Good afternoon and welcome, everyone, to the RenovoRx Fireside Chat. I'm joined today by Shaun Bagai, CEO, and Rick Stark, Commercial Advisor, who recently joined the Renovo team. Before we begin, I'd like to remind everyone that statements made by Renovo's management and advisors during today's presentation may be deemed forward-looking statements within the meaning of the Safe Harbor of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may include, without limitation, statements related to Renovo's RenovoCath commercialization plans, goals, and strategies, and statements related to future milestones for Renovo's ongoing phase III TIGeR-PaC clinical trial. Forward-looking statements are often identified by words such as expect, anticipate, intend, plan, believe, potential, will, should, could, would, or may, and other words of similar meaning. Listeners are cautioned that forward-looking statements are not promises or guarantees of future results, and actual results may differ materially and adversely from results contemplated by forward-looking statements due to a variety of risks, uncertainties, and other factors. For a detailed discussion of some of the ongoing risks and uncertainties of RenovoRx's business, please review RenovoRx's filings made periodically with the SEC. RenovoRx disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless otherwise required by law. I want to thank everyone for joining our call today. We're going to be discussing several interesting topics with Shaun and Rick. As many of you know, RenovoRx is a life sciences company developing novel targeted oncology therapies, currently in phase III, and commercializing RenovoCath, its FDA-cleared local drug delivery platform. In support of the evolving commercialization strategy of RenovoCath, RenovoRx recently retained Rick as Commercial Advisor Consultant. Rick is an accomplished global commercial leader with over 25 years of experience in driving commercialization in medical devices, including as CEO of Innoblative Designs and SVP of Surgical Oncology Unit at AngioDynamics. I welcome Rick to today's call and really appreciate his time. At the conclusion of our call, we'll have a live Q&A. Please submit your questions via the Q&A function at any time. We'll do our best to get to each of your questions within the timeframe allotted for today's call. If for any reason we don't get to your question today, please email our team always at renovorx@kcsa.com. One last note, the call is being recorded today, Tuesday, December 17th, 2024. After the call, there will be a recording available on the company's website. Go to the Investors tab of the homepage and then visit News and Events section. Before we get into the Q&A portion of today's call, I want to give Shaun an opportunity to bring our audience up to speed on the progress we've made recently and what to expect in 2025. Shaun? Valter, thank you so much for setting this up and the introduction. Welcome, everyone. Thank you for spending part of your afternoon with us here. As Valter mentioned, I'll go through a little background on the company, and then we'll get to the chat part of this fireside chat. So I appreciate the time. Before I launch into it, just to set the stage, everyone, I think, is familiar with RenovoRx. We're trying to focus on a different way to treat patients. We think of new therapeutics as drug combinations that try to tackle tumors differently, increase quality of life, and increase survival, but we've been failing as an industry for several years, and I wanted to go through our story about how we're changing the way we're thinking about treating cancer patients. So with that, I'll share a few slides with you to give us a little bit more about our story. So the company was founded in 2009 by a physician with external financing in 2012. The last pre-IPO financing was in 2008 by Boston Scientific, a powerhouse in the interventional oncology space. We went public in Q3 of 2021 and were headquartered in Los Altos, California. The therapy platform we've developed is what we call TAMP, or Transarterial Microperfusion. The goal is really to improve the therapeutic index of drugs, i.e., increase the local drug concentration, tackling the tumor to increase survival, and decreasing the systemic toxicities that cause the all-too-well-known side effects in today's chemotherapies for these types of tumors. Valter mentioned our phase III TIGeR-PaC trial. This is a drug-device combination trial in locally advanced pancreatic cancer. As it's a survival study in an open-label trial, we were able to present the first of two interim analyses in 2023, demonstrating not just an increase in survival for patients, but a 65% reduction in side effects. I'll go into more detail about the data in a minute here. From a drug-device combination perspective, we have FDA orphan drug designation for both pancreatic cancer and for bile duct cancer for intra-arterial gemcitabine. Looking at the market opportunity for our first indication that we're studying right now in locally advanced pancreatic cancer, it's roughly $500 million in the U.S. and over $1 billion globally. What's interesting about the most recent announcements, and I want to share more details here today, is a commercial opportunity that presented itself earlier this calendar year. We now have embarked on a commercialization effort of selling the device component of the drug-device combination as it's already FDA-cleared and there's been a high demand from physicians. We have potential near-term revenue as early as 2025. We've already announced our first sales this year a little bit ahead of schedule. Our initial target markets with the device alone component are several hundred million of dollars estimated in annual sales opportunities with the initial intake of this catheter. That can grow drastically with larger expected markets. I'm going to go into more detail about the pipeline. Let's first talk about what we're doing differently and how this is working. So as we think of cancer therapies and chemotherapy, it's really a systemic therapy that is driving the paradigm to its current treatment. This works when the tumors have large blood feeder vessels that allow the drug to get into the tumor. This also provides for local target. Many tumors don't behave like this, though. For example, pancreatic cancer tumors don't have large blood feeder vessels. So the drug really blasts the entire body with chemotherapy, but very little gets to the tumor. We overcome this issue with our TAMP platform by using a proprietary catheter-based system. This is our FDA-cleared RenovoCath, where a physician can insert the catheter adjacent to the tumor and under X-ray fluoroscopic guidance, the physician targets a segment of artery next to the tumor, isolates that segment with the proprietary nature of our delivery system, and then drives an entire systemic dose and volume of chemotherapy in that small space over 20 minutes, creating a pressure head that forces the drug through the vessel wall to then bathe the tumor in chemotherapy. This is the crux of our delivery platform that can be applicable to many solid tumors. This is really the crux of our patent portfolio as well. We've discovered and developed and driven home positive data showing that going across the vessel wall to saturate tumors in chemotherapy, it looks like it will be successful. We see a hundred-fold tissue increase in concentration of drug at the tumor site than you would with systemic delivery. How does this translate clinically? This is the data that was presented last year. This is the first of two interim analyses in our ongoing phase III trial. In a world where a few weeks of survival turns into a blockbuster drug, we demonstrated in a randomized prospective fashion that we're seeing a six-month survival improvement. These are patients expecting to live around 15 months, are living now close to pushing two years in an intention-to-treat study. The average expectancy for patients with locally advanced pancreatic cancer is that 14 to 18-month range, and our control arm is behaving exactly like we expect based on current historical data. and in a randomized fashion, we're seeing a benefit for our patients where they're pushing over 21 and a half months of survival. That's on the clinical side. The double opportunity here is on the commercialization. We've recently announced the commercialization of our previously FDA-cleared delivery platform. So this is the RenovoCath. This is indicated for temporary vessel occlusion and applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. The first half of this year, we really explored the commercial opportunity with physician groups and reimbursement consultants as a standalone device. And our first purchase orders were received ahead of schedule this quarter in Q4 2024, with expectations that will start to drive our revenue growth early next year in 2025. Currently, we have over 10 medical institutions across the country that have initiated the purchasing process and will be our first customers. Beyond that, we're filling the funnel in terms of additional revenue-generating activity. The initial market for the device represents several hundred million dollars estimated in annual sales opportunity, and that should grow drastically as more and more data comes out and as physicians explore different uses for the catheter beyond the initial feedback we've received. Upcoming milestones, while we've tackled a lot in the last couple of years, including a positive interim readout in the phase III trial, our first orders for the RenovoCath as a standalone device, and in the coming months, we anticipate the second of two interim analyses in our ongoing phase III TIGeR-PaC study for locally advanced pancreatic cancer. Right around the same time, we anticipate enrollment completion and randomization completion with final data readout in 2026. This next calendar year marks an important milestone-generating year for us as we drive the commercial efforts on the catheter in parallel to wrapping up this phase III clinical trial and this phase III asset. From an investment opportunity standpoint, we've de-risked the development pathway of the TAMP platform using a known drug in our combination, where we know the side effect profile so well. We know the drug that we're using works against cancer cells. It's a matter of delivery and getting it there. And we're proving that out in our phase III trial. The billion-dollar market opportunity for the first indication of locally advanced pancreatic cancer is solid, and we have additional opportunities for commercialization as we expand the platform. We're ongoing in discussions with strategic partnerships, both on the commercial catheter-based side and also business development opportunities with other drug-device combinations, including looking at things like immunotherapeutics to treat metastatic cancer. The initial physician feedback indicates the potential for treatment for other tumors beyond just locally advanced pancreatic cancer, and we're able to inexpensively study and publish other applications with different clinical trial designs given the robustness and strength and size of our phase III trial in such a tough disease of pancreatic cancer. From a commercial standpoint, as I mentioned, we're commercializing the RenovoCath device with near-term revenue in 2025, and this gives us also the potential for delivering additional agents beyond what's been studied in the TIGeR-PaC study using gemcitabine. We have an extremely experienced clinical and commercial leadership team and board of directors well-versed in pharmaceuticals, medical devices, drug-device combinations, getting products through phase III clinical trials and the FDA and well into commercialization. We have enough cash on hand to drive us to our next interim readout of the current RenovoCath and the current RenovoCath commercialization efforts, as well as completion of enrollment within the next year or so. As mentioned, we've got the benefit of showing positive data that this therapy looks like it's working with the first interim readout showing not just a six-month survival benefit, but a massive reduction in toxicities for these patients and side effects. So that was a very quick overview, but I wanted to give you a sense of what we've accomplished so far, where we're going, and happy to start answering questions. Thanks, Shaun. That was really helpful. As a reminder to our audience, if you do have a question, please submit it via the Q&A function. I personally have some questions that I think are interesting for discussion. I want to start, Shaun, first with Novocure's data. Many of us on the call today may have seen that data. They're also public. They recently reported positive top-line data for their phase III, also in pancreatic cancer. When you saw the data, how do you compare our trial versus theirs? What are some similarities and what are some data points that you can glean from their positive results? Thank you for the question, Valter. So first off, my hats off and congratulations to Novocure for having a positive result in a pancreatic cancer study. This really does a few things. One is it validates the importance of local control in locally advanced pancreatic cancer. That if you can control the disease locally, there's a chance for extended survival. And they prove that with a significant p-value showing a significant difference in survival of standard of care gemcitabine plus Abraxane versus their therapy. It also validates our control arm. As I mentioned, historical data shows 14-18 months of survival in this patient population. Their control arm was 14 months, right in the sweet spot. Our control arm is 15 and a half months. Now, what's interesting is that their treatment arm was 16 months. So while they only had a two-month survival benefit, that's been proven to move the needle for this patient population in terms of adoption. And it also flanks our control arm. So we'll have to see if our data holds out, but it looks like there might be a great survival benefit as you look to six-month survival improvement. So overall, I'd say the Novocure is great news for patients and also a great prelude to what we can provide to patients as we wrap up our study. Thanks, Shaun. And we talked a little bit about the data from our first interim readout. I think a lot of investors are eagerly anticipating our second interim readout, which should happen by the end of the first half of 2025, obviously keeping in mind that this occurs after the 52nd event. Can you remind our investors what actually happens? So the 52nd event occurs. What are the steps and timeline to actually publicly disclose the data after the event occurs? Thank you for mentioning that, Valter. This question comes up quite frequently. So this is an event-based trial. That next interim analysis, as you mentioned, occurs upon the 52nd event, or deaths is what we're tracking in terms of survival outcome. Once that death occurs and we are notified by it, the data monitors and data management teams have to go through what's called cleaning or monitoring the data. So they check all the source documents, the patient's medical records against the data entered in for accuracy. Once the data is validated and cleaned, it then goes to statisticians to run all the analyses. They do what's called tables, listings, and figures. They run all the charts, the statistics, and then that's presented to the data monitoring committee, an independent kind of behind closed doors board that reviews the data and then opines on what to do with the data and the analysis. After that analysis takes place, then the company finds out about the data, and then there's a potential for publication or presentation and dissemination. That whole process can take a few months, so at this point, I've guided towards a 52nd death around the end of the year. We're getting close to it, and then once that 52nd event or death occurs, that analysis will take place, and then we'll subsequently have the data. Good. That's helpful. And just one final question, Shaun, for me on the clinical trial. We've announced several new sites initiating, which is great. So Sarah Cannon Research Institute recently launched, Northwell Health, a very large and well-known cancer institute. I often give you a lot of questions, a lot of credit, and we talk about it that you often live on a plane, so you're visiting all these sites. Give us an idea, like what's the on-ramping of the onboarding of new sites? What is the feedback so far? Can you just tell us a little bit, give us some insight into the logistics that go into actually onboarding a new site? Yeah, thanks for the question here. So they're excited. So these are powerhouse centers. Sarah Cannon Research Institute, they enroll a ton of patients. Northwell Health is famous for closing out trials. University of Nebraska Medical Center also joined recently. Sometimes they've got patients already in the hopper. In Nebraska, for example, enrolled their first patient very quickly. Sometimes it takes a month or two to find that ideal candidate. Locally advanced pancreatic cancer often comes in waves. They'll see three, four, five, six patients, and then maybe not any for a couple of months. So it's a ramping process for hospitals to start enrolling. These centers are so large in terms of how many patients they see. We anticipate that these three new centers, the most recently launched, can help drive enrollment and accelerate completion the first half of next year. As you mentioned, I live on a plane, and I'm constantly in front of the cross-specialties, medical oncologists, the radiologists, the surgeons, and they're excited to have a new treatment option for their patients, especially with the positive data behind us and the potential to give something different for patients where nothing works in pancreatic cancer, so across the board, they're very excited to participate in something that hopefully should change the face of how we treat pancreatic cancer. Thanks, Shaun. And so just to shift gears just a little bit to our commercialization strategy, we've talked about it pretty openly in recent news releases, but from your point of view, Shaun, why go down this path? What's the opportunity? How do you think about the go-to-market strategy? How do you articulate the opportunity on the commercialization side going forward? You know, it's interesting, Valter, because this is physician-driven, and nothing will give you commercial success like coming from the doctors themselves. As we've been launching this phase III trial for the last several years and wrapping it up soon, there have been a lot of physician interest over the last couple of years saying, "Listen, I've got a patient who doesn't qualify for a very strict controlled randomized trial, i.e., they've had previous chemotherapy, they came from a visiting institution, they wouldn't be able to enroll in a trial, but nothing else works. We like the data we've seen so far. Their catheter is FDA cleared. Can I just buy it and use it?" To date, I've always said no. But now, with the tailwinds behind us of such a high demand from physicians, the fact that the reimbursed landscape is coming in our favor in terms of higher reimbursement for the procedure that's currently already reimbursed and the ability to scale manufacturing, we're starting to answer to physicians, yes. And that's really what's been driving this, is physicians coming to us initially opportunistically to drive this commercial effort. And now that it looks like we could advance commercial efforts a few years ahead of what we expected with this device that's been FDA cleared, it makes sense to embark on that pathway with a high demand and an unmet need with positive data in a space where this looks like it should gain immediate commercial traction. That makes sense. And Rick, a question for you, if I may. And I actually see one of our audience members asked this very question, but obviously your background's clearly very impressive and you're very experienced. Why Renovo? What are you seeing in our technology that drew you to this opportunity? I think it brings me back to Angio, where I worked with targeted technologies kind of focusing on improving patient outcomes. I see Renovo's TAMP as kind of a similar innovation. I think there's a high potential of commercial penetration that can happen without having a large sales force. I think that's great for patients. I believe that the future of oncology is moving towards localized therapies that both enhance survival and quality of life. When Shaun and I got together, I was excited in speaking to him, excited about joining Renovo and kind of the opportunity to collaborate with the talented team that's here. They're dedicated to transforming pancreatic cancer treatment. I came on board as an advisor for equity only because I truly believe in this mission. It's a potential change to the standard of care, and it's going to be great for patients. That's great. Thank you, Rick. Appreciate that, and one last question from me, and I appreciate all the questions coming in. We do have a large audience today, so I try to get to everybody's question, but just getting back, Shaun, too, and you talked about it a little bit. We did receive our first orders for RenovoCath earlier this month. We announced it. From my point of view, it seemed ahead of expectations. Why do you think that occurred so quickly? And you alluded to some of this already, but specifically, how did those orders come in? And I don't think we could talk about specifically who had those orders, but I think it is impressive that already you've started selling the catheter in a short period of time, really. Yeah, thanks for the question, Valter. It's interesting to unfold the story a little bit more, so as I mentioned, we did a lot of research in the first half of the year to see if a commercial opportunity made sense based on initial feedback from physicians. We ran cross-specialty focus groups with medical oncologists, interventional radiologists, surgeons, and then together, and out of that, the answer was not just, "Yes, this was worth commercializing now," but many of those physicians we talked to came out of the room saying, "Can I buy this now? This opportunity is fantastic, and this is great for my patients," so while we planned on ramping and commercializing next calendar year in 2025, based on initial interest, as I mentioned, we got our first orders. We have 10 customers already in the pipeline and the process, well down the sales pathway where they're bought in. They're bought into the opportunity to treat their patients differently and hopefully better. So we did anticipate revenue sometime next year, which I originally got into. And the fact we've got orders in already this year shows that there's potential for deep penetration and market adoption very quickly. Thanks, Shaun. And now getting to our audience questions, we have received many, which is great, and we appreciate it. Our first question is, again, getting back to the go-to-market strategy. Shaun, do you expect to build a large sales force? Are there partnership opportunities? Is it going to be a combination of both? How do you think about specifically partnership versus building your own sales force as you go to market? You know, it's interesting. There's a lot of opportunity here. And what's interesting about these markets is you don't need a large sales force. And that's a big piece that went into the calculus of the timing of commercialization. As I mentioned publicly, we are in conversations with strategic distribution partners and commercial partners so we could utilize the sales footprint that's already there with relationships. But given the organic inbound interest, as I mentioned, it wouldn't take more than a couple of sales reps to really drive in multimillions of revenue. And part of that is if you look at where solid tumors are treated, and especially non-metastatic cancers in general. If you look at the markets, for example, we did a lot of research in locally advanced pancreatic cancer as we're looking at the TIGeR-PaC phase III trial. Less than 100 hospitals treat, or they see, over 50% of non-metastatic pancreatic cancer in the country. So it wouldn't take a large dedicated sales force to be able to tap into a market where you have such a high concentration of patients in these large centers. So it wouldn't take a large sales force to tackle these types of markets. Now, having said that, as we're discussing with potential partners, given the inbound interest, we decided to go ahead and process orders and start to launch the product. So we've got an optionality in terms of what a partnership from a distribution standpoint looks like, or doing this more organically with a very small team that would not cost a lot of money, not a big capital expense from a company standpoint. Thanks, Shaun. And we do have a question from our audience, and I think it's what everyone is curious about, although I don't think it's about revenue over the next couple of years. And while we're not giving specific guidance, let me ask it a different way. How do you quantify what the total addressable market is for the catheter? How many hospitals are there? Are there metrics that you can give us without providing guidance that give us an idea of what the opportunity is? Yeah, what's interesting, without providing kind of forecasts and revenue, if you look at these, as I may not have mentioned earlier, the patients undergo several procedures. It's a disposable device with a large revenue potential of each device. Each patient would undergo between five or 10 or more procedures. So one patient could drive a lot of revenue. If you look at, for example, I characterize a locally advanced pancreatic cancer market well when we looked at the TIGeR-PaC trial, most of the medium-sized centers see between one and five patients per month. So you can imagine capturing a couple of patients per month at an institution, even at 10-20 sites with multiple treatments, that could drive a very high dollar revenue potential. And then as we expand a number of sites, of course, that can grow from there. It's very different than other things where it's a one-and-done procedure with a low-margin product. This is a high-margin product where one patient represents multiple sales potentials and multiple procedures and high-volume centers. Thanks, Shaun. And our next question, we do get quite often as well. And so we've had our first interim readout. We expect our second interim readout to come out sometime in the first half of next year. The question does come up, if the data for the second interim is similar to the first, is the trial powered enough, and what is the probability that the FDA will approve our technology? How do you think about that if and when potentially the data is good when we announce our second interim? Yeah, Valter, our belief is that the data is looking positive from the first interim analysis, which gives us an opportunity. There's a chance we could hit statistical significance with a predefined alpha at this next interim analysis. Now, what's interesting, having said that, we're right around the corner from completing enrollment in the study. So the chance of completely stopping doesn't make sense, but the idea of having discussions when the FDA is saying, "Listen, this looks like it's working for patients. We've hit significance. Let's get this into patients and treat them commercially," and then maybe have a final look at the data once the final data is out, that's not unheard of. The FDA has commonly approved or given conditional approval or accelerated approval for technologies where the trial is not totally done, but looks like there's a benefit to patients without any safety concerns, and then they take a look at the approvals again at the final data cut. So there is an opportunity there. We are around the corner from finishing enrollment in the trial. And in parallel, we've got this optional and parallel track of the device commercialization. Any data that comes out with anything with our technology can help drive commercial efforts and pick up adoption. So we have the opportunity as data is coming out, is there a chance to stop early potentially or get early approvals? But we also have a high-revenue catheter that's actually not that far off from what we would have charged the drug-device combination. Thanks, Shaun. That's helpful. And we have time for one more question. And this is my favorite question. Do you think the stock is undervalued and why? Yeah, it's become one of my favorite questions as well as far as the opportunity here. If you look at a few other analogs, I'd like to point to TriSalus, TLSI, Novocure, NVCR, as I mentioned. You mentioned, I think one of the first questions was the Novocure data that came out, Delcath, DCTH. These are companies that range in valuation from $130 million, $280 million to even Novocure stock would jump to $3.5 billion after the last data cut, almost doubling. And we're sitting at $30 million with the opportunity of a commercial potential here. So I see extreme undervaluation because we not only are looking at revenue-producing without need for much capital in the very near term, but we also have a phase III asset in our back pocket that's wrapping up a clinical trial. You put those together. You look at TriSalus, which is commercial with a phase I trial, drug-device combination. Delcath is more on the pharma side with a drug-device combination, now commercial. Your market valuation is there between $130 and about $280 million. We're like the best of both of those worlds. We're at the tail end of a phase III trial and about to commercialize. And then you look at Novocure, which is an established market. I've always looked at us as being like a Novocure, but a few years behind them with a $3.5 billion valuation. Sitting where our market cap is today at $30 million, there's a lot of opportunity for the potential I've been talking about. Well said, Shaun. Thank you, and we're just at the time for today's call. Shaun, any concluding remarks before we conclude the call? Thank you so much for the time. I appreciate Rick Stark joining the company as we launched in this commercial effort as well and joining on the call very quickly and the opportunity of all to speak to some of our investors. At the core of this, it's all about the patient. I always like to remind people to show not just survival, but a reduction of side effects. This provides an amazing opportunity not just for our investors, but our patients as well, so it's rewarding to see both upsides here in this type of a story. I agree, Shaun, and Rick, thank you so much for joining, and to everyone who participated on today's call, we tried to get to all of your questions. If we didn't answer something, please email us at renovoRx@kcsa.com. Really want to thank everybody for joining. Happy holidays. Happy holidays. Thank you. Thank you.