Humacyte, Inc.

Good morning, ladies and gentlemen, and welcome to HumanSafe's second quarter 2026 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 LifeSci Advisors. 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 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 HemaCite website. Joining me on today's call from HemaCite 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 on the recent weeks. Jim Mercadante will provide an update on commercial transformation and the progress with CIMBEST commercial launch. And 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. And then I'll turn the call over to Jim Mercadante for a review of our commercial progress for our Symbest 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 Symbeth, completion of our VO12 phase 3 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'm happy to report that our second quarter and recent weeks were a transformative period for Humacyte across all of these fronts. And with that, let's begin. In June, we presented breakthrough top-line interim results from our VO-12 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 .0007, thereby meeting the primary efficacy endpoint of the study. And consistent with our expectations for ATEV and hemodialysis, infections of catheters and surgical access wounds were also less common. There were six 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 VO-12 study are a breakthrough for women who have historically been left behind by the fistula procedure, which leaving many women being forced to rely on infection-prone Plastic Catheters, and Graffs. Combined with results from the VO7 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. And to help prepare for that planned commercialization and dialysis access, We have appointed Robert Kosman, MD, and Prabir Roy Chowdhury, MD, PhD, as advisors to Humacyte. Dr. Kosman previously served as executive vice president and the chief medical officer for Fresenius Medical Care North America. Dr. Roy Chowdhury 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 a first in human clinical study of CTEV in coronary artery bypass grafting, or CABG. As you'll 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 five 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, and 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 CTEV in our commercial-scale production facilities, and we plan to initiate the Phase IIa study of CTEV in CABG patients during the current quarter. and with that, I'll now turn it over to Jim for an update on our progress with the global CINVEST commercialization.