RenovoRx Inc Aktie

Good afternoon. I will be your conference call operator today. Please note that today's call is being recorded. [Operator Instructions] I will now turn the call over to Valter Pinto, Managing Director of KCSA Strategic Communications. Please go ahead.

Thank you, operator. Good afternoon, and welcome, everyone, to the RenovoRx Second Quarter 2026 Financial Results Conference Call. I'm joined today by members of our leadership team, including Shaun Bagai, Chief Executive Officer; Dr. Ramtin Agah, Chief Medical Officer, Executive Chair and Founder; and Mark Voll, Chief Financial Officer.

Before we begin, I'd like to remind everyone that statements made during today's call contain or may contain forward-looking statements covered by the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and applicable federal securities laws.

These statements, including statements regarding RenovoRx's clinical and commercial plans, strategies and estimates or expectations of financial or operational performance, including revenue, are based on management's current plans and assumptions, and actual results may differ materially.

Please refer to our filings with the SEC, including our Form 10-Q for the quarter ended June 30, 2026, for a detailed discussion of the risks and uncertainties facing RenovoRx. With that, I'd now like to turn the call over to our Chief Executive Officer, Shaun Bagai.

Thank you, Valter, and good afternoon, everyone. Over the past several quarters, we set out 3 milestones for RenovoRx. And this quarter, we delivered on all 3. First, revenue growth. The second quarter was a record revenue quarter, our strongest to date.

Second, commercial momentum. We activated new commercial cancer centers at a pace ahead of our internal targets. And third, expansion beyond locally advanced pancreatic cancer. For the first time, a treating physician chose RenovoCath to deliver therapy to a patient with a different solid tumor. We told our investors we were going to achieve these goals, and we delivered.

Last quarter, we spoke openly about the meaningful progress we made on the commercialization of RenovoCath, shifting our narrative from concept to execution and growth. This quarter shows our commercial execution in action with our highest quarterly revenue, and we could not be more excited about our future. Our job now is to keep delivering quarter after quarter.

For the second quarter ended June 30, 2026, RenovoRx generated record revenue of $909,000, our strongest quarterly performance to date, increasing approximately 61% sequentially and approximately 115% year-over-year. To put this performance in perspective, our second quarter revenue alone represented approximately 83% of our entire full year 2025 revenue of $1.1 million.

This is the direct measurable result of the commercial model we have described: more active commercial cancer center customers, more procedures and more revenue with each new center we activate adding to our growth and creating a compounding effect. Let's walk through our predictors of our future revenue. Revenue growth is the outcome, but the leading indicator of continued revenue growth in the coming quarters and the metric I would encourage investors to continue to watch most closely is new account activations.

Our activated commercial cancer centers to date have been a source of recurring repeat demand, so the pace at which we activate accounts is what gives us confidence in future revenue growth. On that measure, our progress is clear. At the time of our May 14 earnings call, we had 16 active commercial cancer centers.

We ended the second quarter with 21 active commercial cancer centers, an increase of more than 30% in just 1 quarter. We remain on pace to meet or exceed our target of 36 active commercial cancer centers by year-end 2026. The majority of these paying customers or cancer centers that purchased RenovoCath, are distinct from the clinical trial research sites participating in our Phase III TIGeR-PaC study. And our customer pipeline beyond those active centers is robust.

In addition to our 21 active customers, we have 42 additional centers in various stages of evaluation, approval and activation, representing a total of 63 centers in our commercial funnel. The growth of our total customer funnel is a 31% increase over the 48 centers we reported on our first quarter call. In addition, 15 of our TIGeR-PaC trial sites are positioned to move to commercial RenovoCath use, and several have already begun doing so. As these sites transition, we expect them to be a meaningful contributor to our revenue in the second half of 2026.

Another key metric of commercial success is repeat orders. We continue to see strong repeat ordering from our existing customers, which is one of the clearest indicators of physician satisfaction and product utility in interventional oncology. When a physician places a second, third and fourth order for RenovoCath, it confirms the product is delivering an important treatment option and clinical utility for their patients.

Given our customer pipeline and based on what we're seeing so far in terms of repeat orders, our third quarter revenue is tracking to exceed the second quarter and become yet another record revenue quarter.

This commercial growth and strong customer pipeline are driven by a lean commercial team that is in place and executing. The results certainly speak for themselves. Going forward, we may incrementally add to our sales team where a specific market opportunity warrants it, but our growth model remains focused on efficient capital allocation and investing into our growth as needed.

We are deploying the capital from our March capital raise prudently and effectively, and we are generating a strong return on that investment. We reduced our operating loss for the quarter. And as our revenue scales, we expect our operating loss will continue to decline. Physician-to-physician advocacy continues to grow, which is historically the most powerful driver of adoption in interventional oncology.

Since receiving FDA 510(k) clearance, RenovoCath has been used in more than 900 successful procedures. Before I turn the call over to Ramtin, I want to take a moment to touch on the current overall pancreatic cancer market and how we believe this benefits us. There has been significant industry attention recently on new therapies for pancreatic cancer, and we believe those developments represent a meaningful opportunity for RenovoRx.

Because RenovoCath is a device to deliver treatments more optimally, we see breakthroughs in pancreatic cancer therapy as complementary and as an important tailwind for our business. Beyond always putting the patient first for this deadly disease, I want to remind everyone that our TAMP technology enabled by RenovoCath is a collaborative, localized drug delivery platform with 2 ways emerging therapies can strengthen our opportunity.

First, we can deliver established drugs locally, sequentially to, or concurrently with, novel therapies, creating the potential for improved patient outcomes, concentrating therapy where it is needed. Second, as new drugs come to market, we believe many of them can be delivered directly via RenovoCath device. And in both cases, our view is that novel improved therapies make our targeted delivery platform even more valuable.

We recently announced the first commercial clinical use of RenovoCath in sarcoma treatment, marking the expansion of our targeted drug delivery device to other solid tumors and showing real potential for expansion of localized delivery of chemotherapy.

Ramtin will go into more detail about this milestone, but it's important to note that this expansion is physician-driven, an important and encouraging element as we look towards the potential for broader adoption of RenovoCath.

In closing, I could not be more proud of our team for their execution and hard work. The second quarter was a record quarter for us, not only from a revenue perspective, but also across all our key metrics, including growing customer pipeline, high retention rate and repeat orders. With that, I'll turn the call over to our Chief Medical Officer, Executive Chair and Founder, Dr. Ramtin Agah.

Thank you, Shaun, and good afternoon, everyone. Before discussing the broader opportunity, let me briefly remind everyone of the science at the core of what we're building. Our patented Trans-Arterial Micro-Perfusion, or TAMP, technology enables targeted therapeutic delivery across the arterial wall near the tumor site, designed to bathe the target tumor while potentially minimizing a therapy's toxicity versus systemic intravenous therapy.

For patients fighting solid tumor cancers while also managing the debilitating side effects of treatment, that difference matters. For decades, cancer care has rested on 3 pillars: surgery, radiation, systemic chemotherapy. We believe TAMP, enabled by RenovoCath, represents a fourth option, one that is targeted, tolerable and increasingly supported by growing body of real-world clinical evidence.

As Shaun mentioned, earlier this month, we announced the first commercial clinical use of RenovoCath in sarcoma treatment, showing the real-world potential beyond LAPC for expansion of localized delivery of chemotherapy. This first commercial sarcoma case marks an important milestone for RenovoRx, demonstrating RenovoCath's potential as a stand-alone device for treatment of other solid tumors beyond our core focus on locally advanced adenocarcinoma of the pancreas.

This was a case where a physician who has treated LAPC using RenovoCath came back to RenovoRx with a plan to use our catheter to treat sarcoma, and we believe that this is a powerful endorsement of RenovoCath's potential.

We believe targeted localized delivery may offer advantages over systemic treatment for many other difficult-to-treat solid tumors, and we look forward to working with our cancer center customers to find new and broadening use of RenovoCath within its FDA-cleared fields of use. In the second quarter of 2026, several scientific data updates supported the use of intra-arterial gemcitabine delivery via TAMP in LAPC. A peer-reviewed case study by researchers at Moffitt Cancer Center, published in Radiology Case Reports, found that PET-CT imaging, rather than CT alone, showed a meaningful reduction in tumor metabolic activity after treatment.

These findings suggest that PET imaging may help optimize monitoring of therapeutic response following TAMP-delivered treatment. In addition, the PK substudy of TIGeR-PaC trial has been accepted and soon to be published in the Journal of Cancer Chemotherapy and Pharmacology. The findings support TAMP as a targeted delivery method for gemcitabine, demonstrating its potential to increase local drug potency while reducing systemic exposure and common side effects.

Finally, a peer-reviewed case series in Case Reports in Oncology from researchers at Hackensack Meridian Health's Jersey Shore University's Medical Center was accepted and will be published in the near future. The case series highlights their experience with TAMP procedure in LAPC.

The ramping up of publications of TAMP procedure by physicians, I believe, is another sign of adoption as TAMP progresses from an experimental procedure to becoming standard of care. Earlier this week, we were pleased to announce that RenovoRx has achieved full enrollment in our Phase III TIGeR-PaC trial for locally advanced pancreatic cancer.

This significant milestone reflects years of patient recruitment, clinical execution and collaboration among investigators and study teams evaluating intra-arterial gemcitabine delivered through RenovoRx's Trans-Arterial Micro-Perfusion, or TAMP, platform, and RenovoCath device as a novel drug device product candidate for difficult-to-treat LAPC.

The primary endpoint of the study is overall survival. TIGeR-PaC is designed to evaluate whether RenovoRx's patented method of targeted delivery of the chemotherapy, gemcitabine, improves patient survival, safety and tolerability compared to standard of care, systemic intravenous chemotherapy, gemcitabine plus Abraxane.

On August 7, TIGeR-PaC trial investigators were notified that patient enrollment is closing. Completion of the trial is expected during the first half of 2027 after 86 events have been observed. As of August 11, 2026, 78 events have occurred. Following the completion of the trial, initial top line data is expected to be available during the back half of 2027.

TIGeR-PaC is the cornerstone of our clinical development program, bringing us closer than ever in our effort to validate IAG and its efficacy through rigorous long-term evaluation.

Completing enrollment in the Phase III TIGeR-PaC trial marks a major milestone for RenovoRx and our clinical program.

With enrollment complete, we are now focused on advancing towards final data analysis. We believe TIGeR-PaC will provide meaningful additional validation of our TAMP therapy platform in an area with significant unmet need and limited therapeutic progress.

The trial is designed to demonstrate the potential safety and superiority of intra-arterial gemcitabine delivered via RenovoCath for locally advanced pancreatic cancer versus systemic IV chemotherapy, the current standard of care.

I want to underscore a very important point. The transition of TIGeR-PaC sites is additive to our commercial expansion story, not separate from it. As Shaun noted, several of these sites have already begun moving to commercial RenovoCath use. And as more do, they join our growing network of active commercial cancer centers.

This is an anticipated and meaningful contributor to our second half 2026 revenue. In parallel with TIGeR-PaC, we continue to build the evidence base for TAMP platform. Our post-marketing registry study is a multicenter study generating real-world safety and efficacy data in patients with solid tumors.

We also continue to support investigator-initiated trials, or IITs, in borderline resectable and metastatic pancreatic cancer, which are designed to achieve cost neutrality while broadening the platform's evidence base.

In the second quarter of 2026, we began supporting a new IIT study for cholangiocarcinoma, or bile duct cancer, which is in process to begin soon. Clinical data builds physician confidence. Physician confidence drives adoption and adoption drives revenue. Commercial traction is now the foreground of the RenovoRx's story, and our TIGeR-PaC clinical trial is important background.

We are a scaling commercial business today, not a binary event bet. At the same time, the trial remains a significant long-term value driver and a positive Phase III readout would have meaningful positive implications for physician adoption and reimbursement. Once we reach breakeven, we believe RenovoRx can be a profitable, high-margin, low overhead cash-generating business, a rare profile in our space. Thank you for your interest in RenovoRx. I will turn the call over to our Chief Financial Officer, Mark Voll.

Thank you, Ramtin, and good afternoon, everyone. The second quarter was a strong quarter for RenovoRx, and the financial results reflect meaningful progress on our commercial plan.

Let me walk you through the numbers. For the second quarter ended June 30, 2026, RenovoRx reported record revenue of $909,000, our strongest quarter to date. That is approximately 61% growth versus first quarter revenue of $563,000 and approximately 115% growth versus $422,000 in the second quarter of 2025.

This growth was driven by continued active commercial center expansion and repeat ordering from our existing customer base. Gross profit for the second quarter was $766,000, representing a gross margin of approximately 84%, consistent with our roughly 85% gross margin we reported in the first quarter and reflecting the strong underlying economics of RenovoCath.

Research and development expenses for the second quarter were approximately $1.2 million, reflecting our continued investment in the Phase III TIGeR-PaC trial, in our post-marketing registry study, and our investigator-initiated trial programs. Selling, general and administrative expenses were approximately $2.9 million, reflecting the disciplined investment we have made to build and support our commercial infrastructure.

Loss from operations for the quarter was approximately $3.4 million, an improvement from the $3.5 million operating loss in the prior quarter. However, adjusting both periods to exclude the noncash expense for stock-based compensation, our second quarter operating loss was approximately $370,000 less than our first quarter operating loss.

As our revenue scales, we expect our operating loss will continue to decline.

Net loss per share improved to $0.06 compared to a loss of $0.08 in the second quarter of 2025 and a loss of $0.09 in the prior quarter. As of June 30, 2026, RenovoRx had approximately $9.5 million in cash and cash equivalents compared with approximately $12.4 million at March 31, 2026. This change aligns with our internal forecast and reflects the disciplined deployment of capital we raised in March.

Importantly, assuming our revenue scales as we anticipate, our active site count grows, our cash burn will continue to decline. We believe our cash position provides sufficient runway to fund operations into the second half of 2027 as we continue to work towards our goal of cash flow positive operations. We will be opportunistic if capital market conditions are favorable, but raising capital is not our focus today.

Our priority is revenue generation and execution. Management believes that reaching a quarterly revenue run rate of approximately $5 million would position RenovoRx at cash flow breakeven. Based on our current trajectory, our internal plan anticipates achieving breakeven operations in the fourth quarter of 2027, and we expect to make steady progress towards that run rate as our active site count scales towards and beyond our year-end target of 36 centers.

Reflecting on our strong first half performance, we are raising and tightening the range of our full year 2026 revenue guidance to a range of $3.75 million to $4.25 million from our prior range of $3 million to $4 million. This increase reflects our confidence in continued revenue scaling in the second half of this year. This new guidance implies year-over-year growth of 241% to 286% in 2026 compared to revenue of $1.1 million in 2025.

Beyond revenue, our primary commercial KPI remains active commercial center count. We were at 21 active commercial centers at quarter end and are targeting 36 or more by year-end. As TIGeR-PaC sites continue to transition to commercial use in the second half of this year, we expect that activity contribute meaningful to revenue. Executing within our guidance range keeps us on the path we have laid out towards cash flow positive operations. Thank you. I'll turn the call back to the operator for Q&A.

[Operator Instructions] Our first question is from Justin Walsh with JonesTrading.

I was wondering if you could provide additional color on what prompted the physician to use TAMP and RenovoCath in that particular sarcoma patient?

Justin, thanks for the question. So as we've been talking about, the utility of this technology to reach more tumors is out there. This is a physician who's gotten comfortable with treating pancreatic cancer specifically. And based on that, he saw a case where there's a difficult-to-reach sarcoma tumor.

These are challenging cases in general. And with that, he thought this would be a great opportunity to be able to utilize RenovoCath to isolate flow and really get good tumor penetration of the drug. So it's what we expect. Radiologists are quite inventive in terms of physicians given that they work across the entire body.

And as we've been told by many doctors, is once we get this in their hands, they will get -- see themselves getting in positions where they could utilize this with other tumors and other patients. So it's -- I believe the beginning of adoption across the spectrum in several areas, and it's great to see that he took the opportunity here to help one of his patients with our technology.

Great. And one more question for me. I'm wondering if you can expand on how learnings from activating the first set of commercial centers can help facilitate your efforts to convert the additional centers from your pipeline?

That's a great question, Justin. That's one of the reasons we didn't hire a big sales force last year is to really understand what the sales cycle and sales process is. And we found that there are a lot of moving parts in terms of getting VAC approvals to be able to purchase the catheter.

Also in terms of referring patients and making sure that referring patients know that the technology is now available when it becomes available and the radiologists are connected with those physicians as well. And so I think a lot of the learnings to accelerate that site activation, and we've seen this, is to ensure that we've got buy-in from multiple specialties, strong communication and a lot of touch points.

Now having a field force in the field and constant communication and showing up on site is really helping to drive that. So that was important to have that focus with a small dedicated sales force versus going out to look at a partnership at this early stage of market development to ensure that we actually get products on the shelves and then get referring physicians in with high touch points from our local reps.

Our next question is from Charles Wallace with H.C. Wainwright.

First one for me. So congrats on finishing enrollment for the TIGeR-PaC study. So I was wondering, now that enrollment is closed, how many of the patients actually ended up randomized? I guess I'm asking if the full 114 patients were randomized at this point or if the number actually fell above or below that?

So we haven't yet completed randomization. So that's still in process. And we didn't report publicly the exact number, but we're very close in terms of completing randomization with a handful of patients left. And part of allowing the study to be open a little bit longer than June, like we anticipated, was to be able to have physicians enroll patients, have them in the induction phase.

So if there are dropouts, we'd be able to randomize the 114 patients without issue. And we do have that buffer now. So we'll be pretty close to randomization completion here.

Okay. That's very helpful. And then I guess on the site activation, now that you're at 21 active sites, it's, I think, a 5 gain from the first quarter. So what gives you confidence that you can reach the 36 centers by the end of the year? And how many of these are from the clinical trial conversion?

So it's interesting. The 21 is as of the end of the quarter. So we've activated more since then, which we'll report out in the not-too-distant future. What gives us confidence is that we've got 42 additional centers that are in the process. So well over 36 total with the bulk of the 15 TIGeR-PaC sites not yet treating commercially.

A handful of those wanted to wait until enrollment is complete, so it wouldn't have a competing interest from the physicians. So we anticipate starting to activate those over the next quarter or 2. So those should contribute meaningfully to the revenue. But the other 40 or so plus in the customer pipeline will also allow us to overachieve that 36 target at the end of the year.

That's helpful. And I guess on the -- another follow-up on that. So on the clinical trial sites that have become active commercial sites, what's your anticipation of the timeline from when they're activated to when they order?

Actually, that's a great point, Charles, and good clarification. So when we say active, these are actually -- they've already purchased a catheter and treated a patient. So what we didn't want to do is start looking at sites that either are ready to go or have not purchased the device yet.

So when we say active, these are actually purchasing using customers. And the other 42 in the pipeline could be somewhere along the process, including being greenlit to order, may have ordered already, but haven't treated their first patient. So they're real active commercial sites.

Our next question is from Ed Woo from Ascendiant Capital Markets.

Sure. That is close enough. I want to congratulate you guys on all the progress on both fronts. My question is, as you guys scale up the volume for the RenovoCath, do you think your margins can go higher gross margin, operating margin as you guys scale up in volume?

Yes. Good question. And I think that we have the opportunity to do that when we get to our next-generation product, which will introduce sometime next year. And I think that will allow us to increase the gross margins from our current level.

Great. That sounds good. And then my second question is on these additional centers that you guys have in process. Is there any difference in terms of the volume or business potentials with the first 21 that you have already activated? Are they much smaller? Are they the same size? Revenue potential for these additional centers beyond what you're going to -- that you already have?

Yes. Great question, Ed. And what's great to see is that the 21 is a good representation of this full spectrum. So within those active centers, we have a couple of the high-volume centers, and we have some of the smaller community-based hospitals.

So if you look at the heat map of about 200 target centers with the bulk of them being treated at a small number of centers, we haven't hit all the high-volume places yet. So there's a lot of opportunity here for revenue growth. And Mark, I'm not sure if you want to maybe touch on the 200 a little bit more in detail.

Right. So when we look at the market, it's pretty concentrated. The top 10 advanced cancer centers represent about 25% of the market. And so while we're really targeting the larger ones, we're not -- we're still looking at a broad range of active cancer centers to bring online.

But again, getting the larger centers will get -- will give us the amount -- largest amount of revenue opportunity in those centers.

Great. Well, it's glad that you guys have very good representative samples in your 21 centers so far.

I believe that concludes the questions remaining. I want to thank everyone for joining and excited to have you along this journey as we really demonstrate progress and really, again, capitalizing on our 3 major missions that took place this last quarter in driving revenue, increasing our commercial centers and now expanding the technology beyond pancreatic cancer. Looking forward to many great quarters ahead. And if you have questions, please do follow up.

This concludes today's conference call. Thank you for your participation. You may now disconnect.

Good day, and welcome to the iAccess Alpha Virtual Best Ideas 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 here, CEO of RenovoRx, 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 a tumor and not destroying the patient in the meantime. And what we've seen with therapeutic after 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 it's that kind of balance and give and take on both sides.

At RenovoRx, we're trying to attack this very differently on 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-cleared RenovoCath device. So as a life science company, we have 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 Trans-Arterial Micro-Perfusion 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, we're developing a combination therapy with our proprietary TAMP system, and we have been 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-PaC, 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 trial is evaluating intra-arterial gemcitabine delivered via the RenovoCath FDA-cleared device known as IAG, specifically in locally advanced 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 Trans-Arterial Micro-Perfusion platform, otherwise known as TAMP, utilized with the RenovoCath 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 of 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 of 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 such that you don't have the systemic toxicities and side effects.

So as a 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 100 times the concentration of drug, in this case, gemcitabine at the tissue site when delivered by our TAMP 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 TAMP 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 RenovoCath device. It's a small device that's about 2 millimeters in diameter. A physician, namely interventional radiologists, place 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 feeders that directly access the tumor.

Once they position in the body, the physician is able to position 2 different balloons that are on 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 gemcitabine, for example, they 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 head. 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 bath the local target in tumor and chemotherapy or therapy.

And these aren't high pressures. As you can see by the chart here on the right, it's about 50 to 60 millimeters of mercury 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 chemotherapy, again, in animals, resulting in 100 times 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 on 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 give the medications to make them feel comfortable and then discharge the same day for the most part. From 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, in the liver cancers, 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 their 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 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, our experience has been primarily in locally 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 I and II, potentially for pancreatic cancer, so looking to give before surgery for the rare patients who are identified early or in patients who are even more advanced in that metastases, there are IITs or investigator initiated 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 in the not-too-distant future. Non-small cell lung cancer, some of these tumors could be amenable to this type of approach given the vascularity or lack thereof in these tumors, glioblastoma or brain tumors down the road, sarcomas or bone cancers potentially and uterine tumors and fibroids as well. So there are a lot of growth areas for the technology beyond just pancreatic cancer.

Let's shift gears and talk about the commercial approach first, and then we can talk about some of the data. As mentioned, we did commercialize the RenovoCath 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. 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 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 -- our business, we believe it's a high-margin, large market opportunity for our stand-alone device. If we look at the revenue potential for the company, we believe that it was 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, we'll be at 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 Shaun 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 [indiscernible] 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 non-metastatic 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 the standard 80-20 rule where actually 100 centers treat over 70% of the potential patients. And so with a 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 in revenue in 2025 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 Q1 -- 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 a 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 green lit 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 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 through the device. So as new drugs come on the market, we can actually expand partnerships or uses both commercially and on the clinical research partnership side.

So outside the commercial opportunity here, 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 our TIGeR-PaC 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 in 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 polling physicians, they said, look, if you can give me 4 months, 3 to 4 months of a survival improvement with an 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 into the trial design too much in depth, but just very high level, the Phase III trial is for treatment-naive patients where they 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 the RenovoCath 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 skipped 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 RenovoCath 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 side. We actually saw in addition to 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 interest of using our platform across the board because we're seeing such a better level of toxicity profiles in a space where beating up patients with chemotherapy is considered the standard of care.

Beyond the Phase III TIGeR-PaC 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 as many indications. And it's important to note that these physicians and 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 finances. So I'll turn it back over to Mark.

So Shaun touched on earlier, we had a very strong Q1 as far as revenues, $563,000 in revenue, 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 of 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, one of our most recent Board members added was Dr. Bob Spiegel, who was the Chief Medical Officer of Schering-Plough 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 an all star 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's the Chief of the JNCCN Guideline Committee who writes the 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 RenovoCath device in the 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-initiated trials where the RenovoCath 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 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 TAMP therapy or the RenovoCath, demonstrating the quality of life potential improvements and the hope for continued survival. And I come back to the point of this is a technology that's actually may be benefiting patients across both spectrums. We can extend life potentially and also making the life worth 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 -- the number of active cancer centers 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 to 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.

I've got -- 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, one of the questions is, does the $12 million in the bank get you to breakeven? Do you want to take that one?

I'm sorry, can you -- I didn't see the question.

Does it -- towards the bottom. Does the $12 million in the bank get you to breakeven? The fact that we're well capitalized is something that's very important. So go ahead, Mark.

Yes. Yes, I think that we'll get strongly into the second half of next year. I think at that point in time, we'll probably be looking at some additional -- some small financing at that point in time. But for the most part, I think we're well capitalized to get into that part of the year and beyond.

Thanks, Mark. There's a question of with more than 750 procedures performed to date, what key lessons have you learned from real-world commercial use? This is a very important question because one of the reasons we didn't hire a sales force off the bat is I want to make sure there weren't barriers to adoption and the market is as big as we believe it is. And we found that the technology is relatively easy for physicians to adopt and learn and most patients that we've come across are amenable to the procedure. So we have seen that the technology does not need major modification and there aren't major barriers to deep clinical adoption.

There's another question with -- many investors still view RenovoRx as a clinical stage company. How should investors think about the stand-alone commercial opportunity for RenovoCath today? I think there are several positive answers from here, but maybe, Mark, I'll let you talk about the high growth and margin business first.

So yes, we continue to see strong growth for the companies. We see 85% operating -- or excuse me, gross margins. Again, we have a low overhead. So we have most of the components in place to drive revenue for the next several years. So I think that we're well positioned to drive future revenue and eventually get to breakeven and beyond that. Again, we believe it's a high-margin business that can generate significant margins as we drive further revenue growth.

Thanks, Mark. And this kind of leads an additional question is beyond pancreatic cancer, which additional tumor types represent most attractive expansion opportunities for RenovoCath and TAMP platform? Another question talks about referencing a multibillion-dollar addressable market opportunity. So these fit together. And as we go beyond where we have experienced so far, which we believe is probably a total available market of $1 billion to $2 billion, achieving $400 million of peak sales with the RenovoCath as there's interest beyond just locally advanced pancreatic cancer, which is 20,000 patients a year, there are another 40,000 pancreatic cancer patients that have metastases or can be removed surgically where there's interest in studying this. So the pancreatic cancer market beyond locally advanced is multibillion.

Beyond that, cholangiocarcinoma or bile duct cancer would be a next target where there's interest in using the catheter commercially today and further clinical research trials, non-small cell lung cancer down the road. So as a platform play, there's a lot of opportunity there.

Coming back to the question Mark answered, is this a clinical story or a commercial story? And the amazing part is we actually have kind of both in the sense that if you look at other companies like Chrysalis, NovoCure and Delcath are great analogs of the technology that we have on adjacent tumor spaces where their market caps are $250 million to $300 million to $400 million to $1 billion to $2 billion, it shows where we could go sitting here at less than $100 million market cap with a commercial opportunity where we can break even in the not-too-distant future.

And then on the kind of back end of that, we do have this clinical story where we're waiting for final data that could be even bigger. So there's -- it gives you 2 major opportunities to drive shareholder value at a relatively low valuation of where we sit today in a company that's very well capitalized and doesn't need to raise a lot of money anytime in the near future.

Another question is, you're targeting 36 active commercial centers by year-end. What milestones should investors watch over the next several quarters to measure progress toward that goal? Mark, do you want to take that one?

Yes. I just think continued revenue growth as we, again, sign up more active cancer centers, that should allow us to drive further revenue growth. And we feel very strongly we're well positioned to see that kind of growth this year and next year.

And the other measure I'd look at -- so revenue growth is the obvious one. And as we talked earlier, one of the KPIs is looking at active centers. So going from 8 to 16 -- exiting 2025 to 16 by May, showing on a quarterly basis or even more advancing quickly to that 36 goal and beyond, especially when we have over 48 total, including the active centers in the pipeline, it looks like we're well on our way to that target. So looking at revenue and active centers, just to reiterate what Mark said, is a great indicator of our current and future success.

On that note, there's a question of active commercial centers, cancer centers doubled from 8 to 16 in recent months. What has been the biggest factor driving physician adoption of RenovoCath? This is actually an interesting question because the physicians coming to us saying we need another option is the biggest driver. Again, even with new technologies in the news like revolution medical, one of the biggest issues with cancer therapy to date is the toxicities and side effects is that after 4 -- actually 2 to 6 months of treatment, most patients can't tolerate the systemic therapy. And most therapies don't work drastically. So they often switch to local therapy like radiation, for example, which has not shown a survival benefit.

And so this gives physicians an option where once they've exhausted a few months of chemotherapy with high toxicities, there's an opportunity to try something different that may reduce the side effects, make patients feel better overall and give them hope that there's a survival possibility here to live weeks to months or maybe even years longer as we've had patients out 3, 4, 5 years since diagnosis. So the biggest driver is that really interest in trying to give another option.

So with that, there are a few more questions there. Please feel free to reach out directly. But just to close up as we're a little bit over time here, just to kind of conclude what we're looking at. As we've seen for decades, cancer treatment has really been a blunt instrument. We flood the body with chemotherapy and hope we hit the target harder than it hits everything else, which is not the case. We're changing that model. Precision medicine is really rewriting the rulebook as we look at other therapy types and companies that can deliver treatment directly to the tumor while sparing the rest of the body are solving for one of medicine's longest-standing problems. Our TAMP platform powered by our FDA-cleared RenovoCath device is doing exactly that. And as I mentioned before, the fact that we were just named Fast Company World's Most innovative Companies of 2026 in the medical device category speaks for itself.

I appreciate everyone's time and looking forward to continued dialogue tomorrow.

Thank you. That concludes RenovoRx Inc.'s presentation. You may now disconnect. Please consult the conference agenda for the next presenting company.

Good afternoon. I will be your conference call operator today. Please note that today's call is being recorded. I will now turn the call over to Valter Pinto, Managing Director of KCSA Strategic Communications. Please go ahead.

Thank you, operator. Good afternoon, everyone, and welcome to the RenovoRx First Quarter 2026 Earnings Conference Call. I'm joined today by members of our leadership team, including Dr. Ramtin Agah, Chief Medical Officer and Executive Chair; Shaun Bagai, Chief Executive Officer; and Mark Voll, Chief Financial Officer. Before we begin, I'd like to remind everyone that statements made during today's conference call contain or may contain forward-looking statements covered by the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and applicable federal securities laws. These statements, including statements regarding RenovaRx's clinical and commercial plans, strategies and estimates or expectations of financial results, including revenue and operational performance, are based on management's current plans and assumptions, and actual results may differ materially. Please refer to our filings with the SEC, including our Form 10-Q for the quarter ended March 31, 2026, for a detailed discussion of the risks and uncertainties facing RenovoRx. With that, I'd like to turn the call over to our Chief Executive Officer, Shaun Bagai.

Thank you, Walter, and good afternoon, everyone. When we spoke with you in late March, we told you that Q1 2026 would be our strongest revenue quarter yet. Today, I am pleased to confirm that we delivered on that commitment. Our first quarter results marked an important inflection point for RenovoRx. We are no longer outlining a strategy. We are now executing it. For the first quarter ended March 31, 2026, we generated revenue of $563,000, our highest quarterly revenue to date. This represents approximately 136% growth quarter-over-quarter compared to Q4 2025 revenue of $238,000, more than doubling our revenue in just a single quarter. Just as important, Q1 2026 alone accounts for more than half or approximately 51% of our total 2025 revenue of $1.1 million. This is not a coincidence. It is a direct result of deliberate commercial execution driven by the continued expansion of active cancer centers using our RenovoCath device, exactly as we previously outlined. Based on the momentum we are seeing across our commercial footprint, we expect second quarter 2026 revenue to exceed our first quarter revenue, keeping us nicely on track for our expected 2026 revenue target in the $3 million to $4 million range. The growth we have built is real, measurable and growing with each additional active commercial center. Let me walk you through what's driving this commercial momentum and growth. Our commercial model is straightforward and highly scalable. As more centers approve purchase of the device and become active customers, momentum increases with additional transarterial microperfusion or TAMP procedures using RenovoCath. This rise in TAMP procedures leads to greater revenue growth, keeping in mind, RenovoCath is a single-use device and each patient undergoes several TAMP procedures. The expansion of our active cancer centers and procedures is the clearest indicator of that trajectory. One of the key lessons we learned in 2025 was the time it takes for a center to approve the use of RenovoCath and then for a center to order devices and schedule procedures. We are now beginning to apply these lessons with positive effect. We began 2025 with 5 active commercial cancer centers. And by the year-end, we had grown to 8. As of May 2026, we had 16 active commercial centers. We define an active center as a center actively treating patients. Currently, we have 32 additional centers in various stages of evaluation, approval or activation. In total, these 48 centers represent a quadrupling of our near-term pipeline compared to the first quarter of 2025. As you may recall from our last conference call, our objective is to have 36 centers online and ordering by the end of this year, and our pipeline provides us with the capacity to meet this goal. So that's revenue and customer growth, but I also want to speak to the quality of this growth. We are seeing strong repeat ordering behavior from existing customers, which we view as a clear reflection of physician satisfaction and utility for TAP and RenovoCath in the interventional oncology market. That is the kind of recurring organic physician-driven adoption that is critical and reflects real-world validation that we're building durable long-term commercial growth. Our pipeline of prospective cancer centers remains robust with active value analysis committee or VAC submissions underway across a number of leading institutions. Importantly, we see up to 15 active TIGeR-PaC Phase III trial sites that have used RenovoCath in the trial and are already transitioning to commercial clinical use. We expect these conversions to serve as a meaningful revenue driver in the second half of 2026. Separately, I'm pleased to share that RenovoRx was recently recognized by Fast Company as one of its world's most innovative companies of 2026 in the medical devices category. This acknowledgment reflects broader recognition of our team and dedication to innovation. Turning to our commercial infrastructure. This is where innovation translates into execution. Our relatively small capital-efficient but agile and motivated commercial team is in place and delivering. Their focus is clear and the plan is working. I won't spend time on team composition today as the results speak for themselves. What I will highlight is the growing level of physician-to-physician advocacy, which has been the most powerful driver of adoption in interventional oncology. Since receiving an initial FDA 510(k) clearance in 2014, RenovoCath has been used in more than 750 successful procedures. We are building this commercial franchise in a disciplined systematic way, and our Q1 results demonstrate that the model is validated and scaling. With that, I'll turn the call over to our Chief Medical Officer and Executive Chair, Dr. Ramtin Agah.

Thank you, Sean, and good afternoon, everyone. Let me briefly remind everyone what is the scientific core of what we're building and why it matters. Our patented TAMP therapy platform is designed to deliver targeted chemotherapy through the arterial wall near the tumor site, designed to bake the target tumor at a local level while potentially minimizing the therapy toxicity versus systemic intravenous therapy. This approach concentrates drug delivery at the tumor while potentially reducing systemic exposure and the significant toxicities that often accompany conventional intravenous chemotherapy. For patients diagnosed with difficult-to-treat cancers who are also managing the debilitating side effects of treatment, TAMP can represent a critical and differentiated potential treatment option. Our Phase III TIGeR-PaC trial continues to advance on schedule. Based on current projections, we expect to send notifications of closure of enrollment in the trial in the beginning of June, completing our milestone of finishing trial enrollment by the end of June 2026. As of May 14, 2026, we have randomized 106 patients in the trial, representing approximately 93% of our required 114 patients. And currently, there are 12 enrolled patients induction that allow us to close enrollment by the end of June. 74 events have already been observed of the required 86 events or data analysis in the trial. This progress is an important milestone that reflects strong investigator and patient confidence in the program. We continue to anticipate final data in mid- to late 2027, and the trial is designed to evaluate the safety and effectiveness of intraterial gem known as IAG delivered via RenovoCath for locally advanced pancreatic cancer versus systemic IV chemotherapy, the current standard of care. I want to underscore something important. The completion of TIGeR-PaC enrollment directly supports our commercial expansion story and is not separate from it. As trial sites complete enrollment and transition from a research to a commercial footing, they join our growing network of active commercial centers. This is an anticipated and meaningful contributor to our second half 2026 revenue growth. In parallel, we also continue to advance broader clinical programs by generating new data through our continuing support of investigator-initiated trials in borderline resectable and metastatic pancreatic cancer, use of other agents beyond gemcitabine, along with use of TAMP in other solid tumors. Registry and IIT studies are capital-efficient studies, providing meaningful data that may further broaden the application for TAMP therapy platform, which is enabled by RenovoCath. In terms of scientific data, in January 2026, the pharmacokinetic substudy of TIGeR-PaC was presented at ASCO GI meeting by a TIGeR-PaC investigator from the University of Pittsburgh Medical Center. The abstract offers insight that supports the potential effectiveness of our TAMP therapy platform in LAPC. The abstract concludes that TAMP and IAG resulted in reduced systemic levels of gemcitabine and increased levels of its an active metabolite compared with IV gemcitabine. The full paper is submitted for publication later this year. Clinical data builds physician confidence. Physician confidence drives adoption and adoption drives revenue. RenovoRx commercial progress has become the main focus of our story. While the Phase III clinical trial remains a vital long-term value contributor, offering the potential to further accelerate clinical adoption and expand the broader reimbursement landscape, our current operations are not tied to this time line. RenovoRx commercial achievements stand independently, and we believe our Q1 2026 results clearly reflect this trend. I'm excited about where this company stands today and our progress. We're building a company with both near-term execution and long-term upside, and I believe we are still in the early stages of that growth trajectory. Thank you for your interest in RenovoRx. With that, I will turn the call over to our Chief Financial Officer, Mark Voll.

Thank you, Ramtin, and good afternoon, everyone. The first quarter of 2026 was RenovoRx strongest quarter for revenue to date, and the financial results reflect meaningful progress in implementing our commercial plan. Let me walk you through the financial results for the quarter. For the first quarter ended March 31, 2026, RenovoRx reported revenue of $563,000, our strongest quarter-to-date, representing an approximately 136% growth versus Q4 of 2025 revenue of $238,000. The $323,000 of sequential increase from Q4 to Q1 is a direct result of active commercial cancer center expansion and the commercial infrastructure we have built. On a year-over-year basis, this compares to revenue of $197,000 in Q1 of 2025. Revenue growth was driven by addition of 5 new active commercial cancer centers during the quarter, combined with continued repeat offering from our existing customer base, precisely the dynamics our model is designed to generate. Gross profit for Q1 of 2026 was $479,000, representing gross margin of 85.1% Research and development expenses for the first quarter of 2026 were $1.2 million, reflecting our continued investment in Phase III TIGeR-PaC trial and our post-marketing registry study. Our first quarter research and development was positively impacted by receipts of $141,000 from our TIGeR-PaC clinical study. Selling, general and administrative expenses for the first quarter of 2026 were approximately $2.7 million, reflecting disciplined cost management as our commercial infrastructure executes against the plan. Our operating expenses for the quarter were generally in line with our forecast. Research and development spending came in below expectations, while general and administrative expenses were slightly above projections. In both cases, we believe the variances reflect timing differences and when costs were incurred rather than changes in underlying spending patterns. During the first quarter, we successfully closed an oversubscribed private placement, generating approximately $10 million in gross proceeds, an outcome that reflects strong investor demand and confidence in our story. The financing was led by a high-quality group of new and existing institutional investors with additional participation from members of our Board of Directors and senior management, further underscoring our alignment with shareholders and conviction in RenovoRx long-term opportunity. As of March 31, 2026, RenovoRx had approximately $12.4 million in cash and cash equivalents. This reflects the net proceeds from our $10 million private placement that closed in March. Our cash position provides sufficient runway to fund operations in the second half of 2027 as we work towards cash flow positive operations. Our focus now is on revenue generation as we move towards conclusion of our pivotal Phase III trial. As revenue scales on our active commercial cancer center count grows, cash burn continues to decline. The path towards key milestones, TIGeR-PaC readout and commercial breakeven is well funded. We will be opportunistic if capital markets conditions are favorable, but fundraising is not our focus today. We are reiterating our full year 2026 revenue guidance of $3 million to $4 million, and we remain on track to meet that target. Consistent with what I have said before, we are transitioning to a growth company. I spent my career working with high-growth companies, specifically companies that have proven their product works and are now focused on building a commercial engine to scale. This is exactly where RenovoRx is today. There is meaningful difference between a company still searching for a marketable product and/or a market fit and one that has it. RenovoRx has it, and we are executing. As Sean had stated earlier, our second quarter revenue is tracking well, which gives us confidence in stating we believe it will surpass our first quarter revenue. With 16 active commercial cancer centers as of today and a robust pipeline of centers preparing to come online, the directional trend is clear. As TIGeR-PaC clinical sites continue transitioning to commercial centers, we expect that activity to contribute meaningfully to our revenue growth. Our primary commercial KPI remains active commercial cancer center count. We are at 16 active centers today, targeting 36 by year-end, and the revenue contribution at that level of utilization supports our confidence in our guidance range. In closing, our first quarter is the first in which we clearly demonstrated we are executing on our commercial growth plan we laid out. I look forward to providing further updates as the year progresses. Thank you. I'll turn the call back to the operator for Q&A.

Our first question comes from Scott Henry of Alliance Global.

Some really positive sales momentum. Congratulations for that. Just a couple of questions. First, when we think about the profitability of the catheter revenue, it looks like costs went up a little bit in Q&A or in Q1. I assume the selling is within the G&A. My question is, is there any noise in there that made it go to $2.7 million? And more importantly, do you think that what you're spending now will be pretty stable such that as revenues grow even higher, the profitability of the product should really come through?

So we see that our operating expenses will -- we don't see any real increase in operating expenses as we move forward. As we -- as I had stated during the call, we had some timing differences. So more expenses that we had in Q1 for the SG&A and less in R&D. That was kind of abnormal. But we don't see any real increase in operating expenses. We believe that we're well suited in operating expense levels as we ramp revenue. So we should start to see our cash burn decrease as we go throughout the year. So with our model, there's a lot of leverage. As we grow top line, we should see bottom line, at least when it comes to losses decrease and eventually become profitable and expand from there.

Okay. That's great. I appreciate that color. And when we're looking at the revenue numbers, it's early, but are you starting to reach a state where the numbers are large enough that trends will show out as opposed to some chunkiness, a good quarter and then timing of orders. But are we starting to see more of a steady state where the trend should be apparent?

Yes. We're starting to see that. And the biggest predictor and driver of that is seeing how many centers we're bringing on board as a future predictor of revenue, going from 8 to 16 from the end of the year to now really in 4.5 months is really showing that we should start to see some leveling out of the chunkiness and start to see substantial growth this year. It's going to be different percentages every quarter probably, but we do see an upward momentum of our revenue in general and not so much chunkiness in that regard.

Okay. Great. And then final question. When we think about the second half, when those clinical sites shift over from clinical to commercial, do you find that their behavior or do you expect that their behavior will be pretty predictable? You know a lot of these sites already. But based on your feedback, do you feel pretty confident that they will flip the switch into being commercial payers right out of the gate?

Yes. Thanks for asking that question, Scott. Absolutely. We've had dialogues with almost all of them so far, actually, all of them, and there's a lot of interest and enthusiasm to continue to treat patients given that they've seen how potentially effective and how much better the toxicity profile is for their own patients. So there is definitely interest to continue usage. As far as predictability goes, because it's a pancreatic cancer population and locally advanced is where the driver of the initial uses are and there are other uses, we couldn't tell exact numbers. But given our projections, as Mark had characterized, exiting the year with at least 36 active centers provides us with a great revenue flow in general. And we're not using very large numbers of patients per month per hospital to achieve the revenue forecast we put together. So I'd say predictable in the sense we anticipate hitting a minimum at our baseline. and we do see patients coming through. The other really interesting thing, if you look at the clinical trial enrollment, one of the challenges to enrolling in the TIGeR-PaC study is the fact we're looking for treatment-naive patients with a very narrow scope to really ensure we've got very, very clean data going in the study. And one of the biggest headwinds for our enrollment time line is actually a huge tailwind for commercial because once they've gone through chemo, they've seen the side effects, they don't end up going on the surgery. This is a patient population that is largely unmet and the biggest driver for our commercial success. So I see predictably higher volume of patients coming through from these Tiger pack sites than we did in the trial.

The next question comes from Justin Walsh of Jones Trading.

As physicians have gained experience with RenovoCath, I'm wondering if you've received feedback on what aspects of the technology have resonated the most. And it would be also great to hear if there are use cases for RenovoCath outside of LATC that have generated the most interest from investigators.

Thanks for the question, Justin. So the physicians really are looking at the side effect profile as the largest driver. They've seen after treating patients for decades with current standard of care therapies and even looking to potential future technologies or therapies that are coming out, they've seen that these patients get beat up with systemic therapy and they simply can't tolerate something beyond a few months or several months. And so they're looking forward to the characteristic of the toxicity profile being number one. Number two, the confidence that it's not going to reduce their lifespans; and number three, the hope that it will actually increase their lifespans based on early data. So there are several drivers to why they believe that this could be a great choice for their patients. From a use case perspective, the primary experience we've had to date in trials has been locally advanced pancreatic cancer. And again, that's for the purpose of the clinical trial, but it doesn't stop there. There's a strong level of interest. In fact, there are 2 IITs right now that we've greenlighted that are in the process of getting launched at Moffitt Cancer Center, University of Vermont, looking at metastatic pancreatic cancer patients and even earlier-stage cancer looking at resectable or borderline resectable patients at Moffitt and Vermont, respectively. Beyond that, other tumors where they have issues trying to get drug to the tissue because they don't have a large blood supply is a big area of interest, namely biliary tumors or cholangiocarcinoma is an area of interest next. Beyond that, non-small cell lung cancer, some pelvic tumors and even sarcomas given the vascular nature of those types of tumors. So there are several tumor types where there's interest in using the technology either commercially and/or within investigator-initiated trials.

The next question comes from Ed Hu of Ascendant Capital.

Yes. Congratulations on all the progress that you guys are doing on both fronts. My question is on RenovoCath. Do you have to spend much R&D to develop it? Or is it an ongoing process where you need to continue to make upgrades to it going forward?

Well, thanks for the question, Ed. It's interesting. My whole career spent in innovative medical technologies. It's rare when you get to launch a technology with something that's really close to the same design as you started off with. And what's amazing is the technology seems to be working quite well and is user-friendly enough that we -- it's relatively similar design. So it has not taken and will not take large R&D efforts. Having said that, there are optimizations that we've been working on that we will bring out in the next year or 2 that involve really streamlining the manufacturing process for full market scalability beyond even initial penetration and which will really reduce the COGS of the catheter even further and which is amazing because we already have very high margins. Beyond that, we'll continue to explore if there are other minor aspects that could add to the technology of the device to help make the procedure more predictable or easier to use, but not large R&D efforts, and we don't need any of these changes really to penetrate the full market. These are just more optimizations.

Well, ladies and gentlemen, we have reached the end of the question-and-answer session. This concludes today's conference call. Thank you for your participation, and you may now disconnect your lines.

Good day, and welcome to the iAccess Alpha Virtual Best Ideas Winter Investment Conference 2025. The next presenting company is RenovoRx Inc. [Operator Instructions]

I'd now like to turn the floor over to today's host, Shaun Bagai, CEO at RenovoRx Inc. Sir, the floor is yours.

Thank you for the opportunity, and thank you for those listening in, and I look forward to sharing our updates with you and the progress we've made to date as we are closing up an exciting year in 2025 and really planting the seeds and putting in the positive foundation for growth in 2026. My name is Shaun Bagai, CEO of RenovoRx.

And here at RenovoRx, we are working on a new way to think about cancer. Unfortunately, when you think about new cancer therapeutics, it's really a balance of how much you can actually affect the tumor versus destroying the patient. And unfortunately, as a society and as a medical society as well and as an industry, we've been a little bit myopic on trying to destroy the cancer not taking the patient into account. We're looking at maybe trying to flip that on its head and look at not just the tumor itself, but the patient by localizing therapy for cancers. So with that, I'd like to launch into a little bit of the background of the company and the exciting commercial and clinical progress we've made to date.

Our forward-looking statements on our website and can be seen here. At high level, we have a two-pronged approach to a potential market. One is we've initiated commercialization of our FDA-cleared RenovoCath device this year and we've shown over $900,000 year-to-date revenue through Q3 2025. And what's interesting about this, this was really a test of the market to see exactly how the market would behave to our therapy delivery system and what the adoption looks like, what commercialization efforts should look like and really figure out what it's going to take to scale this and really bring this to market next year. This $900,000 and narrow $1 million of revenue was done without a sales infrastructure, and we've recently put a small lean sales infrastructure in place to progress here.

The market for the device as a standalone is over $400 million of peak revenue in the U.S. alone, looking at indications and areas where the device has been used to date. Beyond that, we're also developing the second prong of the company, which is our therapy combination platform, utilizing our proprietary TAMP mechanism, which is Trans-Arterial Micro-Perfusion, specifically on localizing drugs with a drug device combination for locally advanced pancreatic cancer. In that development program, we are advancing our pivotal Phase III TIGeR-PaC study to completion. We anticipate completing enrollment in this Phase III trial early next year in 2026 with final data the year after. And I can go to more details of how that looks.

From an experienced board member situation and management team, we've got the bench of folks who both have pharmaceutical and medical device experience and combination therapies not just in clinical development, but also in disruptive commercialization.

Let's pause for a moment and talk about how our therapy works and what the mechanisms of action is and how this is different. So when you think about the physiology of cancers that we initially started approaching, it's really about the anatomy that's causing a barrier to success in chemotherapy delivery. Many tumors in the body are considered hypervascular or the giant balls of blood vessels and tumor cells that get high levels of blood flow. This is an advantage to chemotherapy delivery systemically because when you give systemic chemo, it circulates the whole body and does have toxicity, but the drugs can reach the tumor by these tumor feeders that feed the tumor directly and end in the tumor. Unfortunately, many tumors in the body don't have these tumor feeders and are considered hypovascular or don't have a large blood supply.

Simply, they have less of a connection to the circulatory system. So when systemic chemotherapy is delivered, you still have these negative toxic effects on the body as a whole and very little drug gets to the tumor, making this almost chemo-resistant, which is why survival for tumors like pancreatic cancers is so low. We managed to overcome that issue with adoption or introduction of chemotherapy with our TAMP, Trans-Arterial Micro-Perfusion system, which is a catheter-based system plays through a very small incision in a leg artery under x-ray guidance by radiologists to deliver chemotherapy locally. And to overcome this issue with not having large blood vessels feeding the tumor, the way the end of our system works is with 2 balloons, we can isolate this segment adjacent to the tumor and then deliver a full dose and volume of chemotherapy over 20 minutes, creating a pressure ahead to force drug across the blood vessel wall and into the tissue.

At not very high pressures, what this does is imagine about a leader of fluid being forced into a small space in about 1 to 2 milliliters of volume in the blood vessel. And again, that causes pressure enough to push the drug outside of the vessel wall to saturate and bathe the tumor in chemotherapy at levels that it otherwise wouldn't see. The resulting effect is we've seen 100x concentration of therapy at the tissue level. This is a log rate scale. So 100x dose locally. And not surprisingly, because we're delivering systemically, we see a much lower exposure systemically. The panel on the left was done as proof-of-concept in animal lung tissue. And the panel on the right is actually from our human studies. We are currently wrapping up our PK sub-study analysis in our Phase III trial. This was the preliminary data showing that we received about a 50% reduction in toxic chemotherapy doses around the body than you would have with systemic therapy. That final data, I recently announced is coming out in the next quarter or so with that subset analysis complete.

From a patient and clinician experience, the patients received 8 treatments over 4 months. So currently, with chemotherapy, they go in every week or every other week for the most part, infusion share have the side effects. With this experience, patients are in and out the same day. It is an outpatient procedure. The procedure itself is about 90 minutes. So it's not a whole day in a lab. The patients are not put under general anesthesia. It's just conscious sedation, and it's relatively easy to learn and adopt from physicians. We're there for the first handful of cases to teach the physician how to use the device, but these skill sets are familiar to the radiologists to do this as they do similar procedures in those more hypervascular liver type cases. Comparatively, other treatment options generally require more hospital stays, overnights and/or side effects for systemic therapies.

From a market potential, our experience to date has been primarily in locally advanced pancreatic cancer in our clinical trials. But this is a list of cancers that also behave like pancreatic cancers where they're relatively hypovascular or don't have large blood supplies. And specifically, with the same drug we've been using, gemcitabine is being used including cholangiocarcinoma or CCA, some non-small cell lung cancers, glioblastomas, sarcomas, uterine tumors and other tumor types like this could follow.

As I mentioned earlier, we have commercialized the device as a broad delivery system. The device is cleared for chemotherapy delivery to the peripheral vasculature. So we've been able to start marketing this as a delivery system tool for physicians to use how they see fit. With success to date so far, it's really hinged upon these metrics, and we really see ramping growth in 2026 based on some great tailwinds we've had in the last year and what we discovered on market adoption. If you look at analogous pressure-mediated delivery catheters, the reimbursement allows us to charge or allows our analogs to charge between $6,000 to $8,500 per device. With each patient receiving between 5 or 8 or even 10 or more procedures per patient, we could ramp up to initial peak market of $400 million with a device alone sales, looking at just the patient populations where we've had experience to date. From a patent perspective, we have 19 issued patents, 9 of which are in the U.S. and all 10 are pending with the most recent patent expiring in 2043.

Now what's interesting about this commercial opportunity is unlike many new technologies, it's not a heavy expensive lift to really penetrate the market. Given these types of tumors, especially in non-metastatic cancers, a lot of these patients are driven to high-volume surgery centers with the hope of taking the tumor out. Unfortunately, that's not the case. Generally, these types of tumors are diagnosed too late. And this allows us to really focus on very high-volume institutions that are highly concentrated more in the East with a few in the West Coast. So with a very small sales team, we could tackle the bulk of these 200 hospitals and drive meaningful revenue and start tracking towards cash flow breakeven. Again, we did revenue of $900,000 so far this year without a sales force in place. So this was primarily inbound interest from physicians, looking for options for their patients and then work on behalf of my management team.

Currently, we have 14 centers approved to purchase the device, 5 of these centers have used the device in patients to date to drive this almost $1 million revenue, and they've made repeat purchase orders. As far as the pipeline goes, we have 24 additional centers that are requested quotes. And also, we've got 18 centers in our Phase III TIGeR-PaC study that should finish enrollment and could convert to using customers next year already being trained and already having a device on the shelf. As I mentioned earlier, we put the sales infrastructure in place with the recent hiring of a Head of Sales and Market Development. And in alignment with the existing budget, we've actually added 2 regional reps in the Northeast and Southeast regions.

To switch gears now to the other asset in our bag besides the commercial opportunity, let's look at our Phase III trial of the drug device combination as a new drug asset. Specifically, we're focusing this trial on locally advanced pancreatic cancer. If you look at what moves the bar for pancreatic cancer, the last major development was the addition of Abraxane to gemcitabine back in 2013. And this survival curve is important. This is what's considered a blockbuster game-changing disruptive new drug, 7 weeks of survival benefit with worse toxicities. So keep this in mind as we go through some of our early data.

In terms of what patients and physicians are looking for, through surveys with medical oncologists, they basically said, if you give me over 2 months of survival benefits over the current standard of care with a better side effect profile, we send the bulk of our patients with 3 to 4 months being a complete game changer.

To touch on our study design, I'll go over this very quickly and handle Q&A if there's more questions. This trial is meant for treatment-naive locally advanced pancreatic cancer patients where the patients are enrolled and get upfront systemic chemotherapy and radiation and then randomized to standard of care chemotherapy systemically versus 8 treatments of TAMP with our drug device combination of RenovoCath and gemcitabine and then followed for survival. A quick snapshot on statistics and timing. We did complete our first interim analysis. It was a very early 30% look, of which the data was presented. I'll share that here. We also surpassed our second interim analysis with a positive review for the data monitoring committee saying late in the study, let's continue to completion. And then final analysis is expected upon the 86 death or event in 2027.

We're randomizing a total of 114 patients with 86 events triggering the final analysis. And again, we anticipate enrollment completion in 2026 and final data in 2027. Looking at the early snapshot of data that was presented at ESMO GI in 2023, we looked at the first 26 deaths when 45 patients were randomized triggering that data analysis. And if you look at the survival curve, it's much better than what we saw before. You can see a large separation between the 2 arms showing actually a 6-month survival benefit of our TAMP procedure with a drug-device combination for locally advanced pancreatic cancer versus standard of care systemic chemotherapy, which is a market difference. But it's not just the survival that's important here. Again, it's really what's happening with the patient.

And with that reduction in systemic chemotherapy exposure, I mentioned earlier with the PK analysis, we have now seen data that shows a 65% fewer toxicity profile in terms of adverse events and serious adverse events, which is not surprising because we are limiting chemotherapy initially to local tumor with much less systemic exposure. So when you think about chemotherapy patients being debilitated, not eating, not spending time with families, being lethargic, we get to reverse a lot of that with our therapy, and we start seeing patients feeling better.

In addition to the Phase III trial, as we're waiting for final data and that PK analysis coming shortly, we have launched our [ RO5 ] post-marketing registry study, which is a device registry so we can track data within commercial usage to see where else this catheter is being used and can start presenting and publishing data subsets as that trial rolls out this year. We already have 3 centers that are actively looking or enrolling patients that have been launched, and we'll expand that slowly this year.

And the other key thing about this post-market registry and additional investigator-initiated trials is that these are very low cost for the company in terms of expenditure as they are registries and investigator initiated trials. And we are selling devices that are being used for these procedures and collecting data. So that does count towards revenue so far this year and the coming years as well. From a team perspective, to touch on this high level, as I mentioned, we have a very experienced team, both on the medical device standpoint, on the pharmaceutical standpoint, drug device combinations and clinical development and commercialization, both on the management side and our Board of Directors. Most notably, our recent Board addition was Dr. Bob Spiegel, who comes by way of a previous Chief Medical Officer of Schering-Plough, and he brings a lot of expertise in terms of designing clinical trials and advancing the pipeline further in a more cost-effective manner.

Given how strong our data has been and the promise of where we're going, I'm proud to present our Scientific Advisory Board of luminaries known internationally in the oncology field with recent additions of Dr. Thierry de Baère, Michael Ducreux from Gustave Roussy in Paris; and Dr. Tim Donahue from UCLA as a surgical oncologist. So we've got a top, top group of physicians who will help driving our progress and seeing the potential for this therapy and such high unmet needs. Also, the previous addition was Dr. Margaret Tempero, who sits on the NCCN -- the Chairman of the NCCN Guideline Committee that writes the guidelines for pancreatic cancer.

So what's coming? Beyond all the excitement and what we've established in terms of commercial progress to date and clinical trial progress, as I mentioned, we did report out revenues of $900,000 through Q3. We did have a positive recommendation to continue passing the second interim analysis milestone, the Phase III trial. So both those buckets of the commercial device opportunity and the Phase III drug assets. Beyond that, we do have our PK subset analysis coming, completion of the TIGeR-PaC Phase III trial enrollment. And then along the way, we will give out updates on how the investigator-initiated trials are going, including 2 recently approved trials that will launch shortly in both metastatic pancreatic cancer and pretreatment before surgery for surgical resectable cancer and borderline resectable cancer.

Beyond that final update, our final data in TIGeR-PaC is anticipated next year in 2027. And along the way, we're building initial interest in the registry study. And one of the most exciting points of being a Phase III company is actually starting to produce revenue and not just burn cash as we start to roll out our revenue scenarios in the coming year.

Highlighting the financial highlights. I mentioned the revenue to date. We did finish Q3 with over $10 million in the bank, and we do anticipate growing revenues in 2026 will reduce our cash from over time. Large institutional ownership. And again, from a TAM perspective, the device alone is about $400 million in annual RenovoCath sales, and that can go up multiples of the drug device combination approval and J-Code reimbursement akin to other companies like Delcath, for example, that has a niche procedure in an ultra-orphan indication with a drug device combination as we do also have orphan drug designation in 2 areas.

And lastly, I'd like to close with just a highlight of our commercial progress. We have learned a lot in 2025 in terms of where this can take us in 2026 and beyond. Again, achieving almost $1 million this year and to date without a sales infrastructure in place and learning what the right lean infrastructure looks like, we've now put that in place or at least start to scale next year. Of course, in this early stage where each patient can represent between $40,000 and $80,000 of revenue, sales will be lumpy in the beginning as we start to roll this out in just a handful of centers. But with such a strong pipeline of now -- there are 13-plus VAC approvals where they can purchase the device, 5 active customers that last public reporting and these are growing and 10-plus in the pipeline of submissions and dozens we've talked to that are interested in starting the process, we have a strong pipeline that our sales folks can actually now bring to the funnel and start to grow revenues in 2026.

This is still early, but we've created a solid foundation to drive growth. This is really what's going to be exciting for the upcoming year in terms of rolling out additional data and driving commercial progress where we can finally see lighted in the tunnel and look to see when we can actually become a cash flow breakeven company with a device alone with a big potential upside of the Phase III trial.

Thank you so much for your time, and I'm open to questions.

So the question came in on why not go international with sales. Thank you so much for the question. We actually looked at the international market deeply. My backbone has actually been disruptive launching of new technologies, and I've spent most of my career in Europe until now.

And what's interesting and amazing is given the regulatory pathway that we discovered in the U.S., with this device because we're not in the brain of the heart, we went through what's called the 510(k) pathway to get approval for the device with limited clinical data based on similarities to other technologies throughout in the field. As I mentioned, there are analogous therapies in the liver that use other types of devices slightly different, and they work better for those physiologies versus these. So the reimbursement here and the regulatory pathway was simpler and more straightforward and faster, which is not normal for very invasive technologies or surgical implants.

So the potential of revenue stream versus burn in the U.S. makes much more sense for now. The reimbursement is much lower in Europe and other countries than it is here. So it makes much more sense to capitalize on the U.S. market start to build out our balance sheet with revenue and then look to expand in lesser profitable markets outside the U.S. Having said that, obviously, there's a large market in both Asia, Europe and elsewhere. I mean we'll look toward that probably with partners down the road. We have already made inroads and connections with physicians globally. As I mentioned the advisory board. We have a couple from physicians from France as well. They want to start driving this. So we will look at the European and Asian markets in the future. But right now, keeping in mind of our cash burn and our potential success on the finance side here, we started to work here first.

The next question is, how should we think about the pace of RenovoCath adoption in 2026 as more NCI centers complete onboarding. It's going to start ramping. So we -- as I mentioned, we have many centers in the pipeline that are going through the purchasing process, and that involves finding a physician champion, making sure there's multispecialty buy-in and then having the hospital to look at the lucrative reimbursement codes to ensure that they'll be profitable with purchasing the device at our ASPs and then approving a device. And that process can take up to 6 months or more hence, the lumpiness in sales in our first year in commercial, where there's been kind of the start to finish of actually getting someone on board, it takes a while. Now what I see in 2026 is a lot of those discussions and processes coming to fruition.

So I believe the pace will start to ramp later next year, looking forward to really finishing 2025 strong than what we've seen so far without the sales infrastructure. and really ramping towards the end of 2026 as well. So a lot of progress to come given the pipeline we've already built up.

Next question is analogous to what I just mentioned. Can I talk about the sales cycle length and what's driving conversions from initial interest to the first procedure? Absolutely. This is the biggest piece I want to learn this year before wasting money, hiring the wrong types of salespeople and building the wrong processes. So as I mentioned, is generally finding that first champion, physician and then having them pull in the multidisciplinary team to make sure that they will get patient referrals and then go through the purchasing process. Some of these processes can go in parallel hospitals. Others have to be sequentially. And that length, we've seen is roughly anywhere from 3 months to 9 months is the range. So I'd say roughly 6 months once we've started those dialogues. And again, having over 28 quotes requested where 14 have gotten approval and 5 have started using. And then I'd say dozens of what I've said publicly on the back end where we had that initial dialogue, we've really built the pipeline to start ramping in 2026.

How many -- next question, how many of the earlier RenovoCath revenue is structural and recurring versus one-off procedure timing? This is actually a great, very interesting point because we look at analogous technologies like TriSalus and others. And it's really trying to replace an existing device and it's a lot of times one-off procedures until there's deep adoption, so you get that range. But what we're seeing is, especially since patients aren't having the same side effects and toxicities, the $900,000 of revenue is only from 5 customers. So it's absolutely repeat usages. It's very important as you look at early medical device penetration is that you are going deep and not too wide. It's not a matter of dropping off orders. It's not a matter of one-off procedures. This is where you need a very large sales force. It's very expensive. So the very focused effort on customers that will have repeat usage is where we can start to see revenue growth without increasing the burn. And that's exactly what we've seen to date and exactly what we expect for 2026.

What are the main gating factors to expanding RenovoCath use beyond pancreatic cancer into additional solid tumor indications? It's getting that first patient in, and we've already had interest. So as I mentioned, bile duct cancer or cholangiocarcinoma is an obvious next target for us. There are physicians looking for those patients today. So it's once we start getting those first patients in and publishing, although the bulk of our interest has been where our data lies to date. So I do see that growing, but primarily probably what we've seen so far.

Given the $10 million cash balance, how far does your current runway extend under the updated commercial plan? So we reported out about $800,000 of burn per month last quarter. That's increasing slightly with the additional hires. And again, it's a sales force of 3 people, not 50 or 20 or 10. So we've estimated that even with the new infrastructure in place, this gets us into halfway through 2026, at least with our current forecast, and it could be more than that based on revenue increases towards the latter half of the first half of the year.

Next question is how should investors think about pricing reimbursement and margin trajectory as case volume increases? This is a great question as well as we already started to see this. The reimbursement is in place. We have seen these getting paid at high levels of reimbursement that allows us to charge in that range of pricing of $6,000 to $8,500 per device times multiple treatments per patient. Already to date -- and this was in our last 10-Q, our margins are at about 80% to date. And we do see that dropping as we start to scale manufacturing, which has already begun and start to make small design tweaks to decrease the cost of manufacturing and increase margins. So 80% is a high place to start when we have a commercial effort, and we're looking forward to bringing that even higher in terms of margins.

One more question is, can you comment on the level of interest you're seeing from potential partners on either the device or the platform side? Thank you very much for this question. This is exactly where we're heading next. So we have had several conversations and continue to be engaged with medical device companies who see this as a potential drop in their bag as they have a sales force in place that sell to oncologists and radiologists with this type of equipment in, let's say, liver spaces or other areas like that. So those are ongoing continually. We actually looked at this, this year and decided that based on the economics, it makes more sense for us to commercialize with a small dedicated sales force versus the revenue situation today. We continue this dialogue as we look to scale later next year or the year after, whether it comes to a distribution arrangement or a potential acquisition, there is definite interest as this is a first-in-class only-in-class device for these types of tumors. So those dialogues continue.

As a reminder, Boston Scientific led our Series B funding back in 2020 -- or sorry, 2018, and they still remain one of our larger shareholders. They have about 7 other companies that also have a similar sales channel that cater these types of customers and physicians that would be great partners that we continue dialogues with. And that's on the device side. And on the platform side as well, this is a first-in-class delivery system that accomplishes things other things can't do. We've been very successful with the generic cytotoxic drug to date. Going from that, we're looking at what's the next best bullet we can put on our system that could really treat even maybe metastatic pancreatic cancer. So we continue to look at other drugs and have discussions with companies that have new and other agents, both immunotherapeutics, potentially antibodies, antibody drug conjugates. So those dialogues are ongoing as this is a platform that can grow into other drug device combinations.

That's all the questions I have so far, almost out of time. So I'd like to finish with giving you the enthusiasm that I have seen the light in the tunnel. I've been here for 11.5 years and seen this grow to really reach physicians and to be able to commercialize this. In fact, if you go on our Investors section in the news -- clinical news section, we had a recent story in NBC New York and Philadelphia of one of our first commercial patients who's been treated. It's great to see this get to patients and now putting the foundation in place to see the light in the tunnel to get to cash flow breakeven, to get the final data and to really bring this home to patients and return value from our investors. Thank you so much for your time.

That concludes RenovoRx Inc.'s presentation. You may now disconnect. Please consult the conference agenda for the next presenting company.

Good afternoon. I will be your conference call operator today. Please note that today's call is being recorded. [Operator Instructions] I will now turn the call over to Valter Pinto, Managing Director of KCSA Strategic Communications. Please go ahead. Thank you.

Thank you, operator. Good afternoon, everyone, and welcome to RenovoRx's Third Quarter 2025 Conference Call. I'm joined today by members of our leadership team, Dr. Dr. Ramtin Agah, Chairman, Founder and Chief Medical Officer; Shaun Bagai, Chief Executive Officer; Leesa Gentry, Chief Clinical Officer; and Ronald Kocak, VP, Controller and Principal Accounting Officer. Before we begin, I'd like to remind everyone that statements made during today's call contain or may contain forward-looking statements, covered by the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and applicable federal securities laws. These statements, including statements regarding RenovoRx's clinical and commercial plans, strategies and estimates of performance are based on management's current plans and assumptions, and actual results may differ materially.

Please refer to our filings with the SEC, including our Form 10-Q for the third quarter of 2025 and our most recent Form 10-K for a detailed discussion of the risks and uncertainties facing RenovoRx. With that, I'd like to turn the call over to our Chairman, Founder and Chief Medical Officer, Dr. Ramtin Agah.

Thank you, Valter, and good afternoon, everyone. This quarter marks another important step forward in RenovoRx's 14-year journey transforming the bold concept into a new therapeutic option that is now reaching patients across the country. Our proprietary Trans-Arterial Micro-Perfusion therapy platform, or TAMP, is designed for targeted therapeutic drug delivery across the arterial wall near the tumor site to bait the target tumor. By localizing and targeting delivery of therapeutic agents via the peripheral vascular system, TAMP is designed to optimize drug concentration where it's needed. This targeted approach is designed to minimize systemic exposure and toxicities related to chemotherapy and address the long-standing challenge in cancer care of poor blood supply to tumor sites.

We believe that TAMP represents a significant advancement in the way cancer treatment can be approached. For decades, pancreatic cancer treatment has revolved around 3 pillars: surgery, radiation and chemotherapy. We're proud to be introducing TAMP as the fourth option for patients diagnosed with solid tumors. What began as an idea tested in controlled clinical trials is now translating into real-world impact. Several times a week, a patient somewhere in the U.S. is being treated with our TAMP technology, and that is deeply meaningful to our team. The early signs of clinical adoptions are promising. We are seeing interest and adoption from academic medical centers, NCI-designated cancer centers and large community hospitals.

Importantly, physicians who have used TAMP enabled by RenovoCath are treating additional patients, validating the utility and safety of our technology. We are also expanding engagement across disciplines, including interventional radiology, surgical oncology, medical oncology and radiation oncology, reflecting the truly multidisciplinary nature of our platform. To support this effort across multiple specialty lines, we have launched our TAMP Workshop series in an online peer-to-peer forum. We are also proud to be expanding our scientific advisory board with world-renowned physicians who believe in the potential of our technology. Our mission is to integrate our approach to therapeutic drug delivery into the standard of care and ultimately improve patient outcomes by offering a more targeted and tolerable treatment path. With that, I turn it over to our CEO, Shaun Bagai, to share some details on our commercial and clinical progress.

Thank you, Ramtin. Building on our clinical progress, we are also seeing strong commercial momentum for RenovoCath as a stand-alone medical device. Year-to-date revenue through the end of Q3 was approximately $900,000, putting us on track to finish out the year strong as we continue to build a lean, cost-efficient sales and marketing foundation that will enable meaningful revenue acceleration in 2026 and beyond. It's important to remember that we've achieved our RenovoCath sales results with a lean team and within our budget with a relatively small capital outlay. While our goal is to grow from the base we've established, our plan is to remain lean and maintain our philosophy of prudent capital deployment.

Since organically launching commercial sales less than a year ago and without a dedicated sales and marketing team, we've expanded from 5 centers approved to purchase RenovoCath at the start of 2025 to 14 leading cancer centers now approved to purchase. Five of these centers have already used the device in patients and made repeat orders, demonstrating both demand and customer satisfaction. In addition to the 14 centers now approved to purchase RenovoCath, we have delivered product quotes to 10 additional leading centers across the nation, bringing the total to 24 centers that have formally requested quotes for RenovoCath. In addition, we have engaged with dozens of physicians at various medical conferences and in their institutions who have expressed commercial interest in utilizing RenovoCath for their patients.

We continue to nurture and build on this interest that will drive commercial success going forward. Physician feedback continues to underscore what we view are the benefits of the targeted drug delivery that can be achieved with TAMP, including reducing systemic chemotherapy toxicity and improving patient quality of life. With our small team, we've now established a geographically diverse network of clinical institutions using and interested in TAMP enabled by RenovoCath spanning through the United States. This network represents not only leading academic institutions and NCI-designated cancer centers, but also high-volume community hospitals, giving us the confidence in the potential for deep market penetration of our technology.

Our focus remains on strategic data-driven expansion, ensuring each new center is well supported through onboarding, training and case follow-up. We are also seeing growing physician-to-physician advocacy, one of the strongest indicators of adoption in interventional oncology. To support and expand our commercial efforts, in August, we announced the hiring of Phil Stockton as Senior Director of Sales and Market Development. Phil brings more than 25 years of medtech leadership to the team, including a decade focus on interventional oncology. His expertise has been invaluable as we broaden our footprint across the U.S. while maintaining a lean operating structure. In alignment with our existing budget and to respond to growing demand, we have added 2 additional regional sales managers and plan to add a marketing director to drive physician engagement.

It's also been a year of intense learning for us based on our experience in the field, and we've gathered valuable data on metrics like customer preferences and sales cycles. We plan on applying these learnings into 2026. We are pleased to report that we are seeing repeat use and the expansion of interest among a growing number of approved centers and increasing market awareness and interest across oncology disciplines. As we refine and grow our efforts with a small but dedicated and experienced sales and marketing team, we continue to expand our revenues to grow during 2026 and beyond. Taken together, we are encouraged by our early adoption curve and believe our commercial growth strategy positions us for long-term success.

Our vision is for RenovoCath to address a large unmet need in oncology. We continue to estimate that the initial peak U.S. market opportunity of RenovoCath as a stand-alone device is approximately $400 million annually and ultimately a several billion dollar opportunity as we expand into other tumor types. Importantly, as mentioned, we continue to operate with fiscal discipline, positioning RenovoRx for long-term growth as we scale our commercial foundation and prepare for broader adoption. As of September 30, 2025, RenovoRx had over $10 million in cash and cash equivalents. Through the first 9 months of 2025, RenovoCath sales totaled approximately $900,000, which we expect will increase over time and reduce our burn rate.

Based on our current plans, our cash on hand is expected to fund both the RenovoCath commercial scale-up and continued progress of our Phase III TIGeR-PaC trial as well as other activities into the middle of 2026. Of course, any increase in sales momentum beyond our current expectations could extend this time line. As we continue to make progress commercially and as each day we get closer and closer to our Phase III data readout, we have multiple potential opportunities to strengthen our balance sheet as needed even further, including but not limited to debt and/or equity financing as well as our current ongoing licensing and partnership discussions.

I feel it's important to note that the 3-year anniversary of our shelf registration statement is expiring next week, and we will be refreshing this filing. Additionally, we will be establishing an at-the-market offering. All of these financing options should provide our company with the best flexibility as we continue to drive shareholder value. In conclusion, we are excited about where we stand today as a company, progressing our Phase III clinical trial and post-market registry study while growing our RenovoCath sales efforts as we bring our novel technology to more and more doctors and patients. Ramtin spoke of a 14-year journey with our commercial sales efforts for RenovoCath and the end of our Phase III trial around the corner, we are seeing light at the end of the tunnel, and we are all enthusiastic about our future as we've ever been.

We are truly grateful to our investors and other stakeholders, including our early adopter cancer centers and physicians who continue to believe in our mission and are helping make our vision a reality. With that, I'll hand the call over to our Chief Clinical Officer, Leesa Gentry, to provide more detail on our clinical programs.

Thank you, Shaun. The primary goal of our clinical research and scientific programs is to continue to strengthen the evidence base supporting our TAMP platform. Our new post-marketing registry study that we launched in July is progressing well, generating real-world data on the safety and effectiveness of RenovoCath across a range of solid tumors. We are pleased to have initiated the first patient procedure at the University of Vermont Cancer Center in September and to have Baptist Health, Miami Cancer Institute and the University of Pittsburgh Medical Center joining as additional study sites. This capital-efficient multicenter study will generate critical evidence on the long-term safety and performance of RenovoCath across solid tumors.

Importantly, our registry study also advances our future clinical strategy by generating meaningful data that will open the door for how best RenovoCath may be leveraged in additional high unmet need oncology indications beyond locally advanced pancreatic cancer. In addition, we continue to advance investigator-initiated trials in borderline resectable and oligometastatic pancreatic cancer. These studies are designed to be cost neutral to the company while providing meaningful data that may further broaden the application of our TAMP therapy platform. Together, these initiatives reflect how RenovoRx is building a robust body of evidence to integrate our technology into the treatment continuum, not only as an alternative, but as the new fourth option that may enhance the current standard of care.

Finally, our Phase III TIGeR-PaC trial continues to progress with enrollment expected to be completed in early 2026 and final data anticipated in 2027. Last quarter, we reported that the Data Monitoring Committee completed their review of our second preplanned interim analysis and recommended that we continue the study. We believe the DMC's recommendation is an expression of confidence in the potential for a positive outcome in the trial overall. The second interim review of data reinforces that the trial should proceed as planned to the final analysis as we seek to potentially demonstrate the safety and superiority of intra-arterial gemcitabine delivered via RenovoCath for the treatment of locally advanced pancreatic cancer as compared to IV chemotherapy, the current standard of care.

TIGeR-PaC remains the cornerstone of our clinical development program, validating our mechanism of action and safety profile through rigorous long-term evaluation. In closing, I would like to share that we are proud to have recently strengthened our Scientific Advisory Board to now include recognized surgeon and pancreatic cancer expert, Dr. Timothy Donahue, and internationally renowned Interventional oncologist, Dr. Thierry de Baere. Dr. Donahue is Director of UCLA's Agi Hirshberg Center for Pancreatic Diseases and Chief of the Division of Surgical Oncology at the David Geffen School of Medicine. He is also the Garry Shandling Chair in Pancreatic Surgery. Professor de Baere is Head of Interventional Radiology at both the Gustave Roussy Cancer Center and the Université Paris-Saclay in France. With that, I'll hand the call over to our VP, Controller and Principal Accounting Officer, Ron Kocak, to review our financials for the quarter.

Thank you, Leesa. For the third quarter ended September 30, 2025, Renovo reported revenues of approximately $266,000, driven by both new customer orders and repeat purchases of RenovoCath, resulting in a total of approximately $900,000 of revenues through the first 9 months of 2025. This early in commercial launch, we're not surprised by relatively minor fluctuation in sales given that our commercialization efforts are so new, have been handled by limited staff and a handful of patients receiving treatment via RenovoCath can move the needle in product orders. We firmly believe that our efforts to date set the stage for revenue growth going forward.

Research and development expenses were $1.7 million, reflecting our continued investment in TIGeR-PaC and support for investigator-initiated and registry studies. Selling, general and administrative expenses were $1.7 million, reflecting stable operating expenses while we add targeted commercial capabilities. We ended the quarter with over $10 million in cash and cash equivalents. Based on our current operating plan, we believe this cash is sufficient to fund our ongoing commercialization efforts and the completion of enrollment in TIGeR-PaC. As of September 30, 2025, common shares outstanding were approximately 36.6 million. With that, I will now turn the call back to the operator for Q&A.

[Operator Instructions] Our first question comes from Ed Woo with Ascendiant Capital.

Yes. Congratulations on all your progress. I know you guys have your hands full commercializing it in the U.S. But have you thought given the reception -- positive reception of maybe going international?

Thank you for the question. Always great to talk to you. So we've looked at that in the past and the favorable reimbursement and the large interest in the U.S. has determined that we'll focus on the U.S. for now. There's obviously pancreatic cancer and other solid tumors that could be treated potentially effectively with our technology. So it's something we'll explore in the future. But keeping a close eye on capital burn and the large potential market that's right at our fingertips. It makes sense to 100% focus in the U.S. today.

Great. And a little bit about your supply chain. How quickly would you be able to ramp it up if it turns out that expectations are even faster than you expect?

It's actually a great partnership we formed with our contract manufacturer. We announced a stronger collaboration almost a year ago, and they've already begun ramping. We've already reduced our COGS and increased our margins. And the great thing about the way we've built this device is the RenovoCath actually has over a 2-year shelf life. So we're already building stores up with high margins where we can supply what we anticipate the demand to be. And it is a larger operation. We can turnkey and ramp even quicker if we need to. So we've got a good collaboration and good supply chain so far.

Is that supply chain, is it manufactured in the U.S.?

Thanks for asking that question. It's something that comes up quite often. Yes, it is. Our contract manufacturer is based outside of Chicago in the U.S. and largely pretty much all the components used to build the device are also sourced from the U.S. So we've been relatively insulated from the global macro issues in terms of supply chain so far.

Our next question comes from Charles Wallace with HCW.

This is Charles on for RK. So for my first question, can you talk briefly about any fruits you're seeing from the hiring of the new Senior Director of Sales? And then kind of looking ahead, do you hope to -- when you're kind of building out the commercial effort, do you hope to increase the number of approved centers? Or do you hope to focus more on going deeper into the approved centers to get more repeat orders?

Yes. Thanks for the question, Charles. It's a very focused deep effort, and we're starting to increase the breadth with the addition of new hires. So with the addition of kind of the senior salesperson, he's both player coach so he's out there selling and also helping build out the strategy. It's important to note that with a new technology like this, that we're first to market in a brand-new space, and we've learned the multitude of steps that need to be done to get physicians from first engagement to patients and really shorten that time from initial contact to first patient treatment. And I have begun to see the fruits of his labor in that regard and from the 2 new hires he's brought on board as well.

And the good news is that after 6 to 9 months of being in the market, we're not seeing headwinds in our strategy. And we're creating already meaningful market adoption and some revenue with just a small commercial team driving in 2026. So we do anticipate increasing the breadth and the footprint as well. Currently, I've mentioned that we've got 5 active centers treating patients and multiple patients with multiple catheter orders. And in total, 24 hospitals have requested formal quotes for the device. And I'd say dozens on the tails of that, that have expressed interest that my small focused team can go and drive through to get those first patients in. So getting this team in place and learning the strategy very carefully with our burn over the last several months, we're really gearing up to be ready to drive this into the end of the year and then towards a lot of growth for next year and then beyond.

Great. I guess to follow up on what you just said, could you maybe provide a time line that's typical for these hospitals that requested approval to the actual approval?

Yes. So the sales cycle is actually quite wide, and we've seen anything from several weeks in a couple of months to several months beyond that. And I do believe that will get shortened with constant contact with more local representation. We did hire a couple of more regional territory managers to help drive that forward. As far as going deep, taking low-hanging fruit where we can get approvals to get on the shelf and we do have multi-specialty engagements sooner, we can shorten that time line to within a handful of months. And what's great about looking into 2026 is we do have a very strong pipeline already, and it's really been a matter of resources to have reps be able to service those physicians and get this through the approval process onto the shelf and getting to that first patient. So it's -- the time line is where we sit right now with, as I mentioned, 24 requests, another few dozen behind that of interest, we can start to see those really come to fruition in the several months ahead of us.

Great. And then sorry if I missed it, just maybe on the clinical side. Did you provide the patient numbers for how many have enrolled and how many events have occurred in the study? TIGeR-PaC?

So we did at the end of Q2, announcing 95 patients randomized and 61 events by the end of Q2. Now we've updated guidance that we do anticipate final enrollment to be early next year and final data in 2027. Again, as a reminder, we need to randomize a total of 114 patients and the 86 deaths will trigger the final analysis.

[Operator Instructions] As there are no further questions, I would now like to hand the conference over to Shaun Bagai for closing remarks. Thank you.

Thank you, everyone, for calling in and those listening to the recording afterwards. We're very excited with the progress we made. As mentioned, we see light at the end of the tunnel. We're seeing physicians and patients really seeing the opportunity to benefit from our technology here. And I appreciate you joining in and a lot of exciting things to come in the very near future.

Thank you. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

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.