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Adeona Pharmaceuticals Announces Clinical Update and Third Quarter 2008 Results
(Marketwire Via Acquire Media NewsEdge) ANN ARBOR, MI, November 14 / MARKET WIRE/ --
Adeona Pharmaceuticals, Inc. (AMEX: AEN), a
pharmaceutical company developing innovative late-stage drug candidates for
the treatment of autoimmune and central nervous system (CNS) diseases,
today announced its clinical update and results for its third quarter of
2008.
A conference call has been scheduled for 4:00pm EST today. In order to
participate in the conference call, please call toll free:
(877) 852-6581 and international dial-in: (719) 325-4779. A replay of the
conference call will be archived for at least 15 days on Adeona's website
at www.adeonapharma.com.
Third quarter and recent accomplishments included:
-- In-licensed oral, once-daily new chemical entity for the treatment of
rheumatoid arthritis (RA) which has completed a 160 patient, multi-center,
double-blind, randomized, placebo-controlled Phase II clinical trial for
the treatment of rheumatoid arthritis (RA).
-- Presentation by our scientific collaborator has presented new findings
from a phase IIa clinical trial results using estriol for the treatment of
multiple sclerosis at the World Congress on Treatment and Research in
Multiple Sclerosis Meeting (ACTRIMS, ECTRIMS and LACTRIMS) in Montreal,
Canada. Estriol is the active ingredient in TRIMESTA.
-- Presentation by scientific collaborator of Phase II Clinical Findings
for Oral dnaJP1 Presented At The American College of Rheumatology (ACR)
Annual Meeting.
-- Announcing that its double-blind, randomized, placebo-controlled phase
II clinical trial of oral flupirtine for the treatment of fibromyalgia has
received institutional review board (IRB) approval to initiate the clinical
trial.
-- Completion of a corporate name change to Adeona Pharmaceuticals, Inc.;
Adeona is a Roman goddess of safe return and safe journey.
-- 33% decrease or $692,000 in net loss for the quarter ended September
30, 2008 as compared to quarter ended September 30, 2007.
-- Partial realization of cost cutting measures taken in the first half
2008.
Nicholas Stergis, Chief Executive Officer of Adeona, commented, "During the
third quarter, we have made substantial progress in realigning our business
focus through the in-licensing of dnaJP1, an oral tolerogenic molecule
which has already completed a 160 patient, double-blind, placebo-controlled
phase II clinical trial for the treatment of rheumatoid arthritis (RA).
Oral dnaJP1 has been derived from a family of heat shock proteins (hsps)
which have been shown to be elevated in the synovial joint fluid of RA
patients. We are focused on designing additional clinical trials for this
molecule."
Financial Results for Third Quarter 2008
The net loss applicable to common shareholders for the quarter ended
September 30, 2008 was $1,428,839, or $0.07 per share. Of the net loss
applicable to common stockholders for the quarter, $863,272 was
attributable to research and development expenses and $606,685 was
attributable to general and administrative expenses. Research and
development expenses for the three months ended September 30, 2008
decreased by approximately $710,000 as compared to the third quarter of
2007. The decrease is primarily due to a decrease of $575,000 associated
with payments related to the development of our licensed clinical drug
candidates, a decrease in salaries and related taxes of approximately
$198,000, offset by an increase of approximately $80,000 in stock based
compensation charges.
The net loss applicable to common shareholders for the nine months ended
September 30, 2008 was $6,290,008, or $0.31 per share, compared to a net
loss applicable to common shareholders of $19,142,602, or $1.12 per share,
for the comparable period in 2007, representing a decrease of $12,852,594.
The decrease is primarily attributable to a non-cash charge of $12,409,722
taken during the first quarter of 2007 related to the acquisition of
Effective Pharmaceuticals, Inc. The total of the non-cash charge was
reflected through equal and offsetting adjustments to additional
paid-in-capital with no net impact on stockholders' equity. Research and
development expenses increased by $86,473 for the nine months ended
September 30, 2008 as compared to the same period last year. Of this
increase approximately $242,000 related to stock based compensation charges
and $111,000 related to an increase in allocated overhead, offset by a
decrease of approximately $254,000 in salaries and payroll taxes. General
and administrative expenses decreased by $609,271 for the nine months ended
September 30, 2008 as compared to the same period in 2007 which is
primarily due to a decrease in stock-based compensation expense of
approximately $734,000 and a decrease in professional fees of $122,000,
offset by an increase in salaries and related payroll taxes of
approximately $175,000 and an increase in allocated overhead of
approximately $71,000.
At September 30, 2008, Adeona had cash of approximately $6.4 million,
compared to approximately $11.5 million at December 31, 2007. The decrease
of approximately $5.1 million during the first nine months of 2008 is
attributable to net cash used in operations of approximately $4.1 million,
and $900,000 that we elected to use to repay our outstanding equipment
notes payable in full in order to eliminate further monthly interest
payments as well as the security interest on our $2.0 million in equipment
and leasehold improvements primarily relating to our cGMP pharmaceutical
production facility in Ann Arbor, Michigan. The cash spend for the quarter
ended September 30, 2008 is approximately $1.0 million which was all
attributable to net cash used in operations.
We implemented significant downsizing and cost saving measures announced
March 11, 2008 in order to preserve our capital. We are able to realize
the effects of the cost cutting measures through a decrease in operating
expense of $1.7 million or 53% and a decrease in cash used in operations of
approximately $794,000 or 44% as compared to the first quarter of 2008 when
the cost reductions were initiated.
About Adeona Pharmaceuticals, Inc.
Adeona Pharmaceuticals, Inc. is a specialty pharmaceutical company that is
developing proprietary, late-stage drug candidates for the treatment of
neurologic and fibrotic diseases. Adeona's strategy is to exclusively
in-license proprietary, clinical-stage drug candidates and to complete the
further clinical testing, manufacturing and regulatory requirements and
seek marketing authorizations. Adeona is focused on treatments for
rheumatoid arthritis, multiple sclerosis, dry age related macular
degeneration (AMD), and fibromyalgia. For further information, please
visit, www.adeonapharma.com.
This release contains forward-looking statements within the meaning of
Section 21E of the Securities Exchange Act of 1934, as amended, including
statements regarding our products. Words such as, but not limited to, "look
forward to," "believe," "expect," "anticipate," "estimate," "intend,"
"plan," "targets," "likely," "will," "would," "should," and "could," and
similar expressions or words identify forward-looking statements. Such
forward-looking statements are based upon current expectations that involve
risks, changes in circumstances, assumptions and uncertainties and include
statements regarding designing additional clinical trials for Oral dnaJP1.
Adeona is at an early stage of development and may not ever have any
products that generate significant revenue. Important factors that could
cause actual results to differ materially from those reflected in Adeona's
forward-looking statements include, among others, a failure of Adeona's
product candidates to be demonstrably safe and effective, a failure to
obtain regulatory approval for the company's products or to comply with
ongoing regulatory requirements, a lack of acceptance of Adeona's product
candidates in the marketplace, a failure of the company to become or remain
profitable, Adeona's inability to obtain the capital necessary to fund its
research and development activities, a loss of any of the company's key
scientists or management personnel, and other factors described in Adeona's
report on Form 10-Q for the quarter ended September 30, 2008. No
forward-looking statements can be guaranteed and actual results may differ
materially from such statements. The information in this release is
provided only as of the date of this release, and Adeona undertakes no
obligation to update any forward-looking statements contained in this
release on account of new information, future events, or otherwise, except
as required by law.
For Further Information Contact:
Nicholas Stergis
Chief Executive Officer
(734) 332-7800
Redington, Inc.
(Investor Relations)
Thomas Redington
203-222-7399www.redingtoninc.com
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