RenovoRx Reports Initial Revenues from RenovoCath® and Phase III TIGeR-PaC Trial Update
RenovoRx, Inc. (Nasdaq: RNXT), a life sciences company focused on developing innovative targeted oncology therapies and commercializing RenovoCath®, a novel FDA-cleared drug delivery device, has announced its financial results and business updates for the fourth quarter and full year ended December 31, 2024.
Milestone Achievement and Future Growth Plans
In his statement, Shaun Bagai, CEO of RenovoRx, highlighted that the fourth quarter of 2024 was a major milestone in the company’s history. RenovoRx reported its first revenue from the standalone sales of the RenovoCath device, with a solid expectation for substantial revenue growth going forward. The company is confident that its current commercial strategy, which involves a cost-effective approach, can be executed without a significant increase in capital expenditures. This is true whether RenovoRx decides to self-commercialize the device or partner with a larger organization using its existing sales channels.
In addition, RenovoRx is optimistic about its financial position. The company completed a public offering in February 2025, raising $12.1 million in gross proceeds. Combined with $7.2 million in cash on hand at the end of 2024, RenovoRx believes it is fully funded to execute its current operational plan. The company aims to scale up RenovoCath revenues while advancing its Phase III TIGeR-PaC clinical trial to key milestones. Bagai further noted that increasing RenovoCath revenues would likely reduce the company’s burn rate as they continue to deploy capital efficiently to maximize shareholder value.
Bagai also provided insights into the market potential for RenovoCath. Based on internal analysis, RenovoRx estimates the total addressable market (TAM) for the device in its current clinical application to be $400 million in peak annual U.S. sales. Additionally, there are potential expansion opportunities in other indications, which could lead to a multi-billion-dollar U.S. TAM for RenovoCath over time. The company expects revenue to increase into the low six-figure range in the first quarter of 2025, with sequential growth expected through the rest of the year.
RenovoCath Commercialization Progress
RenovoRx made significant progress in its commercialization efforts for RenovoCath. In December 2024, the company received its first commercial purchase orders for the device, resulting in approximately $43,000 in revenue for the fourth quarter. The demand for RenovoCath is strong, with over ten medical institutions initiating the purchase process. Among these, several high-volume National Cancer Institute-designated centers have already placed orders.
RenovoRx is also encouraged by the repeat orders from initial customers. The utilization of RenovoCath by these early adopters has paved the way for continued sales. The twenty cancer centers involved in the TIGeR-PaC trial are also potential customers for RenovoCath once enrollment in the trial concludes later in 2025.
The company has identified its target market to be the top 200 high-volume treatment centers in the U.S. It is confident that with a small, focused commercial team, it can achieve significant market penetration. Additionally, the device is eligible for reimbursement under a current CMS code covering specialty pressure-mediated delivery catheters, providing an added incentive for hospitals to adopt this advanced technology.
Ongoing Phase III TIGeR-PaC Clinical Trial Update
RenovoRx is continuing to make progress on its pivotal Phase III TIGeR-PaC clinical trial. During the fourth quarter of 2024, the company added several prestigious oncology centers to the trial, including the Sarah Cannon Research Institute Oncology Partners in Nashville, TN, and the Northwell Health Cancer Institute in New Hyde Park, NY. These additions are crucial for accelerating patient enrollment, which the company expects to complete in 2025.
The trial’s protocol requires 114 randomized patients, with 86 events (deaths) necessary for the final analysis. As of March 28, 2025, 90 patients have been randomized, and 50 events have occurred. A second interim analysis will be triggered after the 52nd event. The data review process is expected to take several months and will involve a full analysis by the Data Monitoring Committee (DMC). The company anticipates the 52nd event to occur in the second quarter of 2025, with the DMC’s key recommendation regarding the study’s continuation expected to be announced in the second half of 2025.
Fireside Chat and Strategic Update
On April 3, 2025, RenovoRx will host a fireside chat with CEO Shaun Bagai at 12:00 p.m. ET. During the event, Bagai will provide updates on the company’s commercialization progress, including initial revenue from RenovoCath and the ongoing Phase III TIGeR-PaC trial. Dr. Gregory Tiesi, Medical Director of Hepatobiliary Surgery at Hackensack Meridian Jersey Shore University Medical Center, will join the discussion to offer insights on the impact of RenovoCath’s Trans-Arterial Micro-Perfusion (TAMP™) therapy platform on patient care. The hospital began using RenovoCath in December 2024 for its oncology patients.
With promising developments in both commercialization and clinical trials, RenovoRx is positioned for significant growth in 2025 and beyond, as it continues its mission to revolutionize oncology treatment with its innovative RenovoCath technology.
