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

Good day, and welcome to the iAccess Alpha Virtual Best Ideas Fall Investment Conference 2025. The next presenting company is RenovoRx. [Operator Instructions] I'd now like to turn the floor over to today's host, Shaun Bagai, Chief Executive Officer with RenovoRx. Sir, the floor is yours.

Thank you so much for the introduction, and I appreciate those calling in and those listening to the recording afterwards. My name is Shaun Bagai, CEO of RenovoRx, and happy to share our bilateral story with you, both on how we're advancing medicine in a late-stage Phase III trial and also with recent commercial efforts. Our forward-looking statements, cautionary statements are here and also available online. And just to give you kind of a high-level overview, my background has been in medical technology in my whole career with the goal of really trying to advance medicine and medical care and developing innovative new technologies and therapies. And here at RenovoRx, we found a way to do just that. If you think about cancer care today, the biggest issue is you keep battling how much toxicity we give to patients while trying to actually tackle the tumor. And we've discovered, patented and recently commercialized and also in a late-stage Phase III trial have discovered a mechanism of action to really try to balance both of those in a way we've never seen before. Most recently, we've initiated commercialization of our FDA-cleared RenovoCath device. This began earlier this year with revenues in the first half exceeding our expectations, currently with no sales force in place as we start to grow a very small lean commercial organization. Based on customer demand and reimbursement dynamics, this has driven our decision to take this pathway and our initial growth. We've reported out publicly that we have 13 cancer centers for medical institutions approved to purchase the device with 4 of these centers repeat purchasing and treating patients and over 20 additional customers in the pipeline. As a RenovoCath stand-alone device, we're pursuing a $400 million initial market opportunity in spaces where we've seen the catheter use so far with potential to grow this exponentially in the coming years. In parallel to this commercial effort for the device, we're developing combination therapies based on what we call Trans-Arterial Micro-Perfusion, and I'll go into more detail on how that platform works. In parallel to the commercial effort with this combination therapy, we are advancing our Phase III trial. The TIGeR-PaC Phase III trial is well underway and nearing enrollment completion, specifically for the treatment of locally advanced pancreatic cancer. And our team is well pivoted to be able to explore both of these commercial and clinical opportunities and take us into commercialization and really being able to treat patients at a high level. So let's start on how the TAMP platform works or what we call Trans-Arterial Micro-Perfusion. To dive into the physiology and science a little bit, it's important to keep in mind how different tumors behave, and that's what we tackled as a large unmet need. There are many tumors in the body considered hypervascular, and that means they have large blood supplies or in this case, if you look inside the body, they have large blood vessels or tumor feeders that actually feed the tumors and end at the tumor. What this serves is for systemic chemotherapy, if you see the little green dots, systemic chemotherapy can easily reach the tumors because you give it systemically and the blood circulation takes it into the tumor directly. This also serves as a target for local therapy. Under x-ray guidance, a radiologist can position a catheter inside the tumor feeder and deliver drugs directly into the tumor. Unfortunately, there are many tumors in the body that don't have this type of anatomy. We call these hypovascular tumors or tumors with less blood supply. In this case, the panel on the right is an example of a pancreatic tumor where there's blood flow circulating the entire body, but very little gets to the tumor because they're not large direct connections to the blood supply. Not having the circulation connection, very little chemotherapy gets in, rendering these tumors relatively chemo-resistant, which is why the death rates are so high for these patients. We found a way to tackle and overcome this by forcing drug into the tissue itself. The way this procedure is done is via a very small incision in the leg artery, we insert our RenovoCath inside the artery and using x-ray fluoroscopic guidance, a physician can position the RenovoCath adjacent to the tumor. And then via the proprietary mechanism of our RenovoCath device, they can position 2 balloons next to the tumor such that you exclude any side branches or escape routes for chemotherapy. Once they've confirmed isolation, they blow up the balloons and then administer a full dose of therapy over 20 minutes. And what happens is that full dose, for example, in clinical trials, it's 120 milliliters of fluid in that small space between the balloons, which is roughly 1 to 2 milliliters in volume, it creates a pressure head overcoming the space and forcing the drugs or the agents across the vessel wall into the tissue. So what we see is pressures, not high pressures, but high enough to get across the vessel wall without damaging it, that push the drug in the tissue to saturate and invade the tumors in therapy, which creates a very local high drug concentration. Specifically, in animal studies, we've seen, and this was a lung study to demonstrate the potential to take this in lung cancers that you take punch biopsies and we looked at gemcitabine in this case, and we found -- this is a logarithm scale, we found 100x tissue increase in concentration at the tumor site than you would if you gave systemic therapy, which is not surprising because we're pushing such a high volume of drug in the tissue. On the converse, what happens systemically? The panel on the right is preliminary data within our human Phase III TIGeR-PaC clinical trial, looking at systemic gemcitabine levels. And what we've demonstrated is we see a roughly 50% decrease in floating gemcitabine. So you see less exposure systemically to the patients, which is the opposite of the current paradigm in taking care of these patients. This would, of course, expected to reduce toxicities to patients, giving them a much better potential quality of life. Specifically, from a patient experience, the patients have this treatment every 2 weeks. So in the clinical trial so far, it's up to 8 treatments over 4 months, which is comparable to current standard of care systemic chemotherapy, which is generally a weekly treatment or 3 weeks on and 1 week off. So it's less hospital visits. Also, the procedure itself only takes about 90 minutes, which is different than doing with medical technology that sometimes take hours in the cath lab or the operating room with an overnight stay. In our case, with RenovoCath, they're discharged the same day as an outpatient. The infusion itself is about roughly 20 minutes. The other key important factor from a patient experience standpoint is that patients are not put under general anesthesia. So they don't get fully knocked out. It's only conscious sedation and they're able to go home the same day. From a physician standpoint, it's easier to learn from physicians and a relatively quick procedure for interventional radiologists and oncologists. From a proctoring standpoint, we have a physician proctor there for the first handful of cases, maybe 2 to 4 cases per physician training, and then they're free to go on their own. So it's not a complex procedure like neuro medical technologies that require a big field force to train the physicians. So it's relatively easy for physicians to adopt because these radiologists are used to doing analogous procedures in the liver space. If you recall that panel on the left from the previous slides, they can place a small microcatheter in liver tumors, which is current standard of care, and we're trying to change the paradigm for other tumors like the hypovascular tumors. Our experience to date in our clinical trials has been primarily in locally advanced pancreatic cancer or LAPC. But from a market expansion standpoint, if you look at a pipeline potential, looking where gemcitabine has been used, which is the backbone of our drug and the drug device combination, this could easily be used in CCA or cholangiocarcinoma, non-small cell lung cancer. As I mentioned, we had a proof of concept in the animal studies down the road, potentially with glioblastoma. Sarcomas and uterine tumors are other areas that are relatively hypovascular that could really be helped by this technology and this therapy mechanism. So let's flip from the science to commercial opportunity. As I mentioned, we commercialized the FDA-cleared RenovoCath device earlier this year. And looking at the market opportunity here, while we haven't publicly stated the exact ASP for our device, using the same reimbursement coding, analogous companies are charging between $6,000 to $8,500 per device. As a reminder, each of our patients receive between 5 and even 10 or more treatments per patient. It's up to 8 in the clinical trials. If you look at 8 treatments per patient at this 8,000 potential ASP, if you look at where we've seen physicians uses in patients to date, we anticipate a $400 million annual peak U.S. addressable market just in this space, just for this type of combination. And this is the device reimbursement potential and the device sales potential. From a patent perspective, as much as it's a catheter-based balloon system, this is well protected. We have over 19 total issued patents worldwide, 9 in the U.S. and additional 12 patents pending. As we discover further the mechanism of action here, we continue to file new patents around how we do this in order to protect the space. So we're well protected on the patent side as well. Now what's interesting about RenovoRx that's different than many companies entering the commercial realm is we don't have a high burn. Our burn to date has been relatively modest, and we don't need to hire a large sales force to tackle this market, unlike many new medical technologies. My background has been primarily in market development, clinical research and sales, and I've seen where you need many feet on the ground to be able to tackle large markets like this. This is not the case with RenovoCath technology. If you look at pancreatic cancer as an analog or an example, most of these patients that have non-metastatic disease are driven to high-volume surgical centers and academic institutions that see the bulk of the patients. Specifically in pancreatic cancer, as an example, less than 200 hospitals treat the vast majority of pancreatic cancer patients that don't have metastases to see if they can be surgically resectable. So with a very small sales force of even 3 to 5 sales reps, we anticipate we can tackle the bulk of these large academic institutions to be able to drive sales of RenovoCath. To date, as I mentioned, we've got 13 centers that are approved to purchase the device with initial 4 treating patients. With that small number of hospitals, we've driven over $600,000 in revenue in the first half of this year without a sales force in place. With that, I've recently hired a new head of sales and sales rep who's hired a couple more reps, regionally placed to tackle the bulk of these high-volume centers. So with a lean high-impact team, we can really drive massive growth in revenue in 2026 as we build this out this year. So let's switch gears from the commercial efforts of RenovoCath to the other half of the business, which is our drug device combination that's in a pivotal Phase III TIGeR-PaC study. To put this in context, when we look at locally advanced pancreatic cancer, which is the target for the study, the general thought process here is we're trying to give patients as long as they can to survive. And what's been successful in the GI oncology space, unfortunately, is only weeks of survival. If you look at the last major development in pancreatic cancer, the addition of Abraxane to gemcitabine going from a single agent to a double agent systemically gave only 7 weeks of a survival benefit. And I'm not on video. You can't see my air quotes, but I say benefit because that comes with a lot of toxicities. So as much as they're living almost 2 months longer, we're beating them up for months until their demise, unfortunately. So the biggest issue with current standard of care is we're really not treating patients well by balancing the toxicities and side effects that they go through to gain only a few weeks of survival. When polling medical oncologists on what's important for them in terms of survival, they said, look, if you can give me 3 to 4 months of survival, anything over 2 months is the standard or norm of change in practice patterns, we'd be very happy to send the bulk of our patients for this therapy. So the bar is very low in locally advanced pancreatic cancer to really drive deep market penetration with the combination, based on this initial data. So to go into a Phase III trial design, we are treating treatment-naive locally advanced pancreatic cancer patients. Again, these are patients that are not surgically resectable and not yet metastatic. Once they're diagnosed, this is first-line therapy because we have a very prescriptive induction phase where they get upfront systemic therapy of gemcitabine plus Abraxane systemically. It's 3 months of gemcitabine plus Abraxane. We sandwich in SBRT radiation. And after this induction phase, if they're still locally advanced, stable and not metastatic, we then randomize them to 2 arms. So this is a prospective control randomized trial. The control group receives IV gemcitabine plus Abraxane continuing for another 4 months, which is standard of care. And then we randomize to our test arm. The treatment group receives Trans-Arterial Micro-Perfusion, which is a combination of the RenovoCath device plus gemcitabine. This is given every other week over 4 months for 8 total treatments. And after this 4-month randomization phase, they go into continuation therapy until disease progression. Then we follow for survival as our primary endpoint. And if you think about the world of clinical trials today, it's not super common that you see survival as a primary endpoint. So we're really trying to prove out survival and again, balance the systemic toxicities. From a trial design standpoint, we anticipate randomizing a total of 114 patients, 57 in each arm. From an analysis standpoint, we've passed both of the first 2 interim analyses. The first interim analysis was conducted very early. It was a 30% look upon the 26th death, at which time we had 45 patients randomized. At that point, given how early the trial was and given that we jumped straight from a Phase I/II trial to a Phase III trial, we were able to share results, which I'll share with you here in a moment. And the second interim analysis was triggered on the 52nd event or death, which occurred in the second quarter of this year, and with a data monitoring committee report out on the second interim analysis with a positive opinion on moving forward with the trial to completion that occurred earlier this year. And the final analysis will be conducted upon the 86th event or death, which we anticipate late next year in 2026. From an enrollment status standpoint, we anticipate completion of enrollment by the end of this year or early next year as we're marching towards finishing off this trial. I mentioned that we were able to share early data, and this is the interim analysis at the 30% look. And as a reminder, if you remember that survival curve of gemcitabine versus gemcitabine plus Abraxane, there's a very small window of benefit between the 2 curves, almost they were touching in the middle. And what we see here from the Phase III trial and the interim analysis is not just a small separation, but a 6-month survival benefit. The control arm of systemic gemcitabine plus Abraxane lived for about 15.5 months, with our treatment group 21.5 months. So we see a large separation where patients are living not weeks, but several months longer after treatment. But it's also interesting to note that these patients have not only received a benefit of longer survival, but also the flip side of that is toxicity profile. Usually, these bars are flipped. Generally, with more survival, you see more toxicity. In our case, with the Trans-Arterial Micro-Perfusion approach, giving gemcitabine locally via the RenovoCath, we're seeing a 65% reduction in adverse events, so less systemic toxicities. These patients don't look and feel like normal chemo patients. It's great to see these patients actually thriving for the most part and almost going back to normal daily lives. Again, this is very different for a new therapy to not just show a potential survival benefit, but seeing a massive reduction in toxicity and these patients have the opportunity of having a higher quality of life. From a management team perspective, I touched on this in the beginning, we've got a very experienced team that is highly versed on both pharmaceuticals and medical devices and taking drugs and devices through development into commercialization. On the Board, it's the same thing. Drug device experience and combination experience, also taking drugs and drug device combinations through clinical development late into commercialization efforts. On an advisory board standpoint, we've got luminaries in the field, including medical oncologists, Dr. Mike Pishvaian at Johns Hopkins, who's the Head of our TIGeR-PaC study. More recently, we added Dr. Margaret Tempero, who is the Chair of the NCCN Guideline Committee who writes the guidelines on treatment of locally advanced pancreatic cancer; Dr. Karyn Goodman, who's very experienced in medical oncology, specifically in radiation oncology, and a more recent addition of Dr. Michel Ducreux, who's internationally renowned for -- as an oncologist, but also focusing on localized treatments and is helping drive the next steps and stages for drug device combination platforms. We have a lot of upcoming milestones to look forward to for investors. As I mentioned, we had over $600,000 revenue as of the first half of the year. We did pass the second interim analysis with positive feedback from the Data Monitoring Committee on recommending continuation of the TIGeR-PaC study, which gives us as a management team confidence that we will have a successful outcome. What's coming next for the TIGeR-PaC trial? I did touch on interim data of the PK sub-study. Again, this is looking at systemic levels of gemcitabine in the body of systemic chemotherapy versus our local TAMP mechanism. And we have finished -- completed the sub-study, and we anticipate publication of that data sometime in the next couple of quarters. We do anticipate completion of trial enrollment of the TIGeR-PaC trial in the coming quarters as well. And this marks a couple of important milestones, obviously, important for the Phase III study completion, but also to date, we have been selling devices to these clinical trial sites, but not recognizing the revenue. The revenue from the TIGeR-PaC trial has really been going as an R&D offset. And once these TIGeR-PaC sites are done with enrollment, they're already trained on the device. They're already purchasing the device. They already have the referral patterns set up. I've got 16 centers that could be primed for commercialization to help with our commercial ramp next year. Final data in the TIGeR-PaC trial, the final event is estimated towards the end of next year. And then along the way, I haven't mentioned this yet, but we've launched the PanTheR Post-Market Device Registry Study, where physicians can use the RenovoCath commercially, purchase the products and then collect data on these patients across many indications, which can show the potential pipeline expansion as they start using the catheter in different areas in the body with different drugs. So as we progress through the PanTheR Study, we'll be able to report out on progress and clinical data based on how that goes and also potential for expansion of use of the RenovoCath to study the device in different settings. Just to touch on the financing. We did raise a high-quality $12 million deal, a straight common deal earlier this year with brand name institutions that are fundamental long holders. We finished quarter 2 with $12.3 million of cash in the bank. This takes us well into late next year, the second half of 2026. Our burn currently is about $850,000 a year. So you've seen we've remained frugal to keep the cash burn low. And even with the addition of a couple of sales reps, it doesn't drastically increase the burn. As I mentioned, the initial available market for the RenovoCath is estimated at $400 million for the RenovoCath as a stand-alone device. On the tails of that, we can look in the drug device combination and J-code reimbursement with the combination at the completion of the TIGeR-PaC Phase III study. So multiple opportunities for revenue here and partnerships in the future. I appreciate your time, and thank you very much for joining and happy to open up to questions.

Give me a moment here while I pull out the questions. So a question from investor. I appreciate the awareness your team is spreading for this device. As of today, which are multiple indications, including current LAPC do you think have some hard probability of being used for this device, which this company can actively pursue for clinical trials? And also, will the future trials be sped up if it TIGeR-PaC is FDA approved as a new standard of care for LAPC? Thank you for the question. So currently, there's been a lot of interest for the device, obviously, in the locally advanced pancreatic cancer space. Beyond that, there's interest of expanding into other parts of pancreatic cancer. For example, a lot of surgeons are interested in using this in the neoadjuvant setting where they give therapy locally with RenovoCath before giving surgery. Currently, we've been studying in locally advanced nonresectable and also for metastatic pancreatic cancer. There's a notion that local control can be beneficial to patients so they can possibly give therapy locally to the tumor and then also give systemic chemotherapy concurrently. We do anticipate both of these areas being studied within our PanTheR Registry or investigator-initiated trials, and this will also help the commercial effort. Based on data from that initial cases, we could go after drug device combination approvals with additional clinical trials, and we may not need large, randomized trials if and when TIGeR-PaC is successful. Based on that, we could possibly design single-arm studies or even use registry data for further approvals. Again, the beauty of the device side of things is the catheter is broadly labeled. So physicians can today use this commercially in any of these settings that I mentioned. Beyond pancreatic cancer, there has been interest in cholangiocarcinoma or bile duct cancer as it has a very similar anatomy. And then non-small lung cancer, I'd say, is probably the #3 or #4 approach as well. Just reading into the questions here. What metrics are you using to gauge early commercial traction for RenovoCath, and how do you see the order rates trending? Thank you for the question. This is actually very important because not having a sales team in place yet, we can't just look at revenue numbers. As I mentioned, $600,000 from 4 centers, that number can go up or down very easily. If one patient can equal $30,000, $40,000, $50,000, $60,000 per patient, one patient can move the needle. So what I'd like to look at for metrics for this year is really how do we take those 13 centers that have the device approved to start treating beyond the 4? So we have 9 centers that are ready to go looking for their first patient. So I'd look at number of centers that are approved to get the device on the shelf. I'd start looking at number of centers that are starting to treat patients and trying to treat more than one patient at a time. Beyond that, how many centers we have in the pipeline, we've engaged both on a single physician, i.e., a radiologist or a surgeon and a multidisciplinary level. So those are really the 4 big metrics we look at in terms of getting new customers on board. The other important metric that we need to look at is how many patients will each hospital do per month or per year. Our revenue stream looks very different if they're treating maybe 1 or 2 patients per year versus 1 or 2 patients per month. So I'd say in the coming quarters, we'll look closely and we'll report out on some of these metrics will help give us a sense of what 2026 revenue could look like. Next question is, with gross margins already in the mid-60s, what is the path to sustaining or expanding margins as volumes scale? So if we actually look at actual COGS or cost of goods and margins directly on the manufacturing costs, I reported out that most medical devices in this stage of the company are more in the 70 to 90 range. And as we start scaling manufacturing, we start pushing closer to 90 or beyond. So I'd say we're already well beyond the mid-60s. I appreciate the question because that's an important point to note. Next question is, how do you balance near-term catheter commercialization with preserving cash to see TIGeR-PaC through to completion? This is a very good question. I appreciate this. So we are doing this by a very focused sales effort. As I mentioned, many companies would start raising a lot of capital, hire a bunch of reps and try to drive market and get stocking orders. We're doing this more from a market development approach. Let's go deep versus too wide. So hiring a handful of sales reps, even starting with 1 to 2 to 3 can really scale us from that $600,000 of revenue in the first half to really pushing this forward next year without increasing burn. Putting 3 reps on the team would increase our burn by more than $1 million to $2 million for the calendar year. So this can drive us closer to breakeven as we start driving to complete the TIGeR-PaC trial. So we are balancing this and threading the needle very well by not over-hiring or overspending to ensure we have successful commercial efforts. Reading next question here. Are there any plans to partner or sell this technology to another party? I know that Boston Scientific is a very large shareholder and would like to hear if they're interested in investing more funds in the future or taking equity stake moving forward. I appreciate the question. This is an important point. Boston Scientific invested or led our Series B funding, which was our last funding before going public. As a company, their policy has generally been not to invest in public companies, yet we keep in close communication with them because this could fit very nicely in their bag. As many of you know, after their investment in us, they acquired BTG for about $4 billion back in 2018, which now serves as their Interventional Oncology business unit. So this actually fits nicely in their bag, and they have several competitors in the interventional oncology space that we've been in conversations with as well. So we are in constant discussions with possible medical device partners to either partner to scale our commercial efforts without raising large capital later next year or a potential acquisition down the road. So there is strong interest. There is good partnership and feedback from them already, and we'll continue that dialog and decide if we want to continue to be a medical device and/or medical device, drug device combination company as a stand-alone or this might fit better with a great exit for our investors and another bag. A few analogous companies to look at that are going on their own are TriSalus, Delcath and Novocure. These 3 companies in this order have market caps in the $200 million, the $0.5 billion and the several billion. And they have -- TriSalus has a catheter in the liver space for sale. Delcath has a drug device combination with specific indication and J-code reimbursement akin to our drug device combination in the Phase III TIGeR-PaC trial. And then also Novocure is a stand-alone device company. So this -- we have 3 analogs of what this could look like in terms of future valuation as a stand-alone company. And as I mentioned, this is a very attractive fit in other bags as well. So we'll keep those dialogs alive and report out as they come along. I think I have time for one more quick question. Do you envision the FDA engaging on an accelerated approval pathway based on survival or safety signals from TIGeR-PaC? At this stage in the game, we're so close to the end, I believe the FDA is going to want to see the entire data set. What we would push for is a faster review time line. So upon the completion of the data, we would push for a quick review to get to potential commercialization of the drug device combination. One last quick question. You mentioned that 13 centers are approved and 4 are treating patients. When will the other 9 start to treat patients? And how many centers do you think will be approved by the end of the year? How many will be treating patients? Any comment on how many centers could be treating by the end of 2026? We haven't guided to those numbers yet. As I mentioned, the 13 of those, the 9, I hope to start treating patients in the coming quarters. We anticipate ending the year somewhere around that 13 to 20 mark. And then as far as 2026 goes, as I mentioned, we've got another 16 centers in the TIGeR-PaC trial on the heels of this. So exiting 2026 with somewhere between a minimum of 20 to 30 to 40 customers and beyond is highly possible. I do have a couple more questions. So feel free to reach out directly to us or by KCSA and happy to answer them. Thank you again so much for the questions. These helped drive the conversation. Thank you for your time and joining in, and have a great day.

Thank you. This concludes RenovoRx's presentation. You may now disconnect, and please consult the conference agenda for the next presenting company.