Humacyte, Inc.

Good morning, ladies and gentlemen, and welcome to the Humacyte first quarter 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. If anyone should need operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference call is being recorded. I will now turn the call over to Lauren Merrick with FlightSci 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. Any 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 will be filed today and may be accessed from the Investors page of the Humasite 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 before turning it over to Dale for a review of the company's financial results. 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. We appreciate your attendance today. I'll just briefly summarize our recent highlights before turning the call over to Dale for a review of the financials for our first quarter. Then we'll be happy to open up the call to your questions. I'm pleased to report that we had a productive first quarter marked by continued progress advancing our universally implantable bioengineered human tissue platform. We believe our lead candidate, the HAV, is uniquely suited for scenarios in which the current standard of care is either unavailable or is inadequate. This week, we were proud to announce a new initiative in which we are providing our HAVs to frontline hospitals in Ukraine. for the treatment of military and civilian vascular trauma injuries that are resulting from the crisis in the region. During the quarter, we also strengthened our team with the appointment of Dr. Shameek Parikh as our chief medical officer. Dr. Parikh joins us at a pivotal time as we look forward to anticipated completion of our late stage clinical trials in vascular trauma and arteriovenous access for hemodialysis. And if approved, as we endeavor to bring the HAV to market for our initial indication. I'll first begin with our announcement earlier this week of a new initiative to provide our HAVs to multiple hospitals in Ukraine for the treatment of wounded civilians and soldiers who are suffering from vascular traumatic injury. This initiative began as a request from one Ukrainian surgeon who was familiar with our technology and requests from the Ukraine quickly grew to include other surgeons and hospitals around the country. Six hospitals in Kiev, Kharkiv, and other cities will be the recipients of our initial shipment. We continue to receive requests from local surgeons for the product candidate, and we plan to coordinate shipments to additional hospital sites as soon as possible. In launching this initiative, Humacyte worked with the Office of International Programs within the US Food and Drug Administration as well as with the Ukraine Ministry of Health to coordinate the export and import of our investigational HAV for humanitarian use. While this humanitarian effort is outside the scope of the company's ongoing trauma trial, we expect that this program will provide additional real-world evidence of the potential impact of the HAV in the treatment of vascular traumatic injuries. As a company, Humacyte is very proud to contribute to the ongoing medical relief efforts in Ukraine and to support the patients and the brave medical practitioners on the ground during this humanitarian crisis. I'm immensely grateful to the Humacyte team for their tireless work seeing this through, as well as to the surgeons in Poland and in the U.S. who have extensive experience with the HAV and who have volunteered to assist in training the Ukrainian surgeons in the use of the product Candidate. Moving on to our broader platform for HAV and vascular trauma, our Phase 2-3 clinical trial is continuing to progress. As a reminder, this trial is a single-arm, non-randomized, open-label study evaluating the use of HAVs for vascular repair, reconstruction, and replacement in traumatic injury settings. We're pleased with the results from this study to date, showing low rates of infection at approximately 2%. We've also had no reports of limb amputation that occurred as a result of HAV malfunction, and we've observed very high patency of the conduit to date. Results from the trial are expected later this year, and we believe these results will support our planned BLA filing with the FDA, which we intend to submit by the end of 2022 or early 2023. We continue to progress in our discussions with the FDA about the trial design and the required number of subjects to be enrolled. You'll recall that the FDA has granted accelerated approval pathway for HAVs in this indication. The HAV was the subject of multiple presentations at scientific conferences and journal publications during the first quarter. Results from a case study of a patient who received the HAV as a replacement for a synthetic infected iliofemoral bypass grafts were published in the Journal of Vascular Surgery, Cases, Innovations, and Techniques. In this case, at 22 months post-implantation, the patient had resumed regular physical activity and had no signs of infection of the HAV implant. In a first U.S. case series that was published, surgeons from the Uniformed Services University of the Health Sciences and Walter Reed National Medical Center reported on the first eight FDA-approved expanded access cases using the HAV for treatment of critical limb ischemia or vascular trauma. In this case series, the HAV was observed to resist infection and to provide reliable patency and also offered surgeons an immediately available biological conduit. The report of this case series was published last month in the April edition of the Annals of Vascular Surgery. And finally, we're looking forward to the planned presentation of new HAV clinical immunogenicity data, reporting on blood work from patients who have received the HAV during a presentation at the American Transplant Congress that will be taking place in June of 2022 in Boston. The presentation will be delivered during the Bioengineering and Transplantation Where Are We and Where Are We Going session on June 8th at 7 a.m. Eastern Time. This talk will provide quantitative insights into the patient responses and tolerance of the HAV when implanted in various clinical indications. Turning now to our development program of HAVs for arteriovenous or AV access in hemodialysis patients. Enrollment in our Phase III trial is nearing completion. This trial is designed to assess the usability of the HAV for dialysis in comparison to autogenous fistulas in up to 240 patients with end-stage renal disease. We expect enrollment to be completed later this year. Based on the one-year follow-up period built into the study, we anticipate top-line results in 2023, followed by a BLA filing for the dialysis indication. Five-year data from a Phase II clinical trial of patients receiving the HAV for dialysis access were published in the journal EJVES Vascular Forum. Results showed long-term durability and usability of the HAV during the five-year follow-up period with no reports of infection or immunogenicity. As we progress toward commercialization, we look forward to building upon our strong relationship with our global partner and shareholder, Fresenius Medical Care. Fresenius is the global leader in kidney care services, products, and value-based care, and is also providing valuable market insights and commercial launch advantages. We're partnering with Phrenova, a clinical research group owned by Fresenius, to evaluate the costs of hemodialysis access care for vulnerable patients in both the U.S. and Europe. These evaluations will assist us with development of health economic models and value propositions for the HAV in patients with kidney failure. Finally, we're also continuing to make progress in our earlier portfolio programs and other indications. The expanded access program for HAVs in patients with emergency vascular conditions, such as severe peripheral arterial disease, continues to progress. To date, we've implanted roughly 20 patients in the U.S. under this program. And the outcomes of the first eight cases were highlighted in a presentation in January. In addition, enrollment of patients in the Mayo Clinic's investigator-sponsored study of HAVs for the treatment of severe PAD is advancing, and we anticipate providing an update on this study later this year. With respect to our preclinical programs, in January we presented positive results from our first preclinical study of our small diameter HAVs for use in coronary artery bypass grafting, or CABG. This presentation was at the Advanced Therapies Week in January. In this study, the HAV was observed to maintain patency and exhibited host remodeling as well as regeneration in a non-human primate model, thus highlighting the potential use of HAVs in coronary artery bypass grafting. In addition, we continue to be encouraged by our efforts in developing HAVs as complex organ systems. Our biovascular pancreas, or BVP, is an HAV that is coated with islets and designed to deliver insulin to type 1 diabetics. BVP results in a diabetic rodent model were published last year in the Journal of Tissue Engineering. And we're currently moving forward into large animal preclinical studies of this exciting program. As far as other corporate updates, as I mentioned earlier, Last month, we were pleased to announce the appointment of Shameek J. Parikh, MD, as our Chief Medical Officer. In his new role, Dr. Parikh will lead our global clinical development strategy, including oversight of the preclinical and clinical development, clinical operations, and medical affairs functions. Dr. Parikh brings to us more than two decades of leadership experience in academia, the NIH, and at global pharmaceutical companies, including his 16-year tenure at AstraZeneca. Dr. Parikh has led clinical research and development, product launches, medical affairs, and drug safety across multiple therapeutic areas. We're very pleased to have Dr. Parikh with us, and we're looking forward to adding his insights and expertise to the Humacyte team. And with that, I'll turn it over now to Dale for a review of our financial results and for other business developments.