Q1 2025 RenovoRx Inc Earnings Call

Operator: Good afternoon, everyone, welcome to the RenovoRx Q1 2025 Financial and Operational Highlights conference call. All participants will be in a listen-only mode. Should you need assistance, please let know a conference specialist by pressing the star key followed by 0. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star and then 1 on your touch-tone phones. To withdraw your questions, you may press star and 2. Please also note today's event is being recorded. At this time, I'd like to turn the floor over to Valter Pinto, Managing Director at KCSA Strategic Communications. Sir, please go ahead.

Good afternoon, everyone and welcome to the Novo Rx Q1, 2025 financial and operational highlights conference call.

Operator: Good afternoon, everyone, and welcome to the RenovoRx Q1 2025 Financial and Operational Highlights Conference. All participants will be in a listen-only mode. If you need assistance, please contact a conference specialist by pressing the star key followed by zero.

All participants will be in a listen only mode.

Speaker Change: Do you need a system with a lot of companies.

Speaker Change: Especially this by pressing the star key followed by zero.

Speaker Change: After todays presentation, there will be an opportunity to ask questions.

Operator: After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star and then 1 on your touch-tone phone. To withdraw your questions, you may press star and two. Please also note that this event is being recorded.

Speaker Change: To ask a question you May press star one on your Touchtone phone.

Speaker Change: It's your all your questions you May press Star two.

Speaker Change: There's also lots of news event.

Speaker Change: Got it.

Speaker Change: At this time I'd like to turn the floor, but you also Pinto managing director at KFC U S A's strategic communications.

Walter Pinto: At this time, I'd like to turn the floor over to Walter Pinto, Managing Director at KCSA Strategic Communications. Sir, please go ahead. Thank you, operator.

Speaker Change: Okay.

Speaker Change: Please go ahead.

Valter Pinto: Thank you, operator. Good afternoon and welcome everyone to the RenovoRx Q1 2025 Conference Call. I'm joined today by RenovoRx's leadership team, including Dr. Ramtin Agah, Founder and Chief Medical Officer, Shaun Bagai, Chief Executive Officer, and Ronald Kocak, VP Controller and Principal Accounting Officer. Before we begin, I'd like to remind everyone that statements made during today's conference call may be deemed forward-looking statements within the meaning of the safe harbor of the Private Securities Litigation Reform Act of 1995 and applicable federal securities laws. That actual results may differ materially and adversely from what is contemplated by such forward-looking statements due to a variety of substantial risks, uncertainties, and other factors. The company's forward-looking statements are based on management's current plans and assumptions and are subject to the risks and uncertainties more fully described in the company's filings with the SEC.

Speaker Change: Thank you operator, good afternoon, and welcome everyone to the renewal of Rx first quarter 2025 conference call.

Walter Pinto: Good afternoon and welcome everyone to the RenovoRx first quarter 2025 conference call. I'm joined today by RenovoRx's leadership team, including Dr. Ramte Naga, Founder and Chief Medical Officer, John Bagai, Chief Executive Officer, and Ronald Kozak, VP Controller and Principal Accounting Officer.

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the guy: The Guy Chief Executive Officer, and Ralph Kozak, VP controller, and principal accounting officer.

Walter Pinto: Before we begin, I'd like to remind everyone that statements made during today's conference call may be deemed forward-looking statements within the meaning of the safe harbor of the Private Securities Litigation Reform Act of 1995 and applicable federal securities laws, and that actual results may differ materially and adversely from what is contemplated by such forward-looking statements due to a variety of substantial risks, uncertainties, and other factors. The company's forward-looking statements are based on management's current plans and assumptions and are subject to the risks and uncertainties more fully described in the company's filings with the SEC. These statements reflect management's view of current and future market conditions, including but not limited to statements regarding the company's clinical trials and other research studies, including.

Speaker Change: We begin I'd like to remind everyone that statements made during today's conference call maybe deemed as forward looking statements within the meaning of the safe Harbor of the private Securities Litigation Reform Act of 1995.

Speaker Change: And applicable federal Securities laws and.

Speaker Change: And that actual results may differ materially and adversely from what is contemplated by such forward looking statements due to a variety of substantial risks uncertainties and other factors. The company's forward looking statements are based on management's current plans and assumptions and are subject to the risks and uncertainties are more fully described in the company's filings with the SEC. These statements reflect management's view of current and <unk>.

Valter Pinto: These statements reflect management's view of current and future market conditions, including, but not limited to statements regarding the company's clinical trials and other research studies, including timing for potential additional interim data readouts and full patient enrollment for RenovoRx's ongoing phase III TIGeR-PaC clinical trial studying intra-arterial gemcitabine in locally advanced pancreatic cancer. The potential of the RenovoCath device as a standalone commercial product or the Trans-Arterial Micro-Perfusion therapy platform as a mechanism of action. The anticipated timing for and levels of revenue generation from RenovoCath sales and the company's commercialization plans in general. The potential for intra-arterial gemcitabine to treat or provide clinically meaningful outcomes for certain medical conditions or diseases, and RenovoRx's efforts to explore commercialization strategies utilizing the Trans-Arterial Micro-Perfusion therapy platform.

Speaker Change: Market conditions, including but not limited to statements regarding the Companys clinical trials and other research studies, including <unk>.

Walter Pinto: Timing for potential additional interim data readouts and full patient enrollment for RenovoRx's ongoing Phase III TIGERPAC clinical trials studying intraarterial gemcitabine and locally advanced pancreatic cancer. The potential of the RenovoCast device as a standalone commercial product or the transarterial microperfusion therapy platform as a mechanism of action. The anticipated timings for and levels of revenue generation from RenovoCast sales and the company's commercialization plans in general. The potential for intraarterial gemcitabine to treat or provide clinically meaningful outcomes for certain medical conditions or diseases and RenovoRx's efforts to explore commercialization strategies utilizing the transarterial microperfusion therapy platform.

Speaker Change: Timing for potential additional interim data readouts and full patient enrollment or robot Rx is the ongoing phase III type of Tiger past clinical trials studying intra arterial gemcitabine and locally advanced pancreatic cancer.

Speaker Change: All of the renewable cast devices standalone commercial product or the trans arterial my preferred fusion therapy platform as a mechanism of action.

Speaker Change: Anticipated timing for and levels of revenue generation from renewable costs sales and the company's commercialization plans in general.

Speaker Change: Potential for intra arterial gemcitabine to treat or provide clinically meaningful outcomes for certain medical conditions or diseases.

Speaker Change: <unk> is that first steps for commercialization strategies utilizing the trains arterial micro perfusion therapy platform for.

Walter Pinto: For a detailed discussion of some of the material risks and uncertainties facing RenovoRx, I refer you to the company's annual report on Form 10-K for the year ended December 31, 2024, as well as the company's investor presentation and other reports filed periodically with the SEC, including our Form 10-Q for the first quarter of 2025, which was just filed with the SEC. RenovoRx has claimed any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.

Valter Pinto: For a detailed discussion of some of the material risks and uncertainties facing RenovoRx, I refer you to the company's annual report on Form 10-K for the year ended 31 December 2024, as well as the company's investor presentation and other reports filed periodically with the SEC, including our Form 10-Q for Q1 2025, which was just filed with the SEC. RenovoRx disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. With that, it's my pleasure to turn the call over to Dr. Ramtin Agah, Founder and Chief Medical Officer of RenovoRx. Ramtin, please go ahead.

Speaker Change: For a detailed discussion of some of the material risks and uncertainties safety Arbor Novo racks I refer you to the Companys annual report on Form 10-K for the year ended December 31, 2024, as well as the company's Investor presentation, and other reports filed periodically with the SEC, including our Form 10-Q for the first quarter of 2025, which was just filed with the SEC.

Speaker Change: You see we.

Speaker Change: We know how our RASK disclaimed any intention or obligation to update or revise any forward looking statements, whether as a result of new information future events or otherwise, except as required by law with that it's my pleasure to turn the call over to Dr. Ross <unk> founder and Chief Medical Officer of Renault Forex Brompton. Please go ahead.

Dr. Ramtan Agar: With that, it's my pleasure to turn the call over to Dr. Ramtan Agar, Founder and Chief Medical Officer of RenovoRx. Ramtan, please go ahead. Thank you, Walter, and good afternoon, everyone. I appreciate everyone joining us today.

Ramtin Agah: Thank you, Valter, and good afternoon, everyone. I appreciate everyone joining us today. At RenovoRx, we're pioneering a new era in cancer care through our Trans-Arterial Micro-Perfusion, or TAMP therapy platform. By localizing and targeting delivery of therapeutic agents like chemotherapy near the tumor site via the peripheral system, TAMP is designed to optimize drug concentration precisely where it's needed, while potentially minimizing systemic exposure and related toxicities. This targeted approach addresses the longstanding challenge in cancer care, where there is poor tumor blood supply. I believe TAMP represents a significant advancement in the way cancer treatment can be approached. Our mission is to transform patients' outcome by providing a safer, more effective way to deliver therapy directly to hard-to-treat tumors.

Speaker Change: Thank you Walter and good afternoon, everyone I appreciate everyone joining us today.

Dr. Ramtan Agar: At VenovoRx, we're pioneering a new era in cancer care through our Trans-Arterial Microperfusion, or TAMP, therapy platform. By localizing and targeting delivery of therapeutic agents, like chemotherapy, near the tumor site via the peripheral system, TAMP is designed to optimize drug concentration precisely where it's needed, while potentially minimizing systemic exposure and related toxicity. This targeted approach addresses the long-standing challenge in cancer care where there is poor tumor blood supply. I believe TAMP represents a significant advancement in the way cancer treatment can be approached.

Speaker Change: Omar X we are pioneering a new era in Catholic yet you are transferred to you on market confusion or tap therapy platform.

Speaker Change: By localizing I'm targeting delivery of therapeutic agents like chemotherapy near the tumor size via the peripheral system.

Speaker Change: He is designed to optimize drug concentration precisely where you need it while potentially minimizing systemic exposure and related toxicities.

Speaker Change: These targeted approach addresses the long standing challenge in cancer care, where these poor tumor blood supply.

Speaker Change: Relief camp represents a significant advancement in the way cancer treatment can be approached our mission is to transform patients' outcome by providing a safer more effective way to deliver therapy directly to hard to treat tumors.

Dr. Ramtan Agar: Our mission is to transform patients' outcomes by providing a safer, more effective way to deliver therapy directly to hearts to treat tumors. Our ongoing Phase III target-packed clinical trial evaluating the targeted delivery of chemotherapy, gemceptabine, with TAMP via our patented FDA-cleared RenovoCAP device to patients with locally advanced pancreatic cancer is advancing with encouraging results. Our initial interim data showed that the patients experienced median overall survival with standard systemic chemotherapy delivery of 10 months versus 16 months with our targeted approach. This is from the time of randomization. It is important to note that both median overall survival arms calculation for this study in term analysis data do not include approximately five and a half months of life from diagnosis to randomization during the induction chemotherapy and radiation phase of the trial.

Ramtin Agah: Our ongoing phase III TIGeR-PaC clinical trial evaluating the targeted delivery of chemotherapy, gemcitabine, with TAMP via our patented FDA-cleared RenovoCath device to patients with locally advanced pancreatic cancer, is advancing with encouraging results. Our initial interim data showed that the patients experienced median overall survival with standard systemic chemotherapy delivery of 10 months versus 16 months with our targeted approach. This is from the time of randomization. It is important to note that both median overall survival arms calculation for this study interim analysis data do not include approximately 5.5 months of life from diagnosis to randomization during the induction chemotherapy and radiation phase of the trial. Moreover, we observed a 65% reduction in adverse events such as nausea and fatigue, significantly improving patient quality of life.

Speaker Change: Our ongoing phase III target pack clinical trial.

Speaker Change: And winning the targeted delivery of chemotherapy chipset to be we tap via our patented FDA cracked clear then over cap device to patients with locally advanced pancreatic cancer.

Speaker Change: Advancing with encouraging results are.

Speaker Change: Our initial interim data showed that the patients experienced median overall survival with standards systemic chemotherapy. They leave you off 10 months versus 16 months with our targeted approach.

Speaker Change: This is from the time I found the mutation. It is important to note that both median overall survival arms calculation point. This study interim analysis.

Speaker Change: Do not include approximately five and a half months shelf life from diagnosis to randomization during the induction chemotherapy and radiation phase of the trial.

Speaker Change: Moreover, we observed a 65 per cent reduction you adverse events, such as nausea and.

Dr. Ramtan Agar: Moreover, we observed a 65% reduction in adverse events such as nausea and fatigue, significantly improving patient quality of life. These results strengthen our conviction that TAM can redefine outcomes for patients facing some of the most difficult to treat cancer. As we are continuing to increase exposure to TAMP and RenovoCat through our TIGERPACT trial, and more recently, to our commercial efforts for RenovoCat as a standalone device, the reception from physician community has been overwhelmingly positive. Clinical investigators have expressed strong support and enthusiasm to our approach in drug delivery, recognizing the potential clinical benefit and improved tolerability profile that the use of RenovoCat offers.

Speaker Change: Significantly improving patient quality of life.

Ramtin Agah: These results strengthen our conviction that TAMP can redefine outcomes for patients facing some of the most difficult to treat cancer. As we are continuing to increase exposure to TAMP and RenovoCath through our TIGeR-PaC trial, and more recently to our commercial efforts for RenovoCath as a standalone device, the reception from physician community has been overwhelmingly positive. Clinical investigators have expressed strong support and enthusiasm to our approach in drug delivery, recognizing the potential clinical benefit and improved tolerability profile that the use of RenovoCath offers. Their feedback reinforces our belief that RenovoRx is well positioned to establish a new standard of care for LAPC and potentially other indications. As we advance our clinical and commercialization efforts, I'm energized by the transformative potential of our platform and deeply appreciative of your continued support as we work to change the future of cancer treatment.

Speaker Change: These results strengthen our conviction that Tom can redefine outcomes for patients.

Speaker Change: Basically some of the most difficult to treat cancer.

Speaker Change: As we have continued to increase exposure to tap I ran all the cats, who our target backdrop and more recently to our to our commercial efforts for Renova cat at the Standalone device.

Speaker Change: <unk> from physician community has been overwhelmingly positive.

Speaker Change: Clinical investigators have expressed strong support and enthusiasm to our approach and directly with grid, recognizing the potential clinical benefits and improved tolerability profile, but do you use over and over CAC offers.

Dr. Ramtan Agar: Their feedback reinforces our belief that RenovoRx is well positioned to establish a new standard of care for LAPC and potentially other indications.

Speaker Change: Their feedback reinforces our belief that you I know what X is well position to establish a new standard of care.

Speaker Change: On a P C and potentially other indications.

Dr. Ramtan Agar: As we advance our clinical and commercialization efforts, I'm energized by the transformative potential of our platform and deeply appreciate your continued support as we work to change the future of cancer treatment. Thank you for attending and for your support of RenovoRx.

Speaker Change: As we advance our clinical and commercialization efforts.

Speaker Change: I spent the transformative potential of our platform.

Speaker Change: Deeply appreciate your.

Speaker Change: Your continued support as we work to change the future of Catholic treatment.

Ramtin Agah: Thank you for attending and for your support of RenovoRx. With that, I turn over to our CEO, Shaun Bagai.

Speaker Change: Thank you for attending and for your support offering <unk> with that I'll turn it over to our CEO Sean Mackay.

Sean Begay: With that, I turn it over to our CEO, Sean Begay. Thank you, Romton. Q1 of 2025 represented our first quarter of generating revenue from commercial sales. This is the result of the important strategic decision we made in 2024 to focus on implementing a commercial strategy for NovoCath in tandem with our ongoing Phase 3 trial. We plan to launch our commercial efforts for NovoCath during Q1 of this year in response to anticipated strong demand for our technology. However, we received purchase orders ahead of schedule generating $43,000 of revenue in December. I am proud of our team for quickly implementing a go-to-market strategy to meet the demand from the oncology community and therefore made the decision to increase our U.S.-based RenovoCath production last year.

Shaun Bagai: Thank you, Ramtin. Q1 of 2025 represented our first quarter of generating revenue from commercial sales. This is the result of the important strategic decision we made in 2024 to focus on implementing a commercial strategy for RenovoCath in tandem with our ongoing phase III trial. We plan to launch our commercial efforts for RenovoCath during Q1 of this year in response to anticipated strong demand for our technology. However, we received purchase orders ahead of schedule, generating $43,000 of revenue in December. I'm proud of our team for quickly implementing a go-to-market strategy to meet the demand from the oncology community, and therefore made the decision to increase our US-based RenovoCath production last year. Last month, I stated that we expected Q1 revenue to be in the low six-figure range, followed by sequential quarter-over-quarter increases for the remainder of the year.

Sean Mackay: Thank you Robyn you want a 2025 representatives of our first quarter of generating revenue from commercial sales. This is the results of the important strategic decision. We made in 2024 to focus on implementing our commercial strategy for Novo Cas in tandem with our ongoing phase III trial.

Speaker Change: We plan to launch our commercial efforts for <unk>. During Q1 of this year in response to anticipated strong demand for our technology.

Speaker Change: However, we received purchase orders ahead of schedule generating $43000 of revenue in December I'm.

Speaker Change: I am proud of our team for quickly implementing at Goldman market strategy to meet the demand from the oncology community and therefore made the decision to increase our U S base rate, although cat production last year.

Speaker Change: Last month, I stated that we expected Q1 revenue to be in the low six figure range.

Sean Begay: Last month, I stated that we expected Q1 revenue to be in the low six-figure range, followed by sequential quarter-over-quarter increases for the remainder of the year. I am pleased to report that revenue from EnovoCap exceeded our internal expectations to approximately $200,000 in the first quarter, and we anticipate this trend to continue going forward with sequential quarterly growth for the foreseeable future. We are encouraged by the strong organic demand for EnovoCath with more than 10 medical institutions that are not current TigerPak sites having initiated a process for EnovoCath purchase orders. These include several esteemed high-volume academic and community and National Cancer Institute designated centers.

Speaker Change: By sequential quarter over quarter increases for the remainder of the year I am pleased to report that revenue from our Novo Kathy exceeded our internal expectations to approximately $200000 in the first quarter and we anticipate this trend to continue going forward with the sequential quarterly growth for the foreseeable future.

Shaun Bagai: I'm pleased to report that revenue from RenovoCath exceeded our internal expectations to approximately $200,000 in Q1. We anticipate this trend to continue going forward with sequential quarterly growth for the foreseeable future. We are encouraged by the strong organic demand for RenovoCath, with more than 10 medical institutions that are not current TIGeR-PaC sites having initiated a process for RenovoCath purchase orders. These include several esteemed high-volume academic and community and National Cancer Institute-designated centers. We believe the approximately 20 centers that have used RenovoCath as part of our TIGeR-PaC trial could also be potential customers for RenovoCath after completion of TIGeR-PaC enrollment anticipated for later this year. Early utilization of RenovoCath devices by initial customers has led to repeat purchase orders.

Speaker Change: We are encouraged by the strong organic demand for another Catholic more than 10 medical institutions that are not current tiger tax sites, having initiated a process for a hell of a gas purchase orders.

Speaker Change: These include several esteemed high volume academic and community and National Cancer Institute designated centers.

Speaker Change: Further we believe the approximately 20th centers that have user novo cath as part of our Tigertext trial could also be potential customers for novo cast after completion and tigard pack enrollment anticipated for later this year.

Sean Begay: Further, we believe the approximately 20 centers that have used RenovoCath as part of our TigerPAC trial could also be potential customers for RenovoCath after completion of TigerPAC enrollment anticipated for later this year. Additionally, early utilization of RenovoCAP devices by initial customers has led to repeat purchase orders. based on our internal analysis of clinical interest and FDA-cleared applications of the device. We believe that our initial total addressable market for Novocath represents an estimated $400 million peak U.S. annual sales opportunity. We are assuming an average of 8 annual procedures per patient and 7,000 initial target patients at peak market penetration in patient populations where we already have clinical usage.

Speaker Change: Additionally, early utilization of Novo cast devices by initial customers has led to repeat purchase orders.

Shaun Bagai: Based on our internal analysis of clinical interest and FDA-cleared applications of the device, we believe that our initial total addressable market for RenovoCath represents an estimated $400 million peak US annual sales opportunity. We are assuming an average of 8 annual procedures per patient and 7,000 initial target patients at peak market penetration in patient populations where we already have clinical usage. While we haven't publicly disclosed our catheter pricing, technologies utilizing the same reimbursement coding are charging between $6,500 and $8,500 per device. Looking ahead, we see expansion opportunities across other cancer indications that could create the potential for a several billion-dollar US TAM for RenovoCath over time. The prospect of generating even a small portion of this market, combined with the potential to help so many patients, is driving our excitement about this opportunity.

Speaker Change: Based on our internal analysis of clinical interest in FDA cleared applications of the device.

Speaker Change: And believe that our initial total addressable market for Novo cast represents an estimated $400 million peak U S annual sales opportunity.

Speaker Change: We are assuming an average of eight annual procedures per patient and 7000 initial target patients that peak market penetration in patient populations, where we already have clinical usage.

Sean Begay: While we haven't publicly disclosed our catheter pricing, technologies utilizing the same reimbursement coding are charging between $6,500 and $8,500 per device. Looking ahead, we see expansion opportunities across other cancer indications that could create the potential for a several billion dollar U.S. TAM for Novocav over time. the prospect of generating even a small portion of this market combined with the potential to help so many patients is driving our excitement about this opportunity. We believe we can manage meaningful market penetration with a small yet focused commercial team targeting the top 200 high-volume treatment centers. Importantly, we believe this strategy can be executed without a material increase in our expenses, whether through direct commercialization or by partnering with a larger organization with an established sales force, which is a strategy we are actively exploring.

Speaker Change: While we havent publicly disclosed our catheter pricing technologies utilizing the same reimbursement coding are charging between 6000 and $508500 per device.

Speaker Change: Looking ahead, we see expansion opportunities across other cancer indications that could create the potential for a several billion dollar U S. Tam for novo cost overtime.

Speaker Change: The prospect of generating even a small portion of this market combined with the potential to help so many patients is driving our excitement about this opportunity.

Shaun Bagai: We believe we can manage meaningful market penetration with a small yet focused commercial team targeting the top 200 high-volume treatment centers. Importantly, we believe this strategy can be executed without a material increase in our expenses, whether through direct commercialization or by partnering with a larger organization with an established sales force, which is a strategy we are actively exploring. We expect that the growing revenues from RenovoCath will reduce our burn rate and that our cash on hand of $14.6 million at the end of Q1 will fully fund both our RenovoCath scale-up and the continued progress of our phase III TIGeR-PaC clinical trial. On the topic of our TIGeR-PaC clinical trial, during the Q1 of 2025, we announced that Johns Hopkins Medicine has now initiated enrollment in our ongoing phase III TIGeR-PaC trial.

Speaker Change: We believe we can manage meaningful market penetration with a small yet focused commercial team targeting the top 200 high volume treatment centers.

Speaker Change: Certainly we believe this strategy can be executed without a material increase in our expenses.

Speaker Change: Through direct commercialization or by partnering with a larger organization with an established sales force, which is a strategy we are actively exploring.

Sean Begay: We expect that the growing revenues from RenovoCath will reduce our burn rate and that our cash on hand of $14.6 million at the end of the first quarter will fully fund both our RenovoCath scale-up and the continued progress of our Phase III TIGERPAT clinical trial.

Speaker Change: We expect that the growing revenues from our novo capital reduce our burn rate.

Speaker Change: Our cash on hand of $14 6 million at the end of the first quarter will fully fund both our available kind of scale up and the continued progress of our phase III <unk> clinical trial.

Speaker Change: On the topic of our Tiger clinical trials during the first quarter of 2025, we announced the Johns Hopkins Medicine has now initiated enrollment in our ongoing phase III <unk> trial.

Sean Begay: On the topic of our TIGERPAC clinical trial, during the first quarter of 2025 we announced that Johns Hopkins Medicine has now initiated enrollment in our ongoing Phase III TIGERPAC trial. This is a valuable addition to the distinguished network of clinical cancer sites across the U.S. participating in this important trial as we work towards full enrollment. We are continuing to target additional sites and expect that TIGERPAC will achieve full enrollment during 2025. As a reminder, the current protocol and statistical analysis plan for the TIGERPAC trial requires 114 randomized patients, with 86 events or deaths necessary to complete the final analysis.

Shaun Bagai: This is a valuable addition to the distinguished network of clinical cancer sites across the US participating in this important trial as we work towards full enrollment. We are continuing to target additional sites and expect that TIGeR-PaC will achieve full enrollment during 2025. As a reminder, the current protocol and statistical analysis plan for the TIGeR-PaC trial requires 114 randomized patients with 86 events or deaths necessary to complete the final analysis. As of 02 May 2025, 91 patients have been randomized and 56 events have occurred, triggering the second interim analysis. We expect the study's data monitoring committee to review the data in Q3 and eagerly await their recommendations and feedback. Last week, we announced the issuance of a new US patent for our TAMP therapy platform, further enhancing our IP production.

Speaker Change: This is a valuable addition to the distinguished network of clinical cancer sites across the U S. Participating in this important trial as we work towards full enrollment.

Speaker Change: We're continuing to target additional sites unexpected tiger tackle achieved full enrollment during 2025.

Speaker Change: As a reminder, the current protocol and statistical analysis plan for the Tiger Pact trial requires 114 randomized patients with 86 events or deaths necessary to complete the final analysis.

Sean Begay: As of May 2, 2025, 91 patients have been randomized and 56 events have occurred, triggering a second interim analysis. We expect the Studies Data Monitoring Committee to review the data in Q3 and eagerly await their recommendations and feedback.

Speaker Change: As of May <unk>, 2025, 91 patients have been randomized.

Speaker Change: And 56 events have occurred triggering the second interim analysis.

Speaker Change: We expect the study data monitoring committee to review the data in Q3 and eagerly await the recommendations and feedback.

Speaker Change: Last week, we announced the issuance of a new U S patent for a cap therapy platform further enhancing our IP production.

Sean Begay: Last week we announced the issuance of a new U.S. patent for our TAMP therapy platform, further enhancing our IP production. RenovoRx's strong and growing intellectual property portfolio provides key support to the company's continuing commercialization of RenovoCast.

Shaun Bagai: RenovoRx's strong and growing intellectual property portfolio provides key support to the company's continuing commercialization of RenovoCath. The issuance of this new patent highlights the innovation behind our TAMP therapy platform and strengthens our competitive position. Before closing, I want to highlight one final point. During Q1, we announced that in our most recent open trading window, members of the management team and board purchased an aggregate of approximately 143,000 shares of RenovoRx stock in multiple open market purchases. This signals our confidence in our company and its future and underscores our enthusiasm for our company's long-term value proposition. In conclusion, I want to reaffirm our belief that the approximately 20 cancer centers that have used RenovoCath as part of our TIGeR-PaC trial could also be potential customers after the planned completion of enrollment later this year.

Speaker Change: Renewable or actually a strong and growing intellectual property portfolio provides key support to the company's continuing commercialization of our novel Cath.

Speaker Change: The issuance of this new patent highlights the innovation behind our 10th third good platform and strengthens our competitive position.

Sean Begay: The issuance of this new patent highlights the innovation behind our TantTherapy platform and strengthens our competitive position.

Speaker Change: Before closing I want to highlight one final point.

Sean Begay: Before closing, I want to highlight one final point. During the first quarter, we announced that in our most recent open trading window, members of the management team and board purchased an aggregate of approximately 143,000 shares of RenovoRx stock and multiple open market purchases. This signals our confidence in our company and its future and underscores our enthusiasm for our company's long-term value proposition.

Speaker Change: During the first quarter, we announced that in our most recent open trading window. All members of the management team and board purchased an aggregate of approximately 143000 shares of renewable Rx stock and multiple open market purchases.

Speaker Change: This signals our confidence in our company and its future and underscores our enthusiasm for our company's long term value proposition.

Sean Begay: In conclusion, I want to reaffirm our belief that the approximately 20 cancer centers that have used RenovoCath as part of our TigerPak trial could also be potential customers after the planned completion of enrollment later this year.

Speaker Change: In conclusion, I want to reaffirm our belief that the approximately 20 cancer centers that have used from novo cath as part of our Tiger type trial could also be potential customers. After the planned completion of enrollment later this year.

Shaun Bagai: Building upon our recent success, we expect revenue from RenovoCath to increase from the low six-figure range with sequential quarter-over-quarter increases for the remainder of the year as we move along the path to becoming cash flow positive in the future. With that, I'll turn it over to Ron, who will take us through some of the numbers.

Sean Begay: Building upon our recent success, we expect revenue from MenovoCash to increase from the low six-figure range with sequential quarter-over-quarter increases for the remainder of the year as we move along the path to becoming a cash flow positive in the future.

Speaker Change: Building upon our recent success, we expect revenue from Novo Cath to increase from the low six figure range with sequential quarter over quarter increases for the remainder of the year as we move along the path to becoming cash flow positive in the future.

Ron: With that, I'll turn it over to Ron, who will take us through some of the numbers. Thank you, Sean. For the first quarter of 2025, Renovo reported revenue of approximately $200,000 from commercial sales of its FDA-cleared RenovoCast device, exceeding our initial expectations in our first quarter of revenue. Research and development expenses were $1.7 million for the quarter, up from $1.3 million in the first quarter of 2024. This $0.4 million increase was primarily driven by the following. Hire employee compensation due to cost of living adjustments. Increase manufacturing and non-recurring engineering costs to support commercial scale-up. greater participation in conferences and trade shows, and other ongoing R&D activities.

Speaker Change: With that I'll turn it over to Ron who will take us through some of the numbers.

Ronald Kocak: Thank you, Shaun. For Q1 2025, RenovoRx reported revenue of approximately $200,000 from commercial sales of its FDA-cleared RenovoCath device, exceeding our initial expectations in our Q1 revenue. Research and development expenses were $1.7 million for the quarter, up from $1.3 million in Q1 2024. This $0.4 million increase was primarily driven by the following. Higher employee compensation due to cost of living adjustments, increased manufacturing and non-recurring engineering costs to support commercial scale-up, greater participation in conferences and trade shows, and other ongoing R&D activities. Selling, general, and administrative expenses were approximately $1.6 million for the quarter, an increase from $1.2 million in the prior year period.

Ron: Thank you Sean.

Ron: For the first quarter 2025, whenever we reported revenue of approximately 200000 from commercial sales of its FDA cleared Lenovo cast goodbyes exceeding our initial expectations in our first quarter of revenue.

Ron: Research and development expenses were $1 7 million for the quarter up from $1 3 million in the first quarter of 2024.

Ron: This <unk> 4 million increase was primarily driven by the following.

Ron: Our employee compensation due to cost of living adjustments.

Increased manufacturing and nonrecurring engineering costs to support commercial scale up.

Ron: Greater participation in conferences and trade shows and other ongoing R&D activities.

Ron: Selling general and administrative expenses were approximately $1 6 million for the quarter and.

Ron: Selling general and administrative expenses were approximately $1.6 million for the quarter, an increase from $1.2 million in the prior year period. This $0.4 million rise was attributed to increase in personnel-related costs, professional and consulting fees to support commercializations. and other selling general and administrative activities.

Ron: An increase from $1 2 million in the prior year period.

Ronald Kocak: This $0.4 million rise was attributed to increase in personnel-related costs, professional and consulting fees to support commercializations, and other selling, general, and administrative activities. As of 31 March 2025, the company had $14.6 million in cash and cash equivalents. As of 9 May 2025, shares of our common stock outstanding totaled 36,572,232. Now I'll turn the call back to the operator for Q&A.

Ron: This point 4 million rise was attributed to increase in personnel related costs.

Ron: Professional and consulting fees to support commercialization.

Ron: And other selling general and administrative activities.

Ron: As of March 31st, 2025, the company had $14.6 million in cash and cash equivalents. as of May 9, 2025, shares of our common stock outstanding totaled $36,572,232.

Ron: As of March 31, 2025, the company had $14 6 million in cash.

Ron: Cash and cash equivalent.

Ron: As of May nine 2025.

Ron: Shares of our common stock outstanding totaled $36 million 572232.

Operator: And now, I'll turn the call back to the operator for Q&A. Ladies and gentlemen, at this time we'll begin the question and answer session. To ask a question, you may press star and then one on your touch-tone phone. If you are using a speakerphone, we do ask that you please pick up your handset before pressing the keys to ensure the best sound quality. To withdraw your questions, you may press...

Speaker Change: And now I'll turn the call back to the operator for Q&A.

Operator: Ladies and gentlemen, at this time, we'll begin the question-and-answer session. I would like to turn the floor back over to Shaun Bagai for closing comments.

Speaker Change: Ladies and gentlemen at this time, we'll begin the question and answer session.

Speaker Change: To ask a question you May press Star and then one on your Touchtone phone.

Speaker Change: Speakers.

Speaker Change: Please pickup your handset before pressing the keys to ensure the best sound quality.

Speaker Change: It's all your questions you May press star two.

Okay.

Operator: material to assemble the rostrum. And once again, if you would like to ask a question, please press star and 1.

Speaker Change: Turning to assemble the roster.

Speaker Change: And once it gets you would like to ask a question. Please press star and one.

Speaker Change: And I'm showing no questions I would like to turn the floor back over to Sean Mcgowan, who.

Sean Begay: And showing no questions, I would like to turn the floor back over to Sean Beguy for closing comments. Thank you all again for participating in today's presentation. We're very excited about the key strategic steps we've taken over the last year to build long-term value in our And we are beginning to see the tangible results from these efforts. We look forward to the rest of the year unfolding and to providing you with important updates on our progress.

Sean McGowan: For closing comments.

Shaun Bagai: Thank you all again for participating in today's presentation. We're very excited about the key strategic steps we've taken over the last year to build long-term value in our company, and we are beginning to see the tangible results from these efforts. We look forward to the rest of the year unfolding and to providing you with important updates on our progress. Have a great evening.

Sean McGowan: Thank you all again for participating in today's presentation. We're very excited about the key strategic steps we've taken over the last year to build long term value in our company and we are bringing beginning to see the tangible results from these efforts. We look forward to the rest of the year unfolding and to providing you with important updates on our progress have a great.

Sean Begay: Have a great year.

Sean McGowan: Okay.

Operator: Ladies and gentlemen, with that, we'll conclude today's conference call and presentation. We do thank you for joining. Actually, one moment. We do have someone that has joined the question queue late. Let me join in Rafay Khalid from Ascendiant Capital Markets. Please go ahead with your question.

Sean McGowan: And ladies and gentlemen, with that we'll conclude today's conference call and presentation. We do thank you for joining actually one moment. We do have a few we do have someone that has joined the question queue late.

Operator: And ladies and gentlemen, with that, we'll conclude today's conference call and presentation. We do thank you for joining.

Operator: Actually, one moment. We do have a few...

Operator: We do have someone that has joined the question queue late. Let me...

Sean McGowan: Let me.

Rosslyn Rafi: Let me join in Rosslyn Rafi tallied.

Rafay Khalid: Let me join in Rafay Khalid from Ascendant Capital Markets. Please go ahead with your question. Hi. This is Rafay for Edward Wu, Ascending Capital Markets. Can you talk about your plans for the RenovoCath for international markets? Thanks, Rafael, for the question. At this point, we don't have a current CE mark. We're looking into that for the future. We haven't disclosed publicly on timing of international markets, but obviously there's high demand for this type of technology given the unmet need in these types of tumors in both the European countries as well as in a very large market in China, Korea, and Japan as well.

Speaker Change: The Senate capital markets. Please go ahead with your question.

Rafay Khalid: Hi. Thank you. This is Rafay for Edward Woo, Ascendiant Capital Markets. Can you talk about your plans for the RenovoCath for international markets?

Speaker Change: Hi. Thank you. This is a ruse for Edward Woo has any capital markets can you talk about your plans for the Novo cats for international markets.

Shaun Bagai: Thanks, Rafay, for the question. At this point, we don't have a current CE mark. We're looking into that for the future. We haven't disclosed publicly on timing of international markets, but obviously, there's high demand.

Speaker Change: Thanks for pay for the question at this point, we don't have a current CE Mark we're looking into that for the future we.

Speaker Change: We haven't disclosed publicly on timing of international markets, but obviously there is there is high demand for this type of technology, given the unmet need in these types of tumors.

Shaun Bagai: For this type of technology, given the unmet need in these types of tumors in both the European countries as well as in a very large market in China, Korea, and Japan as well. There's interest there. We've talked to physicians, but we plan on really driving hard on the US commercial market, given the reimbursement landscape, and then approaching outside the US markets later, exploring that later this year, potentially next year.

Speaker Change: Both the European countries.

Speaker Change: As well as in a very large market in China Korea.

Speaker Change: And in Japan as well so there is interest there we've talked to physicians.

Sean Begay: So there's interest there. We've talked to physicians, but we plan on really driving hard on the U.S. commercial market given the reimbursement landscape and then approaching outside the U.S.

Speaker Change: We plan on really driving hard in the U S commercial market given the reimbursement landscape and then approaching outside the U S markets later exploring that later this year and potentially next year.

Sean Begay: markets later, exploring that later this year.

Rafay Khalid: Great. One more question. Do you have plans? You talked about partnering with potentially the top 200 cancer centers. Would you use their sales force or would you use distributors to target those partners?

Speaker Change: Great and one more question, yes claims to increase you talked about partnering with the potentially cop 200 cancer centers would you use their sales force or rich you use distributors to target.

Rafay Khalid: And one more question. Do you have plans to increase, you talked about partnering. up to 100 cancer centers, would you use their sales force or would you use distributors to target? So I have yeah, thank you for the question.

Shaun Bagai: Yeah, thank you for the question. I have said it publicly that we are talking to a handful of strategic partners. These are large companies that have sales forces that cater to the interventional oncologists who do the procedures, so the interventional radiologists. We're looking at, from a business perspective, if it makes more sense to hire a small sales force with a handful of reps to get to drive meaningful revenue for the company and/or partner with a strategic partner that has an existing distribution channel. We're exploring both currently, and both are actually well on their way in terms of proving out which plan makes the most financial sense for the company.

Speaker Change: Those partners yes.

Speaker Change: Thank you for the question I have stated publicly that we are talking to a handful of strategic partners. These are large companies that have sales forces that cater to the interventional oncologists, who do the procedures early intervention radiologist.

Sean Begay: I have stated publicly that we are talking to a handful of strategic partners These are large companies that have sales forces that cater to the interventional oncologists who do the procedures or the interventional radiologists so we're looking at the from a business perspective if it makes more sense to hire a small sales force with a handful of reps to get to Drive meaningful revenue for the company and or a partner with a strategic partner that has an existing distribution So we're exploring both currently and both are actually well underway in terms of proving out which plan makes the most financial sense for the company.

Speaker Change: We're looking at the.

Speaker Change: From a business perspective, if it makes more sense to hire a small sales force of a handful of reps to get to drive meaningful revenue for the company and or partnering with a strategic partner that has an existing distribution channel. So we're exploring both the currently.

Speaker Change: And both are actually well underway in terms of proving out which plan makes the most financial sense for the company.

Rafay Khalid: Great. Thank you very much.

Speaker Change: Great. Thank you very much.

Operator: Ladies and gentlemen, at this time, I would turn it back to Mr. Bagai for any additional closing comments.

Operator: And once again, if you would like to ask a question, please press star and then one using a touchtone telephone to withdraw your questions. You may press star and. Once again, that is star and then one to join the.

Speaker Change: And once again, if you would like to ask a question. Please press star and then one using a touchtone telephone.

Speaker Change: To withdraw your question you May press Star two.

Speaker Change: Once again that is star and then one to join the question queue.

Operator: And ladies and gentlemen, at this time, I will, I would turn it back to Mr. Begay for any additional.

Speaker Change: And ladies and gentlemen at this time I will I would turn it back to Mr. Mackay for any additional closing comments.

Shaun Bagai: Thank you again for your time and participating, and have a great evening. Thank you, everyone.

Sean Begay: Thank you again for your time and participating, and have a great evening. Thank you.

Speaker Change: Thank you again for your time in participating and have a great evening. Thank you everyone.

Operator: That will conclude today's conference call and presentation. Thank you for joining. You may now disconnect your lines.

Operator: And that will conclude today's Conference Call-In presentation. Thank you for joining. You may now disconnect.

Speaker Change: And that will conclude today's conference call and presentation. Thank you for joining you may now disconnect your lines.

Speaker Change: [music].

Speaker Change: Okay.

Speaker Change: Okay.

Please go ahead.

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Operator: Thanks for watching!

Speaker Change: Hum.

Speaker Change: Uh huh.

Speaker Change: Okay.

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Speaker Change: [music].