Rilvegostomig

COM701 MAIA-ovarian trial progressing as planned with median progression-free survival data from the interim analysis expected by Q1 2027 Trial-in-progress poster on MAIA-ovarian presented at the ESMO Gynaecological Cancers Congress 2026, reinforcing the biological and clinical rationale for evaluating COM701 in platinum-sensitive ovarian cancer Partner AstraZeneca presented new data at ASCO 2026, including the first overall survival readout from the GEMINI-Hepatobiliary study in first-line biliary tract cancer Gilead-partnered GS-0321 Phase 1 trial continues to progress as planned Solid financial position with cash runway expected to fund operations into 2029 HOLON, Israel, Aug. 3, 2026 /PRNewswire/ -- Compugen Ltd. (NASDAQ: CGEN) (TASE: CGEN), a clinical-stage cancer immunotherapy company and a pioneer in computational drug target discovery powered by AI/ML, today reported financial results for the second quarter of 2026 and provided a corporate update. "Q2 2026 reflects continued execution across the business," said Eran Ophir, Ph.D., President and CEO of Compugen. "Our MAIA-ovarian trial in platinum-sensitive ovarian cancer remains on track for the interim analysis with median progression-free survival data expected by the first quarter of 2027, which would mark a potential inflection point for COM701 in a patient population with a significant unmet need. Our partnered programs also advanced during the quarter, with AstraZeneca initiating an additional Phase 3 trial with rilvegostomig and presenting new rilvegostomig data at ASCO 2026, and the Gilead-partnered GS-0321 Phase 1 trial progressing as planned. With cash runway expected into 2029, we believe we are well positioned to advance our immuno-oncology pipeline." COM701 Compugen continues to advance MAIA-ovarian, its sponsored, randomized, placebo-controlled adaptive platform trial evaluating COM701, a potential first-in-class anti-PVRIG antibody, as maintenance monotherapy in patients with second- and third-line relapsed platinum-sensitive ovarian cancer, a setting with no approved treatment option. The Company anticipates the interim analysis with median progression-free survival data by the first quarter of 2027. During the quarter, Compugen presented a trial-in-progress poster on MAIA-ovarian at the ESMO Gynaecological Cancers Congress in Copenhagen. The poster underscored the strong biological and clinical rationale for evaluating COM701 in this population, including the differentiated biology of the PVRIG pathway versus other checkpoints such as PD-1 and TIGIT, its high expression in ovarian cancer, and the durable responses previously observed with COM701 as mono- and combination therapy in heavily pre-treated platinum-resistant patients. The Company believes that clear prolongation of PFS in these patients versus placebo could inform a registration path for COM701 and establish it as a potential backbone for drug combinations. Clinically meaningful success could also enable a broader clinical development plan across earlier and later lines of ovarian cancer and other indications where clinical signals were previously observed. Rilvegostomig Rilvegostomig is a PD-1/TIGIT bispecific antibody being advanced by Compugen's partner AstraZeneca, the TIGIT component of which is derived from Compugen's fully owned COM902 program. At the 2026 ASCO Annual Meeting, AstraZeneca presented an updated analysis from the GEMINI-Hepatobiliary study of rilvegostomig in combination with chemotherapy in the first-line setting. This was the first overall survival readout for rilvegostomig, with median overall survival of 16.8 months, versus less than 13 months in historical first-line biliary tract cancer trials. The data showed encouraging efficacy together with a manageable safety profile in a setting of high unmet need, while longer follow-up and randomized data from the ongoing Phase 3 trial will ultimately be needed to validate these findings. AstraZeneca continues to advance rilvegostomig across its broad late-stage program in 12 ongoing Phase 3 trials, including the recently initiated trial of rilvegostomig in combination with Datroway in urothelial carcinoma. GS-0321 GS-0321, formerly known as COM503, is a potential first-in-class anti-IL-18 binding protein antibody licensed to Gilead that represents a novel antibody approach to harness cytokine biology for the treatment of cancer, potentially overcoming the limitations of direct cytokine administration. The ongoing Phase 1 dose-escalation trial continues to progress as planned. Early Pipeline Compugen continues to leverage Unigen™, its AI/ML-powered computational discovery platform, to identify novel drug targets and biological pathways grounded in human disease biology. Unigen has already discovered the targets of COM701, COM902, and GS-0321 and we remain committed to identifying and advancing the next generation of immuno-oncology innovation. Second Quarter 2026 Financial Highlights Cash: As of June 30, 2026, Compugen had approximately $125.3 million in cash, cash equivalents, short-term bank deposits, and investment in marketable securities. Compugen expects that its cash and cash-related balances will be sufficient to fund its operating plans into 2029. This does not include any additional cash inflows. The Company has no debt. Revenues for the second quarter of 2026 were approximately $2.6 million, compared to approximately $1.3 million for the comparable period in 2025. Revenues in the second quarters of 2026 and 2025 reflect the recognition of portions of both the upfront payment and the IND milestone payment from the license agreement with Gilead. R&D expenses for the second quarter of 2026 were approximately $6.3 million, compared to approximately $5.6 million in the second quarter of 2025. G&A expenses for the second quarter of 2026 were approximately $2.3 million, compared to approximately $2.2 million in the second quarter of 2025. Net loss for the second quarter of 2026 was approximately $7.0 million, or $0.07 per basic and diluted share, compared to a net loss of approximately $7.3 million, or $0.08 per basic and diluted share, in the second quarter of 2025. Full financial tables are included below. Conference Call and Webcast Information The Company will hold a conference call today, August 3, 2026, at 8:30 AM ET to review its second quarter 2026 results. To access the conference call by telephone, please dial 1-866-744-5399 from the United States, or +972-3-918-0644 internationally. The call will also be available via live webcast through Compugen's website, located at the following link. Following the live audio webcast, a replay will be available on the Company's website. About Compugen Compugen is a clinical-stage therapeutic discovery and development company utilizing Unigen™, its AI/ML powered computational discovery platform, to identify novel drug targets and to develop therapeutics in the field of cancer immunotherapies. Compugen's innovative immuno-oncology pipeline consists of COM701, rilvegostomig and GS-0321 (previously COM503). COM701, a potential first-in-class anti-PVRIG antibody, is currently being evaluated in a blinded randomized ovarian cancer adaptive platform trial as a single agent in maintenance therapy in relapsed platinum sensitive ovarian cancer (named MAIA-ovarian trial). Rilvegostomig, a PD-1/TIGIT bispecific antibody with a TIGIT component that is derived from COM902, Compugen's anti-TIGIT antibody, is being developed by AstraZeneca pursuant to an exclusive license agreement between Compugen and AstraZeneca and is being evaluated in multiple Phase 3, Phase 2 and Phase 1 clinical trials. GS-0321 (previously COM503), Compugen's potential first-in-class high affinity antibody, which blocks the interaction between IL-18 binding protein and IL-18, is licensed to Gilead and is being evaluated in a Phase 1 clinical trial that Compugen is conducting. In addition, Compugen has an early-stage immuno-oncology pipeline that consists of research programs aiming to address various mechanisms to enhance anti-cancer immunity. Compugen's shares are listed on Nasdaq and the Tel Aviv Stock Exchange under the ticker symbol CGEN. Forward-Looking Statement This press release contains "forward-looking statements" within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended, and the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are based on the current beliefs, expectations, and assumptions of Compugen. Forward-looking statements can be identified using terminology such as "will," "may," "expects," "anticipates," "believes," "potential," "plan," "goal," "estimate," "likely," "should," "confident," and "intends," and similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements include, but are not limited to, statements regarding our expectations for COM701 MAIA-ovarian to have median progression-free survival data at the interim analysis by Q1 2027; statements regarding the biological and clinical rationale for evaluating COM701 in platinum-sensitive ovarian cancer and the potential of clear prolongation of PFS in these patients versus placebo to inform a registration path, serve as a backbone for combinations; statements regarding the potential clinical meaningful success of the MAIA-Ovarian trial to enable a broader clinical development across ovarian cancer and other indications; statements regarding AstraZeneca's advancement of its rilvegostomig program; statements regarding the advancement of Phase 1 trial for Gilead-partnered GS-0321; statements to the effect that our cash and cash-related balances will be sufficient to fund our operating plans into 2029. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance, or achievements of Compugen to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Among these risks: the clinical trials of any product candidates that Compugen, or any current or future collaborators, may develop may fail to satisfactorily demonstrate safety and efficacy to the FDA, and Compugen, or any collaborators, may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of these product candidates; Compugen's business model is substantially dependent on entering into collaboration agreements with third parties and Compugen may not be successful in generating adequate revenues or commercializing aspects of its business model; Compugen's approach to the discovery of therapeutic products is based on its proprietary computational target discovery infrastructure, which is unproven clinically; general market, political and economic conditions in the countries in which Compugen operates, including Israel; the effect of the evolving nature of the recent war in Israel; and Compugen does not know whether it will be able to discover and develop additional potential product candidates or products of commercial value. These risks and other risks are more fully discussed in the "Risk Factors" section of Compugen's most recent Annual Report on Form 20-F as filed with the Securities and Exchange Commission (SEC) as well as other documents that may be subsequently filed by Compugen from time to time with the SEC. In addition, any forward-looking statements represent Compugen's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. Compugen does not assume any obligation to update any forward-looking statements unless required by law. Company contact: Lindsey Trickett Head of Investor Relations and Corporate Communications Email: [email protected] Tel: +1 (628) 241-0071 SOURCE Compugen Ltd. 21% more press release views with Request a Demo

点击蓝字 关注我们 本 期 看 点 引言 8月2日，《金融时报》披露，阿斯利康与百时美施贵宝（BMS）近几个月曾讨论潜在合并。报道认为谈判已取得一定进展；路透社随后援引知情人士确认双方进行过初步接触，但无法判断讨论是否仍在继续。 目前，两家公司均未正式确认交易，谁率先发起、可能采取何种交易结构也没有明确答案。媒体所称的“4000亿美元”，主要指合并后集团的估值规模，并非阿斯利康对BMS提出的正式报价。 但两家全球肿瘤业务占比较高的药企开始评估更深层整合，本身已经具有产业意义。 真正需要回答的问题不是谁买下谁，而是两套庞大管线能否补齐彼此短板，以及免疫治疗和实体瘤领域的重叠将带来多高的监管与整合成本。 01 从辉瑞要约到超级合并洽谈 这已经不是阿斯利康首次传出合并和收购的消息。 2014年，辉瑞将收购阿斯利康的最终报价提高至每股55英镑，总额接近700亿英镑。 阿斯利康董事会认为报价低估了公司管线价值，最终拒绝交易。此后，Tagrisso、Imfinzi、Enhertu和Calquence等产品相继兑现，阿斯利康从潜在收购标的转变为全球肿瘤市场的重要参与者。 BMS则在2019年以约740亿美元股权价值收购Celgene，获得Revlimid、Pomalyst、血液瘤研发体系、CELMoD分子胶平台以及细胞治疗资产。交易扩大了BMS的产品和技术边界，也使其此后长期面对专利到期、债务消化和管线整合问题。 2026年2月，阿斯利康普通股开始直接在纽约证券交易所交易，同时保留伦敦和斯德哥尔摩上市。这一调整不是退出英国，而是扩大美国投资者基础，使资本市场结构更贴近其收入来源和业务重心。 当前两家公司也都谈不上经营困难。阿斯利康仍在推进2030年收入达到800亿美元的目标；BMS第二季度收入增长6%至130亿美元，并将2026年收入指引上调至490亿—500亿美元。 因此，这不是一家强势药企拯救另一家公司的故事。双方真正面对的是同一个长期问题：核心产品逐步进入成熟期后，如何建立能够覆盖2030年以后的增长结构。 02 最有价值的互补管线 阿斯利康和BMS都以肿瘤业务见长，但优势所在并不相同。 阿斯利康的核心能力集中在实体瘤精准治疗和适应证拓展。 Tagrisso建立了EGFR突变肺癌优势；Enhertu和Datroway将其带入HER2、TROP2等ADC市场；Imfinzi则由晚期治疗延伸至肺癌、膀胱癌和胃癌围术期。围绕CLDN18.2、MET、DNA损伤修复和下一代免疫双抗，公司已经形成覆盖多个生物标志物和治疗阶段的实体瘤管线。 BMS的积累主要位于免疫治疗、血液瘤和细胞治疗。Opdivo、Yervoy和Opdualag构成成熟的免疫治疗组合；Celgene留下的血液瘤体系继续支持Reblozyl、mezigdomide、golcadomide等产品和管线；Breyanzi与Abecma已经商业化，公司也建立了CAR-T生产、物流、医院准入和治疗中心运营能力。 截至2026年7月底，两家公司公开管线显示，双方最明显的互补位于血液瘤和细胞治疗，而不是PD-1与PD-L1已经内卷到无市场畅想空间的ICIs。 03 监管和整合成本不可回避 除了互补管线的利好因素之外，最直接的冲突来自肿瘤免疫治疗。 Opdivo与Imfinzi、Yervoy与Imjudo已经在肺癌、肝癌、膀胱癌和胃癌等领域直接或间接竞争。下一代产品虽然机制并不完全相同，但pumitamig、volrustomig、rilvegostomig等项目正在争夺相近的一线治疗场景、联合对象和临床资源。 ADC领域的重叠更多体现为开发场景竞争。Enhertu、Datroway、AZD0901与iza-bren靶点不同，但均在乳腺癌、肺癌和消化道肿瘤中布局，并需要与化疗或免疫治疗组合。合并后如果缺乏明确排序，同一癌种内的多个项目可能争夺患者、中心、预算和注册资源。 监管机构也不会只比较当前上市药物，还可能评估交易是否减少未来管线竞争。 2019年BMS收购Celgene时，美国FTC要求剥离Otezla，最终由安进以134亿美元收购。这意味着，阿斯利康与BMS若推进合并，也可能需要出售部分上市产品、区域权益或研发项目。 相比监管审查，更困难的可能是内部整合。PD-1、PD-L1、CTLA-4、LAG-3、TIGIT和VEGF相关项目不可能全部保持原有优先级。研发预算、适应证选择、联合方案和商业资源都必须重新分配。 如果没有及时停止重复项目，合并不仅不会提高效率，反而可能增加决策层级和内部竞争。对于这类超大型交易，主动削减管线与完成交易本身同样重要。 04 中国Biotech的影响 两家公司都是中国创新药的重要合作方。 BMS的EGFR×HER3双抗ADC iza-bren来自SystImmune，交易总金额最高可达84亿美元；阿斯利康从KYM Biosciences引入CLDN18.2 ADC CMG901，目前已推进为AZD0901，同时还通过收购Gracell加强细胞治疗布局。 若双方整合，已经签署的授权协议不会自动失效，但相关资产可能重新接受组合评估。同一靶点、同一癌种或相近治疗机制的项目，可能面临预算、开发顺序和适应证范围调整。 另一面是，监管要求剥离资产或合并后出现新的管线空缺，也可能形成权益转让、区域合作和二次授权机会。 对中国Biotech而言，更直接的变化是资产评价标准提高。面对一个已经拥有数十项肿瘤项目的全球组合，仅有早期缓解率或单臂数据还不够。企业还需要证明资产能够形成怎样的差异化临床定位，能否进入注册性研究，以及为什么值得在高度拥挤的管线中继续获得全球资源。 05 结 语 阿斯利康与BMS的潜在合并仍存在很大不确定性。截至目前，双方尚未正式确认交易，谈判是否继续、由谁推动以及最终采取何种结构均无明确答案。 但从现有管线看，双方确实存在结构性互补。阿斯利康在实体瘤精准治疗、ADC和全球适应证拓展方面更强；BMS在免疫治疗、血液瘤、CELMoD和商业化细胞治疗方面积累更深。 与此同时，双方在肿瘤免疫治疗和部分实体瘤开发场景中的重叠也无法回避。 这笔交易真正需要评估的，不是合并后能否形成一家估值接近4000亿美元的超级药企，而是能否保留阿斯利康的实体瘤开发效率和BMS的血液瘤、细胞治疗能力，同时果断处理重复产品与管线。 管线互补决定双方为什么会坐到谈判桌前；对重叠资产的取舍，才决定这笔交易最终能够创造多少价值。 风险提示： 本文仅为医药产业观察与信息整理，不构成任何投资建议。文中涉及上市公司及相关产品信息，仅用于行业分析，不代表对任何证券、产品或治疗方案的推荐。医药研发和资本市场均存在不确定性，请读者独立判断并注意风险。 ★