3/30/2026

speaker
Operator
Conference Call 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 Walter Pinto, Managing Director of KCSA Strategic Communications. Please go ahead.

speaker
Walter Pinto
Managing Director, KCSA Strategic Communications

Thank you, operator. Good afternoon, everyone, and welcome to the Renovo Rep's fourth quarter and full year 2025 financial results conference call. I'm joined today by members of our leadership team, including Dr. Rampant Agha, executive chair and founder, Sean Bagai, chief executive officer, and Mark Vall, chief financial officer. 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 Private Securities Litigation Reform Act of 1995 and applicable federal securities laws. These statements, including statements regarding Renovo Rx'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 recent uncertainties facing RenovRx. With that, I'll turn the call over to our Chief Executive Officer, Sean Begay.

speaker
Sean Bagai
Chief Executive Officer

Thank you, Walter, and good afternoon, everyone. Before I walk to our results, I want to acknowledge two important developments in our leadership structure. As we recently announced, Dr. Ramtan Agha, 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 Renovo RX moves deeper into the commercial phase of our story, we are positioning ourselves as the commercial stage growth company we have become. Brompton'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 Fall 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's 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 and 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 a big picture. 2025 marked a key year for Renovo RX, 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. 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, Renovo RX generated over $1 million in revenue, reflecting strong initial Renovo cath adoptions. 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 acted at 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 3 TigerPak sites that have used RenovoCAP 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 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 and 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 of Renovacap 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 RenovoCAP, 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 a 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 RenovoCAP'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 or in contracting, or preparing for activation. This is not aspirational growth. It is grounded and 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 RenovoCat 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 510K 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 MedTech leadership, including a decade focused specifically on market development and 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 MedTech 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 discipline and growth. In the first two months of 2026, we are seeing strong commercial activity in terms of news site activations, orders, and position engagements. 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 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. Ramtan Agha.

Disclaimer

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