Exhibit 99.2 Humacyte Second Quarter 2024 Financial Results and Business Update -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., August ...

Friday, the FDA announced it would require additional time to complete its review of Humacyte Inc.'s HUMA Biologic License Application (BLA) for the acellular tissue-engineered vessel (ATEV) in the vascular trauma indication. The ATEV trauma program BLA was submitted to the FDA in December 2023, and the FDA granted a Priority Review in February 2024 and assigned a PDUFA date of August 10, 2024. In a phone call from FDA CBER leadership today, the Company was informed that the FDA required additional time to ...

Core Viewpoint - Humacyte, Inc. announced that the FDA requires additional time to review its Biologic License Application for the acellular tissue engineered vessel (ATEV) intended for vascular trauma, which was initially set for a PDUFA date of August 10, 2024 [1][2] Company Overview - Humacyte is a clinical-stage biotechnology platform company focused on developing universally implantable, bioengineered human tissues at commercial scale [1][4] - The company is working on a portfolio of ATEVs targeting multiple vascular applications, including vascular trauma repair, arteriovenous access for hemodialysis, and peripheral artery disease [4][5] - The ATEV is designed to be a first-in-class bioengineered human tissue that serves as a universally implantable vascular conduit for arterial replacement and repair [2][4] FDA Review Process - The FDA granted a Priority Review for the ATEV, which typically allows for a six-month review cycle compared to the standard ten-month cycle for most products [2] - The BLA for ATEV was submitted in December 2023, and the FDA has conducted inspections and engaged in discussions regarding the application [2][4] - The company remains confident in the approvability of the ATEV based on positive results from clinical studies and real-world evidence [2][4] Clinical Evidence - The BLA included results from the V005 pivotal Phase 2/3 clinical study and evidence from treating wartime injuries in Ukraine [2] - ATEV has been used in various traumatic injury cases, demonstrating high rates of patency and low rates of amputation and infection [2][4]

"We are thrilled to announce positive results for the Phase 3 V007 trial, which we believe highlight the potential of the ATEV to improve AV access in hemodialysis patients who are underserved by the current standard of care," said Laura Niklason, M.D., Ph.D., Chief Executive Officer of Humacyte. "Achievement of this major milestone has taken a tremendous amount of effort and commitment from our patients, clinical investigators, employees, and other collaborators, and I thank them for their great support an ...

Additionally, investors should keep an eye on any recent revisions to analyst forecasts for Humacyte, Inc. Such recent modifications usually signify the changing landscape of near-term business trends. With this in mind, we can consider positive estimate revisions a sign of optimism about the company's business outlook. Heading into today, shares of the company had gained 63.73% over the past month, outpacing the Medical sector's gain of 0.37% and the S&P 500's gain of 1.96% in that time. Research indicates ...

– Third RMAT designation by FDA for ATEV – DURHAM, N.C., July 01, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (NASDAQ:HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, has been granted the U.S. Food and Drug Administration's (FDA's) Regenerative Medicine Advanced Therapy (RMAT) designation for patients with advanced peripheral artery disease (PAD). This RMAT designation is granted at the same time as FDA cleared a new Inve ...

DURHAM, N.C., July 01, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, has been granted the U.S. Food and Drug Administration's (FDA's) Regenerative Medicine Advanced Therapy (RMAT) designation 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 ...

– BioVascular Pancreas (BVP) product candidate is under development as a potential treatment for type 1 diabetes – – Humacyte's stem cell-derived islets observed to restore normal blood glucose in diabetic mice – – Non-human primate models of BVP implantation showed islet survival and continued insulin production – DURHAM, N.C., June 25, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (NASDAQ:HUMA), a clinicalstage biotechnology platform company developing universally implantable, bioengineered human tissues at com ...

Additionally, investors should keep an eye on any recent revisions to analyst forecasts for Humacyte, Inc. Recent revisions tend to reflect the latest near-term business trends. As such, positive estimate revisions reflect analyst optimism about the company's business and profitability. Heading into today, shares of the company had lost 27.32% over the past month, lagging the Medical sector's gain of 0.44% and the S&P 500's gain of 3.15% in that time. Our research reveals that these estimate alterations are ...

– Four unique ICD-10-PCS codes, effective October 1, 2024, for replacement of arteries in the upper and lower extremities using Humacyte's HAV – – BLA submission under Priority Review by FDA for the treatment of vascular trauma, supported by Phase 2/3 clinical trial results and real-world use treating wartime trauma injuries in Ukraine – DURHAM, N.C., June 17, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (NASDAQ:HUMA), a clinicalstage biotechnology platform company developing universally implantable, Human Acell ...