Med BioGene Reports Financial Results for 2013
VANCOUVER, BRITISH COLUMBIA--(Marketwired - Apr 30, 2014) - Med
BioGene Inc. (TSX-VENTURE:MBI) today reported its financial results
for the year ended December 31, 2013 (all amounts are in United
States dollars).
2013 and Q1 2014 Business Highlights:
- MBI's commercial partner, Precision Therapeutics, received
regulatory approval of GeneFx® Lung under CLIA (Clinical Laboratory
Improvement Amendments of 1988), the United States federal
regulations applicable to clinical laboratory testing. With this
approval, Precision may undertake testing of GeneFx Lung in its
CLIA-certified clinical laboratory in Pittsburgh,
Pennsylvania.
- MBI's clinical partner, Princess Margaret Cancer Centre,
University Health Network (UHN) in Toronto, published in the
Journal of Thoracic Oncology data demonstrating a second,
independent validation, conducted in a prospective and blinded
manner, of GeneFx Lung.
- Precision and UHN presented at the American Society of Clinical
Oncology (ASCO) Annual Meeting in Chicago, Illinois, data detailing
successful completion of clinical studies to validate the use of
GeneFx Lung with tissue preserved by RNAlater®, a molecular
fixative.
- Pursuant to a settlement agreement among MBI, Precision, Signal
Genetics LLC and Respira Health LLC, Signal and Respira dismissed
and withdrew with prejudice their legal claims made against MBI and
Precision in the Supreme Court of the State of New York. As part of
MBI and Precision's commercialization agreement, Precision is
solely responsible for all financial obligations under the
settlement agreement.
- MBI successfully opposed a petition filed in the British
Columbia Supreme Court by MBI shareholders Iain Weir-Jones,
Elizabeth Anne Weir-Jones, Graeme May and Tracy May relating to
MBI's adoption of an Advance Notice Policy. The dissident
shareholders discontinued the petition.
- 2,318,000 warrants and agents' warrants to purchase an equal
number of common shares of MBI at a price of $0.10 per share were
exercised for gross proceeds to MBI of C$231,800.
Erinn B. Broshko, MBI's Executive Chairman, commented: "2013 and
the beginning of 2014 has seen Med BioGene achieve some very
important milestones leading up to the commercialization of GeneFx
Lung.
"As we have previously noted to our shareholders, the long-term
commercial success of GeneFx Lung will depend largely upon the
extent to which government payors, specifically Medicare, and other
third-party payors reimburse the test. Precision is developing
their launch strategy to maximize reimbursement opportunities in
light of payor precedent and feedback from Medicare. The timing of
the commercial launch of GeneFx Lung will be established by
Precision in view of these considerations and we will update our
shareholders once a decision has been made."
2013 Financial
Results
During the year ended December 31, 2013, MBI recorded a net loss
of $759,288 (2012 - $368,083), which consists of general and
administrative expenses of $401,583 (2012 - $263,549) and non-cash,
share based payments of $357,705 (2012 - $104,534). During the
year, MBI granted 3,050,000 stock options with a fair value of
$357,705 and expensed it to operations.
The increase in general and administrative expenses during the
year ended December 31, 2013 were due largely to MBI incurring
$125,826 of legal fees relating to MBI's successful opposition of
the above-mentioned petition filed in the British Columbia Supreme
Court on June 4, 2013 by dissident shareholders of MBI..
During the three months ended December 31, 2013 and 2012,
including non-cash, share-based payments relating to the prior
issuance of stock options, MBI incurred a loss of $67,320 ($0.00
per share) and a loss of $66,239, respectively.
Liquidity and
Capital Resources
At December 31, 2013, MBI had cash and equivalents totalling
$181,507 and working capital of $112,624 compared to cash and
equivalents of $355,326 and a working capital of $294,655 at
December 31, 2012.
Cash used in operating activities was $398,294 for the year
ended December 31, 2013 compared to $329,549 for the year ended
December 31, 2012.
Cash provided by financing activities was $225,792 for the year
ended December 31, 2013 compared to $nil for the year ended
December 31, 2012. In May 2013, 2,318,000 warrants and agents'
warrants to purchase an equal number of common shares of MBI at a
price of C$0.10 per share were exercised for gross proceeds to MBI
of C$231,800.
Under MBI and Precision's commercialization agreement, MBI is
eligible to receive from Precision up to $1.0 million in the
following milestone payments, all of which are credited against
future royalties that may be owed to MBI by Precision: following
the commercial launch of GeneFx Lung, amounts totaling $500,000
and, following the achievement of $5 million in net revenues from
GeneFx Lung, amounts totaling $500,000.
As a result of MBI's current cash position, management has
decreased their compensation to provide an extended runway to the
anticipated commercialization of GeneFx Lung and receipt from
Precision of the $500,000 milestone payment noted above.
About Med BioGene
Inc.
MBI is a life science company based in Vancouver, British
Columbia that is currently focused on managing the license and
rights to GeneFx Lung. MBI's common shares are listed for trading
on the TSX Venture Exchange. For more information, please visit
www.medbiogene.com.
About GeneFx
Lung
GeneFx Lung is a proprietary gene expression-based test to
improve upon staging for identifying those patients with
early-stage non-small-cell lung cancer (NSCLC) who, following
surgical removal of their tumor, are at higher and lower risks of
mortality. In an initial study of patient specimens from the
National Cancer Institute of Canada Clinical Trials Group JBR.10
trial, published in the Journal of Clinical Oncology,
patients classified by GeneFx Lung as high risk benefited from
adjuvant chemotherapy, and those classified as low risk did not
benefit and may have experienced a detrimental effect from adjuvant
chemotherapy. In the same study, GeneFx Lung was validated in
predicting patient mortality in four independent studies involving
data from tumor specimens totaling 375 untreated early-stage NSCLC
patients. As published in the Journal of Thoracic
Oncology, GeneFx Lung was also independently validated in a
prospective and blinded manner in predicting patient mortality in a
study of 181 specimens from untreated NSCLC patients. GeneFx Lung
is expected to provide better-informed and personalized treatment
decisions to assist in the selection of patients for adjuvant
chemotherapy.
On April 15, 2011, Precision and MBI closed their
commercialization, license and research reimbursement agreement.
The agreement provides to Precision exclusive global rights to
develop and commercialize GeneFx Lung.
About Precision
Therapeutics
Precision Therapeutics, a leading life science company based in
Pittsburgh, Pennsylvania, is dedicated to improving the outcomes of
cancer patients by providing personalized medicine solutions that
aim to increase quality of life and cancer survival rates.
Precision offers a portfolio of products developed to help guide
physicians and patients with difficult clinical decisions
throughout the continuum of cancer care.
Precision currently markets a number of tests through its
CLIA-certified laboratory, including ChemoFx®, BioSpeciFx® and
GeneFx® Colon.
For more information on Precision, please visit
www.precisiontherapeutics.com.
The TSX Venture Exchange does not accept responsibility for the
adequacy or accuracy of this release.
Certain information in this press release contains
forward-looking information and statements ("forward-looking
information") of MBI under applicable Canadian and United States
legislation. Words such as "anticipates," "believes," "estimates,"
"expects," "intends," "may," "plans," "projects," "will," "would"
and similar expressions are intended to identify forward-looking
information, although not all forward-looking information contains
these identifying words. Forward looking information includes, but
is not limited to, that with respect to the timing, completion
and/or results of clinical trials or studies, the timing for
commercialization of any products, future profits, future product
revenues, future shareholder value, future operations and plans,
the completion and use of proceeds from transactions or financings
and the prospects for negotiating partnerships or collaborations
and their timing. This forward-looking information is only a
prediction based upon MBI's current expectations, and actual events
or results may differ materially. MBI may not actually achieve the
plans, intentions or expectations disclosed in its forward-looking
information. Forward-looking information is subject to known and
unknown risks and uncertainties and is based upon uncertain
assumptions that could cause MBI's actual results and the timing of
events to differ materially from those anticipated in such
forward-looking information. You are cautioned not to place undue
reliance on this forward-looking information, which speak only as
of the date of this press release. MBI's forward-looking
information does not reflect the potential impact of any future
partnerships, collaborations, acquisitions, mergers, dispositions,
joint ventures or investments that MBI may make. All
forward-looking information herein is qualified in its entirety by
this cautionary statement and MBI undertakes no obligation to
revise or update any such forward-looking information as a result
of new information, future events or otherwise after the date of
this press release, other than as required by applicable law.
Certain information included in this press release in respect of
Precision and its scientific, clinical and/ or commercialization
efforts and expectations have been provided to MBI by Precision.
MBI may not have been able to confirm the accuracy of such
information and you should not place undue reliance on any such
information, including any information regarding Precision that may
constitute forward-looking information. A redacted copy of the
commercialization agreement between MBI and Precision may be found
at www.sedar.com. Each trademark, trade name or service mark of any
entity appearing in this press release belongs to its
holder.
Med BioGene Inc.Erinn B. BroshkoExecutive Chairman(800)
641-3593ebroshko@medbiogene.comwww.medbiogene.com
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