Humacyte, Inc.

Good morning, ladies and gentlemen. Welcome to the Humacyte fourth quarter and year-end 2021 results conference call. Currently, all participants are in listen-only mode. Later, we'll conduct a question-and-answer session, and instructions will be given 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. Lauren, 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 our historical experience or present expectations. Additional information concerning factors that could cause actual results to differ materially from forward-looking statements made on this call is contained in our annual report on Form 10-K for the year ended December 31st, 2021, and other filings made with the SEC when available. 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 may be accessed from the Investors 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 year-ended December 31, 2021, 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 on the inaugural Humacyte quarterly results call. As the company progresses toward commercial stage, it's our intent to expand our investor outreach and provide regular opportunities for interactive dialogue. We appreciate your attendance and we look forward to our discussion today on future quarterly calls. Humacyte has made significant progress throughout 2021, including the closing of our business combination agreement with Alpha Healthcare Acquisition Corporation and our debut on the NASDAQ, which provided us a strong foundation that we're continuing to build upon in the early part of 2022. As we progress forward, we remain focused on advancing our first-in-class regenerative medicine platform and our lead bioengineered human tissue product candidate, the Human Acellular Vessel, or HAV, towards regulatory milestones and commercialization. I'll spend just a few brief moments summarizing our recent developments before turning the call over to Dale for a review of our financials. I'll begin with our late phase 2-3 clinical trial that is evaluating HAVs in vascular trauma, which is continuing to progress. As a reminder, this trial is a single-arm, open-label, unblinded study evaluating the use of HAVs for vascular repair, reconstruction, and replacement in traumatic injury. Currently, we've enrolled a total of 50 patients, and we are pleased with the results from this study to date. showing a very low rate of infection at approximately 2%. Furthermore, we've had no reports of limb amputation that occurred as a result of HAV malfunction. And we've seen high patency rates of the conduit. Results from this trial are expected to support a filing with the FDA anticipated in 2022 or 2023. We look forward to ongoing discussions about the trial design and the number of subjects to be enrolled with the FDA. And we'll provide enrollment updates and guidance for completion of the trial when finalized. Concurrent with the advancement of our trauma trial, we've continued our strong working relationship with the Defense Department, or DOD, using HAVs to address the unmet need for repair of vascular injuries incurred by military personnel. The DOD assigned a priority designation to the HAV and has provided approximately $7 million in grant support for the continued development of our HAVs for vascular reconstruction and repair. We expect that as a result of this collaboration, if approved by the FDA, Humacyte will supply HAVs for military hospitals to treat injured soldiers and veterans, as well as supply HAVs to be stockpiled for use in areas where military personnel may be deployed. In addition to vascular trauma, we're also evaluating HAVs for arteriovenous, or AV, access in hemodialysis patients. Last month, five-year data from a Phase II clinical trial of patients receiving the HAV for access in hemodialysis were published in the journal EJVES Vascular Forum. In this trial, clinicians observed long-term usability of the HAV during the five-year follow-up period with no reports of infection or immunogenicity, thus further supporting the continued development of HAVs for hemodialysis. To that end, we're nearing the expected completion of enrollment of our Phase III trial 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. There are currently more than 210 patients enrolled in the trial, and we expect enrollment to be completed 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 later in 2023. As we progress toward commercialization, We continue to work closely with our strategic partner and major shareholder, Fresenius Medical Care, which is a leader in kidney care services, products and value-based care, and providing valuable market insights and commercial launch advantages. During 2021, we successfully deployed our commercial scale manufacturing system for the production of our HAVs. Our commercial scale system is up and running, and is producing HAVs for our ongoing clinical trials. Related to this achievement, positive results from a Phase II clinical trial in hemodialysis using HAVs that were produced in our commercial scale manufacturing system were presented in the Sixth World Congress of the Tissue Engineering and Regenerative Medicine International Society in November of last year. This presentation highlighted 12-month safety and efficacy data that were similar to those of HAVs produced in the legacy developmental scale manufacturing systems. In 2021, the FDA agreed to the use of HAVs produced in the commercial scale system to supply the company's ongoing clinical trials in the United States, thereby reinforcing our confidence in the launch readiness of our commercial scale manufacturing of HAVs. Moving on to our broader pipeline, We're making great progress on our earlier portfolio programs in other indications. HAVs are continuing to be used under an expanded access program, or EAP, which is authorized by the FDA for patients with vascular conditions including critical limb ischemia and peripheral vascular disease, or PAD. To date, we've completed more than 20 implants in the U.S. under this program. The first use of the HAV in the treatment of a patient with an infected prosthetic vascular graft was a procedure performed in 2019 under the EAP and was published in the Journal of Vascular Surgery Cases, Innovations and Techniques in December of 2021. This patient has resumed regular physical activity and has no signs of infection of the HAV. Furthermore, Outcomes of the first series of eight compassionate use cases of HAVs for trauma and critical limb ischemia were highlighted in a presentation at the 46th Annual Winter Meeting of the Vascular and Endovascular Surgical Society in January of 2022. In this high-risk group of patients having no other options for revascularization, five of the bypasses performed with the HAV currently remain functional with follow-up times ranging from 4 to 20 months, and no instances of infection of the HAV have been noted. We believe the positive results highlight the potential of the HAVs for use in vascular reconstruction and limb salvage, where few options exist. With respect to our preclinical programs, Humacyte is investigating HAVs of 3.5 mm diameter as opposed to the six millimeter diameter vessels that are used in our current clinical program. The 3.5 millimeter vessels are being studied in primate models of both coronary artery bypass grafting, or CABG, as well as pediatric heart disease. In January 2022, we presented positive results from our first preclinical study of our small diameter HAVs in CABG at the advanced therapies week. In this study, researchers observed that the HAV maintained patency and exhibited host cell regeneration in a non-human primate model that we believe is highly predictive of human outcomes, thus highlighting the potential of HAVs in CABG. In addition, results from a primate model simulating pediatric heart disease were presented at the American Heart Association Scientific Sessions in November 2021. Researchers observed that each of the HAVs remained patent throughout the study and exhibited repopulation with vascular cells. In addition, we continue to be encouraged by our efforts in developing HAVs as complex organ systems. Our biovascular pancreas, which is an HAV coated with islets and designed to deliver insulin to diabetics in a preclinical model. And these results were published in the Journal of Tissue Engineering last year. We're currently moving into large animal preclinical studies. And we look forward to updating you all on the progress of this exciting program. As we prepare for our next phase of growth and planned expansion of the HAV applications, we're pleased to welcome three surgical key opinion leaders to advisory positions as we announced in December of 2021. Doctors Alan Kipson, Luigi Pascarella, and Todd Rasmussen are experts in the fields of cardiac, vascular, and trauma surgery, respectively. We look forward to their expertise and support to guide the education and clinical advancement efforts of the HAV, as well as help identify opportunities to advance the company's early stage pipeline and platform. And finally, as part of the company's preparation for potential commercial launch of the HAV in vascular trauma and AV access in hemodialysis, market research was conducted with 60 vascular surgeons in the US. Receptivity toward adoption of the HAV was high. According to surgeons queried, approximately 80% of trauma patients requiring vascular bypass would be eligible for HAV if approved by the FDA. Reduced operative time, without an additional infection risk was perceived as being the biggest benefit of the HAV. In addition, surgeons are highly receptive to the HAV for use in AV access if approved by the FDA due to the potential for infection resistance that has been demonstrated to date and the potential of the HAV to reduce catheter exposure in prevalent dialysis patients. We believe there's substantial opportunity for HAVs to deliver value to all relevant stakeholders, especially patients. And we're excited to continue our efforts to plan for approval and commercial launch. And with that, I'll now turn it over to Dale for a review of our financial results and other business developments.