5/15/2025

speaker
Operator
Conference Operator

afternoon everyone and welcome to the renovo rx q1 2025 financial and operational highlights conference call all participants will be in a listen-only mode if you need assistance please email a conference specialist by pressing the star key followed by zero after today's presentation there will be an opportunity to ask questions to ask a question you may press star and then one on your touchtone phones to withdraw your questions you may press star and two Please also note today's event is being recorded. At this time, I'd like to turn the floor over to Walter Pinto, Managing Director at KCSA Strategic Communications. Sir, please go ahead.

speaker
Walter Pinto
Managing Director, KCSA Strategic Communications

Thank you, Operator. Good afternoon, and welcome, everyone, to the Renovo Rx first quarter 2025 conference call. I'm joined today by Renovo RACS's leadership team, including Dr. Ramta Nagar, founder and chief medical officer, Sean Bagai, chief executive officer, and Ronald Kozak, VP controller and principal accounting officer. Before we begin, I'd like to remind everyone the statements made during today's conference call may be deemed forward-looking statements within the meaning of the safe harbor of the Private Securities Litigation Reform Act of 1995 and applicable federal securities laws. and that actual results may differ materially and adversely from what is contemplated by such forward-looking statements due to a variety of substantial risks, uncertainties, and other factors. The company's forward-looking statements are based on management's current plans and assumptions and are subject to the risks and uncertainties more fully described in the company's filings with the SEC. These statements reflect management's view of current and future market conditions, including but not limited to statements regarding the company's clinical trials and other research studies, including... Timing for potential additional interim data readouts and full patient enrollment for RenovoRx's ongoing Phase III TigerPak clinical trial studying intraarterial gemcitabine and locally advanced pancreatic cancer. The potential of the RenovoCast device as a standalone commercial product or the transarterial microprofusion therapy platform as a mechanism of action. The anticipated timings for and levels of revenue generation from RenovoCast sales and and the company's commercialization plans in general, the potential for intraarterial gemcitabine to treat or provide clinically meaningful outcomes for certain medical conditions or diseases, and RenovoRx's efforts to explore commercialization strategies utilizing the transarterial microprofusion therapy platform. For a detailed discussion of some of the material risks and surrogates facing Renova RACs, I refer you to the company's annual report on Form 10-K for the year ended December 31st, 2024, as well as the company's investor presentation and other reports filed periodically with the SEC, including our Form 10-Q for the first quarter of 2025, which was just filed with the SEC. Renova RACs exclaimed any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. With that, it's my pleasure to turn the call over to Dr. Ramtan Agha, founder and chief medical officer of Renova Rx. Ramtan, please go ahead.

speaker
Dr. Ramta Nagar
Founder & Chief Medical Officer, Renovo Rx

Thank you, Walter, and good afternoon, everyone. I appreciate everyone joining us today. At Renova Rx, we're pioneering a new era in cancer care through our trans-arterial microperfusion or TAMP therapy platform. By localizing and targeting delivery of therapeutic agents like chemotherapy near the tumor site via the peripheral system, TAMP is designed to optimize drug concentration precisely where it's needed while potentially minimizing systemic exposure and related toxicities. This target approach addresses the longstanding challenge in cancer care where there is poor tumor blood supply. I believe TAMP represents a significant advancement in the way cancer treatment can be approached. Our mission is to transform patients' outcomes by providing a safer, more effective way to deliver therapy directly to hard-to-treat tumors. Our ongoing Phase III target-packed clinical trial, evaluating the targeted delivery of chemotherapy, gemseptamine, with TAMP via our patented FDA-cleared renal overcap device to patients with locally advanced pancreatic cancer, is advancing with encouraging results. Our initial interim data showed that the patients experienced median overall survival with standard systemic chemotherapy delivery of 10 months versus 16 months with our targeted approach. This is from the time of randomization. It is important to note that both median overall survival arms calculation for the study interim analysis data do not include approximately five and a half months of life from diagnosis to randomization during the induction chemotherapy and radiation phase of the trial. Moreover, we observed a 65% reduction in adverse events such as nausea and fatigue, significantly improving patient quality of life. These results have strengthened our conviction that TAMP can redefine outcomes for patients facing some of the most difficult-to-treat cancers. As we continue to increase exposure to TAMP and Renovacat through our TIGERPAC trial and more recently to our commercial efforts for Renovacat as a standalone device, The reception from physician community has been overwhelmingly positive. Clinical investigators have expressed strong support and enthusiasm to our approach in drug delivery, recognizing the potential clinical benefit and improved tolerability profile that the use of RenovoCAP offers. Their feedback reinforces our belief that RenovoRx is well positioned to establish a new standard of care for LAPC and potentially other indications. As we advance our clinical and commercialization efforts, I'm energized by the transformative potential of our platform and deeply appreciate your continued support as we work to change the future of cancer treatment. Thank you for attending and for your support of RenovRx. With that, I turn over to our CEO, Sean Begay.

Disclaimer

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