MOUNTAIN VIEW, Calif., May 12 CA-Alexza-Reports
MOUNTAIN VIEW, Calif., May 12 /PRNewswire-FirstCall/ -- Alexza
Pharmaceuticals, Inc. (Nasdaq: ALXA) 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.
Product Candidates Development Update
-- AZ-004 (Staccato loxapine). Alexza is developing AZ-004 for the
treatment of acute agitation in patients with schizophrenia or bipolar
disorder. In February 2008, Alexza initiated its first Phase 3
clinical trial, designed to enroll approximately 300 schizophrenic
patients with acute agitation at 25 U.S. clinical centers. The trial
is an in-clinic, multi-center, randomized, double-blind,
placebo-controlled study and will test AZ-004 at two dose levels, 5
and 10 mg. Patients may receive up to 3 doses of study drug in a
24-hour period, depending on their clinical status. The primary
endpoint for the study is the change from baseline in the PEC score,
measured at 2 hours after the first dose. Various assessments of a
patient's agitation state will be conducted at serial time points
using standard agitation scales over the first 4-hour post-dose time
period, with follow-up assessments at the end of the 24-hour study
period. Side effects will be recorded throughout the 24-hour period.
A second Phase 3 clinical trial is projected to begin in the third
quarter of 2008. The design of the second study will be similar to
the first trial, except that the patient population will be patients
with bipolar disease. AZ-004 has been licensed to Symphony Allegro,
Inc., and Alexza has the right to repurchase all rights to this
product candidate.
-- AZ-001 (Staccato prochlorperazine). Alexza is developing AZ-001 to
treat patients suffering from acute migraine headaches. In December
2007, the Company completed enrollment of a thorough QT clinical
trial, in which two doses of AZ-001 (5 and 10 mg) were compared to
active control and to placebo. The purpose of a thorough QT study is
to determine a drug's effect on cardiac rhythms. Based on a
preliminary analysis of the data from the study, neither of the doses
of AZ-001 produced a QT/QTc prolongation that would suggest an
increased risk of cardiac arrhythmia. The Company recently completed
a 28-day repeat dose inhalation study in dogs. Consistent with
previous findings in shorter-term and higher dose studies, the Company
observed dose-related minimal to slight metaplasia in the upper
respiratory tract, primarily in the nasal epithelium, in all treated
groups. These changes were partially reversible by the end of a
28-day post-treatment period. No lower respiratory tract or lung
findings were reported. Alexza has requested an end of Phase 2
meeting with the FDA for AZ-001.
-- AZ-104 (Staccato loxapine). Alexza is developing AZ-104 to treat
patients suffering from acute migraine headaches. AZ-104 is a lower
dose version of AZ-004. In March 2008, the Company announced positive
initial results of an in-clinic, multi-center, randomized,
double-blind, single administration, placebo-controlled Phase 2a
proof-of-concept clinical trial in 168 migraine patients with or
without aura. Three doses of AZ-104 (1.25, 2.5 and 5 mg) were
evaluated against placebo in the clinical trial. Using the IHS
4-point rating scale, the primary efficacy endpoint was pain-relief
response at 2 hours post-administration. AZ-104 met the primary
efficacy endpoint of the clinical trial for the two highest doses of
the drug compared to placebo. Statistically significant
improvements in pain response were observed in 76.7% of patients at
the 5 mg dose (p=0.02), 79.1% of patients at the 2.5 mg dose (p=0.01)
and 67.4% of patients at the 1.25 mg dose (p=0.18), compared to 51.3%
of patients receiving placebo. AZ-104 has been licensed to Symphony
Allegro and the Company has the right to repurchase all rights to this
product candidate.
-- AZ-002 (Staccato alprazolam). Alexza is developing AZ-002 for the
acute treatment of panic attacks associated with panic disorder. The
Company completed enrollment of its Phase 2a proof-of-concept clinical
trial in patients with panic disorder in April 2008. Alexza expects
to report initial results of this trial by the end of the second
quarter of 2008. AZ-002 has been licensed to Symphony Allegro and the
Company has the right to repurchase all rights to this product
candidate.
-- AZ-003 (Staccato fentanyl). Alexza is jointly developing AZ-003 with
Endo Pharmaceuticals Inc. for the treatment of breakthrough pain in
cancer and non-cancer patients. Endo is responsible for regulatory,
pre-clinical and clinical development, and for commercializing the
product in North America. Alexza is responsible for the development
of the Staccato Electric Multiple Dose device, and the Company has the
exclusive right to manufacture the product for clinical development
and commercial supply.
-- AZ-007 (Staccato zaleplon). Alexza is developing AZ-007 for the
treatment of insomnia in patients who have difficulty falling asleep,
including patients who awake in the middle of the night and have
difficulty falling back asleep. In March 2008, Alexza completed
enrollment in a Phase 1 clinical trial of 40 healthy volunteers at a
single U.S. clinical center. The purpose of this trial was to assess
the safety, tolerability and pharmacokinetic parameters of a single
dose of AZ-007. Using a double-blind, randomized, dose-escalation
trial design, 4 doses of AZ-007 (ranging from 0.5 to 4.0 mg) were
compared to placebo.
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.
Alexza Pharmaceuticals, Inc.
(a development stage company)
Condensed Consolidated Statements of Operations
(unaudited, in thousands except per share data)
Three Months Ended
March 31,
2008 2007
Revenue $- $-
Operating expenses:
Research and development 14,693 10,235
General and administrative4,462 3,585
Acquired in-process research and development - -
Total operating expenses 19,155 13,820
Loss from operations (19,155) (13,820)
Interest and other income, net 1,080 1,057
Interest expense(291) (235)
Loss before noncontrolling
interest in Symphony Allegro, Inc. (18,366) (12,998)
Loss attributed to noncontrolling
interest in Symphony Allegro, Inc.3,757 2,082
Net loss$(14,609) $(10,916)
Basic and diluted net loss per share $(0.47)$(0.46)
Shares used to compute
basic and diluted net loss per share 31,225 23,869
Alexza Pharmaceuticals, Inc.
(a development stage enterprise)
Condensed Consolidated Balance Sheets
(in thousands)
March 31, December 31,
2008 2007
Assets Unaudited(1)
Cash, cash equivalents and marketable
securities $75,716 69,391
Investments held by Symphony Allegro, Inc.35,936 39,449
Other current assets 2,350 13,432
Total current assets 114,002122,272
Property and equipment, net 25,999 26,156
Other non-current assets 694697
Total assets 140,695149,125
Liabilities and stockholders' equity
Current liabilities 15,741 16,180
Non-current liabilities 31,986 33,002
Non-controlling interest in
Symphony Allegro, Inc. 20,195 23,952
Stockholders equity 72,773 75,991
Total liabilities and stockholders' equity 140,695149,125
(1) Derived from audited consolidated financial statements at that date.
SOURCE Alexza Pharmaceuticals, Inc.
