Release Date: June 11, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Positive results from the PALISADE-2 US Phase 3 study of fasedienol for the acute treatment of social anxiety disorder (SAD).
- Launch of the PALISADE-3 Phase 3 trial, marking a significant step forward in the registration-directed PALISADE Phase 3 program for fasedienol in SAD.
- Favorable and differentiated safety profiles demonstrated by the non-systemic, neurocircuitry-focused pherines in all clinical studies completed to date.
- Significant decrease in research and development expenses from $44.4 million in 2023 to $20 million in 2024.
- Strong cash position with $119.2 million in cash and cash equivalents as of March 31, 2024.
Negative Points
- No specific guidance provided on enrollment numbers or screen failure rates for the PALISADE-3 trial.
- General and administrative expenses remained relatively high at $14.1 million for the year ended March 31, 2024.
- Net loss attributable to common stockholders was $29.4 million for the year ended March 31, 2024.
- Potential variability in the public speaking challenge protocol and the need for enhanced surveillance and control measures.
- Uncertainty around the outcomes of the repeat dose study and its impact on labeling and safety data.
Q & A Highlights
Q: In PALISADE-3, how many patients have you enrolled so far? And is the enrollment cadence looking stronger or slower than the first couple of studies? Also, can you comment on the screen failure rate and how that compares to the prior studies?
A: We haven’t given any specific guidance on enrollment numbers or screen failure rates. However, we are very happy with the way PALISADE-3 has kicked off. We’ve built in important efficiencies and leveraged lessons learned from previous studies. Our team is well-positioned to continue this study on track, with readouts expected mid-2025 for PALISADE-3 and near the end of 2025 for PALISADE-4.
Q: Can you provide more color on the notable enhancements made to PALISADE-3 and PALISADE-4, such as operational changes and enhanced surveillance?
A: The public speaking challenge design and SUDS as the primary efficacy endpoint remain unchanged. Enhancements include optimal subject screening, precise inclusion/exclusion criteria, and consistent administration of the public speaking challenge protocol. For example, we’ve added exclusion criteria like limiting high-frequency smoking or vaping and recent nasal swabs. We’ve also improved site monitoring and staffing models, allowing for rigorous training and oversight.
Q: What are you looking to achieve with the repeat dose study? Is it more about building the safety database or replicating efficacy with a multi-dose paradigm?
A: The repeat dose study is designed to inform labeling and provide guidance to physicians on how to advise patients. It involves administering a second dose 10 minutes after the first before the public speaking challenge. This study will help us understand the real-world implications of patients potentially taking an additional dose if they still feel nervous after the first.
Q: How many sites are up and enrolling patients for PALISADE-3, and how many of these overlap with PALISADE-1 and PALISADE-2?
A: Currently, we have around 10 sites up for PALISADE-3. Some of these sites overlap with PALISADE-1 and PALISADE-2. We’ve focused on selecting high-quality sites, leveraging our experience to ensure optimal execution. The awareness and understanding of our program have significantly improved, contributing to a higher quality pool of potential sites.
Q: Will the small placebo-controlled repeat dose study record SUDS scores before and after the repeat dose, or is it more focused on safety and tolerability?
A: The study will record SUDS scores identical to those collected in PALISADE-3 and PALISADE-4. The second dose is administered during the 15-minute waiting period before the public speaking challenge, ensuring the study design remains consistent.
Q: Will certain non-response after the first dose trigger the second dose, or will all data be collected regardless of patient response?
A: The second dose is administered during the 15-minute waiting period before the public speaking challenge, not after the challenge. This ensures consistency in the study design and allows us to collect comprehensive data.
Q: Can you elaborate on the potential benefits of the repeat dose study for labeling and physician guidance?
A: The repeat dose study aims to provide real-world data on the effects of a second dose, informing labeling and physician guidance. It includes three arms: placebo followed by placebo, fasedienol followed by placebo, and fasedienol followed by fasedienol. This design helps us understand the implications of multiple dosing within a short timeframe.
Q: How has the experience of conducting studies during the pandemic influenced the design and execution of PALISADE-3 and PALISADE-4?
A: Conducting studies during the pandemic provided valuable lessons that we’ve applied to PALISADE-3 and PALISADE-4. We’ve improved site monitoring, staffing models, and training, allowing for more consistent execution and reduced variability. The stable clinical research environment post-pandemic has also contributed to better site performance and reduced staff turnover.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
