Presentation is with RenovoRx ticker RNXT, with a market cap of approximately $30 million. RenovoRx is an interventional oncology company with a late-stage product in development and a catheter on the market. We cover the company here at AGP with a buy rating and a price target of $3 a share. Trades around $0.75 currently. Presenting for the company is Chief Executive Officer Shaun Bagai. Shaun, take it away, and we'll have some questions at the end. Thanks for participating.
All right. Thanks for the intro, Scott. Thank you, AGP, for the opportunity, and thank you, everyone, for listening and dialing in. Let me share my screen here. I get a little background on the company, and we can go into Q&A here. One second. See my screen okay?
Perfect.
Excellent. Just to give you a little very high level, this is RenovoRx, and we've developed a new way to think about treating cancer. As you probably know, investing in the biotech space, we often have a trade-off with new therapies for cancer treatment, where it's a matter of extending life as long as you can and destroying the body in the process. Unfortunately, we haven't taken into account the patient's well-being, and we're so focused on poisoning the entire body to try to get to the tumor that a lot of that gets lost. What we're trying to do is flip that on its head and actually not just treat patients, extend life, but actually make that quality of life worthwhile. The way we do that with a new system we've developed called TAMP, or Trans-Arterial Micro-Perfusion, it's a localized chemotherapy.
We have developed a delivery platform that, as Scott mentioned, is both in a late phase III clinical trial, and also we have a commercial opportunity that we began exploring this year to commercialize the device component. We initiated commercialization early in 2025 with our FDA-cleared RenovoCath device. Through the end of Q3, we were able to achieve $900,000 in revenue without having a sales and marketing infrastructure. This was really us learning the market, seeing if there are any headwinds or barriers to adoption, and then starting to put in place and strategize on an execution plan to commercialize and really get this ramped up and going next year. For the catheter alone, we anticipate about a $400 million potential peak sales.
Then beyond that, we're developing a combination platform using the RenovoCath plus a drug combination with orphan drug designation, specifically in locally advanced pancreatic cancer that's wrapping up our phase III trial. The phase III trial is anticipated to complete enrollment early next year with final data in 2027. We have the right team in place, both on the pharmaceutical side, the device side, combination side, and all the way through clinical development and sales and marketing to get there. Just to touch on how the technology works and why this is different, I want to dive into the physiology a little bit of different tumor types. Many tumors are balls of tumor cells and blood vessels that feed them. This blood vessel feeds the tumor.
We call it tumor feeders, and it gives a target both for systemic therapy to reach as much as it does cause systemic toxicities, but also a local target to place a small device inside the tumor feeder directly and deliver drugs or some type of therapies. If you look at other tumors like pancreatic tumors, bile duct tumors, glioblastoma, non-small cell lung cancer, bladder cancer, sarcomas, they don't have these large dedicated tumor feeders or blood supplies. The tumors stay relatively disconnected from the circulatory system, which causes them to grow slowly. They die on the inside and are more of a ball of fibrotic cells with some tumor cells in them. This really makes them chemo resistant. We've managed to overcome this chemo resistance with our new delivery mechanism and patented platform. Again, this is called a Trans-Arterial Micro Perfusion or TAMP technique.
The physician places our RenovoCath device with minimally invasive access to the leg artery, and under X-ray guidance, they can place the device adjacent to a tumor. Again, there's no tumor feeder to put this in directly. Using the proprietary nature of the device, they can adjust the system to isolate blood flow to a segment of artery without any branches between the two arteries or between the two balloons. Over 20 minutes, they give a full systemic dose and volume of chemotherapy to perfuse through the vessel wall into the tissue. What this ends up doing is saturating the local area in chemotherapy. What we end up with is a hundred-fold tissue concentration at the tissue level than we would if we gave the drug systemically.
It's a completely different mechanism of action of trying to push chemotherapy through and actually get it locally in these types of tumors. From a commercial standpoint, looking at the market opportunity, we can charge the current existing reimbursement by CMS and outside payers roughly $6,000-$8,500 per device. Each patient has between five or eight or even more procedures. Based on this, looking at where we've seen experience to date, we anticipate about a $400 million potential market of full penetration. That's just for the device by itself. We do have several patents around this, including patents that were recently issued that will go out to 2043. This patent portfolio really protects this new mechanism space that we've seen. From a commercialization strategy standpoint, a lot of 2025 was about learning what's going to drive the market, what are the headwinds.
What we've really found out is there are only 200 hospitals in the U.S. with highly focused cancer centers that could treat most of these patients without metastatic disease. With a very small sales force of about three to five sales reps, we're able to penetrate deeply into this market. This varies very differently from new technologies that require dozens and dozens of very expensive sales reps on the ground. Again, we've already achieved $900,000 of revenue in the first three quarters of this year without a sales force or marketing team in place. With that, we just hired a senior director of Sales and Market Development in Q3 and invited two sales reps in the last couple of months. A marketing director is coming in December, so we can enter 2026 with the right team on the ground to really deeply penetrate this market.
Just to switch gears and touch on the phase III study, to put this in context, we're looking at localizing chemotherapy specifically in locally advanced pancreatic cancer. And as we all well know, there's really not much that moves the needle in pancreatic cancer, and survival by a few more weeks is considered a blockbuster multibillion- dollar drug. The last major advancement was the addition of Abraxane to gemcitabine, and that moved the needle only seven weeks in terms of survival with a lot more systemic toxicities. What's important to adoption in terms of the marketplace?
We polled medical oncologists, and they said, "If you can give me 3-4 months of additional life with less toxicity, that will be enough for them to send almost all of their patients for this treatment." That's the bar we've looked at: seven or eight weeks in terms of a new blockbuster drug approval and adoption, and 3-4 months really take over the market. What we saw in the first interim analysis of the ongoing phase III trial looked at a six-month survival benefit. This early 30% look demonstrated that our patients were living almost two years or 21.5 months in comparison to 15 and a half months for the control arm since diagnosis. That's about what we expect. For non-metastatic locally advanced pancreatic cancer, most of the trials have showed about 12- 18 months.
We're performing as we expect in the control arm and pushing survival by several months with our treatment. Now, the flip side of that I mentioned at the beginning of the call is it's not just survival. The most important thing we've seen as we come into this as well is also quality of life in terms of adverse events. Unlike new therapies where you're losing quality of life with additional survival, we actually see a 65% reduction in systemic toxicities and adverse events based on what the data we saw in this first phase III trial. In fact, it's this data set that's been very important to physicians to reach out to us and say, "Listen, we've got these patients. We don't have great options for cancers like pancreatic cancer. Your toxicity profile is so good.
I'd rather stop chemotherapy after several months and start using your product and push this. Can we please purchase the catheter? That has really been the grassroots efforts that have driven our decision to go commercial with the device as a standalone device for the broad treatment of potential cancers. Also, we just recently announced we're launching a post-marketing registry study for the RenovoCath, where outside of the phase III trial, where this is being used commercially and we're selling catheters, they can start tracking data, and we can start publishing and presenting on data with the device uses as a post-market device registry. This could include many different types of cancers and different ages to be delivered as well, as this is a more platform-based technology.
We launched three sites so far this year, and we'll continue to update the market and how the progress of this goes, what data we see, and where this catheter is being used successfully. It is important to note that they are also purchasing catheters within the study. That also helps in terms of revenue. Lastly, just to touch on our milestones, we did report RenovoCath revenue of $900,000 for the first three quarters without a sales force. This will be lumped in the beginning, of course, with a handful of centers treating patients and multiple catheters per patient. We did also in Q3 announce the Independent Data Monitoring Committee recommendation to continue the trial based on the second-informed results to completion. As far as completion, we expect that to occur in early 2026 with final data in 2027.
Within the TIGeR-PaC phase III trial, we also completed the PK sub-study, which demonstrates the systemic levels of gemcitabine of our technology versus gemcitabine plus Abraxane systemically. That data will be published very soon. Beyond that, we are making progress on investigator-initiated trials. Again, physicians are looking at purchasing our device and starting to study other uses. The two we most recently announced and greenlit are in metastatic pancreatic cancer, which could open this market even bigger, looking at different agents to deliver. We will continue to report out as that goes. On the flip side of locally advanced pancreatic cancer are those that are lucky to get caught early and are given chemotherapy via our catheter presurgically in what we call neoadjuvant. We are looking at phase kind of stage one, stage two cancers as well.
Both of these investigator-initiated trials will be purchasing catheters and then producing data in those additional markets. Along the way, of course, as I mentioned, progress updates in the RR5 registry study in solid tumors. Just to give a quick update on financial highlights, revenue year to end of Q3, $900,000. We did finish Q3 with $10 million in the bank. We anticipate growing revenues from RenovoCath to reduce our cash burn and then fully fund both initial commercialization scale-ups and completion of the TIGeR-PaC trial enrollment. From an ownership standpoint, about 30% is institutional, held by multiple fundamental healthcare institutions. The RenovoCath as a standalone medical device, which is now on the market, is estimated at $400 million TAM. Beyond that, using additional indications beyond what we've seen so far, that could grow.
With the potential approval of a drug-device combination and that drug-device combination for locally advanced pancreatic cancer, getting a J-code drug reimbursement, this TAM could be about five to ten times that as a drug-device combination, which we can anticipate in the future with approval. As far as stock goes, we have 37 million shares, roughly outstanding. Scott mentioned the market cap around $30 million. Thank you so much for your time. Looking forward to the questions.
Thank you, Shaun. We've got a lot of companies to choose from when we put together these days. We chose RenovoRx because you have a late-stage proven molecule in development, but you also have a catheter that generates revenue. We think that this lower risk profile is a good profile to have in the current environment. At this point, we will go into Q&A. I'll get it started with, we'll start with the catheter because that's what's new. It's generating revenue. The launch came out of the gate strong, but it's been kind of lumpy. Now you're adding a marketing effort. Do you think that will make it more predictable? How should we think about the launch in the coming quarters?
Absolutely, Scott. Thank you for the question. As I mentioned, the initial launch kind of carefully understanding the market has included so far five active centers using the device to treat patients. That $900,000 was primarily from five centers starting to use the device, starting to see success, and having repeat patients. It's also interesting to note because each patient has between five and ten treatments at the rough numbers I gave, each patient could represent between $50,000 and $100,000 of revenue. This early, it's kind of hard to demonstrate a consistent growth given that one or two patients could move the needle by a lot of percent when you're starting from zero early this year. It's kind of lumpy this year. What we've built in the last few months is a great pipeline of potential customers.
We have five approved sites that are using the device repeatedly. Beyond that, there are another nine centers that have approved the device for purchase, looking at their first patient to start actually using the catheter. Beyond that, we have 20 in process and about 30-40 more sites that have expressed interest. Given that interest we built up, that's when we decided to go ahead and hire three sales reps to pull those interested sites through the funnel to get sites that have gotten approved to start using it and drive commercial efforts next year. I do see, as you described, next year with the infrastructure and the built-up demand, we can start pulling that through and eventually level out a more consistent growth that should get us to a great place next year.
Thank you, Shaun. Now, with the additional resources that you have, those three individuals, where do you see the break-even, let's say on a quarterly basis, for the catheter? Are you already there such that there's a positive contribution margin?
On the device margins, the answer is yes. We're already there. We have 80% margin on the device. And the sales reps have already started paying for themselves. As we are wrapping up the trial, there's still expenses on the clinical trial side as well. What gets us closer to break-even, and I'll put it in rough numbers of customers, if we can get to 25-50 hospitals actively pulling in one new patient every month or two based on only five procedures to be conservative on our ASP, that would get us to over $1 million of revenue a month, which would cover our burn. If you think about it, we're now in about 10 centers, close to 10 centers, another 30-40 behind them. The big inflection I see next year is at the completion of TIGeR-PaC enrollment.
We've got 16-18 centers that are trained on the device. They've been purchasing the device. So far to date, we don't recognize that as revenue in those phase III sites. It goes towards our R&D offset. They already have the referral pattern set up. We can add another 15, 16, 17 sites pretty quickly after completion of enrollment to get us towards that 25-50+ goal. It'll be great to see coming out of the gates the next two quarters in the first half of the year where that ramp's going. That'll help determine how quickly we can get to break-even. The great news is given those numbers and the progress we've made, it looks like it's within eyeshot.
Okay, great. It's been quite an asset. It sort of came out of nowhere, but it could potentially help you with somewhat non-dilutive funding for the rest of the company. Let's shift over to RenovoGem. How is it different from the catheter? Are any patients using gemcitabine already to really create their own RenovoGem? Or just how should we, maybe how should you differentiate those two in the sales effort?
They're hand in hand, if you will. The end RenovoGem or what we call the intra-arterial gemcitabine via the RenovoCath will end up being a kit akin to DelCath Hepzato for liver treatment. It's basically a drug and a device in a box reimbursed as a drug product. That's what's being studied in the phase III trial. The goal of the phase III is to get on label with a kit we can sell as a new drug product. What's being used commercially is the device as a standalone. People are using because they've had experience there, they're pulling off drugs off the shelf so they can use gemcitabine and other agents. To date, there's been more interest in where we've had gut data. Patients are being treated with gemcitabine and the RenovoCath.
Okay, great. I do have a couple of questions from the audience. Let me try to read those through. For starters, can you clarify the rationale for the recent updates to the primary and secondary endpoints of the TIGeR-PaC clinical trial? For primary outcome measure, a change has been made to statistical analysis method, log rank to Wilcoxon. Was this change discussed, agreed upon with the FDA? In addition, you've made some changes to the secondary outcome measure by removing the patient-reported system log. The questioner would like to get a sense of the reason for these changes and just any understanding you can provide. Thank you.
Yeah, I really appreciate the question. This helps to clarify. I recently found out about this. We actually haven't changed the analysis plan. The analysis has always been overall survival using Wilcoxon from the beginning of the study. I believe there was an error in clinicaltrials.gov. When they went to update on the study, they saw it said log rank erroneously and changed it. They fixed the error on the website, but it's always been a Wilcoxon test. We actually haven't changed the primary analysis endpoint. As far as the patient-reported outcomes and quality of life measures being difficult to measure significantly and statistically, we changed that to more observatory endpoints. We are tracking more measurable endpoints like the PK analysis and other side effects and toxicity profiles that come with it.
There really hasn't been any major changes to the trial design at all.
Okay, thank you, Shaun. Another question from an audience member. Can you clarify the current estimate for final data readout timeline and subsequently study completion? Is it early 2027 now, or what should we expect for that timeline?
Haven't given guidance on exactly when in 2027. We want to see when we complete enrollment, and that would dictate it, of course. The other tough part to tell is this is an event-based trial. Upon the 86th death is when we can do the final analysis. We'll get a better sense of where that lies, I think, later next year. At this point, we believe we'll have that 86th event occur sometime in 2027, which will be predicated upon when we finish enrollment and as the deaths start happening.
Okay. Another question. Are there any active plans for device improvements? Any tweaks to the device you can make that improve it and perhaps patentable? Just trying to get a sense around that.
Yeah, what's been great about this technology and living through the medical device world most of my career is it's rare when you go to market with a device you initially design. It's been great to see the feedback from physicians that this thing works well. It's relatively easy to use. We haven't had to make major modifications. The initial modifications we're making in the near future are more to increase the yield on the catheter and to bring the costs down to get higher margins. We are making some process changes just to improve manufacturing in terms of cost. Nothing that the physicians will really see drastically. Those are to come. We are exploring additional technologies we could apply to the catheter and patent it as well in the future.
Okay. Another question. How does the recent two scientific advisory board esteemed members help RenovoRx in which areas specifically?
Thank you for the question. You know what's interesting? We attracted both of these advisors based on our initial interim results. They're both world-renowned medical oncologists, Dr. Michelle Ducreux and Dr. Gary de Baere, who's very well esteemed in the interventional radiology community. As we look at referrals from oncology to radiology to do these procedures, they're a great team to help explore how we can push the technology. They've also been focused on local delivery. One of the issues they've had with local delivery is due to that physiology of the pancreas, nothing can get there. Upon seeing the initial results and seeing this is working, they got very excited to join us and really think about exploring what's beyond gemcitabine, what's beyond pancreatic cancer.
They're working with us on building out some of the investigator-initiated trials and to see where else we can build this platform, given we have a big market to have right now, but really we're going to take this therapy platform in terms of different agents, drugs, and different tumors.
Okay, great. Thank you, Shaun. Another question from the audience. You are generating one of the more active audiences. I commend you for that, Shaun, by the way. An interesting question. Why did Renovo decide to only deliver gemcitabine versus delivering both gemcitabine and Abraxane as you do in the control arm?
Thank you for the question. This was actually a debate we had with Dr. Dan Von Hoff when designing the study. If you may recall, he was the PI for Abraxane. Before he retired, he was a heavy advisor to the company. He was pushing for the same exact concept. Why not deliver both? What we learned is one of the benefits of Abraxane is it gets more gemcitabine into the cancer cells. As you know, Abraxane is used in conjunction with gemcitabine and never by itself. We discovered that if the issue is delivery and we can overcome that physically, and again, we get 100 times the tissue concentration with local delivery, we could deliver gemcitabine as a single agent more successfully. We also know that gemcitabine works very well against tumor cells in specific cancers.
The issue is delivery both in pancreatic cancer and bile duct cancer where we have orphan drug designation and then other tumors as well. The idea was, let's prove out a drug we know works. We know it's been around for a while. We know the toxicity of the profile. With success, we can start building on more toxic agents. What we were surprised with pleasantly is in the phase I and II is the survival benefit was so many months with just gemcitabine, we decided this makes sense from a business standpoint to partner with a generic and orphan drug designation, not just deliver to Hepzato with DelCath in a larger market space where this could be very successful as a combination product. That's the beauty of a platform.
We've got something that looks like it's working very well, but we can also in the future add additional agents like Abraxane or other drugs, for example, used in FOLFIRINOX or even immunotherapies for metastatic cancer down the road. With initial test of safety, we found efficacy signals and then a great combination with gemcitabine as a standalone.
Okay. Another follow-up question here. Let me just go through these to make sure I'm asking the right one. It appears that a few clinical trial sites have either been terminated or withdrawn over the years. Can you explain why this occurs? Does it affect the speed of recruitment or perhaps they're just not very productive sites to start with your take on that?
Yeah, it's the latter. Exactly, Scott. I appreciate that question as well. We've been pretty aggressive at closing sites if they weren't productive in enrolling patients to reduce costs and keep this focused. What's interesting is a lot of the bigger cancer centers, and without naming names, they have trouble enrolling patients. I think, in fact, there's data that shows only 25% of eligible patients in a whole world spectrum get enrolled in trials. In seeing those barriers for trial enrollment, we decided to close them down. What's interesting is many of those sites have been or are interested in the commercial aspects. I think we announced Moffitt Cancer Center as one of our commercial sites.
They were in the TIGeR-PaC trial, but based on their enrollment patterns and their treatments, they wanted to give higher dose radiation in the study, so they couldn't enroll patients. Now they're a very active commercial user. That's why we closed them down, but these are all potential customers in the not-too-distant future.
Okay, great. The final couple of questions are questions I ask most companies that are in a position like yours where the TIGeR-PaC trial is a somewhat binary event. Tell me in your own words why you're optimistic for success in the trial. I guess it could be two-part in this case. One, what was it in the phase II work that made you confident that it would work this time around? Second, which normally it's one thing, but here, given you had the interim analysis, you can also point to that as perhaps confirming your belief just to get your sense of combining those two things.
Yeah, based on the question, Scott, what gave us confidence initially is the fact that we know that gemcitabine works on these types of pancreatic cancer cells and the etiology of how radiation helps with that as well. Seeing the data at 28 months survival giving radiation plus TAMP, it gave us confidence that we should see a successful randomized study. Taking a glance at that early look at the 30% look with six months survival, and of course, this is part of the dataset, gives us further confidence that this looks like it's actually working. The other side of that as well is the toxicity profile showing that massive reduction in adverse events in and of itself, I believe, is driving some of the commercial market. It gives us confidence that overall the trial looks like it should be good for patients.
Okay, great. How does the interim analysis sort of confirm your positive bias in this case?
In the phase I and II trial, we did it was an all-comer trial where we actually explored different parts of it, and that's where we discovered the radiation combination. The radiation pre-treats the tissue bed to reduce chemotherapy washout. Combining that in a very descriptive induction phase of three months of chemo and radiation and then randomizing to our treatment versus control gave us confidence that this should work. The first interim at a 30% look shows that six-month benefit with a trending P-value gives us confidence that that combination did, in fact, work and really proved out what we saw in the phase I and II trial.
Okay, great. Another interesting question from the audience. Have you had any conversations with other biotech or pharmaceutical companies developing novel therapies with the idea of pairing someone else's drug with your catheter to test that hypothesis?
Yeah, thank you for the question. Absolutely. What's amazing is we're proving out this platform and mechanism works. The issue is keeping hyper-focused on finishing the phase III and our commercial efforts is picking that one or that two kind of next steps on what to use. We do continually talk to biotech companies working on new pharmaceuticals to see if we can increase the profile of their technology, both in terms of reducing side effects and increasing efficacy by local targets. Those dialogues are ongoing. I said publicly, we're in strategic conversation continuously, and not just with pharmaceutical companies in terms of pairing the catheter into a good drug device combination, but also on the catheter side. Boston Scientific was one of our early investors, still a shareholder.
Them, along with several other interventional oncology device companies, are very interested in putting this in their bag in terms of a distribution agreement and acquisition down the road. Those two conversations with both groups continue to go on.
Okay, great, Shaun. Final question. We always like to end with a balance sheet question. I don't believe you have any debt of note, but could you talk about the cash runway and how long that lasts?
Yeah, so no debt exactly $10 million in the bank is what we reported out end of Q3. Our burn is starting to reduce with revenue. So our burn in Q3 was $800,000 per month. Again, we do not need a large sales force to drive this with deep penetration in the marketplace. With the addition of three sales hires and a marketing director, that burn does not increase drastically. As far as the ramp in commercial in the next several months, that should bring the burn down further. We will explore opportunistically. We have a lot of financing options, especially becoming a commercial company that should be less diluted for investors. We have a great runway in the meantime to prove that all out.
Okay, great, Shaun. At this point, we'll end the presentation. I certainly want to thank you for participating. Investors can follow up with us at AGP as well as the company directly. We'll go from there. Thank you again, Shaun.
Thanks for the time, Scott. Appreciate it. Thank you for joining.