Form 8-K
8-K — Stoke Therapeutics, Inc.
Accession: 0001193125-26-145524
Filed: 2026-04-07
Period: 2026-04-03
CIK: 0001623526
SIC: 2834 (PHARMACEUTICAL PREPARATIONS)
Item: Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers
Item: Regulation FD Disclosure
Item: Financial Statements and Exhibits
Documents
8-K — d63742d8k.htm (Primary)
EX-99.1 (d63742dex991.htm)
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8-K
8-K (Primary)
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8-K
NASDAQ false 0001623526 0001623526 2026-04-03 2026-04-03
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): April 3, 2026
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 5.02
Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers
(d) On April 3, 2026, the Board of Directors (the “Board”) of Stoke Therapeutics, Inc. (“Stoke” or the “Company”), increased the size of the Board to ten (10) directors and, following the recommendation of the Nominating and Corporate Governance Committee of the Board, appointed G. Clare Kahn, Ph.D. to serve on the Board as a Class I director, effective immediately, to fill the vacancy created by the increase in Board size. Dr. Kahn shall hold office for a term expiring at the 2026 Annual Meeting of Stoke’s stockholders, which is the next stockholder meeting at which Class I directors will be elected. Dr. Kahn was also appointed to serve on the Nominating and Corporate Governance Committee of the Board and as the chairperson of the Research and Development Committee of the Board, effective as of the date of her appointment.
There is no arrangement or understanding between Dr. Kahn and any other persons pursuant to which Dr. Kahn was selected as a director. Dr. Kahn is not a party to and does not have any direct or indirect material interest in any transaction with Stoke required to be disclosed under Item 404(a) of Regulation S-K. The Board determined that Dr. Kahn qualifies as an independent director pursuant to the Securities Act of 1933, as amended, and the listing standards of the Nasdaq Stock Market, in each case as currently in effect. Dr. Kahn also entered into Stoke’s standard form of indemnity agreement for its directors and executive officers, which was filed as Exhibit 10.1 to Stoke’s S-1 Registration Statement, as filed with the U.S. Securities and Exchange Commission on June 7, 2019.
In connection with her appointment to the Board, and in accordance with the Company’s non-employee director compensation program (the “Director Compensation Program”), Dr. Kahn will receive an annual cash retainer of $45,000 for service on the Board. In addition, in accordance with the Company’s 2019 Equity Incentive Plan (the “Plan”), on the effective date of her appointment, Dr. Kahn was granted an initial stock option to purchase 30,782 shares of the Company’s common stock, which represents a target grant date fair value of approximately $724,000 as calculated in accordance with ASC 718, and will vest in twelve substantially equal quarterly installments on each quarterly anniversary of the date of grant.
Item 7.01
Regulation FD.
On April 7, 2026, the Company issued a press release regarding Dr. Kahn’s appointment, which is included as Exhibit 99.1 to this Form 8-K. The information in Exhibit 99.1 is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section. The information in Exhibit 99.1 shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended.
Item 9.01
Financial Statements and Exhibits.
(d) Exhibits.
Exhibit
Number
Description
99.1
Press release issued by Stoke Therapeutics, Inc. dated April 7, 2026
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: April 7, 2026
By:
/s/ Thomas Leggett
Thomas Leggett
Chief Financial Officer
EX-99.1
EX-99.1
Filename: d63742dex991.htm · Sequence: 2
EX-99.1
Exhibit 99.1
Stoke Therapeutics Appoints Clare Kahn, Ph.D., to its Board of Directors
BEDFORD, Mass., April 7, 2026 – Stoke Therapeutics, Inc. (Nasdaq: STOK) is a biotechnology company dedicated to restoring
protein expression by harnessing the body’s potential with RNA medicine and has a lead investigational medicine, zorevunersen, in development as a first-in-class
potential disease-modifying treatment for Dravet syndrome. Today, the Company announced the appointment of Clare Kahn, Ph.D., to its Board of Directors.
“Clare brings more than three decades of industry experience, and we are very pleased to welcome her to the Board at this pivotal time for Stoke,”
said Ian F. Smith, Chief Executive Officer and Director of Stoke Therapeutics. “Clare’s deep regulatory strategy and drug development expertise, particularly in rare genetic diseases, complements the strong capabilities of our leadership
team and Board. Her insights will have an immediate impact as we advance our Phase 3 study of zorevunersen and work to deliver the first potential disease-modifying medicine to people with Dravet syndrome.”
Dr. Kahn has a proven track record of leadership across medicine development, registration and lifecycle management. Most recently, Dr. Kahn served
as R&D Strategy Officer and Chief Regulatory and Preclinical Development Officer at X-VAX Technology Inc., and she previously held roles of increasing responsibility at Pfizer and GlaxoSmithKline.
Dr. Kahn sits on the Board of Directors for Solid Biosciences and has advised numerous early stage and established companies. She holds a Ph.D. in Biochemical Pharmacology from The Royal Postgraduate Medical School, London.
“Stoke has an opportunity to fundamentally change the course of Dravet syndrome with an investigational medicine that targets the underlying cause of
this devastating disease,” said Dr. Kahn. “I am thrilled to support the team as they progress this promising potential treatment that could make a profound difference in the lives of patients and their families.”
About Dravet Syndrome
Dravet syndrome is a severe
developmental and epileptic encephalopathy (DEE) characterized by recurrent seizures as well as significant cognitive and behavioral impairments. Most cases of Dravet are caused by mutations in one copy of the SCN1A gene, leading to insufficient
levels of NaV1.1 protein in neuronal cells in the brain. Even when treated with the best available anti-seizure medicines (ASMs), up to 57 percent of patients with Dravet syndrome do not achieve
≥50 percent reduction in seizure frequency. Complications of the disease often contribute to a poor quality of life for patients and their caregivers. Developmental and cognitive impairments often include intellectual disability,
developmental delays, movement and balance issues, language and speech disturbances, growth defects, sleep abnormalities, disruptions of the autonomic nervous system and mood disorders. Compared with the general epilepsy population, people living
with Dravet syndrome have a higher risk of sudden unexpected death in epilepsy, or SUDEP; up to 20 percent of children and adolescents with Dravet syndrome die before adulthood due to SUDEP, prolonged seizures,
seizure-related accidents or infections1. Dravet syndrome occurs globally and is not concentrated in a particular geographic area or ethnic group.
Currently, it is estimated that up to 38,000 people are living with Dravet syndrome in the U.S. (~16,000), UK, EU-4 and Japan2. There are no approved
disease-modifying therapies for people living with Dravet syndrome.
About Zorevunersen
Zorevunersen is an investigational antisense oligonucleotide that is designed to treat the underlying cause of Dravet syndrome by increasing functional NaV1.1
protein production in brain cells from the unaffected (wild-type) copy of the SCN1A gene. This highly differentiated mechanism of action aims to reduce seizure frequency beyond what has been achieved with anti-seizure medicines and to improve neurodevelopment, cognition and behavior. Zorevunersen has demonstrated the potential for disease modification and has been granted orphan drug designation by the FDA and the
EMA. The FDA has also granted zorevunersen rare pediatric disease designation and Breakthrough Therapy Designation for the treatment of Dravet syndrome with a confirmed mutation not associated with gain-of-function, in the SCN1A gene. Stoke has a strategic collaboration with Biogen (Nasdaq: BIIB) to develop and commercialize zorevunersen for Dravet syndrome. Under the collaboration, Stoke retains
exclusive rights for zorevunersen in the United States, Canada, and Mexico; Biogen receives exclusive rest of world commercialization rights.
About Stoke Therapeutics
Stoke
Therapeutics (Nasdaq: STOK), is a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine. Using Stoke’s proprietary TANGO (Targeted Augmentation of Nuclear Gene Output)
approach, Stoke is developing antisense oligonucleotides (ASOs) to selectively restore naturally-occurring protein levels. Stoke’s first medicine in development, zorevunersen, has demonstrated the potential for disease modification in patients
with Dravet syndrome and is currently being evaluated in a Phase 3 study. Stoke’s initial focus are diseases of the central nervous system and the eye that are caused by a loss of ~50% of normal protein levels (haploinsufficiency). Proof of
concept has been demonstrated in other organs, tissues, and systems, supporting broad potential for Stoke’s proprietary approach. Stoke is headquartered in Bedford, Massachusetts. For more information,
visit https://www.stoketherapeutics.com/.
Stoke Therapeutics Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation
Reform Act of 1995, including, but not limited to: the ability of zorevunersen to treat the underlying causes of Dravet syndrome and reduce seizures or show improvements in behavior and cognition at the indicated dosing levels or at all; the
potential benefits, safety and efficacy of zorevunersen; the timing and expected progress of clinical trials, data readouts, regulatory meetings, regulatory decisions and other presentations. Statements including words such as “plan,”
“anticipate”, “potential,” “will,” “continue,” “may”, “expect,” or similar words 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 Stoke’s results to differ materially from those expressed or implied by such forward-looking
statements, including, but not limited to, risks and uncertainties related to: Stokes ability to advance, obtain regulatory approval and ultimately commercialize its product candidates; that if collaborators were to breach or terminate their
agreements, Stoke would not obtain the anticipated financial or other benefits; the possibility that Stoke and Biogen may not be successful in their development of zorevunersen and that, even if successful, they may be unable to successfully
commercialize zorevunersen; 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; Stoke’s ability to protect its
intellectual property; Stoke’s ability to fund development activities and achieve development goals into 2028; and the other risks and uncertainties described under the heading “Risk
Factors” in its Annual Report on Form 10-K for the year ended December 31, 2025, its quarterly reports on Form 10-Q, and the other documents it files with the
Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and Stoke undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the
date hereof.
References:
1.
Symonds, J. et al. Early childhood epilepsies: epidemiology, classification, aetiology, and socio-economic
determinants. Brain. 2021;144(9):2879-2891.
2.
Based on Stoke Therapeutics’ preliminary estimates, which scaled annual incidence to prevalence using
country-specific live birth rates over the past 85 years and adjusted for Dravet-specific mortality. The estimate is based on incidence rates published by Wu et al., Pediatrics, 2015.
Stoke Media & Investor Contacts:
Susan Willson
Vice President, Corporate Communications
swillson@stoketherapeutics.com
415-509-8202
Doug Snow
Director, Communications & Investor Relations
IR@stoketherapeutics.com
508-642-6485
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