They're a targeted oncology company developing devices that can be used in targeted delivery of therapeutics. Currently, the company markets RenovoCath and is developing a drug-device combination for treating locally advanced pancreatic cancer. To discuss the company's development strategy, not only in 2025 but also years beyond, I welcome Shaun to this Fireside Chat. Good day, Shaun. Glad to see you and appreciate you accepting our invitation to talk to our audience today.
Thanks for the opportunity.
Just for starters, Shaun, you know, can you please give us an overview of RenovoRx and also your business model?
Absolutely. RenovoRx is built around a very specific mission: improving outcomes for patients with difficult-to-treat cancers. What we've developed, discovered, invented, and patented is what we call Trans-Arterial Micro-Perfusion, or TAMP. TAMP utilizes our FDA-cleared device called RenovoCath that's designed to deliver chemotherapy across the vessel wall to a tumor site directly. It's targeted therapy without having the systemic side effects. We are a dual-track company, which is.
Greetings and thanks for joining us to have a conversation with Shaun Bagai, CEO of RenovoRx. RenovoRx is an innovative targeted oncology company developing devices that can be used in targeted delivery of therapeutics. Currently, the company markets RenovoCath and is developing a drug-device combination for treating locally advanced pancreatic cancer. To discuss the company's development strategy, not only in 2025 but also years beyond, I welcome Shaun to this Fireside Chat. Good day, Shaun. Glad to see you and appreciate you accepting our invitation to talk to our audience today.
Thanks for the opportunity.
Just for starters, Shaun, you know, can you please give us an overview of RenovoRx and also your business model?
Absolutely. RenovoRx is built around a very specific mission: improving outcomes for patients with difficult-to-treat cancers. What we've developed, discovered, invented, and patented is what we call Trans-Arterial Micro-Perfusion, or TAMP. TAMP utilizes our FDA-cleared device called RenovoCath that's designed to deliver chemotherapy across the vessel wall to a tumor site directly. It's targeted therapy without having the systemic side effects. We are a dual-track company, which is a little bit rare. On one side, we've got a commercial opportunity that we've embarked on earlier this year for the commercialization of the RenovoCath device. We commercialized this really late last year, beginning this year in Q1, as a standalone medical device product to deliver therapy locally. On the second hand, we're a late-stage Phase III clinical company. We're late, and I'll go into more details on this, but we're very late in our program in a Phase III clinical trial utilizing the RenovoCath device along with gemcitabine as a drug-device combination for this treatment specifically of locally advanced pancreatic cancer. We've already surpassed two successful interim analyses. We're well on our way for final completion of the study and potential submission for approval of a drug-device combination, and we're actually starting to generate revenue on the commercial side for the device by itself.
Perfect. As you stated, you're commercializing RenovoCath at this point. If you can give a little bit of details regarding what RenovoCath is, is there any competition for such a device out there? Also, what made you bring this to the market?
Yeah, I appreciate the question, Rakesh. The RenovoCath is a double -balloon catheter system. If you think about local delivery, it's not uncommon to deliver drugs locally for solid tumors. In fact, in the liver space, by comparison, there are these large tumor feeders that actually end in the tumors. Physicians can deliver local drugs with just a catheter, or basically a plastic device with a hole at the end, and deliver drugs locally in the tumor. Unfortunately, for a lot of tumors like pancreatic cancer, bile duct cancer, glioblastoma, some non-small cell lung cancer, and many others, they don't have these large blood vessels that feed the tumors. There's not a local target. What we've developed, invented, and patented is RenovoCath, which is a double -balloon catheter system that a physician can minimally invasively put next to the tumor. They blow up two balloons. They can adjust the distance between the balloons such that there's no side branches between, and then deliver an entire systemic volume and dose of chemotherapy in that small space over 20 minutes. That creates a pressure head that forces the drug across the wall of the blood vessel to then really bathe the tumor in chemotherapy. What you see is a very high local drug concentration with very low systemic concentrations and decrease in their toxicity. It's a different mechanism of action. There is nothing out there like this in the market. We patented not just the device itself, but the mechanism of action, the way we cross the vessel wall, the way we saturate the tumor. What's brought this to market is really physician desire. We've seen in our Phase III TIGeR-PaC trial for locally advanced pancreatic cancer, many physicians are finding that some of their patients are not eligible for the study because we want to capture treatment-naive patients. It's difficult to catch these patients right at that early stage. They have many patients that can't be treated within the trial. They said, "Look, your data looks promising so far. There's nothing else out there, and we don't have a good option for these patients. If nothing else, we see a reduction in toxicities and side effects of your technology, and the efficacy data looks promising. It looks like patients might be living longer." Through pure physician demand for us to sell them the device by itself for treating patients outside the trial, we answered that demand with more reimbursement headwinds last year. Now we've decided to commercialize because physicians are interested in this, and patients are very happy to have a local therapy versus a systemic option.
Perfect. While your clinical trial actually utilizes a chemotherapy and the device combination, let's talk a little bit more on RenovoCath. In general, as your current physicians are using the device, how are they using the device in the sense like what are they using it for and what sort of experience are they gaining from this device that kind of helps you understand the utility and how to commercialize the drug-device combination when it comes to the market? Also, any learnings at all? I know you've been commercializing this for not too long of a period, but still with whatever anecdotes that you get from the field, do you think that you need to make any changes when you start commercializing the drug-device combination?
This is actually a great point, Rakesh. This does give us a leg up on the potential drug-device combination commercial effort because we get to test the market now and reduce our burn while we're doing it. It's a great experiment. I believe the demand so far has been for pancreatic cancer because we have such strong data in our Phase I trials and interim analysis of our Phase III where physicians are really seeking to start using this. What we've seen commercial uses so far, they're using this in pancreatic cancer patients, moreover locally advanced, where we've had the most experience to date. Now, because of our success in locally advanced pancreatic cancer so far, there is a strong physician interest in expanding beyond that. We do anticipate usage beyond just locally advanced pancreatic cancer. Where we see the interest is from surgeons to give this in a neoadjuvant fashion, before they do surgery or for borderline patients. This increases the market potential drastically. Beyond that, also for metastatic cancer. There is a notion that local control is important even if the cancer has already spread. To be able to treat the metastases with systemic chemotherapy and then treat the primary tumor with our technology more effectively, potentially, physicians are interested in metastatic cancers as well. Beyond that, there is interest in bile duct cancer that behaves very similar to pancreatic cancer and non-small cell lung cancer, the two areas I see physicians interested in. I did announce in our quarterly earnings that we launched the PanTheR study, which is a post-market device registry. This allows physicians to capture data in these different tumor types that they can start presenting and publishing, which will create great news flow on one side for the investors, but also for the physician community to see where else there may be utility for the RenovoCath. All of these things give us, as you mentioned, a great experience on how to commercialize the technology. We can really see what the cadence of procedures are, which tumors they'd like to use it on, how many treatments per patient. This is a potentially lucrative business for us because each patient receives between 5 and 10 treatments with our device and eventually with a drug-device combination. It gives us a sense of what the volumes look like, how many per patient, and also what the sales footprint needs to be. As I mentioned in previous calls, we only need about three to five reps to penetrate this very concentrated market. It's not a very expensive sales effort. We get to really test that out in the next few quarters.
If you can spend a minute on the PanTheR study there, as you stated, it's a registry study. You kind of get an idea of where surgeons are using this technology. Do you foresee that study actually giving you some additional indications, ideas for some additional indications that you could use your drug-device combination? Is that also a part of the thinking in terms of doing this registry study so that you can expand the indication beyond the locally advanced pancreatic cancer that you're currently looking at with the TIGeR-PaC study?
Yeah, Rakesh, that's a nice point question because you know what it really provides us is optionality. It is exploratory in nature. It does give the physicians an opportunity to capture data with the use of our device. I can see one of two pathways. Either A, it fuels commercial efforts, and that data can fuel commercial efforts as a device standalone. Or B, if there's something very interesting, we could turn that into a longer political development program for drug-device combination approval. Possibly, given how robust the TIGeR-PaC study is for locally advanced pancreatic cancer, using that as a backdrop, we could go to the FDA and even look for different trial designs. It wouldn't be these long, lengthy randomized studies if we show this is promising. There have been single-armed studies that have proved drug-device combinations like this. Namely, Delcal was able to do that based on using prior data. I see both avenues' potentials. Also, back to earlier question, it really gets us to test the market. I can imagine a very lucrative catheter business as a standalone that can be applied to many tumors and many drugs that actually might make more sense than waiting for a long clinical development pathway. This gives us an opportunity to not have to do a large randomized phase III trial for every indication where there's interest because there may be commercial opportunities that exist today we can sell the catheter to.
To talk about, you know, since you said this could be a lucrative business, for the catheter itself, the RenovoCath that you're currently commercializing, what's the price point, you know, that you're commercializing this at? In general, what has been the adoption of this product? I know it's that I've not spent too much time on the market, but still, from what you're seeing and in terms of the demand for that product, do you have any resource constraints in terms of meeting the demand at this point?
From a price point perspective, we haven't publicly stated exactly how much we're charging for the device. Having said that, the reimbursement codes that we're using, there are companies out there that are charging between $6,000- $8,500 per device. I'd say that we're in that range using the same reimbursement codes. As mentioned, each patient has between 5 and 10 procedures. That adds up, multiplies very quickly. For each patient that comes in, provides a lot of revenue. A couple of patients would be about $100,000 in revenue potentially. From a demand standpoint, these hospitals, I'll take locally advanced pancreatic cancer as an example. These hospitals, the large volume cancer centers, and NCI-designated cancer centers that we've started to commercialize with, they probably see between 2 and even 10- 15 locally advanced pancreatic cancer patients per month. It's interesting with just one patient or two patients per month, revenue can add up pretty quickly. From a supply standpoint, we did a large deal with a contract manufacturer based in the U.S. It's outside of Chicago. They're constantly building lots every couple of months. We do have supply built up. Another benefit is a catheter does have a two-and-a-half-year shelf life. We can actually build up stores over time. It makes the supply and demand forecasting and planning much, much easier that we don't have to plan it exactly perfect. We can build up a stockpile as we go into the market.
Perfect. Let's talk a little bit about the TAMP and as well as the TIGeR-PaC study itself. In your initial remarks, you were talking about the TAMP. Can you expand on that? How did you or your team come about thinking this is the way to go? A third piece of that question is, as a toxicologist, I'm always worried about, you know, it's good to increase bioavailability, but at the same time, are we increasing the bioavailability beyond a certain point where we are getting into the toxic range? Any pre-clin data that you have that says you're not really getting into any systemic issues?
Yeah, I appreciate the question. Again, the TIGeR-PaC study utilizes Trans-Arterial Micro-Perfusion with RenovoCath, specifically delivering gemcitabine to locally advanced pancreatic cancer patients. It's the same dose and volume as systemic therapy. What we do is we have an induction phase in the clinical trial where treatment-naive, locally advanced patients receive upfront systemic chemotherapy and radiation. It's three doses of chemo or three rounds of chemo and radiation, which is typical for these patients. They are randomized to continuation of systemic chemotherapy, which is gemcitabine plus another drug called Abraxane, versus our single-agent local gemcitabine for four months. They have up to eight treatments with our treatment, up to four months with gemcitabine plus Abraxane in the control arm. They go on to continuation therapy, and we follow for survival. It's a hard endpoint of overall survival, making the trial very robust. What led to the design of this study was a couple of things. On the toxicity side you mentioned, we did animal studies in the preclinical arena just to make sure that we're not damaging the vessel wall as we push high volumes and doses of drugs. It's not high pressure that forces the drug across the vessel wall. We recruit these tiny little microtunnels. We've actually patented this mechanism to be able to get drugs to the vessel wall without damaging it. We're not seeing any local deleterious effects from a systemic standpoint. We did publish interim results for our PK substudy within the Phase III trial showing a roughly 50% reduction in systemic dosing volume. Actually, you see a reduction of systemic floating gemcitabine, which has translated into a decrease in toxicity, which makes sense. I think I mentioned this previously, but we are publishing the final data from that in a few quarters from now. That's more data that's coming within the Phase III trial. The other flip side in preclinical that we did note, not just this reduction in systemic toxicity, but we did animal studies showing we see a 100x increase in local drug concentration at the tissue site versus getting them systemically. We see both of those sides of the coin, just increased local concentration and also decreased systemic toxicities, which is rare for new therapies.
This is the best place to be. In terms of the study itself, can you give us some details on the design of the study? You were talking about the two interim looks. I believe you published some data from the first interim look. Can we just get the highlights of the data there?
Absolutely. The trial design, I talked about the technical nature of how the flow goes. From a statistical standpoint, we're randomizing 114 patients with the goal of having the final analysis done upon the 86th event. Given that it's a survival study, those events are deaths. Upon the 86th death, we'll do the final analysis. We anticipate late next year, if we can finish enrollment late this year or early next year. The pre-planned interim analyses, there were two. One was a very early look at the 26th event or death. The second was at the 52nd death. At the 26th death, it was a 30% look of the trial. It was early. The company, the data monitoring committee, and our consultants all were going back and forth on whether or not the data should be published and presented. Given that we jumped straight from a Phase I trial to a Phase III study and never did a prospective clean Phase II trial, the thought process is, let's take a look at the data early. It shouldn't bias any results just to make sure we're on track. What we saw in the first interim analysis was a six-month survival difference with our treatment versus the control arm, our standard of care systemic chemotherapy, and a 65% reduction in side effects, which makes sense along this reduction of systemic gemcitabine. The second interim analysis was just completed, the event occurring in Q2. We reported out just, I believe, a week or two ago that the interim analysis was finally reviewed by the data monitoring committee. They gave a favorable decision with confidence to move forward with the study, all of us believing that we should have a good and positive final outcome of the trial. The committee, along with our advisors, decided that this late in the trial and also the fact that we're commercializing the device, it would actually be very prudent to protect the integrity of the trial and reduce biases by not releasing data at this point. At this point, no one in the company actually knows the data outside of the data monitoring committee and the statisticians third party, except for our Chief Medical Officer who obviously is very much involved in the trial. This is interesting because one of the biggest concerns that we had with data coming out is that if patients are randomized, and we've seen this early in the study, but not so much before, and they decide that they want to come off the study to go down the street to just buy the catheter and use it, that's really going to decrease the chance of success of a robust clinical trial.
Shaun, can you please give us some additional details on this design of the TIGeR-PaC study itself? Also, in terms of the interim looks, any details on the first interim look would be helpful.
Yeah, thanks for the question, Rakesh. I mentioned the trial design as far as how the study flow goes. From a statistical standpoint, the trial is designed to randomize 114 patients with the goal of doing the final analysis of the study upon the 86th event, or in this case, as an overall survival study, at 86 deaths. We anticipate that late next year, if we can actually finish enrolling the trial late this year, early next year. There were two pre-planned interim analyses built into the study design. One was a very early look. It was at the 26th event or the 30% mark. As we jumped straight from a Phase I trial to this Phase III TIGeR-PaC trial, without a clean prospective Phase II trial, there was a notion that both from a scientific community and also to raise funding, we wanted to double-check that we're on the right path. We had a very early look with a survival study, believing we wouldn't bias the trial at 30%, where we actually presented data at ESMO GI as a late breaker, where we demonstrated a six-month survival benefit with the TAMP therapy versus standard of care. As importantly, a 65% reduction in toxicity and side effects, which is probably what's pushing our commercial adoption right now, is a reduction of side effects with a promise that it looks like this may be efficacious. The second interim analysis was completed just recently after the 52nd event or death. It's a 60% look. This was reviewed by our independent data monitoring committee, and they gave the positive outcome of continuing with the trial. Given how late we are on the study and given that we're commercializing the standalone device, which could compete with the trial also, the notion was it'd be better to protect the integrity and reduce any biases by continuing the study without publishing data at this point. As a reminder, back when we did the first interim analysis, there was no other option for patients. If they got randomized to control group, for example, they would have no other option but go into the systemic chemotherapy. The trial was intact. Now that we're commercializing the device, a patient could drop out of the control arm once randomized and go down the street and have the therapy. This has been a concern for a while. The idea is to protect the biases and the integrity of the study, we continue with the trial given that we're so much closer to completion.
Very good. I believe you were saying that you expect this study to be completed by the end of next year. Do you think this study alone is enough for getting the regulatory approval, or do you think FDA could ask you for another study so that you can get your marketing approval?
Yeah, so the study, as far as progress goes right now, as of August 12th, we've randomized 95 patients and seen 61 events or deaths towards that 86. We anticipate, based on our initial conversation with the FDA, that this could be the pivotal trial. As we designed this IMD, the original primary endpoint was progression-free survival, and the secondary was overall survival. The FDA said, look, if you want to do one trial for approval, we highly recommend you switch the endpoints. With an overall survival primary endpoint being the center, the gold standard and more robust, the notion is that we should be able to apply for an NDA at the completion of the trial.
Perfect. With the success that you have seen so far, do you think you can utilize the same catheter, but a different drug and also expand on the indication beyond pancreatic cancer?
Actually, that's what's great about this platform, Rakesh. It is a platform-based technology. It's the delivery system that could utilize really any type of drug or agent. There is a world of possibilities in terms of partnerships and looking at different agents beyond even chemotherapy. As we look to immunotherapy, where it hasn't been successful in tumors like pancreatic cancer, if we can actually get the drugs there or the agents there, we actually might elicit an immune response. Through this PanTheR registry and also interest in investigator -initiative trials, we're looking beyond gemcitabine and looking beyond just pancreatic cancer. This is truly a platform play. What's interesting is we hear in the news all the time of some great drug that's cured pancreatic cancer or other cancers in mice. As those programs develop, most of them will fail, we know. Once they do develop, it's not competition for us, but this is actually something we could deliver through our technology if something is more successful.
Perfect. What catalysts should investors be looking out for over the next, say, 6- 12 months?
You know, we have a lot coming. As much as we just began commercializing, we have a lot coming both from the clinical side and the commercial side. On the commercial side, I'm putting in place right now a very small and lean sales and marketing team. This should not increase our burn drastically. I think I've mentioned before that our burn is less than $1 million a month. We don't anticipate going much over that with the hiring of three or four fire sales reps. I look at this year as really building out the commercial, a very small commercial organization to prepare for a revenue ramp in 2026. Seeing how we do getting into the end of the year and priming ourselves for success early next year, not just on revenue quarter -over -quarter, but also on the metrics on how many hospitals you've actually gotten the catheter into, how many hospitals are actually treating patients, what that recurrence looks like is going to be very important. I see seeing commercial success will be a major catalyst for us, especially as we march towards breakeven. With such a low burn and with multiple treatments per patient and high reimbursement, it doesn't take a lot of hospitals to get to a breakeven point. It'll be interesting to start seeing that light at the end of the tunnel that we won't just be a cash-burning company. On the commercial side, there's a lot of catalysts. Beyond that, on the TIGeR-PaC side, as I mentioned, we're publishing the final analysis of the PK substudy to show what the systemic levels are. That publication and presentation should be due in a couple of quarters. Beyond that, the PanTheR registry study will be really interesting. We'll have constant news flow that should catalyze the stock in the company as we show that this can be used beyond just pancreatic cancer, beyond, as you mentioned, just beyond gemcitabine, and really see the platform capability of this both from the commercial side and the downstream clinical side.
Okay. The last question for you is on the cash position itself. What is the strength of the balance sheet at this point, and what sort of a runway can you get out of it?
We finished the quarter with $12.3 million in the bank. With just over $800,000 in burn rate, this takes us well into the second half of 2026. We're actually fairly well capitalized. It really depends on the commercial success. With higher commercial success, it could take us well beyond that. I'd say we're actually in a great cash position sitting here today, late in the Phase III trial. The money we have in the bank right now should take us through completion of enrollment of the Phase III and also help with the building of the small infrastructure on the commercial side, funding the commercial opportunities and continuation of the TIGeR-PaC trial towards the end as well.
Perfect. Thank you very much for your time, Shaun, today. Good luck to you, and talk to you soon.
Thank you, Rakesh. I appreciate the question and the opportunity. See you soon.