Conference Call Scheduled for Today - Wednesday, August 5, 2009 at 5:00 p.m. Eastern Time
MOUNTAIN VIEW, Calif., Aug. 5 /PRNewswire-FirstCall/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) reported today financial results for the quarter ended June 30, 2009, and provided an update on its product candidates. The net loss for the three and six months ended June 30, 2009, as reported in accordance with accounting principles generally accepted in the United States (GAAP), was $17.0 million and $23.9 million, respectively, compared to a net loss of $20.0 million and $38.4 million in the comparable periods in 2008, respectively. Alexza had consolidated cash, cash equivalents and marketable securities (including investments held by Symphony Allegro) at June 30, 2009 of $26.0 million.
"During the second quarter, we continued the wind-up of our clinical program for AZ-004 (Staccato((R)) loxapine), initiating the four remaining NDA-supporting studies and completing two of them. We project to complete all of our NDA-related clinical work by the end of the third quarter," said Thomas B. King, Alexza President and CEO. "In June, we announced the purchase of Symphony Allegro, allowing us to reacquire full ownership of AZ-004, AZ-104 and AZ-002. This is an important step in the commercialization strategy, as we remain on target for our AZ-004 NDA submission in the first quarter of 2010."
Financial Results - Periods Ended June 30, 2009 and 2008
GAAP operating expenses were $16.8 million and $33.2 million in the three and six month periods ended June 30, 2009, respectively, compared to operating expenses of $20.5 million and $39.7 million in the same periods in 2008, respectively. In second quarter, the Company completed the restructuring announced in January 2009, which included a workforce reduction of 50 employees, representing approximately 33% of the Company's total workforce.
The Company anticipates that with current cash, cash equivalents and marketable securities along with interest earned thereon, expected payments from Symphony Allegro and completion of the Symphony Allegro acquisition, 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 its 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 $7.2 million and $12.4 million in the three and six months ended June 30, 2009, respectively, and $5.9 million and $9.6 million in the same periods in 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. During the second quarter, Alexza initiated the four remaining AZ-004 non-pivotal safety and NDA-supporting studies. These studies were a thorough QTc study in healthy subjects, a smoker/non-smoker pharmacokinetic, or PK, study in healthy subjects, a pulmonary safety study in subjects with asthma and a pulmonary safety study in subjects with chronic obstructive pulmonary disease, or COPD.
Alexza completed the Phase 1 placebo-controlled thorough QTc study, in 48 healthy subjects. The purpose of a thorough QTc study is to determine a drug's potential effect on cardiac rhythms. In this study, the active control, moxifloxacin, produced a positive QT/QTc signal, which validated the sensitivity of the study. At all timepoints for the primary analysis, the confidence intervals of the QTc for AZ-004 were within the FDA standard 10 millisecond window, supporting the cardiac safety of AZ-004.
Alexza also completed the Phase 1 smoker/non-smoker PK study, in 35 healthy subjects. Both smokers and non-smokers exhibited comparable blood levels for both AZ-004 and the metabolites of AZ-004. Side-effect profiles were similar in smokers and non-smokers.
Alexza has also completed the enrollment of the two pulmonary safety studies, one in subjects with asthma and one in subjects with COPD. Alexza expects to complete the data collection and data analysis in both of these studies by the end of the third quarter of 2009. In July 2009, Alexza completed its AZ-004 pre-NDA meeting with the FDA and the Company continues to project its AZ-004 NDA submission for the first quarter of 2010.
AZ-104 (Staccato loxapine). Alexza is developing AZ-104 to treat patients suffering from acute migraine headaches. AZ-104 is a lower dose version of AZ-004. In June 2009, Alexza completed enrollment in its AZ-104 Phase 2b clinical trial, enrolling 366 patients with migraines, with or without aura. This outpatient, multi-center, randomized, double-blind, single-dose, placebo-controlled study was initiated in January 2009. Two AZ-104 dose levels, 1.25 mg and 2.5 mg, are being evaluated in the clinical trial. The primary efficacy endpoint is headache pain relief at 2 hours post-dose, using the standard IHS 4-point rating scale. Secondary efficacy endpoints for the trial include pain relief and other symptom assessments at various time points. Safety evaluations were made throughout the clinical trial period.
