Seres Therapeutics(MCRB)

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Seres Therapeutics(MCRB) - 2024 Q4 - Annual Report
2025-03-13 15:24
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].
Seres Therapeutics(MCRB) - 2024 Q4 - Earnings Call Transcript
2025-03-13 15:04
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(MCRB) - 2024 Q4 - Earnings Call Presentation
2025-03-13 12:51
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 ...
Seres Therapeutics(MCRB) - 2024 Q4 - Annual Results
2025-03-13 11:07
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 ...
Seres Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Updates
GlobeNewswire· 2025-03-13 11:00
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 ...
Seres Therapeutics to Announce Fourth Quarter and Full Year 2024 Financial Results and Provide Business Updates on March 13, 2025
GlobeNewswire· 2025-03-04 12:00
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].
Seres Therapeutics Announces Receipt of Expected $50 Million Installment Payment Related to VOWST Sale
GlobeNewswire· 2025-01-16 12:00
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].
Seres Therapeutics Announces New Translational Biomarker Results from SER-155 Phase 1b Clinical Study and Provides Corporate Updates
GlobeNewswire· 2025-01-09 12:00
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]
Seres Therapeutics to Participate in 2025 J.P. Morgan Healthcare Conference
Newsfilter· 2024-12-16 12:00
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 ...
Seres Therapeutics to Participate in Piper Sandler Healthcare Conference
GlobeNewswire News Room· 2024-11-22 12:00
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 ...