Med BioGene Reports Financial Results for 2013
April 30 2014 - 3:08PM
Marketwired Canada
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(R) 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(R), 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(R), BioSpeciFx(R) and GeneFx(R) 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.
FOR FURTHER INFORMATION PLEASE CONTACT:
Med BioGene Inc.
Erinn B. Broshko
Executive Chairman
(800) 641-3593
ebroshko@medbiogene.com
www.medbiogene.com
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