On May 14, 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 first quarter ended March 31, 2026, and is providing shareholders with a business update.

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"We made important strides in the first quarter of 2026 with strong commercial adoption of the TAMP platform enabled by RenovoCath, resulting in record quarterly revenue exceeding 50% of the revenue we generated in all of 2025," said Shaun Bagai, Chief Executive Officer of RenovoRx. "We generated Q1 revenue of $563,000, an increase of 136% compared to the fourth quarter of 2025, mainly driven by the growing number of active cancer centers and rising procedural utilization across our existing customer base. Additionally, we ended the quarter with $12.4 million in cash, which, we believe, is sufficient to fund our operations into at least the second half of 2027. With a solid sales pipeline, we are confident in sustaining growth as our business scales."

"Our commercial momentum is being driven by our focused and scalable expansion strategy into cancer centers," continued Mr. Bagai. "We have grown from 5 active commercial cancer center customers at the beginning of 2025 to 16 today, with 32 additional centers progressing through stages of evaluation, approval, and onboarding. Notably, we are seeing meaningful repeat utilization across our existing centers, which we believe reflects growing physician confidence and clinical utility. As we expand our footprint and deepen utilization, we believe that RenovoRx is building a durable commercial foundation with the potential for predictable, recurring revenue growth."

"Looking ahead, we remain focused on executing against both our near-term commercial priorities and our long-term clinical objectives," added Mr. Bagai. "We expect continued revenue growth throughout 2026, supported by ongoing cancer center activations and continued transition of Phase III TIGeR-PaC trial sites into commercial centers after full enrollment is complete. At the same time, TIGeR-PaC remains on track for complete enrollment in June 2026, reinforcing the strength of our dual-track strategy. With a strengthened balance sheet and growing commercial traction, we believe RenovoRx is well positioned to deliver meaningful value creation in the quarters ahead and continue to expand access to life-changing care for patients battling difficult-to-treat cancers."

RenovoCath Commercialization Update

RenovoRx saw further acceleration in the commercial rollout of RenovoCath during the first quarter of 2026, achieving its strongest quarterly revenue performance to date. Revenue totaled $563,000 for the quarter, representing a 136% quarter-over-quarter increase compared to the fourth quarter of 2025 and totaling more than 50% of the Company’s total revenue generated in 2025. This significant growth reflects continued expansion of active commercial cancer centers and increasing procedural utilization of RenovoCath across the Company’s installed base. The Company defines "active" commercial cancer centers as centers where doctors are actively treating patients with RenovoCath.

RenovoRx’s commercial model remains centered on active cancer center expansion, with additional centers driving increased procedures and revenue growth. RenovoRx began 2025 with 5 active commercial cancer centers, and by end of the year, we had grown to 8. As of May 6, 2026 we had 16 active centers. RenovoRx is also advancing a robust pipeline of 32 additional centers in various stages of evaluation, approval, and onboarding, representing a significant expansion of its near-term commercial footprint. In total, these 48 centers have approximately quadrupled the Company’s near-term commercial sales pipeline compared to the first quarter of 2025, reflecting the rapid expansion of RenovoRx’s commercial footprint year-over-year. Up to 15 TIGeR-PaC Phase III clinical trial sites that have previously utilized RenovoCath are expected to continue transitioning to commercial clinical use following completion of trial enrollment. These anticipated conversions represent a meaningful opportunity to drive incremental revenue growth in the second half of 2026. The Company continues to target 36 active commercial cancer centers by year-end 2026.

RenovoRx continues to observe organic repeat ordering behavior from existing customers, which the Company views as a key indicator of physician satisfaction and clinical utility. As physicians incorporate RenovoCath into routine clinical practice, repeat utilization is expected to drive sustained and compounding revenue growth. The combination of record quarterly revenue, rapid active cancer center expansion, and strong repeat ordering behavior demonstrates accelerating commercial momentum and supports the long-term opportunity for RenovoCath as both a standalone 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, with long-term, several-billion-dollar potential as the platform expands into additional solid tumor indications.

Clinical Research and Scientific Programs
Advancement of the 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) continued in the first quarter of 2026. Based on current projections, RenovoRx expects to send notification of closure of enrollment in the trial in the beginning of June, completing the Company’s milestone of finishing trial enrollment by the end of June 2026. As of May 14, 2026, 106 patients had been randomized in the trial, representing approximately 93% of the required 114 patients, and currently there are 12 enrolled patients in induction, which gives rise to the expectation that enrollment will be closed by the end of June. Seventy-four events (i.e., patient deaths) have been observed of the 86 events required to trigger the final analysis. The Company continues to anticipate final data in mid to late 2027.

During the first quarter of 2026, RenovoRx continued to execute on key operational priorities for TIGeR-PaC, including patient enrollment, site engagement, and maintaining protocol adherence across its clinical network. These efforts build on the successful completion of the second interim analysis in 2025, after which the independent Data Monitoring Committee recommended continuation of the trial without modification. In alignment with standard clinical trial practices and to preserve trial integrity, the Company has elected to defer publication of interim data until study completion.

RenovoRx expects that TIGeR-PaC trial sites will continue transitioning to commercial use following completion of enrollment, representing a meaningful potential driver of revenue growth in the second half of 2026. RenovoRx continues to view the TIGeR-PaC trial as an important long-term value driver, while emphasizing that its current commercial strategy is independent of the trial’s ultimate outcome and timeline.

RenovoRx continues to advance broader clinical programs by generating new data through the Company’s continued support of investigator-initiated trials (IIT) in borderline resectable and metastatic pancreatic cancer, use of other agents beyond gemcitabine (the chemotherapy being used in TIGeR-PaC), and use of TAMP in other solid tumors. Registry and IIT studies are capital-efficient studies providing meaningful data that may further broaden the application for the TAMP therapy platform which is enabled by RenovoCath.

In terms of scientific data, in January 2026, a pharmacokinetic subset study of the TIGeR-PaC trial was presented at the 2026 ASCO (Free ASCO Whitepaper) Gastrointestinal (GI) Cancers Symposium by a TIGeR-PaC Investigator from the University of Pittsburgh Medical Center. The abstract offers insight that supports the potential effectiveness of the TAMP therapy platform in LAPC. The abstract concludes that TAMP and IAG resulted in reduced systemic levels of gemcitabine and increased levels of its inactive metabolite compared with IV gemcitabine. A full paper is submitted for publication later this year.

First Quarter 2026 and Subsequent Key Highlights
RenovoRx continued to execute on its dual clinical and commercial strategy during the first quarter of 2026, leveraging the operational foundation established in 2025 to drive measurable commercial progress. The Company’s lean commercial infrastructure is now actively supporting cancer center expansion and revenue growth, while physician-to-physician advocacy and real-world clinical experience continue to drive adoption.

Since receiving FDA 510(k) clearance in 2014, RenovoCath has been used in 750 successful procedures, underscoring the device’s growing clinical utility and physician acceptance. The Company was also bestowed with external recognition for its innovation, being named one of Fast Company’s "World’s Most Innovative Companies of 2026," in the Medical Devices category.

During the first quarter of 2026, RenovoRx strengthened its balance sheet through the successful completion of an oversubscribed private placement, generating approximately $10 million in gross proceeds. The financing reflects strong institutional investor demand and supports the Company’s ongoing clinical development and commercial expansion initiatives. Proceeds are expected to be used for working capital and general corporate purposes, providing additional flexibility as RenovoRx continues to scale its operations and advance its growth strategy.

Financial Highlights for the First Quarter Ended March 31, 2026

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Revenue for the three months ended March 31, 2026 was $563,000, compared to $197,000, year-over-year. The increase was driven by acceleration in the continued commercialization of RenovoCath and expanding adoption across U.S. cancer centers.
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Research and development expenses were approximately $1.2 million for the three months ended March 31, 2026, compared to approximately $1.6 million year-over-year. The decrease was primarily driven by higher receipts received from the TIGeR-PaC clinical trial.
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Selling, general and administrative expenses were approximately $2.7 million for the three months ended March 31, 2026, compared to approximately $1.6 million year-over-year, a reflection of the Company’s continued execution on its commercial infrastructure strategy.
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Net loss for the quarter ended March 31, 2026 was approximately $3.5 million, compared to approximately $2.4 million for the quarter ended March 31, 2025.
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Cash and cash equivalents were approximately $12.4 million as of March 31, 2026. During the first quarter, the Company strengthened its balance sheet with approximately $10 million in gross proceeds from a March 2026 private placement financing. The Company believes its current cash resources are sufficient to fund operations into at least the second half of 2027.
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Shares Outstanding: As of March 31, 2026, common shares outstanding totaled 45.05 million.
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Guidance: Reiterating full year 2026 revenue guidance of $3 to $4 million.

Conference Call Details
Event: RenovoRx First Quarter 2026 Financial Results and Business Highlights Call

Date: Thursday, May 14, 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 May 28, 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 13760238.

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, MAY 14, 2026, View Source [SID1234665712])