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    SEC Form SC 13G filed by Stoke Therapeutics Inc.

    11/14/24 4:24:49 PM ET
    $STOK
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $STOK alert in real time by email
    SC 13G 1 tm2426483d7_sc13g.htm SC 13G

     

     

     

    SCHEDULE 13G

     

    SECURITIES AND EXCHANGE COMMISSION
    WASHINGTON, DC 20549

     

    Under the Securities Exchange Act of 1934
    (Amendment No. )*

     

    Stoke Therapeutics, Inc.

    (Name of Issuer)

     

    Common Stock, $0.0001 par value per share 

    (Title of Class of Securities)

     

    86150R107

     

    (CUSIP Number)

     

    September 30, 2024

     
      (Date of Event which Requires Filing of this Statement)  

     

    Check the appropriate box to designate the rule pursuant to which this Schedule is filed:

     

    x Rule 13d-1(b)

     

    ¨  Rule 13d-1(c)

     

    ¨  Rule 13d-1(d)

     

    *The remainder of this cover page shall be filled out for a reporting person’s initial filing on this form with respect to the subject class of securities, and for any subsequent amendment containing information which would alter disclosures provided in a prior cover page.

     

    The information required on the remainder of this cover page shall not be deemed to be “filed” for the purpose of Section 18 of the Securities Exchange Act of 1934 (the “Act”) or otherwise subject to the liabilities of that section of the Act, but shall be subject to all other provisions of the Act (however, see the Notes).

     

     

     

     

     

     

    CUSIP No. 86150R107

     

    1  

    NAMES OF REPORTING PERSONS

     

    Baker Bros. Advisors LP  

    2   CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP (See Instructions)  (a) ¨     
     (b) ¨     
    3   SEC USE ONLY
     
    4  

    CITIZENSHIP OR PLACE OF ORGANIZATION

     

    Delaware  

    NUMBER OF
    SHARES
    BENEFICIALLY
    OWNED BY
    EACH
    REPORTING
    PERSON
    WITH
     
    5  

    SOLE VOTING POWER

     

    4,368,443

    6  

    SHARED VOTING POWER

     

    -0-  

    7  

    SOLE DISPOSITIVE POWER

     

    4,368,443

    8  

    SHARED DISPOSITIVE POWER

     

    -0-  

    9  

    AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON

     

    4,368,443

    10   CHECK BOX IF THE AGGREGATE AMOUNT IN ROW (9) EXCLUDES CERTAIN SHARES
    (See Instructions)
    ¨     
    11  

    PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW 9

     

    8.3% (1)

    12  

    TYPE OF REPORTING PERSON (See Instructions)

     

    IA, PN 

               

      (1) Based upon 52,647,799 shares of common stock (“Common Stock”) of Stoke Therapeutics, Inc. (the “Issuer”) outstanding as of July 31, 2024, as reported in the Issuer’s Form 10-Q filed with the Securities and Exchange Commission (“SEC”) on August 7, 2024.

     

    Page 1 of 11 Pages

     

     

    CUSIP No. 86150R107

     

    1  

    NAMES OF REPORTING PERSONS

     

    Baker Bros. Advisors (GP) LLC

    2   CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP (See Instructions)  (a) ¨     
     (b) ¨     
    3   SEC USE ONLY
     
    4  

    CITIZENSHIP OR PLACE OF ORGANIZATION

     

    Delaware  

    NUMBER OF
    SHARES
    BENEFICIALLY
    OWNED BY
    EACH
    REPORTING
    PERSON
    WITH
     
    5  

    SOLE VOTING POWER

     

    4,368,443

    6  

    SHARED VOTING POWER

     

    -0-  

    7  

    SOLE DISPOSITIVE POWER

     

    4,368,443

    8  

    SHARED DISPOSITIVE POWER

     

    -0-  

    9  

    AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON

     

    4,368,443

    10   CHECK BOX IF THE AGGREGATE AMOUNT IN ROW (9) EXCLUDES CERTAIN SHARES
    (See Instructions)
    ¨     
    11  

    PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW 9

     

    8.3% (1)

    12  

    TYPE OF REPORTING PERSON (See Instructions)

     

    HC, OO 

               

      (1) Based upon 52,647,799 shares of Common Stock outstanding as of July 31, 2024, as reported in the Issuer’s Form 10-Q filed with the SEC on August 7, 2024.

     

    Page 2 of 11 Pages

     

     

    CUSIP No. 86150R107

     

    1  

    NAMES OF REPORTING PERSONS

     

    Felix J. Baker

    2   CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP (See Instructions)  (a) ¨     
     (b) ¨     
    3   SEC USE ONLY
     
    4  

    CITIZENSHIP OR PLACE OF ORGANIZATION

     

    United States  

    NUMBER OF
    SHARES
    BENEFICIALLY
    OWNED BY
    EACH
    REPORTING
    PERSON
    WITH
     
    5  

    SOLE VOTING POWER

     

    4,368,443

    6  

    SHARED VOTING POWER

     

    -0-  

    7  

    SOLE DISPOSITIVE POWER

     

    4,368,443

    8  

    SHARED DISPOSITIVE POWER

     

    -0-  

    9  

    AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON

     

    4,368,443

    10   CHECK BOX IF THE AGGREGATE AMOUNT IN ROW (9) EXCLUDES CERTAIN SHARES
    (See Instructions)
    ¨     
    11  

    PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW 9

     

    8.3% (1)

    12  

    TYPE OF REPORTING PERSON (See Instructions)

     

    IN, HC 

               

      (1) Based upon 52,647,799 shares of Common Stock outstanding as of July 31, 2024, as reported in the Issuer’s Form 10-Q filed with the SEC on August 7, 2024.

     

    Page 3 of 11 Pages

     

     

    CUSIP No. 86150R107

     

    1  

    NAMES OF REPORTING PERSONS

     

    Julian C. Baker

    2   CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP (See Instructions)  (a) ¨     
     (b) ¨     
    3   SEC USE ONLY
     
    4  

    CITIZENSHIP OR PLACE OF ORGANIZATION

     

    United States  

    NUMBER OF
    SHARES
    BENEFICIALLY
    OWNED BY
    EACH
    REPORTING
    PERSON
    WITH
     
    5  

    SOLE VOTING POWER

     

    4,368,443

    6  

    SHARED VOTING POWER

     

    -0-  

    7  

    SOLE DISPOSITIVE POWER

     

    4,368,443

    8  

    SHARED DISPOSITIVE POWER

     

    -0-  

    9  

    AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON

     

    4,368,443

    10   CHECK BOX IF THE AGGREGATE AMOUNT IN ROW (9) EXCLUDES CERTAIN SHARES
    (See Instructions)
    ¨     
    11  

    PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW 9

     

    8.3% (1)

    12  

    TYPE OF REPORTING PERSON (See Instructions)

     

    IN, HC 

               

      (1) Based upon 52,647,799 shares of Common Stock outstanding as of July 31, 2024, as reported in the Issuer’s Form 10-Q filed with the SEC on August 7, 2024.

     

    Page 4 of 11 Pages

     

     

    Schedule 13G

     

    Item 1(a) Name of Issuer:

     

    Stoke Therapeutics, Inc. (the “Issuer”)

     

    Item 1(b) Address of Issuer’s Principal Executive Offices:

     

    45 Wiggins Avenue

     

    Bedford, Massachusetts 01730

     

    Item 2(a) Name of Person Filing:

     

    This Schedule 13G is being filed jointly by the Baker Bros. Advisors LP (the “Adviser”), Baker Bros. Advisors (GP) LLC (the “Adviser GP”), Felix J. Baker and Julian C. Baker (collectively, the “Reporting Persons”).

     

    Item 2(b) Address of Principal Business Office or, if None, Residence:

     

    The business address of each of the Reporting Persons is:

     

    c/o Baker Bros. Advisors LP

     

    860 Washington Street, 3rd Floor

     

    New York, NY 10014

     

    (212) 339-5690

     

    Item 2(c) Citizenship:

     

    The Adviser is a limited partnership organized under the laws of the State of Delaware. The Adviser GP is a limited liability company organized under the laws of the State of Delaware. The citizenship of each of Julian C. Baker and Felix J. Baker is the United States of America.

     

    Item 2(d) Title of Class of Securities:

     

    Common Stock, $0.0001 par value per share (“Common Stock”)

     

    Item 2(e) CUSIP Number:

     

    86150R107

     

    Page 5 of 11 Pages

     

     

    Item 3 If this statement is filed pursuant to §§240.13d-1(b) or (c), check whether the person filing is a:

     

      (a) ¨ Broker or dealer registered under Section 15 of the Exchange Act.
           
      (b) ¨ Bank as defined in section 3(a)(6) of the Exchange Act.
           
      (c) ¨ Insurance company as defined in section 3(a)(19) of the Exchange Act.
           
      (d) ¨ Investment company registered under section 8 of the Investment Company Act of 1940.
           
      (e) x An investment adviser in accordance with Rule 13d-1(b)(1)(ii)(E).
           
      (f) ¨  An employee benefit plan or endowment fund in accordance with Rule 13d-1(b)(1)(ii)(F).
           
      (g) x A parent holding company or control person in accordance with Rule 13d-1(b)(1)(ii)(G).
           
      (h) ¨ A savings association as defined in Section 3(b) of the Federal Deposit Insurance Act.
           
      (i) ¨ A church plan that is excluded from the definition of an investment company under section 3(c)(14) of the Investment Company Act of 1940.
           
      (j) ¨ Group, in accordance with Rule 13d-1(b)(1)(ii)(J).

     

    Item 4 Ownership:

     

    Items 5 through 9 and 11 of each of the cover pages to this Schedule 13G are incorporated herein by reference. Set forth below is the aggregate number of shares of Common Stock directly held by each of Baker Brothers Life Sciences, L.P. (“Life Sciences”) and 667, L.P. (“667”, and together with Life Sciences, the “Funds”) which may be deemed to be indirectly beneficially owned by the Reporting Persons, as well as Common Stock that may be acquired upon exercise of pre-funded warrants with no expiration date with an exercise price of $0.0001 per share of Common Stock (“Pre-funded Warrants”), subject to the limitations on exercise described below.

     

    The information set forth below is based on 52,647,799 shares of Common Stock outstanding as of July 31, 2024 as reported in the Issuer’s Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on August 7, 2024. Such percentage figures are calculated in accordance with Rule 13d-3 under the Securities Exchange Act of 1934, as amended.

     

    Page 6 of 11 Pages

     

     

    Name   Number of shares of
    Common
    Stock we own or have the
    right to acquire within 60
    days
        Percent of
    Class
    Outstanding
     
    667, L.P.     370,059       0.7 %
    Baker Brothers Life Sciences, L.P.     3,998,384       7.6 %
    Total     4,368,443       8.3 %

     

    The Pre-funded Warrants are only exercisable to the extent that after giving effect or immediately prior to such exercise the holders thereof, their affiliates and any person who are members of a Section 13(d) group with the holders or one of their affiliates would beneficially own in the aggregate, for purposes of Rule 13d-3 under the Exchange Act, no more than 4.99% of the outstanding Common Stock (the “Maximum Percentage”). By written notice to the Issuer, the Funds may from time to time increase or decrease the Maximum Percentage applicable to that Fund to any other percentage not in excess of 19.99%. Any such increase will not be effective until the 61st day after such notice is delivered to the Issuer.

     

    As a result of these restrictions, the number of shares of Common Stock that may be issued upon exercise of the Pre-funded Warrants by the above holders may change depending upon changes in the outstanding Common Stock. Due to such Maximum Percentage, the Funds cannot presently exercise any shares of Pre-funded Warrants.

     

    Pursuant to the management agreements, as amended, among the Adviser, the Funds and their respective general partners, the Funds’ respective general partners relinquished to the Adviser all discretion and authority with respect to the investment and voting power of the securities held by the Funds, and thus the Adviser has complete and unlimited discretion and authority with respect to the Funds’ investments and voting power over investments.

     

    The Adviser GP is the sole general partner of the Adviser. The Adviser GP, Felix J. Baker and Julian C. Baker as managing members of the Adviser GP, and the Adviser may be deemed to be beneficial owners of securities of the Issuer directly held by the Funds.

     

    Item 5 Ownership of Five Percent or Less of a Class:

     

    If this statement is being filed to report the fact that as of the date hereof the reporting person has ceased to be the beneficial owner of more than five percent of the class of securities, check the following [  ]. N/A

     

    Item 6 Ownership of More than Five Percent on Behalf of Another Person:

     

    N/A

     

    Item 7 Identification and Classification of the Subsidiary Which Acquired the Security Being Reported on by the Parent Holding Company or Control Person:

     

    The information in Item 4 is incorporated herein by reference.

     

    Page 7 of 11 Pages

     

     

    Item 8 Identification and Classification of Members of the Group:

     

    N/A

     

    Item 9 Notice of Dissolution of Group:

     

    N/A

     

    Item 10 Certification:

     

    By signing below I certify that, to the best of my knowledge and belief, the securities referred to above were acquired and are held in the ordinary course of business and were not acquired and are not held for the purpose of or with the effect of changing or influencing the control of the issuer of the securities and were not acquired and are not held in connection with or as a participant in any transaction having that purpose or effect.

     

    Page 8 of 11 Pages

     

     

    SIGNATURE

     

    After reasonable inquiry and to the best of my knowledge and belief, I certify that the information set forth in this statement is true, complete and correct.

     

    November 14, 2024

     

     

    BAKER BROS. ADVISORS LP

     

    By: Baker Bros. Advisors (GP) LLC, its general partner

         
      By: /s/ Scott L. Lessing
        Name: Scott L. Lessing
    Title: President
         
      BAKER BROS. ADVISORS (GP) LLC
         
      By: /s/ Scott L. Lessing
        Name: Scott L. Lessing
    Title: President
         
        /s/ Julian C. Baker
        Julian C. Baker
         
        /s/ Felix J. Baker
        Felix J. Baker

     

    Page 9 of 11 Pages

     

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      – Alignment achieved with U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for EMPEROR – – One-year study of zorevunersen will evaluate reductions in major motor seizure frequency as well as improvements in behavior and cognition in children and adolescents ages 2 to <18 years old – – FDA Breakthrough Therapy designation positions zorevunersen on efficient development path; Company plans to start Phase 3 in mid-2025 – – Webcast and conference call for analysts and investors at 8:00AM Eastern Time today – Stoke Therapeutics, Inc. (NASDAQ:STOK), a biotechnology company dedicated to restoring protein

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      $STOK
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Stoke Therapeutics to Host Webcast to Discuss Successful Global Regulatory Alignment for a Phase 3 Study of Zorevunersen as Potentially the First Disease Modifying Medicine for Dravet Syndrome

      Stoke Therapeutics, Inc. (NASDAQ:STOK), a biotechnology company dedicated to restoring protein expression by harnessing the body's potential with RNA medicine, today announced that its management team will host a webcast and conference call for investors and analysts to discuss successful alignment with global regulatory agencies related to a Phase 3 study of zorevunersen as potentially the first disease-modifying medicine for the treatment of Dravet syndrome. The webcast will be conducted Tuesday, January 7, 2025 at 8:00am Eastern Time and can be accessed from the Investors & News section of Stoke's website at https://investor.stoketherapeutics.com/. Research analysts who plan to join th

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      $STOK
      Biotechnology: Pharmaceutical Preparations
      Health Care