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    SEC Form SC 13G filed by Delcath Systems Inc.

    8/16/23 4:30:56 PM ET
    $DCTH
    Medical/Dental Instruments
    Health Care
    Get the next $DCTH alert in real time by email
    SC 13G 1 d456288dsc13g.htm SC 13G SC 13G

     

     

    UNITED STATES

    SECURITIES AND EXCHANGE COMMISSION

    Washington, D.C. 20549

     

     

    SCHEDULE 13G

    Under the Securities Exchange Act of 1934

    (Amendment No.    )*

     

     

    Delcath Systems, Inc.

    (Name of Issuer)

    Common Stock, par value $0.01 per share

    (Title of Class of Securities)

    24661P807

    (CUSIP Number)

    August 15, 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)

    ☒ 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. 24661P807

     

      1    

      NAMES OF REPORTING PERSONS

      I.R.S. IDENTIFICATION NOS. OF ABOVE PERSONS (ENTITIES ONLY)

     

      Soleus Capital Master Fund, L.P.

      2  

      CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP (SEE INSTRUCTIONS)

      (a)  ☐        (b)  ☐

     

      3  

      SEC USE ONLY

     

      4  

      CITIZENSHIP OR PLACE OF ORGANIZATION

     

      Cayman Islands

    NUMBER OF

    SHARES

     BENEFICIALLY 

    OWNED BY

    EACH

    REPORTING

    PERSON

    WITH:

       5    

      SOLE VOTING POWER

     

      0

       6  

      SHARED VOTING POWER

     

      806,420 (1)

       7  

      SOLE DISPOSITIVE POWER

     

      0

       8  

      SHARED DISPOSITIVE POWER

     

      806,420 (1)

      9    

      AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON

     

      806,420 (1)

    10  

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

     

      ☐

    11  

      PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (9)

     

      5.3% (2)

    12  

      TYPE OF REPORTING PERSON (SEE INSTRUCTIONS)

     

      FI

    FOOTNOTES

    (1)

    The shares of common stock reported in this row are held by Soleus Capital Master Fund, L.P. (“Master Fund”). Soleus Capital, LLC is the sole general partner of Master Fund and thus holds voting and dispositive power over the shares held by Master Fund. Soleus Capital Group, LLC is the sole managing member of Soleus Capital, LLC. Mr. Guy Levy is the sole managing member of Soleus Capital Group, LLC. Each of Soleus Capital Group, LLC, Soleus Capital, LLC and Mr. Guy Levy disclaims beneficial ownership of these securities held by Master Fund and this report shall not be deemed an admission that they are the beneficial owners of such securities for purposes of Section 13(d) of the Exchange Act, or for any other purpose, except to the extent of their respective pecuniary interests therein.

    (2)

    This percentage is calculated based upon 15,276,487 shares of common stock outstanding as of August 3, 2023, as disclosed in the Issuer’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2023 that was filed with Securities and Exchange Commission on August 9, 2023 (the “Form 10-Q”).


    CUSIP NO. 24661P807

     

      1    

      NAMES OF REPORTING PERSONS

      I.R.S. IDENTIFICATION NOS. OF ABOVE PERSONS (ENTITIES ONLY)

     

      Soleus Capital, LLC

      2  

      CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP (SEE INSTRUCTIONS)

      (a)  ☐        (b)  ☐

     

      3  

      SEC USE ONLY

     

      4  

      CITIZENSHIP OR PLACE OF ORGANIZATION

     

      Delaware

    NUMBER OF

    SHARES

     BENEFICIALLY 

    OWNED BY

    EACH

    REPORTING

    PERSON

    WITH:

       5    

      SOLE VOTING POWER

     

      0

       6  

      SHARED VOTING POWER

     

      806,420 (1)

       7  

      SOLE DISPOSITIVE POWER

     

      0

       8  

      SHARED DISPOSITIVE POWER

     

      806,420 (1)

      9    

      AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON

     

      806,420 (1)

    10  

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

     

      ☐

    11  

      PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (9)

     

      5.3% (2)

    12  

      TYPE OF REPORTING PERSON (SEE INSTRUCTIONS)

     

      OO

    FOOTNOTES

    (1)

    The shares of common stock reported in this row are held by Master Fund. Soleus Capital, LLC is the sole general partner of Master Fund and thus holds voting and dispositive power over the shares held by Master Fund. Soleus Capital Group, LLC is the sole managing member of Soleus Capital, LLC. Mr. Guy Levy is the sole managing member of Soleus Capital Group, LLC. Each of Soleus Capital Group, LLC, Soleus Capital, LLC and Mr. Guy Levy disclaims beneficial ownership of these securities held by Master Fund and this report shall not be deemed an admission that they are the beneficial owners of such securities for purposes of Section 13(d) of the Exchange Act, or for any other purpose, except to the extent of their respective pecuniary interests therein.

    (2)

    This percentage is calculated based upon 15,276,487 shares of common stock outstanding as of August 3, 2023, as disclosed in the Form 10-Q.


    CUSIP NO. 24661P807

     

      1    

      NAMES OF REPORTING PERSONS

      I.R.S. IDENTIFICATION NOS. OF ABOVE PERSONS (ENTITIES ONLY)

     

      Soleus Capital Group, LLC

      2  

      CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP (SEE INSTRUCTIONS)

      (a)  ☐        (b)  ☐

     

      3  

      SEC USE ONLY

     

      4  

      CITIZENSHIP OR PLACE OF ORGANIZATION

     

      Delaware

    NUMBER OF

    SHARES

     BENEFICIALLY 

    OWNED BY

    EACH

    REPORTING

    PERSON

    WITH:

       5    

      SOLE VOTING POWER

     

      0

       6  

      SHARED VOTING POWER

     

      806,420 (1)

       7  

      SOLE DISPOSITIVE POWER

     

      0

       8  

      SHARED DISPOSITIVE POWER

     

      806,420 (1)

      9    

      AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON

     

      806,420 (1)

    10  

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

     

      ☐

    11  

      PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (9)

     

      5.3% (2)

    12  

      TYPE OF REPORTING PERSON (SEE INSTRUCTIONS)

     

      OO

    FOOTNOTES

    (1)

    The shares of common stock reported in this row are held by Master Fund. Soleus Capital, LLC is the sole general partner of Master Fund and thus holds voting and dispositive power over the shares held by Master Fund. Soleus Capital Group, LLC is the sole managing member of Soleus Capital, LLC. Mr. Guy Levy is the sole managing member of Soleus Capital Group, LLC. Each of Soleus Capital Group, LLC, Soleus Capital, LLC and Mr. Guy Levy disclaims beneficial ownership of these securities held by Master Fund and this report shall not be deemed an admission that they are the beneficial owners of such securities for purposes of Section 13(d) of the Exchange Act, or for any other purpose, except to the extent of their respective pecuniary interests therein.

    (2)

    This percentage is calculated based upon 15,276,487 shares of common stock outstanding as of August 3, 2023, as disclosed in the Form 10-Q.


    CUSIP NO. 24661P807

     

      1    

      NAMES OF REPORTING PERSONS

      I.R.S. IDENTIFICATION NOS. OF ABOVE PERSONS (ENTITIES ONLY)

     

      Guy Levy

      2  

      CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP (SEE INSTRUCTIONS)

      (a)  ☐        (b)  ☐

     

      3  

      SEC USE ONLY

     

      4  

      CITIZENSHIP OR PLACE OF ORGANIZATION

     

      United States

    NUMBER OF

    SHARES

     BENEFICIALLY 

    OWNED BY

    EACH

    REPORTING

    PERSON

    WITH:

       5    

      SOLE VOTING POWER

     

      0

       6  

      SHARED VOTING POWER

     

      806,420 (1)

       7  

      SOLE DISPOSITIVE POWER

     

      0

       8  

      SHARED DISPOSITIVE POWER

     

      806,420 (1)

      9    

      AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON

     

      806,420 (1)

    10  

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

     

      ☐

    11  

      PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (9)

     

      5.3% (2)

    12  

      TYPE OF REPORTING PERSON (SEE INSTRUCTIONS)

     

      IN

    FOOTNOTES

    (1)

    The shares of common stock reported in this row are held by Master Fund. Soleus Capital, LLC is the sole general partner of Master Fund and thus holds voting and dispositive power over the shares held by Master Fund. Soleus Capital Group, LLC is the sole managing member of Soleus Capital, LLC. Mr. Guy Levy is the sole managing member of Soleus Capital Group, LLC. Each of Soleus Capital Group, LLC, Soleus Capital, LLC and Mr. Guy Levy disclaims beneficial ownership of these securities held by Master Fund and this report shall not be deemed an admission that they are the beneficial owners of such securities for purposes of Section 13(d) of the Exchange Act, or for any other purpose, except to the extent of their respective pecuniary interests therein.

    (2)

    This percentage is calculated based upon 15,276,487 shares of common stock outstanding as of August 3, 2023, as disclosed in the Form 10-Q.


    Item 1.

     

      (a)

    Name of Issuer

    Delcath Systems, Inc.

     

      (b)

    Address of Issuer’s Principal Executive Offices

    1633 Broadway, Suite 22C

    New York, NY 10019

     

    Item 2.

     

      (a)

    Name of Person(s) Filing

    Soleus Capital Master Fund, L.P.

    Soleus Capital, LLC

    Soleus Capital Group, LLC

    Guy Levy

     

      (b)

    Address of Principal Business Office or, if none, Residence

    Soleus Capital Master Fund, L.P.

    104 Field Point Road, 2nd Floor

    Greenwich, CT 06830

    Soleus Capital, LLC

    104 Field Point Road, 2nd Floor

    Greenwich, CT 06830

    Soleus Capital Group, LLC

    104 Field Point Road, 2nd Floor

    Greenwich, CT 06830

    Guy Levy

    c/o Soleus Capital Management, L.P

    104 Field Point Road, 2nd Floor

    Greenwich, CT 06830

     

      (c)

    Citizenship

    Soleus Capital Master Fund, L.P. – Cayman Islands

    Soleus Capital, LLC – Delaware

    Soleus Capital Group, LLC—Delaware

    Guy Levy – United States

     

      (d)

    Title of Class of Securities

    Common Stock, $0.01 par value per share

     

      (e)

    CUSIP Number

    24661P807


    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:

     

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

     

    Item 4.

    Ownership.

    Reference is made to Items 5 – 11 on the preceding pages of this Schedule 13G.

    Master Fund held, as of the close of business on August 15, 2023, an aggregate of 806,420 shares of the common stock of the Issuer. As the general partner of Master Fund, Soleus Capital, LLC may be deemed to have shared power to vote or to direct the vote and to dispose or to direct the disposition of the shares held by Master Fund. As the sole managing member of Soleus Capital, LLC, Soleus Capital Group, LLC may be deemed to have shared power to vote or to direct the vote and to dispose or to direct the disposition of the shares held by Master Fund. As the sole managing member of Soleus Capital Group, LLC, Mr. Guy Levy may be deemed to have shared power to vote or direct the vote and to dispose or to direct the disposition of the Shares held by Master Fund.

    Neither the filing of this Schedule 13G nor any of its contents shall be deemed to constitute an admission that Mr. Levy, Soleus Capital, LLC or Soleus Capital Group, LLC is the beneficial owner of the shares of the common stock of the Issuer referred to herein for purposes of Section 13(d) of the Securities Exchange Act of 1934, as amended, or for any other purpose, and such beneficial ownership is expressly disclaimed, except to the extent of their respective pecuniary interests therein.


    Item 5.

    Ownership of Five Percent or Less of a Class

    Not applicable.

     

    Item 6.

    Ownership of More than Five Percent on Behalf of Another Person.

    Not applicable.

     

    Item 7.

    Identification and Classification of the Subsidiary Which Acquired the Security Being Reported on By the Parent Holding Company

    Not applicable.

     

    Item 8.

    Identification and Classification of Members of the Group

    Not applicable.

     

    Item 9.

    Notice of Dissolution of Group

    Not applicable.

     

    Item 10.

    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, 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, the undersigned certify that the information set forth in this statement is true, complete and correct.

     

    Date: August 16, 2023     Soleus Capital Master Fund, L.P.
        By:   Soleus Capital, LLC, its General Partner
        By:   Soleus Capital Group, LLC, its Managing Manager
        By:  

    /s/ Guy Levy

        Name:   Guy Levy
        Title:   Managing Member
    Date: August 16, 2023     Soleus Capital, LLC
        By:   Soleus Capital Group, LLC, its Managing Manager
        By:  

    /s/ Guy Levy

        Name:   Guy Levy
        Title:   Managing Member
    Date: August 16, 2023     Soleus Capital Group, LLC
        By:  

    /s/ Guy Levy

        Name:   Guy Levy
        Title:   Managing Member
    Date: August 16, 2023    

    /s/ Guy Levy

        Name:   Guy Levy

    Footnotes:

    Attention: Intentional misstatements or omissions of fact constitute Federal criminal violations (See 18 U.S.C. 1001)

     

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    Health Care

    FDA Approval for HEPZATO issued to DELCATH SYSTEMS INC

    Submission status for DELCATH SYSTEMS INC's drug HEPZATO (SUPPL-4) with active ingredient MELPHALAN HYDROCHLORIDE has changed to 'Approval' on 01/22/2024. Application Category: NDA, Application Number: 201848, Application Classification: REMS

    1/23/24 4:36:46 AM ET
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    Medical/Dental Instruments
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    $DCTH
    Large Ownership Changes

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    Amendment: SEC Form SC 13D/A filed by Delcath Systems Inc.

    SC 13D/A - DELCATH SYSTEMS, INC. (0000872912) (Subject)

    11/15/24 10:33:51 AM ET
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    Amendment: SEC Form SC 13D/A filed by Delcath Systems Inc.

    SC 13D/A - DELCATH SYSTEMS, INC. (0000872912) (Subject)

    11/14/24 9:46:56 PM ET
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    Medical/Dental Instruments
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    Amendment: SEC Form SC 13G/A filed by Delcath Systems Inc.

    SC 13G/A - DELCATH SYSTEMS, INC. (0000872912) (Subject)

    11/14/24 7:02:01 PM ET
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    Leadership Updates

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    Beta Bionics Announces Board Appointment of Gerard Michel

    IRVINE, Calif., March 27, 2025 (GLOBE NEWSWIRE) -- Beta Bionics, Inc. (NASDAQ:BBNX), a pioneering leader in the development of advanced diabetes management solutions, today announced the appointment of Gerard Michel as an independent member of its board of directors, effective March 26, 2025. Mr. Michel is Chief Executive Officer of Delcath Systems (NASDAQ:DCTH), a commercial-stage interventional oncology company. "We are excited to welcome Gerard to the Beta Bionics Board," said Sean Saint, President and Chief Executive Officer of Beta Bionics. "Gerard is a highly regarded leader in the pharmaceutical and medical technology industries, and brings deep experience in driving innovation a

    3/27/25 4:45:06 PM ET
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    Delcath Systems Announces Appointment of Bridget Martell, MA, MD to Delcath's Board of Directors

    Delcath Systems, Inc. (NASDAQ:DCTH) (the "Company" or "Delcath"), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, is pleased to announce the appointment of Dr. Bridget Martell to the Company's Board of Directors effective May 23, 2024. "We are pleased to welcome Dr. Martell to the Delcath Board," said John Sylvester, Chairman of the Delcath Board of Directors. "Dr. Martell's extensive experience serving both in senior management roles and as a director at multiple biotechnology companies, as well as her expertise in oncology clinical development, will be a great asset to Delcath as we strive to achieve our mission of improving pa

    5/28/24 9:30:00 AM ET
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    Biotechnology: In Vitro & In Vivo Diagnostic Substances
    Health Care
    Biotechnology: Biological Products (No Diagnostic Substances)
    Medical/Dental Instruments

    Delcath Systems Appoints Martha S. Rook as Chief Operating Officer

    NEW YORK, March 18, 2024 /PRNewswire/ -- Delcath Systems, Inc. (NASDAQ:DCTH) (the "Company" or "Delcath"), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, is pleased to announce the appointment of Martha S. Rook as its new Chief Operating Officer (COO). Martha S. Rook, Ph.D., is an experienced industry leader who brings more than 25 years of academic and industry experience in molecular biology, diagnostics development, biologics process development and biologics manufacturing. She joins Delcath from insitro where she

    3/18/24 5:20:00 PM ET
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    Financials

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    Delcath Systems Reports Third Quarter 2025 Results and Business Highlights

    Conference Call Today at 8:30 a.m. Eastern Time Delcath Systems, Inc. (NASDAQ:DCTH) ("Delcath" or the "Company"), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, today announced financial results and business highlights for the third quarter ended September 30, 2025. Third Quarter 2025 Financial Results Total revenue of $20.6 million, compared with $11.2 million in the third quarter of 2024 HEPZATO KIT™ revenue of $19.3 million, compared to $10.0 million in the third quarter of 2024 CHEMOSAT® revenue of $1.3 million, compared to $1.2 million in the third quarter of 2024 Gross margins of 87%, compared to 85% in the third quarte

    11/4/25 8:00:00 AM ET
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    Medical/Dental Instruments
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    Delcath Systems to Host Third Quarter 2025 Earnings Call

    Delcath Systems, Inc. (NASDAQ:DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced today it will host a conference call on November 4, 2025, at 8:30 AM Eastern Time to discuss results for its third quarter ended September 30, 2025. Conference Call Information To participate in this event, dial in approximately 5 to 10 minutes before the beginning of the call. Event Date: Tuesday, November 4, 2025 Time: 8:30 AM Eastern Time Participant Numbers: Toll Free: 1-877-407-3982 International: 1-201-493-6780 Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1735083&tp_key=a3bb91787b A replay of the webinar will be a

    10/21/25 8:30:00 AM ET
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    Medical/Dental Instruments
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    Delcath Systems Announces Preliminary Third Quarter 2025 Financial Results

    Conference Call October 20, 8:45am EST Delcath Systems, Inc. (NASDAQ:DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, today provided preliminary revenue and financial results for the quarter ended September 30, 2025, and updated 2025 full-year revenue guidance. Preliminary Third Quarter Financial Results (unaudited) Total CHEMOSAT and HEPZATO KIT revenue of approximately $20.5 million HEPZATO KIT revenue of $19.2 million CHEMOSAT revenue of $1.3 million Gross margins expected to be 87% Net income of $0.8 million Positive adjusted EBITDA of $5.3 million Positive operating cashflow of approximately $4.8 mill

    10/18/25 4:15:00 PM ET
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    Medical/Dental Instruments
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