Release Date: November 14, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- BioXcel Therapeutics Inc (BTAI, Financial) announced important milestones with two pivotal Phase 3 trials for BXCL501, targeting agitation associated with bipolar disorder, schizophrenia, and Alzheimer's dementia.
- The SERENITY at home trial for BXCL501 represents a near-term growth opportunity and is the company's immediate focus area.
- The company received a Department of Defense grant to fund a Phase 2a study of BXCL501 for acute stress disorder, highlighting external validation of its therapeutic potential.
- Research and development expenses significantly decreased from $19.6 million in Q3 2023 to $5.1 million in Q3 2024, reflecting cost management and reprioritization efforts.
- BioXcel Therapeutics Inc (BTAI) reported an 89% increase in net revenue for the nine months ended September 30, 2024, compared to the same period in 2023, indicating rising utilization of IGALMI.
Negative Points
- Net revenue for IGALMI decreased to $214,000 in Q3 2024 from $341,000 in Q3 2023, primarily due to the timing of reorders from existing customers.
- The company reported a net loss of $13.7 million for Q3 2024, although this was an improvement from a $50.5 million loss in Q3 2023.
- Cost of goods sold increased significantly to $1.2 million in Q3 2024 from $512,000 in Q3 2023, due to higher non-cash charges for reserves for excess or obsolete inventory.
- BioXcel Therapeutics Inc (BTAI) is working to strengthen its balance sheet and is evaluating strategic financing alternatives, indicating potential financial challenges.
- The TRANQUILITY In-Care trial protocol had to be adjusted following FDA feedback, which could impact timelines and resource allocation.
Q & A Highlights
Q: How has the launch of the SERENITY study gone so far, and what is the expected rate of enrollment?
A: Vincent O'Neill, Chief of Product Development and Medical Officer, explained that the study has kicked off with the first patient randomized recently. They are in the ramp-up phase, which is typical for such studies. Despite the holiday season potentially slowing down site activity, they expect a rebound in January. With 26 active sites for 200 patients, they are comfortable with the nine to 12-month timeline.
Q: Are rescue medications allowed in the SERENITY study, and how might this impact the placebo arm?
A: Robert Risinger, Chief Medical Officer, confirmed that rescue medications are allowed. This is a safety measure, and they are tracking it as an indicator of inefficacy for patients on placebo.
Q: What feedback did you receive from the FDA on the TRANQUILITY trial protocol?
A: Vincent O'Neill stated that the FDA feedback was direct, actionable, and concise. They are satisfied with the feedback received.
Q: Can you provide an update on your cash runway and funding options?
A: Vimal Mehta, CEO, mentioned that they are working on all options to strengthen their balance sheet and reach data readout. They have not provided specific guidance but are focused on achieving these goals.
Q: How important is the SERENITY At-Home trial for potential partnership opportunities?
A: Vimal Mehta emphasized that the SERENITY At-Home trial is crucial for unlocking partnership opportunities in the larger at-home agitation market. The company is more advanced than last year, with ongoing trials that could drive significant value for stakeholders.
Q: Is the TRANQUILITY In-Care trial still including a cohort of 20 patients in the At-Home setting?
A: Vincent O'Neill confirmed that after internal discussions, the pilot cohort was removed from the protocol.
Q: What progress has been made regarding BXCL701?
A: Vincent O'Neill noted that the process is ongoing, with activities such as diligence and discussions with potential partners continuing.
Q: Can you provide details on the inventory write-down and future inventory risks?
A: Richard Steinhart, CFO, stated that they are in good shape with the write-down and have enough product to sustain them for the next couple of years. The charge was non-cash, and they have sufficient inventory to meet potential sales increases.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
