Gemcitabine Hydrochloride

盛传默沙东正就收购生物科技公司Revolution展开深入谈判，交易作价可能高达280亿至320亿美元。无疑证明了Revolution的价值。 Revolution medicines 在KRAS治疗领域具有最广泛且最快的布局，也是因为KRAS突变在多个肿瘤中高表达，意味着KRAS靶点具有治疗肿瘤的广泛性，Revolution聚焦于3个适应症，胰腺癌、非小细胞肺癌和结直肠癌；未来有望拓宽至更广泛的适应症。Part 1: English Transcript Brian Chang (J.P. Morgan Analyst):Good morning. Thanks for joining us for another session at the 44th J.P. Morgan Healthcare Conference. I'm Brian Chang, one of the senior biotech analysts here at the firm. This is a highly anticipated presentation. We have the CEO from RevMed, Mark A. Goldsmith. I will now pass the mic to Mark for a short presentation followed by a live audience Q&A. Mark, the stage is yours. Mark A. Goldsmith (CEO, Revolution Medicines):Thanks for the introduction, Brian, and good morning everyone. It's really great to be here at the J.P. Morgan Healthcare Conference and to share an overview of Revolution Medicines. We've made meaningful progress and have a transformative year ahead of us. As today's presentation will include forward-looking statements, please refer to our legal disclaimer shown here on slide two. At Revolution Medicines, our mission is bold: to revolutionize treatment globally for patients living with RAS-addicted cancers through the discovery, development, and delivery of innovative targeted medicines directed against common mutational drivers of human cancers. We have been pioneers in the RAS targeting field, introducing a number of scientific drug discovery and clinical breakthroughs that create compelling opportunities for patients. RevMed is a late-stage clinical oncology company pushing the boundaries in three common RAS-addicted cancers: pancreatic, non-small cell lung, and colorectal cancer, with four RAS(ON) inhibitors in the clinic and a deep pipeline behind them. We have eight ongoing or announced registrational Phase 3 trials and extensive aggregate clinical experience to date, with more than 2,500 patients having received one or more of our RAS(ON) inhibitors. Today our clinical stage pipeline consists of four investigational drugs that target the major oncogenic drivers. Daraxonrasib, our most advanced program, is a groundbreaking and promising RAS(ON) multi-selective inhibitor. Elironrasib is a highly differentiated, highly active, and well-tolerated RAS(ON) G12C selective inhibitor. Zoldonrasib is an innovative, highly active, and well-tolerated RAS(ON) G12D selective inhibitor. And our newest clinical compound, RMC-5127, is a RAS(ON) G12V selective inhibitor. These clinical programs are backed by a rich pipeline of preclinical and discovery programs, including an innovative and exciting new class of inhibitors that has provided a fifth RAS(ON) inhibitor drug candidate on its way to the clinic. As a company singularly dedicated to RAS-addicted cancers, we are well positioned to bring forward new treatments aimed at changing the global standards of care for patients with common cancers. In pancreatic ductal adenocarcinoma, for which cytotoxic chemotherapy remains the standard of care for most patients, more than 90% of tumors harbor an oncogenic RAS mutation. There's a profound need for RAS targeted therapies for this devastating disease. Likewise, approximately 30% of non-small cell lung cancers carry an oncogenic RAS mutation, including 18% with non-G12C mutations. New effective targeted treatments remain a significant unmet need. In colorectal cancer as well, more than 50% of tumors carry an oncogenic RAS mutation, and there remain high needs there. Our integrated scientific workflow focused on RAS-addicted cancers is engineered as a virtuous cycle of innovation that leverages the research bench, the clinical bedside, and commercial insights. This informs how we discover new ways of targeting RAS through our highly productive Tri-Complex inhibitor platform, develop new investigational drugs through robust and parallel clinical development plans, and systematically expand our commercial and operational capabilities to deliver potential new therapies to patients globally. Pancreatic cancer is our most advanced area of clinical development with multiple registration trials already underway or planned for initiation this year. Daraxonrasib has an unprecedented clinical profile across lines of therapy, RAS mutations, and treatment regimens. The clinical durability observed so far in second line appears promising relative to PFS and OS rates reported for cytotoxic chemotherapy in the second or first-line treatment settings. This investigational drug was recently recognized by the US FDA through the awarding of a Commissioner's National Priority Review Voucher (CNPRV), which noted Daraxonrasib's potential to change the way pancreatic cancer is treated in first-line metastatic disease. Daraxonrasib is currently under evaluation in three randomized registrational studies in pancreatic cancer. "RASolute 302," our second-line metastatic Phase 3 trial, recently completed global enrollment and will read out in the first half of this year. "RASolute 303" in first-line metastatic disease and "RASolute 304" in resectable disease have both been initiated. Zoldonrasib, our covalent G12D selective inhibitor with a highly differentiated safety and tolerability profile, has also shown encouraging anti-tumor activity in pancreatic cancer. We are advancing this compound towards two first-line combination registrational trials in pancreatic cancer in 2026. "RASolute 305" will evaluate Zoldonrasib in combination with chemotherapy, and "RASolute 309" will evaluate the RAS(ON) inhibitor doublet of Zoldonrasib plus Daraxonrasib as a chemotherapy-free approach. RASolute 303 in the first-line metastatic setting is evaluating Daraxonrasib monotherapy and in combination with gemcitabine/nab-paclitaxel (G&nP). This study tests two important independent hypotheses: a chemotherapy-free RAS-targeted monotherapy paradigm, and a combination regimen containing a RAS-targeted drug plus chemotherapy. RASolute 304 in the adjuvant setting evaluates Daraxonrasib monotherapy following surgery and perioperative chemotherapy in patients with resectable pancreatic cancer. If successful, these trials together could establish new standards of care for the majority of pancreatic cancer patients across lines of therapy. I'm pleased to share initial clinical data from the combination of Zoldonrasib with FOLFIRINOX as of a December 1st, 2025 data cutoff date. The initial safety and tolerability profile for the combination of full dose Zoldonrasib (1,200 mg QD) and full dose in the modified FOLFIRINOX regimen was largely consistent with the well-known profile of FOLFIRINOX alone. 63% of patients achieved an objective response, including both confirmed and pending confirmation partial responses. The disease control rate was 95%. A second area of focus where we saw considerable advancement in 2025 was non-small cell lung cancer (NSCLC). "Resolve 301," a global randomized registrational study currently underway evaluating Daraxonrasib monotherapy in previously treated metastatic NSCLC patients, continues to enroll well inside the US and internationally. Early combination data from first-line patients treated with Daraxonrasib plus pembrolizumab were encouraging, and we are planning a first-line registrational trial. Zoldonrasib (G12D selective) and Elironrasib (G12C selective) have also shown encouraging results in NSCLC. Just last week we announced that Zoldonrasib has received Breakthrough Therapy Designation from the FDA—our third BTD award for a RAS(ON) inhibitor. We are in advanced planning for "RASolve 308," our first registrational study of a Zoldonrasib combination regimen in first-line metastatic NSCLC. Elironrasib has shown a strong clinical profile as monotherapy and in combination with pembrolizumab alone or as part of a doublet with Daraxonrasib. In colorectal cancer, we have a range of combination studies ongoing. We also continue supporting our collaboration with Tango Therapeutics studying the combination of our RAS(ON) inhibitors with vopimetastat, a PRMT5 inhibitor, in patients with MTAP deletions. We are also initiating a first-in-human study evaluating the combination of our inhibitors with Summit Therapeutics' ivonescimab, a PD-1/VEGF bispecific antibody. Finally, we have initiated the first-in-human study of RMC-5127, a RAS(ON) G12V selective inhibitor. We are also proud to introduce an innovative new class of RAS(ON) inhibitors specifically designed to overcome RAS-driven acquired drug resistance. We intend to advance the first compound from this class, RM-055, into the clinic this year. Preclinical data shows that RM-055 defeated acquired RAS-dependent resistance in models where tumors had regrown after Daraxonrasib treatment. This year, we plan to share more information about this class and bring RM-055 into the clinic as our fifth investigational drug targeting RAS. A strong financial position with $1.9 billion as of the end of the third quarter, with an additional $1.75 billion in committed capital available from Royalty Pharma, enables broad execution. 2026 will be a year of growing impact for RevMed. We expect to provide several important data disclosures for Daraxonrasib in the first half of 2026, including the readout for the RASolute 302 trial.Q&A Session Brian Chang:Thank you, Mark. Let's start the Q&A. Maybe just to start off with a big picture question: Do you see yourself building something bigger? How do you balance your goal of building a bigger machine versus taking strategic transactions? And ultimately, where do you see RevMed in six months and five years? Mark A. Goldsmith:I have very little to say about the latter part of your question since obviously, we have a well-established company policy of not commenting on rumors or speculation. But regarding what we are building: It's not our goal to build somethingbig. It's our goal to build something that'simpactful. We have tremendous momentum. Our organization grew by something like 400 people in 2025. We're committed to that vision. Brian Chang:Historically, RevMed has disclosed data at your own time. What's the rationale for disclosing data today at the conference of the year? Mark A. Goldsmith:We share data when the data are mature enough to indicate a direction that our program should go. The things I showed today are very much linked to what's going to happen later in the year. The only way for us to move clinical programs forward is to provide the data that supports it so investigators understand why they should participate. Brian Chang:Turning to the second-line trial (RASolute 302). What keeps you up at night regarding the outcome? Mark A. Goldsmith:At this point, it's going very well. It enrolled extraordinarily rapidly. It's an experiment, and so while we think there are a lot of data that justify conducting the study, it's an experiment and we'll see the results when we see them. Brian Chang:Do you have a sense of how close you are to the events (deaths)? Have you seen the interim data? Mark A. Goldsmith:We track OS events, deaths in the trial, because it's an event-driven trial. It's blinded. All we know is a total number. We don't get to take a peek until we unblind it. Brian Chang:Can you talk about what weight the top-line data carries towards the path to approval? Is it sufficient to file? Mark A. Goldsmith:We don't know because we don't know the results. It starts as an interim analysis. It's powered for overall survival, so it's "overpowered" for progression-free survival. Several different scenarios could play out. One could mean the trial is completed and we move forward; one could mean we have some results but not all. Brian Chang:Do you think it's possible that you could get approval this year (2026)? Mark A. Goldsmith:I wouldn't want to speculate on that. There are many factors we don't control. The FDA has made a public commitment to be very efficient, especially under the CNPRV regime, but speculating today would just be speculation. Brian Chang:How should we interpret Zoldonrasib's performance relative to Daraxonrasib? Mark A. Goldsmith:They are different in their characteristics. Only over time, once we've completed randomized Phase 3 trials, will we really be able to compare them. Zoldonrasib has a very favorable tolerability profile, allowing us to combine it with FOLFIRINOX quite readily—an opportunity we did not choose to take with Daraxonrasib. Brian Chang:Why do two parallel studies (305 and 309) for the front line instead of combining them into one multi-arm study? Mark A. Goldsmith:It turns out to be entirely an operational question. A larger trial will take longer to run as opposed to running two smaller trials in parallel. So it's not a cost savings, just practical logistics. Brian Chang:Does Elironrasib (G12C) hinder the growth of RevMed or distract from the priority list? Mark A. Goldsmith:We think Elironrasib is an outstanding compound. It's a bit of the "little brother/sister" because the others address such important gaps in treatment. The G12C space is much more crowded, so we are being much more thoughtful. Before we advance it into a registrational trial, we want to make sure it serves an unmet need. Brian Chang:Which data update are you most excited for this year? Mark A. Goldsmith:Why don't we take a poll in the room and find out what the answer to that is? (Laughs) We'd probably agree with that. Brian Chang:Thanks very much.Part 2: 中文 Brian Chang（摩根大通分析师）：早上好。感谢大家参加第44届摩根大通医疗健康大会的又一场会议。我是Brian Chang，本行的资深生物技术分析师之一。这是一场备受期待的演讲。我们邀请到了RevMed（Revolution Medicines）的首席执行官Mark A. Goldsmith。现在我把麦克风交给Mark，他将进行简短的演讲，随后是现场观众问答环节。Mark，舞台交给你了。 Mark A. Goldsmith（Revolution Medicines 首席执行官）：谢谢你的介绍，Brian，大家早上好。很高兴来到摩根大通医疗健康大会，并与大家分享Revolution Medicines的概况。我们已经取得了有意义的进展，未来一年将是变革性的一年。由于今天的演讲将包含前瞻性陈述，请参阅幻灯片第二页的法律免责声明。 在Revolution Medicines，我们的使命是大胆的：通过发现、开发和提供针对人类癌症常见驱动突变的创新靶向药物，彻底改变全球RAS成瘾性癌症患者的治疗。我们一直是RAS靶向领域的先驱，引入了多项科学药物发现和临床突破，为患者创造了令人信服的机会。 RevMed是一家处于临床后期的肿瘤学公司，正在胰腺癌、非小细胞肺癌和结直肠癌这三种常见的RAS成瘾性癌症中以此前未有的方式拓展治疗边界。我们在临床阶段拥有四种RAS(ON)抑制剂，背后还有深厚的研发管线。我们有八项正在进行或已宣布的注册性三期临床试验，并积累了广泛的临床经验，迄今已有超过2500名患者接受了我们一种或多种RAS(ON)抑制剂的治疗。今天，我们的临床阶段管线包括四种针对主要致癌驱动因子的在研药物。Daraxonrasib是我们进展最快的项目，是一种开创性且充满希望的RAS(ON)多选择性抑制剂。Elironrasib是一种高度差异化、高活性且耐受性良好的RAS(ON) G12C选择性抑制剂。Zoldonrasib是一种创新、高活性且耐受性良好的RAS(ON) G12D选择性抑制剂。我们最新的临床化合物RMC-5127，则是一种RAS(ON) G12V选择性抑制剂。 这些临床项目背后有丰富的临床前和发现阶段项目管线的支持，其中包括一类创新且令人兴奋的新型抑制剂，这类抑制剂已经提供了第五种即将进入临床的RAS(ON)抑制剂候选药物。作为一家专注于RAS成瘾性癌症的公司，我们处于有利地位，能够推出旨在改变常见癌症患者全球护理标准的新疗法。在胰腺导管腺癌中，细胞毒性化疗仍是大多数患者的护理标准，超过90%的肿瘤携带致癌RAS突变。这种毁灭性疾病迫切需要RAS靶向疗法。同样，约30%的非小细胞肺癌携带致癌RAS突变，其中18%为非G12C突变。新的有效靶向治疗仍然是一个巨大的未满足需求。在结直肠癌中，超过50%的肿瘤携带致癌RAS突变，这方面也存在高度需求。 我们专注于RAS成瘾性癌症的综合科学工作流程被设计为一个创新的良性循环，利用实验室研究、临床实践和商业洞察。这指导我们如何通过高效的Tri-Complex（三复合物）抑制剂平台发现靶向RAS的新方法，通过稳健且并行的临床开发计划开发新药，并系统地扩展我们的商业和运营能力，为全球患者提供潜在的新疗法。 胰腺癌是我们临床开发进展最快的领域，多项注册试验已经开始或计划于今年启动。Daraxonrasib在不同治疗线数、RAS突变类型和治疗方案中展现了前所未有的临床特性。目前在二线治疗中观察到的临床持久性，相对于细胞毒性化疗在二线或一线治疗中报告的无进展生存期（PFS）和总生存期（OS）率显得很有希望。该在研药物最近获得了美国FDA授予的“专员国家优先审评券”（CNPRV），这表明Daraxonrasib具有改变一线转移性胰腺癌治疗方式的潜力。 Daraxonrasib目前正在三项胰腺癌随机注册研究中进行评估。“RASolute 302”是我们针对二线转移性胰腺癌的三期试验，近期已完成全球入组，将于今年上半年读出数据。针对一线转移性疾病的“RASolute 303”和针对可切除疾病的“RASolute 304”均已启动。Zoldonrasib是我们共价结合的G12D选择性抑制剂，具有高度差异化的安全性和耐受性特征，在胰腺癌中也显示出令人鼓舞的抗肿瘤活性。我们正推进该化合物在2026年进入两项胰腺癌一线联合治疗的注册试验。“RASolute 305”将评估Zoldonrasib联合化疗的效果，“RASolute 309”将评估Zoldonrasib联合Daraxonrasib的双RAS(ON)抑制剂疗法，这是一种去化疗的治疗方案。 RASolute 303在一线转移性疾病背景下，正在评估Daraxonrasib单药治疗以及与吉西他滨/白蛋白紫杉醇（G&nP）联合治疗的效果。这项研究测试两个重要的独立假设：一种去化疗的RAS靶向单药治疗范式，以及一种包含RAS靶向药物加化疗的联合方案。RASolute 304在辅助治疗背景下，评估可切除胰腺癌患者在手术和围手术期化疗后接受Daraxonrasib单药治疗的效果。如果成功，这些试验共同有望为大多数胰腺癌患者在各个治疗线数上建立新的护理标准。 我很高兴分享截至2025年12月1日，Zoldonrasib联合FOLFIRINOX治疗的初步临床数据。全剂量Zoldonrasib（每日一次1200毫克）与全剂量改良FOLFIRINOX方案联合使用的初步安全性和耐受性特征，与FOLFIRINOX单药的已知特征基本一致。63%的患者达到了客观缓解，包括已确认和待确认的部分缓解。疾病控制率达到了95%。 我们在2025年看到显著进展的第二个重点领域是非小细胞肺癌（NSCLC）。“Resolve 301”是一项正在进行的全球随机注册研究，评估Daraxonrasib单药治疗既往接受过治疗的转移性NSCLC患者，目前在美国和国际上的入组进展顺利。Daraxonrasib联合帕博利珠单抗（pembrolizumab）治疗一线患者的早期联合数据令人鼓舞，我们正在规划一项一线注册试验。Zoldonrasib（G12D选择性）和Elironrasib（G12C选择性）在NSCLC中也显示出令人鼓舞的结果。就在上周，我们宣布Zoldonrasib获得了FDA的突破性疗法认定（BTD）——这是我们获得的第三个RAS(ON)抑制剂BTD。我们正在深入规划“RASolve 308”，这是我们针对一线转移性NSCLC的首个Zoldonrasib联合方案注册研究。Elironrasib在单药治疗、与帕博利珠单抗单药联合、或与Daraxonrasib组成双药方案中均显示出强劲的临床特征。 在结直肠癌领域，我们有一系列联合研究正在进行中。我们还继续支持与Tango Therapeutics的合作，研究我们的RAS(ON)抑制剂与PRMT5抑制剂vopimetastat联合治疗伴有MTAP缺失的患者。我们还启动了一项首次人体研究，评估我们的抑制剂与Summit Therapeutics的依沃西单抗（ivonescimab，一种PD-1/VEGF双特异性抗体）的联合应用。最后，我们已经启动了RMC-5127（RAS(ON) G12V选择性抑制剂）的首次人体研究。 我们还自豪地介绍一类创新的新型RAS(ON)抑制剂，专为克服RAS驱动的获得性耐药而设计。我们打算今年将该类别的首个化合物RM-055推进临床。临床前数据显示，在肿瘤经Daraxonrasib治疗后复发的模型中，RM-055击败了获得性RAS依赖性耐药。今年，我们计划分享更多关于这一类药物的信息，并将RM-055作为我们第五种靶向RAS的在研药物推向临床。 截至第三季度末，我们拥有19亿美元的强劲财务状况，此外还有Royalty Pharma承诺的17.5亿美元可用资本，这使我们能够进行广泛的执行。2026年将是RevMed影响力不断增强的一年。我们预计在2026年上半年提供Daraxonrasib的多项重要数据披露，包括RASolute 302试验的结果解读。问答环节 Brian Chang：谢谢Mark。我们开始问答环节。也许先问一个宏观的问题：你是否认为自己在建立某种更大的事业？你如何在建立更大的机器这一目标与进行战略交易之间取得平衡？最终，你认为RevMed在六个月和五年后会处于什么位置？ Mark A. Goldsmith：关于你问题的后半部分，我无可奉告，因为显然我们有不评论谣言或猜测的既定公司政策。但关于我们在建立什么：我们的目标不是建立“大”的东西，而是建立“有影响力”的东西。我们要保持巨大的势头。我们的组织在2025年增加了大约400人。我们致力于实现这一愿景。 Brian Chang：历史上，RevMed通常按自己的时间表披露数据。今天在这个年度大会上披露数据的理由是什么？ Mark A. Goldsmith：当数据足够成熟，能够表明项目应有的发展方向时，我们就会分享数据。我今天展示的内容与今年晚些时候将发生的事情紧密相关。我们要推动临床项目向前发展的唯一途径就是提供支持数据，这样研究人员才能理解为什么要参与其中。 Brian Chang：回到二线治疗试验（RASolute 302）。关于结果，有什么让你彻夜难眠的担忧吗？ Mark A. Goldsmith：目前来看进展非常顺利。入组速度非常快。这是一个实验，虽然我们认为有很多数据支持进行这项研究，但这终究是个实验，到时候我们自然会看到结果。 Brian Chang：你对事件（死亡病例）数接近程度有概念吗？你看过中期数据了吗？ Mark A. Goldsmith：我们追踪OS事件，即试验中的死亡病例，因为这是一个事件驱动的试验。它是盲态的。我们只知道一个总数。在揭盲之前我们无法查看数据。 Brian Chang：你能谈谈顶线数据对获批路径有多大分量吗？是否足以用于申报？ Mark A. Goldsmith：我们不知道，因为我们还不知道结果。这最初是一个中期分析。它是基于总生存期（OS）设计的功效，所以对于无进展生存期（PFS）来说功效是“溢出”的。可能会出现几种不同的情况。一种情况是试验完成，我们继续推进；另一种情况是我们获得部分所需结果但非全部。 Brian Chang：你认为今年（2026年）有可能获得批准吗？ Mark A. Goldsmith：我不想对此进行推测。有很多因素是我们无法控制的。FDA已公开承诺会非常高效，特别是在CNPRV（优先审评券）机制下，但今天的推测仅仅是推测。 Brian Chang：我们应该如何解读Zoldonrasib相对于Daraxonrasib的表现？ Mark A. Goldsmith：它们的特性不同。只有随着时间的推移，当我们完成随机三期试验后，才能真正进行比较。Zoldonrasib具有非常有利的耐受性特征，使我们能够很容易地将其与FOLFIRINOX联合使用——这是我们在Daraxonrasib上未选择的机会。 Brian Chang：为什么在一线治疗中进行两项并行研究（305和309），而不是将它们合并为一个多臂研究？ Mark A. Goldsmith：这完全是一个操作层面的问题。与并行运行两个较小的试验相比，较大的试验需要更长的时间。所以这并不能节省成本，只是出于实际后勤的考量。 Brian Chang：Elironrasib（G12C）会阻碍RevMed的增长或分散优先事项的注意力吗？ Mark A. Goldsmith：我们认为Elironrasib是一个出色的化合物。它有点像“弟弟妹妹”，因为其他药物填补了极其重要的治疗空白。G12C领域更加拥挤，所以我们必须更加深思熟虑。在将其推进到注册试验之前，我们要确保它能满足未满足的需求。 Brian Chang：今年你最期待哪项数据更新？ Mark A. Goldsmith：不如我们在房间里做个民意调查，看看答案是什么？（笑）我们可能会同意大家的看法。 Brian Chang：非常感谢。 /END/  < · 往期回顾   > △ 精彩回顾 |  2025第七届中国生物医药产业链创新转化论坛，亮点集锦 △ 精彩回顾 | 2024第六届中国生物医药产业链创新转化论坛，亮点集锦 △ 聚焦“国之大者”CBIITA 联合体荣获“中国产学研合作十大好平台” 更多优质内容，欢迎关注  媒体合作 投稿转载/资料领取/加入社群 请添加药小咖 与/智/者/同/行   为/创/新/赋/能

Advisory Board Members Will Provide Strategic Clinical Insights to Further Advance the TAMP™ Therapy Platform in Clinical Indications of High Unmet Medical NeedMOUNTAIN VIEW, Calif., Feb. 10, 2026 (GLOBE NEWSWIRE) -- RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath®, a patented, FDA-cleared drug-delivery device, today announced the formation of a dedicated RenovoCath Medical Advisory Board (“MAB”) to support its clinical and strategic initiatives. The MAB brings together leading US interventional radiology experts to provide strategic clinical insights that further advance the TAMP (Trans-Arterial Micro-Perfusion) therapy platform in clinical indications of high unmet medical need. The MAB compliments the Company’s esteemed and long-standing Scientific Advisory Board that provides specialized guidance on RenovoRx’s scientific research and clinical program strategy. The MAB will support RenovoRx’s ongoing clinical and market strategy and provide important insights into potential investigator-initiated trials supported by the Company. These capital-efficient studies are designed to provide meaningful data that may further broaden the application for the TAMP platform. Enabled by the RenovoCath device, TAMP is designed for targeted therapeutic delivery across the arterial wall near the tumor site to bathe the target tumor, while potentially minimizing a therapy’s toxicities versus systemic intravenous therapy. Current RenovoRx-supported investigator-initiated trials include borderline resectable and metastatic pancreatic cancer and could eventually lead to expansion of targeted indications. The MAB will also provide feedback to RenovoRx’s sales and marketing team as they work to bring RenovoCath to market as a standalone device within its FDA-cleared indications for use. "The formation of the MAB marks an exciting milestone for RenovoRx, and we’re honored to have such respected interventional radiology experts supporting advancement of the RenovoCath device,” said Ramtin Agah, MD, RenovoRx’s Chairman and Chief Medical Officer. “Their collective expertise will help guide real-world evidence generation as we advance our novel approach to localized, targeted drug delivery, aiming to improve outcomes for patients diagnosed with difficult-to-treat cancers.” Initial members of the MAB include: Dr. Nadine Abi-Jaoudeh, MD – UCI Health | Orange County, CA Dr. Abi-Jaoudeh serves as Chief of Interventional Radiology and Director of Clinical Research in the Department of Radiology at the University of California, Irvine as well as Deputy Editor of the Journal of Vascular and Interventional Radiology. She is recognized for her leadership in image-guided oncology and translational research. Her expertise includes minimally invasive procedures including percutaneous ablations and intra-arterial therapies, with a focus on advancing treatments in primary and metastatic hepatobiliary pancreatic cancers. Dr. Mustafa Al-Roubaie, MD – Moffitt Cancer Center | Tampa, FL Dr. Al-Roubaie has a clinical focus in interventional oncology and embolotherapy and is an active investigator with experience in minimally invasive approaches across both malignant and benign disease states. He holds academic appointments as Associate Professor of Radiology and Oncologic Sciences at the University of South Florida School of Medicine. Dr. Khashayar Farsad, MD, PhD – Oregon Health and Science University | Portland, OR Dr. Farsad is the Josef Rosch Professor and Chair of the Department of Interventional Radiology, Director of Dotter Interventional Institute, and Director of Research. He is a Fellow of the Society of Interventional Radiology and actively serves on committees through the American Board of Radiology, the Society of Interventional Radiology, and the American College of Radiology. Dr. Farsad’s areas of clinical and academic interest include interventional management of portal hypertension, image-guided treatment of solid organ malignancies, and endovascular venous reconstruction. Dr. Ripal Gandhi, MD – Baptist Health South Florida | Coral Gables, FL Dr. Gandhi serves as a principal investigator in RenovoRx’s post-marketing Registry Study, which evaluates cancer treatment delivered by RenovoCath to solid tumors. He is a leader in interventional oncology and endovascular therapy with active clinical roles at Miami Cancer Institute and Miami Cardiac & Vascular Institute. His expertise includes minimally invasive treatments for both cancer and vascular disease, and he has trained physicians worldwide while serving as program director and faculty for leading interventional radiology conferences, including Interventional Symposium on Endovascular Therapy and Clinical Interventional Oncology. Dr. Paula Marie Novelli, MD – University of Pittsburgh Medical Center | Pittsburgh, PA Dr. Novelli is a board-certified interventional radiologist with extensive experience in advanced image-guided procedures. She currently practices at University of Pittsburgh Medical Center and is an investigator in RenovoRx’s ongoing Phase III TIGeR-PaC trial evaluating intra-arterial gemcitabine delivery in locally advanced pancreatic cancer. Dr. Jonathan Kessler, MD – City of Hope Comprehensive Cancer Center | Duarte, CA Dr. Kessler is the Chief of the Division of Interventional Radiology at City of Hope, where he directs advanced interventional therapies for solid tumors. He has served at City of Hope for over a decade, with clinical expertise in ablation, embolization, and supportive oncology interventions. About RenovoCath Based on its FDA clearance, RenovoCath® is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to select sites in the peripheral vascular system. RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. For further information regarding our RenovoCath Instructions for Use (“IFU”), please see: IFU-10004-Rev.-G-Universal-IFU.pdf. About RenovoRx, Inc. RenovoRx, Inc. (Nasdaq: RNXT) is a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath®, a novel, U.S. Food and Drug Administration (FDA)-cleared local drug-delivery device, targeting high unmet medical needs. RenovoRx’s patented Trans-Arterial Micro-Perfusion (TAMP™) therapy platform is designed for targeted therapeutic delivery across the arterial wall near the tumor site to bathe the target tumor, while potentially minimizing a therapy’s toxicities versus systemic intravenous therapy. RenovoRx’s novel approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy, and its mission is to transform the lives of cancer patients by providing innovative solutions to enable targeted delivery of diagnostic and therapeutic agents. RenovoRx is in the initial stages of actively commercializing its TAMP technology and FDA-cleared RenovoCath as a stand-alone device. In December 2024, RenovoRx announced the receipt of its first commercial purchase orders for RenovoCath devices, and for the first nine months of 2025, approximately $900,000 of revenues were generated from RenovoCath sales. Several customers have already initiated repeat orders in parallel to RenovoRx expanding the number of medical institutions initiating new RenovoCath orders, including several esteemed, high-volume National Cancer Institute-designated centers. To meet and satisfy the anticipated demand, RenovoRx will continue to actively explore further revenue-generating activity, either on its own or in tandem with a medical device commercial partner. RenovoRx is also evaluating its novel drug-device combination oncology product candidate (intra-arterial gemcitabine delivered via RenovoCath, (known as IAG) in the ongoing Phase III TIGeR-PaC trial. IAG is being evaluated by the Center for Drug Evaluation and Research (the drug division of the FDA) under a U.S. investigational new drug application that is regulated by the FDA’s 21 CFR 312 pathway. IAG utilizes RenovoCath, the Company’s patented, FDA-cleared drug-delivery device, indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. The IAG combination product candidate, which is enabled by the RenovoCath device, is currently under investigation and has not been approved for commercial sale. RenovoCath with gemcitabine received Orphan Drug Designation for pancreatic cancer and bile duct cancer, which provides seven years of market exclusivity upon new drug application approval by the FDA. For more information, visit www.renovorx.com. Follow RenovoRx on Facebook, LinkedIn, and X. Cautionary Note Regarding Forward-Looking Statements This press release and statements of the Company’s management made in connection therewith contain 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, including but not limited to statements regarding the anticipated benefits to the Company of the MAB as described herein as well as (i) our clinical trials and studies, (ii) the potential for our product candidates to treat or provide clinically meaningful outcomes for certain medical conditions or diseases, and (iii) our efforts to commercialize our RenovoCath and our TAMP technology. Statements that are not purely historical are forward-looking statements. The forward-looking statements contained herein are based upon our current expectations and beliefs regarding future events, many of which, by their nature, are inherently uncertain, outside of our control, and involve assumptions that may never materialize or may prove to be incorrect. These may include estimates, projections, and statements relating to our research and development plans, intellectual property development, clinical trials, our therapy platform, business plans, financing plans, objectives, and expected operating results, which are based on current expectations and assumptions that are subject to known and unknown risks and uncertainties that may cause actual results to differ materially and adversely from those expressed or implied by these forward-looking statements. These statements may be identified using words such as “may,” “expects,” “plans,” “aims,” “anticipates,” “believes,” “forecasts,” “estimates,” “intends,” and “potential,” or the negative of these terms or other comparable terminology regarding RenovoRx’s expectations strategy, plans, or intentions, although not all forward-looking statements contain these words. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, that could cause actual events to differ materially from those projected or indicated by such statements, including, among other things: (i) the risk that our exploration of commercial opportunities for our TAMP technology may not lead to viable, revenue generating operations; (ii) circumstances which would adversely impact our ability to efficiently utilize our cash resources on hand or raise additional funding-; (iii) the timing of the initiation, progress, and potential results (including the results of interim analyses) of our preclinical studies, clinical trials, and our research programs; (iv) the possibility that interim results may not be predictive of the outcome of our clinical trials, which may not demonstrate sufficient safety and efficacy to support regulatory approval of our product candidate-;(v) that the applicable regulatory authorities may disagree with our interpretation of the data-, research, and clinical development plans and timelines, and the regulatory process for our product candidates; (vi) future potential regulatory milestones for our product candidates, including those related to current and planned clinical studies; (vii) our ability to use and expand our therapy platform to build a pipeline of product candidates; (viii) our ability to advance product candidates into, and successfully complete, clinical trials; (ix) the timing or likelihood of regulatory filings and approvals; (x) our estimates of the number of patients who suffer from the diseases we are targeting and the number of patients that may enroll in our clinical trials; (xi) the commercialization potential of our product candidates, if approved; (xii) our ability and the potential to successfully manufacture and supply our product candidates for clinical trials and for commercial use, if approved; (xiii) future strategic arrangements and/or collaborations and the potential benefits of such arrangements; (xiv) our estimates regarding expenses, future revenue, capital requirements, and needs for additional financing and our ability to obtain additional capital; (xv) the sufficiency of our existing cash and cash equivalents to fund our future operating expenses and capital expenditure requirements; (xvi) our ability to retain the continued service of our key personnel and to identify, and hire and retain additional qualified personnel; (xvii) the implementation of our strategic plans for our business and product candidates; (xviii) the scope of protection we are able to establish and maintain for intellectual property rights, including our therapy platform, product candidates, and research programs; (xix) our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; (xx) the pricing, coverage, and reimbursement of our product candidates, if approved; and (xxi) developments relating to our competitors and our industry, including competing product candidates and therapies. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in documents that we file from time to time with the Securities and Exchange Commission. Forward-looking statements included herein are made as of the date hereof, and RenovoRx does not undertake any obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as required by law. Contact:KCSA Strategic CommunicationsValter Pinto or Jack PerkinsT: 212-896-1254RenovoRX@KCSA.com