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Mar 31, 2024
Humacyte Q1 2024 Earnings Report
Reported financial results for the first quarter ended March 31, 2024, highlighted FDA acceptance of BLA for HAV with priority review and raised approximately $43 million in net proceeds from a public offering.
Key Takeaways
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.
FDA accepted the Biologics License Application (BLA) for HAV™ and granted Priority Review for vascular trauma indication with a PDUFA date of August 10, 2024.
Raised approximately $43 million in net proceeds from a public offering of common stock.
Completed a Budget Impact Model illustrating the potential economic value of the HAV compared to current standard of care in vascular trauma.
FDA completed its Pre-Licensing Inspection of manufacturing facilities in Durham, North Carolina as part of the BLA review process.
Humacyte
Humacyte
Forward Guidance
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.