RenovoRx Eyes 2027 TIGeR-PaC Readout as RenovoCath Expands to 21 Centers

Key Points

• RenovoRx’s Phase III TIGeR-PaC trial is fully enrolled and had recorded 78 of 86 required events; final events are expected in the first half of 2027, with top-line results anticipated in the second half of 2027. An interim analysis indicated a 65% reduction in toxicities versus systemic chemotherapy, but the survival trend was not statistically significant.
• RenovoCath adoption expanded to 21 treatment centers, up from roughly four or five last year, as physicians cited its potential to deliver localized chemotherapy with lower systemic toxicity and provide a maintenance or “chemotherapy holiday” option for locally advanced pancreatic cancer.
• RenovoRx reported $1.5 million in first-half revenue and approximately $900,000 in quarterly revenue, and management is targeting potential break-even in the fourth quarter of next year. Hospital approval cycles typically take four to six months.

RenovoRx NASDAQ: RNXT executives and physician speakers discussed the treatment landscape for locally advanced pancreatic cancer, the company’s Trans-Arterial Micro-Perfusion, or TAMP, platform, and commercialization progress for its RenovoCath delivery device during a webinar hosted by JonesTrading.

Shaun Bagai, RenovoRx’s chief executive officer, said the company’s approach is designed to deliver chemotherapy locally to tumors while reducing the systemic toxicity associated with intravenous chemotherapy. The TAMP procedure uses the FDA-cleared RenovoCath device, which is positioned through an artery near the tumor. Two balloons isolate blood flow in a targeted area, allowing clinicians to administer therapy under pressure into nearby tissue, according to Bagai.

Bagai said pancreatic tumors can be difficult to treat because they often have limited blood supply and fibrotic tissue that can impede drug penetration. RenovoRx’s approach is intended to increase local drug concentration while limiting exposure elsewhere in the body.

Physicians cite need for lower-toxicity options

Dr. Dae Won Kim, a gastrointestinal medical oncologist at Moffitt Cancer Center, said treatment depends on whether pancreatic cancer is resectable. Patients with resectable disease may undergo surgery followed by chemotherapy, while those with locally advanced or metastatic disease generally receive chemotherapy, with radiation also used for localized disease.

Kim said roughly 50% to 55% of patients have metastatic disease at diagnosis, 30% to 35% have locally advanced unresectable disease, and only 10% to 15% can proceed directly to surgery.

For unresectable cases, patients often require extended chemotherapy treatment, but cumulative side effects can limit their ability to remain on therapy, Kim said. He identified lower toxicity as a central unmet need, particularly for patients who have already received months of chemotherapy and radiation.

Kim, who disclosed research support from Revolution Medicines and RenovoCath, said TAMP may offer a maintenance option for locally advanced patients after initial chemotherapy and radiation. He said patients he has treated with TAMP generally tolerated planned treatment courses and, in one case, regained enough strength to resume systemic chemotherapy after later developing liver metastases.

Kim also discussed emerging KRAS-targeted therapies, including daraxonrasib, saying such drugs could affect pancreatic cancer treatment but would not eliminate the need for local therapies. He said the agent may have toxicity limitations, including severe skin rash in a large proportion of patients, and may require treatment interruptions or dose reductions for some individuals.

TIGeR-PaC data and treatment sequencing

Bagai said RenovoRx’s Phase III TIGeR-PaC study has completed enrollment. The trial is evaluating intra-arterial gemcitabine delivered through RenovoCath in locally advanced pancreatic cancer.

According to Bagai, an earlier interim analysis showed a 65% reduction in toxicities and side effects compared with systemic chemotherapy, as well as a trend toward improved survival. He said the interim analysis was not statistically significant and represented an early look at the data.

Kim said the final TIGeR-PaC results are expected next year and that the key measures will include overall survival, progression-free survival, local tumor control and quality of life. He said historical median overall survival for locally advanced pancreatic cancer has been about 16 to 18 months.

Dr. Ravi Shridhar, a radiation oncologist at AdventHealth Cancer Institute, said his center has used TAMP following chemotherapy and radiation in locally advanced disease. He described the approach as a potential “chemotherapy holiday” that may allow patients to receive targeted treatment while avoiding some cumulative effects of systemic chemotherapy.

Shridhar said one patient with a bulky locally advanced tumor had about 50% tumor shrinkage after three TAMP infusions, though he emphasized that broader evidence will be needed as the TIGeR-PaC data mature. He said patients at his center have generally experienced manageable abdominal discomfort and nausea and have received treatment in an outpatient setting.

Adoption and commercial update

Shridhar said implementation requires experienced interventional radiologists and coordination among medical oncology, radiation oncology, surgical oncology and interventional radiology. He said the learning curve for the procedure was limited after the first several cases, but hospital device-approval processes and scheduling capacity have been practical hurdles.

AdventHealth initially launched the program at one facility and is working to expand it to additional sites, including Tampa, according to Shridhar. He said referrals are increasingly coming from medical oncologists as clinicians observe early patient results.

Bagai said RenovoRx had expanded from approximately four or five active centers last year to 21 centers treating patients. The company has four sales representatives and a head of sales, he said, adding that hospital approval cycles typically take four to six months on average, though timelines can vary.

Bagai said RenovoRx reported $1.5 million in first-half revenue and approximately $900,000 in the most recent quarter, based on the company’s latest earnings update. He said the company is targeting potential break-even in the fourth quarter of next year.

On the clinical-development timeline, Bagai said TIGeR-PaC had recorded 78 of the 86 required events for final analysis. He estimated the final event could occur in the first half of next year, with top-line data in the second half of 2027.

About RenovoRx (NASDAQ:RNXT)

RenovoRx, Inc is a clinical-stage medical technology company focused on the development of proprietary drug-device combination therapies for the treatment of solid tumor malignancies. The company's lead product candidate, RenovoCath™, is an intra-arterial catheter system designed to deliver high concentrations of chemotherapeutic agents directly to tumor sites while minimizing systemic exposure. RenovoRx seeks to improve clinical outcomes and reduce adverse effects by enhancing drug delivery precision in hard-to-treat cancers.

RenovoCath™ is being evaluated in multiple clinical trials targeting advanced pancreatic cancer and metastatic colorectal cancer, among other solid tumors.

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