Alexza Pharmaceuticals, Inc. (ALXA)
Q2 2008 Earnings Call Transcript
August 7, 2008 8:45 am ET
August Moretti – SVP and CFO
Tom King – President and CEO
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I would now like to turn this morning’s conference over to Mr. August Moretti, Senior Vice President and Chief Financial Officer of Alexza. Mr. Moretti, you may begin.
Thank you. Good morning and welcome to our second 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 revenues 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 and in our quarterly report on Form 10-Q, which we filed with the SEC yesterday.
Alexza disclaims any obligation to update or review any forward-looking statements 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 and financial guidance relating to the company’s current cash, cash equivalents and investments is as of June 30, 2008.
I’ll now turn the call over to Tom King, President and CEO of Alexza.
Good morning, everyone, and thank you for joining us. As always, I’d like to thank you and all of our shareholders for the ongoing support and confidence you have shown in Alexza. We look forward to these quarterly conference calls where we can update you on our progress.
Today I’m going to start the conference call with a brief overview of the progress we have made this far toward the accomplishment of our operational goals and then provide a brief summary of the current status of our product candidate. I will then pass the call back to Augie [ph] Moretti to review the second quarter and the year-to-date financials. Following his review, we’ll open up the conference call to Q&A.
2008 continues to be a very productive and exciting year for us. During the first seven months of the year we have met our operational goals. We initiated and completed enrollment in our first Phase 3 study with AZ-004. This is our lead program. As a reminder, AZ-004 is Staccato loxapine, which is being developed for the treatment of agitation and schizophrenic in bipolar disorder patient. We expect to report the topline data from this first Phase 3 study in September. In July, we also announced the initiation of the second Phase 3 study with AZ-004. Earlier this year, we’ve released positive initial positive results of a Phase 2a clinical trial of AZ-104, which is a low dose form of Staccato loxapine that’s being developed to treat migraine.
We also read out positive initial results of the Phase 1 study with AZ-007, which is Staccato zaleplon, and is being developed for the treatment of insomnia. We completed enrollment of our Phase 3 proof-of-concept clinical trial and released initial data for the AZ-002 study, which is Staccato alprazolam, which is being developed for the treatment of acute panic attacks.
We’ve requested and we are granted an end of Phase 2 meeting with the FDA for AZ-001, Staccato prochlorperazine, for t he treatment of migraine. And we initiated development with Endo Pharmaceuticals of AZ-003, which has been renamed EN 3294 by Endo Pharmaceuticals. This product is Staccato fentanyl and is being developed for the treatment of breakthrough pain.
We’ve also completed a number of corporate finance goals in the first half of 2008. We completed a $10 million equity offering with Bio One to support our plan manufacturing operations in Singapore. And we put into place a $50 million equity line of credit with Azimuth Opportunity Limited. Operationally, we completed our move from Palo Alto to our new facilities in Mountain View, which includes our pilot manufacturing state, and closed down our Palo Alto facility. We also established operations in Singapore, establishing the corporate entities to manage our manufacturing activities in Singapore.
During this first period, we have also added substantially to our senior management team as we continue to escalate our commercial activities related mostly to AZ-004. Since January we have Mike Simms, who is our Senior Vice President of Operations and Manufacturing; Carlos Parra, who is our Vice President of Quality; Jeff Williams, who is our President of Alexza Singapore Pte. Limited; Dr. Tony Clarke, who is stationed outside of London, who is our Vice President of International Development Operations; and Chris Kurtz, who is our Vice President of Global Supply Chain and Sustainment Engineering.