Saint Laurent, Quebec--(Newsfile Corp. - August 7, 2014) - IntelGenx Corp. (TSXV: IGX) (OTCQX: IGXT) ("IntelGenx") today announced financial results for the three and six months ended June 30, 2014 and provided an update on corporate developments. All amounts are in U.S. Dollars, unless otherwise stated.
Cash on hand at June 30, 2014 increased to $5.2 million and compares with a cash balance of $5.0 million as at December 31, 2013. The increase in cash on hand at the end of Q2, 2014 relates to net cash provided by financing activities of $1.6 million (2013 - $0.8 million) and relates to the exercise of warrants, partly offset by net cash used in operating activities of $1.2 million (2013 - $0.3 million) and net cash used in investing activities of $0.2 million (2013 - $0.2 million).
Revenue of $0.4 million during the six months ended June 30, 2014 (2013 - $0.7 million) primarily relates to revenue generated by Forfivo XL®, our first product approved by the U.S. Food and Drug Administration ("FDA"). Revenue generated in the first six months of 2013 included project related development milestones totaling $0.5 million for the successful completion of the pivotal bioequivalence study for our VersaFilm™ buprenorphine/naloxone product for the treatment of opiate addiction and confirmation that our New Drug Application ("NDA") submission to the FDA for our anti-migraine VersaFilm™ oral film product was sufficiently complete to permit a substantive review.
Total expenses in the first six months of 2014 were $1.5 million compared with $1.1 million in the same period of 2013. The increase relates primarily to an increase in R&D expenses for costs of a pilot clinical study for our VersaFilm™ product for erectile dysfunction that indicated bioequivalence with the leading brand reference listed drug tadalafil product, together with costs incurred in the development of our second Par project, which is progressing according to plan.
The net loss increased from $0.4 million in the first six months of 2013 to $1.1 million in the same period of 2014. The loss per share was $0.01 in the first six months of 2013 and $0.02 in the first six months of 2013.
Corporate Development Update
Equity Analyst Coverage by H.C. Wainwright
Subsequent to the end of the quarter, on July 1, 2014 we announced that H.C. Wainwright initiated equity analyst coverage of IntelGenx with a "buy" rating and price target of $2. The stock closed at US$0.70 on the OTCQX and at CAD$0.74 on the TSX-V on Friday, June 27, 2014.
A copy of the initiation report can be accessed by clicking:
All reports on us prepared by analysts represent the views of such analysts and are not necessarily those of IntelGenx. We are not responsible for the content, accuracy or timelines provided by analysts.
Anti-migraine VersaFilm™ product
On February 4, 2014, together with our co-development partner RedHill Biopharma Ltd. ("RedHill"), we announced receipt of a Complete Response Letter ("CRL") from the FDA regarding the NDA for our VersaFilm™ product for the treatment of acute migraines. The CRL cited regulatory compliance issues with a supplier of raw materials for the product as an impediment to FDA approval. Since receiving the CRL, we have been diligently working on a variety of options to ensure continued supply of the raw material and have already identified and audited an alternative source of active pharmaceutical ingredient ("API"). Furthermore, IntelGenx and RedHill are preparing to manufacture the batches required for the CRL response and to conduct the stability studies that are required to support the switch to the new API.
On April 28, 2014 IntelGenx and RedHill announced the commencement of a comparative bioavailability clinical study comparing the anti-migraine VersaFilm™ product to the European reference drug, Maxalt® lingua, marketed in Germany by MSD SHARP & DOHME GMBH. In light of the positive results from the bioavailability study, together with data from prior clinical studies, IntelGenx and RedHill plan to submit a European Marketing Authorization Application ("MAA") during the third quarter of 2014.
Government Funding for CNS VersaFilm™ product
On April 30, 2014 we announced financial support from the National Research Council of Canada Industrial Research Assistance Program (NRC-IRAP) to support further development of a product for the treatment of central nervous system (CNS) diseases and disorders. The product will be based upon our proprietary, oral thin film, VersaFilm™, technology.
In order to maintain our competitive advantage, no specific details related to this project are being disclosed at this time.
U.S. patent allowances
On February 26, 2014 we announced receipt of a Notice of Allowance ("NOA") from the United States Patent and Trademark Office ("USPTO") for U.S. Patent Application Serial No. 11/647,033 entitled "Multilayer tablet" which covers the technology used in our hypertension product currently under development. A second NOA has been received for U.S. Patent Application Serial No. 11/782,838 entitled "Controlled-release pharmaceutical tablets" which is related to the drug delivery technology used in Forfivo XL®, our first FDA-approved product currently commercialized in the U.S.
On April 16, 2014 we announced receipt of a further NOA from the USPTO for U.S. Patent Application Serial No. 12/836,810 entitled "Oral mucoadhesive dosage form" which covers IntelGenx' proprietary AdVersa™ mucoadhesive drug delivery technology.
Subsequent to the end of the quarter, on July 15, 2014 we announced that the board of directors (the "Board") of IntelGenx had accepted the resignation of Dr. Rajiv Khosla as President, Chief Executive Officer, and as a member of the Board. The Board immediately appointed Dr. Horst G. Zerbe to serve as our interim President and Interim CEO until a successor is found.
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' development pipeline includes products for the treatment of indications such as severe depression, hypertension, erectile dysfunction, migraine, insomnia, CNS indications, idiopathic pulmonary fibrosis, oncology and pain, as well as animal health products. 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, 2013, 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 OTCQX has neither approved nor disapproved the contents of this press release.
Paul A. Simmons
Chief Financial Officer
IntelGenx Technologies Corp.
T: +1 514-331-7440
F: +1 514-331-0436