Humacyte, Inc.

Good morning, ladies and gentlemen, and welcome to the UMass site third 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. As a reminder, this conference call is being recorded. I will now turn the call over to Lauren Merrick with the 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-Q, which will be filed today and may be accessed from the investor's page of the HemaCite website. Joining me on today's call from HemaCite 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. 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 our third quarter 2022 financial results and business update call. During this call, I'll review our recent highlights and our progress in our key program before turning the call over to Dale for a review of our financial results. Then we'll be happy to open the call up to your questions. We had an exciting third quarter in advancing our bioengineered human tissue platform, which produces the human acellular vessel, or HAV. We completed a productive meeting with the FDA in October for our arterial trauma indication. Also in our pipeline, we initiated an important partnership to facilitate the development of our type 1 diabetes HAV product candidate. We've also strengthened our board of directors and our leadership team with the respective appointments of Lieutenant General Bruce Green and Dr. Cindy Kao. who bring significant experience in public health, drug and biotechnology development that will be invaluable as we move closer to our goal of bringing the HAV to market. I'll begin with an important update on our late stage program for the HAV in arterial trauma. The FDA has previously indicated that the HAV for the indication of vascular trauma qualifies for the accelerated approval pathway. we're pleased to report that we completed a meeting with the FDA in late October. Discussions in the meeting were productive and they focused on a statistical plan that incorporates data from our current ongoing VO5 clinical trial and from patients who we have treated in Ukraine. The discussions during this meeting inform our plan to file the BLA for the trauma indication in mid 2023. Our VO5 Phase 2-3 trial, which is a single-arm study evaluating the use of the HAV in trauma injury settings, currently has 56 patients enrolled, and the results of these patients were shared with the agency at our recent meeting. In addition to the VO5 patients, we've treated nine patients to date in Ukraine with the HAV, and the results of these implants were also shared with the agency. We're continuing to work with the FDA on the complete data package that will be necessary for filing the BLA. Previously, we've guided the market to an expectation of approximately 75 total patients as being needed in order to support a BLA filing in vascular trauma. Including patients from Ukraine and from DO5, that guidance of around 75 total patients remains our current estimate. Importantly, we're also submitting a clinical trial application to Ukraine in preparation for planned addition of Ukrainian sites into the VO5 trial. We continue to be encouraged with our results to date in vascular trauma, which show high rates of patency, a low rate of amputation, and only one case of HAV infection within the VO5 trial. We look forward to continued collaboration and dialogue with the FDA as we advance toward BLA filing next year. The HAV in the vascular trauma context was also the subject of multiple presentations at scientific conferences and publications throughout the third quarter. In October, the U.S. Army published an update in Task and Purpose, describing the use of the HAV in treating the war wounded in Ukraine. In the article, it was also noted that officials with the Defense Department encouraged Humacyte to collaborate with the Medical Technology Enterprise Consortium, or MTAC, EmTech has provided more than $6.8 million in funding to Humacyte to develop the HAV for vascular trauma, and we're grateful for their support. At the European Society for Vascular Surgery annual meeting in September, Ukrainian surgeons presented patient outcomes from the use of the HAV to treat wartime vascular injuries, including blast trauma, shrapnel injuries, and gunshot wounds. The surgeons observed that access to the HAV greatly assisted in limb salvage by improving their ability to perform vascular reconstruction and by eliminating the need to harvest saphenous vein or venous conduit. In addition, Dr. Todd Rasmussen presented an update on the HAV for the treatment of vascular trauma at the 44th International Committee of Military Medicine World Congress in September. Dr. Rasmussen spoke to an audience of NATO and other international surgeons and concluded that injured service members as well as civilians with complex injuries could benefit from the use of a readily available and infection-resistant vascular conduit such as the HAV that would facilitate quick implantation, especially in the setting of contaminated wounds. I'll now provide a quick update on our program of HAVs for arteriovenous or AV access in hemodialysis patients. Enrollment in our current ongoing phase three trial in dialysis access, which is designed to assess the usability of the HAV for dialysis in comparison to autogenous fistulas, is nearing completion of enrollment. With 227 patients out of a target of 240 total patients as of October 26th, We are on track for enrollment to be completed soon. Top line results are anticipated one year after enrollment completion, based upon the one year follow up period that's built into the study. If successful, results from the trial will support a BLA filing for the dialysis access indication for the HAV. As we progress toward commercialization in this indication, We're continuing to strengthen our relationship with our global partner and shareholder, Fresenius Medical Care, which is the global market leader in kidney care services, products, and value-based care. We're partnering with Franova, the clinical research arm owned by Fresenius, to evaluate complications and costs of dialysis access care for vulnerable patients in both the US and Europe. Granular data from more than 600,000 anonymized patients concerning demographics, access complications and failures, access infections, hospitalizations and mortality is being analyzed to provide targeted information on those dialysis patients who may most benefit from the HAV. We're also happy to provide updates in our earlier stage programs as we make progress in preclinical studies of the HAV, particularly in type 1 diabetes and in coronary artery bypass grafting or CABG. In October, we initiated a research partnership with the Diabetes Research Institute, which is a global leader in preclinical studies of novel diabetic therapies in order to facilitate the development of our biovascular pancreas, or BVP. The BVP is our HAV product candidate that is coated with islets and designed to deliver insulin to type 1 diabetics. We're excited for the opportunity to work with the experts at the Diabetes Research Institute in Miami and to accelerate the development of the BVP. Preclinical results from our small diameter HAZ program in CABG were also presented at both the American Heart Association basic cardiovascular sciences sessions in July, as well as at the American Heart Association scientific sessions meeting earlier this month. In a non-human primate model, the HAZ maintains structural integrity and patency for up to six months post implantation as a coronary artery bypass graft. In addition, the HAVs showed evidence of robust host cell repopulation and remodeling. We're excited about our small diameter HAVs that they continue to show promise in an important preclinical CABG model, and we remain hopeful that these HAVs have the potential to address the long-term patency, availability, and consistency issues that are associated with the current standard of care which is harvesting saphnous veins. Finally, Humacyte strengthened our Board of Directors and Leadership Team this quarter with appointments of accomplished medical and industry experts. In September, we welcomed Lieutenant General Bruce Green to our Board of Directors. General Green is a former Surgeon General of the United States Air Force and is an expert in disaster relief and military medical response operations around the globe. In addition, we also welcome Dr. Cindy Cao as our Chief Regulatory Officer. Dr. Cao brings over 20 years of industry experience with expertise in global and U.S. regulatory strategy and policy on biologics, small molecules, and devices. We're very pleased to have General Green and Dr. Cao join us, and we look forward to adding their insights and expertise to the Humacyte team. With that, I'll now turn it over to Dale for a review of our financial results and other business development.