On May 13, 2024DURECT Corporation (Nasdaq: DRRX) reported financial results for the three months ended March 31, 2024 and provided a business update (Press release, DURECT, MAY 13, 2024, View Source [SID1234643168]).

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"We are pleased that the feedback from the U.S. Food and Drug Administration (FDA) supports the advancement of larsucosterol into a single pivotal Phase 3 clinical trial which, if successful, may serve as the basis for a New Drug Application (NDA) in alcohol-associated hepatitis (AH)," stated James E. Brown, D.V.M., President and CEO of DURECT. "We are in the process of designing the registrational Phase 3 trial incorporating the FDA’s comments and insights gained from our Phase 2b AHFIRM trial. In addition, we are excited about the upcoming presentation at the European Association for the Study of the Liver (EASL) Congress 2024, which will be the first presentation of the AHFIRM data at a medical conference. We expect to provide additional details on our planned Phase 3 protocol and present new analyses from AHFIRM later in the year."

Business Update:

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During a Type C meeting with the FDA, DURECT received feedback on the recommendations for a Phase 3 clinical trial for larsucosterol in AH that could support a potential NDA filing. DURECT is in the process of designing its planned Phase 3 clinical trial based on the FDA feedback and the results from its completed Phase 2b AHFIRM clinical trial.
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DURECT announced the acceptance of a late-breaking oral presentation at the European Association for the Study of the Liver (EASL) Congress 2024 to take place June 5-8, 2024 in Milan, Italy. The presentation will feature data from the Company’s Phase 2b AHFIRM trial, which evaluated the safety and efficacy of larsucosterol as a treatment for patients with severe AH.

Financial Highlights for Q1 2024:

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Total revenues were $1.8 million and net loss was $7.6 million for the three months ended March 31, 2024 compared to total revenues of $2.1 million and net loss of $12.0 million for the three months ended March 31, 2023.
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Cash, cash equivalents and investments were $21.6 million at March 31, 2024, compared to $29.8 million at December 31, 2023. Debt at March 31, 2024 was $14.6 million, compared to $16.7 million at December 31, 2023.

Earnings Conference Call

We will host a conference call and webcast today at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss the first quarter 2024 results and provide a corporate update:

Monday, May 13 @ 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time

Toll Free: 1-877-407-0790

International: 1-201-689-8560

Conference ID: 13746111