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 Insights - The FDA has provided constructive feedback on Seres Therapeutics' SER-155 development plans, supporting a Phase 2 study with a primary efficacy endpoint focused on reducing bloodstream infections (BSIs) post-allo-HSCT [1][2][4] - Seres Therapeutics plans to submit a proposed protocol for the next SER-155 study to the FDA in Q2 2025, incorporating the agency's feedback [1][2] - SER-155 has shown a 77% relative risk reduction in BSIs in a Phase 1b study, along with reduced systemic antibiotic exposure and lower incidence of febrile neutropenia [2][4] Company Overview - Seres Therapeutics, Inc. is a clinical-stage company focused on live biotherapeutics aimed at improving outcomes for medically vulnerable populations [5] - The company has received Breakthrough Therapy designation for SER-155, targeting the reduction of BSIs in allo-HSCT patients, and Fast Track designation for reducing infection risk and graft-versus-host disease [5][4] - SER-155 is designed to decolonize gastrointestinal pathogens and improve immune tolerance in patients undergoing allo-HSCT for hematological malignancies [3][5] Future Development Plans - The next study design for SER-155 may retain elements from the previous Phase 1b trial, which demonstrated significant clinical benefits [2][4] - The company is actively seeking partnerships to support the further development of SER-155 in allo-HSCT [2]

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].

Financial Position - As of December 31, 2024, Seres Therapeutics had preliminary cash and cash equivalents of $31 million[7]. - The company expects to receive approximately $75 million from Nestlé Health Science in January and July 2025 related to the VOWST sale, which will support operations into the first quarter of 2026[8]. - The preliminary financial results remain subject to change based on the completion of closing and review procedures[7]. - The company emphasizes that the estimated preliminary financial results have not been audited or reviewed by its independent registered public accounting firm[11]. - Forward-looking statements regarding financial performance and clinical studies are subject to risks and uncertainties that may affect actual results[10]. Clinical Development - SER-155 demonstrated a statistically significant decrease in fecal albumin, indicating improved epithelial barrier integrity in patients undergoing allo-HSCT[6]. - The FDA granted Breakthrough Therapy designation to SER-155 for the reduction of bloodstream infections in adults undergoing allo-HSCT in December 2024[6]. - The company plans to submit a Briefing Book to the FDA regarding a potential next registrational study of SER-155 in allo-HSCT, expecting feedback in Q1 2025[6]. - SER-155's biomarker data supports its potential in reducing bloodstream infections by promoting epithelial barrier integrity[6]. - The company is focused on clinical development plans and anticipates future market potential for SER-155 and other product candidates[9].

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]

Core Insights - Seres Therapeutics, Inc. will present at the 43rd Annual J.P. Morgan Healthcare Conference on January 16, 2025, focusing on its biotherapeutics pipeline and specifically on SER-155 [1][2] Company Overview - Seres Therapeutics is a clinical-stage company specializing in live biotherapeutics aimed at improving outcomes for medically vulnerable populations [3] - The company successfully developed VOWST™, the first FDA-approved orally administered microbiome therapeutic, which was sold to Nestlé Health Science in September 2024 [3] Product Development - SER-155 has received Breakthrough Therapy designation from the FDA for reducing bloodstream infections (BSIs) in adults undergoing allogeneic hematopoietic stem cell transplant [2] - Clinical study results indicated a 77% relative risk reduction in BSIs associated with SER-155, along with a significant decrease in systemic antibiotic exposure and lower incidence of febrile neutropenia [2] - The company is exploring partnerships to enhance the development of SER-155 and other pipeline candidates for various medically vulnerable populations [2][3] Target Populations - SER-155 is intended for use in multiple patient groups, 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 [2][3]

Company Overview - Seres Therapeutics, Inc. 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 shown a significant reduction in bloodstream infections and related complications in a clinical study involving patients undergoing allogeneic hematopoietic stem cell transplantation [3] Pipeline and Development - SER-155 and other pipeline programs are designed to target multiple disease-relevant pathways and are manufactured from standard clonal cell banks via cultivation [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] Upcoming Events - Eric Shaff, President and CEO of Seres Therapeutics, will participate in a fireside chat at the Piper Sandler 36th Annual Healthcare Conference on December 3, 2024, at 4:30 p.m. ET [1] - A live webcast of the chat will be available on the company's website and will be accessible for replay after the event [2]

Financial Performance - The net loss from continuing operations for the three months ended September 30, 2024 was $51,035,000, compared to a loss of $41,015,000 for the same period in 2023, indicating an increase in losses of approximately 24.5%[16]. - The company reported a net income from discontinued operations of $139,811,000 for the three months ended September 30, 2024, compared to a loss of $6,839,000 in the same period of 2023[16]. - The net loss from continuing operations increased to $51.0 million in Q3 2024 from $41.0 million in Q3 2023, an increase of $10.0 million[107]. - The company reported a net loss from continuing operations of $110.1 million for the nine months ended September 30, 2024, compared to a loss of $155.4 million in the same period of 2023, an improvement of $45.3 million[114]. - The company incurred a net loss of $(40,133) thousand for the quarter ending March 31, 2024, and $(32,870) thousand for the quarter ending June 30, 2024[17]. - The company has incurred significant operating losses since its inception and expects to continue incurring losses for the foreseeable future[84]. Assets and Liabilities - Total current assets decreased from $175,410,000 in December 31, 2023 to $72,928,000 as of September 30, 2024, a decline of approximately 58.4%[13]. - Total liabilities decreased from $403,456,000 in December 31, 2023 to $154,823,000 as of September 30, 2024, a reduction of about 61.7%[13]. - The total stockholders' equity improved from a deficit of $44,856,000 as of December 31, 2023 to $23,919,000 as of September 30, 2024[14]. - As of September 30, 2024, total stockholders' equity is reported at $(962,462) thousand, reflecting a net income of $88,776 thousand for the quarter[17]. - The company had cash and cash equivalents of $66,824,000 as of September 30, 2024, down from $127,965,000 at the end of 2023, a decrease of about 47.8%[13]. - Total cash, cash equivalents, and restricted cash amounted to $76,697,000 as of September 30, 2024, down from $136,150,000 as of December 31, 2023[36]. Expenses - Research and development expenses for the three months ended September 30, 2024 were $16,460,000, down from $25,154,000 for the same period in 2023, representing a decrease of approximately 34.0%[16]. - General and administrative expenses for the three months ended September 30, 2024 were $12,710,000, compared to $19,432,000 in the prior year, a decrease of about 34.5%[16]. - Total operating expenses for the nine months ended September 30, 2024 were $92,480,000, down from $158,073,000 for the same period in 2023, a reduction of approximately 41.5%[16]. - Stock-based compensation expense for the quarter ending September 30, 2024, was $5,183 thousand, reflecting ongoing investment in employee incentives[17]. - The company recorded a total stock-based compensation expense of $5,183,000 for the three months ended September 30, 2024, down from $8,673,000 in the same period of 2023, indicating a decrease of approximately 40.5%[69]. Capital and Financing - The additional paid-in capital as of September 30, 2024, stands at $986,211 thousand, indicating a significant capital raise through equity offerings[17]. - The company raised approximately $44.4 million from the sale of 27,018,032 shares of common stock under its at-the-market equity offering program[118]. - The company entered into the Oaktree Credit Agreement establishing a term loan facility of $250,000, with a maturity date of April 27, 2029[58]. - The company raised $4,239 thousand through common stock issuance from at-the-market equity offerings during the quarter ending March 31, 2023[19]. - The company sold 14,285,715 shares to SPN at a purchase price of $1.05 per share, totaling $15,000[63]. Business Transactions - The company completed the sale of its VOWST Business to Nestlé Health Science for a total consideration of $100,000, with additional installment payments of $50,000 and $25,000 due in 2025[23]. - The gain on the sale of the VOWST Business was recorded at $146,707,000, which is included in the net income from discontinued operations for the three and nine months ended September 30, 2024[41]. - The company completed the sale of its VOWST Business to SPN on September 30, 2024, which included all inventory, equipment, patents, and related rights[204]. - The company will share 50/50 in the net profit or net loss achieved during the Profit Sharing Period with SPN, based on net sales of VOWST in the United States and Canada[117]. Research and Development - SER-155, an investigational oral live biotherapeutic, showed significant reduction in bloodstream infections and systemic antibiotic exposure in Phase 1b study[23]. - The company intends to evaluate SER-155 in various medically vulnerable patient populations, including cancer patients and organ transplant recipients[23]. - The company plans to focus on the development of SER-155 and other wholly-owned live biotherapeutic candidates, targeting various medically vulnerable patient populations[83]. - The decrease in R&D expenses was primarily due to a $6.5 million reduction in personnel-related costs from the restructuring plan implemented in 2023[109]. - The company anticipates an overall decrease in R&D expenses in 2024 as it focuses on completing the SER-155 Phase 1b study[100]. Regulatory and Compliance Risks - The company has received Fast Track designation for SER-155 and SER-287, which may facilitate the development process but does not guarantee faster approval[160]. - The company is subject to comprehensive regulation by the FDA and other authorities, affecting commercialization plans[158]. - The company must comply with evolving regulations, such as the EU Clinical Trials Regulation, which may impact development plans[152]. - The company faces significant risks related to its financial position and the need for additional capital, which could adversely affect its growth prospects[135]. - The company has limited experience in commercial-scale manufacturing, which may affect its ability to meet market demands[167]. Legal and Intellectual Property - The company is currently facing a legal complaint from Vedanta Biosciences, Inc. and The University of Tokyo, alleging infringement of multiple U.S. patents, which could result in unspecified damages and injunctive relief[192]. - The biotechnology and pharmaceutical industries are characterized by extensive litigation regarding patents, which could lead to significant costs and management distraction for the company[194]. - The company has obligations under funding arrangements that may affect its intellectual property rights[186]. - The company may face claims challenging the inventorship or ownership of its patents and intellectual property, which could lead to litigation and substantial costs[196]. - The company has successfully obtained multiple patents, but competitors may independently develop equivalent technologies, impacting its market position[185]. Market and Competitive Landscape - The company faces intense competition for hiring qualified personnel from other pharmaceutical and biotechnology companies[199]. - Competition from larger pharmaceutical and biotechnology companies with greater resources poses a significant threat to the company's market position[171]. - The company may not be able to successfully commercialize its product candidates if it fails to establish effective sales and marketing capabilities[170]. - The company has limited sales and marketing infrastructure and experience in commercializing pharmaceutical products, which may hinder future success[170]. - The company may face challenges in obtaining adequate reimbursement for its product candidates from government and private payors[171].

CAMBRIDGE, Mass., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading live biotherapeutics company, today announced that management will host a conference call and live audio webcast on November 13, 2024 at 8:30 a.m. ET to discuss third quarter 2024 financial results and provide business updates. To access the conference call, please dial 800-715-9871 (domestic) or 646-307-1963 (international) and reference the conference ID number 5051385. To join the live webcast, please v ...

CAMBRIDGE, Mass., Sept. 26, 2024 (GLOBE NEWSWIRE) -- Seres Therapeutics, Inc. (Nasdaq: MCRB), ("Seres" or the "Company"), a leading live biotherapeutics company, today announced that its stockholders voted to approve the previously announced proposed sale of the Company's VOWST business to Société des Produits Nestlé S.A. Seres will file a Current Report on Form 8-K with the SEC which details the voting results. The transaction is expected to close on September 30, 2024, subject to the satisfaction of custo ...