RenovoRx Advances TAMP™ into Borderline Resectable Pancreatic Cancer with First Patient Enrolled in Investigator-Initiated PRISM-TAMP Trial

MOUNTAIN VIEW, Calif., Oct. 07, 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, announced today that the first patient has enrolled in PRISM-TAMP, “PDAC Regression and Intraoperative Surgical Margin With Neoadjuvant TAMP,” an investigator-initiated trial (IIT) sponsored by the University of Vermont (UVM). One week after the IIT began, a second patient is also progressing toward TAMP treatment.

PRISM-TAMP is evaluating the approved chemotherapy gemcitabine delivered through RenovoRx’s Trans-Arterial Micro-Perfusion (TAMP) platform, enabled by RenovoCath, as neoadjuvant treatment before surgery in patients with borderline Pancreatic Ductal Adenocarcinoma (PDAC). PRISM-TAMP is the first RenovoRx supported IIT to advance to patient enrollment. UVM plans to enroll approximately 10 patients and is registered on ClinicalTrials.gov (NCT07477418). The primary focus of PRISM-TAMP is to assess PDAC tumor regression, the impact on intraoperative surgical margins following neoadjuvant (pre-surgical) treatment, and overall safety and tolerability.

In borderline resectable pancreatic cancer, the tumor involves nearby blood vessels to a degree that can make complete surgical removal difficult. Patients typically receive chemotherapy, with or without radiation, before surgery, and typically receive such treatment systemically, rather than administered locally near the tumor site as TAMP is designed to do.

“For patients with borderline resectable pancreatic cancer, treatment before surgery can influence both whether surgery is possible and how completely the tumor can be removed,” said Conor O’Neill, MD, Assistant Professor at the UVM Larner College of Medicine and surgical oncologist at the UVM Medical Center, and principal investigator of PRISM-TAMP. “PRISM-TAMP will assess whether delivering chemotherapy directly near the tumor through TAMP before surgery can improve local therapeutic response and surgical outcomes. We are pleased to have enrolled our first patient in this important study.”

“As TAMP becomes more well known in the marketplace, physicians have asked how TAMP could be used in borderline resectable pancreatic cancer and other settings beyond locally advanced pancreatic cancer, which is the focus of our ongoing Phase III clinical trial,” said Leesa Gentry, Chief Clinical Officer of RenovoRx. “Enrolling the first PRISM-TAMP patient marks an important step for our IIT program as it moves from concept to clinical execution. These capital-efficient trials enable independent investigators to generate safety and tolerability data of new applications for TAMP, while we remain focused on completing the Phase III TIGeR-PaC trial and reporting topline data in the second half of 2027.”

UVM is evaluating RenovoRx's novel drug-device combination oncology product candidate intra-arterial gemcitabine delivered via RenovoCath (known as IAG) within the PRISM-TAMP study.

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.-H-Universal-IFU.pdf.

About RenovoRx, Inc.

RenovoRx, Inc. (Nasdaq: RNXT) is a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath^®, a patented, 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 actively commercializing its TAMP technology and FDA-cleared RenovoCath as a standalone device. For its first full year of commercial efforts in 2025, RenovoRx generated approximately $1.1 million in RenovoCath sales, followed by record quarterly revenue of $909,000 in the second quarter of 2026. RenovoRx is actively working to expand the number of medical institutions initiating new RenovoCath orders, including esteemed, high-volume National Cancer Institute-designated centers.

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, which is FDA-cleared for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. RenovoRx achieved full enrollment in the TIGeR-PaC trial in August 2026, with completion of the trial expected in the first half of 2027 and topline data readout expected in the second half of 2027.

The IAG combination product candidate, enabled by the RenovoCath device, is currently under investigation and has not been approved for commercial sale. RenovoCath with gemcitabine received Orphan Drug Designation (ODD) for pancreatic cancer and bile duct cancer, and oxaliplatin has received ODD for pancreatic cancer, each of 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 and third parties 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 (i) our clinical trials and studies (including IITs and including our expectations for trial completion and interim or final data read out), (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 TAMP technology for use in treating pancreatic and other solid tumor cancers, and our expected financial results from such efforts, including our estimates for 2026 annual revenue. 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, commercial and other business plans, intellectual property development, clinical trials, our therapy platform, financing plans, objectives, and expected operating results, all of which are based on current expectations and assumptions that are subject to significant 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,” “aim,” “goal,” “estimates,” “intends,” and “potential,” or derivatives of these terms or other comparable terminology regarding RenovoRx’s statements about the future, 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 commercial efforts for our TAMP technology (enabled by RenovoCath) may not lead to the achievement of our revenue forecasts or to viable, revenue generating operations in general; (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, completion and potential results (including the results of interim analyses) of our preclinical studies, clinical trials, IITs, and our research programs (notably with respect to our TIGeR-PaC trial); (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 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, needs for additional financing, our ability to obtain additional capital and our ability to maintain the listing of our common stock on Nasdaq; (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, hire and retain additional qualified personnel; (xvii) the scope of protection we are able to establish and maintain for intellectual property rights, including our therapy platform, product candidates, and research programs; (xviii) our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; (xix) the pricing, coverage, and reimbursement of our product candidates, if approved; and (xx) 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, which can be accessed at https://ir.renovorx.com/sec-filings.

As a result of the foregoing, readers are cautioned to not place undue reliance on forward-looking statements, which do not represent promises or guarantees by RenovoRx. 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.

Investor Contact:
KCSA Strategic Communications
Valter Pinto or Jack Perkins
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renovorx@kcsa.com

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Hannah Williams
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