RenovoRx, Inc. Q4 FY2025 earnings call

• Leadership changes: Dr. Ramtan Agha transitioned to executive chairman, and Mark Fall joined as CFO. - 2025 was a key year for commercialization with over $1 million in revenue, ending with 9 active commercial centers. 17 Phase 3 TigerPak sites preparing to transition to commercial use. As of February 27, 2026, 12 U.S. cancer centers utilizing RenovoCAP and 21 additional centers in evaluation. Targeting 36 active commercial sites by year end. Hired senior director of sales and market development, regional sales managers, and marketing director. - Phase 3 TigerPak trial advanced with 104 randomized patients as of March 24, 2026, on track to complete enrollment by end of first half of 2026, with final data anticipated in 2027. Advancing broader clinical programs through post - marketing registry studies and investigator - initiated trials.

For the fourth quarter ended December 31st, 2025, Renovo RX reported revenues of $238,000, bringing the full year 2025 revenue to $1.1 million. Gross profit for the quarter was $210,000, representing a gross margin of 88%. Research and development expenses for the fourth quarter were $1.5 million and $6.3 million for the year. Selling general and administrative expenses for the quarter were $2.2 million and $7 million for the full year. As of December 31st, Renovo RX had approximately $7 million in cash and cash equivalents. On March 23rd, 2026, they announced the closing of an oversubscribed private placement resulting in gross proceeds of approximately $10 million. For 2026, they expect Q1 to be the strongest revenue quarter yet with potential growth from Q4, targeting approximately 36 active commercial sites by year end with revenues ranging between $3 and $4 million

• Expect Q1 2026 to be the strongest revenue quarter yet with potential growth from Q4. - Target approximately 36 active commercial sites by year end 2026, aiming for revenues between $3 and $4 million in 2026. - The private placement net proceeds will allow capitalizing on accelerating sales effort to drive revenue growth and achieving significant milestones across 2026 and 2027

Q: Hi, thanks for taking the question. It would be great to hear more about the process of transitioning the TigerPak centers to commercial customers. Other than having physicians who are already familiar with your catheters, are there other ways that the process is simpler than for a brand new commercial prospect center?

A: Yeah, Justin, thank you for the question. It's definitely worthy of discussion. So it is a lot easier, a lot simpler, a lot faster. And really the process is ensuring that they've got a pricing agreement in place that they can purchase devices for the use of commercial use outside the protocol. Initially, some of the centers had just agreed to purchase the device under the guise of the phase three clinical trial. And over the last, I'd say, six months or so, we've been transitioning those pricing agreements to be able to allow them to purchase outside. So the bulk of those have already happened, and that's a continual process. The other piece is that it's not just familiarity. training that these physicians have been using the product. We don't need a proctor there for the most part. So it's a much lighter lift in terms of getting the pharmacy familiar, getting the physicians trained. And further, they've already gone through the VAC approval process to buy the catheter. They've been submitting for reimbursement, getting reimbursed for the most part. And then lastly, from a referral standpoint, they already have referral patterns set up within the tumor boards to refer patients into the study. And they're familiar with their same referral pattern to treat this commercially. So a lot of the, I guess, barriers to quick adoption and or starting have already been accomplished at these tiger pack centers. So they should be able to convert quickly and convert quickly at relatively good volumes compared to brand new sites.

Q: Thank you, and good afternoon. Sean, I just wanted to review the catheter outlook, which sounds very strong. My interpretation would be Q1, you expect it to be above, I think the prior high was 422,000, so a number in excess of that. Is that the correct interpretation?

A: Thanks for the question, Scott. So we're not providing guidance in the first quarter. Having said that, based on what we've seen in the first two months of 2026, in terms of site activity, orders, and position engagement, we have potential significant growth over Q4. So reading between the lines, we're very confident this will be a very strong quarter for us.

Q: Yes, I thought I had heard you said the biggest quarter yet, but regardless, I You know, that's very impressive growth, and that's coming off of kind of two sequentially down quarters, which is suggestive of an inflection. And maybe if you could kind of talk about what you're seeing that's driving this. Is it all new centers? Is it reorders? Because it sounds like, and I thought you did say full year, $3 to $4 million. This sequential growth... Sounds like it would likely continue throughout the year every quarter, maybe some lumpiness. But if you can just talk about the inflection that you're seeing that is driving this growth.

A: Yes, Scott. Thanks for the question. I'm glad you brought this up because it's important to characterize 2025. So thinking about two down quarters, we're talking about tens of thousands of dollars where each patient represents between $50,000 to $80,000 of revenue per So in this early stage of the launch, one or two patients, when their first procedure starts, can really move the needle. And it is primarily the growth we're seeing in Q1 and beyond is primarily the addition of new centers. Once the center's active, they start treating a patient. It's almost like a recurring revenue every couple weeks when the patient comes back for a new treatment, a new catheter replacement. And once they open that seal, they have additional patients that come on board. So the nice uptick in growth we'll plan to see this quarter, can be reflective of the fact that we finished Q3 with about six active sites last year. And then we entered the year with nine, three of which came on board in the last two weeks of December. So they had that first treatment. So we're only talking about a few thousand dollars of revenue recognized from those additions of new centers in the last couple weeks of December. So we'll start to see that ramp this quarter. It's still going to be lumpy, though, I think, in the beginning, but we'll see. So I can't guarantee sequential growth, but I think we'll see definitely significant growth throughout the year. And that'll start to even out once we do go beyond kind of that 10 to 20 centers later this year. So I do have a very strong outlook on where this could be headed. The three to four million, I believe, is conservative. And based on numbers of centers coming on board, it'll be a good predictor of future revenue. Having said that, Going deeper in these accounts is not to be ignored. You did ask, you know, which one is it? Is it more centers or having more uses? And we're seeing both. Once a hospital gets familiar with the technology, we are seeing an uptick in usage there. But I believe the kind of midterm and long - term growth is adding new centers as quickly as we can. And we're starting to see that going from six to nine. I believe we last announced 12. And we're seeing growing beyond that as well.

Q: John, for clarification, or I'm sorry, was there more? No, go ahead. For clarification, I think I read one place that there were 12 centers utilizing RenovoCath, and then you talk about nine active centers. Are there three that tried it and are still not active? How are you classifying those other three between the nine and the 12th?

A: Yeah, so initially I think we talked about 12. I think we had maybe six of 12 active at one point. So once a hospital goes through the process of getting approval to purchase the catheter, it can take some time to find that first patient to treat. And this goes back to Justin's earlier question that TigerPak centers should be able to convert quickly because they have that referral pattern in. This is top of mind. It's not a brand new technology to go educate referring physicians. So in many of the centers in 2025, They went through the weeks or months - long process of getting internal approvals to purchase and may even bought the first set of catheters, but then it took them some time to find that first quote - unquote ideal patient. So currently where we stand is 12 active centers, i.e. they've started treating patients, and then another 21 centers that are in the VAC approval process or started to get approvals to purchase and are looking for that first patient. And then beyond that, we have dozens of centers that are starting to to get engaged with us and go to the multidisciplinary meetings and start to initiate the VAC process. So that's really the metrics that's going to be interesting to focus on is kind of watching those centers go through the sales funnel from initial engagement to VAC submission approval and then starting to use the device and the treating patients. So again, 12 active centers means they're actually treating patients to date. And we've started to grow beyond that as well.

Q: The next question comes from the line of RK Ramakhan with HC Wainwright. Please proceed. Thank you. Good afternoon. This is RK from HC Wainwright. A couple of quick questions. The first one And thanks for explaining in the answer to Squata about having 12 active commercial centers, but nine are currently ordering. And the question I have is, I believe 17 centers have used Renovacat as part of the trial, the TigerPack trial. So what... what does it take for the other five centers to become commercial or to become active?

A: So, based on the question, RK, just to clarify, so the 12 currently active, the vast majority are actually not TigerPack centers. So those are mostly brand - new customers. A couple of them have started to convert. So I think we mentioned a couple have started to convert to outside - the - protocol usage commercial centers as well. So for the other ones to come on board, It's a matter of them being okay with switching gears and treating outside of a study for this type of cancer or other cancers. A lot of them actually want to finish enrollment first for the same reasons I want them to finish enrollment first, is we don't want commercial to compete with completion of the trial enrollment, which should be done here the next few months, if not a lot less than that. So the dialogues have begun. I mentioned the pricing agreement changes, ensuring they can purchase. So some of them are still going through the VAC process to be able to purchase the device. And then it's a matter of continuing discussions once enrollment's complete. So that's a transition that we started months ago that we should hopefully quickly be able to ramp those the latter half of the year. But in the meantime, I still see centers converting as we're wrapping up enrollment here.

Q: And then on that enrollment, you know, in August, you know, you were talking about having... had like 95 patients enrolled into the study, and now you're saying 104 patients enrolled into the study. So what's taking, you know, how does that cadence work in the sense, like, you have nine patients over five or six months now, and then you think that you can get the next 10 patients within three to six months. So what happened during the last... know six seven months that that did not move that enrollment rate as fast as you would think A: okay that's this is worthy of a conversation for a couple minutes so that there's a little confusion somehow on on how the exact trial is conducted so to clarify when a patient comes into a center that has our study they're enrolled treatment naive for the most part where they haven't had any other treatments They then go through a very short, discrete induction phase of chemotherapy and radiation. And after that point, they're randomized if they're still considered locally advanced, not metastatic, not resectable. And importantly, they can tolerate the chemotherapy if they go to the control arm. So the goal is to randomize 114 patients, and we need to enroll enough patients to ensure that. So the 95 and 104 numbers you quoted were patients randomized. So it's 10 patients left to randomize in order to get their We'd have to enroll, you know, basically several months ago, at least 20 or 30 more patients, given about a 20 to 30 percent or 30 to 35 percent dropout rate during induction. So the goal is that we'll complete enrollment such that we can randomize 114 patients in the coming few months, around mid of the year, if not before that. And then the randomizations will occur sometime this year with final data next year. It's a little bit confusing on the enrollment conversion or randomization. The key is we're a handful of patients away from completing enrollment, and then what matriculates based on the patients in the induction phase, we'll be able to randomize our 114 patients this year. The big milestone for us is completing enrollment. Once we can call the trial completion of enrollment, that's going back to the earlier questions when sites will really start to be able to convert to commercial because they can't pull any more patients into the trial And there'll be definitely a strong interest, and that's already been demonstrated, to be able to allow continued access to patients through the treatment. Does that help clarify it, RK?

Q: Yeah, thanks. And then on the last question from me is on the number of events. You know, you have had 72 events so far. Do you need to get to 86 events? And if that is true, can you lock the study even if you don't get to randomized 114 patients?

A: Good question, RK. So yes, 86 events is when the final analysis takes place, and we would need to randomize 114 to get there. The 86th event we anticipate, given the 72 we have right now, wouldn't take place until next year. So there's really not a statistically possible or probable scenario in which we would actually hit the 86th event before we randomize 114. So in that scenario, It is so unlikely that we haven't assessed what happens before. But that's the cadence we expect to see is 114 randomized this year, and then sometime next year, the 86 events.

Q: The next question comes from the line of Ed Wu with Ascending Capital Markets. Please go ahead. Yeah, congratulations on all the progress. My question, just to confirm, you said you have three salespeople now, plan to add two this year. Would that be enough to get you to the 36 active centers goal for this year?

A: Absolutely, Ed. In fact, I believe R3 can do it on their own right now, given that we have over 36 centers in the pipeline, if you include Tiger Pack. So the goal of adding these two additional is to fill parts of the country currently uncovered or sparsely covered to see how quickly we can get the 36 active, how deep we can drive on those centers, and to see how far beyond that we can push. But short answer to your question is yes. I've been saying for the last, I think, seven or eight months, at least, that a sales team of three to five reps should be able to get us to a point of significant adoption and penetration and to a potential break - even point.

Q: Then just a curiosity in terms of the volume per center. Are all these centers equal in potential, or should we view as the first half you added are like the bigger centers and the ones you're adding near the end are smaller volume centers? Or how do we, you know, put value to how big these centers are in terms of potential?

A: You know, and it's actually quite interesting if you look at it. It's really not predictive because it's this interesting place where some of the high volume centers are highly academic and conservative and have a lot of red tape and processes that take longer to launch. So sometimes we can get The largest centers come in later, given that conservative nature. And other times we get the large centers that are very active, trying to be the first to market and the first to offer this and advertise about it and jump on. And then the same goes for the smaller centers. We have the smaller or second or third level volume sites that are interesting and trying to become the bigger players that try to get something in quicker to be able to advertise it. So it's a perfect mix. What we have said publicly is of the centers that we're active in, It's a broad spectrum of very well - known, large NIH - designated academic centers to the kind of high - volume and mid - volume community - based centers. So, it's given us a great example of what the market should look like as we scale, and their volumes are across the board as well. So, some of the large community centers draw a big crowd. They can adopt technologies earlier. They want to be a powerhouse, so they're trying to advertise, and we've seen this with Hackensack and Jersey Shore. where they've done a lot of advertisements around bringing new patients to the center because they're offering new technologies like TAMP. So it is a mix. I wouldn't say it's front - weighted at all. It's a pretty even spread as we go throughout the next year or two.