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EntreMed Inc. Reports Operating Results (10-Q)
Posted by: gurufocus (IP Logged)
Date: May 6, 2009 02:03PM
EntreMed Inc. (ENMD) filed Quarterly Report for the period ended 2009-03-31.
Highlight of Business Operations:
In order to regain compliance with the $1.00 minimum closing bid price, the closing price of our common stock must be at least $1.00 for a minimum of 10 consecutive business days. We will continue to pursue partnering opportunities to raise less-dilutive capital and could defer all or a portion of our product candidate development costs. In the event that our common stock continues to trade under $1.00, we will consider all alternatives in order to maintain the public trading status of our stock.
Research and Development Expenses. Our research and development expenses totaled $1,953,000 for the three months ended March 31, 2009 and $6,187,000 for the corresponding 2008 period. The decrease results primarily from the absence of expenditures on MKC-1 and Panzem® clinical programs and the absence of ENMD-1198 and Panzem® manufacturing costs. Reflected in our R&D expenses for the three-month period ended March 31, 2009 are direct project costs of $772,000 for ENMD-2076, $262,000 for MKC-1, $107,000 for Panzem® and $97,000 for ENMD-1198. The 2008 research and development expenses for the comparable period included $760,000 for ENMD-2076, $1,177,000 for MKC-1, $1,745,000 direct project costs for Panzem® and $1,107,000 for ENMD-1198.
At March 31, 2009, accumulated direct project expenses for Panzem® were $54,225,000, direct ENMD-1198 project expenses totaled $13,063,000; accumulated direct project expenses for MKC-1 totaled $10,219,000, since acquired; and for ENMD-2076, accumulated project expenses totaled $9,895,000. Our R&D expenses also include non-cash stock-based compensation, pursuant to the adoption of SFAS 123R, totaling $57,000 for the three months ended March 31, 2009 and $56,000 for the corresponding 2008 period. The balance of our R&D expenditures includes facilities costs and other departmental overhead, and expenditures related to the advancement of our pre-clinical programs.
Also reflected in our 2009 research and development expenses for the three-month period ended March 31, 2009 are personnel costs of $625,000, patent costs of $169,000 and facility and related expenses of $232,000. In the corresponding 2008 period, these expenses totaled $1,504,000, $151,000 and $370,000, respectively. These decreased expenses result from our corporate restructuring at the end of 2008, which significantly reduced our research and development staff and our facility rental costs.
To date, we have been engaged primarily in research and development activities. As a result, we have incurred and expect to continue to incur operating losses in 2009 and the foreseeable future before we commercialize any products. In January 2006, we acquired Miikana Therapeutics, a private biotechnology company, in exchange for 9.96 million shares of our common stock and the assumption of certain obligations of Miikana. We acquired certain drug candidates in connection with the acquisition, including the lead molecule in the Aurora Kinase Program, ENMD-2076, which advanced into clinical development in 2008. ENMD-2076 is a kinase inhibitor with activity towards Aurora A and multiple other kinases linked to promoting cancer. The dosing of the first patient in ENMD-2076 trials triggered a milestone payment of $2 million to the former Miikana stockholders. In June 2008, 2,564,105 shares of common stock were issued to the former Miikana stockholders as consideration for the satisfaction of the milestone payment. Under the terms of the merger agreement, the former Miikana stockholders may earn up to an additional $16 million of potential payments upon the satisfaction of additional clinical and regulatory milestones. If ENMD-2076 successfully completes Phase 1 clinical trials and advances to Phase 2, the dosing of the first patient will trigger an additional milestone payment of $3 million, which could occur in 2010 and can be paid in cash or stock at our sole discretion. Through the acquisition, we also acquired rights to MKC-1, a Phase 2 clinical candidate licensed from Hoffman-LaRoche, Inc. (Roche) by Miikana in April 2005. Under the terms of the agreement, Roche may be entitled to receive future payments upon successful attainment of certain clinical, regulatory and commercialization milestones; however, we do not expect to trigger any of these milestone payments.
At March 31, 2009, we had cash and short-term investments of $20,826,910 with working capital of $9,417,492. We invest our capital resources with the primary objective of capital preservation. As a result of trends in interest rates, we have invested in some securities with maturity dates of more than 90 days to enhance our investment yields. As such, some of our invested balances are classified as short-term investments rather than cash equivalents in our consolidated financial statements at March 31, 2009.
Stocks Discussed: ENMD,