Alpha Healthcare Services, Inc.

-FDA requires additional time to complete its review of ATEV™ (acellular tissue engineered vessel) BLA for the Treatment of Vascular Trauma- -Reported Positive Topline Results from Phase 3 Trial of ATEV in Hemodialysis Access- -ATEV Received Third Regenerative Medicine Advanced Therapy (RMAT) Designation from FDA in Advanced Peripheral Artery Disease- -Conference call and live webcast at 8:30 a.m. ET today- DURHAM, N.C., Aug. 13, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced financial results for the second quarter ended June 30, 2024 and highlighted recent accomplishments. “We were surprised to be notified by the FDA that they will require additional time to complete their review of the BLA for our ATEV (acellular tissue engineered vessel) in vascular trauma,” said Laura Niklason, M.D., Ph.D., Chief Executive Officer of Humacyte. “FDA leadership noted that Humacyte’s ATEV is a first-in-class product, and that Priority Review had been granted, which involves only a six-month review cycle, as compared to the standard ten-month review cycle for most products. During the course of the BLA review, the FDA has conducted inspections of our manufacturing facilities and clinical sites and has actively engaged with us in multiple discussions regarding our BLA filing, including post-marketing and labeling discussions. Based on these interactions, we are confident in the approvability of the ATEV in treating vascular trauma, although we currently do not yet have a revised action date.” “The ATEV continues to make significant progress in its other investigational indications, including in hemodialysis access,” continued Dr. Niklason. “We were pleased to announce positive top-line results from the V007 Phase 3 clinical trial in patients with end-stage renal disease, in which the ATEV was observed to have superior functional patency over current standard of care. In addition, the ATEV received its third RMAT designation from the FDA, specifically in advanced peripheral artery disease. This serves as a recognition from the Agency that Humacyte’s ATEV may provide an important therapeutic option for patients with advanced arterial disease in their legs, who are facing potential amputation. We are proud that the ATEV’s broad potential continues to be recognized and look forward to presenting additional results across our pipeline at upcoming medical meetings.” Second Quarter 2024 and Recent Corporate Highlights ATEV (acellular tissue engineered vessel) FDA extension of time to complete review of BLA for ATEV in the Treatment of Vascular Trauma– On August 9, 2024, in a phone call, Center for Biologics Evaluation and Research (CBER) leadership from the U.S. Food and Drug Administration (FDA) notified the Company that the FDA will require additional time to complete its review of the Company’s Biologics License Application (BLA) for the ATEV in the vascular trauma indication. The ATEV trauma BLA was submitted to FDA in December 2023, FDA granted a Priority Review in February 2024, and assigned a PDUFA date of August 10, 2024. Positive Topline Results of ATEV in Hemodialysis Access – In July 2024, Humacyte reported positive topline results from the V007 Phase 3 clinical trial (NCT03183245) of the ATEV in arteriovenous (AV) access for patients on hemodialysis. The V007 trial is prospective, multi-center, randomized clinical study in 242 hemodialysis patients in the United States. Participants were randomly assigned to receive either the ​​ATEV or an AV fistula for hemodialysis access and are being followed for up to 24 months. In the trial, the ATEV was observed to provide superior functional patency at six and 12 months (co-primary endpoints; p=0.0071) compared to autogenous fistula, which is the current standard of care for hemodialysis patients. Patients on ATEV also achieved a significantly longer duration of hemodialysis using the ATEV over the first 12 months, as compared to autogenous fistula (p=0.0162). Humacyte anticipates that detailed results from the trial will be presented at upcoming medical meetings. ATEV Received Third Regenerative Medicine Advanced Therapy (RMAT) Designation from FDA – In July 2024, the FDA granted RMAT designation of the ATEV for patients with advanced peripheral artery disease (PAD). This RMAT designation is granted at the same time as FDA cleared a new Investigational New Drug (IND) application for the PAD indication. This is the third RMAT designation granted by the FDA for Humacyte’s ATEV, in addition to previous RMAT designations for vascular trauma repair and AV access in hemodialysis. Medical and Scientific Publications and Presentations PAD Publication: In June 2024, Dr. Todd Rasmussen and colleagues at the Mayo Clinic in Rochester MN published outcomes of arterial bypass using the ATEV in patients with chronic limb ischemia (severe PAD). In this paper, appearing in the Journal of Vascular Surgery in June, all patients treated with the ATEV for severe PAD had no suitable vein of their own for bypass, and were treated under an investigator-sponsored protocol. Outcomes for ATEV patency (or blood flow) and limb salvage in patients with severe PAD and no vein were compared to historical control patients, having similar disease but receiving a bypass using their own vein at the Mayo Clinic. Mayo investigators reported that patency and limb salvage were similar for patients receiving ATEV, and patients receiving bypass with their own vein. This result highlights the potential impact that Humacyte’s ATEV may have on patients suffering from severe PAD and having no vein of their own to perform a bypass operation.Presentations Highlighting Advancement of Diabetes Program – In June 2024, Humacyte presented positive results from ongoing preclinical studies supporting the potential of Humacyte’s BioVascular Pancreas (BVP™) product candidate to enable the delivery and survival of insulin-producing islets as a potential treatment for type 1 diabetes: At a presentation at the Breakthrough T1D (formerly, JDRF) Beta Cell Consortium Meeting in New York City, scientists presented data in which stem cell-derived islets, manufactured at Humacyte, were observed to restore normal blood sugar in diabetic mice. In the mice, the stem cell-derived islets survived and continued to produce insulin, with no evidence of adverse safety events from the stem cell-derived islets. These experiments were performed in collaboration with the Diabetes Research Institute (DRI) at the University of Miami.At the American Diabetes Association annual meeting in Orlando, Florida, Humacyte reported successful implantation of BVPs into non-human primate recipients. In the study, also performed in collaboration with the DRI, primate BVP implants showed islet survival and continued insulin production throughout the three-month duration of the study. Islets also developed capillaries to support survival of the insulin-producing cells. CABG Preclinical Remodeling Results – Preclinical six-month studies have been conducted in non-human primates to support the planned advancement of the small-diameter ATEV into human clinical trials in coronary artery bypass graft (CABG) surgery. Humacyte has observed remodeling of the ATEV to a diameter that closely matches that of the native coronary vessels in non-human primates, which is an outcome not observed with any other conduit and highlights the potential adaptability of the ATEV in vivo. These promising results of ATEV patency and remodeling were presented at the Tissue Engineering and Regenerative Medicine (TERM-2024) Conference on June 11-12, 2024. Corporate Updates Strengthened Board of Directors – In July 2024, Humacyte announced the addition of pharmaceutical industry veteran Dr. John P. Bamforth and distinguished health system and academic physician Dr. Keith Anthony (Tony) Jones to the Company’s Board of Directors. Second Quarter 2024 Financial Highlights There was no revenue for either the second quarter of 2024 or the second quarter of 2023, and there was no revenue for the six months ended June 30, 2024 and 2023.Research and development expenses were $23.8 million for the second quarter of 2024, compared to $20.5 million for the second quarter of 2023, and were $45.0 million for the six months ended June 30, 2024, compared to $37.8 million for the six months ended June 30, 2023. The current-period increases resulted primarily from increased materials and personnel expenses to support expanded research and development initiatives and our clinical trials, including the expansion of manufacturing activities and support of the FDA review of the BLA in vascular trauma.General and administrative expenses were $5.7 million for the second quarter of 2024, compared to $6.2 million for the second quarter of 2023, and were $11.1 million for the six months ended June 30, 2024, compared to $11.4 million for the six months ended June 30, 2023. The slight decreases during 2024, resulted primarily from a decrease in non-cash stock compensation expense, partially offset by increased personnel expenses and increased professional fees.Other net income (expense) was net expense of $27.2 million for the second quarter of 2024, compared to net income of $4.0 million for the second quarter of 2023, and other net expense of $32.5 million for the six months ended June 30, 2024, compared to other net expense of $10.4 million for the six months ended June 30, 2023. The increase in other net expense for the second quarter of 2024 and the six months ended June 30, 2024 compared to 2023 resulted primarily from the non-cash remeasurement of the contingent earnout liability associated with the Company’s August 2021 merger with Alpha Healthcare Acquisition Corp.Net loss was $56.7 million for the second quarter of 2024, compared to $22.7 million for the second quarter of 2023, and net loss was $88.6 million for the six months ended June 30, 2024, compared to $59.7 million for the six months ended June 30, 2023. The current-period increase in net loss resulted primarily from the non-cash remeasurement of the contingent earnout liability, and operating expense increases, described above.The Company reported cash and cash equivalents of $93.6 million as of June 30, 2024. Total net cash provided was $13.1 million for the first six months of 2024, compared to net cash used of $35.2 million for the first six months of 2023. The increase in net cash provided resulted primarily from the receipt of approximately $43.0 million in net proceeds from an underwritten public offering of Humacyte’s common stock in March 2024, and $20 million in proceeds from an additional draw under its funding arrangement with Oberland Capital Management. Conference Call and Webcast Details Title:Humacyte Second Quarter 2024 Financial Results Corporate UpdateDate:Tuesday, August 13, 2024Time:8:30 a.m. ETConference Call Details:Toll-Free: 1- 877-704-4453International: 1-201-389-0920Conference ID #: 13747913Call meTM Feature (avoid waiting for operator):Click HereWebcast:Webcast Link - Click Here A replay of the webcast will be available following the conclusion of the live broadcast and will be accessible on the investors section of the Company’s website for at least 30 days. About Humacyte Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s initial product candidates, a portfolio of ATEVs, are currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, arteriovenous (AV) access for hemodialysis, and peripheral artery disease. A Biologics License Application for the ATEV in the vascular trauma indication is currently under review by the FDA and was granted Priority Review. Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma and for advanced PAD also have received an RMAT designations. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com. The ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency. Forward-Looking Statements This press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, the outcome of the FDA’s review of our BLA seeking approval of the ATEV in the vascular trauma indication; the statements regarding the initiation, timing, progress, and results of our preclinical and clinical trials, the anticipated characteristics and performance of our ATEV; our ability to successfully complete preclinical and clinical trials for our ATEVs; the anticipated benefits of the ATEV relative to existing alternatives; the anticipated commercialization of our ATEVs and our ability to manufacture at commercial scale; the implementation of our business model and strategic plans for our business; and the timing or likelihood of regulatory filings, acceptances, and approvals. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, changes in applicable laws or regulations, the possibility that Humacyte may be adversely affected by other economic, business, and/or competitive factors, and other risks and uncertainties, including those described under the header “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023, filed by Humacyte with the SEC, and in future SEC filings. Most of these factors are outside of Humacyte’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Except as required by law, we have no current intention of updating any of the forward-looking statements in this press release. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. Humacyte Investor Contact:Joyce AllaireLifeSci Advisors LLC+1-617-435-6602jallaire@lifesciadvisors.cominvestors@humacyte.com Humacyte Media Contact:Rich LuchettePrecision Strategies+1-202-845-3924rich@precisionstrategies.commedia@humacyte.com Humacyte, Inc.Condensed Consolidated Statements of Operations and Comprehensive Loss(unaudited)(in thousands except for share and per share amounts) Three Months EndedJune 30, Six Months EndedJune 30, 2024 2023 2024 2023 Revenue$— $— $— $— Operating expenses: Research and development 23,753 20,540 45,017 37,818 General and administrative 5,746 6,191 11,060 11,425 Total operating expenses 29,499 26,731 56,077 49,243 Loss from operations (29,499) (26,731) (56,077) (49,243) Other income (expense), net: Change in fair value of contingent earnout liability (25,571) 3,627 (30,164) (10,564)Other income (expense) (net) (1,593) 398 (2,318) 132 Total other income (expense), net (27,164) 4,025 (32,482) (10,432)Net loss and comprehensive loss$(56,663) $(22,706) $(88,559) $(59,675) Net loss per share, basic and diluted$(0.48) $(0.22) $(0.78) $(0.58)Weighted-average shares outstanding, basic and diluted 119,174,681 103,361,501 113,710,344 103,312,785 Humacyte, Inc.Condensed Consolidated Balance Sheets(unaudited)(in thousands) June 30,2024 December 31,2023Assets Current assets: Cash and cash equivalents$93,563 $80,448 Prepaid expenses and other current assets 2,547 2,830 Total current assets 96,110 83,278 Property and equipment, net 24,820 26,791 Finance lease right-of-use assets, net 16,536 17,313 Other long-term assets 815 841 Total assets $138,281 $128,223 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable$6,005 $6,490 Accrued expenses 8,950 9,340 Other current liabilities 2,802 2,613 Total current liabilities 17,757 18,443 Contingent earnout liability 68,080 37,916 Revenue interest liability 60,078 38,600 Finance lease obligation, net of current portion 15,123 16,293 Other long-term liabilities 5,530 3,425 Total liabilities 166,568 114,677 Stockholders’ equity Common stock and additional paid-in capital 597,586 550,860 Accumulated deficit (625,873) (537,314)Total stockholders’ equity (28,287) 13,546 Total liabilities and stockholders’ equity$138,281 $128,223

-Biologics License Application (BLA) for HAV™ Accepted by FDA- -BLA Granted Priority Review for Vascular Trauma Indication; PDUFA date set for August 10, 2024- -Raised approximately $43 million in net proceeds from public offering of common stock- -Conference call and live webcast at 8:00 a.m. ET today- DURHAM, N.C., May 10, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced financial results for the first quarter ended March 31, 2024 and highlighted recent accomplishments advancing the investigational Human Acellular Vessel™ (HAV) closer to planned U.S. market launch. “During the first quarter of 2024, we achieved a major milestone with the acceptance by the Food and Drug Administration (FDA) of our Biologics License Application (BLA) seeking approval of the HAV in the vascular trauma indication,” said Laura Niklason, M.D., Ph.D., Chief Executive Officer of Humacyte. “The FDA’s decision to grant Priority Review sets a Prescription Drug User Fee Act (PDUFA) date of August 10, 2024, and the entire Humacyte team is working to support our planned U.S. market launch. Among our recent accomplishments is the completion of a Budget Impact Model illustrating the potential economic value of the HAV compared to current standard of care in vascular trauma. In addition, the FDA completed its Pre-Licensing Inspection of our manufacturing facilities in Durham, North Carolina as part of the BLA review process. We remain on track with our BLA review and commercial launch preparations and remain confident in the approvability of the HAV in vascular trauma.” First Quarter 2024 and Recent Corporate Highlights HAV in Vascular Trauma Biologics License Application for HAV Granted Priority Review by U.S. FDA for the Vascular Trauma Indication – In February 2024, the FDA accepted and granted Priority Review to Humacyte’s BLA seeking approval of the HAV in urgent arterial repair following extremity vascular trauma when synthetic graft is not indicated, and when autologous vein use not feasible. The BLA submission is supported by positive results from the V005 Phase 2/3 clinical trial, as well as real-world evidence from the treatment of wartime injuries in Ukraine under a humanitarian aid program. The HAV was observed to have higher rates of patency, or blood flow, and lower rates of amputation and infection, as compared to historic synthetic graft benchmarks.Preparation for Planned U.S. Launch of HAV in Vascular Trauma – Building upon the positive clinical results and the Priority Review grant by the FDA, Humacyte has implemented a company-wide, multi-disciplinary program designed to ensure U.S. launch readiness upon the anticipated approval of the HAV for the vascular trauma indication. Major recent milestones include the completion of a Budget Impact Model illustrating the potential economic value of the HAV compared to current standard of care. Presentations of clinical results and the Budget Impact Model are planned at upcoming medical meetings and in publications during the remainder of 2024. Other ongoing activities to build awareness include demonstrations of the HAV by Humacyte’s Medical Affairs team at medical and military conferences, and at meetings conducted across the U.S. at Trauma medical centers. The Company has also begun the process to procure an ICD-10 PCS code for the HAV with the Centers for Medicare & Medicaid Services (CMS). We have also commenced the recruiting of a high-quality sales team to support the planned market launch. Humacyte is pleased to announce that we have hired Morgan Rankin as Vice President of Sales, joining Humacyte after 12 years at Teleflex Medical. Morgan most recently served as Vice President of Sales, Trauma and Emergency Medicine at Teleflex where she led a team of approximately 100 sales professionals focused on vascular access and hemorrhage control. Medical and Scientific Presentations Presentation Highlighting Advancement of the HAV in Dialysis Access – in April 2024, Humacyte completed one year of follow-up in our Phase 3 clinical trial in arteriovenous (AV) access for hemodialysis comparing the HAV to the current standard of care, autologous arteriovenous fistula. Top line results are expected in the third quarter of this year. In addition, in collaboration with our corporate partner Fresenius Medical Care and its subsidiary Frenova Renal Research, Humacyte conducted a study to review the outcomes of close to 180,000 adult patients who received in-center dialysis at Fresenius Kidney Care dialysis centers. Among the areas of study were the complications and cost of treatment by patient demographic. The objective of the study was to further define patient subgroups who could most benefit from the HAV. Results from the study were presented by clinicians at a virtual KOL event in March 2024 titled “Hemodialysis Access: A Crossroads of Care” (a replay of the webinar is available here https://lifescievents.com/event/humacyte-2/). In the study women, particularly obese and diabetic women, were observed to have higher complication rates, including infections and access failures, and that these factors drive substantially higher treatment costs. The cost of maintaining dialysis access in patients, including costs of infections and fistula failures, average approximately $22,000 to $55,000 per year. In addition, data indicate that vascular access costs for the upper quintile of patients exceed approximately $91,000 per year. Based on the results of this research, Humacyte has commenced a clinical study designed to demonstrate the anticipated clinical and health economic benefits of the HAV in female dialysis patients, a high-unmet-need population.Advancement of Diabetes Program – Results from ongoing preclinical studies support the potential of Humacyte’s BioVascular Pancreas (BVP™) product candidate to enable the delivery and survival of insulin-producing islets as a potential treatment for type 1 diabetes. In three-month studies conducted in non-human primates, researchers observed that insulin-producing cells in the BVP survive after implantation and continue to make insulin. In addition, Humacyte has advanced the manufacturing of islets from human stem cells and has observed that these islets can arrest diabetes in rodent models. These and other preclinical results will be presented at several upcoming scientific conferences, including the American Diabetes Association Annual Meeting 2024 to be held June 21-24, 2024.CABG Preclinical Remodeling Results – Preclinical six-month studies have been conducted in non-human primates to support the planned advancement of the small-diameter HAV into human clinical trials in cardiac bypass graft surgery (CABG). Humacyte has observed remodeling of the HAV to a diameter that closely matches that of the native coronary vessels, which is an outcome not observed with any other conduit. These promising results of HAV patency and remodeling will be presented at the Tissue Engineering and Regenerative Medicine (TERM-2024) Conference on June 11-12, 2024. The HAV and BVP are investigational products and have not been approved for sale by the FDA or any other regulatory agency. First Quarter 2024 Financial Highlights The Company reported cash and cash equivalents of $115.5 million as of March 31, 2024. Total net cash provided was $35.1 million for the first three months of 2024, compared to net cash used of $20.2 million for the first three months of 2023. The increase in net cash provided resulted primarily from the receipt of approximately $43.0 million in net proceeds from an underwritten public offering of Humacyte’s common stock in March 2024, and $20 million in proceeds from an additional draw under its previously disclosed funding arrangement with Oberland Capital Management. Humacyte believes that its cash and cash equivalents will be adequate to finance operations for at least 12 months from the date of this financial report, well past the currently anticipated timelines for FDA approval of commercialization of the HAV in the vascular trauma indication.There was no revenue for either the first quarter of 2024 or the first quarter of 2023.The overall operating expense run rate for the first quarter of 2024 is virtually identical to the fourth quarter of 2024. Total operating expenses, which includes non-cash expenses, were $26.6 million for the first quarter of 2024, largely unchanged compared to $26.2 million incurred for the 4th quarter of 2023.Research and development expenses were $21.3 million for the first quarter of 2024, compared to $17.3 million for the first quarter of 2023. The current-period increase resulted primarily from increased materials and personnel expenses to support expanded research and development initiatives and our clinical trials, including the expansion of clinical development of the HAV for use in AV access for hemodialysis.General and administrative expenses were $5.3 million for the first quarter of 2024, compared to $5.2 million for the first quarter of 2023. The slight increase during the three months ended March 31, 2024 compared to the prior-year period resulted primarily from increased professional fees and external services costs.Other net income (expense) was net expense of $5.3 million for the first quarter of 2024, compared to net expense of $14.5 million for the first quarter of 2023. The decrease in other net expense for the first quarter of 2024 compared to 2023 resulted primarily from the non-cash remeasurement of the contingent earnout liability associated with the Company’s August 2021 merger with Alpha Healthcare Acquisition Corp.Net loss was $31.9 million for the first quarter of 2024, compared to $37.0 million for the first quarter of 2023. The current-period decrease in net loss resulted primarily from the non-cash remeasurement of the contingent earnout liability described above. Conference Call and Webcast Details Title:Humacyte First Quarter 2024 Financial Results Corporate UpdateDate:Friday, May 10, 2024Time:8:00 a.m. ETConference Call Details:Toll-Free: 1- 877-704-4453International: 1-201-389-0920Conference ID #: 13746046Call me™ Feature (avoid waiting for operator):Click HereWebcast:Webcast Link - Click Here A replay of the webcast will be available following the conclusion of the live broadcast and will be accessible on the investors section of the Company’s website for at least 30 days. About Humacyte Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s initial opportunity, a portfolio of HAVs, is currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, AV access for hemodialysis, and peripheral arterial disease. Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm HAV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm HAV for urgent arterial repair following extremity vascular trauma also has received an RMAT designation. The HAV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com. Forward-Looking Statements This press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, statements regarding our plans and ability to execute product development, process development and preclinical development efforts successfully and on our anticipated timelines; our plans and ability to obtain marketing approval from the FDA and other regulatory authorities for the HAV and other product candidates; the outcome of the FDA’s review of our BLA seeking approval of the HAV in the vascular trauma indication; our ability to design, initiate and successfully complete clinical trials and other studies for our product candidates and our plans and expectations regarding our ongoing or planned clinical trials, including for our V007 Phase 3 clinical trial; the characteristics and performance of the HAV; our ability to manufacture HAVs and other product candidates in sufficient quantities to satisfy our clinical trial and commercial needs; our plans and ability to commercialize the HAV and other product candidates, if approved by regulatory authorities; and our anticipated cash runway. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, changes in applicable laws or regulations, the possibility that Humacyte may be adversely affected by other economic, business, and/or competitive factors, and other risks and uncertainties, including those described under the header “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC, and in future SEC filings. Most of these factors are outside of Humacyte’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Except as required by law, we have no current intention of updating any of the forward-looking statements in this press release. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. Humacyte Investor Contact:Joyce AllaireLifeSci Advisors LLC+1-617-435-6602jallaire@lifesciadvisors.cominvestors@humacyte.com Humacyte Media Contact:Rich LuchettePrecision Strategies+1-202-845-3924rich@precisionstrategies.commedia@humacyte.com Humacyte, Inc.Condensed Consolidated Statements of Operations and Comprehensive Loss(unaudited)(in thousands except for share and per share amounts) Three Months EndedMarch 31, 2024 2023 Revenue$— $— Operating expenses: Research and development 21,264 17,278 General and administrative 5,314 5,234 Total operating expenses 26,578 22,512 Loss from operations (26,578) (22,512) Other income (expense), net: Change in fair value of contingent earnout liability (4,593) (14,191)Other expense (net) (725) (266)Total other expense, net (5,318) (14,457)Net loss and comprehensive loss$(31,896) $(36,969) Net loss per share, basic and diluted$(0.29) $(0.36)Weighted-average shares outstanding, basic and diluted 108,246,008 103,263,528 Humacyte, Inc.Condensed Consolidated Balance Sheets(unaudited)(in thousands) March 31,2024 December 31,2023Assets Current assets: Cash and cash equivalents$115,505 $80,448 Prepaid expenses and other current assets 2,421 2,830 Total current assets 117,926 83,278 Property and equipment, net 25,653 26,791 Finance lease right-of-use assets, net 17,059 17,313 Other long-term assets 828 841 Total assets $161,466 $128,223 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable$3,452 $6,490 Accrued expenses 7,917 9,340 Other current liabilities 2,718 2,613 Total current liabilities 14,087 18,443 Revenue interest liability 57,959 38,600 Contingent earnout liability 42,509 37,916 Finance lease obligation, net of current portion 15,850 16,293 Other long-term liabilities 4,909 3,425 Total liabilities 135,314 114,677 Stockholders’ equity Common stock and additional paid-in capital 595,362 550,860 Accumulated deficit (569,210) (537,314)Total stockholders’ equity 26,152 13,546 Total liabilities and stockholders’ equity$161,466 $128,223

-Biologics License Application (BLA) for HAV™ Accepted by FDA on February 8, 2024- -BLA Granted Priority Review for Vascular Trauma Indication; PDUFA date set for August 10, 2024- -Raised approximately $43.1 million in net proceeds from public offering of common stock- -Conference call and live webcast at 8:00 a.m. ET today- DURHAM, N.C., March 22, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced financial results for the fourth quarter and year ended December 31, 2023 and highlighted recent corporate accomplishments in advancing the investigational Human Acellular Vessel (HAV) closer to planned U.S. market launch. “During 2023, we accomplished major goals across all of our clinical programs. In December 2023, we submitted our Biologics License Application (BLA) to the Food and Drug Administration (FDA) seeking approval of the HAV in the vascular trauma indication,” said Laura Niklason, M.D., Ph.D., Chief Executive Officer of Humacyte. “The FDA’s acceptance of our filing in February 2024 brings us another major step closer to our goal of providing an innovative regenerative medicine product for patients suffering traumatic vascular injury. We believe the FDA’s decision to grant Priority Review reflects their recognition that many patients with severe injuries are underserved by the current standard of care. We look forward to working with the agency toward their Prescription Drug User Fee Act (PDUFA) date of August 10, 2024.” “During the year we were also pleased with the progress made in our broader HAV pipeline, including completion of enrollment of our V007 Phase 3 trial of the HAV for use in AV access for hemodialysis, presentation and publication of clinical trial results in severe peripheral artery disease (PAD), and publication of preclinical results for our small caliber HAV in a juvenile heart disease preclinical model. The coming year will be exciting, and we thank the medical professionals, patients, researchers and our employees for their contributions to the continued advancement of the HAV,” concluded Dr. Niklason. Fourth Quarter 2023 and Recent Corporate Highlights Clinical and Regulatory Updates Biologics License Application for HAV Granted Priority Review by U.S. FDA for the Vascular Trauma Indication – In February 2024, the Company announced that the FDA had accepted and granted Priority Review to its BLA seeking approval of the HAV in urgent arterial repair following extremity vascular trauma when synthetic graft is not indicated, and when autologous vein use is not feasible. The BLA submission is supported by positive results from the V005 Phase 2/3 clinical trial, as well as real-world evidence from the treatment of wartime injuries in Ukraine under a humanitarian aid program. The HAV was observed to have higher rates of patency (blood flow), and lower rates of amputation and infection, as compared to historic synthetic graft benchmarks in both the V005 Phase 2/3 clinical trial and the Ukraine humanitarian program.The PDUFA date, the FDA action date for their regulatory decision regarding the BLA, is August 10, 2024. The Priority Review designation is a mechanism reserved by FDA for products that, if approved, would significantly improve the treatment, diagnosis, or prevention of serious conditions. Priority Review applications have a six-month review time instead of ten months for a standard review. The Priority Review aligns with the Regenerative Medicine Advanced Therapy (RMAT) designation granted by the FDA in May 2023 for urgent arterial repair following extremity vascular trauma. The Priority Review is also consistent with the priority designation given by the Secretary of Defense under Public Law 115-92, which was enacted to expedite the FDA’s review of products that are intended to diagnose, treat or prevent serious or life-threatening conditions facing American military personnel. Presentations and Publications Presentations at a Major Vascular Surgery Symposium – Two presentations were made at the VEITH Symposium, a major vascular surgery meeting, held in New York City on November 15-18, 2023. These include an expanded presentation of positive results of the V005 vascular trauma trial, with the HAV observed to have higher rates of patency and lower rates of amputation and infection as compared to historic synthetic graft benchmarks.Results of the V005 trial were presented by Charles J. Fox, MD, FACS, Director of Vascular Surgery at the University of Maryland Capital Region, a clinical investigator in the V005 trial, in a podium presentation titled “Phase 2/3 Study for the Evaluation of Safety and Efficacy of HAV for Vascular Reconstruction in Patients with Limb or Life-Threatening Vascular Trauma.” Results from V005 and the Ukraine humanitarian program, with statistical comparison to historic benchmarks, were presented at a symposium titled “Vascular Trauma Repair Clinical Study Results with Humacyte Human Acellular Vessel (V005 & V017 Data)” by Dr. Moore, Dr. Fox, and Laura Niklason, MD, PhD, Chief Executive Officer of Humacyte. Publication of Preclinical Results in Juvenile Heart Disease Study – In October 2023, a publication in the Journal of Thoracic and Cardiovascular Surgery described a preclinical study showing the potential for the investigational small-diameter HAV to treat tetralogy of Fallot, a heart condition that affects one in every 2,000 babies born each year in the United States. In the preclinical study, researchers from Nationwide Children's Hospital (Columbus, OH) and Humacyte implanted 3.5mm diameter HAVs into a juvenile animal model of pediatric heart disease. The 3.5mm HAVs remained patent for up to six months, and evidence of HAV repopulation by host cells was observed, similar to what has been observed in human patients. In connection with the study, Humacyte produced 3.5mm vessels using the same manufacturing platform used to produce Humacyte’s 6mm HAVs that are in current clinical use. The HAV is an investigational product and has not been approved for sale by the FDA or any other regulatory agencies. Fourth Quarter and Full Year 2023 Financial Highlights The Company reported cash and cash equivalents of $80.4 million as of December 31, 2023. In addition, Humacyte completed two transactions in early 2024 which added to its cash balance. On March 5, 2024, the Company closed an underwritten public offering of its common stock and raised net proceeds of approximately $43.1 million. Furthermore, on March 11, 2024, the Company received $20 million in proceeds from an additional draw under its previously disclosed funding arrangement with Oberland Capital Management. Total net cash used was $69.0 million for the year ended December 31, 2023, compared to $67.7 million for the year ended December 31, 2022. Humacyte believes that its cash and cash equivalents, including net proceeds from the March offering and additional draw under the Oberland funding arrangement, will be adequate to finance operations for at least 12 months from the date of this financial report, well past the currently anticipated timelines for FDA approval of commercialization of the HAV in the vascular trauma indication. There was no revenue for either the fourth quarter of 2023 or the fourth quarter of 2022, and there was no revenue for the year ended December 31, 2023. Revenue was $1.6 million for the year ended December 31, 2022, and was related to a grant supporting the development of the HAV that was completed during 2022. Research and development expenses were $20.2 million for the fourth quarter of 2023, compared to $15.0 million for the fourth quarter of 2022, and were $76.6 million for the year ended December 31, 2023, compared to $63.3 million for the year ended December 31, 2022. The 2023 increases resulted primarily from increased personnel, external services expenses and materials expenses to support expanded research and development initiatives and our clinical trials, including the completion of our V005 Phase 2/3 and V017 Ukraine Humanitarian trials for the use of the HAV in extremity vascular trauma, our BLA filing in December 2023, and expansion of clinical development of the HAV for use in AV access for hemodialysis. General and administrative expenses were $6.0 million for the fourth quarter of 2023, compared to $5.8 million for the fourth quarter of 2022, and were $23.5 million for the year ended December 31, 2023, compared to $22.9 million for the year ended December 31, 2022. The slight net increases in 2023 resulted primarily from increased personnel costs, primarily driven by preparation for the planned commercial launch of the HAV in the vascular trauma indication. Other net income (expense) was net income of $1.1 million for the fourth quarter of 2023, compared to net income of $17.1 million for the fourth quarter of 2022, and was net expense of $10.7 million for the year ended December 31, 2023, compared to net income of $72.6 million for the year ended December 31, 2022. The reduction in other net income for the fourth quarter of 2023, and the increase in other net expense for the year December 31, 2023, resulted primarily from the non-cash remeasurement of the contingent earnout liability associated with the August 2021 merger with Alpha Healthcare Acquisition Corp. Net loss was $25.1 million for the fourth quarter of 2023, compared to $3.7 million for the fourth quarter of 2022, and net loss was $110.8 million for the year ended December 31, 2023, compared to $12.0 million for the year ended December 31, 2022. The 2023 increases in net loss resulted from the non-cash remeasurement of the contingent earnout liability, and operating expense increases, described above. Conference Call and Webcast Details Title:Humacyte Fourth Quarter and Year End 2023 Financial Results and Corporate UpdateDate:Friday, March 22, 2024Time:8:00 a.m. ETConference Call Details:Toll-Free: 1- 877-704-4453International: 1-201-389-0920Conference ID #: 13744046Call meTM Feature (avoid waiting for operator):Click HereWebcast:Webcast Link - Click Here A replay of the webcast will be available following the conclusion of the live broadcast and will be accessible on the investors section of the Company’s website for at least 30 days. About Humacyte Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s initial opportunity, a portfolio of HAVs, is currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, AV access for hemodialysis, and peripheral arterial disease. Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm HAV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm HAV for urgent arterial repair following extremity vascular trauma also has received an RMAT designation. The HAV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com. Forward-Looking Statements This press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, statements regarding our plans and ability to execute product development, process development and preclinical development efforts successfully and on our anticipated timelines; our plans and ability to obtain marketing approval from the FDA and other regulatory authorities for the HAV and other product candidates; the outcome of the FDA’s review of our BLA seeking approval of the HAV in the vascular trauma indication; our ability to design, initiate and successfully complete clinical trials and other studies for our product candidates and our plans and expectations regarding our ongoing or planned clinical trials, including for our V007 Phase 3 clinical trial; the characteristics and performance of the HAV; our ability to manufacture HAVs and other product candidates in sufficient quantities to satisfy our clinical trial and commercial needs; our plans and ability to commercialize the HAV and other product candidates, if approved by regulatory authorities; and our anticipated cash runway. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, changes in applicable laws or regulations, the possibility that Humacyte may be adversely affected by other economic, business, and/or competitive factors, and other risks and uncertainties, including those described under the header “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2022 and in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, each filed by Humacyte with the SEC, and in future SEC filings. Most of these factors are outside of Humacyte’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Except as required by law, we have no current intention of updating any of the forward-looking statements in this press release. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. Humacyte Investor Contact:Joyce AllaireLifeSci Advisors LLC+1-617-435-6602jallaire@lifesciadvisors.cominvestors@humacyte.com Humacyte Media Contact:Rich LuchettePrecision Strategies+1-202-845-3924rich@precisionstrategies.commedia@humacyte.com Humacyte, Inc. Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited) (in thousands except for share and per share amounts) Three Months EndedDecember 31, Year EndedDecember 31, 2023 2022 2023 2022 Grant revenue$— $— $— $1,565 Operating expenses: Research and development 20,180 14,957 76,550 63,260 General and administrative 6,002 5,833 23,497 22,883 Total operating expenses 26,182 20,790 100,047 86,143 Loss from operations (26,182) (20,790) (100,047) (84,578) Other income (expense), net Change in fair value of contingent earnout liability 1,685 17,118 (10,023) 75,767 Other expense (net) (609) (48) (706) (3,154)Total other income (expense), net 1,076 17,070 (10,729) 72,613 Net loss and comprehensive loss$(25,106) $(3,720) $(110,776) $(11,965) Net loss per share, basic and diluted$(0.24) $(0.04) $(1.07) $(0.12)Weighted-average shares outstanding, basic and diluted 103,607,631 103,162,219 103,420,238 103,051,366 Humacyte, Inc. Condensed Consolidated Balance Sheets (unaudited) (in thousands) As of December 31, 2023 2022 Assets Current assets: Cash and cash equivalents$80,448 $149,772 Prepaid expenses and other current assets 2,830 2,329 Short-term investments — 2,107 Total current assets 83,278 154,208 Property, plant and equipment, net 26,791 30,039 Finance lease right-of-use assets, net 17,313 19,373 Other long-term assets 841 682 Total assets $128,223 $204,302 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable$6,490 $1,595 Accrued expenses 9,340 7,108 Other current liabilities 2,613 2,306 SVB loan payable, current portion — 8,571 Total current liabilities 18,443 19,580 Revenue interest liability 38,600 — Contingent earnout liability 37,916 27,893 Finance lease obligation, net of current portion 16,293 18,853 Other long-term liabilities 3,425 712 SVB loan payable, net of current portion — 20,336 Total liabilities 114,677 87,374 Stockholders’ equity Common stock and additional paid-in capital 550,860 543,466 Accumulated deficit (537,314) (426,538)Total stockholders’ equity 13,546 116,928 Total liabilities and stockholders’ equity$128,223 $204,302