Mar 24, 2023

Durham, North Carolina, UNITED STATES -- Enrollment Nearing Completion in Human Acellular Vessel™ (HAV™) Phase 2/3 Trial in Vascular Trauma and Phase 3 Trial in Arteriovenous (AV) Access in Hemodialysis Patients -- Multiple publications and scientific meeting presentations highlighting clinical and preclinical HAV results – -- Conference call and live webcast at 8:00 a.m. ET today – DURHAM, N.C., March 24, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissues and advanced tissue constructs and organ systems at commercial scale, today announced financial results for the fourth quarter and year ended December 31, 2022, and highlighted recent corporate accomplishments. "During 2022, we continued to make significant progress across all of our clinical programs and are poised to maintain this momentum throughout 2023,” said Laura Niklason, M.D., Ph.D., Chief Executive Officer of Humacyte. “With enrollment approaching completion in our Phase 2/3 trial of the HAV in its vascular trauma indication, we have moved substantially closer to our anticipated filing of a Biologics License Application (BLA) in this indication. The potential of the HAV in vascular trauma was highlighted in a compelling key opinion webinar we hosted in December, featuring Ukrainian surgeons Drs. Oleksandr Sokolov, Vasyl Shaprynskyi, and Oleksandr Stanko. We extend our sincere thanks to our Ukrainian colleagues for sharing their experiences using the HAV to treat patients with wartime vascular trauma. In addition to our vascular trauma indication, we are excited to be nearing completion of enrollment in our Phase 3 trial of the HAV in arteriovenous access for hemodialysis patients, with topline results anticipated one year following completion of enrollment. Finally, we continue to be encouraged with the preclinical progress of our small diameter HAV in coronary artery bypass grafting (CABG), which we believe further supports the utility of our HAV as a vascular conduit across multiple indications." Fourth Quarter 2022 and Recent Corporate Highlights Clinical Updates Enrollment nearing completion in Phase 2/3 V005 trial in vascular trauma – A total of 63 patients have received the HAV in the Company’s Phase 2/3 V005 trial in vascular trauma. In addition, 17 vascular trauma patients have been treated with the HAV under the humanitarian program in Ukraine. All patient results will be included in the BLA filing with the FDA. The primary efficacy assessment of the HAV in trauma will be based on a 30-day patency in 50 patients from the V005 trial who have suffered vascular trauma of an extremity. This primary efficacy analysis will not include patients with torso injuries and iatrogenic trauma enrolled in the V005 trial, though data from these patients will contribute to the safety database. Currently, 46 patients comprising the primary endpoint population have been treated with the HAV in the V005 trial, and the Company plans to enroll approximately six more patients to complete the study. Efforts to accelerate the enrollment of the remaining patients in V005 include the recent addition of clinical sites in Israel and ongoing efforts to expand the V005 trial to Ukrainian sites. The Company plans to file a BLA for accelerated approval with the U.S. Food and Drug Administration (FDA) for an indication in vascular trauma within approximately four months after the completion of the V005 trial. The Company plans to seek accelerated approval of the HAV for urgent arterial repair following extremity vascular trauma when synthetic graft is not indicated and when autologous vein is not feasible. Enrollment nearing completion in Phase 3 V007 trial in arteriovenous (AV) access – Currently, 238 patients have been enrolled in the Company’s Phase 3 trial of the HAV for AV access in hemodialysis patients. The V007 trial is designed to assess the usability of the HAV for hemodialysis, in comparison to autogenous fistulas, in up to 240 patients with end stage renal disease. Top-line results are anticipated one year after completion of enrollment of the final patients in the trial, based on the one-year follow-up period built into the study. Publications and Presentations Six-year results from the Company’s Phase 2 trial of the HAV in peripheral artery disease (PAD) were published in Journal of Vascular Surgery – Vascular Science. The article, entitled “6-Year Outcomes of a Phase 2 Study of Human-Tissue Engineered Blood Vessels for Peripheral Arterial Bypass,” reports overall secondary patency rate of 60% at 72 months, as estimated by Kaplan Meier analysis. This patency compares well with outcomes from saphenous vein revascularization. There was no evidence of graft rejection or infection, and no patients underwent amputation of the affected limb out to six years. In December 2022, the Company hosted a key opinion leader (KOL) webinar on its HAV in the treatment of wartime vascular trauma, featuring presentations from Ukrainian surgeons Oleksandr Sokolov, M.D., Ph.D., Vasyl Shaprynskyi, M.D., Ph.D., and Oleksandr Stanko, M.D, who discussed the use of the HAV to treat war-induced traumatic injuries, including case studies from the first nine patients treated under the humanitarian program. Our Ukrainian colleagues observed 30-day patency and zero cases of infection in all patients treated with the HAV. A replay of the event can be accessed on the Humacyte website here . Also in December 2022, Ukrainian surgeons presented patient outcomes from the use of the HAV to treat wartime vascular trauma at two vascular conferences. Drs. Sokolov, Shaprynskyi and Stanko presented at the VI Congress of Vascular Surgeons, Phlebologists, and Angiologists of Ukraine in Kyiv, Ukraine. In addition, Dr. Sokolov presented at the 11th Munich Vascular Conference (MAC) 2022. In November 2022, Alan P. Kypson, M.D., FACS, thoracic surgeon at UNC Rex Hospital and lead investigator in Humacyte’s large animal pre-clinical development of vessels for coronary artery bypass grafting, provided a six-month patency update of the HAV in a baboon coronary artery bypass grafting (CABG) model in an oral presentation at the annual American Heart Association (AHA) Scientific Sessions meeting, held in Chicago, Illinois. Dr. Kypson highlighted that the HAV was observed to maintain structural integrity for up to six months and functioned as intended to conduct blood flow to the heart. In addition, the HAV showed evidence of robust cell repopulation with vascular cells over time, which suggests the potential for the HAV to become a living vascular tissue supplying blood to the heart muscle. The HAV is an investigational product and has not been approved for sale by the FDA or any other regulatory agencies. Fourth Quarter and Year Ended 2022 Financial Highlights There was no revenue for the fourth quarter of 2022 compared to $177.0 thousand for the fourth quarter of 2021, and revenue was $1.6 million for the year ended December 31, 2022, compared to $1.3 million for the year ended December 31, 2021. Revenue in all periods related to grants supporting the development of the HAV. Research and development expenses were $15.0 million for the fourth quarter of 2022, compared to $16.3 million for the fourth quarter of 2021, and were $63.3 million for the year ended December 31, 2022, compared to $61.3 million for the year ended December 31, 2021. The decrease for the quarter ended December 31, 2022 compared to the prior-year quarter resulted primarily from a decrease in non-cash stock-based compensation expense. The increase during the year ended December 31, 2022 compared to 2021 resulted primarily from increased personnel and materials expenses designed to support expanded research and development initiatives and the support of clinical studies. General and administrative expenses were $5.8 million for the fourth quarter of 2022, compared to $5.6 million for the fourth quarter of 2021, and were $22.9 million for the year ended December 31, 2022, compared to $21.1 million for the year ended December 31, 2021. The 2022 increases resulted primarily from the transition to being a public company and preparation for the anticipated U.S. commercial launch of the HAV, including increased personnel costs, external services and insurance costs. Other net income was $17.1 million for the fourth quarter of 2022, compared to $64.2 million for the fourth quarter of 2021, and was $72.6 million for the year ended December 31, 2022, compared to $54.7 million for the year ended December 31, 2021. The reduction in other net income for the fourth quarter of 2022, and increase in other net income for the year December 31, 2022, resulted primarily from non-cash gains related to the remeasurement of the contingent earnout liability associated with the August 2021 merger with Alpha Healthcare Acquisition Corp. Net loss was $3.7 million for the fourth quarter of 2022, compared to net income of $42.6 million for the fourth quarter of 2021, and net loss was $12.0 million for the year ended December 31, 2022, compared to net loss of $26.5 million for the year ended December 31, 2021. The increase in net loss for the current-year fourth quarter compared to 2021 resulted from a decrease in other net income described above. The decrease in net loss during the year ended December 31, 2022 compared to 2021 resulted from the increase in other net income described above, partially offset by operating expense increases also described above. The Company reported cash, cash equivalents and short-term investments of $151.9 million as of December 31, 2022, compared to $225.5 million as of December 31, 2021. The $73.6 million net use of cash, cash equivalents and short-term investments for the year ended December 31, 2022 resulted from spending related to net operating activities for the period, including clinical and earlier-stage research and development programs, and preparation for the Company’s anticipated commercial launch. The Company believes that its cash, cash equivalents and short-term investments are adequate to fund operations through the end of 2024, past the Company’s current expected timelines for potential approval of the HAV in its vascular trauma indication. Conference Call and Webcast Details Date: