[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]

Company Overview - Seres Therapeutics, Inc. (Nasdaq: MCRB) is a clinical-stage company focused on improving patient outcomes in medically vulnerable populations through novel live biotherapeutics [4] - 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 [4] - 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 [4] Clinical Developments - SER-155 has demonstrated a significant reduction in bloodstream infections and related complications compared to placebo in a Phase 1b clinical study involving patients undergoing allo-HSCT [4] - 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 [4] Upcoming Events - Management will host a conference call and live audio webcast on May 7, 2025, at 8:30 a.m. ET to discuss first quarter 2025 financial results and provide business updates [1] - Access to the conference call can be made by dialing 800-715-9871 (domestic) or 646-307-1963 (international) with conference ID number 4618787 [2] - A webcast replay will be available on the Seres website approximately two hours after the event and will be archived for about 21 days [3]

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Clinical Development and Regulatory Designations - SER-155 demonstrated a 77% relative risk reduction in bloodstream infections (BSIs) compared to placebo in the Phase 1b study, with significant reductions in systemic antibiotic exposure and febrile neutropenia incidence[33]. - The FDA granted Breakthrough Therapy designation to SER-155 for the reduction of BSIs in patients 18 years and older undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT) in December 2024[33]. - The company plans to submit a draft protocol for the next SER-155 study to the FDA in Q2 2025, incorporating feedback from the FDA on the development strategy[24]. - SER-155, an investigational oral live biotherapeutic, is designed to reduce bacterial bloodstream infections (BSIs) in patients undergoing allo-HSCT, with Fast Track Designation received in December 2023 and Breakthrough Therapy designation granted in December 2024[64][65]. - In the Phase 1b study of SER-155, the incidence of BSIs was significantly lower in the treatment group (10%) compared to the placebo group (42.9%), representing a relative risk reduction of approximately 77%[70]. - SER-155 administration resulted in a mean reduction of antibiotic treatment duration from 21.1 days in the placebo group to 9.2 days in the SER-155 group[70]. - The company continues to explore the therapeutic mechanisms of SER-155, including promoting intestinal epithelial barrier integrity and reducing systemic inflammatory responses[75]. - The company aims to evaluate SER-155 in various medically vulnerable populations, including autologous-HSCT patients and cancer patients with neutropenia[26]. Product Development and Manufacturing - SER-147 is being developed to prevent bacterial bloodstream and spontaneous bacterial peritonitis infections in patients with chronic liver disease (CLD), which affects nearly 1.7 billion people worldwide[33]. - The company maintains a differentiated live biotherapeutics drug discovery and development platform, including good manufacturing practices (GMP) capabilities[25]. - The company has established a proprietary strain library and bioinformatics tools to track changes in the microbiome and associate them with host physiology[37]. - The successful development and approval of VOWST, the first FDA-approved orally administered microbiome therapeutic, provides the company with regulatory experience for future live biotherapeutic candidates[36]. - The company has developed a proprietary strain library of bacterial isolates, which includes species from healthy individuals and patients, enhancing its ability to translate microbiome biomarker insights into therapeutic applications[39]. - The company’s manufacturing facility in Cambridge, Massachusetts, is designed to meet cGMP standards, positioning it uniquely in the market compared to commercial contract research organizations[41]. - The company has optimized fermentation conditions to enhance bacterial yields, demonstrating its commitment to innovative manufacturing processes[41]. - The company plans to establish commercial manufacturing capabilities or arrange with third-party manufacturers for its product candidates[220]. Financial Performance and Funding - The company received $100 million in cash upon closing the sale of its VOWST business, with additional cash installment payments of $50 million and $25 million due in 2025[52]. - Future milestone payments include $125 million for achieving worldwide annual net sales of $400 million and $150 million for $750 million in sales, highlighting significant revenue potential from the VOWST product[52]. - The company reported a gain of $5.7 million for the year ended December 31, 2024, primarily due to better-than-expected profit sharing from the VOWST product[55]. - The company anticipates needing additional funding to advance the development and commercialization of its product candidates, particularly for SER-155 clinical studies[198]. - The company has incurred significant operating losses since inception and expects to continue incurring losses for the foreseeable future[203]. - The net loss from continuing operations for the years ended December 31, 2024, 2023, and 2022 was $125.8 million, $190.1 million, and $183.6 million respectively, with an accumulated deficit of $978.1 million as of December 31, 2024[203]. - The company has broad discretion in using the proceeds from the transaction, which may not be effectively utilized to improve its financial condition[217]. Market and Competitive Landscape - The company faces competition from major pharmaceutical and biotechnology companies with greater financial resources and established market presence[98]. - The company faces significant uncertainty regarding the coverage and reimbursement status of its product candidates, which may impact sales and profitability[176]. - The company is subject to various governmental cost-containment measures, including price controls and reimbursement restrictions, which could limit net revenue[177]. - The company’s ability to access capital may be adversely affected by market volatility and macroeconomic conditions, including geopolitical conflicts[200]. Intellectual Property and Regulatory Compliance - Protecting intellectual property rights is a key focus for the company to ensure competitive advantage[220]. - The company utilizes trade secrets and confidentiality agreements to protect its proprietary information and competitive position[95]. - The company plans to expand its intellectual property estate by filing patent applications related to its product candidates[89]. Employee and Organizational Structure - The company experienced a headcount reduction of approximately 100 employees following the VOWST Transaction, with a total of 103 full-time employees as of December 31, 2024[188]. - The company emphasizes the importance of attracting and retaining skilled employees as a key driver of its future prospects[190]. - The company has no employees represented by a labor union, indicating a stable relationship with its workforce[188]. Future Outlook and Challenges - The company has identified conditions that raise substantial doubt about its ability to continue as a going concern, depending on various factors including clinical trial costs and regulatory review outcomes[199]. - The company may face challenges in maintaining employee morale and retaining key management following the transaction, which has resulted in a smaller, less diversified business[216][214]. - The company is focused on developing SER-155 and other cultivated live biotherapeutic candidates, but faces risks in achieving regulatory approvals and market acceptance[213][218]. - The acceptance of the product candidates by patients, the medical community, and third-party payors is crucial for future success[220]. - The company aims to maintain a continued acceptable safety profile for its product candidates following approval[220].

Financial Data and Key Metrics Changes - Seres reported a net loss from continuing operations of $15.7 million for Q4 2024, compared to a net loss of $34.7 million for the same period in 2023, indicating a significant improvement [49] - For the full year 2024, the net loss from continuing operations was $125.8 million, down from $190.1 million in 2023, primarily due to lower operating expenses of approximately $74 million [49] - Research and development (R&D) expenses for Q4 2024 were $12.8 million, down from $23 million in Q4 2023, and for the full year, R&D expenses were $64.6 million compared to $117.6 million in 2023 [51] - General and administrative (G&A) expenses for Q4 2024 were $12.5 million, down from $14 million in Q4 2023, and for the full year, G&A expenses were $53.2 million compared to $77.5 million in 2023 [52] Business Line Data and Key Metrics Changes - The company has made substantial progress in advancing its lead program SER-155, which aims to prevent bloodstream infections in allo-HSCT recipients [8][12] - SER-155 showed a clinically meaningful 77% relative risk reduction in bloodstream infection rates in a Phase 1b study [10][23] - The FDA granted breakthrough therapy designation to SER-155, indicating significant progress in its development [13][58] Market Data and Key Metrics Changes - The commercial opportunity in allo-HSCT alone is considered sizable, with potential for indication expansion to adjacent patient populations [39][40] - There are approximately 9,300 allo-HSCT procedures conducted annually in the US, with an estimated 20,000 procedures in Europe [43] Company Strategy and Development Direction - The company is focused on SER-155 and exploring partnerships to support its development and maximize its potential [17][61] - SER-155 is positioned to address a significant unmet need in preventing bacterial bloodstream infections, with plans to extend its application to other medically vulnerable groups [40][61] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress made with SER-155 and the constructive feedback received from the FDA [58] - The company is preparing for the next study of SER-155 and expects to submit a draft study protocol to the FDA in the second quarter [21][22] Other Important Information - The company is now debt-free following the VOWST transaction, which provided $155 million at closing [46][47] - The cash position as of December 31, 2024, was $30.8 million, with expectations to fund operations into the first quarter of 2026 [55] Q&A Session Summary Question: Feedback from the FDA regarding manufacturing and patient enrollment - Management indicated that they received comprehensive feedback from the FDA and are in the process of refining the clinical study protocol [67][70] - The population for the next study is considered appropriate, with plans to manage variability through stratification [72] Question: Recent FDA feedback relative to expectations and Phase 2/3 study differences - Management found the FDA feedback constructive and believes more data is needed for the next study [80][84] - A Phase 2/3 study would require pre-specification and locking of certain items, which could take more time [83] Question: Safety database considerations based on VOWST experience - Management noted that the FDA has a minimum threshold of 300 patients for safety data, but discussions will evolve as more data is generated [92] Question: Potential size of the next study and additional efficacy endpoints - Management indicated that a standalone Phase 2 could provide meaningful data quickly, with various endpoints being considered, including GvHD rates [100][102]

Financial Data and Key Metrics Changes - Seres reported a net loss from continuing operations of $15.7 million for Q4 2024, compared to a net loss of $34.7 million for the same period in 2023, indicating a significant improvement [49] - For the full year 2024, the net loss from continuing operations was $125.8 million, down from $190.1 million in 2023, primarily due to lower operating expenses of approximately $74 million [49] - Research and development (R&D) expenses for Q4 2024 were $12.8 million, down from $23 million in Q4 2023, reflecting a focus on the lead program SER-155 [51] - General and administrative (G&A) expenses for Q4 2024 were $12.5 million, compared to $14 million in Q4 2023, also showing cost management efforts [52] Business Line Data and Key Metrics Changes - The company has made substantial progress with SER-155, a biotherapeutic aimed at preventing bloodstream infections in allo-HSCT patients, showing a 77% relative risk reduction in bloodstream infection rates in a Phase 1b study [10][23] - Manufacturing services expenses were introduced as a new category in 2024, amounting to $3.5 million for Q4 2024, related to services under the transition agreement with Nestle [53] Market Data and Key Metrics Changes - The commercial opportunity in allo-HSCT alone is considered sizable, with approximately 9,300 procedures conducted annually in the US and around 20,000 in Europe [43] - Market research indicates a high unmet need for preventing bacterial bloodstream infections, with healthcare professionals and payers expressing a desire for better prophylactic options [40][41] Company Strategy and Development Direction - The company is focused on advancing SER-155 and exploring partnerships to maximize its potential, with plans to submit a draft study protocol to the FDA in Q2 2025 [21][56] - SER-155 is positioned to address not only allo-HSCT but also other medically vulnerable patient populations, including those with inflammatory bowel disease [35][61] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress made with SER-155, highlighting the breakthrough therapy designation received from the FDA and the constructive feedback from the agency [58] - The company aims to operationally prepare for the next study of SER-155 while seeking additional guidance from the FDA [15][19] Other Important Information - The VOWST sale transaction closed in September 2024, providing Seres with $155 million, which has allowed the company to retire its debt and simplify operations [46][48] - The company expects to fund operations into Q1 2026 based on its current cash position and anticipated payments from the VOWST transaction [55] Q&A Session Summary Question: Feedback from the FDA regarding manufacturing and patient enrollment - Management indicated that the FDA's feedback was comprehensive and that they are confident in their manufacturing plans moving forward [67][75] Question: Recent FDA feedback relative to expectations and Phase 2/3 study differences - Management found the FDA's feedback constructive and noted that a Phase 2/3 study would require more pre-specification and discussions with the agency [80][83] Question: Safety database considerations based on VOWST experience - Management acknowledged the importance of the safety database and indicated that discussions with the FDA would evolve as more data is generated [88][92] Question: Potential size of the next study and additional efficacy endpoints - Management suggested that a standalone Phase 2 study could provide meaningful data quickly, with additional endpoints including febrile neutropenia and antibiotic use being considered [100][102]

Seres Therapeutics Investor Presentation March 2025 Transforming patient outcomes using proprietary consortia of live biotherapeutics Seres Therapeutics Investor Presentation March 2025 Strong Foundation Positive SER-155 Phase 1b Data in Allo-HSCT Blockbuster SER-155 Opportunity • Initial SER-155 development in allo-HSCT • Potential to initiate multiple clinical trials for additional indications • SER-155 represents multi- billion net sales opportunity across indications (e.g., autologous-HSCT, blood cancer ...

Recent FDA feedback received on SER-155 allogeneic hematopoietic stem cell transplant (allo-HSCT) next study provides support for the proposed primary efficacy endpoint of reduction in bloodstream infections (BSIs) at day 30 post-HSCT; Company expects to submit draft study protocol to FDA in Q2 2025 SER-155 Phase 1b placebo-controlled study exploratory translational biomarker data reinforce intended mechanisms of action, are consistent with clinical results that showed a significant reduction (77% relative ...