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| Statement |
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| In addition, we continue building a robust intellectual property portfolio and strengthening our long-term patent protection |
| This provides us with a strong foundation from which we are expanding into development in AAD in our TRANQUILITY program and into development in different settings in the bipolar and schizophrenia populations through the SERENITY program |
| Finally, we are pleased to have received fast track designation from the FDA for BXCL701 |
| First, we are very pleased with the progress of our TRANQUILITY program |
| We are also pleased with progress in other areas of the business |
| This area of neuroscience drug development for an episodic treatment is novel and uncharted, and we believe we are uniquely positioned in this space |
| So I think the choice of 120-microgram dose, we believe, is a good choice for the following reason: efficacy is fundamentally established for that dose |
| These late-stage clinical programs represent groundbreaking opportunities to advance our goal of bringing new treatment options to patients |
| So it's a very good partnership, and we work together to chart out the optimal path |
| We are always in discussion with our strategic partner, and they are very supportive of facilitating and having company be able to get financing, because they really believe in this asset and they see that this is a large market opportunity |
| This is an exciting time for BioXcel Therapeutics |
| Both programs provide significant opportunities for us to address the unmet needs in treating patients is struggling with episodes of acute agitation |
| We're extremely motivated by this potential opportunity to bring a much needed acute treatment option to patients |
| So we feel that building a beachhead there makes a really good commercial sense |
| We're seeing more of that in Q1, and we expect to see continued growth |
| So our trials, we have a tremendous experience in the company |
| In Q4, we saw revenues increase 10% versus Q3 |
| As Vimal said, TRANQUILITY remains a top priority to bring a novel treatment to this large, underserved patient population |
| We have a very good idea in terms of the timing, as well as capital requirement for that trial |
| These trials are capital efficient and the opportunity we have in front of us is very large |
| I would like to end my remarks by emphasizing that we remain focused on strengthening the company's balance sheet |
| To that point, we've had multiple meetings with the FDA for this uncharted regulatory path and have greatly appreciated the agency's guidance as we move forward to advancing our clinical program |
| On January 1, the permanent J Code for IGALMI became effective, and our commercial [Technical Difficulty] efforts continue to progress |
| In terms of the SERENITY at-home trial, we have tremendous experience with SERENITY 1, 2 and SERENITY 3 |
| Have a great day |
| Good morning and thank you for joining us |
| And overall, these trials are capital efficient, and they can be delivered in a reasonable time |
| Sumant Kulkarni Good morning |
| To this end, we are actively exploring multiple financial options to extend our cash runway and fund our key clinical programs in order to create maximum value for our shareholders |
| Richard Steinhart In terms of the run rate, Samir, yes, it's probably a good marker, plus or minus a few dollars, but generally a pretty good marker |
| Statement |
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| Sales are down sequentially |
| Keep in mind the label for IGALMI currently includes a limitation on use, noting the lack of efficacy or safety data beyond 24 hours |
| Then last question, sorry for three, that's bad |
| So after we met with the FDA last year, and we began to think about the design of the study and in depth and in detail and begin to engage with our advisers and KOLs, it became clear that using non-validated caregiver assessed instruments would be challenging and would, frankly, carry risk |
| BioXcel Therapeutics had a net loss of $22.3 million for the fourth quarter of 2023, compared to a net loss of $54.8 million for the same period in 2022 |
| Again, acknowledging you didn't satisfy one of the requirements |
| OpEx is significantly lower in the quarter than I had |
| For the same year -- for the full-year 2023, the company reported a net loss of $179 million, compared to a net loss of $165.8 million for the full-year 2022 |
| Lastly, the FDA has indicated that we will need to generate long-term safety data |
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