to evaluate SER-155 in various medically vulnerable populations, including autologous-HSCT patients and cancer patients with neutropenia[26]. Product Development and Manufacturing - SER-147 is being developed to prevent bacterial bloodstream and spontaneous bacterial peritonitis infections in patients with chronic liver disease (CLD), which affects nearly 1.7 billion people worldwide[33]. - The company maintains a differentiated live biotherapeutics drug discovery and development platform, including good manufacturing practices (GMP) capabilities[25]. - The company has established a proprietary strain library and bioinformatics tools to track changes in the microbiome and associate them with host physiology[37]. - The successful development and approval of VOWST, the first FDA-approved orally administered microbiome therapeutic, provides the company with regulatory experience for future live biotherapeutic candidates[36]. - The company has developed a proprietary strain library of bacterial isolates, which includes species from healthy individuals and patients, enhancing its ability to translate microbiome biomarker insights into therapeutic applications[39]. - The company’s manufacturing facility in Cambridge, Massachusetts, is designed to meet cGMP standards, positioning it uniquely in the market compared to commercial contract research organizations[41]. - The company has optimized fermentation conditions to enhance bacterial yields, demonstrating its commitment to innovative manufacturing processes[41]. - The company plans to establish commercial manufacturing capabilities or arrange with third-party manufacturers for its product candidates[220]. Financial Performance and Funding - The company received $100 million in cash upon closing the sale of its VOWST business, with additional cash installment payments of $50 million and $25 million due in 2025[52]. - Future milestone payments include $125 million for achieving worldwide annual net sales of $400 million and $150 million for $750 million in sales, highlighting significant revenue potential from the VOWST product[52]. - The company reported a gain of $5.7 million for the year ended December 31, 2024, primarily due to better-than-expected profit sharing from the VOWST product[55]. - The company anticipates needing additional funding to advance the development and commercialization of its product candidates, particularly for SER-155 clinical studies[198]. - The company has incurred significant operating losses since inception and expects to continue incurring losses for the foreseeable future[203]. - The net loss from continuing operations for the years ended December 31, 2024, 2023, and 2022 was $125.8 million, $190.1 million, and $183.6 million respectively, with an accumulated deficit of $978.1 million as of December 31, 2024[203]. - The company has broad discretion in using the proceeds from the transaction, which may not be effectively utilized to improve its financial condition[217]. Market and Competitive Landscape - The company faces competition from major pharmaceutical and biotechnology companies with greater financial resources and established market presence[98]. - The company faces significant uncertainty regarding the coverage and reimbursement status of its product candidates, which may impact sales and profitability[176]. - The company is subject to various governmental cost-containment measures, including price controls and reimbursement restrictions, which could limit net revenue[177]. - The company’s ability to access capital may be adversely affected by market volatility and macroeconomic conditions, including geopolitical conflicts[200]. Intellectual Property and Regulatory Compliance - Protecting intellectual property rights is a key focus for the company to ensure competitive advantage[220]. - The company utilizes trade secrets and confidentiality agreements to protect its proprietary information and competitive position[95]. - The company plans to expand its intellectual property estate by filing patent applications related to its product candidates[89]. Employee and Organizational Structure - The company experienced a headcount reduction of approximately 100 employees following the VOWST Transaction, with a total of 103 full-time employees as of December 31, 2024[188]. - The company emphasizes the importance of attracting and retaining skilled employees as a key driver of its future prospects[190]. - The company has no employees represented by a labor union, indicating a stable relationship with its workforce[188]. Future Outlook and Challenges - The company has identified conditions that raise substantial doubt about its ability to continue as a going concern, depending on various factors including clinical trial costs and regulatory review outcomes[199]. - The company may face challenges in maintaining employee morale and retaining key management following the transaction, which has resulted in a smaller, less diversified business[216][214]. - The company is focused on developing SER-155 and other cultivated live biotherapeutic candidates, but faces risks in achieving regulatory approvals and market acceptance[213][218]. - The acceptance of the product candidates by patients, the medical community, and third-party payors is crucial for future success[220]. - The company aims to maintain a continued acceptable safety profile for its product candidates following approval[220].

Financial Data and Key Metrics Changes - Seres reported a net loss from continuing operations of $15.7 million for Q4 2024, compared to a net loss of $34.7 million for the same period in 2023, indicating a significant improvement [49] - For the full year 2024, the net loss from continuing operations was $125.8 million, down from $190.1 million in 2023, primarily due to lower operating expenses of approximately $74 million [49] - Research and development (R&D) expenses for Q4 2024 were $12.8 million, down from $23 million in Q4 2023, and for the full year, R&D expenses were $64.6 million compared to $117.6 million in 2023 [51] - General and administrative (G&A) expenses for Q4 2024 were $12.5 million, down from $14 million in Q4 2023, and for the full year, G&A expenses were $53.2 million compared to $77.5 million in 2023 [52] Business Line Data and Key Metrics Changes - The company has made substantial progress in advancing its lead program SER-155, which aims to prevent bloodstream infections in allo-HSCT recipients [8][12] - SER-155 showed a clinically meaningful 77% relative risk reduction in bloodstream infection rates in a Phase 1b study [10][23] - The FDA granted breakthrough therapy designation to SER-155, indicating significant progress in its development [13][58] Market Data and Key Metrics Changes - The commercial opportunity in allo-HSCT alone is considered sizable, with potential for indication expansion to adjacent patient populations [39][40] - There are approximately 9,300 allo-HSCT procedures conducted annually in the US, with an estimated 20,000 procedures in Europe [43] Company Strategy and Development Direction - The company is focused on SER-155 and exploring partnerships to support its development and maximize its potential [17][61] - SER-155 is positioned to address a significant unmet need in preventing bacterial bloodstream infections, with plans to extend its application to other medically vulnerable groups [40][61] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress made with SER-155 and the constructive feedback received from the FDA [58] - The company is preparing for the next study of SER-155 and expects to submit a draft study protocol to the FDA in the second quarter [21][22] Other Important Information - The company is now debt-free following the VOWST transaction, which provided $155 million at closing [46][47] - The cash position as of December 31, 2024, was $30.8 million, with expectations to fund operations into the first quarter of 2026 [55] Q&A Session Summary Question: Feedback from the FDA regarding manufacturing and patient enrollment - Management indicated that they received comprehensive feedback from the FDA and are in the process of refining the clinical study protocol [67][70] - The population for the next study is considered appropriate, with plans to manage variability through stratification [72] Question: Recent FDA feedback relative to expectations and Phase 2/3 study differences - Management found the FDA feedback constructive and believes more data is needed for the next study [80][84] - A Phase 2/3 study would require pre-specification and locking of certain items, which could take more time [83] Question: Safety database considerations based on VOWST experience - Management noted that the FDA has a minimum threshold of 300 patients for safety data, but discussions will evolve as more data is generated [92] Question: Potential size of the next study and additional efficacy endpoints - Management indicated that a standalone Phase 2 could provide meaningful data quickly, with various endpoints being considered, including GvHD rates [100][102]

Seres Therapeutics Investor Presentation March 2025 Transforming patient outcomes using proprietary consortia of live biotherapeutics Seres Therapeutics Investor Presentation March 2025 Strong Foundation Positive SER-155 Phase 1b Data in Allo-HSCT Blockbuster SER-155 Opportunity • Initial SER-155 development in allo-HSCT • Potential to initiate multiple clinical trials for additional indications • SER-155 represents multi- billion net sales opportunity across indications (e.g., autologous-HSCT, blood cancer ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 9, 2025 SERES THERAPEUTICS, INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37465 27-4326290 (State or other jurisdiction of incorporation) (Commission File Number) (IRS Employer Identification No.) 101 Cambridgepark Drive Cambridge, MA 02140 (Address of princip ...

Recent FDA feedback received on SER-155 allogeneic hematopoietic stem cell transplant (allo-HSCT) next study provides support for the proposed primary efficacy endpoint of reduction in bloodstream infections (BSIs) at day 30 post-HSCT; Company expects to submit draft study protocol to FDA in Q2 2025 SER-155 Phase 1b placebo-controlled study exploratory translational biomarker data reinforce intended mechanisms of action, are consistent with clinical results that showed a significant reduction (77% relative ...

Core Viewpoint - Seres Therapeutics, Inc. will host a conference call on March 13, 2025, to discuss its fourth quarter and full year 2024 financial results and provide business updates [1]. Company Overview - Seres Therapeutics is a clinical-stage company focused on improving patient outcomes in medically vulnerable populations through novel live biotherapeutics [3]. - The company successfully developed and approved VOWST™, the first FDA-approved orally administered microbiome therapeutic, which was sold to Nestlé Health Science in September 2024 [3]. - Seres is developing SER-155, which has received Breakthrough Therapy designation for reducing bloodstream infections in adults undergoing allo-HSCT and Fast Track designation for reducing the risk of infection and graft-versus-host disease in the same patient group [3]. - SER-155 demonstrated a significant reduction in bloodstream infections and related complications compared to placebo in a Phase 1b clinical study [3]. - The company plans to evaluate SER-155 and other cultivated live biotherapeutic candidates in various medically vulnerable patient populations, including autologous-HSCT patients, cancer patients with neutropenia, CAR-T recipients, individuals with chronic liver disease, solid organ transplant recipients, and patients in intensive care units and long-term acute care facilities [3].

Core Viewpoint - Seres Therapeutics has received a $50 million installment payment from Nestlé Health Science related to the sale of its VOWST business, which is expected to support the company's operations into early 2026 [1][2]. Financial Summary - The company anticipates an additional installment payment of $25 million from Nestlé Health Science in July 2025, after accounting for approximately $1.5 million in employment-related payments [2]. - With the current cash position and projected payments, Seres expects to fund its operations through the first quarter of 2026 [2]. Company Overview - Seres Therapeutics is a clinical-stage company focused on live biotherapeutics aimed at improving outcomes for medically vulnerable populations [3]. - The company developed VOWST™, the first FDA-approved orally administered microbiome therapeutic, which was sold to Nestlé Health Science in September 2024 [3]. - Seres is currently developing SER-155, which has received Breakthrough Therapy and Fast Track designations, showing significant efficacy in reducing bloodstream infections in a Phase 1b clinical study [3]. - The company plans to evaluate SER-155 and other candidates in various medically vulnerable patient populations, including those undergoing allo-HSCT, cancer patients with neutropenia, and solid organ transplant recipients [3].

Core Insights - SER-155 demonstrates significant clinical benefits in promoting epithelial barrier integrity and reducing systemic inflammatory biomarkers in allo-HSCT patients compared to placebo [1][3][4] - The clinical results of SER-155 have been accepted for oral presentation at the 2025 TANDEM Meeting, highlighting its relevance in infectious diseases [1][6] - Market research indicates a high unmet need for effective prophylactic options against bloodstream infections (BSIs) in allo-HSCT patients, supporting SER-155's commercial potential [6][8] Clinical Data - SER-155 Phase 1b study shows a statistically significant decrease in fecal albumin, indicating improved epithelial barrier integrity, and a positive impact on systemic inflammation biomarkers [3][4] - The study also reported a 77% relative risk reduction in bloodstream infections, reinforcing the therapeutic potential of SER-155 [4][10] - SER-155 has received Breakthrough Therapy designation from the FDA for its role in reducing BSIs in allo-HSCT patients [10][12] Market Opportunity - Recent payer research highlights the significant clinical burden of BSIs and the lack of effective prophylactic therapies, suggesting a strong value proposition for SER-155 [6][8] - Payers expect SER-155 to be covered under outpatient pharmacy benefits due to its oral administration, facilitating easier access for patients [6][7] - The company is actively seeking partnerships to maximize the commercial opportunity for SER-155 and expand its applications in treating inflammatory diseases [8][11] Financial Position - As of December 31, 2024, the company reported approximately $31 million in cash and cash equivalents, with an expected cash runway extending into Q1 2026 [2][12] - The company anticipates receiving approximately $75 million from Nestlé Health Science related to the sale of VOWST, which will support ongoing operations and development plans for SER-155 [12]

CAMBRIDGE, Mass., Dec. 16, 2024 (GLOBE NEWSWIRE) -- Seres Therapeutics, Inc. (NASDAQ:MCRB), a leading live biotherapeutics company, today announced that management will participate in the 43rd Annual J.P. Morgan Healthcare Conference. Eric Shaff, President and Chief Executive Officer, will present a corporate overview on January 16, 2025 at 7:30 a.m. PT. Seres will highlight its plans to advance its biotherapeutics pipeline, focusing on SER-155, the Company's lead program. The Company recently announced tha ...

CAMBRIDGE, Mass., Nov. 22, 2024 (GLOBE NEWSWIRE) -- Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading live biotherapeutics company, today announced that Eric Shaff, President and Chief Executive Officer, will participate in a fireside chat at the Piper Sandler 36th Annual Healthcare Conference on December 3, 2024, at 4:30 p.m. ET. A live webcast of the chat will be accessible through the “Events and Presentations” tab on the “Investors and News” section of the Company’s website at www.serestherapeutics.com ...