0001558370-25-003985 | 10-K | XBRL Viewer

Fair Value Measurements - Level 3 (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Level 3 liabilities reconciliation
Beginning balance	$ 1,905	$ 2,343
Change in fair value	$ (602)	$ (438)
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	$ 40	$ 1,905
Equity Investment Rights
Level 3 liabilities reconciliation
Termination of Derivative liabilities - Equity Investment Right	$ (1,263)

Document and Entity Information - USD ($)	12 Months Ended
Document and Entity Information - USD ($)	Dec. 31, 2024	Mar. 26, 2025	Jun. 30, 2024
Document and Entity Information
Document Type	10-K
Document Annual Report	true
Document Period End Date	Dec. 31, 2024
Document Transition Report	false
Securities Act 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 Well-known Seasoned Issuer	No
Entity Voluntary Filers	No
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
ICFR Auditor Attestation Flag	false
Entity Shell Company	false
Entity Public Float			$ 41,276,960
Entity Common Stock, Shares Outstanding		5,486,038
Auditor Name	Ernst & Young LLP
Auditor Firm ID	42
Auditor Location	Stamford, Connecticut
Document Financial Statement Error Correction [Flag]	false
Entity Central Index Key	0001720893
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2024
Document Fiscal Period Focus	FY
Amendment Flag	false

Property and Equipment, net

12 Months Ended

Dec. 31, 2024

Property and Equipment, net

Property and Equipment, net

Note 6. Property and Equipment, net

Property and equipment, net consists of the following:


	December 31,		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		(1,502)		(1,193)
Total property and equipment, net	$	475	$	784

Depreciation expense was $309 and $318 for the years ended December 31, 2024 and 2023, respectively.

Fair Value Measurements

12 Months Ended

Dec. 31, 2024

Fair Value Measurements

Fair Value Measurements

Note 15. Fair Value Measurements

The Company groups its assets and liabilities measured at fair value in three levels based on the nature of the inputs and assumptions used to determine fair value. Refer to Note 3, Summary of Significant Accounting Policies, for additional information on the accounting policies related to fair value.

The carrying amounts of Cash and cash equivalents, Accounts receivable, net and Accounts payable approximate fair value due to the short-term nature of these instruments. As of December 31, 2024 and 2023, the Company had $29,036 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 years ended December 31, 2024 and 2023.

Derivative liabilities measured at fair value on a recurring basis are summarized below.


	Year ended
	December 31, 2024
	Fair Value		Level 1		Level 2		Level 3		Total

Derivative liability - BTI Warrants	$	6,593	$	—	$	6,593	$	—	$	6,593
Derivative liability - OnkosXcel Warrants		40		—		—		40		40
Total derivative liabilities	$	6,633	$	—	$	6,593	$	40	$	6,633


	Year ended
	December 31, 2023

	Fair Value		Level 1		Level 2		Level 3		Total

Derivative liability - BTI Warrants	$	1,193	$	—	$	—	$	1,193	$	1,193
Derivative liability - OnkosXcel Warrants		712		—		—		712		712
Total derivative liabilities	$	1,905	$	—	$	—	$	1,905	$	1,905

Derivative liabilities are comprised of the OnkosXcel Warrants and Equity Investment Right held by the Lenders. The fair value of the derivative liabilities was determined using Monte Carlo simulation models for the Equity Investment Right, and Binomial Option Pricing and Distribution models for the OnkosXcel Warrants. As discussed in Note 9, Debt and Credit Facilities, the Equity Investment Right was terminated on November 25, 2024 in connection with the Fifth Amendment to the Credit Agreement.

The following table presents changes in Level 3 liabilities measured at fair value for the year ended December 31, 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.


	Year ended
	December 31,
	2024		2023

Derivative liabilities, Balance - January 1	$	1,905	$	2,343
Termination of Derivative liabilities - Equity Investment Right		(1,263)		—
Change in fair value		(602)		(438)
Derivative liabilities, Balance - December 31	$	40	$	1,905

The derivative liabilities were reported at their fair values in the Consolidated Balance Sheets. The changes in the fair value of the derivative liabilities were reported as gains in the Consolidated Statements of Operations as Other (income) expense, net, for the years ended December 31, 2024 and 2023, in the amounts of $20,181 and $438, respectively.

Inputs used to calculate the estimated fair value of the Equity Investment Right were as follows:


	Equity Investment Right

Strike price relative to volume weighted 30-day average	110.0	%
Volatility (annual)	112.3	%
Probability of exercise	91.0	%
Time period	1.3	years
Estimated premium to 30-day average	24.0	%
Discount rate	4.26	%

The changes in fair value of the Equity Investment Right up to its termination date were recorded in the Consolidated Statements of Operations as Other (income) expense, net. The final carrying value of the Equity Investment Right of $1,263 upon derecognition was recorded was recorded as a reduction of derivative liability with the offset recorded as a gain in Other (income) expense, net, in the Consolidated Statements of Operations.

In estimating the fair value of the derivative liability related to the OnkosXcel Warrants, inputs included third-party fair value estimates of OnkosXcel limited liability company units along with the volatility of those units (which was set at 100% based on the historical volatility of the Company’s stock, along with a peer group of comparable publicly traded companies), and the timing and probability of the relevant capital transactions occurring.

The estimated fair value of the Credit Agreement as of December 31, 2024, was $94,204. 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 following table presents the BTI warrants issued by the Company and the corresponding balance sheet classification:


Warrant Recipient	Warrant Type	Issue Date	Exercise Price		Number of Warrants	Classification

Lenders and RIFA Purchasers	Closing Date Warrants	4/19/2022	$	7.68	17	Equity
Lenders and RIFA Purchasers	2023 Warrants	12/5/2023	$	7.68	4	Equity
Lenders and RIFA Purchasers	2024 Warrants	3/20/2024	$	7.68	6	Equity
Lenders and RIFA Purchasers	New Warrants	11/25/2024	$	0.16	313	Equity
Armistice Capital Master Fund Ltd.	Accompanying Warrants	3/25/2024	$	9.136	534	Derivative Liability
Armistice Capital Master Fund Ltd.	Accompanying Warrants	3/25/2024	$	51.20	5	Derivative Liability
Armistice Capital Master Fund Ltd.	November 2024 Accompanying Warrants	11/25/2024	$	7.68	846	Derivative Liability
Heights Capital Management	November 2024 Accompanying Warrants	11/25/2024	$	7.68	27	Derivative Liability
Hudson Bay Capital Management	November 2024 Accompanying Warrants	11/25/2024	$	7.68	27	Derivative Liability
IntraCoastal Capital, LLC	November 2024 Accompanying Warrants	11/25/2024	$	7.68	13	Derivative Liability
Total warrants issued					1,792

The fair value of the Closing Date Warrants, which was a non-recurring fair value, was determined as of the date of issuance using a Black-Scholes pricing model and the fair value of $3,245 was recorded as a component of stockholders’ equity in Additional-paid-in-capital in the Consolidated Balance Sheets, with the offset recorded as a discount on the amounts funded under the OFA Facilities. This non-recurring measurement is classified as Level 2. The inputs used were a strike price of $320.64, the Company’s stock price of $238.88, 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 Closing Date Warrants granted to the Lenders to have an exercise price of $58.3232 per share.

Using a Black-Scholes pricing model, the Company determined that the Closing Date Warrants’ fair values at the original strike price of $320.64 and the amended strike price of $58.3232 were $548 and $802, respectively, as of the Second Amendment Effective Date. The Closing Date Warrants’ incremental increase in fair value for the repricing of $254, was recorded as a component of stockholders’ equity in Additional-paid-in-capital in the Consolidated Balance Sheets, with the offset recorded as a discount on the amounts refinanced under the Credit Agreement.

In connection with the Second Amendment, the Company issued 4 “2023 Warrants” at a strike price of $58.3232 per share. The fair value of the 2023 Warrants, which is a non-recurring fair value, was determined as of the date of issuance using a Black-Scholes pricing model and the fair value of $200 was recorded as a component of stockholders’ equity in Additional-paid-in-capital in the Consolidated Balance Sheets, with the offset recorded as a discount on the amounts funded under the Credit Agreement. This non-recurring measurement is classified as Level 2. The inputs used were a strike price of $58.3232, the Company’s stock price of $59.36, volatility of 99%, term of 5.4 years and risk-free rate of 4.14%.

In connection with the Fourth Amendment, the Company issued 6 “2024 Warrants” at a strike price of $49.1568 per share. The fair value of the “2024 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 $224 was recorded as a component of stockholders’ equity in Additional-paid-in-capital in the Consolidated Balance Sheets, with the offset recorded as a discount on the amounts funded under the OFA Facilities. This non-recurring measurement is classified as Level 2. The inputs used were a strike price of $49.1568, the Company’s stock price of $44.48, volatility of 112.2%, term of 5 years and risk-free rate of 4.25%.

In addition, in connection with the Fifth Amendment of the Credit Agreement, on the Fifth Amendment Effective Date of November 25, 2024, the Company amended and restated the Closing Date Warrants, 2023 Warrants, and 2024 Warrants granted to the Lenders to have an exercise price of $7.68 per share.

Using a Black-Scholes pricing model, the Company determined that the Closing Date Warrants, 2023 Warrants, and 2024 Warrants’ fair values at the previously amended strike price of $58.3232 and original strike price of $49.1568 the amended strike price of $7.68 were $105 and $164, respectively, as of the Fifth Amendment Effective Date. The Closing Date Warrants, 2023 Warrants, and 2024 Warrants’ incremental increase in fair value for the repricing of $59, was recorded as a component of stockholders’ equity in Additional-paid-in-capital in the Consolidated Balance Sheets, with the offset recorded as a discount on the amounts refinanced under the Credit Agreement.

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 Consolidated Balance Sheets. This fair value measurement is classified as Level 2. The valuation inputs used were a strike price of $51.20, the Company’s stock price of $44.96, volatility of 112.2%, a term of 5 years and a risk-free rate of 4.2%. On November 25, 2024, 534 of the 539 Accompanying Warrants’ strike price were amended to $9.136, as part of the consideration provided to one of the investors in the November 2024 Equity raise discussed in Note 11, Common Stock Financing Activities. The increase in fair value due to the amended strike price of $1,000 was recorded as an increase in the carrying value of the Derivative liability, with the offset recorded as a loss in Other (income) expense, net, in the Company’s Consolidated Statements of Operations. We remeasured the Accompanying Warrants’ fair value at December 31, 2024 of $2,320 and recorded a net gain of $17,027, including the repricing loss of $1,000 for the year ended December 31, 2024, respectively within Other (income) expense, net in the Company’s Consolidated Statements of Operations. The valuation inputs used as of December 31, 2024 were a strike prices of $9.136 and $51.20 for 534 and 5 Accompanying Warrants, respectively, the Company’s stock price of $5.984, volatility of 112.3%, term of 4.2 years and risk-free rate of 4.4%.

The fair value of the November 2024 Accompanying Warrants at issuance on November 25, 2024 was determined using a Black-Scholes pricing model and the fair value of $5,562 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 $7.68, the Company’s stock price of $7.52, volatility of 112.5%, a term of 5 years and a risk-free rate of 4.2%. We remeasured the fair value at December 31, 2024 of $4,273 and recorded an unrealized gain of $1,289 for the year ended December 31, 2024, respectively within Other (income) expense, net in the Company’s Consolidated Statements of Operations. The valuation inputs used as of December 31, 2024 were a strike price of $7.68, the Company’s stock price of $5.984, volatility of 112.3%, term of 4.9 years and risk-free rate of 4.4%.

- 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

Net Loss Per Share (Tables)

12 Months Ended

Dec. 31, 2024

Net Loss Per Share

Schedule of net loss per share


	Year ended
	December 31,
	2024		2023

Net loss (numerator)	$	(59,599)	$	(179,053)
Weighted average shares (denominator)		2,535		1,821
Basic and diluted net loss per share	$	(23.51)	$	(98.33)

Schedule of potentially dilutive securities


	As of
	December 31,
	2024		2023

Stock options		311		311
Restricted stock units		27		12
Performance stock units		70		31
BTI Warrants		1,792		22
Total common stock equivalents		2,200		376

Leases

12 Months Ended

Dec. 31, 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 December 31, 2024, were as follows:


Year ending December 31,	Amount

2025	$	391
2026		65
Thereafter		—
Total lease payments	$	456
Imputed interest		(17)
Total lease liability	$	439
Less current portion of lease liability		(374)
Long-term portion of operating lease liability	$	65

The current portion of the Company’s operating lease liability of $374, as of December 31, 2024, is included in Other current liabilities on the Consolidated Balance Sheets.

Lease expense was $394 and $392 for the years ended December 31, 2024 and 2023, respectively.

Lease renewal options are not included in the ROU asset or lease liability.

Fair Value Measurements (Tables)

12 Months Ended

Dec. 31, 2024

Fair Value Measurements

Schedule of fair value on a recurring basis


	Year ended
	December 31, 2024
	Fair Value		Level 1		Level 2		Level 3		Total

Derivative liability - BTI Warrants	$	6,593	$	—	$	6,593	$	—	$	6,593
Derivative liability - OnkosXcel Warrants		40		—		—		40		40
Total derivative liabilities	$	6,633	$	—	$	6,593	$	40	$	6,633


	Year ended
	December 31, 2023

	Fair Value		Level 1		Level 2		Level 3		Total

Derivative liability - BTI Warrants	$	1,193	$	—	$	—	$	1,193	$	1,193
Derivative liability - OnkosXcel Warrants		712		—		—		712		712
Total derivative liabilities	$	1,905	$	—	$	—	$	1,905	$	1,905

Schedule of changes in Level 3 liabilities


	Year ended
	December 31,
	2024		2023

Derivative liabilities, Balance - January 1	$	1,905	$	2,343
Termination of Derivative liabilities - Equity Investment Right		(1,263)		—
Change in fair value		(602)		(438)
Derivative liabilities, Balance - December 31	$	40	$	1,905

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	1.3	years
Estimated premium to 30-day average	24.0	%
Discount rate	4.26	%

Schedule of warrants outstanding


Warrant Recipient	Warrant Type	Issue Date	Exercise Price		Number of Warrants	Classification

Lenders and RIFA Purchasers	Closing Date Warrants	4/19/2022	$	7.68	17	Equity
Lenders and RIFA Purchasers	2023 Warrants	12/5/2023	$	7.68	4	Equity
Lenders and RIFA Purchasers	2024 Warrants	3/20/2024	$	7.68	6	Equity
Lenders and RIFA Purchasers	New Warrants	11/25/2024	$	0.16	313	Equity
Armistice Capital Master Fund Ltd.	Accompanying Warrants	3/25/2024	$	9.136	534	Derivative Liability
Armistice Capital Master Fund Ltd.	Accompanying Warrants	3/25/2024	$	51.20	5	Derivative Liability
Armistice Capital Master Fund Ltd.	November 2024 Accompanying Warrants	11/25/2024	$	7.68	846	Derivative Liability
Heights Capital Management	November 2024 Accompanying Warrants	11/25/2024	$	7.68	27	Derivative Liability
Hudson Bay Capital Management	November 2024 Accompanying Warrants	11/25/2024	$	7.68	27	Derivative Liability
IntraCoastal Capital, LLC	November 2024 Accompanying Warrants	11/25/2024	$	7.68	13	Derivative Liability
Total warrants issued					1,792

Property and Equipment, net (Tables)

12 Months Ended

Dec. 31, 2024

Property and Equipment, net

Schedule of Property and equipment, net


	December 31,		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		(1,502)		(1,193)
Total property and equipment, net	$	475	$	784

Debt and Credit Facilities (Tables)

12 Months Ended

Dec. 31, 2024

Debt and Credit Facilities

Schedule of debt


	December 31, 2024		December 31, 2023

Credit Agreement and Guaranty	$	102,319	$	102,319
Payable-in-kind ("PIK") interest		4,403		361
Total long-term debt liability	$	106,722	$	102,680
Unamortized debt premiums, discounts and issuance costs		(4,214)		(2,082)
Total long-term debt	$	102,508	$	100,598

Schedule of maturities on long-term debt


	December 31, 2024

2025	$	—
2026	$	22,431
2027	$	84,291
Thereafter	$	—

Schedule of long-term debt interest expense


	Year ended
	December 31,
	2024		2023

Interest expense	$	14,662	$	11,941
Accretion of debt discount and amortization of financing costs		467		1,373
Total interest expense	$	15,129	$	13,314

- 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.

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+ Details

Pay vs Performance Disclosure - USD ($) $ in Thousands	12 Months Ended
Pay vs Performance Disclosure - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
Pay vs Performance Disclosure
Net Income (Loss)	$ (59,599)	$ (179,053)

- Definition

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

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+ Details

Transactions with BioXcel LLC (Tables)

12 Months Ended

Dec. 31, 2024

Transactions with BioXcel LLC

Schedule of service charges


	Year ended December 31,
	2024		2023

Research and development	$	938	$	1,075
Selling, general and administrative		392		211
Total	$	1,330	$	1,286

Accrued Expenses (Details) - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
Accrued Expenses
Accrued research and development expenses	$ 3,107	$ 6,406
Accrued compensation and benefits	35	163
Accrued professional fees	1,604	5,562
Accrued taxes	91	116
Other accrued expenses	322	177
Accrued restructuring costs	603
Total accrued expenses	$ 5,762	$ 12,424

Debt and Credit Facilities - Warrants (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands	Mar. 20, 2024	Apr. 19, 2022	Dec. 31, 2024	Nov. 21, 2024	Mar. 31, 2024	Dec. 05, 2023
Closing Date Warrants
Debt
Warrants to purchase common stock (in shares)		17
Exercise price (in dollars per share)	$ 49.1568	$ 320.64	$ 7.68	$ 7.68		$ 58.3232
Maximum equity investment allowed for lenders		$ 5,000
Premium share price (as a percent)		10.00%
Common stock issuable (in shares)		366			366
New Warrants
Debt
Warrants to purchase common stock (in shares)				313
Exercise price (in dollars per share)			0.16	$ 0.16
Original Warrants
Debt
Warrants to purchase common stock (in shares)				28
Exercise price (in dollars per share)				$ 7.68
2024 Warrant Shares
Debt
Warrants to purchase common stock (in shares)	6
Exercise price (in dollars per share)	$ 49.1568		$ 7.68
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%

Insider Trading Policies and Procedures	12 Months Ended
Insider Trading Policies and Procedures	Dec. 31, 2024
Insider Trading Policies and Procedures [Line Items]
Insider Trading Policies and Procedures Adopted	true

Commitments and Contingencies

12 Months Ended

Dec. 31, 2024

Commitments and Contingencies.

Commitments and Contingencies

Note 18. Commitments and Contingencies

From time to time, in the ordinary course of business, the Company may be subject to litigation and regulatory examinations as well as information gathering requests, inquiries and/or investigations. Other than the below, the Company is not currently subject to any matters where it believes there is a reasonable possibility that a material loss may be incurred.

On July 7, 2023, plaintiff Katelyn Martin filed a class action complaint against the Company and certain executives in the United States District Court for the District of Connecticut, captioned Martin v. BioXcel Therapeutics, et al., 3:23-cv-00915 (D. Conn). The case has since been renamed to Hills et al v. BioXcel Therapeutics, Inc. et al. 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. On February 24, 2025, while the Company’s motion to dismiss remained pending, Plaintiffs moved for leave to further amend their complaint. The Company filed an opposition to the motion on March 17, 2025. Plaintiffs’ reply is due April 7, 2025.

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 reduced 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, paid in the third quarter of 2024 for full settlement for amounts due prior to the July 11, 2024 amendment.

Stock-Based Compensation - ESPP (Details) - 2020 Employee Stock Purchase Plan - shares shares in Thousands				12 Months Ended
	Jan. 01, 2024	Jan. 01, 2023	May 20, 2020	Dec. 31, 2024
Employee Stock Purchase Plan
Authorized shares			6
Annual increase in shares available for grant (as a percent)			1.00%
Maximum number of shares issued or transferred under ESPP			31
Purchase price as a percent of fair market value			85.00%
Increase in shares available for issuance (in shares)	19	18
Shares issued under ESPP				0
Available for grant (in shares)				75

CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares shares in Thousands	Dec. 31, 2024	Dec. 31, 2023
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)	3,102	1,871
Common stock, shares outstanding (in shares)	3,102	1,871

Transactions with BioXcel LLC

12 Months Ended

Dec. 31, 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 had agreed to provide the Company with certain intellectual property prosecution and management and research and development activities.

Under the Services Agreement, the Company had 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. This option was not exercised. However, BioXcel LLC continues to perform certain administrative services under the terms of the expired contract. 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. We did not exercise our option to renew the agreement for product identification and related services utilizing BioXcel LLC’s EvolverAI. Subsequent to December 31, 2024 no development activity has been carried out by BioXcel LLC and none is contemplated.

Service charges recorded under the Services Agreement for the years December 31, 2024 and 2023 were as follows:


	Year ended December 31,
	2024		2023

Research and development	$	938	$	1,075
Selling, general and administrative		392		211
Total	$	1,330	$	1,286

There were no service charges due as of December 31, 2024 and December 31, 2023.

- 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

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-URI https://asc.fasb.org/1943274/2147479134/946-220-S99-1

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+ Details

Fair Value Measurements - Inputs (Details) shares in Thousands, $ in Thousands				12 Months Ended
	Nov. 25, 2024 USD ($) $ / shares Y shares	Nov. 21, 2024 USD ($) $ / shares shares	Dec. 05, 2023 USD ($) $ / shares Y shares	Dec. 31, 2024 USD ($) $ / shares Y shares	Dec. 31, 2023 USD ($)	Mar. 25, 2024 USD ($) $ / shares Y	Mar. 20, 2024 USD ($) $ / shares Y shares	Apr. 19, 2022 USD ($) $ / shares Y shares
Fair value inputs
Fair value debt \| $				$ 94,204
Warrant derivative liability \| $				6,633	$ 1,905
Gain (loss) on derivatives \| $				20,181	438
Fair value adjustment warrants \| $				59	254
Repricing of stock purchase warrants \| $				$ 59	$ 254
Warrants outstanding (in shares) \| shares				1,792
Equity Investment Rights
Fair value inputs
Increase (decrease) carrying value \| $	$ (1,263)			$ (1,263)
Equity Investment Rights \| Strike price
Fair value inputs
Derivative liability input				1.10
Equity Investment Rights \| Volatility (annual)
Fair value inputs
Derivative liability input				1.123
Equity Investment Rights \| Probability of exercise
Fair value inputs
Derivative liability input				0.91
Equity Investment Rights \| Term
Fair value inputs
Derivative liability input \| Y				1.3
Equity Investment Rights \| Estimated premium to 30-day average
Fair value inputs
Derivative liability input				0.24
Equity Investment Rights \| Discount rate
Fair value inputs
Derivative liability input				0.0426
OnkosXcel Warrants
Fair value inputs
Warrants to purchase common stock (in shares) \| shares								175
OnkosXcel Warrants \| Volatility (annual)
Fair value inputs
Derivative liability input				1
Closing Date Warrants
Fair value inputs
Fair value warrant classified as equity \| $		$ 164	$ 802				$ 105	$ 548
Exercise price (in dollars per share)		$ 7.68	$ 58.3232	$ 7.68			$ 49.1568	$ 320.64
Warrants to purchase common stock (in shares) \| shares								17
Repricing of stock purchase warrants \| $		$ 59	$ 254
Warrants outstanding value \| $								$ 3,245
Warrants outstanding (in shares) \| shares				17
Closing Date Warrants \| Strike price
Fair value inputs
Derivative liability input								320.64
Closing Date Warrants \| Volatility (annual)
Fair value inputs
Derivative liability input								0.95
Closing Date Warrants \| Term
Fair value inputs
Derivative liability input \| Y								7
Closing Date Warrants \| Risk-free rate
Fair value inputs
Derivative liability input								0.0295
Closing Date Warrants \| Share price input
Fair value inputs
Derivative liability input								238.88
2023 Warrants
Fair value inputs
Fair value warrant classified as equity \| $			$ 200
Exercise price (in dollars per share)			$ 58.3232	$ 7.68
Warrants to purchase common stock (in shares) \| shares			4
Warrants outstanding (in shares) \| shares				4
2023 Warrants \| Strike price
Fair value inputs
Derivative liability input			58.3232
2023 Warrants \| Volatility (annual)
Fair value inputs
Derivative liability input			0.99
2023 Warrants \| Term
Fair value inputs
Derivative liability input \| Y			5.4
2023 Warrants \| Risk-free rate
Fair value inputs
Derivative liability input			0.0414
2023 Warrants \| Share price input
Fair value inputs
Derivative liability input			59.36
2024 Warrants
Fair value inputs
Fair value warrant classified as equity \| $							$ 224
Exercise price (in dollars per share)							$ 49.1568
Warrants to purchase common stock (in shares) \| shares							6
2024 Warrants \| Strike price
Fair value inputs
Derivative liability input							49.1568
2024 Warrants \| Volatility (annual)
Fair value inputs
Derivative liability input							1.122
2024 Warrants \| Term
Fair value inputs
Derivative liability input \| Y							5
2024 Warrants \| Risk-free rate
Fair value inputs
Derivative liability input							0.0425
2024 Warrants \| Share price input
Fair value inputs
Derivative liability input							44.48
March 2024 Accompanying Warrants
Fair value inputs
Fair value warrant classified as equity \| $				$ 2,320		$ 19,347
Exercise price (in dollars per share)		$ 9.136				$ 51.2
Warrant derivative liability \| $				2,320		$ 19,347
Gain (loss) on derivatives \| $				$ 17,027
Fair value adjustment warrants \| $	$ 1,000	$ 1,000
Warrants outstanding (in shares) \| shares	539
March 2024 Accompanying Warrants \| Strike price
Fair value inputs
Derivative liability input				5.984		51.2
March 2024 Accompanying Warrants \| Volatility (annual)
Fair value inputs
Derivative liability input				1.123		1.122
March 2024 Accompanying Warrants \| Term
Fair value inputs
Derivative liability input \| Y				4.2		5
March 2024 Accompanying Warrants \| Risk-free rate
Fair value inputs
Derivative liability input				0.044		0.042
March 2024 Accompanying Warrants \| Share price input
Fair value inputs
Derivative liability input						44.96
March 2024 Accompanying Warrants, Strike Price Amended
Fair value inputs
Exercise price (in dollars per share)				$ 9.136
Warrants outstanding (in shares) \| shares	534	534		534
March 2024 Accompanying Warrants, Strike Price Amended \| Strike price
Fair value inputs
Derivative liability input				9.136
Exercise price (in dollars per share)	$ 9.136
March 2024 Accompanying Warrants, Strike Price Not Amended
Fair value inputs
Exercise price (in dollars per share)				$ 51.2
Warrants outstanding (in shares) \| shares				5
March 2024 Accompanying Warrants, Strike Price Not Amended \| Strike price
Fair value inputs
Derivative liability input				51.2
November 2024 Accompanying Warrants
Fair value inputs
Fair value warrant classified as equity \| $	$ 5,562			$ 4,273
Warrant derivative liability \| $	$ 5,562			4,273
Gain (loss) on derivatives \| $				$ 1,289
November 2024 Accompanying Warrants \| Strike price
Fair value inputs
Derivative liability input	7.68
Exercise price (in dollars per share)				$ 7.68
November 2024 Accompanying Warrants \| Volatility (annual)
Fair value inputs
Derivative liability input	1.125			1.123
November 2024 Accompanying Warrants \| Term
Fair value inputs
Derivative liability input \| Y	5			4.9
November 2024 Accompanying Warrants \| Risk-free rate
Fair value inputs
Derivative liability input	0.042			0.044
November 2024 Accompanying Warrants \| Share price input
Fair value inputs
Derivative liability input	7.52			5.984

Segment Information

12 Months Ended

Dec. 31, 2024

Segment Information

Segment Information

Note 19. Segment Information

The Company views its operations and manages its business as one operating and reportable segment, utilizing artificial intelligence (“AI”) to develop transformative medicines in neuroscience and immuno-oncology. We are focused on utilizing cutting-edge technology and innovative research to develop high-value therapeutics aimed at transforming patients’ lives. We employ various AI platforms to reduce therapeutic development costs and potentially accelerate development timelines.

Consistent with the operational structure, the Chief Executive Officer, as the chief operating decision maker (“CODM”), reviews weekly cash usage and allocates resources based on consolidated net loss that also is reported on the consolidated statements of operations. The measure of segment assets is reported on the balance sheet as total consolidated assets. The CODM utilizes consolidated net loss by comparing actual results against budgeted amounts on a quarterly basis. As part of this process, consolidated net loss is a critical performance measure used to evaluate the

Company’s operating performance and guide strategic decisions and resource allocations, including additional investments in research and development and commercialization activities.

The following table provides information about the Company’s one reportable segment and includes the reconciliation to consolidated net loss.


	Year ended December 31,
	2024		2023

Product revenue, net	$	2,266	$	1,380
Less:
Cost of goods sold	$	2,143	$	1,260
Research and development costs:
Personnel and related costs	$	9,796	$	16,351
Non-cash stock-based compensation		2,251		6,324
Professional fees		5,067		14,590
Clinical trials expense		9,384		35,094
Chemical, manufacturing and controls cost		1,927		8,687
Other expenses		2,010		3,280
Total research and development costs	$	30,435	$	84,326
Commercial costs:
Personnel and related costs		2,516		19,331
Non-cash stock-based compensation		(401)		1,081
Professional fees		554		965
Commercial and marketing		1,389		12,485
Travel related expenses		309		2,004
Other expenses		906		2,038
Total commercial costs	$	5,273	$	37,904
Selling, general and administrative costs:
Personnel and related costs	$	5,340	$	7,840
Non-cash stock-based compensation		4,306		11,209
Professional fees		15,583		21,345
Commercial and marketing		—		—
Travel related expenses		446		982
Other expenses		3,544		4,133
Total selling, general and administrative costs	$	29,219	$	45,509
Restructuring costs		2,441		4,163
Total operating expenses	$	69,511	$	173,162
Other (income) expense
Interest expense		15,129		13,314
Interest income		(2,602)		(5,649)
Other (income) expense, net		(20,173)		(394)
Segment net loss	$	(59,599)	$	(179,053)
Adjustments and reconciling items		—		—
Consolidated Net Loss	$	(59,599)	$	(179,053)

- Definition

The entire disclosure for reporting segments including data and tables. Reportable segments include those that meet any of the following quantitative thresholds a) it's reported revenue, including sales to external customers and intersegment sales or transfers is 10 percent or more of the combined revenue, internal and external, of all operating segments b) the absolute amount of its reported profit or loss is 10 percent or more of the greater, in absolute amount of 1) the combined reported profit of all operating segments that did not report a loss or 2) the combined reported loss of all operating segments that did report a loss c) its assets are 10 percent or more of the combined assets of all operating segments.

+ References

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+ Details

Restructuring (Details) $ in Thousands				3 Months Ended			12 Months Ended
Restructuring (Details) $ in Thousands	Sep. 17, 2024 USD ($) employee	May 08, 2024	Aug. 08, 2023	Dec. 31, 2024 USD ($)	Sep. 30, 2024 USD ($)	Jun. 30, 2024 USD ($)	Dec. 31, 2024 USD ($)	Dec. 31, 2023 USD ($)
Restructuring
Employees eliminated (as a percent)	28.00%	15.00%	60.00%
Restructuring costs				$ 33	$ 1,553	$ 856	$ 2,441	$ 4,163
Payments for restructuring				983
Employees eliminated \| employee	15
Expected total restructuring charges	$ 1,586
Accrued restructuring costs				$ 603			$ 603
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

CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
OPERATING CASH FLOW ACTIVITIES:
Net loss	$ (59,599)	$ (179,053)
Reconciliation of net loss to net cash used in operating activities
Depreciation	309	318
Accretion of debt discount and amortization of financing costs	467	1,373
Change in fair value of derivative liabilities	(20,180)	(438)
Stock-based compensation expense	6,156	18,614
Payable-in-kind interest on Credit Agreement	6,543	1,872
Loss on disposal of equipment		2
Operating lease right-of-use assets	306	288
Changes in operating assets and liabilities
Accounts receivable	(60)	177
Inventory	1,312	(6)
Prepaid expenses, other current assets and other assets	(1,872)	2,888
Accounts payable, accrued expenses, due to related parties, and other current liabilities	(4,327)	(3,219)
Accrued interest	(736)	2,497
Operating lease liabilities	(346)	(319)
Net cash used in operating activities	(72,027)	(155,006)
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	39,688	27,032
Debt Issuance Costs		(180)
Payment of principal of Long-term debt	(2,500)
Offering costs for common stock and warrants issuance	(474)	(811)
Payment of employee tax obligations related to vesting restricted stock units	(54)	(27)
Exercise of stock options		508
Net cash provided by financing activities	36,660	26,522
Net decrease in cash and cash equivalents	(35,367)	(128,504)
Cash and cash equivalents, beginning of the period	65,221	193,725
Cash and cash equivalents, end of the period	29,854	65,221
Supplemental cash flow information:
Issuance of stock purchase warrants	2,540	200
Repricing of stock purchase warrants	59	254
Interest paid	$ 7,968	7,551
Conversion of accrued interest to long-term debt		$ 767

Debt and Credit Facilities

12 Months Ended

Dec. 31, 2024

Debt and Credit Facilities

Debt and Credit Facilities

Note 9. Debt and Credit Facilities

Debt, net of unamortized discounts and financing costs, consists of the following:


	December 31, 2024		December 31, 2023

Credit Agreement and Guaranty	$	102,319	$	102,319
Payable-in-kind ("PIK") interest		4,403		361
Total long-term debt liability	$	106,722	$	102,680
Unamortized debt premiums, discounts and issuance costs		(4,214)		(2,082)
Total long-term debt	$	102,508	$	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 “RIFA Purchasers”) and OFA as administrative agent. Under the OFA Facilities, the Lenders and the RIFA 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^® 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 RIFA 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 December 31, 2023 was approximately 13.5%.

The remaining tranches may be borrowed at the Company’s option prior to December 31, 2024, subject to satisfaction of certain conditions, including regulatory and financial milestones. Tranche B of the Credit Agreement is $20,000 and is available upon satisfaction of certain conditions and financial milestones. Tranche C of the Credit Agreement is $30,000 and is available upon satisfaction of certain conditions, including receipt of certain regulatory and financial milestones. Tranche D of the Credit Agreement is $50,000 and is available upon satisfaction of the Tranche C Term Loans conditions precedent to, and the funding of Tranche C Loans, including specified minimum net sales of the Company attributable to sales of BXCL501 for a trailing twelve consecutive month period, on or before December 31, 2025.

The loans under the Credit Agreement do not amortize and mature on April 19, 2027. The Company may, at its option, no earlier than September 21, 2026 and no later than October 21, 2026, request an extension of the maturity date to April, 19, 2028, provided that the Company satisfies certain conditions including receipt of certain regulatory and financial milestones. Borrowings under the Credit Agreement are issued at a 200-basis point original issue discount and bear interest at a variable annual rate of TERM SOFR (but not less than 2.5% or more than 5.5%) plus 7.5%, payable quarterly. The rate resets every three months based on the current Term SOFR rate. Of such interest, above 8% per annum is, at the Company’s option, payable in kind by capitalizing and adding such interest to the outstanding principal amount of loans from the first payment date on which such interest is owed through March 31, 2025, unless, with respect to any payment date, the Company elects to pay all or a portion of such interest in cash. The Company is required to pay a ticking fee equal to 0.75% per annum on the undrawn amount of the commitments, payable quarterly commencing 120 days after April 22, 2022 through the termination of the commitments, which is expensed as incurred and recognized as interest expense in the Consolidated Statements of Operations. The Company may voluntarily prepay the Credit Agreement at any time subject to a prepayment fee.

The Company’s obligations under the Credit Agreement are guaranteed by BTI’s existing and subsequently acquired or organized subsidiaries, subject to certain exceptions. BTI’s obligations under the Credit Agreement and the related guarantees thereunder are secured, subject to customary permitted liens and other agreed upon exceptions, by (i) 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.

Waiver and Fifth Amendment to Credit Agreement and Guaranty

On November 21, 2024, the Company entered into the Fifth Amendment to Credit Agreement and Guaranty and First Amendment to Fourth Amendment to Credit Agreement and Guaranty (the “Fifth Amendment”), which amended the Credit Agreement and Guaranty, dated April 19, 2022, by and among the Company, as the borrower, certain subsidiaries of the Company from time to time party thereto as subsidiary guarantors, the lenders party thereto (the “Lenders”), and Oaktree Fund Administration LLC (“OFA”) as administrative agent (as amended by the Waiver and First Amendment to Credit Agreement and Guaranty, dated as of November 13, 2023, the Second Amendment to Credit Agreement and Guaranty and Termination of Revenue Interest Financing Agreement, dated as of December 5, 2023, the Third Amendment to Credit Agreement, dated as of February 12, 2024, and the Fourth Amendment to Credit Agreement and Guaranty, dated as of March 20, 2024 (the “Fourth Amendment”), the “Existing Credit Agreement”).

Pursuant to the Fifth Amendment, the Lenders agreed to, among other things, (i) waive the Credit Agreement’s covenant that the report and opinion the Company will receive from its independent registered public accounting firm with respect to the financial statements for the year ending December 31, 2024 will not contain a “going concern” or similar qualification, (ii) permanently waive the Credit Agreement’s minimum revenue covenant, and (iii) waive the Fourth Amendment’s requirement that the Company raise, after the effective date of the Fourth Amendment and on or before November 30, 2024, at least $50,000 in gross cash proceeds from the issuance of its common stock, warrants, and/or pre-funded warrants, and/or in cash and/or non-cash consideration from newly entered-into partnering transactions.

The Fifth Amendment includes a new capital raising covenant requiring that the Company receive (A) after the effective date of the Fifth Amendment and on or prior to November 27, 2024, at least $7,000 in gross cash proceeds from the issuance of the Company’s common stock, warrants and/or pre-funded warrants(“Raise 1”), (B) after the effective date of the Fifth Amendment and on or before March 15, 2025 (provided that the Company was required to use its commercially reasonable efforts to satisfy the requirement by February 15, 2025), at least $18,000 in net cash proceeds (including the proceeds of Raise 1) from (i) the issuance of the Company’s common stock, warrants and/or pre-funded warrants, (ii) non-refundable cash consideration from partnering transactions entered into after the effective date of the Fifth Amendment (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), (iii) the issuance of the Company’s subordinated debt (subject to terms set forth in the Fifth Amendment), and/or (iv) asset sales permitted pursuant to the Credit Agreement or consented to by the Lenders (such capital raise, “Raise 2”), and (C) after the effective date of the Fifth Amendment and on or prior to the earlier of (x) August 15, 2025 and (y) the date that is 30 days after the final data readout of the SERENITY At-Home Phase 3 trial, at least $29,000 in net cash proceeds (including the proceeds from Raise 1 and Raise 2) from the same permitted capital raising activities listed in the preceding clause (B).

In connection with the Fifth Amendment and the required capital raises described in the preceding paragraph, the Lenders agreed to modify the Credit Agreement’s minimum liquidity covenant to require minimum cash liquidity of $7,500 (instead of $25,000) from and after the closing of Raise 1until March 30, 2025. On March 31, 2025, the minimum liquidity amount will increase to $10,000 and on September 30, 2025, the minimum liquidity amount will further increase to $15,000.

In connection with the Fifth Amendment, the Company paid a one-time amortization payment of $2,500 principal amount, together with accrued and unpaid interest and a portion of the prepayment fee and other fees payable in December 2024.

The Fifth Amendment also modifies the interest rate of the loans provided under the Credit Agreement from a floating rate of Term SOFR plus 7.50% per annum, to a fixed rate of 13% per annum, retroactive to and effective as of September 30, 2024. For the quarterly payment dates ending December 31, 2024, March 31, 2025, and June 30, 2025, the Company will have the ability to make interest payments of up to 10% per annum “in-kind” by capitalizing and adding such interest to the outstanding principal amount of the loans under the Credit Agreement. In addition, pursuant to the Fifth Amendment, the Company will be required to make quarterly amortization payments equal to 5.0% of the principal amount of funded loans, together with applicable prepayment fees, beginning on March 31, 2026.

On the effective date of the Fifth Amendment and as a condition to effectiveness thereof, the Company’s wholly owned subsidiaries OnkosXcel Therapeutics, LLC and OnkosXcel Employee Holdings, LLC (collectively, “OnkosXcel”), which previously provided unsecured guarantees of the Company’s obligations under the Credit Agreement, granted security interests in substantially all of their assets to support such obligations.

The Fifth Amendment amends the negative covenants under the Credit Agreement to remove flexibility the Company and its subsidiaries previously had thereunder to undertake various transactions, including, without limitation, with respect to potential dispositions of OnkosXcel or out-licenses by OnkosXcel of its intellectual property.

Pursuant to the Fifth Amendment, the Company committed to appoint a new independent board director (subject to customary background checks, applicable law, confirmation of independence and Nasdaq rules), and to provide the independent director with various privileges and committee memberships on the board of directors of the Company

(including the appointment of such director on committee to be formed to focus on capital raising and evaluate strategic options). The Company also agreed to engage an investment banker reasonably acceptable to OFA and the Lenders to assist the Company and its board of directors with evaluating and exploring strategic options.

The Company also agreed to covenants requiring that the Company’s cash expenditures be monitored by the Lenders according to a board-approved budget provided to the Lenders prior to the signing of the Fifth Amendment, which cash budget will be updated on a bi-weekly basis going forward. The Company will not be permitted to make disbursements for any two-week period in excess of 115% of the aggregate budgeted amount of disbursements for the applicable period. Finally, pursuant to the Fifth Amendment, the Company is restricted from paying cash bonuses for its employees or executives during the fiscal years 2024 and 2025 without OFA’s consent or increasing the cash compensation for fiscal year 2025 for certain senior officers of the Company from their compensation for fiscal year 2024.

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^®, 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.

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 17 shares of the Company’s common stock at an exercise price of $320.6 per share (the “Closing Date Warrants”). Pursuant to the amendment and restatement of the Closing Date Warrants, dated December 5, 2023 (the “Amended and Restated Closing Date Warrants”), the exercise price of the Closing Date Warrants has been reduced to $58.3232 per share. In addition, the Company granted new warrants to the Lenders to purchase up to 4 shares of the Company’s common stock (the “2023 Warrant Shares”) at an exercise price of $58.3232 per share (the “2023 Warrants” and together with the Amended and Restated Closing Date Warrants, the “Warrants”). The Amended and Restated Closing Date Warrants and the 2023 Warrants will expire on April 19, 2029 and may be net exercised at the holders 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 the Company’s common stock issuable under the Warrants (including the Closing Date Warrants and the 2023 Warrants) and Lenders’ Equity Investment Right was 366 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 6 shares of its common stock (the “2024 Warrant Shares”) at an exercise price of $49.1568 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.

Fifth Amendment Warrants, Registration Rights Agreement and Equity Investment Right Termination

Prior to the Fifth Amendment, pursuant to the Credit Agreement, the Lenders had the right to purchase shares of our common stock, 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”). The Equity investment Right was terminated as part of the Fifth Amendment. We entered into a registration rights agreement with the Lenders (as amended and restated in connection with the Second Amendment, the “Amended and Restated Registration Rights Agreement”) and filed registration statements on Form S-3 to register the shares issuable upon exercise of the Closing Date Warrants, 2023 Warrants and the New Warrants for resale. The maximum shares of our common stock issuable under the Closing Date Warrants, the 2023 Warrants and the Lenders’ Equity Investment Right was 366. On the Effective Date, we further amended and restated the Amended and Restated Registration Rights Agreement (the “Second Amended and Restated Registration Rights Agreement”) with the Lenders. Pursuant to the Second Amended and Restated Registration Rights Agreement, we agreed to register the 2024 Warrant Shares for resale.

In connection with the closing of the Fifth Amendment, the Company agreed to, substantially concurrently with the closing of Raise 1, grant new warrants to the Lenders to purchase an aggregate of 313 shares of common stock on the closing date of the Fifth Amendment, at an exercise price of $0.16 per share (the “New Warrants”). The New Warrants will expire on the seventh anniversary of their issuance.

In addition, the Company agreed to, substantially concurrently with the closing of Raise 1, amend and restate all warrants to purchase stock of the Company issued to the Lenders prior to the effective date of the Fifth Amendment, to revise the exercise price thereunder to an exercise price equal to the lower of (i) the price per share of the common stock of the Company issued in Raise 1 and (ii) 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 Raise 1 (such existing warrants, as amended and restated, the “Original Warrants”). The Original Warrants provide the Lenders with the right to purchase a total of 28 shares of common stock of the Company, and the exercise prices of $58.3232 per share and $49.1568 per share were reduced to $7.68 per share.

On the date of issuance of the New Warrants, the Company agreed to amend and restate its Second Amended and Restated Registration Rights Agreement with the Lenders, dated March 20, 2024. Pursuant to such amendment and restatement (the “Third Amended and Restated Registration Rights Agreement”), the Company will agree to register the shares of common stock issuable under the New Warrants, in addition to all Original Warrants, for resale.

As part of entering into the Credit Agreement, OnkosXcel, a wholly owned subsidiary of BTI, granted the OnkosXcel Warrants to the Lenders to purchase 175 individual limited liability company units. 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.

Maturities of long-term debt are expected to be as follows:


	December 31, 2024

2025	$	—
2026	$	22,431
2027	$	84,291
Thereafter	$	—

Interest expense was as follows:


	Year ended
	December 31,
	2024		2023

Interest expense	$	14,662	$	11,941
Accretion of debt discount and amortization of financing costs		467		1,373
Total interest expense	$	15,129	$	13,314

- 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.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481544/470-10-50-6

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481544/470-10-50-6

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 405
-SubTopic 40
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477092/405-40-50-1

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 405
-SubTopic 40
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (a)(3)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477092/405-40-50-1

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 405
-SubTopic 40
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (a)(2)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477092/405-40-50-1

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 405
-SubTopic 40
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (a)(1)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477092/405-40-50-1

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 405
-SubTopic 40
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477092/405-40-50-1

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1B
-Subparagraph (h)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481139/470-20-50-1B

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 235
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(c))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480678/235-10-S99-1

Reference 10: http://fasb.org/us-gaap/role/ref/legacyRef
-Topic 470
-Name Accounting Standards Codification
-Publisher FASB
-URI https://asc.fasb.org/470/tableOfContent

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-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 12: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1B
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481139/470-20-50-1B

Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1B
-Subparagraph (g)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481139/470-20-50-1B

Reference 14: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
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-Name Accounting Standards Codification
-Section 50
-Paragraph 1B
-Subparagraph (i)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481139/470-20-50-1B

Reference 15: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1C
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481139/470-20-50-1C

Reference 16: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1C
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481139/470-20-50-1C

Reference 17: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1C
-Subparagraph (c)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481139/470-20-50-1C

Reference 18: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1E
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481139/470-20-50-1E

Reference 19: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1I
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481139/470-20-50-1I

Reference 20: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
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-URI https://asc.fasb.org/1943274/2147481139/470-20-50-1I

Reference 21: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
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-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481139/470-20-50-1I

+ Details

Stock-Based Compensation (Tables)

12 Months Ended

Dec. 31, 2024

Stock-Based Compensation

Schedule of stock option activity



	Number of	Weighted average
	shares	price per share

Outstanding as of January 1, 2024	311	$	296.36
Granted	40	$	20.00
Forfeited	(24)	$	214.56
Cancelled	(16)	$	339.74
Exercised	—	$	—
Outstanding as of December 31, 2024	311	$	265.36

Options vested and exercisable as of December 31, 2024	249	$	291.94

Schedule of stock-based compensation charges


	Year ended December 31,
	2024		2023

Research and development	$	2,251	$	6,324
Selling, general and administrative		3,905		12,290
Total	$	6,156	$	18,614

BTI RSU

Stock-Based Compensation

Schedule of activity relating to RSUs



		Number of
		shares

Outstanding as of January 1, 2024		12
Granted		22
Cancelled		(1)
Vested		(6)
Outstanding as of December 31, 2024		27

BTI PSU

Stock-Based Compensation

Schedule of activity relating to PSUs


		Number of
		shares

Outstanding as of January 1, 2024		33
Granted		87
Cancelled		(27)
Exercised		(23)
Outstanding as of December 31, 2024		70

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	(89)	$	5,506
Forfeited	—	$	—
Outstanding as of December 31, 2024	1,166

Vested units as of December 31, 2024	941	$	5,570

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		(41)
Cancelled		(8)
Outstanding as of December 31, 2024		176

Employee Stock Option

Stock-Based Compensation

Schedule of Valuation Assumptions



	Year ended						Year ended
		December 31, 2024					December 31, 2023

Expected term		5.5	years	-	6.1	years	5.5	years	-	6.1	years
Expected stock price volatility		108.0	%	-	112.5	%	96.9	%	-	109.9	%
Risk-free rate of interest		4.0	%	-	4.5	%	3.5	%	-	4.7	%
Expected dividend yield		0.0	%	-	0.0	%	0.0	%	-	0.0	%

Income Taxes - Deferred Tax (Details) - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
Income Taxes
Federal net operating losses	$ 90,853	$ 73,770
State net operating losses	23,152	21,255
Stock options	14,601	13,915
Tax credits	17,188	15,048
Capitalized research & development	44,377	49,603
Accrued expense	202
Depreciation	103	73
Lease accounting - liability	115	212
Disallowed charitable contributions	1
Deferred Costs	674
Cancellation of Debt	1,483
Valuation allowance	(192,149)	(173,679)
Total deferred tax assets	600	197
Debt Amendment	(500)
Unrealized loss		(12)
Right-of-use assets	(100)	(185)
Total deferred tax liabilities	$ (600)	$ (197)

Insider Trading Arrangements	3 Months Ended
Insider Trading Arrangements	Dec. 31, 2024 shares
Trading Arrangements, by Individual
Material Terms of Trading Arrangement	Insider Trading Arrangements (a)On December 14, 2024, Vimal Mehta, Chief Executive Officer, adopted a Rule 10b5-1 trading arrangement that is intended to satisfy the affirmative defense of Rule 10b5-1(c) for the sale of up to 2,184 shares of the Company’s common stock to cover taxes due in connection with the vesting of restricted stock units until December 31, 2025. (b)On December 14, 2024, Richard Steinhart, Chief Executive Officer, adopted a Rule 10b5-1 trading arrangement that is intended to satisfy the affirmative defense of Rule 10b5-1(c) for the sale of up to 1,563 shares of the Company’s common stock to cover taxes due in connection with the vesting of restricted stock units until December 31, 2025. (c)On December 14, 2024, Javier Rodriguez, Senior Vice President, Chief Legal Officer, adopted a Rule 10b5-1 trading arrangement that is intended to satisfy the affirmative defense of Rule 10b5-1(c) for the sale of up to 1,563 shares of the Company’s common stock to cover taxes due in connection with the vesting of restricted stock units until December 31, 2025. (d)On December 14, 2024, Frank Yocca, Chief Scientific Officer, adopted a Rule 10b5-1 trading arrangement that is intended to satisfy the affirmative defense of Rule 10b5-1(c) for the sale of up to 1,563 shares of the Company’s common stock to cover taxes due in connection with the vesting of restricted stock units until December 31, 2025. Each of these plans were terminated effective March 17, 2025.
Vimal Mehta
Trading Arrangements, by Individual
Name	Vimal Mehta
Title	Chief Executive Officer
Rule 10b5-1 Arrangement Adopted	true
Adoption Date	December 14, 2024
Expiration Date	December 31, 2025
Aggregate Available	2,184
Richard Steinhart
Trading Arrangements, by Individual
Name	Richard Steinhart
Title	Chief Executive Officer
Rule 10b5-1 Arrangement Adopted	true
Adoption Date	December 14, 2024
Expiration Date	December 31, 2025
Aggregate Available	1,563
Javier Rodriguez
Trading Arrangements, by Individual
Name	Javier Rodriguez
Title	Senior Vice President, Chief Legal Officer
Rule 10b5-1 Arrangement Adopted	true
Adoption Date	December 14, 2024
Expiration Date	December 31, 2025
Aggregate Available	1,563
Frank Yocca
Trading Arrangements, by Individual
Name	Frank Yocca
Title	Chief Scientific Officer
Rule 10b5-1 Arrangement Adopted	true
Adoption Date	December 14, 2024
Expiration Date	December 31, 2025
Aggregate Available	1,563

Derivative Financial Instruments (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands			12 Months Ended
	Nov. 25, 2024	Nov. 21, 2024	Dec. 31, 2024	Dec. 31, 2023	Mar. 25, 2024
Derivative Financial Instruments
Warrant derivative liability			$ 6,633	$ 1,905
Warrants outstanding (in shares)			1,792
Fair value adjustment warrants			$ 59	254
Gain (loss) on derivatives			20,181	$ 438
Equity Investment Rights
Derivative Financial Instruments
Increase (decrease) carrying value	$ (1,263)		(1,263)
March 2024 Accompanying Warrants
Derivative Financial Instruments
Warrant derivative liability			2,320		$ 19,347
Warrants outstanding (in shares)	539
Exercise price (in dollars per share)		$ 9.136			$ 51.2
Fair value adjustment warrants	$ 1,000	$ 1,000
Gain (loss) on derivatives			$ 17,027
March 2024 Accompanying Warrants, Strike Price Amended
Derivative Financial Instruments
Warrants outstanding (in shares)	534	534	534
Exercise price (in dollars per share)			$ 9.136
November 2024 Accompanying Warrants
Derivative Financial Instruments
Warrant derivative liability	$ 5,562		$ 4,273
Gain (loss) on derivatives			$ 1,289

Fair Value Measurements - Warrants outstanding (Details) - $ / shares shares in Thousands	Dec. 31, 2024	Nov. 25, 2024	Nov. 21, 2024	Mar. 20, 2024	Dec. 05, 2023	Apr. 19, 2022
Derivative Financial Instruments
Number of Warrants (in shares)	1,792
Closing Date Warrants
Derivative Financial Instruments
Exercise price (in dollars per share)	$ 7.68		$ 7.68	$ 49.1568	$ 58.3232	$ 320.64
Number of Warrants (in shares)	17
2023 Warrants
Derivative Financial Instruments
Exercise price (in dollars per share)	$ 7.68				$ 58.3232
Number of Warrants (in shares)	4
2024 Warrant Shares
Derivative Financial Instruments
Exercise price (in dollars per share)	$ 7.68			$ 49.1568
Number of Warrants (in shares)	6
New Warrants
Derivative Financial Instruments
Exercise price (in dollars per share)	$ 0.16		$ 0.16
Number of Warrants (in shares)	313
March 2024 Accompanying Warrants, Strike Price Amended
Derivative Financial Instruments
Exercise price (in dollars per share)	$ 9.136
Number of Warrants (in shares)	534	534	534
March 2024 Accompanying Warrants, Strike Price Not Amended
Derivative Financial Instruments
Exercise price (in dollars per share)	$ 51.2
Number of Warrants (in shares)	5
November 2024 Accompanying Warrants \| Armistice Capital Master Fund
Derivative Financial Instruments
Exercise price (in dollars per share)	$ 7.68
Number of Warrants (in shares)	846
November 2024 Accompanying Warrants \| Heights Capital Management
Derivative Financial Instruments
Exercise price (in dollars per share)	$ 7.68
Number of Warrants (in shares)	27
November 2024 Accompanying Warrants \| Hudson Bay Capital Management
Derivative Financial Instruments
Exercise price (in dollars per share)	$ 7.68
Number of Warrants (in shares)	27
November 2024 Accompanying Warrants \| IntraCoastal Capital
Derivative Financial Instruments
Exercise price (in dollars per share)	$ 7.68
Number of Warrants (in shares)	13

Property and equipment, net (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Property and equipment, net
Total property and equipment	$ 1,977	$ 1,977
Accumulated depreciation	(1,502)	(1,193)
Total property and equipment, net	475	784
Depreciation	309	318
Computers and equipment
Property and equipment, net
Total property and equipment	202	202
Furniture
Property and equipment, net
Total property and equipment	575	575
Leasehold improvements
Property and equipment, net
Total property and equipment	$ 1,200	$ 1,200

Basis of Presentation (Details) - USD ($) $ in Thousands	12 Months Ended
Basis of Presentation (Details) - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
Basis of Presentation
Cash and cash equivalents	$ 29,854	$ 65,221
Accumulated deficit	650,197	590,598
Net losses	59,599	179,053
Net cash used in operating activities	$ 72,027	$ 155,006

- 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

Summary of Significant Accounting Policies - Concentrations (Details)	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Revenue benchmark \| Customer concentration \| Customer one
Concentrations of Risk
Concentration risk (as a percent)	32.00%	39.00%

Net Loss Per Share

12 Months Ended

Dec. 31, 2024

Net Loss Per Share

Net Loss Per Share

Note 17. Net Loss Per Share

Basic and diluted net loss per share are as follows:


	Year ended
	December 31,
	2024		2023

Net loss (numerator)	$	(59,599)	$	(179,053)
Weighted average shares (denominator)		2,535		1,821
Basic and diluted net loss per share	$	(23.51)	$	(98.33)

Potentially dilutive securities outstanding consists of stock options, RSUs and performance units, and BTI warrants. The Company had common stock equivalents outstanding are as follows:


	As of
	December 31,
	2024		2023

Stock options		311		311
Restricted stock units		27		12
Performance stock units		70		31
BTI Warrants		1,792		22
Total common stock equivalents		2,200		376

Leases - Maturities (Details) - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
Maturities of the operating lease liability
2025	$ 391
2026	65
Total lease payments	456
Imputed interest	(17)
Total lease liability	439
Less current portion of lease liability	$ (374)
Operating Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration]	Other Liabilities, Current
Long-term portion of operating lease liabilities	$ 65	$ 440

Subsequent Events

12 Months Ended

Dec. 31, 2024

Subsequent Events

Subsequent Events

Note 20. Subsequent Events

As discussed in Note 11, Common Stock Financing Activities, in connection with the November 2024 issuance and sale in a public offering of (i) 350 shares of the Company’s common stock, and the November 2024 Accompanying Warrants to purchase 350 shares of Common Stock, and (ii) pre-funded warrants to purchase 563 shares of Common Stock, in February 2025, certain investors exercised the remaining 483 pre-funded warrants to purchase 483 shares of Common Stock.

On March 3, 2025, the Company entered into the Purchase Agreement with the Purchaser named therein. Pursuant to the Purchase Agreement, the Company agreed to issue and sell to the Purchaser and the Purchaser agreed to buy in a registered direct offering (i) an aggregate of 188 shares (the “Shares”) of common stock, par value $0.001 per share and accompanying warrants to purchase up to 188 shares of Common Stock at a combined offering price of $3.50 per Share and accompanying warrant, and (ii) the Pre-Funded Warrants to purchase up to 3,812 shares of Common Stock and accompanying warrants to purchase up to 3,812 shares of Common Stock, at a combined offering price of $3.499 per share underlying the Pre-Funded Warrants and accompanying warrant, which equals the offering price per Share and accompanying warrant less the $0.001exercise price per share of the Pre-Funded Warrants, pursuant to an effective registration statement on Form S-3 (File No. 333-275261), including the base prospectus included therein, and prospectus supplement filed with the SEC on March 4, 2025. As of March 28, 2025, 1,688 Pre-Funded Warrants were exercised. In the 2025 Offering, the Company also issued to the Purchaser warrants (the “Option Warrants”), to purchase up to 4,000 shares of Common Stock (or pre-funded warrants in lieu thereof) and accompanying warrants to purchase up to 4,000 shares of Common Stock to the Purchaser. The pre-funded warrants and accompanying warrants issuable upon exercise of the Option Warrants will have substantially identical terms as the Pre-Funded Warrants and the accompanying warrants. The exercise price of the Option Warrants is $3.50 per underlying share of Common Stock and accompanying warrant to purchase one share of Common Stock, or $3.499 per underlying pre-funded warrant to purchase one share of Common Stock and accompanying warrant to purchase one share of Common Stock. The Option Warrants expired on March 18, 2025 without being exercised.

On March 26, 2025, we and Jefferies terminated that certain Open Market Sales Agreement, dated May 10, 2021, as amended on November 1, 2023.

Debt and Credit Facilities - Credit Agreement (Details) - USD ($) $ in Thousands								3 Months Ended	9 Months Ended	12 Months Ended
	Nov. 21, 2024	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, 2024	Dec. 31, 2023	Nov. 12, 2023	Apr. 28, 2022
Debt
Total long-term debt liability										$ 106,722	$ 102,680
Proceeds from issuance of common stock and warrant		$ 25,000						$ 467
Payment of principal of Long-term debt										2,500
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 borrowing capacity					$ 202,319
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%
Total long-term debt liability										$ 102,319	$ 102,319
Remaining borrowing capacity								100,000	$ 100,000
Equity Investment Right								5,000	5,000
Effective interest rate (as a percent)											13.50%
Discount rate (as a percent)							2.00%
Debt Instrument, Variable Interest Rate, Type [Extensible Enumeration]	us-gaap:SecuredOvernightFinancingRateSofrMember									us-gaap:SecuredOvernightFinancingRateSofrMember
Incremental interest rate (as a percent)	7.50%						7.50%
Debt paid-in-kind interest (as a percent)	10.00%						8.00%
Ticking fee (as a percent)							0.75%
Minimum Liquidity Amount			$ 25,000	$ 15,000				25,000	25,000
Minimum revenue required from equity sale				$ 40,000
Proceeds from issuance of common stock and warrant									$ 30,943
Payment of principal of Long-term debt	$ 2,500
Fixed rate	13.00%
Principal payment of loans (as a percent)	5.00%
Maximum percentage of budgeted amount allowed for disbursement	115.00%
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 \| Period one
Debt
Minimum Liquidity Amount	$ 7,500
Minimum revenue required from equity sale	7,000		25,000
Credit Agreement \| Period two
Debt
Minimum Liquidity Amount	10,000
Minimum revenue required from equity sale	18,000		40,000					40,000
Credit Agreement \| Period three
Debt
Minimum Liquidity Amount	15,000
Minimum revenue required from equity sale	$ 29,000		$ 50,000					$ 50,000

Net Loss Per Share - Antidilutive (Details) - shares shares in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Common stock equivalents
Potentially dilutive securities (in shares)	2,200	376
Employee Stock Option
Common stock equivalents
Potentially dilutive securities (in shares)	311	311
BTI RSU
Common stock equivalents
Potentially dilutive securities (in shares)	27	12
BTI PSU
Common stock equivalents
Potentially dilutive securities (in shares)	70	31
BTI Warrants
Common stock equivalents
Potentially dilutive securities (in shares)	1,792	22

Stock-Based Compensation - Description (Details) - shares shares in Thousands	Jan. 01, 2024	Jan. 01, 2023	May 20, 2020	Dec. 31, 2024
2020 Incentive Award Plan
Stock-Based Compensation
Authorized shares			57
Available for grant (in shares)				42
Annual increase in shares available for grant (as a percent)			4.00%
Increase in shares available for issuance (in shares)	75	70
Terms of award			10 years
Vesting period			4 years
2017 Equity Incentive Plan
Stock-Based Compensation
Available for grant (in shares)			15

- 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

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
-SubTopic 10
-Name Accounting Standards Codification
-Section 35
-Paragraph 1D
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480483/718-10-35-1D

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
-SubTopic 10
-Name Accounting Standards Codification
-Section 35
-Paragraph 3
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480483/718-10-35-3

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (a)(1)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480429/718-10-50-2

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (a)(2)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480429/718-10-50-2

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (a)(3)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480429/718-10-50-2

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (c)(1)(i)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480429/718-10-50-2

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (c)(1)(ii)
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-URI https://asc.fasb.org/1943274/2147480429/718-10-50-2

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (c)(1)(iii)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480429/718-10-50-2

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (c)(1)(iv)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480429/718-10-50-2

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (c)(1)(iv)(01)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480429/718-10-50-2

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
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+ Details

Segment Information (Tables)

12 Months Ended

Dec. 31, 2024

Segment Information

Schedule of reportable segment


	Year ended December 31,
	2024		2023

Product revenue, net	$	2,266	$	1,380
Less:
Cost of goods sold	$	2,143	$	1,260
Research and development costs:
Personnel and related costs	$	9,796	$	16,351
Non-cash stock-based compensation		2,251		6,324
Professional fees		5,067		14,590
Clinical trials expense		9,384		35,094
Chemical, manufacturing and controls cost		1,927		8,687
Other expenses		2,010		3,280
Total research and development costs	$	30,435	$	84,326
Commercial costs:
Personnel and related costs		2,516		19,331
Non-cash stock-based compensation		(401)		1,081
Professional fees		554		965
Commercial and marketing		1,389		12,485
Travel related expenses		309		2,004
Other expenses		906		2,038
Total commercial costs	$	5,273	$	37,904
Selling, general and administrative costs:
Personnel and related costs	$	5,340	$	7,840
Non-cash stock-based compensation		4,306		11,209
Professional fees		15,583		21,345
Commercial and marketing		—		—
Travel related expenses		446		982
Other expenses		3,544		4,133
Total selling, general and administrative costs	$	29,219	$	45,509
Restructuring costs		2,441		4,163
Total operating expenses	$	69,511	$	173,162
Other (income) expense
Interest expense		15,129		13,314
Interest income		(2,602)		(5,649)
Other (income) expense, net		(20,173)		(394)
Segment net loss	$	(59,599)	$	(179,053)
Adjustments and reconciling items		—		—
Consolidated Net Loss	$	(59,599)	$	(179,053)

Debt and Credit Facilities - Debt summary (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Debt
Total long-term debt liability	$ 106,722	$ 102,680
Unamortized debt premiums, discounts and issuance costs	(4,214)	(2,082)
Total long-term debt	102,508	100,598
Credit Agreement
Debt
Accrued interest	4,403	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.

+ References

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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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Reference 14: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

- Definition

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

+ References + Details

Fair Value Measurements - Hierarchy (Details) - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
Fair value assets and liabilities
Warrant derivative liability	$ 6,633	$ 1,905
Level 1
Fair value assets and liabilities
Fair value money market accounts	29,036	64,860
Recurring
Fair value assets and liabilities
Warrant derivative liability	6,633	1,905
Recurring \| BTI Warrants
Fair value assets and liabilities
Warrant derivative liability	6,593	1,193
Recurring \| OnkosXcel Warrants
Fair value assets and liabilities
Warrant derivative liability	40	712
Recurring \| Level 2
Fair value assets and liabilities
Warrant derivative liability	6,593
Recurring \| Level 2 \| BTI Warrants
Fair value assets and liabilities
Warrant derivative liability	6,593
Recurring \| Level 3
Fair value assets and liabilities
Warrant derivative liability	40	1,905
Recurring \| Level 3 \| BTI Warrants
Fair value assets and liabilities
Warrant derivative liability		1,193
Recurring \| Level 3 \| OnkosXcel Warrants
Fair value assets and liabilities
Warrant derivative liability	40	712
Recurring \| Fair Value
Fair value assets and liabilities
Warrant derivative liability	6,633	1,905
Recurring \| Fair Value \| BTI Warrants
Fair value assets and liabilities
Warrant derivative liability	6,593	1,193
Recurring \| Fair Value \| OnkosXcel Warrants
Fair value assets and liabilities
Warrant derivative liability	$ 40	$ 712

Accrued Expenses

12 Months Ended

Dec. 31, 2024

Accrued Expenses

Accrued Expenses

Note 7. Accrued Expenses

Accrued expenses consist of the following:


	December 31, 2024		December 31, 2023

Accrued research and development expenses	$	3,107	$	6,406
Accrued compensation and benefits		35		163
Accrued professional fees		1,604		5,562
Accrued taxes		91		116
Other accrued expenses		322		177
Accrued restructuring costs		603		—
Total accrued expenses	$	5,762	$	12,424

Debt and Credit Facilities - Maturities (Details) $ in Thousands	Dec. 31, 2024 USD ($)
Debt and Credit Facilities
2026	$ 22,431
2027	$ 84,291

Subsequent Events (Details) - $ / shares shares in Thousands				1 Months Ended
	Mar. 28, 2025	Mar. 03, 2025	Nov. 22, 2024	Feb. 28, 2025	Dec. 31, 2024	Dec. 31, 2023
Subsequent Events
Common stock, par value (in dollars per share)					$ 0.001	$ 0.001
Underwriting Agreement
Subsequent Events
Shares issued (in shares)			350
Offering price (in dollars per share)			$ 7.68
Underwriting Agreement \| November 2024 Accompanying Warrants
Subsequent Events
Warrants to purchase common stock (in shares)			350
Underwriting Agreement \| November 2024 Pre-Funded Warrants
Subsequent Events
Warrants to purchase common stock (in shares)			563
Subsequent event \| Underwriting Agreement \| November 2024 Pre-Funded Warrants
Subsequent Events
Warrants to purchase common stock (in shares)				483
Exercise of warrants, stock issued (in shares)				483
Subsequent event \| Purchase Agreement
Subsequent Events
Shares issued (in shares)		188
Common stock, par value (in dollars per share)		$ 0.001
Offering price (in dollars per share)		$ 3.5
Subsequent event \| Purchase Agreement \| March 2025 Accompanying Warrants
Subsequent Events
Warrants to purchase common stock (in shares)		188
Offering price (in dollars per share)		$ 3.499
Exercise price (in dollars per share)		$ 3.499
Subsequent event \| Purchase Agreement \| March 2025 Pre-Funded Warrants
Subsequent Events
Warrants to purchase common stock (in shares)		3,812
Exercise of warrants, stock issued (in shares)	1,688
Exercise price (in dollars per share)		$ 0.001
Subsequent event \| Purchase Agreement \| March 2025 Option Warrants
Subsequent Events
Warrants to purchase common stock (in shares)		4,000
Exercise price (in dollars per share)		$ 3.5

CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' (DEFICIT) EQUITY - USD ($) shares in Thousands, $ in Thousands	Common Stock	Additional Paid in Capital	Accumulated Deficit	Total
Beginning Balance at Dec. 31, 2022	$ 28	$ 488,292	$ (411,545)	$ 76,775
Beginning Balance (in shares) at Dec. 31, 2022	1,759
Issuance of common stock, net of offering costs	$ 2	26,219		26,221
Issuance of common stock, net of offering costs (in shares)	88
Stock-based compensation		18,614		18,614
Exercise of stock options		508		508
Exercise of stock options (in shares)	20
Repricing of stock purchase warrants		254		254
Issuance of stock purchase warrants		200		200
Vesting of restricted stock units, net of employee tax obligations		(27)		(27)
Vesting of restricted stock units, net of employee tax obligations (in shares)	4
Net Income (Loss)			(179,053)	(179,053)
Ending Balance at Dec. 31, 2023	$ 30	534,060	(590,598)	$ (56,508)
Ending Balance (in shares) at Dec. 31, 2023	1,871			1,871
Issuance of common stock, net of offering costs	$ 19	9,907		$ 9,926
Issuance of common stock, net of offering costs (in shares)	1,209
Stock-based compensation		6,156		6,156
Repricing of stock purchase warrants		59		59
Issuance of stock purchase warrants		2,540		2,540
Issuance of pre-funded stock purchase warrants		4,379		4,379
Vesting of restricted stock units, net of employee tax obligations		(54)		(54)
Vesting of restricted stock units, net of employee tax obligations (in shares)	22
Net Income (Loss)			(59,599)	(59,599)
Ending Balance at Dec. 31, 2024	$ 49	$ 557,047	$ (650,197)	$ (93,101)
Ending Balance (in shares) at Dec. 31, 2024	3,102			3,102

Transactions with BioXcel LLC (Details) - USD ($) $ in Thousands		12 Months Ended
	Jun. 30, 2017	Dec. 31, 2024	Dec. 31, 2023
Transactions with BioXcel
Research and development		$ 30,435	$ 84,326
Selling, general and administrative		34,492	83,413
Total operating expenses		69,511	173,162
Related Party
Transactions with BioXcel
Other Liabilities, Current		107	107
Related Party \| BioXcel LLC
Transactions with BioXcel
Monthly agreement option fees	$ 18
Research and development		938	1,075
Selling, general and administrative		392	211
Total operating expenses		1,330	1,286
Other Liabilities, Current		$ 0	$ 0
Related Party \| BioXcel LLC \| Development milestones
Transactions with BioXcel
Potential milestone payments	10,000
Related Party \| BioXcel LLC \| Sales milestones
Transactions with BioXcel
Potential milestone payments	$ 30,000
Maximum milestone (as as percent)	3.00%

Income Taxes (Tables)

12 Months Ended

Dec. 31, 2024

Income Taxes

Schedule of net deferred tax assets


	December 31,		December 31,
	2024		2023
Deferred tax assets:
Federal net operating losses	$	90,853	$	73,770
State net operating losses		23,152		21,255
Stock options		14,601		13,915
Tax credits		17,188		15,048
Capitalized research & development		44,377		49,603
Accrued expense		202		—
Depreciation		103		73
Lease accounting - liability		115		212
Disallowed charitable contributions		1
Deferred Costs		674
Cancellation of debt		1,483
Valuation allowance		(192,149)		(173,679)
Total deferred tax assets	$	600	$	197
Deferred tax liabilities:
Debt amendment	$	(500)		—
Unrealized loss		—	$	(12)
Right-of-use assets		(100)		(185)
Total deferred tax liabilities	$	(600)	$	(197)
Net deferred tax asset (liability)	$	—	$	—

Schedule of effective tax rate and statutory rate reconciliation


	2024	2024		2023	2023
Federal statutory rate	(12,516)	21.0	%	(37,601)	21.0	%
Stock based compensation	381	(0.6)	%	(573)	0.3	%
Warrant mark-to-market	(4,238)	7.1	%	—	—	%
Federal and state credits	(1,870)	3.2	%	(4,082)	2.3	%
State taxes	(343)	0.6	%	(14,261)	8.0	%
Other	116	(0.3)	%	1,210	(0.7)	%
Change in valuation allowance	18,470	(31.0)	%	55,307	(30.9)	%
	—	—	%	—	—	%

Debt and Credit Facilities - Revenue Interest Financing (Details) - Revenue interest financing - USD ($) $ in Thousands	Dec. 05, 2023	Apr. 19, 2022	Jul. 08, 2022
Debt
Debt extinguishment	$ 30,000
Maximum borrowing capacity		$ 120,000
Debt to revenue multiplier		0.0175
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			$ 30,000

Stock-Based Compensation - Options (Details) - Employee Stock Option $ / shares in Units, shares in Thousands, $ in Thousands	12 Months Ended
	Dec. 31, 2024 USD ($) $ / shares shares
Number of Shares
Outstanding, beginning balance (in shares) \| shares	311
Options granted (in shares) \| shares	40
Options forfeited (in shares) \| shares	(24)
Options cancelled (in shares) \| shares	(16)
Outstanding, ending balance (in shares) \| shares	311
Options vested and exercisable (in shares) \| shares	249
Weighted Average Exercise Price per Share
Outstanding, beginning balance (in dollars per shares)	$ 296.36
Options granted (in dollars per share)	20
Options forfeited (in dollars per shares)	214.56
Options cancelled (in dollars per shares)	339.74
Outstanding, end balance (in dollars per shares)	265.36
Options vested and exercisable (in dollars per shares)	$ 291.94
Options
Intrinsic value, outstanding \| $	$ 0
Intrinsic value, exercised \| $	0
Intrinsic value, exercisable \| $	$ 0
Weighted-average grant-date fair value of options granted (in dollars per share)	$ 16.63
Weighted-average grant-date fair value of options vested (in dollars per share)	$ 215.98
Weighted average remaining contractual life, exercisable	4 years 10 months 24 days
Weighted average remaining contractual life, outstanding	5 years 7 months 6 days
Unrecognized compensation expense \| $	$ 7,691
Remaining unamortized expense period	10 months 24 days

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

Leases (Tables)

12 Months Ended

Dec. 31, 2024

Leases

Summary of maturities of the operating lease liability


Year ending December 31,	Amount

2025	$	391
2026		65
Thereafter		—
Total lease payments	$	456
Imputed interest		(17)
Total lease liability	$	439
Less current portion of lease liability		(374)
Long-term portion of operating lease liability	$	65

Income Taxes - Reconciliation (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Reconciliation between effective and statutory rate, Amount
Federal statutory rate	$ (12,516)	$ (37,601)
Stock based compensation	381	(573)
Warrant mark-to-market	(4,238)
Federal and state credits	(1,870)	(4,082)
State taxes	(343)	(14,261)
Other	116	1,210
Change in valuation allowance	18,470	55,307
Total effective tax	$ 0	$ 0
Reconciliation between effective and statutory rate, Percent
Federal statutory rate (as a percent)	21.00%	21.00%
Stock based compensation (as a percent)	(0.60%)	0.30%
Warrant mark-to-market (as a percent)	7.10%
Federal and state tax credits (as a percent)	3.20%	2.30%
State Taxes (as a percent)	0.60%	8.00%
Other (as a percent)	(0.30%)	(0.70%)
Valuation allowance (as a percent)	(31.00%)	(30.90%)
Effective tax (as a percent)	0.00%	0.00%
Unrecognized tax benefits	$ 0	$ 0
Income tax related interest and penalties	0	$ 0
Federal
Reconciliation between effective and statutory rate, Percent
Net operating loss carry-forwards	432,634
Operating loss carryforward with no expiration	429,988
Tax credit carry-forwards	15,965
State
Reconciliation between effective and statutory rate, Percent
Net operating loss carry-forwards	443,454
Tax credit carry-forwards	$ 1,548

CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
Current assets
Cash and cash equivalents	$ 29,854	$ 65,221
Accounts receivable, net	131	71
Inventory	679	1,991
Prepaid expenses	5,290	2,782
Other current assets	1,440	2,078
Total current assets	37,394	72,143
Property and equipment, net	475	784
Operating lease right-of-use assets	382	688
Other assets	87	87
Total assets	38,338	73,702
Current liabilities
Accounts payable	15,990	13,654
Accrued expenses	5,762	12,424
Accrued interest		736
Total current liabilities	22,233	27,267
Long-term portion of operating lease liabilities	65	440
Derivative liabilities	6,633	1,905
Long-term debt	102,508	100,598
Total liabilities	131,439	130,210
Commitments and contingencies (Note 18)
Stockholders' (deficit) equity
Preferred stock, $0.001 par value, 10,000 shares authorized; no shares issued and outstanding as of December 31, 2024 and December 31, 2023
Common stock, $0.001 par value, 200,000 and 100,000 shares authorized as of December 31, 2024 and December 31, 2023, respectively; 3,102 and 1,871 shares issued and outstanding as of December 31, 2024 and December 31, 2023, respectively	49	30
Additional paid-in-capital	557,047	534,060
Accumulated deficit	(650,197)	(590,598)
Total stockholders' (deficit) equity	(93,101)	(56,508)
Total liabilities and stockholders' (deficit) equity	38,338	73,702
Related Party
Current liabilities
Other current liabilities	107	107
Nonrelated Party
Current liabilities
Other current liabilities	$ 374	$ 346

CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Revenues
Product revenue, net	$ 2,266	$ 1,380
Operating expenses
Cost of goods sold	2,143	1,260
Research and development	30,435	84,326
Selling, general and administrative	34,492	83,413
Restructuring costs	2,441	4,163
Total operating expenses	69,511	173,162
Loss from operations	(67,245)	(171,782)
Other (income) expense
Interest expense	15,129	13,314
Interest income	(2,602)	(5,649)
Other (income) expense, net	(20,173)	(394)
Net loss	$ (59,599)	$ (179,053)
Basic net loss per share attributable to common stockholders (in dollars per share)	$ (23.51)	$ (98.33)
Diluted net loss per share attributable to common stockholders (in dollars per share)	$ (23.51)	$ (98.33)
Weighted average shares outstanding - basic (in shares)	2,535	1,821
Weighted average shares outstanding - diluted (in shares)	2,535	1,821

Summary of Significant Accounting Policies (Details) $ in Thousands		12 Months Ended
	Feb. 10, 2025	Dec. 31, 2024 USD ($) segment
Summary of Significant Accounting Policies
Deferred offering costs \| $		$ 2,570
Number of operating segments \| segment		1
Subsequent event
Summary of Significant Accounting Policies
Stock split	0.0625
Minimum
Summary of Significant Accounting Policies
Accounts receivable payment term		30 days
Maximum
Summary of Significant Accounting Policies
Accounts receivable payment term		75 days
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

Accrued Expenses (Tables)

12 Months Ended

Dec. 31, 2024

Accrued Expenses

Schedule of accrued expenses


	December 31, 2024		December 31, 2023

Accrued research and development expenses	$	3,107	$	6,406
Accrued compensation and benefits		35		163
Accrued professional fees		1,604		5,562
Accrued taxes		91		116
Other accrued expenses		322		177
Accrued restructuring costs		603		—
Total accrued expenses	$	5,762	$	12,424

Inventory

12 Months Ended

Dec. 31, 2024

Inventory

Inventory

Note 5. Inventory

Inventory consists of the following:


	December 31,		December 31,
	2024		2023

Raw materials	$	506	$	935
Work-in-process		—		651
Finished goods		173		405
Total inventory	$	679	$	1,991

The Company recorded inventory write-downs due to excess inventory of $1,980 and $1,191 for the years ended December 31, 2024 and 2023, respectively.

Restructuring

12 Months Ended

Dec. 31, 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^® in the institutional setting, a reduction of in-hospital commercialization expenses, a suspension of programs no longer determined to be core to ongoing operations, and a prioritization of at-home treatment setting opportunities for BXCL501.

As part of this strategy, the Company’s Board of Directors approved a reduction of approximately 60% of the Company’s workforce. The Company notified impacted employees on August 14, 2023 and recorded total restructuring costs of $4,163 for the year ended December 31, 2023. These costs consisted of severance and benefit costs of $4,063 and contract termination costs of $100. The Company paid $3,998 of severance and benefit costs and $100 of contract termination costs in the year ended December 31, 2023. The Reprioritization is substantially complete as of December 31, 2023, and any remaining costs are expected to be paid during the first quarter of 2024.

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 months 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 incurred aggregate charges in connection with the Clinical Prioritization of $1,586 which relate primarily to severance and benefits costs. Accordingly, the Company recorded a restructuring charge of $1,553 in the third quarter 2024, and $33 in the fourth quarter. The Company completed the Clinical Prioritization in October 2024, and paid $983 of the related costs during the fourth quarter of 2024 and expects to pay the remaining $603 in the first quarter of 2025, which is included in Accrued Expenses on the Consolidated Balance at December 31, 2024.

Stock-Based Compensation - Assumptions (Details)	12 Months Ended
Stock-Based Compensation - Assumptions (Details)	Dec. 31, 2024	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%	96.90%
Expected stock price volatility, maximum (as a percent)	112.50%	109.90%
Risk-free rate of interest, minimum (as a percent)	4.00%	3.50%
Risk-free rate of interest, maximum (as a percent)	4.50%	4.70%
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%	0.00%

Stock-Based Compensation

12 Months Ended

Dec. 31, 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) 57 shares of the Company’s common stock and (ii) 15 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 75 shares and 70 shares on January 1, 2024 and 2023, respectively.

Stock-based awards granted under the 2020 Plan have a term of ten years. The vesting schedule of all awards granted under the 2020 Plan is determined by the Board of Directors, which is generally four years. Stock-based awards granted under the 2020 Plan include stock options, BTI RSUs, and Performance Units.

As of December 31, 2024, there were 42 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		12
Granted		22
Cancelled		(1)
Vested		(6)
Outstanding as of December 31, 2024		27

In 2024, the Company granted 22 time-based BTI RSUs to certain employees, executives, and board members. The RSUs granted to employees and executives vest 100% at the one-year anniversary of the grant date. The weighted average grant date fair value per share for the BTI RSUs granted to employees and executives in 2024 was $23.43. Unrecognized stock-based compensation expense related to these awards was $13 as of December 31, 2024. The RSUs granted to board members vest monthly over a 12-month period, beginning in November 2024. The weighted average grant date fair value per share for the BTI RSUs granted to board members was $9.12. Unrecognized stock-based compensation expense related to these awards was $185 as of December 31, 2024. Unrecognized stock-based compensation expense related to awards issued prior to 2024 was $575 and $1,715 as of December 31, 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		33
Granted		87
Cancelled		(27)
Exercised		(23)
Outstanding as of December 31, 2024		70

In July 2024, the Company granted 87 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 $19.20. None of the Performance Units had vested as of December 31, 2024. Unrecognized stock-based compensation expense related to these Performance Units expected to vest was zero as of December 31, 2024 since it is uncertain whether any performance criteria will be met.

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	(89)	$	5,506
Forfeited	—	$	—
Outstanding as of December 31, 2024	1,166

Vested units as of December 31, 2024	941	$	5,570

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.

The fair values of the PSUs granted in 2024 was $8 per unit, and was estimated at the date of grant using a Black-Scholes option pricing model. The total fair value of the PSUs vested during the year ended December 31, 2024 was $1,165.



	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 the PSUs was $377 as of December 31, 2024.

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		(41)
Cancelled		(8)
Outstanding as of December 31, 2024		176

As of December 31, 2024, the Company had 176 OnkosXcel Restricted Stock Units outstanding. Unrecognized stock-based compensation expense related to the awards expected to vest was approximately $210 as of December 31, 2024.

BTI Stock options

A summary of the Company’s stock option activity for the year ended December 31, 2024, is presented below.



	Number of	Weighted average
	shares	price per share

Outstanding as of January 1, 2024	311	$	296.36
Granted	40	$	20.00
Forfeited	(24)	$	214.56
Cancelled	(16)	$	339.74
Exercised	—	$	—
Outstanding as of December 31, 2024	311	$	265.36

Options vested and exercisable as of December 31, 2024	249	$	291.94

As of December 31, 2024, the intrinsic value of options outstanding was $0. The intrinsic value for stock options is calculated based on the difference between the exercise prices of the underlying awards and the quoted stock price of the Company’s common stock as of the reporting date.

The total intrinsic value of stock options exercised for the year ended December 31, 2024 was $0. The total intrinsic value of stock options exercisable as of December 31, 2024 was $0.

The weighted average grant date fair value of options granted during the year ended December 31, 2024 was $16.63.

The weighted average grant date fair value of options vested as of December 31, 2024 was $215.98.

The weighted average remaining contractual life is 4.9 years for options exercisable as of December 31, 2024. The weighted average remaining contractual life was 5.6 years for options outstanding as of December 31, 2024.

Unrecognized compensation expense related to unvested stock option awards as of December 31, 2024, was $7,691 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 0.9 years.

Stock-Based Compensation

The fair value of options granted during the years ended December 31, 2024 and 2023 was estimated using the Black-Scholes pricing model with the following assumptions:



	Year ended						Year ended
		December 31, 2024					December 31, 2023

Expected term		5.5	years	-	6.1	years	5.5	years	-	6.1	years
Expected stock price volatility		108.0	%	-	112.5	%	96.9	%	-	109.9	%
Risk-free rate of interest		4.0	%	-	4.5	%	3.5	%	-	4.7	%
Expected dividend yield		0.0	%	-	0.0	%	0.0	%	-	0.0	%

In 2024, the Company continued using the historical volatility of its common stock to estimate volatility. Prior to 2023, volatility was estimated using a combination of the historical volatility of publicly traded peer companies and that of the Company’s common stock. The expected term of the awards is estimated based on the simplified method, which calculates the expected term based upon the midpoint of the term of the award and the vesting period. The Company uses the simplified method because it does not have sufficient option exercise data to provide a reasonable basis upon which to estimate the expected term. The expected dividend yield is zero percent as the Company has no history of paying dividends nor does management expect to pay dividends over the contractual terms of these options. The risk-free interest rates are determined by reference to the U.S. Treasury yield curve in effect at the time of grant, with maturities approximating the expected term of the stock options. The fair value of the underlying common stock is generally determined as the closing price of the Company’s common stock on The Nasdaq Capital Market on the grant date, with consideration of whether there is material nonpublic information that could impact that estimated fair value when it is released.

The Company recognized stock-based compensation expense related to awards issued under the 2017 Plan and the 2020 Plan, as well as the OnkosXcel PSUs and OnkosXcel RSU’s, of $6,156 and $18,614 for the years ended December 31, 2024 and 2023, respectively, which were comprised as follows:


	Year ended December 31,
	2024		2023

Research and development	$	2,251	$	6,324
Selling, general and administrative		3,905		12,290
Total	$	6,156	$	18,614

2020 Employee Stock Purchase Plan

The Company’s 2020 Employee Stock Purchase Plan (the “ESPP”) was also approved and became effective at the Company’s 2020 annual meeting of stockholders on May 20, 2020. The ESPP is designed to assist eligible employees of the Company with the opportunity to purchase the Company’s common stock at a discount through accumulated payroll deductions during successive offering periods. The aggregate number of shares that may be issued pursuant to rights granted under the ESPP is 6 shares of common stock. In addition, the number of shares available for issuance under the ESPP will increase on the first day of each calendar year, beginning on January 1, 2021 and ending on and including January 1, 2030, by a number of shares of common stock equal to the lesser of (a) 1% of the shares outstanding on the final day of the immediately preceding calendar year and (b) such smaller number of shares as determined by the Board of Directors. The number of shares that may be issued or transferred pursuant to rights granted under the component of the ESPP that is intended to qualify for favorable U.S. federal tax treatment under Section 423 of the Internal Revenue Code (the “Section 423 Component”) shall not exceed 31 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 19 shares and 18 shares on January 1, 2024 and 2023, respectively. To date, no shares have been sold under the ESPP. There were 75 shares available for issuance as of December 31, 2024.

Segment Information (Details) $ in Thousands	3 Months Ended			12 Months Ended
Segment Information (Details) $ in Thousands	Dec. 31, 2024 USD ($)	Sep. 30, 2024 USD ($)	Jun. 30, 2024 USD ($)	Dec. 31, 2024 USD ($) segment	Dec. 31, 2023 USD ($)
Segment Reporting
Product revenue, net				$ 2,266	$ 1,380
Cost of goods sold				2,143	1,260
Research and development costs:
Total research and development costs				30,435	84,326
Selling, general and administrative costs:
Total selling, general and administrative costs				34,492	83,413
Restructuring costs	$ 33	$ 1,553	$ 856	2,441	4,163
Total operating expenses				69,511	173,162
Other (income) expense
Interest expense				15,129	13,314
Interest income				(2,602)	(5,649)
Other (income) expense, net				(20,173)	(394)
Net loss				$ (59,599)	(179,053)
Number of operating segments \| segment				1
Number of reportable segments \| segment				1
Single reportable segment \| Operating segments
Segment Reporting
Product revenue, net				$ 2,266	1,380
Cost of goods sold				2,143	1,260
Research and development costs:
Personnel and related costs				9,796	16,351
Non-cash stock-based compensation				2,251	6,324
Professional fees				5,067	14,590
Clinical trials expense				9,384	35,094
Chemical, manufacturing and controls cost				1,927	8,687
Travel related expense				2,010	3,280
Total research and development costs				30,435	84,326
Commercial costs:
Personnel and related costs				2,516	19,331
Non-cash stock-based compensation				(401)	1,081
Professional fees				554	965
Commercial and marketing				1,389	12,485
Travel related expenses				309	2,004
Other expenses				906	2,038
Total commercial costs				5,273	37,904
Selling, general and administrative costs:
Personnel and related costs				5,340	7,840
Non-cash stock-based compensation				4,306	11,209
Professional fees				15,583	21,345
Travel related expenses				446	982
Other expenses				3,544	4,133
Total selling, general and administrative costs				29,219	45,509
Restructuring costs				2,441	4,163
Total operating expenses				69,511	173,162
Other (income) expense
Interest expense				15,129	13,314
Interest income				(2,602)	(5,649)
Other (income) expense, net				(20,173)	(394)
Net loss				$ (59,599)	$ (179,053)

Employee Benefit Plan

12 Months Ended

Dec. 31, 2024

Employee Benefit Plan

Employee Benefit Plan

Note 14. Employee Benefit Plan

The Company maintains a defined contribution retirement plan for its employees that complies with Section 401(k) of the Internal Revenue Code (the “401(K) Plan”). Employees are eligible to participate in the 401(K) Plan and can contribute a portion of their pay into the 401(K) Plan, subject to annual limits established by the U.S. Internal Revenue Service. Participating employees receive an employer matching contribution equal to 50% of eligible employee contributions on the first 5% of eligible compensation contributed. Employer contributions to the 401(K) Plan were $289 and $788 for the years ended December 31, 2024 and 2023, respectively.

Basis of Presentation

12 Months Ended

Dec. 31, 2024

Basis of Presentation

Basis of Presentation

Note 2. Basis of Presentation

The accompanying consolidated financial statements include those of the Company and its subsidiaries after elimination of all intercompany accounts and transactions and have been prepared in conformity with United States (“U.S.”) Generally Accepted Accounting Principles (“GAAP”).

As of December 31, 2024, the Company had cash and cash equivalents of $29,854 and an accumulated deficit of $650,197. 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 $59,599 and $179,053 for the years ended December 31, 2024 and 2023, respectively, and had net cash used in operating activities of $72,027 and $155,006 for the years ended December 31, 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 amortization payments under its Credit Agreement, its limited liquidity resources currently on hand, and its dependence on its ability to obtain additional financing to fund its operations after the current resources are exhausted, about which there can be no certainty, have resulted in management’s assessment that there is substantial doubt about the Company’s ability to continue as a going concern for a period of at least 12 months from the issuance date of the financial statements included in this Annual Report on Form 10-K.

This going concern evaluation takes into consideration the potential mitigating effect of management’s Reprioritization (as defined in Note 4, Restructuring). When substantial doubt exists, management evaluates whether the mitigating effect of its plans sufficiently alleviates the substantial doubt about the Company’s ability to continue as a going concern. The mitigating effect of management’s plans, however, is only considered if both (i) it is probable that the plans will be effectively implemented within one year after the date that the financial statements are issued and (ii) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date that the financial statements are issued. Generally, to be considered probable of being effectively implemented, the plans need to be approved by the Company’s Board of Directors. The Company’s Reprioritization was approved by the Board of Directors on August 8, 2023; however, such plans, 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 consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business and does not include any adjustments that may result from the outcome of this uncertainty. The going concern analysis does not consider possible future amendments to or restructuring of the Credit Agreement (as defined in Note 9, Debt and Credit Facilities) or other potential sources of debt or equity capital.

Successful completion of the Company’s development programs and, ultimately, the attainment of profitable operations are dependent upon future events, including obtaining adequate financing to support the Company’s cost structure and operating plan. Management’s plans to improve the Company’s liquidity and reduce its operating expenses and capital requirements include, among other things, pursuing one or more of the following steps to raise additional capital, none of which can be guaranteed or are entirely within the Company’s control:

•raise funding through the sale of the Company’s equity securities;

•raise funding through third-party investments in or other strategic options for OnkosXcel;

•raise funding through debt financing and/or restructuring of its existing OFA Facilities;

•establish collaborations with potential partners to advance the Company’s product pipeline;

•establish collaborations with potential marketing partners;

•reduce overhead and headcount to focus on core priorities; and/or

•any combination of the foregoing.

If the Company is unable to raise capital when needed or on acceptable terms, or if it is unable to procure collaboration arrangements to advance its programs, the Company would be forced to discontinue some of its operations or develop and implement a plan, beyond its Reprioritization initiatives, to further extend payables, reduce overhead, scale back or cease some or all of its revised operating plan until sufficient additional capital is raised to support further operations.

Stock-Based Compensation - Non-options (Details) - USD ($) $ / shares in Units, $ in Thousands	1 Months Ended	12 Months Ended
	Jul. 31, 2024	Dec. 31, 2024	Dec. 31, 2023
BTI RSU
Number of shares
Outstanding, beginning balance (in shares)		12,000
Granted (in shares)		22,000
Vested (in shares)		(6,000)
Cancelled (in shares)		(1,000)
Outstanding, ending balance (in shares)		27,000
Weighted average price
Vesting period		1 year
Vesting (as a percent)		100.00%
Unrecognized stock-based compensation expense		$ 575	$ 1,715
BTI RSU \| Employee
Weighted average price
Granted, Weighted average price (in dollars per share)		$ 23.43
Unrecognized stock-based compensation expense		$ 13
BTI RSU \| Nonemployee consultant
Weighted average price
Granted, Weighted average price (in dollars per share)		$ 9.12
Vesting period		12 months
Unrecognized stock-based compensation expense		$ 185
BTI PSU
Number of shares
Outstanding, beginning balance (in shares)		33,000
Granted (in shares)	87,000	87,000
Vested (in shares)		0
Cancelled (in shares)		(27,000)
Forfeited (in shares)		(23,000)
Outstanding, ending balance (in shares)		70,000
Weighted average price
Granted, Weighted average price (in dollars per share)	$ 19.2
Vesting period	1 year
Unrecognized stock-based compensation expense		$ 0
OnkosXcel PSU
Number of shares
Outstanding, beginning balance (in shares)		1,240
Granted (in shares)		15
Cancelled (in shares)		(89)
Outstanding, ending balance (in shares)		1,166
Vested aggregate (in shares)		941
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)		$ 5,570
Vesting period		48 months
Unrecognized stock-based compensation expense		$ 377
Fair value, non-option		$ 1,165
Fair value (in dollars per share)			$ 8
OnkosXcel RSUs
Number of shares
Outstanding, beginning balance (in shares)		225,000
Vested (in shares)		(41,000)
Cancelled (in shares)		(8,000)
Outstanding, ending balance (in shares)		176,000
Weighted average price
Unrecognized stock-based compensation expense		$ 210

Nature of the Business

12 Months Ended

Dec. 31, 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 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^® (dexmedetomidine or “Dex”) sublingual film for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. IGALMI^® is approved to be self-administrated by patients under the supervision of a health care provider. On July 6, 2022, BTI announced that IGALMI^®, was commercially available in doses of 120 and 180 micrograms.

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

The Company’s advanced immuno-oncology asset, BXCL701, is an investigational, orally administered systemic innate immune activator for the treatment of a rare form of prostate cancer and advanced solid tumors that are refractory or treatment naïve to checkpoint inhibitors.

BTI was incorporated under the laws of the State of Delaware on March 29, 2017. The Company’s principal office is in New Haven, Connecticut.

Employee Benefit Plan (Details) - USD ($) $ in Thousands	12 Months Ended
Employee Benefit Plan (Details) - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
Employee Benefit Plan
Employer matching contribution, percent	50.00%
Employer contribution percent on eligible contribution	5.00%
Employer contribution amount	$ 289	$ 788

Inventory (Tables)

12 Months Ended

Dec. 31, 2024

Inventory

Schedule of inventory


	December 31,		December 31,
	2024		2023

Raw materials	$	506	$	935
Work-in-process		—		651
Finished goods		173		405
Total inventory	$	679	$	1,991

Summary of Significant Accounting Policies (Tables)

12 Months Ended

Dec. 31, 2024

Summary of Significant Accounting Policies

Schedule of property and equipment useful lives


Equipment	3-5 years
Furniture	7 years
Leasehold improvements	Lesser of life of improvement or lease term

Common Stock Financing Activities

12 Months Ended

Dec. 31, 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 88 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 year ended December 31, 2024, the Company sold 240 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 191 shares (the “Shares”) of common stock, par value $0.001 per share, and accompanying warrants (the “Accompanying Warrants”) to purchase up to 191 shares of common stock at a combined offering price of $4.416 per Share and Accompanying Warrant and pre-funded warrants (the “Pre-Funded Warrants”) to purchase up to 348 shares of common stock and Accompanying Warrants to purchase up to 348 shares of common stock, at a combined offering price of $46.40 per share underlying each Pre-Funded Warrant and Accompanying Warrant, which equals the offering price per Share and Accompanying Warrant less the $0.016 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, incurred issuance costs of $248, and received net proceeds of $24,752.

The Pre-Funded Warrants have an exercise price per share of common stock equal to $0.016 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. For the year ended December 31, 2024, 348 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 $51.20 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 Consolidated Balance Sheet as of December 31, 2024.

On November 22, 2024, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with Canaccord Genuity LLC, as underwriter (the “Underwriter”), in connection with the issuance and sale by the Company in a public offering of (i) 350 shares of the Company’s common stock, and accompanying warrants (the “November 2024 Accompanying Warrants”) to purchase 350 shares of Common Stock, at a combined public offering price of $7.68 per share, and, in lieu thereof to certain investors, (ii) pre-funded warrants to purchase 563 shares of Common Stock, and accompanying warrants (the “November 2024 Accompanying Warrants”) to purchase 563 shares of Common Stock, at a combined public offering price of $7.664 per pre-funded warrant, which equals the public offering price per share of Common Stock and accompanying warrant less the $0.016 exercise price per share of the pre-funded warrants, less underwriting discounts and commissions, pursuant to an effective shelf registration statement on Form S-3 (Registration No. 333-275261) and a related prospectus supplement filed with the Securities and Exchange Commission. For the year ended December 31, 2024, 80 pre-funded warrants were exercised and the same number of shares of common stock were issued in exchange for $1 of proceeds received.

Each of the November 2024 Accompanying Warrants in the offering is subject to customary beneficial ownership limitations on exercisability, is exercisable at any time after the date of issuance of such warrant and, in the case of the accompanying warrants, will expire on the fifth anniversary of the date of issuance. Each of the November 2024 Accompanying Warrants will have an exercise price of $7.68 per underlying share of Common Stock.

The Company received net proceeds from the offering of approximately $6,128, after deducting underwriting discounts and commissions and offering expenses of $871. The Company intends to use the net proceeds of the offering to fund the SERENITY At-Home trial, prepare for the initiation of the TRANQUILITY In-Care trial, working capital and general corporate purposes.

Common Stock Financing Activities (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands					1 Months Ended	3 Months Ended	12 Months Ended
	Nov. 22, 2024	Mar. 27, 2024	Mar. 25, 2024	May 31, 2021	Nov. 30, 2023	Sep. 30, 2024	Dec. 31, 2024	Dec. 31, 2023	Nov. 21, 2024
Shares issued
Stock offering costs							$ 474	$ 811
Net proceeds issuance of common stock							$ 39,688	$ 27,032
Common stock, par value (in dollars per share)							$ 0.001	$ 0.001
Proceeds from issuance of common stock and warrant		$ 25,000				$ 467
March 2024 Accompanying Warrants
Shares issued
Exercise price (in dollars per share)			$ 51.2						$ 9.136
Jefferies Sale Agreement
Shares issued
Maximum value shares to be issued				$ 100,000	$ 150,000
Shares issued (in shares)							240	88
Gross proceeds issuance of common stock							$ 7,682	$ 27,032
Stock offering costs							231	811
Net proceeds issuance of common stock							$ 7,451	$ 26,221
Registered direct offering
Shares issued
Shares issued (in shares)			191
Gross proceeds issuance of common stock		25,000
Stock offering costs		248
Net proceeds issuance of common stock		$ 24,752
Common stock, par value (in dollars per share)			$ 0.001
Offering price (in dollars per share)			$ 4.416
Registered direct offering \| March 2024 Accompanying Warrants
Shares issued
Warrants to purchase common stock (in shares)			191
Offering price (in dollars per share)			$ 46.4
Exercise price (in dollars per share)			$ 51.2
Registered direct offering \| March 2024 Pre-Funded Warrants
Shares issued
Warrants to purchase common stock (in shares)			348
Exercise price (in dollars per share)			$ 0.016
Exercise of warrants, stock issued (in shares)							348
Proceeds from warrants							$ 6
Underwriting Agreement
Shares issued
Shares issued (in shares)	350
Stock offering costs	$ 871
Net proceeds issuance of common stock	$ 6,128
Offering price (in dollars per share)	$ 7.68
Underwriting Agreement \| March 2024 Accompanying Warrants
Shares issued
Offering price (in dollars per share)	7.664
Underwriting Agreement \| March 2024 Pre-Funded Warrants
Shares issued
Exercise price (in dollars per share)	$ 0.016
Exercise of warrants, stock issued (in shares)							80
Proceeds from warrants							$ 1
Underwriting Agreement \| November 2024 Accompanying Warrants
Shares issued
Warrants to purchase common stock (in shares)	350
Underwriting Agreement \| November 2024 Pre-Funded Warrants
Shares issued
Warrants to purchase common stock (in shares)	563

Debt and Credit Facilities - Interest (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Debt and Credit Facilities
Interest expense	$ 14,662	$ 11,941
Accretion of debt discount and amortization of financing costs	467	1,373
Total interest expense	$ 15,129	$ 13,314

Income Taxes

12 Months Ended

Dec. 31, 2024

Income Taxes

Income Taxes

Note 16. Income Taxes

The significant components of the Company's net deferred tax assets at December 31, 2024 are shown below. In determining the realizability of the Company's net deferred tax assets, the Company considered numerous factors, including historical profitability, estimated future taxable income, and the industry in which it operates. Based on this

information the Company has provided a valuation allowance for the full amount of its net deferred tax asset because the Company has determined that it is more likely than not that they will not be realized.


	December 31,		December 31,
	2024		2023
Deferred tax assets:
Federal net operating losses	$	90,853	$	73,770
State net operating losses		23,152		21,255
Stock options		14,601		13,915
Tax credits		17,188		15,048
Capitalized research & development		44,377		49,603
Accrued expense		202		—
Depreciation		103		73
Lease accounting - liability		115		212
Disallowed charitable contributions		1
Deferred Costs		674
Cancellation of debt		1,483
Valuation allowance		(192,149)		(173,679)
Total deferred tax assets	$	600	$	197
Deferred tax liabilities:
Debt amendment	$	(500)		—
Unrealized loss		—	$	(12)
Right-of-use assets		(100)		(185)
Total deferred tax liabilities	$	(600)	$	(197)
Net deferred tax asset (liability)	$	—	$	—

The income tax expense/(benefit) for the year ended December 31, 2024 differed from the amounts computed by applying the U.S. federal income tax rate of 21% to loss before tax benefit as a result of tax credits generated and changes in the Company’s valuation allowance.

A reconciliation between the Company’s effective tax rate and the federal statutory rate are as follows:


	2024	2024		2023	2023
Federal statutory rate	(12,516)	21.0	%	(37,601)	21.0	%
Stock based compensation	381	(0.6)	%	(573)	0.3	%
Warrant mark-to-market	(4,238)	7.1	%	—	—	%
Federal and state credits	(1,870)	3.2	%	(4,082)	2.3	%
State taxes	(343)	0.6	%	(14,261)	8.0	%
Other	116	(0.3)	%	1,210	(0.7)	%
Change in valuation allowance	18,470	(31.0)	%	55,307	(30.9)	%
	—	—	%	—	—	%

At December 31, 2024 the Company had approximately $432,634 of gross federal and $443,454 of gross state net operating loss carry-forwards. If not utilized, the federal and state net operating loss carry-forwards will begin to expire in 2037. The federal net operating loss of $429,988 incurred after December 31, 2017 will carryforward indefinitely. The utilization of such net operating loss carry-forwards and realization of tax benefits in future years depends predominantly upon having taxable income. The Company has approximately $15,965 of federal orphan drug credits and research and development credits which will begin to expire in 2037 if not utilized. The Company also has approximately $1,548 of state research and development credits which will begin to expire in 2040 if not utilized.

Utilization of the NOL and research tax credit carryforwards may be subject to a substantial annual limitation due to ownership limitations that has occurred or that could occur in the future, as required by section 382 of the Code, as well as similar state and foreign provisions. These ownership changes may limit the amount of the NOL and research credit carryforwards that can be utilized annually to offset future taxable income and tax, respectively. In general, an

"ownership change" as defined by Section 382 of the Code results from a transaction or series of transactions over a three year period resulting in an ownership change of more than 50 percentage points of the outstanding stock of a by certain stockholders or public groups.

Entities are also required to evaluate, measure, recognize and disclose any uncertain income tax positions taken on their income tax returns. The Company has analyzed its tax positions and has concluded that as of December 31, 2024, there were no uncertain positions. The Company's U.S. federal and state NOLs have occurred since its inception in 2017 and as such, tax years subject to potential tax examination could apply from that date because the utilization of net operating losses from prior years opens the relevant year to audit by the U.S. Internal Revenue Service and/or state taxing authorities. The Company did not have any unrecognized tax benefits and has not accrued any interest or penalties for the years ended December 31, 2024 and 2023.

- Definition

The entire disclosure for income tax.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 12
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482685/740-10-50-12

Reference 2: http://www.xbrl.org/2003/role/exampleRef
-Topic 740
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-Name Accounting Standards Codification
-Section 55
-Paragraph 231
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-URI https://asc.fasb.org/1943274/2147482663/740-10-55-231

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 12C
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482685/740-10-50-12C

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 12B
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-URI https://asc.fasb.org/1943274/2147482685/740-10-50-12B

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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-SubTopic 270
-Name Accounting Standards Codification
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-Paragraph 1
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-URI https://asc.fasb.org/1943274/2147477891/740-270-50-1

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
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-Paragraph 1
-Subparagraph (SAB Topic 6.I.5.Q1)
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Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480990/946-20-50-13

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 235
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-Paragraph 1
-Subparagraph (SX 210.4-08(h)(2))
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
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Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
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-Section 50
-Paragraph 14
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Reference 11: http://www.xbrl.org/2003/role/disclosureRef
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Reference 12: http://www.xbrl.org/2003/role/disclosureRef
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Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
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-Paragraph 2
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Reference 14: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
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-Name Accounting Standards Codification
-Section 50
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-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482603/740-30-50-2

+ Details

Inventory (Details) - USD ($) $ in Thousands	12 Months Ended
Inventory (Details) - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
Inventory
Raw materials	$ 506	$ 935
Work-in-process		651
Finished goods	173	405
Total inventory	679	1,991
Inventory write-downs	$ 1,980	$ 1,191

Net Loss Per Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Net Loss Per Share
Net loss (numerator)	$ (59,599)	$ (179,053)
Weighted average shares (denominator) - basic (in shares)	2,535	1,821
Weighted average shares (denominator) - diluted (in shares)	2,535	1,821
Basic net loss per share (in dollars per share)	$ (23.51)	$ (98.33)
Diluted net loss per share (in dollars per share)	$ (23.51)	$ (98.33)

- Definition

The amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period.

+ References

+ Details

- Definition

The amount of net income (loss) for the period available to each share of common stock or common unit outstanding during the reporting period and to each share or unit that would have been outstanding assuming the issuance of common shares or units for all dilutive potential common shares or units outstanding during the reporting period.

+ References

+ Details

- Definition

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

+ References

+ Details

Summary of Significant Accounting Policies

12 Months Ended

Dec. 31, 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 consolidated financial statements and notes thereto. Estimates are used in the following areas, among others: revenue recognition, inventory valuation, 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.

Reverse Stock Split

On February 10, 2025, the Company completed a 1-for-16 reverse stock split of its issued and outstanding common stock (the “Reverse Stock Split”). As a result of the Reverse Stock Split, each 16 shares of common stock issued and outstanding immediately prior to February 10, 2025 were automatically converted into one of a share of common stock. The Reverse Stock Split affected all common stockholders uniformly and did not alter any stockholder's percentage interest in the Company's equity, except to the extent that the Reverse Stock Split would result in a stockholder owning a fractional share. No fractional shares were issued in connection with the Reverse Stock Split. Stockholders who otherwise would be entitled to receive a fractional share instead were entitled to receive cash in lieu of such fractional share.

The Reverse Stock Split did not change the par value of the common stock or the authorized number of shares of common stock.

All common share and per-share amounts in this Form 10-K have been retroactively restated to reflect the effect of the Reverse Stock Split.

Cash and Cash Equivalents

The Company considers all highly liquid investments with an original maturity of three months or less at the date of purchase to be cash equivalents. As of December 31, 2024 and 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^® and represent amounts due from distributors. Payment terms generally range from 30 to 75 days from the date of the sale transaction, and accordingly, do not involve a significant financing component. Receivables from product sales are recorded net of allowances which generally include distribution fees, prompt payment discounts, chargebacks, and credit losses. Allowances for distribution fees, prompt payment discounts and chargebacks are based on contractual terms. The Company estimated the current expected credit losses of its accounts receivable by assessing the risk of loss and available relevant information about collectability, existing contractual payment terms, actual payment patterns of its customers, individual customer circumstances, and reasonable and supportable forecast of economic conditions expected to exist throughout the contractual life of the receivable. Based on its assessment, as of December 31, 2024, the Company determined that an allowance for credit losses was not required.

Concentrations of Credit Risk

The Company sells IGALMI^® through a drop-ship program under which orders from hospitals and similar health care institutions are processed through wholesalers, but shipments of the product are sent directly to the individual hospitals and similar health care institutions. BTI also contracts directly with intermediaries such as group purchasing organizations (“GPOs”). All trade accounts receivables are due from the distributor that fulfills orders on behalf of the Company. For the years ended December 31, 2024 and 2023, one customer accounted for approximately 32% and 39% of the Company’s net product revenue, respectively.

Inventory

Inventory is stated at the lower of cost or net realizable value. Cost of inventory is determined on a first-in, first-out basis.

BTI capitalizes inventory costs associated with the Company’s products prior to regulatory approval, when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized; otherwise, such costs are expensed as research and development expense in the Consolidated Statements of Operations.

The Company performs an assessment of the recoverability of capitalized inventory during each reporting period and writes down any excess and obsolete inventories to their estimated realizable value in the period in which the impairment is first identified. Such impairment charges, should they occur, will be recorded within Cost of goods sold in the Consolidated Statements of Operations. The determination of whether inventory costs will be realizable requires estimates by management. If actual market conditions are less favorable than projected, write-downs of inventory may be required.

Deferred Initial Public Offering Costs

Deferred initial public offering costs of $2,570, consisted of legal, accounting, and other costs that were directly related to the Company’s proposed initial public offering of OnkosXcel. These costs were charged to the Consolidated Statements of Operations during the year ended December 31, 2023 as the initial public offering was delayed for an extended period of time. The costs were recorded as Selling, general and administrative expenses.

Property and Equipment

Property and equipment are recorded at cost and depreciated over the shorter of their remaining lease term or their estimated useful life on a straight-line basis as follows:


Equipment	3-5 years
Furniture	7 years
Leasehold improvements	Lesser of life of improvement or lease term

Expenditures for maintenance and repairs which do not improve or extend the useful lives of the respective assets are expensed as incurred. When assets are sold or retired, the related cost and accumulated depreciation are removed from their respective accounts and any resulting gain or loss is included within Other (income) expense, net in the Consolidated Statements of Operations.

Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to undiscounted future net cash flows expected to be generated from its use and disposition. Impairment charges are recognized at the amount by which the carrying amount of an asset exceeds the fair value of the asset. Assets to be disposed of are reported at the lower of the carrying amount or the fair value less costs to sell.

Leases

The Company determines if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”) assets, other current liabilities, and the long-term portion of operating lease liabilities in the Consolidated Balance Sheets.

ROU assets represent BTI’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease ROU assets and lease liabilities are recognized at commencement date based on the present value of lease payments over the lease term. The Company uses the implicit rate when readily determinable. As BTI’s leases do not provide an implicit rate, it used an incremental

borrowing rate based on the information available at commencement date in determining the present value of lease payments. The operating lease ROU asset also includes any prepaid lease payments made and is reduced by 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.

The Company entered into financing arrangements, the terms of which involve significant assumptions and estimates, including future net product sales, in determining interest expense, amortization period of the debt discount, as well as the classification between current and long-term portions. In estimating future net product sales, the Company assesses prevailing market conditions using various external market data against the Company’s anticipated sales and planned commercial activities. Consequently, the Company imputes interest on the carrying value of the debt and records interest expense using an imputed effective interest rate. The Company reassesses the expected payments during each reporting period and accounts for any changes through an adjustment to the effective interest rate on a prospective basis, with a corresponding impact to the classification of the Company’s current and long-term portions of the debt.

Derivative Assets and Liabilities

Derivative assets and liabilities are recorded on the Company`s Consolidated Balance Sheets at their fair value on the date of issuance and are revalued on each balance sheet date until such instruments are settled or expire, with changes in the fair value between reporting periods recorded as other income or expense within Other (income) expense, net in the Consolidated Statements of Operations.

The Company does not use derivative instruments for speculative purposes or to hedge exposures to cash-flow or market risks. Certain financing facilities entered into by the Company include freestanding financial instruments and/or embedded features that require separate accounting as derivative assets and/or liabilities.

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

Revenue Recognition

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

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

BTI sells IGALMI^® 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^® is eligible for purchase by, or qualifies for reimbursement from, Medicaid and other U.S. government programs that are eligible for rebates on the price they pay for the product. To determine the appropriate amount to reserve for these rebates, BTI applies the applicable government discount to these sales, and estimates the portion of total rebates that it anticipates will be claimed. The Company deducts certain government rebates from gross product

revenue and accounts receivable at the time it recognizes the related revenue; other government rebates are recognized as an accrued liability at the time BTI recognizes the related revenue.

Chargebacks

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

Product Returns

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

BTI classifies all fees paid to the distributor, other than those discussed above and those related to warehouse operations, as Selling, general and administrative expenses on its Consolidated Statements of Operations. Fees paid to the distributor for warehouse operations are classified as Cost of goods sold on BTI’s Consolidated Statements of Operations.

Cost of Goods Sold

Cost of goods sold includes the cost of producing and distributing inventories that are related to product revenues during the respective period. Cost of goods sold also includes costs related to excess or obsolete inventory adjustment charges, as well as costs related to warehouse operations paid to distributors.

Stock-Based Compensation

The Company measures and recognizes stock-based compensation expense based on estimated fair value for all share-based awards made to employees, non-employee service providers, and directors, including stock options, BTI restricted stock units (“BTI RSUs”), OnkosXcel profit sharing units (“PSUs”), OnkosXcel restricted stock units (“OnkosXcel RSUs”) and BTI performance stock units (“Performance Units”). The Company’s 2017 Equity Incentive Plan (the “2017 Plan”) became effective in August 2017. The Company’s 2020 Incentive Award Plan (the “2020 Plan”) became effective in May 2020. Following the effective date of the 2020 Plan, the Company ceased granting awards under the 2017 Plan; however, the terms and conditions of the 2017 Plan continue to govern any outstanding awards granted thereunder.

The Company’s stock-based awards are valued at fair value on the date of grant and that fair value is recognized as an expense in the Consolidated Statements of Operations over the requisite service period using the accelerated attribution method. The estimated value of the BTI RSUs and Performance Units is based on the Company’s closing stock price on the grant date. The estimated fair value of 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 awards. The Company has elected to account for forfeitures as they occur, by reversing compensation cost when the award is forfeited.

Research and Development Costs

Research and development expenses include wages, benefits, non-cash stock-based compensation, facilities, supplies, external services, clinical study, manufacturing costs related to clinical trials and other expenses that are directly related to the Company’s research and development activities. At the end of the reporting period, the Company estimates the progress toward completion of the research or development objectives and, depending on the amount and timing of payments to the service providers may record net prepaid or accrued expense for associated research and development costs. Such estimates are subject to change as additional information becomes available. The Company expenses research and development costs as incurred.

Most of the Company’s service providers invoice BTI monthly in arrears for services performed. The Company estimates its accrued expenses as of each balance sheet date in the consolidated financial statements based on facts and circumstances known to management at that time. BTI management periodically confirms the accuracy of the Company’s estimates with the service providers and makes adjustments if necessary.

Although management does not expect its estimates to be materially different from amounts actually incurred, management’s understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in BTI reporting amounts that are too high or too low in any particular period.

Patent Costs

Costs related to filing and pursuing patent applications are recorded in Selling, general and administrative expenses in the Consolidated Statements of Operations and are expensed as incurred since recoverability of such expenditures is uncertain.

Fair Value of Financial Instruments

The Company measures certain financial assets and liabilities at fair value, which is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The Company applies a fair value hierarchy that distinguishes between (1) market participant assumptions developed based on market data obtained from independent sources, or observable inputs, and (2) an entity’s own assumptions about market participant assumptions developed based on the best information available in the circumstances, or unobservable inputs. The fair value hierarchy consists of three broad levels, which gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1) and the lowest priority to unobservable inputs (Level 3). Fair value measurements must be classified and disclosed in one of the following three categories:

●

Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs.

●

Level 2: Directly or indirectly observable inputs as of the reporting date through correlation with market data, including quoted prices for similar assets and liabilities in active markets and quoted prices in markets that are not active. Level 2 also includes assets and liabilities that are valued using models or other pricing methodologies that do not require significant judgment since the input assumptions used in the models, such as interest rates and volatility factors, are corroborated by readily observable data from actively quoted markets for substantially the full term of the financial instrument.

●

Level 3: Unobservable inputs that are supported by little or no market activity and reflect the use of significant management judgment. These values are generally determined using pricing models for which the assumptions utilize management’s estimates of market participant assumptions.

In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible, as well as considering counterparty credit risk in its assessment of fair value.

Income Taxes

BTI uses an asset and liability approach for financial accounting and reporting of income taxes. Deferred tax assets and liabilities are determined based on temporary differences between financial reporting and tax basis assets and liabilities and are measured by applying enacted rates and laws to taxable years in which differences are expected to be recovered or settled. Further, the effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that the rate changes. A valuation allowance is required when it is “more likely than not” that all or a portion of deferred tax assets will not be realized.

U.S. GAAP prescribes a comprehensive model for how a company should recognize, measure, present and disclose in its financial statements uncertain tax positions that the Company has taken or expects to take on a tax return, including a decision whether to file or not file a return in a particular jurisdiction. The Company’s financial statements reflect expected future tax consequences of such positions presuming the taxing authorities’ full knowledge of the position and all relevant facts.

The Company does not have any unrecognized tax benefits as of December 31, 2024 and 2023. BTI reviews all tax positions to ensure the tax treatment selected is sustainable based on its technical merits and that the position would be sustained if challenged.

Earnings (Loss) per Share

Earnings (loss) per share (“EPS”) is calculated by dividing net income or loss attributable to common stockholders by the weighted average number of shares of common stock that were outstanding, including pre-funded warrants. Shares of common stock into which the pre-funded warrant may be exercised are considered outstanding for the purposes of computing EPS because the shares may be issued for little or no consideration, are fully vested and are exercisable after the original issuance date. 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. See Note 19, Segment Information for further information

Recent Accounting Pronouncements

Recently adopted accounting pronouncements

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 adopted the new standard in fiscal year 2024 for annual and retrospective reporting periods with all interim disclosures to begin in the first quarter of fiscal year 2025. For additional information, see Note 19, Segment Information.

Accounting Pronouncements effective in future periods

In December 2023, the FASB issued ASU 2023-09, Improvements to income tax disclosures, which requires disclosure of disaggregated income taxes paid by jurisdiction, enhances disclosures in the effective tax rate reconciliation and modifies other income tax-related disclosures. The amendments are effective for annual periods beginning after December 15, 2024. The Company is currently evaluating the effect of adopting this guidance on its consolidated financial statements.

Derivative Financial Instruments

12 Months Ended

Dec. 31, 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 Consolidated Balance Sheets. The respective derivative liabilities are recorded at fair value on the date of issuance and are revalued on each balance sheet date until such instruments are settled or expire, with changes in the fair value between reporting periods recorded within Other (income) expense, net in the Company’s Consolidated Statements of Operations. As discussed in Note 9, Debt and Credit Facilities, the Equity Investment Right was terminated on November 25, 2024 in connection with the Fifth Amendment to the Credit Agreement. The Company recorded the termination gain of $1,263 within Other (income) expense, net in the Company’s Consolidated Statements of Operations for the carrying value of the Equity Investment Right.

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 Consolidated Balance Sheet as of December 31, 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 Consolidated Statements of Operations. We value the Accompanying Warrants using the Black-Scholes option pricing model as discussed in Note 14, Fair measurements.

On November 21, 2024, the exercise price of 534 of the Accompanying Warrants was reduced from $51.20 to $9.136 per share. As a result of the repricing, the Company recorded the increase in fair value of $1,000 as an increase to the carrying value of Derivative liabilities, recorded as an increase to their carrying value, and as a loss in Other (income) expense, net, in the Company’s Consolidated Statements of Operations. For the year ended December 31, 2024, the Company recorded total net gains of $17,027, including the $1,000 repricing loss, in Other (income) expense, net, in the Company’s Consolidated Statements of Operations. As of December 31, 2024, the fair value of the Accompanying Warrants was $2,320.

On November 25, 2024, as discussed below, the Company issued additional warrants (the “November 2024 Accompanying Warrants”). The November 2024 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 Consolidated Balance Sheet as of December 31, 2024. The respective derivative liabilities were recorded at fair value on the date of issuance in the amount of $5,562 and are revalued on each balance sheet date until such instruments are settled or expire, with changes in the fair value between reporting periods recorded within Other (income) expense, net in the Company’s Consolidated Statements of Operations. For the year ended December 31, 2024, the Company recorded total net gains of $1,289 in Other (income) expense, net, in the Company’s Consolidated Statements of Operations. As of December 31, 2024, the fair value of the November 2024 Accompanying Warrants was $4,273.

Stock-Based Compensation - Expense (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Stock-Based Compensation
Share-based compensation costs	$ 6,156	$ 18,614
Research and development
Stock-Based Compensation
Share-based compensation costs	2,251	6,324
Selling, general and administrative
Stock-Based Compensation
Share-based compensation costs	$ 3,905	$ 12,290

- 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 - Additional Information (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Leases
Lease expense	$ 394	$ 392
Option to renew the lease	true
Renewal term	5 years

Summary of Significant Accounting Policies (Policies)

12 Months Ended

Dec. 31, 2024

Summary of Significant Accounting Policies

Basis of Presentation

Use of Estimates

Reverse Stock Split

Reverse Stock Split

The Reverse Stock Split did not change the par value of the common stock or the authorized number of shares of common stock.

All common share and per-share amounts in this Form 10-K have been retroactively restated to reflect the effect of the Reverse Stock Split.

Cash and Cash Equivalents

Accounts Receivable, Net

Accounts Receivable, Net

Concentrations of Credit Risk

Concentrations of Credit Risk

Inventory

Inventory

Inventory is stated at the lower of cost or net realizable value. Cost of inventory is determined on a first-in, first-out basis.

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

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^®.

Trade Discounts and Allowances

Government Rebates

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

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.

●

Income Taxes

Income Taxes

Earnings (Loss) Per Share

Earnings (Loss) per Share

Segment Information

Segment Information

Recent Accounting Pronouncements

Recently adopted accounting pronouncements

Accounting Pronouncements effective in future periods