ANN ARBOR, Mich., Nov. 14, 2011 /PRNewswire/ -- Adeona
Pharmaceuticals, Inc. (AMEX: AEN), a developer of innovative
medicines for serious central nervous system diseases, today
reported its third quarter 2011 financial results for the period
ended September 30, 2011, as well as
updates since the beginning of the third quarter.
Updates since the beginning of the third quarter
include:
Drug Development Programs
Relapsing-Remitting Multiple Sclerosis (MS)
- As of September 19, 2011, the
150th patient was enrolled in the clinical trial evaluating
Trimesta™ (oral estriol) in women suffering from
relapsing-remitting MS, per the original protocol.
- The Lead Principal Investigator, Rhonda
Voskuhl, M.D., Director, University of
California, Los Angeles (UCLA)
Multiple Sclerosis Program, Department of Neurology, is using grant
funding to continue enrollment of an additional 10-20 patients at
all 15 centers in the United
States.
Cognitive Dysfunction in MS
- On November 11, 2011, we
announced that our drug candidate, Trimesta, will be utilized in a
new randomized, double-blind, placebo-controlled Phase II clinical
trial to evaluate its potential therapeutic effect on cognitive
dysfunction in women suffering from MS, a major consequence of this
disease.
- We and the Skirball Foundation have pledged to equally support
this clinical trial led by Dr. Voskuhl. The study, which focuses on
cognition dysfunction in MS patients, also received financial
support from the Sherak Family Fund, the Gustafson Fund, and the
Diamont family.
Fibromyalgia
- In May 2010, we announced a
$17.5 million corporate partnership
with Meda AB for the development and commercialization of
flupirtine for fibromyalgia. Meda assumed all future development
costs and estimates the U.S. market for fibromyalgia to be near
$1 billion at the time of potential
launch of flupirtine. We are eligible to receive up to $15 million of additional milestone payments and
royalties on net sales.
- In its 2010 Annual Report that was publicly disclosed in
May 2011, Meda stated that flupirtine
for fibromyalgia was in Phase II development.
Amyotrophic Lateral Sclerosis (ALS)
- Protocol development and drafting of the Investigational New
Drug (IND) application are underway to conduct a multi-center,
double-blind, placebo-controlled clinical trial for patients
suffering from ALS, also known as Lou
Gehrig's disease. The trial, led by the neurological team at
the PNA Center for Neurological Research (PNA), is intended to
evaluate the safety and efficacy of our proprietary drug candidate,
AEN-100, a once-daily, gastroretentive, sustained-release
zinc-based tablet in ALS patients.
- Currently the clinical investigators at PNA are conducting a
Phase I/II open label study of ALS patients to determine the safety
of zinc in conjunction with low doses of copper. To date, no safety
issues related to zinc therapy have been observed in the ALS
patients. PNA will be presenting the final results from this
open-label study at the 22nd International Symposium on ALS/MND in
Sydney, Australia from
November 30 to December 2, 2011. As
the findings from this study are the basis for our planned clinical
trial, we intend to disclose the results concurrent with the
presentation at the international symposium.
Mild to Moderate Alzheimer's Disease
- After conducting further analyses of the results presented in
April 2011 from the clinical study
evaluating our medical food, reaZin™, an apparent cognitive
benefit was observed in older patients.
- Preparations are underway to conduct a larger clinical study of
AEN-100 (our zinc-based drug candidate) under an IND application in
patients with mild to moderate Alzheimer's disease who are age 70
and older. It is anticipated that the clinical study will enroll
just over 100 patients and that the evaluation period will be at
least 12 months.
Product Development Programs
Reducing the Duration and Symptoms of the Common Cold
- On November 4, 2011, we executed
an agreement with F&F Foods of Chicago, Illinois, to provide commercial-scale
manufacturing of wellZin.
- On August 25, 2011, George A. Eby, a researcher who has conducted
multiple clinical studies of zinc lozenges for the common cold, was
appointed as a member of our Scientific Advisory Board.
Dietary Management of Zinc Deficiency Associated with
Alzheimer's Disease
- In April 2011, clinical study
results were presented that demonstrated, on average, that the
cognitive function of the placebo group, declined over six months
in comparison to patients managed with reaZin, a medical
food. The cognitive function trends favoring the patients managed
with reaZin were observed in all three standardized
cognitive tests utilized in our study and suggest that
reaZin may provide an important benefit to the dietary
management of zinc deficiency associated with Alzheimer's
disease.
- Based on the results of our clinical study, we are developing
reaZin as a medical food for the dietary management of zinc
deficiency associated with Alzheimer's disease. reaZin is a
proprietary, once-daily, gastroretentive, sustained-release, oral
tablet formulation of zinc and cysteine.
Corporate Governance
- On November 2, 2011, we
strengthened our corporate governance practices by appointing
Jeff Riley to serve as our
independent, non-executive Chairman of the Board. Mr. Riley has
served on the Company's Board of Directors since March of 2010, and
will continue to serve on the Audit and Nominations
Committees.
Third Quarter Ended September 30,
2011 Financial Results
Total net revenues for the three and nine months ended
September 30, 2011 were $293,421 and $972,121, respectively, compared to $289,898 and $2,544,825, for the same periods in 2010. For the
nine months ended September 30, 2010,
total net revenues included $2,125,000 from the flupirtine sublicense fee
with Meda AB. Laboratory revenues for the three and nine months
ended September 30, 2011 increased to
$293,421 and $972,121, respectively, from $289,898 and $419,825, for the same periods in 2010. These
changes resulted from an increase in the client base and the
expansion of in-house diagnostic testing services to include a full
array of microbiology testing.
Total costs and expenses for the three and nine months ended
September 30, 2011 were $1,231,650 and $4,256,427, respectively, compared to
$1,023,026 and $3,393,029, for the same periods in 2010.
General and administrative expenses for the three and nine
months ended September 30, 2011 were
$681,805 and $2,649,623, respectively, compared to
$601,806 and $2,000,262, for the same periods in 2010. These
increases are primarily the result of increased salary expense and
consultant fees. For the three and nine months ended September 30, 2011, general and administrative
expenses include a non-cash charge relating to stock-based
compensation expense of $50,509 and
$860,833, respectively, compared to
$68,493 and $252,100 for the same periods in 2010. The
stock-based compensation expense for the nine months ended
September 30, 2011 includes a
one-time charge of $397,767 relating
to the modification of certain stock options, prior to expiration,
held by a member of the Board of Directors.
Research and development expenses for the three and nine months
ended September 30, 2011, were
$288,964 and $800,923, respectively, compared to $229,044 and $962,766 for the same periods in 2010. The
increase for the three months ended September 30, 2011 is primarily the result of
increased costs associated with our new clinical programs and the
development costs associated with the commercialization of
wellZin. The decrease for the nine months ended September 30, 2011 is primarily the result of
decreased costs associated with the discontinuation of some of our
clinical programs in prior periods. For the three and nine months
ended September 30, 2011, research
and development expenses include a non-cash charge relating to
stock-based compensation expense of $5,749 and $20,358,
respectively, compared to $19,817 and
$72,785, for the same periods in
2010.
Costs of laboratory services for the three and nine months ended
September 30, 2011, were $260,881 and $805,881, respectively, compared to $192,176 and $430,001, for the same periods in 2010. These
increases are primarily the result of increased costs associated
with the increased client base and expansion of in-house diagnostic
testing services to include a full array of microbiology testing,
including salary and supply costs.
Total net other expense for the three and nine months ended
September 30, 2011, were $159,750 and $1,680,030, respectively, compared to
$293 and $7,629 of total net other income, for the same
periods in 2010. For the three and nine months ended September 30, 2011, total net other expense
included $164,993 and $1,734,460, respectively, relating to the
estimated fair value of the warrants associated with the
January 2011 and April 2011 financings, adjusted for the change in
their fair value at September 30,
2011. Total net other income for the three months ended
September 30, 2011 included
$6,868 of interest income from our
short-term investments. Other income for the nine months ended
September 30, 2011 included
$62,996 relating to the settlement of
accounts payable previously accrued in prior periods and
$6,868 of interest income from our
short-term investments.
The net loss for the three months ended September 30, 2011, was $1,097,979 or $0.04
per share compared to $732,835 or
$0.03 for the same period in 2010.
The net loss for the nine months ended September 30, 2011, was $4,964,336 or $0.18
per share compared to $840,575 or
$0.04 per share for the same period
in 2010.
As of September 30, 2011, Adeona
had approximately $7.5 million in
cash, cash equivalents and short-term investments compared to
approximately $2.6 million in cash
and cash equivalents on December 31,
2010. As of October 31, 2011,
we had approximately $7.2 million in
cash, cash equivalents and investment in debt securities. Our cash
position should allow us to meet our currently planned operating
needs for at least the next 12 months.
"During the third quarter of 2011, we achieved several clinical
milestones that have positioned us for future growth and expanded
the opportunities we believe exist in our core areas of strength,"
stated James S. Kuo, M.D., M.B.A.,
Adeona's Chief Executive Officer. "We are currently working on
several projects that provide significant opportunities in major
areas of medicine, including the recently announced Phase IIb
clinical trial for our multiple sclerosis (MS) drug and the Phase
IIb clinical trial of our drug for Lou
Gehrig's disease (ALS)."
"We also announced in the third quarter the acquisition of
exclusive access to two sets of clinical data that demonstrate the
safety and efficacy of a particular oral zinc formulation in
reducing the duration and severity of symptoms associated with the
common cold. With this data in hand, we are now planning the
commercial launch of our zinc acetate lozenge, wellZin™, in
time for this year's cold season. We are excited about the
near-term potential wellZin presents, given the large market
that exists for a common cold treatment and the need for a better
zinc cold remedy formulation with positive clinical trial support,"
concluded Dr. Kuo.
Third Quarter 2011 Investor Conference Call
Adeona will hold its third quarter 2011 investor conference call
this afternoon, Monday, November 14,
2011, at 2:00pm (EST).
James S. Kuo, M.D., M.B.A., Adeona's
Chief Executive Officer, will host the call. Adeona will be joined
by special guest, Rhonda Voskuhl,
M.D., Director, UCLA Multiple Sclerosis Program, UCLA Department of
Neurology, and Principal Investigator of the recently announced
clinical trial evaluating the Company's product candidate,
Trimesta™, for cognitive dysfunction in female MS patients. Dr.
Voskuhl is also the Lead Principal Investigator of the ongoing
multi-center clinical trial evaluating Trimesta for
relapsing-remitting MS in women. In addition to providing an
overview of the new trial of Trimesta for cognitive dysfunction,
Dr. Voskuhl will share her insights into the mechanism to treat MS
patients and will take questions about her research.
Interested parties should call toll free 1-800-860-2442 (U.S.)
or 1-866-605-3852 (Canada), or
from outside North America +1
412-858-4600, fifteen minutes before the start of the call to
register and identify themselves as registrants of the 'Adeona'
Conference Call. Any registered caller on the toll free line may
ask to be placed in the queue for the Question & Answer
session. The call will be simulcast on the web at
http://www.videonewswire.com/event.asp?id=83585. If you are unable
to participate during the live conference call, the webcast will be
available for replay at the same URL
(http://www.videonewswire.com/event.asp?id=83585) for 30 days after
the call.
About Adeona Pharmaceuticals, Inc.
Adeona is a pharmaceutical company focused on developing
innovative medicines for the treatment of serious central nervous
system diseases. The Company's strategy is to license product
candidates that have demonstrated a certain level of clinical
efficacy and develop them to a stage that results in a significant
commercial collaboration. Adeona is developing, or has partnered
the development of, drug product candidates to treat relapses in
multiple sclerosis, cognitive dysfunction in multiple sclerosis,
fibromyalgia, amyotrophic lateral sclerosis (ALS) and Alzheimer's
disease. The Company is preparing to make wellZin™, a
homeopathic over-the-counter zinc acetate lozenge to reduce the
duration and symptoms of the common cold, commercially available.
Adeona is also developing reaZin™ as a medical food for the
dietary management of zinc deficiency associated with Alzheimer's
disease. In addition, Adeona operates Adeona Clinical Laboratory, a
wholly owned clinical reference laboratory that provides a broad
array of chemistry and microbiology diagnostic tests. For more
information, please visit Adeona's website at
www.adeonapharma.com.
This release includes forward-looking statements on Adeona's
current expectations and projections about future events. In some
cases forward-looking statements can be identified by terminology
such as "may," "could," "potential," "positions," "continue,"
"expects," "anticipates," "intends," "plans," "believe,"
"estimates," and similar expressions. These statements are based
upon current beliefs, expectations and assumptions and are subject
to a number of risks and uncertainties, many of which are difficult
to predict and include statements regarding the expanded
opportunities that exist for us, the planned commercial launch of
wellZin, as well as the development of reaZin, our ability to
obtain INDs in a timely manner for some of our drug candidates, the
ability of our current cash position to meet our planned needs for
the next 12 month, and the anticipated enrollment, timing or
results of our planned Alzheimer's, ALS or multiple sclerosis
cognition clinical trials. The forward-looking statements
are subject to risks and uncertainties that could cause actual
results to differ materially from those set forth or implied by any
forward-looking statements. Important factors that could cause
actual results to differ materially from those reflected in
Adeona's forward-looking statements include, among others, our
failure to successfully commercialize wellZin for the common
cold, develop reaZin as a medical food for the dietary
management of zinc deficiency associated with Alzheimer's disease,
develop AEN-100 as a treatment for Alzheimer's or ALS, or develop
Trimesta as a treatment for relapses or cognitive dysfunction in
multiple sclerosis, the failure of reaZin or wellZin to be accepted
for either use, failure of future clinical trials of any of our
drug candidates to be enrolled in and completed in the anticipated
time or to achieve the desired results, the failure
of Meda to commercialize flupirtine and to make any other payments
under the sublicense agreement, and other factors described in
Adeona's report on Form 10-K for the year ended December 31, 2010 and any other filings
with the SEC. 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.
SOURCE Adeona Pharmaceuticals, Inc.