RenovoRx, Inc. (RNXT) Earnings Call Transcript & Summary

Good day, and welcome to the iAccess Alpha Virtual Best IDs Summer Investment Conference 2026. Our next presenting company is RenovoRx Inc. [Operator Instructions] I'd now like to turn the floor over to today's host, Shaun Bagai, Chief Executive Officer of RenovoRx Inc. Please go ahead.

Thank you for the introduction, and thank you for the opportunity here, and thanks, everyone, for joining in. Shaun Bagai, CEO of Renewable Rx, and I'm also joined by my CFO, Chief Financial Officer; Mark Voll, who will chime in at the appropriate times. So I wanted to give you a little overview on our company, our background how the technology works and the opportunities that lay ahead of us. When we think about cancer and therapies in cancer, it's quite often a balance of trying to attack the tumor and not destroying the patient in the meantime. And what we've seen with therapeutic epti therapeutic that the biggest blockbusters are let's try to extend life by a few weeks to months. And hopefully, we don't have the worst possible ever quality life for patients and is that kind of balance and give and take on both sides. At RenovoRx we're trying to attack this very differently. Is there a way that we can actually attack the tumor, keep the tumor at bay, extend life and also not destroy the patient in the process and maintain a relatively high quality of life and full function. And it looks like we're starting to achieve that. So as a background, I'll go to our forward-looking statements, which can be found online as well. As a background, we are advancing an FDA clear renewable cap device. So as a life science company, we've had both an FDA-cleared device, which is now in the market obtaining strong commercial momentum, where we last announced we're in 16 active commercial centers, purchasing devices and treating patients as of May 15. And then beyond that, we're also pushing forward our TAMP or transarterial microperfusion platform in clinical trials and here commercially. On the commercial side, with the device, we're pursuing a $400 million peak revenue opportunity with a much larger TAM with additional applications as a stand-alone medical device that's currently for sale right now and in, as I mentioned, 16 sites plus as of May 15. And then on the clinical side or develop the combination therapy with our proprietary TAMP system, and we haven't awarded 3 FDA orphan drug designations for this delivery mechanism in combination with those drugs. As far as a clinical development program, this is late stage on that aspect of the company, where we're advancing a Phase III study called Tiger pack, and we anticipate enrollment completion in the coming days or weeks marking a major milestone in a several year program with final data expected late next year, mid- to late next year. Specifically, the Tiger Pac trials evaluating intra-arterial delivered via the Renovo cat FDA-cleared device known as IHG, specifically in locally evented pancreatic cancer. From a leadership team perspective, both on the Board and the management team, we do have very experienced executives who have taken these types of products through clinical development and in the market. Let's talk about the platform first and the need here. So again, this is called the transarterial microperfusion platform, otherwise known as tamp utilized with a renewable CAF FDA-cleared device. To step back and think about the physiology, when we think about tumors, we think of these balls of blood vessels with tumor cells -- and generally speaking, there's a high blood flow to the tumors. So when you give systemic chemotherapy, you do have the opportunity where chemotherapy flows downstream with the blood flow into the tumor to affect the tumor cells. And these large blood vessels, which we call tumor feeders, actually end in the tumor. So it also provides for a local target where a physician can place a simple, small microcatheter plastic tube inside the tumor directly to deliver some kind of therapy. On the flip side, there are many tumors in the bodies that aren't considered to be heavily vascularized or have large blood flow. These tumors otherwise known as hypovascular are not having many blood feeders like pancreatic cancers are relatively disconnected from the main circulatory system and thereby when systemic chemotherapy is given very little gets to the tumor, but you have all the downsize of systemic toxicities -- so our goal and approach is to drive high volumes of chemotherapy or therapy into tumors to get a higher local drug concentration and at the same time, reduce the overall systemic exposure to the drug or the agent say don't have the systemic toxicities and side effects. So the snapshot of what we've seen so far -- in animal studies, we have demonstrated a high local concentration. This is a log rank scale. We're seeing 100x the concentration of drug, in this case, gemcitabine at the tissue site when delivered by our temp mechanism versus when you give it systemically. On the flip side, we do see a reduction in systemic exposure. So there's about a 50% reduction in systemic exposure of drug when given locally via our temp mechanism, which makes sense because we're localizing the therapy. -- this should and does lead to reduction of side effects down the road, and I'll share some data with you around that. The way our technology works is we've got the device called the Renova CAT device. It's a small device, it's about 2 millimeters in diameter, a physician, namely interventional radiologists, placed this through a very tiny incision in a leg artery and then thread it into the circulatory system minimally invasively under x-ray guidance to position the device adjacent to a tumor. And again, so far, these are tumors that largely don't have blood theaters that directly access the tumor. Once they position in the body, the physician is able to position 2 different balloons that are in the same system and adjust the distance between them such that they isolate blood flow. So there's no leakage of therapy or chemotherapy and over 20 minutes, they give an infusion of a very high volume and dose of therapy. In this case, with semcitabine, for example, to give over a liter of fluid in a small space in a blood vessel that may be 2 to 3 milliliters in volume and that creates a pressure ahead. So over 20 minutes infusion, within the first couple of minutes, we start to see the pressure between the balloons increasing, eventually forcing the chemotherapy, in this case or therapy outside the blood vessels to then saturate and base the local target in tumor and chemotherapy or therapy. And these are high pressures. As you can see by the chart here on the right, it's about 50 million to 60 millimeters of virtuary in an animal or maybe just over 100, 120 in a human to drive the therapy through existing micro channels to actually saturate and bath the tumor in chemotherapy. Again, an animal is resulting in 100x the concentration at the tissue side, which should have a great effect. So what does this mean for patients and physicians looking at other new therapies from a patient perspective, if you look at chemotherapy, generally, patients go into infusion centers on a weekly basis or 2 out of 4 weeks or 3 out of 4 weeks. And in our case, they go every other week. So if the patient goes to the hospital once every 2 weeks, our treatments within the Phase III trial have been up to 8 treatments over 4 months. And it's an outpatient infusion. So they're in there for about 90 minutes from the table approximately with about a 20-minute infusion and then discharge the same day as an outpatient procedure, -- and generally, these patients are not put under general anesthesia. So if you look at more complex invasive devices and approaches to therapy the patients have to be put under general anesthesia. In this case, they're just given medications and make them feel comfortable and then discharge the same day for the most part. From a patient -- a physician perspective, it's relatively easy to understand and develop the techniques around this procedure because it's roughly the same skill sets as they use for liver-directed therapy. If you remember that previous slide I showed you, then liver cancer, they do have these large tumor feeders where a physician can place a small microcatheter. So it's the same anatomy, same skill sets. So we're there for the first maybe 2 or 3 procedures with a proctor -- and then after that, physicians are free to go on their own to continue treating that patient and in other patients, and they can also train their colleagues as well. So it's a pretty low bar in terms of training physicians which from a burn perspective, actually does not require a major field force to support the technology. So far, experience has been primarily in lope advanced pancreatic cancer in the Phase III trial. And now that we've commercialized the technology, there are other areas where this can be expanded into. So the physicians that we've talked to so far have expressed interest in several areas where the tumors behave similar to pancreatic cancers without high blood flow or high supply of large tumor feeders to access. -- namely, the interest level so far has been in locally advanced pancreatic cancer, or LAPC, beyond that expanding into stage 1 and 2, potentially 4 pancreatic cancer. So looking to give before surgery for the rare patients that are identified early or in patients who are even more advanced than metastases there are IITs or investigator initiative trials of interest right now to use the device commercially and for their studies to be able to look into those markets as well. beyond pancreatic cancer, CCA, or cholangiocarcinoma is an area of interest where we should see some usage, hopefully, the not-too-distant future. Non-small cell lung cancer, some of these tumors could be amenable to this type of approach given the vast clarity or lack thereof in these tumors, glioblastoma or brain tumors down the road, sarcomas or bone cancers potentially and uterine tumors and fibers as well. So there are a lot of growth areas of the technology beyond just pancreatic cancer. Let's shift gears and talk about the commercial approach first, then we can talk about some of the data -- as mentioned, we did commercialize the Renova CAD device based on inbound physician interest. This namely came out of physicians who are aware of our clinical trial and said, look, your device is cleared by the FDA. And -- we're very interested in using this for patients who aren't tolerating systemic chemotherapy, which is the vast majority of them, can we please buy your device and start treating patients. And finally, after a few years of discussing this as we're wrapping up the trial, now with good reimbursement in place for the physicians in the hospital, we've decided to go ahead and market the technology, have now launched the technology commercially. So talking about our commercial scale and the opportunities here, before I dive deeper in the market, I'd like to hand it over to Mark Voll, our CFO, to discuss the margin potential of the device and what our TAM looks like. Go ahead, Mark.

So when we look at our market in our business, we believe it's a high margin, a large market opportunity for our stand-alone device. If we look at the revenue potential for the company, we believe that it's approximately $400 million. That's based on delivery of $6,000 to $8,000 per unit and 5 to 6 treatments per patient. If we look at the business model itself, we believe it's really a high-margin business model. Although we're ramping now our business and incurring losses, we believe that by the second half of next year would be a breakeven point Beyond that, we believe it can really be a business that generates high operating margins. So we believe gross margins will be 85% to 90%, really requires low overhead, and that's something that Sean can touch upon shortly. And as a result, we believe this is a business that can generate 30% plus in operating margins. We also have a highly defensible position of well-paced technology well-placed patents. As such, we think it creates really a defensible position for the company.

Thank you, Mark. And to expand on Mark's point about how this is low cost and low burn for us, -- when you look at our commercial efforts, it's a very targeted commercial effort that does not require a big field force. And as we well know, new medical technologies often require large amounts of capital to fund a very large field force to do this market development work and drive revenue. In this case, it's very focused. If you look at, for example, the pancreatic cancer market, -- there are about 200 centers in the U.S. that treat or see the bulk of nonmetastatic pancreatic cancers. Given that we've primarily had experience in the locally advanced or non-metastatic space, -- these are generally centers where patients go once they learn that the tumor has not spread. They go to the large centers that have a large volume of surgeries to see if there's any way they can take the tumor out. Generally speaking, the patients are too advanced, where the tumor has grown beyond the point of resection or removal and they send the patients back to the oncologist to get standard of care systemic therapy. -- this TAMP mechanism provides another alternative where patients may not have the same side effects and actually may live longer as well. If you look at these 200 centers, it follows a standard 80-20 rule, where actually centers treat over 70% of the potential patients. And so the targeted effort on the top 50 to 100 centers in the country, we could drive deep revenue, and it only takes a handful of sales reps to do this. We now have the commercial team in place with about 5 commercial reps in the field to drive deep penetration into this market. As far as our revenue to date, we can go to more detail later, but we did over $1 million of revenue in 2025 and to really explore the market development angle and understand the market before we scale in the wrong direction or with too much. And what we landed on is this perfect model of 3 to 7 sales reps to be able to drive meaningful revenue for the company to drive towards a breakeven endpoint, hopefully, late next year. As far as where we are today, we did show $560,000 of revenue in -- and that was over 50% of our fiscal year 2025 total revenue, and we have guided that we expect our Q2 revenues this year to be even higher. A very important key performance index measurement that we want to look at is how fast we can get hospitals online. Once the hospital comes online because each patient is such high revenue with multiple treatments, it only takes a handful of patients in each hospital to drive meaningful revenue, but not that many centers needed. If you look at 2025, we had about 5 active centers for the bulk of the year, adding a few more in December. What we've seen now is as of exiting the year with 8 active centers we last announced in mid-May, that we had 16 active cancer centers using the technology commercially and paying for the device with 32 additional centers in the pipeline. When I say in the pipeline, these are in the various stages of evaluation of the product to bring it on the shelf, having some of those approved already and onboarding and looking for their first patient, giving us a total of 48 total centers that are either using the product right now or actively pursuing use of the product this year, which almost quadruples what we had just over a year ago. Now we do expect some near-term variability with a handful of customers that seems to be smoothing out with this nice upward shift in revenue as we have more of these centers coming on board. So in addition to looking at our revenue growth over the year, it's important to keep track of how many active centers we have going as this really is a great predictor for future revenue, 1, 2, 3, 4 quarters down the road. The other major inflection point we anticipate this year is we are, as I mentioned, wrapping up our Phase III trial with 15 active centers using the same technology specifically for pancreatic cancer. And of those, we've already started to transition them to be commercial users, treating the patients with the device commercially and paying for the product. And once they finish completion -- or once we complete enrollment in the next few weeks here, or a couple of weeks, we anticipate that these centers, many of these will transition by the end of the year, adding to those additional 48 centers we're looking at to really drive meaningful revenue later this year and into 2027. As far as the pipeline goes, I mentioned a few areas of interest from physicians. Specifically, we have announced publicly that there are 2 investigator-initiated trials that we have greenlit and are in the final processes of launching this year. One is specifically in gemcitabine, where we are looking at borderline pancreatic cancer and also metastatic pancreatic cancer. So this expands beyond what we've been studying in the Phase III Tiger PAC trial in just LAPC or locally advanced pancreatic cancer. We do have orphan drug designation in these indications. And then beyond that, we are launching a what's called a metastatic cancer study. using a different drug locally to show that this is a platform play we can use almost any agent or multiple drugs to do the device. So as new drugs come on the market, we can actually expand partnerships or usage both commercially and on the clinical research partnership side. So outside the commercial opportunity, I'd like to switch gears and talk about the other asset in the company. As this is a dual-pronged approach with both a commercial asset that's launched recently that should drive us towards breakeven cash flow and also a Phase III asset, late stage that we're wrapping up the clinical trial right now for TigerPAC trial. To put this in context, let's look at what the current standard of care is in pancreatic cancer. As I mentioned earlier, we're looking for weeks to months of survival benefit. And so far, we've only seen several weeks of benefit in large randomized studies. The most recent advancement we saw in 2013 of an approved product was the addition of Abraxane to gemcitabine showing just a 7-week survival benefit, so a very narrow window of separation and survival curves with a higher level of toxicity. So you don't have the benefit of both. You have that trade-off. Patients live a few weeks longer, but they're sick for months during the entire treatment paradigm. In pulling physicians, they said, look, if you can give me 4 months -- 3 to 4 months of a survival improvement with increased quality of life -- this is something that's a game changer that will cause me to send almost all of my patients to the therapy. I'm not going to go to trial design too much in depth, but just very high level, the Phase III trial is for treatment-naive patients were going to have upfront chemotherapy plus radiation and then randomized head-to-head against systemic chemotherapy, standard of care, gemcitabine plus Abraxane for 4 months versus our TAMP therapy using gemcitabine with Renovo cap for 4 months. and then continue for survival. Where we sit today in the trial, we've surpassed the first and second interim analysis with the data monitoring committee saying go ahead, proceed given how strong the data may be looking so far. -- and now we're on to our final analysis late next year as we anticipate completion of enrollment in days to weeks from now. Just to touch on the numbers here, we anticipate randomizing a total of 114 patients and we need 86 events or deaths to do the final analysis, which we expect mid- to late next year. From a data perspective, we did have the opportunity, given the early look, we had the first interim analysis was presented as a late breaker at ESMO GI in 2023 and that was a 30% look at the data, given that we skip straight from a Phase I to a Phase III trial, we did demonstrate a 6-month survival increase with our treatment of TAMP given the Renova cat with gemcitabine versus standard of care gemcitabine plus Abraxane. So where we expect patients to live 15 or 16 months, our patients were pushing 2 years of survival trending towards a significant survival benefit. And the great part about this, as I mentioned, if you look at the flip side of it, there's not a payoff on the quality of life size. We actually saw an addition of potential survival benefit we saw a significant reduction in side effects and toxicities nearly 65% across the board, which is not surprising given that we're driving local concentration and reducing systemic therapy. And this data right here is really what's been driving the interest in our technology from physicians in advance of final randomized data, there's the interest of using your platform across the board because we're seeing such a better level of toxicity profiles in a space where beating up patients with chemotherapies is considered the standard of care. Beyond the Phase III Tiger Pack trial, as I mentioned, we are driving efforts on outside of Phase III trials, looking at investigator initiated trials or registry studies using the commercially available product where we can drive both data and presentations and looking at spending indications. And it's important to note that these physicians and the hospitals are paying for the technology, and we can recognize this revenue in the process of doing these studies. So to round out the clinical trial, I'd like to wrap this up with kind of high level where we are in terms of finance. So I'll turn it back over to Mark.

So Sean touched on earlier. We had a very strong Q1 as far as revenues, $563,000 in revenue, a 136% increase over Q4 -- we had guided to our sequential growth in Q2 over our Q1 results. We're well capitalized. We ended Q1 with $12.4 million in cash. We have a very strong outlook for the rest of the year. We're targeting 36 active commercial sites at the end of the year during our call. We announced we had 16 active sites that signed up another 32 that are in the pipeline. As a result of that, we feel confident in our revenue range for the year of $3 million to $4 million in revenue for the year.

Thank you, Mark. These slides, of course, on our website, so I'll skip through quickly. But as I mentioned, we have a strong management team, both on the management side and on the board with depth of experience both in medical devices and on the biotech side and also taking new therapies through clinical trial development and into deep commercialization. On the board side as well, 1 of our most recent Board members added was Dr. Bob Spiegel, who was the Chief Medical Officer of SharingCloud, and is helping further drive advancement of our technology into other areas using more cost-effective clinical trials beyond the Phase III. And we have assembled and also a team of luminaries in the field on different specialties that treat these types of tumors. -- everything from surgical oncologists to medical oncologists, including Dr. Margaret Tempero who is the Chief of the NCCN guideline committee who writes a guidelines on pancreatic cancer and the radiation oncology as well. And then we've recently also assembled a team more to look at the commercial potential of the Renova CAT device in an interventional radiology space at luminaries in the field as well on that side. Lastly, just upcoming milestones. As you've seen, we're not a quiet company. We do have a lot of news flow that shows the shareholder value that we're building. As we're wrapping up the Phase III trial enrollment, we do have initial data coming some coming out of the induction and radiation parts of the Phase III trial. We did recently present the PK data showing reduction in systemic toxicities that will be in full publication later this year. Beyond that, we will give progress updates on the investigator-initiative trials, where the Novacap is being used commercially to show data in other areas beyond pancreatic cancer and then, of course, how we're doing in terms of safety information across a broader range of solid tumors. One other notable is that we were named to the Fast Times the Fast Company's annual list of the world's most innovative companies in 2026, which is a big achievement, which goes to really where this can make a major impact on medicine. Lastly, I'd like to leave you with a little bit on what we're doing for patients. So this has always been key to our mission with everyone employed at RenovoRx where we're seeing patients really potentially benefiting from this therapy. -- in the Investors section of our website, if you go to news and clinical news, there are several stories that have been on various news channels of patients who have been treated with the TAM therapy or the Renova cap demonstrating the quality of life potential improvements and the hope for continued survival. And I come back to the point of this is the technology that's actually may be benefiting patients across both spectrums. We can extend life potentially and also making a life with living by reducing those toxicities that you normally see with chemotherapy. At the same time, we're driving a highly profitable commercial business on our way there in the not-too-distant future. Thank you so much for your time. And at this point, we'll open for questions.

[Operator Instructions]

Okay. So the first question comes what are the primary drivers behind your confidence in achieving the company's 2026 revenue guidance of $3 million to $4 million. Mark, would you like to take that one?

Sure. It's SP-4 The number of active cancer segments is really going to drive revenue. We targeted 36 for the year. As we mentioned on our call, we -- our Q1 conference call, we're at 16%. We have another 32 in the pipeline. We feel that most, if not all of those will come out, convert to active centers by the end of the year. So we feel very confident in our guidance that $3 million or $4 million is a realistic goal for the company.

There's a bunch here, so I'll pick a few of them, and then we'll come to the rest with post follow-ups. So Mark, 1 of the questions is does the $12 million in the bank get you to breakeven? Do you want to take that one?