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EntreMed Inc. Reports Operating Results (10-Q)

May 17, 2010 | About:
10qk

10qk

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EntreMed Inc. (ENMD) filed Quarterly Report for the period ended 2010-03-31.

Entremed Inc. has a market cap of $62.2 million; its shares were traded at around $0.65 with and P/S ratio of 11.77. ENMD is in the portfolios of Jim Simons of Renaissance Technologies LLC, Jim Simons of Renaissance Technologies LLC.

Highlight of Business Operations:

On January 11, 2010, we sold 3,125,000 shares of our common stock, par value $0.01 per share, to an institutional investor for an aggregate purchase price of $2,500,000 or $0.80 per share. On February 3, 2010, we sold 3,846,154 shares of our common stock to the same institutional investor for an aggregate purchase price of $2,500,000, or $0.65 per share. On April 16, 2010, we sold 5,791,505 shares of our common stock to the same institutional investor for an aggregate purchase price of $3,000,000, or $0.518 per share. Our net proceeds from these three offerings were approximately $7.4 million. Additional funds raised by issuing equity securities may result in dilution to existing shareholders. If we fail to obtain additional capital when needed, we may be required to delay, scale back, or eliminate our clinical program.

Additionally, we must continually maintain (1) stockholders equity of at least $2.5 million or (2) a minimum of $35 million in market value of our listed securities for ten consecutive trading days to be in compliance with the continued listing standards for The NASDAQ Capital Market. At March 31, 2010, our consolidated stockholders equity was approximately $817,000 and the market value of our listed securities was $65.1 million. There can be no assurance that we will be able to meet either of these listing standards in the future.

Research and Development Expenses. Our research and development expenses totaled $844,000 for the three months ended March 31, 2010 and $1,953,000 for the corresponding 2009 period. Reflected in our R&D expenses for the three-month period ended March 31, 2010 are direct project costs of $803,000 for ENMD-2076, $29,000 for Panzem® and $12,000 for ENMD-1198. Additionally, during the period ended March 31, 2010, we wrote off approximately $268,000 of costs previously accrued for patients enrolled in MKC-1 clinical trials that wound down before all cycles of treatment were completed. The 2009 research and development expenses for the comparable period included $772,000 for ENMD-2076, $262,000 for MKC-1, $107,000 direct project costs for Panzem® and $97,000 for ENMD-1198. The overall decrease in research and development costs in the three-month period ended March 31, 2010, as compared to same period in 2009, reflects our continued focus on the clinical development of ENMD-2076 as we ceased clinical and manufacturing activities in our discontinued programs.

At March 31, 2010, accumulated direct project expenses for Panzem® oncology were $54,273,000; direct ENMD-1198 project expenses totaled $13,155,000; and, since acquired, accumulated direct project expenses for ENMD-2076 totaled $14,961,000 and for MKC-1, accumulated project expenses totaled $10,138,000. Our research and development expenses also include non-cash stock-based compensation totaling $10,000 for the three months ended March 31, 2010 and $57,000 for the corresponding 2009 period. The decrease in stock-based compensation expense is related to fewer stock options granted in the three months ending March 31, 2010. The balance of our research and development expenditures includes facility costs and other departmental overhead, and expenditures related to the non-clinical support of our programs.

Interest Expense. Interest expense, which relates to a financing transaction with General Electric Capital Corporation (GECC) in September 2007, decreased to approximately $221,000 (including $20,471 of non-cash interest) in the three-month period ended March 31, 2010 from $454,000 (including $40,687 of non-cash interest) in the corresponding 2009 period.

In January 2006, we acquired Miikana Therapeutics, Inc., 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. Dosing of the first patient in ENMD-2076 trials triggered a milestone payment of $2 million to the former Miikana stockholders payable in stock or cash, at the Company s discretion. 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, dosing of the first patient in a Phase 2 trial for ENMD-2076 will trigger an additional milestone payment of $3 million, payable in stock or cash, at the Company s sole discretion. This milestone occurred during April 2010. Beyond the Phase 2 milestone payment, the former Miikana stockholders may earn up to an additional $13 million of potential payments upon the satisfaction of additional clinical and regulatory milestones. We do not expect such additional milestones to be satisfied during 2010. Through the Miikana acquisition, we also acquired rights to MKC-1, a Phase 2 clinical candidate licensed from 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, since ENMD-2076 is the only program currently under active clinical evaluation by the Company, we do not expect to trigger any of these milestone payments during fiscal 2010.

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