Q2 2025 RenovoRx Inc Earnings Call

Speaker #1: Good 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 a listen-only mode.

Operator 2: Good afternoon. I will be your conference call operator today. Please note that today's call is being recorded, and all participants other than management are in a listen-only mode. There will be a Q&A session following management's presentation. I will now turn the call over to Valter Pinto, Managing Director of KCSA Strategic Communications. Please go ahead.

Speaker #1: There will be a Q&A session following management's presentation. I will now turn the call over to Walter Pinto, Managing Director of KCSI, KCSA Strategic Communications.

Speaker #1: Please go ahead.

Speaker #3: Thank you, Operator, and good afternoon. Welcome, everyone, to the RenovoRx second quarter 2025 conference call. I'm joined today by RenovoRx's leadership team, including Dr. Ram Tanagar, Chairman, Founder, and Chief Medical Officer; John Bagai, Chief Executive Officer; Lisa Gentry, Chief Clinical Officer; and Ronald Kozak, VP Controller and Principal Accounting Officer.

Valter Pinto: Thank you, operator, good afternoon. Welcome, everyone, to the RenovoRx Q2 2025 conference call. I'm joined today by RenovoRx's leadership team, including Dr. Ramtin Agah, Chairman, Founder, and Chief Medical Officer, Shaun Bagai, Chief Executive Officer, Leesa Gentry, Chief Clinical Officer, and Ron Kozak, 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 risks, uncertainties, and other factors.

Shawn Bhagat: Thank you, Operator, and good afternoon. Welcome, everyone, to the RenovoRx second quarter 2025 conference call. I'm joined today by RenovoRx's leadership team, including Dr. Ramtan Nagar, Chairman/Founder and Chief Medical Officer; Shawn Bhagat, Chief Executive Officer; Lisa Gentry, Chief Clinical Officer; and Ronald Kozak, 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, and that actual results may differ materially and adversely from what is contemplated by such forward-looking statements due to a variety of 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 #3: 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.

Speaker #3: An applicable federal securities laws. And that after results may differ materially and adversely from what is contemplated by such forward-looking statements, due to a variety of risks, uncertainties, and other factors.

Speaker #3: 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.

Valter Pinto: 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. 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, also known as IAG, in locally advanced pancreatic cancer.

Speaker #3: 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.

Shawn Bhagat: 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, timing for potential additional interim data readouts, and full patient enrollment for RenovoRx's ongoing phase three Tiger Plaque clinical trial studying intraarterial gemcitabine, also known as IAG, and locally advanced pancreatic cancer. The potential of the Renovocath device as a standalone commercial product or the transarterial microprofusion therapy platform, also known as TAMP, as a mechanism of action, the anticipated timing for and levels of revenue generation from Renovocath's sales, the company's commercialization plans in general, the potential for IAG to treat or provide clinically meaningful outcomes for certain medical conditions or diseases, and RenovoRx's efforts to explore commercialization strategies utilizing the TAMP therapy platform.

Speaker #3: Timing for potential additional interim data readouts and full patient enrollment for RenovoRx's ongoing phase three Tiger Plaque clinical trial studying intraarterial gemcitabine also known as IAG and locally advanced pancreatic cancer.

Speaker #3: The potential of the RenovoCast device as a standalone commercial product or the transarterial microperfusion therapy platform also known as TAMP as a mechanism of action, the anticipated timing for and levels of revenue generation from RenovoCast sales, the company's commercialization plans in general, the potential for IAG to treat or provide clinically meaningful outcomes for certain medical conditions or diseases, and RenovoRx's efforts to explore commercialization strategies utilizing the TAMP therapy platform.

Valter Pinto: The potential of the RenovoCath device as a standalone commercial product or the Trans-Arterial Micro-Perfusion therapy platform, also known as TAMP, as a mechanism of action, the anticipated timing for and levels of revenue generation from RenovoCath sales, the company's commercialization plans in general, the potential for IAG to treat or provide clinically meaningful outcomes for certain medical conditions or diseases, and RenovoRx's efforts to explore commercialization strategies utilizing the TAMP therapy platform. For a detailed discussion of 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 the Form 10-Q for Q2 2025, which we just filed with the SEC.

Speaker #3: For detailed discussion of material risks and uncertainties facing RenovoRx, I refer you to the company's annual report on Form 10-K, for the year ended December 31st, 2024, as well as the company's investor presentation and other reports filed periodically with the SEC.

Shawn Bhagat: For a detailed discussion of material risks and uncertainties facing RenovoRx, I refer you to the company's annual report on Form 10-K for the year ended December 31st, 2024, as well as the company's investor presentation and other reports filed periodically with the SEC, including the Form 10-Q for the second quarter of 2025, which was just filed with the SEC. Except as required by law, 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. With that, it's my pleasure to turn the call over to Dr. Ramtan Nagar, Chairman/Founder and Chief Medical Officer of RenovoRx. Ramtan, please go ahead.

Speaker #3: Including the Form 10-Q for the second quarter of 2025, which we just filed with the SEC. Except as required by law, RenovoRx disclaims any intention or obligation to update or revise any forward-looking statements.

Valter Pinto: Except as required by law, 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. With that, it is my pleasure to turn the call over to Dr. Ramtin Agah, Chairman, Founder, and Chief Medical Officer of RenovoRx. Ramtin, please go ahead.

Speaker #3: Whether as a result of new information, future events, or otherwise. With that, it's my pleasure to turn the call over to Dr. Ram Tanagar, Chairman, Founder and Chief Medical Officer of RenovoRx, Ramtan, please go ahead.

Speaker #4: Thank you, Walter, and good afternoon, everyone. 2025 thus far has marked the most transformational period in our company history. As everyone knows, late last year we launched the commercialization of RenovoCast device, as a standalone product within its FDA-cleared indications for use, while we continue to make progress with our phase three Tiger Plaque study.

Ramtin Agah: Thank you, Valter, and good afternoon, everyone. 2025 thus far has marked the most transformational period in our company's history. As everyone knows, late last year, we launched the commercialization of RenovoCath device as a standalone product within its FDA-cleared indications for use while we continue to make progress with our phase III TIGeR-PaC study. Our clinical and commercial team have executed well, and I could not be more excited about our future. Our proprietary Trans-Arterial Micro-Perfusion therapy platform, or TAMP, is designed for targeted therapeutic delivery across the arterial wall near the tumor site to bait the target tumor. By localizing and targeting delivery of therapeutic agents via the peripheral vascular system, TAMP is designed to optimize drug concentration precisely where it is needed.

Dr. Ramtan Nagar: Thank you, Valter, and good afternoon, everyone. 2025 thus far has marked the most transformational period in our company history. As everyone knows, late last year, we launched the commercialization of Renovocath device. As a standalone product, we didn't need to FDA-cleared indications for use, while we continue to make progress with our phase three target-back study. Our clinical and commercial team have executed well, and I could not be more excited about our future. Our proprietary transarterial microprofusion therapy platform, or TAMP, is designed for targeted therapeutic delivery across the arterial wall near the tumor site to bait the target tumor. By localizing and targeting delivery of therapeutic agents via the peripheral vascular system, TAMP is designed to optimize drug concentration precisely where it is needed.

Speaker #4: Our clinical and commercial team have executed well and I could not be more excited about our future. Our property transarterial microperfusion therapy platform, or TAMP, is designed for targeted therapeutic delivery across the arterial wall near the tumor site to date the target tumor.

Speaker #4: By localizing and targeting delivery of therapeutic agents via the peripheral vascular system, TAMP is designed to optimize drug concentration precisely where it is needed.

Speaker #4: This targeted approach can minimize systemic exposure and toxicities related to chemotherapy and addresses the long-standing challenge in cancer care of poor blood supply to tumor sites.

Ramtin Agah: This targeted approach can minimize systemic exposure and toxicities related to chemotherapy and addresses the long-standing challenge in cancer care of poor blood supply to tumor sites. We believe that TAMP, by using the body's existing microvascular pathway, called the vasa vasorum for drug delivery, represents a significant advancement in the way cancer treatment can be approached. We began commercializing RenovoCath in Q4 2024, and with our sales and marketing team in place, we are proud to have achieved over $400,000 in sales in Q2, a significant accomplishment in a short period of time. These initial sales, prior to installing a sales and marketing infrastructure, highlight the strong clinical need and market demand for our patented RenovoCath device as a standalone targeted drug delivery product among both new and existing customers. Equally important is our phase III TIGeR-PaC trial.

Dr. Ramtan Nagar: This targeted approach can minimize systemic exposure and toxicities related to chemotherapy and addresses the longstanding challenge in cancer care of poor blood supply to tumor sites. We believe that TAMP, by using the body's existing microvascular pathway called the vasovascular or drug delivery, represents a significant advancement in the way cancer treatment can be approached. We began commercializing Renovocath in the fourth quarter of 2024, and with all the sales and marketing team we placed, we are proud to have achieved over $400,000 in sales in the second quarter, a significant accomplishment in a short period of time. These initial sales, prior to installing a sales and marketing infrastructure, highlight the strong clinical need and market demand for a patented Renovocath device as a standalone targeted drug delivery product among both new and existing customers. Equally important is our phase three target-back trial.

Speaker #4: We believe that TAMP, by using the body's existing microvascular care pathway called the vasovisor, for drug delivery, represents a significant advancement in the way cancer treatment can be approached.

Speaker #4: We began commercializing RenovoCast in the fourth quarter of 2024, and without the sales and marketing team in place, we are proud to have achieved over 400,000 dollars in sales in the second quarter, a significant accomplishment in a short period of time.

Speaker #4: These initial sales prior to installing the sales and marketing infrastructure highlight the strong clinical need and market demand for our patented RenovoCast device as a standalone targeted drug delivery product among both new and existing customers.

Speaker #4: Equally important is our phase three Tiger Plaque trial. A 50-second event in our trial occurred in Q2, triggering the pre-planned second interim analysis and review by the independent Data Monitoring Committee, known as the DMC, which happened recently.

Ramtin Agah: The 52nd event in our trial occurred in Q2, triggering the preplanned second interim analysis and review by the independent Data Monitoring Committee, known as the DMC, which happened recently. As a reminder, the DMC reviews the trial data and makes recommendation to our company, mainly whether the data was compelling enough from their third-party point of view to move forward with the trial or not. We're excited to report that the DMC recently completed their review of our second planned interim analysis and has recommended that we continue the study. This is great news, as we believe DMC's recommendation is an expression of confidence in the potential for a positive outcome in the trial overall.

Dr. Ramtan Nagar: The 52nd event in our trial occurred in Q2, triggering the pre-planned second interim analysis and review by the Independent Data Monitoring Committee, known as the DMC, which happened recently. As a reminder, the DMC reviews the trial data and makes recommendations to our company, mainly whether the data was compelling enough from their third-party point of view to move forward with the trial or not. We are excited to report that the DMC recently completed the review of our second plan interim analysis and has recommended that we continue the study. This is great news, as we believe DMC's recommendation is an expression of confidence in the potential for a positive outcome in the trial overall.

Speaker #4: As a reminder, the DMC reviews the trial data, and makes recommendations to our company mainly whether the data was compelling enough from their third-party point of view to move forward with the trial or not.

Speaker #4: We're excited to report that the DMC recently completed the review of our second planned interim analysis and has recommended that we continue the study.

Speaker #4: This is great news, as we believe DMC's recommendation is an expression of confidence in the potential for positive outcome in the trial overall. With the view toward preserving the integrity of Tiger Plaque trial for FDA purposes, and following our review of general FDA guidance, discussions with the DMC, and consultation with regulatory advisors, we have decided to defer publishing our second interim data.

Ramtin Agah: With a view toward preserving the integrity of TIGeR-PaC trial for FDA purposes and following our review of general FDA guidance, discussions with the DMC, and consultation with regulatory advisors, we have decided to defer publishing our second interim data. Outside of myself, who has been speaking directly with the DMC, our entire team will remain blinded to the interim data. We will revisit publishing the actual second interim data, most likely upon completion of this study, as is common for pivotal Phase III trials. Meanwhile, the TIGeR-PaC trial is continuing at pace. As of 12 August 2025, 95 patients have been randomized, and 61 events have occurred, putting us on target to complete enrollment later this year or early next year. At RenovoRx, Inc., our mission remains clear. Transform patient outcomes through safer, more effective targeted therapy, especially for those battling difficult-to-treat cancers like locally advanced pancreatic cancer.

Dr. Ramtan Nagar: With a view toward preserving the integrity of target-back trial for FDA purposes and following our review of general FDA guidance, discussions with the DMC, and consultation with regulatory advisors, we have decided to be fair publishing our second interim data. Outside of myself, who has been speaking directly to the DMC, our entire team will remain blinded to the interim data. We will revisit publishing the actual second interim data, most likely upon completion of this study, as is common for pivotal phase three trials. Meanwhile, the target-back trial is continuing at pace. As of August 12th, 2025, 95 patients have been randomized, 61 events have occurred, putting us on target to complete enrollment later this year or early next year. At RenovoRx, our mission remains clear: transform patient outcomes through safer, more effective targeted therapy, especially for those battling difficult-to-treat cancers like locally advanced pancreatic cancer.

Speaker #4: Outside of myself, who has been speaking directly with the DMC, our entire team will remain blinded to the interim data. We will revisit publishing the actual second interim data, most likely upon completion of the study, as is common for pivotal Phase 3 trials.

Speaker #4: Meanwhile, the Tiger Plaque trial is continuing apace. As of August 12, 2025, 95% of patients have been randomized, and 61 events have occurred, putting us on target to complete enrollment later this year or early next year.

Speaker #4: At RenovoRx, our mission remains clear: transform patient outcomes through safer, more effective targeted therapy. Especially for those battling difficult-to-treat cancers, like locally advanced pancreatic cancer.

Speaker #4: Thank you all for your continued support. With that, I will turn the call over to our CEO, Sean Bagai.

Dr. Ramtan Nagar: Thank you all for your continued support. With that, I will turn the call over to our CEO, Shawn Bhagat.

Ramtin Agah: Thank you all for your continued support. With that, I will turn the call over to our CEO, Shaun Bagai.

Speaker #5: Thank you, Ramtan. As Ramtan mentioned, 2025 has been a breakthrough year for our company, and during the second quarter we made meaningful progress commercially and in the clinic.

Shaun Bagai: Thank you, Ramtin Agah. As Ramtin Agah mentioned, 2025 has been a breakthrough year for our company, and during Q2, we made meaningful progress commercially and in the clinic. The Q2 showcased the early impact of our commercial strategy, and we are pleased to report Q2 2025 revenue of over $400 thousand. We are proud of the initial organic revenue growth over the first 2 full quarters since launching RenovoCath commercial sales, especially since this was achieved without a dedicated sales and marketing team. With the recent hiring of Philip Stocton as our Senior Director of Sales and Market Development, our goal was to stay lean while also continuing to build commercialization momentum.

Shawn Bhagat: Thank you, Ramtan. As Ramtan mentioned, 2025 has been a breakthrough year for our company, and during the second quarter, we made meaningful progress commercially and in the clinic. The second quarter showcased the early impact of our commercial strategy, and we are pleased to report second quarter 2025 revenue of over $400,000. We are proud of the initial organic revenue growth over the first two full quarters since launching Renovocath commercial sales, especially since this was achieved without a dedicated sales and marketing team. With the recent hiring of Phil Stockton as our Senior Director of Sales and Market Development, our goal is to stay lean while also continuing to build commercialization momentum.

Speaker #5: The second quarter showcased the thorough impact of our commercial strategy. We are pleased to report second quarter 2025 revenue of over $400,000. We are proud of the initial organic revenue growth over the first two full quarters since launching RenovoCast commercial sales, especially since this was achieved without a dedicated sales and marketing team.

Speaker #5: With the recent hiring of Phil Stockton as our senior director of sales and market development, our goal is to stay lean, while also continuing to build commercialization momentum.

Speaker #5: We will continue to gather important data about our market, such as sales cycles, activation times, individual customer preferences, and other commercial matters, as we seek to grow our customer base, fulfill repeat RenovoCast orders, and position ourselves for commercial growth over the long term.

Shaun Bagai: We will continue to gather important data about our market, such as sales cycles, activation times, individual customer preferences, and other commercial matters as we seek to grow our customer base, fulfill repeat RenovoCath orders, and position ourselves for commercial growth over the long term. We believe RenovoCath is positioned to address a significant unmet need in oncology, supported by a compelling market opportunity as an innovative approach to drug delivery. Our commercial vision and internal market analysis continue to support an initial US total addressable market for RenovoCath as a standalone device as an estimated initial $400 million peak annual US sales opportunity. Beyond historical RenovoCath usage, we are already beginning to see interest in the adoption of our technology for the treatment of other solid tumors through our commercial efforts.

Shawn Bhagat: We will continue to gather important data about our market, such as sales cycles, activation times, individual customer preferences, and other commercial matters as we seek to grow our customer base, fulfill repeat Renovocath orders, and position ourselves for commercial growth over the long term. We believe Renovocath is positioned to address a significant unmet need in oncology, supported by a compelling market opportunity as an innovative approach to drug delivery. Our commercial vision and internal market analysis continue to support an initial US total addressable market for Renovocath as a standalone device, as an estimated initial $400 million peak annual US sales opportunity. Beyond historical Renovocath usage, we are already beginning to see interest in the adoption of our technology for the treatment of other solid tumors through our commercial efforts.

Speaker #5: We believe RenovoCast has positioned to address a significant unmet need in oncology, supported by a compelling market opportunity, as an innovative approach to drug delivery.

Speaker #5: Our commercial vision and internal market analysis continue to support an initial US total addressable market for RenovoCast as a standalone device as an estimated initial $400 million peak annual US sales opportunity.

Speaker #5: Beyond historical RenovoCast usage, we are already beginning to see interest in the adoption of our technology for the treatment of other solid tumors through our commercial efforts.

Speaker #5: This broad interest serves as the basis for our belief in the potential for a several billion dollar total addressable market for the RenovoCast device alone, as we expand into additional cancer applications.

Shawn Bhagat: This broad interest serves as the basis for our belief in the potential for a several billion dollar total addressable market for the Renovocath device alone as we expand into additional cancer applications. On the clinical front, as Ramtan mentioned, we received a positive independent DMC recommendation to continue our phase three Tiger Pack trial based on interim data review. We are very excited about this development and what it means for the future prospects of our phase three trial. I would now like to turn the call over to Lisa Gentry, our Chief Clinical Officer, who will elaborate on our clinical programs. Lisa.

Shaun Bagai: This broad interest serves as the basis for our belief in the potential for a several billion dollar total addressable market for the RenovoCath device alone as we expand into additional cancer applications. On the clinical front, as Ramtin mentioned, we received a positive independent DMC recommendation to continue our phase III TIGeR-PaC trial based on interim data review. We are very excited about this development and what it means for the future prospects of our phase III trial. I would now like to turn the call over to Leesa Gentry, our Chief Clinical Officer, who will elaborate our clinical programs. Leesa.

Speaker #5: On the clinical front, as Ramtan mentioned, we received a positive independent DMC recommendation to continue our Phase 3 Tiger Plaque trial based on interim data review.

Speaker #5: We are very excited about this development, and what it means for the future prospects of our phase three trial. I would now like to turn the call over to Lisa Gentry, our Chief Clinical Officer, who will elaborate our clinical programs.

Speaker #5: Lisa?

Speaker #6: Thank you, Sean. To reiterate, the DMC has recommended that RenovoRx continue the Tiger Plaque trial following their review of the pre-planned second interim analysis, which was triggered at the 52nd event.

Leesa Gentry: Thank you, Shaun. To reiterate, the DMC has recommended that RenovoRx, Inc. continue the TIGeR-PaC trial following their review of the pre-planned second interim analysis, which was triggered at the 52nd event. As Ramtin Agah mentioned, as of 12 August 2025, we have randomized 95 patients, and 61 events have occurred, keeping us on track to complete enrollment later this year or early next year. The trial design calls for 114 patients to be randomized, and the final TIGeR-PaC analysis will be triggered upon the 86th event. We are also advancing our research pipeline. Last week, we announced the launch of our multi-center post-marketing registry study called PanTheR to follow patients undergoing cancer treatment delivered by RenovoCath to solid tumor. The PanTheR study is an important initiative aimed at evaluating the safety and effectiveness of RenovoCath in real-world clinical settings.

Lisa Gentry: Thank you, Shawn. To reiterate, the DMC has recommended that RenovoRx continue the Tiger Pack trial following their review of the pre-planned second interim analysis, which was triggered at the 52nd event. As Ramtan mentioned, as of August 12th, 2025, we have randomized 95 patients and 61 events have occurred, keeping us on track to complete enrollment later this year or early next year. The trial design calls for 114 patients to be randomized, and the final Tiger Pack analysis will be triggered upon the 86th event. We are also advancing our research pipeline. Last week, we announced the launch of our multicenter post-marketing registry study called PANTHER to follow patients undergoing cancer treatment delivered by Renovocath to solid tumors. The PANTHER study is an important initiative aimed at evaluating the safety and effectiveness of Renovocath in real-world clinical settings.

Speaker #6: As Ramtan mentioned, as of August 12th, 2025, we have randomized 95% patients and 61 events have occurred, keeping us on track to complete enrollment later this year or early next year.

Speaker #6: The trial design calls for 114 patients to be randomized, and the final Tiger Plaque analysis will be triggered upon the 86th event. We are also advancing our research pipeline, last week we announced the launch of our multi-center post-marketing registry study called PANTHER, to follow patients undergoing cancer treatment, delivered by RenovoCast to solid tumors.

Speaker #6: The PANTHER study is an important initiative aimed at evaluating the safety and effectiveness of RenovoCast in real-world clinical settings. This study is designed to assess long-term safety and survival outcomes in patients with solid tumors who receive targeted drug delivery via RenovoCast.

Lisa Gentry: This study is designed to assess long-term safety and survival outcomes in patients with solid tumors who receive targeted drug delivery via Renovocath. By collecting real-world data on the use of Renovocath across a broader range of tumor types, the PANTHER study aims to provide valuable insights into patient outcomes and support the generation of additional safety data. PANTHER marks a significant step forward in our commitment to better understand and demonstrate the long-term safety and therapeutic potential of our Renovocath device. And now I will turn it back to Shawn.

Leesa Gentry: This study is designed to assess long-term safety and survival outcomes in patients with solid tumors who receive targeted drug delivery via RenovoCath. By collecting real-world data on the use of RenovoCath across a broader range of tumor types, the PANTHER study aims to provide valuable insights into patient outcomes and support the generation of additional safety data. PANTHER marks a significant step forward in our commitment to better understand and demonstrate the long-term safety and therapeutic potential of our RenovoCath device. Now, I will turn it back to Shaun.

Speaker #6: By collecting real-world data on the use of RenovoCast across a broader range of tumor types, the PANTHER study aims to provide valuable insights into patient outcomes and support the generation of additional safety data.

Speaker #6: PANTHER marks a significant step forward in our commitment to better understand and demonstrate the long-term safety and therapeutic potential of our RenovoCast device. And now, I will turn it back to Sean.

Speaker #5: Thanks, Lisa. You and your team have done a wonderful job with our Phase 3 trial. We are excited about the continued validation of our platform, the progress of our commercial strategy, and the strong execution by our team.

Shaun Bagai: Thanks, Leesa. You and your team have done a wonderful job with our phase III trial. We are excited about the continued validation of our platform, progress of our commercial strategy, and strong execution by our team. Additionally, each cancer center participating in the registry study will purchase RenovoCath devices from RenovoRx for use in the study. With that, I will turn the call over to Ronald Kocak, our VP Controller and Principal Accounting Officer, to review the financials before Q&A. Ron.

Shawn Bhagat: Thanks, Lisa. You and your team have done a wonderful job with our phase three trial. We are excited about the continued validation of our platform, progress of our commercial strategy, and strong execution by our team. Additionally, each cancer center participating in the registry study will purchase Renovocath devices from RenovoRx for use in the study. With that, I'll turn the call over to Ron Kozak, our VP Controller and Principal Accounting Officer, to review the financials before Q&A. Ron?

Speaker #5: Additionally, each cancer center participating in the registry study will purchase RenovoCast devices from RenovoRx for use in the study. With that, I'll turn the call over to Ron Kozak, our VP Controller and Principal Accounting Officer, to review the financials before Q&A.

Speaker #5: Ron?

Speaker #7: Thank you, Sean. For the second quarter of 2025 ending June 30th, Renovo reported revenues of approximately $422,000 from commercial sales of RenovoCast. Driven by new customer purchase orders and early repeat orders from our initial sites.

Ronald Kocak: Thank you, Shaun. For Q2 2025, ending 30 June, RenovoRx, Inc. reported revenues of approximately $422,000 from commercial sales of RenovoCath, driven by new customer purchase orders and early repeat orders from our initial sites. Research and development expenses were $1.4 million for Q2, reflecting a $0.1 million decrease from the same quarter year-over-year. The decrease is primarily due to other clinical and regulatory expenses, including an allocation of selling, general, and administrative expenses of $0.2 million. This decrease was offset by an increase in non-recurring engineering costs on our RenovoCath device of $0.1 million.

Ronald Kozak: Thank you, Shawn. For the second quarter of 2025, ending June 30th, Renovo reported revenues of approximately $422,000 from commercial sales of Renovocath, driven by new customer purchase orders and early repeat orders from our initial sites. Research and development expenses were $1.4 million for the second quarter, reflecting a $0.1 million decrease from the same quarter year over year. The decrease is primarily due to other clinical and regulatory expenses, including an allocation of selling, general, and administrative expenses of $0.2 million. This decrease was offset by an increase in non-returning engineering costs on our Renovocath device of $0.1 million. Selling, general, and administrative expenses were approximately $1.5 million, remaining unchanged from the same quarter last year. We ended the quarter with $12.3 million in cash and cash equivalents on hand. We anticipate revenues from Renovocath sales orders to reduce our burn rate over time.

Speaker #7: Research and development expenses were $1.4 million for the second quarter. Reflecting a 0.1 million decrease from the same quarter year over year. The decrease is primarily due to other clinical and and regulatory expenses, including an allocation of selling general and administrative expenses of 0.2 million.

Speaker #7: This decrease was offset by an increase in non-recurring engineering costs on our RenovoCast device of $0.1 million. Selling, general, and administrative expenses were approximately $1.5 million.

Ronald Kocak: Selling general and administrative expenses were approximately $1.5 million, remaining unchanged from the same quarter last year. We ended the quarter with $12.3 million in cash and cash equivalents on hand. We anticipate revenues from RenovoCath sales orders to reduce our burn rate over time. We believe that cash as of 30 June 2025, will fully fund both ongoing RenovoCath commercial scaleup efforts and additional progress towards the completion in the phase III TIGeR-PaC trial. Common shares outstanding as of 11 August 2025, totaled 36,645,884. With that, I will turn the call back to the operator for Q&A. Operator, please open the line for questions.

Speaker #7: Remaining unchanged from the same quarter last year. We ended the quarter with $12.3 million in cash and cash equivalents on hand. We anticipate revenues from RenovoCast sales orders to reduce our burn rate over time.

Speaker #7: We believe that cash, as of June 30, 2025, will fully fund both ongoing RenovoCast commercial scale-up efforts and additional progress towards the completion of the Phase 3 Tiger Plaque trial.

Ronald Kozak: We believe that cash as of June 30th, 2025, will fully fund both ongoing Renovocath commercial scale-up efforts and additional progress towards the completion in the phase three Tiger Pack trial. Common shares outstanding as of August 11th, 2025, totaled $36,645,884. With that, I will turn the call back to the operator for Q&A. Operator, please open the line for questions.

Speaker #7: Common shares outstanding as of August 11, 2025, totaled $36 million. With that, I will turn the call back to the Operator for Q&A. Operator, please open the line for questions.

Speaker #6: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press *1 on your telephone keypad.

Operator 2: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press star one, star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please while we poll for questions. Our first question comes from Scott Henry with AGP. Please proceed with your question.

Operator: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press star one, star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. Our first question comes from Scott Henry with AGP. Please proceed with your question.

Speaker #6: A confirmation tone will indicate that your line is in the question queue. You may press *1 if you would like to remove your question from the queue.

Speaker #6: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the * keys. One moment, please, while we pull for questions.

Speaker #6: Our first question comes from Scott Henry with AGP. Please proceed with your question.

Speaker #8: Thank you. Good afternoon. Certainly a lot to talk about. I guess just for clarification, the decision was to maintain the trial at the same number of patients.

Scott Henry: Thank you. Good afternoon. Certainly a lot to talk about. I guess just for clarification, the decision was to maintain the trial at the same number of patients. I know sometimes they can add patients. It sounds like they did not, but just want to clarify that.

Scott Henry: Thank you. Good afternoon. Certainly a lot to talk about. I guess just for clarification, the decision was to maintain the trial at the same number of patients. I know sometimes they can add patients. It sounds like they did not, but just to clarify that.

Speaker #8: I know sometimes they can add patients; it sounds like they did not, but just want to clarify that.

Speaker #5: Yeah, thanks for that. Hey, Scott, thanks for the question. Yeah, that's a good thing to point out. The DMC feedback we got seemed very positive, and we maintained the same sample size, the same number of patients, so we did not add patients to the trial.

Shaun Bagai: Yeah, Hey, Scott. Thanks for the question. Yeah, that's a good thing to point out is the DMC feedback we got seemed very positive and maintaining the same sample size, the same number of patients. We did not add patients to the trial.

Shawn Bhagat: Yeah, thanks for the hey, Scott. Thanks for the question. Yeah, that's a good thing to point out is the DMC feedback we got seemed very positive and maintaining the same number, sample size, the same number of patients. So we did not add patients to the trial.

Speaker #8: Okay. Great. And, you know, I know I know after the first analysis you did comment on a lot of the data but not the second analysis; is that because it's closer to the end?

Scott Henry: Okay. Great. You know, I know after the first analysis, you did comment on a lot of the data, but not the second analysis. Is that because it's closer to the end? Is there any kind of reason, why, you know, kind of was okay the first time but not the second time? I certainly understand that's the way a lot of these things work, but I just wanted to hear your thoughts.

Scott Henry: Okay. Great. And you know I know after the first analysis, you did comment on a lot of the data, but not the second analysis. Is that because it's closer to the end? Is there any kind of reason why you know kind of was okay the first time, but not the second time? I certainly understand that's the way a lot of these things work, but I just wanted to hear your thoughts.

Speaker #8: Is there any kind of reason why, you know, kind of it was okay the first time but not the second time? I certainly understand that's the way a lot of these things work, but I just wanted to hear your thoughts.

Speaker #5: Yeah, Scott, you nailed it. As a reminder, we had very significant or positive results from our phase one two trial showing a potential for increasing lifespan of pancreatic cancer patients.

Shaun Bagai: Yeah, Scott, you nailed it. As a reminder, we had very significant or positive results from our phase I/II trial showing a potential for increasing the lifespan of pancreatic cancer patients and really reducing the side effects and toxicities. This allowed us and gave us the confidence to jump straight into a phase III randomized, which would be a pivotal trial. The FDA agreed that based on our preliminary data from the phase I/II trials, we could jump to a phase III. In most circumstances, you do a prospective phase II trial to help inform the design. With that confidence, we went to the phase III.

Shawn Bhagat: Yeah, Scott, you nailed it. As a reminder, we had very significant or positive results from our phase one/two trial showing a potential for increasing the lifespan of pancreatic cancer patients and really reducing the side effects and toxicities. This allowed us and gave us the confidence to jump straight into a phase three randomized, which should be a pivotal trial. And the FDA agreed that based on our preliminary data from the phase one/two trials, we could jump to a phase three. In most circumstances, you do a prospective phase two trial to help inform the design. With that confidence, we went to the phase three. Not having done the phase two, taking a very early look, i.e., 30% of the data would give us confidence that we are on the right track, almost in lieu of a phase two trial.

Speaker #5: And really reducing the side effects and toxicities. This allowed us and gave us the confidence to jump straight into a Phase 3 randomized trial, which should be a pivotal trial. The FDA agreed that based on our preliminary data from the Phase 1/2 trials, we could jump to a Phase 3.

Speaker #5: In most circumstances, you do a prospective Phase 2 trial to help inform the design. Would that confidence we went to the Phase 3 not having done the Phase 2 be taking a very early look?

Shaun Bagai: Not having done the phase II, taking a very early look, i.e., 30% of the data would give us confidence that we are on the right track, almost in lieu of a phase II trial. Being that early in the study, we didn't feel like it would bias or jeopardize the study in any way. You nailed it.

Speaker #5: I.e., 30% of the data would give us confidence that we are on the right track almost in lieu of a phase two trial. And being that early in the study, we didn't feel like it would bias or jeopardize the study in any way.

Shawn Bhagat: And being that early in the study, we didn't feel like it would bias or jeopardize the study in any way. And you nailed it. Now that we're getting nearing the end of the trial and already there's an enthusiasm for the potential positivity, we didn't want to introduce any bias at this late stage in the game, how close we are to the finish line and the DMC's confidence to move forward to completion and then potential preparation of an NDA filing. And to protect the integrity of the trial, it made sense to keep this with the highest chance of success with the FDA at the end.

Speaker #5: And you nailed it. Now that we're getting nearing the end of the trial, and already there's an enthusiasm for the potential positivity, we didn't want to introduce any bias at this late stage in the game.

Shaun Bagai: Now that we're getting nearing the end of the trial, and already there's an enthusiasm for the potential positivity, we didn't want to introduce any bias at this late stage in the game, how close you are to the finish line, and the DMC's confidence to move forward to completion and then potential preparation of an NDA following and to protect the integrity of the trial, it made sense to keep this with the highest chance of success with the FDA at the end.

Speaker #5: How close we are to the finish line and the DMC's confidence to move forward to completion and then potential preparation of an AMA filing and to protect the integrity of the trial made sense to keep this with the highest chance of success with the FDA at the end.

Speaker #8: Okay, makes sense. Certainly. And then, you know, it looks like you need to enroll 19 more patients. You know, the pace of the past few months would seem to indicate that that could, you know, reach to kind of mid-2026, but it sounds like you think it could be a little bit earlier.

Scott Henry: Okay. Makes sense. Certainly. You know, it looks like you need to enroll 19 more patients. You know, the pace of the past few months would seem to indicate that that could, you know, reach till kind of mid-2026, but it sounds like you think it could be a little bit earlier. Are you expecting kind of a ramp up? Is it, you know, kind of the fall, maybe it's slow in the summer. But it seems like the enrollment pace is expected to increase near term.

Scott Henry: Okay. Makes sense. Certainly. And then you know it looks like you need to enroll 19 more patients. The pace of the past few months would seem to indicate that that could reach till kind of mid-2026, but it sounds like you think it could be a little bit earlier. Are you expecting kind of a ramp-up? Is it kind of the fall? Maybe it's slow in the summer, but it seems like the enrollment pace is expected to increase near term.

Speaker #8: Are you expecting kind of a ramp-up? Is it, you know, kind of the fall, maybe it's slow in the summer? But it seems like the enrollment pace is expected to increase in the near term.

Speaker #5: Yeah, Scott, thanks for the question. A couple of things to keep in mind is in terms of enrollment, we do enroll patients treatment naive.

Shaun Bagai: Scott, thanks for the question. A couple of things to keep in mind is in terms of enrollment, we do enroll patients treatment naive. We then go through an induction phase to weed out patients that might have micrometastases and then randomize truly locally advanced pancreatic cancer patients. There is kind of a fallout in that middle phase. We've randomized 95 to date. We need to randomize 114 to stop the study or to complete enrollment and randomization. Enrollment completion is what we're aiming for, and that we anticipate to be towards the end of the year or Q1 next year. As far as a ramp goes, you're 100% correct.

Shawn Bhagat: Yeah, Scott, thanks for the question. A couple of things to keep in mind is in terms of enrollment, we do enroll patients treatment-naive. We then go through an induction phase to weed out patients that might have micrometastases and then randomize truly locally advanced pancreatic cancer patients. So there is kind of a fallout in that middle phase. So we've randomized 95 to date. We need to randomize 114 to stop the study or to complete enrollment and randomization. So enrollment completion is what we're aiming for, and that we anticipate to be towards the end of the year, first quarter next year. As far as a ramp goes, you're 100% correct. We've added some larger volume, more well-known cancer centers in the last several months, including University of Nebraska, Northwell, Johns Hopkins.

Speaker #5: We then go through an induction phase to weed out patients that might have micrometastases and then randomize truly locally advanced pancreatic cancer patients. So there is kind of a fallout in that middle phase.

Speaker #5: So we've randomized 95 to date either randomize 114 to stop the study, or to complete enrollment and randomization. So enrollment completion is what we're aiming for, and that we anticipate to be towards the end of the year or first quarter next year.

Speaker #5: As far as a ramp goes, you're 100% correct. We've added some larger volume to more well-known cancer centers than the last several months. Including University of Nebraska, Northwell, Johns Hopkins, as we anticipate that with these larger cancer centers, we should start to see a ramp as we're coming out of the summer.

Shaun Bagai: We've added some larger volume, more well-known cancer centers in the last several months, including University of Nebraska, Northwell, and Johns Hopkins. As we anticipate that with these larger cancer centers, we should start to see a ramp as we're coming out of the summer. It's a combination of getting enrollment done to be able to randomize that 114th patient and these new centers coming on board in the recent past to help accelerate enrollment towards the end of the year, if not the beginning of next year.

Shawn Bhagat: As we anticipate that with these larger cancer centers, we should start to see a ramp as we're coming out of the summer. So it's a combination of getting enrollment done to be able to randomize that 114th patient and these new centers coming on board in the recent past to help accelerate enrollment towards the end of the year, if not the beginning of next year.

Speaker #5: So it's a combination of getting enrollment done to be able to randomize that 114th patient and these new centers coming on board in the recent past to help accelerate enrollment towards the end of the year if not the beginning of next year.

Speaker #8: Okay, great. Just the final question, then I'll jump into the queue. On the PANTHER trial, you know, when should we see data coming out of that?

Scott Henry: Okay, great. Just the final question, I'll jump into the queue. On the PanTheR trial, you know, when should we see data coming out of that?

Scott Henry: Okay. Great. Just the final question, and then I'll jump into the queue. On the PANTHER trial, you know when should we see data coming out of that?

Speaker #5: It's interesting. It's a broad-based post-market device registry. And so there's not as pre-specified endpoint with data. As investigators, and the company sees interesting findings, we can publish and present on Podium's data along the way.

Shaun Bagai: It's interesting. It's a broad-based post-market device registry, there's not a pre-specified endpoint with data. As investigators and the company sees interesting findings, we can publish and present on podium data along the way. One of the exciting aspects of the PanTheR study, it is a solid tumor registry, and while our experience to date has not fully but been primarily in pancreatic cancer, it does allow us to collect, capture, and then present on data outside of pancreatic cancer. As we start to see either trends in usage or trends in results, we can start to publish and present data along the way.

Shawn Bhagat: It's interesting. It's a broad-based post-market device registry, and so there's not a pre-specified endpoint with data. As investigators and the company see interesting findings, we can publish and present on podium's data along the way. One of the exciting aspects of the PANTHER study, it is a solid tumor registry. And while our experience to date has not fully, but been primarily in pancreatic cancer, it does allow us to collect, capture, and then present on data outside of pancreatic cancer. So as we start to see either trends in usage or trends in results, we can start to publish and present data along the way. So not a great answer in terms of timing, but it is imminent, and we look forward to being able to explore the use of the Renovocath technology beyond where we've seen it to date.

Speaker #5: One of the exciting aspects of the PANTHER study is that it is a solid tumor registry. While our experience to date has not fully, but been primarily, in pancreatic cancer, it does allow us to capture and present data outside of pancreatic cancer.

Speaker #5: So, as we start to see either trends in usage or trends in results, we can start to publish and present data along the way.

Speaker #5: So not a a great answer in terms of timing, but it is imminent and we look forward to being able to explore the use of the RenovoCast technology beyond what we've seen it to date.

Shaun Bagai: Not a great answer in terms of timing, but it is imminent, and we look forward to being able to explore the use of the RenovoCath technology beyond where we've seen it to date. Another interesting aspect about the PanTheR trial is that these centers will be purchasing devices to be able to use to explore further uses of the RenovoCath, which could help with revenue as well.

Speaker #5: And another interesting aspect about the PANTHER trial is that these centers will be purchasing devices to be able to use to explore further uses of the RenovoCast.

Shawn Bhagat: And another interesting aspect about the PANTHER trial is that these centers will be purchasing devices to be able to use to explore further uses of the Renovocath, which could help with revenue as well.

Speaker #5: Which could help with revenue as well.

Speaker #8: Okay. Great. Thank you for taking the questions and congratulations on a lot of progress in the past few months.

Scott Henry: Okay, great. Thank you for taking the questions and congratulations on a lot of progress in the past few months.

Scott Henry: Okay. Great. Thank you for taking the questions, and congratulations on a lot of progress in the past few months.

Speaker #5: Thank you, Scott.

Shaun Bagai: Thank you, Scott.

Shawn Bhagat: Thank you, Scott.

Speaker #1: Our next question comes from Edward Wu with Ascendia Capital Markets. Please proceed with your question.

Operator 2: Our next question comes from Edward Wu with Ascendiant Capital Markets. Please proceed with your question.

Operator: Our next question comes from Edward Wu with Ascending Capital Markets. Please proceed with your question.

Speaker #9: Hi, it's Rafai for Edward, Ascendia Capital Markets. Can you give an update on you previously mentioned partnering with the top 200 cancer centers?

Edward Wu: Hi, it's Edward Wu, Ascendiant Capital Markets. Can you give an update on, you previously mentioned partnering with the top 200 cancer centers?

Rafai: Hi, it's Rafai for Ed Wu, Ascending Capital Markets. Can you give an update on you previously mentioned partnering with the top 200 cancer centers?

Speaker #5: Yeah, thanks for the question. Great to talk to you. Thanks for calling in. As I've kind of outlined in terms of market potential, there are about 200 cancer centers across the U.S. that treat the majority of non-metastatic GI solid tumors.

Shaun Bagai: Yeah. Thanks for the question, Ed. Great to talk to you. Thanks for calling in. As I've kind of outlined in terms of market potential, there are about 200 cancer centers across the US that treat the majority of non-metastatic GI solid tumors. It's a good example market for us for pancreatic cancer. The way I've characterized these 200 centers is it wouldn't take a large sales force to attack them. As we operate in this commercial environment very leanly without hiring a large expensive sales force, we're able to have deep penetration in the broader market by focusing on some of these top centers.

Shawn Bhagat: Yeah, thanks for the question. Great to talk to you. Thanks for calling in. So as I've kind of outlined in terms of market potential, there are about 200 cancer centers across the US that treat the majority of non-metastatic GI solid tumors. So it's a good example market for us for pancreatic cancer. And the way I've characterized these 200 centers is it wouldn't take a large sales force to attack them. And as we operate in this commercial environment very leanly without hiring a large expensive sales force, we're able to have deep penetration in the broader market by focusing on some of these top centers. We've already made announcements that we're in 13 hospitals with VAC approvals, which means that the hospitals who are approved to purchase the device are already issued purchase orders for Renovocath with our early commercial efforts.

Speaker #5: So it's a good example market for us for pancreatic cancer. The way I've characterized these 200 centers is that it wouldn't take a large sales force to attack them.

Speaker #5: And as we operate in this commercial environment, very leanly without hiring a large expensive sales force, we're able to have deep penetration in the broader market by focusing on some of these top centers.

Speaker #5: We've already made announcements that we're in 13 hospitals with VAC approvals, which means that the hospitals are approved to purchase the device or have already issued purchase orders for RenovoCast, with our early commercial efforts.

Shaun Bagai: We've already made announcements that we're in 13 hospitals with VAC approvals, which means that the hospitals are approved to purchase the device or already issued purchase orders for RenovoCath with our early commercial efforts. Those 13 centers are some of the top 200 large volume cancer centers across the US, four of which have started using the device, treating patients and having real orders as well. As far as using their names publicly, we did mention a couple of centers, including Hackensack University Medical Center in New Jersey. As we get permission to use names, we'll start publishing more on exactly which centers we're partnering with. We are also on the verge of launching a RenovoCath website where patients can go to find which centers are offering the technology.

Speaker #5: Those 13 centers are some of the top 200 large volume cancer centers across the US. Four of which have started using the device treating patients and having reorders as well.

Shawn Bhagat: Those 13 centers are some of the top 200 large volume cancer centers across the US, four of which have started using the device, treating patients, and having reorders as well. As far as using their names publicly, we did mention a couple of centers, including Hackensack Medical Center in New Jersey. And as we get permission to use names, we'll start publishing more on exactly which centers we're partnering with. We are also on the verge of launching a Renovocath website where patients can go to to find which centers are offering the technology. So in the not-too-distant future, you'll be able to see which centers are involved as well once we get permission to use your name to help drive patients towards centers to be able to receive treatment.

Speaker #5: As far as using their names publicly, we did mention a couple of centers, including Hackensack Medical Center in New Jersey. As we get permission to use names, we'll start publishing more on exactly which centers we're partnering with.

Speaker #5: We are also on the verge of launching a RenovoCast website. Where patients can go to to find which centers are offering the technology. So in the not too distant future, you'll be able to see which centers are involved as well once we get permission to use your name to help drive patients towards centers to be able to receive treatment.

Shaun Bagai: In the not too distant future, you'll be able to see which centers are involved as well once we get permission to use their name to help drive patients towards centers to be able to receive treatment.

Speaker #9: Okay, great. Can you also discuss any plans for the RenovoCast in international markets?

Edward Wu: Okay, great. Can you also discuss any plans for the RenovoCath for international markets?

Rafai: Okay. Great. Can you also discuss any plans for the Renovocath for international markets?

Speaker #5: Yeah, it's an interesting topic. Given the reimbursement tailwinds, the cost of doing business here in the U.S., and the large market with unmet needs, we're hyper-focused on the U.S. market first.

Shaun Bagai: Yeah. It's an interesting topic, Ed. Given the reimbursement tailwinds and the cost of doing business here in the US and the large market and unmet need here, we're hyper-focused on the US market first. We do anticipate down the road, once we establish the US market, to explore internationally. There is a large volume of cancer patients, without great technologies or therapies across Europe and different Asian countries as well. We've begun to have dialogues with investigators there over the years and also potential partners. As we start to really get traction in the US, we'll further explore outside the US markets, either with a partner or on our own.

Shawn Bhagat: Yeah, it's an interesting topic, and given the reimbursement tailwinds and the cost of doing business here in the US and the large market and unmet need here, we're hyper-focused on the US market first. We do anticipate down the road, once we establish the US market to explore internationally, there is a large volume of cancer patients without great technologies or therapies across Europe and different Asian countries as well. We've begun to have dialogues with investigators there over the years and also potential partners. So as we start to really get traction in the US, we'll further explore outside the US markets, either with a partner or on our own.

Speaker #5: We do anticipate down the road once we establish the US market to explore internationally. There is a large volume of cancer patients, without great technologies or therapies, across Europe and different Asian countries as well.

Speaker #5: We've begun to have dialogues with investigators there over the years, and also potential partners. So as we start to really get traction in the US, we'll further explore outside the US markets, either with a partner or on our own.

Speaker #9: Great, thank you very much.

Edward Wu: Great. Thank you very much.

Rafai: Great. Thank you very much.

Speaker #5: Thanks for the questions, Ed.

Shaun Bagai: Thanks for the question, Ed.

Shawn Bhagat: Thanks for the questions, Ed.

Speaker #1: As a reminder, if you'd like to ask a question, please press *1 on your telephone keypad. Our next question comes from Surya Pakula with HC Wainwright.

Operator 2: As a reminder, if you'd like to ask a question, please press star one on your telephone keypad. Our next question comes from Swayampakula Ramakanth with H.C. Wainwright & Co. Please proceed with your question.

Operator: As a reminder, if you'd like to ask a question, please press star one on your telephone keypad. Our next question comes from Sohyam Pathkula with HC Wainwright. Please proceed with your question.

Speaker #1: Please proceed with your question.

Speaker #10: Thank you. This is RK from HC Wainwright. Good afternoon, Sean. So, looking at your revenues of $420,000, I'm just trying to figure out, is any of it, any of the revenues coming from purchasing for the clinical studies itself, or is all of it really commercial dollars?

Swayampakula Ramakanth: Thank you. This is RK from H.C. Wainwright. Good afternoon, Shaun. You know, looking at your revenues of $422,000, I'm just trying to figure out, is any of the revenues coming from purchasing for the clinical studies itself, or is all of it really commercial dollars?

RK: Thank you. This is RK from HC Wainwright. Good afternoon, Shawn. So, you know, looking at your revenues of $422,000, I'm just trying to figure out, is any of it, any of the revenues coming from purchasing for the clinical studies itself, or is all of it really commercial dollars?

Speaker #5: Okay, this is a great question. I really appreciate you asking them because it's a great delineation. This is all non-Tiger Plaque phase three revenue.

Shaun Bagai: RK, this is a great question. I really appreciate you asking it because it's a great delineation. This is all non-TIGeR-PaC phase III revenue. These are all brand new customers who were outside of the clinical trial or outside usage of the trial. Any revenues, and we do charge for the catheter, and it is reimbursed within the phase III TIGeR-PaC trial, but any revenues from those are not recognized as revenue but considered an R&D offset, which you can see from our filings. It is important to note that the revenue stream is all external to TIGeR-PaC. As mentioned earlier in Scott's question, we do aim to complete enrollment towards the end of this year, beginning of next year.

Shawn Bhagat: RK, this is a great question. I really appreciate you asking it because it's a great delineation. This is all non-Tiger Pack phase three revenue. So these are all brand new customers who were outside of the clinical trial or outside usage of the trial. Any revenues, and we do charge for the catheter, and it is reimbursed within the phase three Tiger Pack trial, but any revenues from those are not recognized as revenue, but considered an R&D offset, which you can see from our filings. So it is important to note that the revenue stream is all external to Tiger Pack. As mentioned earlier in Scott's question, we do aim to complete enrollment towards the end of this year, beginning of next year.

Speaker #5: So these are all brand new customers who were outside of the clinical trial or outside usage of the trial. Any revenues, and we do charge for the catheter, and it is reimbursed within the phase three Tiger Plaque trial.

Speaker #5: But any revenues from those are not recognized as revenue but are considered an R&D offset, which you can see from our filings. So, it is important to note that the revenue stream is all external to Tiger Plaque.

Speaker #5: As mentioned earlier in Scott's question, we do aim to complete enrollment towards the end of this year, beginning of next year. After that, those 18 centers that are in the Tiger Plaque trial, can and most likely will convert to commercial paying customers.

Shaun Bagai: After that, those 18 centers that are in the TIGeR-PaC trial can and most likely will convert to commercial paying customers where they can start treating patients with various ailments or tumors using the device. Those purchases will be revenue towards the company in terms of revenue recognition. The TIGeR-PaC sites using catheters does help our bottom line, but the $422,000 just announced does not include any of that revenue recognition. On the flip side, because the PanTheR study is a post-market device registry, revenue obtained for the PanTheR sites will count towards a revenue recognition.

Shawn Bhagat: After that, those 18 centers that are in the Tiger Pack trial can and most likely will convert to commercial paying customers where they can start treating patients with various ailments or tumors using the device, and those purchases will be revenue towards a company in terms of revenue recognition. So the Tiger Pack sites using catheters does help our bottom line, but the $422,000 just announced does not include any of that revenue recognition. On the flip side, because the PANTHER study is a post-market device registry, revenue obtained for the PANTHER sites will count towards a revenue recognition.

Speaker #5: Where they can start treating patients with various ailments or tumors using the device. Those purchases will be revenue towards a company in terms of revenue recognition.

Speaker #5: So the Tiger Plaque sites using catheters do help our bottom line, but the $420,000 just announced does not include any of that revenue recognition.

Speaker #5: On the flip side, because the PANTHER study is a post-market device registry, revenue obtained for the PANTHER sites will count towards revenue recognition.

Speaker #10: Okay. And then, so on the PANTHER study, since it's a registry study, so do you really have a specific number of centers or anything like that, or it obviously depends upon which center wants to run this utilize the device and be part of the registry?

Swayampakula Ramakanth: Okay. On the PanTheR study, since it's a registry study, do you really have a specific number of centers or anything like that? It obviously depends upon which center wants to run this, you know, utilize the device and, you know, be part of the registry. How does that work?

RK: Okay. And then, so on the PANTHER study, since it's a registry study, so do you really have a specific number of centers or anything like that, or it obviously depends upon which center wants to run this, you know, utilize the device and, you know, be part of the registry? How does that work?

Speaker #10: How does that work?

Speaker #5: It's relatively open, so we don't have a specific small limited number of patients or centers. As we're discussing with centers, if there's academic interest in collecting data around certain patient populations, we'll partner with them.

Shaun Bagai: It's relatively open, we don't have a specific small limited number of patients or centers. As we're discussing with centers, if there's academic interest in collecting data around certain patient populations, we'll partner with them. It's not limited. We are also looking at investigator-initiated trials. There are some very interesting research ideas outside of what we've seen used so far that would most likely fall under the registry or an IIT, and those don't have to be mutually exclusive. We can also perform investigator-initiated studies within the registry and use those research ideas.

Shawn Bhagat: It's relatively open. So we don't have a specific small limited number of patients or centers. As we're discussing with centers, if there's academic interest in collecting data around certain patient populations, we'll partner with them. So it's not limited. We are also looking at investigator-initiated trials. There are some very interesting research ideas outside of where we've seen the usage so far that would most likely fall under the registry or an IIT, and those don't have to be mutually exclusive. We could also perform investigator-initiated studies within the registry and use those research ideas.

Speaker #5: So it's not limited. We are also looking at investigator-initiated trials. There are some very interesting research ideas outside of what we've seen used so far that would most likely fall under the registry or an IIT, and those don't have to be mutually exclusive.

Speaker #5: We could also perform investigator-initiated studies within the registry and use those research ideas. So it gives us a lot of leeway and optionality. In terms of what patients might be studied, and then subsequently what data might be published or presented to show where the RenovoCast can really help patients.

Shawn Bhagat: So it gives us a lot of leeway and optionality in terms of what patients might be studied, and then subsequently what data might be published or presented to show where the Renovocath can really help patients and really push the science behind this and also help us capture additional hospitals with academic interest in these areas.

Shaun Bagai: It gives us a lot of leeway and optionality in terms of what patients might be studied, and then subsequently what data might be published or presented to show where the RenovoCath can really help patients and really push the science behind this and also help us capture additional hospitals with academic interests in these areas.

Speaker #5: And really push the science behind this and also help us capture additional hospitals with academic interest in these areas.

Speaker #10: And then for the PANTHER study, I know we are not really started bringing in patients, but in general, when you started talking, you know, with your advisors and whatnot, what sort of solid tumors, you know, where they're thinking could be a good possibility for the utility of the RenovoCast?

Swayampakula Ramakanth: For the PanTheR study, I know you're not, you know, really started bringing in patients, but in general, when you started talking, you know, with your advisors and whatnot, what sort of solid tumors, you know, were they thinking could be a good possibility for the utility of the RenovoCath?

RK: And then for the PANTHER study, I know you're not really started bringing in patients, but in general, when you started talking with your advisors and whatnot, what sort of solid tumors, you know, were they thinking could be a good, good, good possibility for the utility of the Renovocath?

Speaker #5: RK, I really appreciate this question because given the success we've seen in pancreatic cancer, there is a vast interest beyond what we've studied primarily specifically locally advanced pancreatic cancer.

Shaun Bagai: RK, I really appreciate this question because given the success we've seen in pancreatic cancer, there is a vast interest beyond what we studied primarily, specifically locally advanced pancreatic cancer. The biggest few interests have been, one, in locally advanced pancreatic cancer following FOLFIRINOX treatment. As most are aware, the phase III trial design has a gemcitabine plus nab-paclitaxel induction phase. Many patients opt for FOLFIRINOX, especially the younger, healthier patients. Coupling local treatment with the FOLFIRINOX induction is of interest. Also exploring the use of the technology beyond locally advanced pancreatic cancer, for example, in resectable, in the neoadjuvant setting or borderline resectable pancreatic cancer patients. There's also an interest in studying or using the device in metastatic pancreatic cancer patients.

Shawn Bhagat: RK, I really appreciate this question because given the success we've seen in pancreatic cancer, there is a vast interest beyond what we studied primarily, specifically locally advanced pancreatic cancer. The biggest few interests have been one in locally advanced pancreatic cancer following FOLFIRINOX treatments. As most are aware, the phase three trial design has a gemcitabine plus Abraxane, Abraxane induction phase. Many patients opt for FOLFIRINOX, especially the younger, healthier patients. And so coupling local treatment with the FOLFIRINOX induction is of interest. Also exploring the use of the technology beyond locally advanced pancreatic cancer, for example, in resectable in the neoadjuvant setting or borderline resectable pancreatic cancer patients. There's also an interest in setting or using the device in metastatic pancreatic cancer patients.

Speaker #5: The biggest few interests have been one in locally advanced pancreatic cancer falling following FOLFIRINOX treatment. As most are aware, the phase three trial design has a gemcitabine plus Abraxane, Abraxane induction phase.

Speaker #5: Many patients opt for FOLFIRINOX, especially the younger, healthier patients. Coupling local treatment with FOLFIRINOX induction is of interest. We are also exploring the use of the technology beyond locally advanced pancreatic cancer.

Speaker #5: For example, in resectable in the neoadjuvant setting or borderline resectable pancreatic cancer patients. There's also an interest in setting or using the device in metastatic pancreatic cancer patients.

Speaker #5: Physicians are saying they have patients with a single metastasis or multiple metastases where local control could be important. It could even have effects on the immune system with different agents as they try different agents through the device as well.

Shaun Bagai: Physicians are saying that patients with a single metastases or multi metastases where local control could be important or could even have effects on the immune system with different agents as they try different agents through device as well. Those have been some of the top research, ideas, and interests. Beyond pancreatic cancer, the most common request or discussion is around cholangiocarcinoma or bile duct cancer. Given the similar nature of these tumors being hypovascular, having less blood supply, and also using the same drugs like gemcitabine, for example, to treat. There's also been an interest in studying bile duct cancers. Beyond that, there's been interest in certain subsets of non-small cell lung cancer, sarcomas, head and neck tumors. It's great to see this level of interest across different specialties based on our early success in pancreatic cancer.

Shawn Bhagat: Physicians are saying they have patients with a single metastasis or multiple metastases where local control could be important or could even have effects on the immune system with different agents as they try different agents through the device as well. So those have been some of the top research ideas and interests. Beyond pancreatic cancer, the most common request or discussion is around cholangiocarcinoma or bile duct cancer. Given the similar nature of these tumors being hypovascular, having less blood supply, and also using the same drugs like gemcitabine, for example, to treat, there's also been an interest in studying bile duct cancers. Beyond that, there's been interest in certain subsets of non-small cell lung cancer, sarcomas, head and neck tumors. It's great to see this level of interest across different specialties based on our early success in pancreatic cancer.

Speaker #5: So those have been some of the top research ideas and interests. Beyond pancreatic cancer, the most common requests or discussions are around cholangiocarcinoma or bile duct cancer.

Speaker #5: Given the similar nature of these tumors being hypovascular, having less blood supply, and also using the same drugs, like gemcitabine, for example, to treat, there's also been an interest in studying bile duct cancers beyond that.

Speaker #5: There's been interest in certain subsets of non-small cell lung cancer, sarcomas, head and neck tumors. It's great to see this level of interest across different specialties based on early success in pancreatic cancer.

Speaker #10: So, at one point we were talking about how, outside of the chemotherapy, additional drugs or drug categories could also be part of the RenovoCast.

Swayampakula Ramakanth: At one point, we were talking about how outside of the chemotherapy, additional drugs or drug categories could be also part of the RenovoCath. You know, do you envisage that sort of data within this PanTheR study, or is it going to be purely the typical chemotherapy that, you know, that you're currently using within the TIGeR-PaC study?

RK: So at one point, we were talking about how outside of the chemotherapy, additional drugs or drug categories could be also part of the Renovocath. Do you envisage that sort of data within this PANTHER study, or is it going to be purely the typical chemotherapy that you are currently using within the Tiger Pack study?

Speaker #10: You know, do you envisage that sort of data within this PANTHER study, or is it going to be purely the typical chemotherapy that, you know, that you're currently using within the Tiger Plaque study?

Speaker #5: I do. Beyond other tumor types, that's exactly what we'll be studying: other agents as well. So there's been interest from physicians to move beyond, or in addition to, gemcitabine, either with multiple therapies or other drugs that might be more caustic or toxic to the body.

Shaun Bagai: I do. Beyond other tumor types, that's exactly what will be studied is other agents as well. There's been interest from physicians to move beyond or in addition to gemcitabine, either with multiple therapies or other drugs that might be more caustic or toxic to the body. For example, platinum-based drugs are a big interest and one of the biggest limitations of systemic FOLFIRINOX. Beyond that, there are several classes of immunotherapeutics that have been tried, tested, and failed in pancreatic cancer and other tumors. One of the reasons is because of this desmoplastic barrier, high pressure and really tumor resistance and lack of blood vessels feeding the tumor, and we overcome that with our TAMP system and with the RenovoCath.

Shawn Bhagat: I do. Beyond other tumor types, that's exactly what will be studied is other agents as well. So there's been interest from physicians to move beyond or in addition to gemcitabine, either with multiple therapies or other drugs that might be more caustic or toxic to the body. For example, platinum-based drugs are a big interest and one of the biggest limitations of systemic FOLFIRINOX. Beyond that, there are several classes of immunotherapeutics that have been tried, tested, and failed in pancreatic cancer and other tumors. One of the reasons is because of this desmoplastic barrier, high pressure, and really tumor resistance and lack of blood vessels feeding the tumor. And we overcome that with our TAMP system and with the Renovocath.

Speaker #5: For example, platinum-based drugs are a big interest and one of the biggest limitations of systemic FOLFIRINOX. Beyond that, there are several classes of immunotherapeutics that have been tried, tested, and failed in pancreatic cancer and other tumors.

Speaker #5: One of the reasons is because of this desmoplastic barrier high pressure and really tumor resistance and lack of blood vessels feeding the tumor. And we overcome that with our TAMP system and with the RenovoCast.

Speaker #5: So being able to deliver different agents that might have an immunotherapeutic effect to turn on the body's immune system to attack metastatic disease can really open up a large potential for patients.

Shaun Bagai: Being able to deliver different agents that might have an immunotherapeutic effect to turn on the body's immune system to attack metastatic disease can really open up a large potential for patients. The registry, both in and of itself and then also the IITs that we're discussing and negotiating with physicians, both give us an avenue to look into these areas and collect data and present data in these areas beyond just gemcitabine and beyond just locally advanced pancreatic cancer.

Shawn Bhagat: So being able to deliver different agents that might have an immunotherapeutic effect to turn on the body's immune system to attack metastatic disease can really open up a large potential for patients. So the registry, both in and of itself, and then also the IITs that we're discussing and negotiating with physicians, both give us an avenue to look into these areas and collect data and present data in these areas beyond just gemcitabine and beyond just locally advanced pancreatic cancer.

Speaker #5: So the registry, both in and of itself and then also the IITs that we're discussing and negotiating with physicians, both give us an avenue to look into these areas, collect data, and present data in these areas beyond just gemcitabine and beyond just locally advanced pancreatic cancer.

Speaker #10: Okay. So the last question, I know I've taken a lot of your time, but the last question from me is bringing on board Phil Stockton.

Swayampakula Ramakanth: Okay. The last question, I know I've taken a lot of your time, the last question from me is bringing on board Philip Stocton. You know, what should we expect now that you have, you know, a carrier sales senior executive? Should we expect, say, you know, 3 or 6 months down the line, the trajectory of revenue to be, you know, much better, or is his responsibility more to get ready when you get through the TIGeR-PaC, and get through, you know, any additional FDA approvals?

RK: Okay. So the last question, I know I'm taking a lot of your time, but the last question from me is bringing on board Phil Stockton. So what should we expect now that you have your career cells, senior executive? Should we expect, say, three or six months down the line, the trajectory of revenue to be much better, or is this responsibility more to get ready when you get through the Tiger Pack and get through any additional FDA approvals?

Speaker #10: So you know, what should we expect now that we have our career sales senior executive? Should we expect, say, you know, three or six months down the line, the trajectory of revenue to be, you know, much better?

Speaker #10: Or is it responsibility more to get ready when you get through the Tiger Plaque and get through, you know, any additional FDA approvals?

Speaker #5: I appreciate the question, RK. It's the former. Given the early traction we saw and we posted I believe two good quarters so far, with primarily grassroots efforts on the behalf of me and some of my team members without having a sales and marketing team in place.

Shaun Bagai: I appreciate the question, RK. It's the former. Given the early traction we saw, and we posted, I believe, two good quarters so far with primarily grassroots efforts on the behalf of me and some of my team members without having a sales and marketing team in place. Given that we can see the upside in market penetration and potential to drive revenues to a level that would support the company at some point in time, bringing on Phil to bring on a small team to really start ramping for commercialization efforts now makes sense. That's for the pure RenovoCath, not needing to wait for the drug device combination in TIGeR-PaC. The goal is to have the team fully in place and positioned by the end of the year.

Shawn Bhagat: I appreciate the question, RK. It's the former. Given the early traction we saw, and we posted, I believe, two good quarters so far with primarily grassroots efforts on the behalf of me and some of my team members without having a sales and marketing team in place. Given that we can see the upside in market penetration and potential to drive revenues to a level that would support the company at some point in time, bringing on Phil to bring on a small team to really start ramping for commercialization efforts now makes sense. And that's with a pure Renovocath, not needing to wait for the drug-device combination in Tiger Pack. The goal is to have the team fully in place and positioned by the end of the year.

Speaker #5: Given that we can see the upside in market penetration and potential to drive revenues to a level that would support the company at some point in time, bringing on Phil to bring on a small team to really start ramping for commercialization efforts now makes sense.

Speaker #5: And that's with a pure RenovoCast, not needing to wait for the drug device combination in Tiger Plaque. The goal is to have the team fully in place and position by the end of the year.

Speaker #5: So I anticipate continuing revenue over the year, but really gearing up for success in 2026 to start driving towards profitability at some point in time or cash flow break even.

Shawn Bhagat: So I anticipate continuing revenue over the year but really gearing up for success in 2026 to start driving towards profitability at some point in time or cash flow break even as that team gets in place and we drive market penetration. I see 2025 with Phil at the helm, really learning the sales cycle, the activation timelines, collecting other sales metrics on how we can optimize that, and then really plan for more of a full penetration and launch in 2026 into some of those 200 accounts as Ed alluded to.

Shaun Bagai: I anticipate continuing revenue over the year, but really gearing up for success in 2026 to start driving towards profitability at some point in time or cash flow breakeven as that team gets in place and we drive market penetration. I see 2025 with Phil at the helm really learning the sales cycle, the activation timelines, collecting other sales metrics on how we can optimize that, and then really plan for more of a full penetration and launch in 2026 into some of those 200 accounts as I had alluded to.

Speaker #5: As that team gets in place and we drive market penetration, I see 2025 with Phil at the helm really learning the sales cycle, the activation timelines, collecting other sales metrics on how we can optimize that.

Speaker #5: And then really plan for more of a full penetration and launch in 2026 into some of those 200 accounts as alluded to.

Speaker #10: Okay, thank you. Thanks for taking all my questions, Sean.

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

RK: Okay. Thank you. Thanks for taking all my questions, Shawn.

Speaker #5: Thanks, RK. I appreciate the questions.

Shaun Bagai: Thanks, RK. I appreciate the questions.

Shawn Bhagat: Thanks, RK. I appreciate the questions.

Speaker #1: Our next question comes from Jason McCarthy with Maxim Group. Please proceed with your question.

Operator 2: Our next question comes from Jason McCarthy with Maxim Group. Please proceed with your question.

Operator: Our next question comes from Jason McCarthy with Maxim Group. Please proceed with your question.

Speaker #11: Guys, this is Chad. I'm here for Jason. Thanks for taking the questions. We're wondering, have you all engaged or plan to engage with the FDA regarding a potential accelerated approval pathway?

[Analyst] (Maxim Group): Hi, guys. This is Chad, for Jason. Thanks for taking the questions. We were wondering, have you guys engaged or planned to engage with FDA regarding a potential accelerated approval pathway?

Chad: Hi, guys. This is Chad for Jason. Thanks for taking the questions. We're wondering, have you guys engaged or plan to engage with FDA regarding a potential accelerated approval pathway?

Speaker #5: Thanks for the question, Chad. So from the DMC readout, the goal is to complete the study. As an overall survival study, the plan would be as we prepare for an NDA to engage at that time with the FDA to see if there's an accelerated approval.

Shaun Bagai: Thanks for the question, Chad. From a DMC readout, the goal is to complete the study as an overall survival study. The plan would be, as we prepare for an NDA, to engage at that time with the FDA to see if there's an accelerated approval. Given the unmet need and failed treatments in pancreatic cancer, getting this from trial completion to potential approval as fast as possible makes sense. Short answer to your question is yes. As we start narrowing final data, we will engage with the FDA to see if acceleration is a possibility.

Shawn Bhagat: Thanks for the question, Chad. So from the DMC readout, the goal is to complete the study as an overall survival study. The plan would be, as we prepare for an NDA, to engage at that time with the FDA to see if there's an accelerated approval. Given the unmet need and failed treatments in pancreatic cancer, getting this from trial completion to potential approval as fast as possible makes sense. So the short answer to your question is yes. As we start narrowing final data, we will engage with the FDA to see if acceleration is a possibility.

Speaker #5: Given the unmet need and failed treatments in pancreatic cancer, getting this from trial completion to potential approval as fast as possible makes sense. So, the short answer to your question is yes. As we start narrowing final data, we will engage with the FDA to see if acceleration is a possibility.

Speaker #11: Okay, got it. Thanks. And then how does the 16-month meeting in OS from the first interim compare to outcomes from other trials in the setting that also used induction chemo and SBR2?

[Analyst] (Maxim Group): Okay. Got it. Thanks. How does the 16-month median OS from the first interim compare to outcomes from other trials in this setting that also used induction chemo and SBRT?

Chad: Okay. Got it. Thanks. And then how does the 16-month median OS from the first interim compare to outcomes from other trials in the setting that also used induction chemo and SBRT?

Speaker #5: Chad, I appreciate the question because it's important to see that we're aligning what we expect the patient population to do. Previous large randomized studies have shown that locally advanced pancreatic cancer should yield an overall survival from time of diagnosis to report outs that have been anywhere between 12 to 18 months.

Shaun Bagai: Chad, I appreciate the question because it's important to see that we expect this patient population to do. Previous large randomized studies have shown that locally advanced pancreatic cancer should yield an overall survival from time of diagnosis to and the report out's been anywhere between 12 to 18 months, or 14 to 18 months, maybe more contemporary trials. The 15.5 months, estimated 15.5 months we saw in the control arm in our first interim analysis fits right in the middle of that. Further validation can be seen with the previously completed PANOVA-3 Novocure trial. In their trial, I believe they showed 14.2 months in their gemcitabine plus ABRAXANE control arm and about 16.2 months in their Tumor Treating Fields plus gemcitabine plus ABRAXANE.

Shawn Bhagat: Chad, I appreciate the question because it's important to see that we're aligning with what we expect this patient population to do. Previous large randomized studies have shown that locally advanced pancreatic cancer should yield an overall survival from time of diagnosis to, and the report out's been anywhere between 12 to 18 months or 14 to 18 months, maybe more contemporary trials. So the 15.5 months, estimated 15.5 months we saw in the control arm in our first interim analysis fits right in the middle of that. Further validation can be seen with the previously completed Penova III Novocure trial. In their trial, I believe they showed 14.2 months in their gemcitabine plus Abraxane control arm and about 16.2 months in their tumor treating fields plus gemcitabine plus Abraxane. So we're right smack in the middle of what's expected in locally advanced pancreatic cancer.

Speaker #5: Or 14 to 18 months may have been more contemporary trials. So the 15.5 months estimated 15.5 months we saw in the control arm in our first interim analysis fits right in the middle of that.

Speaker #5: Further validation can be seen with the previously completed Penova III NovoCure trial. In their trial, I believe they showed 14.2 months in their gemcitabine plus Abraxane control arm and about 16.2 months in their tumor treating fields plus gemcitabine plus Abraxane.

Speaker #5: So, we're right smack in the middle of what's expected in locally advanced pancreatic cancer. Now, what's interesting with the NovoCure study is that they were able to achieve local control and a two-month survival benefit.

Shaun Bagai: We're right smack in the middle of what's expected in locally advanced pancreatic cancer. What's interesting with the Novocure study is that they were able to achieve local control and a 2-month survival benefit, which added about $1 billion of market cap to their company with those types of results. It really shows, both on the finance side and also the physician interest side, that the bar is very low for this patient population. To have that much success with a 2-month benefit, we can imagine what we can accomplish achieving much more than that down the road.

Shawn Bhagat: Now, what's interesting with the Novocure study is that they were able to achieve local control and a two-month survival benefit, which added about a billion dollars of market cap to their company with those types of results. And it really shows both on the finance side and also the physician interest side that the bar is very low for this patient population. To have that much success with a two-month benefit, we can imagine what we can accomplish achieving much more than that down the road.

Speaker #5: Which added about a billion dollars of market cap to their company with those types of results. And it really shows both on the finance side and also the physician interest side that the bar is very low for this patient population.

Speaker #5: To have that much success with a two-month benefit we can imagine what we can accomplish achieving much more than that down the road.

Speaker #11: Okay, great. Thanks for taking the questions again and congrats on all the progress.

[Analyst] (Maxim Group): Okay, great. Thanks for taking the questions again, and congrats on all the progress.

Chad: Okay. Great. Thanks for taking the questions again and congrats on all the progress.

Speaker #5: Thanks, Chad.

Shaun Bagai: Thanks, Chad.

Shawn Bhagat: Thanks, Chad.

Speaker #1: Our next question comes from Scott Henry with AGP. Please proceed with your question.

Operator 2: Our next question comes from Scott Henry with AGP. Please proceed with your question.

Operator: Our next question comes from Scott Henry with AGP. Please proceed with your question.

Speaker #8: Thank you for the follow-up. Question. Sean, I just wanted to ask a couple questions about the catheter business. Gross margins I believe they're 64% in the quarter, which is, you know, pretty high number for this level of revenues.

Scott Henry: Thank you for the follow-up question. Shaun, I just wanted to ask a couple questions about the catheter business. Gross margins, I believe they're 64% in the quarter, which is, you know, pretty high number for this level of revenues. Is that a sustainable number? You know, where could gross margins get to on the catheter sales? Thank you.

Scott Henry: Thank you for the follow-up question. Shawn, I just wanted to ask a couple of questions about the catheter business. Gross margins, I believe they're 64% in the quarter, which is a pretty high number for this level of revenues. Is that a sustainable number? And where could gross margins get to on the catheter sales? Thank you.

Speaker #8: Is that a sustainable number? And, you know, where could gross margins get to? On the catheter sales. Thank you.

Speaker #5: Yeah, Scott, I appreciate the question. And that's one of the benefits and the reasons why we're deciding to commercialize because this looks like it could be extremely profitable for the organization.

Shaun Bagai: Scott, I appreciate the question. That's one of the benefits and the reasons why we're deciding to commercialize, because this looks like it could be extremely profitable for the organization. As far as the direct margins in terms of the cost of the actual materials, building the catheter, generally new medical devices, as they start to achieve success, start reaching that 70% to 90% range. We're actually in there. The additional expenses, I believe, reported in the Q. We believe we'll keep pushing that higher towards that 70% to 90% range in the not-too-distant future. I see the gross margins increasing over time as we scale. Again, this is with a reimbursement in place.

Shawn Bhagat: Yeah, Scott, I appreciate the question. And that's one of the benefits and the reasons why we're deciding to commercialize because this looks like it could be extremely profitable for the organization. As far as the direct margins in terms of the cost of the actual materials building the catheter, generally, new medical devices, as they start to achieve success, start reaching that 70 to 90 percent range, and we're actually in there. So there's additional expenses, I believe, reported in the queue. But we believe we'll keep pushing that higher towards that 70 to 90 percent range in the not-too-distant future. So I see the gross margins increasing over time as we scale. Again, this is with a reimbursement in place.

Speaker #5: As far as the direct margins in terms of the cost of the actual materials building on the catheter, generally new medical devices, as they start to achieve success, begin reaching that 70% to 90% range.

Speaker #5: And we're actually in there. So there's additional expenses I believe reported in the queue. But we believe we'll keep pushing that higher towards that 70 to 90% range in not too distant future.

Speaker #5: So I see the gross margins increasing over time as we scale. Again, this is with the reimbursement in place; this is part of the decision to go ahead and commercialize at this stage in the company's development process.

Shaun Bagai: This is part of the decision to go ahead and commercialize at this stage in the company's development process, given the high potential margins of the technology with the current reimbursement landscape.

Shawn Bhagat: This is part of the decision to go ahead and commercialize at this stage in the company's development process, given the high potential margins of the technology with the current reimbursement landscape.

Speaker #5: Given the high potential margins of the technology with the current reimbursement landscape.

Speaker #8: It It would seem with these numbers and just looking at the spending, how it compares to prior quarters, that it's already significant or maybe not significantly, but it's already cash flow positive.

Scott Henry: It would seem with these numbers and just looking at the spending, how it compares to prior quarters, that it's already significant or maybe not significantly, but it's already cash flow positive. By the time you add these up, this team, it should probably still be accretive at that point. Would you agree with that statement?

Scott Henry: It would seem with these numbers and just looking at the spending, how it compares to prior quarters, that it's already significant, maybe not significantly, but it's already cash flow positive. And by the time you add this team, it should probably still be accretive at that point. Would you agree with that statement?

Speaker #8: And by the time you add these up, this team, it should probably still be a creative at that point. Would you agree with that statement?

Speaker #5: I do. It's looking at the device manufacturing itself, it is a creative. And as mentioned, it doesn't take a big expensive sales force. And I think that's really one of the big advantages we have as an emerging commercial medical device organization.

Shaun Bagai: I do. It's looking at the device manufacturing itself, it is accretive. As mentioned, it doesn't take a big, expensive sales force. I think that's really one of the big advantages we have as an emerging commercial medical device organization, outside of the phase III trial, is that usually the burn is very high and the margins are low. We've been able to, as you know, achieve a lot of momentum and success and value creation with very little money. With this type of a niche market, a very focused market, we could achieve high revenues with a handful of sales reps. It's also important to note that with the reimbursement in place, each patient receives multiple treatments. Once the patient's identified at a given hospital, they end up receiving between 5 and 10 treatments.

Shawn Bhagat: I do. It's looking at the device manufacturing itself, it is accretive. And as mentioned, it doesn't take a big expensive sales force. And I think that's really one of the big advantages we have as an emerging commercial medical device organization outside of the phase three trial is that usually the burn is very high and the margins are low. We've been able to, as you know, achieve a lot of momentum and success and value creation with very little money. And with this type of a niche market, very focused market, we could achieve high revenues with a handful of sales reps. It's also important to note that with the reimbursement in place, each patient receives multiple treatments. So once a patient's identified at a given hospital, they end up receiving between 5 and 10 treatments. And so the numbers add up pretty quickly in terms of revenue.

Speaker #5: Outside of the phase three trial is that usually the burn is very high and the margins are low. We've been able to, as you know, achieve a lot of momentum and success and value creation with very little money.

Speaker #5: And with this type of a niche market, very focused market, we could achieve high revenues with a handful of sales reps. It's also important to note that with the reimbursement in place, each patient receives multiple treatments.

Speaker #5: So once a patient's identified at a given hospital, they end up receiving between 5 and 10 treatments. And so the numbers add up pretty quickly in terms of revenue.

Shaun Bagai: The numbers add up pretty quickly in terms of revenue. Without the need for a large sales force, our burn can stay low, but our revenues will continue to ramp through the end of this year and the end of the next year as well.

Speaker #5: So without the need for large sales force, our burden can stay low, but our revenues will continue to ramp through the end of this year and the end of the next year as well.

Shawn Bhagat: So without the need for a large sales force, our burn can stay low, but our revenues will continue to ramp through the end of this year and the end of the next year as well.

Speaker #8: Okay, great. And I would be remiss not to give you an opportunity to talk about your thoughts for the rest of the year of the catheter revenue.

Scott Henry: Okay, great. I would be remiss not to give you an opportunity to talk about your thoughts for the rest of the year, the catheter revenue. You know, I'm not trying to get guidance out of you, would you expect sequential gains in Q3 and Q4? I know sometimes there's a lot of upfront bolus sales, and then you have to wait for reorders, it seems like reorders are moving. Would you expect sequential gains in the coming quarters?

Scott Henry: Okay. Great. And I would be remiss not to give you an opportunity to talk about your thoughts for the rest of the year of the catheter revenue. You know, I'm not trying to get guidance out of you, but would you expect sequential gains in Q3 and Q4? I know sometimes there's a lot of upfront bolus sales, and then you have to wait for reorders, but it seems like reorders are moving. Do you look for, would you expect sequential gains in the coming quarters?

Speaker #8: You know, I'm not trying to get guidance out of you, but would you expect sequential gains in Q3 and Q4? I know sometimes there's a lot of upfront bolus sales, and then you have to wait for reorders, but it seems like reorders are moving. Would you expect sequential gains in the coming quarters?

Speaker #5: So as of course, as you can imagine, with such a new effort, we can't give guidance currently as I really look at 2025 as a learning year.

Shaun Bagai: As, of course, as you can imagine, with such a new effort, we can't give guidance currently. As I really look at 2025 as a learning year, and I wouldn't measure success on a quarterly basis because there will be ups and downs and fluctuations this early in the process, especially since there's multiple procedures per patient. A couple patients can really change the needle. Going from zero, $43,000 or pretty much zero, just over six months ago to where we've achieved so far with $420,000 plus this quarter is fantastic. I do see us driving hard, learning, and penetrating deeply, bringing more of those 13 centers across the finish line to start ordering catheters and treating patients. We do have a pipeline, another 20 or 30 hospitals behind them.

Shawn Bhagat: So, of course, as you can imagine, with such a new effort, we can't give guidance currently as I really look at 2025 as a learning year. And I wouldn't measure success on a quarterly basis because there will be ups and downs and fluctuations this early in the process, especially since there's multiple procedures per patient. A couple of patients can really change the needle. Going from zero, pretty much 43,000 or pretty much zero just over six months ago to where we've achieved so far with 420,000 plus this quarter is fantastic. I do see us driving hard, learning, and penetrating deeply, bringing more of those 13 centers across the finish line to start ordering catheters and treating patients. We do have a pipeline of another 20 or 30 hospitals behind them.

Speaker #5: And I wouldn't measure success on a quarterly basis because there will be ups and downs and fluctuations. This early in the process, especially since there's multiple procedures per patient, a couple of patients can really change the needle going from zero pretty much 43,000 or pretty much zero just over six months ago to where we've achieved so far with 420,000.

Speaker #5: Plus this quarter is fantastic. I do see us driving hard learning and penetrating deeply, bringing more of those 13 centers across the finish line to start ordering catheters and treating patients.

Speaker #5: We do have a pipeline in our 20 or 30 hospitals behind them. So, I do see growth over the next half of the year, but I really see that ramp start to take place with these few new sales hires as we work on infrastructure right now.

Shawn Bhagat: So I do see growth over the next half of the year, but I really see that ramp start to take place with these few new sales hires as we work on infrastructure right now, more in 2026. So I anticipate success throughout the year and then really ramping next year.

Shaun Bagai: I do see growth over the next H2, but I really see that ramp start to take place with these few new sales hires as we work on infrastructure right now, more in 2026. Anticipate success throughout the year and then really ramping next year.

Speaker #5: More in 2026. So, anticipate success throughout the year. And then really ramping next year.

Speaker #8: Okay, great. Thank you for taking the questions.

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

Scott Henry: Okay. Great. Thank you for taking the questions.

Speaker #5: Thanks, Scott. I appreciate it.

Shaun Bagai: Thanks, Scott. I appreciate it.

Shawn Bhagat: Thanks, Scott. I appreciate it.

Speaker #1: As a reminder, if you would like to ask a question, please press *1 on your telephone keypad. Our next question comes from Stephen Reed with HIT Investments.

Operator 2: As a reminder, if you would like to ask a question, please press star one on your telephone keypad. Our next question comes from Steven Reid with Kit Investments. Please proceed with your question.

Operator: As a reminder, if you would like to ask a question, please press star one on your telephone keypad. Our next question comes from Stephen Reed with Pitt Investments. Please proceed with your question.

Speaker #1: Please proceed with your question.

Speaker #11: Hey guys, great progress. I had a couple of questions. On the FOLFIRINOX, are you going to be moving to studying that in pigs first, or what's kind of your next steps?

Steven Reid: Hey, guys. Great progress. I have a couple questions. On the FOLFIRINOX, are you gonna be moved to studying that in pigs first, or what's kind of your next steps?

Stephen Reed: Hey, guys. Great progress. I have a couple of questions. On the FOLFIRINOX, are you going to be moved to turning that in PIGS first, or what's kind of your next steps?

Speaker #5: Thanks for the question, Steve. Always great to catch up with you. So as we look to gemcitabine, one of the reasons we chose gemcitabine initially in the phase three trial is it's so well characterized and we did have a lot of early experience with it.

Shaun Bagai: Thanks for the question, Steve. Always great to catch up with you. As we looked at gemcitabine, one of the reasons we chose gemcitabine initially in the phase III trial it's so well-characterized, and we did have a lot of early experience with it. As we look to other drugs, we will perform animal experience to ensure we're not causing any major detrimental vascular damage. As we discuss IITs and even registry patients with physicians, as we look to other agents, we will make sure we perform preclinical studies in conjunction with those physicians or on our own to ensure as we move into humans, that we don't have issues. Short answer to the question, yes, and we have begun exploring what other drugs do to the vessel wall.

Shawn Bhagat: Thanks for the question, Steve. Always great to catch up with you. So as we look to gemcitabine, one of the reasons we chose gemcitabine initially in the phase three trial is it's so well-characterized, and we did have a lot of early experience with it. As we look to other drugs, we will perform animal experience to ensure we're not causing any major detrimental vascular damage. And as we discuss IITs and even registry patients with physicians, as we look to other agents, we will make sure we perform preclinical studies in conjunction with those physicians or on our own to ensure as we move into humans that we don't have issues. So short answer to your question, yes. And we have begun exploring what other drugs do to the vessel wall. And like gemcitabine so far, it looks like we don't have any issues.

Speaker #5: As we look to other drugs, we will perform animal experience to ensure we're not causing any major detrimental vascular damage. And then as we discuss IITs and even registry patients with physicians, as we look to other agents, we will make sure we perform preclinical studies in conjunction with those physicians or on our own to ensure as we move into humans that we don't have issues.

Speaker #5: So, short answer to your question: yes. We have begun exploring what other drugs do to the vessel wall, and, like gemcitabine so far, it looks like we don't have any issues.

Shaun Bagai: Like gemcitabine so far, it looks like we don't have any issues.

Speaker #11: Okay, so do you think a few of those studies you'll be sharing with us in the next quarters on which preclinical studies those might be?

Steven Reid: Okay. Do you think a few of those studies you'll be sharing with us in the next quarters on which preclinical studies those might be? We have the most interest.

Stephen Reed: Okay. So do you think the few of those studies you'll be sharing with us in the next quarters on which preclinical studies those might be? Where you have the most interest?

Speaker #11: Or you have the most interest?

Shaun Bagai: Well, we Yeah, we haven't disclosed publicly where we are in the process of the preclinical studies in which drugs. For sure, as we move into patients being treated, especially under the guise of launching the registry, either during that time or in advance of that, if we have publishable data, we'll do so.

Speaker #5: Yeah, we haven't disclosed publicly. Where we are in the process of preclinical studies and which drugs but for sure as we move into patients being treated, especially under the guise of launching the registry, either during that time or in advance of that, if we have publishable data, we'll do so.

Shawn Bhagat: Yeah, we haven't disclosed publicly where we are in the process of the preclinical studies and which drugs, but for sure, as we move into patients being treated, especially under the guise of launching the registry, either during that time or in advance of that, if we have publishable data, we'll do so.

Speaker #11: Okay. It's great to see your in-house sales team coming together. I was curious if you could give us an update if you're simultaneously still working on some partnerships, distributors, I saw in March and June that you might have issued some restricted stock.

Steven Reid: Okay. It's great to see your in-house sales team coming together. I was curious if you could give us an update if you're simultaneously still working on some partnerships, distributors. I saw in March and June that you might have issued some restricted stock in consideration for commercial contracts. Really, any color around that would be helpful as well.

Stephen Reed: Okay. It's great to see your in-house sales team coming together. I was curious if you could give us an update if you're simultaneously still working on some partnerships, distributors. I saw in March and June that you might have issued some restricted stock in consideration for commercial contracts. Really, any color around that would be helpful as well.

Speaker #11: In consideration for a commercial contract, really any color around that would be helpful as well.

Speaker #5: Yeah, thanks for the question, Steven. So to clarify, we issued some stock options or restricted stock to our contract manufacturer, Medical Murray. In conjunction with a ramping production to get us to where we are today and then take us to the next level in terms of providing enough catheters for sales to treat patients.

Shaun Bagai: Thanks for the question, Steven. To clarify, we issued some stock options or restricted stock to our contract manufacturer, Medical Murray, in conjunction with a ramping production to get us to where we are today and then take us to the next level in terms of providing enough catheters for sales to treat patients. On the partnership side, on the manufacturing side, that's complete and underway. As far as the distribution side, we've been talking to several potential strategic distribution partners, and what I've said publicly previously is we'll do the math around what makes the most economic sense.

Shawn Bhagat: Yeah, thanks for the question, Steven. So to clarify, we issued some stock options or restricted stock to our contract manufacturer, Medical Marie, in conjunction with a ramping production to get us to where we are today and then take us to the next level in terms of providing enough catheters for sales to treat patients. So that on the partnership side, on the manufacturing side, that's complete and underway. As far as the distribution side, we've been talking to several potential strategic distribution partners. And what I'd said publicly previously is we'll do the math around what makes most economic sense. Given what we've achieved so far without any sales or marketing in-house team, besides myself and a couple of my team members for the most part, it's been prudent financially to make sure we capture all the revenue versus revenue share for this initial market entry.

Speaker #5: So that on the partnership side, on the manufacturing side, that's a complete and underway. As far as the distribution side, we've been talking to several potential strategic distribution partners and what I'd said publicly previously is we'll do the math around what's most economic sense.

Speaker #5: Given what we've achieved so far without any sales or marketing in-house team, besides myself and a couple of my team members for the most part, it's been prudent, financially to make sure we capture all the revenue versus revenue share for this initial market entry.

Shaun Bagai: Given what we've achieved so far without any sales or marketing in-house team, besides myself and a couple of my team members, for the most part, it's been prudent financially to make sure we capture all the revenue versus revenue share for this initial market entry. We've done the math on it, keeping our burn relatively the same with the addition of Philip Stocton, and he's pulling in a handful of sales reps over the next several months or quarters. We'll make a decision down the road as we wanna scale or need to scale based on usage in which tumor types and how far we can scale, if we should grow the sales force even further down the road next year or actually strike a partnership and leverage the distribution channel of a large medical device company.

Speaker #5: We've done the math on it, keeping our burn relatively the same with the addition of Phil Stockton. He's pulling in a handful of sales reps over the next several months or quarters.

Shawn Bhagat: We've done the math on it, keeping our burn relatively the same with the addition of Phil Stockton, and he's pulling in a handful of sales reps over the next several months or quarters. We'll make a decision down the road as we want to scale or need to scale based on usage in which tumor types and how far we can scale. If we should grow the sales force even further down the road next year or actually strike a partnership and leverage the distribution channel of a large medical device company. Those discussions, I said publicly, are ongoing. But for the short term, in the meantime, we do plan on driving with our in-house team to capture the best value for our shareholders.

Speaker #5: We'll make a decision down the road as we want to scale or need to scale based on usage in which tumor types and how far we can scale.

Speaker #5: If we should grow the sales force even further down the road next year or actually strike a partnership and leverage the distribution channel of a large medical device company.

Speaker #5: Those discussions, as I said publicly, are ongoing. But for the short term and, in the meantime, we do plan on driving with our in-house team to capture the best value for our shareholders.

Shaun Bagai: Those discussions, as I said publicly, are ongoing, but for the short term, in the meantime, we do plan on driving with our in-house team to capture the best value for our shareholders.

Speaker #11: Thanks, Sean. That's all I have.

Steven Reid: Thanks, Shaun. That's all I have.

Stephen Reed: Thanks, Shawn. That's all I had.

Speaker #5: Thanks for the question, Steven.

Shawn Bhagat: Thanks for the question, Steven.

Shaun Bagai: Thanks for the question, Steven.

Speaker #1: As a reminder, if you would like to ask a question, please press *1 on your telephone keypad. It appears that there are no further questions today.

Operator 2: As a reminder, if you would like to ask a question, please press star one on your telephone keypad. It appears that there are no further questions today. I would now like to pass the floor over to Shaun Bagai for closing comments.

Operator: As a reminder, if you would like to ask a question, please press star one on your telephone keypad. It appears that there are no further questions today. I would now like to pass the floor over to Shawn Bhagat for closing comments.

Speaker #1: I would now like to pass the floor over to Sean Bagai for closing comments.

Speaker #11: Thank you for the opportunity and for those dialing in and listening. And thank you. And I appreciate the questions from those who called in as well.

Shaun Bagai: Thank you for the opportunity and for those dialing in and listening in. Thank you, and I appreciate the questions from those who called in as well. I'm very happy and thrilled with the results we've had for our Q2 of this year, both in terms of the commercial success to date without an in-house sales and marketing team, and then the progress we're making with the additional hire of Philip Stocton as he builds out his team. Also timing was excellent and a great happenstance to have the DMC have the ability to review the second interim analysis. We're proud and happy to see the continuation, which gives us confidence that we should be hopefully moving towards a successful clinical trial in a phase III manner in locally advanced pancreatic cancer.

Shawn Bhagat: Thank you for the opportunity and for those dialing in and listening in. Thank you, and I appreciate the questions from those who called in as well. I'm very happy and thrilled with the results we've had for our second quarter of this year, both in terms of the commercial success to date without an in-house sales and marketing team, and then the progress we're making with the additional hire of Phil Stockton as he builds out his team. Also, timing was excellent, and a great happenstance to have the DMC have the ability to review the second interim analysis. And we're proud and happy to see the continuation, which gives us confidence that we should be hopefully moving towards a successful clinical trial in a phase three manner in locally advanced pancreatic cancer.

Speaker #11: I'm very happy and thrilled with the results we've had for our second quarter of this year. Both in terms of the commercial success to date without in-house sales and marketing team.

Speaker #11: And then the progress we're making with the additional hire of Phil Stockton as he builds out his team. Also, timing was excellent and it was a great happenstance to have the DMC have the ability to review the second interim analysis.

Speaker #11: And we're proud and happy to see the continuation, which gives us confidence that we should be hopefully moving towards a successful clinical trial in a Phase 3 manner in locally advanced pancreatic cancer.

Speaker #11: I'm also happy with the prudent decision here to protect the integrity of the trial just so we have the best chance of success with a potential NDA application down the road.

Shawn Bhagat: I'm also happy with the prudent decision here to protect the integrity of the trial just so we have the best chance of success with a potential NDA application down the road. Thank you again for everyone chiming in, and I look forward to following up with individuals down the road.

Shaun Bagai: I'm also happy with the prudent decision here to protect the integrity of the trial, thus we have the best chance of success with a potential NDA application down the road. Thank you again for everyone chiming in and look forward to following up with individuals down the road.

Speaker #11: Thank you again for everyone chiming in, and I look forward to following up with individuals down the road.

Operator 2: This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

Operator: This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.