RenovoRx CEO Issues Letter to Shareholders

RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a local drug-delivery platform, today provided a letter to shareholders from Chief Executive Officer, Shaun Bagai.

Dear Fellow RenovoRx Shareholders,

2023 was a pivotal year for RenovoRx, and we believe our accomplishments bode well for the achievement of our anticipated 2024 milestones.

Our team worked diligently on advancing the development of our proprietary targeted combination therapy platform, Trans-Arterial Micro-Perfusion (TAMP), involving our novel and proprietary delivery system, designed to improve the standard of care for patients diagnosed with difficult-to-treat cancers. We are proud to have achieved several key milestones described below, including, importantly, an initial positive interim analysis on our pivotal Phase III TIGeR-PaC clinical trial in locally advanced pancreatic cancer (LAPC).

Among our significant milestones achieved, our recent completion of a $6.1 million private placement has extended our cash runway, allowing us to drive towards our key goal of a second interim analysis for our TIGeR-PaC study, which is expected by late 2024.

TIGeR-PaC is an ongoing Phase III randomized multi-center study evaluating our lead product candidate, RenovoGem for the treatment of LAPC. RenovoGem is a novel oncology drug-device combination product utilizing our TAMP administration technology combined with the FDA-approved cancer drug, gemcitabine. The study is comparing treatment with RenovoGem to the current standard of care of systemic intravenous chemotherapy.

The first interim analysis in the TIGeR-PaC study at the 26^th event of the specified events (deaths), was completed in March 2023, with the Data Monitoring Committee recommending a continuation of the study. The TIGeR-PaC study’s primary endpoint is a 6-month Overall Survival benefit with secondary endpoints including reduced side effects versus standard of care. The data was first presented at the 2023 American Association for Cancer Research Annual Meeting in April 2023 and then as a Late Breaker Oral Presentation with additional secondary endpoint data at the 2023 European Society of Medical Oncology World Congress on Gastrointestinal Cancer in June 2023. The second interim analysis for this study is expected to occur at the 52^nd event which is estimated to occur in late 2024.