Q2 2026 Humacyte Inc Earnings Call & Business Update

August 12, 2026

Speaker #1: Good morning, ladies and gentlemen, and welcome to Humacyte's second quarter 2026 earnings conference call. Currently, all participants are in listen-only mode. Later, we will conduct a question-and-answer session.

Operator: Good morning, ladies and gentlemen, and welcome to Humacyte's Q2 2026 earnings conference call. Currently, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. Instructions will follow at that time. As a reminder, this conference call is being recorded. I will now turn the call over to Tom Johnson with LifeSci Advisors. Please go ahead.

Speaker #1: Instructions will follow at that time. As a reminder, this conference call is being recorded. I will now turn the call over to Tom Johnson with Lifesci Advisors.

Speaker #1: Please go ahead.

Speaker #2: Thank you, operator. Before we begin with the call, I would like to remind everyone that certain statements made during this call are forward-looking statements under U.S.

Operator: Thank you, operator. Before we begin with the call, I would like to remind everyone that certain statements made during this call are forward-looking statements under US federal securities laws. These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations. Additional information concerning factors that could cause actual results to differ from statements made on this call is contained in our periodic reports filed with the SEC. The forward-looking statements made during this call speak only as of the date hereof, and the company undertakes no obligation to update or revise the forward-looking statements, except as required by law. Information presented on this call is contained in the press release we issued this morning and in our Form 10-Q, which, after filing, may be accessed from the investor page of the Humacyte website.

Tom Johnson: Thank you, operator. Before we begin with the call, I would like to remind everyone that certain statements made during this call are forward-looking statements under US federal securities laws. These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations. Additional information concerning factors that could cause actual results to differ from statements made on this call is contained in our periodic reports filed with the SEC. The forward-looking statements made during this call speak only as of the date hereof, and the company undertakes no obligation to update or revise the forward-looking statements, except as required by law. Information presented on this call is contained in the press release we issued this morning and in our Form 10-Q, which, after filing, may be accessed from the investor page of the Humacyte website.

Speaker #2: Federal Securities Laws. These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations.

Speaker #2: Additional information concerning factors that could cause actual results to differ from statements made on this call is contained in our periodic reports filed with the SEC.

Speaker #2: Beforeward-looking statements made during this call speak only as the date herof and the company undertakes no obligation to update or revise the forward-looking statements except as required by law.

Speaker #2: Information presented on this call is contained in the press release we issued this morning and in our Form 10-Q, which, after filing, may be accessed from the investor page of the Humacyte website.

Speaker #2: Joining me on today's call from Humacyte are Dr. Laura Niklason, President and Chief Executive Officer; Jim Mercadante, Chief Commercial Officer; and Dale Sander, Chief Financial Officer and Chief Corporate Development Officer.

Operator: Joining me on today's call from Humacyte are Dr. Laura Niklason, President and Chief Executive Officer, Jim Mercadante, Chief Commercial Officer, and Dale Sander, Chief Financial Officer and Chief Corporate Development Officer. Dr. Niklason will provide a summary of the company's progress for the Q2 and in recent weeks. Jim Mercadante will provide an update on commercial transformation and the progress with Symvess commercial launch. Dale Sander will review the company's financial results for the quarter ended 30 June 2026. With that, I'll now turn the call over to Dr. Niklason. Laura?

Tom Johnson: Joining me on today's call from Humacyte are Dr. Laura Niklason, President and Chief Executive Officer, Jim Mercadante, Chief Commercial Officer, and Dale Sander, Chief Financial Officer and Chief Corporate Development Officer. Dr. Niklason will provide a summary of the company's progress for the Q2 and in recent weeks. Jim Mercadante will provide an update on commercial transformation and the progress with Symvess commercial launch. Dale Sander will review the company's financial results for the quarter ended 30 June 2026. With that, I'll now turn the call over to Dr. Niklason. Laura?

Speaker #2: Dr. Niklason will provide a summary of the company's progress for the second quarter and the recent weeks. Jim Mercadante will provide an update on commercial transformation and the progress with CIMBES commercial launch.

Speaker #2: And Dale Sander will review the company's financial results for the quarter ended June 30, 2026. With that, I'll now turn the call over to Dr. Niklason.

Speaker #2: Laura?

Speaker #3: Thank you, Tom. Good morning, everyone. And thank you all for joining us for our second quarter financial results. And business update call. During today's call, I'll review progress across our development programs, for the quarter and recent weeks, and then I'll turn the call over to Jim Mercadante for a review of our commercial progress for our CIMBES launch in the vascular injury indication.

Laura Niklason: Thank you, Tom. Good morning, everyone, and thank you all for joining us for our Q2 financial results and business update call. During today's call, I'll review progress across our development programs for the quarter and recent weeks. Then I'll turn the call over to Jim Mercadante for a review of our commercial progress for our Symvess launch in the vascular injury indication. As you know, Jim was appointed as our Chief Commercial Officer in April and is a seasoned commercial executive with a track record of successful leadership across medical devices, diagnostics, and healthcare technology. We're pleased to have him with us on today's call. After Jim's update, Dale will review our financial results for the quarter and six months ending 30 June.

Speaker #3: As you know, Jim was appointed as our Chief Commercial Officer in April and is a seasoned commercial executive, with a track record of successful leadership across medical devices, diagnostics, and healthcare technology.

Speaker #3: We're pleased to have him with us on today's call. After Jim's update, Dale will review our financial results for the quarter and six months, ending June 30th.

Speaker #3: As a reminder, our goals for 2026 include the advancing of the U.S. and global commercial launch of CIMBES, completion of our VO12 Phase 3 pivotal trial of our ATAV in dialysis access, and filing of a supplemental BLA with the FDA in the dialysis indication.

Laura Niklason: As a reminder, our goals for 2026 include the advancing of the US and global commercial launch of Symvess, completion of our V012 phase III pivotal trial of our ATEV in dialysis access, filing of a supplemental BLA with the FDA in the dialysis indication, and the commencement of a human study of our coronary tissue engineered vessel, or CTEV, in coronary artery bypass grafting. I am happy to report that our Q2 and recent weeks were a transformative period for Humacyte across all of these fronts. Let us begin. In June, we presented breakthrough top-line interim results from our V012 phase III trial in female dialysis patients at the Vascular Annual Meeting in Boston. Results from this trial exceeded our expectations, showing that our acellular tissue engineered vessel outperformed autologous fistula, which is the current standard of care.

Speaker #3: And the commencement of a human study of our coronary tissue engineered vessel, or CTAV, in coronary artery bypass grafting. I'm happy to report that our second quarter and recent weeks were a transformative period for Humacyte across all of these fronts.

Speaker #3: And with that, let's begin. In June, we presented breakthrough top-line interim results from our VO12 Phase 3 trial in female dialysis patients, in the at the vascular annual meeting in Boston.

Speaker #3: Results from this trial exceeded our expectations, showing that our acellular, tissue-engineered vessel outperformed autologous fistula, which is the current standard of care. In a pre-specified interim analysis of the first 80 patients from the study, women who received the ATAV achieved 91 more catheter-free days than those receiving AV fistula.

Laura Niklason: In a pre-specified interim analysis of the first 80 patients from the study, women who received the ATEV achieved 91 more catheter-free days than those receiving AV fistula. This difference was highly statistically significant, with a p-value of 0.0007, thereby meeting the primary efficacy endpoint of the study, and consistent with our expectations for ATEV and hemodialysis. Infections of catheters and surgical access wounds were also less common. There were 6 infections per 100 patient years with ATEV, as compared to 23 infections per 100 patient years for patients receiving the AV fistula. We believe these data from our V012 study are a breakthrough for women who have historically been left behind by the fistula procedure, leaving many women being forced to rely on infection-prone plastic catheters and grafts.

Speaker #3: This difference was highly statistically significant, with a p-value of 0.0007, thereby meeting the primary efficacy endpoint of the study. And consistent with our expectations for ATAV and hemodialysis.

Speaker #3: Infections of catheters and surgical access wounds were also less common. There were 6 infections per 100 patient-years with ATAV, as compared to 23 infections per 100 patient-years for patients receiving the AV fistula.

Speaker #3: We believe these data from our VO12 study are a breakthrough for women who have historically been left behind by the fistula procedure, which has left many women forced to rely on infection-prone plastic catheters and grafts.

Speaker #3: Combined with results from the VO7 Phase 3 trial that we reported previously, we believe that the ATAV could represent a major advance in hemodialysis—the largest advance in decades.

Laura Niklason: Combined with results from the V007 phase III trial that we reported previously, we believe that the ATEV could represent a major advance in hemodialysis, the largest advance in decades. As I stated earlier, we plan to submit a supplemental biologics license application, or BLA, to the FDA in the H2 of this year. To help prepare for that planned commercialization in dialysis access, we have appointed Robert J. Kossmann, MD, and Prabir Roy-Chaudhury, MD, PhD, as advisors to Humacyte. Dr. Kossmann previously served as Executive Vice President and the Chief Medical Officer for Fresenius Medical Care North America. Dr. Roy-Chaudhury is the immediate past president of the American Society of Nephrology and is co-director of the UNC Kidney Center.

Speaker #3: As I stated earlier, we plan to submit a supplemental biologics license application, or BLA, to the FDA in the second half of this year.

Speaker #3: And to help prepare for that planned commercialization and dialysis access, we have appointed Robert Kossman, MD, and Prabir Roy Choudhury, MD-PhD, as advisors to Humacyte.

Speaker #3: Dr. Kossman previously served as Executive Vice President and the Chief Medical Officer for Fresenius Medical Care North America. Dr. Roy Choudhury is the immediate past president of the American Society of Nephrology, and is co-director of the UNC Kidney Center.

Speaker #3: Both Robert and Prabir are contributing to our health, economic, reimbursement, and market access strategies. And they will also provide peer-to-peer scientific support and medical education as we prepare for the planned hemodialysis access launch.

Laura Niklason: Both Robert and Prabir are contributing to our health, economic reimbursement, and market access strategies, and they will also provide peer-to-peer scientific support and medical education as we prepare for the planned hemodialysis access launch. Turning to our pipeline, we recently announced that the FDA has accepted our investigational new drug application, or IND, for a first in human clinical study of CTEV in coronary artery bypass grafting, or CABG. As you will recall, the CTEV is a smaller diameter version of the ATEV, which was bioengineered to be suitable for CABG surgery. CTEV has been tested in large animals for more than 5 years, and these results have supported the FDA's approval of our IND study.

Speaker #3: Turning to our pipeline, we recently announced that the FDA has accepted our Investigational New Drug application, or IND, for a first-in-human clinical study of CTAV in coronary artery bypass grafting, or CABG.

Speaker #3: As you'll recall, the CTAV is a smaller diameter version of the ATAV, which was bioengineered to be suitable for CABG surgery. CTAV has been tested in large animals for more than 5 years.

Speaker #3: And these results have supported the FDA's approval of our IND study. There have been no new off-the-shelf conduits that have been prospectively tested in CABG in the U.S.

Laura Niklason: There have been no new off-the-shelf conduits that have been prospectively tested in CABG in the US in at least the last 40 years, and our preclinical results suggest that CTEV may be a promising off-the-shelf alternative to saphenous vein grafts. To support this phase IIa study, we completed the first large-scale manufacturing lot of CTEVs in our commercial scale production facilities. We plan to initiate the phase IIa study of CTEV in CABG patients during the current quarter. With that, I'll now turn it over to Jim for an update on our progress with the global Symvess commercialization.

Speaker #3: in at least the last 40 years. And our preclinical results suggest that CTAV may be a promising off-the-shelf alternative to saphenous vein grafts. To support this Phase 2a study, we completed the first large-scale manufacturing lot of CTAVs in our commercial-scale production facilities.

Speaker #3: And we plan to initiate the phase 2A study of CTAV in CABG patients during the current quarter. And with that, I'll now turn it over to Jim for an update on our progress with the global CIMBES commercialization.

Speaker #2: Thank you, Laura, and good morning, everyone. It is a pleasure to be speaking with you all. Our second quarter was focused on rebuilding our commercial effort for CIMBES, designed to drive product adoption by hospitals, expand product usage, and position Humacyte for sustained growth.

Jim Mercadante: Thank you, Laura, and good morning everyone. It is a pleasure to be speaking with you all. Our Q2 was focused on rebuilding our commercial effort for Symvess, designed to drive product adoption by hospitals, expand product usage, and to Humacyte for sustained growth. To that end, we have remodeled our commercial team to ensure that all members have relevant long-term relationships in vascular surgery space. We've also refined our introductory pricing incentive programs, professional education, and a value analysis committee engagement to better drive Symvess adoption. These initiatives are designed to create scalable engine that converts interest in our first in-class product into approvals, utilization, and sustained revenue growth. As we move into the H2 2026, results are beginning to materialize with influential hospitals adopting Symvess and utilization is increasing.

Speaker #2: To that end, we have remodeled our commercial team to ensure that all members have relevant, long-term relationships in the vascular surgery space. We've also refined our introductory pricing incentive programs, peer-to-peer professional education, and analysis committee engagement to better drive CIMBES adoption.

Speaker #2: These initiatives are designed to create scalable engine that converts interest in our first-in-class product into approvals, utilization, and sustained revenue growth. As we move into the second half of 2026, results are beginning to materialize with influential hospitals adopting CIMBES and utilization is increasing.

Speaker #2: Surgeon feedback on patient use cases has been excellent, and we look forward to assisting these physicians as they share their success stories with their colleagues.

Jim Mercadante: Surgeon feedback on patient use cases has been excellent and we look forward to assisting these physicians as they share their success stories with their colleagues. Elsewhere on the commercial front, our Marketing Authorisation Application for approval of Symvess for arterial injury repair was accepted for review by the Israel Ministry of Health in April 2026. The ministry set a 180 day working period for the MAA due to the existing FDA approval of Symvess in extremity vascular injury. Last quarter, we also highlighted the fiscal 2026 U.S. Department of Defense Appropriations Act included dedicated funding to support the evaluation and incorporation of biological vascular repair for the war fighters suffering traumatic vascular injuries. We are continuing to work with leaders in the military and The Pentagon to assure appropriate access to Symvess for American service personnel.

Speaker #2: Elsewhere on the commercial front, our marketing authorization application for approval of CIMBES for arterial injury repair was accepted for review by the Israel Ministry of Health in April 2026.

Speaker #2: The ministry set a 180-day working period for the MMA due to the existing FDA approval of CIMBES in extremity vascular injury. Last quarter, we also highlighted the fiscal 2026 U.S.

Speaker #2: The Department of Defense Appropriations Act included dedicated funding to support the evaluation and incorporation of biological vascular repair for warfighters suffering traumatic vascular injuries.

Speaker #2: We are continuing to work with leaders in the military and the Pentagon to ensure appropriate access to CIMBES for American service personnel. During our second quarter, we also strengthened our team with the appointment of Dr. Todd Rasmussen as our Chief Surgical Officer.

Jim Mercadante: During our Q2, we also strengthened our team with the appointment of Dr. Todd Rasmussen as our Chief Surgical Officer. Todd has extensive experience and expertise in vascular surgery, gained over 28 year career in the U.S. Air Force, during which he deployed multiple times to Iraq and Afghanistan wars. He is a recognized leader in peripheral vascular surgery and trauma repair. At Humacyte, his focus is providing peer-to-peer scientific support, medical education, technical insights to surgeons and other healthcare professionals. He adds experience, surgical perspective, and leadership to our educational clinical support programs and will help us align regulatory guidance with the safe, appropriate, and effective use of Symvess. With that, it is my pleasure to hand the call over to Dale for the review of our Q2 results. Dale?

Speaker #2: Todd has extensive experience and expertise in vascular surgery, gained over 28-year career in the U.S. Air Force, during which he deployed multiple times to Iraq and Afghanistan wars.

Speaker #2: He is a recognized leader in peripheral vascular surgery and trauma repair at Humacyte. His focus is providing peer-to-peer scientific support, medical education, technical insights to surgeons, and other healthcare professionals.

Speaker #2: His expert he has experienced surgical perspective and leadership to our educational clinical support programs and will help us align regulatory guidance with the safe, appropriate, and effective use of CIMBES.

Speaker #2: With that, it is my pleasure to hand the call over to Dale, for the review of our second quarter results. Dale?

Speaker #4: Thank you, Jim. Commercial sales were 0.4 million in the second quarter of 2026, which was really a rebuilding quarter. Compared to 0.1 million for the second quarter of 2025.

Dale Sander: Thank you, Jim. Commercial sales were 0.4 million in Q2 2026, which was really a rebuilding quarter, compared to 0.1 million for Q2 2025. For the six months ended 30 June 2026, commercial sales of Symvess were 0.9 million, compared to 0.2 million for the six months ended 30 June 2025.

Speaker #4: For the six months ended June 30, 2026, commercial sales of CIMBES were $0.9 million, compared to $0.2 million for the six months ended June 30, 2025.

Speaker #4: There was no contract revenue in either of the three or six months ended June 30, 2026, due to completion of our research collaboration project in the prior year.

Dale Sander: There was no contract revenue in either the three or six months ended 30 June 2026, due to completion of a research collaboration project in the prior year, compared to 0.2 million and 0.6 million for the three and six months ended 30 June 2025, respectively. Cost of goods sold were 1.2 million for Q2 2026 compared to 0.2 million for Q2 2025. During Q2 2026, 0.2 million of cost of goods sold related to the cost of units recorded as sales revenue during the period, and the remainder were primarily comprised of a $0.7 million inventory reserve recorded to reduce certain inventory balances to their estimated net realizable value, as well as overhead related to unused production capacity, which was recorded as an expense in the period.

Speaker #4: Compared to 0.2 and 0.6 million for the three and six months ended June 30, 2025, respectively. Cost of goods sold were 1.2 million for the second quarter of 2026, compared to 0.2 million for the second quarter of 2025.

Speaker #4: During the second quarter of 2026, 0.2 million of cost of goods sold related to the cost of units recorded as sales revenue during the period.

Speaker #4: And the remainder were primarily comprised of a $0.7 million inventory reserve, recorded to reduce certain inventory balances to their estimated net realizable value, as well as overhead related to unused production capacity, which was reported as an expense in the period.

Speaker #4: Cost of goods sold was 3.3 million for the six months ended June 30, 2026, compared to 0.4 million for the six months ended June 30, 2025.

Dale Sander: Cost of goods sold was 3.3 million for the six months ended 30 June 2026, compared to 0.4 million for the six months ended 30 June 2025. During the six months ended 30 June 2026, 0.5 million of cost of goods sold related to the cost of units recorded as sales revenue during the period, and the remainder was primarily comprised of a $2.3 million inventory reserve and expenses related to unused production capacity. Research and development expenses for the three and six months of 2026 were 8.1 million and 37.6 million respectively, compared to 22.0 million and 37.4 million for the same periods in 2025. The decrease in research and development expenses during Q2 2026 was primarily due to a reduction in non-commercial manufacturing runs and reduced clinical trial expenses.

Speaker #4: During the six months ended June 30, 2026, $0.5 million of cost of goods sold related to the cost of units recorded as sales revenue during the period.

Speaker #4: And the remainder was primarily comprised of a $2.3 million inventory reserve, and expenses related to unused production capacity. Research and development expenses for the three and six months of 2026 were $8.1 million and $37.6 million, respectively, compared to $22.0 million and $37.4 million for the same periods in 2025.

Speaker #4: The decrease in research and development expenses during the second quarter of 2026 was primarily due to a reduction in non-commercial manufacturing runs and reduced clinical trial expenses.

Speaker #4: Selling general and administrative expenses were 8.0 million and 16 million for the three and six months ended June 30, 2026, respectively. Consistent with the 7.8 million and 16 million recorded for the same periods in 2025.

Dale Sander: Selling, general and administrative expenses were 8.0 million and 16 million for the three and six months ended 30 June 2026, respectively, consistent with the 7.8 million and 16 million recorded for the same periods in 2025. Other net income or expense was a net expense of 9.8 million and net income of 1.5 million for the three and six months ended 30 June 2026, respectively, compared to a net expense of 7.9 million for the three months ended 30 June 2025, and other net income of 54.5 million for the six months ended 30 June 2025. The increase in other net expense for the three months ended 30 June 2026, and the decrease in other net income for the six months ended 30 June 2026, compared to the prior periods, resulted primarily from the non-cash remeasurement of our contingent earn-out liability and other derivative liabilities.

Speaker #4: Other net income or expense was a net expense of $9.8 million and net income of $1.5 million for the three and six months ended June 30, 2026, respectively.

Speaker #4: Compared to a net expense of 7.9 million for the three months ended June 30, 2025. And other net income of 54.5 million for the six months ended June 30, 2025.

Speaker #4: The increase in other net expense for the three months ended June 30, 2026, and the decrease in other net income for the six months ended June 30, 2026, compared to the prior periods.

Speaker #4: Resulted primarily from the non-cash remeasurement of our contingent earn-out liability and other derivative liabilities. Net loss was 36.8 million and 54.4 million for the three and six months ended June 30, 2026, respectively, compared to a net loss of 37.7 million for the three months ended June 30, 2025, and net income of 1.5 million for the six months ended June 30, 2025.

Dale Sander: Net loss was $36.8 million and $54.4 million for the three and six months ended 30 June 2026, respectively, compared to a net loss of $37.7 million for the three months ended 30 June 2025, and net income of $1.5 million for the six months ended 30 June 2025. The increase in net loss for the six months ended 30 June 2026, compared to the prior year period, was primarily due to the non-cash remeasurement of the contingent earn-out liability described earlier. We had cash equivalents, and restricted cash of $80.3 million as of 30 June 2026. Total net cash provided was $29.4 million for the first six months of 2026, compared to total net cash used of $6.9 million for the first six months of 2025.

Speaker #4: The increase in net loss for the six months ended June 30, 2026, compared to the prior year period, was primarily due to the non-cash remeasurement of the contingent earn-out liability described earlier.

Speaker #4: We had cash, cash equivalents, and restricted cash of 80.3 million as of June 30, 2026. Total net cash provided was 29.4 million for the first six months of 2026, compared to net to total net cash used of 6.9 million for the first six months of 2025.

Speaker #4: The increase in total net cash provided for the six months ended June 30, 2026, resulted from higher proceeds from sales of equities and a reduction in net cash used in operations.

Dale Sander: The increase in total net cash provided for the six months ended 30 June 2026, resulted from higher proceeds from sales of equities and a reduction in net cash used in operations. With that, I will turn the call back to Laura.

Speaker #4: With that, I will turn the call back to Laura.

Speaker #1: Thank you, Dale. So we're very pleased with the progress we've made this past quarter. And with the excellent progress in our pipeline programs, and our reinvigorated commercial execution.

Laura Niklason: Thank you, Dale. We are very pleased with the progress we have made this past quarter and with the excellent progress in our pipeline programs and our reinvigorated commercial execution. With our dedicated team, we remain committed to delivering truly transformative regenerative medicine solutions that will improve patient outcomes. We believe we are positioned for growth and value generation for the balance of 2026 and beyond. Operator, we are ready to take questions.

Speaker #1: With our dedicated team, we remain committed to delivering truly transformative regenerative medicine solutions, that will improve patient outcomes. We believe we're positioned for growth and value generation, for the balance of 2026 and beyond.

Speaker #1: Operator, we're ready to take questions.

Speaker #2: Thank you. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue.

Operator: Thank you. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For a participant choosing speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Our first question is from Ryan Zimmerman with BTIG. Please proceed.

Speaker #2: You may press star-2 if you would like to remove your question from the queue. And for participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

Speaker #2: Our first question is from Ryan Zimmerman with US Bank Corp BTIG. Please proceed.

Speaker #5: Good morning, and thank you for taking our question. Maybe to start, question for either Laura or Jim. Around the commercial changes that you're making, I mean, you know, maybe you could reflect on kind of what was challenging, you know, prior to, you know, Jim coming in and taking over, you know, what needed to be refined and kind of, you know, what you're seeing tangibly.

Ryan Zimmerman: Good morning, and thank you for taking our question. Maybe to start, a question for either Laura or Jim around the commercial changes that you are making. Maybe you could reflect on what was challenging prior to Jim coming in and taking over, what needed to be refined, and what you are seeing tangibly. I think, Jim, you talked about utilization picking up since you have made some of those changes. Can you share with us what you are seeing from that front that can give us improved assurances that we could see a commercial inflection in trauma?

Speaker #5: I think Jim, you talked about utilization picking up, you know, since you've made some of those changes. Can you share with us kind of, you know, what you're seeing from that front?

Speaker #5: That kind of can give us, you know, improved assurances that we could see a commercial inflection in trauma.

Speaker #1: So, yeah. So Ryan, thank you for that. You know, I'll sort of answer the pre-Jim question. And then I'll let Jim sort of talk about the changes that he's put in place just in the last three, four months.

Laura Niklason: So, Ryan, thank you for that. I will sort of answer the pre-Jim question and then I will let Jim talk about the changes that he has put in place just in the last 3, 4 months. I think that our commercial uptake in vascular injury was not as rapid as we had been hoping. That led us last fall, actually, to move our prior chief commercial officer out, and then we began a search, and then Jim began in April of this year. What I can say is that as a new conduit, the first new conduit to enter vascular surgery in the last 40 years, and I had said this multiple times, I think that the education challenges were something that I think we underestimated as a company.

Speaker #1: You know, I think that our commercial uptake in vascular injury was not as rapid as we had been hoping. And so that led us last fall, actually, to move our prior chief commercial officer out.

Speaker #1: And then we began a search, and then, you know, Jim began in April of this year. You know, what I can say is that as a new conduit, the first new conduit to enter vascular surgery in the last 40 years, and I had said this multiple times, you know, I think that the education challenges were something that I think we underestimated as a company.

Speaker #1: And so one of the ways we sought to address that is to bring in Rasmussen and really increase our contacts with thought leaders in the industry but in addition, something that I think we didn't appreciate is that if you have something fundamentally new and transformative in the space, you really need sales executives and leaders who have really deep, strong connections with very active practicing vascular surgeons.

Laura Niklason: One of the ways we sought to address that is to bring in Rasmussen and really increase our contacts with thought leaders in the industry. But in addition, something that I think we did not appreciate is that if you have something fundamentally new and transformative in the space, you really need sales executives and leaders who have really deep, strong connections with very active, practicing vascular surgeons. While some of our people had that, a lot of our people did not. That made sort of breaking in with this fundamentally new product more challenging than it had to be. I think that is one of the things that Jim saw immediately when he joined us. I will let him take it from here.

Speaker #1: And while some of our people had that, a lot of our people did not. And so, that made sort of breaking in with this fundamentally new product more challenging than it had to be.

Speaker #1: And I think that's one of the things that Jim saw immediately when he joined us. And I'll let him take it from here.

Speaker #5: Thanks, Laura. I appreciate it. Great question. You know, and I'll echo Laura's comments here. One of the key things when you're looking at a technology like this—and this is the reason why I'm here—I believe this technology is going to revolutionize open surgery, for sure.

Jim Mercadante: Thanks, Laura. I appreciate it, and great question. I will echo Laura's comments here. One of the key things when you are looking at a technology like this, and this is the reason why I am here, I believe this technology is going to revolutionize open surgery for sure over time. But you have to have deep vascular surgery relationship. 90% of the call point is vascular surgery for what we are trying to do here. The people that I am bringing in are people that have deep vascular surgery relationships and have built something from nothing. There is a difference. Those are the type of people that are used to what I call doing therapy development or new product launches. This is a new concept and product going to vascular surgery. But it is being, I will say, well accepted once the story is told.

Speaker #5: Over time. But you have to have deep vascular surgery relationships. This is, you know, 90% of the call point is vascular surgery for what we're trying to do here.

Speaker #5: And so the people that bring it in are people that have deep vascular surgery relationships and have built something from nothing. There's a difference.

Speaker #5: And those are the types of people that are used to what I call doing therapy development or new product launches. And this is a new concept and product going to vascular surgery.

Speaker #5: But it's being I will say, well accepted. Once the story is told. And it's certainly welcomed. And we're already starting to see that uptick just a few months in.

Jim Mercadante: And it is certainly welcomed, and we are already starting to see that uptick just a few months in. Hopefully, that answers your question.

Speaker #5: Hopefully that answers your question. Yeah, thank you. And if I can follow up and turn to dialysis access for a minute here, and just ask—you know, we're in that window of getting the BLA submission into the agency for clearance potentially in the future.

Ryan Zimmerman: Yeah, thank you. If I can follow up and turn to dialysis access for a minute here and just ask, we are in that window of getting the BLA submission into the agency for clearance potentially in the future. So, Laura, maybe you can just talk about what you are doing to de-risk that. Give us maybe a little tenor of the conversations with the agency around submission for ATEV in dialysis access and how you think about potentially bringing that to the market. If you have any thoughts on timing too, certainly those are appreciated. Thank you.

Speaker #5: So, you know, Laura, maybe you could just talk about kind of what you're doing to de-risk that. You know, give us maybe a little tenor of the conversations with the agency.

Speaker #5: Around submission for ATEV and dialysis access. And kind of how you think about, you know, potentially bringing that to the market. If you have any thoughts on timing too, certainly those are appreciated.

Speaker #5: Thank you.

Speaker #1: Yeah. So again, we have had multiple discussions with the FDA. Over the years on dialysis access. And we actually have scheduled a pre-BLA meeting which is happening in the very near future.

Laura Niklason: Yeah. We have had multiple discussions with the FDA over the years on dialysis access. We actually have scheduled a pre-BLA meeting, which is happening in the very near future, which we are excited about. The structure of that meeting is really not around whether to file, but around the structure of the file. Our anticipation is that we will include data from essentially all of our phase III studies, and we have done three of them, as well as a number of phase II studies. The total exposure that we have in our patient population is well over 1,000 patient years. This is the most studied conduit ever in dialysis access. So we believe that the data that we have is not only strong, but there is a lot of it. We do not anticipate any pushback on filing.

Speaker #1: Which we're excited about. But the structure of that meeting is really not around whether to file, but around the structure of the file. Our anticipation is that we will include data from essentially all of our Phase 3 studies—and we've done three of them—as well as a number of Phase 2 studies.

Speaker #1: And so, you know, the total exposure that we have in our patient population is well over 1,000 patient years. This is the most studied conduit ever in dialysis access.

Speaker #1: So, we believe that the data that we have is not only strong, but there's a lot of it. And so we do not anticipate any pushback on filing.

Laura Niklason: It is really about how we structure the file and the overall safety experience. So, that gives us a high index of confidence that this will go forward. I will tell you our plan, we have said H2 filing. Our target right now is that we will file in November, because there is a lot of data to pull together. When we file, we anticipate that we will ask for a priority review. We anticipate that we should receive a priority review because, again, this is a supplemental BLA, and we have multiple priority indications for dialysis access. If we are granted priority review, then we would see a PDUFA date sometime in May, and we would expect to launch at the end of Q2 in 2027.

Speaker #1: It's really about how we structure the file and the overall safety experience. So that, that gives us a high index of confidence that this will go forward.

Speaker #1: I'll tell you our plan: we've always said second-half filing. Our target right now is that we'll file in November, because there is a lot of data to pull together.

Speaker #1: When we file, we anticipate that we'll ask for a priority review. We anticipate that we should receive a priority review, because again, this is a supplemental BLA, and we have multiple priority indications for dialysis access.

Speaker #1: If we're granted priority review, then we would see a PDUFA date sometime in May, and we would expect to launch at the end of Q2 2027.

Laura Niklason: As far as what we are doing to prepare for the launch, there is really a tremendous focus on reimbursement and on creating the value story for insurers, both CMS and private insurers. Dialysis is a huge expenditure for Medicare and for private insurers, and as you know, there is a lot of downward price pressure on reimbursement. Our data from, especially, well, from all of our phase III trials really show that there are patients who get off catheter quicker and more reliably with our vessel than with any other method. There are cost savings to be shown there. We are putting together a budget impact model, and we are also looking at Medicare claims data to really nail that argument to the wall.

Speaker #1: As far as what we're doing to prepare for the launch, there's really, there's really a tremendous focus on reimbursement and on, and creating the value story for insurers, both CMS and private insurers.

Speaker #1: The, you know, dialysis is a huge expenditure for Medicare and for private insurers, and there's, as you know, a lot of downward price pressure on reimbursement.

Speaker #1: But our data from — especially from all of our Phase 3 trials — really show that there are patients who get off catheter quicker and more reliably with our vessel than with any other method.

Speaker #1: And there's cost savings to be shown there. So we're putting together a budget impact model, and we're also looking at Medicare claims data, to really nail that argument to the wall.

Laura Niklason: Because there are many high-risk patients who sit around on catheter for a long time and are extremely expensive to the system and cost an extra $20,000, $30,000, $40,000 per year, every year. By getting those patients off catheter with a low infection conduit, we will be able to save the system money and also just generate better patient outcomes. I know that is a long answer, Ryan.

Speaker #1: Because there are many high-risk patients who sit around on a catheter for a long time and are extremely expensive to the system, costing an extra $20,000, $30,000, $40,000 per year, every year.

Speaker #1: So by getting those patients off catheter, with a low infection conduit, we'll be able to save the system money and also just generate better patient outcomes.

Speaker #1: So, I know that's a long answer, Ryan, but that's how we're thinking about it.

Ryan Zimmerman: No.

Ryan Zimmerman: That is how we are thinking about it.

Laura Niklason: That is how we are thinking about it.

Ryan Zimmerman: Very appreciated. Yes. Thank you so much, and certainly best of luck on the submission this fall. Thank you.

Speaker #5: Right. I appreciate it. Yes. Thank you so much. And certainly best of luck on the submission. This fall. Thank you.

Laura Niklason: Thank you.

Speaker #1: Thank you.

Operator: Our next question is from Josh Jennings with TD Cowen. Please proceed.

Speaker #2: Our next question is from Josh Jennings with TD Cowan. Please proceed.

Josh Jennings: Thanks for taking the questions, Laura, Dale, and Jim. I was hoping to just follow up on some of the details on the rebuild of the commercial effort. Any help just thinking about, I guess, number of reps that are pushing ATEV in the vascular trauma channel today versus prior, and how that could potentially ramp up. Then also any help just thinking about introductory pricing incentives that you have called out and streamlining the VAC process. Sorry, three questions in one, but what does streamlining mean and how many, I guess, processes are in play right now? How many centers could be on the adopter list by the end of this year and then heading into 2027?

Joshua Jennings: Thanks for taking the questions, Laura, Dale, and Jim. I was hoping to just follow up on some of the details on the rebuild of the commercial effort. Any help just thinking about, I guess, number of reps that are pushing ATEV in the vascular trauma channel today versus prior, and how that could potentially ramp up. Then also any help just thinking about introductory pricing incentives that you have called out and streamlining the VAC process. Sorry, three questions in one, but what does streamlining mean and how many, I guess, processes are in play right now? How many centers could be on the adopter list by the end of this year and then heading into 2027?

Speaker #3: Thanks for taking the questions, Laura, Dale, and Jim. I was hoping to just follow up on some of the details on the rebuild of the commercial effort.

Speaker #3: And I mean, any help just thinking about, I guess, the number of reps that are pushing ATEV in the vascular trauma channel today versus prior, and how that could potentially ramp up, and then also any help just thinking about introductory pricing incentives that you've called out.

Speaker #3: And streamlining the VAC process—sorry, that’s three questions in one. But, you know, what does streamlining mean, and how many, I guess, processes are in play right now?

Speaker #3: How many centers could be on the adopter list by the end of this year, and then heading into 2027?

Jim Mercadante: Well, let me see if I can at least get a few of your questions here and start to answer them. First, what I will say is when you look at the submission process for a VAC approval, there is several ways to go about it. We have streamlined it because we became more flexible in the process and made it a little more open, so it is quicker adopted. When you couple that with vascular surgery relationships, major KOLs, across the US that want to try the product, want to use the product, that is how it really speeds up. The second piece to that is you need a national account strategy. When I came in, there was not a national account strategy.

Speaker #5: So let me see if I can at least get a few of your questions here, and start to answer them. First, what I'll say is, when you look at the submission process for a VAC approval, there's several ways to go about it.

Speaker #5: The way we've streamlined it, because we became more flexible in the process, made it a little more open. So we get quicker adoption. And when you couple that with faster surgical relationships, major KOLs across the US that want to try the product, want to use the product, that's how it really speeds up.

Speaker #5: And the second piece to that is, you need a national account strategy. And when I came in, there wasn't a national account strategy. So we hired a very specific individual, who’s done this with me in the past, to build out that national account strategy.

Jim Mercadante: We hired a very specific individual who has done this with me in the past to build out that national account strategy so we can get access to another 1,000 hospitals in the United States, which we currently did not have. Those are some key elements in any commercialization, to have a national account strategy, to streamline the VAC process, et cetera. The creation of introductory pricing is because surgeons, what I love about surgeons in general and vascular surgeons in particular, they really want to know how it behaves in their patients, and they want to try it. You really need to create a system where it becomes easy for them to be able to try it on several patients before they start to adopt it and put it into their practice.

Speaker #5: So you can get access to another 1,000 hospitals in the United States, which we currently didn't have. So those are some key elements in any commercialization to have a national account strategy to streamline the VAC process, et cetera.

Speaker #5: And the creation of introductory pricing is because, you know, surgeons—what I love about surgeons in general, and vascular surgeons in particular—is that they really want to know how it behaves in their patients.

Speaker #5: And they want to try it. And you really need to create a system where it becomes easy for them to be able to try it on several patients before they start to adopt it, and put it into their practice.

Speaker #5: So, one of the key principles is to be easy to do business with. And we've changed our philosophy on how we're interacting with administrations and healthcare systems.

Jim Mercadante: One of the key principles is just to be easy to do business with, and we have changed our philosophy on how we are interacting with administrations at healthcare systems. I can tell you right now, we have got at least 20 major healthcare systems in the US in the process of bringing it into their healthcare systems in the back half of this year. That is not to mention everything else that we are working on. Hopefully, that answers your question.

Speaker #5: I can tell you right now, we've got at least 20 major healthcare systems in the U.S. in the process of bringing it into their healthcare systems in the back half of this year.

Speaker #5: That's not to mention everything else that we're working on. Hopefully, that answers your question.

Josh Jennings: Yeah, that helps. Thank you. I am sorry for loading you up with a three-level question. Just on the Salesforce numbers, have they been reduced? Are they stable? Are they increasing for the vascular trauma? How are you thinking about the commercial strategy for the AV access indication and once that opens up? Will Fresenius play any role in terms of helping drive the initial commercial push, at least at their vascular surgery centers? Thanks for taking all the questions.

Joshua Jennings: Yeah, that helps. Thank you. I am sorry for loading you up with a three-level question. Just on the Salesforce numbers, have they been reduced? Are they stable? Are they increasing for the vascular trauma? How are you thinking about the commercial strategy for the AV access indication and once that opens up? Will Fresenius play any role in terms of helping drive the initial commercial push, at least at their vascular surgery centers? Thanks for taking all the questions.

Speaker #3: Yeah, that helps. Thank you. And I'm sorry for loading you up with a three-level question. But just on this, because Salesforce numbers—I mean, have they been reduced?

Speaker #3: Are they stable? Are they increasing for the vascular trauma? And then how are you thinking about the commercial strategy for the AV access indication?

Speaker #3: And once that opens up, will Fresenius play any role in terms of helping drive the initial commercial push, at least at their vascular surgery centers?

Speaker #3: Thanks for taking all the questions.

Jim Mercadante: Sure. Let me just start with the dialysis one. We have already begun preparation, no matter when we receive approval, on what that launch will look like. We are ready day one. Everything that leads up to that is, if you really look at our strategy, we are using vascular injury now to get into a healthcare system. We are seeing adoption of that. It is certainly a great product, and for the right patient, of course. It is always about patient selection. That prepares us for dialysis because if you are already in the healthcare system and you are through the VAC process and you are already on the shelf and you have another indication, that will accelerate launch when we do launch dialysis. That is the strategy.

Speaker #5: Sure. As we, let me just start with the dialysis one. We have already begun preparation no matter when we receive approval. On what that launch would look like.

Speaker #5: So we're ready day one. So everything that leads up to that is, you know, if you really look at our strategy, we're using vascular injury now to get into a healthcare system.

Speaker #5: And we are seeing adoption of that. I mean, it's certainly a great product. And for the right patient, of course. And it's always about patient selection.

Speaker #5: But that prepares us for dialysis, because if you're already in the healthcare system and you're through the VAC process, and you're already on the shelf, and you have another indication, that will accelerate launch when we do launch dialysis.

Speaker #5: So that's the strategy. The strategy is, you know, we're utilizing our current indication, and that's where we're selling on. But also preparing for dialysis, because if we have it already adopted, into these healthcare systems, and it's on the shelf, and we launch in dialysis, that's instant access to dialysis patients.

Jim Mercadante: The strategy is we're utilizing our current indication, and that's what we're selling on, but also preparing for dialysis because if we have it already adopted into these healthcare systems and it's on the shelf and we launch in dialysis, that's instant access to dialysis patients. That's what we're preparing for. We're also looking at, you mentioned Fresenius. It's a great question. I will say this. Besides Fresenius, we're looking at probably 5 or 6 other strategies and particular verticals for dialysis in the US. I think it's going to be much broader than just working with Fresenius. While we would love to work with Fresenius and will, I think we have to work with some others as well, as we look to launch this in a major way mid-2027, so long we have the approvals that are needed.

Speaker #5: And that's what we're preparing for. Now, we're also looking at—you mentioned Fresenius; it's a great question. I will say this: besides Fresenius, we're looking at probably five or six other strategies and particular verticals for dialysis in the U.S.

Speaker #5: So I think it's going to be much broader than just working with Fresenius while we would love to work with Fresenius and will. But I think we have to work with some others as well, as we look to launch this in a major way mid-2027.

Speaker #5: So long as we have the approvals that are needed.

Josh Jennings: Thanks again.

Joshua Jennings: Thanks again.

Speaker #3: Thanks again.

Jim Mercadante: No problem.

Speaker #5: No problem.

Operator: Our next question is from Bruce Jackson with The Benchmark Company. Please proceed.

Speaker #2: Our next question is from Bruce Jackson, with the benchmark company. Please proceed.

Bruce Jackson: Hi. Thank you for taking my questions. With the 20 new hospital systems that you are looking at right now, how many actual hospitals are associated with those systems?

Speaker #1: Hi, thank you for taking my questions. So with the 20 new hospital systems that you're looking at right now, how many actual hospitals are associated with those systems?

Jim Mercadante: They are going to range. It could be anywhere from five to 50. It just depends on the healthcare system. Right now, I can tell you that when they start to adopt and they start to expand utilization, it starts usually with a surgeon or two, and then it usually transforms itself into the entire department. We have several cases right now that we have been able to transform from what I call dabbling and using it every once in a while to weekly usage. There is a natural progression on the adoption of this product. As I said earlier, vascular surgeons in general, like to try it out first. They want to touch it, they want to feel it, they want to sew, and they want to see how it performs in their particular patient set.

Speaker #5: They're going to range. You know, it could be anywhere from five to 50. So it just depends on the healthcare system. Right now, I can tell you that when they start to adopt and they start to expand utilization, it usually starts with a surgeon or two.

Speaker #5: And then it usually transforms itself into the entire department. We have several cases right now that we've been able to transform from what I call dabbling and using it every once in a while to weekly usage.

Speaker #5: So there's a natural progression in the adoption of this product. As I said earlier, vascular surgeons—surgeons in general—like to try it out first.

Speaker #5: They want to touch it. They want to feel it. They want to sew, and they want to see how it performs in their particular patient set.

Jim Mercadante: It is a process that can be repeated healthcare system to healthcare system. As these healthcare systems adopt, they tend to share their experience with other healthcare systems and other vascular surgeons in the community. It becomes, after a while, after you get some mass, it starts to duplicate itself naturally. Hopefully, that answers your question.

Speaker #5: And so you know, it's a, it's a process that can be repeated. Healthcare system to healthcare system. And as these healthcare systems adopt, they tend to share their experience with other healthcare systems and other vascular surgeons in the community.

Speaker #5: So it becomes after a while, after you get some mass, it starts to, you know, duplicate itself naturally. If that, hopefully that answers your question.

Bruce Jackson: It does. Thank you. One other question on the transition of the sales and marketing effort. Was there any change in the number of contracted hospitals or VAC approvals where there is potentially a slowdown during this quarter?

Speaker #1: It does. Thank you. And then, one other question on the transition of the sales and marketing effort: Was there any change in the number of contracted hospitals or VAC approvals, or was there potentially a slowdown during this quarter?

Jim Mercadante: Are you asking in particular Q2 or in the back half?

Speaker #5: Are you asking about a particular Q2, or in the VAC half?

Bruce Jackson: Just looking at Q2. We had a certain number of contracted hospitals in the first quarter, and I think we were all sort of looking for some sort of a trend going from first quarter to second quarter. Was there any kind of hiccup or break in the trend because of the transition with the sales force?

Speaker #1: Just for looking at Q2. We had a certain number of contracted hospitals in the first quarter, and I think we were all sort of looking for some sort of a trend going from first quarter to second quarter.

Speaker #1: Was there any kind of hiccup or break in the trend because the transition with the Salesforce?

Jim Mercadante: Well, I don't know if there was a hiccup or break. It was more of a, I think you heard earlier, we were literally rebuilding the entire commercial team, not only with personnel, but strategy, tactics, et cetera, across everything, sales, marketing, national accounts. We did it pretty fast. I mean, it's pretty unheard of to do that within three months, but we did it and transformed the whole thing. What you'll see is, you'll see those results in the back half. You didn't see them in Q2. That would've been really quick. But we started to see a minor uptick, but the uptick is really in the back half.

Speaker #5: Well, I don't know if there was a hiccup or break. It was more of a, I think you heard earlier, we were literally rebuilding the entire commercial team.

Speaker #5: Not only with personnel, but strategy, tactics, et cetera—across everything: sales, marketing, national accounts. And we did it pretty fast. I mean, it's pretty unheard of to do that within three months, but we did it and transformed the whole thing.

Speaker #5: And what you'll see is, you'll see those results in the VAC half. You didn't see them in Q2; that would have been really quick.

Speaker #5: But we started to see a minor uptick, but the uptick is really in the VAC half.

Bruce Jackson: Okay. All right. Thank you very much.

Speaker #1: Okay. All right. Thank you very much.

Operator: Our next question is from Swayampakula Ramakanth with H.C. Wainwright. Please proceed.

Speaker #2: Our next question is from Swayampakula Ramankoth, with HC Wainwright. Please proceed.

Swayampakula Ramakanth: Thank you. Good morning. This is RK from H.C. Wainwright. A couple of quick questions. I am sorry if you had given some of this information in the opening remarks because I missed a few minutes of it. On the supplemental BLA for the dialysis, how are you planning to use the RMAT designation that you have? Also, in terms of the label, can you elaborate a little bit about what you are trying to seek on the label, and would you also look to see if you can get at-risk males within that label?

Speaker #4: Thank you. Good morning. This is R.K. from HC Wainwright. A couple of quick questions. I'm sorry if you had given some of this information in the opening remarks, because I've missed a few minutes of it.

Speaker #4: On the supplemental BLA for the dialysis, you know, are you how are you planning to use the RMAT designation that you have? And also in terms of the label, you know, can you elaborate a little bit about what you're trying to seek on the label?

Speaker #4: And, you know, would you also look to see if you can get at-risk males within that label?

Laura Niklason: Hi, RK. This is Laura. Thank you for the question. Yes. So we do have the RMAT designation in dialysis access, and we will use that, along with the fact that we already have approval in another indication to request a priority review. So that means if we file our sBLA sometime in November, which is our current plan, then we would hope, under best case, to get a PDUFA date sometime in May of 2027. That would allow us, best case, to launch in the back end of Q2 2027. If we do not get a priority review, then that would push our PDUFA date sometime into August. So, that is kind of the bracketing of the timing that we see. Of course, as you know, the FDA does not always hit their PDUFA dates, but that is just what we would be expecting.

Speaker #1: Hi, R.K., this is Laura. Thank you for the question. Yes, we do have the RMAT designation in dialysis access. We will use that, along with the fact that we already have approval in another indication, to request priority review.

Speaker #1: So that means, if we file our SBLA sometime in November, which is our current plan, then we would hope under best case to get a PDUFA date sometime in May of 2027.

Speaker #1: That would allow us, best case, to launch in the back end of the second quarter of 2027. If we do not get a priority review, then that would push our PDUFA date sometime into August.

Speaker #1: So that's kind of the bracketing of the timing that we see of course, as you know, you know, the FDA doesn't always hit their PDUFA dates.

Speaker #1: But that's just, you know, that's just what we would be expecting. As far as—gosh, what was the second half of your question, R.K.?

Laura Niklason: As far as, gosh, what was the second half of your question, RK? I am sorry.

Swayampakula Ramakanth: At-risk males. Do you think you will-

Speaker #1: I'm sorry.

Speaker #4: At-risk males. Do you think you're—

Laura Niklason: Yes, yes. So we are, again, the specific label language is always a subject of negotiation with the FDA, but our anticipated label is that Symvess would be indicated for hemodialysis access in patients who are at elevated risk of fistula failure or non-maturation. In parentheses, it might say, "I.e., women and men with risk factors such as obesity and diabetes." So that is the indication that we will put into, the indication language that we will put into our application. Again, the final indication remains to be worked out with the FDA.

Speaker #1: yes. Yes. Yes. So we are, you know, again, the specific label language is always a subject of negotiation with the FDA. But our anticipated label is that ATAV or Simves would be indicated for hemodialysis access in patients who are at elevated risk of fistula failure or non-maturation.

Speaker #1: And in parentheses, it might say IE women, and men with risk factors such as obesity and diabetes. So that is the indication that we will put into the indication language that we'll put into our application.

Speaker #1: But again, the final indication remains to be worked out with the FDA.

Swayampakula Ramakanth: Yeah. Regarding the Fresenius relationship, how do you foresee them helping on your launch, especially given that third amendment that returned the worldwide rights and, also based on that, should we expect some royalty step-down thresholds, especially in the United States?

Speaker #4: Yeah. Yeah. And then regarding the Fresenius relationship, you know, how do you foresee them helping on your launch? Especially given the third amendment that returned the World Wide Rights and, you know, and also based on that, you know, should we expect some royalty step-down thresholds?

Speaker #4: Especially in the United States?

Laura Niklason: I am honestly not sure what you mean about step-down thresholds, but Fresenius does have, I mean, we remain in the commercialization agreement with Fresenius. That has a couple of clauses. One is that they have pledged to adopt this as standard of care in their dialysis access centers for patients in whom we have an indication and for whom the economic benefit makes sense. That is why we are doing a tremendous amount of work on the health economics of particularly getting patients off of catheters, because catheters are expensive for the system, for capitated patients, and they are also even expensive for dialysis centers. Dialysis centers get docked by CMS if they have too many catheter patients. So we expect that relationship with Fresenius to continue.

Speaker #1: So, I'm honestly not sure what you mean about step-down thresholds, but Fresenius does have — I mean, we remain in the commercialization agreement with Fresenius.

Speaker #1: And that has a couple of clauses. One is that they have pledged to adopt this as the standard of care in their dialysis access centers.

Speaker #1: For patients in whom we have an indication and for whom the economic benefit makes sense. And so that's why we're doing a tremendous amount of work on the health economics of particularly getting patients off of catheters.

Speaker #1: Because catheters are expensive for the system, for cathetated patients. And they're also, you know, even expensive for dialysis centers. Dialysis centers get docked if they by CMS, if they have too many catheter patients.

Speaker #1: So we expect that relationship with Fresenius to continue. It's also germane to point out that they get a royalty on every vessel that we sell in any indication.

Laura Niklason: It is also germane to point out that they get a royalty on every vessel that we sell in any indication in the US. There is a lot of aligned motivations for broader adoption in the US. Does that

Speaker #1: In the U.S. So there's a lot of aligned motivations for broader adoption in the U.S. Does that get at your questions?

Swayampakula Ramakanth: Okay

Laura Niklason: get at your questions?

Laura Niklason: -get at your questions?

Swayampakula Ramakanth: Yes. The last question from me is on the CTEV study that you recently got FDA to sign off on. Anything on the timing of the study, and also how does manufacturing of that, does that impact anything with your commercial product manufacturing right now on the ATEV?

Speaker #4: Yes. Yes. And then the last question from me is on the CTEV study. That you recently got FDA to sign off on. Anything on the timing of the study and also if, you know, how does manufacturing of that, does that impact anything with your commercial product manufacturing right now on the ATV?

Laura Niklason: Yeah. You are right, RK, in that the vessels that we make for the CTEV studies are in the same machines, because this is a platform, in the same machines as make our commercial vessels. However, the requirements for numbers of CTEVs are very low for the next year or two. This phase IIa study is only 10 patients. The smallest batch we can make is 100 vessels. So we may make one more CTEV batch next year, but it is not like it is a drain on the system at all. As far as when we expect the trial to start, we are working on getting through the IRB and finishing up that paperwork now that we have FDA sign-off on the IND. So I would expect that study to open up sometime this month. Then it is a question of identifying the correct patients.

Speaker #1: Yeah. So you're right, R.K., in that the vessels that we make for the CTEV studies are in the same machines because this is a platform, in the same machines as make our commercial vessels.

Speaker #1: However, the requirements for numbers of CTEVs are very low for the next year or two. I mean, this phase two A study is only 10 patients.

Speaker #1: The smallest batch we can make is 100 vessels. So you know, we may make one more CTEV batch next year, but it's not like it's a drain on the system at all.

Speaker #1: As far as when we expect the trial to start, we're working on getting through the IRB and finishing up that paperwork now that we have FDA sign-off on the IND.

Speaker #1: So I would expect that to that study to open up sometime this month. And then it's a question of identifying the correct patients, you know, what's really important for this study is that we have the right patient.

Laura Niklason: What is really important for this study is that we have the right patients and that we get outstanding outcomes. That is really what we are focused on. Luckily, we have two surgeons who are participating in this study who have also done all of our large animal work with CTEV and are also obviously extremely experienced cardiac surgeons. We feel like this is in good hands.

Speaker #1: And that, we get outstanding outcomes. And so that's really what we're focused on. Luckily, those participating in the study have also done all of our large animal work with CTEV.

Speaker #1: And are also, obviously, extremely experienced cardiac surgeons. So we feel like this is in good hands.

Swayampakula Ramakanth: Perfect. Thanks for taking all my questions, Laura.

Speaker #4: Perfect. Thanks. Thanks for taking all my questions, Laura.

Speaker #1: Mm-hmm.

Operator: We have reached the end of our question and answer session. I would like to turn the conference back over to Laura for closing remarks.

Speaker #2: We have reached the end of our question-and-answer session. I would like to turn the conference back over to Laura for closing remarks.

Laura Niklason: Thank you very much, everyone, for listening to this Q2 2026 Humacyte update and conference call. We have done a tremendous amount of rebuilding in the last three or four months, especially on the commercial side, and we are very pleased with the new strategy and the new team that we have in place. I believe it will be transformative for Humacyte, going into the H2 of this year and also for 2027 and beyond. In addition to rebuilding the current commercial infrastructure, we have also made great progress on two future indications. We are firing on all cylinders, and I am very pleased that we are where we are now. I look forward to continuing to share our quarterly updates with this group going forward. Thank you very much, everybody.

Speaker #1: Thank you very much, everyone, for listening to this second quarter 2026 Humacyte update and conference call. We have done a tremendous amount of rebuilding in the last three or four months, especially on the commercial side.

Speaker #1: And we're very pleased with the new strategy and the new team that we have in place. I believe it will be transformative for hemocyte going into the second half of this year and also for 2027 and beyond.

Speaker #1: But in addition to rebuilding the current commercial infrastructure, we've also made great progress on two future indications. So we're cooking, you know, we're firing on all cylinders.

Speaker #1: And I'm very pleased that we are where we are now. And I look forward to continuing to share our quarterly updates with this group going forward.

Speaker #1: Thank you very much, everybody.

Operator: Thank you. This will conclude today's conference. You may disconnect at this time, and thank you for your participation.