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    SEC Form SC 13G/A filed by Cabaletta Bio Inc. (Amendment)

    2/14/24 4:21:51 PM ET
    $CABA
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care
    Get the next $CABA alert in real time by email
    SC 13G/A 1 tm242424d12_sc13ga.htm SC 13G/A

     

     

     

    SCHEDULE 13G

     

    SECURITIES AND EXCHANGE COMMISSION
    WASHINGTON, DC 20549

     

    Under the Securities Exchange Act of 1934
    (Amendment No. 1)*

     

    Cabaletta Bio, Inc.

    (Name of Issuer)

     

    Common Stock, par value $0.00001 per share

    (Title of Class of Securities)

     

    12674W109

     

    (CUSIP Number)

     

    December 31, 2023

     
     

    (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.  12674W109

     

     

    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

    1,457,626 (1)

     

    6

     

     

    SHARED VOTING POWER

    -0- 

     

    7

     

     

    SOLE DISPOSITIVE POWER

    1,457,626 (1)

     

    8

     

     

    SHARED DISPOSITIVE POWER

    -0- 

     

    9

     

     

    AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON

    1,457,626 (1)

     

    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

    3.4% (1)(2)

     

    12

     

     

    TYPE OF REPORTING PERSON (See Instructions) 


    IA, PN 

     

    (1) Includes 1,444,295 shares of common stock (“Common Stock”) of Cabaletta Bio, Inc. (the “Issuer”) issuable upon the conversion of Non-Voting Common Stock (as defined in Item 4 and subject to limitations as described therein) held directly by the Funds (as defined in Item 4).
    (2)

    Based upon 41,405,117 shares of Common Stock outstanding as of November 3, 2023, as reported in the Issuer’s Form 10-Q filed with the Securities and Exchange Commission (“SEC”) on November 9, 2023, plus 1,444,295 shares of Common Stock issuable upon conversion of Non-Voting Common Stock (as defined in Item 4) that are subject to the limitations on conversion described in Item 4.

     

     

     

     

    CUSIP No.  12674W109

     

     

    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

    1,457,626 (1) 

     

    6

     

     

    SHARED VOTING POWER

    -0- 

     

    7

     

     

    SOLE DISPOSITIVE POWER

    1,457,626 (1) 

     

    8

     

     

    SHARED DISPOSITIVE POWER

    -0- 

     

    9

     

     

    AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON

    1,457,626 (1) 

     

    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

    3.4% (1)(2) 

     

    12

     

     

    TYPE OF REPORTING PERSON (See Instructions)

     
    HC, OO 

     

    (1) Includes 1,444,295 shares of Common Stock issuable upon the conversion of Non-Voting Common Stock (as defined in Item 4 and subject to limitations as described therein) held directly by the Funds (as defined in Item 4).
    (2)

    Based upon 41,405,117 shares of Common Stock outstanding as of November 3, 2023, as reported in the Issuer’s Form 10-Q filed with the SEC on November 9, 2023, plus 1,444,295 shares of Common Stock issuable upon conversion of Non-Voting Common Stock (as defined in Item 4) that are subject to the limitations on conversion described in Item 4.

     

     

     

     

     CUSIP No.  12674W109

     

      

    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

    1,457,626 (1) 

     

    6

     

     

    SHARED VOTING POWER

    -0- 

     

    7

     

     

    SOLE DISPOSITIVE POWER

    1,457,626 (1) 

     

    8

     

     

    SHARED DISPOSITIVE POWER

    -0- 

     

    9

     

     

    AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON

    1,457,626 (1) 

     

    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

    3.4% (1)(2) 

     

    12

     

     

    TYPE OF REPORTING PERSON (See Instructions)

     
    IN, HC 

     

    (1) Includes 1,444,295 shares of Common Stock issuable upon the conversion of Non-Voting Common Stock (as defined in Item 4 and subject to limitations as described therein) held directly by the Funds (as defined in Item 4).
    (2) Based upon 41,405,117 shares of Common Stock outstanding as of November 3, 2023, as reported in the Issuer’s Form 10-Q filed with the SEC on November 9, 2023, plus 1,444,295 shares of Common Stock issuable upon conversion of Non-Voting Common Stock (as defined in Item 4) that are subject to the limitations on conversion described in Item 4.

     

     

     

     

    CUSIP No.  12674W109

     

      

    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

    1,457,626 (1) 

     

    6

     

     

    SHARED VOTING POWER

    -0- 

     

    7

     

     

    SOLE DISPOSITIVE POWER

    1,457,626 (1) 

     

    8

     

     

    SHARED DISPOSITIVE POWER

    -0- 

     

    9

     

     

    AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON

    1,457,626 (1) 

     

    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

    3.4% (1)(2) 

     

    12

     

     

    TYPE OF REPORTING PERSON (See Instructions)

     

    IN, HC 

     

    (1) Includes 1,444,295 shares of Common Stock issuable upon the conversion of Non-Voting Common Stock (as defined in Item 4 and subject to limitations as described therein) held directly by the Funds (as defined in Item 4).
    (2) Based upon 41,405,117 shares of Common Stock outstanding as of November 3, 2023, as reported in the Issuer’s Form 10-Q filed with the SEC on November 9, 2023, plus 1,444,295 shares of Common Stock issuable upon conversion of Non-Voting Common Stock (as defined in Item 4) that are subject to the limitations on conversion described in Item 4.

     

     

     

     

    Amendment No. 1 to Schedule 13G

     

    This Amendment No. 1 to Schedule 13G amends the previously filed Schedule 13G filed by Baker Bros. Advisors LP (the “Adviser”), Baker Bros. Advisors (GP) LLC (the “Adviser GP”), Julian C. Baker and Felix J. Baker (collectively, the “Reporting Persons”). Except as supplemented herein, such statements, as heretofore amended and supplemented, remain in full force and effect.

     

    Item 1(a) Name of Issuer:

     

    Cabaletta Bio, Inc. (the “Issuer”)

     

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

     

    2929 Arch Street, Ste. 600

     

    Philadelphia, PA 19104

     

    Item 2(a) Name of Person Filing:

     

    This Amendment No. 1 is being filed jointly by 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, par value $0.00001 per share (“Common Stock”).

     

    Item 2(e) CUSIP Number:

     

    12674W109

     

     

     

     

    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 Amendment No. 1 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 shares of Common Stock that may be acquired upon conversion of non-voting common stock convertible at any time on a 1-for-1 basis without consideration into Common Stock (“Non-Voting Common Stock”), subject to the limitations on conversion described below.

     

    The information set forth below is based on 41,405,117 shares of Common Stock outstanding as of November 3, 2023, as reported in the Issuer’s Form 10-Q filed with the Securities and Exchange Commission on November 9, 2023, plus 1,444,295 shares of Common Stock issuable upon conversion of Non-Voting Common Stock that are subject to the limitations on conversion described in Item 4. Such percentage figures are calculated in accordance with Rule 13d-3 under the Securities Exchange Act of 1934, as amended (the “Exchange Act”).

     

     

     

     

    Holder  Number of Shares of Common
    Stock we own or have the right
    to acquire within 60 days
       Percent of Class
    Outstanding
     
    667, L.P.   112,792    0.3%
    Baker Brothers Life Sciences, L.P.   1,344,834    3.1%
    Total   1,457,626    3.4%

     

    The Non-Voting Common Stock is convertible only 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 “Beneficial Ownership Limitation”). By written notice to the Issuer, the Funds may from time to time increase or decrease the Beneficial Ownership Limitation applicable to that Fund. Any such increase will not be effective until the 61st day after such notice is delivered to the Issuer. As a result of this restriction, the number of shares of Common Stock that may be issued upon conversion of the Non-Voting Common Stock by the above holders may change depending upon changes in the outstanding Common Stock.

     

    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.

     

    The Adviser GP is the sole general partner of the Adviser. Pursuant to the management agreements, as amended, among the Adviser, Life Sciences and 667 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.

     

    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 x.

     

    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.

     

    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.

     

     

     

     

    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.

     

    February 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

     

     

     

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    Rese-cel data presented at multiple medical meetings demonstrated potentially transformative, drug-free clinical responses with a favorable safety profile for autoimmune patients supporting outpatient use All myositis patients in the Phase 1/2 DM/ASyS cohort with sufficient follow-up who would have met key criteria for the registrational cohort met the registrational, 16-week primary endpoint Planned BLA submission for rese-cel in 2027 based on 14-patient, single-arm DM/ASyS registrational cohort initiating enrollment this quarter within the RESET-Myositis™ trial FDA alignment on additional registrational cohort designs for RESET-SSc™ and RESET-SLE™ anticipated by year-end 2025 PHILADEL

    11/10/25 7:30:00 AM ET
    $CABA
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    Cabaletta Bio Announces Appointment of Steve Gavel as Chief Commercial Officer and Award of Inducement Grant

    – Gavel brings highly relevant CAR T experience from Legend Biotech where he led the launch and commercialization of CARVYKTI® from 2018 until 2025 – PHILADELPHIA, Oct. 14, 2025 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (NASDAQ:CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced the appointment of Steve Gavel as Chief Commercial Officer, effective immediately. In his role, Mr. Gavel will join the leadership team and will lead all aspects of global commercial strategy and execution for rese-cel (resecabtagene autoleucel, formerly CABA-201), for

    10/14/25 8:00:00 AM ET
    $CABA
    Biotechnology: Biological Products (No Diagnostic Substances)
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    Cabaletta Bio Appoints Global Commercial Leader Shawn Tomasello to Board of Directors

    – Ms. Tomasello created and led global commercial and medical affairs functions at Kite Pharma from pre-launch through its acquisition by Gilead Sciences – PHILADELPHIA, July 24, 2023 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (NASDAQ:CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced the appointment of Shawn Tomasello to its Board of Directors. Ms. Tomasello has over 35 years of experience in the life sciences industry, including specific expertise in CD19-CAR T therapy, where she most recently served as the Chief Commercial Officer of Kite Pharma, Inc. between 20

    7/24/23 8:00:00 AM ET
    $CABA
    Biotechnology: Biological Products (No Diagnostic Substances)
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    $CABA
    Large Ownership Changes

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

    SC 13G/A - Cabaletta Bio, Inc. (0001759138) (Subject)

    12/6/24 4:05:57 PM ET
    $CABA
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

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

    SC 13G/A - Cabaletta Bio, Inc. (0001759138) (Subject)

    12/5/24 4:50:19 PM ET
    $CABA
    Biotechnology: Biological Products (No Diagnostic Substances)
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    Amendment: SEC Form SC 13G/A filed by Cabaletta Bio Inc.

    SC 13G/A - Cabaletta Bio, Inc. (0001759138) (Subject)

    12/5/24 3:36:55 PM ET
    $CABA
    Biotechnology: Biological Products (No Diagnostic Substances)
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    $CABA
    Financials

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    Cabaletta Bio Presents Positive Clinical Safety and Efficacy Data on CABA-201 at ACR Convergence 2024

    – CABA-201 safety profile suggests favorable risk-benefit with no CRS or ICANS in the majority of patients; low-grade CRS in three of eight patients and one previously reported ICANS event – – Compelling clinical responses observed in lupus and myositis patients with up to six months of follow-up; first SSc patient demonstrated an emerging, drug-free clinical response – – All eight patients with active, refractory autoimmune disease discontinued all immunosuppressants prior to CABA-201 infusion and through the follow-up period – – Consistent and complete B cell depletion observed in all patients within the first month after CABA-201 infusion; evidence of transitional naïve B cell repopula

    11/18/24 7:00:00 AM ET
    $CABA
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    Cabaletta Bio Reports Third Quarter 2024 Financial Results and Provides Business Update

    – Clinical data from the RESET-Myositis™ and RESET-SLE™ trials, along with initial clinical data from the RESET-SSc™ trial, to be presented this weekend in oral and poster presentations at ACR Convergence 2024 – – 16 patients enrolled with 10 patients dosed as of November 12 across the RESET™ clinical development program; 40 U.S. clinical sites actively recruiting patients – – Data permitting, anticipate meeting with the FDA in 2025 regarding potential registrational program designs for CABA-201 – – Clinical development expanding efficiently into Europe with EMA CTA authorization for CABA-201 received in lupus; Gerwin Winter appointed as Senior VP and Head of International – – Cash, cash

    11/14/24 7:00:00 AM ET
    $CABA
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    Cabaletta Bio Reports Positive Initial Clinical Data from Phase 1/2 RESET-Myositis™ and RESET-SLE™ Trials of CABA-201

    – No CRS, ICANS, infections or serious adverse events observed in either of the first two patients through data cut-off of May 28, 2024 – – CABA-201 exhibited anticipated profile of CAR T cell expansion and contraction with complete B cell depletion observed in both patients by day 15 post-infusion – – Improvements in both patients' specific disease measures, consistent with academic experience of a similar 4-1BB CD19-CAR T, suggest emerging clinical benefit with CABA-201 while discontinuing all disease-specific therapies other than a planned steroid taper in one patient – – Immature, naïve B cell repopulation in first IMNM patient observed at week 8 consistent with a potential immu

    6/14/24 2:00:00 AM ET
    $CABA
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care