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    Amendment: SEC Form SC 13D/A filed by 89bio Inc.

    8/7/24 5:51:00 PM ET
    $ETNB
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $ETNB alert in real time by email
    SC 13D/A 1 tm2421135d1_sc13da.htm SC 13D/A

     

      

    SECURITIES AND EXCHANGE COMMISSION

    Washington, D.C. 20549

     

    SCHEDULE 13D/A

     

    Under the Securities Exchange Act of 1934

    (Amendment No. 10)*

     

    89bio, Inc.

    (Name of Issuer)

     

    Common Stock, par value $0.001 per share

    (Title of Class of Securities)

     

    282559103

    (CUSIP Number)

     

    RA Capital Management, L.P.

    200 Berkeley Street, 18th Floor

    Boston, MA 02116

    Attn: Peter Kolchinsky

    Telephone: 617.778.2500

    (Name, Address and Telephone Number of Person

    Authorized to Receive Notices and Communications)

     

    August 5, 2024

    (Date of Event Which Requires Filing of this Statement)

     

    If the filing person has previously filed a statement on Schedule 13G to report the acquisition that is the subject of this Schedule 13D, and is filing this schedule because of §§ 240.13d-1(e), 240.13d-1(f) or 240.13d-1(g), check the following box. ¨

     

    Note: Schedules filed in paper format shall include a signed original and five copies of the schedule, including all exhibits. See Section 240.13d-7 for other parties to whom copies are to be sent.

     

    * 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, as amended (“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.   282559103
     
      1.

    Names of Reporting Persons

    RA Capital Management, L.P.

     
      2. Check the Appropriate Box if a Member of a Group (See Instructions)
        (a) ¨
        (b) ¨
     
      3. SEC Use Only
     
      4.

    Source of Funds (See Instructions)

    AF

     
      5. Check if Disclosure of Legal Proceedings Is Required Pursuant to Items 2(d) or 2(e)     ¨
     
      6.

    Citizenship or Place of Organization

    Delaware

     
    Number of
    Shares
    Beneficially
    Owned by
    Each
    Reporting
    Person With
    7.

    Sole Voting Power

    0

     
    8.

    Shared Voting Power

    14,254,298

     
    9.

    Sole Dispositive Power

    0

     
    10.

    Shared Dispositive Power

    14,254,298

     
      11.

    Aggregate Amount Beneficially Owned by Each Reporting Person

    14,254,298

     
      12. Check if the Aggregate Amount in Row (11) Excludes Certain Shares (See Instructions)     ¨
     
      13.

    Percent of Class Represented by Amount in Row (11)

    13.4%

     
      14.

    Type of Reporting Person (See Instructions)

    IA, PN

               

     

     

     

    CUSIP No.   282559103
     
      1.

    Names of Reporting Persons.

    Peter Kolchinsky

     
      2. Check the Appropriate Box if a Member of a Group (See Instructions)
        (a) ¨
        (b) ¨
     
      3. SEC Use Only
     
      4.

    Source of Funds (See Instructions)

    AF

     
      5. Check if Disclosure of Legal Proceedings Is Required Pursuant to Items 2(d) or 2(e)       ¨
     
      6.

    Citizenship or Place of Organization

    United States

     
    Number of
    Shares
    Beneficially
    Owned by
    Each
    Reporting
    Person With
    7.

    Sole Voting Power

    0

     
    8.

    Shared Voting Power

    14,254,298

     
    9.

    Sole Dispositive Power

    0

     
    10.

    Shared Dispositive Power

    14,254,298

     
      11.

    Aggregate Amount Beneficially Owned by Each Reporting Person

    14,254,298

     
      12. Check if the Aggregate Amount in Row (11) Excludes Certain Shares (See Instructions)     ¨
     
      13.

    Percent of Class Represented by Amount in Row (11)

    13.4%

     
      14.

    Type of Reporting Person (See Instructions)

    HC, IN

               

     

     

     

    CUSIP No.   282559103
     
      1.

    Names of Reporting Persons.

    Rajeev Shah

     
      2. Check the Appropriate Box if a Member of a Group (See Instructions)
        (a) ¨
        (b) ¨
     
      3. SEC Use Only
     
      4.

    Source of Funds (See Instructions)

    AF

     
      5. Check if Disclosure of Legal Proceedings Is Required Pursuant to Items 2(d) or 2(e)      ¨
     
      6.

    Citizenship or Place of Organization

    United States

     
    Number of
    Shares
    Beneficially
    Owned by
    Each
    Reporting
    Person With
    7.

    Sole Voting Power

    0

     
    8.

    Shared Voting Power

    14,254,298

     
    9.

    Sole Dispositive Power

    0

     
    10.

    Shared Dispositive Power

    14,254,298

     
      11.

    Aggregate Amount Beneficially Owned by Each Reporting Person

    14,254,298

     
      12. Check if the Aggregate Amount in Row (11) Excludes Certain Shares (See Instructions)      ¨
     
      13.

    Percent of Class Represented by Amount in Row (11)

    13.4%

     
      14.

    Type of Reporting Person (See Instructions)

    HC, IN

               

     

     

     

    CUSIP No.   282559103
     
      1.

    Names of Reporting Persons.

    RA Capital Healthcare Fund, L.P.

     
      2. Check the Appropriate Box if a Member of a Group (See Instructions)
        (a) ¨
        (b) ¨
     
      3. SEC Use Only
     
      4.

    Source of Funds (See Instructions)

    WC

     
      5. Check if Disclosure of Legal Proceedings Is Required Pursuant to Items 2(d) or 2(e)      ¨
     
      6.

    Citizenship or Place of Organization

    Delaware

     
    Number of
    Shares
    Beneficially
    Owned by
    Each
    Reporting
    Person With
    7.

    Sole Voting Power

    0

     
    8.

    Shared Voting Power

    13,840,034

     
    9.

    Sole Dispositive Power

    0

     
    10.

    Shared Dispositive Power

    13,840,034

     
      11.

    Aggregate Amount Beneficially Owned by Each Reporting Person

    13,840,034

     
      12. Check if the Aggregate Amount in Row (11) Excludes Certain Shares (See Instructions)      ¨
     
      13.

    Percent of Class Represented by Amount in Row (11)

    13.1%

     
      14.

    Type of Reporting Person (See Instructions)

    PN

               

     

     

      

    Item 1.Security and Issuer

     

    Item 1 of the Statement is amended and supplemented as follows:

     

    This Amendment No. 10 (this “Amendment No. 10” or this “13D/A”) amends and supplements the Schedule 13D originally filed with the Securities and Exchange Commission (the “SEC”) on November 13, 2019, and amended on July 10, 2020, September 21, 2020, June 2, 2021, July 6, 2022, October 21, 2022, March 30, 2023, August 11, 2023, December 13, 2023 and March 6, 2024 (as amended, the “Statement”), filed by RA Capital Management, L.P., Dr. Kolchinsky, Mr. Shah, and RA Capital Healthcare Fund, L.P. with respect to the common stock, par value $0.001 per share (the “Common Stock”), of 89bio, Inc., a Delaware corporation (the “Issuer”). Unless otherwise defined herein, capitalized terms used in this Amendment No. 10 shall have the meanings ascribed to them in the Statement. Unless amended or supplemented below, the information in the Statement remains unchanged.

     

    Item 2.Identity and Background

     

    Item 2 of the Statement is amended and restated in its entirety to read as follows:

     

    (a)This Amendment No. 10 is being filed on behalf of RA Capital Management, L.P. (“RA Capital”), Peter Kolchinsky, Rajeev Shah, and RA Capital Healthcare Fund, L.P. (the “Fund”), who are collectively referred to herein as the “Reporting Persons.” The agreement among the Reporting Persons to file this 13D/A jointly in accordance with Rule 13d-1(k) of the Securities Exchange Act of 1934, as amended (the “Act”), is attached hereto as Exhibit 1.

     

    The Reporting Persons’ ownership of the Issuer’s securities includes (i) 13,840,034 shares of Common Stock held directly by the Fund; (ii) 335,364 shares of Common Stock held directly by RA Capital Nexus Fund, L.P. (the “Nexus Fund”); (iii) a total of 78,900 vested stock options (right to buy) held by Derek DiRocco for the benefit of RA Capital; and (iv) a total of 1,081,081 pre-funded warrants (“PFWs”), through which the Fund has the right to acquire 1,081,081 shares of Common Stock subject to the PFW Beneficial Ownership Blocker as defined below. The PFWs contain a provision (the “PFW Beneficial Ownership Blocker”) which precludes exercise of the PFWs to the extent that, following the exercise, the Reporting Persons, together with their affiliates and other attribution parties, would beneficially own more than 9.99% of the Issuer’s outstanding Common Stock. By virtue of the PFW Beneficial Ownership Blocker, the PFWs are currently not exercisable.

     

    RA Capital Healthcare Fund GP, LLC is the general partner of the Fund and RA Capital Nexus Fund GP, LLC is the general partner of the Nexus Fund. The general partner of RA Capital is RA Capital Management GP, LLC, of which Dr. Kolchinsky and Mr. Shah are the controlling persons. RA Capital serves as investment adviser for the Fund and the Nexus Fund and may be deemed a beneficial owner, for purposes of Section 13(d) of the Act, of any securities of the Issuer held by the Fund or the Nexus Fund. The Fund and the Nexus Fund have delegated to RA Capital the sole power to vote and the sole power to dispose of all securities held in the Fund’s and the Nexus Fund’s portfolio, including the shares of the Issuer’s Common Stock reported herein. Because the Fund and the Nexus Fund have divested themselves of voting and investment power over the reported securities they hold and may not revoke that delegation on less than 61 days’ notice, the Fund and the Nexus Fund disclaim beneficial ownership of the securities they hold for purposes of Section 13(d) of the Act and therefore disclaim any obligation to report ownership of the reported securities under Section 13(d) of the Act. As managers of RA Capital, Dr. Kolchinsky and Mr. Shah may be deemed beneficial owners, for purposes of Section 13(d) of the Act, of any securities of the Issuer beneficially owned by RA Capital. RA Capital, Dr. Kolchinsky, and Mr. Shah disclaim beneficial ownership of the securities reported in this 13D/A other than for the purpose of determining their obligations under Section 13(d) of the Act, and the filing of this 13D/A shall not be deemed an admission that either RA Capital, Dr. Kolchinsky, or Mr. Shah is the beneficial owner of such securities for any other purpose.

     

    (b)The address of the principal business office of each of the Reporting Persons is 200 Berkeley Street, 18th Floor, Boston, MA 02116.

     

    (c)The Fund is a private investment vehicle. RA Capital provides investment management services to the Fund and the Nexus Fund. The principal occupation of each of Dr. Kolchinsky and Mr. Shah is investment management.

     

    (d)During the last five years, none of the Reporting Persons has been convicted in a criminal proceeding (excluding traffic violations or similar misdemeanors).

     

     

     

     

    (e)During the last five years, none of the Reporting Persons has been a party to a civil proceeding of a judicial or administrative body of competent jurisdiction and as a result of such proceeding was or is subject to a judgment, decree of final order enjoining future violations of, or prohibiting or mandating activities subject to, federal or state securities laws or finding any violation with respect to such laws.

      

    (f)See Item 6 of the cover pages.

     

    Item 5.Interest in Securities of the Issuer

     

    Item 5 of the Statement is hereby amended and restated in its entirety to read as follows:

     

    (a)The information set forth in rows 11 and 13 of the cover pages to this Schedule 13D/A is incorporated by reference. The percentage set forth in row 13 is based on the sum of (i) 105,909,991 shares of Common Stock outstanding as of July 29, 2024, as reported in the Issuer’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 5, 2024; and (ii) 78,900 shares of Common Stock issuable upon exercise of stock options, as applicable.

     

    (b)The information set forth in rows 7 through 10 of the cover pages to this Schedule 13D/A and Item 2 above is incorporated by reference.

     

    (c)No transactions with respect to the securities of the Issuer have been effected during the past sixty days by any Reporting Person. The percentage ownership reported in this 13D/A reflects an increase in the number of outstanding shares of the Issuer.

     

    (d)No person (other than the Reporting Persons) is known to have the right to receive or the power to direct the receipt of dividends from, or the proceeds from the sale of, the shares of Common Stock subject to this 13D/A.

     

    (e)Not applicable.

     

    Item 7.Material to be Filed as Exhibits

     

    Item 7 of the Statement is amended and supplemented by the following:

     

    Exhibit 1 Joint Filing Agreement

     

     

     

     

    SIGNATURES

      

    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: August 7, 2024

     

    RA CAPITAL MANAGEMENT, L.P.  
         
    By: /s/ Peter Kolchinsky  
      Name: Peter Kolchinsky  
      Title: Authorized Signatory  
         
    PETER KOLCHINSKY  
         
    /s/ Peter Kolchinsky  
         
    RAJEEV SHAH  
         
    /s/ Rajeev Shah  
         
    RA CAPITAL HEALTHCARE FUND, L.P.  
         
    By: RA Capital Healthcare Fund GP, LLC  
    Its: General Partner  
         
    By: /s/ Peter Kolchinsky  
      Name: Peter Kolchinsky  
      Title: Manager  

     

     

     

     

    Exhibit 1

     

    JOINT FILING AGREEMENT

     

    This Joint Filing Agreement, dated as of August 7, 2024, is by and among RA Capital Management, L.P., Peter Kolchinsky, Rajeev Shah, and RA Capital Healthcare Fund, L.P. (the foregoing are collectively referred to herein as the “Filers”).

     

    Each of the Filers may be required to file with the United States Securities and Exchange Commission a statement on Schedule 13G and/or 13D with respect to Common Stock, par value $0.001 per share of 89bio, Inc. beneficially owned by them from time to time.

     

    Pursuant to and in accordance with Rule 13(d)(1)(k) promulgated under the Securities Exchange Act of 1934, as amended, the Filers hereby agree to file a single statement on Schedule 13G and/or 13D (and any amendments thereto) on behalf of each of such parties, and hereby further agree to file this Joint Filing Agreement as an exhibit to such statement, as required by such rule.

     

    This Joint Filing Agreement may be terminated by any of the Filers upon one week’s prior written notice or such lesser period of notice as the Filers may mutually agree.

     

    Executed and delivered as of the date first above written.

     

    RA CAPITAL MANAGEMENT, L.P.  
         
    By: /s/ Peter Kolchinsky  
      Name: Peter Kolchinsky  
      Title: Authorized Signatory  
         
    PETER KOLCHINSKY  
         
    /s/ Peter Kolchinsky  
         
    RAJEEV SHAH  
         
    /s/ Rajeev Shah  
         
    RA CAPITAL HEALTHCARE FUND, L.P.  
         
    By: RA Capital Healthcare Fund GP, LLC  
    Its: General Partner  
         
    By: /s/ Peter Kolchinsky  
      Name: Peter Kolchinsky  
      Title: Manager  

      

     

     

     

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    • Director Mcwherter Charles bought $99,850 worth of shares (15,000 units at $6.66), increasing direct ownership by 150% to 25,000 units (SEC Form 4)

      4 - 89bio, Inc. (0001785173) (Issuer)

      1/23/25 7:38:31 PM ET
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      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Chief Executive Officer Palekar Rohan bought $39,450 worth of shares (5,000 units at $7.89), increasing direct ownership by 1% to 471,236 units (SEC Form 4)

      4 - 89bio, Inc. (0001785173) (Issuer)

      12/10/24 6:02:26 AM ET
      $ETNB
      Biotechnology: Pharmaceutical Preparations
      Health Care

    $ETNB
    Financials

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    • 89bio's Phase 2b ENLIVEN Trial of Pegozafermin in Nonalcoholic Steatohepatitis (NASH) Achieved High Statistical Significance on Both Primary Histology Endpoints with Weekly (QW) and Every-Two-Week (Q2W) Dosing at 24 Weeks

      - 44mg Q2W dose had a placebo-adjusted effect size of 20% on at least one-stage fibrosis improvement without worsening of NASH (p=0.008) and 24% on NASH resolution without worsening of fibrosis (p=0.0005) - - 30mg QW dose had a placebo-adjusted effect size of 19% on at least one-stage fibrosis improvement without worsening of NASH (p=0.008) and 21% on NASH resolution without worsening of fibrosis (p=0.0009) - - 44mg Q2W and 30mg QW doses had at least one-stage fibrosis improvement without worsening of NASH at 3.5 times placebo rate and NASH resolution without worsening of fibrosis at 12 to 14 times placebo rate - - Every-two-week dose data reinforces pegozafermin's pot

      3/22/23 7:00:00 AM ET
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      Biotechnology: Pharmaceutical Preparations
      Health Care
    • 89bio Reports Positive Topline Results from ENTRIGUE Phase 2 Trial of Pegozafermin in Patients with Severe Hypertriglyceridemia (SHTG)

      - Trial met primary endpoint demonstrating statistically significant and clinically meaningful reductions across all doses (63% at the 27mg QW dose; p<0.001) in triglycerides (TG) from baseline; results were consistent in patients on or not on background therapy - - Observed significant and potent reductions in atherogenic lipids (non-HDL-C and apo B), liver fat, and improvements in liver enzymes and glycemic control markers - - ENTRIGUE results support 89bio's transition to a late-stage development company; Phase 3 expected to initiate in first half of 2023 - - Conference call and webcast today at 1:30 p.m. PST/4:30 p.m. EST - SAN FRANCISCO, June 28, 2022 (GLOBE NEWSWIRE) -- 89bio, In

      6/28/22 4:01:00 PM ET
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      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Neoleukin Therapeutics Announces Year End 2021 Financial Results and Corporate Update

      - Interim data from NL-201 Phase 1 trial for patients with relapsed and refractory solid tumors anticipated in the second half of 2022 – - $142.5 million in cash and cash equivalents expected to provide runway into the second half of 2023 – - Appointment of Rohan Palekar to Board of Directors – - Company to host conference call today, March 1, 2022 at 1:30 p.m. PT / 4:30 p.m. ET – SEATTLE, March 01, 2022 (GLOBE NEWSWIRE) -- Neoleukin Therapeutics, Inc., "Neoleukin" (NASDAQ:NLTX), a biopharmaceutical company utilizing sophisticated computational methods to design de novo protein therapeutics, today announced financial results and a corporate update for the year ended December 31, 2021.

      3/1/22 4:03:00 PM ET
      $ETNB
      $NLTX
      Biotechnology: Pharmaceutical Preparations
      Health Care