Core Insights - BioXcel Therapeutics has completed the database lock for its SERENITY At-Home pivotal Phase 3 safety trial, with topline results expected in August 2025 [2][3] - The trial aims to evaluate the safety of BXCL501 for the acute treatment of agitation associated with bipolar disorders or schizophrenia in a home setting, addressing a significant unmet medical need [3][5] Company Overview - BioXcel Therapeutics is a biopharmaceutical company focused on developing transformative medicines in neuroscience using artificial intelligence [2][15] - The company has a subsidiary, OnkosXcel Therapeutics, which is dedicated to immuno-oncology [15] Trial Details - The SERENITY At-Home trial is a double-blind, placebo-controlled study involving 200 patients with a history of agitation episodes while on stable treatment for bipolar disorder or schizophrenia [6][8] - Patients self-administered a 120 mcg dose of BXCL501 or placebo during agitation episodes over a 12-week period, with safety data collected throughout [6][8] Collaboration and Oversight - BioXcel partnered with Worldwide Clinical Trials (WCT) to conduct the SERENITY At-Home trial, implementing robust oversight controls to ensure patient safety [4] - Independent industry experts were engaged for additional oversight of high enrolling sites to ensure compliance with Good Clinical Practice (GCP) [4] Product Information - BXCL501 is an investigational orally dissolving film formulation of dexmedetomidine, currently under investigation for treating agitation associated with Alzheimer's dementia and bipolar disorders in the at-home setting [7] - BXCL501 has received Fast Track Designation from the FDA for the acute treatment of agitation associated with bipolar disorders and schizophrenia [5][9] Patient Enrollment and Data Collection - The trial enrolled over 200 patients across 22 sites nationwide, with no single site contributing more than 11% of the total patient population [8] - Data from more than 2,600 agitation episodes was collected during the trial [8]

Core Insights - BioXcel Therapeutics has achieved alignment with the FDA on the supplemental New Drug Application (sNDA) package to expand the IGALMI label for at-home use, with submission expected in Q1 2026 [1][2][3] Group 1: FDA Interaction and Regulatory Progress - The company received positive feedback from the FDA during a pre-sNDA meeting, confirming that the planned regulatory package is sufficient for submission [2][4] - The objectives of the pre-sNDA meeting were accomplished, leading to the cancellation of the originally scheduled meeting [3] - The acceptance of the sNDA will depend on the FDA's review of the complete filing [3] Group 2: Clinical Trials and Product Details - The SERENITY At-Home Phase 3 trial is designed to evaluate the safety of a 120 mcg dose of BXCL501 for treating agitation associated with bipolar disorders or schizophrenia in an at-home setting [6] - The trial involves 200 patients and is a double-blind, placebo-controlled study, with topline data expected soon [4][6] - IGALMI is currently FDA-approved for acute treatment of agitation in medically supervised settings, available in 120 mcg and 180 mcg doses [4][9] Group 3: Market Potential and Designation - BXCL501 has received Fast Track Designation for the acute treatment of agitation associated with bipolar disorders and schizophrenia, with no FDA-approved therapies for at-home treatment currently available [5][8] - The company aims to address the urgent needs of patients suffering from bipolar disorder or schizophrenia, potentially transforming the treatment paradigm [4][5]

Summary of BioXcel Therapeutics (BTAI) Conference Call Company Overview - BioXcel Therapeutics is a publicly traded company listed on NASDAQ under the ticker symbol BTAI, focusing on AI-driven drug re-innovation [1][2] - The company has successfully brought to market a drug named EGALMI, a sublingual formulation of dexmedetomidine for treating acute agitation in neuropsychiatric contexts [4] Clinical Trials and Drug Development - The ongoing pivotal Phase III trial, SERENITY AT HOME, is designed to evaluate the safety and efficacy of BXCL501 in a home setting for patients with schizophrenia and bipolar disorder [6][8] - The trial involves 200 patients, with safety as the primary endpoint and exploratory efficacy endpoints [6][7] - The trial is on track to announce top-line data shortly, having passed two data safety monitoring board reviews [9][10] - The expected safety profile is comparable to that observed in institutional settings, where the drug has shown a favorable safety and tolerability profile [12][14] Market Opportunity - The outpatient market for acute agitation treatment is significantly larger than the institutional market, with estimates suggesting up to 140-150 million episodes of agitation annually when including both neuropsychiatric and dementia-related contexts [36][69] - The inpatient market is estimated at around 60 million episodes per year, while the outpatient market is estimated at 23 million episodes, which may be conservative [36][37][69] - The company anticipates that the at-home setting market could be three to four times larger than the institutional market [39] Regulatory Process - BioXcel is preparing for a meeting with the FDA to discuss the sNDA application, focusing on operational aspects and confirming the sufficiency of the clinical program for filing [30][31] - The timeline for preparing the sNDA is estimated to take about four to six months, with the company already working on nonclinical sections [32][33] Competitive Landscape - BXCL501 is positioned to treat breakthrough agitation episodes, differentiating itself from other treatments like Rexulti, which is approved for chronic agitation but not for acute episodes [45][46][49] - The company believes it will occupy a distinct niche in the market, particularly for treating acute agitation in patients with schizophrenia and bipolar disorder [49] Future Directions - BioXcel is exploring additional indications for BXCL501, including agitation in Alzheimer's patients, with a focus on conducting further studies in both in-care and at-home settings [50][52] - The company is leveraging its AI-driven platform to identify and develop new drug candidates, aiming to expand its pipeline beyond BXCL501 [88][90] Financial Position - As of the latest reports, BioXcel has a strong balance sheet with sufficient capital to support the completion of the SERENITY AT HOME study and the preparation of the sNDA [78][80] - The company is focused on maintaining capital efficiency while exploring strategic partnerships to enhance market access and commercialization efforts [72][73] Conclusion - BioXcel Therapeutics is at a pivotal moment with the upcoming data readout from the SERENITY AT HOME trial and its interaction with the FDA, which could significantly impact its market position and shareholder value [96][95]

Core Viewpoint - BioXcel Therapeutics, Inc. is leveraging artificial intelligence to develop innovative medicines in the field of neuroscience and has announced a virtual fireside chat featuring its CEO, Vimal Mehta, on August 14, 2025 [1][2]. Company Overview - BioXcel Therapeutics, Inc. (Nasdaq: BTAI) focuses on utilizing artificial intelligence for the development of transformative medicines in neuroscience [2]. - The company has a subsidiary, OnkosXcel Therapeutics, which is dedicated to immuno-oncology drug development [2]. - BioXcel employs a drug re-innovation strategy that combines existing approved drugs and clinically validated candidates with big data and proprietary machine learning algorithms to discover new therapeutic uses [2].

Core Insights - BioXcel Therapeutics, Inc. reported a quarterly loss of $2.45 per share, which was worse than the Zacks Consensus Estimate of a loss of $2.3, but an improvement from a loss of $3.36 per share a year ago, indicating a year-over-year improvement in losses [1] - The company posted revenues of $0.12 million for the quarter, missing the Zacks Consensus Estimate by 52% and down from $1.1 million in the same quarter last year [2] - The stock has underperformed the market with a gain of about 7% since the beginning of the year, compared to the S&P 500's gain of 8.4% [3] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$2.57 on revenues of $0.3 million, and for the current fiscal year, it is -$8.60 on revenues of $1.07 million [7] - The estimate revisions trend for BioXcel Therapeutics was favorable ahead of the earnings release, resulting in a Zacks Rank 2 (Buy) for the stock, suggesting it is expected to outperform the market in the near future [6] Industry Context - The Medical - Biomedical and Genetics industry, to which BioXcel Therapeutics belongs, is currently ranked in the bottom 43% of over 250 Zacks industries, indicating potential challenges for stocks in this sector [8]

Summary of BioXcel Therapeutics Conference Call Company Overview - **Company**: BioXcel Therapeutics - **Industry**: Biotechnology - **Key Product**: EGALMI, approved for agitation in schizophrenia and bipolar disorder Key Points and Arguments Upcoming Clinical Trials and Data - BioXcel is preparing for pivotal Phase III trial data related to schizophrenia and bipolar agitation, expected in August [3][4] - The company has already proven safety and efficacy of EGALMI in care settings and is now testing it in home settings [4][6] - The primary endpoint of the home setting trial is safety, with exploratory endpoints focusing on repeat dosing efficacy [10][18] Market Opportunity - Initial estimates indicated 23 million episodes of agitation, but further research suggests a larger market opportunity [5][6] - The company has collected data from 2,200 episodes over a 12-week period, indicating a representative sample of real-world experiences [13][14] - Pricing strategy suggests a potential price of up to $1,400 per prescription, with packaging considerations for home use [26][27] FDA Interactions and Approval Process - Upcoming FDA meeting on August 20 will focus on the format and content of the supplemental new drug application (sNDA) [17][18] - The primary concern for FDA approval is demonstrating safety comparable to previous clinical settings [18][23] - The company has a robust intellectual property portfolio with 13 patents, ensuring market exclusivity until 2043 [35][36] Commercialization Strategy - BioXcel is evaluating options for commercialization, including potential partnerships to expand market reach [32][34] - The company acknowledges the need for education and promotion in the neuropsychiatric market, similar to migraine treatments [32] Alzheimer's Program - BioXcel is also developing a product for acute agitation in Alzheimer's, with plans for a second confirmatory Phase III trial [7][39] - The protocol for the Alzheimer's trial has been agreed upon with the FDA, and the company is in the process of selecting a contract research organization (CRO) [40][41] Financial Position - As of the latest update, BioXcel has $18 million in cash, with additional proceeds expected from recent financing activities [42][44] Additional Important Insights - The trial's real-world setting allows patients to self-administer the treatment, potentially leading to more accurate data on compliance and effectiveness [14][16] - The company is aware of the placebo effect in psychiatric trials but believes prior efficacy data will mitigate its impact [12][18] - The potential for prodromal use of the product is acknowledged, but it will not be part of the official label due to lack of specific study [28][29] This summary encapsulates the critical aspects of BioXcel Therapeutics' conference call, highlighting the company's strategic focus, market potential, and regulatory interactions.

Financial Performance - For the three months ended June 30, 2025, product revenue was $120,000, a decrease of 89% compared to $1,104,000 for the same period in 2024[27]. - The net loss for the three months ended June 30, 2025, was $19,187,000, compared to a net loss of $8,299,000 for the same period in 2024, indicating a significant increase in losses[27]. - The Company reported a basic and diluted net loss per share of $(2.45) for the three months ended June 30, 2025, compared to $(3.30) for the same period in 2024[27]. - For the six months ended June 30, 2025, net losses were $26,441, a decrease of 24% compared to $35,090 for the same period in 2024[41]. - The consolidated net loss for the six months ended June 30, 2025, was $26,441 million, compared to a net loss of $35,090 million for the same period in 2024, indicating a 25% improvement[197]. Operating Expenses - Total operating expenses for the three months ended June 30, 2025, were $15,972,000, down from $18,400,000 in the same period of 2024, representing a decrease of 7.7%[27]. - Research and development expenses for the three months ended June 30, 2025, were $10,256,000, an increase of 27.7% from $8,032,000 in the same period of 2024[27]. - Total research and development costs for the three months ended June 30, 2025, were $10,256 million, compared to $8,032 million for the same period in 2024, reflecting a 28% increase[197]. Cash and Liquidity - Cash and cash equivalents as of June 30, 2025, were $17,435,000, down from $29,854,000 as of December 31, 2024, reflecting a decrease of 41.5%[25]. - The Company had net cash used in operating activities of $24,618 for the six months ended June 30, 2025, down from $40,880 in the same period of 2024, reflecting a 40% improvement[41]. - The Company is evaluating various strategies to improve liquidity, including raising funding through equity securities and establishing collaborations with potential partners[46][53]. - Management has assessed substantial doubt about the Company's ability to continue as a going concern for at least 12 months from the issuance date of the financial statements[43]. Debt and Liabilities - Total liabilities increased to $133,456,000 as of June 30, 2025, compared to $131,439,000 as of December 31, 2024, showing a slight increase of 1.5%[25]. - Total debt as of June 30, 2025, is $108,685 million, an increase from $102,508 million on December 31, 2024, representing a 6.3% increase[66]. - The Company is required to maintain a minimum cash balance of $15,000 million, increasing to $20,000 million upon funding of Tranche B[74]. - The Credit Agreement matures on April 19, 2027, with an option to extend to April 19, 2028, subject to certain conditions[72]. Workforce and Cost Management - The Company reduced its workforce by approximately 15% on May 8, 2024, and an additional 28% on September 17, 2024, to extend its cash runway and prioritize clinical development[56][57]. - Accrued expenses decreased from $5,762 as of December 31, 2024, to $5,090 as of June 30, 2025, indicating a reduction in liabilities[62]. Product Development and Clinical Trials - The company completed the last patient last visit in the pivotal Phase 3 SERENITY At-Home clinical trial for BXCL501, with topline data expected in August 2025[209]. - BXCL501 is being evaluated for treatment of agitation associated with bipolar disorders or schizophrenia in the outpatient or at-home setting[220]. - The independent Data Safety Monitoring Board recommended continuing the SERENITY At-Home trial without modification on May 27, 2025, and July 1, 2025[223]. - The SERENITY At-Home pivotal Phase 3 trial is evaluating a 120 mcg dose of BXCL501 in over 200 patients[223]. Strategic Initiatives - The company utilized an AI platform to potentially reduce therapeutic development costs and accelerate timelines, focusing on neuroscience and immuno-oncology[34]. - The Company is maintaining IGALMI's market presence with minimal commercial resources while seeking potential commercial partners[216]. - The company has deprioritized the development of certain indications for BXCL501 and BXCL701 to focus on core clinical programs[212][213]. Stock and Equity - The Company granted new warrants to the Lenders to purchase an aggregate of 313 shares of common stock at an exercise price of $0.16 per share as part of the Fifth Amendment[104]. - The Company received $25,000 in gross proceeds from the issuance of its common stock, warrants, and pre-funded warrants on March 27, 2024, satisfying the April 15, 2024 covenant requirement of the Fourth Amendment[84]. - The Company sold 97 shares of its common stock for a gross amount of $139 under the Canaccord At-the-Market Program, incurring issuance costs of $4, leading to net proceeds of $135 for the three months ended June 30, 2025[133].

[Overview and Business Updates](index=1&type=section&id=Overview%20and%20Business%20Updates) [Q2 2025 Highlights](index=1&type=section&id=Q2%202025%20Highlights) BioXcel Therapeutics completed its SERENITY At-Home Phase 3 trial, with topline data expected in August 2025, and is preparing for an FDA meeting to discuss a potential sNDA for IGALMI's at-home use, suggesting a larger addressable market - Topline data from the SERENITY At-Home Phase 3 trial for treating agitation in bipolar disorders or schizophrenia is expected in August 2025[1](index=1&type=chunk)[3](index=3&type=chunk) - An FDA meeting is scheduled for August 2025 to support a potential sNDA submission for IGALMI's label expansion into the at-home setting[1](index=1&type=chunk) - The company's research suggests the target addressable market for at-home agitation is **meaningfully larger** than the original estimate of **23 million annual episodes**[4](index=4&type=chunk) - The company has strengthened its cash position through at-the-market sales and warrant exercises subsequent to the quarter's end[2](index=2&type=chunk)[14](index=14&type=chunk) [Clinical Program Updates](index=1&type=section&id=Clinical%20Program%20Updates) The company provided updates on its late-stage clinical programs for BXCL501, including the completed SERENITY At-Home Phase 3 trial, the advancing TRANQUILITY program, and new non-clinical data supporting BXCL501's potential in broader chronic stress-related disorders [SERENITY Program (BXCL501 for Bipolar/Schizophrenia)](index=1&type=section&id=SERENITY%20Program%20(BXCL501%20for%20Bipolar%2FSchizophrenia)) The SERENITY At-Home Phase 3 trial, evaluating a 120 mcg dose of BXCL501 for agitation in bipolar disorders or schizophrenia, has completed enrollment and dosing, collecting data from over 2,200 agitation episodes across more than 200 patients with two favorable DSMB recommendations SERENITY At-Home Phase 3 Trial Statistics | Metric | Value | | :--- | :--- | | Patients Enrolled | >200 | | Study Sites | 22 | | Agitation Episodes Data | >2,200 | | Patient Populations | Balanced (Bipolar & Schizophrenia) | | DSMB Recommendations | 2 (Favorable) | - The vast majority of patients who were dosed completed the full **12-week** study[5](index=5&type=chunk) [TRANQUILITY Program (BXCL501 for Alzheimer's Dementia)](index=2&type=section&id=TRANQUILITY%20Program%20(BXCL501%20for%20Alzheimer's%20Dementia)) The TRANQUILITY In-Care Phase 3 trial, assessing a 60 mcg dose of BXCL501 for acute agitation in Alzheimer's dementia, remains a key strategy, with BioXcel currently evaluating Contract Research Organizations to initiate the trial - The TRANQUILITY program is designed to evaluate a **60 mcg dose** of BXCL501 for agitation in Alzheimer's dementia within care settings[13](index=13&type=chunk) - The company is currently evaluating CROs for trial initiation, indicating the program is moving forward[13](index=13&type=chunk) [BXCL501 in Chronic Conditions](index=2&type=section&id=BXCL501%20in%20Chronic%20Conditions) Recently published non-clinical research in *Frontiers in Pharmacology* demonstrated that BXCL501 significantly reduced stress-induced behaviors in animal models, supporting its mechanism of action and potential utility in broader stress-related psychiatric disorders - Research published in *Frontiers in Pharmacology* showed BXCL501 reduced stress-induced behaviors, supporting its potential for use in chronic stress-related disorders[6](index=6&type=chunk) [Corporate Updates](index=2&type=section&id=Corporate%20Updates) BioXcel is maintaining the market presence of its approved drug, IGALMI, for institutional use, continuing to supply the product and build brand awareness with minimal commercial resources - The company continues to supply IGALMI in the institutional setting and build brand awareness with minimal commercial resources[7](index=7&type=chunk) [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) [Financial Performance Summary](index=2&type=section&id=Financial%20Performance%20Summary) In Q2 2025, BioXcel reported a significant decrease in IGALMI net revenue to $120 thousand from $1.1 million in Q2 2024, with net loss increasing to $19.2 million, while R&D expenses rose due to clinical trial activity and SG&A expenses fell from cost-saving measures Q2 2025 vs. Q2 2024 Financial Performance (in millions) | Metric | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | Net Revenue | $0.12 | $1.1 | -89% | | R&D Expenses | $10.3 | $8.0 | +28.8% | | SG&A Expenses | $5.6 | $9.5 | -41.1% | | Operating Loss | $15.9 | $17.3 | -8.1% | | Net Loss | $19.2 | $8.3 | +131.3% | - The increase in R&D expenses was primarily driven by clinical trial activity for the SERENITY at-home Phase 3 studies[10](index=10&type=chunk) - The decrease in SG&A expenses was attributed to lower personnel costs, professional fees, and marketing costs following reprioritization actions in **2024**[11](index=11&type=chunk) - Cost of Goods Sold in Q2 2025 included a **$95 thousand** charge for reserves for excess or obsolete inventory, which was not present in the same period of **2024**[9](index=9&type=chunk) [Financial Position](index=2&type=section&id=Financial%20Position) The company ended Q2 2025 with $18.6 million in cash, cash equivalents, and restricted cash, subsequently raising an additional $11.5 million from at-the-market sales and $3.6 million from warrant exercises, with an operating cash burn of $12.6 million for the quarter Cash Position as of June 30, 2025 | Item | Amount (in millions) | | :--- | :--- | | Cash and cash equivalents (June 30, 2025) | $18.6 | | Gross proceeds from ATM (post-Q2) | $11.5 | | Proceeds from warrant exercises (post-Q2) | $3.6 | | **Pro-forma Cash** | **$33.7** | - The company used **$12.6 million** in operating cash during the second quarter of **2025**[12](index=12&type=chunk) [Detailed Financial Statements](index=7&type=section&id=Detailed%20Financial%20Statements) This section provides the unaudited condensed statements of operations for the three and six months ended June 30, 2025 and 2024, and the condensed balance sheets as of June 30, 2025, and December 31, 2024 Statements of Operations (Unaudited, in thousands) | | Three months ended June 30, | Six months ended June 30, | | :--- | :--- | :--- | :--- | :--- | | | **2025** | **2024** | **2025** | **2024** | | Product revenues | $120 | $1,104 | $288 | $1,686 | | Total operating expenses | $15,972 | $18,400 | $26,239 | $43,145 | | Loss from operations | $(15,852) | $(17,296) | $(25,951) | $(41,459) | | Net loss | $(19,187) | $(8,299) | $(26,441) | $(35,090) | | Net loss per share | $(2.45) | $(3.30) | $(4.17) | $(15.78) | Condensed Balance Sheets (Unaudited, in thousands) | | **June 30, 2025** | **December 31, 2024** | | :--- | :--- | :--- | | Cash and cash equivalents and restricted cash | $18,575 | $29,854 | | Total assets | $25,789 | $38,338 | | Total liabilities | $133,456 | $131,439 | | Total stockholders' equity (deficit) | $(107,667) | $(93,101) | [Product and Trial Information](index=3&type=section&id=Product%20and%20Trial%20Information) [About BXCL501](index=3&type=section&id=About%20BXCL501) BXCL501 is an investigational, proprietary, orally dissolving film of dexmedetomidine, currently under investigation for acute agitation in Alzheimer's dementia and at-home use in bipolar disorder or schizophrenia, having received FDA Breakthrough Therapy and Fast Track designations - BXCL501 is an investigational, orally dissolving film of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist[15](index=15&type=chunk) - It is being investigated for acute treatment of agitation in Alzheimer's dementia and at-home use for bipolar disorder or schizophrenia[15](index=15&type=chunk) - BXCL501 has received FDA Breakthrough Therapy designation for agitation in dementia and Fast Track designation for agitation in schizophrenia, bipolar disorders, and dementia[15](index=15&type=chunk) [About IGALMI (Approved Drug)](index=4&type=section&id=About%20IGALMI%20(Approved%20Drug)) IGALMI, the FDA-approved dexmedetomidine sublingual film, is indicated for acute agitation in adults with schizophrenia and bipolar I or II disorder, requiring healthcare provider supervision due to potential risks like low blood pressure and significant drowsiness - IGALMI is a prescription medicine for the acute treatment of agitation associated with schizophrenia and bipolar disorder I or II in adults[18](index=18&type=chunk) - It must be administered under the supervision of a healthcare provider, and its safety has not been studied beyond **24 hours** from the first dose[18](index=18&type=chunk) - Important safety risks include decreased blood pressure, slower heart rate, QT interval prolongation, and sleepiness/drowsiness; patients should not drive or operate machinery for at least **8 hours** after taking it[24](index=24&type=chunk) [Clinical Trial Designs](index=3&type=section&id=Clinical%20Trial%20Designs) This section outlines the design of two pivotal Phase 3 trials for BXCL501: the SERENITY At-Home trial evaluating the safety of a 120 mcg dose, and the TRANQUILITY In-Care trial assessing the efficacy of a 60 mcg dose for Alzheimer's-related agitation [SERENITY At-Home Phase 3 Trial Design](index=3&type=section&id=SERENITY%20At-Home%20Phase%203%20Trial%20Design) The SERENITY At-Home trial is a double-blind, placebo-controlled study focused on the safety of a 120 mcg dose of BXCL501, enrolling 200 patients with bipolar disorders or schizophrenia to self-administer the drug at home over a 12-week period, with efficacy as an exploratory endpoint - The trial is a double-blind, placebo-controlled study evaluating the safety of a **120 mcg dose** of BXCL501 for at-home use[16](index=16&type=chunk) - It involves **200 patients** self-administering the drug or placebo during agitation episodes over a **12-week period**, with safety data as the primary collection point[16](index=16&type=chunk) [TRANQUILITY In-Care Phase 3 Trial Design](index=3&type=section&id=TRANQUILITY%20In-Care%20Phase%203%20Trial%20Design) The TRANQUILITY In-Care trial is a double-blind, placebo-controlled study designed to evaluate the efficacy and safety of a 60 mcg dose of BXCL501, aiming to enroll approximately 150 patients aged 55 and older with Alzheimer's dementia in care facilities, with the primary endpoint being the change in PEC score two hours after the first dose - The trial is designed to evaluate the efficacy and safety of a **60 mcg dose** of BXCL501 for agitation in Alzheimer's dementia in a care setting[17](index=17&type=chunk) - The primary endpoint is the change from baseline in the Positive and Negative Syndrome Scale-Excitatory Component (PEC) total score at **two hours** post-dose[17](index=17&type=chunk)

Core Insights - BioXcel Therapeutics is set to release topline data from its SERENITY At-Home Phase 3 trial for the acute treatment of agitation associated with bipolar disorders or schizophrenia in August [1][2] - The company is preparing for a meeting with the FDA to support a potential supplemental New Drug Application (sNDA) for label expansion of IGALMI in the at-home setting [1][2] - Recent research indicates potential applications of BXCL501 in chronic conditions, enhancing its market prospects [1][4] Clinical Trials - The SERENITY At-Home Phase 3 trial is a double-blind, placebo-controlled study evaluating the safety of a 120 mcg dose of BXCL501 for treating agitation in bipolar disorders or schizophrenia at home [4][15] - The trial enrolled over 200 patients across 22 sites, with a balanced distribution between bipolar disorder and schizophrenia populations [6] - The TRANQUILITY In-Care Phase 3 trial is also underway, focusing on agitation associated with Alzheimer's dementia [6][16] Financial Performance - For Q2 2025, net revenue from IGALMI was $120 thousand, a significant decrease from $1.1 million in Q2 2024 [8] - Cost of Goods Sold for Q2 2025 was $107 thousand, up from $62 thousand in the same period last year [9] - Research and Development (R&D) expenses rose to $10.3 million in Q2 2025, compared to $8.0 million in Q2 2024, primarily due to increased clinical trial activities [10] Losses and Cash Position - The company reported an operating loss of $15.9 million and a net loss of $19.2 million for Q2 2025, compared to an operating loss of $17.3 million and a net loss of $8.3 million in Q2 2024 [12] - As of June 30, 2025, cash and cash equivalents totaled $18.6 million, not including an additional $11.5 million from sales and $3.6 million from warrant exercises [13][30]

Core Insights - BioXcel Therapeutics, Inc. is participating in a fireside chat at the Canaccord Genuity 45th Annual Growth Conference on August 12, 2025 [1] - The company utilizes artificial intelligence to develop transformative medicines in neuroscience and has a subsidiary focused on immuno-oncology [3] Company Overview - BioXcel Therapeutics, Inc. is a biopharmaceutical company listed on Nasdaq under the ticker BTAI [3] - The company employs a drug re-innovation approach, leveraging existing approved drugs and big data to identify new therapeutic indications [3] Event Details - The fireside chat will take place at 12 p.m. ET and will be accessible via a webcast on the company's website [1][2] - A replay of the webcast will be available for 90 days following the event [2]