Prepared remarks
Good afternoon. I will be your conference call operator today. Please note that today's call is being recorded and all participants, other than management, are in a listen-only mode. There will be a Q&A session following management's presentation. 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 Follan, 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 include statements regarding RenovoRx's clinical and commercial plans, strategies, and estimates or expectations of financial results, including revenue and operational performance. Such statements 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, Valter, 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 mark 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 a $3 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 Trans-Arterial Micro-Perfusion (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 five active commercial cancer centers, and by year-end, we had grown to eight. 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. 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 order behavior from existing customers, which we view as a clear reflection of physician satisfaction and utility for TAMP and RenovoCath in the interventional oncology market. That recurring, organic, physician-driven adoption 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 (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 acknowledgement 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, Shaun, 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 treat the target tumor at a local level while potentially minimizing systemic 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 or those developing significant side effects from systemic treatment, TAMP can represent a critical and differentiated potential treatment option. Our Phase 3 TIGeR-PaC trial continues to advance on schedule. Based on current projections, we expect to send notifications of closure of enrollment in the trial at 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 in induction that allow us to close enrollment by the end of June. Seventy-four events have already been observed of the required 86 events for 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. The trial is designed to evaluate the safety and effectiveness of intra-arterial gemcitabine, 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 research to commercial, 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 the TAMP therapy platform, which is enabled by RenovoCath. In terms of scientific data, in January 2026, the pharmacokinetic sub-study of the TIGeR-PaC trial was presented at the 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 inactive 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 that timeline. RenovoRx commercial achievements stand independently, and we believe our Q1 2026 results clearly reflect this trend. I'm excited about where we are 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 Follan.
Thank you, Ramtin, and good afternoon, everyone. The first quarter of 2026 was RenovoRx's 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, the strongest quarter to date, representing approximately 136% growth versus Q4 of 2025 revenue of $238,000. The $323,000 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 five new active commercial cancer centers during the quarter, combined with continued repeat ordering 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 the Phase III TIGeR-PaC trial and our post-marketing registry study. Our first quarter research and development was positively impacted by receipt 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. R&D spending came in below expectations, while general and administrative expenses were slightly above projections. In both cases, we believe the variances reflect timing differences in 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's 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 into the second half of 2027 as we work towards cash flow positive operations. Our focus now is on revenue generation as we move towards the conclusion of our pivotal Phase III trial.
As revenue scales and our active commercial cancer center count grows, cash burn should continue to decline. The path towards key milestones, including the TIGeR-PaC data readout and commercial break-even, 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 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 a meaningful difference between a company still searching for a marketable product or market fit and one that has it. RenovoRx has it and we are executing.
As Shaun stated earlier, our second quarter revenue is tracking well, and 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 the guidance range. In closing, our first quarter is the first in which we clearly demonstrated we are executing on the 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.
Questions and answers
We will now begin the question and answer session. Please note for participants making use of speaker equipment, it may be necessary to pick up your handset before pressing the star keys. If you'd like to ask a question, please key in star and then 1 on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may key in star and then 2 to leave the question queue. Our first question comes from Scott Henry of Alliance Global. Please go ahead.
Thank you and good afternoon, 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 Q1. I assume the selling is within the SG&A. My question is, is there any noise in there that made it go to $2.7 million? 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? Thank you.
So we don't see any real increase in operating expenses as we move forward. As I had stated during the call, we had some timing differences, so more expenses that we had in Q1 for SG&A and less in R&D. That was somewhat 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. With our model, there's a lot of leverage. As we grow the top line, we should see the bottom line improve, at least when it comes to losses decreasing, and eventually becoming profitable as we expand from there.
Okay, that's great. I appreciate that. 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?
Yeah, 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 eight to 16 from the end of the year to now, really in four and a half months, is 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 will be pretty predictable? You know many of these sites already, but based on your feedback, do you feel pretty confident that they will flip the switch and be commercial users right out of the gate?
Yeah, 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 the therapy can be and how much better the toxicity profile is for their own patients. So there is definitely an interest to continue usage. As far as predictability goes, because it's a pancreatic cancer population and Locally Advanced Pancreatic Cancer is where the driver of the initial uses are, and there are other uses, we couldn't tell exact numbers, but given our projections, 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 say predictable in the sense we anticipate hitting a minimum 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 that we're looking for treatment-naive patients with a very narrow scope to ensure very clean data going into the study. One of the biggest headwinds for our enrollment timeline is actually a huge tailwind for commercial because once patients have gone through systemic chemotherapy and experienced the side effects, they often don't go on to surgery. This is a patient population that is largely unmet and that is the biggest driver for commercial success. So I see predictably a higher volume of patients coming through from these TIGeR-PaC sites than we did in the trial.
Okay. Great. Well, thank you for taking the questions. Really exciting to see the progress you're having.
The next question comes from Justin Walsh of Jones Trading. Please go ahead.
Hi. Thanks for taking the questions. 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 LAPC that have generated the most interest from investigators?
Thanks for the question, Justin. So physicians are really 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 therapies that are coming out, these patients often get very burdened by systemic therapy and simply can't tolerate treatment beyond a few months. So they're looking for the characteristic of the toxicity profile being improved. Number two, the confidence that the therapy is not going to reduce patients' lifespans. And number three, the hope that it will actually increase lifespans based on early data. So there are several drivers for why they believe 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 are two investigator-initiated trials right now that we've greenlighted that are in the process of launching at Moffitt Cancer Center and the University of Vermont, looking at metastatic pancreatic cancer patients and even earlier-stage patients, looking at resectable or borderline resectable patients at Moffitt and Vermont, respectively. Beyond that, other tumors where drug delivery to the tissue is challenging because of poor blood supply are areas of interest. Namely, biliary tumors or cholangiocarcinoma is an area of next interest. Beyond that, non-small cell lung cancer, some pelvic tumors, and even sarcomas given the vascular nature of those tumor types are being explored. So there are several tumor types where there's interest in using the technology either commercially or within investigator trials.
Great, thanks for taking the questions.
The next question comes from Ed Hu of Ascendiant Capital Markets. Please go ahead.
Yeah, 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. My whole career has been spent in innovative medical technologies. It's rare when you get to launch a technology that's really close to the same design as you started with. What's notable is the technology seems to be working quite well and is user friendly enough that its design remains relatively similar. 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 two. Those involve streamlining the manufacturing process for full market scalability, which will reduce the cost of goods for the catheter even further, and that's important because we already have very high margins. Beyond that, we'll continue to explore minor aspects that could add to the device to help make the procedure more predictable or easier to use, but not large R&D efforts. We don't need any of these changes to penetrate the full market. These are optimizations.
Well, that's great to hear. Thanks for answering my question and I wish you guys good luck.
Thank you. Thank you, Ed.
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.