Q4 2025 RenovoRx Inc Earnings Call

March 30, 2026

Speaker #2: 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. Ramtha Nagar, Executive Chair and Founder; Sean Bagai, Chief Executive Officer; and Mark Voll, Chief Financial Officer.

Speaker #2: Before we begin, I'd like to remind everyone the statements made during today's call may contain forward-looking statements, covered by the Safe Harbor provisions of the Cybersecurity Litigation Reform Act of 1995 and applicable federal securities laws.

Speaker #2: 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.

Speaker #2: Please refer to our filings with the SEC, including our Form 10-K for the year ended December 31, 2025, for a detailed discussion of the risks and uncertainties facing RenovoRx.

Operator: 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.

Speaker #2: With that, I'll turn the call over to our Chief Executive Officer, Sean Bagai.

Speaker #3: Thank you, Walter, 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. Ramtha A. Nagar, our Founder and Inventor of our patented TAMP therapy platform, has transitioned to the role of Executive Chairman.

Valter Pinto: 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.

Speaker #3: 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.

Speaker #3: Ramtha'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.

Speaker #3: 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.

Speaker #3: 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 buildout and strategic development, the exact inflection point where we are at today.

Valter Pinto: Please refer to our filings with the SEC, including our Form 10-K for the year ended December 31, 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.

Speaker #3: The decision to recruit Mark was intentional. He has served as Chief Financial Officer for multiple publicly traded technology companies, where he has successfully led initiatives that scaled operations into high-growth businesses.

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.

Speaker #3: We are a revenue-generating commercial company focused on scaling, and this is precisely the right moment to bring in financial leadership experience and that kind of growth.

Speaker #3: 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.

Speaker #3: Let me start with a big picture. 2025 marked a key year for RenovoRx, as it was our first full year of RenovoCap commercialization. We entered 2025 taking our initial steps towards commercialization with no dedicated sales team and limited approved commercial cancer centers.

Speaker #3: 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.

Shaun Bagai: 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 are 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.

Speaker #3: For the full year 2025, RenovoRx generated over $1 million in revenue, reflecting strong initial RenovoCap adoption. Our fourth-quarter revenues came in at $238,000, tracking closely to our Q3 results.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: 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.

Shaun Bagai: 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 ended 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 Q4 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.

Speaker #3: 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 3 Tiger Pack sites that have used RenovoCap in the trial and are already preparing to transition to a commercial use upon enrollment completion.

Speaker #3: We expect all these sites to fully become commercial sites, ramping up revenue in the second half of the year. A select number of these centers have begun to transition to commercially adopt RenovoCap as a standalone device for drug delivery in the treatment of solid tumors, signaling broader integration into oncology management.

Speaker #3: 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.

Shaun Bagai: We exited Q4 with 9 active commercial centers, with 3 of them becoming active just in the last 2 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.

Shaun Bagai: 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.

Speaker #3: 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.

Speaker #3: While we are still relatively early in the game, we believe we are beginning to unlock the broader commercial potential of RenovoCap as a standalone device.

Speaker #3: Adoption across U.S. cancer centers continues to build, driven by new and repeat orders, growing physician familiarity, and increasing overall patient referrals to our commercial sites.

Shaun Bagai: 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 3 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 revenue in H2 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.

Shaun Bagai: 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 revenue in H2 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.

Speaker #3: As of February 27, 2026, 12 U.S. cancer centers are utilizing RenovoCap, and 21 additional centers that are evaluating the device have completed evaluation or are preparing for activation.

Speaker #3: 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 a fundamental viability of our product.

Speaker #3: 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, a reimbursement pathway, and our ability to support centers clinically and operationally.

Shaun Bagai: 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 of RenovoCath as a standalone device. Adoption across US 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 US 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 Q1 of 2025.

Speaker #3: 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 RenovoCap revenues in 2026 and beyond.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: The rise in RenovoCap clinical adoption is supported by both targeted commercialization efforts, such as the launch of RenovoRx's sales and marketing team in late Q4 2025, and the growing body of real-world clinical evidence regarding the safety and effectiveness of RenovoCap in patients with solid tumors.

Shaun Bagai: 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 RenovoRx's 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.

Speaker #3: Since receiving FDA 510(k) clearance, RenovoCap has been used in more than 700 successful procedures. A focused and dedicated commercial team will be the engine behind this growth.

Speaker #3: In the third quarter of 2025, we hired a Senior Director of Sales and Market Development with over 25 years of medtech leadership, including a decade focused specifically on market development and interventional oncology.

Speaker #3: 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.

Speaker #3: We also hired a marketing director in late 2025 to drive broader physician engagement and awareness. Each of these team members brings extensive medtech expertise with a track record of developing and selling into a multispecialty market.

Speaker #3: We are building this team in a capital-efficient way, consistent with our philosophy of discipline and growth. In the first two months of 2026, we are seeing strong commercial activity in terms of new site activations, orders, and physician engagement.

Shaun Bagai: 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 Q3 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.

Speaker #3: 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.

Speaker #3: Mark will provide more specific context than 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 Chair and Founder, Dr. Ramtin (an) Nigah.

Speaker #4: Thank you, Sean, 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.

Speaker #4: Building a company's heart, 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 transarterial microperfusion therapy platform.

Shaun Bagai: 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.

Speaker #4: 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 bait the tumor target.

Speaker #4: 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.

Speaker #4: 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, and systemic chemotherapy.

Shaun Bagai: 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.

Speaker #4: We believe TAMP enabled by RenovoCap 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.

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 bait the tumor target, 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.

Speaker #4: We recently announced a milestone with our 100 randomized patients in the trial. Enrollment is on track to be completed by the end of the first half of 2026.

Speaker #4: 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 intraarterial gemcitabine delivered via RenovoCath for locally advanced pancreatic cancer versus systemic IV chemotherapy.

Speaker #4: The current standard of care Target Pack 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.

Speaker #4: 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.

Ramtin Agah: 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 have been surgery, radiation, and 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 3 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 H1 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.

Ramtin Agah: 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 have been surgery, radiation, and 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 H1 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.

Speaker #4: This progress is an important milestone that reflects strong investigator and patient confidence in the 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.

Speaker #4: 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 RenovoCap.

Speaker #4: Together, these programs represent how we build physician confidence: clinical data drives adoption, and adoption drives revenue. Two years ago, every quarter was about enrollment in Target Pack.

Speaker #4: And what the data looked like. That made sense then. However, today, while Target Pack remains critically important as a long-term value driver, the story in front of us is a commercial one.

Ramtin Agah: 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 24 March 2026, we have randomized 104 patients into 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 the program. We also continue to advance broader clinical programs by generating new data through post-marketing registry studies in solid tumors and continue to support our investigator-initiated trials, known as IITs, in borderline resectable and metastatic pancreatic cancer, along with exploring physician interest in other areas.

Speaker #4: We are selling a product. We are generating revenue. We're building a network of customers. And now, with Sean 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.

Speaker #4: 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.

Speaker #4: 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 Ball.

Ramtin Agah: 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 drives revenue. 2 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 Sean 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.

Ramtin Agah: 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 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 Sean 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.

Speaker #5: Thank you, Ramthan. Good afternoon, everyone. I want to start with a bit of context for those who may not know my background. I 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.

Speaker #5: This is exactly where RenovoRx is today. And that is 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.

Speaker #5: 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 31, 2025, RenovoRx reported revenues of $238,000, bringing the full-year 2025 revenue to $1.1 million.

Ramtin Agah: 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. With that, I'll turn over the call to our CFO, Mark Voll.

Speaker #5: 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 on an average commercial footprint of five active sites.

Speaker #5: That we had in place for a majority of the year. As we build from our current 12 active sites, and ultimately to our target of 36 active sites by year-end, the potential revenue impact of that expansion is obvious and will be important.

Mark Voll: Thank you, Ramtin. Good afternoon, everyone. I wanna start with a bit of context for those who may not know my background. I 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 Q4 ended December 31, 2025, RenovoRx reported revenues of $238,000, bringing the full year 2025 revenue to $1.1 million.

Speaker #5: 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.

Speaker #5: 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.

Speaker #5: As of December 31, RenovoRx had approximately $7 million in cash and cash equivalents. We continued 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.

Mark Voll: 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 on an average of commercial footprint of 5 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 Q4 were $1.5 million and $6.3 million for the year, reflecting our continued investment in the TIGeR-PaC Phase 3 trial, our post-marketing registry study, and our investigator-initiated trial programs.

Mark Voll: 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 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 Q4 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.

Speaker #5: Additionally, on March 23, 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, Black Roder, and Pathfinder Asset Management, with participation from members of the RenovoRx board of directors and senior management, including myself.

Speaker #5: 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 RenovoCap's market adoption and advancing our clinical development through disciplined execution.

Mark Voll: 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 31, 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 23 March 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, Bleichroder, and Pathfinder Asset Management, with participation from members of RenovoRx Board of Directors and senior management, including myself.

Speaker #5: As we scale our commercial operations, we expect growing revenues to reduce our cash burn and build momentum towards important milestones, including break-even operations and trial data.

Speaker #5: Now 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.

Speaker #5: With a 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.

Speaker #5: 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.

Mark Voll: 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 break-even operations and trial data. Now 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.

Speaker #5: We are targeting approximately 36 active commercial sites by year-end, with 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.

Speaker #5: As that number scales, we expect 2026 revenue 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 and $4 million.

Speaker #5: In closing, I joined RenovoRx because I see a growth story that is just beginning. And it's a story that I've seen and helped manage successfully during my career.

Speaker #5: 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.

Mark Voll: 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 and 4 million.

Speaker #5: And 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.

Speaker #5: Thank you. I'll turn the call back to the operator for Q&A.

Speaker #1: Thank you, sir. Ladies and gentlemen, if you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue.

Speaker #1: 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.

Speaker #1: Before pressing the star keys, our first question comes from the line of Justin Walsh with Jones Trading. Please proceed.

Speaker #4: Hi. Thanks for taking the question. It would be great to hear more about the process of transitioning the Tiger Pack centers to commercial customers.

Mark Voll: 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 three 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.

Speaker #4: 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?

Speaker #1: Yeah, Justin, thank you for the question. It's definitely worthy of discussion. So, it is a lot easier and a lot simpler and a lot faster, and really the process is ensuring that they've got a pricing agreement in place so that they can purchase devices for the use of commercial use outside the protocol.

Speaker #1: Initially, some of the centers had just agreed to purchase the device under the guise of the Phase III clinical trial. And over the last, I'd say, six months or so, we've been transitioning those pricing agreements to be able to allow them to purchase outside.

Speaker #1: So, 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.

Operator: Our first question comes from the line of Justin Walsh with Jones Trading. Please proceed.

Speaker #1: We don't need a proctor there for the most part, so it's a much lighter lift in terms of getting the pharmacy familiar and getting the physicians trained.

Speaker #1: And further, they've already gone through the VAC approval process to buy the catheter. They've been submitting for reimbursement and getting reimbursed for the most part.

Operator: Our first question comes from the line of Justin Walsh with Jones Trading. Please proceed.

Speaker #1: And then, lastly, from a referral standpoint, they already have referral patterns set up within the tumor boards to refer patients into the study. And they're familiar with their same referral pattern to treat this commercially.

Justin Walsh: 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?

Speaker #1: So, a lot of the, I guess, barriers to quick adoption and/or starting have already been accomplished at these Tiger Pack centers. So they should be able to convert quickly, and convert quickly at relatively good volumes compared to brand new sites.

Shaun Bagai: Yeah. Justin, thank you for the question. It's definitely worthy of discussion. It is a lot easier and a lot simpler, a lot faster. The process is ensuring that they've got a pricing agreement in place that they can purchase devices for the use of commercial use outside the protocol. Initially, some of the centers had just agreed to purchase the device under the guise of the Phase 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.

Speaker #4: Thanks for taking the question.

Speaker #1: The next question comes from the line of Scott Henry with Alliance Global. Please proceed.

Speaker #5: Thank you. And good afternoon. Sean, I just wanted to review the catheter outlook, which sounds very strong. My interpretation would be Q1—you expect it to be above, I think, the prior high was 422,000.

Speaker #5: So, a number in excess of that—is that the correct interpretation?

Shaun Bagai: We don't need a proctor there for the most part, so it's a much lighter lift in terms of getting the pharmacy familiar, getting the physicians trained. 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 at relatively good volumes compared to brand-new sites.

Speaker #1: Basically, the question, Scott—so, we're not providing guidance in the first quarter. Having said that, based on what we've seen in the first two months of 2026 in terms of site activity, orders, and physician engagement, we have potential for significant growth over Q4.

Speaker #1: So, reading between the lines, we're very confident this will be a very strong quarter for us.

Speaker #5: Okay. Yes. I thought I heard you say the biggest quarter yet. But regardless, that's very impressive growth. And that's coming off of two sequentially down quarters, which is suggestive of an inflection.

Speaker #5: And maybe if you could kind of talk about what you're seeing that's driving this. Is it all new centers? Is it reorders? Because it sounds like, and I thought you did say, full year three to four million.

Justin Walsh: Thanks for taking my question.

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

Scott Henry: 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?

Speaker #5: This sequential growth sounds like it would likely continue throughout the year every quarter—maybe some lumpiness. But if you can just talk about the inflection that you're seeing that is driving this growth.

Speaker #5: Thank you.

Speaker #1: Yeah, Scott, thanks for the question. I'm glad you brought this up because it's important to characterize 2025. So, the thinking about two down quarters—we're talking about tens of thousands of dollars, where each patient represents between $50,000 to $80,000 of revenue.

Shaun Bagai: Thanks for the question, Scott. We're not providing guidance in Q1. 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.

Speaker #1: So in this early stage of the launch, one or two patients, when their first procedure starts, can really move the needle. And primarily, the growth we're seeing in Q1 and beyond is primarily the addition of new centers.

Scott Henry: 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 to 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.

Scott Henry: 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.

Speaker #1: Once the centers are 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.

Speaker #1: And once they open that seal, they have additional patients to come on board. So the nice uptick in growth we'll plan to see this quarter can be reflective of the fact that we finished Q3 with about six active sites last year, and then we entered the year with nine, three of which came on board in the last two weeks of December.

Speaker #1: So they had that first treatment. So we're only talking about a few thousand dollars of new centers in the last couple of weeks of December.

Speaker #1: So we'll start to see that ramp this quarter. It's still going to be lumpy, though, I think in the beginning, but we'll see. So I can't guarantee sequential growth, but I think we'll see definitely significant growth throughout the year.

Speaker #1: And that'll start to even out once we do go beyond kind of that 10 to 20 centers later this year. So I do have a very strong outlook on where this could be headed.

Shaun Bagai: Yeah, Scott, thanks for the question. I'm glad you brought this up 'cause it's important to characterize 2025. You know, thinking about 2 down quarters, we're talking about tens of thousands of dollars where each patient represents between $50,000 to $80,000 of revenue. In this early stage of the launch, 1 or 2 patients, when their first procedure starts, can really move the needle. The growth we're seeing in Q1 and beyond is primarily the addition of new centers. Once the center is 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 replacement. Once they open that seal, they have additional patients to come on board.

Shaun Bagai: Yeah, Scott, thanks for the question. I'm glad you brought this up 'cause 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 to $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. The growth we're seeing in Q1 and beyond is primarily the addition of new centers. Once the center is 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 replacement. Once they open that seal, they have additional patients to come on board.

Speaker #1: The three to four million, I believe, is conservative. And it was based on numbers of centers coming on board. It'll be a good predictor of future revenue.

Speaker #1: Having said that, going deeper in these accounts is not to be ignored. You did ask, which one is it? Is it more centers or having more uses?

Speaker #1: And we're seeing both. Once a hospital gets familiar with the technology, we are seeing an uptick in usage there. But I believe the kind of mid-term and long-term growth is adding new centers as quickly as we can.

Speaker #1: And we're starting to see that, going from six to nine to, I believe, we last announced twelve. And we're seeing growing beyond that as well.

Shaun Bagai: 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. We're only talking about a few thousand dollars of revenue recognized from those additions of new centers in the last couple of 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 to 20 centers later this year.

Speaker #5: Sean, for clarification—or, I'm sorry, was there more?

Speaker #1: No, go ahead.

Speaker #5: For clarification, I think I read in one place that there were 12 centers utilizing RenovoCath. And then you talk about three that tried it and are still not active?

Speaker #5: Or how are you classifying those other three between the nine and the twelve?

Speaker #1: Yeah, so initially, I think we talked about 12. I think we had maybe six of the 12 active at one point. So, once a hospital goes through the process of getting approval to purchase the catheter, it can take some time to find that first patient to treat.

Shaun Bagai: I do have a very strong outlook on where this could be headed. The $3 to 4 million, I believe, is conservative, and 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 kinda midterm and long-term growth is adding new centers as quickly as we can, and we're starting to see that going from 6 to 9. I believe we last announced 12, and we're seeing growing beyond that as well.

Shaun Bagai: I do have a very strong outlook on where this could be headed. The $3 million-$4 million, I believe, is conservative, and 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 kinda midterm and long-term growth is adding new centers as quickly as we can, and we're starting to see that going from six to nine. I believe we last announced 12, and we're seeing growing beyond that as well.

Speaker #1: And this goes back to Justin's earlier question: that Tiger Pack centers should be able to convert quickly because they have that referral pattern in.

Speaker #1: This is top of mind. It's not a brand-new technology to go educate referring physicians. So, in many of the centers in 2025, they went through the weeks- or months-long process of getting internal approvals to purchase.

Speaker #1: And maybe even bought the first set of catheters, but then it took them some time to find that first 'ideal patient.' So currently, where we stand is 12 active centers—that is, they've started treating patients.

Speaker #1: 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.

Shaun Bagai: Mark Voll, I'm not sure if you also want to comment.

Shaun Bagai: Mark Voll,

Mark Voll: I'm not sure if you also want to comment.

Scott Henry: And just-

Shaun Bagai: Yeah.

Scott Henry: Shaun, for clarification or, I'm sorry, was there more?

Speaker #1: And then beyond that, we have dozens of centers that are starting to get engaged with us and go through the multidisciplinary meetings and start to initiate the VAC process.

Shaun Bagai: No, go ahead.

Scott Henry: For clarification, I think I read one place that there were 12 centers utilizing RenovoCath. Then you talk about 9 active centers. You know, are there 3 that tried it and are still not active? Or how are you classifying those other 3 between the 9 and the 12?

Scott Henry: For clarification, I think I read one place that there were 12 centers utilizing RenovoCath. Then you talk about nine active centers. You know, are there three that tried it and are still not active? Or how are you classifying those other three between the nine and the 12?

Speaker #1: So that's really the metrics that are going to be interesting to focus on—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 treat patients.

Speaker #1: So again, 12 active centers means they're actually treating patients to date. And we've started to grow beyond that as well.

Shaun Bagai: Yeah. Initially, I think we talked about 12. I think we had maybe 6 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. And 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.

Shaun Bagai: 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. And 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.

Speaker #5: Okay, great. Just one final question. On the model, the $2.2 million in G&A for fourth quarter '25, is that indicative of the rate going forward?

Speaker #5: Is that some of the new sales hires? Or is there some noise in that number? Thank you.

Speaker #1: No, I would expect that level to be about that going forward. It will slightly increase, particularly as we add additional sales and marketing personnel throughout the year.

Shaun Bagai: 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 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.

Speaker #5: Okay, great. Thank you for taking the question.

Speaker #1: And 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.

Speaker #1: And the plan is to hire maybe two more through the year. So it's not, given how focused the sales effort is, we don't need a large sales force to get to that breakeven point.

Speaker #1: So it's not a matter of hiring 5, 10, 15, 20 people as other companies have started to do and burn a lot of capital.

Shaun Bagai: 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.

Speaker #5: Okay. Great. Thank you for the call on that. Thank you for taking the questions.

Speaker #1: Thanks, Scott.

Speaker #4: The next question comes from the line of R.K. Ramakhan with H.C. Wainwright. Please proceed.

Speaker #1: Thank you. Good afternoon. This is R.K. from H.C. Wainwright. A couple of quick questions. The first one—thanks for explaining, in the answer to Scott, about having 12 active commercial centers, but 9 are currently ordering.

Scott Henry: Okay, great. Just one final question on the model. The $2.2 million in G&A for Q4 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.

Mark Voll: 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.

Speaker #1: The question I have is, I believe 17 centers have used RenovoCath as part of the trial, the TIGeR-PaC trial. So what does it take for the other five centers to become commercial?

Scott Henry: Okay, great. Thank you for taking the question.

Shaun Bagai: Scott. Yeah, Scott, just to put that in perspective, when we're talking about adding sales and marketing personnel, we finished the year with 3 dedicated sales folks, one of which is the leader and the head of marketing. The plan is to hire maybe 2 more through the year. 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 5, 10, 15, 20 people as other companies have started to do and burn a lot of capital.

Speaker #1: Or to become active? So, basically, the question—okay, just to clarify—of the 12 currently active, the vast majority are actually not Tiger Pack centers.

Speaker #1: So those are mostly brand new customers. A couple of them have started to convert. So I think we mentioned a couple have started to convert to outside the protocol usage—commercial centers as well.

Speaker #1: So for the other ones to come on board, it's a matter of them being okay with switching gears and treating outside of a study for this type of cancer or other cancers.

Scott Henry: Okay, great. Thank you for the color on that. Thank you for taking the questions.

Shaun Bagai: Thanks, Scott.

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

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

Speaker #1: A lot of them actually want to finish enrollment first, for the same reasons I want them to finish enrollment first. As we don't want commercial to compete with completion of the trial enrollment, which should be done here in the next few months, if not a lot less than that.

Swayampakula Ramakanth: Thank you. Good afternoon. This is RK from H.C. Wainwright. A couple of quick questions. One, the first one, and you know, thanks for explaining you know in the answer to Scott about having 12 active commercial centers, but 9 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. What, you know, what does it take for the other 5 centers to become commercial or to become active?

Ramakanth Swayampakula: Thank you. Good afternoon. This is RK from H.C. Wainwright. A couple of quick questions. One, the first one, and 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. What, you know, what does it take for the other five centers to become commercial or to become active?

Speaker #1: So the dialogues have begun. I mentioned the pricing agreement changes, ensuring they can purchase. So some of them are still going through the VAC process to be able to purchase the device.

Speaker #1: And then it's a matter of continuing discussions once enrollment's complete. So, that's a transition that we started months ago that we should hopefully be able to quickly ramp.

Speaker #1: The latter half of the year, but in the meantime, I still see centers converting as we're wrapping up enrollment here.

Speaker #4: Okay, thanks for that. And then on that enrollment—in August, you were talking about having had, like, 95 patients enrolled into the study, and now you're saying 104 patients enrolled into the study.

Shaun Bagai: The basic 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.

Speaker #4: So what's taking—how does that cadence work, in the sense like, you have nine patients over five or six months now? So then you think that you can get the next 10 patients within three to six months.

Speaker #4: So, what happened during the last six or seven months that did not move that enrollment rate as fast as you would think?

Shaun Bagai: A lot of them actually wanna 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. 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.

Speaker #1: Yeah, RK, this is worthy of a conversation for a couple of minutes. So, there's a little confusion somehow on how the exact trial is conducted.

Speaker #1: So to clarify, when a patient comes into a center that has our study, they're enrolled treatment-naive, for the most part, where they haven't had any other treatments.

Speaker #1: They then go through a very short, discrete induction phase of chemotherapy and radiation. And after that point, they're randomized if they're still considered locally advanced, not metastatic, not resectable, and importantly, they can tolerate the chemotherapy if they go to the control arm.

Speaker #1: So the goal is to randomize 114 patients, and we need to enroll enough patients to ensure that. So the 95 and 104 numbers you quoted are for patients randomized.

Swayampakula Ramakanth: Okay. Thanks for that. On that enrollment, you know, in August, you know, you were talking about having, like 95 patients enrolled into the study, and now you're saying 104 patients enrolled into the study. What's taking, you know, how does that cadence work in the sense like you have 9 patients over 5 or 6 months now. You think that you can get the next 10 patients within 3 to 6 months. What happened during the last 6, 7 months that did not move that enrollment rate as fast as you would think?

Ramakanth Swayampakula: Okay. Thanks for that. On that enrollment, you know, in August, you know, you were talking about having, like 95 patients enrolled into the study, and now you're saying 104 patients enrolled into the study. What's taking, you know, 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?

Speaker #1: So it's 10 patients left to randomize. In order to get there, we'd have to enroll basically, several months ago, at least 20 or 30 more patients, given about a 20% to 30% or 30% to 35% dropout rate during induction.

Speaker #1: So the goal is that we'll complete enrollment such that we can randomize 114 patients in the coming few months—around mid-year, if not before that.

Speaker #1: And then the randomizations will occur sometime this year, with final data next year. So it's a little bit confusing on the enrollment conversion and randomization.

Shaun Bagai: Yeah, RK, this is worthy of a conversation for a couple of minutes, so 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. 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. That 95 and 104 numbers you quoted were patients randomized.

Speaker #1: The key is we're a handful of patients away from completing enrollment. And then what matriculates, based on the patient's induction phase, we'll be able to randomize 114 patients this year.

Speaker #1: 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 definitely be a strong interest—and that's already been demonstrated—to be able to allow continued access to patients to the treatment.

Speaker #1: Does that help clarify, RK?

Speaker #4: Yeah. Thanks. And then on one the last question from me is on the number of events. You have had 72 events so far. Do you need to get to 86 events?

Shaun Bagai: 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% to 30% or 30% to 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-year, if not before that. The randomizations will occur sometime this year with final data next year. A little bit confusing on the enrollment conversion or randomization. The key is we're a handful of patients away from completing enrollment. What matriculates based on the patients in the induction phase, we'll be able to randomize our 114th patient this year.

Speaker #4: And if that is true, can you lock the study even if you don't get to randomize 114 patients?

Speaker #1: Good question, RK. So yes, 86 events is when the final analysis takes place. And we would need to randomize 114 to get there.

Speaker #1: The 86th event we anticipate, given the 72 we have right now, wouldn't take place until next year. So there's really not a statistically possible or probable scenario in which we would actually hit the 86th event before we randomize 114.

Speaker #1: So, in that scenario, it is so unlikely that we have assessed what happens before. But that's the cadence we expect to see: 114 randomized this year, and then, sometime next year, the 86th event.

Shaun Bagai: 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?

Speaker #4: Okay. Thank you. Thanks for taking all my questions.

Speaker #1: Thanks for the questions, RK.

Speaker #2: 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 Ed Wu with Ascending Capital Markets.

Swayampakula Ramakanth: 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?

Ramakanth Swayampakula: 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?

Speaker #2: Please go ahead.

Speaker #5: Yeah. Congratulations on all the progress. My question, just to confirm, you said you have three salespeople now and plan to add two this year. Would that be enough to get you to the 36 active centers goal for this year?

Speaker #1: 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 Pack.

Shaun Bagai: 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.

Speaker #1: So, the goal of adding these two additional centers 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 on those centers, and to see how far beyond that we can push.

Speaker #1: But short answer to your question is yes. I've been saying for the last, I think, seven or eight months at least, that a sales team of three to five reps should be able to get us to a point of significant adoption and penetration, and to a potential break-even point.

Speaker #5: That sounds great. Then just a curiosity in terms of the volume per center. Should we—are all these centers equal in potential, or should we view it as the first half you added are like the bigger centers, and the ones you're adding near the end are smaller volume centers?

Swayampakula Ramakanth: Okay. Thank you. Thanks for taking all my questions.

Ramakanth Swayampakula: Okay. Thank you. Thanks for taking all my questions.

Shaun Bagai: Thanks for the questions, RK.

Operator: 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 Wu with Ascendiant Capital Markets. Please go ahead.

Operator: 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 Ed Woo with Ascendiant Capital Markets. Please go ahead.

Speaker #5: Or how do we put value to how big these centers are in terms of potential?

Edward Wu: Yeah, congratulations on all the progress. My question, just to confirm, you said you have 3 salespeople now, planning to add 2 this year. Will that be enough to get you to the 36 active centers goal for this year?

Ed Woo: Yeah, congratulations on all the progress. My question, just to confirm, you said you have three salespeople now, planning to add two this year. Will that be enough to get you to the 36 active centers goal for this year?

Speaker #1: You know, Ed, it's actually quite interesting. If you look at it, it's really not predictive because it's just an 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.

Shaun Bagai: 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 7 or 8 months at least that a sales team of 3 to 5 reps should be able to get us to a point of significant adoption and penetration and to a potential break-even point.

Shaun Bagai: 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 and penetration and to a potential break-even point.

Speaker #1: So sometimes we can get the largest centers come in later, given that conservative nature. And other times we get the large centers that are very active, trying to be the first to market and the first to on.

Speaker #1: And then the same goes for the smaller centers. We have the smaller second- or third-level volume sites that are interested in trying to become the bigger players, that try to get something in quicker to be able to advertise it.

Speaker #1: So it's a perfect mix. What we have said publicly is, of the centers that we're active in, it's a broad spectrum of very well-known, large NIH-designated academic centers.

Edward Wu: 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?

Speaker #1: Two: the kind of high-volume and mid-volume community-based centers. So it's given us a great example of what the market should look like as we scale.

Ed Woo: 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?

Speaker #1: And their volumes are across the board as well. So some of the large community centers draw big crowds. They can adopt technologies earlier. They want to be a powerhouse.

Speaker #1: So they're trying to advertise, and we've seen this with HackySack in 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.

Shaun Bagai: You know, that is 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, conservative, and have a lot of red tape and processes that take longer to launch. Sometimes 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.

Speaker #1: So it is a mix. So 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.

Speaker #5: Great, thanks for answering my questions, and I wish you guys good luck. Thank you.

Speaker #1: Thank you, Ed.

Speaker #2: 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.

Shaun Bagai: It's a perfect mix. What we have said publicly is of the centers that we're active in, it's a broad spectrum of very well-known large NIH designated academic centers to the 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. We've seen this with Hackensack in 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.

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

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

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

Shaun Bagai: Thank you, Ed.

Operator: 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.

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