0001104659-23-060153 | 10-Q | XBRL Viewer

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Acquisition of Flame Biosciences (Details)		1 Months Ended	3 Months Ended
Acquisition of Flame Biosciences (Details)	Jan. 17, 2023 USD ($) shares	Jan. 31, 2023 USD ($) $ / shares shares	Mar. 31, 2023 USD ($) $ / shares shares	Dec. 31, 2022 USD ($)
Asset Acquisition [Table]
Cash			$ 102,038,000	$ 65,500,000
Period to held to special meeting			6 months
Change in fair value of warrant liability			$ 50,000
January 2023 Common Stock Warrants
Asset Acquisition [Table]
Shares issuable upon exercise of warrants \| shares		65,301
Exercise price per share \| $ / shares		$ 0.68	$ 0.680
Series X Preferred Stock
Asset Acquisition [Table]
Shares issuable upon exercise of warrants \| shares			443
Conversion ratio			1,000
Series X Preferred Stock \| January 2023 Series X Preferred Stock Warrants
Asset Acquisition [Table]
Shares issuable upon exercise of warrants \| shares		443	443
Conversion ratio		1,000	1,000
Exercise price per share \| $ / shares		$ 678.48	$ 678.48
Flame
Asset Acquisition [Table]
Percentage of outstanding ordinary shares acquired	100.00%
Number of shares issued \| shares	19,729,010
Holdback shares	15,604
Purchase price	$ 79,016,000
Working capital items	928,000
Acquired I P R & D	(29,582,000)
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	80.00%
Period to held to special meeting			6 months
Period for obtaining stockholder approval from the date of issuance			6 months
Flame \| January 2023 Common Stock Warrants
Asset Acquisition [Table]
Shares issuable upon exercise of warrants \| shares	65,301
Adjustment for amortization		$ 0.68
Flame \| January 2023 Series X Preferred Stock Warrants
Asset Acquisition [Table]
Conversion ratio		1,000
Flame \| Series X Non Voting Convertible Preferred Stock
Asset Acquisition [Table]
Number of shares issued \| shares	136,248
Flame \| Series X Preferred Stock
Asset Acquisition [Table]
Conversion ratio	1,000	1,000	1,000
Flame \| Series X Preferred Stock \| January 2023 Common Stock Warrants
Asset Acquisition [Table]
Shares issuable upon exercise of warrants \| shares		65,301
Flame \| Series X Preferred Stock \| January 2023 Series X Preferred Stock Warrants
Asset Acquisition [Table]
Shares issuable upon exercise of warrants \| shares	443	443
Exercise price per share \| $ / shares		$ 678.48

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
Net loss	$ (41,863)	$ (10,376)
Other comprehensive income (loss):
Foreign currency translation adjustments	227	(158)
Comprehensive loss	$ (41,636)	$ (10,534)

- Definition

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

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+ Details

Leases (Tables)

3 Months Ended

Mar. 31, 2023

Leases

Schedule of future lease payments

Future lease payments under non-cancelable operating leases as of March 31, 2023 are detailed as follows:


Future Operating Lease Payments
2023		339
2024		268
Total Lease Payments		607
Less: imputed interest		(30)
Total operating lease liabilities	$	577

Warrants (Tables)

3 Months Ended

Mar. 31, 2023

Warrants

Schedule of warrants


March 31, 2023
	Number of Common Shares
Description	Issuable	Number of Series X Preferred Shares Issuable		Exercise Price		Expiration Date
January 23 2017 Warrants	54,516		—	$	0.01	Upon M&A Event
2017 Warrants	2,502,382		—	$	1.055	November 2024
2019 Warrants	6,908,257		—	$	1.95	February 2026
March 2020 Pre-funded Warrants	8,247,170		—	$	0.001	No Expiry
March 2020 Coverage Warrants	25,945,035		—	$	2.11	Jan - March 2027
September 2021 Pre-funded Warrants	5,916,030		—	$	0.001	No Expiry
January 2023 Common Stock Warrants	65,301		—	$	0.680	February 2025
January 2023 Series X Preferred Stock Warrants (Convertible 1000 to 1)	—		443	$	678.48	February 2025
	49,638,691		443

Acquisition of Flame Biosciences - Fair value assigned to each component of the purchase consideration (Details) $ / shares in Units, $ in Thousands	Jan. 17, 2023 USD ($) shares	Mar. 31, 2023 $ / shares	Jan. 31, 2023	Dec. 31, 2022 $ / shares
Acquisition of Flame Biosciences
Common stock, par value (in dollars per share) \| $ / shares		$ 0.001		$ 0.001
Series X Preferred Shares
Acquisition of Flame Biosciences
Conversion ratio		1,000
Flame
Acquisition of Flame Biosciences
Equivalent common shares	156,485,311
Direct and incremental costs of the asset acquisition \| $	$ 1,393
Total \| $	$ 79,016
Flame \| Warrant Liability
Acquisition of Flame Biosciences
Number of shares	65,301
Equivalent common shares	65,301
Fair Value (in thousands) \| $	$ 13
Flame \| Common stock
Acquisition of Flame Biosciences
Number of shares	19,729,010
Equivalent common shares	19,729,010
Fair Value (in thousands) \| $	$ 9,805
Flame \| Series X Preferred Shares
Acquisition of Flame Biosciences
Number of shares	136,248
Equivalent common shares	136,248,000
Fair Value (in thousands) \| $	$ 67,715
Conversion ratio	1,000	1,000	1,000
Flame \| Series X Preferred Shares \| Warrant Liability
Acquisition of Flame Biosciences
Number of shares	443
Equivalent common shares	443,000
Fair Value (in thousands) \| $	$ 90

Warrants (Details) $ / shares in Units, $ in Thousands					3 Months Ended	12 Months Ended
Warrants (Details) $ / shares in Units, $ in Thousands	Sep. 24, 2021 $ / shares shares	Jun. 22, 2020 $ / shares shares	Mar. 05, 2020 $ / shares shares	Jan. 03, 2020 item Vote $ / shares shares	Mar. 31, 2023 USD ($) $ / shares shares	Dec. 31, 2022 $ / shares shares	Jan. 31, 2023 $ / shares shares	Feb. 05, 2019 $ / shares shares
Warrants
Number of Shares Issuable					49,638,691
Change in fair value of warrant liability \| $					$ 50
Series X Preferred Stock
Warrants
Warrant to purchase shares of common stock					443
Conversion ratio					1,000
January 23 2017 Warrants
Warrants
Exercise price of warrant \| $ / shares					$ 0.01
Number of Shares Issuable					54,516
March 2020 Pre-funded Warrants
Warrants
Exercise price of warrant \| $ / shares					$ 0.001
Number of Shares Issuable					8,247,170
March 2020 Coverage Warrants
Warrants
Exercise price of warrant \| $ / shares					$ 2.11
Number of Shares Issuable					25,945,035
January 2023 Common Stock Warrants
Warrants
Warrant to purchase shares of common stock							65,301
Exercise price of warrant \| $ / shares					$ 0.680		$ 0.68
Number of Shares Issuable					65,301
January 2023 Series X Preferred Stock Warrants \| Series X Preferred Stock
Warrants
Warrant to purchase shares of common stock					443		443
Exercise price of warrant \| $ / shares					$ 678.48		$ 678.48
Conversion ratio					1,000		1,000
Feb 2019 warrants
Warrants
Purchase price per share \| $ / shares					$ 0.29
2017 Warrants
Warrants
Exercise price of warrant \| $ / shares					$ 1.055
Number of Shares Issuable					2,502,382
2019 Warrants
Warrants
Warrant to purchase shares of common stock								7,557,142
Exercise price of warrant \| $ / shares					$ 1.95			$ 1.95
Number of shares redeemed \| $					$ 100,000
Number of Shares Issuable					6,908,257
March 2020 Warrants
Warrants
Exercise price of warrant \| $ / shares						$ 0.001
Number of warrants or rights exercised						6,166,732
March 2020 Warrants \| Series A Preferred Stock
Warrants
Warrant to purchase shares of common stock			14,413,902
Exercise price of warrant \| $ / shares			$ 0.001
Common stock issued				1,421,801
Purchase price \| $ / shares				$ 10.54
Number of special voting stock \| Vote				1
Number of members to elect of board of directors \| item				1
March 2020 Warrants \| Series B Preferred Stock
Warrants
Exercise price of warrant \| $ / shares			$ 2.11
Common stock issued				1,137,442
Purchase price \| $ / shares				$ 10.55
Conversion of stock, shares issued			11,531,133
March 2020 Warrants \| Common Stock
Warrants
Number of shares issued upon exercise of warrants						6,161,000
September 2021
Warrants
Exercise price of warrant \| $ / shares	$ 0.001				$ 0.001	$ 0.001
Common stock issued	8,771,928
Number of warrants or rights exercised						2,855,898
Number of Shares Issuable					5,916,030
September 2021 \| Common Stock
Warrants
Common stock issued	27,568,072
Purchase price \| $ / shares	$ 2.85
Number of shares issued upon exercise of warrants						2,853,351
June 2020
Warrants
Exercise price of warrant \| $ / shares		$ 0.001				$ 0.001
Number of warrants or rights exercised						1,690,137
Number of Shares Issuable		2,250,000
June 2020 \| Common Stock
Warrants
Common stock issued		20,250,000
Purchase price \| $ / shares		$ 2.00
Number of shares issued upon exercise of warrants						1,688,571

Leases - Future minimum lease payments (Details) $ in Thousands	Mar. 31, 2023 USD ($)
Leases
2023	$ 339
2024	268
Total Lease Payments	607
Less: imputed interest	(30)
Total operating lease liabilities	$ 577

Nature of Business, Basis of Presentation and Liquidity (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022	Dec. 31, 2022
Liquidity
Cash and cash equivalents	$ 102,038		$ 65,500
Accumulated deficit	(360,031)		$ (318,168)
Net loss	$ (41,863)	$ (10,376)

- Definition

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

+ References

+ Details

Acquisition of Flame Biosciences - Net assets acquired (Details) - USD ($) $ in Thousands	Mar. 31, 2023	Jan. 17, 2023	Dec. 31, 2022
Acquisition of Flame Biosciences
Cash and cash equivalents	$ 102,038		$ 65,500
Flame
Acquisition of Flame Biosciences
Acquired I P R & D		$ 29,582
Cash and cash equivalents	$ 29,582	50,362
Accounts payable and accrued liabilities		(928)
Total acquisition value		$ 79,016

Equity Incentive Plans (Details) - USD ($)		3 Months Ended		12 Months Ended
Equity Incentive Plans (Details) - USD ($)	Jan. 20, 2017	Mar. 31, 2023	Mar. 31, 2022	Dec. 31, 2022	Jun. 16, 2022
Options
Outstanding balance at the beginning of the period (in shares)		11,917,331
Granted (in shares)		8,235,000
Forfeited (in shares)		(64,173)
Outstanding balance at the end of the period (in shares)		20,088,158		11,917,331
Options exercisable at the end of the period (in shares)		8,247,158
Options vested and expected to vest at end of period (in shares)		20,088,158
Weighted Average Exercise Price Per Share
Outstanding balance at the beginning of the period (in dollars per share)		$ 3.59
Granted (in dollars per share)		0.34
Forfeited (in dollars per share)		1.90
Outstanding balance at the end of the period (in dollars per share)		2.27		$ 3.59
Options exercisable at the end of the period (in dollars per share)		4.49
Options vested and expected to vest at end of the period (in dollars per share)		$ 2.27
Weighted Average Remaining Life in Years
Outstanding balance		8 years 3 months 29 days		7 years 5 months 19 days
Options exercisable at end of period		6 years 4 months 6 days
Options vested and expected to vest at end of the period		8 years 3 months 29 days
Assumptions used to determine grant-date fair value
Expected Volatility		89.99%	82.70%
Weighted average risk-free interest rate		3.56%	1.67%
Expected dividend yield		0.00%	0.00%
Expected term (in years)		6 years 5 months 1 day	6 years 3 days
Options unvested at end of period (in dollars per share)		$ 0.25	$ 1.39
Expiration period		10 years
unrecognized compensation cost related to non-vested stock options		$ 5,866,000
Weighted average period for recognition of compensation cost		2 years 3 months 14 days
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Non vested, Weighted Average Grant Date Fair Value
Outstanding at end(in dollars per share)		$ 0.25	$ 1.39
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
2016 Plan
Assumptions used to determine grant-date fair value
Annual increase in authorized shares (as a percent)	4.00%
Number of options or stock awards available for grant under the Plan		1,190,949
2022 Plan
Assumptions used to determine grant-date fair value
Number of options or stock awards available for grant under the Plan					7,500,000
Options to purchase common stock [Member]
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		$ 1,310,000	$ 1,204,000
Options to purchase common stock [Member] \| 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		704,000	554,000
Options to purchase common stock [Member] \| 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		$ 606,000	$ 650,000
Restricted stock units to purchase common stock
Assumptions used to determine grant-date fair value
Weighted average period for recognition of compensation cost		1 year 9 months 18 days
Vested		$ 5,850,000
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward]
Vested		(5,850,000)
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		$ 3,353,000
Restricted stock units to purchase common stock \| Executive Officer
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward]
Awarded			2,575,000
Restricted stock units to purchase common stock \| 2016 Plan
Assumptions used to determine grant-date fair value
Options unvested at end of period (in dollars per share)		$ 2.00		$ 1.89
Vested		$ 660,606
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward]
Outstanding at the beginning		3,585,606
Vested		$ (660,606)
Outstanding at the end		2,925,000		3,585,606
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)		$ 1.89
Vested(in dollars per share)		1.42
Outstanding at end(in dollars per share)		$ 2.00		$ 1.89

Summary of Significant Accounting Policies (Tables)

3 Months Ended

Mar. 31, 2023

Summary of Significant Accounting Policies

Schedule of change in the research and development incentive receivable

The following table shows the change in the research and development incentive receivable from January 1, 2022 to March 31, 2023 (in thousands):


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
Australian research and development incentive income, net		272
Foreign currency translation		(28)
Balance at March 31, 2023	$	2,343

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
March 31, 2023
Assets:
Cash equivalents	$	70,704	$	70,704	$	—	$	—
Total assets	$	70,704	$	70,704	$	—	$	—

Liabilities:
Series X Preferred Stock warrant liability	$	40	$	—	$	—	$	40
Total liabilities	$	40	$	—	$	—	$	40

December 31, 2022
Assets:
Cash equivalents	$	62,074	$	62,074	$	—	$	—
Total assets	$	62,074	$	62,074	$	—	$	—

Schedule of the recurring fair value measurements of the warrant derivative liability categorized with Level 3 inputs


Balance at January 17, 2023	$	90
Change in fair value		(50)
Balance at March 31, 2023	$	40

CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands	Mar. 31, 2023	Dec. 31, 2022
Current assets:
Cash and cash equivalents	$ 102,038	$ 65,500
Research and development incentive receivable	2,071	2,099
Prepaid expenses and other current assets	590	351
Total current assets	104,699	67,950
Property and equipment, net	16	20
Right of use assets, net	569	669
Research and development incentive receivable, net of current portion	272
Deferred costs		576
Other long term assets	15	30
Deposits	976	1,108
Total assets	106,547	70,353
Current liabilities:
Accounts payable	5,498	5,657
Accrued expenses	4,388	5,152
Lease liability - current portion	425	416
Total current liabilities	10,311	11,225
Non current liabilities:
Lease liability, net of current portion	152	262
Series X preferred stock warrant liability	40
Total liabilities	10,503	11,487
Mezzanine equity:
Series X Convertible Preferred Stock, $0.001 par value; 10,000,000 shares authorized; 136,248 and 0 shares issued and outstanding as of March 31, 2023 and December 31, 2022, respectively	67,715
Stockholders' equity:
Common stock, $0.001 par value; 240,000,000 shares authorized; 119,410,992 and 99,021,376 shares issued and outstanding as of March 31, 2023 and December 31, 2022, respectively	119	99
Additional paid-in capital	387,886	376,807
Accumulated other comprehensive income	355	128
Accumulated deficit	(360,031)	(318,168)
Total stockholders' equity	28,329	58,866
Total liabilities, mezzanine equity and stockholders' equity	$ 106,547	$ 70,353

Summary of Significant Accounting Policies - Fair Value of Financial Instruments (Details) $ in Thousands	2 Months Ended
	Mar. 31, 2023 USD ($)	Dec. 31, 2022 USD ($)
Assets:
Cash equivalents	$ 70,704	$ 62,074
Total assets	70,704	62,074
Liabilities:
Series X Preferred Stock warrant liability	40
Total liabilities	$ 40
Measurement Input, Expected Dividend Rate [Member]
Fair value measurements of the warrant liability
Warrants and Rights Outstanding, Measurement Input	0
Level 1
Assets:
Cash equivalents	$ 70,704	62,074
Total assets	70,704	$ 62,074
Level 3
Liabilities:
Series X Preferred Stock warrant liability	40
Total liabilities	40
Warrant Liability \| Level 3
Fair value measurements of the warrant liability
Beginning Balance	90
Loss (gain) on change in fair value	(50)
Change in fair value	(50)
Ending Balance	$ 40

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands	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	88,318,454
Balance at the beginning of the period at Dec. 31, 2021	$ 88	$ 371,638	$ (267)	$ (263,572)		$ 107,887
Increase (Decrease) in Stockholders' Equity
Foreign currency translation adjustment			(158)			(158)
Stock-based compensation		1,204				1,204
Net loss				(10,376)		(10,376)
Balance at the end of the period at Mar. 31, 2022	$ 88	372,842	(425)	(273,948)		98,557
Balance at the end of the period (in shares) at Mar. 31, 2022	88,318,454
Balance at the beginning of the period (in shares) at Dec. 31, 2022	99,021,376
Balance at the beginning of the period at Dec. 31, 2022	$ 99	376,807	128	(318,168)		58,866
Increase (Decrease) in Stockholders' Equity
Foreign currency translation adjustment			227			227
Stock-based compensation		1,310				1,310
Net loss				(41,863)		(41,863)
Balance at the end of the period at Mar. 31, 2023	119	387,886	$ 355	$ (360,031)		$ 28,329
Beginning balance (in shares) at Dec. 31, 2022						0
Increase (Decrease) in Stockholders' Equity
Issuance of Series X Preferred Stock in connection with Flame merger					$ 67,715
Issuance of Series X Preferred Stock in connection with Flame merger (in shares)					136,248
Issuance of common stock in connection with Flame merger	$ 19	9,786				$ 9,805
Issuance of common stock in connection with Flame merger (in shares)	19,729,010
Issuance of common stock warrants in connection with Flame merger		13				13
Redemption of 2019 Warrants		(29)				(29)
Issuance of common stock upon vest of restricted stock units	$ 1	$ (1)
Issuance of common stock upon vest of restricted stock units (in shares)	660,606
Ending balance at Mar. 31, 2023					$ 67,715	$ 67,715
Ending balance (in shares) at Mar. 31, 2023	119,410,992				136,248	136,248

Acquisition of Flame Biosciences

3 Months Ended

Mar. 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 issued to the stockholders of Flame (the “Flame Stockholders”) 19,729,010 shares of common stock, and 136,248 shares of Series X non-voting convertible preferred stock (the “Series X Preferred Stock”), which was a newly designated series of preferred stock that is 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 65,301 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 is convertible into 1,000 shares of common stock, subject to the terms of any reverse stock split approved by the stockholders and effected by the Board of Directors. Under the terms of the Merger Agreement, Leap held back approximately 15,604 shares (the “Holdback Shares”) out of the aggregate number of shares of Series X Preferred Stock that the Flame Stockholders otherwise would be entitled to receive pursuant to the Merger so that Leap can have recourse to the Holdback Shares for purposes of satisfying certain claims for indemnification that Leap may have against the Flame Stockholders in connection with the Merger.

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 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 condensed consolidated balance sheet at their historical carrying values, which approximates 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 does 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 condensed consolidated statement of operations during the three months ended March 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 common
	Number of shares	shares	Fair Value
Leap common stock (par value $0.0001 per share)	19,729,010	19,729,010	$	9,805
Leap Series X Preferred Stock (1000:1)	136,248	136,248,000		67,715
Warrants on Leap common stock	65,301	65,301		13
Warrants on Leap Series X Preferred Stock (1000:1)	443	443,000		90
Direct and incremental costs of the asset acquisition				1,393

Total		156,485,311	$	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.

Series X Preferred Stock

Pursuant to the Merger, the Company issued 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. Subject to and upon the requisite approval of the stockholders of Leap, 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 shall convert into 1,000 shares of common stock, subject to the terms of any reverse stock split approved by the stockholders and effected by the Board of Directors. In the event that stockholder approval is not obtained, the Company must also include a proposal to approve the conversion of the Series X Preferred Stock to common stock at a meeting of stockholders (“Special Meeting”), to be held no less than once in each subsequent six-month period beginning on the date of the Special Meeting until such approval is obtained. If stockholders have not approved the conversion of the Series X Preferred Stock into common stock by July 17, 2023 (six months from the Effective Date), then, holders of Series X Preferred Stock may thereafter require the Company to repurchase the Series X Preferred Stock at the then-current fair value of the underlying common stock.

Conversion

Subject to stockholder approval and the terms of any reverse stock split approved by the stockholders and effected by the Board of Directors, the Series X Preferred Stock is convertible into common stock at a rate of approximately 1,000 shares of common stock for every one share of Series X Preferred Stock that is converted. On the second business day following stockholder approval, each share of Series X Preferred Stock then outstanding shall automatically convert into 1,000 shares of common stock, subject to the terms of any reverse stock split approved by the stockholders and effected by the Board of Directors.

Voting Rights

Except as otherwise required by law, the Series X Preferred Stock does not have voting rights. However, as long as any shares of Series X Preferred Stock are outstanding, the Company will not, without the affirmative vote of the holders of a majority of the then-outstanding shares of the Series X Preferred Stock, (a) alter or change adversely the powers, preferences or rights given to the Series X Preferred Stock, (b) alter or amend the Series X Certificate of Designation, (c) amend its certificate of incorporation or other charter documents in any manner that adversely affects any rights of the holders of Series X Preferred Stock, (d) issue shares of Series X Preferred Stock (other than pursuant to, and in accordance with, the Merger Agreement), or increase the number of authorized shares of Series X Preferred Stock, or decrease the number of authorized shares of Series X Preferred Stock below an aggregate number of shares of Series X Preferred Stock then outstanding plus the total number of shares of Series X Preferred Stock issuable pursuant to the Merger Agreement that have not then previously been issued, (e) prior to the requisite approval of the conversion of the Series X Preferred Stock to common stock by the stockholders of Leap, consummate a Fundamental Transaction or any merger or

consolidation of Leap with or into another entity or any stock sale to, or other business combination in which the stockholders of Leap immediately before such transaction do not hold at least a majority of the capital stock of Leap immediately after such transaction, or (f) enter into any agreement with respect to any of the foregoing. The Series X Preferred Stock shall rank, as to distributions of assets upon liquidation, as follows: (i) senior to any class or series of capital stock of Leap created after the closing date specifically ranking by its terms junior to the common stock (“Junior Securities”); (ii) on parity with the common stock and any other class or series of capital stock of Leap created after the closing date specifically ranking by its terms on parity with the Series X Preferred Stock or the common stock (“Parity Securities”); and (iii) junior to any class or series of capital stock of Leap created after the closing specifically ranking by its terms senior to the common stock (“Senior Securities”).

Dividends

Holders of Series X Preferred Stock are entitled to receive dividends on shares of Series X Preferred Stock equal, on an as-if-converted-to-common-stock basis, and in the same form as dividends actually paid on shares of the common stock.

Liquidation and Dissolution

Upon any liquidation, dissolution or winding-up of the Company, whether voluntary or involuntary (“Liquidation”), each holder of Series X Preferred Stock shall be entitled to receive, in preference to any distributions to the holders of the Junior Securities, pari passu with any distributions to the holders of the Parity Securities, and subject and junior to the prior and superior rights of the holders of any Senior Securities to receive any distributions, an equivalent amount of distributions as would be paid on the common stock underlying such holder’s shares of Series X Preferred Stock, determined on an as-converted to common stock basis by treating all then outstanding shares of Series X Preferred Stock as if they had been converted to common stock (without regard to the Beneficial Ownership Limitation) and all then outstanding Parity Securities that are entitled to receive distributions on substantially the same terms as the Series X Preferred Stock as if such then outstanding Parity Securities had been converted to common stock (without regard to any beneficial ownership limitation similar to the Beneficial Ownership Limitation), plus, without duplication, an additional amount equal to any dividends declared but unpaid on such holder’s shares of Series X Preferred Stock, before any distributions to holders of any class of any Junior Securities. If, upon any such Liquidation, the assets of the Company shall be insufficient to pay the holders of shares of the Series X Preferred Stock the amount required under the preceding sentence, then all remaining assets of the Company available for distribution to the stockholders of the Company shall be distributed ratably to the holders and the holders of Parity Securities in accordance with the respective amounts that would be payable on all outstanding Series X Preferred Stock and all outstanding Parity Securities if all amounts payable thereon upon any such Liquidation were paid in full.

Redemption

If Stockholder Approval is not obtained within six months from the date of issuance of the Series X Preferred Stock and the Series X Preferred Stock becomes eligible to be settled in cash, the Company will be required to recognize changes in the redemption value immediately as it occurs and then subsequently adjust the carrying amount of the Series X Preferred Stock to equal the redemption value at the end of each reporting period as if the end of the reporting period were also the redemption date for the Series X Preferred Stock. The change in fair value of the Series X Preferred Stock would be recognized as a deemed dividend, which adjusts retained earnings and earnings available to common stockholders in computing basic and diluted earnings per share. Upon cash settlement, if the fair value of the consideration transferred is greater than the carrying amount of the Series X Preferred Stock surrendered, (1) retained earnings should be reduced by the difference and (2) earnings available to common stockholders would be reduced by the difference in accordance with ASC 260-10, Earnings Per Share.

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 65,301 shares of Leap’s common stock (the “January 2023 Common Stock Warrants”). The January 2023 Common Stock Warrants have an exercise price of $0.68 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”). Each share of Series X Preferred Stock is convertible into 1,000 shares of Common Stock, subject to the terms of any reverse stock split approved by the stockholders and effected by the Board of Directors. The January 2023 Series X Preferred Stock Warrants have an exercise price of $678.48 per share (subject to the terms of any reverse stock split approved by the stockholders and effected by the Board of Directors) and expire in February 2025.

The Company classifies the January 2023 Series X Preferred Stock Warrants as a liability on its consolidated balance sheet. The Company initially recorded the January 2023 Series X Preferred Stock Warrants as a liability on the Effective Date and the warrant liability will be subsequently remeasured to fair value at each reporting date until the Stockholder Approval to convert shares of Series X Preferred Stock into shares of common stock (from mezzanine equity into permanent equity) is obtained.

Changes in the fair value of the warrant liability are recognized as gains (losses) in the Company’s consolidated statement of operations. During the three months ended March 31, 2023, the Company recorded a gain of $50 in its condensed consolidated statement of operations.

Net Loss Per Share - Basic and Diluted (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Numerator:
Net loss	$ (41,863)	$ (10,376)
Net loss attributable to common stockholders for basic loss per share	(41,863)	(10,376)
Net loss attributable to common stockholders for diluted loss per share	$ (41,863)	$ (10,376)
Denominator:
Weighted average number of common shares outstanding - basic	129,344,272	113,248,937
Weighted average number of common shares outstanding - diluted	129,344,272	113,248,937
Net loss per share attributable to common stockholders - basic	$ (0.32)	$ (0.09)
Net loss per share attributable to common stockholders - diluted	$ (0.32)	$ (0.09)
Exercise of the pre-funded warrants	14,217,716	24,930,483

Document and Entity Information - shares	3 Months Ended
Document and Entity Information - shares	Mar. 31, 2023	May 10, 2023
Document and Entity Information
Document Type	10-Q
Document Quarterly Report	true
Document Transition Report	false
Document Period End Date	Mar. 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 St, 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 per share
Trading Symbol	LPTX
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		119,410,992
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2023
Document Fiscal Period Focus	Q1
Entity Central Index Key	0001509745
Amendment Flag	false

Net Loss Per Share

3 Months Ended

Mar. 31, 2023

Net Loss Per Share

Net Loss Per Share

9. Net Loss Per Share

Basic and diluted net loss per share for the three months ended March 31, 2023 and 2022 was calculated as follows (in thousands except share and per share amounts).


	Three Months Ended March 31,
	2023		2022
Numerator:
Net loss	$	(41,863)	$	(10,376)
Net loss attributable to common stockholders for basic and diluted loss per share	$	(41,863)	$	(10,376)

Denominator:
Weighted average number of common shares outstanding – basic and diluted		129,344,272		113,248,937
Net loss per share attributable to common stockholders – basic and diluted	$	(0.32)	$	(0.09)

Included within weighted average common shares outstanding for the three months ended March 31, 2023 and 2022 are 14,217,716 and 24,930,483, respectively, 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.

All warrants and shares of Series X Preferred Stock issued participate on a one-for-one basis with common stock in the distribution of dividends, if and when declared by the board of directors, on the Company’s common stock. For purposes of computing EPS, these warrants are considered to participate with common stock in earnings of the Company. Therefore, the Company calculates basic and diluted EPS using the two-class method. Under the two-class method, net income for the period is allocated between common stockholders and participating securities according to dividends declared and participation rights in undistributed earnings. No income was allocated to the warrants and Series X Preferred Stock for the three months ended March 31, 2023 and 2022, as results of operations were a loss for the period.

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 three months ended March 31, 2023 and 2022, as the effect would be to reduce the net loss per share. The following table includes the potential 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:


	Three Months Ended March 31,
	2023	2022
Restricted stock units to purchase common stock	2,925,000	3,510,606
Options to purchase common stock	20,088,158	9,101,507
Warrants to purchase common stock	35,420,975	35,455,674
	58,434,133	48,067,787

Pursuant to the Merger, the Company issued 136,248 shares of Series X Preferred Stock to Flame Stockholders. As of March 31, 2023, the number of potentially dilutive shares of the Company’s common stock into which these Series X preferred shares can be converted into is 136,248,000, and is not included in diluted earnings per share since the shares are contingently convertible. Subject to and upon the requisite approval of the stockholders of Leap, each issued share of Series X Preferred Stock shall convert into 1,000 shares of common stock, subject to the terms of any reverse stock split approved by the stockholders and effected by the Board of Directors. In the event that stockholder approval is not obtained, the Company must also include a proposal to approve the conversion of the Series X Preferred Stock into common stock at a meeting of stockholders (“Special Meeting”), to be held no less than once in each subsequent six-month period beginning on the date of the Special Meeting until such approval is obtained. If stockholders have not approved the conversion of the Series X Preferred Stock into common stock by July 17, 2023 (six months from the Effective Date), then, holders of Series X Preferred Stock may thereafter require the Company to repurchase the Series X Preferred Stock at the then-current fair value of the underlying common stock.

Commitments and Contingencies

3 Months Ended

Mar. 31, 2023

Commitments and Contingencies

Commitments and Contingencies

10. Commitments and Contingencies

Manufacturing Agreements—The Company is party to manufacturing agreements with vendors to manufacture DKN-01, its lead product candidate, for use in clinical trials. As of March 31, 2023, there were $3,469 noncancelable commitments under these agreements.

License and Service Agreement—On January 3, 2011, the Company entered into a license agreement with Eli Lilly and Company (“Lilly”), a shareholder, to grant a license to the Company for certain intellectual property rights relating to pharmaceutically active compounds that may be useful in the treatment of bone healing, cancer and, potentially, other medical conditions. As defined in the license agreement, the Company would be required to pay royalties to Lilly based upon a percentage in the low single digits of net sales of developed products, if and when achieved. However, there can be no assurance that clinical or commercialization success of developed products will occur, and no royalties have been paid or accrued through March 31, 2023.

License Agreement—On May 28, 2015, the Company entered into a license agreement with Lonza Sales AG (“Lonza”), pursuant to which Lonza granted the Company a world-wide, non-exclusive license for certain intellectual property relating to a gene expression system for manufacturing DKN-01. As defined in the license agreement, the Company would be required to pay royalties to Lonza based on a percentage in the low single digits of net sales of DKN-01, if and when achieved. However, there can be no assurance that clinical or commercialization success will occur, and no royalties have been paid or accrued through March 31, 2023.

Legal Proceedings—At each reporting date, the Company evaluates whether or not a potential loss amount or a potential range of loss is probable and reasonably estimable under the provisions of the authoritative guidance that addresses accounting for contingencies. The Company expenses as incurred the costs related to its legal proceedings. As of the date of this report, the Company is not currently a party to any material legal proceedings.

Indemnification Agreements—In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with members of its board of directors that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited. To date, the Company has not incurred any material costs as a result of such indemnifications. The Company is not aware of any claims under indemnification arrangements, and it has not accrued any liabilities related to such obligations in its condensed consolidated financial statements as of March 31, 2023 or December 31, 2022.

CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares	Mar. 31, 2023	Dec. 31, 2022
CONDENSED CONSOLIDATED BALANCE SHEETS
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	119,410,992	99,021,376
Common stock, outstanding shares	119,410,992	99,021,376
Series X Convertible Preferred Stock, par value (in dollars per share)	$ 0.001	$ 0.001
Series X Convertible Preferred Stock, shares authorized	10,000,000	10,000,000
Series X Convertible Preferred Stock,, shares issued	136,248	0
Series X Convertible Preferred Stock,, shares outstanding	136,248	0

Leases

3 Months Ended

Mar. 31, 2023

Leases

Leases

5. Leases

The Company has operating leases 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 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 lease term. 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 existing net leases 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 of $609. As of March 31, 2023, a right-of-use asset of $569 and lease liability of $577 are reflected on the condensed consolidated balance sheets. The Company recorded rent expense of $114 and $108, respectively, during the three months ended March 31, 2023 and 2022.

Future lease payments under non-cancelable operating leases as of March 31, 2023 are detailed as follows:


Future Operating Lease Payments
2023		339
2024		268
Total Lease Payments		607
Less: imputed interest		(30)
Total operating lease liabilities	$	577

Equity Incentive Plans

3 Months Ended

Mar. 31, 2023

Equity Incentive Plans

Equity Incentive Plans

8. Equity Incentive Plans

Equity Incentive Plans

In September 2012, the Company adopted the 2012 Equity Incentive 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 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 7,500,000 new shares of the Company’s common stock to be granted.

As of March 31, 2023, there were 1,190,949 shares available for grant under the Company’s equity incentive plans.

A summary of stock option activity under the Equity Plans is as follows:


		Weighted
		Average	Weighted	Aggregate
		Exercise Price	Average Remaining	Intrinsic
	Options	Per Share	Life in Years	Value
Outstanding at December 31, 2022	11,917,331	3.59	7.47	—
Granted	8,235,000	0.34
Forfeited	(64,173)	1.90
Outstanding at March 31, 2023	20,088,158	2.27	8.33	—
Options exercisable at March 31, 2023	8,247,158	4.49	6.35	—
Options vested and expected to vest at March 31, 2023	20,088,158	2.27	8.33	—

The grant date fair value of the options granted during the three months ended March 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 three months ended March 31, 2023 and 2022 was $0.25 and $1.39 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 three months ended March 31, 2023 and 2022 were as follows, presented on a weighted average basis:


	Three Months		Three Months
	Ended March 31,		Ended March 31,
	2023		2022

Expected volatility	89.99	%	82.70	%
Weighted average risk-free interest rate	3.56	%	1.67	%
Expected dividend yield	0.00	%	0.00	%
Expected term (in years)	6.42		6.01

Stock options generally vest over a three or four year period, as determined by the compensation committee of the Board of Directors at the time of grant. The options expire 10 years from the grant date. As of March 31, 2023, there was approximately $5,866 of unrecognized compensation cost related to non-vested stock options, which is expected to be recognized over a remaining weighted-average period of approximately 2.29 years.

Restricted Stock Units

During the three months ended March 31, 2022, the Company granted 2,575,000 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 three months ended March 31, 2023.

The following table presents RSU activity under the 2016 Plan during the three months ended March 31, 2023:


		Weighted
		Average Grant
	Number of Shares	Date Fair Value
Outstanding at December 31, 2022	3,585,606	$	1.89
Vested	(660,606)	$	1.42
Outstanding at March 31, 2023	2,925,000	$	2.00

As of March 31, 2023, there were 2,925,000 shares outstanding covered by RSUs that are expected to vest with a weighted average grant date fair value of $2.00 per share and an aggregate grant date fair value of approximately $5,850. As of March 31, 2023, there was approximately $3,353 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 1.8 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 condensed consolidated statements of operations during the three months ending March 31, 2023 and 2022 as follows:

Stock Based Compensation Expense


	Three Months Ended March 31,
	2023		2022

Research and development	$	704	$	554
General and administrative		606		650
Total	$	1,310	$	1,204

Common stock (Details) $ in Thousands		3 Months Ended
Common stock (Details) $ in Thousands	Jan. 17, 2023 shares	Mar. 31, 2023 USD ($) Vote
Number of vote on common shares \| Vote		1
Dividend declared \| $		$ 0
Flame
Percentage of outstanding ordinary shares acquired	100.00%
Number of shares issued \| shares	19,729,010

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Cash flows from operating activities:
Net loss	$ (41,863)	$ (10,376)
Adjustments to reconcile net loss to net cash used in operating activities:
In-process research and development costs acquired in connection with the acquistion of Flame	29,582
Depreciation expense	4	4
Amortization of right-of-use assets	100	104
Stock-based compensation expense	1,310	1,204
Foreign currency transaction (gain) loss	307	(235)
Change in fair value of warrant liability	(50)
Changes in operating assets and liabilities:
Prepaid expenses and other assets	(239)	277
Research and development incentive receivable	(278)	(38)
Accounts payable and accrued expenses	(2,196)	(2,368)
Lease liability	(100)	(106)
Other assets	723	16
Net cash used in operating activities	(12,700)	(11,518)
Cash flows from investing activities:
Cash acquired in connection with the acquisition of Flame	50,362
Payment of direct and incremental costs of the asset acquisition	(1,045)
Net cash provided by investing activities	49,317
Cash flows from financing activities:
Payment of redemption of 2019 warrants	(29)
Payment of deferred costs		(210)
Net cash used in financing activities	(29)	(210)
Effect of exchange rate changes on cash and cash equivalents	(50)	32
Net increase (decrease) in cash and cash equivalents	36,538	(11,696)
Cash and cash equivalents at beginning of period	65,500	114,916
Cash and cash equivalents at end of period	102,038	$ 103,220
Supplemental disclosure of non-cash financing activities:
Issuance of Series X Preferred Stock in connection with acquisition of Flame	67,715
Issuance of warrants to purchase convertible Series X preferred stock in connection with the acquisition of Flame	90
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
Direct and incremental costs of the asset acquisition recorded in accounts payable	348
Issuance of common stock up on the vesting of restricted stock units	1
Net liabilities assumed from acquisition of Flame	$ 928

Commitments and Contingencies - Manufacturing, License and Service Agreements (Details) $ in Thousands	Mar. 31, 2023 USD ($)
Commitments and Contingencies
Manufacturing commitments	$ 3,469
License and service agreements
Commitments and Contingencies
Royalties paid or accrued	0
Licensing agreements
Commitments and Contingencies
Royalties paid or accrued	$ 0

Common Stock

3 Months Ended

Mar. 31, 2023

Common Stock

Common Stock

7. 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 March 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 19,729,010 shares of common stock. The Company also issued Series X Preferred Stock to Flame Stockholders pursuant to the Merger (see Note 3).

In accordance with Nasdaq listing rules, holders of shares of common stock issued by the Company as consideration for the acquisition of Flame are not entitled to vote any of such shares at any shareholder meeting on the approval of the conversion of the Series X Preferred Stock into common stock.

- Definition

The entire disclosure for shareholders' equity comprised of portions attributable to the parent entity and noncontrolling interest, including other comprehensive income. Includes, but is not limited to, balances of common stock, preferred stock, additional paid-in capital, other capital and retained earnings, accumulated balance for each classification of other comprehensive income and amount of comprehensive income.

+ References

Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-URI https://asc.fasb.org/topic&trid=2208762

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 13
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496158-112644

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
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-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496158-112644

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 14
-Subparagraph (c)
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496171-112644

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 14
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496171-112644

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SX 210.3-04)
-URI https://asc.fasb.org/extlink&oid=120397183&loc=d3e187085-122770

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 18
-Subparagraph (d)
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496189-112644

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
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-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496158-112644

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 18
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496189-112644

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
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-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496158-112644

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 14
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-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496171-112644

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
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-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496189-112644

Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 16
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-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496180-112644

Reference 14: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 13
-Subparagraph (i)
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496158-112644

Reference 15: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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-Paragraph 1
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Reference 16: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
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-URI https://asc.fasb.org/extlink&oid=126731327&loc=SL126733271-114008

+ Details

Summary of Significant Accounting Policies (Details) - USD ($) $ in Thousands	3 Months Ended		12 Months Ended
	Mar. 31, 2023	Mar. 31, 2022	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 receivable	$ 2,071		$ 2,099
Research and development incentive income and receivable
Balance at the beginning of the period	2,099	$ 1,189	1,189
Australian research and development incentive income, net	272	$ 37	(2,051)
Cash received for eligible expenses			(1,064)
Foreign currency translation	(28)		(77)
Balance at the end of the period	2,343		2,099
Deferred Offering Costs
Deferred costs			576
Other Assets
Deposits	$ 976		1,108
Incremental borrowing rate	8.00%
License and Service
Other Assets
Deposits	$ 976		$ 1,108

Net Loss Per Share - Antidilutive (Details)		3 Months Ended
Net Loss Per Share - Antidilutive (Details)	Jan. 17, 2023 shares	Mar. 31, 2023 shares	Mar. 31, 2022 shares	Jan. 31, 2023
Securities excluded from computation of diluted net loss per share
Anti-dilutive securities excluded from calculation of diluted net loss per share		58,434,133	48,067,787
Period to held to special meeting		6 months
Series X Preferred Stock
Securities excluded from computation of diluted net loss per share
Temporary Stock Convertible Conversion Ratio		1,000
Flame Biosciences, Inc [Member]
Securities excluded from computation of diluted net loss per share
Number of shares issued	19,729,010
Equivalent common shares	156,485,311
Period to held to special meeting		6 months
Flame Biosciences, Inc [Member] \| Series X Preferred Stock
Securities excluded from computation of diluted net loss per share
Equivalent common shares	136,248,000
Temporary Stock Convertible Conversion Ratio	1,000	1,000		1,000
Flame Biosciences, Inc [Member] \| Flame shareholders \| Series X Preferred Stock
Securities excluded from computation of diluted net loss per share
Number of shares issued		136,248
Equivalent common shares		136,248,000
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		2,925,000	3,510,606
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		20,088,158	9,101,507
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		35,420,975	35,455,674

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Operating expenses:
Research and development	$ 38,942	$ 7,784
General and administrative	3,784	2,848
Total operating expenses	42,726	10,632
Loss from operations	(42,726)	(10,632)
Interest income	848	5
Interest expense		(21)
Australian research and development incentives	272	37
Foreign currency gain (loss)	(307)	235
Change in fair value of Series X preferred stock warrant liability	50
Net loss attributable to common stockholders	$ (41,863)	$ (10,376)
Net loss per share
Basic	$ (0.32)	$ (0.09)
Diluted	$ (0.32)	$ (0.09)
Weighted average common shares outstanding
Basic	129,344,272	113,248,937
Diluted	129,344,272	113,248,937

Equity Incentive Plans (Tables)

3 Months Ended

Mar. 31, 2023

Equity Incentive Plans

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, 2022	11,917,331	3.59	7.47	—
Granted	8,235,000	0.34
Forfeited	(64,173)	1.90
Outstanding at March 31, 2023	20,088,158	2.27	8.33	—
Options exercisable at March 31, 2023	8,247,158	4.49	6.35	—
Options vested and expected to vest at March 31, 2023	20,088,158	2.27	8.33	—

Schedule of assumptions used to determine grant-date fair value of stock options


	Three Months		Three Months
	Ended March 31,		Ended March 31,
	2023		2022

Expected volatility	89.99	%	82.70	%
Weighted average risk-free interest rate	3.56	%	1.67	%
Expected dividend yield	0.00	%	0.00	%
Expected term (in years)	6.42		6.01

Schedule of RSU activity under the 2016 Plan


		Weighted
		Average Grant
	Number of Shares	Date Fair Value
Outstanding at December 31, 2022	3,585,606	$	1.89
Vested	(660,606)	$	1.42
Outstanding at March 31, 2023	2,925,000	$	2.00

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


	Three Months Ended March 31,
	2023		2022

Research and development	$	704	$	554
General and administrative		606		650
Total	$	1,310	$	1,204

Accrued Expenses

3 Months Ended

Mar. 31, 2023

Accrued Expenses

Accrued Expenses

4. Accrued Expenses

Accrued expenses consist of the following:


	March 31,		December 31,
	2023		2022
Clinical trials	$	2,374	$	2,093
Professional fees		398		533
Payroll and related expenses		1,616		2,526
Accrued expenses	$	4,388	$	5,152

Acquisition of Flame Biosciences (Tables)

3 Months Ended

Mar. 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


		Equivalent common
	Number of shares	shares	Fair Value
Leap common stock (par value $0.0001 per share)	19,729,010	19,729,010	$	9,805
Leap Series X Preferred Stock (1000:1)	136,248	136,248,000		67,715
Warrants on Leap common stock	65,301	65,301		13
Warrants on Leap Series X Preferred Stock (1000:1)	443	443,000		90
Direct and incremental costs of the asset acquisition				1,393

Total		156,485,311	$	79,016

Warrants

3 Months Ended

Mar. 31, 2023

Warrants

Warrants

6. Warrants

As of March 31, 2023, the number of shares of common stock and Series X Preferred Stock issuable upon the exercise of outstanding warrants, consisted of the following:


March 31, 2023
	Number of Common Shares
Description	Issuable	Number of Series X Preferred Shares Issuable		Exercise Price		Expiration Date
January 23 2017 Warrants	54,516		—	$	0.01	Upon M&A Event
2017 Warrants	2,502,382		—	$	1.055	November 2024
2019 Warrants	6,908,257		—	$	1.95	February 2026
March 2020 Pre-funded Warrants	8,247,170		—	$	0.001	No Expiry
March 2020 Coverage Warrants	25,945,035		—	$	2.11	Jan - March 2027
September 2021 Pre-funded Warrants	5,916,030		—	$	0.001	No Expiry
January 2023 Common Stock Warrants	65,301		—	$	0.680	February 2025
January 2023 Series X Preferred Stock Warrants (Convertible 1000 to 1)	—		443	$	678.48	February 2025
	49,638,691		443

2017 Warrants

The 2017 Warrants contain full ratchet anti-dilution protection provisions. The Company will recognize on a prospective basis the value of the effect of the down round feature in 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.

2019 Warrants

On February 5, 2019, in connection with the 2019 Public Offering, the Company issued immediately exercisable warrants (the “2019 Warrants”) to purchase 7,557,142 shares of common stock to investors. The 2019 Warrants have an exercise price of $1.95 per share and expire on February 5, 2026. The 2019 Warrants qualify for equity classification.

During the three months ended March 31, 2023, the Company redeemed 100,000 of the 2019 Warrants at a purchase price of $0.29 per share.

March 2020 Warrants

On January 3, 2020, the Company entered into a Securities Purchase Agreement with investors, providing for a private placement transaction exempt from the Securities Act of 1933, as amended, pursuant to which the Company issued and sold 1,421,801 shares of its Series A Preferred Stock, at a purchase price of $10.54 per share, and 1,137,442 shares of its Series B Preferred Stock at a purchase price of $10.55 per share, and one share of the Company’s Special Voting Stock entitling the purchaser of Series A Preferred Stock to elect one member of the Company’s Board of Directors.

On March 5, 2020, the Company’s stockholders approved the conversion of the Series A Preferred Stock into a pre-funded warrant to purchase 14,413,902 shares of common stock at an exercise price of $0.001 (the “March 2020 Pre-funded Warrants”) and the conversion of the Series B Preferred Stock into 11,531,133 shares of common stock. Each investor also received a warrant to purchase an equal number of shares of common stock at an exercise price of $2.11 per share (the “March 2020 Coverage Warrants”). The March 2020 Pre-funded Warrants and the March 2020 Coverage Warrants qualify for equity classification.

The March 2020 Coverage Warrants contain full ratchet anti-dilution protection provisions, relating to the issuance of “Convertible Securities”, as defined therein. The Company will recognize on a prospective basis the value of the effect of the down

round feature in the Coverage 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.

During the year ended December 31, 2022, there were cashless exercises of 6,166,732 March 2020 Pre-funded Warrants, exercise price $0.001 per share, resulting in the issuance of 6,161,000 shares of the Company’s common stock.

June 2020 Warrants

On June 22, 2020, the Company completed a public offering (the “2020 Public Offering”) whereby the Company issued 20,250,000 shares of its common stock, at $2.00 per share and, in lieu of common stock, offered pre-funded warrants (the “June 2020 Pre-funded Warrants”) to purchase up to 2,250,000 shares of its common stock to certain investors. The June 2020 Pre-funded Warrants have an exercise price of $0.001 per share and qualify for equity classification.

During the year ended December 31, 2022, there were cashless exercises of 1,690,137 June 2020 Pre-funded Warrants, exercise price $0.001 per share, resulting in the issuance of 1,688,571 shares of the Company’s common stock.

September 2021 Warrants

On September 24, 2021, the Company completed a public offering (the “2021 Public Offering”) whereby the Company issued 27,568,072 shares of its common stock, at $2.85 per share and, in lieu of common stock, offered pre-funded warrants (the “September 2021 Pre-funded Warrants”) to purchase up to 8,771,928 shares of its common stock to certain investors. The September 2021 Pre-funded Warrants have an exercise price of $0.001 per share and qualify for equity classification.

During the year ended December 31, 2022, there were cashless exercises of 2,855,898 September 2021 Pre-funded Warrants, exercise price $0.001 per share, resulting in the issuance of 2,853,351 shares of the Company's common stock.

January 2023 Common Stock Warrants

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 is convertible into 1,000 shares of common stock, subject to Stockholder Approval and the terms of any reverse stock split approved by the stockholders and effected by the Board of Directors. The January 2023 Series X Preferred Stock Warrants have an exercise price of $678.48 per share (subject to the terms of any reverse stock split approved by the stockholders and effected by the Board of Directors) and expire in February 2025.

Leases (Details) - USD ($) $ in Thousands	3 Months Ended		12 Months Ended
Leases (Details) - USD ($) $ in Thousands	Mar. 31, 2023	Mar. 31, 2022	Dec. 31, 2022
Leases
Right of use assets, net	$ 569		$ 669
Lease liability	577
Additional right of use asset			609
Additional operating lease liability			$ 609
Rent expense	$ 114	$ 108

Nature of Business, Basis of Presentation and Liquidity

3 Months Ended

Mar. 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. 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 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 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. Its 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 extensive experience identifying and developing transformational products to build a pipeline of programs that have the potential to change the practice of cancer medicine.

Basis of Presentation

The accompanying condensed consolidated financial statements as of March 31, 2023, and for the three months ended March 31, 2023 and 2022 have been prepared by the Company, pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”) for interim financial statements. Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) have been condensed or omitted pursuant to such rules and regulations. However, the Company believes that the disclosures are adequate to make the information presented not misleading. These condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the notes thereto for the year ended December 31, 2022, included in the Company’s Annual Report on Form 10-K filed with the SEC on March 24, 2023.

The condensed consolidated financial statements have been prepared on the same basis as the audited consolidated financial statements. In the opinion of management, the accompanying condensed consolidated financial statements contain all adjustments which are necessary for the fair presentation of the Company’s financial position as of March 31, 2023, statements of operations and statements of comprehensive loss for the three months ended March 31, 2023, and 2022 and statements of cash flows for the three months ended March 31, 2023 and 2022. Such adjustments are of a normal and recurring nature. The results of operations for the three months ended March 31, 2023 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2023.

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 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 condensed consolidated financial statements are issued. As of March 31, 2023, the Company had cash and cash equivalents of $102,038. Additionally, the Company had an accumulated deficit of $360,031 at March 31, 2023, and during the three months ended March 31, 2023, the Company incurred a net loss of $41,863. The Company expects to continue to generate operating losses for the foreseeable future. In connection with the merger with Flame and pursuant to the Certificate of Designation of the Series X non-voting convertible preferred stock (the “Series X Preferred Stock”), if stockholder approval for the conversion of the Series X Preferred Stock to common stock (the “Stockholder Approval”) is not obtained from the holders of the Company’s common stock within six months from the date of issuance of the Series X Preferred Stock, the holders of Series X Preferred Stock may require the Company to settle all of the then-outstanding shares of Series X Preferred Stock for cash at fair value. The Company fully expects the vote to pass and for the Series X Preferred Stock to convert into common stock. However, there can be no assurance that the Stockholder Approval will be received. If the Company fails to receive Stockholder Approval within six months from the date of issuance of the Series X Preferred Stock and the Company is required to settle then-outstanding shares of Series X Preferred Stock for cash at fair value, the Company’s financial position would be materially adversely affected and the Company would be forced to seek additional funding, which may not be available on acceptable terms or at all, or reduce or eliminate certain clinical trials, programs and operating expenses, which would adversely affect its business prospects.

The Company believes that its cash and cash equivalents of $102,038 as of March 31, 2023 will be sufficient to fund its operating expenses for at least the next 12 months from 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.

Accrued Expenses (Details) - USD ($) $ in Thousands	Mar. 31, 2023	Dec. 31, 2022
Accrued Expenses
Clinical trials	$ 2,374	$ 2,093
Professional fees	398	533
Payroll and related expenses	1,616	2,526
Accrued expenses	$ 4,388	$ 5,152

Accrued Expenses (Tables)

3 Months Ended

Mar. 31, 2023

Accrued Expenses

Schedule of accrued expenses


	March 31,		December 31,
	2023		2022
Clinical trials	$	2,374	$	2,093
Professional fees		398		533
Payroll and related expenses		1,616		2,526
Accrued expenses	$	4,388	$	5,152

Summary of Significant Accounting Policies

3 Months Ended

Mar. 31, 2023

Summary of Significant Accounting Policies

Summary of Significant Accounting Policies

2. Summary of Significant Accounting Policies

Principles of Consolidation

The accompanying condensed 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 condensed 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 condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.

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.

Under the program, a percentage of eligible research and development expenses incurred by the Company through its subsidiary in Australia are reimbursed. The percentage was 43.5% for the year ended December 31, 2022 and for the three months ended March 31, 2023.

The research and development incentive receivable represents an amount due in connection with the above program. The Company recorded a research and development incentive receivable of $2,343 and $2,099 as of March 31, 2023 and December 31, 2022, respectively, in the condensed consolidated balance sheets and other income from Australian research and development incentives of $272 and $37, respectively, for the three months ended March 31, 2023 and 2022.

The following table shows the change in the research and development incentive receivable from January 1, 2022 to March 31, 2023 (in thousands):


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
Australian research and development incentive income, net		272
Foreign currency translation		(28)
Balance at March 31, 2023	$	2,343

Foreign Currency Translation

The financial statements of the Company’s Australian subsidiary are measured using the local currency as the functional currency. Assets and liabilities of this subsidiary are translated into U.S. dollars at an exchange rate 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 period. The resulting cumulative translation adjustments have been recorded as a separate component of stockholders’ equity. Realized and unrealized foreign currency transaction gains and losses are included in the results of operations.

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 year ended December 31, 2022 or for the three months ended March 31, 2023.

Deposits

As of March 31, 2023 and December 31, 2022, there were $976 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, which were recorded in the condensed consolidated balance sheets.

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”) and in the warrants that were issued in a private placement in March 2020 (the “March 2020 Coverage 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.

The Company classifies the warrants that are exercisable for shares for Series X non-voting convertible preferred stock (the “January 2023 Series X Preferred Stock Warrants”) as a liability on its condensed consolidated balance sheet. The Company initially recorded the January 2023 Series X Preferred Stock Warrants as a liability on January 17, 2023, and the warrant liability will be subsequently remeasured to fair value at each reporting date until the Stockholder Approval to convert shares of Series X Preferred Stock into shares of common stock is obtained. Changes in the fair value of the warrant liability are recognized as gains (losses) in the Company’s condensed consolidated statement of operations.

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.

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
March 31, 2023
Assets:
Cash equivalents	$	70,704	$	70,704	$	—	$	—
Total assets	$	70,704	$	70,704	$	—	$	—

Liabilities:
Series X Preferred Stock warrant liability	$	40	$	—	$	—	$	40
Total liabilities	$	40	$	—	$	—	$	40

December 31, 2022
Assets:
Cash equivalents	$	62,074	$	62,074	$	—	$	—
Total assets	$	62,074	$	62,074	$	—	$	—

Cash equivalents of $70,704 and $62,074 as of March 31, 2023 and December 31, 2022, respectively, consisted of overnight investments and money market funds which are classified within Level 1 of the fair value hierarchy because they are valued using quoted market prices in active markets.

The carrying values of the research and development incentive receivable, accounts payable and accrued liabilities approximate their fair value due to the short-term nature of these assets and liabilities.

A roll-forward of the recurring fair value measurements of the warrant liability categorized with Level 3 inputs are as follows (in thousands):


Balance at January 17, 2023	$	90
Change in fair value		(50)
Balance at March 31, 2023	$	40

The warrant liability in the table above is composed of the fair value of the January 2023 Series X Preferred Stock Warrants. The fair value of the warrant liability was determined based on significant inputs not observable in the market, which represents a Level 3 measurement within the fair value hierarchy. The Company utilized the Black-Scholes option valuation model to fair value the warrant liability. The expected life was estimated to be the term from the valuation date to the warrant expiry date. 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.

Leases

The Company accounts for leases in accordance with Accounting Standards Codification, or ASC, Topic 842, 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. Most 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 Topic 842, 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.

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.

Recent Accounting Pronouncements

For a discussion of recent accounting pronouncements please refer to Note 2, “Summary of Significant Accounting Policies.” in the Company’s previously filed Annual Report on Form 10-K for the year ended December 31, 2022.

Summary of Significant Accounting Policies (Policies)

3 Months Ended

Mar. 31, 2023

Summary of Significant Accounting Policies

Principles of Consolidation

Use of Estimates

Research and development incentive income and receivable

The following table shows the change in the research and development incentive receivable from January 1, 2022 to March 31, 2023 (in thousands):


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
Australian research and development incentive income, net		272
Foreign currency translation		(28)
Balance at March 31, 2023	$	2,343

Foreign Currency Translation

Concentration of Credit Risk

Concentration of Credit Risk

Deposits

Deposits

Warrants

Warrants

Fair Value of Financial Instruments

Fair Value of Financial Instruments

●

Level 1—Quoted prices in active markets for identical assets or liabilities.

●

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
March 31, 2023
Assets:
Cash equivalents	$	70,704	$	70,704	$	—	$	—
Total assets	$	70,704	$	70,704	$	—	$	—

Liabilities:
Series X Preferred Stock warrant liability	$	40	$	—	$	—	$	40
Total liabilities	$	40	$	—	$	—	$	40

December 31, 2022
Assets:
Cash equivalents	$	62,074	$	62,074	$	—	$	—
Total assets	$	62,074	$	62,074	$	—	$	—

A roll-forward of the recurring fair value measurements of the warrant liability categorized with Level 3 inputs are as follows (in thousands):


Balance at January 17, 2023	$	90
Change in fair value		(50)
Balance at March 31, 2023	$	40

Leases

Leases

The Company accounts for leases in accordance with Accounting Standards Codification, or ASC, Topic 842, Leases.

Net Loss per Share

Subsequent Events

Subsequent Events

Recent Accounting Pronouncements

Recent Accounting Pronouncements

Warrants - January 2023 Common Stock Warrants and January 2023 Series X Preferred Stock Warrants (Details)	Mar. 31, 2023 $ / shares shares	Jan. 31, 2023 $ / shares shares
Series X Preferred Shares
Class of Warrant or Right [Line Items]
Shares issuable upon exercise of warrants	443
Conversion ratio	1,000
January 2023 Common Stock Warrants
Class of Warrant or Right [Line Items]
Shares issuable upon exercise of warrants		65,301
Exercise price per share \| $ / shares	$ 0.680	$ 0.68
January 2023 Series X Preferred Stock Warrants \| Series X Preferred Shares
Class of Warrant or Right [Line Items]
Shares issuable upon exercise of warrants	443	443
Exercise price per share \| $ / shares	$ 678.48	$ 678.48
Conversion ratio	1,000	1,000

Net Loss Per Share (Tables)

3 Months Ended

Mar. 31, 2023

Net Loss Per Share

Schedule of basic and diluted net loss per share

Basic and diluted net loss per share for the three months ended March 31, 2023 and 2022 was calculated as follows (in thousands except share and per share amounts).


	Three Months Ended March 31,
	2023		2022
Numerator:
Net loss	$	(41,863)	$	(10,376)
Net loss attributable to common stockholders for basic and diluted loss per share	$	(41,863)	$	(10,376)

Denominator:
Weighted average number of common shares outstanding – basic and diluted		129,344,272		113,248,937
Net loss per share attributable to common stockholders – basic and diluted	$	(0.32)	$	(0.09)

Schedule of potentially anti-dilutive securities excluded from calculation of diluted net loss per share


	Three Months Ended March 31,
	2023	2022
Restricted stock units to purchase common stock	2,925,000	3,510,606
Options to purchase common stock	20,088,158	9,101,507
Warrants to purchase common stock	35,420,975	35,455,674
	58,434,133	48,067,787