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Sep 30, 2024
Humacyte Q3 2024 Earnings Report
Announced financial results for the third quarter ended September 30, 2024 and highlighted recent accomplishments.
Key Takeaways
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.
FDA review of acellular tissue engineered vessel (ATEV™) BLA for the treatment of vascular trauma is ongoing.
Results from the V007 Phase 3 clinical trial of the ATEV in arteriovenous (AV) access for hemodialysis patients presented at American Society of Nephrology’s Kidney Week 2024.
Long-term results from the humanitarian program where the ATEV was used to treat vascular injuries suffered during the Ukraine conflict were presented at the U.S. Department of Defense’s foremost scientific meeting.
The ATEV received its third Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA, specifically in advanced peripheral artery disease.
Forward Guidance
Humacyte is awaiting the outcome of the FDA's review of its BLA for ATEV in vascular trauma and is preparing for the potential commercial launch.
Positive Outlook
- The ATEV was observed to have superior function and patency at six and 12 months (co-primary endpoints) compared to autogenous fistula.
- The ATEV was also observed to have superior function and patency in female, obese, and diabetic patients.
- Positive long-term results from the humanitarian program conducted in Ukraine under which the ATEV was used to treat vascular injuries suffered during the conflict were presented.
- The ATEV was observed to have high rates of patency (blood flow) and the avoidance of amputation and infection despite the severe nature of the wartime injuries treated.
- The U.S. Patent Office allowed a patent covering Humacyte’s BVP product candidate for the treatment of type 1 diabetes.
Challenges Ahead
- The FDA requires additional time to complete review of BLA for ATEV in the Treatment of Vascular Trauma.
- FDA leadership has not provided a timeline for the completion of their review.
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