Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2024 | Oct. 31, 2024 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2024 | |
Document Transition Report | false | |
Entity File Number | 001-38410 | |
Entity Registrant Name | BioXcel Therapeutics, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 82-1386754 | |
Entity Address, Address Line One | 555 Long Wharf Drive | |
Entity Address, City or Town | New Haven | |
Entity Address, State or Province | CT | |
Entity Address, Postal Zip Code | 06511 | |
City Area Code | 475 | |
Local Phone Number | 238-6837 | |
Title of 12(b) Security | Common Stock | |
Trading Symbol | BTAI | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 42,748,364 | |
Entity Central Index Key | 0001720893 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2024 | Dec. 31, 2023 |
Current assets | ||
Cash and cash equivalents | $ 40,387 | $ 65,221 |
Accounts receivable, net | 3 | 71 |
Inventory | 1,525 | 1,991 |
Prepaid expenses | 4,479 | 2,782 |
Other current assets | 1,398 | 2,078 |
Total current assets | 47,792 | 72,143 |
Property and equipment, net | 552 | 784 |
Operating lease right-of-use assets | 461 | 688 |
Other assets | 87 | 87 |
Total assets | 48,892 | 73,702 |
Current liabilities | ||
Accounts payable | 14,889 | 13,654 |
Accrued expenses | 10,193 | 12,424 |
Accrued interest | 736 | |
Total current liabilities | 25,557 | 27,267 |
Long-term portion of operating lease liabilities | 161 | 440 |
Derivative liabilities | 4,367 | 1,905 |
Long-term debt | 104,440 | 100,598 |
Total liabilities | 134,525 | 130,210 |
Commitments and contingencies (Note 16) | ||
Stockholders' (deficit) equity | ||
Preferred stock, $0.001 par value, 10,000 shares authorized; no shares issued and outstanding as of September 30, 2024 and December 31, 2023 | ||
Common stock, $0.001 par value, 100,000 shares authorized as of September 30, 2024 and December 31, 2023; 42,462 and 29,930 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively | 42 | 30 |
Additional paid-in-capital | 553,663 | 534,060 |
Accumulated deficit | (639,338) | (590,598) |
Total stockholders' (deficit) equity | (85,633) | (56,508) |
Total liabilities and stockholders' (deficit) equity | 48,892 | 73,702 |
Related Party | ||
Current liabilities | ||
Other current liabilities | 107 | 107 |
Nonrelated Party | ||
Current liabilities | ||
Other current liabilities | $ 368 | $ 346 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares shares in Thousands | Sep. 30, 2024 | Dec. 31, 2023 |
CONDENSED CONSOLIDATED BALANCE SHEETS | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 10,000 | 10,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 200,000 | 100,000 |
Common stock, shares issued (in shares) | 42,462 | 29,930 |
Common stock, shares outstanding (in shares) | 42,462 | 29,930 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2024 | Sep. 30, 2023 | Sep. 30, 2024 | Sep. 30, 2023 | |
Revenues | ||||
Product revenue, net | $ 214 | $ 341 | $ 1,900 | $ 1,004 |
Operating expenses | ||||
Cost of goods sold | 1,170 | 512 | 1,311 | 546 |
Research and development | 5,101 | 19,619 | 24,534 | 74,392 |
Selling, general and administrative | 7,683 | 24,344 | 30,398 | 73,810 |
Restructuring costs | 1,553 | 4,163 | 2,409 | 4,163 |
Total operating expenses | 15,507 | 48,638 | 58,652 | 152,911 |
Loss from operations | (15,293) | (48,297) | (56,752) | (151,907) |
Other expense (income) | ||||
Interest expense | 3,790 | 3,252 | 11,097 | 9,879 |
Interest income | (616) | (1,068) | (2,234) | (4,703) |
Other (income) expense, net | (4,817) | 5 | (16,875) | (286) |
Net loss | $ (13,650) | $ (50,486) | $ (48,740) | $ (156,797) |
Basic net loss per share attributable to common stockholders (in dollars per share) | $ (0.32) | $ (1.72) | $ (1.29) | $ (5.40) |
Diluted net loss per share attributable to common stockholders (in dollars per share) | $ (0.32) | $ (1.72) | $ (1.29) | $ (5.40) |
Weighted average shares outstanding - basic (in shares) | 42,390 | 29,268 | 37,853 | 29,026 |
Weighted average shares outstanding - diluted (in shares) | 42,390 | 29,268 | 37,853 | 29,026 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' (DEFICIT) EQUITY - USD ($) shares in Thousands, $ in Thousands | Common stock | Additional Paid in Capital 2024 Warrants | Additional Paid in Capital Warrants 2024, Pre Funded Warrants | Additional Paid in Capital | Accumulated Deficit | 2024 Warrants | Warrants 2024, Pre Funded Warrants | Total |
Beginning Balance at Dec. 31, 2022 | $ 28 | $ 488,292 | $ (411,545) | $ 76,775 | ||||
Beginning Balance (in shares) at Dec. 31, 2022 | 28,147 | |||||||
Issuance of common shares, net of offering costs | $ 1 | 23,917 | 23,918 | |||||
Issuance of common shares, net of offering costs (in shares) | 756 | |||||||
Stock-based compensation | 4,877 | 4,877 | ||||||
Exercise of stock options | 258 | 258 | ||||||
Exercise of stock options (in shares) | 173 | |||||||
Vesting of restricted stock units, net of employee tax obligations | (27) | (27) | ||||||
Vesting of restricted stock units, net of employee tax obligations (in shares) | 24 | |||||||
Net Income (Loss) | (52,796) | (52,796) | ||||||
Ending Balance at Mar. 31, 2023 | $ 29 | 517,317 | (464,341) | 53,005 | ||||
Ending Balance (in shares) at Mar. 31, 2023 | 29,100 | |||||||
Beginning Balance at Dec. 31, 2022 | $ 28 | 488,292 | (411,545) | 76,775 | ||||
Beginning Balance (in shares) at Dec. 31, 2022 | 28,147 | |||||||
Net Income (Loss) | (156,797) | |||||||
Ending Balance at Sep. 30, 2023 | $ 29 | 527,705 | (568,342) | (40,608) | ||||
Ending Balance (in shares) at Sep. 30, 2023 | 29,273 | |||||||
Beginning Balance at Dec. 31, 2022 | $ 28 | 488,292 | (411,545) | 76,775 | ||||
Beginning Balance (in shares) at Dec. 31, 2022 | 28,147 | |||||||
Ending Balance at Dec. 31, 2023 | $ 30 | 534,060 | (590,598) | $ (56,508) | ||||
Ending Balance (in shares) at Dec. 31, 2023 | 29,930 | 29,930 | ||||||
Beginning Balance at Mar. 31, 2023 | $ 29 | 517,317 | (464,341) | $ 53,005 | ||||
Beginning Balance (in shares) at Mar. 31, 2023 | 29,100 | |||||||
Stock-based compensation | 6,124 | 6,124 | ||||||
Exercise of stock options | 250 | 250 | ||||||
Exercise of stock options (in shares) | 136 | |||||||
Vesting of restricted stock units, net of employee tax obligations (in shares) | 31 | |||||||
Net Income (Loss) | (53,515) | (53,515) | ||||||
Ending Balance at Jun. 30, 2023 | $ 29 | 523,691 | (517,856) | 5,864 | ||||
Ending Balance (in shares) at Jun. 30, 2023 | 29,267 | |||||||
Stock-based compensation | 4,014 | 4,014 | ||||||
Exercise of stock options (in shares) | 6 | |||||||
Net Income (Loss) | (50,486) | (50,486) | ||||||
Ending Balance at Sep. 30, 2023 | $ 29 | 527,705 | (568,342) | (40,608) | ||||
Ending Balance (in shares) at Sep. 30, 2023 | 29,273 | |||||||
Beginning Balance at Dec. 31, 2023 | $ 30 | 534,060 | (590,598) | $ (56,508) | ||||
Beginning Balance (in shares) at Dec. 31, 2023 | 29,930 | 29,930 | ||||||
Issuance of common shares, net of offering costs | $ 4 | 3,705 | $ 3,709 | |||||
Issuance of common shares, net of offering costs (in shares) | 3,702 | |||||||
Stock-based compensation | 3,433 | 3,433 | ||||||
Issuance of stock purchase warrants | $ 224 | $ 3,570 | $ 224 | $ 3,570 | ||||
Net Income (Loss) | (26,791) | (26,791) | ||||||
Ending Balance at Mar. 31, 2024 | $ 34 | 544,992 | (617,389) | (72,363) | ||||
Ending Balance (in shares) at Mar. 31, 2024 | 33,632 | |||||||
Beginning Balance at Dec. 31, 2023 | $ 30 | 534,060 | (590,598) | $ (56,508) | ||||
Beginning Balance (in shares) at Dec. 31, 2023 | 29,930 | 29,930 | ||||||
Issuance of stock purchase warrants | $ 224 | |||||||
Net Income (Loss) | (48,740) | |||||||
Ending Balance at Sep. 30, 2024 | $ 42 | 553,663 | (639,338) | $ (85,633) | ||||
Ending Balance (in shares) at Sep. 30, 2024 | 42,462 | 42,462 | ||||||
Beginning Balance at Mar. 31, 2024 | $ 34 | 544,992 | (617,389) | $ (72,363) | ||||
Beginning Balance (in shares) at Mar. 31, 2024 | 33,632 | |||||||
Issuance of common shares, net of offering costs | $ 6 | 5,306 | 5,312 | |||||
Issuance of common shares, net of offering costs (in shares) | 6,699 | |||||||
Stock-based compensation | 1,057 | 1,057 | ||||||
Vesting of restricted stock units, net of employee tax obligations | (8) | (8) | ||||||
Vesting of restricted stock units, net of employee tax obligations (in shares) | 52 | |||||||
Net Income (Loss) | (8,299) | (8,299) | ||||||
Ending Balance at Jun. 30, 2024 | $ 40 | 551,347 | (625,688) | (74,301) | ||||
Ending Balance (in shares) at Jun. 30, 2024 | 40,383 | |||||||
Issuance of common shares, net of offering costs | $ 2 | 451 | 453 | |||||
Issuance of common shares, net of offering costs (in shares) | 2,066 | |||||||
Stock-based compensation | 1,865 | 1,865 | ||||||
Vesting of restricted stock units, net of employee tax obligations (in shares) | 13 | |||||||
Net Income (Loss) | (13,650) | (13,650) | ||||||
Ending Balance at Sep. 30, 2024 | $ 42 | $ 553,663 | $ (639,338) | $ (85,633) | ||||
Ending Balance (in shares) at Sep. 30, 2024 | 42,462 | 42,462 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2024 | Sep. 30, 2023 | Sep. 30, 2024 | Sep. 30, 2023 | Dec. 31, 2023 | |
OPERATING CASH FLOW ACTIVITIES: | |||||
Net loss | $ (48,740) | $ (156,797) | |||
Reconciliation of net loss to net cash used in operating activities | |||||
Depreciation | $ 77 | $ 79 | 232 | 240 | |
Accretion of debt discount and amortization of financing costs | 106 | 377 | 245 | 1,066 | |
Change in fair value of derivative liabilities | (16,884) | (316) | |||
Stock-based compensation expense | 6,355 | 15,015 | |||
Payable-in-kind interest on Credit Agreement | 3,821 | 1,215 | |||
Loss on disposal of equipment | 2 | ||||
Operating lease right-of-use assets | 227 | 214 | |||
Changes in operating assets and liabilities | |||||
Accounts receivable | 68 | (487) | |||
Inventory | 466 | (33) | |||
Prepaid expenses, other current assets and other assets | (1,017) | 1,724 | |||
Accounts payable, accrued expenses, due to related parties, and other current liabilities | (997) | 9,098 | |||
Accrued interest | (736) | 1,153 | |||
Operating lease liabilities | (258) | (237) | |||
Net cash used in operating activities | (57,218) | (128,143) | |||
INVESTING CASH FLOW ACTIVITIES: | |||||
Purchases of equipment and leasehold improvements | (20) | ||||
Net cash from investing activities | (20) | ||||
FINANCING CASH FLOW ACTIVITIES: | |||||
Proceeds from issuance of common stock and warrants | 32,687 | 24,657 | |||
Offering costs for common stock and warrants issuance | (295) | (739) | |||
Payment of employee tax obligations related to vesting restricted stock units | (8) | (27) | |||
Exercise of stock options | 508 | ||||
Net cash provided by financing activities | 32,384 | 24,399 | |||
Net decrease in cash and cash equivalents | (24,834) | (103,764) | |||
Cash and cash equivalents, beginning of the period | 65,221 | 193,725 | $ 193,725 | ||
Cash and cash equivalents, end of the period | $ 40,387 | $ 89,961 | 40,387 | $ 89,961 | $ 65,221 |
Supplemental cash flow information: | |||||
Issuance of stock purchase warrants | $ 224 |
Nature of the Business
Nature of the Business | 9 Months Ended |
Sep. 30, 2024 | |
Nature of the Business | |
Nature of the Business | 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 condensed 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 TM TM The Company’s most advanced neuroscience clinical development program is BXCL501. In indications other than those approved by the FDA as IGALMI TM The Company’s most 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. |
Basis of Presentation
Basis of Presentation | 9 Months Ended |
Sep. 30, 2024 | |
Basis of Presentation | |
Basis of Presentation | Note 2. Basis of Presentation The accompanying unaudited interim condensed consolidated financial statements do not include all the information and notes required by Generally Accepted Accounting Principles (“GAAP”) in the U.S. The accompanying year-end balance sheet was derived from audited financial statements but does not include all disclosures required by U.S. GAAP. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of September 30, 2024, the results of its operations for the three and nine months ended September 30, 2024 and 2023 and its cash flows for the nine months ended September 30, 2024 and 2023. The results for the three and nine months ended September 30, 2024 are not necessarily indicative of results to be expected for the year ending December 31, 2024, any other interim periods or any future year or period. The accompanying unaudited interim condensed consolidated financial statements of the Company should be read in conjunction with the audited financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 filed with the Securities and Exchange Commission on March 22, 2024. The accompanying condensed 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 September 30, 2024, the Company had cash and cash equivalents of $40,387 and an accumulated deficit of $639,338. 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 $13,650 and $50,486 for the three months ended September 30, 2024 and 2023, respectively, and $48,740 and $156,797 for the nine months ended September 30, 2024 and 2023, respectively, and had net cash used in operating activities of $57,218 and $128,143 for the nine months ended September, 2024 and 2023, respectively. Under ASC Topic 205-40, Presentation of Financial Statements - Going Concern, 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 payments under its Credit Agreement (as defined in Note 9, Debt and Credit Facilities This going concern evaluation takes into consideration the potential mitigating effect of management’s Reprioritization (as defined in Note 4, Restructuring The accompanying condensed 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 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 actions, 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 Credit Agreement; ● 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, refinance or restructure its existing Credit Agreement or if it is unable to procure collaboration arrangements to advance its programs, the Company would evaluate alternative strategies or initiatives regarding the Company’s future. These options are not limited to but could include plans 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. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2024 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 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 condensed consolidated financial statements and notes thereto. Estimates are used in the following areas, among others: revenue recognition, derivative liabilities, stock-based compensation expense, accrued expenses and income taxes. 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 September 30, 2024 and December 31, 2023, 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 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 certain hospitals, and GPOs. All trade accounts receivables are due from the distributor that fulfills orders on behalf of the Company and other customers. 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 Condensed 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 are recorded within Cost of goods sold in the Condensed 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. 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 Condensed 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 Other (income) expense, net in the Condensed 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 Condensed 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 As discussed in Note 9, Debt and Credit Facilities Derivative Assets and Liabilities Derivative assets and liabilities are recorded on the Company`s Condensed 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 Condensed 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 connection with a registered direct offering completed in March 2024, the Company issued accompanying warrants to purchase 8,620 shares of its common stock that are classified as derivative liabilities, and were measured at fair value upon issuance, with subsequent changes in fair value reported in the Condensed Consolidated Statement of Operations each reporting period. 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 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 condensed 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 BTI sells IGALMI TM 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 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 Condensed Consolidated Statements of Operations. Fees paid to the distributor for warehouse operations are classified as Cost of goods sold on BTI’s Condensed Consolidated Statements of Operations. 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, 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 Condensed 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 value of the OnkosXcel RSUs are based on the OnkosXcel valuation on the grant date. The estimated fair value of stock options 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 condensed 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 Condensed Consolidated Statements of Operations and are expensed as incurred since recoverability of such expenditures is uncertain. 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, as well as considering counterparty credit risk in its assessment of fair value. 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. 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 condensed 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 condensed 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 condensed consolidated financial statements. |
Restructuring
Restructuring | 9 Months Ended |
Sep. 30, 2024 | |
Restructuring | |
Restructuring | 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 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 was substantially complete as of December 31, 2023, and the remaining costs were paid during the first quarter of 2024. On May 8, 2024 the Company took additional actions as part of its continued efforts to preserve cash and prioritize investment in its core clinical programs. As part of these actions, the Company initiated a further reduction of approximately 15% of the Company’s then current workforce. The Company notified impacted employees on May 8, 2024 and recorded total restructuring costs of $856 for the three months ended June 30, 2024. These costs consisted of severance and benefit costs, all of which were paid during the three month period ended June 30, 2024. On September 17, 2024, the Company approved a plan for an additional reduction in its workforce of 15 employees, or approximately 28% of the Company’s headcount (the “Clinical Prioritization”), in order to extend its cash runway and prioritize investment on the clinical development of its lead neuroscience asset, BXCL501. The Company estimates that it will incur aggregate charges in connection with the Clinical Prioritization of approximately $1,553 which relate primarily to severance and benefits costs. Accordingly, the Company recorded a restructuring charge of $1,553 in the third quarter 2024, which is included in Accrued Expenses on the Condensed Consolidated Balance at September 30, 2024. The Company completed the Clinical Prioritization in October 2024, and expects to pay the related costs during the fourth quarter of 2024 and the first quarter of 2025. |
Inventory
Inventory | 9 Months Ended |
Sep. 30, 2024 | |
Inventory | |
Inventory | Note 5. Inventory Inventory consists of the following: September 30, December 31, 2024 2023 Raw materials $ 833 $ 935 Work-in-process — 651 Finished goods 692 405 Total inventory $ 1,525 $ 1,991 The Company recorded inventory write-downs of $1,157 and $1,202 for the three and nine months ended September 30, 2024, respectively. The Company recorded inventory write-downs of $495 for the three and nine months ended September 30, 2023. |
Property and Equipment, Net
Property and Equipment, Net | 9 Months Ended |
Sep. 30, 2024 | |
Property and Equipment, Net | |
Property and Equipment, Net | Note 6. Property and Equipment, Net Property and equipment, net consists of the following: September 30, December 31, 2024 2023 Computers and equipment $ 202 $ 202 Furniture 575 575 Leasehold improvements 1,200 1,200 Total property and equipment $ 1,977 $ 1,977 Accumulated depreciation (1,425) (1,193) Total property and equipment, net $ 552 $ 784 Depreciation expense was $77 and $79 for the three months ended September 30, 2024 and 2023, respectively, and $232 and $240 for the nine months ended September 30, 2024 and 2023, respectively. |
Accrued Expenses
Accrued Expenses | 9 Months Ended |
Sep. 30, 2024 | |
Accrued Expenses | |
Accrued Expenses | Note 7. Accrued Expenses Accrued expenses consist of the following: September 30, 2024 December 31, 2023 Accrued research and development expenses $ 2,763 $ 6,406 Accrued compensation and benefits 39 163 Accrued professional fees 5,520 5,562 Accrued taxes 71 116 Other accrued expenses 247 177 Accrued restructuring costs 1,553 — Total accrued expenses $ 10,193 $ 12,424 |
Transactions with BioXcel LLC
Transactions with BioXcel LLC | 9 Months Ended |
Sep. 30, 2024 | |
Transactions with BioXcel LLC | |
Transactions with BioXcel LLC | 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 Service charges recorded under the Services Agreement for the three and nine months ended September 30, 2024 and 2023, respectively were as follows: Three months ended September 30, Nine months ended September 30, 2024 2023 2024 2023 Research and development $ 230 $ 321 $ 708 $ 950 Selling, general and administrative 120 103 258 189 Total $ 350 $ 424 $ 966 $ 1,139 As of September 30, 2024, there were no outstanding service charges related to the Services Agreement included in Due to related parties in the Company’s Condensed Consolidated Balance Sheets. |
Debt and Credit Facilities
Debt and Credit Facilities | 9 Months Ended |
Sep. 30, 2024 | |
Debt and Credit Facilities | |
Debt and Credit Facilities | Note 9. Debt and Credit Facilities Debt, net of unamortized discounts and financing costs, consists of the following: September 30, 2024 December 31, 2023 Credit Agreement and Guaranty $ 102,319 $ 102,319 Payable-in-kind ("PIK") interest 4,182 361 Total long-term debt liability $ 106,501 $ 102,680 Unamortized debt premiums, discounts and issuance costs (2,061) (2,082) Total long-term debt $ 104,440 $ 100,598 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 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 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 September 30, 2024, $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 September 30, 2024 was approximately 14.0%. 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) 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, 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. Waiver and Third and Fourth Amendments to Credit Agreement and Guaranty 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 March 20, 2024 (the “Effective Date”), the Company entered into the Fourth Amendment to the Credit Agreement and Guaranty (the “Fourth Amendment”), which amended the Credit Agreement. Pursuant to the Fourth Amendment, the Lenders agreed to waive the covenant that the Company shall 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 the Annual Report on Form 10-K for the fiscal year ended December 31, 2023 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 the Company has 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. On March 27, 2024, the Company received Common Stock Financing Activities of gross proceeds from the issuance of the Company’s common stock. As of September 30, 2024, the Company had satisfied gross proceeds requirement. As a result, at September 30, 2024, the Minimum Liquidity Amount increased to 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 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 1.75x 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” 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 March 31, 2024. 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. In connection with the closing of the Fourth Amendment discussed below, 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. Maturities of debt, excluding the impacts of any mandatory payments pursuant to the Revenue Covenant or to meet minimum royalty levels, are expected to be as follows: September 30, 2024 2024 $ — 2025 $ — 2026 $ — 2027 $ 106,501 2028 $ — Thereafter $ — Interest expense was as follows: Three months ended Nine months ended September 30, September 30, 2024 2023 2024 2023 Interest expense $ 3,684 $ 2,875 $ 10,852 $ 8,813 Accretion of debt discount and amortization of financing costs 106 377 245 1,066 Total interest expense $ 3,790 $ 3,252 $ 11,097 $ 9,879 |
Derivative Financial Instrument
Derivative Financial Instruments | 9 Months Ended |
Sep. 30, 2024 | |
Derivative Financial Instruments | |
Derivative Financial Instruments | 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 Condensed Consolidated Balance Sheets. The respective derivative liabilities were 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 Condensed Consolidated Statements of Operations. With respect to the Securities Purchase Agreement discussed in Note 11, Common Stock Financing Activities Fair value measurements . The Company recorded a fair value adjustment resulting in an unrealized gain of |
Common Stock Financing Activiti
Common Stock Financing Activities | 9 Months Ended |
Sep. 30, 2024 | |
Common Stock Financing Activities | |
Common Stock Financing Activities | 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 . For the year ended December 31, 2023, the Company sold 1,408 shares of its common stock for a gross amount of $27,032 , incurred issuance costs of $811 , and received net proceeds of $26,221 . For the three months ended September 30, 2024, the Company sold 361 shares of its common stock for a gross amount of $467 , incurred issuance costs of $14 , and received net proceeds of $453 . For the nine months ended September 30, 2024, the Company sold 3,847 shares of its common stock for a gross amount of $7,682 , incurred issuance costs of $231 , and received net proceeds of $7,451 . On March 25, 2024, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with the purchasers named therein (collectively, the “Purchasers”). Pursuant to the Purchase Agreement, the Company agreed to issue and sell to the Purchasers in a registered direct offering (the “Offering”) under an effective shelf registration statement on Form S-3 (File No. 333-275261) and a related prospectus supplement filed with the Securities and Exchange Commission on March 25, 2024 (the “Prospectus Supplement”) an aggregate of 3,055 shares (the “Shares”) of common stock, par value $0.001 per share, and accompanying warrants (the “Accompanying Warrants”) to purchase up to 3,055 shares of common stock at a combined offering price of $2.901 per Share and Accompanying Warrant and pre-funded warrants (the “Pre-Funded Warrants”) to purchase up to 5,565 shares of common stock and Accompanying Warrants to purchase up to 5,565 shares of common stock, at a combined offering price of $2.900 per share underlying each Pre-Funded Warrant and Accompanying Warrant, which equals the offering price per Share and Accompanying Warrant less the $0.001 exercise price per share of the Pre-Funded Warrants. The Pre-Funded Warrants and Accompanying Warrants are not listed on the Nasdaq Capital Market or any other securities exchange or trading system and the Company does not intend to list them. On March 27, 2024, The Company received $25,000 of gross proceeds from the Offering. The Company intends to use the proceeds from the Offering, together with its existing cash and cash equivalents, to fund planned clinical trials of BXCL501, commercialization activities for IGALMI™ and for working capital and other general corporate purposes. The Pre-Funded Warrants have an exercise price per share of common stock equal to $0.001 per share. The exercise price and the number of shares of common stock issuable upon exercise of the Pre-Funded Warrants are subject to appropriate adjustments in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the common stock. The Pre-Funded Warrants are exercisable at any time after the date of issuance. The Pre-Funded Warrants meet the equity classification criteria and are therefore classified as equity. For the three months ended September 30, 2024, 1,705 Pre-Funded Warrants were exercised and the same number of shares of common stock were issued in exchange for $2 of proceeds received. For the nine months ended September 30, 2024, 5,565 Pre-Funded Warrants were exercised and the same number of shares of common stock were issued in exchange for $6 of proceeds received. The Accompanying Warrants have an exercise price per share of common stock equal to $3.20 per share. The exercise price and the number of shares of common stock issuable upon exercise of the Accompanying Warrants are subject to appropriate adjustments in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the common stock. The Accompanying Warrants will be exercisable at any time after the date of issuance and will expire on the fifth anniversary of the date of issuance. The Accompanying Warrants do not meet certain scope exceptions under U.S. GAAP, primarily because they did not meet the requirements to be indexed to equity and equity classified, and the instruments meet the definition of a derivative instrument. Therefore, these instruments are recorded as Derivative liabilities in the Condensed Consolidated Balance Sheet as of September 30, 2024. |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2024 | |
Stock-Based Compensation | |
Stock-Based Compensation | 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. 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 1,197 shares and 1,126 shares on January 1, 2024 and 2023, respectively. Stock options 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. As of September 30, 2024, there were 369 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, 2024 185 Granted 25 Cancelled (6) Vested (69) Outstanding as of September 30, 2024 135 During the three months ended September 30, 2024, the Company granted 20 time-based BTI RSUs which fully vest on the one 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, 2024 527 Granted 1,388 Cancelled (125) Outstanding as of September 30, 2024 1,790 In July 2024, the Company granted 1,388 Performance Units to employees. The Performance Units vest on the one-year anniversary of the grant date, provided certain performance criteria are met. The weighted average value per share of Performance Units granted in 2024 was $1.20. None of the Performance Units had vested as of September 30, 2024. Unrecognized stock-based compensation expense related to these Performance Units expected to vest was zero as of September 30, 2024 since it is uncertain whether any performance criteria will be met. 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 per share of Performance Units granted in 2023 and cancelled during 2023 and 2024 was $2.43. None of the Performance Units had vested as of September 30, 2024. 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, 2024 1,240 $ 5,626 Granted 15 $ 10,176 Cancelled (79) $ 5,506 Forfeited — $ — Outstanding as of September 30, 2024 1,176 Vested units as of September 30, 2024 906 $ 5,557 During 2024, OnkosXcel Employee Holdings, LLC, a management holding company used to facilitate the grant of equity interests to service providers of OnkosXcel granted 15 individual (not in thousands) time-based PSUs related to OnkosXcel to certain employees of the Company in consideration for services provided to OnkosXcel. The PSUs represent indirect equity interests in OnkosXcel. These PSUs vest ratably over 48 months. During 2023, OnkosXcel Employee Holdings, LLC, 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. The PSUs represent indirect equity interests in OnkosXcel. All PSUs, other than those granted to certain 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 PSUs granted during 2024 were estimated at the date of grant using a Black-Scholes option pricing model and assumptions below. 2024 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 these awards was $496 and $3,203 at September 30, 2024 and 2023, respectively. OnkosXcel restricted stock units The table below summarizes activity relating to the OnkosXcel RSUs. Number of units Outstanding as of January 1, 2024 225 Granted — Vested (35) Cancelled (8) Outstanding as of September 30, 2024 182 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 $261 and $2,151 as of September 30, 2024 and 2023, respectively. BTI Stock options A summary of the Company’s stock option activity for the nine months ended September 30, 2024 is presented below. Number of Weighted average shares price per share Outstanding as of January 1, 2024 4,976 $ 18.52 Granted 632 $ 1.25 Forfeited (141) $ 17.77 Cancelled (238) $ 21.48 Exercised — $ — Outstanding as of September 30, 2024 5,229 $ 16.32 Options vested and exercisable as of September 30, 2024 3,895 $ 18.16 As of September 30, 2024, the intrinsic value of options outstanding was $248. 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. No stock options were exercised for the three and nine months ended September 30, 2024. The total intrinsic value of stock options exercised for the nine months ended September 30, 2023 was $5,928. No stock options were exercised for the three months ended September 30, 2023. As of September 30, 2024 and 2023, the total intrinsic value of stock options exercisable was $248 and $2,628, respectively. The weighted average grant date fair value per share of options vested as of September 30, 2024 was $13.59. The weighted average remaining contractual life is 5.1 years for options exercisable as of September 30, 2024. The weighted average remaining contractual life was 6.0 years for options outstanding as of September 30, 2024. Unrecognized compensation expense related to unvested BTI stock option awards as of September 30, 2024 was $3,651 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 1.4 years. Stock-Based Compensation The fair value of BTI stock options granted during the nine months ended September 30, 2024 and 2023 was estimated using the Black-Scholes pricing model with the following assumptions: Nine months ended Nine months ended September 30, 2024 September 30, 2023 Expected term 5.5 years - 6.1 years 5.5 years - 6.1 years Expected stock price volatility 108.0 % - 112.5 % 96.6 % - 109.2 % Risk-free rate of interest 4.0 % - 4.5 % 3.5 % - 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 life 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 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 RSUs and PSUs, of $1,865 and $4,014 for the three months ended September 30, 2024 and 2023, respectively, and $6,355 and $15,015 for the nine months ended September 30, 2024 and 2023, respectively, which were comprised as follows: Three months ended September 30, Nine months ended September 30, 2024 2023 2024 2023 Research and development $ 884 $ 1,645 $ 2,446 $ 4,840 Selling, general and administrative 981 2,369 3,909 10,175 Total $ 1,865 $ 4,014 $ 6,355 $ 15,015 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 were initially available to be issued pursuant to rights granted under the ESPP was 100 shares of common stock. In addition, the number of shares available for issuance under the ESPP increases 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 299 shares and 281 shares on January 1, 2024 and 2023, respectively. To date, no shares have been sold under the ESPP. There were 1,204 shares available for issuance as of September 30, 2024. |
Leases
Leases | 9 Months Ended |
Sep. 30, 2024 | |
Leases | |
Leases | 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. The future minimum annual lease payments under operating leases, as of September 30, 2024, are as follows: Year ending December 31, Amount Remainder of 2024 $ 95 2025 391 2026 65 2027 — 2028 — Thereafter — Total lease payments $ 551 Imputed interest (22) Total lease liability $ 529 Less current portion of lease liability (368) Long-term portion of operating lease liability $ 161 The current portion of the Company’s operating lease liability of $368 as of September 30, 2024, is included in Other current liabilities Lease expense was $101 and $98 for the three months ended September 30, 2024 and 2023, respectively, and $299 and $294 for the nine months ended September 30, 2024 and 2023, respectively. Lease renewal options are not included in the ROU asset or lease liability. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2024 | |
Fair Value Measurements | |
Fair Value Measurements | Note 14. 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 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 September 30, 2024 and December 31, 2023, the Company had $36,672 and $64,860, 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 three and nine months ended September 30, 2024 and the year ended December 31, 2023. Derivative liabilities measured at fair value on a recurring basis are summarized below. Nine months ended September 30, 2024 Fair Value Level 1 Level 2 Level 3 Total Derivative liability - Equity Investment Right $ 1,311 $ — $ — $ 1,311 $ 1,311 Derivative liability - OnkosXcel Warrants 121 — — 121 121 Derivative liability - BTI Warrants 2,935 2,935 — 2,935 Total derivative liabilities $ 4,367 $ — $ 2,935 $ 1,432 $ 4,367 Derivative liabilities are comprised of the OnkosXcel Warrants, Equity Investment Right held by the Lenders, and BTI Warrants. The fair value of the derivative liabilities was determined using Monte Carlo simulation models for the Equity Investment Right, Binomial Option Pricing and Distribution models for the OnkosXcel Warrants, and using a Black Scholes model for the BTI Warrants. The following table presents changes in Level 3 liabilities measured at fair value for the nine months ended September 30, 2024. Both observable and unobservable inputs were used to determine the fair value of positions that the Company has classified within the Level 3 category. Nine months ended September 30, 2024 2023 Derivative liabilities, Balance - January 1 $ 1,905 $ 2,343 Change in fair value (473) (316) Derivative liabilities, Balance - September 30 $ 1,432 $ 2,027 The change in fair value of the derivative liabilities was reported in the Condensed Consolidated Statements of Operations as Other (income) expense, net, for the three and nine months ended September 30, 2024. Inputs used to calculate the estimated fair value of the Equity Investment Right at September 30, 2024 were as follows: Equity Investment Right Strike price relative to volume weighted 30-day average 110.0 % Volatility (annual) 112.3 % Probability of exercise 91.0 % Time period 1.4 years Estimated premium to 30-day average 25.0 % Discount rate 3.9 % 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 110% based on the historical volatility of the Company’s stock), and the timing and probability of the relevant capital transactions occurring. The estimated fair value of the Credit Agreement as of September 30, 2024 and December 31, 2023 was $93,533 and $88,210, respectively. 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 2024 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 $224 was recorded as a component of stockholders’ equity in Additional-paid-in-capital in the Condensed 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 2. The inputs used were a strike price of $3.0723, the Company’s stock price of $2.78, volatility of 112.2%, term of 5.1 years and risk-free rate of 4.25%. 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 Condensed 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 2. 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 Condensed 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 2. 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 The fair value of the Accompanying Warrants at issuance on March 25, 2024 was determined using a Black-Scholes pricing model and the fair value of $19,347 was recorded as a derivative liability with the offset recorded as a component of stockholders’ equity in Additional-paid-in-capital in the Condensed Consolidated Balance Sheets. This fair value measurement is classified as Level 2. The valuation inputs used were a strike price of $3.20, the Company’s stock price of $2.81, volatility of 112.2%, a term of 5 years and a risk-free rate of 4.2% . We remeasured the fair value at September 30, 2024 of |
Net Loss Per Share
Net Loss Per Share | 9 Months Ended |
Sep. 30, 2024 | |
Net Loss Per Share | |
Net Loss Per Share | Note 15. Net Loss Per Share Basic and diluted net loss per share are as follows Three months ended Nine months ended September 30, September 30, 2024 2023 2024 2023 Net loss (numerator) $ (13,650) $ (50,486) $ (48,740) $ (156,797) Weighted average shares (denominator) 42,390 29,268 37,853 29,026 Basic and diluted net loss per share $ (0.32) $ (1.72) $ (1.29) $ (5.40) The 5,565 Pre-Funded warrants to purchase common shares issued in connection with the registered direct offering completed in March 2024 are included in the calculation of basic and diluted net loss per share as the exercise price of $0.001 per share is non-substantive and virtually assured. As of September 30, 2024, no Pre-Funded Warrants remain unexercised. Potentially dilutive securities outstanding consists of stock options, RSUs, performance units and BTI Warrants. The Company had common stock equivalents outstanding as of September 30, 2024 and 2023 of 16,222 and 5,688 shares, respectively. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2024 | |
Commitments and Contingencies | |
Commitments and Contingencies | Note 16. 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. On July 11, 2024, the Court dismissed the amended complaint without prejudice and, on August 1, 2024, co-Lead Plaintiffs filed a second amended complaint. The second 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. The Company moved to dismiss the second amended complaint on September 6, 2024. The Court has not yet ruled on the motion. 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 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 consolidated action is currently stayed. 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, of which $5,000 was originally due in year ended 2024. On July 11, 2024, the Company entered into an amendment to the commercial supply agreement (the “Product Supply Agreement Amendment”) that reduces the specified minimum annual payment over the next three years starting in the year ended 2024 and, thereafter, for a specified interval, provides for minimum annual payments to the extent that the Company receives approval of a supplemental new drug application (sNDA) or a new drug application (NDA) from the FDA for enumerated indications. The Company’s renegotiated agreement reduces the minimum commitment for 2024 to $1,000 and thereafter for the term of the agreement in annual amounts ranging from $2,000 to $5,000 subject, in certain instances, to the extent that the Company receives approval of an sNDA or NDA from the FDA for enumerated indications. In accordance with the Product Supply Agreement Amendment, the minimum commitments were reduced to $1,000 , $2,000 and $2,000 in the years 2024, 2025, and 2026. In addition, the Company agreed to make a reconciliation payment of $1,200 in the third quarter of 2024 for full settlement for amounts due prior to the July 11, 2024 amendment. |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2024 | Jun. 30, 2024 | Mar. 31, 2024 | Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2024 | Sep. 30, 2023 | |
Pay vs Performance Disclosure | ||||||||
Net Income (Loss) | $ (13,650) | $ (8,299) | $ (26,791) | $ (50,486) | $ (53,515) | $ (52,796) | $ (48,740) | $ (156,797) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Sep. 30, 2024 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2024 | |
Summary of Significant Accounting Policies | |
Use of Estimates | 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 condensed consolidated financial statements and notes thereto. Estimates are used in the following areas, among others: revenue recognition, derivative liabilities, stock-based compensation expense, accrued expenses and income taxes. 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 | 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 September 30, 2024 and December 31, 2023, 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, Net Accounts receivable arise from sales of IGALMI TM |
Concentrations of Credit Risk | 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 certain hospitals, and GPOs. All trade accounts receivables are due from the distributor that fulfills orders on behalf of the Company and other customers. |
Inventory | 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 Condensed 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 are recorded within Cost of goods sold in the Condensed 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. |
Deferred Initial Public Offering Costs | 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 Condensed 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 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 Other (income) expense, net in the Condensed 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 | 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 Condensed 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 | 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 As discussed in Note 9, Debt and Credit Facilities |
Derivative Assets and Liabilities | Derivative Assets and Liabilities Derivative assets and liabilities are recorded on the Company`s Condensed 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 Condensed 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 connection with a registered direct offering completed in March 2024, the Company issued accompanying warrants to purchase 8,620 shares of its common stock that are classified as derivative liabilities, and were measured at fair value upon issuance, with subsequent changes in fair value reported in the Condensed Consolidated Statement of Operations each reporting period. 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 | 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 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 condensed 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 BTI sells IGALMI TM 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 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 Condensed Consolidated Statements of Operations. Fees paid to the distributor for warehouse operations are classified as Cost of goods sold on BTI’s Condensed Consolidated Statements of Operations. |
Cost of Goods Sold | 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, as well as costs related to warehouse operations paid to distributors. |
Stock-Based Compensation | 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 Condensed 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 value of the OnkosXcel RSUs are based on the OnkosXcel valuation on the grant date. The estimated fair value of stock options 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 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 condensed 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 | Patent Costs Costs related to filing and pursuing patent applications are recorded in Selling, general and administrative expenses in the Condensed Consolidated Statements of Operations and are expensed as incurred since recoverability of such expenditures is uncertain. |
Fair Value of Financial Instruments | 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, as well as considering counterparty credit risk in its assessment of fair value. |
Earnings (Loss) Per Share | 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. |
Segment Information | 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 | 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 condensed 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 condensed 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 condensed consolidated financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2024 | |
Summary of Significant Accounting Policies | |
Schedule of Property Plant and Equipment useful lives | Equipment 3-5 years Furniture 7 years Leasehold improvements Lesser of life of improvement or lease term |
Inventory (Tables)
Inventory (Tables) | 9 Months Ended |
Sep. 30, 2024 | |
Inventory | |
Schedule of inventory | September 30, December 31, 2024 2023 Raw materials $ 833 $ 935 Work-in-process — 651 Finished goods 692 405 Total inventory $ 1,525 $ 1,991 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 9 Months Ended |
Sep. 30, 2024 | |
Property and Equipment, Net | |
Schedule of Property and Equipment, net | September 30, December 31, 2024 2023 Computers and equipment $ 202 $ 202 Furniture 575 575 Leasehold improvements 1,200 1,200 Total property and equipment $ 1,977 $ 1,977 Accumulated depreciation (1,425) (1,193) Total property and equipment, net $ 552 $ 784 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 9 Months Ended |
Sep. 30, 2024 | |
Accrued Expenses | |
Schedule of accrued expenses | September 30, 2024 December 31, 2023 Accrued research and development expenses $ 2,763 $ 6,406 Accrued compensation and benefits 39 163 Accrued professional fees 5,520 5,562 Accrued taxes 71 116 Other accrued expenses 247 177 Accrued restructuring costs 1,553 — Total accrued expenses $ 10,193 $ 12,424 |
Transactions with BioXcel LLC (
Transactions with BioXcel LLC (Tables) | 9 Months Ended |
Sep. 30, 2024 | |
Transactions with BioXcel LLC | |
Schedule of service charges | Three months ended September 30, Nine months ended September 30, 2024 2023 2024 2023 Research and development $ 230 $ 321 $ 708 $ 950 Selling, general and administrative 120 103 258 189 Total $ 350 $ 424 $ 966 $ 1,139 |
Debt and Credit Facilities (Tab
Debt and Credit Facilities (Tables) | 9 Months Ended |
Sep. 30, 2024 | |
Debt and Credit Facilities | |
Schedule of debt | September 30, 2024 December 31, 2023 Credit Agreement and Guaranty $ 102,319 $ 102,319 Payable-in-kind ("PIK") interest 4,182 361 Total long-term debt liability $ 106,501 $ 102,680 Unamortized debt premiums, discounts and issuance costs (2,061) (2,082) Total long-term debt $ 104,440 $ 100,598 |
Schedule of maturities on long-term debt | September 30, 2024 2024 $ — 2025 $ — 2026 $ — 2027 $ 106,501 2028 $ — Thereafter $ — |
Schedule of long-term debt interest expense | Three months ended Nine months ended September 30, September 30, 2024 2023 2024 2023 Interest expense $ 3,684 $ 2,875 $ 10,852 $ 8,813 Accretion of debt discount and amortization of financing costs 106 377 245 1,066 Total interest expense $ 3,790 $ 3,252 $ 11,097 $ 9,879 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2024 | |
Stock-Based Compensation | |
Schedule of stock option activity | Number of Weighted average shares price per share Outstanding as of January 1, 2024 4,976 $ 18.52 Granted 632 $ 1.25 Forfeited (141) $ 17.77 Cancelled (238) $ 21.48 Exercised — $ — Outstanding as of September 30, 2024 5,229 $ 16.32 Options vested and exercisable as of September 30, 2024 3,895 $ 18.16 |
Schedule of stock-based compensation charges | Three months ended September 30, Nine months ended September 30, 2024 2023 2024 2023 Research and development $ 884 $ 1,645 $ 2,446 $ 4,840 Selling, general and administrative 981 2,369 3,909 10,175 Total $ 1,865 $ 4,014 $ 6,355 $ 15,015 |
BTI RSU | |
Stock-Based Compensation | |
Schedule of activity relating to RSUs | Number of shares Outstanding as of January 1, 2024 185 Granted 25 Cancelled (6) Vested (69) Outstanding as of September 30, 2024 135 |
BTI PSU | |
Stock-Based Compensation | |
Schedule of activity relating to PSUs | Number of shares Outstanding as of January 1, 2024 527 Granted 1,388 Cancelled (125) Outstanding as of September 30, 2024 1,790 |
OnkosXcel PSU | |
Stock-Based Compensation | |
Schedule of activity relating to PSUs | Weighted average Number of price per unit units (in whole dollars) Outstanding as of January 1, 2024 1,240 $ 5,626 Granted 15 $ 10,176 Cancelled (79) $ 5,506 Forfeited — $ — Outstanding as of September 30, 2024 1,176 Vested units as of September 30, 2024 906 $ 5,557 |
Schedule of Valuation Assumptions | 2024 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 |
OnkosXcel RSUs | |
Stock-Based Compensation | |
Schedule of activity relating to RSUs | Number of units Outstanding as of January 1, 2024 225 Granted — Vested (35) Cancelled (8) Outstanding as of September 30, 2024 182 |
Employee Stock Option | |
Stock-Based Compensation | |
Schedule of Valuation Assumptions | Nine months ended Nine months ended September 30, 2024 September 30, 2023 Expected term 5.5 years - 6.1 years 5.5 years - 6.1 years Expected stock price volatility 108.0 % - 112.5 % 96.6 % - 109.2 % Risk-free rate of interest 4.0 % - 4.5 % 3.5 % - 4.4 % Expected dividend yield 0.0 % - 0.0 % 0.0 % - 0.0 % |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2024 | |
Leases | |
Summary of maturities of the operating lease liability | Year ending December 31, Amount Remainder of 2024 $ 95 2025 391 2026 65 2027 — 2028 — Thereafter — Total lease payments $ 551 Imputed interest (22) Total lease liability $ 529 Less current portion of lease liability (368) Long-term portion of operating lease liability $ 161 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2024 | |
Fair Value Measurements | |
Schedule of fair value on a recurring basis | Nine months ended September 30, 2024 Fair Value Level 1 Level 2 Level 3 Total Derivative liability - Equity Investment Right $ 1,311 $ — $ — $ 1,311 $ 1,311 Derivative liability - OnkosXcel Warrants 121 — — 121 121 Derivative liability - BTI Warrants 2,935 2,935 — 2,935 Total derivative liabilities $ 4,367 $ — $ 2,935 $ 1,432 $ 4,367 |
Schedule of changes in Level 2 and Level 3 liabilities | Nine months ended September 30, 2024 2023 Derivative liabilities, Balance - January 1 $ 1,905 $ 2,343 Change in fair value (473) (316) Derivative liabilities, Balance - September 30 $ 1,432 $ 2,027 |
Schedule of fair value unobservable inputs | Equity Investment Right Strike price relative to volume weighted 30-day average 110.0 % Volatility (annual) 112.3 % Probability of exercise 91.0 % Time period 1.4 years Estimated premium to 30-day average 25.0 % Discount rate 3.9 % |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2024 | |
Net Loss Per Share | |
Schedule of net loss per share | Three months ended Nine months ended September 30, September 30, 2024 2023 2024 2023 Net loss (numerator) $ (13,650) $ (50,486) $ (48,740) $ (156,797) Weighted average shares (denominator) 42,390 29,268 37,853 29,026 Basic and diluted net loss per share $ (0.32) $ (1.72) $ (1.29) $ (5.40) |
Basis of Presentation (Details)
Basis of Presentation (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||||||
Sep. 30, 2024 | Jun. 30, 2024 | Mar. 31, 2024 | Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2024 | Sep. 30, 2023 | Dec. 31, 2023 | |
Basis of Presentation | |||||||||
Cash and cash equivalents | $ 40,387 | $ 40,387 | $ 65,221 | ||||||
Accumulated deficit | (639,338) | (639,338) | $ (590,598) | ||||||
Net Income (Loss) | $ (13,650) | $ (8,299) | $ (26,791) | $ (50,486) | $ (53,515) | $ (52,796) | (48,740) | $ (156,797) | |
Net cash used in operating activities | $ (57,218) | $ (128,143) |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details) shares in Thousands, $ in Thousands | 9 Months Ended |
Sep. 30, 2024 USD ($) segment shares | |
Summary of Significant Accounting Policies | |
Deferred offering costs | $ | $ 2,570 |
Number of segments | segment | 1 |
Warrants to purchase common stock (in shares) | shares | 8,620 |
Equipment | Minimum | |
Summary of Significant Accounting Policies | |
Useful life | 3 years |
Equipment | Maximum | |
Summary of Significant Accounting Policies | |
Useful life | 5 years |
Furniture | |
Summary of Significant Accounting Policies | |
Useful life | 7 years |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Concentrations (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2024 | Sep. 30, 2023 | Sep. 30, 2024 | Sep. 30, 2023 | |
Summary of Significant Accounting Policies | ||||
Product revenue, net | $ 214 | $ 341 | $ 1,900 | $ 1,004 |
Restructuring (Details)
Restructuring (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||
Sep. 17, 2024 USD ($) employee | May 08, 2024 | Aug. 08, 2023 | Sep. 30, 2024 USD ($) | Jun. 30, 2024 USD ($) | Sep. 30, 2023 USD ($) | Sep. 30, 2024 USD ($) | Sep. 30, 2023 USD ($) | Dec. 31, 2023 USD ($) | |
Restructuring | |||||||||
Employees eliminated (as a percent) | 28% | 15% | 60% | ||||||
Restructuring costs | $ 1,553 | $ 1,553 | $ 856 | $ 4,163 | $ 2,409 | $ 4,163 | $ 4,163 | ||
Employees eliminated | employee | 15 | ||||||||
Accrued restructuring costs | $ 1,553 | $ 1,553 | $ 1,553 | ||||||
Severance and benefit costs | |||||||||
Restructuring | |||||||||
Restructuring costs | 4,063 | ||||||||
Payments for restructuring | 3,998 | ||||||||
Contract termination costs | |||||||||
Restructuring | |||||||||
Restructuring costs | 100 | ||||||||
Payments for restructuring | $ 100 |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2024 | Sep. 30, 2023 | Sep. 30, 2024 | Sep. 30, 2023 | Dec. 31, 2023 | |
Inventory | |||||
Raw materials | $ 833 | $ 833 | $ 935 | ||
Work-in-process | 651 | ||||
Finished goods | 692 | 692 | 405 | ||
Total inventory | 1,525 | 1,525 | $ 1,991 | ||
Inventory write-downs | $ 1,157 | $ 495 | $ 1,202 | $ 495 |
Property and Equipment, Net (De
Property and Equipment, Net (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2024 | Sep. 30, 2023 | Sep. 30, 2024 | Sep. 30, 2023 | Dec. 31, 2023 | |
Equipment | |||||
Total property and equipment, gross | $ 1,977 | $ 1,977 | $ 1,977 | ||
Accumulated depreciation | (1,425) | (1,425) | (1,193) | ||
Total property and equipment, net | 552 | 552 | 784 | ||
Depreciation | 77 | $ 79 | 232 | $ 240 | |
Computers and equipment | |||||
Equipment | |||||
Total property and equipment, gross | 202 | 202 | 202 | ||
Furniture | |||||
Equipment | |||||
Total property and equipment, gross | 575 | 575 | 575 | ||
Leasehold improvements | |||||
Equipment | |||||
Total property and equipment, gross | $ 1,200 | $ 1,200 | $ 1,200 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) $ in Thousands | Sep. 30, 2024 | Sep. 17, 2024 | Dec. 31, 2023 |
Accrued Expenses | |||
Accrued research and development expenses | $ 2,763 | $ 6,406 | |
Accrued compensation and benefits | 39 | 163 | |
Accrued professional fees | 5,520 | 5,562 | |
Accrued taxes | 71 | 116 | |
Other accrued expenses | 247 | 177 | |
Accrued restructuring costs | 1,553 | $ 1,553 | |
Total accrued expenses | $ 10,193 | $ 12,424 |
Transactions with BioXcel LLC_2
Transactions with BioXcel LLC (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||
Jun. 30, 2017 | Sep. 30, 2024 | Sep. 30, 2023 | Sep. 30, 2024 | Sep. 30, 2023 | Dec. 31, 2023 | |
Transactions with BioXcel | ||||||
Research and development | $ 5,101 | $ 19,619 | $ 24,534 | $ 74,392 | ||
Selling, general and administrative | 7,683 | 24,344 | 30,398 | 73,810 | ||
Total operating expenses | 15,507 | 48,638 | 58,652 | 152,911 | ||
BioXcel LLC | ||||||
Transactions with BioXcel | ||||||
Monthly agreement option fees | $ 18 | |||||
Maximum milestone (as as percent) | 3% | |||||
BioXcel LLC | Development milestones | ||||||
Transactions with BioXcel | ||||||
Potential milestone payments | $ 10,000 | |||||
BioXcel LLC | Sales milestones | ||||||
Transactions with BioXcel | ||||||
Potential milestone payments | $ 30,000 | |||||
Related Party | ||||||
Transactions with BioXcel | ||||||
Other current liabilities | 107 | 107 | $ 107 | |||
Related Party | BioXcel LLC | ||||||
Transactions with BioXcel | ||||||
Research and development | 230 | 321 | 708 | 950 | ||
Selling, general and administrative | 120 | 103 | 258 | 189 | ||
Total operating expenses | 350 | $ 424 | 966 | $ 1,139 | ||
Other current liabilities | $ 0 | $ 0 |
Debt and Credit Facilities - De
Debt and Credit Facilities - Debt summary (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2024 | Dec. 31, 2023 | |
Debt | ||
Total long-term debt liability | $ 106,501 | $ 102,680 |
Unamortized debt premiums, discounts and issuance costs | (2,061) | (2,082) |
Total long-term debt | 104,440 | 100,598 |
Credit Agreement | ||
Debt | ||
Accrued interest | 4,182 | 361 |
Total long-term debt liability | $ 102,319 | $ 102,319 |
Debt and Credit Facilities - Cr
Debt and Credit Facilities - Credit Agreement (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||||||||
Mar. 27, 2024 | Mar. 20, 2024 | Feb. 12, 2024 | Dec. 05, 2023 | Nov. 13, 2023 | Apr. 19, 2022 | Sep. 30, 2024 | Sep. 30, 2024 | Dec. 31, 2023 | Nov. 12, 2023 | Apr. 28, 2022 | |
Debt | |||||||||||
Total long-term debt liability | $ 106,501 | $ 106,501 | $ 102,680 | ||||||||
Proceeds from issuance of common stock and warrant | $ 25,000 | 467 | |||||||||
Registered direct offering | |||||||||||
Debt | |||||||||||
Proceeds from issuance of common stock and warrant | $ 25,000 | ||||||||||
OFA | |||||||||||
Debt | |||||||||||
Maximum borrowing capacity | $ 260,000 | ||||||||||
Cash maintenance in controlled accounts | 15,000 | ||||||||||
Minimum Liquidity Amount | $ 37,500 | ||||||||||
Subsidiary ownership (as a percent) | 20% | ||||||||||
Outstanding loan (as a percent) | 50% | ||||||||||
OFA | From and after the funding of Tranche B loans | |||||||||||
Debt | |||||||||||
Cash maintenance in controlled accounts | $ 20,000 | ||||||||||
OFA | From and after satisfaction of funding conditions for tranche C loans | |||||||||||
Debt | |||||||||||
Cash maintenance in controlled accounts | $ 15,000 | ||||||||||
Credit Agreement | |||||||||||
Debt | |||||||||||
Maximum investment allowed | $ 30,865 | $ 30,000 | $ 25,000 | ||||||||
Debt instrument fee | $ 180 | ||||||||||
Amendment fee (as a percent) | 0.25% | ||||||||||
Exit fee (as a percent) | 0.25% | 0.25% | |||||||||
Maximum borrowing capacity | $ 202,319 | ||||||||||
Total long-term debt liability | $ 102,319 | $ 102,319 | 102,319 | ||||||||
Remaining borrowing capacity | 100,000 | ||||||||||
Equity Investment Right | $ 5,000 | ||||||||||
Effective interest rate (as a percent) | 14% | 14% | |||||||||
Discount rate (as a percent) | 2% | ||||||||||
Debt Instrument, Variable Interest Rate, Type [Extensible Enumeration] | us-gaap:SecuredOvernightFinancingRateSofrMember | ||||||||||
Incremental interest rate (as a percent) | 7.50% | ||||||||||
Debt paid-in-kind interest (as a percent) | 8% | ||||||||||
Ticking fee (as a percent) | 0.75% | ||||||||||
Minimum Liquidity Amount | $ 25,000 | $ 25,000 | |||||||||
Minimum revenue required from equity sale | $ 40,000 | 30,943 | |||||||||
Credit Agreement | Minimum | |||||||||||
Debt | |||||||||||
Variable rate (as a percent) | 2.50% | ||||||||||
Credit Agreement | Maximum | |||||||||||
Debt | |||||||||||
Variable rate (as a percent) | 5.50% | ||||||||||
Credit Agreement | Tranche A | |||||||||||
Debt | |||||||||||
Face amount borrowed | $ 70,000 | ||||||||||
Total long-term debt liability | 72,319 | ||||||||||
Credit Agreement | Tranche A-2 | |||||||||||
Debt | |||||||||||
Total long-term debt liability | $ 30,000 | ||||||||||
Credit Agreement | Tranche B | |||||||||||
Debt | |||||||||||
Maximum borrowing capacity | $ 20,000 | ||||||||||
Credit Agreement | Tranche C | |||||||||||
Debt | |||||||||||
Maximum borrowing capacity | 30,000 | ||||||||||
Credit Agreement | Tranche D | |||||||||||
Debt | |||||||||||
Maximum borrowing capacity | $ 50,000 | ||||||||||
Credit Agreement | April 2024 | |||||||||||
Debt | |||||||||||
Minimum revenue required from equity sale | $ 25,000 | ||||||||||
Credit Agreement | September 2024 | |||||||||||
Debt | |||||||||||
Minimum Liquidity Amount | 15 | ||||||||||
Minimum revenue required from equity sale | 40 | 40,000 | |||||||||
Credit Agreement | November 2024 | |||||||||||
Debt | |||||||||||
Minimum Liquidity Amount | 25 | ||||||||||
Minimum revenue required from equity sale | $ 50,000 | $ 50,000 |
Debt and Credit Facilities - Re
Debt and Credit Facilities - Revenue Interest Financing (Details) - Revenue interest financing - USD ($) $ in Thousands | Jul. 08, 2022 | Apr. 19, 2022 | Dec. 31, 2022 |
Debt | |||
Debt extinguishment | $ 30 | ||
Maximum borrowing capacity | $ 120 | ||
Effective interest rate (as a percent) | 14% | ||
Debt to revenue multiplier | 1.75 | ||
Minimum | |||
Debt | |||
Borrowing allowed per net sales (as a percent) | 0.375% | ||
Maximum | |||
Debt | |||
Borrowing allowed per net sales (as a percent) | 7.75% | ||
Tranche A | |||
Debt | |||
Face amount borrowed | $ 30 |
Debt and Credit Facilities - Wa
Debt and Credit Facilities - Warrants (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | Mar. 20, 2024 | Apr. 19, 2022 | Sep. 30, 2024 | Dec. 05, 2023 |
Debt | ||||
Warrants to purchase common stock (in shares) | 8,620 | |||
Original Warrants, Issued April 2022 | ||||
Debt | ||||
Warrants to purchase common stock (in shares) | 278 | |||
Exercise price (in dollars per share) | $ 20.04 | $ 3.6452 | ||
Maximum equity investment allowed for lenders | $ 5,000 | |||
Premium share price (as a percent) | 10% | |||
Common stock issuable (in shares) | 5,852 | |||
2023 Warrants | ||||
Debt | ||||
Warrants to purchase common stock (in shares) | 70 | |||
Exercise price (in dollars per share) | $ 3.6452 | |||
2024 Warrants | ||||
Debt | ||||
Warrants to purchase common stock (in shares) | 100 | |||
Exercise price (in dollars per share) | $ 3.0723 | |||
Premium share price (as a percent) | 10% | |||
OnkosXcel Warrants | ||||
Debt | ||||
Warrants to purchase common stock (in shares) | 175 | |||
Premium share price (as a percent) | 10% | |||
Threshold amount of liquidity event for exercise of warrants | $ 20,000 | |||
Percentage of fair value of consideration to be paid | 75% | |||
Percentage of valuation applicable to initial profits | 150% |
Debt and Credit Facilities - Ma
Debt and Credit Facilities - Maturities (Details) $ in Thousands | Sep. 30, 2024 USD ($) |
Debt and Credit Facilities | |
2027 | $ 106,501 |
Debt and Credit Facilities - In
Debt and Credit Facilities - Interest (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2024 | Sep. 30, 2023 | Sep. 30, 2024 | Sep. 30, 2023 | |
Debt and Credit Facilities | ||||
Interest expense | $ 3,684 | $ 2,875 | $ 10,852 | $ 8,813 |
Accretion of debt discount and amortization of financing costs | 106 | 377 | 245 | 1,066 |
Total interest expense | $ 3,790 | $ 3,252 | $ 11,097 | $ 9,879 |
Derivative Financial Instrume_2
Derivative Financial Instruments (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2024 | Sep. 30, 2024 | Mar. 25, 2024 | Dec. 31, 2023 | |
Derivative Financial Instruments | ||||
Warrant derivative liability | $ 4,367 | $ 4,367 | $ 1,905 | |
Warrants 2024, Accompanying Warrants | ||||
Derivative Financial Instruments | ||||
Warrant derivative liability | 2,935 | 2,935 | $ 19,347 | |
Fair value adjustment warrants | $ (4,691) | $ (16,412) |
Common Stock Financing Activi_2
Common Stock Financing Activities (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||
Mar. 27, 2024 | Mar. 25, 2024 | Nov. 30, 2023 | May 31, 2021 | Sep. 30, 2024 | Sep. 30, 2024 | Sep. 30, 2023 | Dec. 31, 2023 | Mar. 31, 2024 | |
Shares issued | |||||||||
Stock offering costs | $ 295 | $ 739 | |||||||
Net proceeds issuance of common stock | $ 32,687 | $ 24,657 | |||||||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 | ||||||
Warrants to purchase common stock (in shares) | 8,620 | 8,620 | |||||||
Proceeds from issuance of common stock and warrant | $ 25,000 | $ 467 | |||||||
Warrants 2024, Pre Funded Warrants | |||||||||
Shares issued | |||||||||
Warrants to purchase common stock (in shares) | 5,565 | ||||||||
Exercise price (in dollars per share) | $ 0.001 | ||||||||
Warrants exercised | 1,705 | 5,565 | |||||||
Proceeds from warrants | $ 2 | $ 6 | |||||||
Jefferies Sale Agreement | |||||||||
Shares issued | |||||||||
Maximum value shares to be issued | $ 150,000 | $ 100,000 | |||||||
Number of shares issued | 361 | 3,847 | 1,408 | ||||||
Gross proceeds issuance of common stock | $ 467 | $ 7,682 | $ 27,032 | ||||||
Stock offering costs | 14 | 231 | 811 | ||||||
Net proceeds issuance of common stock | $ 453 | $ 7,451 | $ 26,221 | ||||||
Registered direct offering | |||||||||
Shares issued | |||||||||
Number of shares issued | 3,055 | ||||||||
Common stock, par value (in dollars per share) | $ 0.001 | ||||||||
Offering price (in dollars per share) | $ 2.901 | ||||||||
Proceeds from issuance of common stock and warrant | $ 25,000 | ||||||||
Registered direct offering | Warrants 2024, Accompanying Warrants | |||||||||
Shares issued | |||||||||
Warrants to purchase common stock (in shares) | 3,055 | ||||||||
Offering price (in dollars per share) | $ 2.900 | ||||||||
Exercise price (in dollars per share) | $ 3.20 | ||||||||
Registered direct offering | Warrants 2024, Pre Funded Warrants | |||||||||
Shares issued | |||||||||
Warrants to purchase common stock (in shares) | 5,565 | ||||||||
Exercise price (in dollars per share) | $ 0.001 |
Stock-Based Compensation - Desc
Stock-Based Compensation - Description (Details) - shares shares in Thousands | Jan. 01, 2024 | Jan. 01, 2023 | May 20, 2020 | Sep. 30, 2024 |
2020 Incentive Award Plan | ||||
Stock-Based Compensation | ||||
Authorized shares | 911 | |||
Available for grant (in shares) | 369 | |||
Annual increase in shares available for grant (as a percent) | 4% | |||
Increase in shares available for issuance (in shares) | 1,197 | 1,126 | ||
Terms of award | 10 years | |||
Vesting period | 4 years | |||
2017 Equity Incentive Plan | ||||
Stock-Based Compensation | ||||
Available for grant (in shares) | 233 |
Stock-Based Compensation - Non-
Stock-Based Compensation - Non-options (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Jul. 31, 2024 | Oct. 31, 2023 | Sep. 30, 2024 | Sep. 30, 2023 | Sep. 30, 2024 | Sep. 30, 2023 | Dec. 31, 2023 | |
Weighted average price | |||||||
Share-based compensation costs recognized | $ 1,865 | $ 4,014 | $ 6,355 | $ 15,015 | |||
BTI RSU | |||||||
Number of shares | |||||||
Outstanding, beginning balance (in shares) | 185,000 | ||||||
Granted (in shares) | 25,000 | ||||||
Vested (in shares) | (69,000) | ||||||
Cancelled (in shares) | (6,000) | ||||||
Forfeited (in shares) | (6,000) | ||||||
Outstanding, ending balance (in shares) | 135,000 | 135,000 | 185,000 | ||||
Weighted average price | |||||||
Granted, Weighted average price (in dollars per share) | $ 19.62 | ||||||
Unrecognized stock-based compensation expense | $ 854 | 3,096 | $ 854 | 3,096 | |||
BTI RSU | RSU vesting 100% at one year anniversary | |||||||
Number of shares | |||||||
Granted (in shares) | 20,000 | 25,000 | |||||
Weighted average price | |||||||
Granted, Weighted average price (in dollars per share) | $ 1.20 | $ 1.46 | |||||
Vesting period | 1 year | 1 year | |||||
BTI RSU | RSU vesting 25% at one year and remaining in 12 quarters | |||||||
Weighted average price | |||||||
Vesting period | 4 years | ||||||
Vesting (as a percent) | 25% | ||||||
BTI PSU | |||||||
Number of shares | |||||||
Outstanding, beginning balance (in shares) | 527,000 | ||||||
Granted (in shares) | 1,388,000 | 543,000 | 1,388,000 | ||||
Vested (in shares) | 0 | ||||||
Cancelled (in shares) | (125,000) | ||||||
Outstanding, ending balance (in shares) | 1,790,000 | 1,790,000 | 527,000 | ||||
Weighted average price | |||||||
Granted, Weighted average price (in dollars per share) | $ 1.20 | $ 2.43 | |||||
Vesting period | 1 year | 1 year | |||||
Unrecognized stock-based compensation expense | $ 0 | $ 0 | |||||
BTI PSU | Tranche One | |||||||
Number of shares | |||||||
Granted (in shares) | 209,000 | ||||||
BTI PSU | Tranche Two | |||||||
Number of shares | |||||||
Granted (in shares) | 334,000 | ||||||
OnkosXcel PSU | |||||||
Number of shares | |||||||
Outstanding, beginning balance (in shares) | 1,240 | ||||||
Granted (in shares) | 15 | 30 | |||||
Cancelled (in shares) | (79) | ||||||
Outstanding, ending balance (in shares) | 1,176 | 1,176 | 1,240 | ||||
Vested aggregate (in shares) | 906 | 906 | |||||
Weighted average price | |||||||
Outstanding, Weighted average price beginning balance (in dollars per share) | $ 5,626 | ||||||
Granted, Weighted average price (in dollars per share) | 10,176 | ||||||
Cancelled, Weighted average price (in dollars per share) | 5,506 | ||||||
Vested, Weighted average price (in dollars per share) | $ 5,557 | $ 5,557 | |||||
Outstanding, Weighted average price ending balance (in dollars per share) | $ 5,626 | ||||||
Vesting period | 48 months | ||||||
Unrecognized stock-based compensation expense | $ 496 | 3,203 | $ 496 | 3,203 | |||
OnkosXcel PSU | Employee | |||||||
Weighted average price | |||||||
Vesting period | 48 months | ||||||
OnkosXcel PSU | Executive officers | |||||||
Weighted average price | |||||||
Vesting period | 24 months | ||||||
OnkosXcel RSUs | |||||||
Number of shares | |||||||
Outstanding, beginning balance (in shares) | 225 | ||||||
Granted (in shares) | 225 | ||||||
Vested (in shares) | (35) | ||||||
Cancelled (in shares) | (8) | ||||||
Outstanding, ending balance (in shares) | 182 | 182 | 225 | ||||
Weighted average price | |||||||
Granted, Weighted average price (in dollars per share) | $ 10 | ||||||
Unrecognized stock-based compensation expense | $ 261 | $ 2,151 | $ 261 | $ 2,151 | |||
OnkosXcel RSUs | Tranche One | |||||||
Number of shares | |||||||
Granted (in shares) | 125,000 | ||||||
Weighted average price | |||||||
Vesting period | 180 days | ||||||
OnkosXcel RSUs | Tranche Two | |||||||
Weighted average price | |||||||
Vesting period | 4 years | ||||||
Vesting (as a percent) | 25% |
Stock-Based Compensation - Opti
Stock-Based Compensation - Options (Details) - Employee Stock Option - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2024 | Sep. 30, 2023 | |
Number of Shares | |||
Outstanding, beginning balance (in shares) | 4,976 | ||
Options granted (in shares) | 632 | ||
Options forfeited (in shares) | (141) | ||
Options cancelled (in shares) | (238) | ||
Options exercised (in shares) | 0 | 0 | |
Outstanding, ending balance (in shares) | 5,229 | ||
Options vested and exercisable (in shares) | 3,895 | ||
Weighted Average Exercise Price per Share | |||
Outstanding, beginning balance (in dollars per shares) | $ 18.52 | ||
Options granted (in dollars per share) | 1.25 | ||
Options forfeited (in dollars per shares) | 17.77 | ||
Options cancelled (in dollars per shares) | 21.48 | ||
Outstanding, end balance (in dollars per shares) | 16.32 | ||
Options vested and exercisable (in dollars per shares) | $ 18.16 | ||
Options | |||
Intrinsic value, outstanding | $ 248 | ||
Intrinsic value, exercised | $ 5,928 | ||
Intrinsic value, exercisable | $ 2,628 | $ 248 | $ 2,628 |
Weighted-average grant-date fair value of options vested (in dollars per share) | $ 13.59 | ||
Weighted average remaining contractual life, exercisable | 5 years 1 month 6 days | ||
Weighted average remaining contractual life, outstanding | 6 years | ||
Unrecognized compensation expense | $ 3,651 | ||
Remaining unamortized expense period | 1 year 4 months 24 days |
Stock-Based Compensation - Assu
Stock-Based Compensation - Assumptions (Details) | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2024 | Sep. 30, 2023 | Dec. 31, 2023 | |
OnkosXcel PSU | |||
Stock-Based Compensation | |||
Expected term | 5 years 9 months 18 days | ||
Expected stock price volatility (as a percent) | 97.40% | ||
Risk-free rate of interest (as a percent) | 3.60% | ||
Expected dividend yield (as a percent) | 0% | ||
Employee Stock Option | |||
Stock-Based Compensation | |||
Expected stock price volatility, minimum (as a percent) | 108% | 96.60% | |
Expected stock price volatility, maximum (as a percent) | 112.50% | 109.20% | |
Risk-free rate of interest, minimum (as a percent) | 4% | 3.50% | |
Risk-free rate of interest, maximum (as a percent) | 4.50% | 4.40% | |
Expected dividend yield (as a percent) | 0% | ||
Employee Stock Option | Minimum | |||
Stock-Based Compensation | |||
Expected term | 5 years 6 months | 5 years 6 months | |
Expected dividend yield (as a percent) | 0% | 0% | |
Employee Stock Option | Maximum | |||
Stock-Based Compensation | |||
Expected term | 6 years 1 month 6 days | 6 years 1 month 6 days | |
Expected dividend yield (as a percent) | 0% |
Stock-Based Compensation - Expe
Stock-Based Compensation - Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2024 | Sep. 30, 2023 | Sep. 30, 2024 | Sep. 30, 2023 | |
Stock-Based Compensation | ||||
Share-based compensation costs recognized | $ 1,865 | $ 4,014 | $ 6,355 | $ 15,015 |
Research and development | ||||
Stock-Based Compensation | ||||
Share-based compensation costs recognized | 884 | 1,645 | 2,446 | 4,840 |
Selling, general and administrative | ||||
Stock-Based Compensation | ||||
Share-based compensation costs recognized | $ 981 | $ 2,369 | $ 3,909 | $ 10,175 |
Stock-Based Compensation - ESPP
Stock-Based Compensation - ESPP (Details) - 2020 Employee Stock Purchase Plan - shares shares in Thousands | 9 Months Ended | |||
Jan. 01, 2024 | Jan. 01, 2023 | May 20, 2020 | Sep. 30, 2024 | |
Employee Stock Purchase Plan | ||||
Authorized shares | 100 | |||
Annual increase in shares available for grant (as a percent) | 1% | |||
Maximum number of shares issued or transferred under ESPP | 500 | |||
Purchase price as a percent of fair market value | 85% | |||
Increase in shares available for issuance (in shares) | 299 | 281 | ||
Shares issued under ESPP | 0 | |||
Available for grant (in shares) | 1,204 |
Leases - Maturities (Details)
Leases - Maturities (Details) - USD ($) $ in Thousands | Sep. 30, 2024 | Dec. 31, 2023 |
Maturities of the operating lease liability | ||
Remainder of 2024 | $ 95 | |
2025 | 391 | |
2026 | 65 | |
Total lease payments | 551 | |
Imputed interest | (22) | |
Total lease liability | 529 | |
Less current portion of lease liability | $ (368) | |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Other Liabilities, Current | |
Long-term portion of operating lease liabilities | $ 161 | $ 440 |
Leases - Additional Information
Leases - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2024 | Sep. 30, 2023 | Sep. 30, 2024 | Sep. 30, 2023 | |
Leases | ||||
Lease expense | $ 101 | $ 98 | $ 299 | $ 294 |
Option to renew the lease | true | |||
Renewal term | 5 years | 5 years |
Fair Value Measurements - Hiera
Fair Value Measurements - Hierarchy (Details) - USD ($) $ in Thousands | Sep. 30, 2024 | Mar. 25, 2024 | Dec. 31, 2023 |
Fair value assets and liabilities | |||
Warrant derivative liability | $ 4,367 | $ 1,905 | |
Warrants 2024, Accompanying Warrants | |||
Fair value assets and liabilities | |||
Warrant derivative liability | 2,935 | $ 19,347 | |
Level 1 | |||
Fair value assets and liabilities | |||
Fair value money market accounts | 36,672 | $ 64,860 | |
Recurring | |||
Fair value assets and liabilities | |||
Warrant derivative liability | 4,367 | ||
Recurring | Equity Investment Rights | |||
Fair value assets and liabilities | |||
Warrant derivative liability | 1,311 | ||
Recurring | OnkosXcel Warrants | |||
Fair value assets and liabilities | |||
Warrant derivative liability | 121 | ||
Recurring | Warrants 2024, Accompanying Warrants | |||
Fair value assets and liabilities | |||
Warrant derivative liability | 2,935 | ||
Recurring | Level 2 | |||
Fair value assets and liabilities | |||
Warrant derivative liability | 2,935 | ||
Recurring | Level 2 | Warrants 2024, Accompanying Warrants | |||
Fair value assets and liabilities | |||
Warrant derivative liability | 2,935 | ||
Recurring | Level 3 | |||
Fair value assets and liabilities | |||
Warrant derivative liability | 1,432 | ||
Recurring | Level 3 | Equity Investment Rights | |||
Fair value assets and liabilities | |||
Warrant derivative liability | 1,311 | ||
Recurring | Level 3 | OnkosXcel Warrants | |||
Fair value assets and liabilities | |||
Warrant derivative liability | 121 | ||
Recurring | Fair Value | |||
Fair value assets and liabilities | |||
Warrant derivative liability | 4,367 | ||
Recurring | Fair Value | Equity Investment Rights | |||
Fair value assets and liabilities | |||
Warrant derivative liability | 1,311 | ||
Recurring | Fair Value | OnkosXcel Warrants | |||
Fair value assets and liabilities | |||
Warrant derivative liability | 121 | ||
Recurring | Fair Value | Warrants 2024, Accompanying Warrants | |||
Fair value assets and liabilities | |||
Warrant derivative liability | $ 2,935 |
Fair Value Measurements - Level
Fair Value Measurements - Level 3 (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2024 | Sep. 30, 2023 | |
Level 3 liabilities reconciliation | ||
Beginning balance | $ 1,905 | $ 2,343 |
Change in fair value | $ (473) | $ (316) |
Fair Value, Liability, Recurring Basis, Unobservable Input Reconciliation, Gain (Loss), Statement of Income or Comprehensive Income [Extensible Enumeration] | Other Nonoperating Income (Expense) | Other Nonoperating Income (Expense) |
Ending balance | $ 1,432 | $ 2,027 |
Fair Value Measurements - Input
Fair Value Measurements - Inputs (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | |||||||
Sep. 30, 2024 USD ($) Y $ / shares | Sep. 30, 2024 USD ($) Y $ / shares | Mar. 31, 2024 $ / shares | Mar. 25, 2024 USD ($) Y $ / shares | Mar. 20, 2024 $ / shares | Dec. 31, 2023 USD ($) $ / shares Y | Dec. 05, 2023 $ / shares | Dec. 31, 2022 $ / shares Y | Apr. 19, 2022 USD ($) $ / shares | |
Fair value inputs | |||||||||
Warrant derivative liability | $ | $ 4,367 | $ 4,367 | $ 1,905 | ||||||
Credit Agreement | |||||||||
Fair value inputs | |||||||||
Fair value debt | $ | 93,533 | 93,533 | 88,210 | ||||||
2024 Warrants | |||||||||
Fair value inputs | |||||||||
Fair value warrant classified as equity | $ | $ 224 | $ 224 | |||||||
Exercise price (in dollars per share) | $ 3.0723 | ||||||||
2023 Warrants | |||||||||
Fair value inputs | |||||||||
Fair value warrant classified as equity | $ | $ 200 | ||||||||
Exercise price (in dollars per share) | $ 3.6452 | ||||||||
Original Warrants, Issued April 2022 | |||||||||
Fair value inputs | |||||||||
Fair value warrant classified as equity | $ | $ 3,245 | ||||||||
Exercise price (in dollars per share) | $ 3.6452 | $ 20.04 | |||||||
Warrants 2024, Accompanying Warrants | |||||||||
Fair value inputs | |||||||||
Fair value of grants per share | $ 0.61 | $ 0.61 | $ 2.81 | ||||||
Warrant derivative liability | $ | $ 2,935 | $ 2,935 | $ 19,347 | ||||||
Fair value adjustment warrants | $ | $ (4,691) | $ (16,412) | |||||||
Warrants 2024, Pre Funded Warrants | |||||||||
Fair value inputs | |||||||||
Exercise price (in dollars per share) | $ 0.001 | ||||||||
Strike price | Equity Investment Rights | |||||||||
Fair value inputs | |||||||||
Derivative liability input | 1.100 | 1.100 | |||||||
Strike price | 2024 Warrants | |||||||||
Fair value inputs | |||||||||
Derivative liability input | 3.0723 | 3.0723 | |||||||
Strike price | 2023 Warrants | |||||||||
Fair value inputs | |||||||||
Derivative liability input | 3.6452 | ||||||||
Strike price | Original Warrants, Issued April 2022 | |||||||||
Fair value inputs | |||||||||
Derivative liability input | 20.04 | ||||||||
Strike price | Warrants 2024, Accompanying Warrants | |||||||||
Fair value inputs | |||||||||
Exercise price (in dollars per share) | $ 3.20 | $ 3.20 | $ 3.20 | ||||||
Volatility (annual) | Equity Investment Rights | |||||||||
Fair value inputs | |||||||||
Derivative liability input | 1.123 | 1.123 | |||||||
Volatility (annual) | OnkosXcel Warrants | |||||||||
Fair value inputs | |||||||||
Derivative liability input | 1.10 | 1.10 | |||||||
Volatility (annual) | 2024 Warrants | |||||||||
Fair value inputs | |||||||||
Derivative liability input | 1.122 | 1.122 | |||||||
Volatility (annual) | 2023 Warrants | |||||||||
Fair value inputs | |||||||||
Derivative liability input | 0.99 | ||||||||
Volatility (annual) | Original Warrants, Issued April 2022 | |||||||||
Fair value inputs | |||||||||
Derivative liability input | 0.95 | ||||||||
Volatility (annual) | Warrants 2024, Accompanying Warrants | |||||||||
Fair value inputs | |||||||||
Derivative liability input | 1.123 | 1.123 | 1.122 | ||||||
Probability of exercise | Equity Investment Rights | |||||||||
Fair value inputs | |||||||||
Derivative liability input | 0.910 | 0.910 | |||||||
Time period | Equity Investment Rights | |||||||||
Fair value inputs | |||||||||
Derivative liability input | Y | 1.4 | 1.4 | |||||||
Time period | 2024 Warrants | |||||||||
Fair value inputs | |||||||||
Derivative liability input | Y | 5.1 | 5.1 | |||||||
Time period | 2023 Warrants | |||||||||
Fair value inputs | |||||||||
Derivative liability input | Y | 5.4 | ||||||||
Time period | Original Warrants, Issued April 2022 | |||||||||
Fair value inputs | |||||||||
Derivative liability input | Y | 7 | ||||||||
Time period | Warrants 2024, Accompanying Warrants | |||||||||
Fair value inputs | |||||||||
Derivative liability input | Y | 4.5 | 4.5 | 5 | ||||||
Estimated premium to 30-day average | Equity Investment Rights | |||||||||
Fair value inputs | |||||||||
Derivative liability input | 0.250 | 0.250 | |||||||
Discount rate | Equity Investment Rights | |||||||||
Fair value inputs | |||||||||
Derivative liability input | 0.039 | 0.039 | |||||||
Risk-free rate | 2024 Warrants | |||||||||
Fair value inputs | |||||||||
Derivative liability input | 0.0425 | 0.0425 | |||||||
Risk-free rate | 2023 Warrants | |||||||||
Fair value inputs | |||||||||
Derivative liability input | 0.0414 | ||||||||
Risk-free rate | Original Warrants, Issued April 2022 | |||||||||
Fair value inputs | |||||||||
Derivative liability input | 0.0295 | ||||||||
Risk-free rate | Warrants 2024, Accompanying Warrants | |||||||||
Fair value inputs | |||||||||
Derivative liability input | 0.036 | 0.036 | 0.042 | ||||||
Share price input | 2024 Warrants | |||||||||
Fair value inputs | |||||||||
Derivative liability input | 2.78 | 2.78 | |||||||
Share price input | 2023 Warrants | |||||||||
Fair value inputs | |||||||||
Derivative liability input | 3.71 | ||||||||
Share price input | Original Warrants, Issued April 2022 | |||||||||
Fair value inputs | |||||||||
Derivative liability input | 14.93 |
Net Loss Per Share (Details)
Net Loss Per Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2024 | Jun. 30, 2024 | Mar. 31, 2024 | Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2024 | Sep. 30, 2023 | |
Derivative Financial Instruments | ||||||||
Net loss (numerator) | $ (13,650) | $ (8,299) | $ (26,791) | $ (50,486) | $ (53,515) | $ (52,796) | $ (48,740) | $ (156,797) |
Weighted average shares (denominator) - basic (in shares) | 42,390 | 29,268 | 37,853 | 29,026 | ||||
Weighted average shares (denominator) - diluted (in shares) | 42,390 | 29,268 | 37,853 | 29,026 | ||||
Basic net loss per share (in dollars per share) | $ (0.32) | $ (1.72) | $ (1.29) | $ (5.40) | ||||
Diluted net loss per share (in dollars per share) | $ (0.32) | $ (1.72) | $ (1.29) | $ (5.40) | ||||
Warrants to purchase common stock (in shares) | 8,620 | 8,620 | ||||||
Potentially dilutive securities (in shares) | 16,222 | 5,688 | ||||||
Warrants 2024, Pre Funded Warrants | ||||||||
Derivative Financial Instruments | ||||||||
Warrants to purchase common stock (in shares) | 5,565 | |||||||
Exercise price (in dollars per share) | $ 0.001 |
Commitments and Contingencies (
Commitments and Contingencies (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | |
Jul. 11, 2024 | Apr. 30, 2022 | Sep. 30, 2024 | |
Commitments and Contingencies | |||
Purchase agreement expected cost | $ 10,000 | ||
Purchase agreement expected term | 3 years | ||
2024 purchase obligation, remainder of year | $ 1,000 | $ 5,000 | |
2025 purchase obligation | 2,000 | ||
2026 purchase obligation | 2,000 | ||
Reconciliation payment | $ 1,200 | ||
Minimum | |||
Commitments and Contingencies | |||
Purchase agreement expected cost | 2,000 | ||
Maximum | |||
Commitments and Contingencies | |||
Purchase agreement expected cost | $ 5,000 |