On Tuesday, BTIG 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. This 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.
The 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. However, management could not provide further details beyond what has already been made public.
In other recent news, Humacyte, a biotechnology firm, has experienced several significant developments. The company announced 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.
In financial news, Humacyte 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.
Humacyte also announced the addition of two new members to its Board of Directors, Dr. John P. Bamforth and Dr. Keith Anthony Jones. In other corporate news, the company has received approval for four new ICD-10-PCS codes from the U.S. Centers for Medicare & Medicaid Services, a significant step towards a New Technology Add-on Payment application expected later in 2024.
The company has also reported successful top-line outcomes from its Phase 3 clinical trial for ATEV. Additionally, Humacyte has entered into a licensing agreement with Pluristyx to utilize their clinical-grade induced Pluripotent Stem Cell line for the production of insulin-producing cells, a significant stride towards treating insulin-dependent diabetes.
Finally, Humacyte has been awarded a third Regenerative Medicine Advanced Therapy designation from the U.S. Food and Drug Administration for its ATEV, intended for patients with advanced peripheral artery disease. These are all recent developments in the company's operations.
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