VANCOUVER, Nov. 5, 2012 /PRNewswire/ - Allon Therapeutics Inc. (TSX: NPC) today announced its unaudited operating results for the
three and nine-month periods ended September 30, 2012. Allon also
reported that it is on track to advance toward commercialization of its
lead neuroprotective drug candidate davunetide as a potential treatment for progressive supranuclear palsy (PSP), a rapidly progressing and fatal degenerative brain disease.
Gordon McCauley, President and CEO of Allon Therapeutics, said the
quarter's progress has kept the company on track to meet its schedule
of completing patient treatment as well as analysis and release of
top-line data before the end of 2012 for the multinational phase 2/3
pivotal clinical trial that is evaluating davunetide in more than 300
PSP patients.
"Our shareholders stand with thousands of patients, caregivers,
families, and health professionals in search of a treatment for this
debilitating and fatal disease," McCauley said.
Allon estimates the market potential for the first approved treatment
for PSP will exceed $700 million in the U.S. and Europe. PSP affects
approximately 25,000 people in the United States and 40,000 people in
the European Union. Patients are typically diagnosed when they are
between 45 and 65 years of age.
Allon's pivotal trial is proceeding under a Special Protocol Assessment
with the U.S. Food and Drug Administration. This multi-national study
is being conducted in the United States, Canada, the United Kingdom,
France, Germany and Australia. The trial is based upon statistically
significant human efficacy demonstrated in patients with amnestic mild
cognitive impairment, cognitive impairment associated with
schizophrenia, and positive biomarker data.
PSP is considered a tauopathy, involving the tau protein in brain cells.
Allon has previously demonstrated, in both preclinical and clinical
studies, that davunetide has an impact on the tau pathology. The
current evaluation of davunetide in a pivotal clinical trial as a
potential treatment for PSP makes it the most advanced tau therapy in
the world.
The Company believes that success in treating PSP with davunetide would
define the opportunity to evaluate davunetide in other tau-related
diseases, such as Alzheimer's, subtypes of frontotemporal dementia, as
well as other neurodegenerative diseases such as schizophrenia and
Parkinson's.
Results of operations
Allon reported a net loss of $1,847,863 ($0.01 per share) for the three
months ended September 30, 2012, compared to a net loss of $2,983,887
($0.04 per share) for the three months ended September 30, 2011,
representing a decrease in net loss of $1,136,024. For the nine months
ended September 30, 2012, the Company reported a net loss of $7,869,780
($0.07 per share), compared to a net loss of $8,877,797 ($0.11 per
share) for the nine months ended September 30, 2011. This decrease in
net loss is explained in the following description of significant
variances from the comparable periods in 2011.
For the three and nine months ended September 30, 2012, research and
development expenses were $1,292,607 and $5,688,077 compared to
$2,235,554 and $6,448,571 for the three and nine months ended September
30, 2011. Research and development expenses were lower compared to the
same period in 2011 due to less clinical trial activities related to
PSP as the clinical trial nears completion. Research and development
expenses for the three and nine months ended September 30, 2012 also
included amortization and depreciation expenses of $127,136 and
$381,961 (2011 - $127,401 and $382,753) and share-based compensation of
$17,013 and $55,597 (2011 - $15,434 and $39,620).
For the three and nine months ended September 30, 2012, general and
administrative expenses were $568,986 and $2,024,416 compared to
$665,722 and $2,204,706 for the three and nine months ended September
30, 2011. General and administrative expenses for the three and nine
months ended September 30, 2012 were lower compared to the same periods
in 2011 primarily due to lower corporate development activities and
lower general overhead expenses partly offset by higher compensation
expenses. Included in general and administrative expenses for the three
and nine months ended September 30, 2012 were share-based compensation
of $77,566 and $231,068 (2011 - $44,440 and $139,642) and amortization
and depreciation expenses of $1004 and $6,007 (2011 - $3,169 and
$10,249).
The Company's other income and expenses are comprised of loss on debt
repayment, interest income/expense and foreign exchange gains/losses.
About Allon
Allon Therapeutics Inc. is a clinical-stage biotechnology company
focused on bringing to market innovative central nervous system
therapies. Allon's lead drug davunetide is proceeding in a pivotal clinical trial in an orphan indication, progressive supranuclear palsy (PSP), under a Special Protocol Assessment (SPA) with the U.S. Food and
Drug Administration (FDA). The trial is fully enrolled and on track to
complete the study, analyse the data and release top-line results
before the end of 2012. This pivotal trial is based upon statistically
significant human efficacy demonstrated in patients with amnestic mild
cognitive impairment, cognitive impairment associated with
schizophrenia, and in positive biomarker data.
The Company is listed on the Toronto Stock Exchange under the trading
symbol "NPC".
Forward Looking Statements
Statements contained herein, other than those which are strictly
statements of historical fact may include forward-looking information.
Such statements will typically contain words such as "believes", "may",
"plans", "will", "estimate", "continue", "anticipates", "intends",
"expects", and similar expressions. While forward-looking statements
represent management's outlook based on assumptions that management
believes are reasonable, forward-looking statements by their nature are
subject to known and unknown risks, uncertainties and other factors
that may cause the actual results, events or developments to be
materially different from any future results, events or developments
expressed or implied by them. Such factors include, among others, the
inherent uncertainty involved in scientific research and drug
development, Allon's early stage of development, lack of product
revenues, its additional capital requirements, the risks associated
with successful completion of clinical trials and the long lead-times
and high costs associated with obtaining regulatory approval to market
any product which Allon may eventually develop. Other risk factors
include the limited protections afforded by intellectual property
rights, rapid technology and product obsolescence in a highly
competitive environment and Allon's dependence on collaborative
partners and contract research organizations. These factors can be
reviewed in Allon's public filings at www.sedar.com and should be considered carefully. Readers are cautioned not to place
undue reliance on such forward-looking statements. Similarly, nothing
in this press release is meant to promote a pharmaceutical product or
make a regulated claim of efficacy.
Carrie Christenson
604-736-0634
info@allontherapeutics.com
www.allontherapeutics.com
SOURCE Allon Therapeutics Inc.