On March 30, 2026 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a life-sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a patented, FDA-cleared drug-delivery device, reported its financial results for the full year and fourth quarter ended December 31, 2025, and is providing a business update to shareholders.

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Shaun Bagai, Chief Executive Officer of RenovoRx, commented, "2025 marked a key year as it was our first full year of RenovoCath commercialization, generating over $1 million in revenue and reflecting strong initial physician adoption and demand in a handful of active commercial cancer centers. We also learned many valuable lessons to finalize our go-to-market strategy that we are implementing and building out a team to drive commercial growth in 2026 and beyond."

Mr. Bagai continued, "We entered 2025 having just taken our initial steps towards commercialization, with no dedicated sales team and limited approved commercial cancer centers. We exited the year with a strong understanding of the market and a clear strategy supported by a focused and agile sales and marketing team. Our network of active commercial cancer center clients continues to grow, resulting in meaningful revenue generation. While we are still relatively early in the game, we believe we are beginning to unlock the broader commercial potential for RenovoCath as a stand-alone device. Adoption across U.S. cancer centers continues to build, driven by new and repeat orders, growing physician familiarity, and increasing procedural utilization. As of February 27, 2026, 12 U.S. cancer centers are utilizing RenovoCath, and 21 additional centers are evaluating the device, have completed evaluation, or are preparing for activation. These 33 centers represent a tripling of our near-term pipeline compared to the first quarter of 2025."

"Importantly, we established our commercial infrastructure in the fourth quarter of 2025, positioning us to scale in 2026 with a targeted focus on high-volume cancer centers. On top of this, we have significantly strengthened our balance sheet with $10 million in gross proceeds (net proceeds of $9.2 million) from recent financing led by new and existing institutional investors including insider participation, giving us $13 million in cash on hand as of today. We strongly believe we now have the funding, business plan, leadership, and infrastructure to propel execution across all of our activities as we drive towards important milestones, including breakeven operations and trial data."

"Simultaneously, we are advancing our pivotal Phase III TIGeR-PaC trial, which remains on track for full enrollment in the near term and with final results anticipated next year. We recently announced the achievement of a milestone by randomizing our 100th patient in the trial. As of March 24, 2026, 104 patients have been randomized with 72 events (deaths) observed. Our target of full enrollment by the middle of this year would ensure a minimum of 114 patients will be randomized. Our study protocol requires us to advance a minimum of 114 patients to randomization, so we are really in the home stretch of this trial. Moreover, our goal is to transition the 17 cancer centers that have used RenovoCath as part of the TIGeR-PaC trial to commercial customers for RenovoCath in the second half of 2026 after completion of TIGeR-PaC enrollment. Select TIGeR-PaC cancer centers have already begun using the TAMP (Trans-Arterial Micro-Perfusion) therapy platform, enabled by the RenovoCath device, for targeted drug-delivery in the treatment of patients diagnosed with solid tumors, giving us even more optimism for the expansion of our revenue potential," concluded Mr. Bagai.

RenovoCath Commercialization Update

RenovoRx achieved key milestones in the commercial launch of RenovoCath in 2025, its first full year of generating revenue. For the year ending December 31, 2025, the Company generated $1.1 million in revenue from RenovoCath sales, driven by both new cancer centers adopting the device and repeat orders from existing customers. This early commercial traction reflects increasing physician interest in targeted intra-arterial drug-delivery and shows that RenovoCath is becoming widely used within clinical workflows at leading, high-volume cancer centers. The Company also learned valuable lessons about cycle trends, activation timelines, customer preferences, and other commercial data which it expects to apply as it seeks to grow RenovoCath revenues in 2026 and beyond.

Adoption continued to expand across the United States, with 12 cancer centers actively utilizing RenovoCath as of early 2026 and a growing pipeline of additional centers evaluating the device, having completed evaluation or are preparing for activation. The Company is also observing repeat ordering patterns and increased procedural utilization among early adopters, reinforcing confidence in physician satisfaction and the potential for recurring revenue. RenovoRx believes these trends support the long-term commercial opportunity for RenovoCath as both a stand-alone device and a foundational platform for future drug-device combination therapies.

RenovoRx continues to estimate that the initial total addressable market (TAM) for RenovoCath as a stand-alone device represents an approximately $400 million peak annual U.S. sales opportunity, and ultimately a multi-billion-dollar potential as the platform expands into additional solid tumor indications.

Clinical Research and Scientific Programs Update

RenovoRx continues to advance its ongoing Phase III TIGeR-PaC clinical trial evaluating intra-arterial delivery of gemcitabine (IAG) via the RenovoCath device for the treatment of locally advanced pancreatic cancer (LAPC). The current protocol and statistical analysis plan for the TIGeR-PaC trial requires 114 randomized patients, with 86 events (deaths) necessary to complete the final analysis. As of March 24, 2026, 104 patients have been randomized and 72 events have occurred. RenovoRx anticipates completion of enrollment by the middle of 2026, ensuring a minimum of 114 patients will be randomized.

During 2025, the TIGeR-PaC trial reached a key milestone with the completion of the second pre-planned interim analysis. Following its review, the independent Data Monitoring Committee for the trial recommended that the study continue without modification, which the Company believes is an expression of confidence in the potential for a positive outcome in the trial overall. TIGeR-PaC remains the cornerstone of RenovoRx’s clinical development strategy and is designed to evaluate overall survival benefit with the potential to support a future New Drug Application submission, if successful.

The Company also continues to advance broader clinical programs by generating new data through post-marketing registry studies in solid tumors and continued support of investigator-initiated trials (IIT) in borderline resectable and metastatic pancreatic cancer, along with exploring physician interest in other areas. Registry and IIT studies achieve cost neutrality as capital-efficient studies providing meaningful data that may further broaden the application for the TAMP (Trans-Arterial Micro-Perfusion) therapy platform which is enabled by RenovoCath.

Fourth Quarter 2025 and Subsequent Key Highlights

During the fourth quarter of 2025, RenovoRx completed the initial buildout of its commercial infrastructure, including the launch of its sales and marketing team, and continued advancing its commercialization strategy.

RenovoRx strengthened its executive leadership team in February 2026 to support the commercial growth of RenovoCath with the appointment of Mark Voll as Chief Financial Officer. Mr. Voll brings more than 30 years of financial leadership experience with a proven track record of guiding high-growth public companies through periods of commercial buildout and strategic development. He has served as Chief Financial Officer for multiple publicly traded technology companies where he successfully led initiatives that scaled operations into high-growth businesses.

In February 2026, the Company established the RenovoCath Medical Advisory Board (MAB) to provide strategic clinical guidance in advancing the TAMP therapy platform across indications of high unmet medical needs. The MAB includes leading interventional oncology experts: Nadine Abi-Jaoudeh, MD of UCI Health, Mustafa Al-Roubaie, MD of Moffitt Cancer Center, Khashayar Farsad, MD, PhD of Oregon Health and Science University, Ripal Gandhi, MD of Baptist Health South Florida, Paula Marie Novelli, MD of University of Pittsburgh Medical Center and Jonathan Kessler, MD of City of Hope Comprehensive Cancer Center.

On March 20, 2026, RenovoRx closed on an oversubscribed private placement of common stock and revenue milestone warrants resulting in gross proceeds of $10 million to RenovoRx, before deducting placement agent fees and offering expenses with net proceeds of $9.2 million. The financing was led by new and existing high-quality institutional investors, and the Company intends to use the net proceeds from the private placement for working capital and general corporate purposes.

The net proceeds of the private placement provide RenovoRx with a total of approximately $13 million cash and cash equivalents in hand to drive its business towards the expected achievement of important milestones in 2026 and 2027.

Financial Highlights for the Full Year Ended December 31, 2025

Revenue for the year ended December 31, 2025, was $1.1 million, compared to $43,000 for the year ended December 31, 2024. Fiscal year 2025 marked our first full year of revenue of RenovoCath and early customer adoption across U.S. cancer centers.

Cash and cash equivalents were approximately $7.0 million as of December 31, 2025. Subsequent to year end, on March 20, 2026, the Company strengthened its balance sheet and closed a private placement offering with gross proceeds of $10 million and net proceeds of $9.2 million.

Research and development expenses were approximately $6.3 million for the year ended December 31, 2025, compared to approximately $6.0 million for the same period last year. The increase was primarily attributable to continued investment in the Company’s ongoing Phase III TIGeR-PaC clinical trial, as well as development activities related to the next generation of the RenovoCath device.

Selling, general, and administrative expenses were approximately $7.0 million for the year ended December 31, 2025, compared to approximately $5.0 million for the year ended December 31, 2024. The increase was primarily driven by the buildout of the Company’s commercial infrastructure, including sales and marketing capabilities, as well as higher professional services and personnel-related costs.

Net loss for the year ended December 31, 2025, was approximately $11.2 million, compared to approximately $8.8 million for the prior year.

Shares of common stock outstanding as of March 23, 2026 was 45,052,706.

Conference Call Details

Event: RenovoRx Fourth Quarter & Full Year 2025 Financial Results and Business Highlights Call
Date: Monday, March 30, 2026
Time: 4:30 p.m. ET
Live Call: 1-877-407-4018 (U.S. Toll Free) or 1-201-689-8471 (International)
Webcast: View Source

For interested individuals unable to join the conference call, a link to the recording will be available on RenovoRx’s Investor Relations website, and a dial-in replay will be available until April 13, 2026 and can be accessed by dialing 1-844-512-2921 (U.S. Toll Free) or 1-412-317-6671 (International) and entering replay pin number 13758677.

A question and answer session will occur at the end of the call, and a link to the recording of this presentation will be available on RenovoRx’s Investor Relations website after the event.

(Press release, Renovorx, MAR 30, 2026, View Source [SID1234664040])