Humacyte, Inc.

Good morning, ladies and gentlemen, and welcome to the EMSITE second 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'll now turn the call over to Lauren Merrick with LifeSciAdvisors. 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. Additional information concerning factors that could cause actual results to differ from statements made on this call is contained in our periodic reports filed at 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 Humacyte 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, and Dale will review the company's financial results. Following their prepared remarks, the management team will be available for 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 second quarter 2022 financial results and business update call. During this call, I'll review our recent highlights and progress of our key programs before turning the call over to Dale for a review of our financial results. Then we will be happy to open up the call for your questions. I'm very pleased with the great progress Humacyte has made throughout the second quarter. in advancing our universally implantable bioengineered human tissue platform. We're continuing to add to the robust body of data, showing that our lead candidate, the human acellular vessel, or HAV, may be uniquely suited for vascular and complex organ applications in which the current standard of care is either unavailable or inadequate. We've also strengthened our board of directors and leadership team with the respective appointments of Dr. Diane Simons, and Dr. Shamik Parikh, who both bring global drug development experience that will be invaluable as we move closer to our goal of bringing the HAV to market. I'll begin with an update on our initiative to provide HAVs to multiple hospitals in Ukraine for the treatment of wounded civilians suffering from vascular trauma injuries. We launched this humanitarian initiative in May in collaboration with the Office of International Programs within the U.S. Food and Drug Administration. as well as the Ukraine Ministry of Health, to coordinate the export and import of our investigational HAV. We're very proud to report that HAVs have been successfully implanted into several Ukrainian patients with vascular trauma injuries. To date, all HAVs that have been implanted have been reported to be functional and infection-free, salvaging limbs in patients who were injured in this wartime conflict zone. This humanitarian program is providing further real-world evidence of the potential impact of the HAV in the treatment of vascular trauma injuries. We're honored to contribute to the ongoing medical relief efforts in Ukraine and to help patients in frontline hospitals that are affected by this humanitarian crisis. In addition, we're inspired by the dedicated medical teams on the ground who were quickly trained on the use of the HAV. As patients are treated with the HAV in Ukraine, we'll continue to work with the FDA and with the Ukrainian Ministry of Health in an effort to help save limbs and save lives in patients of need. Moving on to our late-stage program for the 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 HAVs for vascular repair, reconstruction, and replacement in trauma injury settings. Currently, we have enrolled a total of 55 patients. We're pleased with the results of this study to date, showing very low rates of infection, less than 2%. We've also had no reports of limb amputations that have occurred as a result of HAV malfunction, and we've observed high patency rates of the HAV conduit. Results from the trial are expected to support our planned BLA filing with the FDA, which we plan to submit by the end of 2022 or early 2023. We're continuing to discuss the required number of subjects to be enrolled in the trial with the FDA. The FDA has previously indicated that the HAV for the indication of vascular trauma qualifies for the accelerated approval pathway. The potential of HAVs in vascular trauma was further highlighted in a webinar that we hosted in July, featuring key opinion leaders, Drs. Ernest Moore and Dr. Greg McGee. This was an enlightening discussion of the capacity of the HAV to address current limitations in the standard of care for both vascular and trauma perspectives. And we're grateful to Drs. Moore and McGee for their insightful presentations. A replay of the webinar can be found on the events page of the Humacyte website. The HAV was also the subject of multiple presentations at scientific conferences and journal publications throughout the second quarter. In a publication in the June 2022 edition of JAMA Surgery, clinical researchers emphasized the potential of the HAV to make a significant impact on the clinical care of patients with vascular disease and trauma. This manuscript also highlighted favorable data from multiple clinical trials, encompassing nearly 500 patients and over 1,000 patient years of follow-up. Researchers described the potential advantages of the HAV over existing approaches. I'd like to turn now to our development program of HAVs for arteriovenous, or AV, access in hemodialysis patients. Enrollment is nearing completion in our Phase III trial, which 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. With 222 patients currently enrolled, we are on track for enrollment to be completed this year with top-line results anticipated in late 2023 based upon the one-year follow-up period that's built into the study. Results from the trial, if successful, will support a BLA filing for the dialysis access indication. In addition, in June at the American Transplant Congress, Humacyte presented data on more than 500 patient years of exposure from phase two and phase three clinical trials, demonstrating that the HAV does not stimulate an increase in panel reactive antibodies, which is an adaptive immune response that's correlated with tissue rejection. In addition, in a phase three trial of patients with end-stage renal disease who received either the HAV or synthetic PTFE graft or polytetrafluoroethylene for AV access, the HAV-implanted patients exhibited fewer instances of sensitization than the patients who received the PTFE graft. The benefit of the HAV appeared to be even greater in women who demonstrated fewer increases in antibodies as compared to women who received the PTFE grafts. These results are further consistent with the absence of HAV rejection that's been observed across trials that have been performed with 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 leader in kidney care services, products, and value-based care. We're partnering with Franova, which is the clinical research group owned by Fresenius, to evaluate complications and cost of hemodialysis access care for vulnerable patients in both the US and Europe. These evaluations will assist with development of health economic models and value propositions for the HAV in patients with kidney failure. In our earlier stage programs, we're continuing to advance preclinical studies of the HAV, particularly in coronary artery bypass grafting, or CABG. In July, we presented positive results from a preclinical study of our small diameter HAVs in CABG at the American Heart Association Basic Cardiovascular Sciences Scientific Session. In a non-human primate model, the HAV maintained structural integrity and patency for up to six months post-implantation and showed evidence of robust host cell remodeling and repopulation. We're excited that our small-diameter HAVs continue to show promise in preclinical CABG models, and we look forward to publication of this study in a September issue of the Circulation Research. Finally, humusitis strengthened our Board of Directors and leadership team this quarter with the appointments of seasoned experts in global clinical development. In June, we welcomed Diane Simons, Ph.D., to our Board of Directors. Dr. Simons brings over 22 years of international drug development, partnering, and managerial experience in the biopharmaceutical industry. In 2013, she co-founded Biopharma Excellence, serving as its chief executive officer until its acquisition in 2021. In addition, as announced last quarter, we welcome Shameek Parikh, MD, as our new chief medical officer. Dr. Parikh leads our global clinical development strategy, including oversight of the preclinical and clinical development, clinical operations, and the medical affairs function. We're so pleased to have Drs. Simons and Parikh 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 developments.