MONTREAL, Nov. 9 /PRNewswire-FirstCall/ -- Akela Pharma Inc. (TSX: AKL), a drug development company focused on developing therapies for the inhalation and pain markets, today announced its financial results under Canadian generally accepted accounting principles for the three and six month period ended September 30, 2007 and 2006.
Akela's consolidated net loss for the third quarter of 2007 was $8.6 million compared to net income of $12.0 million for the segmented Pharma results for the same 2006 period. The results of operations for the three and nine months ended September 30, 2006 include a gain on disposal of our interest in LAB Research totaling $18.6 million.
"The Third quarter fiscal 2007 was marked by important clinical achievements. We first announced positive results from our GHRH Phase II trial demonstrating a marked stimulation of growth hormone and IGF-1 production followed by positive results for our lead product Fentanyl TAIFUN(R) for the Phase IIb extension arm trial demonstrating efficacy resulting in faster and superior pain relief. Having once again delivered significantly positive clinical milestones we now continue to confidently advance our product development programs." said Dr Halvor Jaeger, Chief Executive Officer of Akela Pharma Inc.
Other Third Quarter Financial Highlights - Total consolidated revenues for the third quarter of 2007 were $3.1 million, including $1.1 million in co-development fees and $1.9 million of contract services. Total consolidated revenues for the first 9 months of 2007 were $7.9 million, including $1.6 million in co-development fees and $5.7 million of contract services. - Consolidated net loss for the third quarter of 2007 was $8.6 million or ($0.73) per share. Consolidated net loss year-to-date is $23.8 million or ($2.03) per share. 2007 Third Quarter Operational Highlights - Akela announced the signing of a licensing agreement with Janssen Pharmaceutica NV for its lead product, Fentanyl TAIFUN(R) for the European Union, Eastern Europe, Russia, the Middle East and Africa. A signing fee of $10.8 million was received. - Akela announced the change of its corporate name from LAB International Inc. following the approval of a special resolution at its Annual and Special Shareholders meeting. - Akela announced positive interim results from its pilot GHRH Phase II study producing within 4 weeks of treatment a highly significant stimulation of endogenous growth hormone (GH) secretion and a marked increase of circulating insulin-like growth factor (IGF-1) as compared to placebo. - Akela announced positive results from its Fentanyl TAIFUN(R) Phase IIb extension arm demonstrating statistically significant differences compared to placebo in the measured primary and secondary efficacy variables resulting in faster and superior pain relief. Financial Results
The year-over-year increase in the net loss was due to a higher rate of spending on research and development activities and selling, general and administrative expenses.
Consolidated SG&A expenses totaled $4.0 million for the third quarter of 2007 and $10.5 million year-to-date compared to $2.9 million and $11.0 million for the same respective 2006 periods.
R&D costs for the third quarter of 2007 were $5.7 million and $15.4 million year-to-date compared to $2.8 million and $7.6 million for the same respective 2006 periods. The year-to-date amount includes $1.6 million of severance expense and early termination charges relating to the exit of leased premises in Finland. The increase in spending is primarily attributable to the costs associated with the advancement and finalization of the Fentanyl TAIFUN(R) Phase II trial program and the development of our product candidates.
The consolidated net loss for the third quarter of 2007 was $8.6 million, or ($0.73) per share and $23.8 million or ($2.03) per share year-to-date, compared with a consolidated net income for the former Pharma segment of $12.0 million and $0.8 million, respectively.
The Company had cash and cash equivalents as of September 30, 2007 of $15.1 million. compared with $35.3 million as of December 31, 2006.
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About Akela Pharma Inc.
Akela Pharma is an integrated drug development company focused on developing therapies for the growing multi-billion dollar inhalation and pain markets. Its lead product, for the treatment of breakthrough cancer pain, is a fast-acting Fentanyl formulation delivered using the Company's TAIFUN(R) dry powder inhaler platform. Its pipeline also includes therapeutics for asthma, COPD, growth hormone deficiencies and controlled substance abuse deterrent formulations.
Akela's common shares trade on The Toronto Stock Exchange ("TSX") under the symbol "AKL" with 11.7 million shares outstanding.
This news release contains certain forward-looking statements that reflect the current views and/or expectations of Akela Pharma Inc. with respect to its performance, business and future events. Such statements are subject to a number of risks, uncertainties and assumptions. Actual results and events may vary significantly.
