Humacyte, Inc.

Good afternoon, ladies and gentlemen, and welcome to the UMassite third quarter results conference call. Currently, all participants are in a listen-only mode. Later, we will conduct a question and answer session, and instructions will follow at that time. As a reminder, this conference call is being recorded. I will now turn the call over to Lauren Merrick with Lifesize 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 law. 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 afternoon and in our form 10-Q, which after filing may be accessed from the investor's page of the Humacyte website. Joining me on today's call from Humacyte 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 quarter and recent weeks, and Dale will review the company's financial results for the quarter ended September 30th, 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 afternoon, everyone, and thank you for joining us for our third quarter 2023 financial results and business update call. Our third quarter was a highly productive period for Humacyte, during which we achieved significant milestones in the advancement of our universally implantable, bioengineered human tissue product candidate, the human acellular vessel, or HAV. And we've worked on this in multiple indications. This was led by our announcement in September, of positive top-line results from our Phase 2-3 clinical trial in vascular trauma repair, which positions us to submit our BLA filing for approval in this indication during the current quarter. We're also pleased that the potential of our HAV pipeline has been shown in other clinical studies this quarter, including the presentation of Phase 2 results in severe peripheral artery disease, or PAD. In addition, we recently published preclinical results of our small caliber HAV in a juvenile heart disease model. During today's call, I'll review these recent highlights in more detail before turning the call over to Dale for a review of our financial results. Then we'll be happy to open the call to your questions. I'll begin with our HAV program in vascular trauma and the positive top line results that we announced from our VOO5 Phase 2-3 clinical trial of the HAV and trauma repair. In this clinical trial, the HAV had higher rates of patency and lower rates of amputation and infection as compared to historical published benchmarks of synthetic graft function in trauma patients. A total of 69 patients were enrolled in the VOO5 trial, and 51 of these had vascular injury of the extremities, and comprised the primary evaluation group for the study. The 30-day patency or presence of blood flow for the HAV in the clinical trial was 90% as compared to approximately 81% historically reported for synthetic grafts. Importantly, the HAV also demonstrated lower amputation rates with a rate of 9.8% for the HAV as compared to over 20% being reported historically for synthetic grafts. This means that for a vascular trauma patient receiving the HAV, the chances of amputation are less than half of the chances associated with receiving a synthetic graft. It's also important to note that in the VO5 trial, there were no amputations that occurred because of failure of the HAV. All of the amputations occurred because of severe injuries to the limb and not due to loss of blood flow from the HAV implant. The HAV also demonstrated lower rates of infection, with an infection rate of 2% compared to over 8% historically reported for synthetic grafts. In other words, patients receiving the HAV in this trial were less than half as likely to suffer an amputation and one-fourth as likely to have an infection of their graft. as patients who historically got synthetic grafts for their injuries. Building on the momentum of these positive results, we plan to submit a biologics licensing application, or BLA, with the FDA during this quarter. In May of this year, Humacyte received a Regenerative Medicine Advanced Therapy, or RMAT, designation from the FDA, which will allow us to request a priority review of our BLA filing. Since we've also received priority designation from the Department of Defense, we believe that we'll have a high potential for priority review of our planned BLA filing and the trauma indication. Further buttressing the real-world utility of the HAV in treating injured patients, hemocytes vessels have been used in Ukraine under a humanitarian aid program. During the one-year humanitarian effort, 19 vascular trauma patients received the HAV in Ukraine. Results will also be highlighted from these patients in our BLA filing with the FDA. Outcomes from these 19 patients were described in a presentation at the 2023 Military Health Systems Research Symposium in August, with clinicians reporting a very high success rate in treating these patients with the HAV to date. In war-wounded patients in Ukraine who suffered blast and shrapnel injuries that were often severe, both 30-day limb salvage and 30-day patient survival were 100%. 30-day patency or blood flow was 95%, and there were no reported instances of infection of the HAV. We believe that these remarkable results are an important addition to our BLA filings. and we're proud to be able to help our Ukrainian surgeon colleagues save life and limb in this wartime setting. Humacyte and our collaborators expect to make multiple presentations at the Vieth Symposium, which is a major vascular surgery meeting in New York next week. These include an expanded presentation of the results of our V005 vascular trauma trial and also the outcome of research, which seeks to identify which dialysis patients experienced the most difficulties with their dialysis access and which patients may benefit from an access that is both durable and resists infection. In September, clinical results were also presented on an FDA-regulated investigator-sponsored clinical study at the Mayo Clinic. In this study, patients with severe peripheral arterial disease who faced possible limb amputation and who had no vein of their own for bypass surgery were treated with the HAV to restore blood flow to their limb. In the presentation at the Midwestern Vascular Conference, Mayo researchers observed that the HAV was a safe, resilient, and effective conduit for arterial bypass and limb salvage. This is an important result since approximately 40% of patients requiring lower extremity bypass do not have saphenous vein available. In the future, the HAV may represent a promising alternative for preserving limbs in patients with advanced peripheral artery disease. 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, which is a heart condition, that affects one in every 2,000 babies born each year. In this large animal study, Humacyte collaborated with researchers from Nationwide Children's Hospital in Columbus, Ohio, to implant 3.5 millimeter HAVs into a juvenile model of pediatric heart surgery. The 3.5 millimeter HAVs remained patent for up to six months and showed evidence of repopulation by host cells which was similar to what's been observed in human patients. This study also demonstrated the extension of Humacyte's manufacturing platform, adding production of 3.5 millimeter vessels in the same platform that is used to produce Humacyte's 6 millimeter HAVs, which are the ones that are in current clinical use. In July, results from a preclinical study on the ability of the HAV to resist infection were published in the Journal of Vascular Surgery, Vascular Science. This study provides a scientific basis for the low rates of infection that we've observed in clinical trials of the HAV to date. Researchers found that compared to synthetic grafts, the HAV had a significantly lower bacterial infection rate. This infection resistance of the HAV may be due to the native-like biocompatibility of the HAV material. which supports the survival and function of human immune cells that are the key to fighting bacterial infection. These results have broad implications for all of our intended clinical indications and further support the potential of the HAV as an excellent alternative to 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.