TSX: AMF
TORONTO, June 13, 2014 /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 year ended March
31, 2014.
"We continue to execute our strategy of creating strategic
alliances and partnerships to advance our product pipeline of novel
diagnostics and antibody therapeutics", said Dr. Robert Gundel, Amorfix President and Chief
Executive Officer. "Earlier this quarter we announced our
agreement to partner with a major global pharmaceutical company to
complete the optimization and validation of our Alzheimer's disease
diagnostic. The EP-AD diagnostic assay measures aggregated Abeta
oligomers, a hallmark of Alzheimer's disease, in patient cerebral
spinal fluid and can accurately identify individuals (95%
specificity) with mild cognitive impairment who are likely to
develop Alzheimer's disease. In addition, this quarter we
entered into a research collaboration agreement with Trellis
Biosciences, an innovative antibody development company with
proprietary technology that can accurately identify and detect high
quality human antibodies. This collaboration is focused on
developing therapeutic antibodies against misfolded CD38, a cell
surface protein thought to have a significant role in leukemia and
lymphoma. We are in discussions with numerous pharmaceutical
companies for platform technology deals for use of our ProMIS™
discovery and Epitope Protection™ technologies for additional
partnerships and strategic alliances. Finally, we continue to
advance our ovarian cancer and melanoma programs through
preclinical development and expect to complete the proof of concept
in animal models and select a lead candidate for the melanoma
program by year end."
Recent Corporate Highlights
On January 22, 2014, the Company
announced it has entered into an agreement with a major global
pharmaceutical company to optimize and validate the EP-AD
Alzheimer's disease diagnostic prior to using the assay as part of
a clinical trial to investigate the effects of a novel therapeutic
for the treatment of Alzheimer's disease.
In January and Feb 2014, the
Company completed a non-brokered private placement through the
issuance of 3,600,000 common shares of Amorfix (Shares) and
3,600,000 Warrants for gross proceeds of $1,008,000. Each full Warrant entitles the holder
to purchase one Share at a price of $0.45 for a period of 24 months following the
closing date of the Offering, subject to an earlier expiry
provision.
On March 17, 2014, the Company
announced it has entered into a collaboration with Trellis
Bioscience to develop antibodies against misfolded CD38 protein as
a treatment for haematological malignancies including leukemia and
lymphoma. The company's discovery platform, called CellSpot™,
enables discovery of very rare high quality human antibodies
usually not detectable with standard techniques. Together
with Amorfix's ProMIS™ technology, the companies will isolate and
develop fully human therapeutic antibodies that will target only
cancer cells and not healthy ones. Under the terms of the
collaboration, Amorfix will have an exclusive option to develop any
resulting antibodies.
In April 2014, the Company
completed a non-brokered private placement through the issuance of
3,320,333 common shares of Amorfix (Shares) and 3,320,333 Warrants
for gross proceeds of $996,100. Each
full Warrant entitles the holder to purchase one Share at a price
of $0.50 for a period of 24 months
following the closing date of the Offering, subject to an earlier
expiry provision. In conjunction with the offering, the Company
paid $40,016 in finder fees and
issued 133,385 finder warrants which have the same terms as the
Warrants.
On June 2 2014 the Company
received a Notice of Allowance from the United States Patent and
Trademark Office for a broad-based patent covering the use of
antibody therapeutics for the treatment of ALS. The patent also
includes coverage for several disease specific epitopes used to
generate misfolded SOD1 specific antibodies to treat ALS.
Earlier this week the Company announced that Mr. William Wyman has been appointed Chairman of the
Board of Directors. Mr. Wyman began his career at the
management consulting firm Booz Allen and Hamilton and eventually became President of
the Management Consulting Group, a member of the executive
committee, and a member of the Board of Directors. Mr. Wyman
co-founded the management consulting firm, Oliver Wyman & Co.
which eventually merged with the consulting group at Marsh &
McLennan under the Oliver Wyman name. Mr. Wyman was a board
member at Donaldson, Lufkin and Jenrette and has served as a
director/advisor to more than a dozen public and private
companies. He also has served as an advisor to several
private equity partnerships.
Financial Results
The net loss for the year ended March 31,
2014 was $2,253,341 as
compared to the net loss of $2,230,902 for the year ended March 31, 2013. The Company measures
cash burn as the net cash used in operations, which was
$1,798,737 for the year ended
March 31, 2014 as compared to net
cash used in operations of $2,005,242
for the year ended March 31,
2013. The decrease in the cash burn rate is
mostly the result of lower cash-based expenses due to cost
containment decisions.
For the year ended March 31, 2014
revenue from services and sales was $139,968 as compared to $49,516 in the comparative period. Revenue
for the current year related mostly to the Company's EP-AD
diagnostic test. In addition, through research collaboration,
the Company recognized $8,354 in
research revenue for the year ended March
31, 2014. There was no research revenue in the prior
year.
Research and development expenses for the year ended
March 31, 2014 were $1,408,961 compared to $1,798,302 in the year ended March 31, 2013. The decrease in
expenditures related mostly to lower expenses on its cancer
therapeutics and ALS diagnostic research programs, lower facility
costs, lower salaries and travel, partially offset by higher
stock-based compensation expense.
General and administrative expenses for the year ended
March 31, 2014 were $992,702 compared to $484,442 in the year ended March 31, 2013. The increase in
expenditures resulted mostly from higher stock-based compensation
and higher salaries.
The net loss for the three months ended March 31, 2014 was $750,837 compared to a loss of $556,751 for the three months ended March 31, 2013. The increased net loss in
the current period results mainly from higher stock-based
compensation expense, lower program expenditures and higher travel
costs.
For the three months ended March 31,
2014 revenue from services and sales was $43,512, as compared to $31,634 in the comparative
period. Research revenue was $8,354 in the current period. There was no
research revenue in the comparable period.
Research and development expenses for the three months ended
March 31, 2014 were $343,143 compared to $469,841 in the comparable period. The decrease
in expenditures related mostly to lower wages, lower expenditures
on its ALS and cancer programs and offset by higher stock-based
compensation expense.
General and administrative expenses for the three months ended
March 31, 2014 were $459,560 compared to $118,544 in the comparable period. The increase
for the three months ended March 31,
2014 resulted mainly from higher stock-based compensation
expense and higher travel costs.
As at March 31, 2014, the Company
had a cash balance of $136,826 and a
working capital deficit of $90,371.
In April 2014, the Company completed,
in three tranches, a private placement offering for combined gross
proceeds of $996,100. The
Company is actively pursuing a number of financing options and
initiatives at this time and is optimistic of a successful interim
solution
Outlook
The Company's Fiscal 2015 research priorities, subject to the
Company raising additional funds, are to:
- Establish additional collaborations and partnerships for use of
the ProMIS™ discovery and Epitope Protection™ technologies to
continue to build a compelling pipeline of diagnostics and antibody
therapeutics for the treatment of misfolded protein diseases.
- Complete the research and development of an ALS diagnostic test
and ready for out-license.
- Initiate further studies in animal models of ovarian cancer
with AMF-1c-120 antibody.
- Evaluate lung cancer as a potential clinical indications for
AMF-1c-120 development.
- Initiate proof of concept studies in animal models of melanoma
with anti-Fas receptor antibodies and select a lead candidate for
development.
- Identify and complete the initial evaluation of anti-CD38
antibodies as therapeutics for the treatment of leukemia and
lymphoma.
- Complete the validation of the EP-AD Alzheimer's disease
diagnostic and, in collaboration with our pharmaceutical partner,
participate in the evaluation of a novel therapeutic for the
treatment of Alzheimer's disease.
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™, 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™ and AMFIA™, 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.