Nivolumab/Relatlimab

Recently announced 80% of SER-155 recipients achieved immunosuppressive-free clinical response at day 15 for immune checkpoint inhibitor-related enterocolitis (irEC) in the investigator-sponsored trial (IST) conducted by Memorial Sloan Kettering Cancer Center (MSK) IST data support SER-155 as a potential treatment for irEC that may allow patients to continue cancer therapy; Company evaluating irEC clinical development strategy in consultation with KOLs Seres engaging potential partners, seeking capital to advance its SER-155 programs, including for the prevention of bloodstream infections in patients undergoing allo-HCT and those experiencing irEC Seres announces agreement to exit additional leased space early, further reducing ongoing facility-related cash costs, which follows announcement of balance sheet strengthening and facilities cost reduction transactions in June 2026 ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); CAMBRIDGE, Mass., Aug. 05, 2026 (GLOBE NEWSWIRE) -- Seres Therapeutics, Inc. (Nasdaq: MCRB), (Seres or the Company), a leading live biotherapeutics company, today reported second quarter 2026 financial results and provided business updates. "We are very pleased with the recent progress at Seres, including the positive topline data from the investigator-sponsored trial of SER-155 in irEC conducted by MSK, announced last month," said Richard Kender, Executive Chairman and Interim Chief Executive Officer of Seres. "The study demonstrated that 80% of participants achieved an immunosuppressive-free clinical response at day 15, and the accompanying pharmacology data reinforced that our live biotherapeutic operated as designed, including by repairing the mucosal epithelial barrier. SER-155 to treat irEC, a frequent and often severe side effect of widely used immune checkpoint inhibitor (ICI) cancer treatment, represents a meaningful therapeutic and commercial opportunity, as many patients who experience irEC are required to halt their ICI therapy and begin immunosuppressive corticosteroid treatment. We are engaging potential partners, including companies with ICI franchises, as we evaluate the clinical development pathway in this indication and consider sources of financing. In parallel, we continue to pursue partnerships and other financing sources to support development of SER-155 in allo-HCT, and to advance our broader inflammatory and immune portfolio, including SER-603 for inflammatory bowel disease." Marella Thorell, Chief Financial Officer of Seres, added, "Terminating our Sidney Street lease will substantially reduce our future lease obligations and will further lower our ongoing annual fixed costs beginning in 2027. Together with the lease restructuring we announced in June, this transaction reflects our continued focus on rigorous financial discipline, while we maintain the operational infrastructure needed to advance our live biotherapeutic pipeline, including our Phase 2-ready SER-155 program in allo-HCT." Recent Highlights SER-155 in immune checkpoint inhibitor-related enterocolitis (irEC) In July, Seres announced positive topline results from the IST of SER-155 in irEC (NCT06801067) conducted at MSK. The open-label study evaluated SER-155 in 15 participants with moderate-to-severe (Grade 2-3) irEC who were naïve to immunosuppressive therapy. irEC is among the most frequent and severe immune-related adverse reactions in recipients of ICI therapy and, at the moderate-to-severe grade, affects approximately 25% of ICI recipients in the US. In the study, 12 of 15 participants (80%) achieved an immunosuppressive-free clinical response at day 15, the primary efficacy endpoint, defined as at least a 1-grade improvement in diarrhea symptoms without immunosuppressive therapy. SER-155 was generally well tolerated with no safety concerns identified and no serious adverse events assessed as related to SER-155. Participants in the study were on a wide range of ICI types, including PD-1 inhibitors (Keytruda®, Opdivo®, Zynyz®), PD-L1 inhibitors (Imfinzi®, Bavencio®), CTLA-4 inhibitors (Yervoy®, Imjudo®), LAG-3 inhibitor (Opdualag®), and combinations thereof. The promising study results support continued development of SER-155 to treat irEC and the Company is engaging potential partners, including companies with ICI franchises, as it evaluates next steps for the development of SER-155 in irEC. Broader pipeline and portfolio SER-155 remains Phase 2 ready for the prevention of bloodstream infections in patients undergoing allogeneic hematopoietic stem cell transplant (allo-HCT) for the treatment of blood cancer. SER-155 has received Breakthrough Therapy and Fast Track designations for this indication. Efforts to secure funding to advance clinical development for this program continue. The Company continues to advance IND-enabling activities for SER-603, in development for inflammatory bowel disease, and is engaging potential collaborators to support the clinical advancement of this program as a mono and/or combination therapy. Seres continues to progress development of SER-428, an investigational oral liquid formulation based on SER-155 strains supported by a grant from CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator), for dosing in patients who cannot take oral capsules. Seres is designing a Phase 1b open-label trial, in collaboration with Dr. Dan Freedberg at Columbia University, to evaluate SER-428 in medical ICU patients at high risk of infection. Corporate Updates Seres completed the below transactions that will collectively strengthen the Company’s balance sheet and reduce ongoing annual facility cash costs. On July 31, Seres entered into an agreement to terminate the lease for its facility at 200 Sidney Street in Cambridge, MA. This early termination eliminates the Company's remaining obligations under the lease as of December 31, 2026 in exchange for certain consideration and will further significantly reduce ongoing facility-related cash costs beginning in 2027. Additional details regarding the agreement are included in the Company's Report on Form 8-K, which was filed with the Securities and Exchange Commission on August 4, 2026. The accounting for this transaction will be reported in the Company’s third quarter 2026 results. In June, Seres restructured the lease for its facility at 101 CambridgePark Drive in Cambridge, MA, reducing its leased space, rental rate and related operating expenses. The restructured 10-year lease is expected to materially reduce the Company's ongoing annual facility-related cash costs and long-term lease obligations. In June, Seres entered into an amendment to its asset purchase agreement with Nestlé Health Science (Nestlé) under which Nestlé will pay Seres an aggregate $25 million (the Milestone Termination Payment), in two equal installments of $12.5 million on July 1, 2026 (which was received) and $12.5 million which is expected to be received on October 1, 2026, to buy out potential future VOWST net sales-based milestones. Seres sold the VOWST business to Nestlé Health Science in 2024. Second Quarter 2026 Financial Results Net income was $4.6 million for the second quarter of 2026, compared to a net loss of $19.9 million for the same period in 2025. The difference is primarily due to a $25 million Gain on Sale of the VOWST Business recognized in the second quarter of 2026 arising from the Milestone Termination Payment due from Nestlé. Research and development expenses were $9.1 million for the second quarter of 2026, compared with $12.9 million for the same period in 2025, reflecting lower personnel-related expenses, facilities costs, transition services agreement (TSA) costs and SER-155 costs driven by lower activities in these areas and cost reduction efforts. General and administrative expenses were $7.1 million for the second quarter of 2026, compared with $10.3 million for the same period in 2025, due to lower personnel-related expenses, facilities costs, professional services fees, and IT costs, including those related to IT services provided under the TSA. In the second quarter of 2026, there was a $5.8 million impairment charge recorded related to the early termination of a portion of the Company’s leased space at 101 Cambridgepark Drive. There were no manufacturing services expenses in the second quarter of 2026, compared with $1.7 million in the second quarter of 2025, as the Company completed such services under the TSA at the end of 2025. Cash and Cash Runway As of June 30, 2026, Seres had $15.6 million in cash and cash equivalents. Based on Seres’ currently available cash resources, including the $12.5 million Milestone Termination Payment received from Nestlé on July 1, 2026, and the expected receipt of the remaining $12.5 million Milestone Termination Payment from Nestlé on October 1, 2026, and considering future operating plans, the Company expects to fund operations through the first quarter of 2027. This projection excludes proceeds from any potential future partnerships or other sources of capital. About Seres Therapeutics Seres Therapeutics, Inc. (Nasdaq: MCRB) is a clinical-stage biotechnology company developing novel live biotherapeutics products (LBP), designed to address unmet needs in oncology that can lead to interruption to patients' cancer care and/or mortality, and to treat inflammatory and immune (I&I) diseases, by modulating host function to protect and improve mucosal epithelial barrier integrity, induce immune homeostasis and tolerance, and prevent the colonization and overgrowth of pathogens in the gastrointestinal (GI) tract. The Company previously led the development and FDA approval of VOWST™, the first orally administered microbiome therapeutic, which was subsequently divested to Nestlé Health Science. SER-155, an investigational cultivated multi-strain biotherapeutic, which has received Breakthrough Therapy and Fast Track designations, is being advanced for the prevention of bloodstream infections in patients undergoing allogeneic hematopoietic stem cell transplant (allo-HCT), and is Phase 2 ready, pending receipt of funding. SER-155 is also being developed to address immune checkpoint inhibitor-related enterocolitis (irEC) to provide an immunosuppressive-free alternative and enable patients to continue their ICI cancer therapy. Having recently reported promising results from an IST, Seres is evaluating the design of a Phase 2 study in irEC. The Company is advancing IND-enabling studies for SER-603, which is in development for inflammatory bowel disease. Mechanistically, Seres' biotherapeutics target the mucosal epithelial barrier-immune interface and are optimized to modulate host function to increase mucosal epithelium integrity, induce immune homeostasis, and prevent the colonization and overgrowth of harmful bacteria in the GI tract. For more information, please visit Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements about: SER-155 and its intended uses and benefits in irEC; our clinical development plans for SER-155, SER-603 and SER-428; potential accessibility for patients; the timing and results of clinical studies and data readouts; current or future product candidates and their potential impacts and outcomes; engagement with potential partners and financing sources; our ability to access capital to advance our programs; expected receipt of milestone termination payments; our lease restructuring activities and anticipated cost savings and liability reductions; our cash runway; our planned strategic focus; the anticipated timing of any of the foregoing; and other statements that are not historical fact. These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: (1) our need for additional funding; (2) our ability to continue as a going concern; (3) we have incurred significant losses, are not currently profitable and may never become profitable; (4) our cost reduction actions may not achieve their intended benefits, including an extended cash runway; (5) our limited operating history; (6) we may not be able to realize the anticipated benefits of the VOWST sale, and may face new challenges as a smaller, less diversified company; (7) we have in the past and may in the future receive notice of the failure to satisfy a continued listing rule from The Nasdaq Stock Market LLC; (8) our novel approach to therapeutic intervention; (9) our reliance on third parties to conduct our clinical trials and manufacture our product candidates; (10) our ability to achieve market acceptance necessary for commercial success; (11) the competition we will face; (12) our ability to protect our intellectual property; (13) impact of our recent management transitions and appointments and our ability to retain key personnel; and (14) disruptions at the FDA or other government agencies. These and other important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2026, to be filed with the Securities and Exchange Commission (SEC) on August 5, 2026, as well as our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. SERES THERAPEUTICS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited, in thousands, except share and per share data) June 30, December 31, 2026 2025 Assets Current assets: Cash and cash equivalents $ 15,594 $ 45,766 Accounts receivable due from SPN - related party 25,000 360 Accounts receivable 274 157 Prepaid expenses and other current assets 1,480 3,093 Total current assets 42,348 49,376 Property and equipment, net 5,798 7,635 Operating lease assets 51,168 72,483 Restricted cash 2,243 8,668 Other non-current assets 31 31 Total assets $ 101,588 $ 138,193 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable $ 1,186 $ 1,682 Accrued expenses and other current liabilities 3,739 3,972 Accrued liabilities due to SPN - related party 3,278 3,278 Operating lease liabilities 11,828 10,390 Total current liabilities 20,031 19,322 Operating lease liabilities, net of current portion 44,816 72,576 Other long-term liabilities 2,207 2,077 Total liabilities 67,054 93,975 Commitments and contingencies (Note 9) Stockholders’ equity (deficit): Preferred stock, $0.001 par value; 10,000,000 shares authorized at June 30, 2026 and December 31, 2025; no shares issued and outstanding at June 30, 2026 and December 31, 2025 — — Common stock, $0.001 par value; 360,000,000 shares authorized at June 30, 2026 and December 31, 2025; 9,827,569 and 9,556,466 shares issued and outstanding at June 30, 2026 and December 31, 2025, respectively 10 10 Additional paid-in capital 1,022,259 1,016,611 Accumulated deficit (987,735 ) (972,403 ) Total stockholders’ equity 34,534 44,218 Total liabilities and stockholders’ equity $ 101,588 $ 138,193 SERES THERAPEUTICS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE (LOSS) INCOME (unaudited, in thousands, except share and per share data) Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Revenue: Grant revenue 736 — 1,094 — Total revenue 736 — 1,094 — Operating expenses: Research and development expenses 9,141 12,939 22,336 24,760 General and administrative expenses 7,061 10,253 15,131 22,141 Impairment of long-lived assets 5,807 — 5,807 — Manufacturing services — 1,689 — 5,216 Total operating expenses 22,009 24,881 43,274 52,117 Loss from operations (21,273 ) (24,881 ) (42,180 ) (52,117 ) Other income (expense): Gain on sale of VOWST Business 25,000 185 25,000 52,366 Interest income 181 546 506 1,164 Other income (expense) (1) 673 4,295 1,342 11,414 Total other income (expense), net 25,854 5,026 26,848 64,944 Net income (loss) and comprehensive income (loss) $ 4,581 $ (19,855 ) $ (15,332 ) $ 12,827 Net income (loss) per share attributable to common stockholders – basic $ 0.47 $ (2.27 ) $ (1.59 ) $ 1.47 Net income (loss) per share attributable to common stockholders – diluted $ 0.47 $ (2.27 ) $ (1.59 ) $ 1.47 Weighted average common shares outstanding - basic 9,706,193 8,743,733 9,644,704 8,723,589 Weighted average common shares outstanding - diluted 9,747,138 8,743,733 9,644,704 8,732,176 [1] Includes $0, $0, $3,490, and $9,799 for the three and six months ended June 30, 2026 and 2025 related to reimbursement received from SPN (related party) for transition services provided by the Company. Investor and Media Contact: IR@serestherapeutics.com Carlo Tanzi, Ph.D. Kendall Investor Relations ctanzi@kendallir.com

8月3日，阿斯利康与百时美施贵宝曾讨论潜在合并的消息传出。交易尚未得到双方确认，谁先提出、谈到哪一步、最终会采用何种结构，目前均无明确信息。资本市场却先给出了态度。截至伦敦时间12时30分，阿斯利康股价下跌约6%；BMS美股盘前上涨约5%。前一交易日，两家公司市值分别约为2640亿美元和1330亿美元，合计接近4000亿美元。需要说明的是，这只是合计市值，并非正式报价。 一跌一涨背后的逻辑并不复杂：市场担心阿斯利康为一笔超大型交易承担整合、融资和增长稀释风险，却愿意提前给BMS的潜在溢价投票。问题也由此变得更有意思：一家仍在扩大技术边界的进攻型药企（阿斯利康），为什么会考虑与一家更强调现金流、分红和成熟产品接替的“养老型”药企（施贵宝）走到一起？当然，这里的“养老”并不是停止研发，而是行业内戏谑称谓。一、AZ不缺管线，BMS也没有躺平 阿斯利康目前并不需要依靠一笔大型并购来维持增长。毕竟在当年最难的时刻都没有卖给辉瑞，更遑论现在势头正猛。2025年，公司总收入达到587.39亿美元，按固定汇率增长8%；全年获得16项Ⅲ期研究阳性结果，并有超过100项Ⅲ期研究正在开展。公司仍维持2030年收入达到800亿美元的目标。 其扩张路径也十分清楚：以Tagrisso、Imfinzi和Lynparza为基础，通过Enhertu、Datroway和AZD0901加强ADC布局，再通过收购Gracell、Fusion Pharmaceuticals和EsoBiotec进入细胞治疗、核药及体内细胞治疗。这是一套典型的进攻型配置：现有产品继续拓展适应症，同时用外部BD不断增加新的技术平台。 BMS的问题则不是没有新产品，而是接班压力更大。 2026年第二季度，BMS收入达到130亿美元，同比增长约6%；增长产品组合收入76亿美元，同比增长15%。Reblozyl、Breyanzi、Camzyos、Opdualag和Cobenfy仍在放量，但Revlimid和Pomalyst收入分别下降49%和71%。 因此，BMS近年来以140亿美元收购Karuna、收购Mirati和RayzeBio，并引进iza-bren等资产。它的BD部门显然没有准备退休，只是每个项目进入管线后，都要先回答一个问题：能不能及时接替老产品？而BMS的BD，虽然比辉瑞的BD部门要好一些（更换CFO与三期折戟，辉瑞在免疫和ADC时代下的落寞），但相较于AZ而言，稍逊一筹。两家公司都会买资产，但重点不同：阿斯利康更关注下一条增长曲线，BMS更关注下一班接班产品，也凸显出两家MNC的不同风格。二、AZ看中的可能不是产品，而是BMS的家底 从管线看，双方并非简单补缺。 个人推测，阿斯利康真正可能看中的，是BMS在美国积累多年的商业网络、血液瘤体系以及CAR-T生产和治疗中心基础设施。BMS需要的则是阿斯利康在实体瘤、ADC和全球临床开发方面的效率。阿斯利康已经形成从后线验证、一线拓展到围术期前移的开发路径，BMS目前仍在补充这方面的能力。 如果整合顺利，双方按2025年口径计算的合计收入将超过1060亿美元，并同时覆盖ADC、免疫双抗、CAR-T、CELMoD、核药、小分子靶向药和罕见病药物。产品多到足以举办一场“内部ASCO”，但这并不意味着研发效率会自动翻倍。三、合并后最先解决的可能不是“买什么”，而是“砍什么” 双方管线重叠并不少。Opdivo与Imfinzi、Yervoy与Imjudo之间存在直接或间接竞争；免疫双抗、细胞治疗、核药及部分实体瘤项目，也会争夺同一批患者、临床中心和研发预算。 交易若落地，新公司首先需要决定哪些资产继续推进、哪些适应症重新分工、哪些早期项目终止。大型并购最容易得到的是更长的管线表和更多会议，最难保留的是原来的决策速度。 这也是阿斯利康股价下跌的核心原因。市场并不怀疑BMS拥有优质资产，而是怀疑阿斯利康是否有必要用如此庞大的交易，换取自己并不迫切缺少的产品。 对BMS而言，逻辑则更直接：潜在溢价之外，它还可能获得阿斯利康更强的增长预期和研发体系。难怪资本市场暂时把笑脸留给了BMS。 对于中国Biotech，这笔潜在交易也可能带来连锁反应。双方已经通过BD引进多项中国资产，合并后的管线重排可能使部分项目降级、终止或转让；同时，监管剥离和内部资源调整也可能释放新的合作机会。 但可以确定的是，资产进入MNC的门槛会进一步提高。早期缓解率漂亮已经不够，还要说明项目为什么值得在一张更加拥挤的全球管线表中继续获得预算。四、谁能与合并后的AZ+BMS抗衡？ 如果只比较市值，礼来已经明显领先；如果比较收入和综合业务，强生更加接近；如果比较肿瘤研发体系，罗氏和默沙东仍然具有竞争力。但如果同时比较实体瘤、血液瘤、细胞治疗、核药、罕见病和全球商业基础，目前还没有一家MNC能够完全对应。 因此，合并后的AZ+BMS不会在每个细分领域都排名第一，却可能成为业务覆盖最完整的创新药集团之一。强生可以在综合规模上抗衡，罗氏可以在科学平台上抗衡，默沙东仍能在肿瘤商业化上抗衡，礼来则在市值和增长预期上遥遥领先。 没有一家企业能够在所有维度完全复制，但这并不代表合并体天然无敌。制药行业从来不是项目数量比赛，一家公司只要在某个大市场建立足够深的优势，就可能获得更高的增长和估值。五、真正的化学反应，是谁改变谁 理想情况下，阿斯利康主导研发和临床开发，将BMS的现金流、美国商业网络、血液瘤及细胞治疗基础设施转化为新技术的全球开发能力，同时及时削减重复项目。 这样得到的，可能是一家兼具规模、平台宽度和研发效率的创新药集团。 另一种更现实的结果，是双方组成一个庞大的业务联合体：实体瘤、血液瘤、罕见病、心血管和神经科学分别运行，销售、行政及部分研发岗位被整合，财务协同逐步兑现，但决策层级也随之增加。 更值得警惕的是，为维持分红、偿还债务和兑现成本协同，新公司压缩高风险研发投入。届时，BMS获得了更多增长资产，阿斯利康却失去了原有的进攻速度。 因此，这笔交易真正值得关注的，不是谁主动接触了谁，也不只是双方能拼出多少产品。 关键在于，阿斯利康能否把BMS的家底转化为新的增长能力，还是BMS围绕现金流和股东回报形成的财务逻辑，最终让阿斯利康慢下来。 结语 笔者并不认为这样一项大额交易最终能够实现。接近4000亿美元的合计市值、复杂的融资安排、广泛重叠的肿瘤管线，以及潜在的反垄断审查，都意味着交易成本和整合难度远超一般并购。 但这则消息之所以甚嚣尘上，是因为它准确对应了两家公司的现实需求：BMS需要缓解专利到期压力，重新获得增长预期；阿斯利康则希望进一步补强美国商业网络、血液瘤和细胞治疗能力。双方未必真的需要合并，但确实拥有彼此需要的资源。 资本市场的一跌一涨，也说明投资者看到了不同的风险。BMS可能获得溢价和更强的研发体系，阿斯利康却要承担融资、管线取舍和组织整合的主要成本。产品互补只是交易成立的前提，能否提高研发效率才是决定交易价值的关键。 因此，这则传闻真正值得关注的，并不是AZ最终会不会买下BMS，而是全球大型药企正在重新评估规模、技术平台与增长之间的关系。当内部研发难以完全覆盖下一轮技术周期，BD、资产重组乃至大型并购仍会频繁出现。AZ与BMS或许不会真正合并，但围绕专利到期、增长资产和技术平台展开的新一轮行业整合，已经开始。