Core Insights - SER-155 demonstrates significant clinical benefits in promoting epithelial barrier integrity and reducing systemic inflammatory biomarkers in allo-HSCT patients compared to placebo [1][3][4] - The clinical results of SER-155 have been accepted for oral presentation at the 2025 TANDEM Meeting, highlighting its relevance in infectious diseases [1][6] - Market research indicates a high unmet need for effective prophylactic options against bloodstream infections (BSIs) in allo-HSCT patients, supporting SER-155's commercial potential [6][8] Clinical Data - SER-155 Phase 1b study shows a statistically significant decrease in fecal albumin, indicating improved epithelial barrier integrity, and a positive impact on systemic inflammation biomarkers [3][4] - The study also reported a 77% relative risk reduction in bloodstream infections, reinforcing the therapeutic potential of SER-155 [4][10] - SER-155 has received Breakthrough Therapy designation from the FDA for its role in reducing BSIs in allo-HSCT patients [10][12] Market Opportunity - Recent payer research highlights the significant clinical burden of BSIs and the lack of effective prophylactic therapies, suggesting a strong value proposition for SER-155 [6][8] - Payers expect SER-155 to be covered under outpatient pharmacy benefits due to its oral administration, facilitating easier access for patients [6][7] - The company is actively seeking partnerships to maximize the commercial opportunity for SER-155 and expand its applications in treating inflammatory diseases [8][11] Financial Position - As of December 31, 2024, the company reported approximately $31 million in cash and cash equivalents, with an expected cash runway extending into Q1 2026 [2][12] - The company anticipates receiving approximately $75 million from Nestlé Health Science related to the sale of VOWST, which will support ongoing operations and development plans for SER-155 [12]

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

Company Overview - Seres Therapeutics, Inc. is a clinical-stage company focused on improving patient outcomes in medically vulnerable populations through novel live biotherapeutics [3] - The company successfully developed and approved VOWST™, the first FDA-approved orally administered microbiome therapeutic, which was sold to Nestlé Health Science in September 2024 [3] - Seres is developing SER-155, which has shown a significant reduction in bloodstream infections and related complications in a clinical study involving patients undergoing allogeneic hematopoietic stem cell transplantation [3] Pipeline and Development - SER-155 and other pipeline programs are designed to target multiple disease-relevant pathways and are manufactured from standard clonal cell banks via cultivation [3] - The company plans to evaluate SER-155 and other cultivated live biotherapeutic candidates in various medically vulnerable patient populations, including autologous-HSCT patients, cancer patients with neutropenia, CAR-T recipients, individuals with chronic liver disease, solid organ transplant recipients, and patients in intensive care units and long-term acute care facilities [3] Upcoming Events - Eric Shaff, President and CEO of Seres Therapeutics, will participate in a fireside chat at the Piper Sandler 36th Annual Healthcare Conference on December 3, 2024, at 4:30 p.m. ET [1] - A live webcast of the chat will be available on the company's website and will be accessible for replay after the event [2]

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

Financial Data and Key Metrics Changes - Seres reported a net loss from continuing operations of $51 million for Q3 2024, compared to a loss of $41 million in the same period in 2023, primarily due to a loss of $23.4 million associated with the extinguishment of Oaktree debt and a reduction in interest income of $2 million, offset by lower operating expenses of $15.4 million [34][36] - The company had $66.8 million in cash and cash equivalents as of September 30, 2024, and expects to fund operations into Q4 2025 based on existing cash and projected installment payments [38] Business Line Data and Key Metrics Changes - Research and development expenses for Q3 2024 were $16.5 million, down from $25.2 million in Q3 2023, driven by lower personnel costs due to restructuring [35] - General and administrative expenses decreased to $12.7 million in Q3 2024 from $19.4 million in Q3 2023, also due to lower personnel costs and reduced operating costs [36] Market Data and Key Metrics Changes - The market research indicated that healthcare providers treating allo-HSCT patients rated their concern about infections a six on a seven-point scale, reflecting a high level of concern [26] - Incremental costs for patients with bacterial bloodstream infections (BSIs) were estimated at $180,000 per patient, indicating a significant financial burden on healthcare systems [27] Company Strategy and Development Direction - The company aims to advance SER-155 for allo-HSCT patients and is exploring opportunities in additional patient populations such as auto-HSCT and cancer patients with neutropenia [21][43] - Seres is actively seeking a partner to support the advancement of SER-155, focusing on financial support and capabilities to maximize the product's potential [11][55] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about SER-155's potential to transform infection risk management in allo-HSCT patients, with plans to engage with the FDA regarding clinical development [8][22] - The company believes there is a substantial commercial opportunity to address serious bacterial infections across various patient groups, including allo and auto-HSCT, and cancer patients [43][44] Other Important Information - The sale of VOWST to Nestle Health Science provided Seres with a significant capital infusion, allowing the company to retire its debt and streamline operations [12][30] - Following the VOWST transaction, the company's headcount decreased by 100 team members, resulting in a more efficient operational structure [32] Q&A Session Summary Question: Will the additional patient populations for SER-155 require separate Phase I studies or can they be part of a basket trial? - Management indicated that they would look for synergies within the clinical trial structure and do not anticipate needing to start over in a Phase I study due to established safety [48][49] Question: What is the profile of an ideal potential partner for SER-155? - The company seeks partners that can provide capital and capabilities to accelerate bringing SER-155 to patients, with a focus on alignment of values and objectives [54][55] Question: How does the company envision its future with multiple targeted programs in development? - Management expressed a desire to create a vertically integrated company that includes discovery, development, and commercialization, while currently focusing on driving shareholder value through partnerships [61][62]

Exhibit 99.1 SERES THERAPEUTICS REPORTS THIRD QUARTER 2024 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATES SER-155 Phase 1b placebo-controlled clinical results demonstrated significant reduction in both bacterial bloodstream infections and systemic antibiotic exposure, as well as lower incidence of febrile neutropenia, as compared to placebo, through day 100 post allo-HSCT Financial position strengthened following completion of VOWST™ sale; based on existing cash, projected 2025 deal economics and current o ...

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

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

Seres Therapeutics, Inc. (NASDAQ: MCRB ) develops microbiome-based therapeutics to treat conditions caused by imbalances in the human gut flora. Since my January article, the company has made important strides, such as the anticipated sale of VOWST to Nestlé Health My name is Myriam Hernandez Alvarez. I received the Electronics and Telecommunication Engineering degree from the Escuela Politecnica Nacional, Quito, Ecuador, the M.Sc. degree in computer science from Ohio University, Athens, OH, USA, a graduate ...

Seres Therapeuties (MCRB) has been on a downward spiral lately with significant selling pressure. After declining 22.5% over the past four weeks, the stock looks well positioned for a trend reversal as it is now in oversold territory and there is strong agreement among Wall Street analysts that the company will report better earnings than they predicted earlier. Here is How to Spot Oversold Stocks We use Relative Strength Index (RSI), one of the most commonly used technical indicators, for spotting whether ...