CAMBRIDGE, Mass., Oct. 14, 2025 (GLOBE NEWSWIRE) -- Seres Therapeutics, Inc. (Nasdaq: MCRB), (Seres or the Company), a leading live biotherapeutics company, today announced that new post hoc data from its SER-155 Phase 1b trial will be featured in an oral presentation at IDWeek 2025, taking place October 19–22 in Atlanta, Georgia. Presentation DetailsAbstract ID: 2106936Title: Clinical and Microbiology Outcomes of Bloodstream Infections (BSI) in Adults Undergoing Allogeneic Hematopoietic Stem Cell Transplan ...

Group 1 - Seres Therapeutics plans to reduce operating costs and cut its workforce by approximately 25% [1] - These measures, along with current operating plans, are expected to extend the company's cash runway into the second quarter of 2026 [1]

Core Insights - Seres Therapeutics is advancing its SER-155 Phase 2 study protocol for preventing bloodstream infections in adults undergoing allogeneic hematopoietic stem cell transplant, following positive feedback from the FDA [1][2][4] - The company is actively seeking capital to support the Phase 2 study and has implemented cost-reduction measures, including a 25% workforce reduction, to extend its cash runway into Q2 2026 [2][3][5] Company Developments - The SER-155 Phase 2 study is designed to be a placebo-controlled trial with approximately 248 participants, focusing on the prevention of bloodstream infections through 30 days post-transplant as the primary endpoint [4][7] - Interim clinical results are expected within 12 months of study initiation, which will facilitate timely engagement with the FDA regarding a potential Phase 3 study [4][7] - The company has received Breakthrough Therapy designation for SER-155, which has shown a 77% relative risk reduction in bloodstream infections in a prior Phase 1b study [7][8] Financial and Operational Strategy - The workforce reduction is expected to incur cash payments of approximately $1.0 to $1.4 million, primarily for severance costs, to be paid in Q4 2025 [5] - Cost-saving initiatives are anticipated to provide the company with additional opportunities to advance its strategic priorities and support its broader portfolio of product candidates [3][4]

Core Viewpoint - Seres Therapeutics (MCRB) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][4]. Earnings Estimates and Ratings - The Zacks rating system is based solely on a company's changing earnings picture, tracking the Zacks Consensus Estimate for EPS from sell-side analysts [2]. - The Zacks rating upgrade reflects an improvement in Seres Therapeutics' earnings outlook, which is expected to positively impact its stock price [4][6]. Impact of Earnings Estimate Revisions - Changes in a company's future earnings potential, as shown by earnings estimate revisions, are strongly correlated with near-term stock price movements [5]. - Institutional investors often adjust their valuations based on earnings estimates, leading to significant stock price movements [5]. Performance of Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a strong historical performance, particularly for Zacks Rank 1 stocks, which have averaged a +25% annual return since 1988 [8]. - The upgrade of Seres Therapeutics to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating a strong potential for market-beating returns in the near term [10][11]. Recent Earnings Estimate Trends - For the fiscal year ending December 2025, Seres Therapeutics is expected to earn -$0.99 per share, unchanged from the previous year, but the Zacks Consensus Estimate has increased by 40.8% over the past three months [9].

Core Insights - Seres Therapeutics, Inc. is a clinical-stage company focused on live biotherapeutics aimed at improving patient outcomes in medically vulnerable populations [2] - The company will present an overview at the H.C. Wainwright Global Investment Conference on September 8, 2025 [1] Company Overview - Seres Therapeutics is known for developing VOWST™, the first FDA-approved orally administered microbiome therapeutic, which was sold to Nestlé Health Science in September 2024 [2] - The company is currently 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 [2] - SER-155 has shown a significant reduction in bloodstream infections and related complications compared to placebo in a Phase 1b clinical study [2] Pipeline and Future Plans - The company’s pipeline includes SER-155 and other cultivated live biotherapeutic candidates targeting various disease-relevant pathways [2] - In addition to allo-HSCT, SER-155 and other candidates will be evaluated in other medically vulnerable 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 and long-term acute care facilities [2]

PART I – FINANCIAL INFORMATION [Item 1. Condensed Consolidated Financial Statements (unaudited)](index=6&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20%28unaudited%29) This section presents the unaudited condensed consolidated financial statements, including balance sheets, statements of operations, and cash flows, detailing the company's financial position, operational results, and the impact of the VOWST business sale and reverse stock split Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $45,379 | $30,793 | | Total current assets | $48,685 | $38,674 | | Total assets | $143,800 | $139,810 | | Total current liabilities | $30,940 | $41,222 | | Total liabilities | $110,850 | $126,026 | | Total stockholders' equity | $32,950 | $13,784 | Condensed Consolidated Statements of Operations Highlights (in thousands) | Account | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development expenses | $12,939 | $15,806 | $24,760 | $35,300 | | General and administrative expenses | $10,253 | $13,065 | $22,141 | $28,009 | | Loss from operations | ($24,881) | ($28,871) | ($52,117) | ($63,309) | | Gain on sale of VOWST Business | $185 | $— | $52,366 | $— | | Net income (loss) from continuing operations | ($19,855) | ($26,196) | $12,827 | ($59,099) | Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash provided by (used in) operating activities | $13,621 | ($75,047) | | Net cash (used in) provided by investing activities | ($215) | $1,240 | | Net cash provided by financing activities | $1,180 | $18,762 | - The company has identified conditions that raise substantial doubt about its ability to continue as a going concern, as it will require additional funding to support ongoing operations and meet obligations[17](index=17&type=chunk)[48](index=48&type=chunk)[51](index=51&type=chunk) - As of June 30, 2025, the company had an accumulated deficit of **$965.3 million** and cash and cash equivalents of **$45.4 million**[17](index=17&type=chunk)[48](index=48&type=chunk)[51](index=51&type=chunk) - On September 30, 2024, the company completed the sale of its VOWST business to Société des Produits Nestlé S.A. (SPN)[35](index=35&type=chunk)[55](index=55&type=chunk)[65](index=65&type=chunk) - The VOWST transaction is classified as a discontinued operation, and its historical results are reported separately[35](index=35&type=chunk)[55](index=55&type=chunk)[65](index=65&type=chunk) - On April 21, 2025, the company effected a **1-for-20 reverse stock split** of its common stock, with all share and per-share amounts retroactively adjusted in the financial statements[57](index=57&type=chunk)[79](index=79&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=32&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's strategic shift post-VOWST sale, focusing on SER-155 development, while addressing financial condition, including going concern doubts and operational results driven by cost controls and the VOWST sale gain [Overview and Strategy](index=32&type=section&id=Overview%20and%20Strategy) Following the VOWST sale, the company is now a clinical-stage entity focused on advancing SER-155, which has shown positive Phase 1b results and received FDA Breakthrough Therapy designation, but requires additional capital for further development - The company's lead candidate is **SER-155**, an investigational oral live biotherapeutic designed to prevent bacterial bloodstream infections (BSIs) in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT)[111](index=111&type=chunk)[140](index=140&type=chunk) - In a Phase 1b study, SER-155 demonstrated a **77% relative risk reduction** in bacterial BSIs compared to placebo and was granted **Breakthrough Therapy designation** by the FDA in December 2024[112](index=112&type=chunk)[141](index=141&type=chunk)[147](index=147&type=chunk) - The company requires **additional capital** to begin the planned SER-155 Phase 2 study and is in active discussions with multiple parties for partnerships, out-licensing, mergers, or other transactions to secure resources[113](index=113&type=chunk)[114](index=114&type=chunk)[152](index=152&type=chunk) - On September 30, 2024, the company completed the **VOWST business sale** to Société des Produits Nestlé S.A. (SPN), a subsidiary of Nestlé[126](index=126&type=chunk)[127](index=127&type=chunk) [Results of Operations](index=50&type=section&id=Results%20of%20Operations) Operating expenses decreased due to lower R&D and G&A costs, while net income for the first half of 2025 was driven by a significant gain from the VOWST business sale and increased other income from Nestlé reimbursements Comparison of Operating Results (in thousands) | Period | Metric | Q2 2025 | Q2 2024 | Change | H1 2025 | H1 2024 | Change | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | **Operating Expenses** | | | | | | | | | | Research & Development | $12,939 | $15,806 | ($2,867) | $24,760 | $35,300 | ($10,540) | | | General & Administrative | $10,253 | $13,065 | ($2,812) | $22,141 | $28,009 | ($5,868) | | | Manufacturing Services | $1,689 | $— | $1,689 | $5,216 | $— | $5,216 | | **Other Income** | | | | | | | | | | Gain on sale of VOWST Business | $185 | $— | $185 | $52,366 | $— | $52,366 | | | Other income, net | $5,026 | $2,675 | $2,351 | $64,944 | $4,210 | $60,734 | | **Net Income (Loss)** | **from continuing operations** | **($19,855)** | **($26,196)** | **$6,341** | **$12,827** | **($59,099)** | **$71,926** | - The **decrease in R&D expenses** was primarily due to lower clinical trial costs as the SER-155 Phase 1b study has largely been completed, and reduced personnel-related costs from lower headcount[185](index=185&type=chunk)[189](index=189&type=chunk)[197](index=197&type=chunk) - The **decrease in G&A expenses** was mainly due to lower personnel-related costs (salaries, benefits, stock-based compensation) and facility costs following the reduction in headcount[184](index=184&type=chunk)[190](index=190&type=chunk)[198](index=198&type=chunk) - The **increase in Other Income** was primarily driven by a **$50.0 million** installment payment from Nestlé related to the VOWST sale and **$9.8 million** in reimbursement income for services performed under the TSA[187](index=187&type=chunk)[193](index=193&type=chunk) [Liquidity and Capital Resources](index=53&type=section&id=Liquidity%20and%20Capital%20Resources) The company held **$45.4 million** in cash as of June 30, 2025, but faces substantial doubt about its going concern ability, requiring additional funding beyond Q1 2026 despite cash inflows from the VOWST sale and ATM equity offerings - The company had cash and cash equivalents of **$45.4 million** as of June 30, 2025[124](index=124&type=chunk)[203](index=203&type=chunk) - Management has concluded that **substantial doubt** exists about the company's ability to continue as a going concern, as it anticipates requiring additional funding in the **first quarter of 2026**[124](index=124&type=chunk)[204](index=204&type=chunk)[218](index=218&type=chunk) - During the six months ended June 30, 2025, net cash provided by operating activities was **$13.6 million**, a significant improvement from the **$75.0 million** used in the same period of 2024, primarily due to proceeds from the VOWST sale[207](index=207&type=chunk)[208](index=208&type=chunk) - The company raised approximately **$1.0 million** in net proceeds from its "at the market" (ATM) equity offering program during the first six months of 2025[202](index=202&type=chunk)[211](index=211&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=59&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company reports no material changes to its market risk disclosures since the last Annual Report, with primary risks stemming from changes in interest rates and inflation - There have been **no material changes** to the company's market risk disclosures since the year ended December 31, 2024[220](index=220&type=chunk) - The company is exposed to market risk from changes in **interest rates and inflation**[220](index=220&type=chunk) [Item 4. Controls and Procedures](index=59&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that as of June 30, 2025, the company's disclosure controls and procedures were effective, with no material changes to internal control over financial reporting during the quarter - Management concluded that as of June 30, 2025, the company's disclosure controls and procedures were **effective** at the reasonable assurance level[222](index=222&type=chunk) - **No change** in internal control over financial reporting occurred during the three months ended June 30, 2025, that has materially affected, or is reasonably likely to materially affect, internal controls[223](index=223&type=chunk) PART II – OTHER INFORMATION [Item 1. Legal Proceedings](index=60&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no legal proceedings during the period - None[225](index=225&type=chunk) [Item 1A. Risk Factors](index=60&type=section&id=Item%201A.%20Risk%20Factors) This section details significant risks, including the need for additional funding and going concern doubts, uncertainties in clinical development, reliance on third parties, intense competition, intellectual property challenges, and post-VOWST sale operational risks - The company will need **additional funding** to advance its product candidates and has identified conditions that raise **substantial doubt** about its ability to continue as a going concern, anticipating it will require funding in **Q1 2026**[228](index=228&type=chunk)[231](index=231&type=chunk)[234](index=234&type=chunk) - The company is a clinical-stage entity with a history of **significant losses** (**$965.3 million accumulated deficit** as of June 30, 2025) and may never achieve or maintain profitability[235](index=235&type=chunk) - The company's product candidates are based on **live biotherapeutics**, a novel approach with **significant development, regulatory, and manufacturing risks**[251](index=251&type=chunk)[253](index=253&type=chunk)[256](index=256&type=chunk) - The company **relies on third parties** for conducting clinical trials and manufacturing, which increases risks related to **performance, compliance, and supply chain disruptions**[296](index=296&type=chunk)[300](index=300&type=chunk) - The company faces **substantial competition** from major pharmaceutical and biotechnology companies with greater resources, and its products may **fail to gain market acceptance or secure adequate reimbursement**[307](index=307&type=chunk)[313](index=313&type=chunk)[319](index=319&type=chunk) - The company's success is highly dependent on its ability to obtain and defend its **intellectual property**, facing risks of **patent challenges, infringement claims** from third parties (such as an ongoing lawsuit from Vedanta Biosciences), and **changes in patent law**[363](index=363&type=chunk)[383](index=383&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=120&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities or use of proceeds for the period - None[467](index=467&type=chunk) [Item 5. Other Information](index=122&type=section&id=Item%205.%20Other%20Information) This section discloses changes to the Board of Directors, including the resignation of Paul R. Biondi and the appointment of Robert L. Rosiello, and confirms no Rule 10b5-1 trading arrangement changes - Paul R. Biondi **resigned** from the Board of Directors, effective August 5, 2025[470](index=470&type=chunk) - Robert L. Rosiello was **appointed** to the Board as a Class III director and to the Compensation and Talent Committee, effective August 5, 2025[471](index=471&type=chunk) - **No director or officer** of the Company adopted or terminated a **Rule 10b5-1 trading arrangement** during the three months ended June 30, 2025[475](index=475&type=chunk) [Item 6. Exhibits](index=123&type=section&id=Item%206.%20Exhibits) This item lists all exhibits filed with the Quarterly Report on Form 10-Q, including executive letter agreements and required Sarbanes-Oxley Act certifications - The report includes a list of exhibits, such as the company's certificate of incorporation, bylaws, and various certifications[477](index=477&type=chunk) - Filed **new letter agreements** with Eric Shaff, Marella Thorell, and Thomas DesRosier, dated July 21, 2025[477](index=477&type=chunk)

Financial Data and Key Metrics Changes - The company reported a net loss from continuing operations of $19.9 million in Q2 2025, compared to a net loss of $26.2 million in Q2 2024, indicating an improvement in financial performance [17] - Research and development expenses decreased to $12.9 million from $15.8 million in the previous year, reflecting lower costs associated with the SER-155 Phase Ib study and reduced personnel expenses [17] - General and administrative expenses were $10.3 million in Q2 2025, down from $13.1 million in Q2 2024, primarily due to lower personnel and IT-related expenses [18] - As of June 30, 2025, the company had cash and cash equivalents of $45.4 million, and with the recent $25 million payment received, it expects to fund operations into 2026 [18] Business Line Data and Key Metrics Changes - The SER-155 Phase Ib study demonstrated a 77% relative risk reduction in bloodstream infections compared to placebo in patients undergoing allogeneic hematopoietic stem cell transplant, with a number needed to treat of three [6][9] - The company is preparing for a Phase II study with an enrollment goal of approximately 248 participants, focusing on the prevention of bloodstream infections [8] Market Data and Key Metrics Changes - The company has received positive feedback from European physicians regarding SER-155, indicating plans to include the EU in the Phase II study [22][29] - Engagement with EU key opinion leaders (KOLs) confirmed that bloodstream infections in the alloHSCT population remain a significant unmet need [30] Company Strategy and Development Direction - The immediate corporate priority is to secure capital to advance SER-155 and other promising development candidates, exploring various transaction structures including partnerships and mergers [10][11] - The company is actively discussing potential deals with multiple parties to secure necessary resources for clinical milestones [11][28] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of SER-155 to provide transformative clinical benefits for patients with serious infections and inflammatory diseases [5] - The company is mindful of the challenging biotech environment but remains focused on advancing its development programs and securing capital [10] Other Important Information - The company acknowledged the contributions of Eric Schaff, who played a significant role in the maturation of the biotherapeutic field, and welcomed Rob Rossello to the Board [19] Q&A Session Summary Question: How will the company decide the best structure for potential deals? - The company is exploring various deal structures that provide capital to advance SER-155 and leverage expertise in conducting global studies [24][28] Question: Are there plans to include the EU in the Phase II study? - Yes, the Phase II study will be a global study including European countries, and the design is robust and well-powered [29]

Seres Therapeutics Overview - Seres' VOWST, the first-ever oral live microbiome therapeutic, received FDA approval in April 2023 for preventing C difficile infection recurrence, demonstrating approximately 88% sustained clinical response rate[6,9] - The sale of the VOWST asset, completed in September 2024, provided Seres with capital to support pipeline advancement and streamline the organization[9,10] - As of June 30, 2025, Seres had approximately $45.4 million in cash and cash equivalents, projecting a cash runway into Q1 2026[92] SER-155 Clinical Development - SER-155 Phase 1b data in allo-HSCT showed a 77% relative risk reduction in bacterial bloodstream infections (BSIs) compared to placebo[6,45,92] - SER-155 Phase 1b data also showed significantly lower mean cumulative exposure to systemic antibacterials/antimycotics compared to placebo (9.2 days vs 21.1 days)[45,50] - SER-155 Phase 1b data also showed a lower incidence rate of febrile neutropenia in SER-155-treated subjects vs placebo[46] - A Phase 2 study protocol for SER-155 in allo-HSCT was submitted to the FDA in May 2025, with study commencement dependent on funding and aiming to enroll 248 patients[6,31,78] Pipeline and Future Opportunities - Seres is developing SER-147 to prevent infections in chronic liver disease patients, with preclinical data showing a 1-3 log reduction of E coli in in vitro models[6,80] - Seres is also developing SER-603 to target inflammatory drivers of Inflammatory Bowel Disease (IBD)[83] - Seres is engaging with multiple parties regarding various deal structures to secure capital for the clinical advancement of SER-155 and other live biotherapeutic product candidates[6,78,92]

Core Insights - Seres Therapeutics, Inc. will host a conference call on August 6, 2025, at 8:30 a.m. ET to discuss its second quarter 2025 financial results and provide 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 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 population [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 - Seres Therapeutics has appointed Thomas DesRosier and Marella Thorell as co-CEOs, succeeding Eric Shaff who will remain a Director on the Board [1][3] - The company is actively engaging with multiple parties for potential business development and partnerships to secure additional capital for the advancement of SER-155 and other live biotherapeutic candidates [1][2] Leadership Transition - Eric Shaff is stepping down after a decade, during which he led significant advancements including the first FDA-approved oral microbiome therapy [3] - Thomas DesRosier and Marella Thorell bring extensive experience in biopharma, with DesRosier previously serving as Chief Legal Officer and Thorell as Chief Financial Officer [4][6] Product Development - SER-155 has received Breakthrough Therapy designation for reducing bloodstream infections in adults undergoing allo-HSCT, showing a 77% relative risk reduction in a Phase 1b study [2][7] - The company aims to leverage its live biotherapeutics platform to address various inflammatory and immune diseases, including ulcerative colitis and Crohn's disease [2][7] Strategic Focus - Seres is focused on advancing its pipeline, particularly SER-155, and is exploring various deal structures to enhance its capital resources [2][7] - The company intends to evaluate SER-155 in other medically vulnerable populations, including cancer patients and organ transplant recipients [7]