SAINT LAURENT, QUEBEC--(Marketwire - Nov. 10, 2010) - IntelGenx Technologies Corp. (TSX VENTURE:IGX)(OTCBB:IGXT) ("IntelGenx") today announced its financial results for the three and nine month period ended September 30, 2010 and presented highlights of recent business developments. All figures are in U.S. dollars, unless otherwise stated.
"The third quarter was a very productive period for the Company, both from a development and a financial perspective," commented Dr. Horst G. Zerbe, President and Chief Executive Officer of IntelGenx. "We continue to generate new and exciting clinical data from our VersaFilm™ oral pharmaceutical film platform. This quarter we delivered what we believe to be the first human data with a pharmaceutical film containing a PDE-5 inhibitor for the treatment of erectile dysfunction. This is the second oral film where IntelGenx has successfully completed human bioequivalency studies, the first being our anti-migraine film, which we recently partnered with RedHill Biopharma in a co-development agreement."
Dr. Zerbe added, "We also completed a successful private placement during the third quarter. The proceeds from this fundraising, combined with the cash from the completion of the RedHill deal, put IntelGenx in a comfortable financial position as we head into 2011."
Private Placement Financing:
On August 27, 2010 IntelGenx announced that it has closed a private placement offering of 6,500,000 units at CAD$0.40 per unit for gross proceeds of CAD$2.6 million. Each unit consists of one common share in the capital of the Company and one common share purchase warrant. Each warrant entitles the holder thereof to purchase one common share in the capital of the Company at an exercise price of CAD$0.50 expiring on August 27, 2013. The proceeds of the private placement will be used to support the Company's strategic development projects and for working capital purposes.
On August 30, 2010 IntelGenx and RedHill Biopharma Ltd., an Israeli corporation ("RedHill") announced that they have entered into a co-development and commercialization agreement for IntelGenx' first oral thin film product based upon the Company's proprietary VersaFilm™ technology. Under the terms of the definitive agreement, RedHill has obtained certain exclusive worldwide rights to market and sell IntelGenx' rapidly dissolving anti-migraine oral film product.
In exchange IntelGenx will receive upfront, milestone, and external development fees totaling up to $2.1 million from RedHill. RedHill will also be responsible for regulatory filing fees, if necessary. Furthermore, upon commercialization of the product, IntelGenx could receive, depending on the circumstance, up to 75% of all proceeds including, but not limited to, all sales milestones and income from the product world-wide.
Erectile Dysfunction Film:
On September 2, 2010 IntelGenx announced the completion of a pilot study that indicates that IntelGenx has successfully developed a novel oral film, INT007, that is bioequivalent to a leading branded tablet containing a phosphodiesterase type 5 (PDE-5) inhibitor for the treatment of erectile dysfunction. INT007 has been developed using IntelGenx' proprietary immediate release VersaFilm™ drug delivery technology.
This was a randomized, two-period, two-way crossover study in healthy male subjects. The study was designed to determine whether INT007 was bioequivalent to a leading branded PDE-5 inhibitor tablet as measured by industry standard pharmacokinetic measures, peak plasma concentration (Cmax) and area under the curve (AUC). The study results demonstrated that INT007 was within the range of bioequivalency on both of these measures. The study also measured time to peak concentration (Tmax), a common determinant of rate of absorption. IntelGenx' INT007 film achieved Tmax 27% quicker than the oral tablet formulation, indicating a potentially faster onset of action.
YEAR-TO-DATE FINANCIAL HIGHLIGHTS:
Cash and cash equivalents at September 30, 2010 of approximately $1.7 million (2009: $2.2 million).
Total Revenue of $1.2 million (2009: $1.1 million).
Total Expenses increased by $0.7 million to $3.3 million (2009: $2.6 million) primarily due to $1.0 million related to the Biovail litigation and $0.3 million related to the foreign exchange impact arising from the translation of the Company's operating currency (CAD$) into its reporting currency (US$), partly compensated by the reduction of financing fees of $0.7 million following repayment of the convertible debt in Q3, 2009.
The Net Loss widened by $0.7 million to $2.1 million (2009: $1.4 million).
The Basic and Diluted Loss Per Common Share remained constant at $0.06.
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 pain, hypertension, erectile dysfunction and depressive disorders. 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, 2009, 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.
For more information, please contact
IntelGenx Technologies Corp.
Dr. Horst G. Zerbe
President and CEO
+1 514-331-7440 (ext. 201)
+1 514-331-0436 (FAX)