MOUNTAIN VIEW, Calif.--(

加利福尼亚州山景城--(

BUSINESS WIRE

商业热线

)--

)--

RenovoRx, Inc

RenovoRx，股份有限公司。

. (“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

，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

续订Cath

®

®

, a novel, FDA-cleared delivery platform, today announced three abstracts were accepted to be presented at several upcoming industry conferences including ASCO Gastrointestinal Cancers Symposium (ASCO GI) 2025, Society of Interventional Oncology (SIO) 2025 and Society of Surgical Oncology (SSO) 2025..

，一个新的，FDA批准的交付平台，今天宣布三篇摘要被接受在几个即将举行的行业会议上发表，包括ASCO胃肠道癌症研讨会（ASCO GI）2025，介入肿瘤学会（SIO）2025和外科肿瘤学会（SSO）2025。。

The abstracts support RenovoRx’s novel and patented

摘要支持雷诺沃克斯的小说和专利

TAMP

夯实

therapy platform via additional human PK data and pre-clinical data. 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. RenovoRx’s novel approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy..

通过其他人类PK数据和临床前数据的治疗平台。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。。

RenovoRx’s pivotal ongoing Phase III

RenovoRx关键的正在进行的第三阶段

TIGeR-PaC clinical trial is evaluating the Company’s

TIGeR PaC临床试验正在评估该公司的

first product candidate, a novel investigational oncology drug-device combination utilizing the Company’s FDA-cleared

第一个候选产品，一种利用该公司FDA批准的新型研究性肿瘤药物装置组合

RenovoCath

续订Cath

device via TAMP for the intra-arterial administration of chemotherapy, gemcitabine. RenovoRx currently anticipates completion of both patient enrollment and the second interim analysis for TIGeR-PaC by the end of the first half of 2025.

通过TAMP进行动脉内化疗吉西他滨的装置。RenovoRx目前预计在2025年上半年结束前完成患者登记和TIGeR PaC的第二次中期分析。

Abstract Details:

摘要详细信息：

ASCO GI 2025

《京都议定书》2025

Title:

标题：

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

Authors:

作者：

Paula Novelli MD, Amer Zureikat MD, Michael Pishvaian MD, Kenneth Meredith MD, Hassan Hatoum MD, Emmanuel Zervos MD, Reza Nazemzadeh MD, Sandeep Loria MD, Ramtin Agah MD

Paula Novelli医学博士、Zureikat医学博士、Michael Pishvian医学博士、Kenneth Meredith医学博士、Hassan Hatoum医学博士、Emmanuel Zervos医学博士、Nazemzadeh医学博士，Sandeep Loria医学博士、Ramtin Agah医学博士

Location:

地点：

Moscone West, San Francisco CA

加利福尼亚州旧金山Moscone West

Date/Time:

日期/时间：

January 24, 2025 at 11:30 a.m. PT

2025年1月24日上午11:30 PT

SIO 2025

SIO 2025

Title:

标题：

Micro-CT imaging following intra-arterial delivery of a radiopaque silicone polymer using a double-balloon occlusion catheter in pigs: a model to analyze tissue penetration via the trans-arterial micro perfusion (TAMP) technique

在猪中使用双球囊闭塞导管动脉内递送不透射线的有机硅聚合物后的显微CT成像：通过经动脉微灌注（TAMP）技术分析组织穿透的模型

Authors:

作者：

Paula Novelli MD, Christopher Laing MD, Aloke Finn MD, Frank Kolodgie PhD, Robert Strasser BSc, Ramtin Agah MD

Paula Novelli医学博士，Christopher Laing医学博士，Aloke Finn医学博士，Frank Kolodgie博士，Robert Strasser理学学士，Ramtin Agah医学博士

Location:

地点：

Horseshoe Las Vegas, Las Vegas NV

拉斯维加斯，拉斯维加斯

Date/Time:

日期/时间：

February 2, 2025 at 12:30 p.m. PT

2025年2月2日下午12:30 PT

SSO 2025

SSO 2025

Title:

标题：

Pharmacodynamics of Intra-arterial vs. Intravenous Gemcitabine in Locally Advanced Pancreatic Cancer: Results of a Phase III Randomized Clinical Trial

局部晚期胰腺癌动脉内与静脉内吉西他滨的药效学：III期随机临床试验的结果

Authors:

作者：

Emmanuel Zervos MD, Paula Novelli MD, Amer Zureikat MD, Michael Pishvaian MD, Kenneth Meredith MD, Hassan Hatoum MD, Reza Nazemzadeh MD, Sandeep Loria MD, Ramtin Agah MD

Emmanuel Zervos医学博士、Paula Novelli医学博士、Zureikat医学博士、Michael Pishvian医学博士、Kenneth Meredith医学博士、Hassan Hatoum医学博士、Nazemzadeh医学博士，Sandeep Loria医学博士、Ramtin Agah医学博士

Location:

地点：

Tampa Convention Center, Tampa FL

佛罗里达州坦帕市坦帕会议中心

Dates:

日期：

March 27 – 29, 2025

2025年3月27日至29日

The abstracts accepted at ASCO GI 2025 and SSO 2025 are sub-studies of the ongoing Phase III TIGeR-PaC clinical trial.

ASCO GI 2025和SSO 2025接受的摘要是正在进行的III期TIGeR PaC临床试验的子研究。

“These abstracts support the potential for our TAMP therapy platform to provide a meaningful advancement in the standard of care for cancer treatment,” said Ramtin Agah, MD, Chief Medical Officer and Founder of RenovoRx. “TAMP focuses on drug concentration optimization in tumors by delivering therapies with our RenovoCath delivery system.

“这些摘要支持我们的TAMP治疗平台在癌症治疗标准方面提供有意义的进步的潜力，”雷诺沃克斯首席医疗官兼创始人Ramtin Agah医学博士说。“TAMP通过我们的RenovoCath输送系统提供治疗，专注于肿瘤中药物浓度的优化。

This targeted approach to cancer treatment is designed to enable physicians to isolate segments of the vascular anatomy closest to tumors and ensure precise therapeutic delivery, while potentially minimizing a therapy’s toxicities versus the standard of care. Specifically, our approach enables physicians to utilize RenovoCath to use pressure to force chemotherapy across the arterial wall near the tumor site to bathe the target tumor.”.

这种有针对性的癌症治疗方法旨在使医生能够分离出最接近肿瘤的血管解剖部分，并确保精确的治疗效果，同时可能最大限度地减少治疗的毒性。具体而言，我们的方法使医生能够利用RenovoCath使用压力迫使化疗穿过肿瘤部位附近的动脉壁以沐浴目标肿瘤。“。

Dr. Agah added, “We also look forward to the completion of patient enrollment and our second interim analysis in our pivotal Phase III TIGeR-PaC clinical trial in LAPC by the end of the first half of 2025.”

Agah博士补充道：“我们也期待着在2025年上半年结束之前，在LAPC关键的III期TIGeR PaC临床试验中完成患者登记和第二次中期分析。”

About RenovoCath

关于RenovoCath

Based on its FDA clearance,

根据FDA的批准，

RenovoCath

续订Cath

®

®

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: .

有关RenovoCath使用说明（“IFU”）的更多信息，请参阅：。

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

IFU-10004-Rev.F-大学版-IFU.pdf

.

.

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 the Company’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的第一个使用TAMP技术的候选产品是一种新型的研究性肿瘤药物装置组合，利用该公司的FDA批准

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。该研究的主要终点是总体生存获益，次要终点包括与标准护理相比副作用减少。

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 late 2024 or early 2025. The second interim data readout would follow thereafter, with the timing for such readout depending 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），估计发生在2024年末或2025年初。随后将进行第二次临时数据读取，读取时间取决于常规因素，例如分析所需的时间。RenovoRx还计划在2025年上半年完成TIGeR PaC研究的患者登记。。

About RenovoRx, Inc.

关于RenovoRx，股份有限公司。

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®

续订Cath®

, 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，可能最大程度地降低治疗的毒性。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。。

The Company’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

该公司的III期领先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

续订Cath

®

®

,

,

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后提供了7年的市场排他性。。

RenovoRx is also actively exploring other commercialization strategies utilizing its TAMP technology and FDA-cleared RenovoCath delivery system as a stand-alone device.

RenovoRx还积极探索其他商业化策略，利用其TAMP技术和FDA批准的RenovoCath输送系统作为独立设备。

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

,

,

LinkedIn

LinkedIn

, and

，以及

X

十

.

.

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存在重大不利差异。

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存在重大差异，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。