RenovoRx Reports Commercial Revenue Growth in the Second Quarter 2025 and Announces Positive Independent Data Monitoring Committee Recommendation to Continue Pivotal Phase III TIGeR-PaC Trial Based on Interim Data Review

Reports Commercial Revenue Growth in the Second Quarter 2025 and Announces Positive Independent Data Monitoring Committee Recommendation

to Continue Pivotal Phase III TIGeR-PaC Trial Based on Interim Data Review

from RenovoCath device totaled over $400,000 for the Second Quarter 2025

of June 30, 2025, the Company had $12.3 million in cash and cash equivalents

to host conference call today at 4:30p.m. ET

VIEW, Calif. - August 14, 2025 - 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, today announced its financial results and business update to shareholders for the second quarter ended

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. 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. With the recent hiring of Phil Stocton as our

Senior Director of Sales and Market Development, our goal is to stay lean, while also continuing to build commercialization

momentum. We will continue to gather important data about our market (such as such as sales cycles, activation times, individual

customer preferences and other commercial matters), as we seek to grow our customer base, fulfill repeat RenovoCath orders, and

position ourselves for commercial growth over the long term," said Shaun Bagai, CEO of RenovoRx.

the same time, we are very excited to report that the independent Data Monitoring Committee (DMC) 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. 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," continued Mr. Bagai.

a view towards preserving the integrity of the TIGeR-PaC trial for FDA purposes, and following our review of general FDA guidance, discussions

with the DMC, and consultation with regulatory advisors, we are deferring publishing our second interim data. Outside of

our Chief Medical Officer, Dr. Ramtin Agah, who has been speaking directly with the DMC, our entire team will remain blinded to the interim

data. We will revisit publishing the actual second interim data, most likely upon completion of the study as is common for pivotal

Phase III trials. As of August 12, 2025, 95

patients have been randomized and 61 events have occurred, putting us on target to complete enrollment this year or early next year,"

concluded Mr. Bagai.

Commercialization Update

continued its RenovoCath commercialization progress, with thirteen cancer center customers approved to purchase the device, including

several high-volume, National Cancer Institute (NCI)-designated academic and community centers, an 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 made repeat purchase orders

subsequently. RenovoRx believes that many of the 18 cancer centers that have used RenovoCath as part of its ongoing, pivotal Phase III

TIGeR-PaC trial could also be potential customers for RenovoCath after the completion of TIGeR-PaC enrollment, which is expected later

this year or early next year. All of this is being accomplished in-house by RenovoRx without a dedicated sales and marketing team. RenovoRx

plans to strategically add a small number of sales personnel in the second half of 2025 as it looks to widen market penetration in 2026.

believes that the initial total addressable market (TAM) for RenovoCath as a stand-alone device represents an estimated initial $400

million peak annual U.S. sales opportunity. Beyond historical RenovoCath usage, RenovoRx commercial efforts are already indicating the

adoption of RenovoCath technology for the treatment of other solid tumors. This serves as the basis for our belief in the potential for

a several-billion-dollar TAM as we expand into additional applications.

Pivotal Phase III TIGeR-PaC Trial Update

the TIGeR-PaC trial, RenovoRx is evaluating its first investigational drug-device combination oncology product candidate which uses the

proprietary Trans-Arterial Micro-Perfusion (TAMP ) therapy platform enabled by RenovoCath for the treatment of locally advanced

pancreatic cancer (LAPC). RenovoRx's combination product candidate utilizes RenovoCath for the intra-arterial administration of

the chemotherapy gemcitabine (or IAG).

current protocol and statistical analysis plan for the Phase III TIGeR-PaC trial requires 114 randomized patients, with 86 events, or

deaths, necessary to complete the final analysis.

the second quarter of 2025, the 52nd death triggered the second pre-planned interim analysis to be reviewed by the independent

Data Monitoring Committee. The DMC has concluded its review and has recommended that the Company continue with the trial. To avoid compromising

the integrity of the trial with the FDA, and after discussions with the DMC and consultation with its regulatory advisors, RenovoRx elected

to defer publishing the interim data. RenovoRx will revisit publishing the actual second interim data, most likely upon completion

of the study as is common for pivotal Phase III trials.

Quarter 2025 and Subsequent Key Highlights

the second quarter of 2025, RenovoRx increased production of the RenovoCath device to meet increased

demand for the targeted delivery of diagnostic and/or therapeutic agents from oncologists and interventional radiologists. The principal

manufacturer of RenovoCath devices is Medical Murray Inc., based in the U.S. in North Barrington, IL.

highlighted strong progress in its commercialization efforts. Since launching its commercial efforts in December 2024, RenovoRx has established

commercial momentum for RenovoCath, with thirteen cancer center customers approved to purchase the device, including several high-volume,

National Cancer Institute (NCI)-designated academic and community centers, an 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 made repeat purchase orders subsequently.

momentum highlights the growing clinical demand across the United States for novel, localized solid tumor drug-delivery options beyond

methods like systemic intravenous delivery of chemotherapy. RenovoRx believes that many of the 18 cancer centers that have used RenovoCath

as part of its ongoing, pivotal Phase III TIGeR-PaC trial could also be potential customers for RenovoCath after the completion of TIGeR-PaC

enrollment, which is expected later this year or early next year.

coordinate, execute, and expand its commercial efforts for RenovoCath, subsequent to the quarter, RenovoRx hired Philip Stocton as Senior

Director of Sales and Market Development. Mr. Stocton brings over 25 years of experience in MedTech sales, marketing, and leadership

from various commercial positions at Terumo, Johnson & Johnson, Varian (acquired by Siemens), and, most recently, Sirtex Medical.

Over the past 10 years, he has specialized in interventional oncology in both domestic and international roles. Prior to his hiring,

Mr. Stocton had been consulting for RenovoRx in connection with its RenovoCath commercial launch planning efforts.

the quarter, RenovoRx initiated patient enrollment with Johns Hopkins Medicine for the Phase III TIGeR-PaC clinical trial, becoming the

newest addition to a distinguished network of clinical cancer sites across the United States participating in the trial.

also received an Issue Notification from the U.S. Patent and Trademark Office (USPTO) indicating that U.S. patent No. 12,290,564 became

effective on May 6. This patent, titled "Methods for Treating Tumors," expands protection of methods for drug delivery with

RenovoRx's TAMP therapy platform, enabled by RenovoCath. The patent covers new methods for treating a tumor by delivering drugs

locally to a region of an artery or blood vessel that is near the tumor after treating this region to reduce the microvasculature. The

new patent provides protection through November of 2037.

to the quarter, RenovoRx launched a multi-center post-marketing registry study to follow patients undergoing cancer treatment delivered by its RenovoCath

device to solid tumors. The PanTheR study is an important initiative aimed at evaluating the safety and effectiveness of RenovoCath in

real-world clinical settings. This multi-center, post-marketing observational registry study is designed to assess long-term safety and

survival outcomes in patients with solid tumors who receive targeted drug delivery via RenovoCath. By collecting real-world data on the

use of RenovoCath across a broader range of tumor types, PanTheR aims to provide valuable insights into patient outcomes and support

the generation of additional safety data.

Highlights for the Second Quarter Ended June 30, 2025

RenovoRx reported second quarter revenues of approximately $422,000 from commercial sales of the RenovoCath device, driven by

new customer purchase orders and early repeat orders from our initial sites. June 30, 2025 marked our second full quarter of revenue

generation from RenovoCath sales.

Position: As of June 30, 2025, the Company had $12.3 million in cash and cash equivalents. The Company's plan is for

revenues from RenovoCath sales to reduce its burn rate over time. The Company believes that cash as of June 30, 2025 will fully fund

both ongoing RenovoCath scale-up efforts and additional progress towards the completion in the Phase III TIGeR-PaC trial.

Expenses: Research and development expenses were $1.4 million, for the quarter ended June 30, 2025, compared to $1.5 million

for the quarter ended June 30, 2024. The $0.1 million decrease was primarily driven by a decrease in other clinical and regulatory expenses

including an allocation of selling, general and administrative expenses to research and development of $0.2 million. This decrease was

offset by an increase in non-recurring engineering costs to scale manufacturing and the development of our next generation RenovoCath

delivery system by $0.1 million to support and expand our commercial program.

Expenses: Selling, general, and administrative expenses were approximately $1.5 million, for the quarter ended June 30, 2025,

remaining relatively unchanged from the same period in the prior year.

Loss: Net loss was $2.9 million for the quarter ended June 30, 2025, compared to a net loss of $2.4 million for the quarter

ended June 30, 2024. The $0.5 million increase was primarily due to the change in the fair value of the warrant liability of $0.9 million

offset by a decrease in loss from operations of $0.4 million.

Outstanding: As of August 11, 2025, shares of common stock outstanding totaled 36,645,884.