Financial Performance - Total current assets increased to $44,403,000 as of September 30, 2025, compared to $37,394,000 as of December 31, 2024, representing a 19% increase[27]. - Product revenue for the three months ended September 30, 2025, was $98,000, a decrease of 54% from $214,000 in the same period of 2024[29]. - Total operating expenses decreased to $14,326,000 for the three months ended September 30, 2025, down from $15,507,000 in 2024, a reduction of 8%[29]. - Net loss for the three months ended September 30, 2025, was $30,911,000, compared to a net loss of $13,650,000 for the same period in 2024, indicating a 126% increase in losses[29]. - Cash and cash equivalents increased to $36,176,000 as of September 30, 2025, from $29,854,000 at the end of 2024, reflecting a 21% increase[27]. - The company reported a basic and diluted net loss per share of $2.18 for the three months ended September 30, 2025, compared to $5.15 in the same period of 2024[29]. - The company reported net losses of $30,911 for the three months ended September 30, 2025, compared to $13,650 for the same period in 2024, and net losses of $57,352 for the nine months ended September 30, 2025, compared to $48,740 for the same period in 2024[43]. Expenses and Liabilities - Total liabilities as of September 30, 2025, were $133,711,000, slightly up from $131,439,000 as of December 31, 2024[27]. - Total debt liability as of September 30, 2025, was $112,156,000, an increase from $106,722,000 as of December 31, 2024, representing a rise of about 5.4%[68]. - The Company has a total debt of $109,125,000 as of September 30, 2025, after accounting for unamortized debt premiums, discounts, and issuance costs[68]. - The total stockholders' equity deficit improved to $(88,919,000) as of September 30, 2025, from $(93,101,000) at the end of 2024[27]. - The Company recorded total inventory of $459 as of September 30, 2025, down from $679 as of December 31, 2024, with inventory write-downs of $0 for the three months ended September 30, 2025[62]. - The Company’s total accrued expenses were $4,363 as of September 30, 2025, down from $5,762 as of December 31, 2024[64]. - The Company’s total property and equipment, net, was $249 as of September 30, 2025, compared to $475 as of December 31, 2024[63]. Research and Development - Research and development expenses for the nine months ended September 30, 2025, were $23,550,000, compared to $24,534,000 in 2024, showing a decrease of 4%[29]. - The Company has deprioritized the development of certain indications for BXCL501 and BXCL701 to focus on core clinical programs[208][209]. - BXCL501 is being evaluated for treatment of opioid use disorder, acute stress disorder, and post-traumatic stress disorder in clinical trials[217]. - The SERENITY At-Home pivotal Phase 3 trial for BXCL501 met its primary endpoint, with plans for a supplemental new drug application (sNDA) submission in early Q1 2026[204]. - The SERENITY At-Home trial met its primary endpoint, supporting the sNDA submission for label expansion of IGALMI®[221]. Capital and Financing - The company is exploring various strategies to raise additional capital, including equity sales and collaborations[48][54]. - The Company entered into the Fourth Amendment to the Credit Agreement on March 20, 2024, which included a waiver of the "going concern" qualification in the independent auditor's report for the fiscal year ended December 31, 2023[80]. - The Fourth Amendment requires the Company to raise at least $25,000 in gross proceeds by April 15, 2024, and $50,000 by November 30, 2024, from stock issuance or partnering transactions[81]. - The Company has $80,000,000 in commitments under the Credit Agreement that remains unfunded as of September 30, 2025[70]. - The Company must maintain a minimum liquidity amount of $15,000,000, which can increase to $37,500,000 under certain conditions related to the sale of OnkosXcel[75]. Stock and Equity - The Company granted new warrants to the Lenders to purchase shares at an exercise price of $49.1568 per share, expiring on April 19, 2029[99]. - The Company issued a total of 3,179 warrants, with the most recent being the 2024 Warrants at a strike price of $7.68 per share[181]. - The Company recorded a termination gain of $369 related to the Option Warrants, which expired unexercised[115]. - The Company raised approximately $6.128 million from the November 2024 Offering after deducting underwriting discounts and commissions of $871[122]. - The Company recorded a net loss of $586 million for the three months ended September 30, 2025, related to the remeasurement of the BTI Warrants[173]. Workforce and Operations - The company reduced its workforce by approximately 15% on May 8, 2024, and by an additional 28% on September 17, 2024, to extend its cash runway and prioritize clinical development[58][59]. - The Company is maintaining IGALMI's market presence with minimal commercial resources while seeking potential commercial partners following its Clinical Prioritization in 2024[212]. Legal and Compliance - The Company is currently involved in multiple litigation matters, including a class action complaint filed on July 7, 2023, alleging violations of the Securities Exchange Act of 1934[189]. - The Company signed a commercial supply agreement with minimum annual payments totaling $10,000 over three years, with a reduced commitment of $1,000 for 2024 and $2,000 to $5,000 for subsequent years, contingent on FDA approvals[194].

Financial Performance - The company reported a net loss of $30.9 million, or $2.18 per share, for the third quarter of 2025, compared to a net loss of $13.7 million, or $5.15 per share, in the same quarter last year [1] - Product revenues decreased to $98,000 from $214,000 year-over-year [1] Clinical Development Updates - BXCL501 showed a mean reduction in mCGI-S score from baseline compared to placebo at 2 hours during the SERENITY at-home phase 3 safety trial, indicating positive efficacy [2] - The SERENITY at-home supporting correlation study demonstrated a high correlation between validated clinician assessments and the mCGI-S scale, reinforcing its use as a measurement for exploratory efficacy outcomes [3] Future Plans - The company is preparing to initiate the TRANQUILITY In-Care Phase 3 Trial to evaluate BXCL501 for agitation associated with Alzheimer's dementia [4] - A supplemental New Drug Application for at-home use of IGALMI for the acute treatment of agitation related to bipolar disorders or schizophrenia is planned for submission in early Q1 2026 [4] - As of pre-market hours, the company's stock is trading at $1.9, reflecting a decline of 5.94 percent on the Nasdaq [4]

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]

Core Insights - BioXcel Therapeutics plans to submit a supplemental New Drug Application (sNDA) in early Q1 2026 for the at-home use of IGALMI® based on positive results from the SERENITY At-Home trial [1][2] - The company is also preparing to initiate the TRANQUILITY In-Care Phase 3 Trial for BXCL501 targeting agitation associated with Alzheimer's dementia [1][6] Financial Performance - For Q3 2025, net revenue from IGALMI® was $98 thousand, a decrease from $214 thousand in Q3 2024 [9] - Cost of Goods Sold (COGS) for Q3 2025 was $11 thousand, significantly lower than $1.17 million in Q3 2024 [10] - Research and Development (R&D) expenses increased to $8.7 million in Q3 2025 from $5.1 million in Q3 2024, primarily due to heightened clinical trial activities [11] - Selling, General and Administrative (SG&A) expenses decreased to $5.4 million in Q3 2025 from $7.7 million in Q3 2024 [12] - The company reported a net loss of $30.9 million for Q3 2025, compared to a net loss of $13.7 million in Q3 2024 [13] Clinical Development Programs - The SERENITY At-Home Phase 3 trial involved 246 patients and evaluated the safety of a 120 mcg dose of BXCL501 for treating agitation in a home setting [6][19] - The TRANQUILITY In-Care Phase 3 trial is designed to assess the efficacy and safety of a 60 mcg dose of BXCL501 for agitation associated with Alzheimer's dementia in care settings [6][20] - The SERENITY At-Home trial demonstrated a mean reduction in the modified Clinical Global Impression-Severity (mCGI-S) score at 2 hours post-treatment compared to placebo [6] Market Insights - The potential at-home market for agitation treatment is estimated to encompass 57 to 77 million annual episodes in the U.S., significantly higher than the previously estimated 23 million episodes [2][17] - The company continues to supply IGALMI® to patients and providers while building brand awareness with limited commercial resources [8] Cash Position - As of September 30, 2025, the company had cash and cash equivalents totaling $37.3 million, with an additional $4.9 million raised post-quarter-end [14]

Core Viewpoint - Halper Sadeh LLC is investigating potential breaches of fiduciary duties by certain officers and directors of BioXcel Therapeutics, Inc. [1] Group 1 - The investigation focuses on whether the actions of BioXcel's leadership have harmed shareholder interests [1] - Long-term shareholders of BioXcel may have the opportunity to seek corporate governance reforms and financial incentives [1] - The law firm is exploring options for shareholders, including the return of funds to the company and other forms of relief [1]

Core Insights - BioXcel Therapeutics has completed clinical trials necessary for a supplemental New Drug Application (sNDA) submission, which is planned for the first quarter of 2026 [1] - The company reported positive results from the SERENITY At-Home trial, indicating a strong correlation between clinician assessments and patient/caregiver-rated outcomes [3][4] Group 1: Clinical Trial Results - The SERENITY At-Home trial showed a statistically significant correlation between the Positive and Negative Syndrome Scale – Excited Component (PEC) and the modified Clinical Global Impression – Severity Scale (mCGI-S), with correlation coefficients of ρ=0.89 for patients and ρ=0.88 for informants, both with p<0.0001 [3] - The mCGI-S scale was developed in consultation with the FDA to allow patients and caregivers to assess efficacy in an outpatient setting [2][6] Group 2: Safety and Efficacy - No serious adverse events were reported during the trials, and the safety profile of BXCL501 remains consistent with the existing IGALMI label [4] - BXCL501 is being investigated for the acute treatment of agitation associated with Alzheimer's dementia and bipolar disorders in the at-home setting, with Breakthrough Therapy and Fast Track designations from the FDA [8] Group 3: Future Plans - The findings from the SERENITY At-Home study will be included in the upcoming sNDA package [4] - Additional data and results from the trials are expected to be presented at future medical meetings and conferences [5]

Core Insights - BioXcel Therapeutics, Inc. is celebrating a significant milestone by ringing the Nasdaq Stock Market Closing Bell, highlighting its progress in addressing unmet needs in psychiatry, particularly in treating agitation associated with bipolar disorders and schizophrenia [1][2]. Company Overview - BioXcel Therapeutics, Inc. is a biopharmaceutical company that leverages artificial intelligence to develop transformative medicines in neuroscience. The company also has a subsidiary, OnkosXcel Therapeutics, focused on immuno-oncology [3]. Recent Developments - The company has successfully completed its SERENITY At-Home pivotal trial, moving closer to its goal of redefining agitation management and bringing its product IGALMI® to patients in their homes [2]. - The Nasdaq Closing Bell ceremony is scheduled for October 14, 2025, and will be broadcast live [2]. Strategic Focus - BioXcel aims to transform the standard of care in neuropsychiatry by combining technology and compassion to deliver meaningful changes in patient care [2].

Core Viewpoint - BioXcel Therapeutics, Inc. has regained compliance with Nasdaq's market value of listed securities requirement, indicating a positive development for the company's listing status [1][2]. Company Compliance - The company was previously notified on March 20, 2025, that it was not in compliance with Nasdaq Listing Rule 5550(b)(2) due to its market value being below $35.0 million for 30 consecutive business days [2]. - Following a hearing on May 1, 2025, the company received an exception to regain compliance, and on September 17, 2025, Nasdaq confirmed that the company has met all listing requirements [2]. Company Overview - BioXcel Therapeutics, Inc. is a biopharmaceutical company that utilizes artificial intelligence to develop transformative medicines in neuroscience [3]. - The company's subsidiary, OnkosXcel Therapeutics, focuses on immuno-oncology drug development [3]. - BioXcel employs a drug re-innovation approach, leveraging existing approved drugs and big data to identify new therapeutic indications [3].

Core Insights - BioXcel Therapeutics is making significant progress in expanding treatment options for managing acute agitation, particularly in home settings [3] - The company has reported positive exploratory efficacy results along with primary safety data, indicating a step forward in patient care [3] Company Overview - BioXcel Therapeutics aims to transform patient care by addressing the challenges faced by patients and families dealing with acute agitation [3] - The leadership team includes Vimal Mehta as CEO, Dr. Leslie Citrome as a clinical expert, and Dusan Kostic overseeing clinical and medical affairs [2]

Core Insights - BioXcel Therapeutics, Inc. released topline exploratory efficacy data from the SERENITY At-Home Pivotal Phase 3 safety trial, showing that BXCL501 has continued effects and consistent benefits with repeat dosing [1] - The trial evaluated a 120 mcg dose of BXCL501 for agitation associated with bipolar disorders or schizophrenia, demonstrating significant efficacy compared to placebo [2] Efficacy Results - Across 2,433 treated episodes, BXCL501 showed a significant mean reduction in the modified Clinical Global Impression–Severity (mCGI-S) score from baseline compared to placebo at 2 hours [2] - Complete resolution of agitation symptoms was observed in 50% of patients in the BXCL501 arm compared to 33% in the placebo group [3] - Severe agitation episodes fully resolved in 61% of cases in the BXCL501 arm versus 18% on placebo, while moderate and mild episodes resolved in 43% and 60% of cases, respectively, compared to 34% and 40% on placebo [4] Dosage Impact - A mean reduction in mCGI-S score of 1.2 was noted after the first 12 doses, increasing to a mean reduction of 1.4 after 13 or more doses of BXCL501 [5] - Igalmi, the formulation of BXCL501, is currently FDA-approved for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in medically supervised settings [5] Market Reaction - BioXcel Therapeutics shares increased by 3.07% to $3.69 at the time of publication, trading within a 52-week range of $1.17 to $13.36 [6]