RNXT

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 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 RenovoRx'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, 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 the $3 million-$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 five active commercial cancer centers, and by the 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. That's revenue and customer growth. 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 TAMP and RenovoCath in the interventional oncology market. That is a 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 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. 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 bait the target tumor at a local level while potentially minimizing a 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 patient in induction that allow us to close enrollment by the end of June. 74 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, and 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 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 trial 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 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 timeline. RenovoRx commercial achievements stand independently, and we believe our Q1 2026 results clearly reflect this strength. 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 five 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 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 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 and 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-$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 Shaun 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.

Thank you. 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 one on your telephone keypad. A confirmation tone will indicate that one is in the question queue. You may key in star and then two to leave the question queue. Our first question comes from Scott Henry of Alliance Global Partners. Please go ahead.

Thank you and good afternoon. Some really positive sales momentum. Congratulations for that. Just a couple questions. First, you know, 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 G&A. My question 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.

We don't see any real increase in operating expenses as we move forward. As I'd 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. 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 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. 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, you know, some chunkiness, a good quarter and then, you know, timing of orders? Are we starting to see more of a steady state where the trend should be apparent?

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 8-16 from the end of the year to now, you know, really in 4.5 months is really showing that we should start to see some leveling out of the chunkiness and start to see a substantial growth this year. It's gonna be different percentages every quarter probably, but we do see an upwards momentum of our revenue in general and not so much chunkiness in that regard.

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

Thanks for asking that question, Scott. Absolutely. We've had dialogues with almost all of them so far, actually all of them. 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. There is definitely an 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 their other uses, we couldn't tell the exact numbers. 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.

We're not using very large numbers of patients per month per hospital to achieve the revenue forecast we put together. 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 clean data going into the study.

The one of the biggest headwinds for our enrollment timeline 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 to surgery, this is a patient population that is largely unmet and the biggest driver for our commercial success. 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.

Thanks, Scott.

Thank you. The next question comes from Justin Walsh of JonesTrading. 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. It'll 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. 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. They're looking forward to the characteristic of the toxicity profile being number one. Number two, the confidence that it's not gonna reduce their lifespans. Number three, the hope that it'll actually increase their lifespans based on early data. 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. 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 two 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 vascularity nature of those types of tumors. There are several tumor types where there's interest in using the technology either commercially and/or within investigator-initiated trials.

Great. Thanks for taking the question.

Thank you, Justin.

The next question comes from Ed Woo of Ascendiant Capital. 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 continually make upgrades to it going forward?

Well, thanks for the question, Ed. You know, it's interesting. My, 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. What's amazing is the technology seems to be working quite well and is user-friendly enough that it's relatively similar design. It has not taken, 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 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 'cause 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. We don't need any of these changes really to penetrate the full market. These are just more 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. Anyone now disconnect your line.

Good afternoon. I'll be your conference call operator today. Please note that today's call is being recorded and all participants, other than management, are in listen-only mode. There will be a Q&A session following management's presentation. I'll 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 fourth quarter and full year 2025 financial results conference call. I'm joined today by members of our leadership team, including Dr. Ramtin Agah, Executive Chairman and Founder, 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 call 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 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-K for the year ended December 31st, 2025 for a detailed discussion of the risks and uncertainties facing RenovoRx. With that, I'll turn the call over to our Chief Executive Officer, Shaun Bagai.

Thank you, Valter, and good afternoon, everyone. Before I walk through our results, I want to acknowledge two important developments in our leadership structure. As we recently announced, Dr. Ramtin Agah, our founder and inventor of our patented TAMP therapy platform, has transitioned to the role of Executive Chairman. This evolution reflects a deliberate and positive step in our company's maturation. As RenovoRx moves deeper into the commercial phase of our story, we are positioning ourselves as the commercial stage growth company we have become. Ramtin's deep clinical and scientific expertise is a tremendous asset to our company. After spending time in the field, we are seeing the early benefits of his impact on helping to drive the commercial efforts at both the physician-to-physician level and helping shape our commercial strategy. His leadership as Executive Chairman will continue to shape our long-term direction.

I am pleased he is joining us on today's call. I also want to formally welcome Mark Voll as our new Chief Financial Officer. Mark brings more than 30 years of financial leadership experience and a proven track record of guiding high-growth public companies through periods of commercial build-out and strategic development, the exact inflection point where we're at today. The decision to recruit Mark was intentional. He has served as Chief Financial Officer for multiple publicly traded technology companies, where he successfully led initiatives that scaled operations into high-growth businesses. We are a revenue-generating commercial company focused on scaling, and this is precisely the right moment to bring in financial leadership experience in that kind of growth. Mark will review our financials shortly, and I encourage all of you to listen carefully to his perspective on our revenue trajectory and 2026 outlook.

Let me start with the big picture. 2025 marked a key year for RenovoRx, as it was our first full year of RenovoCath commercialization. We entered 2025 taking our initial steps towards commercialization with no dedicated sales team and limited approved commercial cancer centers. We exited the year with a strong understanding of the market and a clear strategy supported by a focused and agile sales and marketing team, resulting in meaningful revenue from a small group of centers. For the full year 2025, RenovoRx generated over $1 million in revenue, reflecting strong initial RenovoCath adoption. Our fourth quarter revenues came in at $238,000, tracking closely to our Q3 results. The reason for this is straightforward. With a small number of active commercial centers, our initial quarterly revenue is naturally subject to variability.

We exited Q4 with nine active commercial centers, with three of them becoming active just in the last two weeks of the year. When each patient receives multiple treatments over time, the timing of a single patient's first treatment can move our quarterly revenue this early in a product launch. Our quarterly revenue is a reflection of the number of active commercial centers. Our Q4 revenue specifically is not a reflection of physician demand, product satisfaction, or the long-term commercial opportunity. All three of these elements continue to be strong. What it shows is a scale limitation that we are actively addressing.

I will talk about our positive 2025 market penetration in a moment, but it is critical to keep in mind that we currently have 17 phase III TIGeR-PaC sites that have used RenovoCath in the trial and are already preparing to transition to a commercial use upon enrollment completion. We expect all these sites to fully become commercial sites ramping up in revenue in the second half of the year. A select number of these centers have begun to transition to commercially adopt RenovoCath as a standalone device for drug delivery in the treatment of solid tumors, signaling broader integration into oncology management. This is an encouraging development that represents an important additional channel for commercial cancer center expansion. The most important metric to understand RenovoRx's commercial trajectory is the growth of our active commercial site network.

Our network of active commercial cancer center clients continues to grow significantly, resulting in meaningful revenue generation, which we expect to see beginning right here in Q1 of this year and going forward. While we are still relatively early in the game, we believe we are beginning to unlock the broader commercial potential for RenovoCath as a standalone device. Adoption across U.S. cancer centers continues to build, driven by new and repeat orders, growing physician familiarity, along with increasing overall patient referrals to our commercial sites. As of February 27, 2026, 12 U.S. cancer centers are utilizing RenovoCath, and 21 additional centers are evaluating the device, have completed evaluation, or are preparing for activation. These 33 centers represent a tripling of our near-term pipeline compared to the first quarter of 2025.

What 2025 and the first months of 2026 demonstrated, despite early-stage quarterly revenue fluctuations, was the fundamental viability of our product, our ability to convert centers to active commercial use, and the early proof points that centers who adopt TAMP continue to use it. 2025 validated our commercial model, our reimbursement pathway, and our ability to support centers clinically and operationally. We also learned valuable lessons in 2025 about cycle trends, activation timelines, customer preferences, and other commercial data which we expect to apply as we seek to grow RenovoCath revenues in 2026 and beyond. We are targeting approximately 36 active commercial sites by year-end, which represents tripling our current commercial footprint. The 2026 site expansion plan is supported by a robust pipeline of centers that have already completed evaluations, are in contracting, or are preparing for activation. This is not aspirational growth.

It is grounded in measurable commercial activity. We believe this expansion, combined with deepening utilization at existing sites, will be the primary driver of revenue growth. The rise in RenovoCath clinical adoption is supported by both targeted commercialization efforts, such as the launch of RenovoRx's sales and marketing team in late 2025, and the growing body of real-world clinical evidence regarding the safety and effectiveness of RenovoCath in patients with solid tumors. Since receiving FDA 510(k) clearance, RenovoCath has been used in more than 700 successful procedures. A focused and dedicated commercial team will be the engine behind this growth. In the third quarter of 2025, we hired a Senior Director of Sales and Market Development with over 25 years of med tech leadership, including a decade focused specifically on market development in interventional oncology.

At the end of 2025, he recruited two regional sales managers to expand our geographic reach and plans to add a third and fourth soon. We also hired a Marketing Director in late 2025 to drive broader physician engagement and awareness. Each of these team members brings extensive med tech expertise with a track record of developing and selling into a multi-specialty market. We are building this team in a capital-efficient way consistent with our philosophy of disciplined growth. In the first two months of 2026, we are seeing strong commercial activity in terms of new site activations, orders, and physician engagement. I am confident that we will continue to utilize knowledge from successful traction in a handful of centers in 2025 to drive meaningful revenue growth in 2026 and beyond.

Mark will provide more specific context on what we are seeing, but we are excited about the momentum we are generating. With that, I'll turn our call over to our Executive Chairman and Founder, Dr. Ramtin Agah.

Thank you, Shaun, and good afternoon, everyone. I want to begin by saying that I'm genuinely excited about where this company stands today, not despite our challenges, but in full view of them. Building a company is hard. Being first to address unmet clinical needs using a different approach is hard. We have done both, and we now have a product in the hands of physicians across the country for treating and achieving real benefits with our proprietary Trans-Arterial Micro-Perfusion therapy platform. This is not a small thing. Let me briefly remind everyone what we have built. Our patented TAMP technology enables targeted therapies delivered across the arterial wall near the tumor site to target the tumor while potentially minimizing the therapy's toxicity versus systemic intravenous therapy. This approach localizes drug concentration at the tumor while minimizing systemic exposure and the toxicities that accompany conventional intravenous chemotherapy.

For patients diagnosed with solid tumors who are fighting cancer while managing debilitating side effects, this is a critical differentiation. For decades, the pillar of cancer care has been surgery, radiation, systemic chemotherapy. We believe TAMPs enabled by RenovoCath represents a fourth option, one that is targeted, tolerable, and increasingly supported by real-world evidence. Our phase III TIGeR-PaC trial continues to advance on schedule. We recently announced a milestone with our 100th randomized patient in the trial, and enrollment is on track to be completed by the end of first half of 2026, ensuring that the required minimum of 114 patients will be randomized, with final data anticipated in 2027. The trial is designed to potentially demonstrate the safety and superiority of intra-arterial gemcitabine delivered via RenovoCath for locally advanced pancreatic cancer versus systemic IV chemotherapy, the current standard of care.

TIGeR-PaC remains the cornerstone of our clinical validation strategy, and a positive data readout will be transformative, not just for the business, but for our patients. As of March 24, 2026, we have randomized 104 patients in the trial, representing approximately 91% of our required 114 patients, and with 72 events observed of the required 86 events to trigger the final analysis. This progress is an important milestone that reflects strong investigator and patient confidence in this program. We also continue to advance broader clinical programs by generating new data through post-marketing registry studies in solid tumors and continued support of investigator-initiated trials, known as IITs, in borderline resectable and metastatic pancreatic cancer, along with exploring physician interest in other areas.

Registry and IIT trials achieve cost neutrality as capital efficient studies providing meaningful data that may further broaden the application for the TAMP therapy platform, which is enabled by RenovoCath. Together, these programs represents how we build physician confidence. Clinical data drives adoption, and adoption drives revenue. Two years ago, every quarter was about enrollment in TIGeR-PaC and what the data looked like. That made sense then. However, today, while TIGeR-PaC remains critically important as a long-term value driver, the story in front of us is a commercial one. We are selling a product. We are generating revenue. We're building a network of customers. Now with Shaun leading the commercial strategy and Mark providing the financial rigor of a high-growth strategy CFO, our company is structured to execute on that opportunity.

I'm very excited to dedicate more of my time to RenovoRx as it grows and looks to realize its full potential. My focus as Executive Chair is on the long-term strategic direction, ensuring we remain true to our scientific mission, our patients, and the clinical evidence that underpins everything we've done to date. I believe the best is still ahead of us. Thank you for your interest in RenovoRx, and with that, I turn over the call to our CFO, Mark Voll.

Thank you, Ramtin. Good afternoon, everyone. I want to start with a bit of context for those who may not know my background. I have spent my career working in high-growth stage companies, specifically companies that have proven their product works and are now focused on building the commercial engine to scale. This is exactly where RenovoRx is today, and that's exactly why I joined the team. There is a 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 now the work is about execution. Let me walk you through our Q4 and full year 2025 financial results. For the fourth quarter ended December 31st, 2025, RenovoRx reported revenues of $238,000, bringing the full year 2025 revenue to $1.1 million.

Gross profit for the quarter was $210,000, representing a gross margin of 88%. The right way to look at 2025 revenue is in context. We generated $1.1 million in, on an average of commercial footprint of five active sites that we had in place for a majority of the year. As we build from our current 12 active sites into ultimately our target of 36 active sites by year-end, the potential revenue impact of that expansion is obvious and will be important. Research and development expenses for the fourth quarter were $1.5 million and $6.3 million for the year, reflecting our continued investment in the TIGeR-PaC phase III trial, our post-marketing registry study, and our investigator-initiated trial programs.

Selling, general, and administrative expenses for the quarter were $2.2 million and $7 million for the full year, reflecting disciplined cost management as we continue to build our commercial capabilities in a targeted and capital-efficient manner. As of December 31st, RenovoRx had approximately $7 million in cash and cash equivalents. We continue to manage our capital with discipline. Our balance sheet provides us with financial flexibility to fund both our commercial scale-up and completion of our TIGeR-PaC enrollment. Additionally, on March 23rd, 2026, we announced the closing of our oversubscribed private placement, which resulted in gross proceeds of approximately $10 million. The financing was led by new and existing institutional investors, including Transcend Partners, AIGH Capital Management, Bleichroeder, and Pathfinder Asset Management, with participation from members of RenovoRx's board of directors and senior management, including myself.

The net proceeds will allow us to capitalize on accelerating our sales effort to drive revenue growth while providing runway to achieve several significant milestones across 2026 and 2027, including accelerating RenovoCath market adoption and advancing our clinical development through disciplined execution. As we scale our commercial operations, we expect growing revenues to reduce our cash burn and build momentum towards important milestones, including breakeven operations and trial data. Let's share our perspective on 2026. First, the near-term picture. Based on what we're seeing in the first two months of 2026 in terms of site activity, orders, and physician engagement, we expect Q1 to be the strongest revenue quarter yet, with the potential for multiple revenue expansion from Q4.

I want to be measured in how I frame our prospects, as we are not providing specific revenue guidance for the quarter, but it is clear the directional trend is up. The data we have in hand supports our confidence. For the full year 2026, our commercial strategy centers on a single overachieving objective, active site expansion. We are targeting approximately 36 active commercial sites by year-end, the goal of tripling our current footprint of 12.

Our site expansion plan is supported by a robust pipeline of centers that have completed evaluations, are in contracting, or are preparing for activation. As that number scales, we expect 2026 revenues to be substantially higher than 2025. As a result, if we execute according to our plan, we expect our revenue for the year will range between $3 million and $4 million. In closing, I joined RenovoRx because I see growth story that is just beginning, and it's a story that I've seen and helped manage successfully during my career. We have a patented and differentiated product. We have physician demand. We have a phase III trial nearing completion that could serve as a significant catalyst. Now we have a commercial team, financial leadership, and funding in place to execute.

These are exciting times, and I look forward to updating you on our progress throughout the year. Thank you. I'll turn the call back to the operator for Q&A.

Thank you, sir. Ladies and gentlemen, if you would like to ask a question, please press star one on your telephone keypad, and a confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Our first question comes from the line of Justin Walsh with JonesTrading. Please proceed.

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

Yeah, Justin, thank you for the question. It's definitely worthy of discussion. It is a lot easier and a lot simpler and a lot faster. The process is ensuring that they've got a pricing agreement in place, that they can purchase devices for commercial use outside the protocol. Initially, some of the centers had just agreed to purchase the device under the guise of the phase III clinical trial. Over the last, I'd say six months or so, we've been transitioning those pricing agreements to be able to allow them to purchase outside. The bulk of those have already happened, and that's a continual process. The other piece is that it's not just familiarity, it's training that these physicians have been using the product. We don't need a proctor there for the most part.

It's a much lighter lift in terms of getting the pharmacy familiar, getting the physicians trained. Further, they've already gone through the VAC approval process to buy the catheter. They've been submitting for reimbursement, getting reimbursed for the most part. Then lastly, from a referral standpoint, they already have referral patterns set up within the tumor boards to refer patients into the study, and they're familiar with their same referral pattern to treat this commercially. A lot of the, I guess, barriers to quick adoption and/or starting have already been accomplished at these TIGeR-PaC centers. They should be able to convert quickly and convert quickly at relatively good volumes compared to brand-new sites.

Thanks for taking the question.

The next question comes from the line of Scott Henry with Alliance Global Partners. Please proceed.

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

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

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

Yeah, Scott, thanks for the question. I'm glad you brought this up because it's important to characterize 2025. You know, thinking about two down quarters, we're talking about tens of thousands of dollars, where each patient represents between $50,000-$80,000 of revenue. In this early stage of the launch, one or two patients, when their first procedure starts, can really move the needle. And the growth we're seeing in Q1 and beyond is primarily the addition of new centers. Once the center's active, they start treating a patient, it's almost like a recurring revenue every couple of weeks when the patient comes back for a new treatment, a new catheter placement. Once they open that seal, they have additional patients that come on board.

The nice uptick in growth we'll plan to see this quarter can be reflective of the fact that we finished Q3 with about six active sites last year, and then we entered the year with nine, three of which came on board in the last two weeks of December. They had that first treatment, so we're only talking about a few thousand dollars of revenue recognized from those additions of new centers in the last couple weeks of December. We'll start to see that ramp this quarter. It's still gonna be lumpy, though, I think in the beginning, but we'll see. I can't guarantee sequential growth, but I think we'll see definitely significant growth throughout the year, and that'll start to even out once we do go beyond kind of that 10 centers-20 centers later this year.

I do have a very strong outlook on where this could be headed. The $3 million-$4 million I believe is conservative, you know, based on numbers of centers coming on board it'll be a good predictor of future revenue. Having said that, going deeper in these accounts is not to be ignored. You did ask, you know, which one is it? Is it more centers or having more uses? We're seeing both. Once a hospital gets familiar with the technology, we are seeing an uptick in usage there. I believe the kind of midterm and long-term growth is adding new centers as quickly as we can, and we're starting to see that going from six to nine to I believe we last announced 12, and we're seeing growing beyond that as well. Mark might want to-

It just-

Make a comment. Yeah.

Shaun, for clarification. I'm sorry, was there more?

No, go ahead.

For clarification, I think I read one place that there were 12 centers utilizing RenovoCath, and then you talk about nine active centers. You know, are the three that tried it and are still not active, or what. How are you classifying those other three between the nine and the 12?

Yeah. Initially I think we talked about 12. I think we had maybe six of 12 active at one point. Once a hospital goes through the process of getting approval to purchase the catheter, it can take some time to find that first patient to treat. This goes back to Justin's earlier question that TIGeR-PaC centers should be able to convert quickly because they have that referral pattern in. This is top of mind. It's not a brand-new technology to go educate referring physicians. In many of the centers in 2025, they went through the weeks- or months-long process of getting internal approvals to purchase, and may even bought the first set of catheters, but then it took them some time to find that first quote unquote ideal patient.

Currently where we stand is 12 active centers, i.e., they've started treating patients, and then another 21 centers that are in the VAC approval process or have started to get approvals to purchase and are looking for that first patient. Then beyond that, we have dozens of centers that are starting to get engaged with us and go through the multidisciplinary meetings and go start to initiate the VAC process. That's really the metrics. It's gonna be interesting to focus on is kind of watching those centers go through the sales funnel from initial engagement to VAC submission, approval, and then starting to use the device and they're treating patients. Again, 12 active centers means they're actually treating patients to date. We've started to grow beyond that as well.

Okay. Great. Just one final question on the model. The $2.2 million in G&A for fourth quarter 2025 is that indicative of the rate going forward? Is that some of the new sales hires, or is there some noise in that number? Thank you.

No, I would expect that level to be about that going forward. It will slightly increase, particularly as we add additional sales marketing personnel throughout the year.

Okay. Great. Thank you for taking the question.

Scott? Yeah, Scott, just to put that in perspective, when we're talking about adding sales and marketing personnel, we finished the year with three dedicated sales folks, one of which is the leader and the head of marketing. The plan is to hire maybe two more through the year. It's not given how focused the sales effort is, we don't need a large sales force to get to that break-even point. It's not a matter of hiring five, 10, 15, 20 people as other companies have started to do and burn a lot of capital.

Okay. Great. Thank you for the color on that. Thank you for taking the questions.

Thanks, Scott.

The next question comes from the line of RK Ramakanth with H.C. Wainwright. Please proceed.

Thank you. Good afternoon. This is RK from H.C. Wainwright. Couple of quick questions. One, the first one, you know, thanks for explaining, you know, in the answer to Scott about having 12 active commercial centers, but nine are currently ordering. They. The question I have is, I believe 17 centers have used RenovoCath as part of the trial, the TIGeR-PaC trial. So what, you know, what does it take for the other five centers to become commercial or to become active?

To answer your question, RK, just to clarify, the 12 currently active, the vast majority are actually not TIGeR-PaC centers. Those are mostly brand-new customers. A couple of them have started to convert. I think we mentioned a couple have started to convert to outside the protocol usage, commercial centers as well. For the other ones to come on board, it's a matter of them being okay with switching gears and treating outside of a study for, you know, this type of cancer or other cancers.

A lot of them actually want to finish enrollment first for the same reasons I want them to finish enrollment first, is we don't want commercial to compete with completion of the trial enrollment, which should be done here in the next few months, you know, if not a lot less than that. The dialogues have begun. I mentioned the pricing agreement changes ensuring they can purchase. Some of them are still going through the VAC process to be able to purchase the device. And then it's a matter of continuing discussions once enrollment's complete. That's a transition that we started months ago that we should hopefully quickly be able to ramp those the latter half of the year. In the meantime, I still see centers converting as we're wrapping up enrollment here.

Okay, thanks for that. On that enrollment in August, you were talking about having 95 patients enrolled into the study, and now you're saying 104 patients enrolled into the study. What's taking, how does that cadence work in the sense like you have nine patients over five or six months now. You think that you can get the next 10 patients within three to six months. What happened during the last six, seven months that did not move that enrollment rate as fast as you would think?

Yeah, RK, this is worthy of a conversation for a couple minutes. There's a little confusion somehow on how the exact trial is conducted. To clarify, when a patient comes into a center that has our study, they're enrolled treatment naive for the most part, where they haven't had any other treatments. They then go through a very short discrete induction phase of chemotherapy and radiation. After that point, they're randomized if they're still considered locally advanced, not metastatic, not resectable, and importantly, they can tolerate the chemotherapy if they go to the control arm. The goal is to randomize 114 patients, and we need to enroll enough patients to ensure that. The 95 and 104 numbers you quoted were patients randomized, so it's 10 patients left to randomize.

In order to get there, we'd have to enroll, you know, basically several months ago, at least 20 or 30 more patients, given about a 20%-30% or 30%-35% dropout rate during induction. The goal is that we'll complete enrollment such that we can randomize 114 patients in the coming few months, around mid of the year, if not before that. Then the randomizations will occur sometime this year, with final data next year. A little bit confusing on the enrollment conversion to randomization. The key is we're a handful of patients away from completing enrollment, and then what materializes based on the patients in the induction phase, we'll be able to randomize our 114th patient this year. The big milestone for us is completing enrollment.

Once we can call the trial completion of enrollment, that's going back to the earlier questions when sites will really start to be able to convert to commercial, because they can't pull any more patients into the trial, and there'll be definitely a strong interest, and that's already been demonstrated, to be able to allow continued access to patients to the treatment. Does that help clarify, RK?

Yeah. Thanks. One last question from me is on the number of events. You know, you have had 72 events so far. Do you need to get to 86 events? If that is true, can you lock the study even if you don't get to randomize 114 patients?

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

Okay. Thank you. Thanks for taking all my questions.

Thanks for the questions, RK.

As a reminder, ladies and gentlemen, if you would like to ask a question, please press star one on your telephone keypad. The next question will come from the line of Edward Woo with Ascendiant Capital Markets. Please go ahead.

Congratulations on all the progress. My question, just to confirm, you said you have three salespeople now, plan to add two this year. Would that be enough to get you to the 36 active centers goal for this year?

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

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

You know, Ed, it's actually quite interesting if you look at it. It's really not predictive because it's this interesting place where some of the high-volume centers are highly academic and conservative and have a lot of red tape and processes that take longer to launch. Sometimes we can get the largest centers come in later, given that conservative nature. Other times we get the large centers that are very active trying to be the first to market and the first to offer this and advertise about it and jump on. The same goes for the smaller centers. We have the smaller, you know, second or third level volume sites that are interesting and trying to become the bigger players. They try to get something in quicker to be able to advertise it.

It's the perfect mix. What we have said publicly is of the centers that we're active in, it's a broad spectrum of very well-known large NIH-designated academic centers to the kinda high-volume and mid-volume community-based centers. It's given us a great example of what the market should look like as we scale. Their volumes are across the board as well. Some of the large community centers draw a big crowd. They can adopt technologies earlier. They wanna be a powerhouse, so they're trying to advertise, and we've seen this with Hackensack and Jersey Shore, where they've done a lot of advertisements around bringing new patients to the center because they're offering new technologies like TAMP. It is a mix. I wouldn't say it's front-weighted at all.

It's a pretty even spread as we go throughout the next year or two.

Great. Thanks for answering my questions, and I wish you guys good luck. Thank you.

Thank you, Ed.

Thank you. This concludes the question and answer session, and this will also conclude today's conference. You may disconnect your lines at this time, and we thank you for your participation.