Today, and welcome to the iAccess Alpha Virtual Best Ideas Winter Investment Conference 2025. The next presenting company is RenovoRx Inc. If you'd like to ask a question during the webcast, you may do so at any point during the presentation by clicking the Ask Question button on the left side of your screen. Type your question into the box and hit Send to submit. I'd now like to turn the floor over to today's host, Shaun Bagai, CEO at RenovoRx Inc. Sir, the floor is yours. Thank you for the opportunity, and thank you for those listening in. I look forward to sharing our updates with you and the progress we've made to date as we're closing up an exciting year in 2025 and really planting the seeds and putting in the positive foundation for growth in 2026. My name is Shaun Bagai, CEO of RenovoRx, and here at RenovoRx, we are working on a new way to think about cancer. Unfortunately, when you think about new cancer therapeutics, it's really a balance of how much you can actually affect the tumor versus destroying the patient, and unfortunately, as a society and as a medical society as well, and as an industry, we've been a little bit myopic on trying to destroy the cancer, not taking the patient into account. We're looking at maybe trying to flip that on its head and look at not just the tumor itself, but the patient by localizing therapy for cancers. So with that, I'd like to launch into a little bit of the background of the company and the exciting commercial and clinical progress we've made to date. Our forward-looking statements are on our website and can be seen here. At high level, we have a two-prong approach to a potential market. One is we've initiated commercialization of our FDA-cleared RenovoCath device this year, and we've shown over $900,000 year-to-date revenue through Q3 2025. What's interesting about this, this was really a test of the market to see exactly how the market would behave to our therapy delivery system and what the adoption looks like, what commercialization efforts should look like, and really figure out what it's going to take to scale this and really bring this to market next year. This $900,000 and near $1 million of revenue was done without a sales infrastructure, and we've recently put a small lean sales infrastructure in place to progress here. The market for the device as a standalone is over $400 million peak revenue in the U.S. alone, looking at indications and areas where the device has been used to date. Beyond that, we're also developing the second prong of the company, which is our therapy combination platform utilizing our proprietary TAMP mechanism, which is Trans-Arterial Micro-Perfusion, specifically on localizing drugs with a drug-device combination for locally advanced pancreatic cancer. In that development program, we are advancing our pivotal phase III TIGeR-PaC study to completion. We anticipate completing enrollment in this phase III trial early next year in 2026, with final data the year after. I can go into more details of how that looks. From an experienced board member situation and management team, we've got the bench of folks who both have pharmaceutical and medical device experience and combination therapies, not just in clinical development, but also in disruptive commercialization. Let's pause for a moment and talk about how our therapy works and what the mechanisms of action is and how this is different. So when you think about the physiology of cancers that we initially started approaching, it's really about the anatomy that's causing a barrier to success in chemotherapy delivery. Many tumors in the body are considered hypervascular, or they're giant balls of blood vessels and tumor cells that get high levels of blood flow. This is an advantage to chemotherapy delivery systemically because when you give systemic chemo, it circulates the whole body and does have toxicity, but the drugs can reach the tumor via these tumor feeders that feed the tumor directly and end in the tumor. Unfortunately, many tumors in the body don't have these tumor feeders and are considered hypovascular or don't have a large blood supply. Simply, they have less of a connection to the circulatory system, so when systemic chemotherapy is delivered, you still have these negative toxic effects on the body as a whole, and very little drug gets to the tumor, making these almost chemo resistant, which is why survival for tumors like pancreatic cancers is so low. We've managed to overcome that issue with adoption or introduction of chemotherapy with our TAMP Trans-Arterial Micro-Perfusion system, which is a catheter-based system placed through a very small incision in a leg artery under X-ray guidance by a radiologist to deliver chemotherapy locally. To overcome this issue with not having large blood vessels feeding the tumor, the way the end of our system works is with two balloons, we can isolate a segment adjacent to the tumor and then deliver a full dose and volume of chemotherapy over 20 minutes, creating a pressure head to force drug across the blood vessel wall and into the tissue. At not very high pressures, what this does is imagine about a liter of fluid being forced into a small space in about one to two milliliters of volume in the blood vessel. Again, that causes pressure enough to push the drug outside of the vessel wall to saturate and bathe the tumor in chemotherapy at levels that it otherwise wouldn't see. The resulting effect is we've seen 100x concentration of therapy at the tissue level. This is a log-rank scale, so 100x dose locally, and not surprisingly, because we're delivering systemically, we see a much lower exposure systemically. The panel on the left was done as proof of concept in animal lung tissue, and the panel on the right is actually from our human studies. We are currently wrapping up our PK sub-study analysis in our phase III trial. This was the preliminary data showing that we received about a 50% reduction in toxic chemotherapy dosage around the body than you would with systemic therapy. That final data I recently announced is coming out in the next quarter or so with that subset analysis complete. From a patient and clinician experience, the patients receive eight treatments over four months. Currently, with chemotherapy, they go in every week or every other week for the most part, sit in infusion chair, have the side effects. With this experience, patients are in and out the same day. It is an outpatient procedure. The procedure itself is about 90 minutes, so it's not a whole day in a lab. The patients are not put under general anesthesia. It's just conscious sedation, and it's relatively easy to learn and adopt from physicians. We're there for the first handful of cases to teach the physician how to use the device, but these skill sets are familiar to the radiologists who do this as they do similar procedures in those more hypervascular liver-type cases. Comparatively, other treatment options generally require more hospital stays, overnights, and/or side effects for systemic therapies. From a market potential, our experience to date has been primarily in locally advanced pancreatic cancer in our clinical trials, but this is a list of cancers that also behave like pancreatic cancers where they're relatively hypovascular or don't have large blood supplies, and specifically, where the same drug we've been using, gemcitabine, is being used, including cholangiocarcinoma or CCA, some non-small cell lung cancers, glioblastomas, sarcomas, uterine tumors, and other tumor types like this could follow. As I mentioned earlier, we have commercialized the device as a broad delivery system. The device is cleared for chemotherapy delivery to the peripheral vasculature, so we've been able to start marketing this as a delivery system tool for physicians to use how they see fit. With success to date so far, it's really hinged upon these metrics, and we really see ramping growth in 2026 based on some great tailwinds we've had in the last year and what we've discovered on market adoption. If you look at analogous pressure-mediated delivery catheters, the reimbursement allows us to charge, or allows our analogues to charge, between $6,000-$8,500 per device. With each patient receiving between five or eight or even 10 or more procedures per patient, we could ramp up to an initial peak market of $400 million with a device-alone sales, looking at just the patient populations where we've had experience to date. From a patent perspective, we have 19 issued patents, nine of which are in the U.S. and 12 pending, with the most recent patent expiring in 2043. Now, what's interesting about this commercial opportunity is, unlike many new technologies, it's not a heavy, expensive lift to really penetrate the market. Given these types of tumors, especially in non-metastatic cancers, a lot of these patients are driven to high-volume surgery centers with the hope of taking the tumor out. Unfortunately, that's not the case. Generally, these types of tumors are diagnosed too late, and this allows us to really focus on very high-volume institutions that are highly concentrated more in the east with a few on the west coast. So with a very small sales team, we could tackle the bulk of these 200 hospitals and drive meaningful revenue and start tracking towards cash flow break-even. Again, we did revenue of $900,000 so far this year without a sales force in place. This was primarily inbound interest from physicians looking for options for their patients and then work on behalf of my management team. Currently, we have 14 centers approved to purchase the device. Five of these centers have used the device in patients to date to drive this almost $1 million revenue, and they've made repeat purchase orders. As far as the pipeline goes, we have 24 additional centers that have requested quotes. Also, we've got 18 centers in our phase III TIGeR-PaC study that should finish enrollment and could convert to using customers next year, already being trained and already having the device on the shelf. As I mentioned earlier, we put the sales infrastructure in place with a recent hiring of a head of sales and market development. In alignment with the existing budget, we've actually added two regional reps in the northeast and southeast regions. To switch gears now to the other asset in our bag besides the commercial opportunity, let's look at our phase III trial and drug-device combination as a new drug asset. Specifically, we're focusing this trial on locally advanced pancreatic cancer. If you look at what moves the bar for pancreatic cancer, the last major development was the addition of Abraxane to gemcitabine back in 2013, and this survival curve is important. This is what's considered a blockbuster, game-changing, disruptive new drug: seven weeks of survival benefit with worst toxicities, so keep this in mind as we go through some of our early data. In terms of what patients and physicians are looking for, through surveys with medical oncologists, they basically said, "If you give me over two months of survival benefit over the current standard of care with a better side effect profile, we'd send the bulk of our patients, with three to four months being a complete game changer." To touch on our study design, I'll go over this very quickly and handle Q&A if there's more questions. This trial is meant for treatment-naive locally advanced pancreatic cancer patients where the patients are enrolled and get upfront systemic chemotherapy and radiation, and then randomized to standard of care chemotherapy systemically versus eight treatments of TAMP with our drug-device combination of RenovoCath and gemcitabine, and then followed for survival. A quick snapshot on statistics and timing: we did complete our first interim analysis. It was a very early 30% look, of which the data was presented. I'll share that here. We also surpassed our second interim analysis with a positive review from the data monitoring committee, saying, "late in this study, let's continue to completion." And then final analysis is expected upon the 86th death or event in 2027. We're randomizing a total of 114 patients with 86 events triggering the final analysis. And again, we anticipate enrollment completion in 2026 and final data in 2027. Looking at the early snapshot of data that was presented at ESMO GI in 2023, we looked at the first 26 deaths when 45 patients were randomized triggering that data analysis. And if you look at the survival curve, it's much better than what we saw before. You can see a large separation between the two arms showing actually a six-month survival benefit of our TAMP procedure with a drug-device combination for locally advanced pancreatic cancer versus standard of care systemic chemotherapy, which is a marked difference, but it's not just the survival that's important here. Again, it's really what's happening to the patient, and with that reduction in systemic chemotherapy exposure I mentioned earlier with the PK analysis, we have now seen data that shows a 65% fewer toxicity profile in terms of adverse events than serious adverse events, which is not surprising because we are limiting chemotherapy initially to local tumor with much less systemic exposure, so when you think about chemotherapy patients being debilitated, not eating, not spending time with families, being lethargic, we get to reverse a lot of that with our therapy, and we start seeing patients feeling better. In addition to the phase III trial, as we're waiting for final data and that PK analysis coming shortly, we have launched our RR5 P ost-Marketing Registry Study, which is a device registry so we can track data within commercial usage to see where else this catheter is being used and can start presenting and publishing data subsets as that trial rolls out this year. We already have three centers that are actively looking or enrolling patients, that have been launched, and we'll expand that slowly this year. And the other key thing about this post-market registry and additional investigator-initiated trials is that these are very low cost for the company in terms of expenditure as they are registries and investigator-initiated trials, and we are selling devices that are being used for these procedures and collecting data, so that does count towards revenue so far this year and the coming years as well. From a team perspective, to touch on this high level, as I mentioned, we have a very experienced team both on the medical device standpoint, on the pharmaceutical standpoint, drug-device combinations, and clinical development and commercialization, both on the management side and our board of directors. Most notably, our recent board addition was Dr. Bob Spiegel, who comes by way of a previous Chief Medical Officer, Schering-Plough, and he brings a lot of expertise in terms of designing clinical trials and advancing the pipeline further in a more cost-effective manner. Given how strong our data has been and the promise of where we're going, I'm proud to present our scientific advisory board of luminaries known internationally in the oncology field with recent additions of Dr. Thierry de Baère and Michel Ducreux from Gustave Roussy in Paris and Dr. Timothy Donahue from UCLA as a surgical oncologist. So we've got a top, top group of physicians who are helping drive our progress and seeing the potential for this therapy and such high unmet needs. Also, the previous addition was Dr. Margaret Tempero, who sits on the NCCN, the Chairman of the NCCN Guideline Committee that writes the guidelines for pancreatic cancer. So what's coming? Beyond all the excitement and what we've established in terms of commercial progress to date and clinical trial progress, as I mentioned, we did report out revenues of $900,000 through Q3. We did have a positive recommendation to continue passing the second interim analysis milestone, the phase III trial, so both those buckets of the commercial device opportunity and the phase III drug asset. Beyond that, we do have our PK subset analysis coming, completion of the TIGeR-PaC phase III trial enrollment, and then along the way, we will give out updates on how the investigator-initiated trials are going, including two recently approved trials that will launch shortly in both metastatic pancreatic cancer and pretreatment before surgery for surgical resectable cancer and borderline resectable cancer. Beyond that, final update or final data in TIGeR-PaC is anticipated next year in 2027, and along the way, we're building initial interest in the registry study, and one of the most exciting points of being a phase III company is actually starting to produce revenue and not just burn cash as we start to roll out our revenue scenarios in the coming year. Highlighting the financial highlights, I mentioned the revenue to date. We did finish Q3 with over $10 million in the bank, and we do anticipate growing revenues in 2026. We'll reduce our cash burn over time, large institutional ownership, and again, from a TAMP perspective, the device alone is about $400 million in annual RenovoCath sales, and that can go up multiples of the drug-device combination approval and J-code reimbursement akin to other companies like Delcath, for example, that has a niche procedure and an ultra-orphan indication with a drug-device combination, as we do also have orphan drug designation in two areas, and lastly, I'd like to close with just a highlight of our commercial progress. We have learned a lot in 2025 in terms of where this can take us in 2026 and beyond. Again, achieving almost $1 million this year and to date without a sales infrastructure in place and learning what the right lean infrastructure looks like, we've now put that in place to at least start to scale next year. Of course, in this early stage where each patient can represent between $40,000 and $80,000 of revenue, sales will be lumpy in the beginning as we start to roll this out in just a handful of centers. But with such a strong pipeline of now 13+ VAC approvals where they can purchase the device, five active customers that last public reporting, and these are growing, and 10+ in the pipeline of submissions, and dozens we've talked to that are interested in starting the process, we have a strong pipeline that our sales folks can actually now bring to the funnel and start to grow revenues in 2026. This is still early, but we've created a solid foundation to drive growth. This is really what's going to be exciting for the upcoming year in terms of rolling out additional data and driving commercial progress where we can finally see light at the end of the tunnel and look to see when we can actually become a cash flow break-even company with a device alone with a big potential upside of the phase III trial. Thank you so much for your time, and I'm open to questions, so the question came in on why not go international with sales. Thank you so much for the question. We actually looked at the international market deeply. My background has actually been disruptive launching of new technologies, and I've spent most of my career in Europe until now. And what's interesting and amazing is given the regulatory pathway that we discovered in the U.S. with this device, because we're not in the brain or the heart, we went through what's called the 510(k) pathway to get approval for the device with limited clinical data based on similarities to other technologies throughout in the field. As I mentioned, there are analogous therapies in the liver that use other types of devices, slightly different, and they work better for those physiologies versus these. So the reimbursement here and the regulatory pathway was simpler and more straightforward and faster, which is not normal for very invasive technologies or surgical implants. So the potential of revenues reimbursed burn in the U.S. makes much more sense for now. The reimbursement is much lower in Europe and other countries than it is here. So it makes much more sense to capitalize on the U.S. market, start to build out our balance sheet with revenue, and then look to expand in lesser profitable markets outside the U.S. Having said that, obviously, there's a large market in both Asia, Europe, and elsewhere, and we will look to that probably with partners down the road. We have already made inroads and connections with physicians globally. As I mentioned, our advisory board, we have a couple from physicians from France as well. They want to start driving this. So we will look to the European and Asian markets in the future. But right now, keeping in mind of our cash burn and our potential success on the finance side here, we started to work here first. The next question is, how should we think about the pace of RenovoCath adoption in 2026 as more NCI centers complete onboarding? It's going to start ramping, so as I mentioned, we have many centers in the pipeline that are going through the purchasing process, and that involves finding a physician champion, making sure there's multi-specialty buy-in, and then having the hospital look at the lucrative reimbursement codes to ensure that they'll be profitable with purchasing the device at our ASPs and then approving the device, and that process can take up to six months or more, hence the lumpiness in sales in our first year in commercial where there's been kind of the start to finish of actually getting someone onboard. It takes a while. Now, what I see in 2026 is a lot of those discussions and processes coming to fruition. So I believe the pace will start to ramp later next year. Looking forward to really finishing 2025 strong with what we've seen so far without the sales infrastructure and really ramping towards the end of 2026 as well. So a lot of progress to come given the pipeline we've already built up. Next question is analogous to what I just mentioned. Can I talk about the sales cycle length and what's driving conversions from initial interest to the first procedure? Absolutely. This is the biggest piece I want to learn this year before wasting money hiring the wrong types of salespeople and building the wrong processes. So as I mentioned, it's generally finding that first champion physician and then having them pull in the multidisciplinary team to make sure that they will get patient referrals and then go through the purchasing process. Some of these processes can go in parallel with hospitals. Others have to be sequentially, and that length we've seen is roughly anywhere from three months to nine months, is the range. So I'd say roughly six months once we've started those dialogues, and again, having over 28 quotes requested where 14 have gotten approval and five have started using, and then I'd say dozens of what I've said publicly on the back end where we had that initial dialogue, we've really built the pipeline to start ramping in 2026. Next question, how many of the early RenovoCath revenue is structural and recurring versus one-off procedure timing? This is actually a great, very interesting point because we look at analogous technologies like TriSalus and others, and it's really trying to replace an existing device, and it's a lot of time as one-off procedures until there's deep adoption. You get that range. With what we're seeing is, especially since patients aren't having the same side effects and toxicities, the $900,000 of revenue is only from five customers. It's absolutely repeat usages. It's very important as you look at early medical device penetration is that you are going deep and not too wide. It's not a matter of dropping off orders. It's not a matter of one-off procedures. This is where you need a very large sales force that's very expensive. With a very focused effort on customers that will have repeat usage is where we can start to see revenue growth without increasing the burn. That's exactly what we've seen to date and exactly what we expect for 2026. One of the main gating factors to expanding RenovoCath use beyond pancreatic cancer into additional solid tumor indications is getting that first patient in. We've already had interest. So as I mentioned, bile duct cancer or cholangiocarcinoma is an obvious next target for us. There are physicians looking for those patients today. So it's once we start getting those first patients in and publishing, although the bulk of our interest has been where our data lies to date. So I do see that growing, but primarily probably what we've seen so far. Given the $10 million cash balance, how far does your current runway extend under the updated commercial plan? So we reported out about $800,000 of burn per month last quarter. That's increasing slightly with the additional hires. And again, it's a sales force of three people, not 50 or 20 or 10. We've estimated that even with the new infrastructure in place, this gets us into halfway through 2026 at least with our current forecast, and it could be more than that based on revenue increases towards the latter half of the first half of the year. Next question is, how should investors think about pricing, reimbursement, and margin trajectory as case volume increases? This is a great question as well, as we already started to see this. Reimbursement's in place. We have seen these getting paid at high levels of reimbursement that allow us to charge in that range of pricing of $6,000-$8,500 per device times multiple treatments per patient. Already, to date, and this was in our last 10-Q, our margins are at about 80% to date. We do see that dropping as we start to scale manufacturing, which has already begun, and start to make small design tweaks to decrease the cost of manufacturing and increase margins. So 80% is a high place to start when you have a commercial effort, and we're looking forward to bringing that even higher in terms of margins. One more question is, can you comment on the level of interest you're seeing from potential partners on either the device or the platform side? Thank you very much for this question. This is exactly where we're heading next. So we have had several conversations and continue to be engaged with medical device companies who see this as a potential drop in their bag as they have a sales force in place that sells to oncologists and radiologists with this type of equipment in, let's say, liver spaces or other areas like that. So those are ongoing continually. We actually looked at this this year and decided that based on the economics, it makes more sense for us to commercialize with a small dedicated sales force versus a revenue share situation today. We continue this dialogue as we look to scale later next year or the year after, whether it comes to a distribution arrangement or a potential acquisition. There is definite interest as this is a first-in-class, only-in-class device for these types of tumors. So those dialogues continue. As a reminder, Boston Scientific led our Series B funding back in 2018, and they still remain one of our larger shareholders. They have about seven other companies that also have a similar sales channel that cater these types of customers of physicians that would be great partners that we continue dialogues with. And that's on the device side and on the platform side as well. This is a first-in-class delivery system that accomplishes things other things can't do. We've been very successful with a generic cytotoxic drug to date. Going from that, we're looking at what's the next best bullet we can put on our system that could really treat even maybe metastatic pancreatic cancer. So we continue to look at other drugs and have discussions with companies that have new and other agents, both immunotherapeutics, potentially antibodies, antibody drug conjugates. So those dialogues are ongoing as this is a platform that can grow into other drug device combinations. That's all the questions I have so far. Almost out of time. So I'd like to finish with giving you the enthusiasm that I have seen light at the end of the tunnel. I've been here for 11 and a half years and seeing this grow to really reach physicians and to be able to commercialize this. In fact, if you go on our investor section in the clinical news section, we had a recent story in NBC, New York, and Philadelphia of one of our first commercial patients who's being treated. It's great to see this get to patients and now putting the foundation in place to see the lights in the tunnel to get to cash flow break-even, to get to final data, and to really bring this home to patients and return value for my investors. Thank you so much for your time. That concludes RenovoRx, Inc's presentation. You may now disconnect. Please consult the conference agenda for the next presenting company.