Financial Data and Key Metrics Changes - The company raised $4.9 million through ATM sales in the third quarter, with reported shares increasing from approximately 14.4 million in Q2 to approximately 21.8 million in Q3, a difference of 7.3 million shares [9][10] Business Line Data and Key Metrics Changes - The drug Serenity was originally approved in April 2022, with two doses approved: 120 micrograms and 180 micrograms [10] Market Data and Key Metrics Changes - There is no specific market data or key metrics changes mentioned in the provided content Company Strategy and Development Direction and Industry Competition - The company is currently in compliance with the minimum bid price requirements at the Nasdaq Capital Market and has proposed a reverse stock split as a precautionary measure to provide additional flexibility for future compliance [8][13] Management's Comments on Operating Environment and Future Outlook - Management did not provide specific comments on the operating environment or future outlook in the provided content Other Important Information - The company has approved the appointment of Ernst & Young LLP as its independent registered public accounting firm for the fiscal year ending December 31, 2025 [13] - The advisory vote on the compensation of named executive officers has been approved [13] Q&A Session Summary Question: What was the average cost per share traded, and how many shares did the company sell? - The 14.4 million shares in Q2 were as of the filing date, not the end of the quarter, and the 21.8 million shares in Q3 were also as of the filing date, which is mid-November [9][10] Question: When was the drug Serenity approved, and how many doses have been issued? - The drug was originally approved in April 2022, with two doses approved, and there is no black box warning on the current label [10]

Financial Data and Key Metrics Changes - The company raised $4.9 million through ATM sales in the third quarter, with reported shares increasing from approximately 14.4 million in Q2 to approximately 21.8 million in Q3, a difference of 7.3 million shares [9] - The low trade price during this period was $1.18, which would have returned over $8 million [9] Business Line Data and Key Metrics Changes - The drug SERENITY was originally approved in April 2022, with two doses approved: 120 micrograms and 180 micrograms [10] Company Strategy and Development Direction - The company is currently in compliance with the minimum bid price requirements at the Nasdaq Capital Market and has proposed a reverse stock split as a precautionary measure to provide additional flexibility for future compliance [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's current compliance status and the strategic measures being taken to ensure future flexibility in operations [8] Other Important Information - The company has appointed Ernst & Young LLP as its independent registered public accounting firm for the fiscal year ending December 31, 2025, which has been ratified by stockholders [13] - The advisory vote on the compensation of named executive officers has also been approved [13] Q&A Session Summary Question: Average cost per share traded and number of shares sold - The average cost per share traded was not disclosed, but the company clarified that the share counts reported were as of the filing dates, not the end of the quarters [9] Question: Approval and dosage information for the drug SERENITY - The drug SERENITY was approved in April 2022, with no black box warning on the current label, and two doses are available [10]

Financial Data and Key Metrics Changes - The company raised $4.9 million through ATM sales in the third quarter, with reported shares increasing from approximately 14.4 million in Q2 to approximately 21.8 million in Q3, a difference of 7.3 million shares [9][10] Business Line Data and Key Metrics Changes - The drug Serenity was originally approved in April 2022, with two doses approved: 120 micrograms and 180 micrograms [10] Market Data and Key Metrics Changes - There is no mention of specific market data or key metrics changes in the provided content Company Strategy and Development Direction and Industry Competition - The company is currently in compliance with the minimum bid price requirements at the Nasdaq Capital Market and has proposed a reverse stock split as a precautionary measure to provide additional flexibility for future compliance [8] Management's Comments on Operating Environment and Future Outlook - Management has indicated that they are open to communication with shareholders and are willing to address any questions through their investor relations [10] Other Important Information - The company has approved several proposals during the meeting, including the election of directors and the ratification of Ernst & Young LLP as the independent registered public accounting firm for fiscal year 2025 [13] Q&A Session Summary Question: What was the average cost per share traded, and how many shares did the company sell? - The company clarified that the 14.4 million shares in Q2 were as of the filing date, not the end of the quarter, and that the 21.8 million shares in Q3 were also as of the filing date [9][10] Question: When was the drug Serenity approved, and does it have a black box warning? - The drug Serenity was approved in April 2022, with no black box warning on the current label [10]

Core Viewpoint - The discussion focuses on addressing acute agitation associated with schizophrenia and bipolar disorders, emphasizing the need for patient-centered innovations in non-clinical settings [1][3]. Group 1: Company Mission and Commitment - BioXcel Therapeutics aims to transform patient care by advancing solutions that alleviate the burden of acute agitation on patients, caregivers, and the healthcare system [3]. - The company recognizes the significant challenges posed by episodes of acute agitation, particularly outside clinical environments, highlighting the urgency for practical innovations [3]. Group 2: Event Structure and Participants - The event features a roundtable discussion moderated by Anjalee Khemlani, an award-winning journalist known for her in-depth reporting on healthcare [2]. - The participation of clinical experts is intended to provide valuable insights into the management of agitation in real-world settings [2].

Event Sponsored by BioXcel Therapeutics Set for 10 a.m. EST on Monday, Dec. 8 Topics Covered by Drs. Leslie Citrome, Marc Milano, and Leon Ravin to Include Opportunities and Advantages of Self-Administered Treatments at Home NEW HAVEN, Conn., Dec. 03, 2025 (GLOBE NEWSWIRE) -- As millions of patients and caregivers continue to struggle with acute agitation episodes associated with bipolar disorder and schizophrenia, a timely and highly anticipated virtual roundtable will bring together leading medical exper ...

Core Insights - BioXcel Therapeutics, Inc. reported a quarterly loss of $2.18 per share, which was worse than the Zacks Consensus Estimate of a loss of $1.54, representing an earnings surprise of -41.56% [1] - The company generated revenues of $0.1 million for the quarter ended September 2025, missing the Zacks Consensus Estimate by 34.67% and down from $0.21 million a year ago [2] - BioXcel shares have declined approximately 66.2% year-to-date, contrasting with the S&P 500's gain of 16.4% [3] Financial Performance - The company has surpassed consensus EPS estimates two times over the last four quarters [2] - The current consensus EPS estimate for the upcoming quarter is -$0.82 on revenues of $0.2 million, while for the current fiscal year, it is -$6.93 on revenues of $0.64 million [7] Market Outlook - The earnings outlook and estimate revisions will significantly influence the stock's immediate price movement [3][4] - The Zacks Rank for BioXcel is currently 3 (Hold), indicating expected performance in line with the market in the near future [6] - The Medical - Biomedical and Genetics industry is ranked in the top 34% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8]

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]