Humacyte reports Q1 EPS (29c), consensus (22c)

Reports Q1 research and development expenses were $21.3M.The Company reported cash and cash equivalents of $115.5M as of March 31. “During the Q1 we achieved a major milestone with the acceptance by the FDA of our Biologics License Application (BLA) seeking approval of the HAV in the vascular trauma indication,” said Laura Niklason, CEO. “The FDA’s decision to grant Priority Review sets a Prescription Drug User Fee Act date of August 10, 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.”