Stoke Therapeutics, Inc 10-K for FY2021

Stoke Therapeutics, Inc. (STOK)

10-K 2022-03-10 For: 2021-12-31

Added on April 08, 2026

About this 10-K

Stoke Therapeutics, Inc filed this 10-K on March 10, 2022, covering the fiscal year ended December 31, 2021 (FY2021).

Headline figures

Fiscal year ended December 31, 2021, as reported in this filing, compared with the same period a year earlier where the filing states it.

Net loss: $85.81M; compared with a net loss of $52.24M a year earlier

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Delaware	47-1144582
(State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification No.)
45 Wiggins Ave Bedford, Massachusetts	01730
(Address of principal executive offices)	(Zip Code)

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
Emerging growth company	☒


		Page
Special Note Regarding Forward-Looking statements		i
PART I
Item 1.	Business	1
Item 1A.	Risk Factors	35
Item 1B.	Unresolved Staff Comments	79
Item 2.	Properties	79
Item 3.	Legal Proceedings	79
Item 4.	Mine Safety Disclosures	79

PART II
Item 5.	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	80
Item 6.	[Reserved]	80
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	81
Item 7A.	Quantitative and Qualitative Disclosures About Market Risk	94
Item 8.	Financial Statements and Supplementary Data	94
Item 9.	Changes in and Disagreements With Accountants on Accounting and Financial Disclosure	94
Item 9A.	Controls and Procedures	94
Item 9B.	Other Information	95
Item 9C.	Disclosure Regarding Foreign Jurisdictions That Prevent Inspections	95

PART III
Item 10.	Directors, Executive Officers and Corporate Governance	96
Item 11.	Executive Compensation	96
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	96
Item 13.	Certain Relationships and Related Transactions, and Director Independence	96
Item 14.	Principal Accounting Fees and Services	96

PART IV
Item 15.	Exhibits, Financial Statement Schedules	97
Item 16.	Form 10-K Summary	99

	Year ended December 31,
	2021		2020
	(in thousands)
STK-001	$	18,778	$	11,055
STK-002		3,436		414
Non-program specific and unallocated research and development expenses		31,954		20,728
Total research and development expenses	$	54,168	$	32,197

	Year ended December 31,
	2021			2020
	(in thousands)
Consolidated statements of operations and
comprehensive loss:
Revenue	$	—		$	—
Operating expenses:
Research and development		54,168			32,197
General and administrative		31,897			20,847
Total operating expenses		86,065			53,044
Loss from operations		(86,065	)		(53,044	)
Other income (expense):
Interest income (expense), net		120			700
Other income (expense), net		140			101
Total other income (expense)		260			801
Net loss		(85,805	)		(52,243	)
Net loss per share—basic and diluted	$	(2.34	)	$	(1.56	)
Weighted average common shares outstanding—basic and diluted		36,739,269			33,488,456
Comprehensive loss:
Net loss	$	(85,805	)	$	(52,243	)
Other comprehensive loss:
Unrealized loss on marketable securities		(168	)		—
Total other comprehensive loss	$	(168	)	$	—
Comprehensive loss		(85,973	)		(52,243	)

	Payments Due by Period
	Total		Less Than 1 Year		1 to 3 Years		4 to 5 Years		More than 5 Years
	(in thousands)
Operating lease obligations	$	7,437	$	2,124	$	5,140	$	173	$	—
Total	$	7,437	$	2,124	$	5,140	$	173	$	—

	STOKE THERAPEUTICS, INC.

Date: March 10, 2022	By:	/s/ Edward M. Kaye, M.D.
		Edward M. Kaye, M.D.
		Chief Executive Officer

Name	Title	Date

/s/ Edward M. Kaye	Chief Executive Officer and Director	March 10, 2022
Edward M. Kaye, M.D.	(Principal Executive Officer)

/s/ Stephen J. Tulipano	Chief Financial Officer	March 10, 2022
Stephen J. Tulipano	(Principal Financial and Accounting Officer)

/s/ Julie A. Smith	Director	March 10, 2022
Julie A. Smith

/s/ Seth L. Harrison	Director	March 10, 2022
Seth L. Harrison, M.D.

/s/ Adrian R. Krainer	Director	March 10, 2022
Adrian R. Krainer, Ph.D.

/s/ Arthur A. Levin	Director	March 10, 2022
Arthur A. Levin, Ph.D.

/s/ Arthur O. Tzianabos	Director	March 10, 2022
Arthur O. Tzianabos, Ph.D.

/s/ Jennifer C. Burstein	Director	March 10, 2022
Jennifer C. Burstein

/s/ Garry E. Menzel	Director	March 10, 2022
Garry E. Menzel

	Page

Report of independent registered public accounting firm	102

Consolidated balance sheets	103

Consolidated statements of operations and comprehensive loss	104

Consolidated statements of stockholders’ equity	105

Consolidated statements of cash flows	106

Notes to consolidated financial statements	107

	As of December 31,
	2021			2020
Assets
Current assets:
Cash and cash equivalents	$	144,895		$	287,308
Marketable securities		74,915			—
Prepaid expenses and other current assets		9,159			6,435
Deferred financing costs		117			181
Interest receivable		132			6
Total current assets		229,218			293,930
Restricted cash		569			205
Operating lease right-of-use assets		4,939			1,115
Property and equipment, net		4,139			2,675
Total assets	$	238,865		$	297,925
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable	$	2,385		$	1,495
Accrued and other current liabilities		14,754			9,930
Total current liabilities		17,139			11,425
Long term liabilities		3,949			422
Total liabilities		21,088			11,847
Commitments and contingencies (Note 7)
Stockholders’ equity
Common stock, par value of $0.0001 per share; 300,000,000 shares authorized, 36,902,499 and 36,577,149 shares issued and outstanding as of December 31, 2021 and 2020, respectively		4			4
Additional paid-in capital		414,024			396,352
Accumulated other comprehensive loss		(168	)		—
Accumulated deficit		(196,083	)		(110,278	)
Total stockholders’ equity		217,777			286,078
Total liabilities and stockholders’ equity	$	238,865		$	297,925

	Year Ended December 31,
	2021			2020
Revenue	$	—		$	—
Operating expenses:
Research and development		54,168			32,197
General and administrative		31,897			20,847
Total operating expenses		86,065			53,044
Loss from operations		(86,065	)		(53,044	)
Other income (expense):
Interest income (expense), net		120			700
Other income (expense), net		140			101
Total other income (expense)		260			801
Net loss		(85,805	)		(52,243	)
Net loss per share—basic and diluted	$	(2.34	)	$	(1.56	)
Weighted average common shares outstanding—basic and diluted		36,739,269			33,488,456
Comprehensive loss:
Net loss	$	(85,805	)	$	(52,243	)
Other comprehensive loss:
Unrealized loss on marketable securities		(168	)		—
Total other comprehensive loss	$	(168	)	$	—
Comprehensive loss		(85,973	)		(52,243	)

	Common Stock				Additional paid-in			Accumulated Other Comprehensive			Accumulated
	Shares		Amount		capital			Gain (Loss)			deficit			Stockholders’ equity
Balance as of December 31, 2019		32,861,842		3	$	282,460			—		$	(58,035	)	$	224,428
Stock-based compensation		—		—		5,768			—			—			5,768
Issuance of common stock upon exercise of stock options		822,916		—		2,843			—			—			2,843
Issuance of common stock related to employee stock purchase plan		17,391		—		352			—			—			352
Issuance of common stock upon follow-on offering, net of underwriting discounts, commissions, and offering costs		2,875,000		1		104,929			—			—			104,930
Net loss		—		—		—			—			(52,243	)		(52,243	)
Balance as of December 31, 2020		36,577,149	$	4	$	396,352		$	-		$	(110,278	)	$	286,078
Unrealized loss on marketable securities		—		—		—			(168	)		—			(168	)
Stock-based compensation		—		—		16,450			—			—			16,450
Issuance of common stock upon exercise of stock options		304,857		—		777			—			—			777
Issuance of common stock related to employee stock purchase plan		20,493		—		509			—			—			509
Issuance of common stock upon follow-on offering, net of underwriting discounts, commissions, and offering costs		—		—		(64	)		—			—			(64	)
Net loss		—		—		—			—			(85,805	)		(85,805	)
Balance as of December 31, 2021		36,902,499	$	4	$	414,024		$	(168	)	$	(196,083	)	$	217,777

Property and equipment		Estimated useful life
Computer and office equipment		3-5 years
Laboratory equipment and Furniture and fixtures		5-7 years
Leasehold improvements		Lesser of estimated useful life or remaining lease term

	Fair value measurements as of December 31, 2021
	Level 1		Level 2		Level 3		Total
Cash equivalents:
Money market funds	$	144,897	$	—	$	—	$	144,897
Total	$	144,897	$	—	$	—	$	144,897

Marketable Securities:
Corporate bonds	$	—	$	17,524	$	—	$	17,524
Commercial paper	$	—	$	27,487	$	—	$	27,487
US Government debt securities	$	—	$	29,904	$	—	$	29,904
Total	$	—	$	74,915	$	—	$	74,915

	December 31, 2021
	Amortized Cost		Unrealized Gains		Unrealized Loss			Fair Value
Marketable securities:
Corporate bonds	$	17,598	$	—	$	(74	)	$	17,524
Commercial paper	$	27,487	$	—	$	—		$	27,487
US Government debt securities	$	29,998	$	—	$	(94	)	$	29,904
Total	$	75,083	$	—	$	(168	)	$	74,915

2022		2,124
2023		2,532
2024		2,608
2025		173
Total lease payments	$	7,437
Less imputed interest		(462	)
Present value of lease liabilities	$	6,975

Weighted average remaining lease term in years			3.1
Weighted average discount rate			4.14	%

	Number of shares			Weighted average exercise price		Weighted average remaining contractual life (years)		Aggregate intrinsic value⁽¹⁾
Outstanding as of December 31, 2020		4,454,422		$	8.80		8.0	$	236,685
Granted		1,311,897			53.93
Exercised		(287,566	)		2.70
Forfeited		(41,973	)		40.12
Expired		(1,476	)		28.73
Outstanding as of December 31, 2021		5,435,304		$	19.77		8.0	$	64,981
Exercisable as of December 31, 2021		3,103,635		$	9.74		6.9	$	52,003

	December 31,
	2021		2020
Outstanding options to purchase common stock		5,435,304		4,454,424