Humacyte, Inc.

Good morning, ladies and gentlemen, and welcome to Humacyte fourth quarter and full year 2025 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 LifeSite Advisors. Please go ahead.

Thank you, Operator. Before we proceed with the call, I'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 historical experience or present expectations. Additional information concerning factors that could cause actual results to differ from statements made in this call is contained in our periodic reports filed with the SEC. Forward-looking statements made during this call speak only as of the date hereof, and the company undertakes no obligation to update or revise these forward-looking statements except as required by law. Information presented on this call is contained in the press releases issued this morning and in our Form 10-K, which after filing may be accessed from the investor page of the HumaCite website. Joining me on today's call from HumaCite are Dr. Laura Nicholson, President and Chief Executive Officer, and Dale Sander, Chief Financial Officer. and Chief Development Officer. Dr. Nicholson will provide a summary of the company's progress for the fourth quarter and in recent weeks, and Dale will review the financial results for the quarter and year end of December 31, 2025. I will now turn the call over to Dr. Nicholson. Laura?

Thank you, Tom. Good morning, everyone, and thank you for joining us for our 2025 fourth quarter and year financial results and business update call. I'm pleased to report that our fourth quarter and recent weeks have been a productive period for Humacyte with continued execution of our commercial program for Symbeth and the advancement of other bioengineered vessel programs. During today's call, I'll review progress across our commercial and development program before turning the call over to Dale for a review of our financial results for the year. I'll begin with the commercial launch of Symbeth. We continue to execute our U.S. market launch of Symbeth, and in parallel, we've taken major steps to expand the commercialization of the product into international markets. To date, there are a total of 27 VAC approvals for Symbeth in the U.S., and furthermore, an additional 43 VAC committees are currently conducting their review process. Our rate of success with VAC submissions is roughly 70%, which is a good success rate. To date, 27 hospitals have ordered SimVest, with the majority of these hospitals placing reorders. Fourth quarter product sales were $0.4 million for the quarter and $1.4 million for the year. We're pleased that the U.S. Defense Department has dedicated funding for evaluation and incorporation of new biologic vascular repair technologies. In appropriating the funding, the lawmakers demonstrated that they recognize and understand the need for human-derived bioengineered blood vessels to save life and limb in the battlefield. We believe this historic, first-of-its-kind federal investment will help ensure that our soldiers continue to have access to cutting-edge treatments and state-of-the-art care wherever and whenever they need it. We look forward to working with leaders in our military and in the DoD to ensure that the American service personnel will have access to this groundbreaking technology. Internationally, interest in CIMVIS has been highlighted by two recent announcements. Early this month, we received a $1.475 million purchase commitment that will facilitate the clinical evaluation and outreach program in hospitals within the Kingdom of Saudi Arabia. The planned clinical evaluation program is going to be conducted in parallel with ongoing negotiations with a kingdom-based entity for establishment of a joint venture and a license to commercialize SimVest within country. Also, in March, we submitted a marketing authorization application, or MAA, with the Israeli Ministry of Health for SimVest for arterial trauma repair. In response to surgeon requests, we're also pursuing a mechanism for making SimVest available in Israel on a hospital-by-hospital basis, even in advance of MAA approval. Commercial adoption of CINVEST was further supported by publication of several important papers, including long-term safety data from our V005 Phase 2-3 trial in the Journal of Vascular Surgery Cases, Innovations, and Techniques. These data were also presented last January by Dr. Michael Currie of the New Jersey Medical School. at the annual winter meeting of the Vascular and Endovascular Surgery Society. Among those treated in the VOO5 study were 54 patients who underwent extremity vascular repair with Simvest, for whom treatment with autologous vein, which is the standard of care, was not feasible. Within this patient population, once early complications from the traumatic injuries resolved, the rates of conduit infection, limb salvage, and patient survival plateaued, and remained relatively constant through the three years of follow-up. StimVest maintained an infection-free rate of 92.9% from months three to 36 with no infections after day 37. Limb salvage rates were 87.3% at 12 months and 82.5% at 24 months, despite a severely injured trauma cohort. Long-term mechanical durability was also demonstrated during the VO5 study, with SimVest diameters maintained constant over three years of follow-up. And importantly, no deaths or amputations or mechanical failures were attributed to SimVest in this high-risk trauma population. There were no evidence of spontaneous ruptures or structural failures in any patient throughout the follow-up period. These outcomes point to the potential of SimVest to provide meaningful benefits for patients who are facing life or limb-threatening injury where autologous reconstruction is not an option. In addition, durability data in the military trauma setting was highlighted in an October 2025 publication in Oxford Academics Military Medicine, which describes positive long-term results from a humanitarian program using SimVest to treat wartime vascular injuries in Ukraine. The publication reported on 17 trauma patients with wartime extremity injuries. who were treated with SimVest and were followed for up to 18 months. These wartime patients were observed to have a high SimVest patency rate of 87.1% and also 100% limb salvage, showing the durability of SimVest in treatment of real-world combat injuries. Also in October, a new study comparing the clinical outcomes of SimVest to autologous vein in the treatment of extremity arterial trauma was published in the American Association for the Surgery of Trauma, or the AAST, Trauma Surgery and Acute Care Open Journal. This study showed that in comparison to trauma registry pre-existing patients who were treated with autologous vein, the patients who were treated with CIMVES experienced similar short-term outcomes for patency and limb salvage and infection. In fact, there were no significant differences for any of these outcomes. between patients who were treated with CIMBES and the prior registry patients who had been treated with autologous pain. I'll now turn to our program, which is our next priority, which is dialysis access. As we reported last quarter, positive two-year results from the VO7 Phase III trial of the ATEV and dialysis patients were presented at the American Society of Nephrology's Kidney Week. The ATEV demonstrated superior duration of use over 24 months compared to the gold standard autogenous fistula, particularly in high-need subgroups having historically poor outcomes with AV fistula procedures. In particular, women who received ATEV for dialysis access had approximately six additional months of usability of the access as compared to fistula. This is a dramatic and significantly longer duration of ATEV use over two years in female patients. And this observation could greatly reduce the reliance on catheters for dialysis access for these patients. Catheters are a major cause of complications, morbidity, and cost for dialysis patients, especially women in the US, where nearly 30% rely on catheters for dialysis. The complications from dialysis catheters result in excess costs of tens of thousands of dollars per year per patient. Indeed, the catheter use nationwide in the US has been rising for both men and women since 2019. Women and men with obesity and diabetes make up more than half of the dialysis access market and are historically underserved by fistulas, which often fail to mature or become usable in these patients. It's been known for decades that women suffer lower rates of fistula maturation than do men. as evidenced by the fact that only 50% of women dialyze with a fistula nationwide, compared to more than 60% of men. However, a chronic lack of better access options has limited progress for these high-risk and expensive patients. We believe that the efficacy and safety results in these high unmet need groups, combined with the approximately 50% failure rate of fistulas, makes women and high-risk men a potentially important population for treatment with ATEP. We're nearing an exciting milestone, and we're currently working to complete a pre-specified interim analysis of our ongoing V12 Phase III trial that is being conducted in women specifically. The V12 trial compares the ATEV to fistula for hemodialysis access in female patients. A total of 116 patients have been enrolled to date in the trial. The planned interim analysis will be conducted when the first 80 patients reach one year of follow-up. and the top line interim results will be reported by early June, 2026. Subject to these interim results, our plan is to submit a supplemental BLA in the second half of 2026, which will include data from VO12 and the VO7 phase three pivotal study to add dialysis, which is a major market, as an indication for the ATEP. And finally, I'll briefly discuss one of our earlier stage programs that we're also very excited about. our coronary tissue engineered vessel, or CTEV, for use in coronary artery bypass grafting. Positive results of a preclinical study evaluating the CTEV as a coronary artery bypass graft in a non-human primate model were published in September of 2025. In that study, the CTEV was observed to sustain blood flow, recellularize with the animal cell, and remodel to bring the diameter of the CTEV in line with the animal's native coronary artery. We're on track with our plan to advance CTEV into first in human use in coronary artery bypass grafting later in 2026. We submitted an investigational new drug application to the FDA for this indication late last year in the fourth quarter. To support this plan study, we initiated the first large-scale manufacturing of CTEV in our commercial-scale manufacturing facility. We plan to commence the first in human phase 1-2 study in coronary artery bypass in the second half of 2026 upon completion of manufacturing and clearance by the FDA.