RenovoRx Pre-Clinical Results Supporting TAMP™ as a Targeted Locoregional Drug Delivery Platform to Receive Award at SIR 2025 Annual Scientific Meeting

Rhea-AI Summary

RenovoRx (Nasdaq: RNXT) announces that their research on the Trans-Arterial Micro-Perfusion (TAMP) therapy platform will be honored at the SIR 2025 Annual Scientific Meeting as a Journal of Vascular and Interventional Radiology Award-Winning Paper.

The peer-reviewed research demonstrates that TAMP significantly enhances drug delivery with a 100-fold increase in local tissue concentration compared to conventional intravenous delivery. The paper, titled 'Double-Balloon Catheter–Mediated Transarterial Chemotherapy Delivery in a Swine Model,' will be presented by Dr. Ramtin Agah at the conference in Nashville on April 1, 2025.

Unlike traditional systemic chemotherapy, TAMP's innovative approach uses RenovoCath®, an FDA-cleared drug-delivery device, to directly target solid tumors while potentially reducing systemic toxicity. The company is currently conducting the TIGeR-PaC Phase III clinical trial and accelerating the commercialization of RenovoCath as a standalone device through partnerships with leading oncology centers nationwide.

Peer-reviewed paper will be honored as a Journal of Vascular and Interventional Radiology Award-Winning Paper

Pre-clinical data show that TAMP increases intra-arterial pressure, improving drug delivery with 100-fold increase in local tissue concentration of the therapy

TAMP offers the potential to increase efficacy, improve safety and widen therapeutic window of existing and new treatments

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, is proud to announce that a publication supporting the Company’s proprietary Trans-Arterial Micro-Perfusion (TAMP) therapy platform for targeted locoregional drug delivery will be recognized in the Journal of Vascular and Interventional Radiology (JVIR) Award-Winning Paper Scientific Session during the upcoming Society of Interventional Radiology (SIR) 2025 Annual Scientific Meeting.

The peer-reviewed paper, published in the July 2024 edition of JVIR, is being honored during the conference’s JVIR Award-Winning Paper Scientific Session in Nashville, TN, scheduled at 3:00-4:30 PM CT on Tuesday, April 1, 2025. The session will be moderated by Daniel Sze, MD, PhD, Stanford University. This paper is one of nine 2024 JVIR papers to be awarded for outstanding laboratory investigation during the conference.

The JVIR Award-Winning Paper, titled “Double-Balloon Catheter–Mediated Transarterial Chemotherapy Delivery in a Swine Model: A Mechanism Recruiting the Vasa Vasorum for Localized Therapies,” is authored by Khashayar Farsad, MD, PhD of the Department of Interventional Radiology at Oregon Health and Science University, and co-authored by Paula M. Novelli, MD, of the University of Pittsburgh Hillman Cancer Center, together with other researchers, including RenovoRx’s founder and Chief Medical Officer, Dr. Ramtin Agah. During JVIR Award-Winning Paper Scientific Session, Dr. Agah will present the findings of the paper. The JVIR abstract can be accessed here: https://pubmed.ncbi.nlm.nih.gov/38508449/.

“We are deeply honored to be recognized for our research at SIR 2025 Annual Scientific Meeting in the JVIR Award-Winning Paper Scientific Session,” said Dr. Agah. “This recognition reflects RenovoRx’s innovation and treatment paradigm that may translate to benefits in treatment of patients with solid tumors. I look forward to presenting these findings at the upcoming conference, and my colleagues and I are grateful for this recognition and validation of our commitment to advancing the field of interventional oncology.”

Currently, most cancer patients with solid tumors receive chemotherapy intravenously, introducing the drug systemically into the entire body. This is well-known to cause adverse side effects. RenovoRx’s patented TAMP therapy platform is designed to bypass traditional systemic delivery methods and provide targeted delivery to bathe the target solid tumor in chemotherapy. This locoregional delivery also creates the potential to minimize a therapy’s systemic toxicities.

The pre-clinical data published in JVIR showed a 100-fold (two orders of magnitude) increase in local tissue concentration of the therapy with TAMP compared to conventional intravenous (IV) delivery. TAMP also showed advantages compared to historically available intra-arterial (IA) delivery approaches. TAMP’s novel approach to treatment offers the potential to increase an oncology therapy’s efficacy, improve safety, and widen its therapeutic window by focusing its distribution uniformly in target tissue.

“TAMP has the potential to provide a valuable treatment option to patients who have been diagnosed with solid tumors that may be difficult-to-treat,” said Dr. Farsad. “This platform also has the potential to extend across a variety of unmet needs for localized therapeutic drug delivery. This study shows a possible mechanism for how TAMP can increase local therapeutic tissue concentration in solid tumors that is independent from traditional catheter-directed therapy. We are awaiting final outcomes from RenovoRx’s TIGeR-PaC Phase III clinical trial, currently underway, to further validate this benefit.”

“We believe this award further supports our decision to accelerate the commercialization of our proprietary RenovoCath as a standalone device,” said Shaun Bagai, CEO of RenovoRx. “We are rapidly expanding efforts and forging stronger relationships with leading oncology centers nationwide who are using RenovoCath. This progress not only positions our company for growth but also reinforces our growing leadership in the oncology space, unlocking substantial value-creation opportunities. We continue to scale our commercialization efforts and, in tandem, progress our Phase III TIGeR-PaC trial in the most capital efficient manner.”

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 intra-arterial infusion of chemotherapy, gemcitabine, utilizing 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.

Cautionary Note Regarding Forward-Looking Statements

This press release, the fireside chat referred to herein, and statements of the Company’s management 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 pre-clinical and clinical trials and studies, including the overall timing and timing for additional interim data readouts and full patient enrollment for our ongoing TIGeR-PaC Phase III clinical trial study in LAPC, (ii) the potential of RenovoCath^® or TAMP™ as standalone commercial products, our anticipated timing for and levels of revenue generation from RenovoCath sales, 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 (iv) 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, commercial 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 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,” “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 execution of our commercial strategy for RenovoCath or our TAMP technology may not lead to viable or repeating 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.

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KCSA Strategic Communications

Valter Pinto or Jack Perkins

T:212-896-1254

RenovoRX@KCSA.com

Source: RenovoRx, Inc.

FAQ

What are the key findings of RenovoRx's TAMP therapy research being presented at SIR 2025?

The research shows TAMP therapy achieves a 100-fold increase in local tissue concentration compared to conventional IV delivery, potentially improving drug efficacy while reducing systemic toxicity.

When and where will RenovoRx (RNXT) present their award-winning TAMP research?

The research will be presented on April 1, 2025, at 3:00-4:30 PM CT during the SIR 2025 Annual Scientific Meeting in Nashville, TN.

How does RenovoRx's TAMP therapy platform differ from traditional chemotherapy delivery?

TAMP uses RenovoCath to deliver chemotherapy directly to solid tumors locally, unlike traditional IV chemotherapy which distributes drugs throughout the entire body.

What are the potential benefits of RenovoRx's TAMP therapy for cancer patients?

TAMP therapy may increase treatment efficacy, improve safety, and widen the therapeutic window while minimizing systemic side effects in patients with solid tumors.

What is the current development status of RenovoRx's (RNXT) TAMP therapy?

RenovoRx is conducting the TIGeR-PaC Phase III clinical trial while simultaneously commercializing RenovoCath as a standalone device through oncology center partnerships.