BioXcel Therapeutics(BTAI) - 2025 Q3 - Quarterly Results

Revenue Performance - Net revenue from IGALMI® was $98 thousand for Q3 2025, down from $214 thousand in Q3 2024, representing a decrease of approximately 54.5%[8] - Product revenues for Q3 2025 were $98,000, a decrease of 54.4% compared to $214,000 in Q3 2024[28] Expenses - Cost of Goods Sold for Q3 2025 was $11 thousand, significantly reduced from $1.17 million in Q3 2024, indicating a decrease of about 99.1%[9] - Research and Development (R&D) expenses increased to $8.7 million in Q3 2025 from $5.1 million in Q3 2024, reflecting a rise of approximately 70.6% due to increased clinical trial activity[10] - Selling, General and Administrative (SG&A) expenses decreased to $5.4 million in Q3 2025 from $7.7 million in Q3 2024, a reduction of about 29.9%[11] - Total operating expenses for Q3 2025 were $14,326,000, a slight decrease of 7.6% from $15,507,000 in Q3 2024[28] Net Loss - The net loss for Q3 2025 was $30.9 million, compared to a net loss of $13.7 million in Q3 2024, representing an increase in net loss of approximately 125.4%[12] - The net loss for Q3 2025 was $30,911,000, compared to a net loss of $13,650,000 in Q3 2024, representing an increase of 126.7%[28] - The company reported a net loss per share of $2.18 for Q3 2025, compared to a loss of $5.15 per share in Q3 2024[28] Cash and Assets - The company reported an operating cash usage of $18.8 million during Q3 2025[12] - Cash and cash equivalents totaled $37.3 million as of September 30, 2025, with an additional $4.9 million raised post-quarter-end[13] - Cash and cash equivalents as of September 30, 2025, were $37,320,000, up from $29,854,000 at the end of 2024[28] - Total assets increased to $44,792,000 as of September 30, 2025, compared to $38,338,000 at the end of 2024[28] - Total liabilities stood at $133,711,000 as of September 30, 2025, slightly up from $131,439,000 at the end of 2024[28] Clinical Trials and Market Potential - The SERENITY At-Home Phase 3 trial involved 246 patients and collected data on 2,628 agitation episodes, demonstrating no discontinuations due to tolerability[3] - The total addressable market for agitation episodes is estimated at 57 to 77 million annually in the U.S., significantly higher than the previous estimate of 23 million[7] - The company plans to submit a supplemental New Drug Application (sNDA) in early Q1 2026 for expanded usage of IGALMI® based on positive trial data[1] Company Focus - The company is focused on advancing its SERENITY and TRANQUILITY programs and utilizing AI-driven drug discovery for innovative therapies[25]