BioXcel Therapeutics(BTAI) - 2023 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Research and development expenses decreased to $19.6 million for Q3 2023 from $22.1 million in Q3 2022, primarily due to reduced costs associated with BXCL501 SERENITY III and TRANQUILITY II clinical trials [19] - The company reported a net loss of $50.5 million for Q3 2023, compared to a net loss of $41.8 million for the same period in 2022 [20] - Selling, general and administrative expenses increased to $24.3 million for Q3 2023 from $17.1 million in Q3 2022, attributed to one-time legal fees and costs related to OnkosXcel's potential public offering [26] - Cash and cash equivalents totaled $90 million as of September 30, 2023, with an estimated runway through mid-2024 [27] Business Line Data and Key Metrics Changes - Net revenue from IGALMI was approximately $341,000 for the quarter [25] - The company is focusing on enhancing operational and financial flexibility through strategic financing agreements with Oaktree Capital and Qatar Investment Authority [15] Market Data and Key Metrics Changes - The company is positioned to address a large and underserved market for the acute treatment of agitation associated with Alzheimer's disease, with no FDA-approved drugs currently available for this indication [10] Company Strategy and Development Direction - The company is advancing its late-stage clinical programs for BXCL501, specifically the TRANQUILITY and SERENITY III programs, with a focus on at-home treatment settings [8][14] - The company aims to leverage its unique use of artificial intelligence to drive drug innovation and enhance its clinical development programs [17] - The company is prioritizing the TRANQUILITY program due to its significant market opportunity and is actively working on protocol development for the upcoming trial [75] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the alignment with the FDA regarding the development paths for TRANQUILITY and SERENITY III, which are expected to create significant value [8][9] - The management highlighted the importance of the recent positive survival data for BXCL501 in trials for metastatic castrate-resistant prostate cancer, indicating potential strategic options for OnkosXcel [23] - Management emphasized the ongoing support from strategic financial partners and the positive implications of the recent financing agreement [15][63] Other Important Information - The company is conducting a NIDA-funded trial for BXCL501 aimed at treating opioid use disorder, which is considered an emerging national threat [17] - The issuance of a J-Code by CMS is expected to streamline the reimbursement process for IGALMI, potentially increasing its market access [16][91] Q&A Session Summary Question: Can you provide more color on the TRANQUILITY development strategy? - Management confirmed alignment with the FDA to conduct a home-setting trial, emphasizing the importance of providing access to a broad patient population [30] Question: What is the ultimate path forward for BXCL501 in chronic agitation? - Management stated that while there is potential for chronic treatment, the current focus remains on acute treatment in the home setting [39] Question: Can you clarify the safety long-term requirements for submission for the TRANQUILITY program? - Management indicated that long-term safety discussions will continue with the FDA, focusing on the episodic nature of agitation [82] Question: What is the expected impact of the J-Code on sales trajectory? - Management expressed optimism that the J-Code will alleviate economic concerns for hospitals and clinics, facilitating broader use of IGALMI [91]