Humacyte, Inc.

Good morning, ladies and gentlemen, and welcome to the Humacite first quarter results 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 is being recorded. I will now turn the conference to call over to Tom Johnson with LifeSci Advisors. Please go ahead, sir.

Thank you, Operator. Before we proceed with the call, we'd like to remind everyone that certain statements made 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 historic 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 a 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 Hema site website. Joining me on today's call from Hema site are Dr. Laura Nicholson, President and Chief Executive Officer, Dale Sander, Chief Financial Officer, and Chief Corporate Development Officer, and BJ Sashley, Chief Commercial Officer. Dr. Nicholson will provide a summary of the company's progress for the first quarter and recent weeks, and Dale will review the financial results for the quarter ended March 31, 2025. Following their prepared remarks, BJ will join Laura and Dale for the Q&A session. I will now turn the call over to Dr. Nicholson. Laura?

Thank you, Tom, and good morning, everyone. and thank you for joining us for our first 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 late last year, we're keenly focused on the commercial launch of this groundbreaking product. Supporting the launch is our number one priority, and we're pleased by the traction gained in our interactions with hospitals despite the current volatile economic environment. Based upon our March 2025 financing and some recent cost reductions, we've taken steps to extend Humacyte's cash runway. With this extended runway, we'll continue to aggressively expand our commercial launch while creating additional enterprise value from our bioengineering pipeline. Upcoming major value drivers that we anticipate include publication of additional clinical results in trauma and in dialysis access, and filing an IND with the FDA later this year to enable first in human clinical testing of our small diameter ATEV in coronary artery bypass grafting. In addition, as a result of reaching a major milestone in enrollment in our VO12 phase three trial in dialysis, we're also on track for filing a supplemental BLA for the ATEV in dialysis in 2026. 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 Chesley, our Chief Commercial Officer, will then join us to help answer your questions. As I start the review of the quarter, I want to acknowledge the strong support that we've had from surgeons who have treated patients with SimVest and the resiliency of our team members in the face of some unfounded negative press regarding SimVest and Humacyte. As you probably know, we've addressed these critiques in public statements in recent weeks. In short, we believe that these criticisms are ill-informed and without merit. Over the last two decades, we've worked hard to build Humacyte into what it is today. The body of clinical results supporting the use of Symves in extremity vascular trauma will be further strengthened by upcoming publication in peer-reviewed medical journals of our long-term patient outcomes. We will continue to combat unfounded attacks with science-based facts. With that out of the way, I'm proud to report that Humacyte commenced its commercial launch of SimVest in late February 2025. The first commercial shipments containing multiple units of SimVest were made during the first quarter to three level one trauma centers. As a reminder, commencement of sales to hospitals for new products typically requires review and approval by a value analysis committee or VAC. which is a centralized decision-making body within the institution. Only a few months after commercial launch, we're excited that 45 hospitals have already commenced an evaluation of SIMVAS as part of their VAC approval process, approximately one quarter of all level one trauma centers nationwide. The VACs of five hospitals have already approved the purchase of SIMVAS, and we expect this number to grow throughout the second quarter based on current discussions with hospitals. Our commercial launch of SimVest is further supported by publication in March of 2025 of our budget impact model in the peer-reviewed Journal of Medical Economics. This publication shows that SimVest provides economic value to the healthcare system. By reducing conduit infections and limb amputations, SimVest provides a strong opportunity for cost reduction as compared to synthetic conduits and as compared to xenografts and the like. In addition to the civilian market, Humacyte has been working to address the military market for SimVest and extremity vascular trauma. Multiple military treatment facilities have already expressed an interest in purchasing SimVest. To facilitate these purchases, we expect that SimVest will shortly be listed in the electronic catalog, or ECAT, which is an internet system that provides the Department of Defense and other federal agencies with access to manufacturers' products. As we've previously reported, due to the nature of the VAC process, we have consistently forecast that the majority of first-year sales will occur in the second half of the year. We're pleased that the sales and the VAC activity to date is in line with our goals for this early period of market launch. The U.S. commercial launch of SimVest this quarter was a major milestone for Humacyte, and we're excited to provide this transformative product to surgeons and patients in need of a new option to save limbs and lives. Let me turn now to the ADEV indication that is our next priority, which is in dialysis access. As you'll recall, about six months ago, we reported top line results on our prospective randomized head-to-head VO7 phase three trial, which compared our vessel to the gold standard, which is autogenous fistula. This trial met its primary endpoints and showed superior patency at six and 12 months as compared to fistula. We were also able to identify two subgroups of patients who could benefit the most from the ATEV, which includes all women and men with diabetes and obesity. These two groups make up more than half of the dialysis access market. We believe that the efficacy and safety results in the subgroups, combined with the approximately 50% failure rate of standard of care in these vulnerable populations, means that they are important targets for the marketing of ATEV in dialysis access. We expect that the results from the VO7 Phase III trial will be published in a major peer-reviewed medical journal in the near term. We're also conducting an ongoing Phase III dialysis access trial in women, which has passed a major enrollment milestone. The VO12 study is a small Phase III trial of 150 patients, which compares the efficacy and safety of ATEV to fistula for hemodialysis. A total of 84 patients has already been enrolled in the trial to date. An interim analysis for the VO12 trial is planned for April 2026, when the first 80 patients will have reached the 12-month follow-up. Our plan is to submit a supplemental BLA in the second half of 2026, which includes data from the VO12 and VO7 Phase III pivotal studies, and to add AV access for hemodialysis as an indication for the ATEF. Finally, I'll briefly discuss some of our earlier stage programs that we're also excited about. Our small diameter ATEV for the treatment of coronary artery disease. During the first quarter, we announced plans to file an IND application with the FDA to allow first in human clinical testing of the small diameter acellular tissue engineered vessel, which is 3.5 millimeters in diameter, rather than the 6 millimeter diameter of the approved SimVest conduit. Our plans for IND filing in 2025 to support a first in human trial in coronary bypass are based on the outcome of a recent meeting held with the FDA. To date, only the six millimeter configuration of our vessel has been studied in human trials to include AV access for hemodialysis, trauma, and peripheral arterial disease. We're very pleased to be moving closer to human clinical studies of the small diameter ATEF in coronary artery bypass surgery. and we believe our planned IND filing and initiation of first human study after FDA clearance will be another major milestone for Humacyte. So we're off to a good start in 2025, and we look forward to sharing our continued progress with all of you as the rest of the year unfolds. And with that, I'll now turn it over to Dale for a review of our financial results and other business developments.