BioXcel Therapeutics(BTAI) - 2024 Q3 - Quarterly Results

Company Overview and Strategic Updates BioXcel Therapeutics is advancing BXCL501's clinical development for agitation in various neurological conditions and strengthening its intellectual property portfolio Introduction and Strategic Focus BioXcel Therapeutics is focusing on the clinical development of BXCL501, advancing pivotal Phase III trials for acute treatment of agitation associated with bipolar disorder, schizophrenia (outpatient), and Alzheimer's disease (inpatient), aiming to expand market potential - The company continues to focus on the clinical development of BXCL501, advancing the SERENITY At-Home trial (for outpatient treatment of acute agitation associated with bipolar disorder or schizophrenia) and the TRANQUILITY In-Care trial (for agitation associated with Alzheimer's disease)[2] - The company is committed to meeting the needs of patients, caregivers, and healthcare providers, and sees significant market expansion potential for its primary neuroscience asset[2] Clinical Development Updates The company has made progress on the BXCL501 program, initiating the SERENITY At-Home trial, receiving FDA feedback for the TRANQUILITY In-Care trial, and supporting new investigator-sponsored trials BXCL501 Pivotal Phase 3 Trials The company has initiated the SERENITY At-Home trial and received FDA feedback for the TRANQUILITY In-Care trial for BXCL501 - The SERENITY At-Home trial has randomized its first patient for acute treatment of agitation associated with bipolar disorder or schizophrenia, with the trial expected to last 9 to 12 months[3] - The TRANQUILITY In-Care trial has received FDA feedback on the BXCL501 protocol for treating agitation associated with Alzheimer's disease, with the company submitting the protocol on September 5, 2024[3] BXCL501 Investigator-Sponsored Trials The Department of Defense has awarded a grant to fund a Phase IIa trial of BXCL501 for acute stress disorder - The U.S. Department of Defense awarded a grant to the University of North Carolina at Chapel Hill to fund a Phase IIa efficacy and safety trial of BXCL501 for acute stress disorder[4] - Patient enrollment for this trial is expected to begin in the first half of 2025, marking the second externally funded stress-related trial[4] Patent Portfolio BioXcel Therapeutics continues to strengthen its intellectual property portfolio for IGALMI™ (dexmedetomidine) sublingual film, currently holding 12 Orange Book-listed patents valid until 2037-2043, with a new patent granted until 2043 - The company currently holds 12 Orange Book-listed patents for IGALMI™, with validities ranging from 2037 to 2043[5] - A recent U.S. Patent (U.S. Patent No. 12,138,247) for IGALMI™ was granted, valid until January 12, 2043, and is expected to be eligible for Orange Book listing[5] Third Quarter 2024 Financial Performance The company significantly reduced its net loss in Q3 2024 due to substantial decreases in R&D and SG&A expenses, despite a quarterly decline in IGALMI net revenue Key Financial Highlights BioXcel Therapeutics reported a significantly reduced net loss in Q3 2024, primarily due to substantial decreases in R&D and SG&A expenses following strategic reprioritization and workforce reductions, despite a decline in quarterly net revenue for IGALMI - Net loss for Q3 2024 was $13.7 million, a significant reduction from $50.5 million in the same period of 2023[10] - Research and development expenses and selling, general and administrative expenses significantly decreased due to reprioritization in August 2023 and workforce reductions in May 2024[8][9] - IGALMI net revenue for Q3 2024 was $0.214 million, lower than $0.341 million in Q3 2023, but net revenue for the nine months ended September 30, 2024, increased by 89% to $1.9 million year-over-year[6] Detailed Financial Results The company experienced a sequential decline in Q3 2024 product revenue, but significant cumulative revenue growth over nine months, while successfully reducing operating expenses through cuts in R&D and SG&A, thereby narrowing its net loss Net Revenue IGALMI net revenue declined in Q3 2024 due to reordering schedules but showed strong growth over the nine-month period IGALMI Net Revenue | Metric | Q3 2024 (in thousands) | Q3 2023 (in thousands) | Change (%) | | :----- | :--------------------- | :--------------------- | :--------- | | Net Revenue | $214 | $341 | -37.2% | | Nine Months Ended Sep 30 | | | | | Net Revenue | $1,900 | $1,004 | +89.2% | - The decline in Q3 sales was primarily due to the timing of reorders from existing customers[6] - The nine-month sales growth reflects new customer acquisition and increased sales activities, indicating higher utilization[6] Cost of Goods Sold Cost of goods sold increased in Q3 2024, primarily due to higher provisions for excess or obsolete inventory Cost of Goods Sold | Metric | Q3 2024 (in thousands) | Q3 2023 (in thousands) | Change (%) | | :----- | :--------------------- | :--------------------- | :--------- | | Cost of Goods Sold | $1,170 | $512 | +128.5% | - The increase in cost of goods sold was primarily due to higher provisions for excess or obsolete inventory in Q3 2024 compared to the same period in 2023[7] Research and Development (R&D) Expenses R&D expenses significantly decreased in Q3 2024 due to reduced clinical trial costs, professional services, and personnel expenses R&D Expenses | Metric | Q3 2024 (in thousands) | Q3 2023 (in thousands) | Change (%) | | :----- | :--------------------- | :--------------------- | :--------- | | R&D Expenses | $5,101 | $19,619 | -74.0% | - The decrease in R&D expenses was primarily due to reduced clinical trial costs, professional service fees, and personnel and related costs resulting from the company's reprioritization in August 2023 and workforce reductions in May 2024[8] Selling, General and Administrative (SG&A) Expenses SG&A expenses significantly decreased in Q3 2024 due to reduced personnel, professional services, and commercial expenses SG&A Expenses | Metric | Q3 2024 (in thousands) | Q3 2023 (in thousands) | Change (%) | | :----- | :--------------------- | :--------------------- | :--------- | | SG&A Expenses | $7,683 | $24,344 | -68.4% | - The decrease in SG&A expenses was primarily due to reduced personnel and related costs resulting from the company's reprioritization in August 2023 and workforce reductions in May 2024, as well as lower professional service fees and commercial expenses[9] Net Loss and Cash Position The company reported a significantly reduced net loss in Q3 2024, with operating cash outflow and a closing cash balance of $40.4 million Net Loss | Metric | Q3 2024 (in thousands) | Q3 2023 (in thousands) | Change (%) | | :----- | :--------------------- | :--------------------- | :--------- | | Net Loss | $(13,650) | $(50,486) | -73.0% | - Operating cash outflow for Q3 2024 was $16.3 million[10] - Cash and cash equivalents totaled $40.4 million as of September 30, 2024[10] Product and Company Information This section provides essential information on IGALMI™ and the investigational drug BXCL501, along with an overview of BioXcel Therapeutics' AI-driven biopharmaceutical approach About IGALMI™ (dexmedetomidine) sublingual film IGALMI™ is an FDA-approved prescription sublingual film for the acute treatment of agitation associated with schizophrenia and bipolar I or II disorder in adults, requiring administration under healthcare provider supervision with attention to potential serious side effects INDICATION IGALMI™ is indicated for acute agitation in adults with schizophrenia or bipolar disorder, with safety and efficacy not studied beyond 24 hours or in children - IGALMI™ (dexmedetomidine) sublingual film is a prescription medicine used under the supervision of a healthcare provider for the acute treatment of agitation associated with schizophrenia and bipolar I or II disorder in adults[13] - The safety and effectiveness of IGALMI™ have not been studied beyond 24 hours after the first dose or in children[13] IMPORTANT SAFETY INFORMATION IGALMI™ carries important safety information regarding potential serious side effects like hypotension and bradycardia, and contraindications for patients with certain cardiac conditions - IGALMI™ may cause serious side effects, including low blood pressure, orthostatic hypotension, and slow heart rate, which may be more common in patients with hypovolemia, diabetes, chronic hypertension, and the elderly[14] - IGALMI™ should not be given to patients with abnormal heart rhythms, a history of irregular heartbeats, slow heart rate, low potassium, low magnesium, or those taking other medications that may affect heart rhythm, as it may increase the risk of Torsades de Pointes and sudden death[14] - Common side effects include somnolence/drowsiness, oral paresthesia or numbness, dizziness, dry mouth, hypotension, and orthostatic hypotension[15] - Patients should inform their healthcare provider about their medical history, pregnancy or breastfeeding status, and all medications they are taking[16] About BXCL501 (Investigational Drug) BXCL501 is an investigational dexmedetomidine oral film, distinct from the approved IGALMI™ indications, currently being studied for acute treatment of agitation associated with Alzheimer's disease dementia and bipolar I or II disorder or schizophrenia in an at-home setting, and has received FDA Breakthrough Therapy and Fast Track designations - BXCL501 is an investigational proprietary oral film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist[18] - BXCL501 is being studied by BioXcel Therapeutics for the acute treatment of agitation associated with Alzheimer's disease dementia, and for acute at-home treatment of agitation associated with bipolar I or II disorder or schizophrenia[18] - BXCL501 has received FDA Breakthrough Therapy designation for the acute treatment of agitation associated with dementia and Fast Track designation for the acute treatment of agitation associated with schizophrenia, bipolar disorder, and dementia[18] About BioXcel Therapeutics, Inc. BioXcel Therapeutics is a biopharmaceutical company leveraging artificial intelligence to develop transformative neuroscience drugs, with its wholly-owned subsidiary OnkosXcel Therapeutics focusing on immuno-oncology drug development. The company employs a drug re-innovation approach, combining big data and proprietary machine learning algorithms to identify new therapeutic indications for existing or clinically validated product candidates - BioXcel Therapeutics, Inc. is a biopharmaceutical company leveraging artificial intelligence to develop transformative drugs in neuroscience[19] - Its wholly-owned subsidiary, OnkosXcel Therapeutics, focuses on the development of immuno-oncology drugs[19] - The company employs a drug re-innovation approach, utilizing existing approved drugs and/or clinically validated product candidates, combined with big data and proprietary machine learning algorithms, to identify new therapeutic indications[19] Additional Information This section provides important disclosures regarding forward-looking statements, details on the Q3 2024 earnings conference call, and company contact information Forward-Looking Statements This press release contains forward-looking statements regarding future events and company performance, which are subject to various risks and uncertainties that could cause actual results to differ materially from expectations - This press release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995, intended to be covered by the safe harbor provisions[20] - Forward-looking statements are based on the company's current expectations and various assumptions but are inherently uncertain, and actual results may differ materially from those described or implied due to various important factors[20] - Important factors include but are not limited to: limited operating history, significant losses, need for substantial additional funding, significant indebtedness, substantial doubt about ability to continue as a going concern, limited drug discovery and development experience, risks related to the TRANQUILITY program, reliance on IGALMI™ and other product candidates, potential overestimation of market size, lack of drug marketing and sales experience, regulatory requirements, preliminary data not predicting final results, ability to obtain regulatory approvals, patient enrollment, adverse side effects, novel approach based on EvolverAI, significant influence and reliance on BioXcel LLC, patent infringement litigation, reliance on third parties, ability to comply with applicable regulations, impact of data breaches or cyberattacks, increased scrutiny related to environmental, social, and governance (ESG) matters, risks related to federal, state or foreign healthcare 'fraud and abuse' laws, and ability to commercialize its product candidates[20] Conference Call and Webcast BioXcel Therapeutics held a conference call and webcast on November 14, 2024, to discuss its third-quarter financial results, providing access details and replay information, and noting the company website as a channel for important information - BioXcel Therapeutics held a conference call and webcast on November 14, 2024, at 8:00 AM ET, to discuss its Q3 2024 financial results[11] - The conference call could be accessed by dialing 877-407-5795 or 201-689-8722, or via webcast on the investor section of the company's website bioxceltherapeutics.com, with a replay available for 90 days[11] - The company may use its website as a channel for distributing important company information[12] Contact Information Contact information for BioXcel Therapeutics' company/investor relations and media inquiries is provided - Company/Investor Contact: Erik Kopp, BioXcel Therapeutics, Phone: 1.203.494.7062[21] - Media Contact: David Schull, Russo Partners, Phone: 1.858.717.2310[21] Financial Statements This section presents the unaudited consolidated statements of operations and condensed balance sheets for the specified periods Statements of Operations This section presents the unaudited consolidated statements of operations for the three and nine months ended September 30, 2024, and 2023, detailing the company's revenues, operating expenses, net loss, and net loss per share BioXcel Therapeutics, Inc. Statements of Operations (Unaudited, in thousands, except per share amounts) | Revenues | Three months ended Sep 30, 2024 | Three months ended Sep 30, 2023 | Nine months ended Sep 30, 2024 | Nine months ended Sep 30, 2023 | | :-------------------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Product revenues | $214 | $341 | $1,900 | $1,004 | | Operating expenses | | | | | | Cost of goods sold | 1,170 | 512 | 1,311 | 546 | | Research and development | 5,101 | 19,619 | 24,534 | 74,392 | | Selling, general and administrative | 7,683 | 24,344 | 30,398 | 73,810 | | Restructuring costs | 1,553 | 4,163 | 2,409 | 4,163 | | Total operating expenses | 15,507 | 48,638 | 58,652 | 152,911 | | Loss from operations | (15,293) | (48,297) | (56,752) | (151,907) | | Other (income) expense | | | | | | Interest expense, net | 3,790 | 3,252 | 11,097 | 9,879 | | Interest income | (616) | (1,068) | (2,234) | (4,703) | | Other (income) expense, net | (4,817) | 0 | (16,875) | (286) | | Net loss and comprehensive loss | $(13,650) | $(50,486) | $(48,740) | $(156,797) | | Net loss per share - basic and diluted | $(0.32) | $(1.72) | $(1.29) | $(5.40) | | Weighted average shares outstanding - basic and diluted | 42,390 | 29,268 | 37,853 | 29,026 | Condensed Balance Sheets This section provides unaudited condensed balance sheet data as of September 30, 2024, and December 31, 2023, including cash and cash equivalents, total assets, total liabilities, and total stockholders' equity (deficit) BioXcel Therapeutics, Inc. Condensed Balance Sheets (Unaudited, in thousands) | Metric | September 30, 2024 | December 31, 2023 | | :----------------------------------- | :----------------- | :---------------- | | Cash and cash equivalents | $40,387 | $65,221 | | Total assets | $48,892 | $73,702 | | Total liabilities | $134,525 | $130,210 | | Total stockholders' equity (deficit) | $(85,633) | $(56,508) |