0001558370-24-015629 | 10-Q | XBRL Viewer

Debt and Credit Facilities

9 Months Ended

Sep. 30, 2024

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 sublingual film. In addition, the OFA Facilities are intended to support the expansion of clinical development efforts of BXCL501, which includes a Phase 3 program for the acute treatment of agitation in patients with Alzheimer’s disease, and for general corporate purposes. The Lenders and Purchasers are comprised of affiliates of Oaktree Capital Management, L.P. and Qatar Investment Authority.

Waiver and First Amendment to Credit Agreement and Guaranty

On November 13, 2023, the Company, the lenders party to the Credit Agreement and OFA entered into a Waiver and First Amendment to Credit Agreement and Guaranty (the “First Amendment”) that provided for (i) a waiver and a modification to the covenant in the Credit Agreement regarding investments in OnkosXcel and (ii) an agreement among 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 or before February 20, 2024. The Company did not meet this condition and therefore the Third Amendment did not become effective.

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 $25,000 in gross proceeds from the issuance of its common stock, warrants, and pre-funded warrants discussed in Note 11, Common Stock Financing Activities, satisfying the April 15, 2024 covenant requirement of the Fourth Amendment. During the third quarter of 2024, the Company received $467 of gross proceeds from the issuance of the Company’s common stock. As of September 30, 2024, the Company had satisfied $30,943 of the $40,000 required to maintain the Minimum Liquidity Amount and the $50,000 gross proceeds requirement. As a result, at September 30, 2024, the Minimum Liquidity Amount increased to $25,000. As of September 30, 2024, we were in compliance with all restrictive and financial covenants under the Credit Agreement.

Revenue Interest Financing Agreement

As noted, the RIFA was terminated when the Company entered into the Second Amendment, which amended the Credit Agreement (as amended by the First Amendment). The $30,000 Tranche A previously provided to the Company under the RIFA was converted to the Tranche A-2 Term Loan. Prior to termination, the RIFA provided up to $120,000 in potential financing in exchange for a capped revenue interest on net sales of IGALMI^TM, and other future BXCL501 products, if any, that received regulatory approval for sale. The initial Tranche A of $30,000 was funded on July 8, 2022. The effective interest rate on the RIFA as of December 31, 2022, was approximately 14%.

Under the terms of the RIFA, the Purchasers were to receive tiered revenue interest payments on U.S. net sales of IGALMI™, and other future BXCL501 products, if any, that receive regulatory approval for sale, equal to a royalty ranging from 0.375% to 7.750% of net sales of IGALMI™, and other future BXCL501 products, if any, approved for sale in the U.S., subject to a hard cap equal to 1.75x 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” and together with the Amended and Restated Original Warrants, the “Warrants”). The Amended and Restated Original Warrants and the 2023 Warrants will expire on April 19, 2029 and may be net exercised at the holder’s election. In addition, pursuant to the Credit Agreement, the Lenders have the right to purchase shares of the Company’s common stock after the Second

Amendment Effective Date, so long as borrowings under the Credit Agreement are outstanding, for a purchase price of $5,000 at a price per share equal to a 10% premium to the volume-weighted average price of the common stock over the 30 trading days prior to the Lenders’ election to proceed with such equity investment (the “Equity Investment Right”). BTI entered into a registration rights agreement (the “Registration Rights Agreement”) with the Lenders and filed a registration statement on Form S-3 to register the shares issuable upon exercise of the Warrants and, if issued, the shares related to the Equity Investment Right, for resale. The maximum shares of BTI common stock issuable under the Warrants (including the Original Warrants and the 2023 Warrants) and Lenders’ Equity Investment Right was 5,852 as of March 31, 2024. On the Second Amendment Effective Date, Company amended and restated its Registration Rights Agreement (the “Amended and Restated Registration Rights Agreement”) with the Lenders, dated April 19, 2022, pursuant to which the Company agreed to register the 2023 Warrant Shares for resale.

As part of the Credit Agreement, OnkosXcel, a wholly owned subsidiary of BTI, granted warrants to the Lenders to purchase 175 individual limited liability company units (which number of units is not in thousands; referred to herein as the “OnkosXcel Warrants”). The strike price of the OnkosXcel Warrants is formulaic based on the value of OnkosXcel at the time of exercise and can only be exercised upon occurrence of an equity related liquidity event for OnkosXcel of at least $20,000. The exercise price per unit of the OnkosXcel Warrants will be set upon the earlier of the closing of the next sale (or series of related sales) by OnkosXcel of equity securities of OnkosXcel with aggregate proceeds of not less than $20,000 to unrelated third parties (the “Next Equity Financing”) at an exercise price per unit equal to a 10% premium over the price per unit of the equity securities sold by OnkosXcel in such Next Equity Financing or, in the event of a sale of OnkosXcel prior to the Next Equity Financing or an initial public offering constituting the Next Equity Financing, the lesser of (x) 75% of the fair value of the consideration to be paid for a unit upon the consummation of such transaction and (y) 150% of the valuation applicable to the initial profits units issued by OnkosXcel after the closing of the Credit Agreement. The OnkosXcel Warrants are transferable with approval from BTI, which cannot be unreasonably withheld, expire on April 19, 2029, and may be net exercised at the holder’s election.

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

- Definition

The entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.

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+ Details

Insider Trading Arrangements	3 Months Ended
Insider Trading Arrangements	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

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

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

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

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.

Stock-Based Compensation - Assumptions (Details)	9 Months Ended		12 Months Ended
Stock-Based Compensation - Assumptions (Details)	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)			0.00%
Employee Stock Option
Stock-Based Compensation
Expected stock price volatility, minimum (as a percent)	108.00%	96.60%
Expected stock price volatility, maximum (as a percent)	112.50%	109.20%
Risk-free rate of interest, minimum (as a percent)	4.00%	3.50%
Risk-free rate of interest, maximum (as a percent)	4.50%	4.40%
Expected dividend yield (as a percent)	0.00%
Employee Stock Option \| Minimum
Stock-Based Compensation
Expected term	5 years 6 months	5 years 6 months
Expected dividend yield (as a percent)	0.00%	0.00%
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)		0.00%

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	%

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

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-year anniversary of the grant date. During the nine months ended September 30, 2024, the Company granted 25 time-based BTI RSUs which fully vest on the one-year anniversary of the grant date. The average grant date fair value per share for the BTI RSUs for the three months ended September 30, 2024 was $1.20. The average grant date fair value per share for the BTI RSUs for the nine months ended September 30, 2024 was $1.46. During the nine months ended September 30, 2024, 6 BTI RSUs were cancelled. The outstanding RSUs generally vest over four years, with 25% vesting at the one-year anniversary of the grant date and the balance vesting ratably over the remaining 12 quarters of the vesting period. The weighted average grant date fair value per share for the BTI RSUs granted in 2023 was $19.62. Unrecognized stock-based compensation expense related to these awards was approximately $854 and $3,096 as of September 30, 2024 and 2023, respectively.

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.

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

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 $18 per month from March 13, 2023 to December 31, 2024 in exchange for this option. We agreed to negotiate any such collaborative services agreement in good faith and to incorporate reasonable market-based terms, including consideration for BioXcel LLC reflecting a low, single-digit royalty on net sales and reasonable development and commercialization milestone payments, provided that (i) development milestone payments shall not exceed $10,000 in the aggregate and not be payable prior to proof of concept in humans and (ii) commercialization milestone payments shall be based on reaching annual net sales levels, be limited to 3% of the applicable net sales level, and not exceed $30,000 in the aggregate.

Service charges recorded under the Services Agreement for the 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.

- Definition

The entire disclosure for related party transactions. Examples of related party transactions include transactions between (a) a parent company and its subsidiary; (b) subsidiaries of a common parent; (c) and entity and its principal owners; and (d) affiliates.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480990/946-20-50-2

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
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-Name Accounting Standards Codification
-Section 50
-Paragraph 5
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
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-URI https://asc.fasb.org/1943274/2147480990/946-20-50-6

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 235
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-Section 50
-Paragraph 2
-Subparagraph (c)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477968/946-235-50-2

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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-Paragraph 2
-Subparagraph (e)
-Publisher FASB
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Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 850
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Reference 7: http://www.xbrl.org/2003/role/disclosureRef
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 220
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.6-07(2)(e))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479134/946-220-S99-1

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Topic 850
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-URI https://asc.fasb.org/850/tableOfContent

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Topic 850
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483326/850-10-50-6

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Topic 850
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483326/850-10-50-1

Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Topic 850
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483326/850-10-50-1

+ Details

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)					25.00%
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)							25.00%

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

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

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 and represent amounts due from distributors and group purchasing organizations (“GPOs”). Payment terms generally range from 30 to 90 days from the date of the sale transaction, and accordingly, do not involve a significant financing component. Receivables from product sales are recorded net of allowances which generally include distribution fees, prompt payment discounts, chargebacks, and credit losses. Allowances for distribution fees, prompt payment discounts and chargebacks are based on contractual terms. The Company estimated the current expected credit losses of its accounts receivable by assessing the risk of loss and available relevant information about collectability, existing contractual payment terms, actual payment patterns of its customers, individual customer circumstances, and reasonable and supportable forecast of economic conditions expected to exist throughout the contractual life of the receivable. Based on its assessment, as of September 30, 2024, the Company determined that an allowance for credit losses was not required.

Concentrations of Credit Risk

The Company sells IGALMI^TM through a drop-ship program under which orders from hospitals and similar health care institutions are processed through wholesalers, but shipments of the product are sent directly to the individual hospitals and similar health care institutions. BTI also contracts directly with 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” section of this Note and as a debt discount. The Company accounts for debt as liabilities measured at amortized cost and amortizes the resulting debt discount from the allocation of proceeds to interest expense using the effective interest method over the expected term of the debt instrument. The Company considers whether there are any embedded features in debt instruments that require bifurcation and separately accounts for them as derivative financial instruments.

As discussed in Note 9, Debt and Credit Facilities, on April 19, 2022, the Company entered into the Revenue Interest Financing Agreement (the “RIFA”), the terms of which involved significant assumptions and estimates, including future net product sales, in determining interest expense, amortization period of the debt discount, as well as the classification between current and long-term portions. In estimating future net product sales, the Company assessed prevailing market conditions using various external market data against the Company’s anticipated sales and planned commercial activities. Consequently, the Company imputed interest on the carrying value of the debt and records interest expense using an imputed effective interest rate. The Company reassessed the expected payments during each reporting period and accounted for any changes through an adjustment to the effective interest rate on a prospective basis, with a corresponding impact to the classification of the Company’s current and long-term portions of the debt. The RIFA was terminated on December 5, 2023.

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 in the U.S. through arrangements with a distributor, wholesalers, and GPOs. The distributor and wholesalers help process and fulfill orders from hospitals on the Company’s behalf. The Company believes the hospitals are its customers.

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 is to deliver the quantity of product ordered to the location specified by the customer’s order. The Company records shipping and handling costs associated with delivery of product to its customers within Selling, general and administrative expenses on its Condensed Consolidated Statements of Operations. Under the Company’s current product sales arrangements, BTI does not have contract assets (unbilled receivables), as it generally invoices its customer at the time of revenue recognition.

BTI sells IGALMI^TM at wholesale acquisition cost less any agreed upon discounts, and calculates product revenue net of variable consideration and consideration payable to third parties associated with distribution of product. The Company records reserves, based on contractual terms, for the following components of consideration related to product sold during the reporting period. Calculating these amounts involves estimates and judgments, and the Company reviews these estimates quarterly and records any material adjustments in the period they are identified, which affects net product revenue and earnings in the period such variances occur.

Trade Discounts and Allowances

The Company provides the distributor and wholesalers with discounts for prompt payment and pays fees to the distributor, wholesalers and GPOs related to distribution of the product. BTI expects the relevant third parties to earn these discounts and fees, and therefore it deducts such amounts from gross product revenue and accounts receivable at the time it recognizes the related revenue.

Government Rebates

IGALMI^TM is eligible for purchase by, or qualifies for reimbursement from, Medicaid and other U.S. government programs that are eligible for rebates on the price they pay for the product. To determine the appropriate amount to

reserve for these rebates, BTI applies the applicable government discount to these sales, and estimates the portion of total rebates that it anticipates will be claimed. The Company deducts certain government rebates from gross product revenue and accounts receivable at the time it recognizes the related revenue; other government rebates are recognized as an accrued liability at the time BTI recognizes the related revenue.

Chargebacks

BTI provides product discounts to hospitals associated with certain GPOs. The Company estimates the chargebacks that it expects to be obligated to provide based upon the terms of the applicable arrangements. BTI deducts such amounts from gross product revenue and accounts receivable at the time it recognizes the related revenue.

Product Returns

The Company provides contractual return rights to its customers including the right to return product within six months of product expiration and up to 12 months after product expiration, as well as for incorrect shipments, and damaged or defective product, which the Company expects to be rare. Management expects product returns to be minimal, thus BTI recognizes a nominal allowance for product returns at the time of each sale. In the future, if any of these factors and/or the history of product returns changes, the Company will adjust the allowance for product returns.

BTI classifies all fees paid to the distributor, other than those discussed above and those related to warehouse operations, as Selling, general and administrative expenses on its 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.

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

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

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Reference 10: http://www.xbrl.org/2003/role/disclosureRef
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Reference 15: http://www.xbrl.org/2003/role/disclosureRef
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Reference 16: http://www.xbrl.org/2003/role/disclosureRef
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Reference 26: http://www.xbrl.org/2009/role/commonPracticeRef
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Reference 27: http://www.xbrl.org/2009/role/commonPracticeRef
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-Name Accounting Standards Codification
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-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482900/835-30-50-1

+ Details

- Definition

Amount of unamortized debt discount (premium) and debt issuance costs.

+ References + Details

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

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)

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

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

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.

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

- Definition

Tabular disclosure of long-debt instruments or arrangements, including identification, terms, features, collateral requirements and other information necessary to a fair presentation. These are debt arrangements that originally required repayment more than twelve months after issuance or greater than the normal operating cycle of the entity, if longer.

+ References

Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.5-02(22))
-SubTopic 10
-Topic 210
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480566/210-10-S99-1

Reference 2: http://www.xbrl.org/2003/role/exampleRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 55
-Paragraph 69B
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481568/470-20-55-69B

Reference 3: http://www.xbrl.org/2003/role/exampleRef
-Topic 470
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-Name Accounting Standards Codification
-Section 55
-Paragraph 69E
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481568/470-20-55-69E

Reference 4: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 235
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 3
-Subparagraph (SX 210.12-04(a))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480678/235-10-S99-3

Reference 5: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 835
-SubTopic 30
-Name Accounting Standards Codification
-Section 45
-Paragraph 2
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482925/835-30-45-2

Reference 6: http://fasb.org/us-gaap/role/ref/legacyRef
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-Section 50
-Paragraph 3
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-3

Reference 7: http://fasb.org/us-gaap/role/ref/legacyRef
-Name Accounting Standards Codification
-Topic 942
-SubTopic 470
-Section 50
-Paragraph 3
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-URI https://asc.fasb.org/1943274/2147477734/942-470-50-3

Reference 8: http://fasb.org/us-gaap/role/ref/legacyRef
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-URI https://asc.fasb.org/1943274/2147481112/505-10-50-8

Reference 9: http://fasb.org/us-gaap/role/ref/legacyRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-6

Reference 10: http://fasb.org/us-gaap/role/ref/legacyRef
-Topic 505
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-Name Accounting Standards Codification
-Section 50
-Paragraph 7
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-7

+ Details

Debt and Credit Facilities - Maturities (Details) $ in Thousands	Sep. 30, 2024 USD ($)
Debt and Credit Facilities
2027	$ 106,501

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

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.

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

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

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

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)		10.00%
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)	10.00%
OnkosXcel Warrants
Debt
Warrants to purchase common stock (in shares)		175
Premium share price (as a percent)		10.00%
Threshold amount of liquidity event for exercise of warrants		$ 20,000
Percentage of fair value of consideration to be paid		75.00%
Percentage of valuation applicable to initial profits		150.00%

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	%

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

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

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)

Document and Entity Information - shares	9 Months Ended
Document and Entity Information - shares	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

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, for additional information on the accounting policies related to fair value.

The carrying amounts of cash and cash equivalents, accounts receivable, net, and accounts payable approximate fair value due to the short-term nature of these instruments. As of 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, in connection with the closing of the Second Amendment of the Credit Agreement, on the Second Amendment Effective Date, the Company amended and restated the Original Warrants granted to the Lenders to have an exercise price of $3.6452 per share.

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 $2,935 and recorded an unrealized gain of $4,691 and $16,412 for the three and nine months ended September 30, 2024, respectively within Other (income) expense, net in the Company’s Condensed Consolidated Statements of Operations. The valuation inputs used as of September 30, 2024 were a strike price of $3.20, the Company’s stock price of $0.61, volatility of 112.3%, term of 4.5 years and risk-free rate of 3.6%.

- Definition

The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.

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+ Details

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, BTI determined that the Accompanying Warrants fail the equity classification criteria and are therefore classified as liabilities in accordance with ASC 480, Distinguishing Liabilities from Equity ("ASC 480") and ASC 815, Derivatives and Hedging (“ASC 815”). The Accompanying Warrants failed to meet the requirements to be indexed to equity and equity classified, and 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. The respective derivative liabilities were recorded at fair value on the date of issuance in the amount of $19,347 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. We value the Accompanying Warrants using the Black-Scholes option pricing model as discussed in Note 14, Fair value measurements. As of September 30, 2024, the fair value of the Accompanying Warrants was $2,935. The Company recorded a fair value adjustment resulting in an unrealized gain of $4,691 and $16,412 for the three and nine months ended September 30, 2024, respectively.

Pay vs Performance Disclosure - USD ($) $ in Thousands	3 Months Ended						9 Months Ended
Pay vs Performance Disclosure - USD ($) $ in Thousands	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)

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

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-Paragraph 1A
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-Topic 942
-SubTopic 220
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.9-04(22))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147478524/942-220-S99-1

+ Details

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

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

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+ Details

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 (dexmedetomidine or “Dex”) sublingual film for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. IGALMI^TM is approved to be self-administrated by patients under the supervision of a health care provider. On July 6, 2022, BTI announced that IGALMI^TM, was commercially available in doses of 120 and 180 micrograms.

The Company’s most advanced neuroscience clinical development program is BXCL501. In indications other than those approved by the FDA as IGALMI^TM, BXCL501 is an investigational proprietary, orally dissolving, film formulation of Dex for the treatment of agitation associated with psychiatric and neurological disorders.

The Company’s 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.

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

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)			1.00%
Maximum number of shares issued or transferred under ESPP			500
Purchase price as a percent of fair market value			85.00%
Increase in shares available for issuance (in shares)	299	281
Shares issued under ESPP				0
Available for grant (in shares)				1,204

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)						20.00%
Outstanding loan (as a percent)						50.00%
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)							14.00%	14.00%
Discount rate (as a percent)						2.00%
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)						8.00%
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

Basis of Presentation (Details) - USD ($) $ in Thousands	3 Months Ended						9 Months Ended
Basis of Presentation (Details) - USD ($) $ in Thousands	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)

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

+ References

+ Details

- Definition

Amount of accumulated undistributed earnings (deficit).

+ References + Details

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

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

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)	3.00%
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

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

- Definition

Amount, excluding tax collected from customer, of revenue from satisfaction of performance obligation by transferring promised good or service to customer. Tax collected from customer is tax assessed by governmental authority that is both imposed on and concurrent with specific revenue-producing transaction, including, but not limited to, sales, use, value added and excise.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
-Section 50
-Paragraph 41
-Subparagraph (a)
-Publisher FASB
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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-SubTopic 10
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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-Section 50
-Paragraph 4
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-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-4

+ Details

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)			14.00%
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

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

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)			4.00%
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

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

+ 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

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

Restructuring (Details) $ in Thousands				3 Months Ended			9 Months Ended		12 Months Ended
Restructuring (Details) $ in Thousands	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)	28.00%	15.00%	60.00%
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

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References + Details

Inventory (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
Inventory (Details) - USD ($) $ in Thousands	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

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), its limited liquidity resources currently on hand, and its dependence on its ability to obtain additional financing to fund its operations after the current resources are exhausted, about which there can be no certainty, have resulted in management’s assessment that there is substantial doubt about the Company’s ability to continue as a going concern for a period of at least 12 months from the issuance date of the financial statements included in this Quarterly Report on Form 10-Q.

This going concern evaluation takes into consideration the potential mitigating effect of management’s Reprioritization (as defined in Note 4, Restructuring) and the additional restructuring actions taken in the second and third quarters of 2024. When substantial doubt exists, management evaluates whether the mitigating effect of its plans sufficiently alleviates the substantial doubt about the Company’s ability to continue as a going concern. The mitigating effect of management’s plans, however, is only considered if both (i) it is probable that the plans will be effectively implemented within one year after the date that the financial statements are issued and (ii) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date that the financial statements are issued. Generally, to be considered probable of being effectively implemented, the plans need to be approved by the Company’s Board of Directors. The Company’s Reprioritization was approved by the Board of Directors on August 8, 2023; however, such plans, including the additional restructuring actions taken in the second and third quarters of 2024, will not mitigate the entity’s ability to continue as a going concern within one year after the date that the financial statements are issued.

The accompanying 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) or other potential sources of debt or equity capital.

Successful completion of the Company’s development programs and, ultimately, the attainment of profitable operations are dependent upon future events, including obtaining adequate financing to support the Company’s cost structure and operating plan. Management’s plans to improve the Company’s liquidity and reduce its operating expenses and capital requirements include, among other 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.

Fair Value Measurements - Inputs (Details) $ / shares in Units, $ in Thousands	3 Months Ended	9 Months Ended
	Sep. 30, 2024 USD ($) $ / shares Y	Sep. 30, 2024 USD ($) $ / shares Y	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

Summary of Significant Accounting Policies (Policies)

9 Months Ended

Sep. 30, 2024

Summary of Significant Accounting Policies

Use of Estimates

Cash and Cash Equivalents

Cash and Cash Equivalents

Accounts Receivable, Net

Accounts Receivable, Net

Concentrations of Credit Risk

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.

Deferred Initial Public Offering Costs

Deferred Initial Public Offering Costs

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

Leases

Debt and Detachable Warrants

Debt and Detachable Warrants

Derivative Assets and Liabilities

Derivative Assets and Liabilities

In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible.

Revenue Recognition

Revenue Recognition

The Company’s revenues consist of product sales of IGALMI^TM.

Trade Discounts and Allowances

Government Rebates

Chargebacks

Product Returns

Cost of Goods Sold

Cost of Goods Sold

Stock-Based Compensation

Research and Development Costs

Patent Costs

Fair Value of Financial Instruments

●

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.

●

Earnings (Loss) Per Share

Segment Information

Segment Information

Recent Accounting Pronouncements

Recently adopted accounting pronouncements

Accounting Pronouncements effective in future periods

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 on the Condensed Consolidated Balance Sheets.

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.

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

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

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 IGALMI^TM in the institutional setting, a reduction of in-hospital commercialization expenses, a suspension of programs no longer determined to be core to ongoing operations, and a prioritization of at-home treatment setting opportunities for BXCL501.

As part of this strategy, the Company’s Board of Directors approved a reduction of approximately 60% of the Company’s workforce. The Company notified impacted employees on August 14, 2023 and recorded total restructuring costs of $4,163 for the year ended December 31, 2023. These costs consisted of severance and benefit costs of $4,063 and contract termination costs of $100. The Company paid $3,998 of severance and benefit costs and $100 of contract

termination costs in the year ended December 31, 2023. The Reprioritization 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.

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.

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.