Dear Fellow RenovoRx Shareholders,
The first quarter of 2024 marked a significant period in our company's evolution, and we have set the stage for significant milestones in the foreseeable future. Our team is steadfast in RenovoRx's mission to continue on a clinical pathway towards improving patients' lives by using our patented products to deliver precision therapies that have the potential to transform the standard of care in difficult-to-treat cancers.
With $17.2 million in gross proceeds raised since the beginning of 2024, and with a proven history of prudent stewardship of our capital resources, RenovoRx has sufficient funding to advance our pivotal Phase III TIGeR-PaC clinical trial and expand the development pipeline into additional cancer indications. Our priority remains on TIGeR-PaC in Locally Advanced Pancreatic Cancer (LAPC) first and foremost, and its progress towards a second interim readout triggered by the 52nd event (death) in the trial estimated late 2024, and ultimate completion thereafter. Additionally, we intend to pursue the expansion of our proprietary Trans-Arterial Micro-Perfusion (TAMP™) therapy platform and the clinical development of our pipeline into additional cancer indications. Lastly, we will continue to investigate our ongoing exploration of new commercial business development opportunities with our therapeutic technologies.
During the first quarter, we continued to progress the TIGeR-PaC clinical trial, an ongoing randomized multi-center study in LAPC using RenovoRx's TAMP therapy platform to evaluate its first product candidate, RenovoGem™, a novel oncology drug-device combination product. The study is comparing treatment with TAMP to the current standard of care (systemic intravenous chemotherapy).
In tandem with the positive progress that we have made in advancing TAMP with our TIGeR-PaC study, we made important additions to our management team and Scientific Advisory Board, bolstering our strong leadership. These additions enhance our already deep expertise resident at RenovoRx.
In March, RenovoRx promoted Leesa Gentry to Chief Clinical Officer and Ronald B. Kocak to Principal Accounting Officer. These promotions reflect our commitment to assembling a dynamic team poised to continue to lead a successful clinical pathway for our proprietary therapy platform. We have streamlined our team, focusing our efforts on strategic initiatives to drive growth and innovation. On behalf of our Board of Directors, I extend our gratitude to Leesa and Ron for their hard work and dedication to date and congratulate them on their well-deserved promotions.
In March, important research studies were published supporting the TAMP therapy platform, including:
- A publication of pre-clinical studies supporting the efficacy and drug-delivery mechanism potential of TAMP to improve targeted cancer drug treatment delivery was published in the peer-reviewed Journal of Vascular Interventional Radiology. The manuscript was authored by Khashayar Farsad, MD, PhD of the Department of Interventional Radiology at Oregon Health and Science University, and co-authored by Paula M. Novelli, MD, of the University of Pittsburgh Hillman Cancer Center, together with other researchers, including RenovoRx's Chief Medical Officer, Ramtin Agah, MD. View press release.
- David Sperling, MD, Associate Professor of Radiology at Columbia University Irving Medical Center in New York, presented a clinical data abstract at the recent 2024 Society of Interventional Radiology Annual Scientific Meeting. The abstract highlighted a sub-study of the TIGeR-PaC clinical trial and featured important data to assist in optimization of TAMP with better risk stratification of patients while improving guidance of TAMP therapy for LAPC treatment. It is important to understand appropriate candidates for TAMP, and managing patients who could be at any risk is paramount to helping underserved patient populations, like those diagnosed with LAPC. This is especially important given the potential of the TAMP therapy platform. View press release.
The first interim analysis in the Phase III clinical trial was completed in March 2023, with the Data Monitoring Committee recommending a continuation of the study. The TIGeR-PaC study is investigating TAMP in LAPC. The study's primary endpoint is a 6-month Overall Survival benefit with secondary endpoints including reduced side effects versus standard of care. We are expecting the clinical events necessary for a second interim analysis should take place by the end of this year, and we are eagerly anticipating the outcome of this analysis.
In closing, I want to extend our appreciation to our clinical sites and patients in our Phase III clinical trial, along with our long-term and newer shareholders. With your support, our team is very well positioned to continue its commitment to improving patients' lives and lifespans by delivering precision therapies that have the potential to revolutionize the current paradigm of cancer care. Your trust and confidence in RenovoRx have helped us build the remarkable company we have become, and one whose future has never been brighter.
We encourage anyone interested to visit our website, renovorx.com, to learn more, and email us at [email protected] to contact us.
Sincerely,
Shaun R. Bagai, CEO