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Alexza Pharmaceuticals, Inc. (ALXA)
Q4 2008 Earnings Call Transcript
March 10, 2009, 2009 4:30 pm ET
August Moretti – SVP and CFO
Tom King – President and CEO
Ted Tenthoff – Piper Jaffray
Jason Kantor – RBC Capital Markets
Charles Duncan – JMP Securities
Joe Carroll – IMS Health
Previous Statements by ALXA
» Alexza Pharmaceuticals, Inc., Q3 2009 Earnings Call Transcript
» Alexza Pharmaceuticals, Inc. Q3 2008 Earnings Call Transcript
» Alexza Pharmaceuticals, Inc. Q2 2008 Earnings Call Transcript
I would now like to turn this afternoon’s conference over to August J. Moretti, Senior Vice President and Chief Financial Officer for Alexza.
Thank you, operator. Good afternoon and welcome to the 2008 year end financial results conference call. Before we get started, I would like to remind you that the matters discussed on the call contain forward-looking statements that involve risks and uncertainties, including those relating to the potential results of future clinical development, Alexza’s ability to commercialize products, the timing of the commercialization of such products, and our projected revenue and expenses. Actual results may differ materially from the results predicted, and recorded results should not be considered an indication of future performance.
These and other risk factors are more fully discussed in our Annual Report on Form 10-K, including under the caption Risk Factors that we filed with the SEC earlier today. Alexza disclaims any obligation to update or revise any forward-looking statement made on this call as a result of new information or future developments. 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 its 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 March 10, and financial guidance relating to the company’s current cash, cash equivalents, and investments is as of December 31, 2008.
I’ll now turn the call over to Tom King, President and CEO of Alexza.
Thank you, Augi. Good afternoon and thank you for joining us. I would like to thank all of you and all of our stockholders for the ongoing support and confidence you have shown in Alexza. We look forward to these conference calls when we can update you on our progress and our results.
Notwithstanding these incredible challenges of our current financial markets, Alexza has made great progress with our lead program in 2008, significantly ahead of original expectations for its clinical development and regulatory timelines. I am going to start with a brief description of our operational goals for 2009 and then provide a brief summary of the current status of our product candidate development programs. I will then pass the call back to Augi Moretti to review the fourth quarter and 2008 year end financials. After that we will open up the conference call for questions and answers.
As we have previously disclosed, our efforts in 2009 are going to be 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, which we are projecting for early Q1 2010. As a reminder, Alexza is developing AZ-004 for the acute treatment of agitation in patients with schizophrenia and bipolar disorder.
In September 2008 and December 2008, the company announced positive results from its two phase III clinical trials of AZ-004. The trials enrolled 344 acutely agitated patients with schizophrenia and 314 acutely agitated patients with bipolar disorder respectively. Both trials were designed as in clinic, multi center, randomized, double blind and placebo controlled studies. Both trials tested AZ-004 at two dose levels, the 5 milligram and the 10 milligram. Patients are eligible to receive up to three doses of study drug in the 24-hour study period, depending upon their clinical status.
Patients eligible for the study included those who were admitted through an emergency department and those who were already in patients in a hospital setting as long as they had acute agitation at the time of the patient randomization. The primary endpoint for these studies were the commonly used measure of the reduction of agitation, defined as a change in baseline in the PANSS scale, or positive and negative symptoms scale, the excited component, sub component of that score, commonly called the PEC score, measured at two hours after the first dose.
The key secondary end point of both studies was the clinical global impression of improvement commonly called the CGII score also measured at two hours after the first dose. It is important to note that both the five milligram and 10 milligram doses of AZ-004 met both these primary and secondary end points in both trials, with highly statistical significant findings. All results were considered statistically significant at the T is less than 0.05 level as compared to placebo and all statistical analysis were made on an intent to treat basis.
Also in both patients populations, the 10 milligram dose of AZ-004 exhibited a very rapid onset of effect, the statistically significant reductions in agitation at 10 minutes post does, which was the first time point measured in the study. This reduction of agitation was generally sustained throughout the entire 24-hour study period. Side-effects were recorded for each patient throughout the clinical trial period and in both studies, the administration of AZ-004 was generally safe and well tolerated in these patients populations.