MOUNTAIN VIEW, Calif., May 12 /PRNewswire-FirstCall/ -- Alexza Pharmaceuticals, Inc. reported today financial results for its fiscal quarter ended March 31, 2008 and provided an update on the Company’s progress with its product candidates. The net loss for the 2008 first fiscal quarter, as reported in accordance with accounting principles generally accepted in the United States (GAAP), was $14.6 million, compared to a net loss of $10.9 million in the comparable period in 2007. Alexza had consolidated cash, cash equivalents and marketable securities (including investments held by Symphony Allegro) at March 31, 2008 of $111.7 million.
“The first four months of 2008 have been very productive for Alexza, as we have continued to make progress on all of our product candidates. Importantly, we initiated our first pivotal Phase 3 trial with AZ-004 (Staccato(R) loxapine),” said Thomas B King, President and CEO of Alexza. “We have a comprehensive plan in place to collect the data and other supporting information we will need to submit an NDA for AZ-004. We plan to initiate our second AZ-004 Phase 3 clinical trial in the third quarter of 2008.”
Financial Results -- Three Months Ended March 31, 2008 and 2007
GAAP operating expenses were $19.2 million in the first quarter of 2008, compared to $13.8 million for the comparable period in 2007. The first quarter increase resulted from increased spending on AZ-004 and AZ-104 as the Company continued development of these product candidates under the Symphony Allegro agreement, increased spending on AZ-003 with continued development of this product candidate under the development agreement with Endo Pharmaceuticals, increased spending for device development and manufacturing process scale-up efforts, increased personnel related costs to support these efforts, and increased share-based compensation costs.
On January 1, 2006, Alexza adopted FAS 123R and reports employee share-based compensation expense based on the fair value of the award. Share-based compensation was $1,191,000 in the first quarter of 2008 compared to $719,000 in the comparable period in 2007.
Alexza’s Consolidated Statements of Operations include the operations of Symphony Allegro, Inc., its variable interest entity. As the Company has no direct ownership in Allegro, it reduces its net loss by the losses incurred by Allegro. “Loss attributed to noncontrolling interest in Symphony Allegro, Inc.” reduced net loss for the first quarter of 2008 by $3.8 million and reduced net loss for the first quarter of 2007 by $2.1 million.
In April 2008, Alexza announced positive initial results from the Phase 1 study. AZ-007 delivered an IV-like pharmacokinetic profile with a median time to peak venous concentration (Tmax) of 1.6 minutes. Zaleplon exposure was dose proportional across the 4 doses studied, as calculated by power analysis. Pharmacodynamics, measured as sedation self-assessed on a 100 mm visual-analog scale, showed onset of effect as early as 2 minutes after dosing with AZ-007. There were no serious adverse events. The most frequently reported adverse events in subjects receiving AZ-007 were dizziness and somnolence. These data indicate a rapid onset of effect, apparently directly related to the IV-like pharmacokinetics, and showed that AZ-007 was generally safe and well tolerated in this population of healthy volunteers.
Conference Call Information
Alexza will host a conference call today at 4:30 p.m. Eastern Time. A replay of the call will be available for two weeks following the event. The conference call, replay and webcast are open to all interested parties.
To access the conference call via the Internet, go to http://www.alexza.com, under the “Investor Relations” link. Please join the call at least 15 minutes prior to the start of the call to ensure time for any software downloads that may be required. Interested parties may also pre-register to avoid pre-call delays at https://www.theconferencingservice.com/prereg/key.process?key=P9XDCERPG.
To access the live conference call via phone, dial 1-888-713-4211. International callers may access the live call by dialing 1-617-213-4864. The reference number to enter the call is 47115180.
The replay of the conference call may be accessed via the Internet, at http://www.alexza.com, or via phone at 1-888-286-8010 for domestic callers or 1-617-801-6888 for international callers. The reference number to enter the replay of the call is 41081227.
About Alexza Pharmaceuticals
Alexza Pharmaceuticals is an emerging specialty pharmaceutical company focused on the development and commercialization of novel, proprietary products for the treatment of acute and intermittent conditions. The Company’s technology, the Staccato system, vaporizes unformulated drug to form a condensation aerosol that allows rapid systemic drug delivery through deep lung inhalation. The drug is quickly absorbed through the lungs into the bloodstream, providing speed of therapeutic onset that is comparable to intravenous administration, but with greater ease, patient comfort and convenience.
Alexza has six product candidates in clinical development. Alexza’s lead program, AZ-004 (Staccato loxapine) for the treatment of acute agitation in schizophrenic or bipolar disorder patients, is in Phase 3 testing. AZ-001 (Staccato prochlorperazine) for the acute treatment of migraine headaches has completed Phase 2 testing. AZ-104 (Staccato loxapine) for the acute treatment of migraine headaches and AZ-002 (Staccato alprazolam) for the acute treatment of panic attacks associated with panic disorder are in Phase 2 testing. Product candidates in Phase 1 testing include AZ-003 (Staccato fentanyl) for the treatment of breakthrough pain, which is partnered with Endo Pharmaceuticals in North America, and AZ-007 (Staccato zaleplon) for the treatment of insomnia. More information, including this and past press releases from Alexza is available online at http://www.alexza.com.
Safe Harbor Statement
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 May 12, 2008 and financial guidance relating to the Company’s current cash, cash equivalents and investments is as of March 31, 2008.
This press release includes forward-looking statements regarding the development of the Company’s product candidates, projected clinical trial enrollment and data reporting timelines, and safety of the Company’s products and technologies. Any statement describing a product candidate or Alexza’s goals, expectations or beliefs is a forward-looking statement, as defined in the Private Securities Litigation Reform Act of 1995, and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of developing and commercializing drugs. The Company’s forward-looking statements also involve assumptions that, if they prove incorrect, would cause its results to differ materially from those expressed or implied by such forward-looking statements. These and other risks concerning Alexza’s business are described in additional detail in the Company’s Annual Report on Form 10-K for the year ended December 31, 2007, and the Company’s other Periodic and Current Reports filed with the Securities and Exchange Commission including the risks under the headings “We have a history of net losses. We expect to continue to incur substantial and increasing net losses for the foreseeable future, and we may never achieve or maintain profitability.”, “We will need substantial additional capital in the future. If additional capital is not available, we will have to delay, reduce or cease operations.”, “Failure or delay in commencing or completing clinical trials for our product candidates could harm our business.”, and “If our product candidates do not meet safety and efficacy endpoints in clinical trials, they will not receive regulatory approval, and we will be unable to market them.” Forward-looking statements contained in this announcement are made as of this date, and we undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
CONTACT: Thomas B. King, President & CEO, +1-650-944-7634,
tking@alexza.com, or August J. Moretti, Senior Vice President and CFO,
+1-650-944-7788, amoretti@alexza.com, both of Alexza Pharmaceuticals, Inc.
Web site: http://www.alexza.com/
