Conference Call Scheduled for Today - Thursday, May 7, 2009 at 5:30 p.m. Eastern Time
MOUNTAIN VIEW, Calif., May 7 /PRNewswire-FirstCall/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) reported today financial results for the quarter ended March 31, 2009, and provided an update on its product candidates. The net loss for the quarter, as reported in accordance with accounting principles generally accepted in the United States (GAAP), was $6.9 million compared to a net loss of $18.4 million in the comparable period in 2008. Alexza had consolidated cash, cash equivalents and marketable securities (including investments held by Symphony Allegro) at March 31, 2009 of $40.7 million.
'During the first four months of 2009, we have continued to keep pace with our AZ-004 (Staccato(R) loxapine) NDA timeline,' said Thomas B. King, President and CEO of Alexza. 'Our clinical and regulatory plan is on track, as is the continued scale-up of our commercial manufacturing and quality systems processes. We continue to target our AZ-004 NDA submission for the first quarter of 2010.'
Financial Results - Periods Ended March 31, 2009 and 2008
GAAP operating expenses were $16.4 million and $19.2 million in the quarters ended March 31, 2009 and 2008, respectively. In January 2009, the Company announced that it had consolidated its operations, with a primary focus on the continued development of AZ-004 (Staccato loxapine). The restructuring included a workforce reduction of 50 employees, representing approximately 33% of the Company's total workforce. With the reduction in headcount and focus on the development of AZ-004, the Company expects to reduce its expenses by approximately $21.5 million, net of severance costs, for fiscal year 2009, compared to fiscal year 2008, and another reduction of approximately $11.1 million for fiscal year 2010, compared to fiscal year 2009.
The Company now anticipates that with current cash, cash equivalents and marketable securities along with interest earned thereon, expected payments from Symphony Allegro, the proceeds from option exercises, and purchases of common stock pursuant to its Employee Stock Purchase Plan, the Company will be able to maintain its currently planned operations through the first quarter of 2010. Changing circumstances may cause the Company to consume capital significantly faster or slower than currently anticipated.
Alexza's Consolidated Statements of Operations include the operations of Symphony Allegro, Inc., its variable interest entity. In January 2009, the Company adopted the provisions of Statement of Financial Accounting Standards, No. 160. Under SFAS 160, the Company no longer reverses from our net loss from operations the 'Loss attributed to noncontrolling interest in Symphony Allegro, Inc.' This is now reported as a line item below the net loss calculation. Net loss attributable to noncontrolling interests in Symphony Allegro was $5.2 million and $3.8 million in the three months ended March 31, 2009 and 2008, respectively.
Product Candidates Development Update
- AZ-004 (Staccato loxapine). Alexza is developing AZ-004 for the acute treatment of agitation in patients with schizophrenia or bipolar disorder. The Company projects an NDA submission for AZ-004 in the first quarter of 2010.
During 2008, Alexza successfully initiated, enrolled and completed its two pivotal Phase 3 clinical trials, announcing positive results from both studies. During 2009, Alexza has five non-pivotal safety and NDA-supporting studies to conduct, which are intended to complete the Company's NDA clinical work. During the first quarter, Alexza completed a Phase 1 placebo-controlled study in 30 healthy subjects to assess the pulmonary safety of AZ-004. The Company observed that AZ-004, administered twice within a 24-hour period, was safe and generally well tolerated in the study. There were no systematic differences in post-dose pulmonary function between AZ-004 and placebo, and no respiratory adverse events. In April 2009, Alexza initiated a thorough QTc study in healthy subjects and a smoker/non-smoker pharmacokinetic study in healthy subjects. The Company expects to initiate the remaining two studies during the current quarter and projects that all of the clinical work for the NDA will be completed by the end of the third quarter of 2009.
- AZ-104 (Staccato loxapine).
