Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark one) ☒ Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the fiscal year ended December 31, 2025 or ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to . Commission file number 001-38410 BioXcel Therapeutics, Inc. (Exact name of Registrant as specified in its charter) Delaware (State or other ...

"2025 was a successful year for our Company, setting the stage for the potential label expansion of IGALMI in the at-home setting and continuing progress with commercial plans for the potential launch of IGALMI," said Vimal Mehta, Ph.D., Chief Executive Officer of BioXcel Therapeutics. "Our confidence in the substantial market opportunity in the at-home setting, where there are no FDA-approved options available, is reiterated by our recent market opportunity assessment. We also remain focused on advancing o ...

sNDA submitted seeking approval of IGALMI® in the at-home (outpatient) setting for the treatment of acute agitation associated with bipolar disorders or schizophrenia sNDA submission timeline supports potential approval as early as year-end 2026 Advancing commercial and launch plans based on third-party market assessment NEW HAVEN, Conn., March 27, 2026 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company built on artificial intelligence (“AI”) to develop transformativ ...

HARTFORD, Conn., March 23, 2026 (GLOBE NEWSWIRE) -- Levi & Korsinsky, LLP announces that the United States District Court for the District of Connecticut has approved the following announcement of a proposed class action settlement that would benefit purchasers of BioXcel Therapeutics, Inc. securities (NASDAQ: BTAI): SUMMARY NOTICE TO: ALL PERSONS OR ENTITIES WHO PURCHASED OR ACQUIRED BIOXCEL THERAPEUTICS, INC. SECURITIES FROM MARCH 9, 2023 THROUGH JUNE 28, 2023, BOTH DATES INCLUSIVE. YOU ARE HEREBY NOTIFIE ...

Core Viewpoint - BioXcel Therapeutics, Inc. has entered into a securities purchase agreement for a registered direct offering of 4,500,785 shares of common stock at a price of $1.739 per share, along with accompanying warrants [1][3] Group 1: Offering Details - The offering includes 4,500,785 shares of common stock and warrants to purchase an equal number of shares at an exercise price of $1.614, expiring five years from issuance [1] - The transaction is expected to generate approximately $8.0 million in gross proceeds before deducting fees and expenses [3] - The closing of the offering is anticipated to occur on or about March 11, 2026, pending customary closing conditions [3] Group 2: Warrant Adjustments - The company has agreed to reduce the exercise price of existing warrants held by the investor to $1.614 per share and extend their expiration to five years from the closing of the offering [2] - The investor will pay approximately $173,000 for this adjustment in the exercise price of the warrants [2] Group 3: Company Overview - BioXcel Therapeutics, Inc. focuses on developing transformative medicines in neuroscience using artificial intelligence [6] - The company’s subsidiary, OnkosXcel Therapeutics, is dedicated to immuno-oncology drug development [6] - The company employs a drug re-innovation approach, leveraging existing approved drugs and big data to identify new therapeutic indications [6]

Core Insights - BioXcel Therapeutics Inc. (NASDAQ:BTAI) shares have declined following a previous rally due to positive drug development news, specifically regarding BXCL501 for opioid withdrawal treatment [1][5] Group 1: Drug Development and Clinical Trials - BXCL501 has shown promise in a Phase 2 study for treating opioid withdrawal symptoms, potentially being as effective or superior to BioCorRx Pharmaceuticals Inc.'s lofexidine [2] - Patients receiving BXCL501 experienced over a 30% reduction in withdrawal symptoms compared to a placebo, with significant improvements noted on days three and four of the trial [2][3] - The data suggests BXCL501's versatility as a treatment option, indicating potential applicability for acute agitation associated with bipolar disorder and schizophrenia [3] Group 2: Stock Performance and Technical Analysis - The stock is currently trading 3.9% below its 20-day simple moving average (SMA) and 17.9% below its 100-day SMA, indicating challenges in gaining traction in the short to medium term [4] - Over the past 12 months, shares have decreased approximately 41.24%, positioning them closer to their 52-week lows than highs [4] - The Relative Strength Index (RSI) is at 46.86, suggesting the stock is in neutral territory, while the MACD indicates bullish momentum despite the overall bearish trend [4][5]

Core Insights - BioXcel Therapeutics Inc. shares have increased in premarket trading following positive results from a Phase 2 study of BXCL501 for opioid withdrawal symptoms [1] Study Results - The Phase 2 trial, conducted by Columbia University, indicated that BXCL501 may be as effective or superior to BioCorRx Pharmaceuticals' lofexidine (Lucemyra) in reducing opioid withdrawal symptoms during methadone taper, with a more convenient dosing regimen [2] - Patients receiving BXCL501 240 µg BID experienced over a 30% reduction in Short Opiate Withdrawal Scale-Gossop (SOWS-Gossop) scores, with peak symptom improvement noted on days 3 and 4 [3] - The reduction in withdrawal symptoms with BXCL501 was numerically greater than that observed with lofexidine 0.54 mg administered four times daily, and BXCL501 showed a favorable tolerability profile compared to lofexidine [3] Product Pipeline - BXCL501 is positioned as a "pipeline within a product," with potential applications across various indications, including acute agitation associated with bipolar disorder and schizophrenia [4] - In September 2025, BioXcel Therapeutics released topline exploratory efficacy data from the SERENITY At-Home Pivotal Phase 3 safety trial, demonstrating continued effects and consistent benefits with repeat dosing of BXCL501 [4] Technical Analysis - The stock is trading 1.5% above its 20-day simple moving average (SMA) and 5.2% below its 100-day SMA, indicating short-term strength but longer-term challenges [5] - Over the past 12 months, shares have decreased approximately 76% and are closer to their 52-week lows than highs [5] - The Relative Strength Index (RSI) is at 50.00, indicating neutral territory, while the MACD is at 0.10, below its signal line at 0.15, suggesting bearish pressure on the stock [6] Price Action - BioXcel Therapeutics shares rose 17.58% to $1.94 during premarket trading, with key resistance at $2.00 and key support at $1.50 [7]

Core Insights - BXCL501 has shown clinical benefits and a favorable tolerability profile for treating opioid withdrawal symptoms, supporting its potential future development in this area [1][2][3] Company Overview - BioXcel Therapeutics, Inc. is a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience [10] - The company is focused on re-innovating existing approved drugs and leveraging big data and machine learning to identify new therapeutic indications [10] Study Findings - The Phase 2 trial indicated that BXCL501 may be as effective as or superior to lofexidine for reducing opioid withdrawal symptoms during methadone taper, with a more convenient dosing regimen [3][4] - BXCL501 demonstrated lower rates of cardiovascular effects compared to lofexidine, particularly in orthostatic hypotension (18% for BXCL501 vs 50% for lofexidine, p<0.05) [3] - Patients receiving BXCL501 240 µg experienced over a 30% reduction in withdrawal symptoms as measured by the Short Opiate Withdrawal Scale-Gossop (SOWS-Gossop) [8] Market Context - Opioid use disorder (OUD) is a significant global health crisis, affecting approximately 5.9 million adults in the U.S. and an estimated 36 to 61 million people worldwide [9] - Despite the high prevalence of OUD, only about 25% of individuals with substance use disorders receive specialized treatment, indicating a substantial treatment gap [9] Product Profile - BXCL501 is an investigational orally dissolving film formulation of dexmedetomidine, designed for the acute treatment of agitation associated with various conditions, including opioid withdrawal [11] - The product has been granted Breakthrough Therapy designation by the FDA for certain indications, highlighting its potential as a safe and effective treatment option [11]

Core Insights - The discussion focuses on the urgent need for treatments addressing acute agitation episodes in Alzheimer's dementia, highlighting a significant gap in current FDA-approved options [3]. Company Commitment - BioXcel Therapeutics is dedicated to advancing innovation in areas of unmet medical need, specifically targeting the acute treatment of agitation in Alzheimer's dementia with its product BXCL501 [4]. - BXCL501 has shown promising results in a Phase III pivotal study, being well tolerated and meeting its primary efficacy endpoint [4]. Industry Context - There are currently no FDA-approved treatments specifically for acute agitation episodes in Alzheimer's dementia, indicating a critical need for effective solutions for patients, caregivers, and clinicians [3].

BioXcel Therapeutics KOL Virtual Roundtable Summary Company Overview - **Company**: BioXcel Therapeutics (NasdaqCM: BTAI) - **Focus**: Development of BXCL501 for the treatment of acute agitation episodes in Alzheimer's dementia Key Industry Insights - **Alzheimer's Agitation**: There are currently no FDA-approved treatments specifically for acute agitation episodes in Alzheimer's dementia, highlighting a significant gap in care [2][11][93] - **Demographic Trends**: The Alzheimer's population is expected to double in the coming decades, with over 7 million individuals currently affected, leading to increased neuropsychiatric issues, particularly agitation [20][21] Core Points Discussed - **BXCL501 Development**: BXCL501 has shown to be well-tolerated and met its primary efficacy endpoint in a Phase 3 pivotal study for treating acute agitation in Alzheimer's dementia [3] - **Current Treatment Landscape**: Existing treatments primarily address chronic agitation, with off-label use of antipsychotics and sedatives being common, which can lead to increased risks such as sedation and falls [10][21][22][34] - **Need for Rapid Action**: BXCL501 is designed to provide rapid control of agitation, with effects seen within minutes, contrasting with existing treatments that may take days to titrate [22][23][49] Additional Important Insights - **Impact on Caregivers**: The unpredictability of agitation episodes significantly affects the quality of life for both patients and caregivers, necessitating effective management solutions [29][82] - **Potential for Home Use**: There are plans for at-home studies to evaluate the safety and efficacy of BXCL501 in non-professional settings, which could ease the burden on caregivers [47][48] - **Safety Profile**: BXCL501 has a favorable safety profile, with mild side effects reported in clinical trials, making it a viable option for older adults [49][50][56] - **Administration Method**: The sublingual film formulation of BXCL501 is seen as advantageous compared to injections, which can be distressing for patients [68][70] Market Opportunity - **Care Settings**: BXCL501 could be beneficial in various settings, including home care, assisted living, and skilled nursing facilities, helping to maintain patient independence and reduce the need for institutionalization [82][85] - **Cost Implications**: Effective management of acute agitation could potentially reduce healthcare costs associated with emergency room visits and hospitalizations [19][22][67] Conclusion - **Commitment to Innovation**: BioXcel Therapeutics is dedicated to addressing the unmet needs in the treatment of acute agitation in Alzheimer's dementia, with BXCL501 positioned as a promising solution [2][93]