TORONTO, Nov. 14, 2011 /CNW/ - Amorfix Life Sciences, a product
development company focused on diagnostics and therapeutics for
misfolded protein diseases, today announced its operational and
financial results for the second quarter ended September 30, 2011.
"We have made significant advancements in our therapeutic and diagnostic
programs this quarter," said Dr. Robert Gundel, Amorfix President and
Chief Executive Officer. "We have achieved a significant milestone
related to our Alzheimer's disease diagnostic and we will continue to
develop this assay as a tool to identify early-symptomatic patients who
could best benefit from treatment. This is where there is a recognized
need by the medical community and we believe our diagnostic shows great
promise. We are currently seeking a development partner to make this
important new diagnostic tool available to clinicians as quickly as
possible. In addition, our therapeutic antibody programs are moving
forward and we now have tumour specific antibodies for several of our
therapeutic targets. The recent collaboration with Helix BioPharma will
enable the development of antibody-toxin conjugate therapeutics that
specifically seek out tumours and selectively deliver the toxin killing
the tumour but sparing normal tissue."
Recent Corporate Highlights
On September 30, 2011, the Company announced it has achieved 85 percent
specificity and sensitivity with its EP-AD CSF Diagnostic Test. When
the scores from the Amorfix test were correlated with scores from the
MMSE (Mini-Mental State Examination, a clinical test used to measure
disease severity), the results demonstrated that aggregates were not
only found in cerebrospinal fluid (CSF) from late-stage Alzheimer's
disease (AD), but also in patients with early stage AD or mild
cognitive impairment (MCI). In addition, the data suggest that the
Amorfix test is superior for identification of patients with MCI when
compared to the measurements of monomeric Abeta 1-42 alone.
On November 11, 2011, the Company announced that it has entered into an
agreement with Helix BioPharma, a biotechnology company that has a
toxin conjugate with properties that suggest it will bind successfully
to its PrP lead antibody. The company expects to initiate cell based
studies in the fourth quarter of this fiscal year and if successful,
will then initiate in vivo proof of concept studies.
The net loss for the three months ended September 30, 2011 was $580,725
compared to net income of $83,101 for the three months ended September
30, 2010. The net loss for the six months ended September 30, 2011 was
$1,110,209 compared to a net loss of $1,590,480 for the six months
ended September 30, 2010.
For the three and six months ended September 30, 2011 revenue from
services and sales was $39,466 and $72,328, respectively as compared to
$61,126 and $84,899 in the comparative periods. Substantially all of
this revenue was from the Company's A4 test. Revenue from license fees was $nil for the three and six months
ended September 30, 2011 compared to $1,030,600 for the comparative
periods. The Company entered into a license agreement with Biogen Idec
in July 2010 and received a US$1,000,000 non-refundable fee.
Research and development expenditures for the three months ended
September 30, 2011 were $515,210 compared to $638,491 in the comparable
period. Research and development expenditures decreased mainly from
reduced staffing associated with the decision to suspend
commercialization of the Company's vCJD program in June 2010 and by
lower expenditures related to the ALS and ProMIS programs.
Research and development expenditures for the six months ended September
30, 2011 were $931,154 compared to $2,094,268 in the comparable period.
Research and development expenditures decreased mainly from the Company
having fewer employees than in the comparable period, to the severance
costs incurred in June 2010 associated with the decision to suspend
commercialization of the Company's vCJD program, and lower expenditures
related to the ProMIS program.
General and administrative costs for the three months ended September
30, 2011 were $109,649 compared to $383,525 in the comparable period
and for the six months ended September 30, 2011 were $261,018 compared
to $644,737 in the comparable period. The decrease for the three and
six months ended September 30, 2011 resulted mainly from the severance
costs incurred in the comparable periods and higher share based payment
expense recorded in the comparable periods.
At September 30, 2011, the Company had working capital of $1,242,421 and
50,609,959 common shares outstanding. Management projects that its
current working capital will fund the Company's operations into the
fourth quarter of fiscal 2012. The Company is actively pursuing
financing alternatives, but there is no assurance that these
initiatives will be successful, timely or sufficient.
The Company's Fiscal 2012 research priorities, subject to the Company
raising additional funds, are to:
Advance our ProMISTM antibody program targeting disease specific epitopes for both
therapeutics and companion diagnostics for cancer and other misfolded
protein diseases to a lead compound for late-stage preclinical
Grow the revenue from our A4 testing service for cell culture, tissue and blood in animal models of
Alzheimer's disease (AD);
Complete development of a human Alzheimer's test adapting the A4 test protocol to detect aggregated Abeta, the hallmark of the disease,
in human plasma and cerebro-spinal fluid;
Additional information about the Company, including the MD&A and
financial results may be found on SEDAR at www.sedar.com.
Amorfix Life Sciences Ltd. (TSX:AMF) is a product development company
developing therapeutic products and diagnostic devices targeting
misfolded protein diseases including Alzheimer's Disease (AD), cancers,
and ALS. Amorfix utilizes its computational discovery platform,
ProMIS™, to predict novel Disease Specific Epitopes ("DSEs") on the
molecular surface of misfolded proteins. Amorfix's lead programs
include therapeutics and companion diagnostics for cancers, antibodies
and vaccines to DSEs in ALS and AD diagnostic tests. In addition,
Amorfix's proprietary Epitope Protection™ technology enables it to
specifically identify very low levels of misfolded proteins in a
biological sample. The Company's diagnostic programs include an
ultrasensitive method for the detection of aggregated beta-Amyloid in
brain tissue, CSF and blood from animal models of AD, months prior to
observable amyloid formation, and development of a human screening test
for AD. For more information about Amorfix, visit www.amorfix.com.
The TSX has not reviewed and does not accept responsibility for the
adequacy or accuracy of this release. This information release may
contain certain forward-looking information. Such information involves
known and unknown risks, uncertainties and other factors that may cause
actual results, performance or achievements to be materially different
from those implied by statements herein, and therefore these statements
should not be read as guarantees of future performance or results. All
forward-looking statements are based on the Company's current beliefs
as well as assumptions made by and information currently available to
it as well as other factors. Readers are cautioned not to place undue
reliance on these forward-looking statements, which speak only as of
the date of this press release. Due to risks and uncertainties,
including the risks and uncertainties identified by the Company in its
public securities filings, actual events may differ materially from
current expectations. The Company disclaims any intention or obligation
to update or revise any forward-looking statements, whether as a result
of new information, future events or otherwise.
SOURCE Amorfix Life Sciences Ltd.
For further information:
| Dr. Robert Gundel |
President and Chief Executive Officer
Amorfix Life Sciences Ltd.
Tel: (416) 847-6957
Fax: (416) 847-6899
| || || || Janet Clennett |
Acting Chief Financial Officer
Amorfix Life Sciences Ltd.
Tel: (416) 847-6926
Fax: (416) 847-6899