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Delcath Systems Provides Update on Corporate Developments

NEW YORK, March 12 /PRNewswire-FirstCall/ -- Delcath Systems, Inc. (Nasdaq: DCTH), which is testing its proprietary treatment system for primary and metastatic cancers to the liver, today provided an update on recent corporate developments.  

Recent Highlights

  • Reached sufficient number of events in the Company's Phase III metastatic melanoma trial to allow initiation of data analysis, which is expected to be completed in April;
  • During the recent pre-NDA meeting with the FDA, and pursuant to the Company's Fast Track Status, the FDA confirmed the rolling submission filing strategy;
  • Signed the first research, distribution, sales and marketing agreement for the Delcath PHP System™ with Chi-Fu Trading Co., Ltd. in Taiwan;
  • Allowed by the FDA to initiate an Expanded Use Protocol for patients with ocular and cutaneous melanoma metastatic to the liver;
  • Initiated expansion of the Company's Scientific Advisory Board with the appointment of Professor Riccardo Lencioni, founder of the International Liver Cancer Association;
  • Significantly strengthened financial position via $32.6 million offering;
  • Cash and cash equivalents at February 26, 2010 was approximately $32.5 million;
  • The Company sponsored a Symposium on the Delcath PHP System during the Society of Surgical Oncology annual meeting in St. Louis, MO, March 3-7, 2010;
  • Delcath's PHP System is scheduled to be included in the following presentations in March and April:
    • The Seventh International Symposium on Melanoma and Other Cutaneous Malignancies, New York, New York, March 12-13;
    • The Society of Interventional Radiology 35th Annual Scientific Meeting, Tampa, Florida, March 13-18;
    • The 9th World Congress of the International Hepato-Pancreato-Biliary Association, Buenos Aires, Argentina, April 18-22; and
    • The Second European Conference on Interventional Oncology, Florence, Italy, April 21-24;
    • The AmSECT 48th International Conference, Reno, NV, April 28-May 1

"Since mid-November, our team has focused on executing our strategies to gain regulatory approval to market the Delcath PHP System both in the U.S. and in Europe, expand the potential benefits of the Delcath PHP System to patients worldwide and build increasing returns to our shareholders," said Eamonn P. Hobbs, President & CEO.  "Overall, we have made significant progress towards our goals and expect to begin the New Drug Application (NDA) process for FDA approval as soon as practically possible."

"The next operational milestone for our company is the April completion of data analysis from our Phase III trial," said Mr. Hobbs.  "The trial's data analysis involves the initial review by the principal clinical investigators at each enrolling center, an additional review by the Company's retained Clinical Research Organization, and a final review of medical images for verification of results conducted by an independent core lab before final statistical results are compiled by an independent biostatistical group.  We remain highly confident that the trial's data will meet the trial's primary endpoint, and our confidence was recently further buoyed by the FDA's acknowledgement of an expanded access program," added Mr. Hobbs. "Operationally, we are on track to have an inspectable Quality System at our Queensbury manufacturing facility by April, which is a key step in the positioning of the Company for commercialization."

"Our only recent adjustment to our plan has been a revision in our filing schedule to obtain CE Mark in Europe.  We recently confirmed that the Delcath PHP System will be treated as a Class III device in Europe, requiring additional validation testing and documentation. We anticipate filing for this approval by the end of the year, or approximately six months later than originally envisioned.  Once complete, these data will also be used to complete the CMC module of our rolling NDA submission in the U.S.  All other approval timelines are expected to remain on track," said Mr. Hobbs.

"We continue to actively negotiate strategic partnership transactions similar in structure to the agreement recently reached with Chi-Fu Trading Co. for the Taiwan market.  Our goal is to execute additional partnerships that will serve both strategic and financial needs. These partnerships will provide distribution and expanded clinical indications in key Asian markets as well as strengthen our capital position. Given that the timing of such agreements is unpredictable, we will continue to review other financing options to assure that the company maintains flexibility and is adequately capitalized to execute on the opportunities ahead of us as we move toward commercialization," concluded Mr. Hobbs.

About Delcath Systems, Inc.

Delcath Systems, Inc. is a medical technology company specializing in cancer treatment. The Company is testing a proprietary, patented drug delivery system for the treatment of primary and metastatic liver cancers. Delcath's novel drug delivery platform is testing the delivery of ultra-high doses of anti-cancer agents to the liver while controlling the systemic exposure of those agents.  In addition to its fully enrolled Phase III metastatic melanoma study, the Company is currently conducting trials to treat other liver cancers. The Company maintains a broad intellectual property portfolio on a worldwide basis including the U.S., Europe, Asia and Canada. For more information, please visit the Company's website at

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 our ability to successfully complete Phase III clinical trials and secure regulatory approval of our current or future drug-delivery system and uncertainties regarding our ability to obtain financial and other resources for any research, development 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.

    Delcath Systems, Inc.                                                   
    Balance Sheets as of December 31, 2009 and 2008 
                                                  December 31,  December 31, 
                                                      2009          2008 
                                                      ----          ---- 
    Current assets                                                          
      Cash and cash equivalents                   $35,486,319    $6,939,233 
      Investments - certificates of deposit                 -     3,847,904 
      Investments - treasury bills                          -       200,710 
      Prepaid expenses and other assets               799,416       353,346 
                                                      -------       ------- 
        Total current assets                       36,285,735    11,341,193 
    Property, plant and equipment                                           
      Furniture and fixtures                           36,800        23,170 
      Computers and equipment                          78,063        21,030 
      Leasehold improvements                          431,425             - 
                                                      -------        ------ 
                                                      546,288        44,200 
      Less: accumulated depreciation                  (24,982)      (26,711)
                                                      -------       ------- 
      Property, plant and equipment, net              521,306        17,489 
                                                      -------        ------ 
        Total assets                              $36,807,041   $11,358,682 
                                                  ===========   =========== 
    Liabilities and Stockholders' Equity                                    
    Current liabilities                                                     
      Accounts payable and accrued expenses        $1,841,480      $703,489 
      Derivative instrument liability              11,207,214       448,318 
                                                   ----------       ------- 
        Total current liabilities                  13,048,694     1,151,807 
                                                   ----------     --------- 
    Commitments and contingencies                           -             - 
    Stockholders' equity                                                    
      Preferred stock, $.01 par value,                                      
       10,000,000 shares authorized; no shares                              
       issued and outstanding                               -             - 
      Common stock, $.01 par value; 70,000,000                              
       shares authorized; 36,223,097 and                                    
       25,383,354 shares issued and 36,194,997                              
       and 25,355,254 outstanding at December                               
       31, 2009 and December 31, 2008,                                      
       respectively                                   362,231       253,834 
      Additional paid-in capital                   92,835,174    57,343,507 
      Deficit accumulated during development                                
       stage                                      (69,371,755)  (47,315,163)
      Treasury stock, at cost: 28,100 shares at                             
       December 31, 2009 and December 31, 2008        (51,103)      (51,103)
      Accumulated other comprehensive loss            (16,200)      (24,200)
                                                      -------       ------- 
        Total stockholders' equity                 23,758,347    10,206,875 
                                                   ----------    ---------- 
        Total liabilities and stockholders'                                 
         equity                                   $36,807,041   $11,358,682 
                                                  ===========   =========== 
    Delcath Systems, Inc.
    Income Statements as of December 31, 2009 and 2008
                            Quarter      Quarter        Year         Year 
                             ended        ended         ended        ended
                            December     December      December     December
                            31, 2009     31, 2008      31, 2009     31, 2008
                            --------     --------      --------     --------
    Costs and expenses:
      General and
       expenses           $1,771,374     $977,815    $3,898,705   $2,687,688
      Research and
       costs               3,653,658    1,645,345     9,637,050    5,378,335
                           ---------    ---------     ---------    ---------
        Total costs
         and expenses      5,425,032    2,623,160    13,535,755    8,066,023
                           ---------    ---------     ---------    ---------
         loss             (5,425,032)  (2,623,160)  (13,535,755)  (8,066,023)
       (expense) income     (270,959)     296,335    (8,567,917)   1,103,682
      Interest income          1,850       20,317        73,833      299,956
      Other expense           (3,441)    (202,500)      (26,753)    (202,500)
      Interest expense             -            -             -            -
                           ---------    ---------     ---------    ---------
        Net loss         $(5,697,582) $(2,509,008) $(22,056,592) $(6,864,885)
                         ===========  ===========  ============  ===========
    Common share data:
      Basic and diluted
       loss per share         $(0.18)      $(0.10)       $(0.82)      $(0.27)
                              ======       ======        ======       ======
      Weighted average
       number of basic
       and diluted
       outstanding        31,040,910   25,346,756    27,072,556   25,300,703
    Delcath Systems, Inc.                                                     
    Statement of Cash Flows as of December 31, 2009 and 2008      
                                                         2009         2008 
                                                         ----         ---- 
    Cash flows from operating activities:                                     
      Net loss                                      $(22,056,592) $(6,864,885)
      Adjustments to reconcile net loss to net                                
       cash used in operating activities:                                     
        Stock option compensation expense              1,578,673      379,546 
        Stock and warrant compensation expense           736,416      287,566 
        Depreciation expense                               7,981        5,861 
        Amortization of organization costs                     -            - 
        Loss on disposal of equipment                      3,442            - 
        Derivative liability fair value adjustment     8,567,917   (1,103,682)
      Changes in assets and liabilities:                                      
        Increase in prepaid expenses and other                                
         assets                                         (438,070)      (5,894)
        Increase (decrease) in accounts payable                               
         and accrued expenses                          1,137,991      578,211 
                                                       ---------      ------- 
          Net cash used in operating activities      (10,462,242)  (6,723,277)
                                                     -----------   ---------- 
    Cash flows from investing activities:                                     
      Purchase of equipment or furniture and                                  
       fixtures                                         (515,440)      (8,313)
      Proceeds from sale of equipment                        200            - 
      Purchase of short-term investments                       -     (200,710)
      Purchase of marketable equity securities                 -      (46,200)
      Proceeds from maturities of short-term                                  
       investments                                     4,048,614    9,878,700 
                                                       ---------    --------- 
          Net cash provided by investing activities    3,533,374    9,623,477 
    Cash flows from financing activities:                                     
      Net proceeds from sale of stock and exercise                            
       of stock options and warrants                  35,475,954            - 
      Repurchases of common stock                              -            - 
      Dividends paid on preferred stock                        -            - 
      Proceeds from short-term borrowings                      -            - 
                                                      ----------    --------- 
          Net cash provided by financing activities   35,475,954            - 
                                                      ----------    --------- 
          Increase in cash and cash equivalents       28,547,086    2,900,200 
    Cash and cash equivalents at beginning of                                 
     period                                            6,939,233    7,886,937 
    Cash and cash equivalents at end of period       $35,486,319  $10,787,137 
                                                     ===========  =========== 
    Supplemental cash flow information:                                       
      Cash paid for interest                                  $-           $- 
                                                            ====         ==== 
    Supplemental non-cash activities:                                         
      Cashless exercise of stock options                      $-       $1,950 
                                                            ====       ====== 
      Conversion of debt to common stock                      $-           $- 
                                                            ====         ====
      Common stock issued for preferred stock                                 
       dividends                                              $-           $- 
                                                            ====         ====
      Conversion of preferred stock to common stock           $-           $- 
                                                            ====         ====
      Common stock issued as compensation for                                 
       stock sale                                             $-           $- 
                                                            ====         ====
      Fair value of warrants issued                   $2,190,979           $- 
                                                      ==========         ==== 

SOURCE Delcath Systems, Inc.

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SOURCE Delcath Systems, Inc.
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