RenovoRx, Inc. (Nasdaq: RNXT) reported second quarter 2025 revenue of over $400,000 from commercial sales of its FDA-cleared RenovoCath drug-delivery device, demonstrating strong market demand for targeted oncology therapies. The company also announced that the independent Data Monitoring Committee (DMC) for its ongoing Phase III TIGeR-PaC trial has recommended continuation of the study following review of the second pre-planned interim analysis.
Commercial Momentum Accelerates
The life sciences company has expanded its commercial footprint to thirteen cancer center customers approved to purchase RenovoCath, including several high-volume National Cancer Institute (NCI)-designated academic and community centers. This represents a significant increase from five centers in the first quarter of 2025. Four of these thirteen cancer centers have used the device in patients, and all have subsequently made repeat purchase orders.
"We are pleased to report second quarter 2025 revenue of over $400,000. This growth highlights the strong clinical need and market demand for our patented RenovoCath device as a standalone targeted drug-delivery product among both new and existing customers," said Shaun Bagai, CEO of RenovoRx. "We are proud of the initial organic revenue growth over the first two full quarters since launching RenovoCath commercial sales, especially since this was achieved without a dedicated sales and marketing team."
The company believes that many of the 18 cancer centers participating in its ongoing Phase III TIGeR-PaC trial could become potential customers for RenovoCath after trial enrollment completion, expected later this year or early next year.
Phase III Trial Receives Positive DMC Recommendation
The independent Data Monitoring Committee completed its review of the second pre-planned interim analysis for the Phase III TIGeR-PaC trial and recommended that the company continue the study. As of August 12, 2025, 95 patients have been randomized and 61 events have occurred, putting the trial on target to complete enrollment this year or early next year.
"We are very excited to report that the independent Data Monitoring Committee for our ongoing Phase III TIGeR-PaC trial recently completed their review of our second pre-planned interim analysis and has recommended that we continue the study," continued Bagai. "This is great news, as we believe the DMC's recommendation is an expression of confidence in the potential for a positive outcome in the trial overall."
The TIGeR-PaC trial evaluates RenovoRx's investigational drug-device combination oncology product candidate, which uses the proprietary Trans-Arterial Micro-Perfusion (TAMP) therapy platform enabled by RenovoCath for treating locally advanced pancreatic cancer. The combination utilizes RenovoCath for intra-arterial administration of chemotherapy gemcitabine.
To preserve trial integrity for FDA purposes, RenovoRx elected to defer publishing the interim data following discussions with the DMC and consultation with regulatory advisors. The current protocol requires 114 randomized patients with 86 events necessary for final analysis.
Strategic Leadership Addition
To coordinate and expand its commercial efforts, RenovoRx hired Philip Stocton as Senior Director of Sales and Market Development. Stocton brings over 25 years of experience in MedTech sales, marketing, and leadership from positions at Terumo, Johnson & Johnson, Varian, and Sirtex Medical. Over the past 10 years, he has specialized in interventional oncology in both domestic and international roles.
Market Opportunity and Technology Platform
RenovoRx estimates the initial total addressable market for RenovoCath as a stand-alone device represents approximately $400 million in peak annual U.S. sales opportunity. The company believes this could expand to a several-billion-dollar market as adoption extends to additional solid tumor applications beyond historical usage.
Dr. Gregory Tiesi, Chief of Hepatobiliary Surgery at Hackensack Meridian Jersey Shore University Medical Center, stated: "We are proud to be the first medical institution in New Jersey to offer RenovoRx's Trans-Arterial Micro-Perfusion therapy platform using the RenovoCath device, enabling targeted locoregional delivery of chemotherapy. This approach to targeted delivery offers the potential to reduce systemic toxicity and associated side effects and to enhance the quality of life for patients undergoing treatment."
Financial Performance
The company reported research and development expenses of $1.4 million for the quarter ended June 30, 2025, compared to $1.5 million for the same period in 2024. Selling, general, and administrative expenses remained relatively unchanged at approximately $1.5 million. Net loss was $2.9 million for the quarter, compared to $2.4 million in the prior year period.
As of June 30, 2025, RenovoRx had $12.3 million in cash and cash equivalents. The company believes this cash position will fully fund both ongoing RenovoCath scale-up efforts and additional progress toward completion of the Phase III TIGeR-PaC trial.
Regulatory and Intellectual Property Developments
During the quarter, RenovoRx received notification that U.S. patent No. 12,290,564 became effective on May 6, titled "Methods for Treating Tumors." This patent expands protection of methods for drug delivery with RenovoRx's TAMP therapy platform and provides protection through November 2037.
The company also launched a multi-center post-marketing registry study called PanTheR to follow patients undergoing cancer treatment delivered by RenovoCath to solid tumors. This observational registry study aims to assess long-term safety and survival outcomes in real-world clinical settings across a broader range of tumor types.
