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    SEC Form SC 13G/A filed by DBV Technologies S.A. (Amendment)

    2/14/24 8:56:45 PM ET
    $DBVT
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care
    Get the next $DBVT alert in real time by email
    SC 13G/A 1 tm246235d24_sc13ga.htm SC 13G/A

     

     

     

    UNITED STATES

    SECURITIES AND EXCHANGE COMMISSION

    WASHINGTON, D.C. 20549

     

    SCHEDULE 13G/A

     

    UNDER THE SECURITIES EXCHANGE ACT OF 1934
    (Amendment No. 2)*

      

    DBV Technologies S.A.

    (Name of Issuer)

     

    Ordinary Shares, €0.10 nominal value per share

    (Title of Class of Securities)

     

    23306J101 (American Depositary Shares, each representing one-half of one Ordinary Share)

    (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. 23306J101Page 2 of 17

     

     

               
    1.  

    Name of reporting persons

     

    Venrock Healthcare Capital Partners II, L.P.

    2.  

    Check the Appropriate Box if a Member of a Group (See Instructions)

    (a) x1 (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

     

    9,654,6562

    7.  

    Sole Dispositive Power

     

    0

    8.  

    Shared Dispositive Power

     

    9,654,6562

    9.  

    Aggregate Amount Beneficially Owned by Each Reporting Person

     

    9,654,6562

    10.  

    Check if the Aggregate Amount in Row (9) Excludes Certain Shares (See Instructions) ¨

     

    11.  

    Percent of Class Represented by Amount in Row (9)

     

    9.99%3

    12.  

    Type of Reporting Person (See Instructions)

     

    PN

                     
    1Venrock Healthcare Capital Partners II, L.P., VHCP Co-Investment Holdings II, LLC, Venrock Healthcare Capital Partners III, L.P., VHCP Co-Investment Holdings III, LLC, Venrock Healthcare Capital Partners EG, L.P., VHCP Management II, LLC, VHCP Management III, LLC, VHCP Management EG, LLC, Nimish Shah and Bong Koh are members of a group for the purposes of this Schedule 13G/A.

     

    2Consists of (i) 951,439 shares and 36,283 shares issuable upon the exercise of immediately exercisable pre-funded warrants (“Warrants”) held by Venrock Healthcare Capital Partners II, L.P., (ii) 385,717 shares and 14,709 shares issuable upon the exercise of Warrants held by VHCP Co-Investment Holdings II, LLC, (iii) 2,093,431 shares and 79,833 shares issuable upon the exercise of Warrants held by Venrock Healthcare Capital Partners III, L.P., (iv) 209,422 shares and 7,986 shares issuable upon the exercise of Warrants held by VHCP Co-Investment Holdings III, LLC and (v) 5,659,991 shares and 215,844 shares issuable upon the exercise of Warrants held by Venrock Healthcare Capital Partners EG, L.P. The share numbers in the preceding sentence represent the maximum number of ordinary shares issuable upon exercise of the Warrants held by the Reporting Persons as a result of the beneficial ownership provision described in the following sentence. Under the terms of the Warrants, the Issuer may not effect the exercise of any such Warrant, and a holder will not be entitled to exercise any portion of such Warrant, if, upon giving effect to such exercise, the aggregate number of ordinary shares beneficially owned by the holder (together with its affiliates and other attribution parties) would exceed 9.99% of the number of ordinary shares outstanding immediately after giving effect to the exercise.

     

    3This percentage is calculated based upon the sum of (i) 96,288,553 ordinary shares outstanding as of October 31, 2023, as reported in the Issuer’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on October 31, 2023; and (ii) 354,656 shares issuable upon the exercise of the Warrants described in Footnote 2 above.

     

     

    CUSIP No. 23306J101Page 3 of 17

     

     

               
    1.  

    Name of reporting persons

     

    VHCP Co-Investment Holdings II, LLC

    2.  

    Check the Appropriate Box if a Member of a Group (See Instructions)

    (a) x1 (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

     

    9,654,6562

    7.  

    Sole Dispositive Power

     

    0

    8.  

    Shared Dispositive Power

     

    9,654,6562

    9.  

    Aggregate Amount Beneficially Owned by Each Reporting Person

     

    9,654,6562

    10.  

    Check if the Aggregate Amount in Row (9) Excludes Certain Shares (See Instructions) ¨

     

    11.  

    Percent of Class Represented by Amount in Row (9)

     

    9.99%3

    12.  

    Type of Reporting Person (See Instructions)

     

    OO

                     
    1Venrock Healthcare Capital Partners II, L.P., VHCP Co-Investment Holdings II, LLC, Venrock Healthcare Capital Partners III, L.P., VHCP Co-Investment Holdings III, LLC, Venrock Healthcare Capital Partners EG, L.P., VHCP Management II, LLC, VHCP Management III, LLC, VHCP Management EG, LLC, Nimish Shah and Bong Koh are members of a group for the purposes of this Schedule 13G/A.

     

    2Consists of (i) 951,439 shares and 36,283 shares issuable upon the exercise of immediately exercisable pre-funded warrants (“Warrants”) held by Venrock Healthcare Capital Partners II, L.P., (ii) 385,717 shares and 14,709 shares issuable upon the exercise of Warrants held by VHCP Co-Investment Holdings II, LLC, (iii) 2,093,431 shares and 79,833 shares issuable upon the exercise of Warrants held by Venrock Healthcare Capital Partners III, L.P., (iv) 209,422 shares and 7,986 shares issuable upon the exercise of Warrants held by VHCP Co-Investment Holdings III, LLC and (v) 5,659,991 shares and 215,844 shares issuable upon the exercise of Warrants held by Venrock Healthcare Capital Partners EG, L.P. The share numbers in the preceding sentence represent the maximum number of ordinary shares issuable upon exercise of the Warrants held by the Reporting Persons as a result of the beneficial ownership provision described in the following sentence. Under the terms of the Warrants, the Issuer may not effect the exercise of any such Warrant, and a holder will not be entitled to exercise any portion of such Warrant, if, upon giving effect to such exercise, the aggregate number of ordinary shares beneficially owned by the holder (together with its affiliates and other attribution parties) would exceed 9.99% of the number of ordinary shares outstanding immediately after giving effect to the exercise.

     

    3This percentage is calculated based upon the sum of (i) 96,288,553 ordinary shares outstanding as of October 31, 2023, as reported in the Issuer’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on October 31, 2023; and (ii) 354,656 shares issuable upon the exercise of the Warrants described in Footnote 2 above.

     

     

    CUSIP No. 23306J101Page 4 of 17

     

     

               
    1.  

    Name of reporting persons

     

    Venrock Healthcare Capital Partners III, L.P.

    2.  

    Check the Appropriate Box if a Member of a Group (See Instructions)

    (a) x1 (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

     

    9,654,6562

    7.  

    Sole Dispositive Power

     

    0

    8.  

    Shared Dispositive Power

     

    9,654,6562

    9.  

    Aggregate Amount Beneficially Owned by Each Reporting Person

     

    9,654,6562

    10.  

    Check if the Aggregate Amount in Row (9) Excludes Certain Shares (See Instructions) ¨

     

    11.  

    Percent of Class Represented by Amount in Row (9)

     

    9.99%3

    12.  

    Type of Reporting Person (See Instructions)

     

    PN

                     
    1Venrock Healthcare Capital Partners II, L.P., VHCP Co-Investment Holdings II, LLC, Venrock Healthcare Capital Partners III, L.P., VHCP Co-Investment Holdings III, LLC, Venrock Healthcare Capital Partners EG, L.P., VHCP Management II, LLC, VHCP Management III, LLC, VHCP Management EG, LLC, Nimish Shah and Bong Koh are members of a group for the purposes of this Schedule 13G/A.

     

    2Consists of (i) 951,439 shares and 36,283 shares issuable upon the exercise of immediately exercisable pre-funded warrants (“Warrants”) held by Venrock Healthcare Capital Partners II, L.P., (ii) 385,717 shares and 14,709 shares issuable upon the exercise of Warrants held by VHCP Co-Investment Holdings II, LLC, (iii) 2,093,431 shares and 79,833 shares issuable upon the exercise of Warrants held by Venrock Healthcare Capital Partners III, L.P., (iv) 209,422 shares and 7,986 shares issuable upon the exercise of Warrants held by VHCP Co-Investment Holdings III, LLC and (v) 5,659,991 shares and 215,844 shares issuable upon the exercise of Warrants held by Venrock Healthcare Capital Partners EG, L.P. The share numbers in the preceding sentence represent the maximum number of ordinary shares issuable upon exercise of the Warrants held by the Reporting Persons as a result of the beneficial ownership provision described in the following sentence. Under the terms of the Warrants, the Issuer may not effect the exercise of any such Warrant, and a holder will not be entitled to exercise any portion of such Warrant, if, upon giving effect to such exercise, the aggregate number of ordinary shares beneficially owned by the holder (together with its affiliates and other attribution parties) would exceed 9.99% of the number of ordinary shares outstanding immediately after giving effect to the exercise.

     

    3This percentage is calculated based upon the sum of (i) 96,288,553 ordinary shares outstanding as of October 31, 2023, as reported in the Issuer’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on October 31, 2023; and (ii) 354,656 shares issuable upon the exercise of the Warrants described in Footnote 2 above.

     

     

    CUSIP No. 23306J101Page 5 of 17

     

     

               
    1.

    Name of reporting persons

     

    VHCP Co-Investment Holdings III, LLC

    2.  

    Check the Appropriate Box if a Member of a Group (See Instructions)

    (a) x1 (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

     

    9,654,6562

    7.  

    Sole Dispositive Power

     

    0

    8.  

    Shared Dispositive Power

     

    9,654,6562

    9.  

    Aggregate Amount Beneficially Owned by Each Reporting Person

     

    9,654,6562

    10.  

    Check if the Aggregate Amount in Row (9) Excludes Certain Shares (See Instructions) ¨

     

    11.  

    Percent of Class Represented by Amount in Row (9)

     

    9.99%3

    12.  

    Type of Reporting Person (See Instructions)

     

    OO

                       
    1Venrock Healthcare Capital Partners II, L.P., VHCP Co-Investment Holdings II, LLC, Venrock Healthcare Capital Partners III, L.P., VHCP Co-Investment Holdings III, LLC, Venrock Healthcare Capital Partners EG, L.P., VHCP Management II, LLC, VHCP Management III, LLC, VHCP Management EG, LLC, Nimish Shah and Bong Koh are members of a group for the purposes of this Schedule 13G/A.

     

    2Consists of (i) 951,439 shares and 36,283 shares issuable upon the exercise of immediately exercisable pre-funded warrants (“Warrants”) held by Venrock Healthcare Capital Partners II, L.P., (ii) 385,717 shares and 14,709 shares issuable upon the exercise of Warrants held by VHCP Co-Investment Holdings II, LLC, (iii) 2,093,431 shares and 79,833 shares issuable upon the exercise of Warrants held by Venrock Healthcare Capital Partners III, L.P., (iv) 209,422 shares and 7,986 shares issuable upon the exercise of Warrants held by VHCP Co-Investment Holdings III, LLC and (v) 5,659,991 shares and 215,844 shares issuable upon the exercise of Warrants held by Venrock Healthcare Capital Partners EG, L.P. The share numbers in the preceding sentence represent the maximum number of ordinary shares issuable upon exercise of the Warrants held by the Reporting Persons as a result of the beneficial ownership provision described in the following sentence. Under the terms of the Warrants, the Issuer may not effect the exercise of any such Warrant, and a holder will not be entitled to exercise any portion of such Warrant, if, upon giving effect to such exercise, the aggregate number of ordinary shares beneficially owned by the holder (together with its affiliates and other attribution parties) would exceed 9.99% of the number of ordinary shares outstanding immediately after giving effect to the exercise.

     

    3This percentage is calculated based upon the sum of (i) 96,288,553 ordinary shares outstanding as of October 31, 2023, as reported in the Issuer’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on October 31, 2023; and (ii) 354,656 shares issuable upon the exercise of the Warrants described in Footnote 2 above.

     

     

    CUSIP No. 23306J101Page 6 of 17

     

     

               
    1.  

    Name of reporting persons

     

    Venrock Healthcare Capital Partners EG, L.P.

    2.  

    Check the Appropriate Box if a Member of a Group (See Instructions)

    (a) x1 (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

     

    9,654,6562

    7.  

    Sole Dispositive Power

     

    0

    8.  

    Shared Dispositive Power

     

    9,654,6562

    9.  

    Aggregate Amount Beneficially Owned by Each Reporting Person

     

    9,654,6562

    10.  

    Check if the Aggregate Amount in Row (9) Excludes Certain Shares (See Instructions) ¨

     

    11.  

    Percent of Class Represented by Amount in Row (9)

     

    9.99%3

    12.  

    Type of Reporting Person (See Instructions)

     

    PN

                     
    1Venrock Healthcare Capital Partners II, L.P., VHCP Co-Investment Holdings II, LLC, Venrock Healthcare Capital Partners III, L.P., VHCP Co-Investment Holdings III, LLC, Venrock Healthcare Capital Partners EG, L.P., VHCP Management II, LLC, VHCP Management III, LLC, VHCP Management EG, LLC, Nimish Shah and Bong Koh are members of a group for the purposes of this Schedule 13G/A.

     

    2Consists of (i) 951,439 shares and 36,283 shares issuable upon the exercise of immediately exercisable pre-funded warrants (“Warrants”) held by Venrock Healthcare Capital Partners II, L.P., (ii) 385,717 shares and 14,709 shares issuable upon the exercise of Warrants held by VHCP Co-Investment Holdings II, LLC, (iii) 2,093,431 shares and 79,833 shares issuable upon the exercise of Warrants held by Venrock Healthcare Capital Partners III, L.P., (iv) 209,422 shares and 7,986 shares issuable upon the exercise of Warrants held by VHCP Co-Investment Holdings III, LLC and (v) 5,659,991 shares and 215,844 shares issuable upon the exercise of Warrants held by Venrock Healthcare Capital Partners EG, L.P. The share numbers in the preceding sentence represent the maximum number of ordinary shares issuable upon exercise of the Warrants held by the Reporting Persons as a result of the beneficial ownership provision described in the following sentence. Under the terms of the Warrants, the Issuer may not effect the exercise of any such Warrant, and a holder will not be entitled to exercise any portion of such Warrant, if, upon giving effect to such exercise, the aggregate number of ordinary shares beneficially owned by the holder (together with its affiliates and other attribution parties) would exceed 9.99% of the number of ordinary shares outstanding immediately after giving effect to the exercise.

     

    3This percentage is calculated based upon the sum of (i) 96,288,553 ordinary shares outstanding as of October 31, 2023, as reported in the Issuer’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on October 31, 2023; and (ii) 354,656 shares issuable upon the exercise of the Warrants described in Footnote 2 above.

     

     

    CUSIP No. 23306J101Page 7 of 17

     

     

               
    1.  

    Name of reporting persons

     

    VHCP Management II, LLC

    2.  

    Check the Appropriate Box if a Member of a Group (See Instructions)

    (a) x1 (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

     

    9,654,6562

    7.  

    Sole Dispositive Power

     

    0

    8.  

    Shared Dispositive Power

     

    9,654,6562

    9.  

    Aggregate Amount Beneficially Owned by Each Reporting Person

     

    9,654,6562

    10.  

    Check if the Aggregate Amount in Row (9) Excludes Certain Shares (See Instructions) ¨

     

    11.  

    Percent of Class Represented by Amount in Row (9)

     

    9.99%3

    12.  

    Type of Reporting Person (See Instructions)

     

    OO

                     

    1Venrock Healthcare Capital Partners II, L.P., VHCP Co-Investment Holdings II, LLC, Venrock Healthcare Capital Partners III, L.P., VHCP Co-Investment Holdings III, LLC, Venrock Healthcare Capital Partners EG, L.P., VHCP Management II, LLC, VHCP Management III, LLC, VHCP Management EG, LLC, Nimish Shah and Bong Koh are members of a group for the purposes of this Schedule 13G/A.

     

    2Consists of (i) 951,439 shares and 36,283 shares issuable upon the exercise of immediately exercisable pre-funded warrants (“Warrants”) held by Venrock Healthcare Capital Partners II, L.P., (ii) 385,717 shares and 14,709 shares issuable upon the exercise of Warrants held by VHCP Co-Investment Holdings II, LLC, (iii) 2,093,431 shares and 79,833 shares issuable upon the exercise of Warrants held by Venrock Healthcare Capital Partners III, L.P., (iv) 209,422 shares and 7,986 shares issuable upon the exercise of Warrants held by VHCP Co-Investment Holdings III, LLC and (v) 5,659,991 shares and 215,844 shares issuable upon the exercise of Warrants held by Venrock Healthcare Capital Partners EG, L.P. The share numbers in the preceding sentence represent the maximum number of ordinary shares issuable upon exercise of the Warrants held by the Reporting Persons as a result of the beneficial ownership provision described in the following sentence. Under the terms of the Warrants, the Issuer may not effect the exercise of any such Warrant, and a holder will not be entitled to exercise any portion of such Warrant, if, upon giving effect to such exercise, the aggregate number of ordinary shares beneficially owned by the holder (together with its affiliates and other attribution parties) would exceed 9.99% of the number of ordinary shares outstanding immediately after giving effect to the exercise.

     

    3This percentage is calculated based upon the sum of (i) 96,288,553 ordinary shares outstanding as of October 31, 2023, as reported in the Issuer’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on October 31, 2023; and (ii) 354,656 shares issuable upon the exercise of the Warrants described in Footnote 2 above.

     

     

    CUSIP No. 23306J101Page 8 of 17

     

     

               
    1.  

    Name of reporting persons

     

    VHCP Management III, LLC

    2.  

    Check the Appropriate Box if a Member of a Group (See Instructions)

    (a) x1 (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

     

    9,654,6562

    7.  

    Sole Dispositive Power

     

    0

    8.  

    Shared Dispositive Power

     

    9,654,6562

    9.  

    Aggregate Amount Beneficially Owned by Each Reporting Person

     

    9,654,6562

    10.  

    Check if the Aggregate Amount in Row (9) Excludes Certain Shares (See Instructions) ¨

     

    11.  

    Percent of Class Represented by Amount in Row (9)

     

    9.99%3

    12.  

    Type of Reporting Person (See Instructions)

     

    OO

                     

    1Venrock Healthcare Capital Partners II, L.P., VHCP Co-Investment Holdings II, LLC, Venrock Healthcare Capital Partners III, L.P., VHCP Co-Investment Holdings III, LLC, Venrock Healthcare Capital Partners EG, L.P., VHCP Management II, LLC, VHCP Management III, LLC, VHCP Management EG, LLC, Nimish Shah and Bong Koh are members of a group for the purposes of this Schedule 13G/A.

     

    2Consists of (i) 951,439 shares and 36,283 shares issuable upon the exercise of immediately exercisable pre-funded warrants (“Warrants”) held by Venrock Healthcare Capital Partners II, L.P., (ii) 385,717 shares and 14,709 shares issuable upon the exercise of Warrants held by VHCP Co-Investment Holdings II, LLC, (iii) 2,093,431 shares and 79,833 shares issuable upon the exercise of Warrants held by Venrock Healthcare Capital Partners III, L.P., (iv) 209,422 shares and 7,986 shares issuable upon the exercise of Warrants held by VHCP Co-Investment Holdings III, LLC and (v) 5,659,991 shares and 215,844 shares issuable upon the exercise of Warrants held by Venrock Healthcare Capital Partners EG, L.P. The share numbers in the preceding sentence represent the maximum number of ordinary shares issuable upon exercise of the Warrants held by the Reporting Persons as a result of the beneficial ownership provision described in the following sentence. Under the terms of the Warrants, the Issuer may not effect the exercise of any such Warrant, and a holder will not be entitled to exercise any portion of such Warrant, if, upon giving effect to such exercise, the aggregate number of ordinary shares beneficially owned by the holder (together with its affiliates and other attribution parties) would exceed 9.99% of the number of ordinary shares outstanding immediately after giving effect to the exercise.

     

    3This percentage is calculated based upon the sum of (i) 96,288,553 ordinary shares outstanding as of October 31, 2023, as reported in the Issuer’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on October 31, 2023; and (ii) 354,656 shares issuable upon the exercise of the Warrants described in Footnote 2 above.

     

     

    CUSIP No. 23306J101Page 9 of 17

     

     

               
    1.  

    Name of reporting persons

     

    VHCP Management EG, LLC

    2.  

    Check the Appropriate Box if a Member of a Group (See Instructions)

    (a) x1 (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

     

    9,654,6562

    7.  

    Sole Dispositive Power

     

    0

    8.  

    Shared Dispositive Power

     

    9,654,6562

    9.  

    Aggregate Amount Beneficially Owned by Each Reporting Person

     

    9,654,6562

    10.  

    Check if the Aggregate Amount in Row (9) Excludes Certain Shares (See Instructions) ¨

     

    11.  

    Percent of Class Represented by Amount in Row (9)

     

    9.99%3

    12.  

    Type of Reporting Person (See Instructions)

     

    OO

                     
    1Venrock Healthcare Capital Partners II, L.P., VHCP Co-Investment Holdings II, LLC, Venrock Healthcare Capital Partners III, L.P., VHCP Co-Investment Holdings III, LLC, Venrock Healthcare Capital Partners EG, L.P., VHCP Management II, LLC, VHCP Management III, LLC, VHCP Management EG, LLC, Nimish Shah and Bong Koh are members of a group for the purposes of this Schedule 13G/A.

     

    2Consists of (i) 951,439 shares and 36,283 shares issuable upon the exercise of immediately exercisable pre-funded warrants (“Warrants”) held by Venrock Healthcare Capital Partners II, L.P., (ii) 385,717 shares and 14,709 shares issuable upon the exercise of Warrants held by VHCP Co-Investment Holdings II, LLC, (iii) 2,093,431 shares and 79,833 shares issuable upon the exercise of Warrants held by Venrock Healthcare Capital Partners III, L.P., (iv) 209,422 shares and 7,986 shares issuable upon the exercise of Warrants held by VHCP Co-Investment Holdings III, LLC and (v) 5,659,991 shares and 215,844 shares issuable upon the exercise of Warrants held by Venrock Healthcare Capital Partners EG, L.P. The share numbers in the preceding sentence represent the maximum number of ordinary shares issuable upon exercise of the Warrants held by the Reporting Persons as a result of the beneficial ownership provision described in the following sentence. Under the terms of the Warrants, the Issuer may not effect the exercise of any such Warrant, and a holder will not be entitled to exercise any portion of such Warrant, if, upon giving effect to such exercise, the aggregate number of ordinary shares beneficially owned by the holder (together with its affiliates and other attribution parties) would exceed 9.99% of the number of ordinary shares outstanding immediately after giving effect to the exercise.

     

    3This percentage is calculated based upon the sum of (i) 96,288,553 ordinary shares outstanding as of October 31, 2023, as reported in the Issuer’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on October 31, 2023; and (ii) 354,656 shares issuable upon the exercise of the Warrants described in Footnote 2 above.

     

     

    CUSIP No. 23306J101Page 10 of 17

     

     

               
    1.  

    Name of Reporting Persons

     

    Shah, Nimish

    2.  

    Check the Appropriate Box if a Member of a Group (See Instructions)

    (a) x1 (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

     

    9,654,6562

    7.  

    Sole Dispositive Power

     

    0

    8.  

    Shared Dispositive Power

     

    9,654,6562

    9.  

    Aggregate Amount Beneficially Owned by Each Reporting Person

     

    9,654,6562

    10.  

    Check if the Aggregate Amount in Row (9) Excludes Certain Shares (See Instructions) ¨

     

    11.  

    Percent of Class Represented by Amount in Row (9)

     

    9.99%3

    12.  

    Type of Reporting Person (See Instructions)

     

    IN

     

    1Venrock Healthcare Capital Partners II, L.P., VHCP Co-Investment Holdings II, LLC, Venrock Healthcare Capital Partners III, L.P., VHCP Co-Investment Holdings III, LLC, Venrock Healthcare Capital Partners EG, L.P., VHCP Management II, LLC, VHCP Management III, LLC, VHCP Management EG, LLC, Nimish Shah and Bong Koh are members of a group for the purposes of this Schedule 13G/A.

     

    2Consists of (i) 951,439 shares and 36,283 shares issuable upon the exercise of immediately exercisable pre-funded warrants (“Warrants”) held by Venrock Healthcare Capital Partners II, L.P., (ii) 385,717 shares and 14,709 shares issuable upon the exercise of Warrants held by VHCP Co-Investment Holdings II, LLC, (iii) 2,093,431 shares and 79,833 shares issuable upon the exercise of Warrants held by Venrock Healthcare Capital Partners III, L.P., (iv) 209,422 shares and 7,986 shares issuable upon the exercise of Warrants held by VHCP Co-Investment Holdings III, LLC and (v) 5,659,991 shares and 215,844 shares issuable upon the exercise of Warrants held by Venrock Healthcare Capital Partners EG, L.P. The share numbers in the preceding sentence represent the maximum number of ordinary shares issuable upon exercise of the Warrants held by the Reporting Persons as a result of the beneficial ownership provision described in the following sentence. Under the terms of the Warrants, the Issuer may not effect the exercise of any such Warrant, and a holder will not be entitled to exercise any portion of such Warrant, if, upon giving effect to such exercise, the aggregate number of ordinary shares beneficially owned by the holder (together with its affiliates and other attribution parties) would exceed 9.99% of the number of ordinary shares outstanding immediately after giving effect to the exercise.

     

    3This percentage is calculated based upon the sum of (i) 96,288,553 ordinary shares outstanding as of October 31, 2023, as reported in the Issuer’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on October 31, 2023; and (ii) 354,656 shares issuable upon the exercise of the Warrants described in Footnote 2 above.

     

     

    CUSIP No. 23306J101Page 11 of 17

     

      

               
    1.  

    Name of Reporting Persons

     

    Koh, Bong

    2.  

    Check the Appropriate Box if a Member of a Group (See Instructions)

    (a) x1 (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

     

    9,654,6562

    7.  

    Sole Dispositive Power

     

    0

    8.  

    Shared Dispositive Power

     

    9,654,6562

    9.  

    Aggregate Amount Beneficially Owned by Each Reporting Person

     

    9,654,6562

    10.  

    Check if the Aggregate Amount in Row (9) Excludes Certain Shares (See Instructions) ¨

     

    11.  

    Percent of Class Represented by Amount in Row (9)

     

    9.99%3

    12.  

    Type of Reporting Person (See Instructions)

     

    IN

     

    1Venrock Healthcare Capital Partners II, L.P., VHCP Co-Investment Holdings II, LLC, Venrock Healthcare Capital Partners III, L.P., VHCP Co-Investment Holdings III, LLC, Venrock Healthcare Capital Partners EG, L.P., VHCP Management II, LLC, VHCP Management III, LLC, VHCP Management EG, LLC, Nimish Shah and Bong Koh are members of a group for the purposes of this Schedule 13G/A.

     

    2Consists of (i) 951,439 shares and 36,283 shares issuable upon the exercise of immediately exercisable pre-funded warrants (“Warrants”) held by Venrock Healthcare Capital Partners II, L.P., (ii) 385,717 shares and 14,709 shares issuable upon the exercise of Warrants held by VHCP Co-Investment Holdings II, LLC, (iii) 2,093,431 shares and 79,833 shares issuable upon the exercise of Warrants held by Venrock Healthcare Capital Partners III, L.P., (iv) 209,422 shares and 7,986 shares issuable upon the exercise of Warrants held by VHCP Co-Investment Holdings III, LLC and (v) 5,659,991 shares and 215,844 shares issuable upon the exercise of Warrants held by Venrock Healthcare Capital Partners EG, L.P. The share numbers in the preceding sentence represent the maximum number of ordinary shares issuable upon exercise of the Warrants held by the Reporting Persons as a result of the beneficial ownership provision described in the following sentence. Under the terms of the Warrants, the Issuer may not effect the exercise of any such Warrant, and a holder will not be entitled to exercise any portion of such Warrant, if, upon giving effect to such exercise, the aggregate number of ordinary shares beneficially owned by the holder (together with its affiliates and other attribution parties) would exceed 9.99% of the number of ordinary shares outstanding immediately after giving effect to the exercise.

     

    3This percentage is calculated based upon the sum of (i) 96,288,553 ordinary shares outstanding as of October 31, 2023, as reported in the Issuer’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on October 31, 2023; and (ii) 354,656 shares issuable upon the exercise of the Warrants described in Footnote 2 above.

     

     

    CUSIP No. 23306J101Page 12 of 17

     

     

    Introductory Note: This Schedule 13G is filed on behalf of Venrock Healthcare Capital Partners II, L.P., a limited partnership organized under the laws of the State of Delaware (“VHCP II LP”), VHCP Co-Investment Holdings II, LLC, a limited liability company organized under the laws of the State of Delaware (“VHCP Co-Investment II”), Venrock Healthcare Capital Partners III, L.P., a limited partnership organized under the laws of the State of Delaware (“VHCP III LP”), VHCP Co-Investment Holdings III, LLC, a limited liability company organized under the laws of the State of Delaware (“VHCP Co-Investment III”), Venrock Healthcare Capital Partners EG, L.P., a limited partnership organized under the laws of the State of Delaware (“VHCP EG”), VHCP Management II, LLC, a limited liability company organized under the laws of the State of Delaware (“VHCP Management II”), VHCP Management III, LLC, a limited liability company organized under the laws of the State of Delaware (“VHCP Management III”), VHCP Management EG, LLC, a limited liability company organized under the laws of the State of Delaware (“VHCP Management EG” and collectively with VHCP II LP, VHCP Co-Investment II, VHCP III LP, VHCP Co-Investment III, VHCP EG, VHCP Management II and VHCP Management III, the “Venrock Entities”), Nimish Shah (“Shah”) and Bong Koh (“Koh”) in respect of Ordinary Shares of DBV Technologies S.A.

     

    Item 1.

     

      (a)  Name of Issuer

     

    DBV Technologies S.A.

     

      (b)  Address of Issuer’s Principal Executive Offices

     

    177-181 avenue Pierre Brossolette

    92120 Montrouge France 

     

    Item 2.

     

      (a)  Name of Person Filing

     

    Venrock Healthcare Capital Partners II, L.P.

    VHCP Co-Investment Holdings II, LLC

    Venrock Healthcare Capital Partners III, L.P.

    VHCP Co-Investment Holdings III, LLC

    Venrock Healthcare Capital Partners EG, L.P.

    VHCP Management II, LLC

    VHCP Management III, LLC

    VHCP Management EG, LLC

    Nimish Shah

    Bong Koh

     

      (b)  Address of Principal Business Office or, if none, Residence

     

      New York Office: Palo Alto Office:
      7 Bryant Park 3340 Hillview Avenue
      23rd Floor Palo Alto, CA 94304
      New York, NY 10018  

     

      (c)  Citizenship

     

    All of the Venrock Entities were organized in Delaware. The individuals are both United States citizens.

     

     

    CUSIP No. 23306J101Page 13 of 17

     

     

      (d)  Title of Class of Securities

     

    Ordinary shares, €0.10 nominal value per share (the “Ordinary Shares”).

     

      (e)  CUSIP Number

     

    23306J101

     

    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

     

    Item 4. Ownership

     

      (a)  Amount Beneficially Owned as of December 31, 2023:

     

    Venrock Healthcare Capital Partners II, L.P.   9,654,656(1)
    VHCP Co-Investment Holdings II, LLC   9,654,656(1)
    Venrock Healthcare Capital Partners III, L.P.   9,654,656(1)
    VHCP Co-Investment Holdings III, LLC   9,654,656(1)
    Venrock Healthcare Capital Partners EG, L.P.   9,654,656(1)
    VHCP Management II, LLC   9,654,656(1)
    VHCP Management III, LLC   9,654,656(1)
    VHCP Management EG, LLC   9,654,656(1)
    Nimish Shah   9,654,656(1)
    Bong Koh   9,654,656(1)

     

      (b)  Percent of Class as of December 31, 2023:

     

    Venrock Healthcare Capital Partners II, L.P.   9.99%
    VHCP Co-Investment Holdings II, LLC   9.99%
    Venrock Healthcare Capital Partners III, L.P.   9.99%
    VHCP Co-Investment Holdings III, LLC   9.99%
    Venrock Healthcare Capital Partners EG, L.P.   9.99%
    VHCP Management II, LLC   9.99%
    VHCP Management III, LLC   9.99%
    VHCP Management EG, LLC   9.99%
    Nimish Shah   9.99%
    Bong Koh   9.99%

     

      (c)  Number of shares as to which the person has, as of December 31, 2023:

     

      (i)  Sole power to vote or to direct the vote

     

    Venrock Healthcare Capital Partners II, L.P.   0 
    VHCP Co-Investment Holdings II, LLC   0 
    Venrock Healthcare Capital Partners III, L.P.   0 
    VHCP Co-Investment Holdings III, LLC   0 
    Venrock Healthcare Capital Partners EG, L.P.   0 
    VHCP Management II, LLC   0 
    VHCP Management III, LLC   0 
    VHCP Management EG, LLC   0 
    Nimish Shah   0 
    Bong Koh   0 

     

     

    CUSIP No. 23306J101Page 14 of 17

     

     

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

     

    Venrock Healthcare Capital Partners II, L.P.   9,654,656(1)
    VHCP Co-Investment Holdings II, LLC   9,654,656(1)
    Venrock Healthcare Capital Partners III, L.P.   9,654,656(1)
    VHCP Co-Investment Holdings III, LLC   9,654,656(1)
    Venrock Healthcare Capital Partners EG, L.P.   9,654,656(1)
    VHCP Management II, LLC   9,654,656(1)
    VHCP Management III, LLC   9,654,656(1)
    VHCP Management EG, LLC   9,654,656(1)
    Nimish Shah   9,654,656(1)
    Bong Koh   9,654,656(1)

     

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

     

    Venrock Healthcare Capital Partners II, L.P.   0 
    VHCP Co-Investment Holdings II, LLC   0 
    Venrock Healthcare Capital Partners III, L.P.   0 
    VHCP Co-Investment Holdings III, LLC   0 
    Venrock Healthcare Capital Partners EG, L.P.   0 
    VHCP Management II, LLC   0 
    VHCP Management III, LLC   0 
    VHCP Management EG, LLC   0 
    Nimish Shah   0 
    Bong Koh   0 

     

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

     

    Venrock Healthcare Capital Partners II, L.P.   9,654,656(1)
    VHCP Co-Investment Holdings II, LLC   9,654,656(1)
    Venrock Healthcare Capital Partners III, L.P.   9,654,656(1)
    VHCP Co-Investment Holdings III, LLC   9,654,656(1)
    Venrock Healthcare Capital Partners EG, L.P.   9,654,656(1)
    VHCP Management II, LLC   9,654,656(1)
    VHCP Management III, LLC   9,654,656(1)
    VHCP Management EG, LLC   9,654,656(1)
    Nimish Shah   9,654,656(1)
    Bong Koh   9,654,656(1)

     

    (1)Consists of (i) 951,439 shares and 36,283 shares issuable upon the exercise of immediately exercisable pre-funded warrants (“Warrants”) held by Venrock Healthcare Capital Partners II, L.P., (ii) 385,717 shares and 14,709 shares issuable upon the exercise of Warrants held by VHCP Co-Investment Holdings II, LLC, (iii) 2,093,431 shares and 79,833 shares issuable upon the exercise of Warrants held by Venrock Healthcare Capital Partners III, L.P., (iv) 209,422 shares and 7,986 shares issuable upon the exercise of Warrants held by VHCP Co-Investment Holdings III, LLC and (v) 5,659,991 shares and 215,844 shares issuable upon the exercise of Warrants held by Venrock Healthcare Capital Partners EG, L.P. The share numbers in the preceding sentence represent the maximum number of ordinary shares issuable upon exercise of the Warrants held by the Reporting Persons as a result of the beneficial ownership provision described in the following sentence. Under the terms of the Warrants, the Issuer may not effect the exercise of any such Warrant, and a holder will not be entitled to exercise any portion of such Warrant, if, upon giving effect to such exercise, the aggregate number of ordinary shares beneficially owned by the holder (together with its affiliates and other attribution parties) would exceed 9.99% of the number of ordinary shares outstanding immediately after giving effect to the exercise.

    VHCP Management II, LLC is the general partner of Venrock Healthcare Capital Partners II, L.P. and the manager of VHCP Co-Investment Holdings II, LLC. VHCP Management III, LLC is the general partner of Venrock Healthcare Capital Partners III, L.P. and the manager of VHCP Co-Investment Holdings III, LLC. VHCP Management EG, LLC is the general partner of Venrock Healthcare Capital Partners EG, L.P. Messrs. Shah and Koh are the voting members of VHCP Management II, LLC, VHCP Management III, LLC and VHCP Management EG, LLC.

     

     

    CUSIP No. 23306J101Page 15 of 17

     

     

    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 ¨.

     

    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 a 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. 

     

     

    CUSIP No. 23306J101Page 16 of 17

     

     

    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

     

    Venrock Healthcare Capital Partners II, L.P.   Venrock Healthcare Capital Partners III, L.P.
       
    By: VHCP Management II, LLC   By: VHCP Management III, LLC
    Its: General Partner   Its: General Partner
     
    By: /s/ Sherman G. Souther   By: /s/ Sherman G. Souther
      Name: Sherman G. Souther     Name: Sherman G. Souther
      Its: Authorized Signatory     Its: Authorized Signatory
         
    VHCP Co-Investment Holdings II, LLC   VHCP Co-Investment Holdings III, LLC
     
    By: VHCP Management II, LLC   By: VHCP Management III, LLC
    Its: Manager   Its: Manager
     
    By: /s/ Sherman G. Souther   By: /s/ Sherman G. Souther
      Name: Sherman G. Souther     Name: Sherman G. Souther
      Its: Authorized Signatory     Its: Authorized Signatory
         
    Venrock Healthcare Capital Partners EG, L.P.   VHCP Management EG, LLC
         
    By: VHCP Management EG, LLC   By: /s/ Sherman G. Souther
    Its: General Partner     Name: Sherman G. Souther
          Its: Authorized Signatory
    By: /s/ Sherman G. Souther    
      Name: Sherman G. Souther    
      Its: Authorized Signatory    
         
    VHCP Management II, LLC   VHCP Management III, LLC
     
    By: /s/ Sherman G. Souther   By: /s/ Sherman G. Souther
      Name: Sherman G. Souther     Name: Sherman G. Souther
      Its: Authorized Signatory     Its: Authorized Signatory
         
    Nimish Shah   Bong Koh
     
    By: /s/ Sherman G. Souther   By: /s/ Sherman G. Souther
      Sherman G. Souther, as attorney-in-fact     Sherman G. Souther, as attorney-in-fact

     

     

    CUSIP No. 23306J101Page 17 of 17

     

     

    EXHIBITS

     

    A:Joint Filing Agreement (incorporated by reference to Exhibit B to Schedule 13G filed on June 23, 2022)

     

    B:Power of Attorney for Nimish Shah (incorporated by reference to Exhibit B to Schedule 13G filed on June 23, 2022)

     

    C:Power of Attorney for Bong Koh (incorporated by reference to Exhibit B to Schedule 13G filed on June 23, 2022)

     

     

     

     

     

     

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    • DBV Technologies downgraded by Goldman with a new price target

      Goldman downgraded DBV Technologies from Buy to Neutral and set a new price target of $1.50 from $6.00 previously

      5/10/22 7:37:51 AM ET
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      Biotechnology: Biological Products (No Diagnostic Substances)
      Health Care

    $DBVT
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    • Information regarding the total number of voting rights and total number of shares of the Company as of April 30, 2025

      Information regarding the total number of voting rights and total number of shares of the Company as of April 30, 2025 (Article 223-16 of the General Regulations of the Autorité des Marchés Financiers) Market : NYSE Euronext Paris ISIN Code: FR 0010417345   Date   Total number of shares Total number of voting rights 04/30/2025   136,948,872     Total gross of voting rights: 136,948,872     Total net* of voting rights: 136,762,549   * Net total = total number of voting rights attached to shares – shares without voting rights Attachment PDF Version

      5/6/25 4:30:00 PM ET
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      Biotechnology: Biological Products (No Diagnostic Substances)
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    • DBV Technologies to Participate in the Citizens JMP Life Sciences Conference

      Châtillon, France, May 5, 2025 DBV Technologies to Participate in the Citizens JMP Life Sciences Conference DBV Technologies (TRQX:DBVp), a clinical-stage biopharmaceutical company, today announced Daniel Tassé, Chief Executive Officer, will participate in a fireside chat at the Citizens JMP Life Sciences Conference on Wednesday, May 7, 2025, at 11:00am ET, in New York, NY. A live webcast of the fireside chat can be accessed here, and will also be available on the Events section of the Company's Investors website: https://dbv-technologies.com/investor-overview/events/ A replay will also be available on DBV Technologies' website for 90 days after the event. About DBV TechnologiesDBV Tech

      5/5/25 4:30:00 PM ET
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      Biotechnology: Biological Products (No Diagnostic Substances)
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    • DBV Technologies Reports First Quarter 2025 Financial Results

      Châtillon, France, April 30, 2025   DBV Technologies Reports First Quarter 2025 Financial Results DBV Technologies (TRQX:DBVp), a clinical-stage biopharmaceutical company, today reported financial results for the First Quarter of 2025. The quarterly and three months financial statements were approved by the Board of Directors on April 30, 2025. Financial Highlights for the First Quarter Ended March 31, 2025 The Company's interim condensed consolidated financial statements for the three months ended March 31, 2025, are prepared in accordance with accounting principles generally accepted in the United States ("U.S. GAAP"). Cash and Cash Equivalents Our Condensed Consolidated Financial

      4/30/25 4:00:00 PM ET
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      Biotechnology: Biological Products (No Diagnostic Substances)
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    • New insider Bpifrance Investissement S.A.S. claimed ownership of 226,133 units of Ordinary Shares (SEC Form 3)

      3 - DBV Technologies S.A. (0001613780) (Issuer)

      4/24/25 4:01:16 PM ET
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      Biotechnology: Biological Products (No Diagnostic Substances)
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    • New insider Bpifrance Sa claimed ownership of 10,898,595 units of Ordinary Shares (SEC Form 3)

      3 - DBV Technologies S.A. (0001613780) (Issuer)

      4/7/25 4:01:09 PM ET
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    • SEC Form 4 filed by Director Baker Bros. Advisors Lp

      4 - DBV Technologies S.A. (0001613780) (Issuer)

      3/31/25 6:56:23 PM ET
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    • DBV Technologies Announces Positive 3-Year Results from EPITOPE Phase 3 Open-Label Extension Study

      Châtillon, France, January 8th, 2025 DBV Technologies Announces Positive 3-Year Results from EPITOPE Phase 3 Open-Label Extension Study EPITOPE OLE data demonstrates continued improvement in treatment benefit of VIASKIN® Peanut patch in toddlers 1 – 3 years through 36 months 68.2% of subjects completed the oral food challenge (~12-14 peanut kernels) without meeting stopping criteria, compared to 30.7% at month 12No treatment-related anaphylaxis or serious treatment-related Treatment-Emergent Adverse Events (TEAEs) occurred in year three of EPITOPE OLE    DBV also announced daily patch wear time data from EPITOPE that is supportive of the Company's proposed labeling approach shared with FD

      1/8/25 4:05:00 PM ET
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      Biotechnology: Biological Products (No Diagnostic Substances)
      Health Care
    • DBV Confirms Alignment with U.S. FDA on Accelerated Approval Pathway for the Viaskin® Peanut Patch in Toddlers 1 – 3 Years-Old

      Châtillon, France, December 11th, 2024 DBV Confirms Alignment with U.S. FDA on Accelerated Approval Pathway for the Viaskin® Peanut Patch in Toddlers 1 – 3 Years-Old DBV and FDA aligned on key study design elements for the COMFORT Toddlers study in 1 – 3 year-olds, including study size and wear time collection methodology and analysis COMFORT Toddlers study on-track to initiate in 2Q 2025Viaskin Peanut patch BLA submission for the Toddlers indication anticipated for 2H 2026 FDA confirmed criteria for post-marketing confirmatory study in toddlers 1 – 3 years-oldCompany to host investor webcast today at 5:00pm ET DBV Technologies (TRQX:DBVp), a clinical-stage biopharmaceutical company, tod

      12/11/24 4:05:00 PM ET
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      Biotechnology: Biological Products (No Diagnostic Substances)
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    • DBV Announces Positive Regulatory Updates for the Viaskin® Peanut Patch in the United States and Europe

      Châtillon, France, October 22, 2024 DBV Announces Positive Regulatory Updates for the Viaskin® Peanut Patch in the United States and Europe DBV to pursue an Accelerated Approval pathway for toddlers ages 1 – 3 years-old BLA submission under Accelerated Approval is subject to completion of a six-month supplemental safety study in toddlers to be initiated in Q2 2025VITESSE Phase 3 study evaluating the Viaskin Peanut patch in children ages 4 – 7 years-old exceeded enrollment goals; Topline results on track for 4Q 2025  European Medicines Agency (EMA) scientific advice confirms registration path for a Marketing Authorization Application (MAA) with the modified Viaskin peanut patch for a 1 – 7

      10/22/24 4:45:00 PM ET
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      Biotechnology: Biological Products (No Diagnostic Substances)
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