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RenovoRx, Inc

RenovoRx，股份有限公司。

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.

(“RenovoRx” or the “Company”) (Nasdaq: RNXT)

（“RenovoRx”或“公司”）（纳斯达克：RNXT）

, a life sciences company developing novel targeted oncology therapies and commercializing

RenovoCath

RenovoCath

®

®

, a novel, FDA-cleared delivery platform, today announced an abstract presentation highlighting promising pharmacokinetic (known as PK) data

，一个新的，FDA批准的交付平台，今天宣布了一个抽象的介绍，突出了有希望的药代动力学（称为PK）数据

from the use of RenovoRx’s patented

使用RenovoRx的专利

Trans-Arterial Micro-Perfusion (TAMP™)

经动脉微灌注（TAMP™）

therapy platform in treating locally advanced pancreatic cancer (LAPC).

治疗局部晚期胰腺癌（LAPC）的治疗平台。

The abstract was presented at the ASCO Gastrointestinal Cancers Symposium (ASCO GI) 2025, by Paula Novelli, MD, University of Pittsburgh Medical Center, which is currently underway in San Francisco, CA.

该摘要由匹兹堡大学医学中心医学博士PaulaNovelli在2025年ASCO胃肠道癌症研讨会（ASCO GI）上发表，该研讨会目前正在加利福尼亚州旧金山进行。

Dr. Novelli, together with her co-authors, presented “

Novelli博士及其合著者介绍了“

Intra-arterial Gemcitabine Versus Intravenous Gemcitabine: Pharmacokinetic Sub-study of the TIGeR-PaC Phase 3 Clinical Trial

动脉内吉西他滨与静脉内吉西他滨：TIGeR PaC 3期临床试验的药代动力学亚研究

,” a sub-study of RenovoRx’s ongoing pivotal Phase III TIGeR-PaC clinical trial in LAPC. In this sub-study, PK analyses were performed on a sample of participants across TIGeR-PaC study clinical sites. These analyses compared treatment with intra-arterial gemcitabine (IAG), using the RenovoCath delivery system via TAMP, versus systemic intravenous gemcitabine, which is the current standard of care for patients with LAPC..

，“RenovoRx正在LAPC进行的关键性III期TIGeR PaC临床试验的子研究。在这项子研究中，对TIGeR PaC研究临床站点的参与者样本进行了PK分析。这些分析比较了使用经TAMP的RenovoCath递送系统与动脉内吉西他滨（IAG）的治疗与全身静脉注射吉西他滨（目前LAPC患者的护理标准）的治疗。。

Results of the sub-study showed RenovoRx’s IAG approach to drug delivery via TAMP decreased systemic levels of gemcitabine versus standard of care. In addition to providing increased local drug potency, the IAG approach may also be beneficial to decreasing gemcitabine-related systemic side effects. TAMP is designed to ensure precise 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..

该子研究的结果显示，与标准治疗相比，RenovoRx通过TAMP进行药物输送的IAG方法降低了吉西他滨的全身水平。除了提供增加的局部药物效力外，IAG方法还可能有利于减少吉西他滨相关的全身副作用。TAMP旨在确保通过肿瘤部位附近的动脉壁进行精确的治疗输送，以沐浴目标肿瘤，同时与全身静脉治疗相比，可能最大程度地降低治疗的毒性。。

“Pancreatic cancer remains one of the most challenging cancers to treat, and this new data further highlights the potential of RenovoRx’s TAMP therapy platform as a transformative therapeutic option,” said Paula Novelli MD, TIGeR-PaC Principal Investigator at University of Pittsburgh Medical Center.

匹兹堡大学医学中心TIGeR PaC首席研究员Paula Novelli医学博士说：“胰腺癌仍然是治疗最具挑战性的癌症之一，这一新数据进一步突显了RenovoRx的TAMP治疗平台作为一种变革性治疗选择的潜力。”。

“TAMP is intended to direct a drug and more effectively target the tumor while minimizing systemic impact, and this sub-study shows that despite delivering more gemcitabine in a shorter time, the total systemic drug exposure was significantly lower compared to intravenous treatment. This data further demonstrates that TAMP has the potential to deliver gemcitabine to the tumor more efficiently, enhancing local treatment effectiveness while reducing the broader impact on the body, ultimately minimizing the systemic side effects of chemotherapy.”.

“TAMP旨在指导药物并更有效地靶向肿瘤，同时最大程度地减少全身影响，这项亚研究表明，尽管在较短时间内提供更多吉西他滨，但与静脉注射治疗相比，全身药物暴露总量显着降低。这一数据进一步表明，TAMP有可能更有效地将吉西他滨递送至肿瘤，提高局部治疗效果，同时减少对身体的更广泛影响，最终最大程度地减少化疗的全身副作用。”。

About the TIGeR-PaC Clinical Trial

关于TIGeR PaC临床试验

TIGeR-PaC is an ongoing Phase III randomized multi-center study evaluating the proprietary

TIGeR PaC是一项正在进行的III期随机多中心研究，评估专利

TAMP™

TAMP™

(Trans-Arterial Micro-Perfusion) therapy platform for the treatment of locally advanced pancreatic cancer (LAPC.) RenovoRx’s first product candidate using the TAMP technology, is a novel investigational oncology drug-device combination utilizing RenovoRx’s FDA-cleared

（经动脉微灌注）治疗局部晚期胰腺癌（LAPC）的治疗平台。RenovoRx的第一个候选产品使用TAMP技术，是一种利用RenovoRx的FDA批准的新型研究性肿瘤药物装置组合

RenovoCath

续订Cath

®

®

device for the intra-arterial administration of chemotherapy, gemcitabine.

用于动脉内化疗的装置，吉西他滨。

The first interim analysis in the Phase III clinical trial was completed in March 2023, with the Data Monitoring Committee recommending a continuation of the study. The study's primary endpoint is an Overall Survival benefit with secondary endpoints including reduced side effects versus standard of care.

第三阶段临床试验的第一次中期分析于2023年3月完成，数据监测委员会建议继续研究。。

The second interim analysis for this study will be triggered by the 52.

这项研究的第二次中期分析将由52引发。

nd

nd公司

event (i.e., patient death), which is estimated to occur in early 2025. The second interim data readout is anticipated to occur by the end of the first half of 2025, with the timing for such readout, however, being dependent on customary factors such as time needed for analysis. RenovoRx is also aiming to complete patient enrollment in the TIGeR-PaC study in the first half of 2025..

事件（即患者死亡），预计发生在2025年初。第二次中期数据读出预计将在2025年上半年结束前进行，但读出时间取决于常规因素，如分析所需的时间。RenovoRx还计划在2025年上半年完成TIGeR PaC研究的患者登记。。

About RenovoCath

关于RenovoCath

Based on its FDA clearance,

根据FDA的批准，

RenovoCath

RenovoCath

®

®

is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system. RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion.

用于隔离血流并将液体（包括诊断和/或治疗剂）输送至外周血管系统中的选定部位。RenovoCath还适用于动脉造影，术前闭塞和化疗药物输注等应用中的临时血管闭塞。

For further information regarding our RenovoCath Instructions for Use (“IFU”), please see: .

。

IFU-10004-Rev.-F-Universal-IFU.pdf

IFU-10004-Rev.-F-Universal-IFU.pdf

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About RenovoRx, Inc.

关于RenovoRx, Inc.

RenovoRx is a life sciences company developing novel targeted oncology therapies and commercializing

RenovoRx是一家生命科学公司，开发新型靶向肿瘤疗法并将其商业化

RenovoCath

RenovoCath

®

®

, a novel, U.S. Food and Drug Administration (FDA)-cleared local drug-delivery platform, targeting high unmet medical needs. RenovoRx’s patented

，一个新颖的，美国食品和药物管理局（FDA）批准的当地药物输送平台，针对高度未满足的医疗需求。RenovoRx的专利

Trans-Arterial Micro-Perfusion (TAMP™)

经动脉微灌注（TAMP™）

therapy platform is designed to ensure precise 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..

治疗平台旨在确保通过肿瘤部位附近的动脉壁进行精确的治疗输送，以沐浴目标肿瘤，同时与全身静脉治疗相比，潜在地最大限度地减少治疗的毒性。RenovoRx的新型靶向治疗方法具有提高安全性，耐受性和改善疗效的潜力，其使命是通过提供创新的解决方案来实现诊断和治疗药物的靶向递送，从而改变癌症患者的生活。。

RenovoRx’s Phase III lead product candidate is a novel oncology drug-device combination product. It is being investigated under a U.S. investigational new drug application that is regulated by the FDA’s 21 CFR 312 pathway. The investigational drug-device combination candidate utilizes RenovoCath

RenovoRx的III期先导产品候选产品是一种新型肿瘤药物-装置组合产品。目前正在根据美国FDA的21 CFR 312途径监管的美国研究性新药申请进行调查。研究药物装置组合候选人利用RenovoCath

,

,

the Company’s FDA-cleared drug-delivery device, indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. The intra-arterial infusion of chemotherapy, gemcitabine, utilizing the RenovoCath catheter is currently being evaluated for the treatment of locally advanced pancreatic cancer (LAPC) by the Center for Drug Evaluation and Research (the drug division of FDA)..

该公司的FDA批准的药物输送装置，适用于动脉造影，术前闭塞和化疗药物输注等应用中的临时血管闭塞。目前，药物评估和研究中心（FDA药物部门）正在评估使用RenovoCath导管动脉内输注化疗吉西他滨治疗局部晚期胰腺癌（LAPC）。。

The intra-arterial infusion of gemcitabine by the RenovoCath catheter 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 7 years of market exclusivity upon NDA approval by the FDA..

目前正在研究RenovoCath导管动脉内输注吉西他滨，尚未批准商业销售。RenovoCath和吉西他滨获得了胰腺癌和胆管癌的孤儿药指定，在FDA批准NDA后，该药物具有7年的市场排他性。。

RenovoRx is also engaged in implementing commercialization strategies utilizing its TAMP technology and FDA-cleared RenovoCath delivery system as a stand-alone device. In December 2024, RenovoRx announced the receipt of its first commercial purchase orders for RenovoCath devices. Additionally, over ten medical institutions have initiated the process for RenovoCath purchase orders.

RenovoRx还利用其TAMP技术和FDA批准的RenovoCath输送系统作为独立设备，实施商业化战略。2024年12月，RenovoRx宣布收到其第一批RenovoCath设备的商业采购订单。此外，十多家医疗机构已经启动了RenovoCath采购订单的流程。

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..

为了满足预期的需求，RenovoRx将继续积极探索进一步的创收活动，无论是自己还是与医疗器械商业合作伙伴合作。。

For more information, visit

有关更多信息，请访问

www.renovorx.com

www.renovorx.com

. Follow RenovoRx on

.跟随RenovoRx

Facebook

脸书

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LinkedIn

LinkedIn

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Cautionary Note Regarding Forward-Looking Statements

关于前瞻性声明的警示说明

This press release and statements of the Company’s management made in connection therewith and at the investor conference described herein 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 (i) our clinical trials and studies, including the overall timing and timing for additional interim data readouts for our ongoing TIGeR-PaC Phase III clinical trial study in LAPC, (ii) the potential of RenovoCath.

本新闻稿和公司管理层就此发表的声明以及在本文所述的投资者会议上发表的声明包含《1933年证券法》第27A节和《1934年证券交易法》第21E节所指的前瞻性声明，包括但不限于以下声明：（i）我们的临床试验和研究，包括我们正在LAPC进行的TIGeR PaC III期临床试验研究的总体时间和额外中期数据读数的时间，（ii）RenovoCath的潜力。

®

®

or TAMP™ as standalone commercial products and our commercialization plans in general, (iii) the potential for our product candidates to treat or provide clinically meaningful outcomes for certain medical conditions or diseases and (iii) our efforts to explore commercialization strategies utilizing our TAMP technology.

或TAMP™作为独立的商业产品和我们的商业化计划，（iii）我们的候选产品治疗某些医疗条件或疾病或提供具有临床意义的结果的潜力，以及（iii）我们利用TAMP技术探索商业化策略的努力。

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.

不纯粹是历史性的陈述是前瞻性陈述。本文所含的前瞻性陈述基于我们目前对未来事件的期望和信念，其中许多本质上是不确定的，超出了我们的控制范围，并且涉及可能永远不会实现或可能被证明是不正确的假设。

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.

这些可能包括与我们的研发计划、知识产权开发、临床试验、我们的治疗平台、商业计划、融资计划、目标和预期经营成果有关的估计、预测和陈述，这些估计、预测和陈述基于当前的预期和假设，这些预期和假设受到已知和未知风险和不确定性的影响，这些风险和不确定性可能导致实际结果与这些前瞻性陈述所表达或暗示的结果产生重大不利影响。

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.

这些陈述可以使用“可能”、“预期”、“计划”、“目标”、“预期”、“相信”、“预测”、“估计”、“打算”和“潜在”等词语，或者这些词语的否定词或其他与RenovoRx的预期策略、计划或意图有关的类似术语来识别，尽管并非所有前瞻性陈述都包含这些词语。

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.

这些前瞻性声明受到许多风险、不确定性和假设的影响，这些风险、不确定性和假设可能导致实际事件与此类声明所预测或指示的事件有重大差异，其中包括：（i）风险。

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.

本文件中包含的前瞻性声明是在本文件签署之日做出的，除法律要求外，RenovoRx不承担任何义务公开更新此类前瞻性声明以反映后续事件或情况。