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    SEC Form SC 13G/A filed by MoonLake Immunotherapeutics (Amendment)

    2/15/24 8:00:58 AM ET
    $MLTX
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $MLTX alert in real time by email
    SC 13G/A 1 tm246392d1_sc13ga.htm SC 13G/A

     

     

      

    UNITED STATES

    SECURITIES AND EXCHANGE COMMISSION

    Washington, D.C. 20549

     

    SCHEDULE 13G

    (Rule 13d-102)

     

    INFORMATION TO BE INCLUDED IN STATEMENTS FILED PURSUANT

    TO § 240.13d-1(b), (c), AND (d) AND AMENDMENTS THERETO FILED

    PURSUANT TO § 240.13d-2

     

    (Amendment No. 2)*

     

    MoonLake Immunotherapeutics
    (Name of Issuer)
     
    Class A ordinary share, par value $0.0001 per share
    (Title of Class of Securities)
     
    G4444C102
    (CUSIP Number)
     
    31 December 2023
    (Date of Event Which Requires Filing of the Statement)

     

     

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

     

    o       Rule 13d-1(b)

    x       Rule 13d-1(c)

    o       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. G4444C102 13G Page 2 of 7 Pages

      

    1.

    NAME OF REPORTING PERSONS

    Merck Healthcare KGaA, Darmstadt Germany an affiliate of Merck KGaA, Darmstadt, Germany

         

    2.

    CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP (see instructions)

    (a) o

    (b) o

    3.

    SEC USE ONLY

     

            

    4.

    CITIZENSHIP OR PLACE OF ORGANIZATION

     Germany

         

    NUMBER OF

    SHARES

    BENEFICIALLY

    OWNED BY

    EACH

    REPORTING

    PERSON

    WITH

    5.

     

    SOLE VOTING POWER

     2,787,5091

         

    6.

     

    SHARED VOTING POWER

     0

         

    7.

     

    SOLE DISPOSITIVE POWER

     2,787,5091

         

    8.

     

    SHARED DISPOSITIVE POWER

    0 

         

    9.

    AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON

    2,787,5091

         

    10.

    CHECK IF THE AGGREGATE AMOUNT IN ROW (9) EXCLUDES CERTAIN SHARES (SEE INSTRUCTIONS)

    o

       11.

    PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (9)

    4.7%2

         

    12.

    TYPE OF REPORTING PERSON (SEE INSTRUCTIONS)

    CO 

         

       


    1 The record holder of the securities covered by this Schedule 13G is Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA Darmstadt, Germany. Merck Healthcare KGaA, Darmstadt Germany is a dominantly controlled subsidiary of Merck KGaA, Darmstadt, Germany and E.Merck KG, Darmstadt Germany. Merck KGaA, Darmstadt, Germany is a publicly traded company (Frankfurt Stock Exchange, DAX 40) and the beneficiary of Merck Healthcare KGaA, Darmstadt Germany. Merck KGaA, Darmstadt Germany is dominantly controlled by E.Merck KG, Darmstadt Germany. Merck Healthcare KGaA, Darmstadt Germany, currently holds 2,787,509 Class A ordinary shares of the Issuer.

    2 This percentage is based upon 59,940,529 Class A ordinary shares outstanding as of November 01 2023 as reported in the Issuer’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 14, 2022.

     

     

     

     

    Cusip No. G4444C102 13G Page 3 of 7 Pages

     

    1.

    NAME OF REPORTING PERSONS

     Merck KGaA, Darmstadt, Germany

         

    2.

    CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP (see instructions)

    (a) o

    (b) o

    3.

    SEC USE ONLY

     

            

    4.

    CITIZENSHIP OR PLACE OF ORGANIZATION

     Germany

         

    NUMBER OF

    SHARES

    BENEFICIALLY

    OWNED BY

    EACH

    REPORTING

    PERSON

    WITH

    5.

     

    SOLE VOTING POWER

     2,787,5093

         

    6.

     

    SHARED VOTING POWER

     0

         

    7.

     

    SOLE DISPOSITIVE POWER

    2,787,5093 

         

    8.

     

    SHARED DISPOSITIVE POWER

    0 

         

    9.

    AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON

     2,787,5093

         

    10.

    CHECK IF THE AGGREGATE AMOUNT IN ROW (9) EXCLUDES CERTAIN SHARES (SEE INSTRUCTIONS)

    o

    11.

    PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (9)

    4.7%4 

         

    12.

    TYPE OF REPORTING PERSON (SEE INSTRUCTIONS)

    CO 

         

      


    3 The record holder of the securities covered by this Schedule 13G is Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA Darmstadt, Germany. Merck Healthcare KGaA, Darmstadt Germany is a dominantly controlled subsidiary of Merck KGaA, Darmstadt, Germany and E.Merck KG, Darmstadt Germany. Merck KGaA, Darmstadt, Germany is a publicly traded company (Frankfurt Stock Exchange, DAX 40) and the beneficiary of Merck Healthcare KGaA, Darmstadt Germany. Merck KGaA, Darmstadt Germany is dominantly controlled by E.Merck KG, Darmstadt Germany. Merck Healthcare KGaA, Darmstadt Germany, currently holds 2,787,509 Class A ordinary shares of the Issuer.

    4 This percentage is based upon 59,940,529 Class A ordinary shares outstanding as of November 01 2023 as reported in the Issuer’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 14, 2022.

     

     

     

     

    Cusip No. G4444C102 13G Page 4 of 7 Pages

      

    1.

    NAME OF REPORTING PERSONS

    E.Merck KG, Darmstadt Germany

         

    2.

    CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP (see instructions)

    (a) o

    (b) o

    3.

    SEC USE ONLY

     

            

    4.

    CITIZENSHIP OR PLACE OF ORGANIZATION

     Germany

         

    NUMBER OF

    SHARES

    BENEFICIALLY

    OWNED BY

    EACH

    REPORTING

    PERSON

    WITH

    5.

     

    SOLE VOTING POWER

     2,787,5095

         

    6.

     

    SHARED VOTING POWER

     0

         

    7.

     

    SOLE DISPOSITIVE POWER

     2,787,5095

         

    8.

     

    SHARED DISPOSITIVE POWER

    0 

         

    9.

    AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON

    2,787,5095

         

    10.

    CHECK IF THE AGGREGATE AMOUNT IN ROW (9) EXCLUDES CERTAIN SHARES (SEE INSTRUCTIONS)

    o

    11.

    PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (9)

    4.7%6

         

    12.

    TYPE OF REPORTING PERSON (SEE INSTRUCTIONS)

    CO 

         

        


    5 The record holder of the securities covered by this Schedule 13G is Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA Darmstadt, Germany. Merck Healthcare KGaA, Darmstadt Germany is a dominantly controlled subsidiary of Merck KGaA, Darmstadt, Germany and E.Merck KG, Darmstadt Germany. Merck KGaA, Darmstadt, Germany is a publicly traded company (Frankfurt Stock Exchange, DAX 40) and the beneficiary of Merck Healthcare KGaA, Darmstadt Germany. Merck KGaA, Darmstadt Germany is dominantly controlled by E.Merck KG, Darmstadt Germany. Merck Healthcare KGaA, Darmstadt Germany, currently holds 2,787,509 Class A ordinary shares of the Issuer.

    6 This percentage is based upon 59,940,529 Class A ordinary shares outstanding as of November 01 2023 as reported in the Issuer’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 14, 2022.

     

     

     

     

     Cusip No. G4444C102 13G Page 5 of 7 Pages

     

    Item 1(a). Name of Issuer:
       
      MoonLake Immunotherapeutics
       
    Item 1(b). Address of Issuer’s Principal Executive Offices:
       
      Dorfstrasse 29
      Zug, Switzerland 6300
       
    Item 2(a). Name of Person Filing:
       
     

    This Schedule 13G is being filed by each of the following persons (each, a “Reporting Person” and together, the “Reporting Persons”):

     

    Merck Healthcare KGaA, Darmstadt, Germany an affiliate of Merck KGaA Darmstadt Germany

    Merck KGaA, Darmstadt, Germany

    E.Merck KG, Darmstadt, Germany

     

    The Reporting Persons have entered into a Joint Filing Agreement, a copy of which is filed with this Schedule 13G as Exhibit 99.1, pursuant to which the Reporting Persons have agreed to file this Schedule 13G jointly in accordance with the provisions of Rule 13d-1(k)(l) of the Securities Exchange Act of 1934, as amended.

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

    Merck Healthcare KGaA, Darmstadt, Germany an affiliate of Merck KGaA Darmstadt, Germany, and Merck KGaA: Frankfurter Strasse 250, 64293 Darmstadt, Germany

    E.Merck KG: Emanuel-Merck-Platz 1, 64293 Darmstadt, Germany

       
    Item 2(c). Citizenship:
       
      The Reporting Persons Merck Healthcare KGaA an affiliate of Merck KGaA Darmstadt Germany, Merck KGaA and E.Merck KG are organized in Germany.  
       
    Item 2(d). Title of Class of Securities:
       
      Class A ordinary shares, par value $ 0.0001 per share
       
    Item 2(e). CUSIP Number:
       
      G4444C102
       
    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:
     

     

    Not applicable

      

      (a) o Broker or dealer registered under Section 15 of the Act (15 U.S.C. 78o);
      (b) o Bank as defined in Section 3(a)(6) of the Act (15 U.S.C. 78c);
      (c) o Insurance company as defined in Section 3(a)(19) of the Act (15 U.S.C. 78c);
      (d) o Investment company registered under Section 8 of the Investment Company Act of 1940 (15 U.S.C. 80a-8);
      (e) o An investment adviser in accordance with § 240.13d-1(b)(1)(ii)(E);
      (f) o An employee benefit plan or endowment fund in accordance with § 240.13d-1(b)(1)(ii)(F);
      (g) o A parent holding company or control person in accordance with § 240.13d-1(b)(1)(ii)(G);
      (h) o A savings association as defined in Section 3(b) of the Federal Deposit Insurance Act (12 U.S.C. 1813);
      (i) o A church plan that is excluded from the definition of an investment company under Section 3(c)(14) of the Investment Company Act (15 U.S.C. 80a-3);
      (j) o A non-U.S. institution in accordance with § 240.13d-1(b)(1)(ii)(J);
      (k) o Group, in accordance with § 240.13d-1(b)(1)(ii)(K).

      

     

     

     

     Cusip No. G4444C102 13G Page 6 of 7 Pages

      

    Item 4. Ownership:
       
      Provide the following information regarding the aggregate number and percentage of the class of securities of the issuer identified in Item 1.

     

      (a) Amount beneficially owned: Each of the Reporting Persons may be deemed to beneficially own 2,787,509 Class A ordinary shares. See notes 1, 3 and 5 on the Cover Pages, which are incorporated herein.
         
      (b) Percent of class: 4.7%; see notes 2, 4 and 6 on the Cover Pages, which are incorporated herein.
         
      (c) Number of shares as to which the Reporting Persons have:

      

        (i) Sole power to vote or to direct the vote: 2,787,509
        (ii) Shared power to vote or to direct the vote: 0
        (iii) Sole power to dispose or to direct the disposition of: 2,787,509
        (iv) Shared power to dispose or to direct the disposition of: 0

      

    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 x.
       
    Item 6. Ownership of More Than Five Percent on Behalf of Another Person:
       
      Not applicable 
       
    Item 7. Identification and Classification of the Subsidiary Which Acquired the Security Being Reported on By the Parent Holding Company:
       
      Not applicable 
       
    Item 8. Identification and Classification of Members of the Group:
       
      Not applicable
       
    Item 9. Notice of Dissolution of Group:
       
      Not applicable
       
    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.

     

     

     

     

    Cusip No. G4444C102 13G Page 7 of 7 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.

     

    MERCK HEALTHCARE KGAA, DARMSTADT, GERMANY an affiliate of Merck KGaA, Darmstadt, Germany   MERCK HEALTHCARE KGAA, DARMSTADT, GERMANY an affiliate of Merck KGaA, Darmstadt, Germany
    Date: February 14, 2024   Date: February 14, 2024
             
             
             
    By:  /s/ Matthias Muellenbeck   By:  /s/ Jens Eckhardt
             
    Name:  Matthias Muellenbeck   Name: Jens Eckhardt
             
    Title:  SVP Business Development and Alliance Management   Title: Head of Legal Business Development

        

    MERCK KGAA, DARMSTADT, GERMANY   MERCK KGAA, DARMSTADT, GERMANY 
             
    Date: February 14, 2024   Date: February 14, 2024
             
             
             
    By:  /s/ Jens Eckhardt   By: /s/ Johannes Eckhardt
             
    Name: Jens Eckhardt   Name:  Johannes Eckhardt
             
    Title: Head of Legal Business Development   Title:  Head of Legal – M&A, Ventures & Finance

     

    E.MERCK KG, DARMSTADT, GERMANY   E.MERCK KG, DARMSTADT, GERMANY
             
    Date: February 14, 2024   Date: February 14, 2024
             
             
             
    By:  /s/ Johannes Eckhardt   By:  /s/ Kristin Eibisch
             
    Name: Johannes Eckhardt   Name: Kristin Eibisch
             
    Title: Attorney-in-Fact   Title: Attorney-in-Fact

     

     

     

     

    Cusip No. G4444C102 13G Exhibits

     

    EXHIBIT INDEX

     

    Exhibit 99.1     Joint Filing Agreement, dated August 01, 2022, by and between Merck Healthcare KGaA an affiliate of Merck KGaA, Darmstadt, Germany, Merck KGaA, Darmstadt, Germany and E.Merck KG, Darmstadt, Germany.

    Exhibit 99.2     Power of Attorney

     

     

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    MoonLake Immunotherapeutics Reports First Quarter 2025 Financial Results and Provides a Business Update Continued to make significant progress with the development of the Nanobody® sonelokimab across portfolio of indications, including Phase 3 studies in hidradenitis suppurativa (HS), psoriatic Arthritis (PsA) and adolescent HS, as well as Phase 2 studies in palmoplantar pustulosis (PPP) and axial spondyloarthritis (axSpA)Announced completion of enrollment of patients in the Phase 3 program in HS (the VELA program) and disclosed baseline characteristics, replicating the Phase 2 MIRA trialPresented an interim readout of the Phase 2 LEDA study in PPP, highlighting the potential of sonelokimab

    5/12/25 4:00:00 PM ET
    $HTGC
    $MLTX
    Investment Managers
    Finance
    Biotechnology: Pharmaceutical Preparations
    Health Care

    MoonLake Immunotherapeutics Reports Full Year 2024 Financial Results and Provides a Business Update

    Initiated the Phase 3 VELA program of the Nanobody® sonelokimab in patients with moderate-to-severe hidradenitis suppurativa (HS) and the Phase 3 IZAR program in patients with active psoriatic arthritis (PsA) following positive FDA and EMA regulatory feedback, continuing to support a potential best-in-class profile across two key indicationsInitiated three new trials in the beginning of 2025 with the Nanobody® sonelokimab: Phase 3 VELA-TEEN trial in adolescent hidradenitis suppurativa (HS), Phase 2 LEDA trial in palmoplantar pustulosis (PPP) and Phase 2 S-OLARIS trial in axial spondyloarthritis (axSpA)Signed a three-year technology partnership with Komodo Health to advance research on inflam

    2/26/25 7:00:00 AM ET
    $MLTX
    Biotechnology: Pharmaceutical Preparations
    Health Care