Leap Therapeutics (LPTX) 10-K 18 Mar 24 2023 FY Annual report Financial data

Document and Entity Information

Document and Entity Information - USD ($) $ in Millions	12 Months Ended
	Dec. 31, 2023	Mar. 13, 2024	Jun. 30, 2023
Document and Entity Information
Document Type	10-K
Document Annual Report	true
Document Transition Report	false
Document Period End Date	Dec. 31, 2023
Entity File Number	001-37990
Entity Registrant Name	LEAP THERAPEUTICS, INC.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	27-4412575
Entity Address, Address Line One	47 Thorndike Street
Entity Address, Address Line Two	Suite B1-1
Entity Address, City or Town	Cambridge
Entity Address, State or Province	MA
Entity Address, Postal Zip Code	02141
City Area Code	617
Local Phone Number	714-0360
Title of 12(b) Security	Common Stock, par value $0.001
Trading Symbol	LPTX
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
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		25,600,137
Entity Public Float			$ 77.7
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2023
Document Fiscal Period Focus	FY
Entity Central Index Key	0001509745
Amendment Flag	false
ICFR Auditor Attestation Flag	false
Document Financial Statement Error Correction [Flag]	false
Auditor Name	EisnerAmper LLP
Auditor Firm ID	274
Auditor Location	Philadelphia, Pennsylvania

CONSOLIDATED BALANCE SHEETS

CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands	Dec. 31, 2023	Dec. 31, 2022
Current assets:
Cash and cash equivalents	$ 70,643	$ 65,500
Research and development incentive receivable	771	2,099
Prepaid expenses and other current assets	183	351
Total current assets	71,597	67,950
Property and equipment, net	5	20
Right of use assets, net	257	669
Deferred costs	0	576
Other long term assets		30
Deposits	966	1,108
Total assets	72,825	70,353
Current liabilities:
Accounts payable	6,465	5,657
Accrued expenses	5,957	5,152
Lease liability - current portion	262	416
Total current liabilities	12,684	11,225
Non current liabilities:
Lease liability, net of current portion		262
Total liabilities	12,684	11,487
Stockholders' equity:
Preferred stock, $0.001 par value; 10,000,000 shares authorized; 0 shares issued and outstanding
Common stock, $0.001 par value; 240,000,000 shares authorized; 25,565,414 and 9,902,137 shares issued and outstanding as of December 31, 2023 and 2022, respectively	26	10
Additional paid-in capital	459,591	376,896
Accumulated other comprehensive income	106	128
Accumulated deficit	(399,582)	(318,168)
Total stockholders' equity	60,141	58,866
Total liabilities and stockholders' equity	$ 72,825	$ 70,353

CONSOLIDATED BALANCE SHEETS (Pa

CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares	Dec. 31, 2023	Dec. 31, 2022
CONSOLIDATED BALANCE SHEETS
Preferred stock par value (in dollars per share)	$ 0.001	$ 0.001
Preferred Stock, shares authorized	10,000,000	10,000,000
Preferred stock shares issued	0	0
Preferred Stock, Shares Outstanding	0	0
Common stock, par value (in dollars per share)	$ 0.001	$ 0.001
Common stock, authorized shares	240,000,000	240,000,000
Common stock, issued shares	25,565,414	9,902,137
Common stock, outstanding shares	25,565,414	9,902,137

CONSOLIDATED STATEMENTS OF OPER

CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022
Operating expenses:
Research and development	$ 73,234	$ 44,965
General and administrative	13,807	11,798
Total operating expenses	87,041	56,763
Loss from operations	(87,041)	(56,763)
Interest income	4,027	925
Interest expense		(54)
Australian research and development incentives	1,101	2,051
Other income	500
Foreign currency loss	(13)	(608)
Change in fair value of Series X preferred stock warrant liability	12
Loss before income taxes	81,414	54,449
Provision for income taxes		(147)
Net loss attributable to common stockholders	$ (81,414)	$ (54,596)
Net loss per share
Basic (in dollars per share)	$ (3.98)	$ (4.82)
Diluted (in dollars per share)	$ (3.98)	$ (4.82)
Weighted average common shares outstanding
Basic (in shares)	20,445,109	11,323,909
Diluted (in shares)	20,445,109	11,323,909

CONSOLIDATED STATEMENTS OF COMP

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
Net loss	$ (81,414)	$ (54,596)
Other comprehensive income (loss):
Foreign currency translation adjustments	(22)	395
Comprehensive loss	$ (81,436)	$ (54,201)

CONSOLIDATED STATEMENT OF STOCK

CONSOLIDATED STATEMENT OF STOCKHOLDERS' EQUITY - USD ($)	Common Stock	Additional Paid-in Capital.	Accumulated Other Comprehensive Income (Loss)	Accumulated Deficit	Series X Non Voting Convertible Preferred Stock	Total
Balance at the beginning of the period (in shares) at Dec. 31, 2021	8,831,845
Balance at the beginning of the period at Dec. 31, 2021	$ 9,000	$ 371,717,000	$ (267,000)	$ (263,572,000)		$ 107,887,000
Increase (Decrease) in Stockholders' Equity
Foreign currency translation adjustment			395,000			395,000
Stock-based compensation		5,180,000				5,180,000
Net Income (Loss)				(54,596,000)		(54,596,000)
Issuance of common stock upon exercise of prefunded warrants	$ 1,000	(1,000)
Issuance of common stock upon exercise of prefunded warrants (in shares)	1,070,292
Balance at the end of the period at Dec. 31, 2022	$ 10,000	376,896,000	128,000	(318,168,000)		58,866,000
Balance at the end of the period (in shares) at Dec. 31, 2022	9,902,137
Ending balance at Dec. 31, 2022					$ 0
Ending balance (in shares) at Dec. 31, 2022					0
Increase (Decrease) in Stockholders' Equity
Foreign currency translation adjustment	$ 0	0	(22,000)	0	$ 0	(22,000)
Stock-based compensation		5,128,000				5,128,000
Net Income (Loss)				(81,414,000)		(81,414,000)
Conversion of Series X preferred stock to common stock	$ 14,000	67,701,000				67,715,000
Conversion of Series X preferred stock to common stock (in shares)	13,624,800
Issuance of Series X Preferred Stock in connection with Flame merger					$ 67,715,000
Issuance of Series X Preferred Stock in connection with Flame merger (in shares)					136,248
Issuance of common stock in connection with Flame merger	$ 2,000	9,803,000				9,805,000
Issuance of common stock in connection with Flame merger (in shares)	1,972,901
Issuance of common stock warrants in connection with Flame merger	$ 0	13,000	0	0	$ 0	13,000
Redemption of 2019 Warrants		(29,000)				(29,000)
Issuance of common stock upon vest of restricted stock units (in shares)	66,061
Conversion of Series X preferred stock to common stock					$ (67,715,000)
Conversion of Series X preferred stock to common stock (in shares)					(136,248)
Reclassification of Series X preferred stock warrants to equity		78,000				78,000
Fractional value paid in cash		1,000				1,000
Fractional shares paid in cash (in shares)	(485)
Balance at the end of the period at Dec. 31, 2023	$ 26,000	$ 459,591,000	$ 106,000	$ (399,582,000)	$ 0	$ 60,141,000
Balance at the end of the period (in shares) at Dec. 31, 2023	25,565,414

CONSOLIDATED STATEMENTS OF CASH

CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022
Cash flows from operating activities:
Net loss	$ (81,414)	$ (54,596)
Adjustments to reconcile net loss to net cash
In-process research and development costs acquired in connection with the acquisition of Flame	29,582
Depreciation expense	15	16
Change in right-of-use asset	412	399
Stock-based compensation expense	5,128	5,180
Foreign currency loss	13	608
Changes in operating assets and liabilities:
Prepaid expenses and other assets	164	416
Deferred tax asset		152
Research and development incentive receivable	1,302	(1,009)
Accounts payable and accrued expenses	712	945
Lease liability	(415)	(400)
Other assets	748	(755)
Net cash used in operating activities	(43,753)	(49,044)
Cash flows from investing activities:
Cash acquired in connection with the acquistion of Flame	50,362
Payment of direct and incremental costs of the asset acquisition	(1,393)
Net cash provided by investing activities	48,969
Cash flows from financing activities:
Payment of redemption of 2019 warrants	(29)
Payment of fractional shares	(1)
Payment of deferred costs		(210)
Net cash used in financing activities	(30)	(210)
Effect of exchange rate changes on cash and cash equivalents	(43)	(162)
Net increase (decrease) in cash and cash equivalents	5,143	(49,416)
Cash and cash equivalents at beginning of year	65,500	114,916
Cash and cash equivalents at end of year	70,643	65,500
Supplemental disclosure of non-cash financing activities:
Deferred costs in accounts payable and accrued expense - January 2023 Flame Merger		576
Remeasrement of right-of-use asset and lease liability		$ 609
Issuance and conversion of Series X Preferred Stock issued in connection with the acquisition of Flame to common stock	67,715
Reclassification of Series X Preferred Stock Warrants from liability to equity	78
Issuance of common stock in connection with the acquisition of Flame	9,805
Issuance of warrants for the purchase of common stock in connection with the acquisition of Flame	13
Net liabilities assumed from acquistion of Flame	$ 928

Nature of Business, Basis of Pr

Nature of Business, Basis of Presentation and Liquidity	12 Months Ended
	Dec. 31, 2023
Nature of Business, Basis of Presentation and Liquidity
Nature of Business, Basis of Presentation and Liquidity	1. Nature of Business, Basis of Presentation and Liquidity Nature of Business Leap Therapeutics, Inc. (“the Company”) was incorporated in the state of Delaware on January 3, 2011. During 2015, HealthCare Pharmaceuticals Pty Ltd. (“HCP Australia”) was formed and is a wholly owned subsidiary of the Company. On December 10, 2015, the Company entered into a merger agreement with GITR Inc. (“GITR”), an entity under common control, whereby a wholly owned subsidiary was merged with GITR and the surviving name of the wholly owned subsidiary was GITR Inc. On August 29, 2016, the Company entered into a merger agreement with Macrocure Ltd. (“Macrocure”), a publicly held, clinical-stage biotechnology company based in Petach Tikva, Israel. In connection with the merger, the Company applied to be listed on the Nasdaq Global Market. Nasdaq approved the listing, and trading in the Company’s common stock commenced on January 24, 2017, under the trading symbol “LPTX.” On February 1, 2017, Macrocure’s name was changed to Leap Therapeutics Ltd. In 2020, Leap Therapeutics Ltd. was dissolved. On December 15, 2021, Leap Securities Corp. was formed and is a wholly owned subsidiary of the Company. On January 17, 2023, the Company entered into a merger agreement with Flame Biosciences, Inc., a privately held, biotechnology corporation (“Flame”), whereby Flame became a wholly owned subsidiary of the Company under the name Flame Biosciences, LLC. The mailing address of the Company’s principal executive office is 47 Thorndike Street, Suite B1-1, Cambridge, MA 02141. The Company’s telephone number is 617-714 -0360 and its website address is www.leaptx.com The Company is a biopharmaceutical company developing novel biomarker-targeted antibody therapies designed to treat patients with cancer by inhibiting fundamental tumor-promoting pathways, targeting cancer-specific cell surface molecules, and harnessing the immune system to attack cancer cells. The Company’s strategy is to identify, acquire, and develop molecules that will rapidly translate into high impact therapeutics that generate durable clinical benefit and enhanced patient outcomes. The Company’s lead clinical stage program is DKN-01, a monoclonal antibody that inhibits Dickkopf-related protein 1, or DKK1. The Company is currently studying DKN-01 in multiple ongoing clinical trials in patients with esophagogastric cancer, gynecologic cancers, or colorectal cancer. It’s second clinical stage program is FL-301, a monoclonal antibody that targets cells that express Claudin18.2 on their cell surface. The Company also has two preclinical antibody programs, FL-302 and FL-501. In January 2020, the Company entered into an Option and License Agreement with BeiGene, Ltd., or BeiGene, which granted BeiGene an option to obtain an exclusive license from the Company that would grant to BeiGene the right to develop and commercialize DKN-01 in Asia (excluding Japan), Australia, and New Zealand. In March 2023, BeiGene notified the Company that it did not intend to exercise its option, and the agreement is continuing as a clinical collaboration. The Company intends to apply its experience identifying and developing products to build a pipeline of programs relating to the practice of cancer medicine. Basis of Presentation The accompanying consolidated financial statements of the Company include the accounts of its wholly owned subsidiaries and have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Reverse Stock Split On June 21, 2023, the Company effected a one 1. Nature of Business, Basis of Presentation and Liquidity (continued) Liquidity Since inception, the Company has been engaged in organizational activities, including raising capital, and research and development activities. The Company does not yet have a product that has been approved by the Food and Drug Administration (the “FDA”), has not generated any product sales revenues and has not yet achieved profitable operations, nor has it ever generated positive cash flows from operations. There is no assurance that profitable operations, if achieved, could be sustained on a continuing basis. Further, the Company’s future operations are dependent on the success of the Company’s efforts to raise additional capital, its research and commercialization efforts, regulatory approval, and, ultimately, the market acceptance of the Company’s products. In accordance with Accounting Standards Codification (“ASC”) 205-40, Going Concern, the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the consolidated financial statements are issued. As of December 31, 2023, the Company had cash and cash equivalents of $70,643. Additionally, the Company had an accumulated deficit of $399,582 at December 31, 2023, and during the year ended December 31, 2023, the Company incurred a net loss of $81,414. The Company expects to continue to generate operating losses for the foreseeable future. The Company believes that its cash and cash equivalents of $70,643 as of December 31, 2023 will be sufficient to fund its operating expenses for at least 12 months from the issuance of these financial statements. In addition, to support its future operations, the Company will likely seek additional funding through public or private equity financings or government programs and will seek funding or development program cost-sharing through collaboration agreements or licenses with larger pharmaceutical or biotechnology companies. If the Company does not obtain additional funding or development program cost-sharing, or exceeds its current spending forecasts or fails to receive the research and development tax incentive payment, the Company has the ability and would be forced to: delay, reduce or eliminate certain clinical trials or research and development programs, reduce or eliminate discretionary operating expenses, and delay company and pipeline expansion, any of which could adversely affect its business prospects. The inability to obtain funding, as and when needed, could have a negative impact on the Company’s financial condition and ability to pursue its business strategies.

Summary of Significant Accounti

Summary of Significant Accounting Policies	12 Months Ended
	Dec. 31, 2023
Summary of Significant Accounting Policies
Summary of Significant Accounting Policies	2. Summary of Significant Accounting Policies Principles of Consolidation The accompanying consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany accounts and transactions are eliminated upon consolidation. Use of Estimates The presentation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Cash and Cash Equivalents The Company considers all highly liquid investments with maturities of three months or less when purchased to be cash equivalents. Cash equivalents consisted of overnight investments and money market funds. 2. Summary of Significant Accounting Policies (continued) Research and Development Expense Research and development costs are expensed as incurred. Research and development expenses include personnel costs associated with research and development activities, including noncash share-based compensation and costs for third-party contractors to perform research, conduct clinical trials and manufacture drug supplies and materials. The Company accrues for costs incurred by external service providers, including contract research organizations and clinical investigators, based on its estimates of service performed and costs incurred. These estimates include the level of services performed by the third parties, patient enrollment in clinical trials, administrative costs incurred by the third parties, and other indicators of the services completed. Based on the timing of amounts invoiced by service providers, the Company may also record payments made to those providers as prepaid expenses that will be recognized as expense in future periods as the related services are rendered. Research and development incentive income and receivable The Company recognizes other income from Australian research and development incentives when there is reasonable assurance that the income will be received, the relevant expenditure has been incurred, and the consideration can be reliably measured. The research and development incentive is one of the key elements of the Australian Government’s support for Australia’s innovation system and is supported by legislative law primarily in the form of the Australian Income Tax Assessment Act 1997 as long as eligibility criteria are met. Management has assessed the Company’s research and development activities and expenditures to determine which activities and expenditures are likely to be eligible under the research and development incentive regime described above. At each period end management estimates the refundable tax offset available to the Company based on available information at the time. This estimate is also reviewed by external tax advisors on an annual basis. Under the program, a percentage of eligible research and development expenses incurred by the Company through its subsidiary in Australia is reimbursed. This percentage was 43.5% for the years ended December 31, 2023 and 2022. The research and development incentive receivable represents an amount due in connection with the above program. The Company has recorded a research and development incentive receivable of $771 and $2,099 as of December 31, 2023 and 2022, respectively, in the consolidated balance sheets and other income from Australian research and development incentives of $1,101 and $2,051, in the consolidated statements of operations for the years ended December 31, 2023 and 2022, respectively, related to refundable research and development incentive program payments in Australia. The following table shows the change in the research and development incentive receivable from January 1, 2022 to December 31, 2023: ​ ​ ​ ​ ​ Balance at January 1, 2022 $ 1,189 Australian research and development incentive income, net ​ 2,051 Cash received for 2021 eligible expenses ​ (1,064) Foreign currency translation ​ ​ (77) Balance at December 31, 2022 ​ 2,099 Cash received for 2022 eligible expenses ​ ​ (2,333) Australian research and development incentive income, net ​ ​ 1,101 Foreign currency translation ​ (96) Balance at December 31, 2023 ​ $ 771 ​ ​ 2. Summary of Significant Accounting Policies (continued) Concentration of Credit Risk Financial instruments which potentially subject the Company to credit risk consist principally of cash and cash equivalents. All cash and cash equivalents are held in United States or Australian financial institutions and money market funds. At times, the Company may maintain cash balances in excess of the federally insured amount of $250 per depositor, per insured bank, for each account ownership category. Although the Company currently believes that the financial institutions with whom it does business will be able to fulfill their commitments to the Company, there is no assurance that those institutions will be able to continue to do so. The Company has not experienced any credit losses associated with its balances in such accounts for the years ended December 31, 2023 and 2022. Income Taxes The Company accounts for income taxes using the asset and liability method. Under the asset and liability method, deferred income taxes are recognized for differences between the financial reporting and tax bases of assets and liabilities at enacted statutory tax rates in effect for the years in which the differences are expected to reverse. The effect on deferred taxes of a change in tax rates is recognized in income in the period that includes the enactment date. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized. The Company follows accounting guidance concerning provisions for uncertainty in income tax positions. This guidance clarifies the accounting for income taxes by prescribing a minimum probability threshold that an uncertain tax position must meet before a financial statement benefit is recognized. The minimum threshold is defined as a tax position that is more likely than not to be sustained upon examination by the applicable taxing authority, of any related appeals or litigation processes, based on the technical merits of the position. The tax benefit to be recognized is measured as the largest amount of benefit that is greater than 50% likely of being realized upon ultimate settlement. The Company recognizes accrued interest and penalties associated with uncertain tax position as part of the income tax provision. There were no uncertain tax positions or income tax related interest and penalties recorded for the years ended December 31, 2023 and 2022. The income tax returns of the Company for the year ended December 31, 2020 and subsequent years are subject to examination by the Internal Revenue Service and other taxing authorities, generally for three years after the return is filed. Foreign Currency Translation The financial statements of the Company’s foreign subsidiary are measured using the local currency as the functional currency. Assets and liabilities of this subsidiary are translated into U.S. dollars at exchange rates as of the consolidated balance sheet date. Equity is translated at historical exchange rates. Revenues and expenses are translated into U.S. dollars at average rates of exchange in effect during the year. The resulting cumulative translation adjustments have been recorded as a separate component of stockholders’ deficiency. Foreign currency transaction gains and losses are included in the results of operations. Property and Equipment Property and equipment are stated at cost less accumulated depreciation. Depreciation expense is recognized using the straight-line method over the estimated useful life of each asset. Computer equipment is depreciated over three years. Laboratory equipment office equipment ​ 2. Summary of Significant Accounting Policies (continued) Impairment of Long-Lived Assets Long-lived assets consist of property and equipment. Long-lived assets to be held and used are tested for recoverability whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. Factors that the Company considers in deciding when to perform an impairment review include significant underperformance of the business in relation to expectations, significant negative industry or economic trends and significant changes or planned changes in the use of the assets. If an impairment review is performed to evaluate a long-lived asset group for recoverability, the Company compares forecasts of undiscounted cash flows expected to result from the use and eventual disposition of the long-lived asset group to its carrying value. An impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of an asset group are less than its carrying amount. The impairment loss would be based on the excess of the carrying value of the impaired asset group over its fair value. The Company did not record any impairment losses on long-lived assets during 2023 and 2022. Deferred Costs The Company capitalizes certain legal, professional, accounting and other third-party fees that are directly associated with in-process equity financings as deferred costs until such financings are consummated. After consummation of the equity financing, these costs are recorded in stockholders’ equity (deficiency) as a reduction of additional paid-in capital generated as a result of the offering. As of December 31, 2022 there was $576 of deferred costs. As of December 31, 2023, the Company did not have any deferred costs. Deposits Deposits as of December 31, 2023 and 2022 included $966 and $1,108, respectively, of deposits made by the Company with certain service providers that are to be applied to future payments due under the service agreements or returned to the Company if not utilized. Warrants The Company will recognize on a prospective basis the value of the effect of the down round feature in the warrants to purchase shares of common stock that were issued in a private placement in November 2017 (the “2017 Warrants”) when it is triggered (i.e., when the exercise price is adjusted downward). This value is measured as the difference between (1) the financial instrument’s fair value (without the down round feature) using the pre-trigger exercise price and (2) the financial instrument’s fair value (with the down round feature) using the reduced exercise price. The value of the effect of the down round feature will be treated as a dividend and a reduction to income available to common stockholders in the basic EPS calculation. Fair Value of Financial Instruments Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: ● Level 1—Quoted prices in active markets for identical assets or liabilities. 2. Summary of Significant Accounting Policies (continued) ● Level 2—Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. ● Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. During the years presented, the Company has not changed the manner in which it values assets and liabilities that are measured at fair value using Level 3 inputs. The Company recognizes transfers between levels of the fair value hierarchy as of the end of the reporting period. There were no transfers within the hierarchy during the years ended December 31, 2023 and 2022. A summary of the assets and liabilities carried at fair value in accordance with the hierarchy defined above is as follows (in thousands): ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Total Level 1 Level 2 Level 3 December 31, 2023 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Assets: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Cash equivalents ​ $ 39,065 ​ $ 39,065 ​ $ — ​ $ — Total assets ​ $ 39,065 ​ $ 39,065 ​ $ — ​ $ — ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, 2022 ​ ​ ​ ​ Assets: ​ ​ ​ ​ Cash equivalents ​ $ 62,074 ​ $ 62,074 ​ $ — ​ $ — Total assets ​ $ 62,074 ​ $ 62,074 ​ $ — ​ $ — ​ Cash equivalents of $39,065 and $62,074 as of December 31, 2023 and 2022, respectively, consisted of overnight investments and money market funds and are classified within Level 1 of the fair value hierarchy because they are valued using quoted market prices in active markets. The carrying value of the research and development incentive receivable, accounts payable and accrued expenses approximate their fair value due to the short-term nature of these assets and liabilities. Leases At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present. All leases with a term greater than one year are recognized on the balance sheet as right-of-use assets, lease liabilities and, if applicable, long-term lease liabilities. The Company has elected not to recognize on the balance sheet leases with terms of one year or less. Operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected remaining lease term. The Company has determined that the rate implicit in the lease is not determinable and the Company does not have borrowings with similar terms and collateral. Therefore, the Company considered a variety of factors, including observable debt yields from comparable companies and the volatility in the debt market for securities with similar terms, in determining that 8% was reasonable to use as the incremental borrowing rate for purposes of the calculation of lease liabilities. In accordance with the guidance in ASC 842 “Leases”, components of a lease should be split into three categories: lease components (e.g. land, building, etc.), non-lease components (e.g. common area maintenance, maintenance, consumables, etc.), and non-components (e.g. property taxes, insurance, etc.). Then the fixed and in-substance fixed contract consideration (including any related to non-components) must be allocated based on fair values to the lease components and non-lease components. 2. Summary of Significant Accounting Policies (continued) Although separation of lease and non-lease components is required, certain practical expedients are available. Entities may elect the practical expedient to not separate lease and non-lease components. Rather, they would account for each lease component and the related non-lease component together as a single component. The Company has elected to account for the lease and non-lease components of each of its operating leases as a single lease component and allocate all of the contract consideration to the lease component only. The lease component results in an operating right-of-use asset being recorded on the consolidated balance sheets and amortized such that lease expense is recorded on a straight line basis over the term of the lease. Segment Information The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. The Company’s singular focus is developing novel, targeted drugs for the treatment of cancer. Substantially all of the Company’s tangible assets are held in the United States. Patent Costs All patent related costs incurred in connection with filing and prosecuting patent applications are expensed as incurred due to the uncertainty about the recovery of the expenditure. Amounts incurred are classified as general and administrative expenses. Stock-Based Compensation The Company measures all stock options and other stock-based awards granted to employees, consultants and nonemployees based on the fair value on the date of the grant and recognizes compensation expense of those awards over the requisite service period, which is generally the vesting period of the respective award. Generally, the Company issues stock options with only service-based vesting conditions and records the expense for these awards using the straight-line method. Stock-based compensation is classified in the accompanying consolidated statements of operations based on the function to which the related services are provided. ​ 2. Summary of Significant Accounting Policies (continued) The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option-pricing model. The expected volatility is based on the historical volatility of the Company. The expected term of the Company’s stock options granted to employees has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options. The expected term of stock options granted to nonemployees is equal to the contractual term of the option award. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield of zero is based on the fact that the Company has never paid cash dividends on common stock and does not expect to pay any cash dividends in the foreseeable future. Net Loss per Share Basic net loss per share is computed using the weighted average number of common shares outstanding during the period. Diluted net loss per share is computed using the weighted average number of common shares outstanding during the period and, if dilutive, the weighted average number of potential shares of common stock, including the assumed exercise of stock options and warrants. Subsequent Events The Company considers events or transactions that occur after the balance sheet date but prior to the issuance of the financial statements to provide additional evidence for certain estimates or to identify matters that require additional disclosure. Subsequent events have been evaluated as required. Recently Adopted Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) and are early adopted by the Company or adopted as of the specified effective date. Unless otherwise discussed below, the Company does not believe that the adoption of recently issued standards have or may have a material impact on its consolidated financial statements or disclosures. In May 2021, FASB issued ASU 2021-04, Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options. FASB issued this update to clarify the accounting by issuers for modifications or exchanges of equity-classified warrants. The updated guidance is effective for the Company for annual periods beginning after December 15, 2021, including interim periods within those fiscal years. The Company adopted ASU 2021-04 in the first quarter of fiscal 2022 and the Company’s adoption of this standard did not have an effect on the Company’s consolidated financial statements. In August 2020, FASB issued ASU 2020-06, Debt—Debt with Conversion and Other Options, or ASC 470 and Derivatives and Hedging—Contracts in Entity’s Own Equity, or ASC 815. FASB issued this update to simplify the accounting for certain financial instruments with characteristics of liabilities and equity. The updated guidance is effective for the Company for annual periods beginning after December 15, 2021, including interim periods within those fiscal years. The Company adopted ASC 470 in the first quarter of fiscal 2022 and the Company’s adoption of this standard did not have an effect on the Company’s consolidated financial statements.

Acquisition of Flame Bioscience

Acquisition of Flame Biosciences	12 Months Ended
	Dec. 31, 2023
Acquisition of Flame Biosciences
Acquisition of Flame Biosciences	3. Acquisition of Flame Biosciences Merger On January 17, 2023 (the “Effective Date”), Leap acquired 100% of the outstanding equity of Flame, in accordance with the terms of the Agreement and Plan of Merger, dated as of the Effective Date (the “Merger Agreement”), by and among Leap, Fire Merger Sub, Inc., a Delaware corporation and a wholly owned subsidiary of Leap (“First Merger Sub”), Flame Biosciences LLC, a Delaware limited liability company and wholly owned subsidiary of Leap (“Second Merger Sub”), Flame, and the Stockholder Representative named therein. Pursuant to the Merger Agreement, First Merger Sub merged with and into Flame, and Flame was the surviving corporation of such merger and became a wholly owned subsidiary of Leap (the “First Merger”). Immediately following the First Merger, Flame merged with and into Second Merger Sub, and Second Merger Sub was the surviving entity of such merger (together with the First Merger, the “Merger”). Pursuant to the Merger, Leap agreed to issue to the stockholders of Flame (the “Flame Stockholders”) 1,972,901 shares of common stock, and 136,248 shares of Series X Preferred Stock, which was a newly designated series of preferred stock that was intended to have economic rights equivalent to the common stock, but with limited voting rights, and issued to the warrant holders of Flame (the “Flame Warrant Holders”) the right to acquire 6,530 shares of common stock (the “January 2023 Common Stock Warrants”) and 443 shares of Series X Preferred Stock (the “January 2023 Series X Preferred Stock Warrants”). Each share of Series X Preferred Stock converted into 100 shares of common stock during the year ended December 31, 2023, as a result of the one On June 16, 2023, the Company obtained Stockholder Approval to convert the Series X Preferred Stock into shares of its common stock, which occurred on June 21, 2023. ​ 3. Acquisition of Flame Biosciences (continued) The Company accounted for the acquisition of Flame as an asset acquisition allocating the purchase price under GAAP of $79,016 to net assets acquired. Although there is a presumption under SEC Rule 11-01(d) (“11-01(d)”) that when a legal entity is acquired, it represents a business acquisition, the Company concluded that, in this case, the transaction did not represent the acquisition of a business. After considering the criteria set forth in 11-01(d), the Company concluded that the acquisition of Flame by the Company was an acquisition of assets and not an acquisition of a business in accordance with 11-01(d). Specifically, the Company concluded that 1) the entity did not generate revenue and 2) there was not sufficient continuity of Flame’s operations prior to and following the transaction, in that no facilities, employees, sales force, distribution system, customer base, trade names or production techniques remained with the entity after the acquisition. Leap primarily acquired cash of $50,362, certain working capital items ($928) and a portfolio of clinical- and pre-clinical-stage intellectual property, in connection with the acquisition of Flame. The Company accounted for the acquisition of Flame by recording the cash and any other assets and liabilities of Flame on its consolidated balance sheet at their historical carrying values, which approximated fair values. The remaining fair value of the consideration transferred was allocated to the in-process research and development (“IPR&D”) assets acquired. Certain transaction costs that were not deemed to meet the criteria of costs directly attributable to the issuance of securities were capitalized in accordance with ASC 805-50-30-1 and recognized as part of fair value of assets acquired. As the Company concluded that such IPR&D did not have an alternative future use, the relative fair value allocated to acquired IPR&D of $29,582 was expensed in research and development expenses within the Company’s consolidated statement of operations during the year ended December 31, 2023. The following table summarizes the net assets acquired based on their estimated fair values as of January 17, 2023 (in thousands): ​ ​ ​ ​ Acquired IPR&D $ 29,582 Cash and cash equivalents ​ 50,362 Accounts payable and accrued liabilities ​ (928) Total acquisition value ​ $ 79,016 ​ The fair value assigned to each component of the purchase consideration, including direct costs of the acquisition of $1,393, as of the Effective Date is set forth in the table below (in thousands, except share and per share amounts): ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Equivalent ​ ​ ​ ​ ​ Number of ​ common ​ Fair ​ shares shares Value Leap common stock (par value $0.0001 per share) 1,972,901 1,972,901 ​ $ 9,805 Leap Series X Preferred Stock (100:1) 136,248 13,624,800 ​ 67,715 Warrants on Leap common stock 6,530 6,530 ​ 13 Warrants on Leap Series X Preferred Stock (100:1) 443 44,300 ​ 90 Direct and incremental costs of the asset acquisition ​ ​ ​ 1,393 ​ ​ ​ ​ ​ ​ ​ ​ Total ​ ​ 15,648,531 ​ $ 79,016 ​ In addition, subject to and upon the terms and conditions set forth in the Merger Agreement, the Company may also (i) pay Contingent Merger Consideration (as defined in the Merger Agreement) that may become payable if, and only if, certain assets of Flame related to Flame’s FL-101 program and/or FL-103 program are sold after the consummation of the Merger pursuant to the FL-101/103 Disposition Agreement (as defined in the Merger Agreement), which Contingent Merger Consideration shall be 80% of the after-tax net proceeds of such sale, if any, and the payment thereof is subject to the terms and conditions set forth in the Merger Agreement and (ii) issue pursuant to the Merger additional shares of Series X Preferred Stock or common stock as a result of any applicable post-closing purchase price adjustment in the event that Flame’s actual Company Net Cash (as defined in the Merger Agreement) as of the Effective Date is determined to be greater than Flame’s estimated Company Net Cash as of the closing. 3. Acquisition of Flame Biosciences (continued) Sale of FL-101/FL-103 to AlmataBio, Inc. On December 6, 2023 the Company sold certain IPR&D assets previously acquired from Flame related to Flame’s FL-101/FL-103 program which included permits, clinical trial material, clinical data, and related identified contracts, such as licensing, research, clinical trials, and various other agreements. The Company received total consideration in the form of a non-refundable closing date cash payment of $500. Pursuant to the terms of the asset purchase agreement, the Company is entitled to receive milestone payments of up to $70,000 upon achievement of certain regulatory approval and sales milestones specified in the asset purchase agreement. The IPR&D assets sold related to Flame’s FL-101/FL-103 program did not meet the definition of a business and had a carrying value of $0 at the time of the sale. In addition, the Company estimated the likelihood of receiving any milestone payments to be remote. As such, management elected the most likely amount method to determine the transaction price of the sale, which included the non-refundable closing date cash payment of $500 and future milestone payments of $0. Therefore, the Company recognized a non-operating gain in other income for the difference between the amount of non-refundable consideration received of $500 and the carrying value of $0 during the year ended December 31, 2023. In the event of a change in circumstances, such that it becomes likely that the Company will receive milestone payments, the Company will recognize income for the change in transaction price in the period in which the transaction price changes. In addition, during the year ended December 31, 2023, the Company incurred various qualified expenses, such as legal fees, consulting and general and administrative expenses in connection with the sale of Flame’s FL-101 program. Such expenses exceeded the non-refundable consideration received of $500, and therefore, the Company was not obligated to pay Contingent Merger Consideration to the Flame Stockholders. Series X Preferred Stock Pursuant to the Merger, the Company agreed to issue 136,248 shares of Series X Preferred Stock to Flame Stockholders and January 2023 Series X Preferred Stock Warrants for 443 shares of Series X Preferred Stock to Flame Warrant Holders. The Company obtained Stockholder Approval during the year ended December 31, 2023 to convert each issued share of Series X Preferred Stock and each share of Series X Preferred Stock issuable pursuant to the January 2023 Series X Preferred Stock Warrants into 100 shares of its common stock. The Series X Preferred Stock was converted to common stock on June 21, 2023, and the carrying value of the Series X Preferred Stock was reclassified from mezzanine equity to permanent equity. 3. Acquisition of Flame Biosciences (continued) January 2023 Common Stock Warrants and January 2023 Series X Preferred Stock Warrants In January 2023, pursuant to the Merger, the warrants held by the Flame Warrant Holders became exercisable for 6,530 shares of Leap’s common stock (the “January 2023 Common Stock Warrants”). The January 2023 Common Stock Warrants have an exercise price of $6.78 per share and expire in February 2025. The January 2023 Common Stock Warrants qualify for equity classification. Also in January 2023, pursuant to the Merger, the warrants held by the Flame Warrant Holders became exercisable for 443 shares of Series X Preferred Stock (the “January 2023 Series X Preferred Stock Warrants”). Upon obtaining Stockholder Approval for the conversion of the Series X Preferred Stock and the one Changes in the fair value of the warrant liability are recognized as gains (losses) in the Company’s consolidated statement of operations. During the year ended December 31, 2023, the Company recorded a gain of $12 in its consolidated statement of operations.

Property and Equipment, Net

Property and Equipment, Net	12 Months Ended
	Dec. 31, 2023
Property and Equipment, Net
Property and Equipment, Net	4. Property and equipment, net ​ Property and equipment, net consisted of the following: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ 2023 2022 Computer office equipment ​ $ 51 ​ $ 51 Leasehold improvements ​ ​ 69 ​ ​ 69 Lab equipment ​ 76 ​ 76 Furnitures and fixtures ​ 30 ​ 30 ​ ​ 226 ​ 226 Less: accumulated depreciation ​ (221) ​ (206) Property and equipment, net ​ $ 5 ​ $ 20 ​ Depreciation expense was $15 and $16 for the years ended December 31, 2023 and 2022, respectively.

Accrued Expenses

Accrued Expenses	12 Months Ended
	Dec. 31, 2023
Accrued Expenses
Accrued Expenses	5. Accrued Expenses Accrued expenses consist of the following: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ 2023 2022 Clinical trials ​ $ 2,522 ​ $ 2,093 Professional fees ​ 254 ​ 533 Payroll and related expenses ​ 3,181 ​ 2,526 Accrued expenses ​ $ 5,957 ​ $ 5,152 ​

Leases

Leases	12 Months Ended
	Dec. 31, 2023
Leases
Leases	6. Leases The Company has an operating lease for real estate in the United States and does not have any finance leases. The Company’s leases may contain options to renew and extend lease terms and options to terminate leases early. Reflected in the right-of-use asset and lease liability on the Company’s consolidated balance sheets are the periods provided by renewal and extension options that the Company is reasonably certain to exercise, as well as the periods provided by termination options that the Company is reasonably certain to not exercise. The Company’s existing 47 Thorndike Street Lease was set to expire in July 2024. In January 2024 the Company entered into a fourth amendment with its 47 Thorndike Street Lease (“Fourth Amendment”), extending the lease through July 2025 (see Note 15). The 47 Thorndike Street Lease includes variable lease and non-lease components that are not included in the right-of-use asset and lease liability and are reflected as an expense in the period incurred. Such payments primarily include common area maintenance charges and increases in rent payments that are driven by factors such as future changes in an index (e.g., the Consumer Price Index). In calculating the present value of future lease payments, the Company utilized its incremental borrowing rate based on the remaining lease term at the date of adoption. The Company has elected to account for each lease component and its associated non-lease components as a single lease component and has allocated all of the contract consideration across lease components only. This will potentially result in the initial and subsequent measurement of the balances of the right-of-use asset and lease liability for leases being greater than if the policy election was not applied. The Company has an existing net lease in which the non-lease components (e.g. common area maintenance, maintenance, consumables, etc.) are paid separately from rent based on actual costs incurred and therefore are not included in the right-of-use asset and lease liability and are reflected as an expense in the period incurred. During the year ended December 31, 2022, the Company extended the term of its operating lease and recorded an additional right-of-use asset and lease liability Future lease payments under non-cancelable operating leases as of December 31, 2023 are detailed as follows: ​ ​ ​ ​ ​ Future Operating Lease Payments 2024 ​ 268 Total Lease Payments ​ 268 Less: imputed interest ​ (6) Total operating lease liabilities $ 262 ​

Warrants

Warrants	12 Months Ended
	Dec. 31, 2023
Warrants
Warrants	7. Warrants As of December 31, 2023, outstanding warrants to purchase common stock, all of which are classified as equity warrants, consisted of the following: ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, 2023 ​ ​ ​ ​ Number of Common Shares ​ ​ ​ ​ Description Issuable Exercise Price Expiration Date January 23, 2017 Warrants 5,450 ​ $ 0.10 ​ Upon M&A Event 2017 Warrants ​ 250,227 ​ $ 10.55 ​ November 2024 2019 Warrants ​ 690,813 ​ $ 19.50 ​ February 2026 March 2020 Pre-funded Warrants ​ 824,716 ​ $ 0.01 ​ No Expiry March 2020 Coverage Warrants ​ 2,594,501 ​ $ 21.10 ​ Jan - March 2027 September 2021 Pre-funded Warrants 591,602 ​ $ 0.01 ​ No Expiry January 2023 Common Stock Warrants ​ 50,830 ​ $ 6.78 ​ February 2025 ​ ​ 5,008,139 ​ ​ ​ ​ ​ ​ 2019 Warrants During the year ended December 31, 2023, the Company redeemed 10,000 of the 2019 Warrants at a purchase price of $2.90 per share. January 2023 Common Stock Warrants In January 2023, pursuant to the Merger, the warrants held by the Flame Warrant Holders became exercisable for 6,530 shares of Leap’s common stock (the “January 2023 Common Stock Warrants”). The January 2023 Common Stock Warrants have an exercise price of $6.78 per share and expire in February 2025. The January 2023 Common Stock Warrants qualify for equity classification. January 2023 Series X Preferred Stock Warrants In January 2023, pursuant to the Merger, the warrants held by the Flame Warrant Holders also became exercisable for 443 shares of Series X Preferred Stock (the “January 2023 Series X Preferred Stock Warrants”). Each share of Series X Preferred Stock converted into 100 shares of common stock, following Stockholder Approval during the year ended December 31, 2023. The January 2023 Series X Preferred Stock Warrants have an exercise price of $6.78 per share and expire in February 2025. The Company initially recorded the January 2023 Series X Preferred Stock Warrants as a liability on its consolidated balance sheet as of the Effective Date and subsequently remeasured the warrant liability to fair value at each reporting date and on the date Stockholder Approval was obtained to convert shares of Series X Preferred Stock into shares of common stock. Changes in the fair value of the warrant liability were recognized as gains (losses) in the Company’s consolidated statement of operations. During the year ended December 31, 2023, the Company recorded a gain of $12 in its consolidated statement of operations. During the year ended December 31, 2023, upon obtaining Stockholder Approval, the January 2023 Series X Preferred Stock Warrants were converted into common stock warrants and reclassified from liability to equity.

Common Stock

Common Stock	12 Months Ended
	Dec. 31, 2023
Common Stock
Common Stock	8. Common Stock Each share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders. Common stockholders are entitled to receive dividends, as may be declared by the board of directors, if any, subject to the preferential dividend rights of the preferred stockholders. Through December 31, 2023, no dividends have been declared for shares of common stock. Acquisition of Flame – January 2023 On January 17, Leap acquired 100% of the outstanding equity of Flame. Pursuant to the Merger, Leap issued to Flame Stockholders 1,972,901 shares of common stock. The Company also issued Series X Preferred Stock to Flame Stockholders pursuant to the Merger (see Note 3).

Stock-Based Compensation

Stock-Based Compensation	12 Months Ended
	Dec. 31, 2023
Stock-Based Compensation
Stock-Based Compensation	9. Stock-Based Compensation Equity Incentive Plans In September 2012, the Company adopted the 2012 Equity Incentive Plan (the “2012 Plan”), as amended, which provides designated employees of the Company and its affiliates, certain consultants and advisors who perform services for the Company and its affiliates, and nonemployee members of the Board of Directors of the Company and its affiliates with the opportunity to receive grants of incentive stock options, nonqualified stock options and stock awards. During the year ended December 31, 2022, the 2012 Equity Plan expired. On January 20, 2017, the Company’s stockholders approved the 2016 Equity Incentive Plan (the “2016 Plan”). Beginning on January 1, 2018, the number of shares of common stock authorized for issuance pursuant to the 2016 Plan was increased each January 1 by an amount equal to four percent (4%) of the Company’s outstanding common stock as of the end of the immediately preceding calendar year or such other amount as determined by the compensation committee of the Company’s board of directors. On June 16, 2022, the Company’s stockholders approved the 2022 Equity Incentive Plan (the “2022 Plan”), which provides for a total of 750,000 new shares of the Company’s common stock to be granted. In addition, on June 16, 2023, stockholders approved 2,250,000 new shares of the Company’s common stock to be added to the 2022 Plan for future issuance. As of December 31, 2023, there were 1,016,023 shares available for grant under the Company’s Equity Incentive Plans, which excludes the 2012 Plan which expired during the year ended December 31, 2022. 9. Stock-Based Compensation (continued) A summary of stock option activity under the Company’s Equity Incentive Plans is as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted ​ ​ ​ ​ ​ ​ ​ Average Weighted Aggregate ​ ​ ​ Exercise Price Average Remaining Intrinsic ​ ​ Options Per Share ​ Life in Years ​ Value Outstanding at December 31, 2021 ​ 852,266 ​ $ 44.76 ​ 7.58 ​ $ 7,670 Granted 402,490 ​ $ 15.03 ​ ​ Forfeited ​ (63,041) ​ $ 21.65 ​ ​ ​ ​ ​ Outstanding at December 31, 2022 1,191,715 ​ $ 35.94 7.47 ​ $ 7,673 Granted 2,393,500 ​ $ 2.67 ​ ​ Forfeited ​ (200,849) ​ $ 9.73 ​ ​ ​ ​ ​ Outstanding at December 31, 2023 ​ 3,384,366 ​ $ 13.97 ​ 8.40 ​ $ 3,431 Options exercisable at December 31, 2023 1,382,078 ​ $ 28.80 6.87 ​ ​ ​ Options vested and expected to vest at December 31, 2023 3,384,366 ​ $ 13.97 8.40 ​ $ 3,431 ​ The grant date fair value of the options granted during the years ended December 31, 2023 and 2022 was estimated at the date of grant using the Black-Scholes option valuation model. The expected life was estimated using the “simplified” method as defined by the SEC’s Staff Accounting Bulletin 107, Share-Based Payment. The expected volatility was based on the historical volatility of the Company. The risk-free interest rate was based on the continuous rates provided by the U.S. Treasury with a term approximating the expected life of the option. The expected dividend yield was 0% because the Company does not expect to pay any dividends for the foreseeable future. The Company elected the straight-line attribution method in recognizing the grant date fair value of options issued over the requisite service periods of the awards, which are generally the vesting periods. ​ The weighted average grant date fair value for the stock options granted during the years ended December 31, 2023 and 2022 was $2.07 and $10.84 per share, respectively. ​ The assumptions that the Company used to determine the grant-date fair value of stock options granted to employees and directors during the years ended December 31, 2023 and 2022 were as follows, presented on a weighted average basis: ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ ​ 2023 2022 ​ Expected volatility 90.44 % 82.70 % Weighted average risk-free interest rate 4.05 % 3.10 % Expected dividend yield ​ 0.00 % 0.00 % Expected term (in years) ​ 6.49 ​ 6.42 ​ ​ Stock options generally vest over a three 9. Stock-Based Compensation (continued) Restricted Stock Units During the year ended December 31, 2022 the Company granted 265,000 restricted stock units (“RSUs”) to employees that will cliff vest and will be settled after three years of continuous service, or upon a change of control of the Company, whichever is earlier, pursuant to the 2016 Plan. The Company did not grant any RSUs during the year ended December 31, 2023. During the years ended December 31, 2023 and 2022, the Company recognized $1,632 and $2,086, respectively, of stock based compensation expense related to these equity classified RSUs. ​ The following table presents RSU activity under the 2016 Plan as of December 31, 2023: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted ​ Number of Average Grant ​ Shares Date Fair Value Outstanding at December 31, 2021 93,560 ​ $ 17.60 Awarded ​ 265,000 ​ $ 19.40 Outstanding at December 31, 2022 ​ 358,560 ​ $ 18.90 Vested ​ (66,060) ​ $ 14.20 Forfeited (30,000) ​ $ 19.40 Outstanding at December 31, 2023 262,500 ​ $ 19.97 ​ As of December 31, 2023, there were 262,500 shares outstanding covered by RSUs that were vested and expected to vest with a weighted average grant date fair value of $19.97 per share and an aggregate grant date fair value of $5,242. As of December 31, 2023, there was approximately $1,682 of unrecognized compensation costs related to RSUs granted to employees, which are expected to be recognized as expense over a remaining weighted average period of 1.1 years. ​ The Company recognized stock-based compensation expense related to the issuance of stock option awards and RSUs to employees and non-employees in the consolidated statements of operations during the years ended December 31, 2023 and 2022 as follows: Stock Based Compensation Expense ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ ​ December 31, ​ 2023 2022 Research and development $ 2,647 ​ $ 2,540 General and administrative ​ 2,481 ​ 2,640 Total ​ $ 5,128 ​ $ 5,180 ​

Income Taxes

Income Taxes	12 Months Ended
	Dec. 31, 2023
Income Taxes
Income Taxes	10. Income Taxes There is no provision for income taxes in the United States because the Company has historically incurred operating losses and maintains a full valuation allowance against its deferred tax assets in these jurisdictions. Loss before income taxes consisted of the following: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ ​ December 31, ​ 2023 2022 U.S. ​ $ (80,895) ​ $ (50,325) Foreign ​ (519) ​ (4,124) Loss before income taxes ​ $ (81,414) ​ $ (54,449) ​ A summary of the Company’s current and deferred expense for income tax is as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ ​ December 31, ​ 2023 2022 Current expense (benefit): ​ ​ ​ ​ ​ ​ Federal ​ $ — ​ $ — State ​ — ​ — Foreign ​ — ​ — Total current expense (benefit): ​ $ — ​ $ — Deferred expense (benefit): ​ ​ ​ ​ ​ ​ Federal ​ $ — ​ $ — State ​ — ​ — Foreign ​ — ​ ​ 147 Total deferred expense ​ $ — ​ $ 147 Total income tax expense ​ $ — ​ $ 147 ​ A reconciliation of the Company’s statutory income tax rate to the Company’s effective income tax rate is as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ ​ December 31, ​ ​ 2023 2022 Income at US Statutory Rate 21.0 % 21.0 % State taxes, net of federal benefit 4.1 % 6.0 % Flame IPR&D write off 0.0 % 0.0 % Permanent differences 0.3 % 0.7 % Research and development credits 1.6 % 1.0 % Foreign rate differential ​ 0.0 % 0.3 % Change in valuation allowance 63.5 % (27.3) % Section 382 limitations (90.1) % 0.0 % Other (0.4) % (1.7) % ​ 0.0 % 0.0 % ​ 10. Income Taxes (continued) ​ The significant components of the Company’s deferred tax assets as of December 31, 2023 and 2022 were as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ ​ December 31, ​ 2023 2022 Federal net operating loss carryforwards ​ $ 3,672 ​ $ 44,202 State net operating loss carryforwards ​ ​ 967 ​ 12,104 Foreign net operating loss carryforwards ​ ​ — ​ 98 Research and development (R&D) tax credits ​ ​ 1,649 ​ ​ 9,358 Capitalized R&D expenses ​ ​ 2,413 ​ ​ 9,312 Start-up costs ​ ​ 11,355 ​ ​ — Stock based compensation ​ ​ 5,812 ​ ​ 4,757 Accrued expenses ​ ​ 831 ​ ​ — License fees ​ ​ 676 ​ 840 Other ​ ​ 10,867 ​ ​ 297 Total deferred tax assets ​ ​ 38,242 ​ ​ 80,968 Valuation allowance ​ (38,242) ​ (80,968) Net deferred tax assets ​ $ — ​ $ — ​ As of December 31, 2023, the Company had federal and state net operating loss (“NOL”) carryforwards of approximately $17,487, and $18,532, respectively. The Company’s federal NOL’s can be carried forward indefinitely and the state NOL’s begin to expire in 2038. Under Internal Revenue Code Section 382, if a corporation undergoes an “ownership change,” the corporation’s ability to use its pre-change NOL carryforwards and other pre-change tax attributes to offset its post-change income may be limited. The Company has completed a study to assess whether an ownership change occurred or whether there had been multiple ownership changes since the Company became a “loss corporation” as defined in Section 382. The Company experienced multiple ownership changes occurring in 2019, 2020, and 2023. The ownership changes have and will continue to subject the Company’s pre-ownership change NOL carryforwards to an annual limitation, which will significantly restrict its ability to use them to offset taxable income in periods following the ownership changes. In general, the annual use limitation equals the aggregate value of the Company’s stock at the time of the ownership change multiplied by a specified tax-exempt interest rate. As a result of the ownership changes, the Company is limited to a $0 annual limitation on its ability to utilize its NOL’s and research and development (“R&D”) credits recognized prior to the Flame merger. Due to this limitation, approximately $210,844 of the federal NOL’s and $7,889 of federal R&D credits that had been available to offset future taxable income prior to the date of the ownership change, will expire unutilized. Additionally, approximately $192,689 and $1,771 of state NOL’s and R&D tax credits that had been available to offset future taxable income prior to the date of the ownership change, will expire unutilized. As a result, during the year ended December 31, 2023, the Company has reduced its deferred tax assets related to the federal and state NOL and R&D credits which is offset by the corresponding decrease in a valuation allowance. In addition, As of December 31, 2023, the Company has federal and state R&D tax credits of approximately $1,466 and $231, respectively, that begin to expire in 2043 and 2038, respectively, for federal and state tax purposes. As of December 31, 2023 and 2022, the Company has provided a full valuation allowance against its net deferred tax assets, as realization of any associated tax benefit in the future is not more likely than not. The valuation allowance decreased by $42,726 and increased by $14,886 during the years ended December 31, 2023 and 2022, respectively. The decrease in valuation allowance during the year ended December 31, 2023 is due primarily to Section 382 limitations on NOL’s and R&D tax credits. 10. Income Taxes (continued) The Tax Cuts and Jobs Act (“TCJA”) resulted in significant changes to the treatment of R&D expenditures under Section 174. For tax years beginning after December 31, 2021, taxpayers are required to capitalize and amortize all R&D expenditures that are paid or incurred in connection with their trade or business. Specifically, costs for U.S.-based R&D activities must be amortized over five years and costs for foreign R&D activities must be amortized over 15 years, both using a midyear convention. During the year ended December 31, 2023, the Company capitalized $41,838 of R&D expenses. The Company follows the authoritative guidance on accounting for and disclosure of uncertainty in tax positions, which requires the Company to determine whether a tax position of the Company is more likely than not to be sustained upon examination, including resolution of any related appeals of litigation processes, based on the technical merits of the position. For tax positions meeting the more likely than not threshold, the tax amount recognized in the financial statements is reduced by the largest benefit that has a greater than 50% likelihood of being realized upon the ultimate settlement with the relevant taxing authority. As of December 31, 2023, the Company has not recorded any uncertain tax positions. The Company files tax returns as prescribed by the tax laws of the jurisdictions in which it operates. In the normal course of business the Company is subject to examination by federal and state jurisdictions, where applicable. There are currently no pending tax examinations. The earliest tax years that may be subject to examination by jurisdiction are 2020 for both federal and state purposes. The Company’s policy is to record interest and penalties related to income taxes as part of the tax provision. There were no interest and penalties pertaining to uncertain tax positions for the years ended December 31, 2023 or 2022.

Net Loss Per Share

Net Loss Per Share	12 Months Ended
	Dec. 31, 2023
Net Loss Per Share
Net Loss Per Share	11. Net Loss Per Share Basic and diluted net loss per share for the years ended December 31, 2023 and 2022 was calculated as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ 2023 2022 Numerator: ​ ​ ​ ​ ​ Net loss ​ $ (81,414) ​ $ (54,596) Net loss attributable to common stockholders for basic and diluted loss per share ​ $ (81,414) ​ $ (54,596) ​ ​ ​ ​ ​ ​ ​ Denominator: ​ ​ ​ ​ ​ ​ Weighted average number of common shares outstanding - basic and diluted ​ 20,445,109 ​ 11,323,909 Net loss per share attributable to common stockholders - basic and diluted ​ $ (3.98) ​ $ (4.82) ​ Included within weighted average common shares outstanding for the years ended December 31, 2023 and 2022, are 1,421,768 common shares issuable upon the exercise of the pre-funded warrants and penny warrants, as the warrants are exercisable at any time for nominal consideration, and as such, the shares are considered outstanding for the purpose of calculating basic and diluted net loss per share attributable to common stockholders. 11. Net Loss Per Share (continued) The Company’s potentially dilutive securities include RSUs, stock options and warrants. These securities were excluded from the computations of diluted net loss per share for the years ended December 31, 2023 and 2022, as the effect would be to reduce the net loss per share. The following table includes the potential common shares of common stock, presented based on amounts outstanding at each period end, that were excluded from the computation of diluted net loss per share attributable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect: ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ 2023 2022 Restricted stock units to purchase common stock 262,500 ​ 358,560 Options to purchase common stock ​ 3,384,366 ​ 1,191,715 Warrants to purchase common stock ​ 3,586,371 ​ 3,545,567 ​ 7,233,237 ​ 5,095,842 ​

Commitments and Contingencies

Commitments and Contingencies	12 Months Ended
	Dec. 31, 2023
Commitments and Contingencies
Commitments and Contingencies	12. Commitments and Contingencies Manufacturing Agreements— License and Service Agreements— ​ License Agreement— Collaboration Agreement 12. Commitments and Contingencies (continued) License Agreement Legal Proceedings— Indemnification Agreements—

Defined Contribution Plan

Defined Contribution Plan	12 Months Ended
	Dec. 31, 2023
Defined Contribution Plan
Defined Contribution Plan	13. Defined Contribution Plan The Company has a 401(k) defined contribution plan (the “401(k) Plan”) for substantially all of its employees. Eligible employees may make pretax contributions to the 401(k) Plan up to statutory limits. The Company makes matching employee contributions in cash to the 401(k) Plan at a rate of 100% of the first 3% of earnings contributed and 50% of the next 2% of earnings contributed. Employees participating in the 401(k) Plan are fully vested in the Company matching contributions, and investments are directed by participants. The Company made matching contributions of $443 and $333 for the years ended December 31, 2023 and 2022, respectively.

Related Party Transactions

Related Party Transactions	12 Months Ended
	Dec. 31, 2023
Related Party Transactions
Related Party Transactions	14. Related Party Transactions The Company has a license agreement with a stockholder (See Note 12).

Subsequent Events

Subsequent Events	12 Months Ended
	Dec. 31, 2023
Subsequent Events
Subsequent Events	15. Subsequent Events On January 3, 2024, the Company entered into a Fourth Amendment. Under the Fourth Amendment, the Company extended the term of the 47 Thorndike Street Lease through July 31, 2025. Under the Fourth Amendment, the Company will continue to pay the current monthly base rent amount of $38,335 contemplated by the 47 Thorndike Street Lease through July 31, 2024, with an increase commencing on August 1, 2024 adjusting the monthly base rent amount to approximately $38,974 through July 31, 2025. In January 2024, the Company released the Holdback Shares to the Flame Shareholders (see Note 3).

Summary of Significant Accoun_2

Summary of Significant Accounting Policies (Policies)	12 Months Ended
	Dec. 31, 2023
Summary of Significant Accounting Policies
Principles of Consolidation	Principles of Consolidation The accompanying consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany accounts and transactions are eliminated upon consolidation.
Use of Estimates	Use of Estimates The presentation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.
Cash and Cash Equivalents	Cash and Cash Equivalents The Company considers all highly liquid investments with maturities of three months or less when purchased to be cash equivalents. Cash equivalents consisted of overnight investments and money market funds.
Research and Development Expense	Research and Development Expense Research and development costs are expensed as incurred. Research and development expenses include personnel costs associated with research and development activities, including noncash share-based compensation and costs for third-party contractors to perform research, conduct clinical trials and manufacture drug supplies and materials. The Company accrues for costs incurred by external service providers, including contract research organizations and clinical investigators, based on its estimates of service performed and costs incurred. These estimates include the level of services performed by the third parties, patient enrollment in clinical trials, administrative costs incurred by the third parties, and other indicators of the services completed. Based on the timing of amounts invoiced by service providers, the Company may also record payments made to those providers as prepaid expenses that will be recognized as expense in future periods as the related services are rendered.
Research and development incentive income and receivable	Research and development incentive income and receivable The Company recognizes other income from Australian research and development incentives when there is reasonable assurance that the income will be received, the relevant expenditure has been incurred, and the consideration can be reliably measured. The research and development incentive is one of the key elements of the Australian Government’s support for Australia’s innovation system and is supported by legislative law primarily in the form of the Australian Income Tax Assessment Act 1997 as long as eligibility criteria are met. Management has assessed the Company’s research and development activities and expenditures to determine which activities and expenditures are likely to be eligible under the research and development incentive regime described above. At each period end management estimates the refundable tax offset available to the Company based on available information at the time. This estimate is also reviewed by external tax advisors on an annual basis. Under the program, a percentage of eligible research and development expenses incurred by the Company through its subsidiary in Australia is reimbursed. This percentage was 43.5% for the years ended December 31, 2023 and 2022. The research and development incentive receivable represents an amount due in connection with the above program. The Company has recorded a research and development incentive receivable of $771 and $2,099 as of December 31, 2023 and 2022, respectively, in the consolidated balance sheets and other income from Australian research and development incentives of $1,101 and $2,051, in the consolidated statements of operations for the years ended December 31, 2023 and 2022, respectively, related to refundable research and development incentive program payments in Australia. The following table shows the change in the research and development incentive receivable from January 1, 2022 to December 31, 2023: ​ ​ ​ ​ ​ Balance at January 1, 2022 $ 1,189 Australian research and development incentive income, net ​ 2,051 Cash received for 2021 eligible expenses ​ (1,064) Foreign currency translation ​ ​ (77) Balance at December 31, 2022 ​ 2,099 Cash received for 2022 eligible expenses ​ ​ (2,333) Australian research and development incentive income, net ​ ​ 1,101 Foreign currency translation ​ (96) Balance at December 31, 2023 ​ $ 771
Concentration of Credit Risk	Concentration of Credit Risk Financial instruments which potentially subject the Company to credit risk consist principally of cash and cash equivalents. All cash and cash equivalents are held in United States or Australian financial institutions and money market funds. At times, the Company may maintain cash balances in excess of the federally insured amount of $250 per depositor, per insured bank, for each account ownership category. Although the Company currently believes that the financial institutions with whom it does business will be able to fulfill their commitments to the Company, there is no assurance that those institutions will be able to continue to do so. The Company has not experienced any credit losses associated with its balances in such accounts for the years ended December 31, 2023 and 2022.
Income Taxes	Income Taxes The Company accounts for income taxes using the asset and liability method. Under the asset and liability method, deferred income taxes are recognized for differences between the financial reporting and tax bases of assets and liabilities at enacted statutory tax rates in effect for the years in which the differences are expected to reverse. The effect on deferred taxes of a change in tax rates is recognized in income in the period that includes the enactment date. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized. The Company follows accounting guidance concerning provisions for uncertainty in income tax positions. This guidance clarifies the accounting for income taxes by prescribing a minimum probability threshold that an uncertain tax position must meet before a financial statement benefit is recognized. The minimum threshold is defined as a tax position that is more likely than not to be sustained upon examination by the applicable taxing authority, of any related appeals or litigation processes, based on the technical merits of the position. The tax benefit to be recognized is measured as the largest amount of benefit that is greater than 50% likely of being realized upon ultimate settlement. The Company recognizes accrued interest and penalties associated with uncertain tax position as part of the income tax provision. There were no uncertain tax positions or income tax related interest and penalties recorded for the years ended December 31, 2023 and 2022. The income tax returns of the Company for the year ended December 31, 2020 and subsequent years are subject to examination by the Internal Revenue Service and other taxing authorities, generally for three years after the return is filed.
Foreign Currency Translation	Foreign Currency Translation The financial statements of the Company’s foreign subsidiary are measured using the local currency as the functional currency. Assets and liabilities of this subsidiary are translated into U.S. dollars at exchange rates as of the consolidated balance sheet date. Equity is translated at historical exchange rates. Revenues and expenses are translated into U.S. dollars at average rates of exchange in effect during the year. The resulting cumulative translation adjustments have been recorded as a separate component of stockholders’ deficiency. Foreign currency transaction gains and losses are included in the results of operations.
Property and Equipment	Property and Equipment Property and equipment are stated at cost less accumulated depreciation. Depreciation expense is recognized using the straight-line method over the estimated useful life of each asset. Computer equipment is depreciated over three years. Laboratory equipment office equipment
Impairment of Long-Lived Assets	Impairment of Long-Lived Assets Long-lived assets consist of property and equipment. Long-lived assets to be held and used are tested for recoverability whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. Factors that the Company considers in deciding when to perform an impairment review include significant underperformance of the business in relation to expectations, significant negative industry or economic trends and significant changes or planned changes in the use of the assets. If an impairment review is performed to evaluate a long-lived asset group for recoverability, the Company compares forecasts of undiscounted cash flows expected to result from the use and eventual disposition of the long-lived asset group to its carrying value. An impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of an asset group are less than its carrying amount. The impairment loss would be based on the excess of the carrying value of the impaired asset group over its fair value. The Company did not record any impairment losses on long-lived assets during 2023 and 2022.
Deferred Costs	Deferred Costs The Company capitalizes certain legal, professional, accounting and other third-party fees that are directly associated with in-process equity financings as deferred costs until such financings are consummated. After consummation of the equity financing, these costs are recorded in stockholders’ equity (deficiency) as a reduction of additional paid-in capital generated as a result of the offering. As of December 31, 2022 there was $576 of deferred costs. As of December 31, 2023, the Company did not have any deferred costs.
Deposits	Deposits Deposits as of December 31, 2023 and 2022 included $966 and $1,108, respectively, of deposits made by the Company with certain service providers that are to be applied to future payments due under the service agreements or returned to the Company if not utilized.
Warrants	Warrants The Company will recognize on a prospective basis the value of the effect of the down round feature in the warrants to purchase shares of common stock that were issued in a private placement in November 2017 (the “2017 Warrants”) when it is triggered (i.e., when the exercise price is adjusted downward). This value is measured as the difference between (1) the financial instrument’s fair value (without the down round feature) using the pre-trigger exercise price and (2) the financial instrument’s fair value (with the down round feature) using the reduced exercise price. The value of the effect of the down round feature will be treated as a dividend and a reduction to income available to common stockholders in the basic EPS calculation.
Fair Value of Financial Instruments	Fair Value of Financial Instruments Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: ● Level 1—Quoted prices in active markets for identical assets or liabilities. ● Level 2—Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. ● Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. During the years presented, the Company has not changed the manner in which it values assets and liabilities that are measured at fair value using Level 3 inputs. The Company recognizes transfers between levels of the fair value hierarchy as of the end of the reporting period. There were no transfers within the hierarchy during the years ended December 31, 2023 and 2022. A summary of the assets and liabilities carried at fair value in accordance with the hierarchy defined above is as follows (in thousands): ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Total Level 1 Level 2 Level 3 December 31, 2023 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Assets: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Cash equivalents ​ $ 39,065 ​ $ 39,065 ​ $ — ​ $ — Total assets ​ $ 39,065 ​ $ 39,065 ​ $ — ​ $ — ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, 2022 ​ ​ ​ ​ Assets: ​ ​ ​ ​ Cash equivalents ​ $ 62,074 ​ $ 62,074 ​ $ — ​ $ — Total assets ​ $ 62,074 ​ $ 62,074 ​ $ — ​ $ — ​ Cash equivalents of $39,065 and $62,074 as of December 31, 2023 and 2022, respectively, consisted of overnight investments and money market funds and are classified within Level 1 of the fair value hierarchy because they are valued using quoted market prices in active markets. The carrying value of the research and development incentive receivable, accounts payable and accrued expenses approximate their fair value due to the short-term nature of these assets and liabilities.
Leases	Leases At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present. All leases with a term greater than one year are recognized on the balance sheet as right-of-use assets, lease liabilities and, if applicable, long-term lease liabilities. The Company has elected not to recognize on the balance sheet leases with terms of one year or less. Operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected remaining lease term. The Company has determined that the rate implicit in the lease is not determinable and the Company does not have borrowings with similar terms and collateral. Therefore, the Company considered a variety of factors, including observable debt yields from comparable companies and the volatility in the debt market for securities with similar terms, in determining that 8% was reasonable to use as the incremental borrowing rate for purposes of the calculation of lease liabilities. In accordance with the guidance in ASC 842 “Leases”, components of a lease should be split into three categories: lease components (e.g. land, building, etc.), non-lease components (e.g. common area maintenance, maintenance, consumables, etc.), and non-components (e.g. property taxes, insurance, etc.). Then the fixed and in-substance fixed contract consideration (including any related to non-components) must be allocated based on fair values to the lease components and non-lease components. Although separation of lease and non-lease components is required, certain practical expedients are available. Entities may elect the practical expedient to not separate lease and non-lease components. Rather, they would account for each lease component and the related non-lease component together as a single component. The Company has elected to account for the lease and non-lease components of each of its operating leases as a single lease component and allocate all of the contract consideration to the lease component only. The lease component results in an operating right-of-use asset being recorded on the consolidated balance sheets and amortized such that lease expense is recorded on a straight line basis over the term of the lease.
Segment Information	Segment Information The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. The Company’s singular focus is developing novel, targeted drugs for the treatment of cancer. Substantially all of the Company’s tangible assets are held in the United States.
Patent Costs	Patent Costs All patent related costs incurred in connection with filing and prosecuting patent applications are expensed as incurred due to the uncertainty about the recovery of the expenditure. Amounts incurred are classified as general and administrative expenses.
Stock-Based Compensation	Stock-Based Compensation The Company measures all stock options and other stock-based awards granted to employees, consultants and nonemployees based on the fair value on the date of the grant and recognizes compensation expense of those awards over the requisite service period, which is generally the vesting period of the respective award. Generally, the Company issues stock options with only service-based vesting conditions and records the expense for these awards using the straight-line method. Stock-based compensation is classified in the accompanying consolidated statements of operations based on the function to which the related services are provided. ​ 2. Summary of Significant Accounting Policies (continued) The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option-pricing model. The expected volatility is based on the historical volatility of the Company. The expected term of the Company’s stock options granted to employees has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options. The expected term of stock options granted to nonemployees is equal to the contractual term of the option award. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield of zero is based on the fact that the Company has never paid cash dividends on common stock and does not expect to pay any cash dividends in the foreseeable future.
Net Loss per Share	Net Loss per Share Basic net loss per share is computed using the weighted average number of common shares outstanding during the period. Diluted net loss per share is computed using the weighted average number of common shares outstanding during the period and, if dilutive, the weighted average number of potential shares of common stock, including the assumed exercise of stock options and warrants.
Subsequent Events	Subsequent Events The Company considers events or transactions that occur after the balance sheet date but prior to the issuance of the financial statements to provide additional evidence for certain estimates or to identify matters that require additional disclosure. Subsequent events have been evaluated as required.
Recently Adopted Accounting Pronouncements	Recently Adopted Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) and are early adopted by the Company or adopted as of the specified effective date. Unless otherwise discussed below, the Company does not believe that the adoption of recently issued standards have or may have a material impact on its consolidated financial statements or disclosures. In May 2021, FASB issued ASU 2021-04, Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options. FASB issued this update to clarify the accounting by issuers for modifications or exchanges of equity-classified warrants. The updated guidance is effective for the Company for annual periods beginning after December 15, 2021, including interim periods within those fiscal years. The Company adopted ASU 2021-04 in the first quarter of fiscal 2022 and the Company’s adoption of this standard did not have an effect on the Company’s consolidated financial statements. In August 2020, FASB issued ASU 2020-06, Debt—Debt with Conversion and Other Options, or ASC 470 and Derivatives and Hedging—Contracts in Entity’s Own Equity, or ASC 815. FASB issued this update to simplify the accounting for certain financial instruments with characteristics of liabilities and equity. The updated guidance is effective for the Company for annual periods beginning after December 15, 2021, including interim periods within those fiscal years. The Company adopted ASC 470 in the first quarter of fiscal 2022 and the Company’s adoption of this standard did not have an effect on the Company’s consolidated financial statements.

Summary of Significant Accoun_3

Summary of Significant Accounting Policies (Tables)	12 Months Ended
	Dec. 31, 2023
Summary of Significant Accounting Policies
Schedule of change in the research and development incentive receivable	​ ​ ​ ​ ​ Balance at January 1, 2022 $ 1,189 Australian research and development incentive income, net ​ 2,051 Cash received for 2021 eligible expenses ​ (1,064) Foreign currency translation ​ ​ (77) Balance at December 31, 2022 ​ 2,099 Cash received for 2022 eligible expenses ​ ​ (2,333) Australian research and development incentive income, net ​ ​ 1,101 Foreign currency translation ​ (96) Balance at December 31, 2023 ​ $ 771
Schedule of assets and liabilities carried at fair value in accordance with the hierarchy	A summary of the assets and liabilities carried at fair value in accordance with the hierarchy defined above is as follows (in thousands): ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Total Level 1 Level 2 Level 3 December 31, 2023 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Assets: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Cash equivalents ​ $ 39,065 ​ $ 39,065 ​ $ — ​ $ — Total assets ​ $ 39,065 ​ $ 39,065 ​ $ — ​ $ — ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, 2022 ​ ​ ​ ​ Assets: ​ ​ ​ ​ Cash equivalents ​ $ 62,074 ​ $ 62,074 ​ $ — ​ $ — Total assets ​ $ 62,074 ​ $ 62,074 ​ $ — ​ $ —

Acquisition of Flame Bioscien_2

Acquisition of Flame Biosciences (Tables)	12 Months Ended
	Dec. 31, 2023
Acquisition of Flame Biosciences
Summary of net assets acquired based on their estimated fair values as of acquisition date	The following table summarizes the net assets acquired based on their estimated fair values as of January 17, 2023 (in thousands): ​ ​ ​ ​ Acquired IPR&D $ 29,582 Cash and cash equivalents ​ 50,362 Accounts payable and accrued liabilities ​ (928) Total acquisition value ​ $ 79,016
Schedule of fair value assigned to each component of the purchase consideration, including direct costs of the acquisition of $1,393, as of the Effective Date	The fair value assigned to each component of the purchase consideration, including direct costs of the acquisition of $1,393, as of the Effective Date is set forth in the table below (in thousands, except share and per share amounts): ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Equivalent ​ ​ ​ ​ ​ Number of ​ common ​ Fair ​ shares shares Value Leap common stock (par value $0.0001 per share) 1,972,901 1,972,901 ​ $ 9,805 Leap Series X Preferred Stock (100:1) 136,248 13,624,800 ​ 67,715 Warrants on Leap common stock 6,530 6,530 ​ 13 Warrants on Leap Series X Preferred Stock (100:1) 443 44,300 ​ 90 Direct and incremental costs of the asset acquisition ​ ​ ​ 1,393 ​ ​ ​ ​ ​ ​ ​ ​ Total ​ ​ 15,648,531 ​ $ 79,016

Property and Equipment, Net (Ta

Property and Equipment, Net (Tables)	12 Months Ended
	Dec. 31, 2023
Property and Equipment, Net
Schedule of property and equipment, net	​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ 2023 2022 Computer office equipment ​ $ 51 ​ $ 51 Leasehold improvements ​ ​ 69 ​ ​ 69 Lab equipment ​ 76 ​ 76 Furnitures and fixtures ​ 30 ​ 30 ​ ​ 226 ​ 226 Less: accumulated depreciation ​ (221) ​ (206) Property and equipment, net ​ $ 5 ​ $ 20 ​

Accrued Expenses (Tables)

Accrued Expenses (Tables)	12 Months Ended
	Dec. 31, 2023
Accrued Expenses
Schedule of accrued expenses	​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ 2023 2022 Clinical trials ​ $ 2,522 ​ $ 2,093 Professional fees ​ 254 ​ 533 Payroll and related expenses ​ 3,181 ​ 2,526 Accrued expenses ​ $ 5,957 ​ $ 5,152 ​

Leases (Tables)

Leases (Tables)	12 Months Ended
	Dec. 31, 2023
Leases
Schedule of future lease payments	Future lease payments under non-cancelable operating leases as of December 31, 2023 are detailed as follows: ​ ​ ​ ​ ​ Future Operating Lease Payments 2024 ​ 268 Total Lease Payments ​ 268 Less: imputed interest ​ (6) Total operating lease liabilities $ 262 ​

Warrants (Tables)

Warrants (Tables)	12 Months Ended
	Dec. 31, 2023
Warrants
Schedule of warrants	​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, 2023 ​ ​ ​ ​ Number of Common Shares ​ ​ ​ ​ Description Issuable Exercise Price Expiration Date January 23, 2017 Warrants 5,450 ​ $ 0.10 ​ Upon M&A Event 2017 Warrants ​ 250,227 ​ $ 10.55 ​ November 2024 2019 Warrants ​ 690,813 ​ $ 19.50 ​ February 2026 March 2020 Pre-funded Warrants ​ 824,716 ​ $ 0.01 ​ No Expiry March 2020 Coverage Warrants ​ 2,594,501 ​ $ 21.10 ​ Jan - March 2027 September 2021 Pre-funded Warrants 591,602 ​ $ 0.01 ​ No Expiry January 2023 Common Stock Warrants ​ 50,830 ​ $ 6.78 ​ February 2025 ​ ​ 5,008,139 ​ ​ ​ ​ ​

Stock-Based Compensation (Table

Stock-Based Compensation (Tables)	12 Months Ended
	Dec. 31, 2023
Stock-Based Compensation
Schedule of stock option activity under the Equity Plans	​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted ​ ​ ​ ​ ​ ​ ​ Average Weighted Aggregate ​ ​ ​ Exercise Price Average Remaining Intrinsic ​ ​ Options Per Share ​ Life in Years ​ Value Outstanding at December 31, 2021 ​ 852,266 ​ $ 44.76 ​ 7.58 ​ $ 7,670 Granted 402,490 ​ $ 15.03 ​ ​ Forfeited ​ (63,041) ​ $ 21.65 ​ ​ ​ ​ ​ Outstanding at December 31, 2022 1,191,715 ​ $ 35.94 7.47 ​ $ 7,673 Granted 2,393,500 ​ $ 2.67 ​ ​ Forfeited ​ (200,849) ​ $ 9.73 ​ ​ ​ ​ ​ Outstanding at December 31, 2023 ​ 3,384,366 ​ $ 13.97 ​ 8.40 ​ $ 3,431 Options exercisable at December 31, 2023 1,382,078 ​ $ 28.80 6.87 ​ ​ ​ Options vested and expected to vest at December 31, 2023 3,384,366 ​ $ 13.97 8.40 ​ $ 3,431
Schedule of assumptions used to determine grant-date fair value of stock options	​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ ​ 2023 2022 ​ Expected volatility 90.44 % 82.70 % Weighted average risk-free interest rate 4.05 % 3.10 % Expected dividend yield ​ 0.00 % 0.00 % Expected term (in years) ​ 6.49 ​ 6.42 ​
Schedule of RSU activity under the 2016 Plan	​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted ​ Number of Average Grant ​ Shares Date Fair Value Outstanding at December 31, 2021 93,560 ​ $ 17.60 Awarded ​ 265,000 ​ $ 19.40 Outstanding at December 31, 2022 ​ 358,560 ​ $ 18.90 Vested ​ (66,060) ​ $ 14.20 Forfeited (30,000) ​ $ 19.40 Outstanding at December 31, 2023 262,500 ​ $ 19.97
Schedule of recognized stock-based compensation expense related to the issuance of stock option awards and RSUs to employees and non-employees in the condensed consolidated statements of operations	​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ ​ December 31, ​ 2023 2022 Research and development $ 2,647 ​ $ 2,540 General and administrative ​ 2,481 ​ 2,640 Total ​ $ 5,128 ​ $ 5,180 ​

Income Taxes (Tables)

Income Taxes (Tables)	12 Months Ended
	Dec. 31, 2023
Income Taxes
Schedule of loss before income taxes	​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ ​ December 31, ​ 2023 2022 U.S. ​ $ (80,895) ​ $ (50,325) Foreign ​ (519) ​ (4,124) Loss before income taxes ​ $ (81,414) ​ $ (54,449)
Schedule of Company's current and deferred expense for income tax	​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ ​ December 31, ​ 2023 2022 Current expense (benefit): ​ ​ ​ ​ ​ ​ Federal ​ $ — ​ $ — State ​ — ​ — Foreign ​ — ​ — Total current expense (benefit): ​ $ — ​ $ — Deferred expense (benefit): ​ ​ ​ ​ ​ ​ Federal ​ $ — ​ $ — State ​ — ​ — Foreign ​ — ​ ​ 147 Total deferred expense ​ $ — ​ $ 147 Total income tax expense ​ $ — ​ $ 147 ​
Schedule of reconciliation of the Company's statutory income tax rate to the Company's effective income tax rate	​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ ​ December 31, ​ ​ 2023 2022 Income at US Statutory Rate 21.0 % 21.0 % State taxes, net of federal benefit 4.1 % 6.0 % Flame IPR&D write off 0.0 % 0.0 % Permanent differences 0.3 % 0.7 % Research and development credits 1.6 % 1.0 % Foreign rate differential ​ 0.0 % 0.3 % Change in valuation allowance 63.5 % (27.3) % Section 382 limitations (90.1) % 0.0 % Other (0.4) % (1.7) % ​ 0.0 % 0.0 %
Schedule of significant components of the Company's deferred tax assets	​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ ​ December 31, ​ 2023 2022 Federal net operating loss carryforwards ​ $ 3,672 ​ $ 44,202 State net operating loss carryforwards ​ ​ 967 ​ 12,104 Foreign net operating loss carryforwards ​ ​ — ​ 98 Research and development (R&D) tax credits ​ ​ 1,649 ​ ​ 9,358 Capitalized R&D expenses ​ ​ 2,413 ​ ​ 9,312 Start-up costs ​ ​ 11,355 ​ ​ — Stock based compensation ​ ​ 5,812 ​ ​ 4,757 Accrued expenses ​ ​ 831 ​ ​ — License fees ​ ​ 676 ​ 840 Other ​ ​ 10,867 ​ ​ 297 Total deferred tax assets ​ ​ 38,242 ​ ​ 80,968 Valuation allowance ​ (38,242) ​ (80,968) Net deferred tax assets ​ $ — ​ $ —

Net Loss Per Share (Tables)

Net Loss Per Share (Tables)	12 Months Ended
	Dec. 31, 2023
Net Loss Per Share
Schedule of basic and diluted net loss per share	​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ 2023 2022 Numerator: ​ ​ ​ ​ ​ Net loss ​ $ (81,414) ​ $ (54,596) Net loss attributable to common stockholders for basic and diluted loss per share ​ $ (81,414) ​ $ (54,596) ​ ​ ​ ​ ​ ​ ​ Denominator: ​ ​ ​ ​ ​ ​ Weighted average number of common shares outstanding - basic and diluted ​ 20,445,109 ​ 11,323,909 Net loss per share attributable to common stockholders - basic and diluted ​ $ (3.98) ​ $ (4.82)
Schedule of potentially anti-dilutive securities excluded from calculation of diluted net loss per share	​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ 2023 2022 Restricted stock units to purchase common stock 262,500 ​ 358,560 Options to purchase common stock ​ 3,384,366 ​ 1,191,715 Warrants to purchase common stock ​ 3,586,371 ​ 3,545,567 ​ 7,233,237 ​ 5,095,842 ​

Nature of Business, Basis of _2

Nature of Business, Basis of Presentation and Liquidity (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022
Liquidity
Cash and cash equivalents	$ 70,643	$ 65,500
Accumulated deficit	(399,582)	(318,168)
Net Income (Loss)	$ (81,414)	$ (54,596)

Nature of Business, Basis of _3

Nature of Business, Basis of Presentation and Liquidity - Reverse Stock Split (Details) - Series X Preferred Stock	Jun. 21, 2023 shares
Reverse Stock Split
Reverse stock split, conversion ratio	100
Conversion ratio	0.1

Summary of Significant Accoun_4

Summary of Significant Accounting Policies (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022
Research and development incentive income and receivable
Research and development expenses reimbursed (as a percent)	43.50%	43.50%
Research and development incentive income and receivable
Balance at the beginning of the period	$ 2,099	$ 1,189
Australian research and development incentive income	1,101	2,051
Cash received for eligible expenses	(2,333)	(1,064)
Foreign currency translation	(96)	(77)
Balance at the end of the period	771	2,099
Income Taxes
Uncertain tax positions	0	0
Other Assets
Deposits	$ 966	1,108
Incremental borrowing rate	8%
License and Service
Other Assets
Deposits	$ 966	$ 1,108
Computer equipment
Property and equipment, net
Useful life (in years)	3 years
Lab equipment
Property and equipment, net
Useful life (in years)	5 years
Office Equipment
Property and equipment, net
Useful life (in years)	5 years
Furnitures and fixtures
Property and equipment, net
Useful life (in years)	5 years

Summary of Significant Accoun_5

Summary of Significant Accounting Policies - Fair Value of Financial Instruments (Details) - USD ($) $ in Thousands	Dec. 31, 2023	Dec. 31, 2022
Assets:
Cash equivalents	$ 39,065	$ 62,074
Total assets	39,065	62,074
Level 1
Assets:
Cash equivalents	39,065	62,074
Total assets	$ 39,065	$ 62,074

Acquisition of Flame Bioscien_3

Acquisition of Flame Biosciences (Details)		1 Months Ended	12 Months Ended
	Jan. 17, 2023 USD ($) shares	Jan. 31, 2023 USD ($) $ / shares shares	Dec. 31, 2023 USD ($) $ / shares shares	Dec. 31, 2022 USD ($)
Acquisition of Flame Biosciences
Percentage of outstanding ordinary shares acquired	100%
Number of shares issued	1,972,901
Cash | $			$ 70,643,000	$ 65,500,000
Exercise price per share | $ / shares			$ 6.78
Change in fair value of warrant liability | $			$ 12,000
January 2023 Common Stock Warrants
Acquisition of Flame Biosciences
Shares issuable upon exercise of warrants		6,530
Exercise price per share | $ / shares		$ 678	$ 6.78
Series X Preferred Stock | January 2023 Series X Preferred Stock Warrants
Acquisition of Flame Biosciences
Shares issuable upon exercise of warrants		443
Conversion ratio		100
Exercise price per share | $ / shares		$ 6.78
Flame
Acquisition of Flame Biosciences
Percentage of outstanding ordinary shares acquired	100%
Number of shares issued	1,972,901
Holdback shares	15,604
Number of common stock held back upon conversion of Series X Preferred shares	1,560,400
Purchase price | $	$ 79,016,000
Working capital items | $	928,000
Cash | $	50,362,000		$ 29,582,000
Direct and incremental costs of the asset acquisition | $	$ 1,393,000
Percentage of contingent merger consideration on after tax net proceeds	80%
Flame | January 2023 Common Stock Warrants
Acquisition of Flame Biosciences
Shares issuable upon exercise of warrants	6,530
Adjustment for amortization | $		$ 6.78
Flame | January 2023 Series X Preferred Stock Warrants
Acquisition of Flame Biosciences
Conversion ratio			100
Reverse stock split, conversion ratio		0.1
Flame | Series X Non Voting Convertible Preferred Stock
Acquisition of Flame Biosciences
Number of shares issued	136,248
Flame | Series X Preferred Stock
Acquisition of Flame Biosciences
Conversion ratio	100		100
Reverse stock split, conversion ratio	0.1
Flame | Series X Preferred Stock | January 2023 Common Stock Warrants
Acquisition of Flame Biosciences
Shares issuable upon exercise of warrants		6,530
Flame | Series X Preferred Stock | January 2023 Series X Preferred Stock Warrants
Acquisition of Flame Biosciences
Shares issuable upon exercise of warrants	443		443

Acquisition of Flame Bioscien_4

Acquisition of Flame Biosciences - Net assets acquired (Details) - USD ($) $ in Thousands	Dec. 31, 2023	Jan. 17, 2023	Dec. 31, 2022
Acquisition of Flame Biosciences
Cash and cash equivalents	$ 70,643		$ 65,500
Flame
Acquisition of Flame Biosciences
Acquired IPR&D		$ 29,582
Cash and cash equivalents	$ 29,582	50,362
Accounts payable and accrued liabilities		(928)
Total acquisition value		$ 79,016

Acquisition of Flame Bioscien_5

Acquisition of Flame Biosciences - Fair value assigned to each component of the purchase consideration (Details) - Flame $ in Thousands	Jan. 17, 2023 USD ($) shares
Acquisition of Flame Biosciences
Equivalent common shares	15,648,531
Fair Value | $	$ 1,393
Direct and incremental costs of the asset acquisition | $	1,393
Total | $	$ 79,016
Common stock
Acquisition of Flame Biosciences
Number of shares	1,972,901
Equivalent common shares	1,972,901
Fair Value | $	$ 9,805
Common stock | Warrant Liability
Acquisition of Flame Biosciences
Number of shares	6,530
Equivalent common shares	6,530
Fair Value | $	$ 13
Series X Preferred Shares
Acquisition of Flame Biosciences
Number of shares	136,248
Equivalent common shares	13,624,800
Fair Value | $	$ 67,715
Series X Preferred Shares | Warrant Liability
Acquisition of Flame Biosciences
Number of shares	443
Equivalent common shares	44,300
Fair Value | $	$ 90

Acquisition of Flame Bioscien_6

Acquisition of Flame Biosciences - Sale of FL-101/FL (Details) - Flame - USD ($) $ in Thousands		12 Months Ended
	Dec. 06, 2023	Dec. 31, 2023	Jan. 17, 2023
Acquisition of Flame Biosciences
Acquired IPR&D			$ (29,582)
AlmataBio, Inc | Acquired In-process research and development (Sale Agreement)
Acquisition of Flame Biosciences
Consideration, non-refundable	$ 500	$ 500
Milestone Payments to Received		0
Acquired IPR&D		$ 0
AlmataBio, Inc | Acquired In-process research and development (Sale Agreement) | Achievement of regulatory approval and commercial milestone
Acquisition of Flame Biosciences
Milestone payments entitled to receive	$ 70,000

Property and Equipment, Net (De

Property and Equipment, Net (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022
Property and Equipment, Net
Property and equipment, gross	$ 226	$ 226
Less: accumulated depreciation	(221)	(206)
Property and equipment, net	5	20
Depreciation expense	15	16
Computer office equipment
Property and Equipment, Net
Property and equipment, gross	51	51
Leasehold improvements
Property and Equipment, Net
Property and equipment, gross	69	69
Lab equipment
Property and Equipment, Net
Property and equipment, gross	76	76
Furnitures and fixtures
Property and Equipment, Net
Property and equipment, gross	$ 30	$ 30

Accrued Expenses (Details)

Accrued Expenses (Details) - USD ($) $ in Thousands	Dec. 31, 2023	Dec. 31, 2022
Accrued Expenses
Clinical trials	$ 2,522	$ 2,093
Professional fees	254	533
Payroll and related expenses	3,181	2,526
Accrued expenses	$ 5,957	$ 5,152

Leases (Details)

Leases (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022
Leases
Additional right of use asset		$ 609
Additional operating lease liability		609
Right of use assets, net	$ 257	669
Lease liability	262
Operating lease costs	449	443
Cash paid for measurement of lease liabilities	$ 452	$ 445

Leases - Future minimum lease p

Leases - Future minimum lease payments (Details) $ in Thousands	Dec. 31, 2023 USD ($)
Leases
2024	$ 268
Total Lease Payments	268
Less: imputed interest	(6)
Total operating lease liabilities	$ 262

Warrants (Details)

Warrants (Details) - USD ($) $ / shares in Units, $ in Thousands	12 Months Ended
	Dec. 31, 2023	Jan. 31, 2023
Warrants
Exercise price of warrant	$ 6.78
Number of Common shares issuable	5,008,139
Change in fair value of warrant liability	$ 12
January 23, 2017 Warrants
Warrants
Exercise price of warrant	$ 0.10
Number of Common shares issuable	5,450
2017 Warrants
Warrants
Exercise price of warrant	$ 10.55
Number of Common shares issuable	250,227
2019 Warrants
Warrants
Number of Common shares issuable	690,813
January 2023 Common Stock Warrants
Warrants
Warrant to purchase shares of common stock		6,530
Exercise price of warrant	$ 6.78	$ 678
Number of Common shares issuable	50,830
January 2023 Series X Preferred Stock Warrants | Series X Preferred Stock
Warrants
Warrant to purchase shares of common stock		443
Exercise price of warrant		$ 6.78
Conversion ratio		100
September 2021
Warrants
Exercise price of warrant	$ 0.01
Number of Common shares issuable	591,602
2019 Warrants
Warrants
Exercise price of warrant	$ 19.50
Purchase price per share	$ 2.90
Number of warrants or rights exercised	10,000
Warrants March 2020 Two
Warrants
Exercise price of warrant	$ 21.10
Number of Common shares issuable	2,594,501
Warrants March 2020 One
Warrants
Exercise price of warrant	$ 0.01
Number of Common shares issuable	824,716

Warrants - January 2023 Common

Warrants - January 2023 Common Stock Warrants and January 2023 Series X Preferred Stock Warrants (Details) - $ / shares	Dec. 31, 2023	Jan. 31, 2023
Warrants
Exercise price per share	$ 6.78
January 2023 Common Stock Warrants
Warrants
Shares issuable upon exercise of warrants		6,530
Exercise price per share	$ 6.78	$ 678
January 2023 Series X Preferred Stock Warrants | Series X Preferred Shares
Warrants
Shares issuable upon exercise of warrants		443
Exercise price per share		$ 6.78
Conversion ratio		100

Common Stock (Details)

Common Stock (Details) $ in Thousands		12 Months Ended
	Jan. 17, 2023 shares	Dec. 31, 2023 USD ($) Vote
Common Stock
Number of vote on common shares | Vote		1
Percentage of outstanding ordinary shares acquired	100%
Dividend declared | $		$ 0
Number of shares issued	1,972,901
Flame
Common Stock
Percentage of outstanding ordinary shares acquired	100%
Number of shares issued	1,972,901

Common stock - Public Offering

Common stock - Public Offering of Common Stock (Details)	Dec. 31, 2023 $ / shares
Exercise price of warrant	$ 6.78
September 2021
Exercise price of warrant	$ 0.01

Stock-Based Compensation (Detai

Stock-Based Compensation (Details) - USD ($) $ / shares in Units, $ in Thousands			12 Months Ended
	Jun. 16, 2023	Jan. 20, 2017	Dec. 31, 2023	Dec. 31, 2022	Dec. 31, 2021	Jun. 16, 2022
Options
Outstanding balance at the beginning of the period (in shares)			1,191,715	852,266
Granted (in shares)			2,393,500	402,490
Forfeited (in shares)			(200,849)	(63,041)
Outstanding balance at the end of the period (in shares)			3,384,366	1,191,715	852,266
Options exercisable at the end of the period (in shares)			1,382,078
Options vested and expected to vest at end of period (in shares)			3,384,366
Weighted Average Exercise Price Per Share
Outstanding balance at the beginning of the period (in dollars per share)			$ 35.94	$ 44.76
Granted (in dollars per share)			2.67	15.03
Forfeited (in dollars per share)			9.73	21.65
Outstanding balance at the end of the period (in dollars per share)			13.97	$ 35.94	$ 44.76
Options exercisable at the end of the period (in dollars per share)			28.80
Options vested and expected to vest at end of the period (in dollars per share)			$ 13.97
Weighted Average Remaining Life in Years
Outstanding balance			8 years 4 months 24 days	7 years 5 months 19 days	7 years 6 months 29 days
Options exercisable at end of period			6 years 10 months 13 days
Options vested and expected to vest at end of the period			8 years 4 months 24 days
Aggregate Intrinsic Value
Outstanding balance			$ 3,431	$ 7,673	$ 7,670
Options vested and expected to vest at end of the period			$ 3,431
Assumptions used to determine grant-date fair value
Expected volatility			90.44%	82.70%
Weighted average risk-free interest rate			4.05%	3.10%
Expected dividend yield			0%	0%
Expected term (in years)			6 years 5 months 26 days	6 years 5 months 1 day
Expiration period			10 years
Unrecognized compensation cost related to non-vested stock options			$ 5,444
Minimum
Assumptions used to determine grant-date fair value
Vesting period			3 years
Maximum
Assumptions used to determine grant-date fair value
Vesting period			4 years
Weighted Average [Member]
Assumptions used to determine grant-date fair value
Weighted average period for recognition of compensation cost			2 years 2 months 8 days
2016 Plan
Assumptions used to determine grant-date fair value
Annual increase in authorized shares (as a percent)		4%
Number of options or stock awards available for grant under the Plan			1,016,023
2022 Plan
Assumptions used to determine grant-date fair value
Number of options or stock awards available for grant under the Plan						750,000
Additional shares approved for future issuance	2,250,000
Options to purchase common stock
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Non vested, Weighted Average Grant Date Fair Value
Stock Based Compensation Expense			$ 5,128	$ 5,180
Options to purchase common stock | Research and development
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Non vested, Weighted Average Grant Date Fair Value
Stock Based Compensation Expense			2,647	2,540
Options to purchase common stock | General and administrative
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Non vested, Weighted Average Grant Date Fair Value
Stock Based Compensation Expense			2,481	$ 2,640
Restricted stock units to purchase common stock
Assumptions used to determine grant-date fair value
Vested			5,242
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Non vested, Weighted Average Grant Date Fair Value
Unrecognized compensation costs related to RSUs granted to employees			$ 1,682
Restricted stock units to purchase common stock | Executive Officer
Assumptions used to determine grant-date fair value
Vesting period			3 years
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward]
Awarded				265,000
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Non vested, Weighted Average Grant Date Fair Value
Stock Based Compensation Expense			$ 1,632	$ 2,086
Restricted stock units to purchase common stock | 2016 Plan
Options
Forfeited (in shares)			(30,000)
Weighted Average Exercise Price Per Share
Forfeited (in dollars per share)			$ 19.40
Assumptions used to determine grant-date fair value
Options unvested at end of period (in dollars per share)			$ 19.97	$ 18.90	$ 17.60
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward]
Outstanding at the beginning			358,560	93,560
Vested (in shares)			(66,060)
Awarded				265,000
Outstanding at the end			262,500	358,560	93,560
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Non vested, Weighted Average Grant Date Fair Value
Outstanding at beginning( in dollars per share)			$ 18.90	$ 17.60
Vested(in dollars per share)			14.20
Awarded				19.40
Outstanding at end(in dollars per share)			$ 19.97	$ 18.90	$ 17.60

Stock-Based Compensation - Equi

Stock-Based Compensation - Equity Incentive Plans (Details) - USD ($) $ / shares in Units, $ in Thousands		12 Months Ended
	Jan. 20, 2017	Dec. 31, 2023	Dec. 31, 2022
Stock-Based Compensation
Granted (in shares)		2,393,500	402,490
Granted (in dollars per share)		$ 2.67	$ 15.03
Stock Option
Stock-Based Compensation
Granted (in dollars per share)		$ 2.07	$ 10.84
Restricted stock units to purchase common stock
Stock-Based Compensation
Vested		$ 5,242
Unrecognized compensation costs related to RSUs granted to employees		$ 1,682
Unrecognized costs weighted-average period		1 year 1 month 6 days
2016 Plan
Stock-Based Compensation
Annual increase in authorized shares (as a percent)	4%
Number of options or stock awards available for grant under the Plan		1,016,023

Income Taxes - Operating loss c

Income Taxes - Operating loss carryforwards (Details) $ in Thousands	12 Months Ended
	Dec. 31, 2023 USD ($)
Operating Loss Carryforwards
Annual limitation	$ 0
Federal
Operating Loss Carryforwards
Net operating loss carryforwards	17,487
Research and development tax credits	1,466
NOL carryforwards that will expire unutilized	210,844
R&D carryforwards that will expire unutilized	7,889
State
Operating Loss Carryforwards
Net operating loss carryforwards	18,532
Research and development tax credits	231
NOL carryforwards that will expire unutilized	192,689
R&D carryforwards that will expire unutilized	$ 1,771

Income Taxes (Details)

Income Taxes (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022
Income (Loss) before income taxes
U.S.	$ (80,895)	$ (50,325)
Foreign	(519)	(4,124)
Loss before income taxes	$ (81,414)	$ (54,449)

Income Taxes - Current and defe

Income Taxes - Current and deferred expense for income tax (Details) $ in Thousands	12 Months Ended
	Dec. 31, 2022 USD ($)
Deferred expense (benefit):
Foreign	$ 147
Total deferred expense	147
Total income tax expense	$ 147

Income Taxes - Reconciliation o

Income Taxes - Reconciliation of statutory income tax rate to effective income tax rate (Details)	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022
Reconciliation of the statutory income tax rate to the Company's effective income tax rate
Income at US Statutory Rate	21%	21%
State taxes, net of federal benefit	4.10%	6%
Flame IPR&D write off	0%	0%
Permanent differences	0.30%	0.70%
Research and development credits	1.60%	1%
Foreign rate differential	0%	0.30%
Change in valuation allowance	63.50%	(27.30%)
Section 382 limitations	(90.10%)	0%
Other	(0.40%)	(1.70%)
Effective income tax rate	0%	0%

Income Taxes - Components of de

Income Taxes - Components of deferred tax assets (Details) - USD ($) $ in Thousands	Dec. 31, 2023	Dec. 31, 2022
Deferred tax assets
Federal net operating loss carryforwards	$ 3,672	$ 44,202
State net operating loss carryforwards	967	12,104
Foreign net operating loss carryforwards		98
Research and development (R&D) tax credits	1,649	9,358
Capitalized R&D expenses	2,413	9,312
Start-up costs	11,355
Stock based compensation	5,812	4,757
Accrued expenses	831
License Fees	676	840
Other	10,867	297
Total deferred tax assets	38,242	80,968
Valuation allowance	$ (38,242)	$ (80,968)

Income Taxes - Valuation Allowa

Income Taxes - Valuation Allowance and Tax Reforms (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022
Valuation allowance
Research and development expenses	$ 41,838,000
Uncertain tax positions
Interest and penalties pertaining to uncertain tax positions	0	$ 0
AUSTRALIAN
Valuation allowance
Deferred tax assets valuation allowance	$ (42,726)	$ 14,886

Net Loss Per Share - Basic and

Net Loss Per Share - Basic and Diluted (Details) - USD ($) $ / shares in Units, $ in Thousands	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022
Numerator:
Net Income (Loss)	$ (81,414)	$ (54,596)
Net loss attributable to common stockholders for basic loss per share	(81,414)	(54,596)
Net loss attributable to common stockholders for diluted loss per share	$ (81,414)	$ (54,596)
Denominator:
Weighted average number of common shares outstanding - basic	20,445,109	11,323,909
Weighted average number of common shares outstanding - diluted	20,445,109	11,323,909
Net loss per share attributable to common stockholders - basic	$ (3.98)	$ (4.82)
Net loss per share attributable to common stockholders - diluted	$ (3.98)	$ (4.82)
Weighted Average Number Of Shares Outstanding Exercise Of Pre Funded Warrants And Penny Warrants	1,421,768	1,421,768

Net Loss Per Share - Antidiluti

Net Loss Per Share - Antidilutive (Details) - shares	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022
Securities excluded from computation of diluted net loss per share
Anti-dilutive securities excluded from calculation of diluted net loss per share	7,233,237	5,095,842
Restricted stock units to purchase common stock
Securities excluded from computation of diluted net loss per share
Anti-dilutive securities excluded from calculation of diluted net loss per share	262,500	358,560
Options to purchase common stock
Securities excluded from computation of diluted net loss per share
Anti-dilutive securities excluded from calculation of diluted net loss per share	3,384,366	1,191,715
Warrants to purchase common stock
Securities excluded from computation of diluted net loss per share
Anti-dilutive securities excluded from calculation of diluted net loss per share	3,586,371	3,545,567

Commitments and Contingencies -

Commitments and Contingencies - Manufacturing, License and Service Agreements (Details) $ in Thousands	Dec. 31, 2023 USD ($)
Commitments and Contingencies
Manufacturing commitments	$ 558
License and service agreements
Commitments and Contingencies
Royalties paid or accrued	0
Licensing agreements
Commitments and Contingencies
Royalties paid or accrued	$ 0

Defined Contribution Plan (Deta

Defined Contribution Plan (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022
Defined Contribution Plan
Contributions to the 401(k) Plan	$ 443	$ 333
Layering first
Defined Contribution Plan
Eligible Employees to contribute (as a percent)	3%
Company's match (as a percent)	100%
Layering second
Defined Contribution Plan
Eligible Employees to contribute (as a percent)	2%
Company's match (as a percent)	50%

Subsequent Events (Details)

Subsequent Events (Details) - Subsequent event $ in Thousands	Jan. 03, 2024 USD ($)
Subsequent Events
Monthly base rent expense	$ 38,335
Increased monthly base rent	$ 38,974

Pay vs Performance Disclosure

Pay vs Performance Disclosure - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022
Pay vs Performance Disclosure
Net Income (Loss)	$ (81,414)	$ (54,596)

Insider Trading Arrangements

Insider Trading Arrangements	3 Months Ended
	Dec. 31, 2023
Trading Arrangements, by Individual
Rule 10b5-1 Arrangement Adopted	false
Non-Rule 10b5-1 Arrangement Adopted	false
Rule 10b5-1 Arrangement Terminated	false
Non-Rule 10b5-1 Arrangement Terminated	false