Humacyte, Inc.

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

Thank you, Operator. Before we proceed with today's call, I would like to remind everyone that certain statements made during the 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 are contained in our periodic reports filed with the SEC. The forward-looking statements made during this call speak only as a date of hear of, and the company undertakes no obligation to update or revise forward-looking statements except required by law. Information presented on this call contained in the press release we issued this morning and in our Form 10-K, which after filing may be accessed from the investor page of the Humacyte website. Joining me on today's call from Humacyte are Dr. Laura Nicholson, President and Chief Executive Officer, and Dale Sander, Chief Financial Officer and Chief Corporate Development Officer. Dr. Nicholson will provide a summary of the company's major events for the fourth quarter and recent weeks, and Dale will review the company's financial results for the year ended December 31, 2024. Following their prepared remarks, we will open the call to questions from covering analysts. With that, I will now turn the call over to Dr. Nicholson. Laura?

Thank you, Tom. Good morning, everyone, and thanks for joining us for our fourth quarter and full year 2024 financial results and business update call. 2024 has been a landmark year for Humacyte, highlighted by the FDA's full approval of SimVest for the treatment of extremity vascular trauma. StimVest is a biological product that went through more than 20 years of research and development, and we believe that this first-in-class approval marks an important new era in vascular surgery. We're thrilled to deliver this transformative innovation to surgeons and to patients in need of a new option to save limbs and lives. Results from our preclinical studies and our clinical studies suggest that there are patients walking around on their own legs today who would not be doing so if SimVest were not available. Our commercial launch of SimVest is proceeding at full speed, and we're excited with the response to date from hospitals and healthcare providers. So far, the market has responded well, with 34 hospitals already having initiated their Value Analysis Committee, or VAC, approval process. These hospitals are a mix of leading trauma centers that were participants in Humacyte's clinical studies and are combined with institutions that have been newly introduced to SIMVAS. VACs have been engaged in individual institutions and in centers from much larger networks, meaning that individual VAC approvals could apply to multiple hospitals. Although the VAC process often takes three to six months to complete, three hospitals have already approved the purchase of SIMVAS. We're also excited that just 16 days after having the commercial inventory availability, we made our first shipments of SimVest. These first commercial shipments were made last week to several level one trauma centers. The potential health benefits of SimVest are also supported by our budget impact model that was just published in the Journal of Medical Economics. This paper concludes that the avoidance of vascular infections and amputations drive the cost reductions that are associated with the use of SimVest in traumatic injury. Based on the model, the per patient cost of treating patients with SimVest is estimated to be less than the cost of treating trauma patients with either synthetic grafts, cryopreserved allografts, or xenografts. On a related note, in October 2024, we submitted a new technology add-on payment or NTAP application for SimVest to the Centers for Medicare and Medicaid Services, or CMS. And we presented the CMVS data at a public town hall with CMS in December of 2024. There are really two important criteria for getting an NTAP. First is that the technology is new, for which we clearly qualify. The second is that the technology provides an important clinical benefit above and beyond what's currently available. We believe that we check both of these boxes. and that we have a strong case for getting NTAP reimbursement. If successful, NTAP reimbursement will begin on October 1, 2025, offering hospitals additional payment to cover the cost associated with purchasing SimVest. In January of 2025, Humacyte was issued a new U.S. patent covering key aspects of the manufacturing system for SimVest and other bioengineered human tissues. The newly issued patent provides protection into 2040. The new patent complements a family of existing patents and patent applications, encompassing the design and the composition of matter of SimVest and our other product candidates, as well as their methods of manufacture. Before moving into development elsewhere in our pipeline, I'd like to take a moment to acknowledge our exceptional commercial team, which is led by BJ Shesley, our chief commercial officer, which has been crucial in the early success of this launch. To drive adoption, we recruited and trained a highly experienced sales team for the commercial launch of SimVest. All sales team members are multi-year President's Club winners, representing the top 10% of achievers in their prior sales organizations. Team members also have experience in vascular and trauma surgery, prior experience selling regenerative therapies, and are expert at selling clinically differentiated and disruptive technologies and premium price portfolios. This is a highly experienced and a highly motivated group that is deeply committed to ensuring that CIMVEST reaches hospitals and vascular surgeons, both civilian and military. We have complete confidence in their ability to execute our commercial strategy and drive adoption, and their expertise has been invaluable in these early stages of commercial launch. This team will continue to work closely with healthcare providers to make SimVest available to patients in need nationwide. Going beyond the trauma indication, we're also very excited about the ATEV program right behind it, which is in dialysis access. As you'll recall, in last October, our VO7 Phase III clinical trial of the ATEV in AV access for patients with end-stage renal disease were presented at the American Society of Nephrology Kidney Week. The Phase III study met its co-primary endpoints, and the ATF was observed to have superior function and patency at 6 and 12 months as compared to AV fistula, which is the current standard of care for hemodialysis patients. The ATF was also observed to have superior function in female, obese, and diabetic patients each of which is a high-risk subgroup having historically poor outcomes with AV fistula. In addition, we've already enrolled 76 patients in our VO12 Phase III clinical study, which is a trial designed to assess the usability of the ATEM for dialysis as compared to fistulas in female patients. This is the first study of its kind that's been done in females. An interim analysis is planned when the first 80 female patients reach one year of follow-up, and we're very close to this 80 patient interim enrollment target. Subject to these interim results, our plan is to submit a supplemental BLA in the second half of 2026 that includes data from the VO12 study and the VO7 study in order to add AV access for hemodialysis as an indication for the ATEF. And finally, I'll briefly discuss one of our earlier stage programs that we're also very excited about, our small diameter ATEV for the treatment of coronary artery bypass grafting, or CABG. In January, we announced our plans to file an IND application with the FDA to allow a first in human clinical testing of our small diameter 3.5 millimeter ATEV in coronary artery bypass. Our plans are based on the outcome of a recent meeting held with the FDA. including agreements that were reached with the agency on the filing of an IND. The planned IND filing is supported in part by the results of a six-month preclinical study of the small-diameter ATEV in primates, which was presented in November 2024 at the American Heart Association. In the preclinical CABG model, our small-diameter ATEV was observed to sustain patency. It recellularized with the host animal cells and it also remodeled so as to match the size of the animal's native coronary arteries. We're very pleased to be moving closer to human clinical studies of the ATEV in CABG, and we believe our IND filing and initiation of first in human study after the FDA clearance of the IND will be another major milestone for Humacyte. So 2025 will be an exciting year for all of us, and we look forward to sharing our progress with all of you as 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.