Our next fireside chat is with RenovoRx, ticker RNXT, with a market cap of approximately $40 million. RenovoRx is an interventional oncology company with a late-stage product in development and products on the market. We cover the company here at AGP with a buy rating and price target of $3 per share. Trades currently around $0.85. Presenting for the company, we have Chief Executive Officer, Shaun Bagai, as well as Chief Financial Officer, Mark Voll. Shaun, why don't you get us started and take a couple of minutes to tell our audience a bit about yourself and RenovoRx, and thank you both for joining.
Thanks for the opportunity, Scott and AGP. Glad to be here, thank you everyone for joining. At RenovoRx, we're looking at trying to treat cancer in a very different way. When we think about cancer treatment, we think about patients receiving toxic systemic chemotherapy that blasts through the entire body with very little getting to the tumor. We've developed a new mechanism and platform called TAMP, or Trans-Arterial Micro-Perfusion, to force drug locally in the tumor site to really saturate the tumor in chemotherapy versus giving systemic toxicity. Maybe it's okay, I'll start off with a quick video on exactly how the technology works, we can talk about how it's being applied and where our success lies.
That'd be great.
See my screen okay?
We can. It looks good.
Great. The platform of our technology, as I mentioned, is called TAMP, or Trans-Arterial Micro-Perfusion, and this is empowered by what we call the RenovoCath device. It's a catheter that's inserted into the body by a radiologist, and under X-ray guidance, the physician is allowed to see exactly with the position of the catheter adjacent to a tumor, and these are in tumors that don't have high blood flow or blood supply.
By positioning the catheter next to the tumor via an artery, the physician's able to isolate a segment of artery without these side branches, position the device in a manner that can fill up that small space between two balloons, and give a full dose and volume of systemic chemotherapy over the course of 20 minutes, causing a pressure head to force the drug across the vessel wall and then saturate and bathe the tissue in therapy. Our primary focus has been so far on pancreatic cancer, where we've got a phase III trial ongoing, and in animal studies, we've shown that we can get 100 x the dose concentration at the tissue site than you would if you gave it systemically. Scott, just as far as my background goes, I've been in the medical technology space my whole career.
I've really been on a mission to try to find new therapies and developments to create market development and new products that can really affect patient care in a meaningful and different way. Very lucky this is several companies beyond my initial startup companies where we're seeing a major impact on patients and cancer care. Maybe Mark, want to give a little background about yourself?
Sure. I've been a Chief Financial Officer for more than three decades,two decades of which has been in the public market sector. I directed the IPO of three of those companies. Companies did well and were sold. This is my first endeavor in the healthcare sector, and I just saw the tremendous opportunity that's here for growth and excited to be on board here.
Okay, that's great. Thank you both for that background. One of the reasons we wanted to have RenovoRx present at this conference was because there's a lot of microcap companies with big ideas that could work out with big upside, and you guys have that. But you also have revenue generation which can at least, at minimum, take a little of the load off the R&D and help amortize that out and help the company advance with managing the balance sheet as well. Let's dig in a little bit. Shaun, you just had strong Q1 results. Tell us about these catheters you sell. It's very similar. It's the same one, but you can sell it direct. It'd be great to hear about that and how that business model is working. Thank you.
Scott, what's interesting is as much as we're in a phase III trial specifically for locally advanced pancreatic cancer, the backbone of our platform is FDA cleared. The RenovoCath is available for sale, we found as we're wrapping up the phase III trial, given that the catheter is cleared for general indications of delivery and chemotherapy delivery, we found that physicians have a lot of patients that don't have many options. They're coming to us over the last couple of years saying, "Look, your data so far looks strong. We've got several potential applications for the technology. We don't have good options for the patients where we don't destroy them with chemotherapy.
Can we just buy the catheter and start using it?" Over the last couple of years, we very carefully looked at what could a commercial opportunity look like, and we launched the catheter as a standalone medical device early last year with no salesforce infrastructure to really test the market, see what would take, what the salesforce size looks like, and was able to pull in about $1.1 million of revenue in 2025 and have actually achieved over half of that in the first quarter of this year with catheter sales, and that is growing drastically as we see a major pipeline of customers coming on board.
Well, that's fantastic. Anytime we see a big quarter like that, I think as you mentioned it, as much as half of the year before, we're always wondering, is that a one-time event or is that a trend? How would you describe that as far as momentum building or a one-time event?
I see it momentum building and really a platform from which we see this taking off. Other areas that should be interesting to focus on is how many customers we're bringing on board. As probably one of the biggest KPIs, we could look at how many active customers we have using the device with repeat orders. Looking at 2025, we started exactly a year ago with about five active customers. We finished the year with eight, really ramping towards end of the year, and now we've got 16. Those results are starting to show with the revenue ramp. As you see those numbers increase, we do expect a nice growth with a strong finish in the year. I do see this as now a platform that we're launching from to show this massive revenue growth.
Whereas 2025 was lumpy with a handful of customers, we do see this growth being real.
Okay. I'll kick it over to the numbers guy, Mark Voll. Mark, what are the incremental costs of running this business? When you think about the gross margin levels, is it already cash flow accretive? At what level does this contribute cash to the business?
Sure. First of all, the company has strong gross margins. Gross margins are 85%, that gives it a big impetus going forward. Right now our cash burn is about $1 million per month. We see that decreasing as the year goes on, as we bring on more cancer centers, as we drive revenue growth. We think we'll be driving towards a break even sometime the back half of next year. It's not really a big leap to get there. We think that about $4.5 million-$5 million gets us to break even operations. Again, we see that we can attain that sometime the second half of next year.
Okay. That's fantastic. That's a pretty lean operation. Final question on the catheter business before we go over to TIGeR-PaC. Where do we think peak sales could get in this catheter business as a standalone unit, and how do you arrive at those numbers?
What's amazing about this, Scott, is we have such a focused market. Each patient receives multiple treatments. As a standalone disposable device with strong reimbursement in place, it doesn't take a lot of patients to get to a very high number. If you think about each hospital bringing in somewhere between a minimum, I think three, four, five new patients per year, up to let's say 10-20, with each patient receiving at least 5-10 treatments. Given the current reimbursement landscape, we can charge at least $7,000, $8,500 per device. With that, at peak in areas where we've seen catheter usage so far, we believe we could have about a $400 million recurring revenue, just in about 7,000 patients or so. That's a platform. We can look at different tumors, different drugs.
I see at minimum, there's an opportunity here in the next several years to build out a $400 million market and then potentially beyond into the $1 billion-$2 billion range as we go outside where we've had experience so far.
Okay, great. Quite an addition to the company, that unit that's only been around, I would say inside of the last two years. Let's shift over to RenovoGem, which is pretty much the catheter with gemcitabine, which used to be, I believe, Eli Lilly's Gemzar at one point. How does that compare to traditional chemotherapy? What are the advantages and how should we think about that product?
Well, Scott, as I mentioned, one of the biggest differences is how we apply the technology on having localized delivery. Especially with non-metastatic cancers, if you look at the standard of care of gemcitabine plus ABRAXANE or other more toxic combinations like FOLFIRINOX, it's systemic chemotherapy with a lot of side effects and it's a balance of killing every cell in the body versus trying to actually attack the tumor. What we found in their early results is that patients had a massive reduction in toxicity and side effects. In fact, in the first interim analysis of this phase III TIGeR-PaC trial, we saw a significant reduction, in fact, 65% reduction in systemic side effects and toxicity with local delivery via TAMP of gemcitabine versus systemic. That came with an efficacy signal of patients living longer. By concentrating drug locally, we're seeing a massive potential effect.
Okay, great. This TIGeR-PaC pivotal trial, which is ongoing for this approval, what are the clinical milestones such as full enrollment and other key events investors should focus on?
I think the number one you mentioned is full enrollment. That's the question I get from investors all the time. Is the trial done yet? Is it done yet? Is it enrolled? These are tough trials to enroll because it's such a clean, robust study, trying to get treatment-naive patients, randomize them, catching that patient exactly at the right time. We did announce that we do anticipate enrollment on time from the last announcement. That'll be in June of this year where we can complete enrollment. This serves two purposes. One is as a major milestone in the trial, we're looking forward to final data in mid to late 2027 based on the event rates we expect. In fact, we've achieved the vast majority of events to be able to trigger that. On the flip side, this actually lends to commercial.
We've got 15 centers that are believers in the technology enrolling in the trial, and we've already begun transitioning them to commercial customers to start using the technology as a standalone device. That milestone was major because it gives us the one leg of the trial that's moving along well, and the second is a commercial opportunity. Beyond that, we did finish the PK sub-study in our trial, where we looked at systemic levels of gemcitabine. That has been initially presented at ASCO GI. Additional presentation at ASCO coming up here on the corner, and that publication is under review that we anticipate publishing later this year. We may have other data cuts throughout the next year or two, but those are the major milestones we anticipate for the TIGeR-PaC phase III trial.
Okay, great. You've probably hit on this already a little bit, but whenever I'm dealing with a developmental company with clinical data coming up, I always try to ask this question, and sometimes it's worth asking twice. Why are you optimistic about a positive clinical readout from TIGeR-PaC? I know you've had some interim analysis that could contribute to that, as well as earlier stage clinical work.
It's three things, actually. One is we were optimistic in launching this study because theoretically it makes sense. We're taking a drug that we know works against pancreatic cancer cells, and the biggest issue is actually getting the concentration to the tumor site. It does get there with our technology. With our phase I, II trials, we saw a 28-month survival from diagnosis. More of a retrospective study. We launched a phase III based on that, the phase III trial, the first interim analysis did have a positive trend towards efficacy, showing a six-month survival benefit. The second interim analysis had a readout where the data monitoring committee said, "Looks good, go forward. No changes. Continue to final analysis." We've had some milestones along the way that give us confidence that it looks like we may be having a positive effect here.
Okay. Shaun, the flip side of that coin is what keeps you up at night with regard to the TIGeR-PaC trial? What are the risks of it not executing as planned? Or maybe it's just enrollment.
Yeah. I think the biggest risk we've had is timing enrollment completion. That's something that's taken a long time, and it's great to see that that's wrapping up now. The next is how long it takes for events to occur. It's a tough situation that we don't have control over, but really, it's unfortunately as a primary endpoint of survival, we're waiting for patients to pass away. Unfortunately, in this patient population, there's a lot of data we know pretty well what that time horizon looks like, which gives us confidence in a final data readout mid to late 2027.
Now it's just a matter of executing the enrollment and the trial, getting patients into randomization, and then we have had data cleaning efforts ongoing in the background, so ensuring we're able to clean the data in a timely manner, such that we could look at what the final data looks like next year. It's more execution at this point than other risks.
Okay, great. As we get closer to that readout, at some point you'll have to file it, and then you'll want to launch the product. Do you have any thoughts on your go-to-market strategy for this product, the RenovoGem?
That's what makes RenovoRx a very different animal in the sense we have this two-pronged approach of commercial now with the standalone device, and then the drug device combination opportunity. We actually have the opportunity to put in a commercial infrastructure, sales channel, and patient and physician awareness today to start to drive the commercial effort, such that with a positive data readout and potential subsequent FDA approval of the combination, we could almost drop this in, and then it's a drug potential reimbursement. Really the upside we see from the trial is furthering device sales, and/or increasing the ASPs by using a drug code versus a device or procedure code.
The go-to-market strategy is really going to be on the heels of what were tested last year, and then now initiating this year, and we'll have a pretty good commercial traction and force by the time we get final data.
Okay. We are starting to run out of time a little bit, so I'll just go to some of our wrap-up questions. Mark, we always like to end with the balance sheet. Could you talk about current cash you have on hand and the run rate and what kind of runway that leaves you?
Sure. We completed a $10 million financing late in March. We ended the Q1 with $12.4 million in cash and cash equivalents on the balance sheet. We really feel that we have a cash sufficient for us to drive our business into the second half of 2027. We're not looking at any further financing in the near term. Our focus now is on really just growing the business.
Okay. Good to hear. I guess the final question, Shaun, if you could talk about the key catalysts. I mean, we've talked about it already, but it's sometimes good to summarize that for investors wondering why they should get involved right now. The key catalysts over the next 12-18 months and anything else you want to slip in there, and then we'll wrap it up right there.
Absolutely, Scott. Just to jump ahead, and maybe I can talk to a slide real quick as this might help map out the picture for us. Key catalysts that we see, as I mentioned, is completing enrollment in the next few weeks. We've already announced that we're going to start sending letters to sites to let them know that enrollment's wrapping up. The data presentation at ASCO around the corner, and then the PK final publication will be coming out. One thing we didn't talk about is the platform build beyond just TIGeR-PaC phase III trial and the commercial. We have initiated investigator-initiated trials in other areas like metastatic pancreatic cancer, like potentially bile duct cancer. We're looking at even surgically resectable pancreatic cancer. We'll start rolling out news on how those outside uses are doing and additional data coming out down the road.
We see several little catalysts along the way, with the major ones being completion of enrollment and then commercial growth. As you noticed, we doubled our revenue in Q1. Our revenue in the first quarter was about half of what we did or more than half last quarter, and we already have indications that we're going to have a strong Q2, and we should be growing beyond our Q1 earnings as well. We do see a lot of potential growth and opportunity here. The biggest tailwind behind all of this, we haven't had a lot in the past, is being fully funded through these initial commercial launch and these next major clinical milestones.
Okay, great. Well, we are now out of time, but that's a great way to end the presentation. Thank you, Shaun, thank you, Mark, for participating in the conference. We look forward to watching the company progress over the coming years. Thank you