Humacyte Earnings Reports

In Q4 2024, Humacyte recorded no revenue and a net loss of $20.9 million, down from $25.1 million in the same quarter last year. Operating expenses rose slightly year-over-year due to commercial launch preparations, while other income improved due to non-cash remeasurement of contingent earnout liabilities.

Humacyte reported no revenue for Q3 2024. Research and development expenses were $22.9 million, while general and administrative expenses were $7.3 million. The net loss for the quarter was $39.2 million. Cash, cash equivalents, and restricted cash totaled $71 million as of September 30, 2024.

Humacyte announced that the FDA requires additional time to complete its review of the Biologic License Application (BLA) for the acellular tissue engineered vessel (ATEV) in the vascular trauma indication. The company was informed by FDA CBER leadership that additional time was needed, and a revised action date is not yet available.

Humacyte announced the FDA's acceptance and priority review of its BLA for the HAV in vascular trauma, setting a PDUFA date of August 10, 2024. The company raised approximately $43 million in net proceeds from a public offering and believes its cash and cash equivalents will be adequate to finance operations for at least 12 months.

Humacyte reported no revenue for Q4 2023, research and development expenses of $20.2 million, general and administrative expenses of $6.0 million, and a net loss of $25.1 million. The company's BLA for HAV was accepted by the FDA and granted priority review. They raised approximately $43.1 million in net proceeds from a public offering of common stock.

Humacyte announced positive top line results from its V005 Phase 2/3 trial of the HAV in vascular trauma repair and plans to file a BLA for an indication in vascular trauma with the FDA during the current quarter. The company reported cash and cash equivalents of $100.0 million as of September 30, 2023.

Humacyte reported no revenue for Q2 2023. Enrollment was completed in the Phase 2/3 V005 trial of HAV™ in Vascular Trauma Repair. Top-line results are expected in Q3 2023, followed by a planned BLA filing in Q4 2023. Cash and cash equivalents were $114.6 million as of June 30, 2023.

Humacyte reported its Q1 2023 financial results, highlighting the second RMAT designation by the FDA for Vascular Trauma and the completion of enrollment in the Phase 3 trial of HAV in Hemodialysis Access in End-Stage Renal Disease Patients. The company's net loss increased due to a change in the fair value of the contingent earnout liability.

Humacyte reported no revenue for Q4 2022, research and development expenses of $15.0 million, general and administrative expenses of $5.8 million, and a net loss of $3.7 million. The company's cash, cash equivalents, and short-term investments totaled $151.9 million as of December 31, 2022.

Humacyte reported $31 thousand in revenue for Q3 2022, primarily from grants. The company's net loss was $25.3 million, and they had $171.7 million in cash, cash equivalents, and short-term investments as of September 30, 2022. They anticipate filing their BLA in mid 2023.

Humacyte reported revenue of $1.3 million for the second quarter of 2022, compared to $0.7 million for the second quarter of 2021. Net income was $36.9 million for the second quarter of 2022, compared to a net loss of $17.2 million for the second quarter of 2021. The company's cash, cash equivalents and short-term investments totaled $189.0 million as of June 30, 2022.

Humacyte reported first quarter 2022 financial results, with revenue of $233 thousand and a net loss of $19.8 million. The company's cash, cash equivalents, and short-term investments totaled $206.2 million as of March 31, 2022, which is expected to fund operations through the end of 2024.

Humacyte completed its business combination with Alpha Healthcare Acquisition Corp. and raised $242M in proceeds. The company progressed advanced-stage clinical- and early-stage programs of the human acellular vessel (HAV™) and other engineered tissue platform applications.