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

    2/14/24 4:21:50 PM ET
    $KALA
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $KALA alert in real time by email
    SC 13G/A 1 tm242424d20_sc13ga.htm SC 13G/A

     

     

     

    SCHEDULE 13G

     

    SECURITIES AND EXCHANGE COMMISSION
    WASHINGTON, DC 20549

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

     

    KALA BIO, Inc. (f/k/a Kala Pharmaceuticals, Inc.)

    (Name of Issuer)

     

    Common Stock, par value $0.001 per share

    (Title of Class of Securities)

     

    483119202

     

     

    (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. 483119202

     

    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  

    269,213 (1)
    6   SHARED VOTING POWER  

    -0-  
    7   SOLE DISPOSITIVE POWER  

    269,213 (1)
    8   SHARED DISPOSITIVE POWER  

    -0-  

    9   AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON

    269,213 (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

    9.99% (1)(2)
    12   TYPE OF REPORTING PERSON (See Instructions)  

    IA, PN 
             
               

     

      (1) Includes 2,600 shares of Common Stock (“Common Stock”) of KALA BIO, Inc. (the “Issuer”) issuable upon conversion of 26 shares of Series E Convertible Preferred or Series F Convertible Preferred (as defined in Item 4 and subject to the limitations as described therein) (or some combination thereof) directly held by the Funds (as defined in Item 4 below).

     

      (2) Based on 2,693,116 shares of Common Stock of the Issuer outstanding as of November 10, 2023, as reported in the Issuer’s Form 10-Q filed with the Securities and Exchange Commission (“SEC”) on November 13, 2023, plus 2,600 shares of Common Stock issuable upon the conversion of 26 shares of Series E Convertible Preferred or Series F Convertible Preferred (as defined in Item 4 below) (or some combination thereof) that are subject to the limitations on conversion described in Item 4.

     

     

     

     

    CUSIP No. 483119202

     

    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  

    269,213 (1)
    6   SHARED VOTING POWER  

    -0-  
    7   SOLE DISPOSITIVE POWER  

    269,213 (1)
    8   SHARED DISPOSITIVE POWER  

    -0-  

    9   AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON

    269,213 (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

    9.99% (1)(2)
    12   TYPE OF REPORTING PERSON (See Instructions)  

    HC, OO
             
               

     

      (1) Includes 2,600 shares of Common Stock of the Issuer issuable upon conversion of 26 shares of Series E Convertible Preferred or Series F Convertible Preferred (as defined in Item 4 and subject to the limitations as described therein) (or some combination thereof) directly held by the Funds (as defined in Item 4 below).

     

      (2) Based on 2,693,116 shares of Common Stock of the Issuer outstanding as of November 10, 2023, as reported in the Issuer’s Form 10-Q filed with the SEC on November 13, 2023, plus 2,600 shares of Common Stock issuable upon the conversion of 26 shares of Series E Convertible Preferred or Series F Convertible Preferred (as defined in Item 4 below) (or some combination thereof) that are subject to the limitations on conversion described in Item 4.

     

     

     

     

    CUSIP No. 483119202

     

    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  

    269,213 (1)
    6   SHARED VOTING POWER  

    -0-  
    7   SOLE DISPOSITIVE POWER  

    269,213 (1)
    8   SHARED DISPOSITIVE POWER  

    -0-  

    9   AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON

    269,213 (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

    9.99% (1)(2)
    12   TYPE OF REPORTING PERSON (See Instructions)  

    IN, HC
             
               

     

      (1) Includes 2,600 shares of Common Stock of the Issuer issuable upon conversion of 26 shares of Series E Convertible Preferred or Series F Convertible Preferred (as defined in Item 4 and subject to the limitations as described therein) (or some combination thereof) directly held by the Funds (as defined in Item 4 below).

     

      (2) Based on 2,693,116 shares of Common Stock of the Issuer outstanding as of November 10, 2023, as reported in the Issuer’s Form 10-Q filed with the SEC on November 13, 2023, plus 2,600 shares of Common Stock issuable upon the conversion of 26 shares of Series E Convertible Preferred or Series F Convertible Preferred (as defined in Item 4 below) (or some combination thereof) that are subject to the limitations on conversion described in Item 4.

     

     

     

     

    CUSIP No. 483119202

     

    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  

    269,213 (1)
    6   SHARED VOTING POWER  

    -0-  
    7   SOLE DISPOSITIVE POWER  

    269,213 (1)
    8   SHARED DISPOSITIVE POWER  

    -0-  

    9   AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON

    269,213 (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

    9.99% (1)(2)
    12   TYPE OF REPORTING PERSON (See Instructions)  

    IN, HC
             
               

     

      (1) Includes 2,600 shares of Common Stock of the Issuer issuable upon conversion of 26 shares of Series E Convertible Preferred or Series F Convertible Preferred (as defined in Item 4 and subject to the limitations as described therein) (or some combination thereof) directly held by the Funds (as defined in Item 4 below).

     

      (2) Based on 2,693,116 shares of Common Stock of the Issuer outstanding as of November 10, 2023, as reported in the Issuer’s Form 10-Q filed with the SEC on November 13, 2023, plus 2,600 shares of Common Stock issuable upon the conversion of 26 shares of Series E Convertible Preferred or Series F Convertible Preferred (as defined in Item 4 below) (or some combination thereof) 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 and restates 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:

     

    KALA BIO, Inc. (the “Issuer”)

     

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

     

    1167 Massachusetts Avenue

     

    Arlington, MA 02476

     

    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, $0.001 par value per share (“Common Stock”)

     

    Item 2(e)   CUSIP Number:

     

    483119202

     

    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 Series E convertible non-redeemable preferred stock which is a Common Stock equivalent with no voting rights and convertible at any time on a 1-to-100 basis without consideration into Common Stock (“Series E Convertible Preferred”) and Series F convertible non-redeemable preferred stock which is a Common Stock equivalent with no voting rights and convertible at any time on a 1-to-100 basis without consideration into Common Stock (“Series F Convertible Preferred” and together with Series E Convertible Preferred, the “Series E and F Convertible Preferred”), subject to the limitations on conversion described below.

     

    The information set forth below is based upon 2,693,116 shares of Common Stock outstanding as of November 10, 2023, as reported in the Issuer’s Form 10-Q filed with the Securities and Exchange Commission on November 13, 2023, plus 2,600 shares of Common Stock issuable upon the conversion of 26 shares of Series E Convertible Preferred or Series F Convertible Preferred (or some combination thereof) that are subject to the limitations on conversion described below. 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.   26,574    0.99%
    Baker Brothers Life Sciences, L.P.   242,639    9.00%
    Total   269,213    9.99%

     

    The Series E and F Convertible Preferred are only convertible to the extent that after giving effect or immediately prior to such conversion the holders thereof and their affiliates and any persons who are members of a Section 13(d) group with the holders or their affiliates would beneficially own in the aggregate, for purposes of Rule 13d-3 under the Exchange Act, no more than 9.99% of the outstanding Common Stock of the Issuer (the “Beneficial Ownership Limitation”). As a result of the Beneficial Ownership Limitation, the number of shares of Common Stock that may be issued upon conversion of the shares of Series E and F Convertible Preferred by the above holders may change depending upon changes in the outstanding shares of Common Stock. By notice to the Issuer, the Funds may increase or decrease the Beneficial Ownership Limitation applicable to that Fund to any other percentage not in excess of 19.99%; provided that any such increase will not be effective until the 61st day after such notice is delivered to the Issuer.

     

    Pursuant to the management agreements, as amended, among the Adviser, the Funds 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.

     

    The Adviser GP is the sole general partner of the Adviser. 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.

     

    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 ¨. N/A

     

    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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      -- Announced positive data from initial safety portion of CHASE Phase 2b clinical trial of KPI-012; now enrolling primary safety and efficacy portion of trial, with topline data targeted in 1Q 2024 ---- Received FDA Fast Track designation for KPI-012 for the treatment of PCED ---- Strengthened clinical R&D team with appointment of Dr. Francis Mah as Chief Medical Advisor – -- Awarded $15 million grant from CIRM to support the KPI-012 PCED program -- ARLINGTON, Mass., May 09, 2023 (GLOBE NEWSWIRE) -- Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for rare and sever

      5/9/23 8:00:00 AM ET
      $KALA
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Kala Pharmaceuticals Appoints Dr. Francis Mah as Chief Medical Advisor

      ARLINGTON, Mass., March 29, 2023 (GLOBE NEWSWIRE) -- Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for rare and severe diseases of the eye, today announced the appointment of Francis Mah, M.D., as Chief Medical Advisor. In this newly established role, Dr. Mah will provide support for Kala's clinical development and medical activities and will play a key role in interactions with eye care professionals. Dr. Mah will serve in this role on a part time basis while continuing his ongoing position as Director of Cornea and External Disease and the Co-Director, Refractive Su

      3/29/23 8:00:00 AM ET
      $KALA
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Kala Pharmaceuticals downgraded by JP Morgan

      JP Morgan downgraded Kala Pharmaceuticals from Neutral to Underweight

      3/30/22 7:39:31 AM ET
      $KALA
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • HC Wainwright & Co. reiterated coverage on Kala Pharmaceuticals with a new price target

      HC Wainwright & Co. reiterated coverage of Kala Pharmaceuticals with a rating of Buy and set a new price target of $11.00 from $14.00 previously

      8/6/21 6:36:47 AM ET
      $KALA
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Kala Pharmaceuticals downgraded by JP Morgan

      JP Morgan downgraded Kala Pharmaceuticals from Overweight to Neutral

      8/6/21 5:55:07 AM ET
      $KALA
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • SEC Form SC 13G filed by KALA BIO Inc.

      SC 13G - KALA BIO, Inc. (0001479419) (Subject)

      11/14/24 4:49:42 PM ET
      $KALA
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • SEC Form SC 13D filed by KALA BIO Inc.

      SC 13D - KALA BIO, Inc. (0001479419) (Subject)

      7/8/24 8:54:55 PM ET
      $KALA
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • SEC Form SC 13D filed by KALA BIO Inc.

      SC 13D - KALA BIO, Inc. (0001479419) (Subject)

      6/28/24 4:11:51 PM ET
      $KALA
      Biotechnology: Pharmaceutical Preparations
      Health Care

    $KALA
    Insider Purchases

    Insider purchases reveal critical bullish sentiment about the company from key stakeholders. See them live in this feed.

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    • Large owner Baker Bros. Advisors Lp bought $2,000,000 worth of shares (310,559 units at $6.44) (SEC Form 4)

      4 - KALA BIO, Inc. (0001479419) (Issuer)

      12/31/24 4:00:18 PM ET
      $KALA
      Biotechnology: Pharmaceutical Preparations
      Health Care