BioXcel Therapeutics, Inc. 10-K

Item 9A. Controls and Procedures Evaluation of Disclosure Controls and Procedures Our management, with the participation of our Chief Executive Officer and Chief Financial Officer (our principal executive officer and principal financial officer, respectively), evaluated the effectiveness of our disclosure controls and procedures as of December 31, 2023. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the rules and forms of the SEC. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of December 31, 2023, our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level. Management’s Annual Report on Internal Controls Over Financial Reporting Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act. Our management conducted an assessment of the effectiveness of our internal control over financial reporting based on the criteria set forth in “Internal Control-Integrated Framework (2013)” issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on this assessment, management concluded that, as of December 31, 2023, our internal control over financial reporting was effective. Attestation Report of the Registered Public Accounting Firm This Annual Report on Form 10-K does not include an attestation report of our independent registered public accounting firm on internal control over financial reporting as we are a “non-accelerated filer” as defined under SEC rules. Changes in Internal Control over Financial Reporting There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the three months ended December 31, 2023, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. Item 9B. Other Information (a) On March 20, 2024 (the “Effective Date”), we entered into a Fourth Amendment (the “Fourth Amendment”) to the Credit Agreement and Guaranty (as amended, the “Credit Agreement”) by and among the Company, as the borrower, certain subsidiaries of the Company from time to time party thereto as subsidiary guarantors, the lenders party thereto (the “Lenders”), and Oaktree Fund Administration LLC (“OFA”) as administrative agent (the “Administrative Agent”), pursuant to which the Lenders waived the covenant that we not receive a report and opinion from our independent registered public accounting firm that contains a “going concern” or similar qualification with respect to our financial statements for the year ended December 31, 2023. Accordingly, while our independent registered public accounting 137 Table of Contents firm’s report contained in this Annual Report on Form 10-K contains a “going concern” explanatory paragraph, it does not constitute an event of default under the Credit Agreement. The Fourth Amendment includes a covenant that we will receive, (i) after the Effective Date and on or before April 15, 2024, at least $25,000,000 in gross proceeds from the issuance of our common stock, warrants and/or pre-funded warrants, and/or in non-refundable cash consideration from partnering transactions entered into after the Effective Date (so long as such partnering transactions would not require us or any of our subsidiaries to make any cash investments in connection with the partnering transactions and no such cash investments are made), and (ii) after the Effective Date and on or before November 30, 2024, at least $50,000,000 (for the avoidance of doubt, inclusive of amounts previously counted toward the preceding clause (i)) in gross proceeds from the issuance of our common stock, warrants and/or pre-funded warrants, and/or in cash and/or non-cash consideration (measured at fair market value, as determined by the Administrative Agent in its sole discretion ) from partnering transactions entered into after the Effective Date. Failure to perform this covenant would constitute (A) a default under the Credit Agreement and (B) an event of default under the Credit Agreement, subject to a cure period, solely in the case of clause (i) of the preceding sentence, until May 15, 2024 (for the avoidance of doubt, failure to perform clause (ii) of the preceding sentence would constitute an immediate event of default under the Credit Agreement without any cure or grace period). In addition, the Fourth Amendment provides that if we have not, after the Effective Date and on or before September 30, 2024, received at least $40,000,000 in gross proceeds from the issuance of our common stock, warrants and/or pre-funded warrants, and/or cash and/or non-cash consideration (measured at fair market value, as determined by the Administrative Agent in its sole discretion) from partnering transactions entered into after the Effective Date, the “Minimum Liquidity Amount” (as defined in the Credit Agreement) that we are required to maintain at all times will increase to $25,000,000 from $15,000,000, unless and until we have received, after the Effective Date and on or before November 30, 2024, at least $50,000,000 in gross proceeds from the issuance of our common stock, warrants and/or pre-funded warrants, and/or in cash and/or non-cash consideration (measured at fair market value, as determined by the Administrative Agent in its sole discretion) from partnering transactions entered into after the Effective Date. In connection with the Fourth Amendment, on the Effective Date, we granted new warrants to the Lenders to purchase up to 100,000 shares of our common stock (the “2024 Warrant Shares”) at an exercise price of $3.0723 per share (the “2024 Warrants”), which represents a 10% premium over the arithmetic average of the volume-weighted average price of our common stock on the Nasdaq Capital Market during the 30 trading days preceding the Effective Date. The 2024 Warrants will expire on April 19, 2029 and may be net exercised at the holder’s election. The 2024 Warrants were issued, and the 2024 Warrant Shares will be issued (if at all), in reliance upon an exemption from the registration requirements of the Securities Act of 1933, as amended (the “Securities Act”), contained in Section 4(a)(2) of the Securities Act. The Lenders have represented that they are acquiring the securities for investment only and not with a view towards, or for resale in connection with, the public sale or distribution thereof, and appropriate legends have been or will be affixed to the securities. On the Effective Date, we amended and restated our Amended and Restated Registration Rights Agreement (the “Second Amended and Restated Registration Rights Agreement”) with the Lenders, originally dated April 19, 2022. Pursuant to the Second Amended and Restated Registration Rights Agreement, we agreed to register the 2024 Warrant Shares for resale. The foregoing summary of the Fourth Amendment, the 2024 Warrants and the Second Amended and Restated Registration Rights Agreement are qualified in their entirety by the complete text of such agreements, copies of which are filed hereto as Exhibit 10.22.4, 4.5 and 4.6, respectively. (b) On December 14, 2023 , Vimal Mehta , Chief Executive Officer , adopted a Rule 10b5-1 trading arrangement that is intended to satisfy the affirmative defense of Rule 10b5-1(c) for the sale of up to 34,938 shares of the Company’s common stock to cover taxes due in connection with the vesting of restricted stock units until December 31, 2024. On December 14, 2023 , Richard Steinhart , Chief Executive Officer , adopted a Rule 10b5-1 trading arrangement that is intended to satisfy the affirmative defense of Rule 10b5-1(c) for the sale of up to 25,000 shares of the Company’s common stock to cover taxes due in connection with the vesting of restricted stock units until December 31, 2024. 138 Table of Contents On December 14, 2023 , Javier Rodriguez , Senior Vice President, Chief Legal Officer , adopted a Rule 10b5-1 trading arrangement that is intended to satisfy the affirmative defense of Rule 10b5-1(c) for the sale of up to 25,000 shares of the Company’s common stock to cover taxes due in connection with the vesting of restricted stock units until December 31, 2024. On December 14, 2023 , Matthew Wiley , Chief Commercial Officer , adopted a Rule 10b5-1 trading arrangement that is intended to satisfy the affirmative defense of Rule 10b5-1(c) for the sale of up to 25,000 shares of the Company’s common stock to cover taxes due in connection with the vesting of restricted stock units until December 31, 2024. On December 14, 2023 , Frank Yocca , Chief Scientific Officer , adopted a Rule 10b5-1 trading arrangement that is intended to satisfy the affirmative defense of Rule 10b5-1(c) for the sale of up to 25,000 shares of the Company’s common stock to cover taxes due in connection with the vesting of restricted stock units until December 31, 2024. Item 9C. Disclosure Regarding Foreign Jurisdictions That Prevent Inspections Not applicable. ​ 139 Table of Contents PART III Item 10. Directors, Executive Officers, and Corporate Governance. INFORMATION ABOUT OUR DIRECTORS & EXECUTIVE OFFICERS The following information with respect to our Board of Directors (the "Board") and executive officers is presented as of March 22, 2024: ​ ​ ​ Name ​ Age ​ Position at BioXcel ​ Principal Employment Vimal Mehta, Ph.D. ​ 63 ​ Chief Executive Officer and President, and Director ​ Same Richard Steinhart ​ 66 ​ Senior Vice President and Chief Financial Officer ​ Same Matthew Wiley ​ 52 ​ Senior Vice President and Chief Commercial Officer ​ Same Frank Yocca, Ph.D. ​ 68 ​ Senior Vice President and Chief Scientific Officer ​ Same Vincent O’Neill, M.D. ​ 54 ​ Executive Vice President, Chief of Product Development and Medical Officer ​ Same Javier Rodriguez ​ 52 ​ Senior Vice President, Chief Legal Officer and Corporate Secretary ​ Same Peter Mueller, Ph.D. ​ 67 ​ Chairman of the Board ​ President at Mueller Health Foundation, a private foundation tackling globally lethal infectious diseases June Bray ​ 70 ​ Director ​ Former Senior Vice President, Global Regulatory Affairs and Medical Writing at Allergan, Inc., a pharmaceutical company Sandeep Laumas, M.D. ​ 55 ​ Director ​ Chief Business Officer and Chief Financial Officer at Instil Bio, Inc., a pharmaceutical company Michael Miller ​ 66 ​ Director ​ Former Executive Vice President, U.S. Commercial at Jazz Pharmaceuticals, Inc., a pharmaceutical company Michael Votruba, M.D. ​ 58 ​ Director ​ Director at the Gradus/RSJ Life Sciences Fund, a dedicated fund ​ The information required by this Item is incorporated herein by reference to the information that will be contained in our proxy statement related to our annual meeting of stockholders to be held in 2024 (the “2024 Annual Meeting of Stockholders”), which we intend to file with the SEC within 120 days of the year ended December 31, 2023. Item 11. Executive Compensation The information required by this Item is incorporated herein by reference to the information that will be contained in our proxy statement related to the 2024 Annual Meeting of Stockholders, which we intend to file with the SEC within 120 days of the year ended December 31, 2023. 140 Table of Contents Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters The information required by this Item is incorporated herein by reference to the information that will be contained in our proxy statement related to the 2024 Annual Meeting of Stockholders, which we intend to file with the SEC within 120 days of the year ended December 31, 2023. Item 13. Certain Relationships and Related Transactions, and Director Independence The information required by this Item is incorporated herein by reference to the information that will be contained in our proxy statement related to the 2024 Annual Meeting of Stockholders, which we intend to file with the SEC within 120 days of the year ended December 31, 2023. ​ Item 14. Principal Accounting Fees and Services The information required by this Item is incorporated herein by reference to the information that will be contained in our proxy statement related to the 2024 Annual Meeting of Stockholders, which we intend to file with the SEC within 120 days of the year ended December 31, 2023. ​ PART IV Item 15. Exhibits, Financial Statement Schedules (a) The following documents are filed as part of this report: (1) Financial Statements: Report of Independent Registered Public Accounting Firm (PCAOB ID: 00042) F-2 Consolidated Balance Sheets as of December 31, 2023 and 2022 F-3 Consolidated Statements of Operations for the Years Ended December 31, 2023 and 2022 F-4 Consolidated Statements of Changes in Stockholders’ Equity for the Years Ended December 31, 2023 and 2022 F-5 Consolidated Statements of Cash Flows for the Years Ended December 31, 2023 and 2022 F-6 Notes to C onsolidated Financial Statements F-7 (2) Financial Statement Schedules: All financial statement schedules have been omitted because they are not applicable, not required or the information required is shown in the financial statements or the notes thereto. (3) Exhibits. Exhibit Number Description Form File No. Exhibit Filing Date Filed/ Furnished Herewith 3.1 ​ Amended and Restated Certificate of Incorporation ​ 10-Q ​ 001-38410 ​ 3.1 ​ 08/10/2021 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 3.2 ​ Amended and Restated Bylaws ​ 8-K ​ 001-38410 ​ 3.2 ​ 03/13/2018 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 4.1 ​ Description of the Registrant’s Securities Registered Under Section 12 of the Exchange Act ​ ​ ​ ​ ​ * ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 4.2 ​ Specimen Stock Certificate evidencing the shares of common stock ​ S-1/A ​ 333-222990 ​ 4.2 ​ 02/26/2018 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 141 Table of Contents Exhibit Number Description Form File No. Exhibit Filing Date Filed/ Furnished Herewith 4.3 ​ Form of Amended and Restated Warrant Agreement, dated December 5, 2023 ​ 8-K ​ 001-38410 ​ 4.1 ​ 12/06/2023 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 4.4 ​ Form of Warrant Agreement, dated December 5, 2023 ​ 8-K ​ 001-38410 ​ 4.2 ​ 12/06/2023 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 4.5 ​ Form of Warrant Agreement, dated March 20, 2024 ​ ​ ​ ​ ​ ​ ​ ​ ​ * ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 4.6 ​ Second Amended and Restated Registration Rights Agreement, between the Company and the parties thereto, dated March 20, 2024. ​ ​ ​ ​ ​ ​ ​ ​ ​ * ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.1+ ​ Second Amended and Restated Separation and Shared Services Agreement, dated March 6, 2020 , by and between BioXcel Corporation and BioXcel Therapeutics, Inc. ​ 10-K ​ 001-38410 ​ 10.2 ​ 03/09/2020 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.2# ​ F irst Amendment to Second Amended and Restated Separation and Shared Services Agreement, dated March 3, 2021, by and between BioXcel LLC and BioXcel Therapeutics Inc . ​ 10-K ​ 001-38410 ​ 10.3 ​ 03/12/2021 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.3 ​ Second Amendment to Second Amended and Restated Separation and Shared Services Agreement, dated March 3, 2021, by and between BioXcel LLC and BioXcel Therapeutics Inc. ​ 10-Q ​ 001-38410 ​ 10.2 ​ 05/09/2022 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.4# ​ Amended and Restated Asset Contribution Agreement, effective November 7, 2017, by and between BioXcel LLC and BioXcel Therapeutics, Inc. ​ S-1/A ​ 333-222990 ​ 10.2 ​ 02/12/2018 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.5 ​ Lease Agreement, dated as of August 20, 2018, by and between Fusco Harbour Associates, LLC, as Landlord, and BioXcel Therapeutics, Inc., as Tenant ​ 8-K ​ 001-38410 ​ 10.1 ​ 08/23/2018 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.6 ​ First Amendment, dated August 19, 2020, to Lease Agreement, dated as of August 20, 2018, by and between Fusco Harbour Associates, LLC, as Landlord, and BioXcel Therapeutics, Inc., as Tenant ​ 10-Q ​ 001-38410 ​ 10.1 ​ 11/12/2020 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.7 @ ​ 2017 Equity Incentive Plan ​ S-1/A ​ 333-222990 ​ 10.3 ​ 02/12/2018 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 142 Table of Contents Exhibit Number Description Form File No. Exhibit Filing Date Filed/ Furnished Herewith 10.8 @ ​ Form of Incentive Stock Option Agreement under the 2017 Equity Incentive Plan ​ S-1/A ​ 333-222990 ​ 10.4 ​ 02/12/2018 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.9 @ ​ Form of Non-Statutory Stock Option Agreement under the 2017 Equity Incentive Plan ​ S-1/A ​ 333-222990 ​ 10.5 ​ 02/12/2018 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.10 @ ​ BioXcel Therapeutics, Inc. 2020 Incentive Award Plan and forms of award agreements thereunder ​ 10-Q ​ 001-38410 ​ 10.1 ​ 08/14/2020 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.11 @ ​ BioXcel Therapeutics, Inc. 2020 Employee Stock Purchase Plan ​ 10-Q ​ 001-38410 ​ 10.2 ​ 08/14/2020 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.12 @ ​ Form of Indemnification Agreement with directors and executive officers ​ S-1/A ​ 333-222990 ​ 10.6 ​ 02/12/2018 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.13 @ ​ Employment Agreement, dated March 7, 2018 by and between BioXcel Therapeutics, Inc. and Vimal Mehta ​ 8-K ​ 001-38410 ​ 10.1 ​ 03/13/2018 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.14 @ ​ Employment Agreement, dated February 12, 2018, by and between BioXcel Therapeutics, Inc. and Frank Yocca ​ S-1/A ​ 333-222990 ​ 10.11 ​ 02/12/2018 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.15 @ ​ Employment Agreement, effective October 2, 2017, by and between BioXcel Therapeutics, Inc. and Richard Steinhart ​ S-1/A ​ 333-222990 ​ 10.12 ​ 02/12/2018 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.16 @ ​ Employment Agreement, dated June 1, 2018, by and between BioXcel Therapeutics, Inc. and Dr. Vincent O’Neill, M.D. ​ 8-K ​ 001-38410 ​ 10.1 ​ 06/07/2018 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.17 @ ​ Employment Agreement between Javier Rodriguez and BioXcel Therapeutics, Inc., dated February 15, 2021. ​ 10-K ​ 001-38410 ​ 10.19 ​ 03/12/2021 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.18 @ ​ Employment Agreement between Matthew Wiley and BioXcel Therapeutics, Inc., dated January 12, 2022. ​ 10-K ​ 001-38410 ​ 10.20 ​ 03/11/2022 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.19@ ​ Employment Agreement BioXcel Therapeutics, Inc. and Vincent O’Neill, M.D. dated July 1, 2022 ​ 10-Q ​ 001-38410 ​ 10.2 ​ 05/08/2023 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.20 @ ​ Non-Employee Director Compensation Program ​ 10-Q ​ 001-38410 ​ 10.4 ​ 08/11/2022 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.21 ​ BioXcel Trademark License Agreement, between the Company and BioXcel LLC ​ 10-Q ​ 001-38410 ​ 10.1 ​ 05/09/2022 ​ ​ 143 Table of Contents Exhibit Number Description Form File No. Exhibit Filing Date Filed/ Furnished Herewith ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.22+& ​ Credit Agreement and Guaranty, by and among BioXcel Therapeutic, Inc., Oaktree Fund Administration, LLC, the Subsidiary Guarantors from time to time party thereto and the Lenders from time to time party thereto, dated April 19, 2022 ​ 10-Q ​ 001-38410 ​ 10.1 ​ 08/11/2022 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.22.1+& ​ Waiver and First Amendment to Credit Agreement and Guaranty, by and between the Company, the lenders party thereto and Oaktree Fund Administration LLC dated November 13, 2023. ​ 10-Q ​ 001-38410 ​ 10.2 ​ 11/14/2023 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.22.2& ​ Second Amendment to Credit Agreement and Guaranty and Termination of Revenue Interest Financing Agreement dated December 5, 2023, to the Credit Agreement and Guaranty, dated April 19, 2022, by and among the Company, as the borrower, certain subsidiaries of the Company from time to time party thereto as subsidiary guarantors, the lenders party thereto, and Oaktree Fund Administration LLC, as administrative agent (as amended) ​ ​ 8-K ​ 001-38410 ​ 10.1 ​ 02/08/2024 ​ ​ 10.22.3& ​ Third Amendment to Credit Agreement and Guaranty dated February 12, 2024, to the Credit Agreement and Guaranty, dated April 19, 2022, by and among the Company, as the borrower, certain subsidiaries of the Company from time to time party thereto as subsidiary guarantors, the lenders party thereto, and Oaktree Fund Administration LLC, as administrative agent (as amended) ​ 8-K ​ 001-38410 ​ 10.1 ​ 02/12/2024 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.22.4 ​ Fourth Amendment to Credit Agreement and Guaranty, dated March 20, 2024, to the Credit Agreement and Guaranty, dated April 19, 2022, by and among the Company, as the borrower, certain subsidiaries of the Company from time to time party thereto as subsidiary guarantors, the lenders party thereto, and Oaktree Fund Administration LLC, as administrative agent (as amended) ​ ​ ​ ​ ​ ​ ​ ​ ​ * ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.23+& ​ Commercial Supply Agreement, between ARx, LLC and BioXcel Therapeutics, Inc., dated April 1, 2022 ​ 10-Q ​ 001-38410 ​ 10.3 ​ 08/11/2022 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 144 Table of Contents Exhibit Number Description Form File No. Exhibit Filing Date Filed/ Furnished Herewith 10.24@ ​ OnkosXcel Therapeutics, LLC and OnkosXcel Employee Holdings, LLC Management Incentive Plan ​ 8-K ​ 001-38410 ​ 10.1 ​ 08/19/2022 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.25@ ​ Form of Profits Interest Award Agreement under the Management Incentive Plan ​ 8-K ​ 001-38410 ​ 10.2 ​ 08/19/2022 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.26@ ​ Form of RSU Agreement pursuant to the OnkosXcel Therapeutics, LLC and OnkosXcel Employee Holdings, LLC Management Incentive Plan. ​ 10-Q ​ 001-38410 ​ 10.3 ​ 05/08/2023 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.27+ ​ Non-Compete Agreement, by and among the Company, Dr. Krishnan Nandabalan, InveniAI LLC, Invea Therapeutics, Inc. and the other parties thereto, dated September 19, 2023. ​ 8-K ​ 001-38410 ​ 10.1 ​ 09/25/2023 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 21.1 ​ Subsidiaries of BioXcel Therapeutics, Inc. ​ ​ ​ ​ ​ ​ ​ ​ ​ * ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 23.1 ​ Consent of Ernst & Young LLP ​ ​ ​ ​ ​ ​ ​ ​ ​ * ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 31.1 ​ Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. ​ ​ ​ ​ ​ ​ ​ ​ ​ * ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 31.2 ​ Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. ​ ​ ​ ​ ​ ​ ​ ​ ​ * ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 32.1 ​ Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. ​ ​ ​ ​ ​ ​ ​ ​ ​ ** ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 32.2 ​ Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. ​ ​ ​ ​ ​ ​ ​ ​ ​ ** ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 97.1 ​ Policy for Recovery of Erroneously Awarded Compensation ​ ​ ​ ​ ​ ​ ​ ​ ​ * ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 101.INS ​ Inline eXtensible Business Reporting Language (XBRL) Instance Document – the instance document does not appear in the Interactive Data File because its XBRL ​ ​ ​ ​ ​ ​ ​ ​ ​ * 145 Table of Contents Exhibit Number Description Form File No. Exhibit Filing Date Filed/ Furnished Herewith tags are embedded within the Inline XBRL document ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 101.SCH ​ Inline XBRL Taxonomy Extension Schema Document ​ ​ ​ ​ ​ ​ ​ ​ ​ * ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 101.CAL ​ Inline XBRL Taxonomy Extension Calculation Linkbase Document ​ ​ ​ ​ ​ ​ ​ ​ ​ * ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 101.DEF ​ Inline XBRL Taxonomy Extension Definition Linkbase Document ​ ​ ​ ​ ​ ​ ​ ​ ​ * ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 101.LAB ​ Inline XBRL Taxonomy Extension Label Linkbase Document ​ ​ ​ ​ ​ ​ ​ ​ ​ * ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 101.PRE ​ Inline XBRL Taxonomy Extension Presentation Linkbase Document ​ ​ ​ ​ ​ ​ ​ ​ ​ * ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 104 ​ Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) ​ ​ ​ ​ ​ ​ ​ ​ ​ * ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ @ Indicates a management contract or any compensatory plan, contract or arrangement. + Portions of this exhibit have been omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K. # Confidential treatment has been granted for portions omitted from this exhibit and those portions have been separately filed with the Securities and Exchange Commission. & Annexes, schedules, and certain exhibits have been omitted pursuant to Item 601(a)(5)(b)(2) of Regulation S-K. The Registrant hereby agrees to furnish supplementally a copy of any omitted annex, schedule or exhibit to the SEC upon request. * Filed herewith. ** Furnished herewith. ​ Item 16. Form 10-K Summary Not applicable ​ 146 Table of Contents ​ SIGNATURES Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized. ​ ​ BioXcel Therapeutics, Inc. ​ ​ Dated: March 22, 2024 By: ​ /s/ Vimal Mehta ​ Vimal Mehta, Ph.D. ​ Chief Executive Officer ​ (Principal Executive Officer) ​ ​ Dated: March 22, 2024 By: ​ /s/ Richard Steinhart ​ Richard Steinhart ​ Chief Financial Officer ​ (Principal Financial Officer) ​ ​ 11 Signature Title Date ​ ​ ​ ​ ​ /s/ Vimal Mehta Vimal Mehta, Ph.D. Chief Executive Officer and Director (Principal Executive Officer) March 22, 2024 ​ ​ ​ ​ ​ /s/ Richard Steinhart Richard Steinhart Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) March 22, 2024 ​ ​ ​ ​ ​ /s/ Peter Mueller Peter Mueller, Ph.D. Chairman of the Board of Directors March 22, 2024 ​ ​ ​ ​ ​ /s/ June Bray June Bray Director March 22, 2024 ​ ​ ​ ​ ​ /s/ Sandeep Laumas Sandeep Laumas, M.D. Director March 22, 2024 ​ ​ ​ ​ ​ /s/ Michael Miller Michael Miller Director March 22, 2024 ​ ​ ​ ​ ​ /s/ Michal Votruba Michal Votruba ​ Director ​ March 22, 2024 ​ ​ ​ 147 Table of Contents Report of Independent Registered Public Accounting Firm ​ To the Stockholders and the Board of Directors of BioXcel Therapeutics, Inc. ​ Opinion on the Financial Statements ​ We have audited the accompanying consolidated balance sheets of BioXcel Therapeutics, Inc. (the Company) as of December 31, 2023 and 2022, the related consolidated statements of operations, changes in stockholders' (deficit) equity and cash flows for the years then ended, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2023 and 2022, and the results of its operations and its cash flows for the years then ended in conformity with U.S. generally accepted accounting principles. ​ The Company’s Ability to Continue as a Going Concern ​ The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 2 to the consolidated financial statements, the Company has suffered recurring losses from operations, has used significant cash in operations and has stated that substantial doubt exists about the Company’s ability to continue as a going concern. Management's evaluation of the events and conditions and management’s plans regarding these matters are also described in Note 2. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. ​ Basis for Opinion ​ These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB. ​ We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion. ​ Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion. ​ Critical Audit Matter ​ The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the Audit Committee and that: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective or complex judgment. The communication of the critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosure to which it relates. ​ F-1 Table of Contents ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ As of December 31, 2023, research and development expenses and accrued research and development expenses includes clinical trial expenses and related accrued clinical trial expenses. ​ ​ ​ ​ Description of the Matter ​ ​ ​ ​ How We Addressed the Matter in Our Audit ​ ​ ​ Clinical trial expense and related accrued clinical trial expenses ​ As discussed in Note 3 to the consolidated financial statements, at the end of the reporting period, the Company estimates the progress toward completion of the research or development objectives, and depending on the amount and timing of payments to the service providers may record net prepaid or accrued expense for associated research and development costs. As of December 31, 2023, research and development expenses and accrued research and development expenses includes clinical trial expenses and related accrued clinical trial expenses. Auditing the Company’s clinical trial expenses and related accrued clinical trial expenses was complex because the evidence is accumulated from multiple third-party service providers and in certain circumstances, the nature and amount of services that have been rendered during the reporting period does not correspond to the timing and pattern of vendor invoicing. To test the clinical trial expenses and accrued clinical trial expenses, our audit procedures included, among others, evaluating the significant assumptions used by management to estimate the clinical trial expenses and testing the accuracy and completeness of the underlying data. To test the significant assumptions, we inspected the Company's contracts with third-party service providers, corroborated the progress of clinical trials and other research and development projects with the Company’s internal personnel that oversee these activities, and obtained information directly from third-party service providers which included the third parties’ estimates of clinical trial costs incurred to date. We also examined invoices received from vendors and cash disbursements made to third-party service providers subsequent to December 31, 2023 to assess the completeness of the recorded accruals. ​ ​ ​ /s/ Ernst & Young LLP ​ We have served as the Company’s auditor since 2021. ​ Stamford, Connecticut March 22, 2024 ​ ​ ​ ​ F-2 Table of Contents BIOXCEL THERAPEUTICS, INC. ​ CONSOLIDATED BALANCE SHEETS (amounts in thousands, except per share amounts) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, December 31, ​ ​ 2023 ​ 2022 ASSETS ​ ​ Current assets ​ ​ Cash and cash equivalents ​ $ 65,221 ​ $ 193,725 Accounts receivable, net ​ ​ 71 ​ 248 Inventory ​ 1,991 ​ 1,985 Prepaid expenses ​ 2,782 ​ 3,067 Other current assets ​ 2,078 ​ 3,843 Total current assets ​ $ 72,143 ​ $ 202,868 Property and equipment, net ​ 784 ​ 1,084 Operating lease right-of-use assets ​ ​ 688 ​ ​ 976 Other assets ​ ​ 87 ​ ​ 925 Total assets ​ $ 73,702 ​ $ 205,853 ​ ​ ​ ​ ​ ​ ​ LIABILITIES AND STOCKHOLDERS' (DEFICIT) EQUITY ​ ​ Current liabilities ​ ​ Accounts payable ​ $ 13,654 ​ $ 10,228 Accrued expenses ​ 12,424 ​ 18,669 Due to related parties ​ 107 ​ 422 Accrued interest ​ ​ 736 ​ ​ 3,175 Other current liabilities ​ ​ 346 ​ ​ 404 Total current liabilities ​ $ 27,267 ​ $ 32,898 Long-term portion of operating lease liabilities ​ ​ 440 ​ 786 Derivative liabilities ​ ​ 1,905 ​ ​ 2,343 Long-term debt ​ ​ 100,598 ​ ​ 93,051 Total liabilities ​ $ 130,210 ​ $ 129,078 ​ ​ ​ ​ ​ ​ ​ Commitments and contingencies (Note 18) ​ ​ ​ ​ ​ ​ Stockholders' (deficit) equity ​ ​ Preferred stock, $ 0.001 par value, 10,000 shares authorized; no shares issued and outstanding as of December 31, 2023 and December 31, 2022 ​ $ — ​ $ — Common stock, $ 0.001 par value, 100,000 shares authorized as of December 31, 2023 and December 31, 2022; 29,930 and 28,147 shares issued and outstanding as of December 31, 2023 and December 31, 2022, respectively ​ ​ 30 ​ ​ 28 Additional paid-in-capital ​ 534,060 ​ 488,292 Accumulated deficit ​ ( 590,598 ) ​ ( 411,545 ) Total stockholders' (deficit) equity ​ $ ( 56,508 ) ​ $ 76,775 Total liabilities and stockholders' (deficit) equity ​ $ 73,702 ​ $ 205,853 ​ The accompanying notes are an integral part of these consolidated financial statements. ​ F-3 Table of Contents BIOXCEL THERAPEUTICS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS (amounts in thousands, except per share amounts) ​ ​ ​ ​ ​ ​ ​ ​ ​ Year ended December 31, ​ 2023 2022 ​ ​ ​ ​ ​ ​ ​ Revenues ​ ​ ​ ​ ​ ​ Product revenue, net ​ $ 1,380 ​ $ 375 ​ ​ ​ ​ ​ ​ ​ Operating expenses ​ ​ Cost of goods sold ​ $ 1,260 ​ $ 20 Research and development ​ ​ 84,326 ​ ​ 91,239 Selling, general and administrative ​ 83,413 ​ 68,761 Restructuring costs ​ ​ 4,163 ​ ​ — Total operating expenses ​ $ 173,162 ​ $ 160,020 Loss from operations ​ $ ( 171,782 ) ​ $ ( 159,645 ) Other expense (income) ​ ​ Interest expense ​ 13,314 ​ 8,213 Interest income ​ ​ ( 5,649 ) ​ ​ ( 2,528 ) Other (income) expense, net ​ ​ ( 394 ) ​ ​ 427 Net loss ​ $ ( 179,053 ) ​ $ ( 165,757 ) Basic and diluted net loss per share attributable to common stockholders ​ $ ( 6.15 ) ​ $ ( 5.92 ) Weighted average shares outstanding - basic and diluted ​ 29,129 ​ 28,015 ​ The accompanying notes are an integral part of these consolidated financial statements. ​ F-4 Table of Contents BIOXCEL THERAPEUTICS, INC. CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ (DEFICIT) EQUITY (amounts in thousands) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Additional ​ ​ ​ ​ ​ ​ ​ ​ Common Stock ​ Paid in ​ Accumulated ​ ​ ​ ​ Shares Amount Capital Deficit Total Balance as of January 1, 2022 27,980 ​ $ 28 ​ $ 467,427 ​ $ ( 245,788 ) ​ $ 221,667 Issuance of stock purchase warrants ​ — ​ ​ — ​ ​ 3,245 ​ ​ — ​ ​ 3,245 Stock-based compensation ​ — ​ ​ — ​ ​ 17,337 ​ ​ — ​ ​ 17,337 Exercise of stock options ​ 167 ​ ​ — ​ ​ 283 ​ ​ — ​ ​ 283 Net loss ​ — ​ ​ — ​ ​ — ​ ​ ( 165,757 ) ​ ​ ( 165,757 ) Balance as of December 31, 2022 ​ 28,147 ​ $ 28 ​ $ 488,292 ​ $ ( 411,545 ) ​ $ 76,775 Issuance of common stock, net of offering costs ​ 1,408 ​ ​ 2 ​ ​ 26,219 ​ ​ — ​ ​ 26,221 Stock-based compensation ​ — ​ ​ — ​ ​ 18,614 ​ ​ — ​ ​ 18,614 Exercise of stock options ​ 310 ​ ​ — ​ ​ 508 ​ ​ — ​ ​ 508 Repricing of stock purchase warrants ​ — ​ ​ — ​ ​ 254 ​ ​ — ​ ​ 254 Issuance of stock purchase warrants ​ — ​ ​ — ​ ​ 200 ​ ​ — ​ ​ 200 Vesting of restricted stock units, net of employee tax obligations ​ 65 ​ ​ — ​ ​ ( 27 ) ​ ​ — ​ ​ ( 27 ) Net loss ​ — ​ ​ — ​ ​ — ​ ​ ( 179,053 ) ​ ​ ( 179,053 ) Balance as of December 31, 2023 ​ 29,930 ​ $ 30 ​ $ 534,060 ​ $ ( 590,598 ) ​ $ ( 56,508 ) ​ The accompanying notes are an integral part of these consolidated financial statements. ​ F-5 Table of Contents BIOXCEL THERAPEUTICS, INC. CONSOLIDATED STATEMENTS OF CASH FLOWS (amounts in thousands) ​ ​ ​ ​ ​ ​ ​ ​ ​ Year ended December 31, ​ 2023 2022 OPERATING CASH FLOW ACTIVITIES: ​ ​ Net loss ​ $ ( 179,053 ) ​ $ ( 165,757 ) Reconciliation of net loss to net cash used in operating activities ​ ​ ​ ​ Depreciation ​ 318 ​ 327 Accretion of debt discount and amortization of financing costs ​ ​ 1,373 ​ ​ 860 Change in fair value of derivative liabilities ​ ​ ( 438 ) ​ ​ 389 Stock-based compensation expense ​ 18,614 ​ 17,337 Payable-in-kind interest on Credit Agreement ​ ​ 1,872 ​ ​ 807 Loss on disposal of equipment ​ ​ 2 ​ ​ 22 Operating lease right-of-use assets ​ ​ 288 ​ ​ 271 Changes in operating assets and liabilities ​ ​ ​ ​ Accounts receivable ​ ​ 177 ​ ( 248 ) Inventory ​ ( 6 ) ​ ( 1,985 ) Prepaid expenses, other current assets and other assets ​ 2,888 ​ ( 3,905 ) Accounts payable, accrued expenses, due to related parties, and other current liabilities ​ ( 3,219 ) ​ 13,030 Accrued interest ​ ​ 2,497 ​ ​ 3,804 Operating lease liabilities ​ ​ ( 319 ) ​ ​ ( 293 ) Net cash used in operating activities ​ $ ( 155,006 ) ​ $ ( 135,341 ) ​ ​ ​ ​ ​ ​ ​ INVESTING CASH FLOW ACTIVITIES: ​ ​ Purchases of equipment and leasehold improvements ​ $ ( 20 ) ​ $ ( 139 ) Net cash used in investing activities ​ $ ( 20 ) ​ $ ( 139 ) ​ ​ ​ ​ ​ ​ ​ FINANCING CASH FLOW ACTIVITIES: ​ ​ Proceeds from long-term debt ​ $ — ​ $ 98,600 Debt issuance costs ​ ​ ( 180 ) ​ ​ ( 2,646 ) Proceeds from issuance of common stock ​ ​ 27,032 ​ ​ — Offering costs for common stock issuance ​ ​ ( 811 ) ​ ​ — Payment of employee tax obligations related to vesting restricted stock units ​ ​ ( 27 ) ​ ​ — Exercise of stock options ​ ​ 508 ​ ​ 283 Net cash provided by financing activities ​ $ 26,522 ​ $ 96,237 ​ ​ ​ ​ ​ ​ ​ Net decrease in cash and cash equivalents ​ $ ( 128,504 ) ​ $ ( 39,243 ) Cash and cash equivalents, beginning of the period ​ 193,725 ​ 232,968 Cash and cash equivalents, end of the period ​ $ 65,221 ​ $ 193,725 ​ ​ ​ ​ ​ ​ ​ Supplemental cash flow information: ​ ​ Issuance of stock purchase warrants ​ $ 200 ​ $ 3,245 Repricing of stock purchase warrants ​ $ 254 ​ $ — Interest paid ​ $ 7,551 ​ $ 2,697 Conversion of accrued interest to long-term debt ​ $ 767 ​ $ — ​ The accompanying notes are an integral part of these consolidated financial statements. ​ F-6 Table of Contents ​ BIOXCEL THERAPEUTICS, INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (amounts in thousands, except per share amounts and where otherwise noted) Note 1. Nature of the Business BioXcel Therapeutics, Inc. (“BTI” or the “Company”) is a biopharmaceutical company utilizing artificial intelligence (“AI”) approaches to develop transformative medicines in neuroscience and immuno-oncology. The Company is focused on utilizing cutting-edge technology and innovative research to develop high-value therapeutics aimed at transforming patients’ lives. BTI employs a unique AI platform to reduce therapeutic development costs and potentially accelerate timelines. The Company’s approach leverages existing approved drugs and/or clinically evaluated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indices. BTI management believes this differentiated approach has the potential to reduce the expense and time associated with drug development in diseases with substantial unmet medical needs. As used in these consolidated financial statements, unless otherwise specified or the context otherwise requires, the terms “BioXcel LLC” refers to the Company’s former parent and current significant stockholder, BioXcel LLC and, its predecessor, BioXcel Corporation. “OnkosXcel” refers to BTI’s wholly owned subsidiary for its advanced immuno-oncology assets, OnkosXcel Therapeutics, LLC. On April 6, 2022, BTI announced that the United States (“U.S.”) Food and Drug Administration (“FDA”) approved IGALMI TM (dexmedetomidine or “Dex”) sublingual film for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. IGALMI TM is approved to be self-administrated by patients under the supervision of a health care provider. On July 6, 2022, BTI announced that IGALMI TM , was commercially available in doses of 120 and 180 micrograms. The Company’s most advanced clinical development program is BXCL501. In indications other than those approved by the FDA as IGALMI TM , BXCL501 is an investigational proprietary, orally dissolving, film formulation of Dex for the treatment of agitation associated with psychiatric and neurological disorders. The Company’s advanced immuno-oncology asset, BXCL701, is an investigational, orally administered systemic innate immune activator for the treatment of a rare form of prostate cancer and advanced solid tumors that are refractory or treatment naïve to checkpoint inhibitors. BTI was incorporated under the laws of the State of Delaware on March 29, 2017. The Company’s principal office is in New Haven, Connecticut. Note 2. Basis of Presentation The accompanying consolidated financial statements include those of the Company and its subsidiaries after elimination of all intercompany accounts and transactions and have been prepared in conformity with United States (“U.S.”) Generally Accepted Accounting Principles (“GAAP”). The accompanying consolidated financial statements include the accounts for the Company and all entities where BTI has a controlling financial interest after elimination of all intercompany accounts and transactions and have been prepared in conformity with U.S. GAAP. As of December 31, 2023, the Company had cash and cash equivalents of $ 65,221 and an accumulated deficit of $ 590,598 . BTI has incurred substantial net losses and negative cash flows from operating activities in nearly every fiscal period since inception and expects this trend to continue for the foreseeable future. The Company recognized net losses of $ 179,053 and $ 165,757 for the years ended December 31, 2023 and 2022, respectively, and had net cash used in operating activities of $ 155,006 and $ 135,341 for the years ended December 31, 2023 and 2022, respectively. F-7 Table of Contents Management is required at each reporting period to evaluate whether there are conditions and events, considered in the aggregate, that raise substantial doubt about an entity’s ability to continue as a going concern within one year after the date that the financial statements are issued. The Company’s history of significant losses, its negative cash flows from operations, potential near-term increased covenant-driven amortization payments under its Credit Agreement, its limited liquidity resources currently on hand, and its dependence on its ability to obtain additional financing to fund its operations after the current resources are exhausted, about which there can be no certainty, have resulted in management’s assessment that there is substantial doubt about the Company’s ability to continue as a going concern for a period of at least 12 months from the issuance date of the financial statements included in this Annual Report on Form 10-K. This going concern evaluation takes into consideration the potential mitigating effect of management’s Reprioritization (as defined in Note 4, Restructuring). When substantial doubt exists, management evaluates whether the mitigating effect of its plans sufficiently alleviates the substantial doubt about the Company’s ability to continue as a going concern. The mitigating effect of management’s plans, however, is only considered if both (i) it is probable that the plans will be effectively implemented within one year after the date that the financial statements are issued and (ii) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date that the financial statements are issued. Generally, to be considered probable of being effectively implemented, the plans need to be approved by the Company’s Board of Directors. The Company’s Reprioritization was approved by the Board of Directors on August 8, 2023; however, such plans will not mitigate the entity’s ability to continue as a going concern within one year after the date that the financial statements are issued. The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business and does not include any adjustments that may result from the outcome of this uncertainty. The going concern analysis does not consider possible future amendments to or restructuring of the Credit Agreement (as defined in Note 9, Debt and Credit Facilities) or other potential sources of debt or equity capital. Successful completion of the Company’s development programs and, ultimately, the attainment of profitable operations are dependent upon future events, including obtaining adequate financing to support the Company’s cost structure and operating plan. Management’s plans to improve the Company’s liquidity and reduce its operating expenses and capital requirements include, among other things, pursuing one or more of the following steps to raise additional capital, none of which can be guaranteed or are entirely within the Company’s control: • raise funding through the sale of the Company’s equity securities; • raise funding through third-party investments in or other strategic options for OnkosXcel; • raise funding through debt financing and/or restructuring of its existing OFA Facilities; • establish collaborations with potential partners to advance the Company’s product pipeline; • establish collaborations with potential marketing partners; • reduce overhead and headcount to focus on core priorities; and/or • any combination of the foregoing. If the Company is unable to raise capital when needed or on acceptable terms, or if it is unable to procure collaboration arrangements to advance its programs, the Company would be forced to discontinue some of its operations or develop and implement a plan, beyond its Reprioritization initiatives, to further extend payables, reduce overhead, scale back or cease some or all of its revised operating plan until sufficient additional capital is raised to support further operations. F-8 Table of Contents Note 3. Summary of Significant Accounting Policies Use of Estimates The preparation of financial statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect amounts reported in the consolidated financial statements and notes thereto. Although these estimates are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may ultimately materially differ from these estimates. Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of three months or less at the date of purchase to be cash equivalents. As of December 31, 2023 and 2022, cash equivalents were comprised primarily of money market funds. Cash and cash equivalents held at financial institutions may at times exceed federally insured amounts. BTI management believes it mitigates such risk by investing in or through major financial institutions. Accounts Receivable, Net Accounts receivable arise from sales of IGALMI TM and represent amounts due from distributors. Payment terms generally range from 30 to 75 days from the date of the sale transaction, and accordingly, do not involve a significant financing component. Receivables from product sales are recorded net of allowances which generally include distribution fees, prompt payment discounts, chargebacks, and credit losses. Allowances for distribution fees, prompt payment discounts and chargebacks are based on contractual terms. The Company estimated the current expected credit losses of its accounts receivable by assessing the risk of loss and available relevant information about collectability, existing contractual payment terms, actual payment patterns of its customers, individual customer circumstances, and reasonable and supportable forecast of economic conditions expected to exist throughout the contractual life of the receivable. Based on its assessment, as of December 31, 2023, the Company determined that an allowance for credit losses was not required. Concentrations of Credit Risk The Company sells IGALMI TM through a drop-ship program under which orders from hospitals and similar health care institutions are processed through wholesalers, but shipments of the product are sent directly to the individual hospitals and similar health care institutions. BTI also contracts directly with intermediaries such as group purchasing organizations (“GPOs”). All trade accounts receivables are due from the distributor that fulfills orders on behalf of the Company. Inventory Inventory is stated at the lower of cost or net realizable value. Cost of inventory is determined on a first-in, first-out basis. BTI capitalizes inventory costs associated with the Company’s products prior to regulatory approval, when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized; otherwise, such costs are expensed as research and development expense in the Consolidated Statements of Operations. The Company performs an assessment of the recoverability of capitalized inventory during each reporting period and writes down any excess and obsolete inventories to their estimated realizable value in the period in which the impairment is first identified. Such impairment charges, should they occur, will be recorded within Cost of goods sold in the Consolidated Statements of Operations. The determination of whether inventory costs will be realizable requires estimates by management. If actual market conditions are less favorable than projected, write-downs of inventory may be required. F-9 Table of Contents Deferred Initial Public Offering Costs Deferred initial public offering costs of $ 2,570 , consisted of legal, accounting, and other costs that were directly related to the Company’s proposed initial public offering of OnkosXcel. These costs were charged to the Consolidated Statements of Operations during the year ended December 31, 2023 as the initial public offering was delayed for an extended period of time. The costs were recorded as Selling, general and administrative expenses. Property and Equipment Property and equipment are recorded at cost and depreciated over the shorter of their remaining lease term or their estimated useful life on a straight-line basis as follows: ​ ​ ​ Equipment 3 - 5 years Furniture 7 years Leasehold improvements Lesser of life of improvement or lease term ​ Expenditures for maintenance and repairs which do not improve or extend the useful lives of the respective assets are expensed as incurred. When assets are sold or retired, the related cost and accumulated depreciation are removed from their respective accounts and any resulting gain or loss is included within Selling, general and administrative expenses in the Consolidated Statements of Operations. Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to undiscounted future net cash flows expected to be generated from its use and disposition. Impairment charges are recognized at the amount by which the carrying amount of an asset exceeds the fair value of the asset. Assets to be disposed of are reported at the lower of the carrying amount or the fair value less costs to sell. Leases The Company determines if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”) assets, other current liabilities, and the long-term portion of operating lease liabilities in the Consolidated Balance Sheets. ROU assets represent BTI’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease ROU assets and lease liabilities are recognized at commencement date based on the present value of lease payments over the lease term. The Company uses the implicit rate when readily determinable. As BTI’s leases do not provide an implicit rate, it used an incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments. The operating lease ROU asset also includes any prepaid lease payments made and excludes lease incentives. The Company’s leases may include options to extend the lease; such options are included in determining the lease term when it is reasonably certain that BTI will exercise that option. Lease expense is recognized on a straight-line basis over the lease term. Debt and Detachable Warrants Detachable warrants are evaluated for classification as either equity instruments, derivative liabilities, or liabilities depending on the specific terms of the warrant agreement. In circumstances in which debt is issued with equity-classified warrants, the proceeds from the issuance of debt are first allocated to the debt and then the warrants at their estimated fair values. The portion of the proceeds allocated to the warrants are accounted for as paid-in capital and a debt discount. The remaining proceeds, as further reduced by discounts created by the bifurcation of any embedded derivatives, are allocated to the debt. Detachable warrants classified as derivative liabilities are accounted for as indicated under “ Derivative Assets and Liabilities ” section of this Note and as a debt discount. The Company accounts for debt as liabilities measured at amortized cost and amortizes the resulting debt discount from the allocation of proceeds to interest expense using the effective interest method over the expected term of the debt instrument. The Company considers F-10 Table of Contents whether there are any embedded features in debt instruments that require bifurcation and separately accounts for them as derivative financial instruments. The Company entered into financing arrangements, the terms of which involve significant assumptions and estimates, including future net product sales, in determining interest expense, amortization period of the debt discount, as well as the classification between current and long-term portions. In estimating future net product sales, the Company assesses prevailing market conditions using various external market data against the Company’s anticipated sales and planned commercial activities. Consequently, the Company imputes interest on the carrying value of the debt and records interest expense using an imputed effective interest rate. The Company reassesses the expected payments during each reporting period and accounts for any changes through an adjustment to the effective interest rate on a prospective basis, with a corresponding impact to the classification of the Company’s current and long-term portions of the debt. Derivative Assets and Liabilities Derivative assets and liabilities are recorded on the Company`s Consolidated Balance Sheets at their fair value on the date of issuance and are revalued on each balance sheet date until such instruments are settled or expire, with changes in the fair value between reporting periods recorded as other income or expense within Other (income) expense, net in the Consolidated Statements of Operations. The Company does not use derivative instruments for speculative purposes or to hedge exposures to cash-flow or market risks. Certain financing facilities entered into by the Company include freestanding financial instruments and/or embedded features that require separate accounting as derivative assets and/or liabilities. In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. Revenue Recognition The Company’s revenues consist of product sales of IGALMI TM . BTI recognizes revenue when its customers obtain control of promised goods or services, in an amount that reflects the consideration that the Company expects to receive in exchange for those goods or services. To determine revenue recognition, BTI management performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price, including variable consideration, if any; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies a performance obligation. Arrangements that include rights to additional goods or services that are exercisable at a customer’s discretion are generally considered options. The Company assesses if these options provide a material right to the customer and if so, they are considered performance obligations. The exercise of a material right may be accounted for as a contract modification or as a continuation of the contract for accounting purposes. The Company assesses whether the goods or services promised within each contract are distinct to identify those that are performance obligations. This assessment involves subjective determinations and requires management to make judgments about the individual promised goods or services and whether such goods and services are separable from the other aspects of the contractual relationship. Promised goods and services are considered distinct provided that: (i) the customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer and (ii) the Company’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract. The Company allocates the transaction price (the amount of consideration it expects to be entitled to from a customer in exchange for the promised goods or services) to each performance obligation and recognizes the associated revenue when (or as) each performance obligation is satisfied. The Company’s estimate of the transaction price for each contract includes all variable consideration to which the Company expects to be entitled. BTI distributes IGALMI TM in the U.S. through arrangements with a distributor, wholesalers, and GPOs. The distributor and wholesalers help process and fulfill orders from hospitals on the Company’s behalf. The Company believes the hospitals are its customers. F-11 Table of Contents The Company recognizes product revenues, net of consideration payable to customers, as well as variable consideration related to certain allowances and accruals that are determined using either the expected value or most likely amount method, depending on the type of the variable consideration, in its consolidated financial statements at the point in time when control transfers to the customer, which is typically when the product has been delivered to the customer’s location. The amount included in the transaction price is constrained to the amount for which it is probable that a significant reversal of cumulative revenue recognized will not occur. The Company’s only performance obligation identified for IGALMI TM is to deliver the quantity of product ordered to the location specified by the customer’s order. The Company records shipping and handling costs associated with delivery of product to its customers within Selling, general and administrative expenses on its Consolidated Statements of Operations. Under the Company’s current product sales arrangements, BTI does not have contract assets (unbilled receivables), as it generally invoices its customer at the time of revenue recognition. BTI sells IGALMI TM at wholesale acquisition cost and calculates product revenue net of variable consideration and consideration payable to third parties associated with distribution of product. The Company records reserves, based on contractual terms, for the following components of consideration related to product sold during the reporting period. Calculating these amounts involves estimates and judgments, and the Company reviews these estimates quarterly and records any material adjustments in the period they are identified, which affects net product revenue and earnings in the period such variances occur. Trade Discounts and Allowances The Company provides the distributor and wholesalers with discounts for prompt payment and pays fees to the distributor, wholesalers and GPOs related to distribution of the product. BTI expects the relevant third parties to earn these discounts and fees, and therefore it deducts such amounts from gross product revenue and accounts receivable at the time it recognizes the related revenue. Government Rebates IGALMI TM is eligible for purchase by, or qualifies for reimbursement from, Medicaid and other U.S. government programs that are eligible for rebates on the price they pay for the product. To determine the appropriate amount to reserve for these rebates, BTI applies the applicable government discount to these sales, and estimates the portion of total rebates that it anticipates will be claimed. The Company deducts certain government rebates from gross product revenue and accounts receivable at the time it recognizes the related revenue; other government rebates are recognized as an accrued liability at the time BTI recognizes the related revenue. Chargebacks BTI provides product discounts to hospitals associated with certain GPOs. The Company estimates the chargebacks that it expects to be obligated to provide based upon the terms of the applicable arrangements. BTI deducts such amounts from gross product revenue and accounts receivable at the time it recognizes the related revenue. Product Returns The Company provides contractual return rights to its customers including the right to return product within six months of product expiration and up to 12 months after product expiration, as well as for incorrect shipments, and damaged or defective product, which the Company expects to be rare. Management expects product returns to be minimal, thus BTI recognizes a nominal allowance for product returns at the time of each sale. In the future, if any of these factors and/or the history of product returns changes, the Company will adjust the allowance for product returns. BTI classifies all fees paid to the distributor, other than those discussed above and those related to warehouse operations, as Selling, general and administrative expenses on its Consolidated Statements of Operations. Fees paid to the distributor for warehouse operations are classified as Cost of goods sold on BTI’s Consolidated Statements of Operations. F-12 Table of Contents Cost of Goods Sold Cost of goods sold includes the cost of producing and distributing inventories that are related to product revenues during the respective period. Cost of goods sold also includes costs related to excess or obsolete inventory adjustment charges, as well as costs related to warehouse operations paid to distributors. Stock-Based Compensation The Company measures and recognizes stock-based compensation expense based on estimated fair value for all share-based awards made to employees, non-employee service providers, and directors, including stock options, BTI restricted stock units (“BTI RSUs”), OnkosXcel profit sharing units (“PSUs”), OnkosXcel restricted stock units (“OnkosXcel RSUs”) and BTI performance stock units (“Performance Units”). The Company’s 2017 Equity Incentive Plan (the “2017 Plan”) became effective in August 2017. The Company’s 2020 Incentive Award Plan (the “2020 Plan”) became effective in May 2020. Following the effective date of the 2020 Plan, the Company ceased granting awards under the 2017 Plan; however, the terms and conditions of the 2017 Plan continue to govern any outstanding awards granted thereunder. The Company’s stock-based awards are valued at fair value on the date of grant and that fair value is recognized as an expense in the Consolidated Statements of Operations over the requisite service period using the accelerated attribution method. The estimated value of the BTI RSUs and Performance Units is based on the Company’s closing stock price on the grant date. The estimated fair value of stock-options, OnkosXcel RSUs and PSUs was determined using the Black-Scholes pricing model on the date of grant. For awards subject to performance-based vesting conditions, the Company recognizes stock-based compensation expense when the achievement of the performance condition becomes probable. The Black-Scholes pricing model is affected by the Company’s stock price, as well as assumptions regarding variables including, but not limited to, the strike price of the instrument, the risk-free rate, the expected stock price volatility over the term of the awards, and expected term of the award. The Company has elected to account for forfeitures as they occur, by reversing compensation cost when the award is forfeited. Research and Development Costs Research and development expenses include wages, benefits, non-cash stock-based compensation, facilities, supplies, external services, clinical study, manufacturing costs related to clinical trials and other expenses that are directly related to the Company’s research and development activities. At the end of the reporting period, the Company estimates the progress toward completion of the research or development objectives and, depending on the amount and timing of payments to the service providers may record net prepaid or accrued expense for associated research and development costs. Such estimates are subject to change as additional information becomes available. The Company expenses research and development costs as incurred. Most of the Company’s service providers invoice BTI monthly in arrears for services performed. The Company estimates its accrued expenses as of each balance sheet date in the consolidated financial statements based on facts and circumstances known to management at that time. BTI management periodically confirms the accuracy of the Company’s estimates with the service providers and makes adjustments if necessary. Although management does not expect its estimates to be materially different from amounts actually incurred, management’s understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in BTI reporting amounts that are too high or too low in any particular period. Patent Costs Costs related to filing and pursuing patent applications are recorded in Selling, general and administrative expenses in the Consolidated Statements of Operations and are expensed as incurred since recoverability of such expenditures is uncertain. F-13 Table of Contents Fair Value of Financial Instruments The Company measures certain financial assets and liabilities at fair value, which is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The Company applies a fair value hierarchy that distinguishes between (1) market participant assumptions developed based on market data obtained from independent sources, or observable inputs, and (2) an entity’s own assumptions about market participant assumptions developed based on the best information available in the circumstances, or unobservable inputs. The fair value hierarchy consists of three broad levels, which gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1) and the lowest priority to unobservable inputs (Level 3). Fair value measurements must be classified and disclosed in one of the following three categories: ● Level 1 : Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. ● Level 2 : Directly or indirectly observable inputs as of the reporting date through correlation with market data, including quoted prices for similar assets and liabilities in active markets and quoted prices in markets that are not active. Level 2 also includes assets and liabilities that are valued using models or other pricing methodologies that do not require significant judgment since the input assumptions used in the models, such as interest rates and volatility factors, are corroborated by readily observable data from actively quoted markets for substantially the full term of the financial instrument. ● Level 3 : Unobservable inputs that are supported by little or no market activity and reflect the use of significant management judgment. These values are generally determined using pricing models for which the assumptions utilize management’s estimates of market participant assumptions. In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible, as well as considering counterparty credit risk in its assessment of fair value. Income Taxes BTI uses an asset and liability approach for financial accounting and reporting of income taxes. Deferred tax assets and liabilities are determined based on temporary differences between financial reporting and tax basis assets and liabilities and are measured by applying enacted rates and laws to taxable years in which differences are expected to be recovered or settled. Further, the effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that the rate changes. A valuation allowance is required when it is “more likely than not” that all or a portion of deferred tax assets will not be realized. U.S. GAAP prescribes a comprehensive model for how a company should recognize, measure, present and disclose in its financial statements uncertain tax positions that the Company has taken or expects to take on a tax return, including a decision whether to file or not file a return in a particular jurisdiction. The Company’s financial statements reflect expected future tax consequences of such positions presuming the taxing authorities’ full knowledge of the position and all relevant facts. The Company does not have any unrecognized tax benefits as of December 31, 2023 and 2022. BTI reviews all tax positions to ensure the tax treatment selected is sustainable based on its technical merits and that the position would be sustained if challenged. Earnings (Loss) per Share Earnings (loss) per share (“EPS”) is calculated by dividing net income or loss attributable to common stockholders by the weighted average number of shares of common stock that were outstanding. Diluted EPS is calculated by adjusting the weighted average number of shares of common stock that were outstanding for the dilutive effect of common stock equivalents. In periods in which a net loss is recorded, no effect is given to potentially dilutive securities, since the effect would be antidilutive. F-14 Table of Contents Segment Information The Company operates in a single segment. Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker in making decisions regarding resource allocation and assessing performance. To date, the Company’s chief operating decision maker has made such decisions and assessed performance at the Company level as one segment. Recent Accounting Pronouncements Recently adopted accounting pronouncements In June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, and subsequent amendments to the initial guidance (collectively, “Topic 326”). Topic 326 requires measurement and recognition of expected credit losses for financial assets held. Topic 326 was to be effective for reporting periods beginning after December 15, 2019, with early adoption permitted. In November 2019, the FASB issued ASU No. 2019-10, Financial Instruments - Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842) - Effective Dates, which deferred the effective dates of Topic 326 for the Company, until fiscal year 2023. The Company adopted Topic 326 in 2023 and it did not have a material impact on its consolidated financial statements. Accounting Pronouncements effective in future periods In November 2023, the FASB issued ASU 2023-07, Segment reporting, which requires disclosure of incremental segment information on an annual and interim basis. The standard is effective for years beginning after December 15, 2023, and interim periods beginning after December 15, 2024 and early adoption is permitted. The Company is currently evaluating the effect of adopting this guidance on its consolidated financial statements. In December 2023, the FASB issued ASU 2023-09, Improvements to income tax disclosures, which requires disclosure of disaggregated income taxes paid by jurisdiction, enhances disclosures in the effective tax rate reconciliation and modifies other income tax-related disclosures. The amendments are effective for annual periods beginning after December 15, 2024. The Company is currently evaluating the effect of adopting this guidance on its consolidated financial statements. ​ ​ Note 4. Restructuring On August 8, 2023, the Company’s Board of Directors approved a broad-based strategic reprioritization (the “Reprioritization”). The Company took actions to reduce certain operational and workforce expenses that were no longer deemed core to ongoing operations in order to extend its cash runway and drive innovation and growth in high potential clinical development and value creating opportunities. These actions included a shift in commercial strategy for IGALMI TM in the institutional setting, a reduction of in-hospital commercialization expenses, a suspension of programs no longer determined to be core to ongoing operations, and a prioritization of at-home treatment setting opportunities for BXCL501. As part of this strategy, the Company’s Board of Directors approved a reduction of approximately 60 % of the Company’s workforce. The Company notified impacted employees on August 14, 2023 and recorded total restructuring costs of $ 4,163 for the year ended December 31, 2023. These costs consisted of severance and benefit costs of $ 4,063 and contract termination costs of $ 100 . The Company paid $ 3,998 of severance and benefit costs and $ 100 of contract termination costs in the year ended December 31, 2023. The Reprioritization is substantially complete as of December 31, 2023, and any remaining costs are expected to be paid during the first quarter of 2024. ​ F-15 Table of Contents Note 5. Inventory Inventory consists of the following: ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, December 31, ​ 2023 2022 ​ ​ ​ ​ ​ ​ ​ Raw materials ​ $ 935 ​ $ 682 Work-in-process ​ ​ 651 ​ ​ 708 Finished goods ​ ​ 405 ​ ​ 595 Total inventory ​ $ 1,991 ​ $ 1,985 ​ The Company recorded inventory write-downs of $ 1,191 for the year ended December 31, 2023. No write-downs of inventory were recorded for the year ended December 31, 2022 . ​ Note 6. Property and Equipment, net Property and equipment, net consists of the following: ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, December 31, ​ 2023 2022 ​ ​ ​ ​ ​ ​ ​ Computers and equipment ​ $ 202 ​ $ 213 Furniture ​ ​ 575 ​ ​ 575 Leasehold improvements ​ ​ 1,200 ​ ​ 1,181 Total property and equipment ​ $ 1,977 ​ $ 1,969 Accumulated depreciation ​ ​ ( 1,193 ) ​ ​ ( 885 ) Total property and equipment, net ​ $ 784 ​ $ 1,084 ​ Depreciation expense was $ 318 and $ 327 for the years ended December 31, 2023 and 2022, respectively . ​ Note 7. Accrued Expenses Accrued expenses consist of the following: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ December 31, ​ 2023 2022 ​ ​ ​ ​ ​ Accrued research and development expenses ​ $ 6,406 ​ $ 8,659 Accrued compensation and benefits ​ ​ 163 ​ ​ 6,370 Accrued professional fees ​ 5,562 ​ 2,738 Accrued taxes ​ ​ 116 ​ ​ 82 Other accrued expenses ​ ​ 177 ​ ​ 820 Total accrued expenses ​ $ 12,424 ​ $ 18,669 ​ ​ Note 8. Transactions with BioXcel LLC The Company entered into a Separation and Shared Services Agreement with BioXcel LLC that took effect on June 30, 2017, as amended and restated thereafter (the “Services Agreement”), pursuant to which BioXcel LLC has agreed to provide the Company with certain intellectual property prosecution and management and research and development activities. Under the Services Agreement, we have an option, exercisable until December 31, 2024, to enter into a separate collaborative services agreement with BioXcel LLC pursuant to which BioXcel LLC shall perform product identification and related services for us utilizing its EvolverAI. We agreed to pay BioXcel LLC $ 18 per month from March 13, 2023, to December 31, 2024 in exchange for this option. We agreed to negotiate any such collaborative services agreement in F-16 Table of Contents good faith and to incorporate reasonable market-based terms, including consideration for BioXcel LLC reflecting a low, single-digit royalty on net sales and reasonable development and commercialization milestone payments, provided that (i) development milestone payments shall not exceed $ 10,000 in the aggregate and not be payable prior to proof of concept in humans and (ii) commercialization milestone payments shall be based on reaching annual net sales levels, be limited to 3 % of the applicable net sales level, and not exceed $ 30,000 in the aggregate. Service charges recorded under the Services Agreement for the years December 31, 2023 and 2022 were as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year ended December 31, ​ ​ 2023 ​ 2022 ​ ​ ​ ​ ​ ​ ​ Research and development ​ $ 1,075 ​ $ 1,151 Selling, general and administrative ​ 211 ​ ​ 250 Total ​ $ 1,286 ​ $ 1,401 ​ As of December 31, 2023 and 2022, $ 0 and $ 310 , respectively, of these service charges are included in Due to related parties in the Company’s Consolidated Balance Sheets. ​ ​ Note 9. Debt and Credit Facilities Debt, net of unamortized discounts and financing costs, consists of the following: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, 2023 December 31, 2022 ​ ​ ​ ​ ​ ​ ​ Revenue Interest Financing Agreement ("RIFA") ​ $ — ​ $ 30,000 RIFA accrued interest ​ ​ — ​ ​ 2,041 RIFA payments ​ ​ — ​ ​ ( 10 ) RIFA debt liability ​ $ — ​ $ 32,031 Estimated Portion of RIFA debt liability to be paid within one-year ​ ​ — ​ ​ ( 1,401 ) RIFA long-term debt liability ​ $ — ​ $ 30,630 Credit Agreement and Guaranty ​ ​ 102,319 ​ ​ 70,000 Payable-in-kind ("PIK") interest ​ ​ 361 ​ ​ 807 Total long-term debt liability ​ $ 102,680 ​ $ 101,437 Unamortized debt premiums, discounts and issuance costs ​ ​ ( 2,082 ) ​ ​ ( 8,386 ) Total long-term debt ​ $ 100,598 ​ $ 93,051 ​ On April 19, 2022, the Company entered into two strategic financing agreements: (i) a Credit Agreement and Guaranty (the “Credit Agreement”) by and among the Company, as the borrower, certain subsidiaries of the Company from time to time party thereto as subsidiary guarantors, the lenders party thereto (the “Lenders”), and Oaktree Fund Administration LLC (“OFA”) as administrative agent, and (ii) a Revenue Interest Financing Agreement (the “RIFA”; and together with the Credit Agreement, the “OFA Facilities”) by and among the Company, the purchasers party thereto (the “Purchasers”) and OFA as administrative agent. Under the OFA Facilities, the Lenders and the Purchasers agreed to, in the aggregate between the two OFA Facilities, provide up to $ 260,000 in gross funding to support the Company’s commercial activities of IGALMI TM sublingual film. In addition, the OFA Facilities are intended to support the expansion of clinical development efforts of BXCL501, which includes a Phase 3 program for the acute treatment of agitation in patients with Alzheimer’s disease, and for general corporate purposes. The Lenders and Purchasers are comprised of affiliates of Oaktree Capital Management, L.P. and Qatar Investment Authority. Waiver and First Amendment to Credit Agreement and Guaranty ​ On November 13, 2023, the Company, the lenders party to the Credit Agreement and OFA entered into a Waiver and First Amendment to Credit Agreement and Guaranty (the “First Amendment”) that provided for (i) a waiver and a modification to the covenant in the Credit Agreement regarding investments in OnkosXcel and (ii) an agreement among F-17 Table of Contents the parties to further revise key financial terms in the Credit Agreement and terminate the RIFA. Pursuant to the First Amendment, the Lenders agreed to permit the Company to invest up to a maximum of $ 30,000 at any time outstanding in OnkosXcel, increased from $ 25,000 at any time outstanding. The First Amendment also waived any defaults or events of default arising under the Credit Agreement due to a breach prior to the date of the First Amendment of the OnkosXcel investment covenant, or a breach of the Company’s obligation to notify OFA of such default. In connection with the First Amendment, the Company paid the Lenders a fee of $ 180 (representing 0.25 % of the loans outstanding under the Credit Agreement on the date of the First Amendment) and agreed to pay to the Lenders an exit fee equal to 0.25 % of the loans under the Credit Agreement repaid upon maturity or prepayment of the loans. ​ Second Amendment to Credit Agreement and Guaranty and Termination of the RIFA ​ On December 5, 2023, (the “Second Amendment Effective Date”), the Company entered into the Second Amendment to Credit Agreement and Guaranty and Termination of Revenue Interest Financing Agreement (the “Second Amendment”), which further amended the Credit Agreement. On the Second Amendment Effective Date, the Credit Agreement was amended to provide up to $ 202,319 in senior secured term loans, including the initial Tranche A of $ 70,000 , which was funded on April 28, 2022, and related capitalized interest on Tranche A through the Second Amendment Effective Date in the amount of $ 72,319 . In addition, the $ 30,000 in financing previously provided to the Company under the RIFA on July 8, 2022 was converted to a term loan under the Credit Agreement (the “Tranche A-2 Term Loan”). The RIFA and all commitments for potential future funding thereunder were terminated. In addition, pursuant to the Second Amendment, the Lenders agreed to permit the Company to invest up to a maximum of $ 30,865 at any time outstanding in OnkosXcel, increased from $ 30,000 . In connection with the Second Amendment, the Company agreed to pay to the Lenders an exit fee equal to 0.25 % of the loans under the Credit Agreement repaid upon maturity or prepayment of the loans (which exit fee is in addition to, and not in lieu of, the exit fee provided for by the First Amendment). As of December 31, 2023, $ 100,000 in commitments under the Credit Agreement remains unfunded, and Oaktree has an Equity Investment Right (as defined below) to purchase up to $ 5,000 of Common Stock from the Company. The blended effective interest rate on the Tranches A-1 and A-2 as of December 31, 2023 was approximately 13.5 %. ​ The remaining tranches may be borrowed at the Company’s option prior to December 31, 2024, subject to satisfaction of certain conditions, including regulatory and financial milestones. Tranche B of the Credit Agreement is $ 20,000 and is available upon satisfaction of certain conditions and financial milestones. Tranche C of the Credit Agreement is $ 30,000 and is available upon satisfaction of certain conditions, including receipt of certain regulatory and financial milestones. Tranche D of the Credit Agreement is $ 50,000 and is available upon satisfaction of the Tranche C Term Loans conditions precedent to, and the funding of Tranche C Loans, including specified minimum net sales of the Company attributable to sales of BXCL501 for a trailing twelve consecutive month period, on or before December 31, 2025. The loans under the Credit Agreement do not amortize and mature on April 19, 2027. The Company may, at its option, no earlier than September 21, 2026 and no later than October 21, 2026, request an extension of the maturity date to April, 19, 2028, provided that the Company satisfies certain conditions including receipt of certain regulatory and financial milestones. Borrowings under the Credit Agreement are issued at a 200 -basis point original issue discount and bear interest at a variable annual rate of TERM SOFR (but not less than 2.5 % or more than 5.5 %) plus 7.5 %, payable quarterly. The rate resets every three months based on the current Term SOFR rate. Of such interest, above 8 % per annum is, at the Company’s option, payable in kind by capitalizing and adding such interest to the outstanding principal amount of loans from the first payment date on which such interest is owed through March 31, 2025, unless, with respect to any payment date, the Company elects to pay all or a portion of such interest in cash. The Company is required to pay a ticking fee equal to 0.75 % per annum on the undrawn amount of the commitments, payable quarterly commencing 120 days after April 22, 2022 through the termination of the commitments, which is expensed as incurred and recognized as interest expense in the Consolidated Statements of Operations. The Company may voluntarily prepay the Credit Agreement at any time subject to a prepayment fee. The Company’s obligations under the Credit Agreement are guaranteed by BTI’s existing and subsequently acquired or organized subsidiaries, subject to certain exceptions. BTI’s obligations under the Credit Agreement and the related guarantees thereunder are secured, subject to customary permitted liens and other agreed upon exceptions, by (i) F-18 Table of Contents a pledge of all of the equity interests of all of the Company’s existing and any future direct subsidiaries, and (ii) a perfected security interest in all of its and the guarantors’ tangible and intangible assets (except that the guarantees provided by the BXCL701 Subsidiaries (as defined below) are unsecured). The Credit Agreement contains customary representations and warranties and customary affirmative and negative covenants, including, among other things, restrictions on indebtedness, liens, investments, mergers, dispositions, prepayment of other indebtedness, and dividends and other distributions, subject to certain exceptions, including specific exceptions with respect to product commercialization and development activities. The Company must also comply with certain financial covenants, including (i) maintenance of cash or permitted cash equivalent investments in accounts controlled by OFA for the Lenders, of at least (a) initially, $ 15,000 , (b) from and after the funding of the Tranche B loans, $ 20,000 , and (c) from and after the Company’s satisfaction of the funding conditions for the Tranche C loans, $ 15,000 , provided, that the liquidity covenant applicable at any time will be increased upon certain events related to a sale of OnkosXcel (up to a maximum amount equal to $ 37,500 ), provided that the minimum liquidity amount will in no event exceed 50 % of the aggregate amount of loans outstanding under the Credit Agreement at any time; and (ii) a minimum revenue test, measured quarterly beginning with the Company’s fiscal quarter ending on December 31, 2024 (such six-month period the “Revenue Covenant Measurement Period”), that requires it and its subsidiaries’ consolidated net revenue for the six consecutive month period ending on the last day of each such fiscal quarter to not be less than a minimum revenue amount specified in the Credit Agreement (such testing date, the “Revenue Covenant Measurement Testing Date” and the covenant described in this clause (ii) the “Revenue Covenant”). The Company’s failure to comply with the financial covenants will result in an event of default, subject to certain cure rights with respect to the Revenue Covenant. If, as of a Revenue Covenant Measurement Testing Date, the Company’s revenue for the applicable Revenue Covenant Measurement Period is less than the minimum revenue amount specified for the applicable period then required under the Revenue Covenant, the Company would have a right to cure such shortfall for a total of three fiscal periods by making a revenue cure payment (which would be treated as prepayments of the loans subject to a prepayment fee) to the Lenders in an amount equal to the difference between such minimum required revenue amount and the Company’s actual revenues for such Revenue Covenant Measurement Period, such payment to not be less than $1,000. If paid, the Company will be deemed to have complied with the Revenue Covenant as of such Revenue Covenant Measurement Testing Date. Any such payment will be applied to the prepayment of the loans under the Credit Agreement. Notwithstanding the foregoing, the Credit Agreement permits OnkosXcel (together with OnkosXcel Employee Holdings, LLC (“Employee Holdings”), a subsidiary of BTI, and their respective subsidiaries, the “BXCL701 Subsidiaries”) to receive third-party investment or transfer all or substantially all of their assets to an unaffiliated third party, in each case subject to terms and conditions set forth in the Credit Agreement, including the escrow of certain proceeds received by BTI and its subsidiaries (other than the BXCL701 Subsidiaries) in respect of these disposition events and, under circumstances set forth in the Credit Agreement, the mandatory prepayment of such escrowed amounts. The Company’s equity interests in the BXCL701 Subsidiaries have been pledged in support of its obligations under the Credit Agreement, and the BXCL701 Subsidiaries have provided direct guarantees of BTI’s obligations under the Credit Agreement on an unsecured basis. However, the pledge, guarantee and other obligations of the BXCL701 Subsidiaries under the Credit Agreement will be released upon certain agreed upon events (“Permitted BXCL701 Release Events”), including an initial public offering by the BXCL701 Subsidiaries or the ownership by unaffiliated third parties of at least 20 % of the equity interests in the BXCL701 Subsidiaries. The Credit Agreement contains events of default that are customary for financings of this type relating to, among other things, payment defaults, breach of covenants, breach of representations and warranties, cross default to material indebtedness, bankruptcy-related defaults, judgment defaults, breach of the financial covenants described above, and the occurrence of certain change of control events. In certain circumstances, events of default are subject to customary cure periods. The Credit Agreement also contains certain regulatory-related events of default, which do not have cure periods. Following an event of default and any applicable cure period, the Lenders will have the right upon notice to terminate any undrawn commitments and may accelerate all amounts outstanding under the Credit Agreement, in addition to other remedies available to them as the Company’s secured creditors. F-19 Table of Contents Revenue Interest Financing Agreement As noted, the RIFA was terminated when the Company entered into the Second Amendment, which amended the Credit Agreement (as amended by the First Amendment). The $ 30,000 Tranche A previously provided to the Company under the RIFA was converted to the Tranche A-2 Term Loan. Prior to termination, the RIFA provided up to $ 120,000 in potential financing in exchange for a capped revenue interest on net sales of IGALMI TM , and other future BXCL501 products, if any, that received regulatory approval for sale. The initial Tranche A of $ 30,000 was funded on July 8, 2022. The effective interest rate on the RIFA as of December 31, 2022, was approximately 14 %. Under the terms of the RIFA, the Purchasers were to receive tiered revenue interest payments on U.S. net sales of IGALMI™, and other future BXCL501 products, if any, that receive regulatory approval for sale, equal to a royalty ranging from 0.375 % to 7.750 % of net sales of IGALMI™, and other future BXCL501 products, if any, approved for sale in the U.S., subject to a hard cap equal to 1.75 x the total amount funded. The Company would also have been required to make certain additional payments to the Purchasers from time to time to ensure that the aggregate amount of payments received by the Purchasers under the RIFA were at least equal to certain agreed upon minimum levels as of certain specified dates, subject to terms and conditions set forth in the RIFA. Revenue interest payments due under the RIFA were payable quarterly based on net sales. Warrants and Equity Investment Right In connection with the closing of the Second Amendment, on the Second Amendment Effective Date, the Company amended and restated the warrants granted to the Lenders on April 19, 2022 to purchase up to 278 shares of the Company’s common stock at an exercise price of $ 20.04 per share (the “Original Warrants”). Pursuant to the amendment and restatement of the Original Warrants, dated December 5, 2023 (the “Amended and Restated Original Warrants”), the exercise price of the Original Warrants has been reduced to $ 3.6452 per share. In addition, the Company granted new warrants to the Lenders to purchase up to 70 shares of the Company’s common stock (the “2023 Warrant Shares”) at an exercise price of $ 3.6452 per share (the “2023 Warrants” and together with the Amended and Restated Original Warrants, the “Warrants”). The Amended and Restated Original Warrants and the 2023 Warrants will expire on April 19, 2029 and may be net exercised at the holder’s election. In addition, pursuant to the Credit Agreement, the Lenders have the right to purchase shares of the Company’s common stock after the Second Amendment Effective Date, so long as borrowings under the Credit Agreement are outstanding, for a purchase price of $ 5,000 at a price per share equal to a 10 % premium to the volume-weighted average price of the common stock over the 30 trading days prior to the Lenders’ election to proceed with such equity investment (the “Equity Investment Right”). BTI entered into a registration rights agreement (the “Registration Rights Agreement”) with the Lenders and filed a registration statement on Form S-3 to register the shares issuable upon exercise of the Warrants and, if issued, the shares related to the Equity Investment Right, for resale. The maximum shares of BTI common stock issuable under the Warrants (including the Original Warrants and the 2023 Warrants) and Lenders’ Equity Investment Right was 5,852 as of December 31, 2023. On the Second Amendment Effective Date, Company amended and restated its Registration Rights Agreement (the “Amended and Restated Registration Rights Agreement”) with the Lenders, dated April 19, 2022, pursuant to which the Company agreed to register the 2023 Warrant Shares for resale. As part of the Credit Agreement, OnkosXcel, a wholly owned subsidiary of BTI, granted warrants to the Lenders to purchase 175 individual limited liability company units (which number of units is not in thousands; referred to herein as the “OnkosXcel Warrants”). The strike price of the OnkosXcel Warrants is formulaic based on the value of OnkosXcel at the time of exercise and can only be exercised upon occurrence of an equity related liquidity event for OnkosXcel of at least $ 20,000 . The exercise price per unit of the OnkosXcel Warrants will be set upon the earlier of the closing of the next sale (or series of related sales) by OnkosXcel of equity securities of OnkosXcel with aggregate proceeds of not less than $ 20,000 to unrelated third parties (the “Next Equity Financing”) at an exercise price per unit equal to a 10 % premium over the price per unit of the equity securities sold by OnkosXcel in such Next Equity Financing or, in the event of a sale of OnkosXcel prior to the Next Equity Financing or an initial public offering constituting the Next Equity Financing, the lesser of (x) 75 % of the fair value of the consideration to be paid for a unit upon the consummation of such transaction and (y) 150 % of the valuation applicable to the initial profits units issued by OnkosXcel after the closing of the Credit Agreement. The OnkosXcel Warrants are transferable with approval from BTI, which cannot be unreasonably withheld, expire on April 19, 2029, and may be net exercised at the holder’s election. F-20 Table of Contents Maturities of long-term debt are expected to be as follows: ​ ​ ​ ​ ​ ​ ​ ​ December 31, 2023 ​ ​ ​ ​ ​ 2024 ​ $ — ​ 2025 ​ $ — ​ 2026 ​ $ — ​ 2027 ​ $ 102,680 ​ 2028 ​ $ — ​ Thereafter ​ $ — ​ ​ Interest expense was as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year ended ​ ​ December 31, ​ ​ 2023 ​ 2022 ​ ​ ​ ​ ​ ​ ​ Interest expense ​ $ 11,941 ​ $ 7,353 Accretion of debt discount and amortization of financing costs ​ 1,373 ​ ​ 860 Total interest expense ​ $ 13,314 ​ $ 8,213 ​ ​ Note 10. Derivative Financial Instruments BTI identified certain freestanding financial instruments and/or embedded features that require separate accounting from the borrowings under the OFA Facilities. This includes the OnkosXcel Warrants and Equity Investment Right held by the Lenders, along with certain put/call options. The OnkosXcel Warrants and Equity Investment Right do not meet certain scope exceptions under U.S. GAAP, primarily because the exercise prices and number of shares of the Company’s common stock issuable under the instruments are variable, and the instruments meet the definition of a derivative instrument. Therefore, these instruments are recorded as Derivative liabilities in the Consolidated Balance Sheets. The respective derivative liabilities are recorded at fair value on the date of issuance and are revalued on each balance sheet date until such instruments are settled or expire, with changes in the fair value between reporting periods recorded within Other (income) expense, net in the Company’s Consolidated Statements of Operations. ​ Note 11. Common Stock Financing Activities In May 2021, the Company entered into an Open Market Sale Agreement (as amended, supplemented and/or restated from time to time, the “Sale Agreement”) with Jefferies LLC (“Jefferies”) pursuant to which the Company could offer and sell shares of its common stock, having an aggregate offering price of up to $ 100,000 , from time to time, through an “at the market offering” program under which Jefferies will act as sale agent. In November 2023, the Company amended the Sale Agreement to increase the size of the “at the market offering" program to $ 150,000 . The Company sold 1,408 shares under the Sale Agreement in the year ended December 31, 2023 for net proceeds of $ 26,221 . For the year ended December 2023, the Company sold shares for the gross amount of $ 27,032 , and incurred issuance costs of $ 811 . The Company did not sell any shares, and thus did no t receive any proceeds under this program, for the year ended December 31, 2022 . ​ Note 12. Stock-Based Compensation 2017 Equity Incentive Plan The Company’s 2017 Plan became effective in August 2017. Following the effective date of the Company's 2020 Plan, the Company ceased granting awards under the 2017 Plan, however, the terms and conditions of the 2017 Plan continue to govern any outstanding awards granted thereunder. F-21 Table of Contents 2020 Incentive Award Plan The Company’s 2020 Plan was approved and became effective at the Company’s 2020 annual meeting of stockholders on May 20, 2020, and unless earlier terminated by the Board of Directors, will remain in effect until March 26, 2030. The 2020 Plan originally authorized for issuance the sum of (i) 911 shares of the Company’s common stock and (ii) 233 shares of the Company’s common stock, which represents the number of shares that remained available for issuance under the 2017 Plan immediately prior to the approval of the 2020 Plan by the Company’s stockholders. Any shares of common stock which, immediately prior to the approval of the 2020 Plan by the Company’s stockholders, were subject to awards granted under the 2017 Plan that are forfeited or lapse unexercised and are not issued under the 2017 Plan will increase the number of shares of common stock available for grant under the 2020 Plan. In addition, the number of shares available for issuance under the 2020 Plan will increase on the first day of each calendar year, beginning January 1, 2021 and ending on and including January 1, 2030, by a number of shares equal to the lesser of (A) 4 % of the aggregate number of shares of the Company’s common stock outstanding on the final day of the immediately preceding calendar year and (B) such smaller number of shares of common stock as determined by the Board of Directors. The shares available for issuance under the 2020 Plan increased by 1,126 shares and 1,119 shares on January 1, 2023 and 2022, respectively. Stock-based awards granted under the 2020 Plan have a term of ten years . The vesting schedule of all awards granted under the 2020 Plan is determined by the Board of Directors, which is generally four years . Stock-based awards granted under the 2020 Plan include stock options, BTI RSUs, and Performance Units. As of December 31, 2023, there were 664 shares available to be granted under the 2020 Plan. BTI Restricted stock units The table below summarizes activity relating to BTI RSUs. ​ ​ ​ ​ ​ ​ ​ ​ ​ Number of ​ shares ​ ​ ​ Outstanding as of January 1, 2023 119 Granted ​ 133 Vested ​ ( 67 ) Outstanding as of December 31, 2023 ​ 185 ​ In 2023, the Company granted 133 time-based BTI RSUs to certain employees. All of the BTI RSUs vest over four years , with 25 % vesting at the one-year anniversary of the grant date and the balance vesting ratably over the remaining 12 quarters of the vesting period. The weighted average grant date fair value per share for the BTI RSUs was $ 19.62 . Unrecognized stock-based compensation expense related to these awards was $ 1,417 as of December 31, 2023. In 2022, the Company granted 122 ( 119 , net of forfeitures) time-based BTI RSUs to certain employees and consultants. The majority of BTI RSUs granted to employees vest over four years , with 25 % vesting at the one-year anniversary of the grant date and the balance vesting ratably over the remaining 12 quarters of the vesting period. There were 25 BTI RSUs granted to the employees in May 2022 which fully vested at the one-year anniversary of the grant date. BTI RSUs granted to a third-party consultant vest 50 % each on the first and second anniversaries of the grant date. The weighted average grant date fair value per share for the BTI RSUs granted in 2022 was $ 14.38 . Unrecognized stock-based compensation expense related to these awards was $ 298 as of December 31, 2023. F-22 Table of Contents BTI Performance stock units The table below summarizes activity relating to Performance Units related to BTI common stock. ​ ​ ​ ​ ​ ​ ​ Number of ​ ​ shares ​ ​ ​ ​ ​ Outstanding as of January 1, 2023 — ​ Granted ​ 543 ​ Cancelled ​ ( 16 ) ​ Outstanding as of December 31, 2023 ​ 527 ​ ​ In October 2023, the Company granted 543 Performance Units to employees. 209 Performance Units vest on the one-year anniversary of the grant date, and the remaining 334 Performance Units are performance based and vest on the one-year anniversary of the grant date, provided certain performance criteria are met. The weighted average value of Performance Units granted and cancelled during 2023 was $ 2.43 . None of the Performance Units had vested as of December 31, 2023. Unrecognized stock-based compensation expense related to the awards expected to vest was $ 515 as of December 31, 2023. OnkosXcel Profit sharing units The table below summarizes activity relating to the PSUs associated with OnkosXcel as described below. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted average ​ ​ Number of ​ price per unit ​ units ​ (in whole dollars) ​ ​ ​ ​ ​ ​ Outstanding as of January 1, 2023 1,310 ​ $ 5,506 Granted ​ 30 ​ $ 10,176 Cancelled ​ ( 100 ) ​ $ 5,506 Forfeited ​ — ​ $ — Outstanding as of December 31, 2023 ​ 1,240 ​ ​ ​ ​ ​ ​ ​ ​ ​ Vested units as of December 31, 2023 ​ 676 ​ $ 5,533 ​ During 2023, Employee Holdings, a management holding company used to facilitate the grant of equity interests to service providers of OnkosXcel granted 30 individual (not in thousands) time-based PSUs related to OnkosXcel to certain employees of the Company in consideration for services provided to OnkosXcel. In 2022, Employee Holdings granted 1,310 (not in thousands) PSUs to employees and a consultant of the Company for services provided to OnkosXcel. The PSUs represent indirect equity interests in OnkosXcel. All PSUs, other than those granted to certain F-23 Table of Contents executive employees of the Company, vest ratably over 48 months . PSUs granted to certain executive employees of the Company, vested ratably over 24 months . The fair values of the PSUs granted in 2023 and 2022 were $ 8 per unit and $ 4 per unit, respectively, and were estimated at the date of grant using a Black-Scholes option pricing model. The total fair value of the PSUs vested during the year ended December 31, 2023 was $ 1,942 . ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 2023 grant profit share unit valuation inputs ​ ​ ​ ​ ​ ​ Expected volatility ​ 97.4 % ​ Risk-free rate of interest ​ 3.6 % ​ Expected dividend yield ​ — % ​ Expected term ​ 5.8 years ​ ​ Unrecognized stock-based compensation expense related to the PSUs was $ 971 and $ 4,588 as of December 31, 2023 and 2022, respectively. OnkosXcel restricted stock units The table below summarizes activity relating to the OnkosXcel RSUs. ​ ​ ​ ​ ​ ​ ​ ​ ​ Number of ​ units ​ ​ ​ Outstanding as of January 1, 2023 — Granted ​ 225 Outstanding as of December 31, 2023 ​ 225 ​ During the year ended December 31, 2023, the Company granted 225 individual (not in thousands) OnkosXcel RSUs to certain employees. 125 of the OnkosXcel RSUs vest upon the earlier to occur of (a) 180 days after an initial public offering of OnkosXcel, or (b) a change in control of OnkosXcel. The remaining OnkosXcel RSUs vest over four years , with 25 % vesting at the one-year anniversary of the grant date and the balance vesting ratably over the remaining 12 quarters of the vesting period. The weighted average grant date fair value per unit for the OnkosXcel RSUs was approximately $ 10 . Unrecognized stock-based compensation expense related to the awards expected to vest was approximately $ 552 as of December 31, 2023. F-24 Table of Contents BTI Stock options A summary of the Company’s stock option activity for the year ended December 31, 2023, is presented below. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Number of ​ Weighted average ​ ​ shares price per share ​ ​ ​ ​ ​ ​ ​ Outstanding as of January 1, 2023 4,882 ​ $ 17.23 ​ Granted ​ 1,090 ​ $ 19.35 ​ Forfeited ​ ( 651 ) ​ $ 17.84 ​ Cancelled ​ ( 36 ) ​ $ 24.67 ​ Exercised ​ ( 309 ) ​ $ 1.65 ​ Outstanding as of December 31, 2023 ​ 4,976 ​ $ 18.52 ​ ​ ​ ​ ​ ​ ​ ​ Options vested and exercisable as of December 31, 2023 3,479 ​ $ 17.32 ​ ​ As of December 31, 2023, the intrinsic value of options outstanding was $ 3,149 . The intrinsic value for stock options is calculated based on the difference between the exercise prices of the underlying awards and the quoted stock price of the Company’s common stock as of the reporting date. The total intrinsic value of stock options exercised for the years ended December 31, 2023 and 2022 was $ 5,928 and $ 2,437 , respectively. The total intrinsic value of stock options exercisable as of December 31, 2023 and 2022 was $ 3,148 and $ 40,255 , respectively. The weighted average grant date fair value of options granted during the years ended December 31, 2023 and 2022 was $ 15.53 and $ 11.62 , respectively. The weighted average grant date fair value of options vested as of December 31, 2023 was $ 12.86 . The weighted average remaining contractual life is 5.5 years for options exercisable as of December 31, 2023. The weighted average remaining contractual life was 6.4 years for options outstanding as of December 31, 2023. Unrecognized compensation expense related to unvested stock option awards as of December 31, 2023, was $ 9,478 and will be recognized over the remaining vesting periods of the underlying awards. The weighted-average period over which such compensation is expected to be recognized is 1.1 years. Stock-Based Compensation The fair value of options granted during the years ended December 31, 2023 and 2022 was estimated using the Black-Scholes pricing model with the following assumptions: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year ended ​ Year ended ​ ​ December 31, 2023 ​ December 31, 2022 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Expected term ​ ​ 5.5 years - 6.1 years ​ 5.5 years - 6.1 years Expected stock price volatility ​ ​ 96.9 % - 109.9 % ​ 92.7 % - 99.4 % Risk-free rate of interest ​ ​ 3.5 % - 4.7 % ​ 1.5 % - 4.4 % Expected dividend yield ​ ​ 0.0 % - 0.0 % ​ 0.0 % - 0.0 % ​ In 2023, the Company began using the historical volatility of its common stock to estimate volatility. Prior to 2023, volatility was estimated using a combination of the historical volatility of publicly traded peer companies and that of the Company’s common stock. The expected term of the awards is estimated based on the simplified method, which calculates the expected term based upon the midpoint of the term of the award and the vesting period. The Company uses the simplified method because it does not have sufficient option exercise data to provide a reasonable basis upon which to estimate the expected term. The expected dividend yield is zero percent as the Company has no history of F-25 Table of Contents paying dividends nor does management expect to pay dividends over the contractual terms of these options. The risk-free interest rates are determined by reference to the U.S. Treasury yield curve in effect at the time of grant, with maturities approximating the expected term of the stock options. The fair value of the underlying common stock is generally determined as the closing price of the Company’s common stock on The Nasdaq Capital Market on the grant date, with consideration of whether there is material nonpublic information that could impact that estimated fair value when it is released. The Company recognized stock-based compensation expense related to awards issued under the 2017 Plan and the 2020 Plan, as well as the OnkosXcel PSUs and OnkosXcel RSU’s, of $ 18,614 and $ 17,337 for the years ended December 31, 2023 and 2022, respectively, which were comprised as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year ended December 31, ​ ​ 2023 ​ 2022 ​ ​ ​ ​ ​ ​ ​ Research and development ​ $ 6,324 ​ $ 4,558 Selling, general and administrative ​ 12,290 ​ ​ 12,779 Total ​ $ 18,614 ​ $ 17,337 ​ 2020 Employee Stock Purchase Plan The Company’s 2020 Employee Stock Purchase Plan (the “ESPP”) was also approved and became effective at the Company’s 2020 annual meeting of stockholders on May 20, 2020. The ESPP is designed to assist eligible employees of the Company with the opportunity to purchase the Company’s common stock at a discount through accumulated payroll deductions during successive offering periods. The aggregate number of shares that may be issued pursuant to rights granted under the ESPP is 100 shares of common stock. In addition, the number of shares available for issuance under the ESPP will increase on the first day of each calendar year, beginning on January 1, 2021 and ending on and including January 1, 2030, by a number of shares of common stock equal to the lesser of (a) 1 % of the shares outstanding on the final day of the immediately preceding calendar year and (b) such smaller number of shares as determined by the Board of Directors. The number of shares that may be issued or transferred pursuant to rights granted under the component of the ESPP that is intended to qualify for favorable U.S. federal tax treatment under Section 423 of the Internal Revenue Code (the “Section 423 Component”) shall not exceed 500 shares. The purchase price will be determined by the administrator of the ESPP and, for purposes of the Section 423 Component, shall not be less than 85 % of the fair value of a share on the first trading day or on the last trading day of the applicable offering period, whichever is lower. The shares available for issuance under the ESPP increased by 281 shares and 280 shares on January 1, 2023 and 2022, respectively. To date, no shares have been sold under the ESPP. There were 905 shares available for issuance as of December 31, 2023. ​ Note 13. Leases BTI leases office space for its corporate headquarters at 555 Long Wharf Drive, New Haven, Connecticut (the “HQ Lease”) under an operating lease that expires in February 2026. The Company has an option to renew the HQ Lease for one additional five-year term. Payments under the HQ Lease are fixed. The Company also leases equipment such as copiers and information technology equipment. F-26 Table of Contents The future minimum annual lease payments under operating leases, as of December 31, 2023, were as follows: ​ ​ ​ ​ ​ Year ending December 31, Amount ​ ​ ​ ​ 2024 ​ ​ 381 2025 ​ ​ 391 2026 ​ ​ 65 2027 ​ ​ — 2028 ​ ​ — Thereafter ​ ​ — Total lease payments ​ $ 837 Imputed interest ​ ​ ( 51 ) Total lease liability ​ $ 786 Less current portion of lease liability ​ ​ ( 346 ) Long-term portion of operating lease liability ​ $ 440 ​ The current portion of the Company’s operating lease liability of $ 346 , as of December 31, 2023, is included in Other current liabilities on the Consolidated Balance Sheets. Lease expense was $ 392 and $ 410 for the years ended December 31, 2023 and 2022, respectively. Lease renewal options are not included in the ROU asset or lease liability. ​ Note 14. Employee Benefit Plan The Company maintains a defined contribution retirement plan for its employees that complies with Section 401(k) of the Internal Revenue Code (the “401(K) Plan”). Employees are eligible to participate in the 401(K) Plan and can contribute a portion of their pay into the 401(K) Plan, subject to annual limits established by the U.S. Internal Revenue Service. Participating employees receive an employer matching contribution equal to 50 % of eligible employee contributions on the first 5 % of eligible compensation contributed. Employer contributions to the 401(K) Plan were $ 788 and $ 568 for the years ended December 31, 2023 and 2022, respectively. ​ Note 15. Fair Value Measurements The Company groups its assets and liabilities measured at fair value in three levels based on the nature of the inputs and assumptions used to determine fair value. Refer to Note 3, Summary of Significant Accounting Policies, for additional information on the accounting policies related to fair value. The carrying amounts of Cash and cash equivalents, Accounts receivable, net and Accounts payable approximate fair value due to the short-term nature of these instruments. As of December 31, 2023 and 2022, the Company had $ 64,860 and $ 191,022 , respectively, primarily in money market funds that hold U.S. government cash equivalent instruments (included in Cash and cash equivalents) which were valued based on Level 1 inputs. There were no transfers between levels within the hierarchy during the years ended December 31, 2023 and 2022. Derivative liabilities measured at fair value on a recurring basis are summarized below. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year ended ​ ​ December 31, 2023 ​ ​ Fair Value ​ Level 1 ​ Level 2 ​ Level 3 ​ Total ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Derivative liability - Equity Investment Right ​ $ 1,193 ​ $ — ​ $ — ​ $ 1,193 ​ $ 1,193 Derivative liability - OnkosXcel Warrants ​ ​ 712 ​ ​ — ​ ​ — ​ ​ 712 ​ ​ 712 Total derivative liabilities ​ $ 1,905 ​ $ — ​ $ — ​ $ 1,905 ​ $ 1,905 ​ F-27 Table of Contents Derivative liabilities are comprised of the OnkosXcel Warrants and Equity Investment Right held by the Lenders. The fair value of the derivative liabilities was determined using Monte Carlo simulation models for the Equity Investment Right, and Binomial Option Pricing and Distribution models for the OnkosXcel Warrants. The following table presents changes in Level 3 liabilities measured at fair value for the year ended December 31, 2023. Both observable and unobservable inputs were used to determine the fair value of positions that the Company has classified within the Level 3 category. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year ended ​ ​ December 31, ​ ​ 2023 ​ 2022 ​ ​ ​ ​ ​ ​ ​ Derivative liabilities, Balance - January 1 ​ $ 2,343 ​ $ 1,954 Change in fair value ​ ​ ( 438 ) ​ ​ 389 Derivative liabilities, Balance - December 31 ​ $ 1,905 ​ $ 2,343 ​ The derivative liabilities were reported at their fair values in the Consolidated Balance Sheets. The changes in the fair value of the derivative liabilities were reported in the Consolidated Statements of Operations as Other (income) expense, net, for the years ended December 31, 2023 and 2022. Inputs used to calculate the estimated fair value of the Equity Investment Right were as follows: ​ ​ ​ ​ ​ ​ ​ Equity Investment Right ​ ​ ​ ​ Strike price relative to volume weighted 30-day average ​ 110.0 % Volatility (annual) ​ 99.1 % Probability of exercise ​ 90.0 % Time period ​ 3.3 years Estimated premium to 30-day average ​ 24.0 % Discount rate ​ 4.4 % ​ In estimating the fair value of the derivative liability related to the OnkosXcel Warrants, inputs included third-party fair value estimates of OnkosXcel limited liability company units along with the volatility of those units (which was set at 100 % based on the historical volatility of the Company’s stock, along with a peer group of comparable publicly traded companies), and the timing and probability of the relevant capital transactions occurring. The estimated fair value of the Credit Agreement as of December 31, 2023, was $ 88,210 . Both observable and unobservable inputs were used to determine the fair value of long-term debt, which was classified within the Level 3 category. The fair value of the 2023 Warrants, which is a non-recurring fair value, was determined as of the date of issuance using a Black-Scholes pricing model and the fair value of $ 200 was recorded as a component of stockholders’ equity in Additional-paid-in-capital in the Consolidated Balance Sheets, with the offset recorded as a discount on the amounts funded under the Credit Agreement. This non-recurring measurement is classified as Level 3. The inputs used were a strike price of $ 3.6452 , the Company’s stock price of $ 3.71 , volatility of 99 %, term of 5.4 years and risk-free rate of 4.14 %. ​ The fair value of the Original Warrants, which was a non-recurring fair value, was determined as of the date of issuance using a Black-Scholes pricing model and the fair value of $ 3,245 was recorded as a component of stockholders’ equity in Additional-paid-in-capital in the Consolidated Balance Sheets, with the offset recorded as a discount on the amounts funded under the OFA Facilities. This non-recurring measurement is classified as Level 3. The inputs used were a strike price of $ 20.04 , the Company’s stock price of $ 14.93 , volatility of 95 %, term of 7 years and risk-free rate of 2.95 %. As discussed in Note 9, Debt and Credit Facilities, in connection with the closing of the Second Amendment of the Credit Agreement, on the Second Amendment Effective Date, the Company amended and restated the Original Warrants granted to the Lenders to have an exercise price of $ 3.6452 per share. F-28 Table of Contents ​ Using a Black-Scholes pricing model, the Company determined that the Amended and Restated Original Warrants’ fair values at the original strike price of $ 20.04 and the amended strike price of $ 3.6452 were $ 548 and $ 802 , respectively, as of the Second Amendment Effective Date. The Amended and Restated Original Warrants’ incremental increase in fair value for the repricing of $ 254 , was recorded as a component of stockholders’ equity in Additional-paid-in-capital in the Consolidated Balance Sheets, with the offset recorded as a discount on the amounts refinanced under the Credit Agreement. ​ Note 16. Income Taxes There is no provision for income taxes because the Company has historically incurred operating losses and maintains a full valuation allowance against its net deferred tax assets. The reported amount of income tax expense for the years differs from the amount that would result from applying domestic federal statutory tax rates to pretax losses primarily because of changes in valuation allowance. For tax years beginning on or after January 1, 2022, the 2017 Tax Cuts and Jobs Act amended Section 174 of the U.S. Tax Code to eliminate current-year deductibility of research and development expenses and requires taxpayers to capitalize and amortize them over five years for research activities performed in the U.S. and fifteen years for research activities performed outside of the U.S. For the 2023 tax year, the Company capitalized $ 78,002 of research and development expenses. This resulted in an increase in the deferred tax asset associated with capitalized research and development of $ 20,985 . In determining the realizability of the Company’s net deferred tax asset, the Company considered numerous factors, including historical profitability, estimated future taxable income, and the industry in which it operates. Based on this information the Company has provided a valuation allowance for the full amount of its net deferred tax asset because the Company has determined that it is more likely than not that it will not be realized. The significant components of the Company’s net deferred tax assets are as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ December 31, ​ ​ 2023 ​ 2022 Deferred tax assets: ​ ​ ​ ​ ​ ​ Federal net operating losses ​ $ 73,770 ​ $ 46,695 State net operating losses ​ 21,255 ​ 11,271 Stock options ​ 13,915 ​ 10,705 Tax credits ​ ​ 15,048 ​ ​ 10,689 Capitalized research & development ​ 49,603 ​ 36,663 Accrued expense ​ ​ — ​ ​ 2,171 Depreciation ​ 73 ​ 42 Lease liability ​ ​ 212 ​ ​ 290 Unrealized loss ​ ​ — ​ ​ 103 Valuation allowance ​ ​ ( 173,679 ) ​ ​ ( 118,373 ) Total deferred tax assets ​ $ 197 ​ $ 256 Deferred tax liabilities: ​ ​ ​ ​ Unrealized gain ​ ​ ( 12 ) ​ ​ — Right-of-use assets ​ $ ( 185 ) ​ $ ( 256 ) Total deferred tax liabilities ​ $ ( 197 ) ​ $ ( 256 ) Net deferred tax asset (liability) ​ $ — ​ $ — ​ The income tax benefit for the year ended December 31, 2023 differed from the amounts computed by applying the U.S. federal income tax rate of 21 % to loss before tax benefit as a result of nondeductible expenses, tax credits generated and increases in the amount of the Company’s valuation allowance. F-29 Table of Contents A reconciliation between the Company’s effective tax rate and the federal statutory rate are as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ Year ended December 31, ​ ​ 2023 ​ 2022 Federal statutory rate ​ 21.0 % ​ 21.0 % Stock based compensation ​ 0.3 % ​ ( 0.4 ) % Federal tax credits ​ 2.3 % ​ 2.1 % State taxes ​ 8.0 % ​ 4.2 % Other ​ ( 0.7 ) % ​ 1.1 % Valuation allowance ​ ( 30.9 ) % ​ ( 28.0 ) % ​ ​ — % ​ — % ​ As of December 31, 2023, the Company had approximately $ 351,284 of gross federal and $ 360,081 of gross state net operating loss (“NOL”) carryforwards. If not utilized, the federal and state NOL carryforwards will begin to expire in 2037. The federal NOL of $ 348,638 incurred after December 31, 2017, will be carried forward indefinitely. The utilization of such NOL carryforwards and realization of tax benefits in future years depends predominantly upon having taxable income. The Company has approximately $ 14,345 of federal orphan drug and research development credits which will begin to expire in 2037 if not utilized. The Company also has approximately $ 1,206 of state drug research development credits which will begin to expire in 2040 if not utilized. ​ Utilization of the NOL and research tax credit carryforwards may be subject to a substantial annual limitation due to ownership limitations that have occurred or that could occur in the future, as required by section 382 of the U.S. Tax Code, as well as similar state and foreign provisions. These ownership changes may limit the amount of the NOL and research credit carryforwards that can be utilized annually to offset future taxable income and tax, respectively. In general, an "ownership change," as defined by Section 382 of the U.S. Tax Code, results from a transaction or series of transactions over a three-year period resulting in an ownership change of more than 50 percentage points of the outstanding stock by certain stockholders or public groups. ​ Entities are also required to evaluate, measure, recognize and disclose any uncertain income tax positions taken on their income tax returns. The Company has analyzed its tax positions and has concluded that as of December 31, 2023, there were no uncertain positions. The Company's U.S. federal and state NOLs have occurred since its inception in 2017 and as such, tax years subject to potential tax examination could apply from that date because the utilization of NOLs from prior years opens the relevant year to audit by the U.S. Internal Revenue Service and/or state taxing authorities. BTI did no t have any unrecognized tax benefits and has no t accrued any interest or penalties for the years ended December 31, 2023 and 2022. ​ Note 17. Net Loss Per Share Basic and diluted net loss per share are as follows : ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year ended ​ ​ December 31, ​ ​ 2023 2022 ​ ​ ​ ​ ​ ​ ​ Net loss (numerator) ​ $ ( 179,053 ) ​ $ ( 165,757 ) Weighted average shares (denominator) ​ ​ 29,129 ​ ​ 28,015 Basic and diluted net loss per share ​ $ ( 6.15 ) ​ $ ( 5.92 ) ​ Potentially dilutive securities outstanding consists of stock options, RSUs and performance units, and BTI warrants. The Company had common stock equivalents outstanding as of December 31, 2023 and 2022 of 6,036 and 5,280 shares, respectively. ​ F-30 Table of Contents Note 18. Commitments and Contingencies From time to time, in the ordinary course of business, the Company may be subject to litigation and regulatory examinations as well as information gathering requests, inquiries and/or investigations. Other than the below, the Company is not currently subject to any matters where it believes there is a reasonable possibility that a material loss may be incurred. On July 7, 2023, plaintiff Katelyn Martin filed a class action complaint against the Company and certain executives in the United States District Court for the District of Connecticut, captioned Martin v. BioXcel Therapeutics, et al., 3:23-cv-00915 (D. Conn). On October 4, 2023, pursuant to the Private Securities Litigation Reform Act, the court appointed two co-Lead Plaintiffs. The co-Lead Plaintiffs filed an amended complaint on December 5, 2023, alleging violations of Sections 10(b) and 20A of the Securities and Exchange Act of 1934 (the “Exchange Act”) and SEC Rule 10b-5 promulgated thereunder. The amended complaint alleges that defendants made false or misleading statements regarding the TRANQUILITY II trial and the development of BXCL501 for an expanded indication related to the treatment of certain Alzheimer’s-related agitation. Defendants filed a motion to dismiss on February 6, 2024, which has not been decided. On November 28, 2023, Plaintiffs Pratheesan Panancherry and Jeffrey Bastress filed a stockholder derivative complaint in the United States District Court for the District of Connecticut purportedly on behalf of the Company and against Vimal Mehta, Richard I. Steinhart, Peter Mueller, June Bray, Sandeep Laumas, Michael Miller, Michal Votruba, and Krishnan Nandabalan as Defendants, and the Company as Nominal Defendant under the caption Panancherry et al v. Mehta et al, 3:23-cv-1554. Following the initial action, Plaintiffs Maria Vomvolakis (3:24-cv-3) and Kelly Fowler (3:24-cv-203) each filed separate stockholder derivative complaints in the District of Connecticut raising similar claims as Panancherry and Bastress, including business torts and violations of the Securities Exchange Act of 1934. The cases have been consolidated under the caption In re BioXcel Therapeutics, Inc. Stockholder Derivative Litigation, 3:23-cv-1554 (D. Conn.). The above-captioned consolidated action is currently stayed. On January 11, 2024, Plaintiff Jeremy Smith filed a stockholder derivative complaint in the United States District Court for the District of Delaware purportedly on behalf of the Company and against Vimal Mehta, Peter Mueller, June Bray, Sandeep Laumas, Michael Miller, Michal Votruba, Richard I. Steinhart, Robert Risinger, and Krishnan Nandabalan as Defendants, and the Company as Nominal Defendant under the caption Smith v. Mehta et al, 1:24-cv-00041. Following the initial action, Plaintiff Janice Korff filed a stockholder derivative complaint in the District of Delaware raising similar claims as Smith (1:24-cv-130), including business torts and violations of the Securities Exchange Act of 1934. The cases have been consolidated under the caption In re BioXcel Therapeutics, Inc. Derivative Litigation, 1:24-cv-00041 (D. Del.). The Company expects to seek a stay in the above-captioned consolidated action. ​ At this time, the Company does not believe the claims in the above-captioned matters have merit, and intends to vigorously defend against them; however, the potential costs and liabilities associated with this litigation are uncertain. ​ In April 2022, the Company signed a commercial supply agreement that requires minimum annual payments for the first three years of the agreement that in aggregate total $ 10,000 for the three-year period . ​ Note 19. Subsequent Events On February 12, 2024, the Company entered into the Third Amendment to Credit Agreement and Guaranty (the “Third Amendment”), which amended the Credit Agreement. Pursuant to the Third Amendment, the Lenders agreed to waive the covenant that the Company shall not receive a report and opinion from the Company’s independent auditors that contains a “going concern” or like qualification or exception or emphasis of matter of going concern footnote with respect to the Company’s financial statements for the fiscal year ended December 31, 2023 and, as a result, such event shall not be an event of default. As a condition to the effectiveness of the Third Amendment, among other things, the Company shall have received at least $ 40,000 in gross proceeds from a registered public sale of the Company’s common stock, warrants and/or pre-funded warrants on or before February 20, 2024. The Company did not meet this condition and therefore the Third Amendment did not become effective. ​ F-31 Table of Contents On March 20, 2024 (the “Effective Date”), the Company entered into a Fourth Amendment (the “Fourth Amendment”) to the Credit Agreement and Guaranty (as amended from time to time, the “Credit Agreement”) by and among the Company, as the borrower, certain subsidiaries of the Company from time to time party thereto as subsidiary guarantors, the Lenders, and OFA as administrative agent, pursuant to which the Lenders waived the covenant that the Company not receive a report and opinion from the Company’s independent registered public accounting firm that contains a “going concern” or similar qualification with respect to the Company’s financial statements for the year ended December 31, 2023. Accordingly, while the Company’s independent registered public accounting firm’s report contained in this Annual Report on Form 10-K contains a “going concern” explanatory paragraph, it does not constitute an event of default under the Credit Agreement. ​ The Fourth Amendment includes a covenant that the Company will receive, (i) after the Effective Date and on or before April 15, 2024, at least $ 25,000 in gross proceeds from the issuance of its common stock, warrants and/or pre-funded warrants, and/or in non-refundable cash consideration from partnering transactions entered into after the Effective Date (so long as such partnering transactions would not require the Company or any of its subsidiaries to make any cash investments in connection with the partnering transactions and no such cash investments are made) and (ii) after the Effective Date and on or before November 30, 2024, at least $ 50,000 (for the avoidance of doubt, inclusive of amounts previously counted toward the preceding clause (i)) in gross proceeds from the issuance of its common stock, warrants and/or pre-funded warrants, and/or in cash and/or non-cash consideration (measured at fair market value, as determined by the Administrative Agent (as defined in the Credit Agreement) in its sole discretion ) from partnering transactions entered into after the Effective Date. Failure to perform this covenant would constitute (A) a default under the Credit Agreement and (B) an event of default under the Credit Agreement, subject to a cure period, solely in the case of clause (i) of the preceding sentence, until May 15, 2024. For the avoidance of doubt, failure to perform clause (ii) of the preceding sentence would constitute an immediate event of default under the Credit Agreement without any cure or grace period. ​ In addition, the Fourth Amendment provides that if the Company has not, after the Effective Date and on or before September 30, 2024, received at least $ 40,000 in gross proceeds from the issuance of its common stock, warrants and/or pre-funded warrants, and/or cash and/or non-cash consideration (measured at fair market value, as determined by the Administrative Agent in its sole discretion) from partnering transactions entered into after the Effective Date, the “Minimum Liquidity Amount” (as defined in the Credit Agreement) that the Company is required to maintain at all times will increase to $ 25,000 from $ 15,000 , unless and until we have received, after the Effective Date and on or before November 30, 2024, at least $ 50,000 in gross proceeds from the issuance of the Company’s common stock, warrants and/or pre-funded warrants, and/or in cash and/or non-cash consideration (measured at fair market value, as determined by the Administrative Agent in its sole discretion) from partnering transactions entered into after the Effective Date. ​ In connection with the Fourth Amendment, on the Effective Date, the Company granted new warrants to the Lenders to purchase up to 100 shares of its common stock (the “2024 Warrant Shares”) at an exercise price of $ 3.0723 per share (the “2024 Warrants”), which represents a 10 % premium over the arithmetic average of the volume-weighted average price of the Company’s common stock on the Nasdaq Capital Market during the 30 trading days preceding the Effective Date. The 2024 Warrants will expire on April 19, 2029 and may be net exercised at the holder’s election. On the Effective Date, the Company amended and restated its Amended and Restated Registration Rights Agreement (the “Second Amended and Restated Registration Rights Agreement”) with the Lenders, originally dated April 19, 2022. Pursuant to the Second Amended and Restated Registration Rights Agreement, the Company agreed to register the 2024 Warrant Shares for resale. ​ As discussed in Note 11, Common Stock Financings Activities, the Company has previously entered into an Open Market Sale Agreement (the “Sale Agreement”) with Jefferies LLC (“Jefferies”), as amended, pursuant to which the Company could offer and sell shares of its common stock, having an aggregate offering price of up to $ 150,000 , from time to time, through an “at the market offering” program under which Jefferies will act as sale agent. From January 1, 2024 through March 19, 2024, the Company sold 647 shares under the Sale Agreement for gross proceeds of $ 1,743 and received proceeds of $ 1,691 , net of issuance costs of $ 52 . ​ ​ ​ ​ F-32