Humacyte Reports Promising 1Q 2024 Results and FDA Progress for HAV

Humacyte's Biologics License Application for its Human Acellular Vessel was accepted by the FDA with Priority Review, setting a PDUFA date for August 10, 2024. The company reported a net loss of $31.9 million in Q1 2024 and strengthened its balance sheet with $115.5 million in cash and cash equivalents.

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Humacyte Reports Promising 1Q 2024 Results and FDA Progress for HAV

Humacyte Reports Promising 1Q 2024 Results and FDA Progress for HAV

Humacyte Inc. (NASDAQ: HUMA) announced its first quarter 2024 financial results and provided a business update on May 12, 2024. The regenerative medicine company reported significant progress with its lead product candidate, the Human Acellular Vessel (HAV), which is being developed for vascular trauma indications.

The U.S. Food and Drug Administration (FDA) accepted Humacyte's Biologics License Application (BLA) for the HAV in vascular trauma in February 2024, granting it Priority Review with a PDUFA date set for August 10, 2024. The BLA submission included positive results from the company's V005 Phase 2/3 clinical trial and real-world evidence from the treatment of wartime injuries in Ukraine under an FDA-supported humanitarian aid program.

Why this matters: The approval of Humacyte's HAV could revolutionize the treatment of vascular trauma, providing a new and innovative solution for patients suffering from traumatic vascular injuries. This development also highlights the potential of regenerative medicine to address unmet medical needs and improve patient outcomes.

"The start of 2024 has been highly productive for Humacyte," said Dr. Laura Niklason, President and Chief Executive Officer of Humacyte. "We remain on track with our BLA review and commercial launch preparations and we remain confident in the approvability of the HAV in vascular trauma."

Humacyte strengthened its balance sheet in the first quarter, raising $43 million in equity in February 2024 and securing $20 million in funding under its arrangement with Oberland Capital. As of March 31, 2024, the company had cash and cash equivalents of $115.5 million.

In preparation for the anticipated U.S. market launch of the HAV, Humacyte has been actively engaged in commercial readiness activities. The company has implemented a multidisciplinary program to ensure launch readiness, completed a budget impact model demonstrating the HAV's potential economic value compared to the current standard of care, and commenced recruiting a high-quality sales team, including hiring Morgan Rankin as Vice President of Sales.

During the company's earnings call, Chief Operating Officer Heather Prichard mentioned that the pre-licensing inspection of Humacyte's manufacturing facility was successful, indicating confidence in the approval of the HAV in vascular trauma. The company's current manufacturing capacity is approximately 8,000 HAVs per year, with the potential to expand up to 40,000 HAVs annually as needed.

Humacyte reported a net loss of $31.9 million for the first quarter of 2024, an improvement from the $37.0 million net loss in the same period of 2023. The company did not report any revenues for either quarter. Research and development expenses increased to $21.3 million in Q1 2024 from $17.3 million in Q1 2023, while general and administrative expenses remained relatively stable at $5.3 million compared to $5.2 million in the prior year.

Looking ahead, Humacyte plans to present data from its V007 trial, considering all patients and specific demographic subsets, which could influence discussions with regulatory agencies. The company has also submitted an application for an ICD-10 code for HAV implantation procedures, receiving a positive recommendation from the Centers for Medicare & Medicaid Services (CMS), with a final decision expected by June 2024. With the HAV's anticipated approval in August 2024, Humacyte is poised to introduce an innovative regenerative medicine product for patients suffering from traumatic vascular injuries.

Key Takeaways

  • Humacyte's HAV BLA accepted by FDA with Priority Review and PDUFA date set for August 10, 2024.
  • HAV could revolutionize vascular trauma treatment, providing a new and innovative solution for patients.
  • Humacyte strengthened its balance sheet, raising $43M in equity and securing $20M in funding.
  • Company prepares for US market launch, completing commercial readiness activities and hiring sales team.
  • Humacyte reports net loss of $31.9M for Q1 2024, with R&D expenses increasing to $21.3M.