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 listen-only mode. There will be a Q&A session following the management's presentation. I will now turn the call over to Walter Pinto, Managing Director of KCSA Strategic Communications. Please go ahead. Thank you.

Thank you, Operator. Good afternoon, everyone, and welcome to Renovo Rx's third quarter 2025 conference call. I'm joined today by members of our leadership team, Dr. Ramtan Agha, Chairman, Founder, and Chief Medical Officer, Sean Begay, Chief Executive Officer, Lisa Gentry, Chief Clinical Officer, and Ronald Kozak, VP, Controller, and Principal Accounting Officer. Before we begin, I'd like to remind everyone that statements made during today's call contain or may contain forward-looking statements. covered by the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and applicable federal securities laws. These statements, including statements regarding Renovo's clinical and commercial plans, strategies, and estimates of performance, are based on management's current plans and assumptions, and actual results may differ materially. Please refer to our filings with the SEC, including our Form 10-Q for the third quarter of 2025 and our most recent Form 10-K, for a detailed discussion of the risks and uncertainties facing Renovo Rx. With that, I'd like to turn the call over to our chairman, founder, and chief medical officer, Dr. Ramtan Agha.

Thank you, Walter, and good afternoon, everyone. This quarter marks another important step forward in Renovo Rx's 14-year journey transforming a bold concept into a new therapeutic option that is now reaching patients across the country. Our Preparatory Transverterial Microperfusion Therapy Platform, or TAMP, is designed for targeted therapeutic drug delivery across the arterial wall near the tumor site to bait the target tumor. By localizing and targeting delivery of therapeutic agents via the peripheral vascular system, TAMP is designed to optimize drug concentration where it's needed. This targeted approach is designed to minimize systemic exposure and toxicities related to chemotherapy and address the longstanding challenge in cancer care of poor blood supply to tumor sites. We believe that TAMP represents a significant advancement in the way cancer treatment can be approached. For decades, pancreatic cancer treatment has revolved around three pillars, surgery, radiation, and chemotherapy. We're proud to be introducing TAMP as the fourth option for patients diagnosed with solid tumors. What began as an idea tested in controlled clinical trials is now translating into real-world impact. Several times a week, a patient somewhere in the US is being treated with our TAMP technology. and that is deeply meaningful to our team. The early signs of clinical adoptions are promising. We're seeing interest and adoption from academic medical centers, NCI-designated cancer centers, and large community hospitals. Importantly, physicians who have used TAMP enabled by reNOVA-CAB are treating additional patients, validating the utility and safety of our technology. We are also expanding engagement across disciplines, including interventional radiology, surgical oncology, medical oncology, and radiation oncology, reflecting the truly multidisciplinary nature of our platform. To support this effort across multiple specialty lines, we have launched our TAMP workshop series in an online peer-to-peer forum. We're also proud to be expanding our scientific advisory board with world-renowned physicians who believe in the potential of our technology. Our mission is to integrate our approach to therapeutic drug delivery into the standard of care and ultimately improve patient outcomes by offering a more targeted and tolerable treatment path. With that, I turn it over to our CEO, Sean Begay, to share some details on our commercial and clinical progress.

Thank you, Ramtan. Building on our clinical progress, we are also seeing strong commercial momentum for Novocath as a standalone medical device. Year-to-date revenue through the end of Q3 was approximately $900,000, putting us on track to finish out the year strong as we continue to build a lean, cost-efficient sales and marketing foundation that will enable meaningful revenue acceleration in 2026 and beyond. It's important to remember that we've achieved our Novocast sales results with a lean team and within our budget with a relatively small capital outlay. While our goal is to grow from the base we've established, our plan is to remain lean and maintain our philosophy of prudent capital deployment. Since organically launching commercial sales less than a year ago and without a dedicated sales and marketing team, we've expanded from five centers approved to purchase RenovoCath at the start of 2025 to 14 leading cancer centers now approved to purchase. Five of these centers have already used the device in patients and made repeat orders, demonstrating both demand and customer satisfaction. In addition to the 14 centers now approved to purchase RenovoCath, we have delivered product quotes to 10 additional leading centers across the nation, bringing the total to 24 centers that have formally requested quotes for RenovoCath. In addition, we have engaged with dozens of physicians at various medical conferences and in their institutions who have expressed commercial interest in utilizing RenovoCath for their patients. We continue to nurture and build on this interest that will drive commercial success going forward. Physician feedback continues to underscore what we view are the benefits of the targeted drug delivery that can be achieved with TAMP, including reducing systemic chemotherapy toxicity and improving patient quality of life. With our small team, we've now established a geographically diverse network of clinical institutions using and interested in TAMP enabled by Renovacath spanning through the United States. This network represents not only leading academic institutions and NCI-designated cancer centers, but also high-volume community hospitals, giving us the confidence and the potential for deep market penetration of our technology. Our focus remains on strategic data-driven expansion, ensuring each new center is well-supported through onboarding, training, and case follow-up. We are also seeing growing physician-to-physician advocacy, one of the strongest indicators of adoption in interventional oncology. To support and expand our commercial efforts, in August, we announced the hiring of Phil Stockton as Senior Director of Sales and Market Development. Phil brings more than 25 years of MedTech leadership to the team, including a decade focus on interventional oncology. His expertise has been invaluable as we broaden our footprint across the U.S. while maintaining a lean operating structure. In alignment with our existing budget and to respond to growing demand, we have added two additional regional sales managers and plan to add a marketing director to drive physician engagement. It's also been a year of intense learning for us based on our experience in the field, and we've gathered valuable data on metrics like customer preferences and sales cycles. We plan on applying these learnings into 2026. We are pleased to report that we are seeing repeat use and expansion of interest among a growing number of approved centers and increasing market awareness and interest across oncology disciplines. As we refined and grow our efforts with a small but dedicated and experienced sales and marketing team, We continue to expand our revenues to grow during 2026 and beyond. Taken together, we are encouraged by our early adoption curve and believe our commercial growth strategy positions us for long-term success. Our vision is for RenovoCath to address a large unmet need in oncology. We continue to estimate that the initial PQS market opportunity of RenovoCath as a standalone device is approximately $400 million annually, and ultimately a several-billion-dollar opportunity as we expand into other tumor types. Importantly, as mentioned, we continue to operate with fiscal discipline, positioning Renovo Rx for long-term growth as we scale our commercial foundation and prepare for broader adoption. As of September 30, 2025, Renovo Rx had over $10 million in cash and cash equivalents. Through the first nine months of 2025, Renovo cap sales totaled approximately $900,000, which we expect will increase over time and reduce our burn rate. Based on our current plans, our cash on hand is expected to fund both the renewable cath commercial scale-up and continued progress of our Phase 3 Tiger Pact file, as well as other activities into the middle of 2026. Of course, any increase in sales momentum beyond our current expectations could extend this timeline. As we continue to make progress commercially, and as each day we get closer and closer to our Phase 3 data readout, we have multiple potential opportunities to strengthen our balance sheet as needed even further, including when not limited to debt and or equity financing, as well as our current ongoing licensing and partnership discussions. I feel it's important to note that the three-year anniversary of our shelf registration statement is expiring next week, and we will be refreshing this following. Additionally, we will be establishing an out-the-market offering. All of these financing options should provide our company with the best flexibility as we continue to drive shareholder value. In conclusion, we are excited about where we stand today as a company, progressing our Phase 3 clinical trial and post-market registry study while growing our NovoCath sales efforts as we bring our novel technology to more and more doctors and patients. We often spoke of a 14-year journey. With our commercial sales efforts for NovoCath and the end of our Phase 3 trial around the corner, we are seeing light at the end of the tunnel, and we are all enthusiastic about our future as we've ever been. We are truly grateful to our investors and other stakeholders, including our early adopter cancer centers and physicians, who continue to believe in our mission of helping make our vision a reality. With that, I'll hand the call over to our Chief Clinical Officer, Lisa Gentry, to provide more detail on our clinical programs.

Thank you, Sean. The primary goal of our clinical research and scientific programs is to continue to strengthen the evidence-based supporting our TAMP platform. Our new post-marketing registry study that we launched in July is progressing well, generating real-world data on the safety and effectiveness of Renovacath across a range of solid tumors. We are pleased to have initiated the first patient procedure at the University of Vermont Cancer Center in September and to have Baptist Health Miami Cancer Institute and the University of Pittsburgh Medical Center joining as additional study sites. This capital-efficient multi-center study will generate critical evidence on the long-term safety and performance of Renovocast across solid tumors. Importantly, our registry study also advances our future clinical strategy by generating meaningful data that will open the door for how best Renovocast may be leveraged in additional high unmet need oncology indications beyond locally advanced pancreatic cancer. In addition, we continue to advance investigator-initiated trials in borderline resectable and oligometastatic pancreatic cancer. These studies are designed to be cost-neutral to the company while providing meaningful data that may further broaden the application of our TANF therapy platform. Together, these initiatives reflect how Renovo Rx is building a robust body of evidence to integrate our technology into the treatment continuum, not only as an alternative, but as the new fourth option that may enhance the current standard of care. Finally, our Phase III TIGERPACK trial continues to progress with enrollment expected to be completed in early 2026 and final data anticipated in 2027. Last quarter, we reported that the Data Monitoring Committee completed their review of our second preplanned interim analysis and recommended that we continue the study. We believe the DMC's recommendation is an expression of confidence in the potential for a positive outcome in the trial overall. The second interim review of data reinforces that the trial should proceed as planned to the final analysis as we seek to potentially demonstrate the safety and superiority of inter-arterial gemcitabine delivered via Renovacast for the treatment of locally advanced pancreatic cancer as compared to IV chemotherapy, the current standard of care. TigerPak remains the cornerstone of our clinical development program, validating our mechanism of action and safety profile through rigorous long-term evaluation. In closing, I would like to share that we are proud to have recently strengthened our scientific advisory board to now include recognized surgeon and pancreatic cancer expert, Dr. Timothy Donahue, and internationally renowned interventional oncologist, Dr. Thierry Debert, Dr. Donahue is Director of UCLA's Auggie Hirshberg Center for Pancreatic Diseases and Chief of the Division of Surgical Oncology at the David Geffen School of Medicine. He is also the Gary Shandling Chair in Pancreatic Surgery. Professor DeBeer is Head of Interventional Radiology at both the Gustave Rossi Cancer Center and the Université Paris-Saclay in France. With that, I'll hand the call over to our VP Controller and Principal Accounting Officer, Ron Kosak, to review our financials for the quarter.

Thank you, Lisa. For the third quarter ended September 30th, 2025, Renovo reported revenues of approximately $266,000, driven by both new customer orders and repeat purchases of RenovoCast. resulting in a total of approximately $900,000 of revenues through the first nine months of 2025. This early in commercial launch, we're not surprised by relatively minor fluctuation in sales, given that our commercialization efforts are so new, have been handled by limited staff, and a handful of patients receiving treatment via renovoCAS can move the needle in product orders. We firmly believe that our efforts to date set the stage for revenue growth going forward. Research and development expenses were 1.7 million, reflecting our continued investment in target pack and support for investigator-initiated and registry studies. Selling, general, and administrative expenses were 1.7 million. reflecting stable operating expenses while we add targeted commercial capabilities. We ended the quarter with over $10 million in cash and cash equivalents. Based on our current operating plan, we believe this cash is sufficient to fund our ongoing commercialization efforts and the completion of enrollment in TigerPath. As of September 30, 2025, common shares outstanding were approximately 36.6 million. With that, I will now turn the call back to the operator for Q&A.

Thank you.

Ladies and gentlemen, we will now be conducting a question and answer session. If you would like to ask a question, please press star and one on the telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star and two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Ladies and gentlemen, we will wait for a moment while we poll for questions.

Thank you.

Our first question comes from Ed Wu with Ascendian Capital. Please go ahead.

Yeah, congratulations on all your progress. I know you guys have your hands full, you know, commercializing in the U.S., but have you thought, you know, given the reception, positive reception of maybe going international?

Yeah, thank you for the question. Always great to talk to you. So we've looked at it in the past and the favorable reimbursement and the large interest in the U.S. has determined that we'll focus on the U.S. for now. There's obviously pancreatic cancer and other solid tumors that could be treated potentially effectively with our technology. So something we'll explore in the future, but keeping a close eye on capital burn and the large potential market that's right at our fingertips. It makes sense to 100% focus in the U.S. today.

Great. And a little bit about your supply chain. How quickly would you be able to ramp it up if it turns out that expectations are even faster than you expect?

It's actually a great partnership we formed with our contract manufacturer. We announced a stronger collaboration almost a year ago, and they've already begun ramping. We've already reduced our COGS and increased our margins. And the great thing about the way we built this device is the renovo cap actually has over a two-year shelf life so we're already building stores up uh with high margins where we can supply what we anticipate the demand to be and it is a larger operation we can turn key and ramp even quicker if we need to so we've got a good collaboration and good supply chain so far is that a supply chain is it manufactured in the u.s Thanks for asking that question. It's something that comes up quite often. Yes, it is. Our contract manufacturer is based outside of Chicago in the U.S., and largely pretty much all the components used to build the device are also sourced from the U.S. So we've been relatively insulated from the global macro issues in terms of supply chain so far.

Great. Well, thanks for answering my questions, and I wish you guys good luck. Thank you. Thank you, Ed.

Thank you. Our next question comes from Charles Wallace with HCW. Please go ahead.

Hi. Thanks for taking my question. This is Charles. I'm for RK. So for my first question, can you talk briefly about any fruits you're seeing from the hiring of the new senior director of sales? And then kind of looking ahead, do you hope to, when you're kind of building out the commercial effort, do you hope to increase the number of approved centers? Or do you hope to focus more on going deeper into the approved centers to get more repeat orders?

Yeah, thanks for the question, Charles. It's a very focused, deep effort, and we're starting to increase the breadth with the addition of the new hires. So with the addition of kind of the senior salesperson, he's both player coach, so he's out there selling and also helping build out the strategy. It's important to note that with a new technology like this, that we're first to market in a brand new space. And we've learned the multitude of steps that need to be done to get physicians from first engagement to patients, really shorten that time from initial contact to first patient treatment. And I have begun to see the fruits of his labor in that regard and from the two new hires he's brought on board as well. And the good news is that after six to nine months of being in the market, we're not seeing headwinds in our strategy. And we're creating already meaningful market adoption and some revenue with just a small commercial team driving to 2026. So we do anticipate increasing the breadth and the footprint as well. Currently, I've mentioned that we've got five active centers treating patients and multiple patients with multiple catheter orders. And in total, 24 hospitals have requested formal quotes for the device. And I'd say dozens on the tails of that that have expressed interest that my small focus team can go and drive through to get those first patients in. So getting this team in place and learning the strategy very carefully with our burn over the last several months, we're really gearing up to be ready to drive this into the end of the year and then towards a lot of growth for next year and then beyond.

Great. I guess to follow up on what you just said, could you maybe provide a timeline that's typical for these hospitals that have requested approval to the actual approval?

Yeah, so the sales cycle is actually quite wide, and we've seen anything from several weeks in a couple months to several months beyond that. And I do believe that will get shortened with constant contact with more local representation. We did hire a couple more regional territory managers to help drive that forward. As far as going deep, taking low-hanging fruit, where we can get approvals to get on the shelf, and we do have multi-specialty engagement sooner, we can shorten that timeline to within a handful of months. And what's great about looking into 2026 is we do have a very strong pipeline already, and it's really been a matter of resources to have reps be able to service those physicians and get this through the approval process onto the shelf and getting to that first patient. So the timeline is where we sit right now with, as I mentioned, 24 requests, another few dozen behind that of interest. We can start to see those really come to fruition in the several months ahead of us.

Great. And then, sorry if I missed it, just maybe on the clinical side, did you provide the patient numbers for how many have enrolled and how many events have occurred in the study for TIGERPAC?

We did at the end of Q2 announcing 95 patients randomized and 61 events by the end of Q2. Now we've updated guidance that we do anticipate final enrollment to be early next year and final data in 2027. Again, as a reminder, we need to randomize a total of 114 patients and the 86 deaths will trigger the final analysis.

Okay. Thanks for taking my questions. Great. Thank you. Thanks, Charles.

Thank you. Ladies and gentlemen, a reminder to all the participants, if you would like to ask a question, please press star N1 on your telephone keypad.

Thank you.

As there are no further questions, I would now like to hand the conference over to Sean Bagai for closing remarks. Thank you.

Thank you, everyone, for calling in and those listening to the recording afterwards. We're very excited with the progress you've made. As mentioned, we see life in the tunnel. We're seeing physicians and patients really seeing the opportunity to benefit from our technology here. And I appreciate you joining in and a lot of exciting things to come in the very near future.

Thank you. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.