BTIG has adjusted its price target for Humacyte (NASDAQ: HUMA), a biotechnology company, reducing it to $10.00 from the previous $11.00 while keeping a Buy rating on the stock. The revision comes on the heels of Humacyte's second-quarter financial results for 2024, which reported no revenue and a loss per share (LPS) of $(0.48).
These figures stood in contrast to the anticipated LPS of $(0.25)/$(0.24) by BTIG and consensus estimates. The change in the price target reflects an increase in the number of shares outstanding.
Humacyte's quarterly performance showed higher-than-expected operating expenses, as well as changes in the fair value of the company's contingent earn-out liability. Despite the lack of revenue and the wider loss, the analyst emphasized the company's ongoing efforts to advance its ATEV product within the field of Vascular Trauma.
The company had a setback last Friday when the U.S. Food and Drug Administration (FDA) required additional time to review the ATEV, leading to a delay beyond the previously anticipated Prescription Drug User Fee Act (PDUFA) date of August 10, 2024.
This delay came as a surprise to both investors and the company. However, management expressed that such delays are not uncommon, with approximately 25% of Biologics License Applications (BLAs) receiving clearance either before or after the expected PDUFA date.
Management has been in discussions with BTIG analysts both last week and again on Tuesday, conveying confidence that the delay is not indicative of any fundamental issues with the ATEV's approval for Vascular Trauma or any future indications.
The company has had positive interactions with the FDA concerning post-market activities, labeling, facility inspections, and clinical results, all of which suggest that clearance is likely.
In other recent news, Humacyte said that the FDA has extended its review of Humacyte's Biologic License Application for its acellular tissue-engineered vessel (ATEV) designed for vascular trauma. Despite the delay, Humacyte remains confident in the approvability of ATEV, which has shown promising results in clinical studies and real-world applications.
It reported a net loss of $31.9 million for the first quarter of 2024 but secured $63 million in funding, ending the quarter with $115.5 million in cash and cash equivalents. TD Cowen has maintained a buy rating on Humacyte, expressing confidence in the company's potential.
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