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Mar 31, 2023
Humacyte Q1 2023 Earnings Report
Announced first quarter 2023 financial results and business update.
Key Takeaways
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.
Received second RMAT designation from the FDA for HAV in vascular trauma, potentially expediting BLA review.
Completed enrollment in Phase 3 trial of HAV in Hemodialysis Access, with top-line results expected in 2024.
Published data in The Lancet Regional Health - Europe highlighting successful HAV use in treating vascular trauma in Ukraine.
Announced collaboration with JDRF International to advance the development of the Biovascular Pancreas (BVP) product candidate for Type 1 diabetes.
Humacyte
Humacyte
Forward Guidance
Humacyte believes that its cash, cash equivalents short-term investments and planned funding from the Oberland funding agreement are adequate to fund operations past the anticipated timelines for potential approval and commercialization of the HAV in vascular trauma.
Positive Outlook
- Progress toward planned BLA filing of HAV in vascular trauma
- Granted FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation for the HAV
- RMAT designation allows for more interactions with the FDA and expedited development and review of regenerative medicine products within the U.S.
- Completed enrollment of a Phase 3 trial in hemodialysis access
- Collaboration with JDRF International to advance the development of Humacyte’s BVP product candidate
Challenges Ahead
- Changes in applicable laws or regulations
- Humacyte may be adversely affected by other economic, business, and/or competitive factors
- The possibility of not receiving the necessary regulatory approvals for our products
- The outcome of ongoing discussions with the FDA concerning the design of our ongoing V005 Phase 2/3 clinical trial
- Uncertainties regarding the timing, scope, and rate of reimbursement for our HAVs