Verekitug

– Company rapidly advancing toward Q1 2027 initiation of Phase 3 trials designed to deliver best-in-class efficacy with convenient quarterly dosing in both severe asthma and CRSwNP; End-of-Phase 2 interactions with FDA on track – – Completed enrollment in Phase 2 trial in COPD; data expected in the second half of 2027 – – Clinical data presentations continue to emphasize differentiated pro verekitug in multiple indications – WALTHAM, Mass., Aug. 11, 2026 (GLOBE NEWSWIRE) -- Upstream Bio, Inc. (Nasdaq: UPB), a clinical-stage company developing treatments for severe inflammatory respiratory diseases, today reported financial results and business updates for the second quarter ended June 30, 2026. The Company highlighted its continued progress in developing verekitug to deliver potential best-in-class efficacy with quarterly dosing across three target indications: severe asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), and chronic obstructive pulmonary disease (COPD). Verekitug is the only known antagonist currently in clinical development that targets and inhibits the thymic stromal lymphopoietin (TSLP) receptor. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); “We continued to make progress toward the initiation of our Phase 3 trials in severe asthma and CRSwNP in the first quarter of 2027. Our End-of-Phase 2 interactions with the FDA are on schedule, and we look forward to sharing more details about our Phase 3 development plans soon,” said Rand Sutherland, MD, Chief Executive Officer of Upstream Bio. “With more than 500 participants treated in verekitug clinical trials thus far, and with compelling Phase 2 results now demonstrated in both severe asthma and CRSwNP, we have built a substantial and consistent body of clinical evidence supporting verekitug’s potential to deliver durable, best-in-class efficacy with convenient quarterly dosing. In addition, our CMC and device development efforts continue to advance, and we are working diligently to provide options for both at-home and in-office administration at launch.” “I am pleased to share that we have completed enrollment in our ongoing Phase 2 VENTURE trial in COPD, with 481 participants enrolled; data from this important Phase 2 study, expected in the second half of 2027, will provide valuable insights into the potential of verekitug for the treatment of COPD,” added Aaron Deykin, MD, Chief Medical Officer and Head of Research & Development at Upstream Bio. “Additionally, verekitug’s differentiated clinical pro severe asthma and CRSwNP continues to be reinforced through additional data recently presented at the ATS and EAACI medical congresses, and our team is looking forward to the upcoming late-breaking presentation of our Phase 2 VALIANT trial of verekitug in severe asthma at the ERS Congress in early September. Collectively, these data further strengthen our conviction about the potential for verekitug to advance the standard of care.” Recent Business Highlights Upcoming Initiation of Phase 3 Trials in Severe Asthma and CRSwNP The Company remains on track to initiate Phase 3 clinical trials in severe asthma and CRSwNP in the first quarter of 2027. End-of-Phase 2 interactions with the U.S. Food and Drug Administration (FDA) for both severe asthma and CRSwNP are on track. These interactions will support the Phase 3 development plans in both indications. The Company has previously communicated that it plans to pursue a Phase 3 development strategy designed to deliver best-in-class efficacy with a high-dose quarterly regimen in broad patient populations in both severe asthma and CRSwNP. Phase 2 VENTURE Trial in COPD Enrollment Completed The Company has completed enrollment in the VENTURE trial in COPD with 481 participants. Data are expected in the second half of 2027, and the Company believes that these analyses will provide important insights into the potential clinical impact of verekitug in COPD. VENTURE ( NCT06981078 ) is a Phase 2, global, randomized, double-blind, placebo-controlled, parallel-group clinical trial designed to assess the efficacy and safety of verekitug in participants with moderate-to-severe COPD across extended dosing-interval arms of 12 and 24 weeks. Additional Analyses of Phase 2 VIBRANT Trial in CRSwNP Presented at American Thoracic Society (ATS) International Conference 2026 and European Academy of Allergy and Clinical Immunology (EAACI) Congress 2026 ATS International Conference, May 2026 : The data, presented in two posters, demonstrated the positive effect of verekitug in participants with CRSwNP and comorbid asthma, as well as its impact on type 2 inflammatory biomarkers in blood and nasal secretions. Verekitug led to statistically significant and clinically meaningful improvement in asthma symptom control as measured by the Asthma Control Questionnaire-6 (ACQ-6) in participants with CRSwNP and comorbid asthma. Verekitug led to improvements in nasal polyp score (NPS) in participants with and without comorbid asthma, as well as rapid and sustained reductions in blood and nasal type 2 inflammatory biomarkers. EAACI Congress, June 2026 : The new post-hoc responder analyses further demonstrated that the significant majority of verekitug-treated participants achieved clinically meaningful improvements in NPS, the primary endpoint, and across key secondary endpoints in the Phase 2 VIBRANT trial. Verekitug, administered once every three months, led to clinically meaningful improvements in NPS in approximately 80% of participants. A majority of verekitug-treated participants experienced clinically meaningful improvements across key secondary endpoints, including 72% in nasal congestion and 83% in CRSwNP total symptom score. These findings provide additional support for the continued development of verekitug and ongoing planning for Phase 3 registrational studies. Phase 2 VALOUR Long-Term Extension Study in Severe Asthma Eligible participants with severe asthma who completed the Phase 2 VALIANT clinical trial were offered enrollment in VALOUR ( NCT06966479 ), a long-term extension (LTE) study designed to evaluate the long-term safety and efficacy of verekitug. The study completed enrollment in March 2026 with more than 90% retention of eligible participants from the Phase 2 VALIANT study. Data from the study are expected in the second half of 2027. Second Quarter 2026 Financial Results As of June 30, 2026, Upstream Bio had cash, cash equivalents and short-term investments of $261.3 million, which is expected to fund planned operations through 2027. Research and development expenses were $36.1 million for the quarter ended June 30, 2026, compared to $37.9 million for the same period in 2025. The decrease of $1.8 million was primarily driven by a decrease in manufacturing expenses, partially offset by an increase in personnel-related expenses, including share-based compensation, and an increase in clinical costs related to the Company’s verekitug programs. General and administrative expenses were $7.1 million for the quarter ended June 30, 2026, compared to $7.4 million for the same period in 2025. The decrease of $0.3 million was primarily driven by a decrease in professional fees, partially offset by an increase in personnel-related expenses, including share-based compensation. Net loss was $39.7 million for the quarter ended June 30, 2026, compared to a net loss of $40.0 million for the same period in 2025. Upcoming Events Upstream Bio expects to participate in the following upcoming medical congresses: European Respiratory Society (ERS) Congress 2026, September 5-9, Barcelona About Upstream Bio Upstream Bio is a clinical-stage biotechnology company developing treatments for severe inflammatory respiratory diseases. The Company is developing verekitug, the only known antagonist currently in clinical development that targets and inhibits the receptor for thymic stromal lymphopoietin (TSLP), a cytokine which is a clinically validated driver of inflammatory response positioned upstream of multiple inflammatory pathways. With more than 500 participants treated with verekitug across its clinical development programs and positive Phase 2 results in chronic rhinosinusitis with nasal polyps (CRSwNP) and severe asthma, verekitug has a substantial body of clinical evidence supporting its advancement into Phase 3 development in both diseases. Verekitug is also being evaluated in an ongoing Phase 2 trial in chronic obstructive pulmonary disease (COPD). Upstream Bio is focused on leveraging verekitug’s differentiated mechanism, potency, and potential for extended dosing to develop a treatment which may deliver best-in-class efficacy and quarterly dosing for patients underserved by today’s standard of care. To learn more, please visit . Upstream Bio intends to use the investor relations page on its website as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor its website in addition to following press releases, filings with the Securities and Exchange Commission (SEC), public conference calls, presentations and webcasts. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “continue,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “predict,” “project,” “seeks,” “should,” “target,” “will” and variations of these words or similar expressions. Any statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements include, without limitation, express or implied statements regarding: the clinical development of verekitug for the treatment of severe asthma, CRSwNP and COPD, including the initiation, timing, progress and results of ongoing and planned clinical trials; expectations regarding the differentiation, safety, efficacy, tolerability, or extended dosing interval of verekitug; certain activities and next steps to support the Company’s maturation into a late clinical-stage company; expectations regarding regulatory interactions with the FDA on the data from the VIBRANT and VALIANT Phase 2 trials and the outcomes of any such interactions; advancement of the Company’s chemistry, manufacturing and controls and device development efforts and the potential for both at-home and in-office administration at launch; Upstream Bio’s expected operating expenses and capital expenditure requirements, including its cash runway through 2027; and participation at upcoming investor conferences and medical congresses. Any forward-looking statements in this press release are based on the Company’s current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Readers are cautioned that actual results, levels of activity, safety, efficacy, performance or events and circumstances could differ materially from those expressed or implied in the Company’s forward-looking statements due to a variety of risks and uncertainties, which include, without limitation, risks and uncertainties related to: Upstream Bio’s ability to advance verekitug through clinical development, and to obtain regulatory approval of and ultimately commercialize verekitug on the expected timeline, if at all; the results of preclinical studies or clinical studies not being predictive of future results in connection with future studies; the initiation, timing, progress and results of clinical trials; Upstream Bio’s ability to fund its development activities and achieve development goals; Upstream Bio’s dependence on third parties to conduct clinical trials and manufacture verekitug, and commercialize verekitug, if approved; Upstream Bio’s ability to attract, hire and retain key personnel, and protect its intellectual property; Upstream Bio’s financial condition and need for substantial additional funds in order to complete development activities and commercialize verekitug, if approved; regulatory developments and approval processes of the U.S. Food and Drug Administration and comparable foreign regulatory authorities; Upstream Bio’s competitors and industry; and other risks and uncertainties described in greater detail under the caption “Risk Factors” in Upstream Bio’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, as well as any subsequent filings with the SEC. Any forward-looking statements represent Upstream Bio’s views only as of today and should not be relied upon as representing its views as of any subsequent date. Upstream Bio explicitly disclaims any obligation or undertaking to update any forward-looking statements contained herein to reflect any change in its expectations or any changes in events, conditions or circumstances on which any such statement is based except to the extent required by law, and claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Investor and Media Contact: Meggan Buckwell Director, Corporate Communications and Investor Relations ir@upstreambio.com UPSTREAM BIO, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (IN THOUSANDS) (UNAUDITED) June 30, December 31, 2026 2025 Assets Current assets: Cash and cash equivalents $ 79,397 $ 101,578 Short-term investments 181,910 239,931 Accounts receivable 772 668 Prepaid expenses and other current assets 17,523 9,620 Total current assets 279,602 351,797 Property and equipment, net 460 559 Operating lease right-of-use assets 915 1,222 Restricted cash 194 194 Total assets $ 281,171 $ 353,772 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable $ 2,314 $ 2,726 Accrued expenses and other current liabilities 6,946 10,006 Operating lease liabilities, current portion 728 720 Total current liabilities 9,988 13,452 Operating lease liabilities, net of current portion 226 549 Total liabilities 10,214 14,001 Stockholders’ equity: Common stock 54 54 Additional paid-in capital 685,542 673,410 Accumulated other comprehensive income (expense) (123 ) 530 Accumulated deficit (414,516 ) (334,223 ) Total stockholders’ equity 270,957 339,771 Total liabilities and stockholders’ equity $ 281,171 $ 353,772 UPSTREAM BIO, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (IN THOUSANDS) (UNAUDITED) Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Collaboration revenue $ 773 $ 937 $ 1,807 $ 1,503 Operating expenses: Research and development 36,089 37,865 72,654 63,662 General and administrative 7,052 7,419 15,136 14,201 Total operating expenses 43,141 45,284 87,790 77,863 Loss from operations (42,368 ) (44,347 ) (85,983 ) (76,360 ) Other income (expense): Interest income 2,659 4,431 5,713 9,174 Other income (expense), net 7 (50 ) (23 ) (50 ) Total other income, net 2,666 4,381 5,690 9,124 Net loss $ (39,702 ) $ (39,966 ) $ (80,293 ) $ (67,236 )

🧩导读：安斯泰来制药（Astellas Pharma Inc.）是总部位于日本东京的跨国制药企业，在免疫抑制与器官移植领域拥有深厚技术积淀。近年来公司战略聚焦肿瘤免疫、靶向蛋白降解、基因调控、眼科再生四大核心方向，自身免疫性疾病领域以成熟商业化产品为基石，早期创新管线随战略调整有所优化。本文基于公开信息系统梳理其自免领域的产品与管线布局。 🔬一、自免领域商业化产品 安斯泰来已上市的自免相关产品以免疫抑制剂为核心，覆盖器官移植排斥、皮肤自免、风湿免疫等多个临床场景。 通用名 商品名 作用机制 主要自免相关获批适应症 主要获批地区与时间 剂型 他克莫司（Tacrolimus） 普乐可复®（Prograf）、新普乐可复®（Advagraf）、普特彼®（外用软膏）等 钙调磷酸酶抑制剂，阻断T淋巴细胞活化与炎症因子释放 1. 肝、肾、心、肺等实体器官移植的排斥反应预防与治疗2. 中重度特应性皮炎（外用）3. 狼疮性肾炎（日本获批）4. 类风湿关节炎、溃疡性结肠炎、重症肌无力等（部分地区获批） 1993年日本首次获批；1998年中国获批口服剂型；外用软膏于中国获批 口服普通胶囊、缓释胶囊、颗粒剂、注射液、外用软膏 培非替尼（Peficitinib Hydrobromide） Smyraf® JAK家族激酶抑制剂，抑制炎症因子信号传导 常规治疗应答不佳的类风湿关节炎（含预防关节结构损伤） 2019年日本获批；2020年韩国、中国台湾地区获批 口服片剂 他克莫司：安斯泰来最具代表性的免疫抑制剂，属于大环内酯类钙调磷酸酶抑制剂，通过抑制钙调磷酸酶活性阻断T细胞活化及下游细胞因子转录，发挥强效免疫抑制作用。该产品上市超过30年，是全球器官移植抗排斥治疗的经典基石药物；同时通过外用剂型拓展至特应性皮炎等皮肤自免领域，口服剂型在部分地区获批用于狼疮性肾炎、类风湿关节炎等多种自身免疫性疾病。目前已形成多剂型产品矩阵，覆盖全球主要医药市场。 培非替尼：培非替尼是安斯泰来自主研发的口服JAK抑制剂，对JAK1、JAK3具有优先抑制活性，每日一次口服给药。2019年率先在日本获批用于类风湿关节炎，后续在韩国、中国台湾地区获批。其通过阻断JAK-STAT信号通路抑制多种炎症因子介导的免疫反应，为类风湿关节炎患者提供了口服靶向治疗选择。 🔬二、自免领域核心产品 安斯泰来自免领域的核心产品为他克莫司与培非替尼，二者共同构成其在免疫抑制与风湿自免领域的商业化基石。 通用名 核心定位 市场地位 产品价值 他克莫司 自免与移植领域基石产品 全球器官移植免疫抑制经典用药，中国他克莫司市场原研份额处于领先地位 疗效确切、临床应用广泛，覆盖多科室多适应症，贡献长期稳定收入 培非替尼 新一代口服自免靶向创新药物 日本、韩国等亚洲地区类风湿关节炎口服治疗的重要选择 体现公司在炎症信号通路领域的研发积累，丰富自免口服治疗产品线 核心价值总结 他克莫司凭借广泛的临床应用与医生认可度，是安斯泰来在免疫领域的压舱石产品；培非替尼作为公司在自免领域的新一代小分子创新药，填补了亚洲市场类风湿关节炎口服靶向治疗的部分空白。二者形成经典基础用药+创新靶向药物的产品梯队。 🔬三、自免领域在研临床管线 受公司整体战略资源向核心领域倾斜影响，安斯泰来自免领域自主研发管线有所收缩，多个早期项目因战略调整终止。以下为公开可查的临床阶段自免相关管线（含已终止项目）。 （一）III期临床阶段 无公开披露的自主活跃自免领域III期研发项目。 （二）II期临床阶段 药物名称 靶点/机制 适应症 当前状态 备注 ASP5094 抗整合素α9人源化单克隆抗体 类风湿关节炎 已终止 II期临床未达到主要疗效终点，研发终止 Verekitug（UPB-101） 抗胸腺基质淋巴细胞生成素受体（TSLPR）全人源单抗 重度哮喘、慢性鼻窦炎伴鼻息肉、慢性阻塞性肺疾病 活跃（II期） 原安斯泰来研发，2021年全球权益出售给Upstream Bio，现由后者独立推进 （三）I期临床阶段 药物名称 靶点/机制 适应症 当前状态 备注 ASP5502 口服小分子STING抑制剂 原发性干燥综合征 已终止 2026年3月终止I期临床，为公司商业决策，与试验中观察到的安全性、有效性信号无关 管线整体特征 安斯泰来当前自主推进的自免领域临床管线以早期项目为主，近年持续进行投资组合优化，终止了多个非核心方向的早期项目。公司将研发资源更多集中于肿瘤免疫、靶向蛋白降解等战略重点领域，自免领域的创新资产更多通过对外授权、资产出售等方式实现价值转化。 🔬四、最具潜力的自免临床管线 从机制差异化、临床数据表现、疾病价值维度来看，原研自安斯泰来、现由Upstream Bio推进的Verekitug是其自免/炎症领域研发产出中最具潜力的资产。 药物名称 靶点/机制 适应症 临床阶段 潜力分析 权益状态 Verekitug（UPB-101） TSLP受体拮抗剂，全人源IgG1单克隆抗体 重度哮喘、慢性鼻窦炎伴鼻息肉、慢性阻塞性肺疾病 II期临床 1. 全球唯一进入临床开发阶段的TSLP受体靶向抗体，作用位点差异化于已上市TSLP配体单抗2. II期临床数据积极：哮喘适应症中100mg每12周给药方案使年度加重率降低56%；慢性鼻窦炎伴鼻息肉II期达到主要终点3. 长效给药优势，支持每12周至每24周一次给药，患者依从性潜力更佳 安斯泰来原研，2021年将全球权益出售给Upstream Bio Verekitug靶向TSLP受体而非TSLP配体，理论上可实现更完全的通路阻断与更长的作用持续时间。其II期临床数据显示出显著的抗炎效果与长效给药潜力，在2型炎症相关疾病中具备差异化竞争优势。尽管该资产已不再归属安斯泰来，但仍是其自免炎症领域研发积累中最具临床价值的成果之一。 🔬五、总结 安斯泰来在自身免疫性疾病领域整体呈现基石稳固、创新收缩、价值外溢的格局： 1. 商业化层面：以他克莫司为核心的经典免疫抑制剂构筑了稳固的市场基础，覆盖移植与多类自免疾病；培非替尼作为口服创新药补充了风湿自免领域的产品矩阵，在亚洲市场占据一席之地。 2. 研发层面：受公司整体战略调整影响，自免领域自主创新管线有所收缩，多个早期项目终止，研发资源向肿瘤、眼科等核心赛道集中。 3. 创新价值层面：公司在炎症靶点领域仍有技术积累，Verekitug等对外授权资产展现出差异化的临床潜力，通过资产交易方式实现了研发价值的变现。 整体而言，安斯泰来并非自免领域的头部创新药企，但其在免疫抑制领域的深厚积淀与成熟产品矩阵，使其在器官移植与部分自免细分市场保持着稳定影响力。未来公司在自免领域的布局预计将延续成熟产品深耕+创新资产对外合作的模式。 📌数据来源 1. 安斯泰来制药官方网站产品与管线公开信息（2026年4月更新）          2. 安斯泰来2025年R&D Day公开演示资料          3. ClinicalTrials.gov临床试验登记信息           ⚠️ 【免责声明】本文仅为医药行业公开信息整理与客观分析，不构成任何诊疗建议、用药指导或投资决策参考。在研药物研发存在不确定性，最终适应症、获批时间及商业价值以监管机构正式审批及企业官方披露为准。 分享，点赞，评论，关注自身免疫领域，推动机制研究与新药研发。 跨国药企｜日本制药巨头明治制果药业（Meiji Seika Pharma）自身免疫性疾病领域布局 全球自身免疫疾病领域新技术路径汇总 PD-1靶点反向革命：从肿瘤到自免的全新赛道 2026年7月全球自身免疫疾病领域创新药研发进展 头部跨国药企卫材（Eisai Co., Ltd.）在自身免疫性疾病领域的布局 跨国药企默沙东 MSD在自免领域的商业化+在研临床管线布局 日本田边制药（Tanabe Pharma ）在自身免疫疾病领域的商业化和临床管线布局 自免领域Top14跨国药企适应症布局和研发汇总 跨国药企大冢制药（Otsuka ）在自身免疫疾病领域的商业化+精准临床管线布局 日本头部跨国制药企业|协和麒麟（Kyowa Kirin）在自免领域的管线布局 全球12+头部跨国药企在自身免疫性疾病领域的布局 日本跨国药企第一三共（Daiichi Sankyo）在自身免疫疾病领域的布局 跨国生物公司|渤健（Biogen）在自身免疫疾病领域的商业化产品+临床在研管线+临床管线竞争梳理 制药巨头吉利德科学（Gilead）自身免疫与炎症领域管线 跨国药企安进（Amgen）自身免疫疾病领域管线 百时美施贵宝（BMS）自身免疫疾病领域管线 全球制药企业优时比（UCB）自免领域管线 跨国药企|武田制药Takeda|在自身免疫疾病领域的布局（商业化和临床管线） 葛兰素史克（GSK）在自免和炎症领域的布局|3款重磅药 + 8 条临床管线！ 跨国药企|辉瑞（Pfizer）在自身免疫疾病领域的商业化产品与临床研发管线 跨国药企|阿斯利康自身免疫疾病领域商业化产品和临床管线 跨国药企|罗氏（Roche）在自免领域的商业化产品及临床管线 自免领域|通用型CAR-T产品新进展|全球首款靶向CD19与CD38双靶点的通用型CAR-T：FT839 美万亿美元市值制药巨头|礼来（Eli Lilly & Co.）|自身免疫疾病领域商业化产品和临床管线 瑞士全球性制药公司|诺华Novartis自身免疫疾病领域商业化产品和临床管线 勃林格殷格翰|那米司特（Nerandomilast）治疗特发性肺纤维化（IPF）与进展性肺纤维化（PPF）的两项全球多中心 III 期临床试验回溯总结 跨国药企|艾伯维（AbbVie）自身免疫疾病领域|商业化产品和临床管线 跨国制药巨头|赛诺菲（Sanofi）|自身免疫与炎症领域：商业化产品和临床管线 迎接七月|自身免疫疾病领域IL-17A靶点临近上市资产重磅 BD 合作 跨国制药巨头Johnson & Johnson Pharmaceutical（强生制药）自身免疫疾病领域核心产品与临床管线 2026年6月全球自身免疫性疾病创新药研发进展 跨国药企全球 Top15|在自身免疫疾病领域的商业布局与重点研发管线 中国本土创新药企（不含跨国药企）在自免领域的布局总结 CD38单抗达雷妥尤单-治疗系统性红斑狼疮单臂Ⅱ期临床试验完整总结 再闯港股IPO！岸迈生物凭差异化TCE技术，改写自免创新竞争格局 突破SLE治疗瓶颈！惠和生物CC312解锁自免TCE一年长效免疫重置新范式 Kali Therapeutics, Inc：可控型T细胞衔接技术，重塑自身免疫疾病精准治疗赛道 肠道菌群：自身免疫病的关键诱因 自免药研社声明：本公众号所有文章系出于传递更多信息之目的，且已注明创作信息来源。本公众号欢迎分享朋友圈或大群，但谢绝媒体或机构未经授权以任何形式转载至其他平台。