RenovoRx Reports Strong Q2 2025 Revenue Growth and Receives Positive Independent Committee Recommendation to Continue Phase III TIGeR-PaC Trial
RenovoRx, Inc. (Nasdaq: RNXT), a clinical-stage life sciences company pioneering targeted oncology drug delivery therapies, announced financial results for the second quarter ended June 30, 2025, alongside a significant business update that underscores both its commercial progress and clinical development momentum.
The company, which is commercializing RenovoCath®, its FDA-cleared novel drug-delivery device, and advancing its pivotal Phase III TIGeR-PaC trial for locally advanced pancreatic cancer (LAPC), reported second-quarter revenue exceeding $400,000. At the same time, the independent Data Monitoring Committee (DMC) overseeing TIGeR-PaC recommended that the trial continue following the second pre-planned interim analysis—an endorsement of both the trial’s design and its potential for meaningful patient benefit.
CEO Commentary: A Dual Track of Growth
RenovoRx Chief Executive Officer Shaun Bagai highlighted that the company’s performance in Q2 represents a critical inflection point.
“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,” Bagai said.
This marks the second full quarter of commercial revenue since RenovoCath’s market launch, and importantly, it was achieved without a dedicated sales and marketing team. According to Bagai, this validates the device’s clinical utility and the interest from cancer centers across the country.
The company recently appointed Phil Stocton as Senior Director of Sales and Market Development, with more than 25 years of MedTech and interventional oncology experience. His mandate will be to scale commercialization while keeping operations lean.
On the clinical side, Bagai noted:
“We are very excited to report that the 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.”
Importantly, RenovoRx has chosen not to publish the interim data at this time in order to preserve trial integrity for regulatory purposes, aligning with FDA guidance.
Commercial Progress: Expanding Adoption of RenovoCath
The commercialization of RenovoCath has shown meaningful traction in the early months following its launch.
- Thirteen cancer centers are now approved to purchase RenovoCath—up from five in Q1 2025.
- These include National Cancer Institute (NCI)-designated academic and community centers, underscoring adoption by high-volume, influential institutions.
- Of these, four centers have already used RenovoCath in patients and have followed up with repeat purchase orders.
This adoption is notable given that RenovoRx has yet to deploy a full-scale commercial salesforce. Instead, the company has strategically focused on building a foundation of key opinion leaders (KOLs) and high-volume centers, which could help accelerate adoption post–Phase III trial completion.
RenovoRx estimates an initial total addressable market (TAM) of $400 million annually in the U.S. for RenovoCath as a standalone device. Beyond pancreatic cancer, the device is being evaluated and considered for other solid tumor applications, which could expand the TAM into the multi-billion-dollar range.
Clinical Update: The TIGeR-PaC Pivotal Phase III Trial
RenovoRx’s flagship clinical program is TIGeR-PaC, a pivotal Phase III trial testing its proprietary Trans-Arterial Micro-Perfusion (TAMP™) therapy platform. The platform, enabled by RenovoCath, delivers the chemotherapy drug gemcitabine directly into the arteries feeding the tumor, with the goal of achieving high local drug concentrations while minimizing systemic exposure and toxicity.
- Indication: Locally advanced pancreatic cancer (LAPC), a condition with a poor prognosis and limited treatment options.
- Design: The trial requires 114 randomized patients, with 86 events (deaths) needed for final analysis.
- Status (as of August 12, 2025):
- 95 patients randomized
- 61 events occurred
- Enrollment expected to complete in late 2025 or early 2026
The second interim analysis was triggered by the 52nd death. After reviewing the data, the DMC recommended continuation without modification, signaling no safety concerns and potential for efficacy.
To safeguard the trial’s regulatory standing, RenovoRx has deferred releasing the interim results. The company expects to consider publishing the data upon trial completion, consistent with practices for pivotal oncology studies.
Operational and Business Highlights
RenovoRx achieved several operational milestones in Q2 and the weeks following:
- Increased Device Production
- To meet growing demand, RenovoRx scaled up production of RenovoCath.
- Manufacturing is led by Medical Murray Inc., based in North Barrington, IL.
- Strategic Hiring: Phil Stocton
- Brought on board as Senior Director of Sales and Market Development.
- Brings two decades of global experience at Johnson & Johnson, Terumo, Varian (Siemens), and Sirtex Medical.
- Previously consulted with RenovoRx on commercial launch planning.
- Expanded Clinical Trial Network
- Johns Hopkins Medicine joined as a participating site in TIGeR-PaC.
- Patent Expansion
- U.S. Patent No. 12,290,564, titled “Methods for Treating Tumors”, became effective May 6, 2025.
- Protects drug-delivery methods through November 2037.
- Launch of PanTheR Registry Study
- A multi-center, post-marketing registry to track real-world RenovoCath use across solid tumors.
- Designed to evaluate long-term safety, survival outcomes, and broader applications.
Financial Performance
For the quarter ended June 30, 2025:
- Revenue: $422,000 (vs. $0 in Q2 2024), reflecting both new customer adoption and early repeat orders.
- Cash Position: $12.3 million in cash and equivalents. Management believes this will fund ongoing scale-up and clinical progress.
- R&D Expenses: $1.4 million, slightly lower than $1.5 million in Q2 2024, driven by reduced regulatory expenses but offset by higher costs tied to next-gen RenovoCath development.
- SG&A Expenses: $1.5 million, flat year-over-year.
- Net Loss: $2.9 million, compared to $2.4 million in Q2 2024. The change primarily reflects fair-value adjustments on warrants.
- Shares Outstanding: 36.6 million as of August 11, 2025.
Despite reporting a net loss, RenovoRx emphasized that revenues from RenovoCath are expected to help offset cash burn over time as adoption grows.
Strategic Positioning: Building for Long-Term Growth
RenovoRx’s trajectory illustrates the dual value creation engine driving the company forward:
- Commercial Pathway
- RenovoCath adoption by prestigious cancer centers is validating the clinical need for targeted intra-arterial delivery.
- With repeat orders already coming in, RenovoRx is positioning for sustained revenue growth.
- The PanTheR registry may further bolster real-world data to support expanded adoption.
- Clinical Pathway
- TIGeR-PaC’s progression toward full enrollment and completion is a pivotal catalyst.
- A positive outcome could validate TAMP™ therapy as a transformative modality in oncology drug delivery.
- Expansion into other solid tumors could multiply the market potential.
Conference Call and Investor Access
RenovoRx will host a conference call on August 14, 2025, at 4:30 p.m. ET to discuss results.
- Dial-in (U.S. Toll Free): 1-877-407-4018
- International: 1-201-689-8471
- Webcast: RenovoRx Investor Relations
A replay will be available until September 14, 2025.
About RenovoCath®
RenovoCath is FDA-cleared for the isolation of blood flow and targeted delivery of diagnostic or therapeutic agents in the peripheral vascular system. Its applications include:
- Drug infusion for solid tumors
- Temporary vessel occlusion
- Arteriography and preoperative occlusion
This versatile profile supports its role not only in pancreatic cancer but potentially in a broad array of oncology indications.
Outlook: A Company at the Crossroads of Commercial and Clinical Validation
RenovoRx’s Q2 2025 performance highlights a company steadily moving from a clinical-stage biotech to a commercial-stage oncology player. The combination of growing revenues, expanding customer adoption, strengthened intellectual property, and positive trial oversight positions RenovoRx as a company with multiple catalysts ahead.
- Short-term: Continue enrollment in TIGeR-PaC, expand RenovoCath’s adoption among U.S. cancer centers, and generate additional real-world data via the PanTheR registry.
- Medium-term: Scale sales efforts in 2026, broaden RenovoCath’s use cases, and leverage interim and final trial results to position for FDA approval of the TAMP-enabled gemcitabine therapy.
- Long-term: Establish RenovoRx as a leader in targeted oncology drug delivery, with a multi-billion-dollar TAM spanning multiple tumor types.
As CEO Shaun Bagai emphasized, the dual focus on commercialization and clinical advancement is central to RenovoRx’s growth strategy:
“We are working to grow our customer base, fulfill repeat RenovoCath orders, and position ourselves for long-term commercial growth—while also advancing a pivotal Phase III trial that has the potential to redefine how chemotherapy is delivered in hard-to-treat cancers.”
