RenovoRx, Inc.

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.

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.

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.

Thank you, Ramtan. Keyword of 2025 represented our first quarter of generating revenue from commercial sales. important strategic decision we made in 2024 to focus on implementing a commercial strategy for Novocath in tandem with our ongoing phase three trial. We plan to launch our commercial efforts for Novocath during Q1 of this year in response to anticipated strong demand for our technology. However, we received purchase orders ahead of schedule, generating $43,000 of revenue in December. I am proud of our team for quickly implementing a go-to-market strategy to meet the demand from the oncology community and therefore made the decision to increase our U.S.-based RenovoCath production last year. Last month, I stated that we expected Q1 revenue to be in the low six-figure range, followed by sequential quarter-over-quarter increases for the remainder of the year. I am pleased to report that revenue from RenovoCath exceeded our internal expectations to approximately $200,000 in the first quarter, and we anticipate this trend to continue going forward with sequential quarterly growth for the foreseeable future. We were encouraged by the strong organic demand for RenovoCath with more than 10 medical institutions that are not current TigerPak sites having initiated a process for RenovoCath purchase orders. These include several esteemed high-volume academic and community and National Cancer Institute designated centers. Further, we believe the approximately 20 centers that have used RenovoCath as part of our TigerPak trial could also be potential customers for RenovoCath after completion of TigerPak enrollment anticipated for later this year. Additionally, early utilization of RenovoCath devices by initial customers has led to repeat purchase orders. Based on our internal analysis of clinical interest and FDA-cleared applications of the device, we believe that our initial total addressable market for RenovoCath represents an estimated $400 million peak U.S. annual sales opportunity. We are assuming an average of eight annual procedures per patient and 7,000 initial target patients at peak market penetration in patient populations where we already have clinical usage. While we haven't publicly disclosed our catheter pricing, technologies utilizing the same reimbursement coding are charging between $6,500 and $8,500 per device. Looking ahead, we see expansion opportunities across other cancer indications that could create the potential for a several billion-dollar U.S. TAM for Novocath over time. The prospect of generating even a small portion of this market combined with the potential to help so many patients is driving our excitement about this opportunity. We believe we can manage meaningful market penetration with a small yet focused commercial team targeting the top 200 high-volume treatment centers. Importantly, we believe this strategy can be executed without a material increase in our expenses, whether through direct commercialization or by partnering with a larger organization with an established sales force, which is a strategy we are actively exploring. We expect that the growing revenues from Renovocath will reduce our burn rate and that our cash on hand of $14.6 million at the end of the first quarter will fully fund both our Renovocath scale-up and the continued progress of our Phase 3 TigerPak clinical trial. On the topic of our TigerPak clinical trial, during the first quarter of 2025, we announced that Johns Hopkins Medicine has now initiated enrollment in our ongoing Phase 3 TigerPak trial. This is a valuable addition to the distinguished network of clinical cancer sites across the U.S. participating in this important trial as we work towards full enrollment. We are continuing to target additional sites and expect that TigerPak will achieve full enrollment during 2025. As a reminder, the current protocol and statistical analysis plan for the TIGER-PAG trial requires 114 randomized patients with 86 events or deaths necessary to complete the final analysis. As of May 2nd, 2025, 91 patients have been randomized and 56 events have occurred, triggering the second interim analysis. We expect the study's data monitoring committee to review the data in Q3 and eagerly await their recommendations and feedback. Last week, we announced the issuance of a new U.S. patent for our Tant Therapy platform, further enhancing our IP production. RenovoRx's strong and growing intellectual property portfolio provides key support to the company's continuing commercialization of RenovoCath. The issuance of this new patent highlights the innovation behind our Tant Therapy platform and strengthens our competitive position. Before closing, I want to highlight one final point. During the first quarter, we announced that in our most recent open trading window, members of the management team and board purchased an aggregate of approximately 143,000 shares of Renovo RX stock and multiple open market purchases. This signals our confidence in our company and its future and underscores our enthusiasm for our company's long-term value proposition. In conclusion, I want to reaffirm our belief that the approximately 20 cancer centers that have used RenovoCath as part of our TigerPak trial could also be potential customers after the planned completion of enrollment later this year. Building upon our recent success, we expect revenue from RenovoCath to increase from the low six figure range with sequential quarter over quarter increases for the remainder of the year as we move along the path to becoming a cashflow positive in the future. With that, I'll turn it over to Ron who will take us through some of the numbers.

Thank you, Sean. For the first quarter of 2025, Renovo reported revenue of approximately 200,000 from commercial sales of its FDA-cleared RenovoCast device, exceeding our initial expectations in our first quarter of revenue. Research and development expenses were 1.7 million for the quarter, up from 1.3 million in the first quarter of 2024. This $0.4 million increase was primarily driven by the following, higher employee compensation due to cost of living adjustments, increased manufacturing and non-recurring engineering costs to support commercial scale-up, greater participation in conferences and trade shows, and other ongoing R&D activities. Selling, general, and administrative expenses were approximately $1.6 million for the quarter, an increase from 1.2 million in the prior year period. This 0.4 million rise was attributed to increase in personnel related costs, professional and consulting fees to support commercializations, and other selling general and administrative activities. As of March 31st, 2025, the company had 14.6 million in cash and cash equivalent. As of May 9th, 2025, Shares of our common stock outstanding totaled $36,572,232. And now, I'll turn the call back to the operator for Q&A.

Ladies and gentlemen, at this time, we'll begin the question and answer session. To ask a question, you may press star and then one on your touchtone phones. If you are using a speaker phone, we do ask that you please pick up your handset before pressing the keys to ensure the best sound quality.

To answer all your questions, you may press star and two. We'll pause momentarily to assemble the roster. And once again, if you would like to ask a question, please press star and one.

And in showing no questions, I would like to turn the floor back over to Sean Beguy for closing comments.

Thank you all again for participating in today's presentation.

We were very excited about the key strategic steps we've taken over the last year to build long-term value in our company. And we are beginning to see the tangible results from these efforts.

We look forward to the rest of the year unfolding and to providing you with important updates on our progress. Have a great evening.

And ladies and gentlemen, with that, we'll conclude today's conference call and presentation. We do thank you for joining. Actually, one moment. We do have someone that has joined the question queue late. Let me join in, Rafay Khalid from Ascendant Capital Markets. Please go ahead with your question.

Hi, thank you. This is Rafay for Edward Wu, Ascendant Capital Markets. Can you talk about your plans for the Renovo Cath for international markets?

Thanks for the question. At this point, we don't have a current CE mark. We're looking into that for the future. We haven't disclosed publicly on timing of international markets, but obviously there's high demand for this type of technology given the unmet need in these types of tumors in both the European countries as well as a very large market in China, Korea, and Japan as well. So there's interest there. We've talked to physicians. But we plan on really driving hard in the U.S. commercial market, given the reimbursement landscape, and then approaching outside the U.S. markets later, exploring that later this year, potentially next year.

Great. And one more question. Do you have plans to increase – you talked about partnering with potentially the top 200 cancer centers. Would you use their sales force, or would you use distributors to target those partners?

So I have – Yeah, thank you for the question. I have stated publicly that we are talking to a handful of strategic partners. These are large companies that have sales forces that cater to the interventional oncologists who do the procedures, so the interventional radiologists. So we're looking at the, from a business perspective, if it makes more sense to hire a small sales force with a handful of reps to get to drive meaningful revenue for the company and or partner with a strategic partner that has an existing distribution channel. So we're exploring both currently And both are actually well on their way in terms of proving out which plan makes the most financial sense for the company.

Great. Thank you very much.

And once again, if you would like to ask a question, please press star and then one using a touch-tone telephone. To withdraw your questions, you may press star and two. Once again, that is star and then one to join the question queue. And ladies and gentlemen, at this time, I would turn it back to Mr. Begay for any additional closing comments.

Thank you again for your time and participating, and have a great evening. Thank you, everyone.

And that will conclude today's conference call-in presentation. Thank you for joining. You may now disconnect your lines.