Alexza Pharmaceuticals, Inc. (ALXA)
Q3 2008 Earnings Call Transcript
November 6, 2008, 4:30 pm ET
August Moretti – SVP and CFO
Tom King – President and CEO
Ted Tenthoff – Piper Jaffray
Jason Kantor – RBC Capital Markets
Art Georaver – Georaver
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I would now like to turn this afternoon’s conference over to Mr. August Moretti, Senior Vice President and Chief Financial Officer of Alexza. Mr. Moretti, you may begin.
Thank you. Good afternoon and welcome to the third quarter 2008 financial results conference call. Before we get started, I would like to remind you that the matters discussed on this call contain forward-looking statements that involve risks and uncertainties, including those relating to the potential results of future clinical development, our 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 discussion under the caption Risk Factors and in our quarterly report on Form 10-Q, which we filed with the SEC earlier today.
Alexza disclaims any obligation to update or revise any forward-looking statements made on this call as a result of new information or future developments. 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 November 6, 2008, and financial guidance relating to the company’s current cash, cash equivalents, and investments is as of September 30, 2008.
I’ll now turn the call over to Tom King, President and CEO of Alexza.
Thank you Augie. Good afternoon and thank you for joining us. We always look forward to these quarterly conference calls where we can update you on our progress.
Notwithstanding the incredible challenges of the current financial markets Alexza continues to make great progress with our lead program ahead of even our own original expectations.
I’m going to start with a brief overview of the progress we have made this past quarter towards the accomplishment of our operational goals and then provide a brief summary of the current status of each of our product candidate programs. I will then pass the call back to Augie Moretti to review the third quarter financials. After that, we’ll open up the call up for questions and answers.
During the past three months, we have met or exceeded our own internal operational goals. As a brief reminder in the first half of 2008 we initiated and completed the enrollment of our first Phase 3 pivotal study with AZ-004. This is our lead program, which is for the treatment of agitation and schizophrenia in bipolar patients.
In early September we reported the initial data from the study. The initial results were very strong showing highly statistically significant improvements in patients receiving AZ-004 and the study met all of its primary and secondary endpoints. In addition to the data we have released in the financial world data, from the study will be presented in a scientific form in December at the 47th annual meeting of the ACNP.
In July, we also announced the initiation of our second AZ-004 Phase 3 study. This study was our first clinical trial in bipolar patients and it is the second of two pivotal studies for our AZ-004 new drug application. In October, we announced completion of enrollment of this study and we expect to report top line results before the end of this year.
In the third quarter we conducted our end of Phase II meeting with the FDA for AZ-001, Staccato prochlorperazine, for the treatment of migraine.
In October, we submitted our updated IND for AZ-104 the low dose version of Staccato prochlorperazine, which is being developed for the treatment of migraine.
I’d like to provide a brief summary now of each of the programs and key next milestones. AZ-004, Staccato loxapine, again we’re developing AZ-004 for the treatment of acute agitation in patients with schizophrenia or bipolar disorder. With the strong results from our first Phase 3 clinical trial and our expectation of releasing data from the second pivotal trial in the next two months the company projects an NDA filing for AZ-004 in early 2010.
The second Phase 3 trial has completed enrollment of 314 patients with bipolar disorder and with acute agitation conducted at 17 US clinical centers. This trial was an in-clinic, multi-center, randomized, double-blind, placebo-controlled study and tested two doses of AZ-004, the 5 milligram and 10 milligram. The patients could receive up to 3 doses of the study drug in a 24-hour study period depending on their clinical status. Patients eligible for the study included those who were admitted through an emergency department and those who are already inpatients in a hospital setting as long as they had acute agitation at the time of patient randomization.