Data demonstrate clinical translation of VOWST mechanisms of action in both first and multiply recurrent CDI patients Seres MbTx® platform provides high-resolution functional biological understanding of live biotherapeutics and supports the advancement of Seres’ portfolio, including Phase 2-ready lead candidate SER-155 CAMBRIDGE, Mass., Jan. 06, 2026 (GLOBE NEWSWIRE) -- Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading live biotherapeutics company, today announced the publication of two manuscripts in Natu ...

Industry Overview - The biotech and drug industry experienced a significant rebound in 2025 after a cautious start, driven by drug pricing agreements and increased M&A activity [1] - The FDA approved 44 novel therapies in 2025, with 26 approvals occurring in the second half of the year, indicating an acceleration in regulatory activity [1][2] Company Analysis: Altimmune (ALT) - Altimmune is focused on developing therapies for liver diseases, with its lead candidate pemvidutide currently in mid-stage studies for metabolic dysfunction-associated steatohepatitis (MASH) [4] - Shares of Altimmune have decreased over 46% year-to-date due to mixed results from the phase IIb IMPACT study, although it met one primary endpoint related to MASH resolution [5] - Recent 48-week results from the IMPACT study showed further improvements in non-invasive tests and significant reductions in liver health biomarkers [6] - Altimmune plans to initiate a late-stage study for pemvidutide in MASH in 2026 after aligning with the FDA on key parameters [7] - The company is also exploring pemvidutide for alcohol use disorder and alcohol-associated liver disease, with data expected next year [8] Company Analysis: ImmunityBio (IBRX) - ImmunityBio focuses on therapies for cancer and infectious diseases, with its marketed drug Anktiva approved for bladder cancer [11] - Shares of ImmunityBio have declined over 16% this year due to a regulatory setback from the FDA regarding a label expansion for Anktiva [12] - Despite the setback, Anktiva generated nearly $75 million in sales this year, a significant increase from $7 million in the previous year, and the company is seeking EU market expansion [13] - ImmunityBio is also developing Anktiva for other cancer indications, with promising data in non-small cell lung cancer and glioblastoma expected to be updated in 2026 [14] - Loss per share estimates for 2026 have improved from $0.37 to $0.33 in the past 60 days [15] Company Analysis: Seres Therapeutics (MCRB) - Seres Therapeutics is developing SER-155, an oral live biotherapeutic aimed at preventing bloodstream infections in patients undergoing stem cell transplantation [16] - Investor interest in SER-155 increased after a phase Ib study showed a 77% relative reduction in bacterial infections compared to placebo [17] - The FDA has provided positive feedback for SER-155's advancement to mid-stage development, with an interim update expected within 12 months of study initiation [18] - Shares of Seres Therapeutics have decreased nearly 12% year-to-date, but loss per share estimates for 2026 have improved from $10.66 to $7.67 in the past 60 days [18]

Summary of Seres Therapeutics FY Conference Call Company Overview - **Company**: Seres Therapeutics (NasdaqGS:MCRB) - **Industry**: Biotechnology, specifically microbiome therapy - **Key Products**: - VOWST for recurrent C. difficile infections - SER-155 for reducing GI infections, bacteremia, and graft-versus-host disease in allogeneic hematopoietic stem cell transplant patients - SER-603 for ulcerative colitis and Crohn's disease [1][1][1] Core Technology and Development - **Microbiome Technology**: Seres utilizes a platform to design drugs as consortia of bacteria with specific functional properties, targeting pathways related to human diseases [4][4][4] - **Manufacturing Expertise**: Unique skills in cultivating and producing microbiome therapies, with established FDA CMC processes [6][6][6] SER-155 Program - **Unmet Medical Need**: SER-155 addresses high infection rates in stem cell transplant patients, which can reach around 4% even with standard antibiotic prophylaxis. The infection rate is increasing due to new treatment protocols [9][10][10] - **Clinical Data**: Phase 1B study showed a 77% relative risk reduction in bloodstream infections compared to placebo, along with lower antibiotic use and febrile neutropenia [13][13][13] - **FDA Engagement**: Positive feedback from the FDA on the design of the upcoming Phase 2 study, which will include 248 patients and focus on reducing bloodstream infections [17][18][18] Commercial Opportunity - **Market Size**: Approximately 40,000 allogeneic stem cell transplants occur annually worldwide, with a tight commercial footprint allowing for efficient education and adoption of new products [20][20][20] - **Pricing Strategy**: The estimated cost of a stem cell transplant is $400,000, with an additional $200,000 incurred during infections. SER-155 is expected to be priced at a premium due to its value proposition [23][23][23] Future Development and Indications - **Potential Indications**: SER-155 may also be applicable in autologous transplants and broader cancer populations, with an estimated 60,000 autologous transplants and 500,000 cancer patients annually [26][27][27] - **SER-603 Development**: SER-603 aims to treat ulcerative colitis and Crohn's disease, leveraging advancements in microbiome research to target specific patient populations more effectively [34][35][35] Financial Position - **Funding Status**: Seres ended the third quarter with $48 million, which has since increased to over $50 million. This funding is expected to last through the second quarter of the following year, focusing on advancing the Phase 2 study for SER-155 [40][40][40]

Financial Performance - Total revenue for the three months ended September 30, 2025, was $351,000, compared to $0 for the same period in 2024, indicating a significant increase[22] - Net income from continuing operations for the three months ended September 30, 2025, was $8,204,000, compared to a loss of $51,035,000 in the same period of 2024[22] - The company reported a gain on the sale of the VOWST Business of $27,222,000 for the three months ended September 30, 2025[22] - The company reported a net income of $21,031 for the nine months ended September 30, 2025, compared to $15,773 for the same period in 2024, representing a year-over-year increase of 33.8%[29] - The company incurred a loss from operations of $74,594,000 for the nine months ended September 30, 2025[51] - The company reported a significant reduction in expenses related to the live biotherapeutics platform, totaling $6.165 million for Q3 2025, down from $7.458 million in Q3 2024, representing a decrease of approximately 17.3%[111] - The company reported a gain of $27.2 million on the sale of the VOWST Business during the three months ended September 30, 2025[198] Expenses and Cost Management - Research and development expenses for the nine months ended September 30, 2025, were $37,376,000, down 28% from $51,759,000 in the same period of 2024[22] - The company reported total operating expenses of $22,828,000 for the three months ended September 30, 2025, down from $29,170,000 in the same period of 2024[22] - Stock-based compensation expense for the nine months ended September 30, 2025, was $7,641, down from $17,206 in 2024, indicating a decrease of 55.6%[29] - General and administrative expenses were $9.5 million for the three months ended September 30, 2025, compared to $12.7 million in 2024, a decrease of $3.2 million[196] - General and administrative expenses were $31.6 million for the nine months ended September 30, 2025, down from $40.7 million in 2024, a decrease of $9.1 million[202] Assets and Liabilities - Total assets increased to $143,473,000 as of September 30, 2025, from $139,810,000 as of December 31, 2024[20] - Total liabilities decreased to $99,776,000 as of September 30, 2025, from $126,026,000 as of December 31, 2024, reflecting improved financial health[20] - The company’s stockholders' equity increased to $43,697,000 as of September 30, 2025, compared to $13,784,000 as of December 31, 2024[20] - As of September 30, 2025, the Company had an accumulated deficit of $957,068,000 and cash and cash equivalents of $47,638,000[49] Cash Flow and Funding - The company reported a net cash provided by operating activities of $15,827 for the nine months ended September 30, 2025, compared to a net cash used of $109,727 in 2024[29] - Cash, cash equivalents, and restricted cash at the end of the period were $56,306, down from $76,697 at the end of the same period in 2024[29] - The company expects to incur approximately $1,027,000 in restructuring costs due to workforce reductions of about 25%[47] - The Company will require additional funding to support ongoing operations and meet obligations, raising substantial doubt about its ability to continue as a going concern[52] - Cash provided by operating activities was $15.8 million for the nine months ended September 30, 2025, compared to a cash used of $109.7 million in 2024[217] Business Operations and Strategic Initiatives - The company completed the sale of its VOWST microbiome therapeutic business to Nestlé Health Science for a cash payment of $100,000, with additional milestone payments to be received[35] - The company plans to explore SER-155 in various medically vulnerable patient populations, including those undergoing allogeneic hematopoietic stem cell transplantation[32] - The company has built a reverse translational platform for the discovery and development of live biotherapeutics, enhancing its research capabilities[34] - The company entered into a Transition Services Agreement (TSA) with NESA to provide manufacturing and administrative services related to the VOWST Business[40] - The company will provide manufacturing services under a Transition Services Agreement until December 31, 2025, with NESA reimbursing for certain costs[140] Research and Development - SER-155 demonstrated a 77% relative risk reduction in bacterial bloodstream infections in a Phase 1b study, indicating significant efficacy in the target patient population[32] - The SER-155 Phase 2 study is expected to enroll approximately 248 participants, with interim clinical results anticipated within twelve months following study initiation[118] - A CARB-X grant of up to $3.6 million was awarded to support the development of an oral liquid formulation of SER-155 for medically vulnerable patients[159] - SER-155 was associated with lower levels of fecal albumin and reduced concentrations of systemic inflammatory biomarkers during the HSCT peri-transplant period[161] - The company has an extensive patent portfolio related to SER-155 and SER-147, extending through at least 2043, with 24 active patent families and 33 issued U.S. patents[172] Stock and Equity - The weighted average common shares outstanding increased to 8,758,692 for the three months ended September 30, 2025, compared to 7,632,242 for the same period in 2024[22] - The company implemented a 1-for-20 reverse stock split, retroactively adjusting all share amounts in financial statements[58] - The 2025 Incentive Award Plan was approved, authorizing the issuance of 2,230,243 shares, extending the plan's term to March 3, 2035[83] - The company raised approximately $996 from the sale of 54,806 shares at an average price of $18.60 per share during the nine months ended September 30, 2025[85] - The company has sold 1,772,037 shares of common stock under the Sales Agreement, raising approximately $52.2 million in net proceeds[214]

Financial Data and Key Metrics Changes - Seres Therapeutics reported a net income from continuing operations of $8.2 million in Q3 2025, compared to a net loss of $51 million in Q3 2024, reflecting a significant turnaround in financial performance [15] - R&D expenses decreased to $12.6 million from $16.5 million in the same quarter last year, attributed to lower personnel costs and reduced clinical expenses [16] - G&A expenses were $9.5 million in Q3 2025, down from $12.7 million in Q3 2024, primarily due to lower personnel and IT-related expenses [16] Business Line Data and Key Metrics Changes - The company is focusing on advancing SER-155, its lead investigational oral live biotherapeutic, into a phase two study, which is expected to generate meaningful clinical results within 12 months of study initiation [4][6] - SER-155 has shown a 77% relative risk reduction in bacterial bloodstream infections in the phase one B study, indicating its potential effectiveness [4] Market Data and Key Metrics Changes - The potential market for SER-155 spans multiple medically vulnerable populations, including alloHSCT patients, autologous HSCT patients, and cancer patients, representing a multi-billion dollar commercial opportunity [7][8] - The company received a non-dilutive award of up to $3.6 million from CARB-X to support the development of an oral liquid formulation of SER-155, highlighting the recognition of its potential in addressing antimicrobial resistance [10][11] Company Strategy and Development Direction - The primary strategic focus is on advancing SER-155 while exploring potential R&D partnerships for other investigational live biotherapeutics targeting inflammatory and immune diseases [13][14] - Cost reduction measures, including a workforce reduction of approximately 25%, have been implemented to extend the cash runway and prioritize core development activities [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of SER-155 to transform patient management in alloHSCT and other high-risk populations, with a focus on addressing unmet medical needs [5][6] - The company anticipates obtaining additional SER-155 clinical results in early 2026, which could highlight therapeutic opportunities in new patient populations [17] Other Important Information - The company has classified all historical operating results for the VAST business within discontinued operations, indicating a strategic shift in focus [15] - As of September 30, 2025, Seres Therapeutics had $47.6 million in cash and cash equivalents, with expectations to fund operations through the second quarter of 2026 [16] Q&A Session Summary Question: Can you provide more details on the study design at Memorial Sloan Kettering Cancer Center for immune checkpoint inhibitor-related enterocolitis? - The study is a small, phase I open-label study expected to provide safety and pharmacology data, with results anticipated in early 2026 [23] Question: What is the commercial opportunity for SER-155 in this context? - The condition is common among patients on immune checkpoint inhibitors, with significant implications for treatment and hospitalizations, indicating a substantial market need for SER-155 [27][28] Question: How much capital is needed to reach initial SER-155 data within 12 months? - Specific capital needs have not been disclosed, but the company is prioritizing obtaining partnerships or other sources of capital to support the study [34]

Financial Performance - Seres reported a net income of $8.2 million for Q3 2025, compared to a net loss of $51.0 million in Q3 2024, primarily due to a $27.2 million gain from the sale of VOWST[11] - Total revenue for the three months ended September 30, 2025, was $351,000, compared to $0 for the same period in 2024, indicating a significant increase[19] - The company reported a net income from continuing operations of $8,204,000 for the three months ended September 30, 2025, compared to a net loss of $51,035,000 in the same period of 2024[19] - The gain on the sale of the VOWST Business was $27,222,000 for the three months ended September 30, 2025, contributing significantly to the overall financial performance[19] - The company reported a net income per share attributable to common stockholders of $0.94 for the three months ended September 30, 2025, compared to a loss of $6.69 per share in the same period of 2024[19] Expenses - Research and development (R&D) expenses decreased to $12.6 million in Q3 2025 from $16.5 million in Q3 2024, driven by reduced personnel and clinical expenses[11] - General and administrative (G&A) expenses fell to $9.5 million in Q3 2025, down from $12.7 million in Q3 2024, reflecting lower personnel and IT-related costs[11] - Research and development expenses for the three months ended September 30, 2025, were $12,616,000, down 23% from $16,460,000 in the same period of 2024[19] - General and administrative expenses decreased to $9,476,000 for the three months ended September 30, 2025, from $12,710,000 in the same period of 2024, representing a 25% reduction[19] Cash and Assets - As of September 30, 2025, Seres had $47.6 million in cash and cash equivalents, expecting to fund operations through Q2 2026[9] - Total current assets increased to $51,527,000 as of September 30, 2025, from $38,674,000 as of December 31, 2024, reflecting a growth of 33%[18] - Total liabilities decreased to $99,776,000 as of September 30, 2025, down from $126,026,000 as of December 31, 2024, indicating a reduction of approximately 21%[18] - Stockholders' equity increased significantly to $43,697,000 as of September 30, 2025, compared to $13,784,000 as of December 31, 2024, marking a growth of over 217%[18] Clinical Development - The SER-155 Phase 2 study is expected to enroll approximately 248 participants, with interim clinical results anticipated within 12 months of study initiation[6] - SER-155 demonstrated a 77% relative risk reduction in bacterial bloodstream infections (BSIs) in a Phase 1b study[13] - The company received a grant of up to $3.6 million from CARB-X to support the development of an oral liquid formulation of SER-155[6] - An ongoing investigator-sponsored study on SER-155 in immune checkpoint related enterocolitis is expected to provide initial results in early 2026[5] - SER-155 has received Breakthrough Therapy designation for the reduction of bloodstream infections in adults undergoing allogeneic hematopoietic stem cell transplantation[14] Cost Management - Cost-reduction measures implemented during Q3 2025 included workforce reductions, aimed at extending the company's cash runway[3] - Weighted average common shares outstanding increased to 8,758,692 for the three months ended September 30, 2025, compared to 7,632,242 for the same period in 2024, reflecting a growth in shareholder base[19]

Core Insights - Seres Therapeutics is finalizing the Phase 2 study protocol for SER-155 aimed at preventing bloodstream infections in adults undergoing allogeneic hematopoietic stem cell transplant, following positive feedback from the FDA [1][2][3] - The company is actively seeking funding to support the Phase 2 study, with interim clinical results expected within 12 months of study initiation [1][2][3] - Cost-reduction measures have been implemented, and the company anticipates funding operations through Q2 2026 based on current plans [2][3][9] SER-155 Development - SER-155 has received Breakthrough Therapy designation and is expected to enroll approximately 248 participants in the Phase 2 study, which will include an adaptive design and interim data analysis [3][12] - Positive results from the Phase 2 study could lead to a significant value-creating event for the company and its shareholders, potentially advancing to a Phase 3 trial [2][3] - An ongoing investigator-sponsored study at Memorial Sloan Kettering Cancer Center is expected to provide insights into SER-155's broader therapeutic potential, with initial results anticipated in early 2026 [2][7] Financial Performance - For Q3 2025, Seres reported a net income of $8.2 million, a significant improvement from a net loss of $51.0 million in Q3 2024, primarily due to a gain on the sale of VOWST [8][20] - Research and development expenses decreased to $12.6 million in Q3 2025 from $16.5 million in Q3 2024, reflecting cost-reduction efforts [8][20] - As of September 30, 2025, the company had $47.6 million in cash and cash equivalents, expecting to fund operations through Q2 2026 [9][20] Strategic Initiatives - The company is exploring various deal structures to leverage its expertise in live biotherapeutics, as demonstrated by the successful development of VOWST [3] - Seres is also investigating potential partnerships to advance the development of its biotherapeutics targeting inflammatory and immune diseases, including ulcerative colitis and Crohn's disease [7]

Core Insights - Seres Therapeutics, Inc. will host a conference call on November 5, 2025, at 8:30 a.m. ET to discuss Q3 2025 financial results and business updates [1][2] 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 developed 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 infection risk 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 populations, including autologous-HSCT patients, cancer patients with neutropenia, CAR-T recipients, and solid organ transplant recipients [3]

Core Insights - Seres Therapeutics has received up to $3.6 million in non-dilutive funding from CARB-X to support the development of an oral liquid formulation of SER-155, aimed at improving access for medically vulnerable patients, particularly those in intensive care who cannot take oral capsules [1][3][5] - SER-155 is being developed for patients undergoing allogeneic hematopoietic stem cell transplants (allo-HSCT) and has shown a 77% reduction in bacterial bloodstream infections (BSIs) compared to placebo in a Phase 1b study [2][5] - The development of a liquid formulation is expected to broaden the impact of SER-155 in additional high-risk patient populations susceptible to BSIs and antimicrobial resistant infections [3][5] Funding and Support - CARB-X, a global non-profit partnership, is providing funding to accelerate the development of antibacterial products, specifically targeting drug-resistant bacteria [1][4] - The funding is supported by various federal and international health organizations, including the U.S. Department of Health and Human Services and the UK Department of Health and Social Care [3][4] Clinical Development - SER-155 has received Breakthrough Therapy designation and Fast Track designation from the FDA, indicating its potential to significantly reduce the risk of infections in allo-HSCT patients [5][6] - The company is finalizing the clinical protocol for a well-powered, placebo-controlled Phase 2 study following positive feedback from the FDA [2][5] Company Background - Seres Therapeutics is focused on improving outcomes for medically vulnerable populations through live biotherapeutics and has previously developed VOWST™, the first FDA-approved orally administered microbiome therapeutic [5][6] - The company aims to evaluate SER-155 in various patient populations, including those undergoing autologous-HSCT, cancer patients with neutropenia, and patients in intensive care [6]

Core Insights - Seres Therapeutics, Inc. announced new post hoc data from its SER-155 Phase 1b trial, which will be presented at IDWeek 2025 [1] - SER-155 demonstrated a 77% reduction in bloodstream infections (BSIs) in patients undergoing allogeneic hematopoietic stem cell transplant (allo-HSCT) [3] - The company received positive FDA feedback for a Phase 2 study design of SER-155 and is finalizing the clinical protocol [4] Presentation Details - The presentation will cover clinical and microbiology outcomes of BSIs in adults undergoing allo-HCT, including differences in bacterial and fungal organisms between SER-155 and placebo groups [2] - The session is scheduled for October 20, 2025, at 10:30-10:42 am EDT [2] Company Background - Seres Therapeutics focuses on live biotherapeutics to improve outcomes in medically vulnerable populations [6] - The company developed VOWST™, the first FDA-approved orally administered microbiome therapeutic, sold to Nestlé Health Science in September 2024 [6] - SER-155 has received Breakthrough Therapy and Fast Track designations for its potential in reducing infections and complications in allo-HSCT patients [6]