RenovoRx (NasdaqCM:RNXT) FY Conference Transcript

Summary of the Conference Call Company Overview - Company: RenovoRx - Industry: Targeted Oncology - Product: RenovoCath, a device for targeted delivery of therapeutics, particularly for difficult-to-treat cancers like locally advanced pancreatic cancer [1][4][6] Core Points and Arguments - Business Model: RenovoRx operates on a dual-track model, focusing on both the commercialization of the RenovoCath device and late-stage Phase III clinical trials for drug-device combinations [6][8] - Transarterial Microperfusion (TAMP): The patented technology allows for localized delivery of chemotherapy, minimizing systemic side effects. The device is FDA-cleared and designed to deliver chemotherapy directly to tumor sites [6][10][26] - Clinical Trials: The ongoing Phase III TIGeR-PaC trial is evaluating the efficacy of the RenovoCath device combined with gemcitabine for treating locally advanced pancreatic cancer. The trial has shown promising interim results, including a 30% survival benefit and a 65% reduction in side effects compared to standard care [7][31][36] - Market Demand: There is significant physician interest in the device due to its potential to reduce toxicities and improve patient outcomes. The company has initiated commercialization based on physician demand [11][12][23] Financial Insights - Revenue Potential: Each patient may require 5 to 10 treatments, leading to substantial revenue potential. The price range for the device is estimated between $6,000 to $8,500, with potential revenue of around $100,000 per patient [22][23] - Cash Position: The company reported $12.3 million in cash with a burn rate of approximately $800,000 per month, providing a runway into the second half of 2026 [45] Additional Important Content - PANTHER Registry: A post-market registry study to capture data on the device's use across various tumor types, which may lead to expanded indications for the drug-device combination [16][19] - Regulatory Pathway: The company anticipates that the TIGeR-PaC study could serve as a pivotal trial for FDA approval, with a focus on overall survival as the primary endpoint [39][40] - Future Catalysts: Key upcoming events include the publication of pharmacokinetic data, updates from the PANTHER registry, and commercial progress as the company builds its sales team [42][44] Conclusion RenovoRx is positioned to capitalize on a unique market opportunity with its innovative device for targeted cancer therapy. The ongoing clinical trials and commercial efforts are expected to drive growth and enhance patient outcomes in oncology.