RNXT RenovoRx Inc

RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a life sciences company developing novel targeted oncology therapies and commercializing RenovoCath, a novel, FDA-cleared delivery platform, today announced that it has received its first purchase orders for RenovoCath devices.

This milestone marks a positive continuation of RenovoRx’s previously announced efforts to commercialize RenovoCath as a standalone device to be used by doctors in accordance with its FDA-cleared instructions for use. RenovoCath is powered by the Company's patented Trans-Arterial Micro-Perfusion (TAMP™) therapy platform.

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.

“The progress for RenovoCath procurement by medical institutions across the United States, as well as our ability to secure our first purchase orders ahead of internal projections, is a strong indicator of the unmet need and particular value our delivery system offers to the oncology market,” said Shaun Bagai, CEO of RenovoRx. “With RenovoCath being successfully used by clinicians in over 500 procedures as part of clinical trials over the past several years, we made the strategic decision earlier this year to move forward with a direct-to-market commercialization strategy for RenovoCath. We previously announced an expanded relationship with our manufacturing partner, and our team is building an initial sales pipeline organically based on incoming demand from doctors and without the current need to expend significant operating costs associated with a direct sales force or third-party medical device commercial partners. The growth of our pipeline, positive feedback and demand further validates the market need for RenovoCath and reaffirms our path towards accelerated revenue generation for our company. We look forward to further refining our sales and marketing strategies for RenovoCath in the coming months as we seek to optimize this exciting opportunity.”

Mr. Bagai added, “In parallel with the commercialization of RenovoCath, we remain laser focused on our pivotal Phase III TIGeR-PaC clinical trial studying our investigational drug-device product candidate utilizing our TAMP therapy platform in combination with an existing chemotherapy as a treatment for locally advanced pancreatic cancer. With high-volume clinical oncology institutions, such as the recent addition of Northwell Health Cancer Institute, participating in TIGeR-PaC, we anticipate completion of both patient enrollment and the study’s next interim analysis by the end of the first half of 2025.”

The RenovoCath® Device

RenovoRx’s initial anticipated market for RenovoCath as a standalone product will be of interest to health care providers (HCPs) to focus on targeted delivery of fluids in the peripheral vascular system per approved indication, where there are a variety of clinical settings with high unmet needs. RenovoRx estimates these initial markets represent a total annual sales opportunity worth hundreds of millions of dollars. In the future, RenovoRx will target expansion applications for its delivery system, which is expected to significantly increase the potential total addressable market.  

“Clinical practice has been waiting decades for meaningful advances in targeted drug-delivery,” said Dr Ken Meredith, Medical Director of Sarasota Memorial Health Care System Gastrointestinal Cancer Specialty Program. “RenovoCath’s proprietary TAMP clinical data observed a 100-fold improvement in surrounding tissue concentration compared to conventional intravenous delivery. There have been multiple peer-reviewed publications substantiating the TAMP mechanism of action provided by this delivery system.”

In support of its RenovoCath commercialization strategy, RenovoRx has retained Richard Stark as a Commercial Advisor consultant. Mr. Stark is an accomplished global commercial leader with over 25 years of experience in driving commercialization in medical devices. He has extensive experience in multiple executive and senior advisory roles for biotech, oncology and medical device companies, including as Chief Executive Officer of Innoblative Designs, Inc. and Senior Vice President of Surgical Oncology Unit at AngioDynamics.

As previously announced, commercialization efforts for the RenovoCath delivery system were initiated in response to increasing demand from oncology and interventional radiology physicians indicating a need for improved, targeted delivery of therapeutic and diagnostic agents. RenovoRx recently signed a new work order with its manufacturing partner, Medical Murray, to increase production of its RenovoCath devices.

About RenovoCathBased 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 product candidate using the TAMP technology, is a novel investigational oncology drug-device combination utilizing the Company’s FDA-cleared RenovoCath® device for the intra-arterial administration of chemotherapy, gemcitabine.

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 TIGeR-PaC study is investigating TAMP in LAPC. The study’s primary endpoint is an overall survival benefit with secondary endpoints including reduced side effects versus standard of care. The second interim analysis for this study will be triggered by the 52nd 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.

About RenovoRx, Inc.RenovoRx is a life sciences company developing novel targeted oncology therapies and commercializing RenovoCath®, a novel, U.S. Food and Drug Administration (FDA)-cleared local drug-delivery platform, 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.

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 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 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).

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

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

Cautionary Note Regarding Forward-Looking StatementsThis press release 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) the potential of RenovoCath® or TAMP™ as standalone commercial products, the estimated maximum total annual sales and addressable market for RenovoCath and our commercialization plans in general, (ii) the prospects of our marketing and sales strategies, (iii) 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, (iv) the potential for our product candidates to treat or provide clinically meaningful outcomes for certain medical conditions or diseases and (v) our 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 or profitable 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 and cause delays in research and clinical development plans and timelines, and the regulatory process for our product candidates; (vii) 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 other 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.

Contact:KCSA Strategic CommunicationsValter Pinto or Jack PerkinsT:212-896-1254RenovoRX@KCSA.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/74c419a6-852b-44f3-ba06-fda395a23091