Humacyte, Inc.

Good morning, ladies and gentlemen, and welcome to the Humacyte 2023 fourth quarter near-end 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 Lauren Merrick with Lifestyle Advisors. Please go ahead.

Thank you, Operator. Before we proceed 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-K, which, after filing, may be accessed from the investor's 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 Dr. Heather Pritchard, Chief Operating Officer. Dr. Nicholson will provide a summary of the company's progress during the year and recent weeks, and Dale will review the company's financial results for the quarter and year ended December 31st, 2023. Following their prepared remarks, the management team will be available for your questions. I will now turn the call over to Dr. Nicholson.

Thank you, Lauren. Good morning, everyone, and thank you for joining us for our 2023 financial results and business update call. Our fourth quarter and the start of 2024 have been highly productive for Humacyte. Importantly, Humacyte completed submission of our BLA in December, and the FDA accepted our biologics license application for the HAV in the vascular trauma indication in February of this year. Over the course of 2023, We also made progress on our broader HAV pipeline, including the completion of enrollment of our phase three trial in dialysis access, presentation and publication of clinical trial results in peripheral arterial disease, and publication of preclinical results for our small caliber HAV in a juvenile heart model. 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. Then we'll be happy to open up the call to your questions. I'll begin with our HAV program in vascular trauma. In December 2023, we submitted our BLA to the FDA. This was supported by a robust data package that included positive results from our VO5 Phase 2-3 clinical trial. The BLA package also included real-world evidence from the treatment of wartime injuries in Ukraine under the humanitarian aid program that was supported by the FDA. Our data package showed that the HAV had higher rates of patency and lower rates of amputation and infection as compared to historic synthetic graft benchmarks. In the two trials combined, the 30-day patency or presence of blood flow for the HAV was 91.5% for extremity patients compared to 78.9% historically reported for synthetic grafts. The HAV also demonstrated lower amputation rates with a rate of 4.5% as compared to 24.3% for synthetic grafts. And furthermore, the HAV had lower infection rates at 30 days with a rate of 0.9% as compared to 8.4% historically for synthetic grafts. In other words, patients treated with the HAV were only 40% as likely to lose blood flow through their conduit after one month, which is a key period for recovery after traumatic injury. HAV patients were also only 1 5th as likely to suffer an amputation and only 1 9th as likely to have an infection of their graft as compared to patients who were treated with a synthetic graft. These results were also provided in November at multiple presentations at the Wyss Symposium, which is a major vascular surgery meeting held in New York. In February of 2024, the FDA accepted our BLA in vascular trauma, also granting priority review and establishing a Prescription Drug User Fee Act, or PDUFA, goal date for action of August 10, 2024. The FDA's decision to grant priority review aligns with their prior grant of a Regenerative Medicine Advanced Therapy, or RMAT, designation for the HAV for urgent arterial repair. We believe this also reflects their recognition that many patients with severe injuries are underserved by the current standards of care. Priority review is also consistent with the priority designation that was given by the Secretary of Defense under a law enacted to expedite the FDA's review of products that are intended to diagnose, treat or prevent serious life-threatening conditions that are facing American military personnel. The BLA acceptance brings us another step closer to our goal of providing an innovative regenerative medicine product for patients who are suffering traumatic vascular injury. Based on the strength of the data package from our V05 trial in vascular trauma, combined with data from the humanitarian experience in Ukraine, we look forward to the PDUFA date with confidence. In preparation for an anticipated FDA approval, Humacyte is also working to build up the commercial team as part of our go-to-market strategy. Health economic models have been developed, which are derived from large national databases of traumatic injury care in the U.S. Based upon historical results for synthetic graft outcomes, it's clear that the HAV can provide important health benefits as well as important economic benefits for the healthcare system. Costs of conduit infection, sepsis, and amputation are extremely high, adding tens or even hundreds of thousands of dollars to the costs of trauma care. Avoidance of these costly complications will, we believe, help to drive market uptake of this revolutionary product candidate in the care of traumatically injured patients. Turning now to our program in peripheral artery disease, in the fall, results were presented from an FDA-regulated and investigator-sponsored clinical study that's being conducted at the Mayo Clinic of the HAV in patients with chronic limb-threatening ischemia, which is the end stage of PAD. Most patients treated as part of the program required bypass surgery below the knee, which is a type of disease that is typically not well treated with stents and angioplasty procedures. Treated patients did not have suitable vein of their own to perform a needed bypass procedure and so received the HAV to revascularize their critically ischemic lower limbs. In presentations at the Wyss Symposium and at the Midwestern Vascular Conference, researchers observed that in the clinical study, the HAV was a safe, resilient, and effective conduit for arterial bypass and limb salvage. in patients who did not have vein to provide a conduit to restore blood flow. This is an important result since approximately 40% of patients requiring lower extremity bypass do not have saphenous vein available for revascularization. With regard to publications, in October of 2023, a publication in the Journal of Thoracic and Cardiovascular Surgery described a preclinical study showing the potential for the investigational small diameter HAV to treat Tetralogy of Fallot. This is a heart condition that affects one in every 2,000 babies born in the U.S. each year. In this preclinical study, researchers from Nationwide Children's Hospital in Columbus, Ohio implanted 3.5 millimeter diameter HAVs into a juvenile large animal model of pediatric heart disease. In long-term follow-up in these animals, the 3.5 millimeter HAVs remained patent for up to six months and showed evidence of cellular repopulation by host cells, which is similar to what's been observed in human patients. The pediatric heart study also demonstrated the extension of Humacyte's manufacturing platform, adding the 3.5 millimeter vessels to the 6 millimeter vessels that have been manufactured for more than a decade. As a reminder, our 3.5-millimeter vessels are currently being evaluated in IND-enabling preclinical studies in large animals to support future advancement of the HAV into human clinical trials in coronary artery bypass. We've previously reported excellent long-term six-month results in coronary artery bypass in large animals, and cardiac implantations are continuing this year as we gather data in support of an IND filing in heart bypass surgery. In July, results of a preclinical study were also published in the Journal of Vascular Surgery, Vascular Science. This study provides a scientific basis for the low rates of infection that have been observed in our clinical trials of the HAV. Researchers found that, compared to synthetic grafts, the HAV had a significantly lower bacterial infection rate. The infection resistance may be due to the HAV's native-like tissue structure that supports superior compatibility with the body's own immune cells. These results have broad implications for all of our intended HAV indications and further support the HAV's potential as a solution to the limitations of synthetic grafts in a wide range of medical conditions. And with that, I'll now turn it over to Dale for a review of our financial results and other business developments.