Release Date: August 07, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: Can you explain why higher inhaled treprostinil exposure is beneficial for PAH and PH-ILD? A: Roger Jeffs, CEO, explained that prostacyclins allow for continuous titration to effect, which is crucial for progressive diseases like PAH and PH-ILD. YUTREPIA offers the benefits of parenteral and oral products with fewer systemic side effects, allowing for higher dosing flexibility and effectiveness. Rajeev Saggar, CMO, added that higher doses have shown improved outcomes in clinical observations, making YUTREPIA a potentially best-in-class treatment.
Q: When can we expect comprehensive data from the ASCENT trial, and what key questions will it address? A: Rajeev Saggar, CMO, stated that the ASCENT trial focuses on safety, tolerability, and exploratory efficacy of YUTREPIA in PH-ILD patients. The study aims to demonstrate durability and optimal dosing. Preliminary data will be presented at upcoming conferences, with full results expected by year-end and publication in 2025.
Q: What are the next steps in the UT case against the FDA, and how might it affect the YUTREPIA NDA decision? A: Rusty Schundler, General Counsel, mentioned that the court could either hold an oral argument or rule on the briefs regarding the motion to dismiss. The company cannot comment on FDA communications, but they remain focused on obtaining approval for YUTREPIA.
Q: Can you provide details on the L606 registrational study and the ASCENT study's progress? A: Rajeev Saggar, CMO, noted that the L606 study will start by year-end, focusing on 6-minute walk distance as the primary endpoint. The ASCENT study has tripled its sites and aims to complete by year-end, with 15 patients expected by month-end.
Q: How does the company plan to manage cash burn, and are there plans to respond to United's citizens' petition? A: Mike Kaseta, CFO, stated that Liquidia has $133 million in cash and is confident in its financial position to support key objectives. Rusty Schundler, General Counsel, added that they do not plan to publicly respond to the citizens' petition, focusing instead on direct communications with the FDA.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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