Afternoon, and welcome, everyone, to the RenovoRx First Quarter twenty twenty five Conference Call. I'm joined today by RenovoRx's leadership team including Doctor. Ramten Aga, Founder and Chief Medical Officer Sean Bagay, Chief Executive Officer and Ronald Kozak, VP Controller and Principal Accounting Officer. 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 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 TIGRPAC clinical trial studying intra arterial gemcitabine locally advanced pancreatic cancer. The potential of the Renovocast device as a standalone commercial product or the transarterial microperfusion therapy platform as a mechanism of action.

The anticipated timing for and levels of revenue generation from Renovocast sales, and the company's commercialization plans in general, the potential for intra arterial 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 microperfusion therapy platform. For a detailed discussion of some of the material risks and uncertainties facing RenovoRx, I refer you to the company's annual report on Form 10 ks for the year ended 12/31/2024, 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 twenty twenty five, which was just filed with the SEC. RenovoRx has claimed 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 Doctor. Ram Tinaga, Founder and Chief Medical Officer of RenovoRx. Rampton, please go ahead. Thank you, Walter, and good afternoon, everyone. I appreciate everyone joining us today.

At RenovoRx we're pioneering a new era in cancer care our transarter arterial microperfusion. Or TAP therapy platform. By localizing and targeting delivery of therapeutic agents like chemotherapy, near the tumor site via the peripheral system. CAMP 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's 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 outcome by providing a safer, more effective way to deliver therapy directly to hard to treat tumors. Our ongoing Phase three TIGER PACT clinical trial evaluating the target delivery of chemotherapy gemcitabine. We tap via our patented FDA cleared Renovo Cap 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 ten months versus sixteen 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 sixty five percent reduction in adverse events such as nausea and fatigue. Significantly improving patient quality of life. These results strengthen our conviction that TAMP can redefine outcomes for patients facing some of the most difficult to treat cancer. As we are continuing to increase exposure to TAP and RenovoCast, [indiscernible] and more recently to our commercial efforts for RenovoCat 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 delivery. Recognizing this potential clinical benefit and improved tolerability profile that the use of Renovo Cap 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 cancer treatment. Thank you for attending. For your support of RenovoRx. With that, I turn over to our CEO, Sean Beguy.

Thank you, Ramchin. Q1 of twenty twenty five represented our first quarter of generating revenue from commercial sales. This is the result of the important strategic decision we made in 2024 to focus on a commercial strategy for RenovoCast in tandem with our ongoing Phase III trial.

We plan to launch our commercial efforts for RenovoCath 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'm 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 Renovo cap production last year.

Last month I stated that we expected Q1 revenue to be in the low 6 figure range. Followed by sequential quarter over quarter increases for the remainder of the year I'm pleased to report that revenue from Renovacath exceeded our internal expectations for 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 are encouraged by the strong organic demand for Renovocath with more than 10 institutions that are not current Tiger Pak sites having initiated a process for Renovo GAAP 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 Renovo as part of our TIGER PACT trial could also be potential customers for RenovoCath after completion of TIGER PACT enrollment anticipated for later this year. Additionally, early utilization of RenovoCath devices by initial customer has led to repeat purchase orders. Based on our internal analysis of clinical interest, FDA cleared applications of the device, We believe that our initial total addressable market for Renovacath represents an estimated $400,000,000 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 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. TAM for Renovocath 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 when 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 $14,600,000 at the end of the first quarter will fully fund both our RenovoCat scale up and the continued progress of our Phase three TIGER PATCH clinical trial. On the topic of our TIGER PATCH clinical trial, during the first quarter of twenty five, we announced that Johns Hopkins Medicine has now initiated enrollment in our ongoing Phase three TIGER PACT 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 Tiger Pak will achieve full enrollment during 2025. As a reminder, the current protocol and statistical analysis plan for the TIGER PACT trial requires 114 randomized patients. With 86 events or deaths necessary to complete the final analysis. As of 05/02/2025, 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 US patent for our TAMP therapy platform further enhancing our IP production. RenovoRx is 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 ten 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 RenovoRx 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 Renovacath as part of our TIGRPAC trial could also be potential customers after the planned completion of enrollment later this year. Building upon our recent success, we expect revenue from Renovo to increase from the low 6 figure range with sequential quarter over quarter increases for the remainder of the year as we move along the path to becoming cash flow 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 twenty twenty five 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 expenses were $1,700,000 for the quarter, up from $1,300,000 in the first quarter of twenty twenty four. This $400,000 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 and D activities. Selling, general and administrative expenses were approximately $1,600,000 for the quarter. An increase from 1,200,000.0 in the prior year period. This $400,000 rise was attributed to increase in personnel related costs, professional and consulting fees to support commercialization, and other selling, general and administrative activities. As of 03/31/2025, the company had 14,600,000.0 in cash and cash equivalents. As of 05/09/2025, shares of our common stock outstanding totaled 36,572,232. And now, I'll turn the call back to the operator for Q and 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 touch tone 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 withdraw your questions, you may press star and two. We'll pause moment to assemble the roster. And once again, if you would like to ask a question, please press star and one. And it's showing no questions. I would like to turn the floor back over to Sean DeGaide for closing comments.

Thank you all again for participating in today's presentation. We were very excited about the key strategic steps taken over the last year to build long term value in our company. And we are bringing beginning to see the tangible results from these efforts. We look forward to the rest of the year unfolding and 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 that has joined the question queue late Let me Let me join in Rafay Khalid. From Ascendant Capital Markets. Please go ahead with your question.

Hi. Thank you. Is a refrain for Edward Wu, S and E Capital Markets.

Can you talk about your plans for the Renovo cath for international markets?

Thanks, Rupee, 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 in 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 the [indiscernible] top 200 cancer centers. Would you use their Salesforce, or would you use distributors to target?

Those partners? So I thank you for the question. I have said 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 or the interventional radiologists.

So we're looking at the from a business perspective, if it makes more sense to hire a small Salesforce, the handful of reps to get to drive meaningful revenue for the company and or partner with strategic partner that has an existing distribution channel. So we're exploring both currently and both are actually well underway in terms of proving out which plan makes the most financial sense the company.

Great. Thank you very much.

Press star and then one using a touch tone telephone. To withdraw your questions, you may press star and 2. Once again, that is star and then 1. To join the question queue. And ladies and gentlemen, at this time, I will 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, And that will conclude today's conference call and presentation. Thank you for joining. You may now disconnect your lines.