Hey, thank you, Jim. I'm Scott Henry, healthcare analyst at Alliance Global Partners. We'll get started momentarily with RenovoRx. I just wanna make sure they're in the system. Shaun is. So our next fireside chat is with RenovoRx, ticker RNXT. Market cap, approximately $35 million. RenovoRx is an interventional oncology company with a late-stage product in development. We cover the company here at Alliance Global Partners with a buy rating and a price target of $3.50 per share, trades around $1.40. Presenting for the company is Chief Executive Officer, Shaun Bagai. Shaun, would you like to take a couple minutes to tell our audience a bit about yourself and RenovoRx?
Well, thank you, AGP, for hosting, and Scott, thanks for the introduction. My name is Shaun Bagai. I'm the CEO of RenovoRx, and we're a company focused on tackling cancer in a very different way. When we think about cancer, cancer patients, and unfortunately, a lot of our loved ones, and when they're diagnosed with cancer, we go straight to pretty much systemic chemotherapy, which the goal is to poison the body, hoping that some of that poison gets to the tumor and killing the tumor before we do the patient. We found a different mechanism. We found that a lot of drugs work in different cancers, like pancreatic cancer, and specifically in pancreatic cancer, one of the biggest issues is getting tumor penetration.
But the therapeutic window is very small for these types of treatments, and we've now got proof of concept in the data of our own phase III trial in a positive interim analysis result, that showing if we can localize chemotherapy to pancreatic tumors and other tumors, not only will patients live longer, but they'll actually have almost back to normal daily lives. I'd love to dive more into that with you, Scott, but appreciate the introduction.
Okay, great. Thank you for that background, Shaun. You know, we had a lot of companies to choose from for these fireside chats. The reason we picked RenovoRx is because it has such a late-stage compound, a proven molecule. And therefore, we think that the lower risk profile with late stage is a good combination in the current environment. So we'll dip into Q&A. To get us started, could you tell us a little bit about the RenovoCath system, how it works? And I think you might have a video as well.
Absolutely. Thanks, Scott. Can you see my screen okay?
I can.
Great, so just to take a step back and looking at... I alluded to this. Standard of care right now is systemic chemotherapy, which does work for some tumors, like liver tumors, for example. A lot of liver tumors and other vascularized tumors have a large blood supply that feeds the tumor. Here you can see a dedicated blood vessel that feeds the tumor directly, so giving systemic therapy gets there, and there's also a local target. Unfortunately, there are many tumors in the body that don't have this direct connection to the blood supply, i.e., pancreatic cancer tumors. So here you can see there's not a large blood feeder. Very little chemotherapy actually gets to the tumor itself. The tumors grow slowly, they die on the inside, and this poses a chemo resistance problem.
Our therapy mechanism is called TAMP, or trans-arterial microperfusion, and it's a delivery mechanism where a physician or radiologist places our delivery system adjacent to the tumor, and using a proprietary mechanism, they change the distance between the balloons, with the goal of isolating a segment of artery next to the tumor, and they give a full systemic dose and volume of therapy or chemotherapy in that small space over 20 minutes, creating a pressure head that forces the drug through the vessel wall into the tissue. We're not relying on nonexistent tumor feeders to feed these tumors. What we're doing is really bathing and saturating the chemotherapy into the tumor directly. What we're seeing with this is about a 100-fold increase in tissue concentration without the massive systemic exposure.
So that's the crux of the whole therapy platform in tackling these types of tumors, and we've had great results so far.
Okay, great, Shaun. That's a great video, really helpful for investors on the line. Now, obviously, with an oncology treatment, we're going to look at survival data, but when we're talking about local delivery, can you just talk a little bit about the patient experience on your product versus traditional chemotherapy to get a feel for what really separates it, in addition to the strong clinical data?
Yes, Scott, I'm glad you asked the question because it's something that's often overlooked in cancer therapy. We get so hyper-focused on trying to kill the tumor, we don't account for the collateral damage of what happens to the patients and the patients' families. What we're seeing on this therapy, because we're localizing chemotherapy, and we've shown this in our current phase III clinical trial with a subset of a PK study, we've shown a greater than 50% reduction in systemic gemcitabine, so we're not seeing the same side effects. In fact, just to touch on it, this is data that came out last year in the interim analysis. We actually saw a reduction of side effects with our therapy.
There was over a 65% reduction, and this is very rare to have a new cancer therapy that shows an extension of life. Usually, the trade-off is you have to also have an higher toxicities and higher adverse events. Almost across the board, we saw a reduction of side effects and adverse events. And how does this trend to the patients? Patients don't feel like- look like normal chemo patients. They're gaining weight. They're eating. A lot of our patients and are in, across the board of clinical trials, are almost returning back to normal daily life, which is rare for a new therapeutic that looks like it's actually having an extension of survival benefit as well.
Okay, that's great, Shaun, and that's the trend we see, is an increased focus on quality of life in addition to just duration. But obviously, step one is getting this product approved at the FDA, and the pivotal trial is the TIGeR-PaC. Can you tell us a little bit about that trial and why you're optimistic for positive results?
Absolutely. So just to give you a sense of what the trial looks like, it's, it's a very robust, randomized study. We're now well into the... This is a phase III trial. This is capturing patients that have non-metastatic pancreatic cancer, where local disease control can have a massive benefit for the patients. So we're capturing treatment-naive, locally advanced pancreatic cancer patients. They get a small window of upfront systemic chemotherapy and radiation therapy, and this is really to test, to make sure we're testing in a true, locally advanced, non-metastatic population. Once they go through the induction phase, they get randomized to continuation standard of care, systemic chemo, versus our localized therapy that we call RenovoGem, by the TAMP mechanism, which is 8 treatments over 4 months. So instead of weekly hospital visits to an infusion chair, they come in every other week.
It's an outpatient procedure. They're not under general anesthesia, so it's relatively simple for the patients, and then we follow for survival. So this is the crux of our randomized phase III trial design called the TIGeR-PaC, and we expect the next interim analysis of this out later this year, early next year.
Okay. Thank you, Shaun. You did conduct the first interim analysis. Can you tell me your thoughts on that and how we should think about the next one because of what we learned the first time around?
Yeah, it's the first one really substantiated our early pre-phase III data, which the totality of which is, and this is public information, will be published later this year. What we saw here was a 6-month separation in survival curves, which is phenomenal. So in a 45-patient randomized, the first 45 patients randomized in the trial that had adverse or events or deaths, we track based on the number of events. At the 26th death, this interim analysis was performed and uncovered, and the standard of care arm of gemcitabine plus Abraxane lived 15.5 months since diagnosis, which is what we expect. So the trial is performing like we expect, based on the historical data, and our patients were pushing 2 years.
On an intention to treat basis, we're seeing a 21.5-month survival from this patient population, which is great to tell a patient that they've got pancreatic cancer, and it's not a matter of you're gonna die in 12-15, 18 months, but there's actually a greater than 50% chance that you're gonna go well beyond that 12 months and potentially into 2 years.
Okay, great. And, I know what I liked about the TIGeR-PaC as well, is it's an active control arm, so it really gives you a good sense of how it's working versus standard of care. So with regards to the TIGeR-PaC trial, you know, what are the risks? What keeps you up at night? I mean, obviously, any trial can has a degree of variability. You know, what are some of the levers that you think about with regards to this one?
You know, it's, as you mentioned, any trial has a risk. We've seen a lot of... In pancreatic cancer specifically, we've seen a lot of great mice data or phase I data that didn't translate to successful phase II or phase III trials. What actually gives me confidence is that risk doesn't seem as high here because we know the mechanism. Gemcitabine has been around for decades. We know it kills pancreatic tumor cells. The biggest issue is delivery. So the fact that we can deliver high doses of concentration to the tumor, we all strongly believe this would work. What's great about this interim data is it gives us even more confidence that this is working in a randomized, robust setting. So really, the risks I see are, did we get a false positive signal?
I don't think so, given what we've seen in terms of all three trials that have been going on. And then it's just a matter of finishing the trial out. We anticipate second interim analysis towards the end of this year and completion of enrollment mid-next year. We're well on the pathway there with new sites coming on board as well. There was always... The biggest risk I always saw before was finance risk. Can we actually finish this next interim, get enrollment done? And then we resolved for that earlier this year. As you know, we raised $17.2 million within the last quarter. That gives us runway well into 2025 and in 2026.
Any other clinical risk you see with clinical trials, of course, is always there, but we're confident this is really working.
Okay, you know, with any compound in development, always wanna get a sense of what the runway is. If it is approved, how should we think about intellectual property and exclusivity for this product?
So from an IP standpoint, there's two buckets I like to look at for, from protection, from competition. One is on the regulatory side. So we have orphan drug protection for gemcitabine used for both pancreatic cancer and bile duct cancer. So post potential FDA approval of this drug device combination, it gives us seven years of market exclusivity. Beyond that, we've got eight patents issued in the U.S., one in Europe, and about nine more pending across Europe, U.S., and Asia. And those patents are really the broad spectrum of device patents and method patents. We have two patents issued on this device, one on a future generation, and it really goes around the adjustability of the balloons, the dedicated infusion ports to be able to deliver locally. And then we've invented...
tested, proved out, and patented this mechanism of what we call transarterial microperfusion, and that's using pressure to push drug across the vessel wall. We also have patents around applying radiation up front to decrease washout prior to TAMP. So we've really bucketed and kind of isolated this whole idea of transarterial therapy, for these types of tumor treatments.
Okay, great. Now, if you get to FDA approval, what did you plan for go-to-market strategy? Do you go alone? Are you gonna partner? Company sale? How do you think about that event?
So we've got ongoing dialogues and optionality. We're constantly in discussions with the strategics, both commercial and also drug partners. My background is commercializing disruptive medical technologies. This is exactly one of those. The beauty about being public is that we have an option to do that by raising our own sales force. We've already mapped out what that looks like. Now, having said that, Boston Scientific is one of our larger shareholders. They led our Series B private funding before we went public. They've got a very strong interventional oncology sales force, where this would drop right in their bag very well, and they have several competitors we have ongoing dialogues with also.
So there are several sales forces out there who could easily run with this post-approval or post-commercial launch, and we're in constant dialogues with all of those to date. So I see this more as probably collaborative efforts, but the great part from a negotiation standpoint is we don't have to get acquired, we don't have to use another company's sales force, but there is strong interest amongst those strategic investors and collaborators as we finish up the trial and look at a commercial effort.
Okay, great. Now, if you were to take it to market yourself, you know, what size sales force would you need for this category, this indication?
Yeah, I'm glad you asked the question because from my cardiology background, you need many, many sales reps to tackle the many cardiologists out there. For this first beachhead in pancreatic cancer, it's a very dedicated sales and marketing effort. If you look at where these patients come from, looking at non-metastatic pancreatic cancer, they generally funnel into large academic institutions to see if they can have surgery and take the tumor out. Unfortunately, these patients are discovered later stage, and it's too late to remove the tumor, but this provides an option of a non-systemic chemo, better quality of life, and potentially better survival results, where the surgeons actually refer directly to interventional radiology and/or a tumor board that can refer them in.
So roughly about 50-100 centers across the US see the majority of non-metastatic pancreatic cancer patients at one time or another. So the small sales force of, let's say, 10-20 sales reps, we could capture deep penetration of the entire market in the US alone, and then most likely work with distributors as we look at OUS.
Okay, great. And, Shaun, we've talked a lot about RenovoCath or, RenovoGem, and but the TAMP technology platform in theory, could work in a lot of avascular tumors. How should we think about other indications? How big is this market beyond RenovoGem? Kind of, I know it's the lead indication, but in the bigger picture, you know what? How big is it relative to the opportunity?
I appreciate this question, Scott, because this is a platform. We, we've developed this amazing delivery system that works in these hypovascular tumors. And beyond just locally advanced pancreatic cancer, the next obvious spot for us is cholangiocarcinoma or bile duct cancer. And I'll share my screen again here. This is what a pipeline could look like for RenovoGem, which is again, the combination of gemcitabine plus the RenovoCath delivery system. The next obvious is a bile duct cancer. We've done some work in animals in lung tissue, and we've demonstrated a 100-fold increase in tissue concentration of gemcitabine in lung tissue adjacent to the tumor. Outside of that, glioblastoma, sarcomas, uterine tumors, these are all considered hypovascular, avascular tumors that behave like pancreatic cancer tumors, where gemcitabine is used systemically.
So these are the next potential targets for us as we scale up the platform. And beyond that, we're also working with partners on what other agents can be used besides this cytotoxic gemcitabine drug, possibly immunotherapeutics to expand into metastatic pancreatic cancer or other tumors. We announced a deal with Imugene last year, using their oncolytic virus to see the compatibility with our catheter to see if immunotherapeutics could work with our platform as well. So looking at these cancers specifically, it's about 125,000 patients per year that are diagnosed with non-metastatic or Stage III tumors that could be treated with RenovoGem in the long term. But the sky's the limit in terms of what we could do in terms of partnerships and looking at these tumors and other tumors as well.
Okay, great. Investors are always looking for catalysts to change the valuation over the coming 6-12 months. Can you talk about your kind of catalyst calendar and, and what we should be focusing on going forward?
Absolutely. So the next major milestone we see is the conclusion of the next interim analysis, which is expected on the 52nd event or death. That 52nd event is anticipated towards the end of this year. And in the meantime, as I mentioned earlier, this is public information that we're publishing the pre-phase III results, a minor catalyst, but it gives us more substantiation of our data. We actually just announced this morning that there is an article, a peer-reviewed journal article published on the TAMP mechanism in the JVIR journal. That really dives deeper into the mechanism of how this transarterial approach works using pressure, what kind of concentrations we're getting. So this year is really gonna be about building out additional data...
Both in the Phase III study and outside the Phase III study, and then launching into partnerships and the platform. So as I mentioned, we're talking to strategics, both in terms of agents we can combine with, with our delivery system and also potential commercial partnerships.
Okay, great. Now, Shaun, with these interim analysis, I, I know the first one was a very high threshold for the data halt for positive efficacy. I think it was a 0.001 P value. Can you talk about how the P values change on the first interim analysis to the second and the third? And I mean, again, the first was a very much a long shot. How should we think about the second interim analysis, at least from a probability P value standpoint, and then the final readout?
Yeah, Scott, I appreciate the question. So the first one, you're correct, is 0.0001. The bar was high. That was more because we never did a clean phase II prospective trial. We wanted to take a peek and see if the trial is actually working, so these pre-planned interim analysis were that. So a small alpha penalty for that 0.0001. The next interim analysis to achieve significance is 0.008, and which leaves us a final alpha, if you will, or a P value required, for success of 0.048. The smaller alpha spends in terms of having a large chance of success at the end. As you recall, the first interim analysis had a P of 0.056, so we're trending very close. With that small initial subset, we're trending towards a positive end result.
I'd say this next interim analysis, the goal of this next interim is to really show that this is still working, we're still trending in a positive direction. The chance of stopping early is probably a coin toss, a 50/50 chance that we hit significance, as that is a high bar of .008. But the goal really is to show that this is still on trend to complete the trial with a positive result.
Okay, it is time for us to start wrapping up. I'd like to end with the balance sheet question. You know, congratulations on the recent cash raise. I mean, you can now buy the green bananas again for the kitchen. But how should we think about the runway you have from here and relative to the burn rate?
So as you know, we've been a very capital-efficient company. Our burn is between $600,000-$700,000 a month. Having raised $17.2 million, we've got cash through 2025 and early 2026 with our current forecast. So I believe that we're well capitalized to remain capital efficient and continue to drive this phase III trial. I'm always looking for non-dilutive and strategic partners, and that's something that's gonna be important as we build this out this year, is looking for partnerships, both in terms of what do our next clinical trials look like? Can we make sure those are funded externally? And also, what kind of partnership makes sense for us with potentially even upfront payments as we gear up for potential commercialization.
Okay. Great, Shaun. We are out of time. I wanna thank you again for participating. Look forward to talking to you soon.
Thank you, Scott and AGP. Talk to you.