DCTH Delcath Systems Inc.

16.76
-0.1  -1%
Previous Close 16.86
Open 17
52 Week Low 5.15
52 Week High 35
Market Cap $68,996,797
Shares 4,116,754
Float 3,685,117
Enterprise Value $61,607,472
Volume 105,569
Av. Daily Volume 49,424
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Upcoming Catalysts

Drug Stage Catalyst Date
Melphalan/HDS - FOCUS
Liver-dominant ocular melanoma
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Melphalan/HDS - ALIGN
Intrahepatic Cholangiocarcinoma
Phase 3
Phase 3
Phase 3 trial has been initiated.

Latest News

  1. NEW YORK, Nov. 11, 2020 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (NASDAQ:DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today reported business highlights and financial results for the third quarter ended September 30, 2020.

    Recent Business Highlights

    During and since the third quarter of 2020, the company:

    • Strengthened the executive team with the appointment of Gerard Michel as Chief Executive Officer.
    • Announced the conditional acceptance by the FDA of the trade name HEPZATO™ KIT (melphalan hydrochloride for injection/hepatic delivery system) for Melphalan/HDS.
    • Announced the treatment of the final patient in the FOCUS trial; to date, 91 patients have been treated with a…

    NEW YORK, Nov. 11, 2020 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (NASDAQ:DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today reported business highlights and financial results for the third quarter ended September 30, 2020.

    Recent Business Highlights

    During and since the third quarter of 2020, the company:

    • Strengthened the executive team with the appointment of Gerard Michel as Chief Executive Officer.
    • Announced the conditional acceptance by the FDA of the trade name HEPZATO™ KIT (melphalan hydrochloride for injection/hepatic delivery system) for Melphalan/HDS.
    • Announced the treatment of the final patient in the FOCUS trial; to date, 91 patients have been treated with a total of 356 treatments.
    • Confirmed the expected announcement of topline data in early 2021 and updated the expected NDA submission timing to the first quarter of 2022.
    • Provided details that for analytical purposes, the FOCUS trial should demonstrate an overall response rate of at least 21% to show superiority over a meta-analysis of immuno-oncology trials in metastatic ocular melanoma (mOM).
    • Held a key opinion leader call with Dr. Mark Burgmans, Head of Interventional Radiology at the Leiden University Medical Center, to discuss the results of a prospective study, published in August 2020 in the Annals of Surgical Oncology, which reported an overall response rate of 72% in patients with metastatic ocular melanoma with metastases confined to the liver. As stated in the publication, treating the patients early in the disease cycle and the exclusion of patients with extra-hepatic disease likely contributed to the favorable outcome observed in this study. Observed safety events were primarily hematological in nature and deemed to be expected and manageable.

    "I have joined the Delcath team at an exciting moment in the company's history as we approach the announcement of the FOCUS trial's topline results and the evidence continues to build that HEPZATO has the potential to be an important treatment for metastatic ocular melanoma," said Gerard Michel, CEO of Delcath. "2021 will represent an inflection point for the company as we execute on four key priorities including compiling the HEPZATO KIT NDA, preparing for commercialization, raising awareness with investors and expanding the development of HEPZATO into additional areas of high unmet need."

    Third Quarter 2020 Financial Results:

    Income Statement Highlights.

    Product revenue for the three months ended September 30, 2020 was approximately $340 thousand, compared to $216 thousand for the prior year period from our sales of CHEMOSAT procedures in Europe. Selling, general and administrative expenses were approximately $2.0 million compared to $4.0 million in the prior year quarter. Research and development expenses for the third quarter were $3.3 million compared to $1.8 million in the prior year quarter. Total operating expenses for the third quarter were $5.3 million compared with $5.8 million in the prior year quarter.

    We recorded a net loss for the three months ended September 30, 2020, of $5.0 million, compared to a net loss of $7.5 million for the same period in 2019.

    Balance Sheet Highlights.

    At September 30, 2020, we had cash, cash equivalents and restricted cash totaling $11.1 million, as compared to cash, cash equivalents and restricted cash totaling $10.2 million at December 31, 2019 and $15.5 million at September 30, 2019. During the three months ended September 30, 2020 and September 30, 2019, we used $5.2 million and $12.4 million, respectively, of cash in our operating activities.

    Conference Call Information

    To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.

    Date: November 11, 2020

    Time: 8:30 AM Eastern Time

    Toll Free: 877-407-8035

    International: 201-689-8035

    The call will also be available over the Internet and accessible at: https://www.webcaster4.com/Webcast/Page/2475/38241

    About Delcath Systems, Inc.

    Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. Our investigational product – HEPZATO KIT (melphalan hydrochloride for injection/hepatic delivery system) – is designed to administer high-dose chemotherapy to the liver while minimizing systemic exposure and associated side effects. In addition to the FOCUS Trial which is investigating the treatment of mOM, we have initiated a global Phase 3 clinical trial for intrahepatic cholangiocarcinoma (ICC) called the ALIGN Trial. We have paused our work on the ALIGN Trial while we reevaluate the trial design. HEPZATO KIT has not been approved by the U.S. Food & Drug Administration (FDA) for sale in the U.S. In Europe, our system is marketed under the trade name Delcath CHEMOSAT® Hepatic Delivery System for Melphalan (CHEMOSAT) and has been CE Marked and used at major medical centers to treat a wide range of cancers of the liver. CHEMOSAT is being marketed under an exclusive licensing agreement with medac GmbH, a privately held multi-national pharmaceutical company headquartered in Germany that specializes in the treatment and diagnosis of oncological, urological and autoimmune diseases.

    Safe Harbor / Forward-Looking Statements

    The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This news release contains forward-looking statements, which are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to, uncertainties relating to: the timing and results of the Company's clinical trials, including without limitation the mOM and ICC clinical trial programs, our determination whether to continue the ICC clinical trial program or to focus on other alternative indications, and timely monitoring and treatment of patients in the global Phase 3 mOM clinical trial and the impact of the COVID-19 pandemic on the completion of our clinical trials; the impact of the presentations at major medical conferences and future clinical results consistent with the data presented; approval of Individual Funding Requests for reimbursement of the CHEMOSAT procedure; the impact, if any, of ZE reimbursement on potential CHEMOSAT product use and sales in Germany; clinical adoption, use and resulting sales, if any, for the CHEMOSAT system to deliver and filter melphalan in Europe including the key markets of Germany and the UK; the Company's ability to successfully commercialize the HEPZATO KIT/CHEMOSAT system and the potential of the HEPZATO KIT/CHEMOSAT system as a treatment for patients with primary and metastatic disease in the liver; our ability to obtain reimbursement for the CHEMOSAT system in various markets; approval of the current or future HEPZATO KIT/CHEMOSAT system for delivery and filtration of melphalan or other chemotherapeutic agents for various indications in the U.S. and/or in foreign markets; actions by the FDA or foreign regulatory agencies; the Company's ability to successfully enter into strategic partnership and distribution arrangements in foreign markets and the timing and revenue, if any, of the same; uncertainties relating to the timing and results of research and development projects; and uncertainties regarding the Company's ability to obtain financial and other resources for any research, development, clinical trials and commercialization activities. These factors, and others, are discussed from time to time in our filings with the Securities and Exchange Commission. You should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. We undertake no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after the date they are made.

    Contact:

    Delcath Investor Relations

    Email:

    Hayden IR

    James Carbonara

    (646)-755-7412





    DELCATH SYSTEMS, INC.


    Condensed Consolidated Balance Sheets

    (Unaudited)

    (in thousands, except share and per share data)

          
     September 30,  December 31, 
     2020  2019 
    Assets       
    Current assets       
    Cash and cash equivalents$10,899  $10,002 
    Restricted cash 181   181 
    Accounts receivables, net 103   21 
    Inventories 839   654 
    Prepaid expenses and other current assets 1,860   1,759 
    Total current assets 13,882   12,617 
    Property, plant and equipment, net 1,318   735 
    Deferred offering costs 268    
    Right-of-use assets 1,097   860 
    Total assets$16,565  $14,212 
            
    Liabilities and Stockholders' Equity (Deficit)       
    Current liabilities       
    Accounts payable$1,502  $4,533 
    Accrued expenses 6,085   6,947 
    Deferred revenue, current 501   482 
    Lease liabilities, current 556   664 
    Convertible notes payable, current 2,000    
    Warrant liability    3,368 
    Total current liabilities 10,644   15,994 
    Deferred revenue, non-current 2,103   2,378 
    Lease liabilities, non-current 542   197 
    Convertible notes payable, non-current    2,000 
    Total liabilities 13,289   20,569 
            
    Commitments and contingencies (Note 13)     
            
    Stockholders' equity (deficit)       
    Preferred stock, $.01 par value; 10,000,000 shares authorized; 21,473 and 41,517 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively     
    Common stock, $.01 par value; 1,000,000,000 shares authorized; 4,035,558 and 67,091 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively* 40   1 
    Additional paid-in capital 391,545   364,785 
    Accumulated deficit (388,298)  (371,171)
    Accumulated other comprehensive income (11)  28 
    Total stockholders' equity (deficit) 3,276   (6,357)
    Total liabilities and stockholders' equity (deficit)$16,565  $14,212 
            
    * reflects, a one-for-seven hundred (1:700) reverse stock split effected on December 24, 2019. 
      
      

    DELCATH SYSTEMS, INC.

    Condensed Consolidated Statements of Operations and Comprehensive Loss

    (Unaudited)

    (in thousands, except share and per share data)

                    
     Three months ended

    September 30,
      Nine months ended

    September 30,
     
     2020  2019  2020  2019 
    Product revenue$340  $216  $778  $528 
    Other revenue 126   164   361   535 
    Cost of goods sold (188)  (172)  (434)  (440)
    Gross profit 278   208   705   623 
                    
    Operating expenses:               
    Research and development expenses 3,260   1,778   8,457   6,789 
    Selling, general and administrative expenses 1,998   4,002   6,571   9,204 
    Total operating expenses 5,258   5,780   15,028   15,993 
    Operating loss (4,980)  (5,572)  (14,323)  (15,370)
                    
    Change in fair value of the warrant liability, net    434   (2,832)  451 
    Loss on issuance of financial instrument    (1,714)     (1,721)
    Interest expense (44)  (671)  (154)  (4,735)
    Other income 33   4   182   4 
    Net loss (4,991)  (7,519)  (17,127)  (21,371)
                    
    Deemed dividend for triggering of warrant down round feature       (55)   
    Net loss attributable to common stockholders$(4,991) $(7,519) $(17,182) $(21,371)
                    
    Net loss$(4,991) $(7,519) $(17,127) $(21,371)
                    
    Other comprehensive (loss) income:               
    Foreign currency translation adjustments (103)  89   (39)  39 
    Total other comprehensive loss$(5,094) $(7,430) $(17,166) $(21,332)
                    
    Common share data:               
    Basic loss per common share*$(1.16) $(73.82) $(7.75) $(207.58)
    Diluted loss per common share*$(1.16) $(73.82) $(7.75) $(207.58)
                    
    Weighted average number of basic shares outstanding* 4,288,593   101,862   2,217,611   102,956 
    Weighted average number of diluted shares outstanding* 4,288,593   101,862   2,217,611   102,956 
                    
    * reflects, one-for-seven hundred (1:700) reverse stock split effected on December 24, 2019.         

     

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  2. NEW YORK, Nov. 02, 2020 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (NASDAQ:DCTH), an interventional oncology company focused on liver-directed treatment of primary and metastatic cancers, today announced management will participate in the Oppenheimer Fall MedTech Summit on Thursday, November 12, 2020.  

    Management will be available for virtual one-on-one meetings during the conference. To schedule a meeting with management, please contact your conference representative or 

    About Delcath Systems, Inc.

    Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. Our investigational product Melphalan Hydrochloride for Injection for use with the Delcath Hepatic…

    NEW YORK, Nov. 02, 2020 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (NASDAQ:DCTH), an interventional oncology company focused on liver-directed treatment of primary and metastatic cancers, today announced management will participate in the Oppenheimer Fall MedTech Summit on Thursday, November 12, 2020.  

    Management will be available for virtual one-on-one meetings during the conference. To schedule a meeting with management, please contact your conference representative or 

    About Delcath Systems, Inc.

    Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. Our investigational product Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) is designed to administer high-dose chemotherapy to the liver while minimizing systemic exposure and associated side effects. In addition to the Phase 3 FOCUS Trial which is evaluating the safety and efficacy of Melphalan/HDS to treat patients with hepatic-dominant ocular melanoma, we are also evaluating the potential for Melphalan/HDS to treat other forms of metastatic liver cancers. Melphalan/HDS has not been approved by the U.S. Food & Drug Administration (FDA) for sale in the U.S. In Europe, our system is marketed under the trade name Delcath CHEMOSAT® Hepatic Delivery System for Melphalan (CHEMOSAT) and has been CE Marked and used at major medical centers to treat a wide range of cancers of the liver. CHEMOSAT is being marketed under an exclusive licensing agreement with medac GmbH, a privately held multi-national pharmaceutical company headquartered in Germany that specializes in the treatment and diagnosis of oncological, urological and autoimmune diseases.

    Contact:

    Hayden IR

    James Carbonara

    (646)-755-7412

    View Full Article Hide Full Article
  3. NEW YORK, Nov. 02, 2020 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (NASDAQ:DCTH), an interventional oncology company focused on liver-directed treatment of primary and metastatic cancers, today announced that it will host a conference call on November 11, 2020 at 8:30 AM Eastern Time to discuss results for its third quarter ended September 30, 2020.

    Conference Call Information

    To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.

    Date: November 11, 2020
    Time: 8:30 AM Eastern Time
    Toll Free: 877-407-8035
    International: 201-689-8035

    The call will also be available over the Internet and accessible at: https://www.webcaster4.com/Webcast/Page/2475/38241.

    About Delcath Systems, Inc.

    Delcath Systems…

    NEW YORK, Nov. 02, 2020 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (NASDAQ:DCTH), an interventional oncology company focused on liver-directed treatment of primary and metastatic cancers, today announced that it will host a conference call on November 11, 2020 at 8:30 AM Eastern Time to discuss results for its third quarter ended September 30, 2020.

    Conference Call Information

    To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.

    Date: November 11, 2020

    Time: 8:30 AM Eastern Time

    Toll Free: 877-407-8035

    International: 201-689-8035

    The call will also be available over the Internet and accessible at: https://www.webcaster4.com/Webcast/Page/2475/38241.

    About Delcath Systems, Inc.

    Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. Our investigational product Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) is designed to administer high-dose chemotherapy to the liver while minimizing systemic exposure and associated side effects. In addition to the Phase 3 FOCUS Trial which is evaluating the safety and efficacy of Melphalan/HDS to treat patients with hepatic-dominant ocular melanoma, we are also evaluating the potential for Melphalan/HDS to treat other forms of metastatic liver cancers. Melphalan/HDS has not been approved by the U.S. Food & Drug Administration (FDA) for sale in the U.S. In Europe, our system is marketed under the trade name Delcath CHEMOSAT® Hepatic Delivery System for Melphalan (CHEMOSAT) and has been CE Marked and used at major medical centers to treat a wide range of cancers of the liver. CHEMOSAT is being marketed under an exclusive licensing agreement with medac GmbH, a privately held multi-national pharmaceutical company headquartered in Germany that specializes in the treatment and diagnosis of oncological, urological and autoimmune diseases.

    Contact:

    Hayden IR

    James Carbonara

    (646)-755-7412

    View Full Article Hide Full Article
  4. NEW YORK, Oct. 29, 2020 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (NASDAQ:DCTH), an interventional oncology company focused on liver-directed treatment of primary and metastatic cancers, today announced that the Company will be hosting a Key Opinion Leader (KOL) call with Dr. Mark Burgmans, an Interventional Radiologist at the Leiden University Medical Center (LUMC) in The Netherlands, on Thursday, November 5, 2020, at 11:30am ET.

    Dr. Mark Burgmans will discuss results from a prospective phase II study conducted at Leiden University Medical Center on the use of the Delcath CHEMOSAT® Hepatic Delivery System with Melphalan (CHEMOSAT) to treat patients with metastatic ocular melanoma with liver metastases. The publication is entitled "Percutaneous…

    NEW YORK, Oct. 29, 2020 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (NASDAQ:DCTH), an interventional oncology company focused on liver-directed treatment of primary and metastatic cancers, today announced that the Company will be hosting a Key Opinion Leader (KOL) call with Dr. Mark Burgmans, an Interventional Radiologist at the Leiden University Medical Center (LUMC) in The Netherlands, on Thursday, November 5, 2020, at 11:30am ET.

    Dr. Mark Burgmans will discuss results from a prospective phase II study conducted at Leiden University Medical Center on the use of the Delcath CHEMOSAT® Hepatic Delivery System with Melphalan (CHEMOSAT) to treat patients with metastatic ocular melanoma with liver metastases. The publication is entitled "Percutaneous Hepatic Perfusion with Melphalan in Patients with Unresectable Ocular Melanoma Metastases Confined to the Liver: A Prospective Phase ll Study" and was published in Annals of Surgical Oncology.1

    Unlike other published and ongoing studies investigating the use of CHEMOSAT to treat patients with metastatic ocular melanoma, this study enrolled a patient population which had not yet progressed to extra-hepatic metastases. In addition, for 60% of the patients, treatment with CHEMOSAT was used in a first line setting. The overall response rate observed in these earlier stage patients was 72% (complete response of 3% and partial response of 69%) with a median overall survival of 19.1 months. The investigators noted that while this prospective study was not designed for direct comparison, the results indicate that CHEMOSAT is more effective in treating liver metastases from ocular melanoma than systemic therapies.

    Although grade 3 or 4 hematologic events were observed in the majority of patients, they were all well manageable or self-limiting and there were no treatment-related deaths. In an earlier publication of this study, the investigators noted that the hematologic and hepatic toxicity percentages were significantly lower compared to studies using an earlier generation of CHEMOSAT which utilized a different filter system.2 Based on a validated quality of life tool used in the trial, the investigators concluded that CHEMOSAT is well-tolerated with maintenance of quality of life, with only a mild and temporary impairment of physical functioning noted at 6 weeks after the second CHEMOSAT treatment.

    The full article is available online at:

    https://rdcu.be/b9nnn

    The presentation will be live webcast at http://investors.delcath.com/events-presentations. For those not available to listen to the live broadcast, a replay will be archived and available at http://investors.delcath.com/events-presentations.

    The CHEMOSAT Hepatic Delivery System is not approved in the United States. In the United States the Melphalan/Hepatic Delivery System is currently being investigated in a phase 3 trial in patients with metastatic ocular melanoma.

    1) Meijer, T.S., Burgmans, M.C., de Leede, E.M. et al. Percutaneous Hepatic Perfusion with Melphalan in Patients with Unresectable Ocular Melanoma Metastases Confined to the Liver: A Prospective Phase II Study. Ann Surg Oncol (2020). https://doi.org/10.1245/s10434-020-08741-x

    2) Meijer, T. S., Burgmans, M. C., Fiocco, M., de Geus-Oei, L. F., Kapiteijn, E., de Leede, E. M., Martini, C. H., van der Meer, R. W., Tijl, F., & Vahrmeijer, A. L. (2019). Safety of Percutaneous Hepatic Perfusion with Melphalan in Patients with Unresectable Liver Metastases from Ocular Melanoma Using the Delcath Systems' Second-Generation Hemofiltration System: A Prospective Non-randomized Phase II Trial. Cardiovascular and interventional radiology42(6), 841–852. https://doi.org/10.1007/s00270-019-02177-x

    Contact:

    Hayden IR

    James Carbonara

    (646)-755-7412

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    • Gerard Michel Brings the Experience Needed to Lead Delcath as it Transitions from a Development to Commercial Stage Company
    • John Purpura Appointed Chief Operating Officer with Operational, Manufacturing and Regulatory Responsibilities

    NEW YORK, Oct. 01, 2020 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (NASDAQ:DCTH) today announced that the Board of Directors appointed Gerard Michel as Chief Executive Officer, effective October 1, 2020. Mr. Michel will also serve as a member of the Delcath Systems Board of Directors. In his most recent role, Mr. Michel was the Chief Financial Officer and Vice President of Corporate Development at Vericel Corporation. Mr. Michel was a key member of the executive team that successfully restructured Vericel enabling…

    • Gerard Michel Brings the Experience Needed to Lead Delcath as it Transitions from a Development to Commercial Stage Company
    • John Purpura Appointed Chief Operating Officer with Operational, Manufacturing and Regulatory Responsibilities

    NEW YORK, Oct. 01, 2020 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (NASDAQ:DCTH) today announced that the Board of Directors appointed Gerard Michel as Chief Executive Officer, effective October 1, 2020. Mr. Michel will also serve as a member of the Delcath Systems Board of Directors. In his most recent role, Mr. Michel was the Chief Financial Officer and Vice President of Corporate Development at Vericel Corporation. Mr. Michel was a key member of the executive team that successfully restructured Vericel enabling it to become a commercial leader in the fields of advanced Cell Therapy and specialty Biologics.

    In addition to Mr. Michel's appointment as CEO, John Purpura, was appointed as Chief Operating Officer. Mr. Purpura's leadership and operational excellence in areas of regulatory affairs, manufacturing and distribution have been a critical component of preparing Delcath for its planned New Drug Application (NDA) resubmission to the FDA in mid-2021.

    "Following an intensive process, the Board determined that Gerard is the right leader for Delcath at this critical juncture," said Dr. Roger Stoll, Chairman, Delcath Systems. "He is uniquely qualified to take on this role given his track record of success and experience across therapeutics classes. Gerard's extensive experience in strategy, operations, commercialization, business development and capital markets will be a tremendous asset." Dr. Stoll added, "We thank John for successfully guiding Delcath as interim CEO over recent months. On behalf of the Board, I congratulate him on his appointment to COO."

    Mr. Michel commented, "I am excited to join the talented Delcath team ahead of a transformational year as we prepare to report phase 3 FOCUS trial data in metastatic ocular melanoma (mOM) in early 2021. I am committed to leading the organization towards its goal of making Melphalan/HDS the first product specifically labeled for metastatic ocular melanoma patients, a population which currently has limited therapeutic options."

    Mr. Michel added, "Interventional oncology is a rapidly growing segment of comprehensive oncology care. Within that segment Melphalan/HDS is a clinically differentiated, high-value platform with the potential to address multiple cancer indications of high-unmet medical need. I look forward to building value both through the successful commercialization of Melphalan/HDS in mOM and initiating additional targeted clinical programs to expand the market opportunity of this platform technology."

    Mr. Michel joins Delcath Systems with over 30 years of experience in the pharmaceutical and medical technology industries across multiple functional areas. Prior to Delcath, he was Chief Financial Officer of Vericel since June 2014 where he was a key member of the management team which integrated a transformative acquisition and revised the company's business model from a research focused company to a fully integrated, profitable commercial business. Mr. Michel also served as Chief Financial Officer and Vice President, Corporate Development of Biodel from November 2007 to May 2014, and Chief Financial Officer and Vice President of Corporate Development of NPS Pharmaceuticals Inc. from August 2002 to November 2007. Prior to that, Mr. Michel was a Principal at Booz Allen and held a variety of commercial roles at both Lederle Labs and Wyeth Labs. Mr. Michel holds a M.S in Microbiology from the University of Rochester School of Medicine, an M.B.A. from the Simon School of Business, and a B.S. in both Biology and Geology from the University of Rochester.

    Inducement Grant Under NASDAQ Listing Rule 5635(c)(4)

    The Company also announced the grant of an option award to Mr. Michel, which was approved by the Board on August 31, 2020 as an inducement material to his entering employment with the Company in accordance with NASDAQ Listing Rule 5635(c)(4). The inducement award was approved subject to his commencement of employment with the Company on October 1, 2020 and consists of an option to purchase up to 498,000 shares of the Company's common stock. The option will be exercisable at a price of (i) $11.67 per share (the closing price on October 1, 2020) as to the first 396,000 shares to vest, (ii) 1.5 times the closing trading price per share of the Company's common stock on October 1, 2020 as to the next 51,000 shares to vest and (iii) 2.0 times the closing trading price per share of the Company's common stock on October 1, 2020 as to the remaining 51,000 shares to vest and will vest ratably over thirty-six months, provided that he remains employed by Delcath on each vesting date.

    About Delcath Systems, Inc.

    Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. Our investigational product Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) – is designed to administer high-dose chemotherapy to the liver while minimizing systemic exposure and associated side effects. The phase 3 FOCUS trial in metastatic Ocular Melanoma (mOM) is approaching completion. We are also currently evaluating other forms of primary and metastatic liver cancers.  Melphalan/HDS has not been approved by the U.S. Food & Drug Administration (FDA) for sale in the U.S. In Europe, our system is marketed under the trade name Delcath CHEMOSAT® Hepatic Delivery System for Melphalan (CHEMOSAT) and has been CE Marked and used at major medical centers to treat a wide range of cancers of the liver. CHEMOSAT is being marketed under an exclusive licensing agreement with medac GmbH, a privately held multi-national pharmaceutical company headquartered in Germany that specializes in the treatment and diagnosis of oncological, urological and autoimmune diseases.

    Safe Harbor / Forward-Looking Statements

    Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This news release contains forward-looking statements, which are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to, uncertainties relating to the timing and results of the Company's  clinical trials, including without limitation the mOM clinical trial program, timely enrollment and treatment of patients in the global Phase 3 mOM clinical trial and the impact of the COVID-19 pandemic on the enrollment and completion of our clinical trial; subject enrollment in the Phase 3 mOM trial; the impact of the presentations at major medical conferences and future clinical results consistent with the data presented; approval of Individual Funding Requests for reimbursement of the CHEMOSAT procedure; the impact, if any  of ZE reimbursement on potential CHEMOSAT product use and sales in Germany; clinical adoption, use and resulting sales, if any, for the CHEMOSAT system to deliver and filter melphalan in Europe including the key markets of Germany and the UK; the Company's ability to successfully commercialize the Melphalan HDS/CHEMOSAT system and the potential of the Melphalan HDS/CHEMOSAT system as a treatment for patients with primary and metastatic disease in the liver; our ability to obtain reimbursement for the CHEMOSAT system in various markets; approval of the current or future Melphalan HDS/CHEMOSAT system for delivery and filtration of melphalan or other chemotherapeutic agents for various indications in the U.S. and/or in foreign markets; actions by the FDA or other foreign regulatory agencies; the Company's ability to successfully enter into strategic partnership and distribution arrangements in foreign markets and the timing and revenue, if any, of the same; uncertainties relating to the timing and results of research and development projects; and uncertainties regarding the Company's ability to obtain financial and other resources for any research, development, clinical trials and commercialization activities. These factors, and others, are discussed from time to time in our filings with the Securities and Exchange Commission. You should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. We undertake no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after the date they are made.

    Contact:

    Hayden IR

    James Carbonara

    (646)-755-7412

    Brett Maas

    (646) 536-7331

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