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Last updated on April 17, 2014 at 21:23 EDT

Amorfix announces fiscal 2013 year end results

June 28, 2013

TSX: AMF

TORONTO, June 28, 2013 /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 year ended March
31, 2013.

“We continue to advance our diagnostic and therapeutic antibody programs
and have recently reached a number of critical milestones”, said Dr.
Robert Gundel, Amorfix President and Chief Executive Officer.  “On the
cancer front, we have established proof of concept for our lead
antibody conjugate in ovarian cancer which validates the ProMIS(TM)
discovery technology in terms of identifying disease specific epitopes
(DSEs) for the generation of antibodies that bind only to tumor cells
and not to normal cells.  These results provide an important and
necessary component to our data package demonstrating the utility of
the technology for the generation of targeted therapeutics.  With these
data in hand we are confident that we can attract top tier
pharmaceutical companies for product-based collaborations. The ProMIS(TM)
approach for the development of novel therapeutics is unique to Amorfix
and we are receiving increased recognition from leading cancer
researchers.   This is demonstrated by our recent collaboration with
Dr. Pataer of MD Anderson and also by the invitation to present our
technology at the April 2013 annual meeting of the American Association
for Cancer Research (AACR). On the financial front, we have
successfully raised capital to support the advancement of our programs
in a challenging global market.  This is a testament to the potential
of our novel technology and innovative approach to the development of
therapeutic antibodies and diagnostics that address large commercial
market opportunities with high unmet medical needs”.

Recent Corporate Highlights

On March 20, 2013, the Company announced the progress it had made
towards developing a blood test for the diagnosis of ALS. The Company
announced it had cloned ultra-high affinity antibodies that detect a
misfolded version of the enzyme superoxide dismutase 1 (SOD1).  This
new antibody will be used to improve the sensitivity of the bead assay
being developed by the company for the detection of SOD1 in plasma.

In two tranches, April 4th and April 22nd, 2013, the Company completed a
non-brokered private placement (the Offering) pursuant to which a total
of 1,250,000 Units were issued for total gross proceeds $325,000 under
this Offering.

Each Unit consisted of one common shares of Amorfix (Shares) and one
common share purchase warrant of Amorfix (Warrants). Each Warrant
entitles the holder to purchase one Share at a price of CDN$ 0.50 for a
period of 24 months following the closing date of the Offering, subject
to earlier expiry in the event (a trigger event) that, following the
expiry of the four month hold period, the volume-weighted average price
of Amorfix’s common shares on the Toronto Stock Exchange (TSX) over a
period of twenty consecutive trading days exceeds $1.00. On the
occurrence of a trigger event, Amorfix may give notice to holders to
accelerate the expiry to a date which is not less than 30 calendar days
after such notice is sent to the holders.

On April 9, 2013, Amorfix CSO Dr. Neil Cashman provided an update of the
Company’s ovarian cancer therapeutic antibody program at the annual
meeting of the American Association for Cancer Research (AACR) in
Washington, DC. The presentation was well received by the audience
comprised of academic researchers and pharmaceutical industry
scientists and executives.

On April 9, 2013 the Company reported the completion of the first in a
series of studies with its anti-misfolded prion protein antibody in
animal models of ovarian cancer with promising preliminary results on
reducing tumor volume. In this initial study, the antibody urease
conjugate showed a reduction in median and mean tumor volume as
compared to the non-treated group.  The Company also announced that it
had completed a study that shows that the treatment of cancer cells
with chemotherapeutic agents increases the amount of misfolded prion
protein at the cell surface, and the subsequent binding of anti-prion
protein antibodies while showing no increase in misfolded prion protein
on the surface of normal ovarian cells. These important scientific
findings are the first of its kind and suggests that a combination of
standard chemotherapy drugs with antibodies directed against misfolded
protein targets could provide a much more effective therapeutic benefit
to cancer patients.

On April 25, 2013, the Company announced that it had signed a
collaboration agreement with The University of Texas MD Anderson Cancer
Center for the use of the Company’s anti-cancer antibodies in a lung
cancer research program.  Under the agreement, Apar Pataer, M.D.,
Ph.D., associate professor of Thoracic and Cardiovascular Surgery at MD
Anderson will use the Amorfix antibodies to identify misfolded proteins
expressed on the surface of various human lung cancer cell lines.  In
addition, studies will be conducted to identify other potential
candidate misfolded protein targets for analysis with the Company’s
proprietary ProMIS(TM) discovery technology to identify immunotherapeutic
targets for the generation and development of therapeutic antibodies
for use in the treatment of lung cancer.

On June 5, 2013, the Company announced that it completed a second series
of studies with its lead ovarian cancer antibody in a preclinical
ovarian cancer animal model.  In this study there was a statistically
significant decrease in tumor volume compared to control animals.

The Company recently terminated its agreement with PREVENT for the
development of an ALS vaccine and will be seeking an alternative
development partner for this technology for completion of preclinical
studies and a more rapid advancement into clinical development.

On June 26, 2013 the Company announced that it closed the first tranche
of a non-brokered private placement (the Offering) pursuant to which
1.5 units (Units) were issued at a price of CDN$350,000 per unit for
gross proceeds of CDN$525,000. The total amount that can be raised
under the Offering is $1,400,000.

Each Unit consists of one million common shares of Amorfix (Shares) and
one million common share purchase warrants of Amorfix (Warrants). Each
Warrant entitles the holder to purchase one Share at a price of CDN$
0.55 for a period of 24 months following the closing date of the
Offering, subject to earlier expiry in the event (a trigger event)
that, following the expiry of the four month hold period, the
volume-weighted average price of Amorfix’s common shares on the Toronto
Stock Exchange (TSX) over a period of twenty consecutive trading days
exceeds $1.00. On the occurrence of a trigger event, Amorfix may give
notice to holders to accelerate the expiry to a date which is not less
than 30 calendar days after such notice is sent to the holders.

In connection with the Offering, Amorfix will pay CDN$42,000 in finder
fees and issue 40,000 finder warrants which have the same terms as the
Warrants.

Financial Results

For the year ended March 31, 2013 the Company reported a net loss from
operations of $2,230,902 ($0.04 per share) compared with a net loss of
$2,543,813 ($0.05 per share) for the year ended March 31, 2012. The
reduced net loss results mostly from lower program expenditures on its
AD diagnostic program and lower stock based compensation.  Research and
development expenses for the year ended December 31, 2013 were
$1,798,302 compared to $2,037,424 in the comparable period. General and
administrative expenses for the year ended March 31, 2013 were $484,442
compared to $610,771 in the comparable period last year.

For the three months ended March 31, 2013 the Company reported a net
loss from operations of $556,751 ($0.01 per share) compared to net loss
of $702,317 ($0.01 per share) for the three months ended March 31,
2012.  The decreased net loss in the current period results mainly form
lower program expenditures and lower stock-based compensation. Research
and development expenses for the three months ended March 31, 2013 were
$469,841 compared to $526,049 in the comparable period. General and
administrative expenses for the three months ended March 31, 2013 were
$118,544 compared to $177,792 in the comparable prior year period.

At March 31, 2013, the Company had a working capital deficit of
$328,015. Subsequent to year end the Company completed two private
placement offerings for combined gross proceeds of $850,000. Presently,
the Company does not have sufficient working capital to continue its
research and development programs.  The Company is actively pursuing a
number of financing options and initiatives at this time and
anticipates a successful interim solution shortly.

Outlook

The Company’s Fiscal 2014 research priorities, subject to the Company
raising additional funds, are to:

        --  Establish additional collaborations and partnerships for use of
            the ProMIS(TM) discovery technology to continue to build a
            compelling pipeline of novel antibody therapeutics for the
            treatment of cancer
        --  Complete the research and development of an ALS diagnostic test
        --  Initiate further studies in animal models of ovarian cancer
            with anti-PrP antibodies
        --  Initiate proof of concept studies in animal models of cancer
            with anti-Fas receptor antibodies
        --  Complete the validation of a human Alzheimer's disease test to
            detect aggregated Abeta, a hallmark of the disease, in
            cerebrospinal fluid



Additional information about the Company, including the MD&A and
financial results may be found on SEDAR at www.sedar.com.

About Amorfix

Amorfix Life Sciences Ltd. (TSX:AMF) is an early-stage product
development company developing therapeutic antibodies and diagnostics
targeting misfolded protein diseases. Amorfix utilizes its
computational discovery platform, ProMIS(TM), to predict novel Disease
Specific Epitopes (DSEs) on the molecular surface of misfolded
proteins. Using this technology, Amorfix is developing novel antibody
therapeutics and companion diagnostics for cancer and amyotrophic
lateral sclerosis (ALS). In addition, Amorfix has developed two
proprietary technologies to specifically identify very low levels of
misfolded proteins in a biological sample: Epitope Protection(TM) and
AMFIA(TM), an ultra-sensitive dual-bead immunoassay. Use of these
technologies has generated a cerebrospinal fluid (CSF) screening test
for both Alzheimer’s disease (AD) and mild cognitive impairment (MCI),
and an ultrasensitive method for detecting the hallmark of AD,
aggregated beta-Amyloid, in brain tissue, CSF and blood from animal
models of 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.


Source: PR Newswire