SER-155 Clinical Data and Development - SER-155 Phase 1b study showed a 77% relative risk reduction in bacterial bloodstream infections (BSIs) compared to placebo[6,44,83] - SER-155 treatment was associated with significantly lower mean cumulative exposure to systemic antibacterials/antimycotics compared to placebo[44,49] - The company plans to submit a Phase 2 protocol to the FDA in Q2 2025, incorporating FDA feedback[6,31,73,83] - The FDA granted SER-155 Breakthrough Therapy designation in December 2024[6,73,82] Financial Position and Strategy - The VOWST asset sale to Nestlé closed in September 2024, providing capital to support SER-155 advancement[6,9,10,12,83] - The VOWST asset sale included a $100 million upfront payment, less ~$20 million in net obligations, a $15 million equity investment, and a $60 million prepaid sales-based milestone at closing[10] - As of March 31, 2025, the company had approximately $588 million in cash/cash equivalents, projecting a cash runway into Q1 2026[83] - The company is pursuing a strategic partnership for SER-155 to accelerate the next study in allo-HSCT and expand to multiple target populations[6,73,83] Pipeline and Platform - VOWST was FDA approved in April 2023 to prevent the recurrence of C difficile infection in adults, demonstrating an approximately 88% sustained clinical response rate[6,9] - SER-155 is being developed initially in allo-HSCT, with potential to expand to autologous-HSCT, blood cancers, and CAR-T recipients[6,30] - SER-147 is designed to prevent infections in chronic liver disease, with IND-enabling activities underway[6,30,74,82]

Core Insights - Seres Therapeutics is presenting new exploratory biomarker data from its SER-155 Phase 1b study at the 2025 ASCO Annual Meeting, highlighting its potential role in promoting peripheral T-cell recovery and immune reconstitution post allo-HSCT [1][2] Group 1: SER-155 Study Findings - The SER-155 Phase 1b study showed improved intestinal epithelial barrier integrity and modulation of systemic inflammatory responses, with a 77% relative risk reduction in bloodstream infections (BSIs) [2][5] - New biomarker data indicates significantly higher levels of the homeostatic cytokine IL-7 and increased frequency of CD4+ T cells in the SER-155 treatment group compared to placebo, suggesting enhanced immune recovery [2][3] Group 2: Clinical Development Plans - The company plans to submit a Phase 2 trial protocol for SER-155 to the FDA soon and is seeking partners for continued clinical development [3] - SER-155 has received Breakthrough Therapy designation for reducing bloodstream infections and Fast Track designation for reducing infection risk and graft-versus-host disease in allo-HSCT patients [5][6] Group 3: About SER-155 - SER-155 is an investigational oral live biotherapeutic designed to decolonize gastrointestinal pathogens, improve epithelial barrier integrity, and induce immune homeostasis to prevent bacterial bloodstream infections in allo-HSCT patients [4][6] - The product has demonstrated a significant reduction in bloodstream infections and related complications in a Phase 1b clinical study [6]

Core Viewpoint - Seres Therapeutics (MCRB) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook based on rising earnings estimates, which significantly influence stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system emphasizes the importance of earnings estimate revisions, which are strongly correlated with near-term stock price movements [4][6]. - An increase in earnings estimates typically leads to higher fair value calculations by institutional investors, resulting in stock price movements [4]. Recent Performance of Seres Therapeutics - Seres Therapeutics is projected to earn -$1.67 per share for the fiscal year ending December 2025, reflecting a year-over-year change of 89.7% [8]. - Over the past three months, the Zacks Consensus Estimate for Seres Therapeutics has increased by 85%, indicating a positive trend in earnings expectations [8]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 (Strong Buy) stocks historically generating an average annual return of +25% since 1988 [7]. - The upgrade of Seres Therapeutics to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [10].

Core Viewpoint - Seres Therapeutics (MCRB) shows significant upside potential with a mean price target of $60.25, indicating a 713.1% increase from its current price of $7.41 [1] Price Targets and Analyst Consensus - The average price target for MCRB ranges from a low of $6 to a high of $200, with a standard deviation of $93.35, indicating high variability among analysts [2] - The lowest estimate suggests a 19% decline from the current price, while the highest estimate indicates a potential upside of 2599.1% [2] - A tight clustering of price targets, represented by a low standard deviation, suggests a high degree of agreement among analysts regarding the stock's price movement [9] Earnings Estimates and Analyst Optimism - Analysts have shown strong agreement in revising MCRB's earnings estimates higher, which correlates with potential stock price increases [11] - Over the last 30 days, the Zacks Consensus Estimate for the current year has increased by 80.3%, with three estimates moving higher and no negative revisions [12] - MCRB holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates [13]

PART I – FINANCIAL INFORMATION [Item 1. Condensed Consolidated Financial Statements (unaudited)](index=5&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) Presents Seres Therapeutics' unaudited condensed consolidated financial statements, including the VOWST business sale and going concern assessment [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Cash and cash equivalents increased to **$58.8 million** by March 31, 2025, improving total stockholders' equity to **$50.5 million** Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $58,849 | $30,793 | | Total current assets | $66,078 | $38,674 | | Total assets | $164,182 | $139,810 | | **Liabilities & Equity** | | | | Total current liabilities | $31,323 | $41,222 | | Total liabilities | $113,717 | $126,026 | | Total stockholders' equity | $50,465 | $13,784 | [Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Income%20(Loss)) Net income from continuing operations reached **$32.7 million** in Q1 2025, driven by a **$52.2 million** gain on VOWST sale Condensed Consolidated Statements of Operations Highlights (in thousands) | Account | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development expenses | $11,821 | $19,494 | | General and administrative expenses | $11,888 | $14,944 | | Total operating expenses | $27,236 | $34,438 | | Gain on sale of VOWST Business | $52,181 | $— | | Net income (loss) from continuing operations | $32,682 | $(32,903) | | Net income (loss) per share - basic | $3.76 | $(5.49) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash provided by operating activities was **$26.9 million** in Q1 2025, a significant improvement from **$35.2 million** cash used in Q1 2024 Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash provided by (used in) operating activities | $26,910 | $(35,236) | | Net cash used in investing activities | $(34) | $(62) | | Net cash provided by financing activities | $1,180 | $18,762 | | Net increase (decrease) in cash, cash equivalents, and restricted cash | $28,056 | $(16,536) | [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the VOWST business sale, a **$50 million** installment, a 1-for-20 reverse stock split, and going concern doubt - The company completed the sale of its **VOWST microbiome therapeutic business** to Nestlé on September 30, 2024, accounted for as a discontinued operation[35](index=35&type=chunk)[65](index=65&type=chunk) - The company received a **$50 million** cash installment on January 15, 2025, with a final **$25 million** due July 1, 2025, contingent on TSA compliance[35](index=35&type=chunk)[68](index=68&type=chunk) - Management concluded substantial doubt exists about the company's ability to continue as a **going concern**, requiring additional funding for ongoing operations[51](index=51&type=chunk)[52](index=52&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[57](index=57&type=chunk)[80](index=80&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the strategic shift to **SER-155** after the VOWST sale, analyzing Q1 2025 financial results and liquidity, noting going concern doubt - Following the VOWST sale, the company focuses on developing **SER-155** to prevent bacterial bloodstream infections in allo-HSCT patients[110](index=110&type=chunk) - The FDA granted **Breakthrough Therapy designation** to **SER-155** in December 2024, providing feedback for a planned Phase 2 study[111](index=111&type=chunk)[146](index=146&type=chunk) - The company actively seeks a partner to provide financial resources and capabilities for the **SER-155** program[111](index=111&type=chunk)[113](index=113&type=chunk) - Management concluded substantial doubt exists about the company's ability to continue as a **going concern**, anticipating additional funding needed in Q1 2026[120](index=120&type=chunk)[193](index=193&type=chunk)[205](index=205&type=chunk) [Results of Operations](index=31&type=section&id=Results%20of%20Operations) Total operating expenses decreased by **$7.2 million** in Q1 2025, with significant other income from the VOWST sale gain Research and Development Expenses Breakdown (in thousands) | Category | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Live biotherapeutics platform | $5,123 | $9,164 | $(4,041) | | SER-155 | $577 | $2,400 | $(1,823) | | Personnel-related | $6,118 | $7,845 | $(1,727) | | **Total R&D Expenses** | **$11,821** | **$19,494** | **$(7,673)** | General and Administrative Expenses Breakdown (in thousands) | Category | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Personnel related | $4,173 | $6,641 | $(2,468) | | Professional fees | $3,180 | $2,628 | $552 | | Facility-related and other | $4,535 | $5,675 | $(1,140) | | **Total G&A Expenses** | **$11,888** | **$14,944** | **$(3,056)** | - Manufacturing services expenses of **$3.5 million** were recorded in Q1 2025 for services performed for Nestlé under the TSA for VOWST manufacturing[181](index=181&type=chunk) - Other income, net, increased to **$59.9 million** in Q1 2025, primarily due to the **$50.0 million** Nestlé installment and **$6.3 million** TSA reimbursement income[182](index=182&type=chunk) [Liquidity and Capital Resources](index=33&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2025, the company had **$58.8 million** in cash, but projects additional funding is needed by Q1 2026, raising going concern doubt - As of March 31, 2025, the company had cash and cash equivalents of **$58.8 million** and an accumulated deficit of **$945.4 million**[192](index=192&type=chunk) - The company received a **$50 million** installment in January 2025 and expects a final **$25 million** payment on July 1, 2025, from the VOWST sale, contingent on TSA compliance[187](index=187&type=chunk) - Based on current plans, the company anticipates requiring additional funding in Q1 2026, raising substantial doubt about its ability to continue as a **going concern**[193](index=193&type=chunk)[205](index=205&type=chunk) Cash Flow Summary (in thousands) | Period | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Cash provided by (used in) operating activities | $26,910 | $(35,236) | | Cash provided by financing activities | $1,180 | $18,762 | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=37&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) No material changes to market risk disclosures regarding interest rates and inflation since the December 31, 2024 Annual Report - No material changes occurred in the company's market risk exposures for interest rates and inflation during Q1 2025[207](index=207&type=chunk) [Item 4. Controls and Procedures](index=37&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of March 31, 2025, with no material changes in internal control - The principal executive and financial officers concluded the company's disclosure controls and procedures were effective as of March 31, 2025[209](index=209&type=chunk) - No material changes occurred in the company's internal control over financial reporting during Q1 2025[210](index=210&type=chunk) PART II – OTHER INFORMATION [Item 1. Legal Proceedings](index=38&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no material legal proceedings during the period - The company reports no legal proceedings to disclose for the period[212](index=212&type=chunk) [Item 1A. Risk Factors](index=38&type=section&id=Item%201A.%20Risk%20Factors) Outlines significant risks, including urgent funding needs, substantial doubt about going concern, and challenges in clinical development and IP [Risks Related to Financial Position and Capital Needs](index=38&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Need%20for%20Additional%20Capital) The company faces critical financial risks, requiring additional funding by Q1 2026, raising substantial doubt about going concern - The company will need additional funding to advance product candidates, including the planned **SER-155** Phase 2 study, or risk program delays[215](index=215&type=chunk) - Conditions raise substantial doubt about the company's ability to continue as a **going concern**, with funding required in Q1 2026[221](index=221&type=chunk) - The company incurred significant losses since inception, with a net loss of **$125.8 million** in FY2024 and an accumulated deficit of **$945.4 million** as of March 31, 2025[224](index=224&type=chunk) - Future installment and milestone payments from the **VOWST** sale are subject to risks, including TSA compliance and sales targets, and may not be fully realized[230](index=230&type=chunk)[231](index=231&type=chunk) [Risks Related to Discovery, Development, and Regulatory Approval](index=41&type=section&id=Risks%20Related%20to%20the%20Discovery%2C%20Development%20and%20Regulatory%20Approval%20of%20Our%20Product%20Candidates) Product candidates based on novel live biotherapeutics face lengthy, expensive, and uncertain clinical development and regulatory approval processes - The company's product candidates, based on novel **live biotherapeutics**, may face longer FDA review processes due to lack of evaluation experience[242](index=242&type=chunk) - Clinical drug development is a risky, lengthy, and expensive process with uncertain outcomes, where early positive results do not guarantee later-stage success[243](index=243&type=chunk) - The **Breakthrough Therapy designation** for **SER-155** does not guarantee faster development, review, or increased likelihood of approval[270](index=270&type=chunk)[271](index=271&type=chunk) - Disruptions at the FDA and other government agencies, such as funding shortages or health crises, could hinder timely product review and approval[280](index=280&type=chunk) [Risks Related to Dependence on Third Parties and Manufacturing](index=51&type=section&id=Risks%20Related%20to%20our%20Dependence%20on%20Third%20Parties%20and%20Manufacturing) Seres relies heavily on third parties for clinical trials and manufacturing, introducing risks of non-performance, delays, and limited commercial-scale experience - The company relies on third parties like CROs to conduct clinical trials, and their unsatisfactory performance could delay or jeopardize development programs[283](index=283&type=chunk)[285](index=285&type=chunk) - Reliance on third-party manufacturers increases risks of insufficient quantities, unacceptable costs, or quality issues, impairing development and commercialization[287](index=287&type=chunk) - The company has limited experience in commercial-scale manufacturing and cannot guarantee regulatory compliance or viable cost[291](index=291&type=chunk) [Risks Related to Intellectual Property](index=60&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) Success depends on obtaining and maintaining patent protection and trade secrets, facing risks of uncertain patentability, challenges, and infringement - The company's ability to protect proprietary technology through patents is uncertain, and issued patents may not prevent competitors from designing around them[343](index=343&type=chunk)[347](index=347&type=chunk) - Changes in U.S. patent law and Supreme Court rulings on patent eligibility for natural products increase uncertainty and could diminish patent value[357](index=357&type=chunk)[360](index=360&type=chunk) - The company faces risk of third-party legal proceedings alleging intellectual property infringement, which could be costly and materially adverse to the business[364](index=364&type=chunk) - Protecting trade secrets and know-how is critical, but confidentiality agreements may be breached, and misappropriation claims are difficult to enforce[355](index=355&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=76&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities during the period - None reported[444](index=444&type=chunk) [Item 3. Defaults Upon Senior Securities](index=76&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - None reported[445](index=445&type=chunk) [Item 4. Mine Safety Disclosures](index=77&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - None reported[446](index=446&type=chunk) [Item 5. Other Information](index=77&type=section&id=Item%205.%20Other%20Information) The company reports no other material information required to be disclosed - None reported[447](index=447&type=chunk) [Item 6. Exhibits](index=77&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the quarterly report, including corporate documents and officer certifications - Key exhibits filed include the **2025 Incentive Award Plan** and certifications by the CEO and CFO[449](index=449&type=chunk)

Financial Data and Key Metrics Changes - Seres Therapeutics reported a net income from continuing operations of $32.7 million in Q1 2025, compared to a net loss of $32.9 million in Q1 2024, primarily driven by a $50 million installment payment received from Nestle [14] - Research and development expenses decreased to $11.8 million from $19.5 million in Q1 2024, reflecting lower personnel expenses and reduced costs related to the SER-155 Phase Ib study [15] - General and administrative expenses were $11.9 million in Q1 2025, down from $14.9 million in Q1 2024, mainly due to lower personnel and contractor expenses [15] - As of March 31, 2025, the company had cash and cash equivalents of $58.8 million, with an expected second installment payment of approximately $23.5 million from Nestle in July 2025 [15][16] Business Line Data and Key Metrics Changes - The company is advancing SER-155 into the next stage of development in allo HSCT, with a Phase 1b study showing a 77% relative risk reduction in bloodstream infections compared to placebo [6][7] - SER-155 is positioned to redefine the standard of care for allo HSCT recipients and other vulnerable patient groups at risk of bloodstream infections, indicating significant commercial opportunities [7][12] Market Data and Key Metrics Changes - Feedback from healthcare providers at the European Society for Blood and Marrow Transplantation Conference highlighted the ongoing clinical challenge of preventing bloodstream infections, with enthusiasm for SER-155's safety and efficacy results [8] - The company received external validation for SER-155, as its poster won the best clinical poster award at the conference, reinforcing the patient need and scientific rigor [9] Company Strategy and Development Direction - The company aims to submit a Phase II study protocol to the FDA in the coming weeks, incorporating constructive feedback received from the agency [10][18] - Seres Therapeutics is exploring partnerships to secure financial support for advancing SER-155, recognizing the challenging biotech financing environment [12][16] - The strategic focus includes not only allo HSCT but also addressing gut-related inflammatory and immune diseases such as IBD, indicating a broader therapeutic potential for live biotherapeutics [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress made with SER-155, citing encouraging clinical data and constructive regulatory feedback [18] - The company is prioritizing activities that advance clinical and strategic goals while exploring additional capital sources to support the Phase II study [16] Other Important Information - A one-for-20 reverse stock split was executed on April 21, 2025, with trading on a split-adjusted basis commencing on April 22, 2025, leading to regained compliance with NASDAQ listing requirements [16] Q&A Session Summary Question: Are partnership discussions gated by progress around SER-155? - Management indicated that securing a partnership is a key long lead time item for moving forward with the study, while they are advancing other necessary preparations [23][24] Question: Can you outline the powering assumptions for the Phase II study? - Management stated that the Phase II study is designed to allow data to be used for both efficacy and safety components for submission to the FDA, with an interim analysis planned [25][26][28] Question: Any updates on FDA interactions and partnership discussions? - Management reported constructive and regular interactions with the FDA, which have been helpful in moving forward, and they are making progress in partnership discussions [33][36][38] Question: Will the Phase II study include overall survival as an endpoint? - The primary endpoint for the Phase II study is bloodstream infection reductions, with discussions ongoing regarding potential efficacy measures for a Phase III study [46][49]

Financial Data and Key Metrics Changes - The company reported a net income from continuing operations of $32.7 million in Q1 2025, compared to a net loss of $32.9 million in Q1 2024, primarily driven by a $50 million installment payment received from Nestle [15][16] - Research and development expenses decreased to $11.8 million from $19.5 million in the same quarter last year, reflecting lower personnel expenses and reduced costs related to the SER-155 Phase Ib study [16] - General and administrative expenses were $11.9 million, down from $14.9 million in Q1 2024, primarily due to lower personnel and contractor expenses [16] - As of March 31, 2025, the company had cash and cash equivalents of $58.8 million, with an expected second installment payment of approximately $23.5 million from Nestle in July 2025 [16][17] Business Line Data and Key Metrics Changes - SER-155 remains the top corporate priority, with significant progress towards initiating the next clinical study, following a Phase 1b study that showed a 77% relative risk reduction in bloodstream infections compared to placebo [5][6] - The Phase 1b study also demonstrated a favorable safety profile consistent with historical data across the live biotherapeutic product platform [6] Market Data and Key Metrics Changes - The company received positive feedback from the transplant community at the European Society for Blood and Marrow Transplantation Conference, emphasizing the need for new approaches to prevent bloodstream infections [7][8] - The SER-155 poster received the best clinical poster award, validating the patient need and the scientific rigor of the study [9] Company Strategy and Development Direction - The company aims to develop SER-155 and other live biotherapeutics to prevent infections in various patient groups, including allo HSCT, autologous HSCT, cancer patients with neutropenia, and solid organ transplant recipients [12] - The strategic focus includes addressing gut-related inflammatory and immune diseases such as IBD, with an emphasis on the compromised gut epithelial barrier as a core component of underlying pathology [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the constructive interactions with the FDA, which have been regular and supportive, particularly due to the breakthrough therapy designation for SER-155 [36] - The company is actively exploring partnerships to secure financial support and maximize the clinical and commercial value of SER-155, given the challenging biotech financing environment [12][17] Other Important Information - A one-for-20 reverse stock split was executed, and the company regained compliance with NASDAQ's bid price requirement [17] - The company is prioritizing activities that advance clinical and strategic goals while preserving cash [17] Q&A Session Summary Question: Are partnership discussions gated by progress around SER-155? - Management indicated that securing a partnership is a key long lead time item for moving forward with the study, while they are advancing other necessary preparations [24][25] Question: Can you outline the proposed powering assumptions for the Phase II study? - Management stated that the powering included in the design will allow data from this study to be used for both efficacy and safety components for FDA submission [27][28] Question: Have there been any large staffing changes at the FDA? - Management noted that their interactions with the FDA have been constructive and regular, and they are pleased with the feedback received [36] Question: Will the Phase II study be designed to evaluate overall survival? - The primary endpoint for the Phase II study is bloodstream infection reductions, with discussions ongoing regarding potential efficacy measures for Phase III [50][52]

[Business Updates and Strategy](index=1&type=section&id=Business%20Updates%20and%20Strategy) Seres Therapeutics prioritizes SER-155 development, seeks partnerships, explores biotherapeutics for inflammatory diseases, and regained Nasdaq compliance [SER-155 Program for Bloodstream Infection Prevention](index=1&type=section&id=SER-155%20Program%20for%20Bloodstream%20Infection%20Prevention) Seres prioritizes SER-155 for bloodstream infection prevention, preparing a Phase 2 study protocol after FDA feedback, and actively seeking a partner - Seres plans to submit a Phase 2 study protocol for SER-155 to the FDA in the coming weeks, following recent constructive feedback[1](index=1&type=chunk)[3](index=3&type=chunk) - The planned Phase 2 study will be placebo-controlled, target **248 participants**, and include an interim data analysis. A successful outcome could support advancing to a single Phase 3 study for registration[3](index=3&type=chunk)[7](index=7&type=chunk) - Clinical results from the Phase 1b study showed a significant **77% relative risk reduction** in bloodstream infections (BSIs)[1](index=1&type=chunk)[17](index=17&type=chunk) - Seres is actively engaged in discussions to find a strategic partner to provide financial and other support for SER-155's development and commercialization[3](index=3&type=chunk)[4](index=4&type=chunk) [Development of Biotherapeutics for Inflammatory and Immune Diseases](index=2&type=section&id=Development%20of%20Biotherapeutics%20for%20Inflammatory%20and%20Immune%20Diseases) Seres explores biotherapeutics for inflammatory and immune diseases, leveraging SER-155 biomarker data for intestinal barrier and inflammation - Exploratory biomarker data from the SER-155 study reinforce its intended mechanisms, including promoting intestinal epithelial barrier integrity and reducing systemic inflammation, supporting potential use in inflammatory and immune diseases[6](index=6&type=chunk)[8](index=8&type=chunk) - Seres presented data at the DDW conference identifying microbiome-based biomarkers for patient selection in clinical trials for ulcerative colitis, receiving a **"Poster of Distinction" award**[12](index=12&type=chunk) - The company is exploring options to advance its investigational live biotherapeutics in inflammatory and immune diseases, including ulcerative colitis and Crohn's disease[12](index=12&type=chunk) [Recent Corporate Update](index=3&type=section&id=Recent%20Corporate%20Update) Seres completed a 1-for-20 reverse stock split in April 2025 and regained Nasdaq listing compliance in May 2025 - On April 21, 2025, Seres implemented a **1-for-20 reverse stock split**[9](index=9&type=chunk) - On May 6, 2025, Nasdaq confirmed that the company regained compliance with the Nasdaq Bid Price Requirement[9](index=9&type=chunk) [Anticipated Upcoming Milestones](index=3&type=section&id=Anticipated%20Upcoming%20Milestones) Seres anticipates key milestones including SER-155 Phase 2 protocol submission, ASCO 2025 results, a Nestlé payment, and partnership updates - Submit SER-155 Phase 2 study protocol to the FDA in the coming weeks[12](index=12&type=chunk) - Present additional SER-155 clinical results at the ASCO 2025 conference (May 30 - June 3, 2025)[12](index=12&type=chunk) - Expect receipt of a **$25 million installment payment** from Nestlé in July 2025[12](index=12&type=chunk) - Provide updates regarding SER-155 partnership discussions[12](index=12&type=chunk) [Q1 2025 Financial Results](index=3&type=section&id=Q1%202025%20Financial%20Results) Seres reported Q1 2025 net income of **$32.7 million** from continuing operations, driven by a Nestlé payment and reduced operating expenses [Financial Performance Summary](index=3&type=section&id=Financial%20Performance%20Summary) Seres reported Q1 2025 net income of **$32.7 million** from continuing operations, driven by a **$52.2 million** gain on VOWST sale and reduced operating expenses Q1 2025 vs Q1 2024 Financial Highlights (Continuing Operations) | Financial Metric | Q1 2025 (in millions) | Q1 2024 (in millions) | Change | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | **Net Income (Loss)** | $32.7 | $(32.9) | +$65.6 | Primarily driven by $50M installment payment from Nestlé | | **R&D Expenses** | $11.8 | $19.5 | -$7.7 | Lower personnel expenses and platform investments | | **G&A Expenses** | $11.9 | $14.9 | -$3.0 | Lower personnel/contractor expenses and cost management | | **Basic EPS** | $3.76 | $(4.50) | +$8.26 | Reflects net income and share count changes | - The VOWST business has been classified under discontinued operations, with no ongoing activity in the current period[11](index=11&type=chunk) [Cash Position and Runway](index=4&type=section&id=Cash%20Position%20and%20Runway) Seres held **$58.8 million** in cash as of March 31, 2025, expecting to fund operations into Q1 2026 with an additional **$25 million** Nestlé payment - Cash and cash equivalents were **$58.8 million** as of March 31, 2025[13](index=13&type=chunk) - Current cash and the anticipated **$25 million Nestlé payment** are expected to fund operations into Q1 2026[13](index=13&type=chunk) [Financial Statements](index=7&type=section&id=Financial%20Statements) Condensed consolidated financial statements detail Seres' Q1 2025 financial position, showing **$164.2 million** total assets and a shift to net income from continuing operations [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, Seres' balance sheet shows total assets of **$164.2 million**, total liabilities of **$113.7 million**, and stockholders' equity of **$50.5 million** Balance Sheet Summary (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Cash and cash equivalents** | $58,849 | $30,793 | | **Total current assets** | $66,078 | $38,674 | | **Total assets** | $164,182 | $139,810 | | **Total current liabilities** | $31,323 | $41,222 | | **Total liabilities** | $113,717 | $126,026 | | **Total stockholders' equity** | $50,465 | $13,784 | [Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Income%20(Loss)) Seres reported Q1 2025 net income from continuing operations of **$32.7 million**, driven by a **$52.2 million** gain on VOWST sale, contrasting with a prior year loss Statement of Operations Summary (in thousands) | Account | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Total operating expenses | $27,236 | $34,438 | | Loss from operations | $(27,236) | $(34,438) | | Gain on sale of VOWST Business | $52,181 | $— | | **Net income (loss) from continuing operations** | **$32,682** | **$(32,903)** | | Net (loss) from discontinued operations | $— | $(7,230) | | **Net income (loss)** | **$32,682** | **$(40,133)** |

Core Insights - Seres Therapeutics is preparing to submit a Phase 2 study protocol for SER-155 to the FDA, targeting bloodstream infections in adults undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT) [1][4][10] - The Phase 1b study of SER-155 demonstrated a significant 77% relative risk reduction in bloodstream infections, reinforcing its potential in treating inflammatory and immune diseases [1][15] - The company is actively seeking strategic partnerships to support the development of SER-155 and expand its application to other vulnerable patient populations [3][4] Financial Performance - For Q1 2025, Seres reported a net income of $32.7 million, a significant improvement from a net loss of $32.9 million in Q1 2024, primarily due to a $50 million installment payment from Nestlé [16][25] - Research and development expenses decreased to $11.8 million in Q1 2025 from $19.5 million in Q1 2024, reflecting cost management efforts [16][25] - General and administrative expenses also declined to $11.9 million in Q1 2025 from $14.9 million in Q1 2024 [16][25] Development Updates - The upcoming Phase 2 study is expected to enroll 248 participants and will include an adaptive design with an interim analysis planned after half of the participants reach the primary endpoint [4][5] - SER-155 has received Breakthrough Therapy and Fast Track designations from the FDA, highlighting its potential to address significant unmet medical needs in the allo-HSCT patient population [15][17] - The company is exploring the use of SER-155 in additional patient populations, including those undergoing autologous-HSCT, cancer patients with neutropenia, and solid organ transplant recipients [3][17] Recent Corporate Actions - On April 21, 2025, Seres executed a 1-for-20 reverse stock split, which commenced trading on a split-adjusted basis on April 22, 2025 [7][16] - As of March 31, 2025, Seres had $58.8 million in cash and cash equivalents, which is expected to fund operations into Q1 2026 [12][16] Upcoming Milestones - The company plans to present additional SER-155 clinical results at the American Society of Clinical Oncology (ASCO) 2025 conference from May 30 to June 3, 2025 [10] - Seres anticipates receiving a $25 million installment payment from Nestlé in July 2025 [10]

Core Insights - Seres Therapeutics, Inc. will present three related posters at the 2025 Digestive Disease Week (DDW) Conference, highlighting advancements in live biotherapeutics for inflammatory and immune diseases [1][2] Company Developments - The company previously reported exploratory translational biomarker data from its SER-155 Phase 1b study, indicating its potential to enhance intestinal epithelial barrier integrity and modulate systemic inflammatory responses [2] - Seres is actively seeking partnership opportunities to further develop its biotherapeutics targeting inflammatory and immune diseases [3] Presentation Details - The first presentation will focus on the characterization of IBD microbiomes to evaluate candidate biomarkers for patient selection, scheduled for May 3, 2025 [4] - The second presentation will discuss candidate biomarkers of microbiome disruption for patient selection in clinical trials of microbiome therapeutics in ulcerative colitis, also on May 3, 2025 [4] - An encore presentation will cover pharmacokinetic and pharmacodynamic results from a Phase 1b study of SER-155 in adults undergoing allo-HCT, set for May 4, 2025 [5] Industry Context - The Digestive Disease Week (DDW) is a significant international event in gastroenterology, showcasing nearly 6,000 abstracts and over 1,000 invited talks on the latest advances in GI research, medicine, and technology [5]