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

    2/14/24 3:49:24 PM ET
    $NUVL
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $NUVL alert in real time by email
    SC 13G/A 1 tm245759d4_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)*

     

     

      

    NUVALENT, INC.

    (Name of Issuer)

     

    Class A Common Stock, Par Value $0.0001

    (Title of Class of Securities)

     

    670703107

    (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:

     

    ¨ 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. 670703107    

     

    1.  

    Names of Reporting Persons

    I.R.S. Identification No. of Above Persons (Entities Only)

     

    Fairmount Funds Management 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

     

    1,924,626(1)

     

      7.  

    Sole Dispositive Power

     

    0

     

      8.  

    Shared Dispositive Power

     

    1,924,626(1)

    9.  

    Aggregate Amount Beneficially Owned by Each Reporting Person

     

    1,924,626(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)

     

    3.4%(2)

     

    12.  

    Type of Reporting Person (See Instructions)

     

    IA

     

                 

    (1) The shares reported herein for the Reporting Person represent 1,924,626 shares of the Issuer’s Common Stock held by Fairmount Healthcare Fund II LP (“Fund II”).

     

    (2) Calculated based on 57,194,841 shares of the Issuer’s Common Stock outstanding as of October 31, 2023, as disclosed on Form 10-Q filed by the Issuer with the Securities and Exchange Commission on November 14, 2023.

     

     

     

         
    CUSIP No. 670703107    

     

    1.  

    Names of Reporting Persons

    I.R.S. Identification No. of Above Persons (Entities Only)

     

    Peter Harwin

     

    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

     

    0

     

      6.  

    Shared Voting Power

     

    1,924,626(1)

     

      7.  

    Sole Dispositive Power

     

    0

     

      8.  

    Shared Dispositive Power

     

    1,924,626(1)

    9.  

    Aggregate Amount Beneficially Owned by Each Reporting Person

     

    1,924,626(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)

     

    3.4%(2)

     

    12.  

    Type of Reporting Person (See Instructions)

     

    HC, IN

     

                 

      

    (1) The shares reported herein for the Reporting Person represent 1,924,626 shares of the Issuer’s Common Stock held by Fairmount Healthcare Fund II LP (“Fund II”).

     

    (2) Calculated based on 57,194,841 shares of the Issuer’s Common Stock outstanding as of October 31, 2023, as disclosed on Form 10-Q filed by the Issuer with the Securities and Exchange Commission on November 14, 2023.

     

     

     

     

    CUSIP No. 670703107    

     

    1.  

    Names of Reporting Persons

    I.R.S. Identification No. of Above Persons (Entities Only)

     

    Tomas Kiselak

     

    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

     

    Slovak Republic

     

    Number of

    Shares

    Beneficially

    Owned by

    Each

    Reporting

    Person

    With

     

      5.  

    Sole Voting Power

     

    0

     

      6.  

    Shared Voting Power

     

    1,924,626(1)

     

      7.  

    Sole Dispositive Power

     

    0

     

      8.  

    Shared Dispositive Power

     

    1,924,626(1)

    9.  

    Aggregate Amount Beneficially Owned by Each Reporting Person

     

    1,924,626(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)

     

    3.4%(2)

     

    12.  

    Type of Reporting Person (See Instructions)

     

    HC, IN

     

                 

    (1) The shares reported herein for the Reporting Person represent 1,924,626 shares of the Issuer’s Common Stock held by Fairmount Healthcare Fund II LP (“Fund II”).

     

    (2) Calculated based on 57,194,841 shares of the Issuer’s Common Stock outstanding as of October 31, 2023, as disclosed on Form 10-Q filed by the Issuer with the Securities and Exchange Commission on November 14, 2023.

     

     

     

     

    CUSIP No. 670703107    

     

    1.  

    Names of Reporting Persons

    I.R.S. Identification No. of Above Persons (Entities Only)

     

    Fairmount Healthcare Fund II 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

     

    1,924,626(1)

     

      7.  

    Sole Dispositive Power

     

    0

     

      8.  

    Shared Dispositive Power

     

    1,924,626(1)

    9.  

    Aggregate Amount Beneficially Owned by Each Reporting Person

     

    1,924,626(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)

     

    3.4%(2)

     

    12.  

    Type of Reporting Person (See Instructions)

     

    PN

     

                 

    (1) The shares reported herein for the Reporting Person represent 1,924,626 directly owned shares of the Issuer’s Common Stock.

     

    (2) Calculated based on 57,194,841 shares of the Issuer’s Common Stock outstanding as of October 31, 2023, as disclosed on Form 10-Q filed by the Issuer with the Securities and Exchange Commission on November 14, 2023.

     

     

     

         

     Item 1.  

     

      (a) Name of Issuer: Nuvalent, Inc.

     

      (b) Address of Issuer’s Principal Executive Offices: One Broadway, 14th Floor, Cambridge, MA 02142.

     

    Item 2.

     

    This Amendment No. 2 to Schedule 13G amends and restates the statements on Schedule 13G originally filed on November 9, 2022 and Amendment No. 1 filed on February 14, 2023.

     

     

      (a)

    Name of Person(s) Filing: This joint statement on Schedule 13G is being filed by Fairmount Funds Management LLC (“Fairmount”), Peter Harwin, Tomas Kiselak, and Fairmount Healthcare Fund II L.P. (“Fund II”). Fairmount, Mr. Harwin, Mr. Kiselak, and Fund II are collectively referred to herein as the “Reporting Persons.”

     

    The Common Stock reported herein includes Common Stock beneficially owned directly by Fund II. Fairmount Healthcare Fund II GP LLC is the general partner of Fund II. The controlling persons of Fairmount are Mr. Harwin and Mr. Kiselak. Fairmount serves as investment adviser for Fund II and may be deemed a beneficial owner, for purposes of Section 13(d) of the Act, of any securities of the Issuer held by Fund II. Fund II has delegated to Fairmount the sole power to vote and the sole power to dispose of all securities held in Fund II’s portfolio, including the shares of the Issuer’s Common Stock reported herein. Because Fund II has divested voting and investment power over the reported securities and cannot revoke such delegation on less than 61 days’ notice, Fund II disclaims beneficial ownership of the securities for purposes of Section 13(d) of the Act and therefore disclaims any obligation to report ownership of the reported securities under Section 13(d) of the Act. As managing members of Fairmount, Mr. Harwin and Mr. Kiselak may be deemed beneficial owners, for purposes of Section 13(d) of the Act, of any securities of the Issuer beneficially owned by Fairmount. Fairmount, Mr. Harwin, and Mr. Kiselak disclaim beneficial ownership of the securities reported in this Schedule 13G Statement (the “Statement”) other than for the purpose of determining their obligations under Section 13(d) of the Act, and the filing of the Statement shall not be deemed an admission that any of Fairmount, Mr. Harwin, or Mr. Kiselak is the beneficial owner of such securities for any other purpose.

     

      (b) Address of Principal Business Office: The principal business office of the Reporting Persons is c/o Fairmount Funds Management LLC, 200 Barr Harbor Drive, Suite 400, West Conshohocken, PA 19428.

     

      (c) Citizenship: Fairmount is a Delaware limited liability company. Mr. Harwin is a United States citizen. Mr. Kiselak is a Slovak Republic citizen.  

     

      (d) Title of Class of Securities: Class A Common stock, Par Value $0.0001 (“Common Stock”)  

     

      (e) CUSIP Number: 670703107    
         
    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)   ¨   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 association 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

     

    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:

     See the response(s) to Item 9 on the attached cover page(s).

     

    (b)Percent of Class:

     See the response(s) to Item 11 on the attached cover page(s).

     

    (c)Number of shares as to which such person has:
    (i)        sole power to vote or to direct the vote:

    See the response(s) to Item 5 on the attached cover page(s).

     

    (ii)        shared power to vote or to direct the vote

    See the response(s) to Item 6 on the attached cover page(s).

     

    (iii)        sole power to dispose or to direct the disposition of

    See the response(s) to Item 7 on the attached cover page(s).

     

    (iv)        shared power to dispose or to direct the disposition of

    See the response(s) to Item 8 on the attached cover page(s).

     

    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

     

    Not applicable.

     

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

     

    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. Certification

     

    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.

     

    Dated: February 14, 2024

     

    FAIRMOUNT FUNDS MANAGEMENT LLC
           
      By:  

    /s/ Peter Harwin

    /s/Tomas Kiselak 

      Name:   Peter Harwin     Tomas Kiselak
      Title:   Managing Member Managing Member

     

     

      PETER HARWIN
         
      By:  

    /s/ Peter Harwin 

     

     

      TOMAS KISELAK
         
      By:  

    /s/Tomas Kiselak 

     

     

     

    FAIRMOUNT HEALTHCARE FUND II L.P.

    By: Fairmount Healthcare Fund II GP LLC

           
      By:  

    /s/ Peter Harwin 

    /s/Tomas Kiselak 

      Name:   Peter Harwin                Tomas Kiselak
      Title:   Member                        Member
             

     

     

     

    Exhibit A

     

    Joint Filing Agreement

     

    In accordance with Rule 13d-1(k)(1) under the Securities Exchange Act of 1934, as amended, the undersigned and each other person executing this joint filing agreement (this “Agreement”) agree as follows:

     

    (i) The undersigned and each other person executing this Agreement are individually eligible to use the Schedule 13G to which this Exhibit is attached and such Schedule 13G is filed on behalf of the undersigned and each other person executing this Agreement; and

     

    (ii) The undersigned and each other person executing this Agreement are responsible for the timely filing of such Schedule 13G and any amendments thereto, and for the completeness and accuracy of the information concerning such person contained therein; but none of the undersigned or any other person executing this Agreement is responsible for the completeness or accuracy of the information statement concerning any other persons making the filing, unless such person knows or has reason to believe that such information is inaccurate.

     

    This Agreement may be executed in any number of counterparts, each of which shall be deemed to be an original, but all of which, taken together, shall constitute one and the same instrument.

     

    Dated: February 14, 2024

     

    FAIRMOUNT FUNDS MANAGEMENT LLC
           
      By:  

    /s/ Peter Harwin 

    /s/Tomas Kiselak 

      Name:   Peter Harwin Tomas Kiselak
      Title:   Managing Member Managing Member
             

     

      PETER HARWIN
         
      By:  

    /s/ Peter Harwin 

     

     

      TOMAS KISELAK
         
      By:  

    /s/Tomas Kiselak 

     

     

     

    FAIRMOUNT HEALTHCARE FUND II L.P.

    By: Fairmount Healthcare Fund II GP LLC

           
      By:  

    /s/ Peter Harwin 

    /s/Tomas Kiselak 

      Name:   Peter Harwin Tomas Kiselak
      Title:   Member Member

     

     

     

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    5/27/26 6:30:00 AM ET
    $NUVL
    Biotechnology: Pharmaceutical Preparations
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    Nuvalent Appoints Ron Squarer to Board of Directors

    CAMBRIDGE, Mass., Dec. 10, 2025 /PRNewswire/ -- Nuvalent, Inc. (NASDAQ:NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the appointment of Ron Squarer to its Board of Directors. "We welcome Ron to our Board of Directors, where his personal dedication to advancing oncology therapeutics, demonstrated success in evolving research and development organizations to fully integrated businesses, and proven global commercial acumen will strengthen and sharpen our pre-launch

    12/10/25 4:01:00 PM ET
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    Biotechnology: Pharmaceutical Preparations
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    Nuvalent Highlights Pipeline and Business Achievements, Reiterates Key Anticipated Milestones, and Reports Second Quarter 2025 Financial Results

    Initiated rolling NDA submission for zidesamtinib for TKI pre-treated patients with advanced ROS1-positive NSCLC, with target completion in the third quarter of 2025 Initiated ALKAZAR Phase 3 randomized, controlled trial of neladalkib for front-line ALK-positive NSCLC Topline pivotal data for neladalkib for TKI pre-treated patients with advanced ALK-positive NSCLC expected by year-end 2025 Preliminary data for neladalkib in patients with ALK-positive solid tumors beyond NSCLC to be presented at the ESMO Congress 2025 Jason Waters, MBA, promoted to Senior Vice President, Commercial CAMBRIDGE, Mass., Aug. 7, 2025 /PRNewswire/ -- Nuvalent, Inc. (NASDAQ:NUVL), a clinical-stage biopharmaceutical

    8/7/25 6:30:00 AM ET
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    Biotechnology: Pharmaceutical Preparations
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    Nuvalent Announces Positive Topline Pivotal Data from ALKOVE-1 Clinical Trial of Neladalkib for TKI Pre-treated Patients with Advanced ALK-positive NSCLC

    In 253 ALK TKI pre-treated patients, ORR by BICR was 31% (95% CI: 26, 37), with initial estimated durability of response of 64% and 53% at the 12-month and 18-month landmarks, respectivelyIn the subset of 63 TKI pre-treated patients who were lorlatinib-naïve, ORR by BICR was 46% (95% CI: 33, 59), with initial estimated durability of response of 80% and 60% at the 12- and 18-month landmarks, respectivelyNeladalkib demonstrated intracranial responses, ability to address key drivers of disease progression, and a generally well-tolerated safety profile with low rates of dose discontinuation (5%) and dose reduction (17%) due to TEAEs, consistent with its ALK-selective, TRK-sparing designCompany p

    11/17/25 6:30:00 AM ET
    $NUVL
    Biotechnology: Pharmaceutical Preparations
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    Nuvalent Announces Timing of Topline Pivotal Data for TKI Pre-treated Patients with Advanced ALK-positive NSCLC from ALKOVE-1 Clinical Trial of Neladalkib

    Company to host webcast and conference call on November 17, 2025 at 8:00am ET CAMBRIDGE, Mass., Nov. 14, 2025 /PRNewswire/ -- Nuvalent, Inc. (NASDAQ:NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that the company will host a webcast and conference call on Monday, November 17, 2025 at 8:00 a.m. ET, to discuss topline pivotal data for neladalkib, an investigational ALK-selective inhibitor, in TKI pre-treated patients with advanced ALK-positive non-small cell lung cancer from the global ALKOVE-1 Phase 1/2 clinical trial.

    11/14/25 4:01:00 PM ET
    $NUVL
    Biotechnology: Pharmaceutical Preparations
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    Nuvalent Announces Positive Pivotal Data from ARROS-1 Clinical Trial of Zidesamtinib for TKI Pre-treated Patients with Advanced ROS1-positive NSCLC

    Aligned with FDA on NDA submission strategy for TKI pre-treated patients with advanced ROS1-positive NSCLC and participation in Real-Time Oncology Review; the company plans to initiate a rolling NDA submission in July 2025 with target completion in the third quarter of 2025In 117 ROS1 TKI pre-treated patients, including 50% who had received ≥ 2 prior ROS1 TKIs ± chemotherapy, ORR by BICR was 44% (95% CI: 34, 53) with initial estimated durability of response of 78% at the 12-month landmark and 62% at the 18-month landmarkIn the subset of 55 patients treated with 1 prior ROS1 TKI (crizotinib or entrectinib) ± chemotherapy, ORR was 51% (95% CI: 37, 65) with initial estimated durability of respo

    6/24/25 6:30:00 AM ET
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    Biotechnology: Pharmaceutical Preparations
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    Large Ownership Changes

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

    SC 13G/A - Nuvalent, Inc. (0001861560) (Subject)

    11/14/24 4:50:28 PM ET
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    Biotechnology: Pharmaceutical Preparations
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    Amendment: SEC Form SC 13G/A filed by Nuvalent Inc.

    SC 13G/A - Nuvalent, Inc. (0001861560) (Subject)

    11/14/24 4:34:36 PM ET
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    SEC Form SC 13G/A filed by Nuvalent Inc. (Amendment)

    SC 13G/A - Nuvalent, Inc. (0001861560) (Subject)

    5/15/24 6:39:30 PM ET
    $NUVL
    Biotechnology: Pharmaceutical Preparations
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