RenovoRx (RNXT) investor relations material

Commercial progress and market opportunity

• Adoption of RenovoCath is accelerating, with 12 U.S. cancer centers actively using it and 21 more evaluating or preparing for activation as of February 2026, tripling the near-term pipeline from early 2025.

• Over 700 RenovoCath procedures have been completed since FDA clearance in 2014, with a 2026 revenue outlook of $3-4 million and a targeted 36 active commercial sites by year-end.

• The device is protected by patents through 2045, with an estimated initial peak annual U.S. revenue opportunity of $400M.

• 2025 revenue exceeded $1 million, achieved before the establishment of a dedicated sales and marketing team, and cash reserves stood at $13 million at year-end.

• Commercial scale-up is supported by a focused sales team, with revenue ramp and cashflow breakeven expected in the second half of 2026.

Technology and clinical platform

• The proprietary Trans-Arterial Micro-Perfusion (TAMP) platform enables targeted drug delivery, increasing drug concentration at the tumor site by ~100x and reducing systemic exposure by 43.5% compared to IV administration.

• TAMP is designed to address hypovascular tumors, such as pancreatic cancer, where traditional therapies are less effective due to poor blood supply.

• The mechanism involves vessel isolation and pressure-mediated delivery, forcing drugs into tumor tissue.

• RenovoCath procedures are outpatient, require only conscious sedation, and are easy for interventional radiologists to learn.

• The platform is broadly applicable to multiple solid tumor types, representing a multibillion-dollar opportunity.

Clinical development and trial results

• The pivotal Phase III TIGER-PAC trial is evaluating intra-arterial gemcitabine (IAG) delivered via RenovoCath for locally advanced pancreatic cancer (LAPC), with FDA Orphan Drug Designation granted.

• Interim analysis showed a 6-month median overall survival benefit and a 65% reduction in side effects compared to standard IV therapy.

• As of March 2026, 104 patients had been randomized, with enrollment completion expected by mid-2026 and final data anticipated in 2027.

• The trial is powered to detect a hazard ratio of 0.6 for overall survival, with primary and secondary endpoints including progression-free survival and quality of life.

• Registry and investigator-initiated trials are expanding evidence for RenovoCath in additional solid tumor indications.