Pre-Clinical Data Recently Presented at the SIO 2025 Annual Conference Show that Intra-Arterial Administration of a Drug with the RenovoCath® Delivery System via TAMP May Improve Delivery in Difficult-to-Treat Cancers

The Results of this Pre-clinical Study Support a More Optimized Drug Delivery Method in Tumors that Lack Sufficient Blood Supply for Adequate Drug Penetration During Therapy

RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a life sciences company developing novel targeted oncology therapies and commercializing RenovoCath, an innovative, FDA-cleared device, highlighted its recent abstract presentation at the 2025 Society of Interventional Oncology Annual Conference (“SIO 2025”) in Las Vegas, Nevada. The abstract published promising pre-clinical data from the use of RenovoRx’s patented Trans-Arterial Micro-Perfusion (TAMP) therapy platform, which aims to optimize local and targeted drug delivery in difficult-to-treat cancers.

The abstract, titled “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,” was presented at SIO 2025 on February 3, 2025 by Paula Novelli, MD, of the University of Pittsburgh Medical Center.

The results of the study support a more optimized drug delivery method for tumors that suffer from limited blood supply and poor drug penetration. The TAMP technique was evaluated in a porcine (pig) model utilizing micro-CT imaging for precise monitoring of drug penetration into tissue.

The pre-clinical data shows that drug delivery with the patented, FDA-cleared dual balloon RenovoCath device via TAMP potentially may improve localized drug delivery by achieving greater drug penetration in the microvasculature near the target tumor. The data shows that, by using RenovoCath, researchers were able to isolate sections of the blood vessel through the adjustment of the distance between the occlusion balloons, thereby excluding any off-target side branches. Researchers were able to confirm the level of penetration into the targeted area utilizing micro-CT imaging. The penetration achieved appears to be consistent with a more optimized drug delivery. The observed effect is expected to be even stronger if radiation is applied beforehand.

“This study highlights that TAMP is an encouraging approach for improving localized drug delivery to difficult-to-treat tumor areas. By understanding how the infusion medium penetrates tissue, techniques can be refined for better clinical outcomes, especially for patients with cancers like pancreatic adenocarcinoma,” said Dr. Ramtin Agah, RenovoRx’s Founder, Chairman of the Board and Chief Medical Officer and one of the study’s authors. “We look forward to continued research in hypovascular tumors using minimally invasive procedures and are also working on a radiation sub-study. With continued investigation, we believe TAMP has the potential to revolutionize how interventional oncologists approach cancer treatment, offering a more targeted, effective solution for challenging cases.”

The procedure in this study utilized a porcine model, where the RenovoCath device was effectively employed to deliver a technique involved inflating the catheter balloons in the splenic artery, the superior mesenteric artery and renal artery. This approach enabled precise side branch exclusion in both vascular regions, ensuring targeted and controlled intervention, allowing for extensive filling of the microvessels with Microfil® (a micro-CT imaging following an injection of a radiopaque silicone rubber imaging reagent) in the perivascular space. In comparison, the control group, where balloons in the splenic arteries were left deflated, showed minimal Microfil filling beyond the main artery, as confirmed by micro-CT imaging. These striking differences highlight the potential of this technique to drive forward the development of targeted therapies, especially for complex cancers like pancreatic adenocarcinoma.

“We are excited to highlight this pre-clinical data abstract presented at SIO 2025. Including procedures performed as part of clinical trials, intra-arterial drug delivery by RenovoCath has been used in over 500 procedures by oncologists and interventional radiologists over the past several years,” said Shaun Bagai, RenovoRx CEO.

Mr. Bagai added, “Based on recent positive feedback we have received from medical practitioners, we have launched an effort to commercialize RenovoCath as a stand-alone device within its FDA-cleared indications for use in temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion.”

Additionally, the TAMP therapy platform was the topic of the SIO 2025 panel discussion “Breaking Barriers in Drug Delivery: Trans-Arterial Micro-Perfusion,” where key interventional oncologists including Dr. Novelli, Khashayar Farsad, MD, PhD, Oregon Health and Science University, and David Sperling, MD, FSIR, Columbia University Irving Medical Center discussed their experience with the therapy platform and the RenovoCath device.

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 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. For further information regarding our RenovoCath Instructions for Use (“IFU”), please see: IFU-10004-Rev.-F-Universal-IFU.pdf.

About RenovoRx, Inc.

RenovoRx 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 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.

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, 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 device 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).

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.

RenovoRx is also engaged in implementing commercialization strategies utilizing its TAMP technology and FDA-cleared RenovoCath device 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. 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.

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 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 pre-clinical and 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® 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. 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 TIGeR-PaC and any other 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.

KCSA Strategic Communications Valter Pinto or Jack Perkins T:212-896-1254 RenovoRX@KCSA.com

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