PLYMOUTH MEETING, Pa., March 31 /PRNewswire-FirstCall/ -- Genaera Corporation (Nasdaq: GENR) today announced its financial results for the year and quarter ended December 31, 2007. The net loss for the year ended December 31, 2007 was $15.7 million, or $(0.90) per share basic and diluted, as compared to a net loss of $21.2 million, or $(1.46) per share basic and diluted, for the year ended December 31, 2006. The net loss for the quarter ended December 31, 2007 was $5.8 million, or $(0.33) per share basic and diluted, as compared to a net loss of $3.6 million, or $(0.21) per share basic and diluted, for the quarter ended December 31, 2006. The loss from operations for the year and quarter ended December 31, 2007 was $17.2 million and $6.1 million, respectively, as compared to $22.8 million and $4.0 million for the same periods in 2006.
Genaera's research and development expenses for the year and quarter ended December 31, 2007 were $13.1 million and $3.6 million, respectively, compared to $17.7 million and $3.1 million, respectively, for the same periods in 2006. The decrease in research and development expenses for the year ended December 31, 2007 as compared to the same period in 2006 was primarily due to a decrease in clinical, manufacturing and personnel costs as a result of the discontinuation of the EVIZON(TM) (squalamine lactate) program for the treatment of wet age-related macular degeneration. This decrease was partially offset by an increase in clinical, manufacturing, research and personnel costs related to the trodusquemine (MSI-1436) program for the treatment of type 2 diabetes and obesity. The increase in research and development expenses for the quarter ended December 31, 2007 as compared to the same period in 2006 was primarily due to an increase in clinical, manufacturing, research and personnel costs related to the trodusquemine (MSI-1436) program for the treatment of type 2 diabetes and obesity and an increase in stock-based compensation related to stock options granted throughout the year. This increase was partially offset by a decrease in indirect personnel costs associated with reductions in force in 2007.
Genaera's general and administrative expenses for the year and quarter ended December 31, 2007 were $6.8 million and $2.5 million, respectively, compared to $6.0 million and $1.5 million, respectively, for the same periods in 2006. The increase in general and administrative expenses for the year ended December 31, 2007 as compared to the same period in 2006 was due principally to an increase in legal fees associated with the Company's 2007 strategic review and realignment costs associated with reductions in force in 2007. The increase in general and administrative expenses for the quarter ended December 31, 2007 as compared to the same period in 2006 was due principally to an increase in stock-based compensation related to stock options granted throughout the year.
The Company's cash, cash equivalents and short-term investment balance was $20.9 million at December 31, 2007.
"In early 2007, we conducted a comprehensive review of our development portfolio to focus on Genaera's product assets with the greatest commercial potential," stated Jack Armstrong, President and CEO. "As a result, we undertook a restructuring and strategic refocusing initiative to concentrate on two core programs, MSI-1436 for the treatment of type 2 diabetes and obesity being developed internally, and MEDI-528 for the treatment of asthma being developed by our partner, MedImmune, Inc. Both programs advanced in the clinic in 2007. The first phase 1 trial of MSI-1436 in healthy, obese and overweight volunteers was completed in October 2007 and a second phase 1 study in obese type 2 diabetics was initiated in early 2008. We hope to demonstrate proof-of-concept for MSI-1436 in type 2 diabetes in a phase 1b multiple- ascending dose study planned to start later this year. MedImmune has initiated four phase 2 trials of MEDI-528 to date. We are excited to be part of this partnership and look forward to reporting data as it becomes available. I believe we continue to make solid progress and 2008 will be a pivotal year for Genaera."
Genaera Corporation is focused on advancing the science and treatment of metabolic diseases. The Company has significant market opportunities with a first-in-class molecule, trodusquemine (MSI-1436), that has the potential to redefine the treatment paradigm for obesity and type 2 diabetes and is presently in a phase 1 trial in obesity. In addition, Genaera has a value- driven, fully out-licensed partnership with MedImmune for a second core program that is presently undergoing phase 2 clinical testing in asthma. Genaera is committed to directing resources to its core program and the aggressive clinical development of its key assets to build stockholder value. For further information, please see our website at http://www.genaera.com.
This announcement contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 that are
subject to risks and uncertainties, known and unknown. Forward-looking
statements reflect management's current views and are based on certain
expectations and assumptions. Such statements include, among others,
statements regarding the preliminary results, clinical development plans
and prospects for Genaera's programs including trodusquemine (MSI-1436) and
the IL-9 antibody program. You may identify some of these forward-looking
statements by the use of words in the statements such as "anticipate,"
"believe," "continue," "develop," "expect," "plan" and "potential" or other
words of similar meaning. Genaera's actual results and performance could
differ materially from those currently anticipated and expressed in these
and other forward-looking statements as a result of a number of risk
factors, including, but not limited to: Genaera's history of operating
losses since inception and its need for additional funds to operate its
business; the costs, delays and uncertainties inherent in scientific
research, drug development, clinical trials and the regulatory approval
process; the risk that clinical trials for Genaera's product candidates
including trodusquemine (MSI-1436) and the IL-9 antibody program may be
delayed or may not be successful; the risk that Genaera may not obtain
regulatory approval for its products, whether due to adequacy of the
development program, the conduct of the clinical trials, changing
regulatory requirements, different methods of evaluating and interpreting
data, regulatory interpretations of clinical risk and benefit, or
otherwise; Genaera's reliance on its collaborators, in connection with the
development and commercialization of Genaera's product candidates; market
acceptance of Genaera's products, if regulatory approval is achieved;
competition; general financial, economic, regulatory and political
conditions affecting the biotechnology and pharmaceutical industry; and the
other risks and uncertainties discussed in this announcement and in
Genaera's filings with the U.S. Securities and Exchange Commission, all of
which are available from the Commission in its EDGAR database at
http://www.sec.gov as well as other sources. You are encouraged to read these
reports. Given the uncertainties affecting development stage pharmaceutical
companies, you are cautioned not to place undue reliance on any such
forward-looking statements, any of which may turn out to be wrong due to
inaccurate assumptions, unknown risks, uncertainties or other factors.
Genaera does not intend (and it is not obligated) to publicly update,
revise or correct these forward-looking statements or the risk factors that
may relate thereto.
STATEMENTS OF OPERATIONS
(In thousands, except per share data)
Year Ended Quarter Ended
December 31, December 31,
2007 2006 2007 2006
Revenues $ 2,737 $ 892 $ 76 $ 528
Costs and expenses:
Research and development 13,097 17,669 3,640 3,057
General and administrative 6,792 5,996 2,534 1,505
19,889 23,665 6,174 4,562
Loss from operations (17,152) (22,773) (6,098) (4,034)
Interest income 1,278 1,542 268 422
Loss on sale of fixed assets -- (3) -- (3)
Loss before income taxes (15,874) (21,234) (5,830) (3,615)
Income tax benefit 147 -- -- --
Net loss $(15,727) $(21,234) $(5,830) $(3,615)
Net loss per share -
basic and diluted $ (0.90) $ (1.46) $ (0.33) $ (0.21)
Weighted average shares
outstanding - basic and 17,452 14,513 17,461 17,435
CONDENSED BALANCE SHEETS
December 31, 2007 December 31, 2006
Cash, cash equivalents and
short-term investments $20,900 $33,806
Prepaid expenses and other
current assets 356 629
Fixed assets, net 374 759
Other assets 56 56
Total assets $21,686 $35,250
Current liabilities $3,377 $2,427
Long-term liabilities 70 1,770
Stockholders' equity 18,239 31,053
Total liabilities and
stockholders' equity $21,686 $35,250
|SOURCE Genaera Corporation|
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