|By Marketwired .||
|November 29, 2012 10:30 PM EST||
VANCOUVER, BRITISH COLUMBIA -- (Marketwire) -- 11/30/12 -- Med BioGene Inc. (TSX VENTURE:MBI) today reported its financial results for the nine months ended September 30, 2012 (all amounts are in United States dollars).
Commercialization of LungExpress Dx
MBI announced in October 2012 that its commercial partner, Precision Therapeutics, Inc., expects to commence commercialization of LungExpress Dx, a proprietary gene expression-based test for early-stage non-small-cell lung cancer, in its CLIA-certified laboratory by mid-2013.
-- In advance of commercialization, Precision has established an advisory board comprised of world leaders in lung cancer research and treatment from the United States, Canada, France and Italy. -- LungExpress Dx is currently validated for use with frozen tumour tissue. Precision is responsible for all costs associated with the development and commercialization of LungExpress Dx and is commencing clinical studies to validate the use of LungExpress Dx with tissue preserved by RNARetain, a molecular fixative. RNARetain eliminates the need to flash- freeze specimens and to keep specimens frozen throughout storage and transport, a process that can be cumbersome and costly. It also eliminates the need for preserving tissue in formalin, which is known to cross-link and degrade the nucleic acids rendering them less suitable for specific downstream molecular applications. -- These clinical studies are being conducted using patient specimens collected prospectively by Precision from a consortium of medical centers in the United States. This collection is complete and the final step of validation using RNARetain has begun.
Erinn Broshko, Executive Chairman of MBI, commented: "The commercial success of a molecular diagnostic test depends, in large measure, upon the extent of its integration into current pathological processes. The use of LungExpress Dx with RNARetain will allow pathologists to avoid the logistics involved with using flash-frozen tumor specimens and, instead, to handle and ship specimens at room temperature, thereby simplifying the process significantly. We believe that this will materially enhance the commercial prospects of our test and are encouraged by the progress made by Precision."
Restructuring of Milestone Payments Under Commercialization Agreement
Under the terms of MBI's commercialization agreement with Precision, Precision has paid to MBI license fees and research reimbursement of $2.3 million, half of which is credited against future royalties that may be owed to MBI by Precision. In addition, MBI is eligible to receive up to $1 million in payments based on the achievement of certain milestones, all of which are credited against future royalties that may be owed to MBI by Precision. MBI and Precision amended in September 2012, among other things, these milestone payments such that Precision will now pay to MBI, following the commercial launch of LungExpress Dx, amounts totaling $500,000 and, following the achievement of $5 million in net revenues from LungExpress Dx, amounts totaling $500,000.
MBI will also receive royalty payments in the high single digits based on a percentage of Precision's future net revenues associated with the commercialization of LungExpress Dx.
Erinn Broshko further commented: "By restructuring the milestone payments in our commercialization agreement, we expect to extend MBI's cash runway following the commercialization of LungExpress Dx to allow us the opportunity to demonstrate increasing clinical and commercial success of our test. As a result of our focused burn rate, we believe that MBI currently has sufficient cash resources to continue with operations until approximately the first quarter of 2014. If Precision commercializes LungExpress Dx around the expected timeframe then, with receipt of the $500,000 in milestone payments from Precision relating to commercial launch, we believe that MBI will have sufficient cash resources to fund operations until approximately the third quarter of 2015."
Third Quarter 2012 Financial Results
MBI incurred a loss of $301,667 ($0.00 per share) for the nine months ended September 30, 2012 compared to having net income of $1,790,427 ($0.02 per share) for the nine months ended September 30, 2011. MBI incurred a loss of $78,239 ($0.00 per share) in the third quarter of 2012 compared to having net income of $1,575,650 ($0.02 per share) in the third quarter of 2011. MBI did not generate any revenue during the nine months ended September 30, 2012, but generated net licensing revenue of $2,069,773 during the nine months ended September 30, 2011.
Research and Development
Research and development expenses were $nil for the nine months ended September 30, 2012 compared to $123,161 for the nine months ended September 30, 2011. Comparing the third quarter of 2012 with the corresponding quarter of 2011, research and development expenses decreased to $nil from $14,511. Under the terms of MBI's partnership with Precision, Precision is responsible for all future costs associated with the development and commercialization of LungExpress Dx.
General and Administrative
General and administrative expenses, including non-cash share-based expenses associated with the prior issuance of stock options and foreign exchange, were $301,844 for the nine months ended September 30, 2012 compared to $443,397 for the nine months ended September 30, 2011, representing a decrease of 32%. Comparing the third quarter of 2012 with the corresponding quarter from 2011, general and administrative expenses decreased by 57% to $78,249 from $183,958.
Consistent with MBI's cost saving initiatives, general and administrative expenses, exclusive of non-cash share-based expenses associated with the prior issuance of stock options and foreign exchange, were $199,511 for the nine months ended September 30, 2012 and $59,474 for the three months ended September 30, 2012.
Liquidity and Capital Resources
At September 30, 2012, MBI had cash and equivalents totalling $458,964 and working capital of $356,614 compared to cash and equivalents of $685,170 and a working capital of $556,446 at December 31, 2011.
Cash used in operating activities was $226,923 for the nine months ended September 30, 2012 compared to cash provided by operating activities of $472,724 for the nine months ended September 30, 2011.
Cash provided by investing activities was $nil for the nine months ended September 30, 2012 compared to $64,499 for the nine months ended September 30, 2011. The cash provided by investing activities consisted of proceeds from the disposal of capital assets.
Cash provided by financing activities was $nil for the nine months ended September 30, 2012 compared to $212,930 for the nine months ended September 30, 2011. The cash provided by financing activities consisted of proceeds on issuance of shares.
About Med BioGene
MBI is a life science company based in Vancouver, British Columbia, that is currently focused on managing the license and rights to LungExpress Dx, a proprietary gene expression-based test for early-stage non-small-cell lung cancer. LungExpress Dx is expected to provide better-informed and personalized treatment decisions to assist in the selection of patients for adjuvant chemotherapy. MBI has partnered with Precision Therapeutics for the global commercialization of LungExpress Dx. MBI's common shares are traded on the TSX Venture Exchange. For more information regarding MBI, please visit www.medbiogene.com. For more information regarding Precision, please visit www.precisiontherapeutics.com.
Certain statements in this press release contain forward-looking statements and information ("forward-looking statements") under applicable United States and Canadian securities legislation. Words such as "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward looking statements include, but are 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. These forward-looking statements are only a prediction based upon the party's current expectations, and actual events or results may differ materially. A party may not actually achieve the plans, intentions or expectations disclosed in its forward-looking statements. Forward-looking statements are subject to known and unknown risks and uncertainties and are based on uncertain assumptions that could cause a party'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 these forward-looking statements, which speak only as of the date of this press release. A party's forward-looking statements do not reflect the potential impact of any future partnerships, collaborations, acquisitions, mergers, dispositions, joint ventures or investments that that party may make. All forward-looking statements are qualified in their entirety by this cautionary statement and a party undertakes no obligation to revise or update any forward-looking statements 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 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 would constitute forward-looking information. A redacted copy of the amended 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 news release belongs to its holder.
The TSX Venture Exchange does not accept responsibility for the adequacy or accuracy of this release.
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