BioXcel Therapeutics(BTAI)
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BioXcel Therapeutics(BTAI) - 2025 Q2 - Quarterly Report
2025-08-12 13:02
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].
BioXcel Therapeutics(BTAI) - 2025 Q2 - Quarterly Results
2025-08-12 12:05
[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)
BioXcel Therapeutics Reports Second Quarter 2025 Financial Results and Recent Business Updates
Globenewswire· 2025-08-12 11:55
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]
BioXcel Therapeutics to Participate in Canaccord Genuity 45th Annual Growth Conference
Globenewswire· 2025-08-11 11:00
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]
BioXcel Therapeutics Announces Last Patient Last Visit in SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or Schizophrenia
Globenewswire· 2025-08-01 11:00
Core Insights - BioXcel Therapeutics has completed the last patient last visit (LPLV) in the pivotal Phase 3 SERENITY At-Home clinical trial, with topline data expected to be released this month to support a supplemental New Drug Application (sNDA) for IGALMI in the at-home setting [1][3] Group 1: Clinical Trial Details - 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 associated with bipolar disorders or schizophrenia in an at-home setting [2][4] - The trial enrolled over 200 patients across 22 sites nationwide, ensuring no single site enrolled more than 11% of the total patient population, with a balanced distribution between bipolar disorders and schizophrenia [2][4] Group 2: Market Opportunity - There are approximately 23 million episodes of agitation related to bipolar disorders or schizophrenia annually in the U.S. that occur at home, with no FDA-approved therapies currently available for acute treatment in this setting [3][4] - The company aims to provide a much-needed at-home treatment option for individuals experiencing such agitation, marking a significant milestone in its development efforts [3] Group 3: Product Information - BXCL501, known as IGALMI, is an investigational orally dissolving film formulation of dexmedetomidine, currently approved for use under healthcare supervision for acute treatment of agitation associated with schizophrenia and bipolar disorder [5][6] - The product has received Breakthrough Therapy designation from the FDA for treating agitation associated with dementia and Fast Track designation for agitation related to schizophrenia and bipolar disorders [5]
BioXcel Therapeutics Submits Pre-Supplemental New Drug Application Meeting Package in Support of Potential Label Expansion for IGALMI®
Globenewswire· 2025-07-21 11:00
Core Points - BioXcel Therapeutics is focused on obtaining FDA approval for outpatient use of IGALMI® for treating agitation associated with bipolar disorders or schizophrenia [1][2] - A pre-sNDA meeting with the FDA is scheduled for August 20, 2025, to align on the submission process [2] - The SERENITY At-Home Phase 3 trial is nearing completion, with top-line results expected to be reported this quarter [3] Company Overview - BioXcel Therapeutics, Inc. utilizes artificial intelligence to develop transformative medicines in neuroscience [1][13] - The company has received Breakthrough Therapy designation for BXCL501 for treating agitation associated with dementia and Fast Track designation for schizophrenia and bipolar disorders [5] Clinical Development - The SERENITY At-Home trial is a double-blind, placebo-controlled study evaluating the safety of a 120 mcg dose of BXCL501 for acute agitation in the home setting [6] - The trial involves 200 patients with a history of agitation episodes, self-administering the treatment during episodes over a 12-week period [6] Market Opportunity - An estimated 23 million annual episodes of agitation associated with bipolar disorders or schizophrenia occur in the at-home setting in the U.S., with no FDA-approved therapies currently available for this treatment [3][17]
BioXcel Therapeutics Receives Second Positive Recommendation from Data Safety Monitoring Board (DSMB) to Continue SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or Schizophrenia
GlobeNewswire News Room· 2025-07-01 11:00
Core Insights - BioXcel Therapeutics, Inc. received a second positive recommendation from an independent Data Safety Monitoring Board (DSMB) to continue the SERENITY At-Home pivotal Phase 3 safety trial of BXCL501 for the acute treatment of agitation associated with bipolar disorders or schizophrenia [1][2] - The trial is fully enrolled with 178 patients dosed as of the May 28, 2025 cutoff date, and topline data is expected in Q3 2025 [2][7] - BXCL501 is an investigational sublingual film formulation of dexmedetomidine, currently under investigation for treating agitation in various conditions, including Alzheimer's dementia and bipolar disorders [5][6] Company Overview - BioXcel Therapeutics utilizes artificial intelligence to develop transformative medicines in neuroscience and has a subsidiary focused on immuno-oncology [13] - The company aims to address a significant unmet medical need for patients experiencing agitation related to bipolar disorders and schizophrenia, with no FDA-approved therapies currently available for at-home treatment [3][5] Trial Details - The SERENITY At-Home Phase 3 trial is a double-blind, placebo-controlled study designed to evaluate the safety of a 120 mcg dose of BXCL501 in 200 patients [6] - Patients are self-administering the drug during agitation episodes over a 12-week period, with safety data collected throughout the trial [6][3] - The trial's exploratory endpoints include assessments of severity and change in agitation two hours post-dosing [6] Regulatory and Market Potential - The trial data is intended to support a potential supplemental New Drug Application (sNDA) submission to expand the IGALMI® label for at-home use [3][16] - BXCL501 has received Breakthrough Therapy designation for treating agitation associated with dementia and Fast Track designation for agitation related to schizophrenia and bipolar disorders [5]
BioXcel Therapeutics Receives Positive Recommendation from Data Safety Monitoring Board (DSMB) to Continue SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or Schizophrenia
GlobeNewswire· 2025-05-27 12:01
Core Insights - BioXcel Therapeutics, Inc. announced that the independent Data Safety Monitoring Board (DSMB) recommended the continuation of the SERENITY At-Home pivotal Phase 3 safety trial of BXCL501 without modification, with topline data expected in Q3 2025 [2][9] Company Overview - BioXcel Therapeutics, Inc. is a biopharmaceutical company focused on utilizing artificial intelligence to develop transformative medicines in neuroscience [15] - The company is also involved in immuno-oncology through its subsidiary, OnkosXcel Therapeutics [15] Trial Details - The SERENITY At-Home Phase 3 trial is a double-blind, placebo-controlled study designed to evaluate the safety of a 120 mcg dose of BXCL501 for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home setting [4][7] - The trial is fully enrolled with more than 205 patients dosed, and over 150 patients have received multiple doses during the 12-week trial period [3][9] Product Information - BXCL501 is an investigational proprietary, orally dissolving film formulation of dexmedetomidine, which is under investigation for the acute treatment of agitation associated with Alzheimer's dementia, bipolar disorders, and schizophrenia [6] - BXCL501 has received Breakthrough Therapy designation from the FDA for the acute treatment of agitation associated with dementia and Fast Track designation for agitation associated with schizophrenia and bipolar disorders [6] Future Prospects - The results from the SERENITY trial are intended to support a potential supplemental New Drug Application (sNDA) submission for label expansion of IGALMI in the at-home setting, addressing a significant unmet medical need [4]
BioXcel Therapeutics Granted Extension to Regain Compliance with Nasdaq Continued Listing Requirement
Globenewswire· 2025-05-27 11:00
Core Viewpoint - BioXcel Therapeutics, Inc. has received approval from the Nasdaq Hearings Panel to continue its listing on The Nasdaq Stock Market, with a deadline to regain compliance by September 16, 2025 [1][2]. Company Overview - BioXcel Therapeutics is a biopharmaceutical company that leverages artificial intelligence to develop innovative medicines in the field of neuroscience [12]. - The company is also focused on immuno-oncology through its subsidiary, OnkosXcel Therapeutics [12]. Compliance and Listing - The Nasdaq Panel reviewed BioXcel's compliance plan during a hearing on May 1, 2025, and granted an extension for compliance with the MVLS Rule [2]. - The company is committed to executing its compliance plan to meet the necessary requirements within the specified timeframe [2][3]. Product Development - BioXcel is advancing multiple strategic initiatives, including the SERENITY At-Home pivotal Phase 3 safety trial of BXCL501, aimed at supporting a supplemental New Drug Application (sNDA) to expand the IGALMI label [3]. - BXCL501 is an investigational sublingual film formulation of dexmedetomidine, currently under investigation for treating agitation associated with Alzheimer's dementia and bipolar disorders [4]. SERENITY At-Home Phase 3 Trial - The SERENITY At-Home trial is a double-blind, placebo-controlled study evaluating the safety of a 120 mcg dose of BXCL501 for treating agitation in patients with bipolar disorders or schizophrenia [5]. - The trial involves 200 patients self-administering BXCL501 or placebo during agitation episodes over a 12-week period, with safety data collected throughout [5]. IGALMI Overview - IGALMI (dexmedetomidine) is a prescription medicine used for the acute treatment of agitation associated with schizophrenia and bipolar disorder in adults [6]. - The safety and effectiveness of IGALMI have not been established beyond 24 hours from the first dose [6]. Safety Information - IGALMI can cause serious side effects, including decreased blood pressure and slower heart rate, particularly in patients with certain pre-existing conditions [7][8]. - Common side effects reported in clinical studies include sleepiness, dizziness, and dry mouth [9].
BioXcel Therapeutics, Inc. (BTAI) Reports Q1 Loss, Lags Revenue Estimates
ZACKS· 2025-05-12 13:15
Company Performance - BioXcel Therapeutics reported a quarterly loss of $1.50 per share, significantly better than the Zacks Consensus Estimate of a loss of $2.72, and an improvement from a loss of $13.92 per share a year ago, resulting in an earnings surprise of 44.85% [1] - The company posted revenues of $0.17 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 44%, and down from $0.58 million in the same quarter last year [2] - Over the last four quarters, BioXcel has surpassed consensus EPS estimates four times and topped consensus revenue estimates two times [2] Stock Performance - BioXcel Therapeutics shares have declined approximately 74.4% since the beginning of the year, contrasting with the S&P 500's decline of 3.8% [3] - The current consensus EPS estimate for the upcoming quarter is -$2.24 on revenues of $0.4 million, and for the current fiscal year, it is -$16.44 on revenues of $3.51 million [7] Industry Outlook - The Medical - Biomedical and Genetics industry, to which BioXcel belongs, is currently ranked in the top 34% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact stock performance [5]