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    Amendment: SEC Form SC 13G/A filed by REGENXBIO Inc.

    11/14/24 9:00:57 PM ET
    $RGNX
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care
    Get the next $RGNX alert in real time by email
    SC 13G/A 1 tm2427858d8_sc13ga.htm SC 13G/A

     

     

    UNITED STATES 

    SECURITIES AND EXCHANGE COMMISSION 

    Washington, D.C. 20549

     

    SCHEDULE 13G

     

    Under the Securities Exchange Act of 1934 

    (Amendment No. 2)

     

    REGENXBIO Inc. 

    (Name of Issuer)

     

    Common Stock, par value $0.0001 per share 

    (Title of Class of Securities)

     

    75901B107

    (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:

     

      ¨ Rule 13d-1(b)

     

      x 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 the disclosures provided in a prior cover page.

     

    The information required in 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 (“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. 75901B107

    1

    Name of Reporting Person

     

    Redmile Group, 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

     

    0

    6

    Shared Voting Power

     

    4,942,312 (1)

     

    7

    Sole Dispositive Power

     

    0

    8

    Shared Dispositive Power

     

    4,942,312 (1)

     

    9

    Aggregate Amount Beneficially Owned by Each Reporting Person

     

    4,942,312 (1)

     

    10

    Check if the Aggregate Amount in Row (9) Excludes Certain Shares (See Instructions)

     

     ¨

    11

     Percent of Class Represented by Amount in Row (9)

     

    9.9% (2)

     

    12

    Type of Reporting Person (See Instructions)

     

    IA, OO

           

     

    (1) Redmile Group, LLC’s (“Redmile”) beneficial ownership of the Issuer’s common stock (“Common Stock”) is comprised of 4,892,902 shares of Common Stock owned by certain private investment vehicles and/or sub-advised accounts managed by Redmile, including Redmile Biopharma Investments III, L.P. (“RBI III”). Subject to the Beneficial Ownership Blocker (as defined below), Redmile may also be deemed to beneficially own 1,324,740 shares of Common Stock issuable upon exercise of certain pre-funded warrants to purchase Common Stock (the “Warrants”). Pursuant to the terms of the Warrants, the Issuer may not effect any exercise of the Warrant, and a holder of a Warrant does not have the right to exercise the Warrant held by such holder, to the extent that after giving effect to such issuance after exercise, the holder (together with the holder’s affiliates, and any other persons acting as a group together with the holder or any of the holder’s affiliates), would beneficially own in excess of 9.99% (the “Beneficial Ownership Limitation”) of the number of shares of Common Stock outstanding immediately after giving effect to the issuance of shares of Common Stock issued upon exercise of the Warrant (the “Beneficial Ownership Blocker”). The Beneficial Ownership Limitation may be changed at a holder’s election upon 61 days’ notice to the Issuer. The 4,942,312 shares of Common Stock reported as beneficially owned by Redmile in this Schedule 13G represent 9.99% of the outstanding shares of Common Stock (calculated in accordance with footnote (2) below). The reported securities may be deemed beneficially owned by Redmile as investment manager of such private investment vehicles and/or sub-advised accounts. The reported securities may also be deemed beneficially owned by Jeremy C. Green as the principal of Redmile. Redmile and Mr. Green each disclaim beneficial ownership of these shares, except to the extent of its or his pecuniary interest in such shares, if any.

    (2) Percentage based on the sum of (a) 49,423,188 shares of Common Stock outstanding as of July 25, 2024, as reported by the Issuer in its Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2024 filed with the Securities and Exchange Commission on August 1, 2024 (the “Form 10-Q”), plus (b) 49,410 shares of Common Stock issuable upon exercise of the Warrants, which due to the Beneficial Ownership Limitation is the maximum number of shares that could be issued upon exercise of the Warrants. 

     

     

     

     

    CUSIP No. 75901B107

    1

    Name of Reporting Person

     

    Jeremy C. Green

    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 Kingdom

     

     

     

     

    number of
    shares
    beneficially
    owned by
    each
    reporting
    person with

     

     

    5

    Sole Voting Power

     

    0

    6

    Shared Voting Power

     

    4,942,312 (3)

     

    7

    Sole Dispositive Power

     

    0

    8

    Shared Dispositive Power

     

    4,942,312 (3)

     

    9

    Aggregate Amount Beneficially Owned by Each Reporting Person

     

    4,942,312 (3)

    10

    Check if the Aggregate Amount in Row (9) Excludes Certain Shares (See Instructions)

     

     ¨

    11

    Percent of Class Represented by Amount in Row (9)

     

    9.9% (4)

    12

    Type of Reporting Person (See Instructions)

     

    IN, HC

           

     

    (3) Jeremy C. Green’s beneficial ownership of Common Stock is comprised of 4,892,902 shares of Common Stock owned by certain private investment vehicles and/or sub-advised accounts managed by Redmile, including RBI III. Subject to the Beneficial Ownership Blocker, Mr. Green may also be deemed to beneficially own 1,324,740 shares of Common Stock issuable upon exercise of the Warrants. Pursuant to the terms of the Warrants, the Issuer may not effect any exercise of the Warrant, and a holder of a Warrant does not have the right to exercise the Warrant held by such holder, to the extent that the Beneficial Ownership Blocker applies. The 4,942,312 shares of Common Stock reported as beneficially owned by Mr. Green in this Schedule 13G represent 9.99% of the outstanding shares of Common Stock (calculated in accordance with footnote (4) below). The reported securities may be deemed beneficially owned by Redmile as investment manager of such private investment vehicles and/or sub-advised accounts. The reported securities may also be deemed beneficially owned by Jeremy C. Green as the principal of Redmile. Redmile and Mr. Green each disclaim beneficial ownership of these shares, except to the extent of its or his pecuniary interest in such shares, if any.

    (4) Percentage based on the sum of (a) 49,423,188 shares of Common Stock outstanding as of July 25, 2024, as reported in the Form 10-Q, plus (b) 49,410 shares of Common Stock issuable upon exercise of the Warrants, which due to the Beneficial Ownership Limitation is the maximum number of shares that could be issued upon exercise of the Warrants.

     

     

     

     

    CUSIP No. 75901B107

    1

    Name of Reporting Person

     

    Redmile Biopharma Investments III, L.P.

    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

     

    0

    6

    Shared Voting Power

     

    3,007,807 (5)

     

    7

    Sole Dispositive Power

     

    0

    8

    Shared Dispositive Power

     

    3,007,807 (5)

     

    9

    Aggregate Amount Beneficially Owned by Each Reporting Person

     

    3,007,807 (5)

    10

    Check if the Aggregate Amount in Row (9) Excludes Certain Shares (See Instructions)

     

    ¨ 

    11

    Percent of Class Represented by Amount in Row (9)

     

    6.1% (6)

    12

    Type of Reporting Person (See Instructions)

     

    PN

           

     

    (5) RBI III’s beneficial ownership of Common Stock is comprised of 2,958,397 shares of Common Stock. Subject to the Beneficial Ownership Blocker, RBI III may also be deemed to beneficially own 869,603 shares of Common Stock issuable upon exercise of the Warrants directly held by RBI III. Pursuant to the terms of the Warrants, the Issuer may not effect any exercise of any Warrant, and a holder of a Warrant does not have the right to exercise any portion of the Warrant held by such holder, if the Beneficial Ownership Blocker applies. The shares of Common Stock reported as beneficially owned by RBI III in this Schedule 13G represent the shares of Common Stock held directly by RBI III and the 49,410 shares of Common Stock that could be issued to RBI III upon exercise of certain of the Warrants directly held by RBI III under the Beneficial Ownership Blocker.

    (6) Percentage based on the sum of (a) 49,423,188 shares of Common Stock outstanding as of July 25, 2024, as reported in the Form 10-Q, plus (b) 49,410 shares of Common Stock issuable upon exercise of the Warrants directly held by RBI III, which due to the Beneficial Ownership Limitation is the maximum number of shares that could be issued upon exercise of the Warrants. 

     

     

     

     

    Item 1.

     

      (a) Name of Issuer

     

    REGENXBIO Inc.

     

      (b) Address of Issuer’s Principal Executive Offices

     

    9804 Medical Center Drive 

    Rockville, MD 20850

     

    Item 2.

     

      (a) Names of Persons Filing

     

    Redmile Group, LLC
    Jeremy C. Green 

    Redmile Biopharma Investments III, L.P.

     

      (b) Address of Principal Business office or, if None, Residence

     

    Redmile Group, LLC

    One Letterman Drive
    Building D, Suite D3-300
    The Presidio of San Francisco
    San Francisco, California 94129

     

    Jeremy C. Green
    c/o Redmile Group, LLC (NY Office)
    45 W. 27th Street, Floor 11
    New York, NY 10001

     

    Redmile Biopharma Investments III, L.P. 

    c/o Redmile Group, LLC
    One Letterman Drive
    Building D, Suite D3-300
    The Presidio of San Francisco
    San Francisco, California 94129

     

      (c) Citizenship

     

    Redmile Group, LLC: Delaware
    Jeremy C. Green: United Kingdom 

    Redmile Biopharma Investments III, L.P.: Delaware

     

      (d) Title of Class of Securities

     

    Common Stock, par value $0.0001 per share

     

      (e) CUSIP Number

     

    75901B107

     

     

     

     

    Item 3. If this statement is filed pursuant to §§ 240.13d-1(b) or 240.13d-2(b) or (c), check whether the person filing is a:

     

      (a) ¨ Broker or dealer registered under section 15 of the Act (15 U.S.C. 78o);

     

      (b) ¨ Bank as defined in section 3(a)(6) of the Act (15 U.S.C. 78c);

     

      (c) ¨ Insurance company as defined in section 3(a)(19) of the Act (15 U.S.C. 78c);

     

      (d) ¨ Investment company registered under section 8 of the Investment Company Act of 1940 (15 U.S.C 80a-8);

     

      (e) ¨ An investment adviser in accordance with § 240.13d-1(b)(1)(ii)(E);

     

      (f) ¨ An employee benefit plan or endowment fund in accordance with § 240.13d-1(b)(1)(ii)(F);

     

      (g) ¨ A parent holding company or control person in accordance with § 240.13d-1(b)(1)(ii)(G);

     

      (h) ¨ A savings associations as defined in Section 3(b) of the Federal Deposit Insurance Act (12 U.S.C. 1813);

     

      (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 (15 U.S.C. 80a-3);

     

      (j) ¨ A non-U.S. institution in accordance with § 240.13d-1(b)(1)(ii)(J);

     

      (k) ¨ Group, in accordance with § 240.13d-1(b)(1)(ii)(K). If filing as a non-U.S. institution in accordance with § 240.13d-1(b)(1)(ii)(J), please specify the type of institution: __________

     

    Item 4. Ownership.

     

      (a) Amount beneficially owned:

     

    Redmile Group, LLC – 4,942,312 (1)
    Jeremy C. Green – 4,942,312 (1)

    Redmile Biopharma Investments III, L.P. – 3,007,807 (2)

     

      (b) Percent of class:

     

    Redmile Group, LLC – 9.9% (3)
    Jeremy C. Green – 9.9% (3)

    Redmile Biopharma Investments III, L.P. – 6.1% (3)

     

      (c) Number of shares as to which Redmile Group, LLC has:

     

      (i) Sole power to vote or to direct the vote:

     

    0

     

      (ii) Shared power to vote or to direct the vote:

     

    4,942,312 (1)

     

      (iii) Sole power to dispose or to direct the disposition of:

     

    0

     

      (iv) Shared power to dispose or to direct the disposition of:

     

    4,942,312 (1)

     

    Number of shares as to which Jeremy C. Green has:

     

      (i) Sole power to vote or to direct the vote:

     

    0

     

      (ii) Shared power to vote or to direct the vote:

     

    4,942,312 (1)

     

      (iii) Sole power to dispose or to direct the disposition of:

     

    0

     

     

     

     

      (iv) Shared power to dispose or to direct the disposition of:

     

    4,942,312 (1)

     

    Number of shares as to which Redmile Biopharma Investments III, L.P. has:

     

      (i) Sole power to vote or to direct the vote:

     

    0

     

      (ii) Shared power to vote or to direct the vote:

     

    3,007,807 (2)

     

      (iii) Sole power to dispose or to direct the disposition of:

     

    0

     

      (iv) Shared power to dispose or to direct the disposition of:

     

    3,007,807 (2)

     

      (1) Redmile’s and Jeremy C. Green’s beneficial ownership of the Issuer’s Common Stock is comprised of 4,892,902 shares of Common Stock owned by certain private investment vehicles and/or sub-advised accounts managed by Redmile, including RBI III.  Subject to the Beneficial Ownership Blocker, Redmile and Mr. Green may also be deemed to beneficially own 1,324,740 shares of Common Stock issuable upon exercise of the Warrants. Pursuant to the terms of the Warrants, the Issuer may not effect any exercise of any Warrant, and a holder of a Warrant does not have the right to exercise any portion of the Warrant held by such holder, if the Beneficial Ownership Blocker applies.  The 4,942,312 shares of Common Stock reported as beneficially owned by Redmile and Mr. Green in this Schedule 13G represent 9.99% of the outstanding shares of Common Stock (calculated in accordance with footnote (3) below).  The reported securities may be deemed beneficially owned by Redmile as investment manager of such private investment vehicles and/or sub-advised accounts. The reported securities may also be deemed beneficially owned by Jeremy C. Green as the principal of Redmile. Redmile and Mr. Green each disclaim beneficial ownership of these shares, except to the extent of its or his pecuniary interest in such shares, if any.

     

      (2) RBI III’s beneficial ownership of Common Stock is comprised of 2,958,397 shares of Common Stock. Subject to the Beneficial Ownership Blocker, RBI III may also be deemed to beneficially own 869,603 shares of Common Stock issuable upon exercise of the Warrants directly held by RBI III. Pursuant to the terms of the Warrants, the Issuer may not effect any exercise of any Warrant, and a holder of a Warrant does not have the right to exercise any portion of the Warrant held by such holder, if the Beneficial Ownership Blocker applies. The shares of Common Stock reported as beneficially owned by RBI III in this Schedule 13G represent the shares of Common Stock held directly by RBI III and the 49,410 shares of Common Stock that could be issued to RBI III upon exercise of certain of the Warrants directly held by RBI III under the Beneficial Ownership Blocker.

     

      (3) Percentage based on the sum of (i) 49,423,188 shares of Common Stock outstanding as of July 25, 2024, as reported by the Issuer in its Form 10-Q, plus (ii) 49,410 shares of Common Stock issuable upon exercise of certain of the Warrants, which due to the Beneficial Ownership Limitation is the maximum number of shares that could be issued upon exercise of the Warrants.

     

    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 5 percent of the class of securities, check the following ¨

     

      

    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.

     

    See the response to Item 4.

     

     

     

     

    Item 8. Identification and Classification of Members of the Group.

     

    N/A.

     

    Item 9. Notice of Dissolution of Group.

     

    N/A.

     

    Item 10. Certifications.

     

    By signing below I certify that, to the best of my knowledge and belief, the securities referred to above 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, other than activities solely in connection with a nomination under § 240.14a-11.

     

     

     

     

    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.

     

    Date: November 14, 2024

     

      Redmile Group, LLC

     

      By: /s/ Jeremy C. Green

     

        Name: Jeremy C. Green
        Title: Managing Member
         
        /s/ Jeremy C. Green
        Jeremy C. Green

                

      Redmile Biopharma Investments III, L.P. 

      By: Redmile Biopharma Investments III (GP), LLC, its general partner
         
      By: /s/ Jeremy C. Green
        Name: Jeremy C. Green
        Title: Managing Member

     

     

     

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    NEW YORK, Dec. 6, 2024 /PRNewswire/ -- S&P Dow Jones Indices ("S&P DJI") will make the following changes to the S&P 500, S&P MidCap 400, and S&P SmallCap 600 indices effective prior to the open of trading on Monday, December 23, to coincide with the quarterly rebalance. The changes ensure each index is more representative of its market capitalization range. All companies being added to the S&P 500 are more representative of the large-cap market space, all companies being added to the S&P MidCap 400 are more representative of the mid-cap market space, and all companies being added to the S&P SmallCap 600 are more representative of the small-cap market space. The companies being removed from t

    12/6/24 6:29:00 PM ET
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    $APO
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    REGENXBIO Appoints Mitchell Chan as Chief Financial Officer

    Life sciences veteran Mitchell Chan joins the company ahead of multiple catalysts across late-stage gene therapy programsVit Vasista steps down following more than 15 years at the CompanyROCKVILLE, Md., Sept. 17, 2024 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced that Mitchell Chan has been appointed as Executive Vice President and Chief Financial Officer, effective today. A veteran finance executive and operating partner in the biotechnology industry, Mr. Chan has held key roles in raising capital, business development transactions and operations for nearly 20 years.  "We are excited to welcome Mitchell at this exciting time for REGENXBIO," said Curran Simpson, President and

    9/17/24 7:05:00 AM ET
    $RGNX
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    REGENXBIO Announces Leadership Transition

    Curran Simpson, Chief Operating Officer, Appointed as President and CEOCo-Founder Kenneth T. Mills to Step Down as President and CEO; Named Chairman of the Board ROCKVILLE, Md., June 12, 2024 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced that Curran Simpson, Chief Operating Officer, has been appointed as President, Chief Executive Officer and a member of the Board of Directors, effective July 1, 2024. Co-Founder Kenneth T. Mills will step down as President and Chief Executive Officer following 15 years of leadership at the Company, and he is taking on an expanded role on the Board as Chairman. In connection with these changes, Board member Daniel Tassé has been appointed as RE

    6/12/24 7:05:00 AM ET
    $RGNX
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

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    REGENXBIO Reports Second Quarter 2025 Financial Results and Operational Highlights

    RGX-202 in Duchenne muscular dystrophy on track for topline results 1H 2026 and BLA submission mid-2026Pivotal trial enrollment accelerated, expected to complete in October 2025 ahead of previous guidanceClemidsogene lanparvovec (RGX-121) on track to be first gene therapy and one-time treatment for MPS II; FDA inspections completed successfullyPre-license inspection (PLI) of in-house manufacturing facility, quality systems and processes completed with no observationsBioresearch monitoring information (BIMO) inspection of laboratory and clinical data practices completed with no observationsSurabgene lomparvovec (sura-vec, ABBV-RGX-314) on track to be first gene therapy in chronic retinal dise

    8/7/25 7:05:00 AM ET
    $RGNX
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    REGENXBIO to Host Conference Call on August 7 to Discuss Second Quarter 2025 Financial Results and Operational Highlights

    ROCKVILLE, Md., July 31, 2025 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced that it will host a conference call on Thursday, August 7, at 8:00 a.m. ET to discuss its financial results for the second quarter ended June 30, 2025, and operational highlights. Listeners can register for the webcast via this link. Analysts wishing to participate in the question and answer session should access the live call by dialing (646) 307-1963 (domestic) or (800) 715-9871 (international) and enter the passcode 9571992. A replay of the webcast will be available via the company's investor website approximately two hours after the call's conclusion. Those who plan on participating are advised to

    7/31/25 7:05:00 AM ET
    $RGNX
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    REGENXBIO Reports First Quarter 2025 Financial Results and Recent Operational Highlights

    RGX-202 in Duchenne muscular dystrophy on track for BLA submission mid-2026Pivotal trial more than half enrolled, with completion expected in 2025 Additional Phase I/II functional data expected 1H 2025 Initiating commercial supply manufacturing in Q3 2025FDA acceptance of Biologics License Application (BLA) for clemidsogene lanparvovec (RGX-121, partnered with Nippon Shinyaku) expected in May 2025 Pivotal data evaluating the safety and efficacy of the subretinal delivery of surabgene lomparvovec (ABBV-RGX-314, partnered with AbbVie) in patients with wet age-related macular degeneration are expected in 2026 and planning of diabetic retinopathy pivotal study continuesConference call today at 4

    5/12/25 4:05:00 PM ET
    $RGNX
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    $RGNX
    Large Ownership Changes

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    Amendment: SEC Form SC 13G/A filed by REGENXBIO Inc.

    SC 13G/A - REGENXBIO Inc. (0001590877) (Subject)

    11/14/24 9:00:57 PM ET
    $RGNX
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    Amendment: SEC Form SC 13G/A filed by REGENXBIO Inc.

    SC 13G/A - REGENXBIO Inc. (0001590877) (Subject)

    11/12/24 4:47:45 PM ET
    $RGNX
    Biotechnology: Biological Products (No Diagnostic Substances)
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    Amendment: SEC Form SC 13G/A filed by REGENXBIO Inc.

    SC 13G/A - REGENXBIO Inc. (0001590877) (Subject)

    11/4/24 1:49:56 PM ET
    $RGNX
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care