Humacyte, Inc.

Good morning, ladies and gentlemen, and welcome to the Humacyte fourth quarter and year-end 2022 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 LifeSci 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 morning and in our Form 10-K, which will be filed today and may be accessed from the Investor's Page of the Humasite website. Joining me on today's call from Humasite 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 and year ended December 31, 2022. 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 fourth quarter and year-end 2022 Financial Results and Business Update Call. Humacyte has made significant progress throughout 2022 in advancing our universally implantable, bioengineered human tissue product candidate, the HAV, or human acellular vessel. We're very close to completing enrollment in two trials of the HAV, both in vascular trauma and in arteriovenous access. and we also continue to advance our earlier stage programs. As we begin 2023, we remain focused on advancing our HAV towards regulatory milestones and commercialization, beginning with the vascular trauma indication. During this call, I will review our recent highlights and the progress of our key programs 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. We're pleased that our Phase 2-3 VO5 trial is nearing enrollment completion. We currently have a total of 63 patients who've received the HAV in the VO5 trial and an additional 17 patients who've been treated with the HAV under our humanitarian program in Ukraine, bringing the total patients treated with the HAV for traumatic injury to 80. All patient results will be included in our upcoming BLA filing with the FDA. The efficacy of the endpoint of the HAV and trauma will be based on the 30-day patency in 50 patients from the VO5 trial who suffered vascular trauma in an extremity, either the arm or the leg. The primary efficacy analysis will not include torso injuries or iatrogenic trauma, which is trauma caused by physicians, in patients who were enrolled in the VO5 trial, although data from these patients will contribute to the safety database. Currently, in the VO5 trial, 46 patients comprising the extremity injury population have been treated with the HAV. We expect to enroll approximately six additional patients to support the BLA filing. This should bring us past the target of 50 patients that was discussed with the FDA in recent meetings. we're working expeditiously to enroll the remaining six patients in VO5. In addition to the recent addition of clinical sites in Israel, we now have efforts underway to add sites in Ukraine to the VO5 trial in order to speed enrollment. We've been pleased to partner with the US FDA and map out our strategy for BLA filing and trauma. Within approximately four months after completion of the VO5 trial with the additional six patients, we plan to file a BLA for accelerated approval for an indication in vascular trauma. The targeted indication will be an accelerated approval of the HAV for arterial repair following extremity trauma when synthetic graft is not indicated and when autologous vein is not feasible. Our plans for the BLA filing, including the primary efficacy analysis, are consistent with a recent pre-BLA meeting and other meetings that we've held with the FDA over the past several months. The potential of the HAV in vascular trauma, particularly in the wartime setting, was further highlighted in a webinar that we hosted in December, featuring Ukrainian surgeons, Dr. Alexander Sokolov, Dr. Vasil Shaprinsky, and Dr. Alexander Stanko, who shared their experiences using the HAV to treat patients with wartime traumatic injuries. As I mentioned previously, 17 patients in Ukraine have now been treated with the HAV, and our Ukrainian colleagues shared a series of case studies highlighting the types of injuries they're treating with the HAV and their successful outcomes to date. As highlighted in the webinar, results have demonstrated a 30-day patency that is excellent with zero cases of infection in all the patients treated. A replay of the webinar can be found on the Investors page of the Humacyte website. In addition to the webinar, our Ukrainian colleagues also presented patient outcomes at two vascular conferences in December of last year, the Congress of Vascular Surgeons, Phlebiologists and Angiologists in Ukraine, and the Munich Vascular Conference in 2022. We extend our sincere gratitude to our colleagues for joining us for this webinar and sharing their positive experiences using the HAV for the medical community. Similar to our vascular trauma trial, Our Phase III VO7 trial of the HAV and arteriovenous access in hemodialysis patients is also nearing completion. As a reminder, the VO7 trial is designed to assess the usability of the HAV for hemodialysis in comparison to autogenous fistulas. This will be done in up to 240 patients with end-stage renal disease. We're pleased to report that, as of today, 238 patients have been enrolled in this trial, meaning that we are on track to complete enrollment with the remaining two patients very shortly. Top-line results are anticipated about one year after enrollment completion, and this is based on the one-year follow-up period that's built into the study. If successful, results from this trial will support a BLA filing for its secondary indication in dialysis access. Turning to our earlier stage programs, we're happy to provide updates on our recent progress, particularly in peripheral arterial disease, coronary artery bypass grafting, and type 1 diabetes. Results from our phase 2 trial in peripheral arterial disease, or PAD, were recently published in the Journal of Vascular Surgery, Vascular Science. This publication describes the six-year analysis of the phase 2 study. and researchers observed that HAVs provide long-term blood flow to patients with critical limb ischemia, with a secondary patency rate of 60% at six years. Importantly, there was no evidence of graft rejection or infection over this follow-up period, and no patients underwent amputation of the treated limb. We're pleased that these results highlight the long-term durability of the HAV in a relevant and a clinically complex patient population. We also continue to make progress in our preclinical coronary artery bypass grafting, or CABG, program. In November of 2022, Dr. Alan Kipson of UNC-Rex Hospital presented a six-month patency update of the HAV in a baboon CABG model at an oral presentation at the annual American Heart Association Scientific Sessions meetings. In his presentation, Dr. Kipson highlighted that the HAV maintains structural integrity and patency for up to six months post implantation as a heart bypass graft, and also showed evidence of robust host cell repopulation and remodeling. We're thrilled about the promising results of our small diameter HAVs in preclinical CABG models, and we look forward to providing additional updates on this exciting program as it continues to advance into IND-enabling preclinical study. In addition, Humacyte is happy to announce a recently funded award from the Juvenile Diabetes Research Foundation, or JDRF. JDRF is the world's largest nonprofit funder of type 1 diabetes research. Humacyte and the JDRF will collaborate on the development of Humacyte's product candidate, the biovascular pancreas, which is directed at the treatment of patients with type 1 diabetes. With that, I'll turn it over to Dale now for a review of our financial results and other business developments.