SAINT LAURENT, QUEBEC--(Marketwire - Aug. 9, 2011) - IntelGenx Technologies Corp. (TSX VENTURE:IGX)(OTCBB:IGXT) ("IntelGenx") today announced its financial results for the three and six month periods ended June 30, 2011 and highlighted recent business developments. All amounts are in U.S. dollars, unless otherwise stated.
"We had a very busy second quarter, completing fundraising activities to raise over $3 million, filing the resubmission of our NDA 505(b)(2) as required for the approval of our lead product CPI-300, successfully completing another bio-study for a VersaFilm™ product for insomnia and executing a term-sheet with RedHill Biopharma to co-develop and license our anti-psychotic oral thin film," commented Dr. Horst G. Zerbe, President and Chief Executive Officer of IntelGenx. "Another major milestone in our goal to commercialize CPI-300 was recently realised when Pillar5 Pharma passed a pre-approval inspection by the FDA and we now look forward to the FDA's response targeted for November 13, 2011."
On June 22, 2011, we announced the closing of two concurrent private placement offerings in the U.S. and Canada. We issued approximately 4.8 million shares of common stock at $0.67 per share and three-year warrants to purchase up to approximately 2.4 million shares of common stock at an exercise price of US$0.74 per share, for aggregate gross proceeds of approximately US$3.2 million. We intend to use the net proceeds to support our strategic development projects and for working capital.
Subsequent to the end of the second quarter, warrants and stock options have been exercised for a total of 920,652 common shares for cash consideration of approximately $0.5 million.
CPI-300 Antidepressant Tablet:
On May 16, 2011, we announced that we had submitted our reply to the Complete Response Letter ("CRL") issued in February 2010, by the FDA, and on June 14, 2011, we announced that the FDA has accepted the resubmission of our NDA 505(b)(2) in response to the CRL. In addition, the FDA has established November 13, 2011, as its target action date under the Prescription Drug User Fee Act ("PDUFA").
Subsequent to the end of the quarter, on August 2, 2011, we announced that Pillar5 Pharma Inc. ("Pillar5") successfully passed a pre-approval inspection by the FDA for CPI-300. Pillar5, the contract manufacturing organization ("CMO") selected by IntelGenx for the manufacture of CPI-300, successfully responded to all queries from the FDA for its pre-approval site inspection.
On February 7, 2011, we announced the completion of a pilot study that indicates we have successfully developed a novel oral film, INT0022, which is likely to be bioequivalent to a leading anti-psychotic in a pivotal bioequivalency study. INT0022 has been developed using our proprietary immediate release "VersaFilm™" drug delivery technology.
On June 14, 2011, we announced the execution of a binding term-sheet with RedHill Biopharma Ltd. ("RedHill"), an Israeli corporation, to co-develop and license our anti-psychotic oral thin film. The term-sheet sets forth the main criteria to be incorporated into a license agreement, under which RedHill would obtain exclusive worldwide rights to market and sell our rapidly dissolving anti-psychotic oral film product. In exchange, we would receive upfront, milestone and external development fees totalling up to U.S.$2.3 million from RedHill. Upon commercialization of the product, we would receive up to 50% of all proceeds including all sales milestones and income from the product world-wide.
On April 6, 2011, we announced the completion of a pilot biostudy indicating that we have developed a novel oral film, INT0020, which suggests bioequivalency to a leading branded product for the treatment of insomnia. INT0020 has been developed using our proprietary immediate release "VersaFilm™" drug delivery technology.
|U.S. $ Millions except Per Share Data|
|As of six month period ended:|
|June 30, 2011||June 30, 2010|
|Cash Equivalents||$ 3.2||$ 0.4|
|Revenue||$ 0.1||$ 0.3|
|Expenses||$ 1.3||$ 2.0|
|Net Loss||$ 1.2||$ 1.7|
|Loss Per Share||$ 0.03||$ 0.05|
IntelGenx is a drug delivery company focused on the development of oral controlled-release products as well as novel rapidly disintegrating delivery systems. IntelGenx uses its unique multiple layer delivery system to provide zero-order release of active drugs in the gastrointestinal tract. IntelGenx has also developed novel delivery technologies for the rapid delivery of pharmaceutically active substances in the oral cavity based on its experience with rapidly disintegrating films. IntelGenx' research and development pipeline includes products for the treatment of severe depression, hypertension, erectile dysfunction, benign prostatic hyperplasia, migraine, insomnia, bipolar disorder, idiopathic pulmonary fibrosis, allergies and pain management. More information is available about the company at www.intelgenx.com.
Forward Looking Statements:
This document may contain forward-looking information about IntelGenx' operating results and business prospects that involve substantial risks and uncertainties. Statements that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, but are not limited to, statements about IntelGenx' plans, objectives, expectations, strategies, intentions or other characterizations of future events or circumstances and are generally identified by the words "may," "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates," "could," "would," and similar expressions. All forward looking statements are expressly qualified in their entirety by this cautionary statement. Because these forward-looking statements are subject to a number of risks and uncertainties, IntelGenx' actual results could differ materially from those expressed or implied by these forward looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed under the heading "Risk Factors" in IntelGenx' annual report on Form 10-K for the fiscal year ended December 31, 2010, filed with the United States Securities and Exchange Commission and available at www.sec.gov, and also filed with Canadian securities regulatory authorities and www.sedar.com. IntelGenx assumes no obligation to update any such forward-looking statements.
Each of the TSX Venture Exchange and OTC Bulletin Board has neither approved nor disapproved the contents of this press release.
IntelGenx Technologies Corp.
Dr. Horst G. Zerbe
President and CEO
+1 514-331-7440 (ext. 201)
+1 514-331-0436 (FAX)