Humacyte, Inc.

Good morning, ladies and gentlemen, and welcome to the Humacyte second quarter 2025 results conference call. Currently, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. As a reminder, this conference is being recorded. I would now like to turn the call over to Tom Johnson with LifeSci Advisors. Please go ahead.

Thank you, Operator. Before we proceed with the call, I'd like to remind everyone that certain statements during this call are forward-looking statements under U.S. 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've issued this morning and in our Form 10-Q, which after the filing may be accessed from the investor page of the Humusite website. Joining me today on today's call from Humusite are Dr. Laura Nicholson, President and Chief Executive Officer, Dale Sander, Chief Financial Officer, and Chief Corporate Development Officer, and B.J. Chesley, Chief Commercial Officer. Dr. Nicholson will provide a summary of the company's progress for the quarter in recent weeks, and Dale will review the company's financial results for the quarter ending June 30, 2025. Following their prepared remarks, BJ will join Laura and Dale for a Q&A session. And I'll turn the call over to Dr. Laura Nicholson. Go ahead, Laura.

Thank you, Tom. Good morning, everyone, and thank you for joining us for our second quarter 2025 financial results and business update call. Following the landmark success of obtaining FDA approval of SimVest for the treatment of extremity vascular trauma last year, we continue to execute on the commercial launch of this groundbreaking product. Progress during our second quarter and recent weeks was marked by continued expansion of our Value Analysis Committee, or VAC, approvals. This has led to a major expansion of the number of approvals that are now able to purchase SimVest. Recently, we also announced that the U.S. Defense Logistics Agency granted electronic catalog or ECAT listing approval to CINVAS. Going along with this, we have recorded our first sale to a U.S. military facility. We did encounter some headwinds during April and May due to unsubstantiated public attacks by certain detractors. However, we've seen an acceleration in VAC approval activity and commercial sales in June and July. Coupled with the continued advancement of our Acellular Tissue Engineered Vessel, or ATAP, in our pipeline program, we believe that we're positioned for growth and value generation in 2025 and beyond. During today's call, I'll review these developments in more detail before turning the call over to Dale for a review of our financial results. BJ Shesley, our Chief Commercial Officer, will then join us to help answer your questions. Beginning with our commercial launch of SimVest, we're pleased by the traction that we've continued to gain in our interactions with civilian hospitals. To date, a total of 13 organizations have completed the VAC process and have approved the purchase of SimVest. Because some of these VAC approvals include multi-hospital networks, a total of 82 civilian hospitals are now eligible to purchase SimVest. This is an enormous increase from the five civilian hospitals that were eligible to purchase CINVEST at our last quarterly earnings call. Furthermore, an additional 40 VAC sites are currently conducting reviews of CINVEST, and we expect that the number of hospitals eligible to purchase CINVEST will continue to grow. After VAC approval, contracting and negotiations with each individual hospital are completed before sales and shipment to that hospital can commence. Currently, our sales team is actively targeting high volume sensors, having back approval for contracting negotiations. July product sales of approximately 0.3 million exceeded the total sales that we recorded for the first half of the year. Also in July, we announced that CIMVEST was awarded the electronic catalog or ECAT listing approval from the US Defense Logistics Agency. ECAT is an internet system that provides the Department of Defense and other federal agencies with access to manufacturers' and distributors' products. The ECAT approval makes CIMVEST available to healthcare professionals treating military service members, veterans, and other patients receiving care at approximately 35 military treatment facilities and approximately 160 U.S. Department of Veterans Affairs hospitals. With ECAT approval in place, it's not generally necessary to also obtain VAC approval at the military treatment facilities or VA sites. Instead, purchase is facilitated directly through the ECAT system. Since obtaining ECAT approval just a few weeks ago, we've already recorded our first commercial sale to a US military facility. This facility is a state-of-the-art medical complex located on a major US military base. and provides healthcare to approximately 200,000 active duty service personnel, retirees, and their family members. Subsequent to the initial shipment, this facility has also reordered Symbeth. We have great interest in improving the medical options that are available to healthcare professionals who are treating military personnel and their families, and we're actively advancing our discussions with additional military treatment facilities. In August, we were notified that the Centers for Medicare and Medicaid Services, or CMS, declined to approve our application for the New Technology Add-on Payment, or NTAP, for CMVS. Our application was submitted in October of 2024, and along with the majority of applications that were submitted to CMS this cycle, our application was also denied. The reason provided by CMS was that CMVS does not have a unique mechanism of action as compared to veins or synthetic grafts and therefore did not qualify for their newness criterion. This conclusion was extremely surprising to us. We believe that the potential impact of the NTAP on our commercial success is fairly limited because only about 4.3% of vascular trauma patients who are falling within our approved indication are covered under Medicare reimbursement. because private pay insurers are the most common source of reimbursement for vascular trauma patients that are falling within our indication. We're engaging in discussions with private payers about supplemental reimbursement for SIMVEST in the trauma indication. We believe that the results of our budget impact model, or BIM, which we published several months ago, along with our published clinical trial results, will encourage supplemental reimbursement from private payers. I'll now turn to the ATAS, a program which is our next priority, which is the dialysis access for patients with end-stage kidney failure. We're pleased to see that results from our VO7 phase 3 trial were presented in a plenary session at the Society of Vascular Surgery annual meeting in June. The VO7 results presentation that was focused on patients at high risk of fistula non-maturation was one of only three selected for special mention by the society in their own announcement. The VO7 clinical trial enrolled a total of 242 patients, of which 110 were considered to be at high risk of fistula non-maturation. Among this high risk cohort, functional patency at six months and secondary patency at 12 months were significantly higher in ATEV recipients as compared with fistula. Duration of access usability over the first year was also significantly higher in the ATEV group at eight months versus only four and a half months for arteriovenous fistula with a p-value of 0.0002. Results of the VO7 trial have also been accepted for presentation at the annual kidney week meeting for 2025 later this year. Women and men having diabetes and obesity make up more than half of the dialysis access market. Patients with a high risk of fistula non-maturation have historically been underserved by the current standard of care since waiting for fistula maturation can result in prolonged catheter exposure, increased risk of infection and additional procedures performed to assist in the maturation of the non-functioning fistula. Because of these risks, patients with fistula non-maturation have a high unmet medical need We believe that the efficacy and safety results of the VO7 subgroup, combined with the approximately 50% official failure rate in this high-risk group, means that this is an excellent population for us to target in the market. We look forward to publication of the results from the VO7 Phase III trial in a major peer-reviewed medical journal later this year. After discussions with the FDA about a supplemental BLA filing in dialysis access, we're planning to target the general subgroup of patients at high risk of fistula non-maturation. Before we file a supplemental BLA, which we anticipate later in 2026, our plan is to complete the interim analysis of the currently ongoing VO12 phase three trial that's being conducted only in women and which compares the ATEV to fistula for hemodialysis access. To date, a total of 100 patients have been enrolled in the VO12 Phase III trial out of a target of approximately 150 patients. An interim analysis is planned when the first 80 patients reach one year of follow-up, and this enrollment threshold was achieved in April of 2025. Subject to these interim results, Humacyte's plan is to submit a supplemental BLA in the second half of 2026, including data from VO12 and the VO7 phase three pivotal studies to expand the CINVES label and add AV access for hemodialysis as an indication. We're pleased with the progress that we're making in 2025, and we look forward to sharing our progress with all of you as the rest of the year unfolds. With that, I'll now turn it over to Dale for a review of our financial results and other business developments.