RenovoRx Highlights New Human Pharmacokinetic Data Abstract at SSO 2025 Annual Meeting

Data supports the novel Trans-Arterial Micro-Perfusion (TAMPTM*) therapy platform for targeted chemotherapy delivery for the potential to minimize a therapy’s toxicities versus systemic intravenous therapies*

Data shows localized, intra-arterial delivery of gemcitabine with FDA-cleared RenovoCath® device (known as IAG) resulted in lower systemic levels of drug compared to intravenous delivery of gemcitabine

MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--RenovoRx, Inc**. (“RenovoRx” or the “Company”) (Nasdaq: RNXT)**, a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath®, a novel, FDA-cleared drug-delivery device, announced today that a new human pharmacokinetic (PK) data abstract was presented at the Society of Surgical Oncology (SSO) 2025 Annual Meeting on March 27 – 29, 2025 in Tampa, FL: ePoster P379.

The abstract provides new human PK data relevant to RenovoRx’s proprietary Trans-Arterial Micro-Perfusion (TAMPTM) therapy platform. TAMP is key to the Company’s Phase III investigational drug-device combination oncology product candidate (intra-arterial gemcitabine, with RenovoCath, known as IAG) and is designed to ensure 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 therapies. RenovoRx’s novel approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy.

The abstract, titled “Pharmacodynamics of Intra-arterial vs. Intravenous Gemcitabine in Locally Advanced Pancreatic Cancer: Results of a Phase III Randomized Clinical Trial,” was authored by Emmanuel E. Zervos, M.D. of East Carolina University, and co-authored by Ramtin Agah, M.D., founder and Chief Medical Officer of RenovoRx and others.

“The data presented in this abstract support the potential for the TAMP therapy platform to provide a meaningful advancement in the standard of care for oncology therapy in difficult-to-treat tumors,” said Dr. Zervos. “This study shows additional support for TAMP as a potential treatment option in locally advanced pancreatic cancer (LAPC). Specifically, in this analysis, localized, dual-balloon catheter-mediated IAG resulted in lower systemic levels of gemcitabine compared to intravenous gemcitabine. IAG may prove beneficial in decreasing chemotherapy-related systemic side effects. We are awaiting final outcomes in the ongoing Phase III TIGeR-PaC clinical trial for IAG to validate this benefit.”

PK analyses were performed on 19 patients with locally advanced pancreatic cancer receiving IAG from six sites as part of the TIGeR-PaC trial. In this analysis, localized, dual-balloon catheter-mediated IAG resulted in lower systemic levels compared to intravenous delivery of gemcitabine. As such, the study found that IAG may be beneficial in decreasing chemotherapy-related systemic side effects. Correlative patient reported outcomes in patients receiving IAG supports this approach as an alternative for LAPC patients who are having difficulty tolerating more traditional systemic regimens.

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 the TIGeR-PaC Clinical Trial

TIGeR-PaC is an ongoing Phase III randomized multi-center study evaluating the proprietary TAMP™ (Trans-Arterial Micro-Perfusion) therapy platform for the treatment of LAPC. RenovoRx’s first investigational drug-device combination product candidate using the TAMP therapy platform enabled with the Company’s FDA-cleared RenovoCath® device for the intra-arterial administration of chemotherapy, gemcitabine (IAG).

About RenovoRx, Inc.

RenovoRx (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 to ensure 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.

In addition to the RenovoCath device, RenovoRx is also evaluating our novel Phase III drug-device combination oncology product candidate (intra-arterial gemcitabine, known as IAG). IAG is being evaluated under a U.S. investigational new drug application that is regulated by the FDA’s 21 CFR 312 pathway. The investigational IAG 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 combination of intra-arterial infusion of chemotherapy, gemcitabine, and the RenovoCath device is currently being evaluated for the treatment of LAPC by the Center for Drug Evaluation and Research (the drug division of FDA).

The combination product candidate, which is enabled 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 7 years of market exclusivity upon new drug application approval by the FDA.

RenovoRx is also engaged in implementing commercialization strategies utilizing its TAMP technology and FDA-cleared RenovoCath device as stand-alone device. In December 2024, RenovoRx announced the receipt of its first commercial purchase orders for RenovoCath devices. Additionally, certain of these customers have already initiated repeat orders as RenovoRx works to expand the number medical institutions that have initiated the process for RenovoCath purchase 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.

For more information, visit www.renovorx.com. Follow RenovoRx on Facebook, LinkedIn, and X.

Contacts

KCSA Strategic Communications Valter Pinto or Jack Perkins T: 212-896-1254 [email protected]