Alexza Pharmaceuticals, Inc. (ALXA)
Q3 2009 Earnings Call
November 9, 2009 5:00 AM ET
August J. Moretti – Senior Vice President and Chief Financial Officer
Thomas King – President and Chief Executive Officer
Ted Tenthoff – Piper Jaffray
Jason Kantor – RBC Capital Markets
Good afternoon, everyone, and welcome to the Alexza Pharmaceuticals 2009 third quarter financial results conference call. (Operator Instructions).
I would now like to turn this afternoon’s conference over to August J. Moretti, Senior Vice President and Chief Financial Officer of Alexza.
Previous Statements by ALXA
» Alexza Pharmaceuticals, Inc. Q4 2008 Earnings Call Transcript
» Alexza Pharmaceuticals, Inc. Q3 2008 Earnings Call Transcript
» Alexza Pharmaceuticals, Inc. Q2 2008 Earnings Call Transcript
These and other risk factors are more fully discussed in our annual report on Form 10-K which we filed with the SEC in March and our quarterly report on Form 10-Q which we filed with the SEC earlier today, most particularly under the caption of risk factors in both reports. Alexza disclaims any obligatin to update or revise any forward-looking statements made on this call as a result of new information or future development.
As a reminder, Alexza’s policy is to only provide guidance on product candidates and corporate goals for the future one to two fiscal quarters and to provide update or reconfirm guidance only by issuing a press release or filing updated guidance with the SEC in a publicly accessible document. Clinical guidance is as of today, November 9, 2009, and financial guidance relating to the company’s current cash, cash equivalents, and investments is as of September 30, 2009.
I’ll now turn the call over to Tom King, President and CEO of Alexza.
I would like to thank and all of our stockholders for the ongoing support and confidence you have shown in Alexza. We look forward to these conference calls. We’re going to update you on Alexza’s progress and results. I’m going to open this conference call with a brief update on operations thus far in 2009 and then provide a summary of the current status of AZ-004. I will then pass the call back to August Moretti to review the third quarter financials, and after that I will have closing comments, and we will open up the call for Q&A.
Our efforts in 2009 have been primarily focused on the clinical, non-clinical, regulatory manufacturing, and quality systems work necessary to move AZ-004, our lead product candidate, to an NDA filing. We remain very much on the timeline we outlined at the beginning of the year and continue to protect our AZ-004 NDA filing for early 2010.
As a reminder, Alexza is developing AZ-004 for the acute treatment of agitation in patients with schizophrenia or bipolar disorder.
In September 2008 and December 2008, we reported strong positive results in our pivotal studies which were phase III efficacy studies. In addition to our corporate news releases, data from these two studies have been presented at the 2009 APA Annual Meeting in May in San Francisco and most recently at the 2009 US Psychiatric and Mental Health Congress which was held last week in Las Vegas. Scientific publications of these data are in progress, and we look forward to seeing peer-reviewed publications of the AZ-004 data in 2010.
During the third quarter, we completed all of the planned clinical work for our AZ-004 NDA. Notably, we completed the enrolment and the data analysis of the remaining AZ-004 non-pivotal safety and NDA supporting studies. These studies were a pulmonary safety study in subjects with chronic obstructive pulmonary disease or COPD and a pulmonary safety study in subjects with asthma.
For the COPD study, we completed a phase I placebo-controlled study in 53 subjects with predominantly moderate to severe COPD. For the asthma study, we completed a phase I placebo-controlled study in 52 subjects with mild-to-moderate persistent asthma.
The primary aim of these two studies was to assess the pulmonary safety of AZ-004 in these specific populations. Both studies employed double-blind parallel group designs. In each study, subjects were given two doses of Staccato, either Staccato placebo or 10 mg Staccato AZ-004. Doses were administered 10 hours apart.
Spirometry testing and other safety assessments were performed several time points up to 24 hours after the second dose. The primary safety measure was FEV1, also known as the forced expiratory volume in one second, which is a standard test of lung function. Decreases in FEV1 versus baseline, respiratory symptoms, and the use of quick relief bronchodilators occurred in both treatment groups, but were more frequent in each study group after treatment with AZ-004 as expected. There were no serious or severe respiratory adverse events. All respiratory symptoms developing after treatment were either self-limiting or readily managed with an inhaled bronchodilator.
We have now completed the five planned non-pivotal safety and NDA supporting studies for the AZ-004 NDA. This is a profound accomplishment in just the first nine months of 2009. We believe that these new data along with the data from our other efficacy and safety trails conducted with AZ-004 adequately demonstrate the safety and efficacy of AZ-004 for the proposed indication for AZ-004 NDA. We have also previously reported that we completed our AZ-004 pre-NDA meeting with the FDA in July 2009. To reiterate, we remain firmly on track for our AZ-004 NDA submission in early 2010.