Humacyte, Inc.

Good morning, ladies and gentlemen, and welcome to the Humacyte first quarter 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 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 morning and in our Form 10-Q, which, after filing, may be accessed from the Investor's page of the HumaCite website. Joining me on today's call from HumaCite 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 March 31, 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 first quarter 2023 financial results and business update call. This quarter was highly productive for Humacyte as we continued to advance our universally implantable bioengineered human tissue product candidate, or the human acellular vessel, or HAV, in multiple indications. We completed enrollment of our Phase III HAV trial in arteriovenous access in late March, and we're very close to completing enrollment of our Phase III trial in vascular trauma. We also recently received the Regenerative Medicine Advanced Therapy designation from the FDA for the HAV in arterial repair following extremity vascular trauma. This makes the second indication for which the HAV has received the RMAT designation from the FDA. In addition, we continue to add to the growing body of scientific publications highlighting the clinical potential of the HAV. And lastly, we recently announced our collaboration with the Juvenile Diabetes Research Foundation, or JDRF, to advance our biovascular pancreas product candidates. During this 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 up the call for your questions. I'll begin with our HAV program in vascular trauma. We're excited to have recently received the FDA's Regenerative Medicine Advanced Therapy, or RMAT, designation for the HAV for urgent arterial repair following extremity vascular trauma. This is Humacyte's second RMAT designation for the HAV, the first being for arteriovenous access for hemodialysis. With the RMAT designation in extremity vascular trauma, as well as our previously received priority designation from the Defense Department, we anticipate a higher potential for priority review of our planned BLA filing in the trauma indication. Regarding our Phase 2.3 VO5 trial in vascular trauma, were very close to enrollment completion. As you may recall from our discussion last quarter, the efficacy endpoint of the HAV in the VO5 trial will be based on 30-day patency in 50 patients who suffered vascular trauma of an extremity, either the arm or the leg. To date, we currently have a total of 66 patients who have received the HAV in the VO5 trial, 49 of which comprise the primary endpoint population. of extremity injuries. We plan to file a BLA with the FDA later in 2023 after we have enrolled 50 or more patients with extremity injuries. This BLA will be for the treatment of extremity vascular trauma when synthetic graft is not indicated and when autologous vein is not feasible. We believe that our plans for the BLA filing, including the primary efficacy analysis in extremity patients, are consistent with a pre-BLA meeting and with other discussions that we've had with the FDA over the past several months. The potential of the HAV in vascular trauma was further highlighted in two recent peer-reviewed publications. In April of 2023, a preclinical study of the HAV compared ePTFE grafts, which are Teflon grafts, in vascular repair following arterial trauma in a porcine model. that was published in the Journal of Trauma and Acute Care Surgery. Results from this study suggested that the HAV is potentially superior to PTFE across multiple metrics, including recovery of limb function after prolonged ischemia, conduit patency, and host resellularization. Importantly, the HAV showed no evidence of infection, degradation, aneurysm, or mechanical failure in the study. In addition, as announced earlier this week, a letter describing the use of the HAV to treat battlefield and other vascular trauma injuries in Ukraine was published in the Lancet Regional Health Europe. This publication describes how Ukrainian surgeons are using the HAV to save life and limb in a wartime setting and also reports clinical outcomes of the first nine patients treated with the HAV in Ukraine. Since June of 2022, a total of 19 patients have been treated with the HAV under our humanitarian program, with most patients sustaining vascular injuries from blasts and shrapnel, and with overall excellent outcomes to date. We continue to be grateful to our Ukrainian colleagues and to all of those involved in the humanitarian program for their support, and we're proud to help these medical professionals save lives during this conflict. Turning now to our trial of the HAV in arteriovenous access in hemodialysis patients, we recently announced completion of enrollment of our Phase III VO7 trial. We're pleased to have reached this milestone that brings us closer to a planned BLA filing in this indication. As a reminder, the VO7 trial is designed to compare the HAV to an arteriovenous fistula in 240 hemodialysis patients suffering from end-stage renal disease. This trial will evaluate the usability of the conduit for dialysis during the first year, with top-line results that are anticipated to be available in 2024. Finally, we're happy to announce our collaboration with the Juvenile Diabetes Research Foundation, or JDRF, which is the world's largest nonprofit funder of type 1 diabetes research. Humacyte and the JDRF will collaborate on the development of Humacyte's biovascular pancreas, or BVP, which is our product candidate for the treatment of patients with type 1 diabetes. The BVP is designed to enable the delivery and survival of insulin-producing islets using the HAV as the carrier for delivery into the patient. We believe that the BVP has the potential to transform the treatment of type 1 diabetes And we're thrilled to have JDRF support in advancing this technology. And with that, I'll now turn it over to Dale for a review of our financial results and other business developments.