Analyst Summary:
DURECT Corporation (Nasdaq: DRRX) reported financial results for Q4 2022, showing revenues of $14.4 million, and FY 2022 with revenues of $56.3 million. The company also reported a net loss of $31.4 million, or $0.11 per share, for Q4 2022 and a net loss of $95.4 million, or $0.34 per share, for FY 2022. DURECT is on track to complete enrollment for its AHFIRM trial in Q2 2023, with topline data expected in H2 2023. Larsucosterol has the potential to be the first FDA-approved treatment for alcohol-associated hepatitis. The trial is being conducted across 60 study sites globally. The company has a cash and investments balance of $43.7 million at December 31, 2022. In addition, DURECT entered into a $21.0 million registered direct offering of common stock and warrants with a leading institutional healthcare investor and an existing institutional investor. Management believes a positive outcome from the AHFIRM trial would support a New Drug Application and ultimately lead to regulatory approval, making it an attractive asset for the company.
CEO James E. Brown, D. V. M stated, "We are poised to complete enrollment in our potentially pivotal AHFIRM trial in the second quarter of 2023 and report topline data in the second half of 2023. Larsucosterol has the potential to be the first FDA-approved treatment for alcohol-associated hepatitis, representing a significant step forward in treating patients afflicted with this highly lethal condition."
Forward-looking statements in the press release regarding the completion of enrollment for the company's pivotal AHFIRM trial, the potential FDA approval of larsucosterol, the ability of a positive outcome in the AHFIRM trial to support regulatory filings, the commercialization of POSIMIR by Innocoll, and the potential to develop larsucosterol for other indications are subject to risks and uncertainties, which could cause actual results to differ materially from those projected. These risks include the ongoing impact of COVID-19 on clinical trials and the possibility that FDA or other government agencies may require additional clinical trials for drug approval.