Humacyte, Inc. Common Stock 2026 Q2 Earnings Call

Please go ahead. 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. 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.

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 second quarter 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 June 30, 2026. With that, I'll now turn the call over to Dr. Niklason.

Laura? 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. 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 June 30th.

As a reminder, our goals for 2026 include the advancing of the U.S. and global commercial launch of SYMVESS, completion of our V012 Phase III pivotal trial of our ATEV in dialysis access, and 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 second quarter and recent weeks were a transformative period for Humacyte across all of these fronts. With that, 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.

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. 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.

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 second half 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.

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 our 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. There have been no new off-the-shelf conduits that have been prospectively tested in CABG in the U.S.

in at least the last 40 years, 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 will now turn it over to Jim for an update on our progress with the global SYMVESS commercialization.

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 SYMVESS, designed to drive product adoption by hospitals, expand product usage, and to strengthen the site 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 have 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 second half of 2026, results are beginning to materialize with influential hospitals adopting SYMVESS and utilization is increasing.

Surgeon feedback on patient use cases has been excellent. 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 acute injury repair was accepted for review by the Israel Ministry of Health in April of 2026. The Ministry set 180-day working period for the MAA through 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 corporation of biological vascular repair for the war fighters suffering traumatic vascular injuries. We are continuing to work with leaders in the military and Pentagon to ensure appropriate access to SYMVESS 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. 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 second quarter results.