Q1 2024 DURECT Corp Earnings Call Transcript
Key Points
- Durect Corp (DRRX) reported significant reductions in 90-day mortality rates in the AHFIRM trial, showing a 41% reduction with the 30 milligram dose and a 35% reduction with the 90-milligram dose of larsucosterol compared to placebo.
- Larsucosterol exhibited an excellent safety profile in the AHFIRM trial with no serious adverse events reported and a greater than 20% reduction in the number of treatment-emergent adverse events for both active arms.
- The company received positive feedback from the FDA indicating that a single successful Phase 3 trial could be sufficient to support an NDA filing for larsucosterol in treating alcohol-associated hepatitis (AH).
- Durect Corp (DRRX) has sufficient cash on hand, amounting to $21.6 million as of March 31, 2024, to fund operations through the end of the year.
- The AHFIRM data has been accepted for an oral, late-breaker presentation at the upcoming EASL conference, providing an opportunity to share significant clinical results with the medical community.
- Total revenues in the first quarter of 2024 decreased to $1.8 million from $2.1 million in the same period in 2023, primarily due to lower revenues from feasibility agreements and product sales.
- The company experienced a significant cash burn of $8.9 million in the first quarter of 2024, excluding net proceeds of approximately $650,000 from ATM financing.
- Neither the primary endpoint nor the key secondary endpoint of the AHFIRM trial achieved statistical significance, despite showing numerical improvements.
- Durect Corp (DRRX) will need additional financing to complete the upcoming Phase 3 trial, with the specifics of this financing still being determined.
- There are currently no approved therapies for AH, indicating a high risk and uncertainty surrounding the potential market approval and commercial success of larsucosterol.
Greetings, and welcome to the DURECT Corporation first-quarter 2024 earnings conference call. At this time all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. (Operator Instructions) As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Tim Papp, Chief Financial Officer. Thank you, sir. You may begin.
Good afternoon, and welcome to DURECT Corporation's first-quarter 2024 earnings conference call. This is Tim Papp, Chief Financial Officer of DURECT. Before we begin, I would like to remind you of our Safe Harbor statement. During the course of this call, we may make forward-looking statements regarding DURECT's products in development, expected product benefits, our development plans, future clinical trials or projected financial results.
These forward-looking statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Further information
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