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of Contents](#TOC)\n\n​\n\n​\n\n**UNITED STATES**\n\n**SECURITIES AND EXCHANGE COMMISSION**\n\n**WASHINGTON, D.C. 20549**\n\n**FORM ****10-Q**\n\n**(Mark One)**\n\n​\n\n**☒**\n\n**QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934**\n\n​\n\n**For the quarterly period ended****March 31,****2026**\n\n​\n\n**OR**\n\n​\n\n**☐**\n\n**TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934**\n\n​\n\n**For the transition period from to**\n\n​\n\n**Commission File Number:****001-38410**\n\n**BioXcel Therapeutics, Inc.**\n\n(Exact name of registrant as specified in its charter)\n\n​\n\n​\n\n​\n\n​\n\n**Delaware**\n\n**82-1386754**\n\n(State or other jurisdiction of\nincorporation or organization)\n\n(I.R.S. Employer\nIdentification No.)\n\n​\n\n​\n\n**555 Long Wharf Drive**\n\n​\n\n**New Haven****,****CT**\n\n**06511**\n\n(Address of principal executive offices)\n\n(Zip Code)\n\n​\n\n**(****475****)****238-6837**\n\n(Registrant’s telephone number, including area code)\n\n​\n\n**N/A**\n\n(Former name, former address and former fiscal year, if changed since last report)\n\n​\n\n​\n\n​\n\n​\n\n​\n\n​\n\n**Securities registered pursuant to Section 12(b) of the Act:**\n\n​\n\n**Title of each class**\n\n​\n\n**Trading Symbol(s)**\n\n​\n\n**Name of each exchange on which registered**\n\nCommon Stock,\n$0.001 par value per share\n\n​\n\nBTAI\n\n​\n\nNasdaq Capital Market\n\n​\n\nIndicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ⌧ No ◻\n\n​\n\nIndicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ⌧ No ◻\n\n​\n\nIndicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.\n\n​\n\nLarge accelerated filer ☐\n\nAccelerated filer ☐\n\n​\n\n​\n\nNon-accelerated filer ☒\n\nSmaller reporting company ☒\n\n​\n\n​\n\n​\n\nEmerging growth company ☐\n\n​\n\nIf an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐\n\n​\n\nIndicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒\n\n​\n\n​\n\nThe number of shares of the registrant’s common stock, $0.001 par value per share, outstanding at May 14, 2026 was 30,877,605.\n\n​\n\n​\n\n​\n\n​\n\n[Table of Contents](#TOC)\n\n**Table of Contents**\n\n​\n\n​\n\n​\n\n​\n\n​\n\n**Page**\n\n**PART I - FINANCIAL INFORMATION**\n\n​\n\n​\n\n[Forward Looking Statements](#FORWARDLOOKINGSTATEMENTS_531719)\n\n3\n\n​\n\n[Summary Risk Factors](#Summary_Risk_Factors)\n\n4\n\n[Item 1.](#Item1FinancialStatements_877614)\n\n[Financial Statements (Unaudited)](#Item1FinancialStatements_877614)\n\n7\n\n​\n\n[Condensed Consolidated Balance Sheets as of March 31, 2026 and December 31, 2025](#BALANCESHEETS_142330)\n\n7\n\n​\n\n[Condensed Consolidated Statements of Operations for the three months ended March 31, 2026 and 2025](#STATEMENTSOFOPERATIONS_842353)\n\n8\n\n​\n\n[Condensed Consolidated Statements of Changes in Stockholders’ (Deficit) Equity for the three months ended March 31, 2026 and 2025](#STATEMENTSOFCHANGESINSTOCKHOLDERSEQUITY_)\n\n9\n\n​\n\n[Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2026 and 2025](#STATEMENTSOFCASHFLOWS_929012)\n\n10\n\n​\n\n[Notes to Condensed Consolidated Financial Statements](#NOTESTOFINANCIALSTATEMENTS_349172)\n\n11\n\n[Item 2.](#Item2MANAGEMENTSDISCUSSIONANDANALYSIS_22)\n\n[Management’s Discussion and Analysis of Financial Condition and Results of Operations](#Item2MANAGEMENTSDISCUSSIONANDANALYSIS_22)\n\n41\n\n[Item 3.](#Item3QuantitativeandQualitativeDisclosur)\n\n[Quantitative and Qualitative Disclosures About Market Risk](#Item3QuantitativeandQualitativeDisclosur)\n\n68\n\n[Item 4.](#Item4ControlsandProcedures_79336)\n\n[Controls and Procedures](#Item4ControlsandProcedures_79336)\n\n68\n\n​\n\n​\n\n​\n\n**PART II OTHER INFORMATION**\n\n​\n\n[Item 1.](#Item1LegalProceedings_771938)\n\n[Legal Proceedings](#Item1LegalProceedings_771938)\n\n69\n\n[Item 1A.](#Item1ARiskFactors_143189)\n\n[Risk Factors](#Item1ARiskFactors_143189)\n\n69\n\n[Item 2.](#Item2UnregisteredSalesofEquitySecurities)\n\n[Unregistered Sales of Equity Securities and Use of Proceeds](#Item2UnregisteredSalesofEquitySecurities)\n\n136\n\n[Item 3.](#Item3DefaultsUponSeniorSecurities_782584)\n\n[Defaults Upon Senior Securities](#Item3DefaultsUponSeniorSecurities_782584)\n\n136\n\n[Item 4.](#Item4MineSafetyDisclosures_613042)\n\n[Mine Safety Disclosures](#Item4MineSafetyDisclosures_613042)\n\n136\n\n[Item 5.](#Item5OtherInformation_348642)\n\n[Other Information](#Item5OtherInformation_348642)\n\n136\n\n[Item 6.](#Item6Exhibits_836986)\n\n[Exhibits](#Item6Exhibits_836986)\n\n137\n\n[Signatures](#SIGNATURES_228043)\n\n140\n\n​\n\n​\n\n​\n\n2\n\n[Table of Contents](#TOC)\n\n**FORWARD-LOOKING STATEMENTS**\n\nThis Quarterly Report on Form 10-Q (this “Quarterly Report”) contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). The words “anticipate,” “believe,” “can,” “continue,” “could,” “designed,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. All statements contained in this Quarterly Report, other than statements of historical fact, are forward-looking statements, including, without limitation, statements regarding:\n\n●our ability to raise additional capital and continue as a going concern;\n\n●our sales strategy for IGALMI®;\n\n●our ability to stay listed on the Nasdaq Capital market;\n\n●compliance with covenants under our financing arrangements;\n\n●developments relating to our SERENITY and TRANQUILITY programs;\n\n●the size of our total addressable markets and related underlying estimates;\n\n●our plans relating to clinical trials and marketing applications for our product candidates;\n\n●our plans to research, develop and commercialize our current and future product candidates;\n\n●our plans to seek to enter into collaborations for the development and commercialization of certain product candidates;\n\n●the potential benefits of any future collaboration;\n\n●the timing of and our ability to obtain and maintain regulatory approvals for our product candidates;\n\n●the timing of and results of discussions we have with regulators;\n\n●the rate and degree of market acceptance, clinical utility, number of prescribers and formulary wins of IGALMI® and any product candidates for which we receive marketing approval;\n\n●our commercialization, marketing and manufacturing capabilities and strategy, including the potential benefits from any advertising campaigns;\n\n●our participation in, and any potential benefits from, events, conferences, presentations and conventions;\n\n●our intellectual property position and strategy;\n\n●our estimates regarding expenses, future revenue, capital requirements and need for additional financing;\n\n●potential investments in, or other strategic options for, our subsidiary, OnkosXcel Therapeutics, LLC (“OnkosXcel”);\n\n●developments relating to our competitors and our industry;\n\n●the impact of government laws and regulations;\n\n●developments related to legal proceedings and investigations; and\n\n●our relationship with BioXcel LLC.\n\nThese forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, those listed under “Summary Risk Factors,” Part II, Item 1A. “Risk Factors,” and Part I, Item 2. “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in this Quarterly Report. These and other important factors discussed under the caption “Risk Factors” in our other filings with the Securities and Exchange Commission (“SEC”) could cause actual results to differ materially from those indicated by the forward-looking statements made in this filing. Given these uncertainties, you should not rely on these forward-looking statements as predictions of future events. While we may elect to update forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.\n\nAs used in this Quarterly Report, unless otherwise specified or the context otherwise requires, the terms “we,” “our,” “us,” the “Company” or “BTI” refer to BioXcel Therapeutics, Inc. and “BioXcel LLC” refers to the Company’s former parent company, BioXcel LLC and its predecessor, BioXcel Corporation. All brand names or trademarks appearing in this Quarterly Report are the property of their respective owners, including IGALMI®, which is a trademark of BioXcel Therapeutics, Inc.\n\n3\n\n[Table of Contents](#TOC)\n\nWe may use our website as a distribution channel for material information about the Company. Financial and other important information regarding the Company is routinely posted on and accessible through the Investors & Media section of its website at *www.bioxceltherapeutics.com*. In addition, you may automatically receive email alerts and other information about the Company when you enroll your email address by visiting the “Email Alerts” option under the News / Events menu of the Investors & Media section of our website at *www.bioxceltherapeutics.com*. The information contained in, or accessible through, our website does not constitute part of this quarterly report and the inclusion of our website address in this quarterly report is an inactive textual reference only.\n\n​\n\n​\n\n**SUMMARY RISK FACTORS**\n\nOur business is subject to numerous risks and uncertainties, including those described in Part II, Item 1A. “Risk Factors” in this Quarterly Report. You should carefully consider these risks and uncertainties when investing in our common stock. The principal risks and uncertainties affecting our business include the following:\n\n●We have identified conditions and events that raise substantial doubt about our ability to continue as a going concern.\n\n●We have a limited operating history and have not generated substantial product revenues to date, which may make it difficult to evaluate the success of our business to date and to assess our future viability.\n\n●We have incurred significant operating losses since inception and anticipate that we will continue to incur substantial operating losses for the foreseeable future and may never achieve or maintain profitability.\n\n●We will need substantial additional funding, and if we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts or otherwise seek strategic alternatives.\n\n●If we do not maintain compliance with the listing standards of the Nasdaq Capital Market, Nasdaq may delist our common stock from trading on its exchange, which could limit investors' ability to make transactions in our securities and subject us to additional trading restrictions.\n\n●We have significant indebtedness and other contractual obligations that could impair our liquidity, restrict our ability to do business and thereby harm our business, results of operations and financial condition. We may not have sufficient cash flow from operations to satisfy our obligations under the Credit Agreement.\n\n●Our strategic clinical reprioritization and other workforce reductions in force may not achieve our intended outcome.\n\n●We have limited experience in drug discovery and drug development.\n\n●Developments relating to our TRANQUILITY II Phase 3 trial may impact the timing of our development plans for, and prospects for seeking or obtaining regulatory approval of, BXCL501 for the acute treatment of agitation (non-daily) associated with dementia in patients with probable Alzheimer’s disease and may also subject us to additional risks and uncertainties, including regulatory, stockholder or other actions, loss of investor confidence and negative impacts on the trading price of our common stock.\n\n●In the near term, we are dependent on the success of IGALMI®, and our lead product candidate, BXCL501. If we are unable to complete the clinical development of or obtain marketing approval for our product candidates or successfully commercialize IGALMI® or our lead product candidate, either alone or with a collaborator, or if we experience significant delays in doing so, our business could be substantially harmed.\n\n●Interim “top-line” and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.\n\n4\n\n[Table of Contents](#TOC)\n\n●The regulatory approval processes of the United States (“U.S.”) Food and Drug Administration (“FDA”), and comparable foreign authorities are lengthy, time consuming, expensive and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmed.\n\n●Clinical trials are expensive, difficult to design, difficult to conduct and involve an uncertain outcome.\n\n●We depend on enrollment of patients in our clinical trials to continue development of our product candidates. If we are unable to enroll patients in our clinical trials, our research and development efforts could be adversely affected.\n\n●Our estimated number of episodes of agitation and our corresponding estimated total addressable market are subject to inherent challenges and uncertainties. If we have overestimated the number of episodes or the size of our total addressable market for our current and potential future products or product candidates, or if any approval that we obtain is based on a narrower definition of the patient population, our revenue and ability to achieve profitability may be harmed.\n\n●The discovery and development of product candidates based on EvolverAI, BioXcel LLC’s proprietary pharmaceutical discovery and development engine, as well as and our own AI platform is novel and unproven, and we do not know whether we will be able to develop any products of commercial value.\n\n●Regulators may limit our ability to develop or implement our proprietary AI algorithms and/or may eliminate or restrict the confidentiality of our proprietary technology, which could have an adverse effect on our business, results of operations, and financial condition.\n\n●Although the FDA has approved IGALMI® for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder, we will still face extensive and ongoing regulatory requirements and obligations for IGALMI® and for any product candidates for which we obtain approval.\n\n●Although we obtained FDA approval for IGALMI®, our products and product candidates may not be accepted by physicians or the medical community in general, and there may be insufficient insurance coverage and reimbursement.\n\n●If we are found in violation of federal, state or foreign health care “fraud and abuse” laws, we may be required to pay significant fines and penalties, which may adversely affect our business, financial condition and results of operations.\n\n●We continue to depend on BioXcel LLC to provide us with certain services for our business.\n\n●We are substantially dependent on third parties for the manufacture of our clinical supplies of our product candidates, and our commercial supplies of IGALMI®, and we intend to rely on third parties to produce commercial supplies of any other approved product candidate.\n\n●We rely on third parties to conduct our preclinical and clinical trials. If these third parties do not successfully perform their contractual legal and regulatory duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our product candidates and our business could be substantially harmed.\n\n●Data breaches or cyber-attacks could disrupt our business operations, information technology systems, and financial results, or result in the loss or exposure of confidential or sensitive Company information.\n\n●We are and may in the future be subject to legal proceedings, claims and investigations in or outside the ordinary course of business. Such proceedings, claims and investigations could be costly and time-consuming to defend and could result in unfavorable outcomes, which may have a material adverse effect on our business, operating results and financial condition, and negatively affect the price of our common stock.\n\n5\n\n[Table of Contents](#TOC)\n\n●Unfavorable global political or economic events and conditions could adversely affect our business, financial condition or results of operations.\n\n●We face risks associated with the increased scrutiny relating to environmental, social and governance matters.\n\n●It is difficult and costly to protect our proprietary rights, and we may not be able to ensure their protection.\n\n​\n\n**TRADEMARKS, TRADE NAMES AND SERVICE MARKS**\n\nThis Quarterly Report includes our trademarks, trade names and service marks, including, without limitation, “IGALMI®” and our logo, which are our property and are protected under applicable intellectual property laws. Solely for convenience, trademarks, trade names and service marks may appear in this Quarterly Report without the ®, TM and SM symbols, but such references are not intended to indicate, in any way, that we or the applicable owner forgo or will not assert, to the fullest extent permitted under applicable law, our rights or the rights of any applicable licensors to these trademarks, trade names and service marks. We do not intend our use or display of other parties’ trademarks, trade names or service marks to imply, and such use or display should not be construed to imply a relationship with, or endorsement or sponsorship of us by, these other parties.\n\n**INDUSTRY AND OTHER DATA**\n\nUnless otherwise indicated, information contained in this Quarterly Report concerning our industry and the markets in which we operate, including our general expectations, market position and market opportunity, is based on our management’s estimates and research, as well as industry and general publications and research, surveys and studies conducted by third parties. While we believe the information from these third-party publications, research, surveys and studies included in this Quarterly Report is reliable, we do not guarantee the accuracy or completeness of such information, and we have not independently verified this information. Management’s estimates are derived from publicly available information, their knowledge of our industry and their assumptions based on such information and knowledge, which we believe to be reasonable. This data involves a number of assumptions and limitations which are necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described in this Quarterly Report under “Forward-Looking Statements” and Part II, Item 1A “Risk Factors.” These and other factors could cause our future performance and market expectations to differ materially from our assumptions and estimates.\n\n​\n\n6\n\n[Table of Contents](#TOC)\n\nPART I. FINANCIAL INFORMATION"}