0000950170-24-035908.txt : 20240325 0000950170-24-035908.hdr.sgml : 20240325 20240325160320 ACCESSION NUMBER: 0000950170-24-035908 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 12 CONFORMED PERIOD OF REPORT: 20240325 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20240325 DATE AS OF CHANGE: 20240325 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Stoke Therapeutics, Inc. CENTRAL INDEX KEY: 0001623526 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] ORGANIZATION NAME: 03 Life Sciences IRS NUMBER: 471144582 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-38938 FILM NUMBER: 24779171 BUSINESS ADDRESS: STREET 1: 45 WIGGINS AVENUE CITY: BEDFORD STATE: MA ZIP: 01730 BUSINESS PHONE: 781-430-8200 MAIL ADDRESS: STREET 1: 45 WIGGINS AVENUE CITY: BEDFORD STATE: MA ZIP: 01730 FORMER COMPANY: FORMER CONFORMED NAME: ASOthera Pharmaceuticals, Inc. DATE OF NAME CHANGE: 20141028 8-K 1 stok-20240325.htm 8-K 8-K
0001623526false00016235262024-03-252024-03-25

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): March 25, 2024

 

 

Stoke Therapeutics, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-38938

47-1144582

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

45 Wiggins Ave

 

Bedford, Massachusetts

 

01730

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (781) 430-8200

 

 

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common Stock, $0.0001 par value per share

 

STOK

 

Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

Item 2.02 Results of Operations and Financial Condition.

On March 25, 2024, Stoke Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the year ended December 31, 2023. A copy of the press release is attached as Exhibit 99.1 to this report.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit

Number

Description

99.1

Press release issued by Stoke Therapeutics, Inc. regarding its full year 2023 financial results, dated March 25, 2024

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

STOKE THERAPEUTICS, INC.

 

 

 

 

Date:

March 25, 2024

By:

/s/ Stephen J. Tulipano

 

 

 

Stephen J. Tulipano
Chief Financial Officer

 

 EX-99.1 2 stok-ex99_1.htm EX-99.1 EX-99.1

 

 

EX 99.1

Stoke Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results

– As of December 31, 2023, Company had $201.4 million in cash, cash equivalents, and marketable securities, anticipated to fund operations to the end of 2025 –

BEDFORD, Mass., March 25, 2024 – Stoke Therapeutics, Inc. (Nasdaq: STOK), a biotechnology company dedicated to addressing the underlying cause of severe diseases by upregulating protein expression with RNA-based medicines, today reported financial results for the full year ended December 31, 2023.

Year End 2023 Financial Results

•
As of December 31, 2023, Stoke had $201.4 million in cash, cash equivalents, and marketable securities, which is anticipated to fund operations to the end of 2025.
•
Revenue recognized for upfront license fees and services provided from a License and Collaboration Agreement with Acadia Pharmaceuticals for the year ended December 31, 2023 was $8.8 million, compared to $12.4 million, for the year ended December 31, 2022.
•
Net loss for the year ended December 31, 2023 was $104.7 million, or $2.38 per share compared to $101.1 million, or $2.60 per share for 2022.
•
Research and development expenses for the year ended December 31, 2023 were $82.2 million, compared to $77.8 million for 2022.
•
General and administrative expenses for the year ended December 31, 2023 were $41.3 million, compared to $38.9 million for 2022.
•
The increase in expenses for the year ended December 31, 2023 as compared to the same period in 2022 primarily relate to increases in costs associated with personnel, third party contracts, consulting, facilities and other costs associated with development activities for STK-001 and STK-002, research on additional therapeutics and growing a public corporation.

Fourth Quarter 2023 Financial Results

•
Revenue recognized for upfront license fees and services provided from a License and Collaboration Agreement with Acadia Pharmaceuticals for the three months ended December 31, 2023 was $2.8 million, compared to $3.3 million, for the same period in 2022.
•
Net loss for the three months ended December 31, 2023 was $27.0 million, or $0.60 per share, compared to $25.7 million, or $0.65 per share, for the same period in 2022.
•
Research and development expenses for the three months ended December 31, 2023 were $21.8 million, compared to $21.1 million for the same period in 2022.

 

•
General and administrative expenses for the three months ended December 31, 2023 were $10.6 million, compared to $9.4 million for the same period in 2022.
•
The increase in expenses for the three months ended December 31, 2023 as compared to the same period in 2022 primarily relate to increases in costs associated with personnel, third party contracts, consulting, facilities and other costs associated with development activities for STK-001 and STK-002, research on additional therapeutics and growing a public corporation.

About Stoke Therapeutics

Stoke Therapeutics (Nasdaq: STOK), is a biotechnology company dedicated to addressing the underlying cause of severe diseases by upregulating protein expression with RNA-based medicines. Using Stoke’s proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) approach, Stoke is developing antisense oligonucleotides (ASOs) to selectively restore protein levels. Stoke’s first compound, STK-001, is in clinical testing for the treatment of Dravet syndrome, a severe and progressive genetic epilepsy. Dravet syndrome is one of many diseases caused by a haploinsufficiency, in which a loss of ~50% of normal protein levels leads to disease. Stoke is pursuing the development of STK-002 for the treatment of autosomal dominant optic atrophy (ADOA), the most common inherited optic nerve disorder. Stoke’s initial focus is haploinsufficiencies and diseases of the central nervous system and the eye, although proof of concept has been demonstrated in other organs, tissues, and systems, supporting its belief in the broad potential for its proprietary approach. Stoke is headquartered in Bedford, Massachusetts with offices in Cambridge, Massachusetts. For more information, visit https://www.stoketherapeutics.com/.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provision of the Private Securities Litigation Reform Act of 1995, including, but not limited to, the Company’s cash runway. Statements including words such as “anticipate,” “plan,” “will,” “continue,” “expect,” or “ongoing” and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they prove incorrect or do not fully materialize, could cause our results to differ materially from those expressed or implied by such forward-looking statements, including, but not limited to, risk and uncertainties related to: the Company’s ability to advance, obtain regulatory approval of, and ultimately commercialize its product candidates; the timing of data readouts and interim and final results of preclinical and clinical trials; positive results in a clinical trial may not be replicated in subsequent trials or successes in early stage clinical trials may not be predictive of results in later stage trials; preliminary interim data readouts of ongoing trials may show results that change when such trials are completed; the Company’s ability to fund development activities and achieve development goals into 2025; the Company’s ability to protect its intellectual property; the direct or indirect impact of global business, political and macroeconomic conditions, including inflation, interest rate volatility, cybersecurity events, uncertainty with respect to the federal budget, instability in the global banking system and

 

volatile market conditions, and global events, including public health crises, and ongoing geopolitical conflicts, such as the conflicts in Ukraine and the Middle East; and other risks and uncertainties described under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, its quarterly reports on Form 10-Q, and the other documents the Company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the Company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.

 

Financial Tables Follow

 

 

 

Stoke Therapeutics, Inc. and subsidiary

Consolidated balance sheets

(in thousands, except share and per share amounts)

 

 

 

 

As of December 31,

 

 

 

2023

 

 

2022

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

191,442

 

 

$

113,556

 

Marketable securities

 

 

9,952

 

 

 

116,039

 

Prepaid expenses

 

 

11,320

 

 

 

10,932

 

Other current assets

 

 

2,561

 

 

 

2,955

 

Interest receivable

 

 

64

 

 

 

588

 

Total current assets

 

$

215,339

 

 

$

244,070

 

Restricted cash

 

 

569

 

 

 

569

 

Operating lease right-of-use assets

 

 

6,611

 

 

 

4,753

 

Property and equipment, net

 

 

5,823

 

 

 

6,675

 

Total assets

 

$

228,342

 

 

$

256,067

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

1,695

 

 

$

766

 

Accrued and other current liabilities

 

 

13,815

 

 

 

15,748

 

Deferred revenue - current portion

 

 

15,309

 

 

 

14,880

 

Total current liabilities

 

$

30,819

 

 

$

31,394

 

Deferred revenue - net of current portion

 

 

33,074

 

 

 

36,856

 

Other long term liabilities

 

 

4,884

 

 

 

2,968

 

Total long term liabilities

 

$

37,958

 

 

$

39,824

 

Total liabilities

 

$

68,777

 

 

$

71,218

 

Stockholders’ equity

 

 

 

 

 

 

Common stock, par value of $0.0001 per share; 300,000,000 shares authorized, 45,918,233 and 39,439,575 shares issued and outstanding as of December 31, 2023 and 2022, respectively

 

 

5

 

 

 

4

 

Additional paid-in capital

 

 

561,433

 

 

 

483,170

 

Accumulated other comprehensive loss

 

 

(24

)

 

 

(1,175

)

Accumulated deficit

 

 

(401,849

)

 

 

(297,150

)

Total stockholders’ equity

 

$

159,565

 

 

$

184,849

 

Total liabilities and stockholders’ equity

 

$

228,342

 

 

$

256,067

 

 

 

 

Stoke Therapeutics, Inc. and subsidiary

Consolidated statements of operations and comprehensive loss

(in thousands, except share and per share amounts)

 

 

 

Three months ended
December 31,
(unaudited)

 

 

Year Ended
December 31,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Revenue

 

$

2,801

 

 

$

3,269

 

 

$

8,780

 

 

$

12,405

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

21,778

 

 

 

21,061

 

 

 

82,231

 

 

 

77,837

 

General and administrative

 

 

10,610

 

 

 

9,383

 

 

 

41,322

 

 

 

38,924

 

Total operating expenses

 

 

32,388

 

 

 

30,444

 

 

 

123,553

 

 

 

116,761

 

Loss from operations

 

 

(29,587

)

 

 

(27,175

)

 

 

(114,773

)

 

 

(104,356

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

Interest income (expense), net

 

 

2,587

 

 

 

1,479

 

 

 

9,908

 

 

 

3,122

 

Other income (expense), net

 

 

42

 

 

 

41

 

 

 

166

 

 

 

167

 

Total other income (expense)

 

 

2,629

 

 

 

1,520

 

 

 

10,074

 

 

 

3,289

 

Net loss

 

$

(26,958

)

 

$

(25,655

)

 

$

(104,699

)

 

$

(101,067

)

Net loss per share—basic and diluted

 

$

(0.60

)

 

$

(0.65

)

 

$

(2.38

)

 

$

(2.60

)

Weighted average common shares outstanding—basic and diluted

 

 

44,958,894

 

 

 

39,434,027

 

 

 

43,994,862

 

 

 

38,897,442

 

Comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(26,958

)

 

$

(25,655

)

 

$

(104,699

)

 

$

(101,067

)

Other comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain (loss) on marketable securities

 

 

122

 

 

 

528

 

 

 

1,151

 

 

 

(1,007

)

Total other comprehensive gain (loss)

 

$

122

 

 

$

528

 

 

$

1,151

 

 

$

(1,007

)

Comprehensive loss

 

$

(26,836

)

 

$

(25,127

)

 

$

(103,548

)

 

$

(102,074

)

 

 

 

Stoke Media & Investor Contacts:

Dawn Kalmar

Chief Communications Officer

dkalmar@stoketherapeutics.com

781-303-8302

 

Eric Rojas

Vice President, Investor Relations

IR@stoketherapeutics.com

617-312-2754

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