Genaera Corporation Announces Third Quarter 2005 Financial Results
PLYMOUTH MEETING, Pa., Nov. 9 /PRNewswire-FirstCall/ -- Genaera Corporation announced today its financial results for the three and nine months ended September 30, 2005. The net loss for the three months ended September 30, 2005 was $7.5 million, or $(0.13) per share basic and diluted, as compared to a net loss of $4.7 million, or $(0.09) per share basic and diluted, for the three months ended September 30, 2004. The net loss for the nine months ended September 30, 2005 was $18.5 million, or $(0.32) per share basic and diluted, as compared to a net loss of $13.0 million, or $(0.25) per share basic and diluted, for the nine months ended September 30, 2004.
Genaera's research and development expenses for the three- and nine-month periods ended September 30, 2005 were $6.5 million and $15.8 million, respectively, compared to $4.2 million and $10.4 million, respectively, for the same periods in 2004. The increase was primarily due to increases in clinical trial and manufacturing costs related to EVIZON(TM) (squalamine lactate) for the treatment of age-related macular degeneration (AMD) and resulting increases in personnel expenses, as well as an increase in clinical trial costs related to our LOMUCIN(TM) program. These increases were partially offset by the absence of continuing compensation and stock compensation expense relating to former executives and decreases in third-party contract research costs resulting from the progression of EVIZON through Phase II and into Phase III clinical trials.
Genaera's general and administrative expenses for the three- and nine- month periods ended September 30, 2005 were $1.2 million and $3.6 million, respectively, compared to $1.2 million and $3.5 million, respectively, for the same periods in 2004. The difference in the nine-month period ended September 30, 2005, as compared to the same period in 2004, was due principally to increases in personnel as a result of expanded development efforts and increased professional fees. These increases were partially offset by a decrease in patent expenditures.
The Company's cash, cash equivalents and short-term investment balance was $37.2 million at September 30, 2005.
"During the third quarter, we continued to progress our first Phase III trial of EVIZON in "wet" AMD," commented Jack L. Armstrong, President and COO of Genaera. "Our highest priority is demonstrating the enormous potential for EVIZON to be a competitive therapy in the rapidly growing wet AMD market due to its systemic delivery and ability to treat both affected eyes simultaneously. We look forward to communicating continued progress in our clinical trials during the remainder of this year."
"With respect to our other programs, in the third quarter we announced the start of a pivotal Phase II, multi-center, double-masked, placebo-controlled trial to evaluate LOMUCIN as an oral mucoregulator in 200 individuals with cystic fibrosis," continued Mr. Armstrong. "In addition, MedImmune continues to progress MEDI-528 (neutralizing antibody to IL9) for treating asthma and other respiratory disorders, with the successful completion of one Phase I program."
Genaera Corporation is a biopharmaceutical company committed to developing medicines to address substantial unmet medical needs in major pharmaceutical markets. The Company has four products in development for the treatment of eye, cancer and respiratory disorders. EVIZON(TM) (squalamine lactate) is Genaera's lead product in development for ophthalmic indications, specifically "wet" age-related macular degeneration (AMD). Genaera's other programs include: squalamine for the treatment of cancer; interleukin-9 antibody, a respiratory treatment based on the discovery of a genetic cause of asthma; and LOMUCIN(TM), a mucoregulator to treat the overproduction of mucus and secretions involved in many forms of chronic respiratory disease.
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. 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 EVIZON, 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; the risk that EVIZON ceases to meet the criteria for CMA2 Pilot or Fast Track designation at some point in the future; 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 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.
http://www.genaera.com GENAERA CORPORATION STATEMENTS OF OPERATIONS (Unaudited) (In thousands, except per share data) Three Months Ended Nine Months Ended September 30, September 30, 2005 2004 2005 2004 Revenues $14 $672 $404 $844 Costs and expenses Research and development 6,541 4,241 15,755 10,392 General and administrative 1,176 1,194 3,639 3,548 7,717 5,435 19,394 13,940 Loss from operations (7,703) (4,763) (18,990) (13,096) Interest income, net 177 73 478 203 Loss on sale of equipment -- -- -- (118) Net loss $(7,526) $(4,690) $(18,512) $(13,011) Net loss per share - basic and diluted $(0.13) $(0.09) $(0.32) $(0.25) Weighted average shares outstanding - basic and diluted 59,210 52,607 57,851 52,012 CONDENSED BALANCE SHEETS (Unaudited) (In thousands) September 30, December 31, 2005 2004 Cash, cash equivalents and investments $37,175 $32,151 Prepaid expenses and other current assets 1,813 602 Fixed assets, net 797 736 Other assets 58 59 Total assets $39,843 $33,548 Current liabilities $4,049 $3,886 Long-term liabilities 1,785 580 Stockholders' equity 34,009 29,082 Total liabilities and stockholders' equity $39,843 $33,548Genaera Corporation
CONTACT: Jennifer Bilotti of Genaera Corporation, +1-610-941-4020;Investor: Jonathan Fassberg, ext. 16, Media: Dan Budwick ext. 14, both ofThe Trout Group-BMC Communications, +1-212-477-9007, for GenaeraCorporation
Web site: http://www.genaera.com/