RenovoRx, Inc.

Good afternoon. I will be your conference call operator today. Please note that today's call is being recorded and all participants other than management are in a listen-only mode. There will be a Q&A session following management's presentation. I will now turn the call over to Walter Pinto, Managing Director of KCSA Strategic Communications. Please go ahead.

Thank you, operator, and good afternoon. Welcome everyone to the Renova Rx second quarter 2025 conference call. I'm joined today by Renova Rx leadership team including Dr. Ramten Agha, Chairman, Founder, and Chief Medical Officer, John Bagai, Chief Executive Officer, Lisa Gentry, Chief Clinical Officer, and Renal Kozak, VP Controller and Principal Accounting Officer. Before we begin, I'd like to remind everyone that statements made during today's conference call may be deemed forward-looking statements within the meaning of the safe harbor of the Privacy 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 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, timing for potential additional interim data readouts and full patient enrollment for Renova Rx's ongoing Phase III Tiger plaque clinical trials studying intra-ritorial gemcitivine, also known as IAG, and locally advanced pancreatic cancer, the potential of the RenovaCast device as a standalone commercial product, or the trans-ritorial microprofusion therapy platform, also known as TAMP, as a mechanism of action, the anticipated timing for and levels of revenue generation from RenovaCast sales, the company's commercialization plans in general, the potential for IAG to treat or provide clinically meaningful outcomes for certain medical conditions or diseases, and Renova Rx's efforts to explore commercialization strategies as utilizing the TAMP therapy platform. For a detailed discussion of material risks and uncertainties facing Renova Rx, 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 the Form 10-Q for the second quarter of 2025, which was just filed with the SEC. Except as required by law, Renova Rx disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. With that, it's my pleasure to turn the call over to Dr. Ramten Agha, Chairman, Founder, and Chief Medical Officer of Renova Rx. Ramten, please go ahead.

Thank you, Walter, and good afternoon, everyone. 2025 thus far has marked the most transformational period in our company's history. As everyone knows, late last year, we launched the commercialization of RenovaCast device. As a standalone product, we do need to SBA clear the indications for use. While we continue to make progress with our Phase III target pack study, our clinical and commercial team have executed well, and I could not be more excited about our future. Our proprietary trans-arterial microperfusion therapy platform, or TAMP, is designed for targeted therapeutic delivery across the arterial wall near the tumor site to date the target tumor. By localizing and targeting delivery of therapeutic agents via the peripheral vascular system, TAMP is designed to optimize drug concentration precisely where it is needed. This targeted approach can minimize systemic exposure and toxicities related to chemotherapy and addresses the long-standing challenge in cancer care of poor blood supply to tumor sites. We believe that TAMP, by using the body's existing microvascular pathway called the VES of the serum, or drug delivery, represents a significant advancement in the way cancer treatment can be approached. We began commercializing RenovaCast in the fourth quarter of 2024, and without a sales and marketing team in place, we are proud to have achieved over $400,000 in sales in the second quarter, a significant accomplishment in a short period of time. These initial sales prior to installing a sales and marketing infrastructure highlights the strong clinical need and market demands for our patented RenovaCast device as a standalone targeted drug delivery product among both new and existing customers. Equally important is the R-Phase III Target Pack trial. The 50-second event in our trial occurred in Q2, treating the pre-planned second interim analysis and reviewed by the independent data monitoring committee, known as the DMC, which happened recently. As a reminder, the DMC reviews the trial data and makes recommendations to our company, mainly whether the data was compelling enough from their third-party point of view to move forward with the trial or not. We are excited to report that the DMC recently completed the review of our second planned interim analysis and has recommended that we continue the study. This is great news, as we believe DMC's recommendation is an expression of confidence in the potential for a positive outcome in the trial overall. With a view toward preserving the integrity of Target Pack trial for FDA purposes and following our review of general FDA guidance, discussions with the DMC, and consultation with regulatory advisors, we have decided to defer publishing our second interim data. Outside of myself, who has been speaking directly with the DMC, our entire team will remain blinded to the interim data. We will revisit publishing the actual second interim data, most likely upon completion of this study, as is common for pivotal phase III trials. Meanwhile, the Target Pack trial is continuing at pace. As of August 12, 2025, 95 patients have been randomized and 61 events have occurred, putting us on target to complete enrollment later this year or early next year. At RenovarX, our mission remains clear, transform patient outcomes through safer, more effective targeted therapy, especially for those battling difficult to treat cancers like locally advanced pancreatic cancer. Thank you all for your continued support. With that, I will turn the call over to our CEO, Sean Bagaio.