IntelGenx Reports Q3, 2014 Results and Provides Corporate Development Update

Saint Laurent, Quebec--(Newsfile Corp. - November 12, 2014) - IntelGenx Corp. (TSXV: IGX) (OTCQX: IGXT) ("IntelGenx") today announced financial results for the three and nine months ended September 30, 2014 and provided an update on corporate developments. All amounts are in U.S. Dollars, unless otherwise stated.

Financial Results:

Cash on hand at September 30, 2014 decreased to $4.4 million and compares with a cash balance of $5.0 million as at December 31, 2013. The decrease in cash on hand at the end of Q3, 2014 relates to net cash used by operating activities of $1.6 million (2013: $0.7 million), net cash used in investing activities of $0.3 million (2013 - $0.3 million), and the negative effect of foreign exchange influences on cash balances of $0.3 million (2013: $Nil), partly offset by net cash provided by financing activities of $1.6 million (2013: $1.5 million).

Revenue of $0.8 million during the nine months ended September 30, 2014 (2013 - $0.8 million) includes $0.5 million (2013: 0.3 million) generated by Forfivo XL®, our first product approved by the U.S. Food and Drug Administration ("FDA"). Sales of Forfivo XL® experienced significant quarterly growth in 2014 to date. Net trade sales in the second quarter of 2014 grew by 55% when compared with the previous quarter, and grew by a further 31% in Q3, 2014. Net trade sales in the third quarter of 2014 were more than double those recorded in the first quarter. Management anticipates that sales of Forfivo XL® will continue to grow at a significant rate. Revenue for the nine months ended September 30, 2014 also includes an aggregate $0.3 million (2013: $0.5 million) in payments received for successfully achieving certain R&D development milestones for certain R&D development projects currently under development.

Total expenses in the first nine months of 2014 were $2.3 million compared with $1.8 million in the same period of 2013. The increase relates primarily to costs incurred in the development of our second Par project, which is progressing according to plan, and also to the costs of a pilot clinical study for our VersaFilm™ product for erectile dysfunction that was completed in Q1, 2014 and that indicated bioequivalence with the leading brand reference listed drug tadalafil product.

The net loss increased from $1.0 million in the first nine months of 2013 to $1.5 million in the same period of 2014 with the corresponding loss per share at $0.02 and $0.03 respectively.

Corporate Development Update

Equity Analyst Coverage by H.C. Wainwright

On July 1, 2014 we announced that H.C. Wainwright initiated equity analyst coverage of IntelGenx.

A copy of the initiation report can be accessed by clicking:

https://hcwco.bluematrix.com/docs/pdf/ff51024b-71e2-47c5-ab58-7d05118ab4aa.pdf.

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") (IntelGenx and RedHill together, the "Companies"), we announced receipt of a Complete Response Letter ("CRL") from the FDA regarding the New Drug Application ("NDA") for our VersaFilm™ product for the treatment of acute migraines. The anti-migraine VersaFilm™ product is a proprietary oral thin film formulation of rizatriptan benzoate, a 5-HT1 receptor agonist and the active drug in Merck & Co.'s Maxalt®. The questions raised by the FDA in the CRL regarding the NDA for the anti-migraine VersaFilm™ product primarily relate to Chemistry, Manufacturing and Controls ("CMC") and to the packaging and labeling of the product.

On March 3, 2014 the Companies announced the submission of a response to the FDA's CRL and on April 24, 2014 the Companies reported that the FDA had acknowledged receipt of our response and has requested additional CMC data, which the Companies believe they can supply based on available information. The Companies further reported that the supplier of the active pharmaceutical ingredient ("API") of the product is currently holding compliance discussions with the FDA following a temporary import ban of the API. These discussions are independent of RedHill and IntelGenx and are not specific to our anti-migraine VersaFilm™ product. The Companies are diligently working on a variety of options to ensure continued supply of the raw material regardless of the result of these compliance discussions and have already identified and audited an alternative active pharmaceutical ingredient ("API") supplier.

On April 28, 2014 the Companies announced the commencement of a comparative bioavailability clinical study comparing the anti-migraine VersaFilm™ product to the European reference drug. The study is intended to support the planned submission of a European Marketing Authorization Application and follows a positive scientific advice meeting with the German Federal Institute for Drugs and Medical Devices announced by RedHill in November 2013. On May 21, 2014 the Companies announced positive results from the comparative bioavailability study.

Subsequent to the end of the quarter, on October 1, 2014 the Companies announced that they have submitted a Marketing Authorization Application ("MAA") to the German Federal Institute for Drugs and Medical Devices ("BfArM") seeking European marketing approval of their oral thin film formulation of rizatriptan for acute migraines, under the brand name RIZAPORT®. The brand name RIZAPORT® was also conditionally approved by the FDA as part of the NDA review process in the U.S.

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.

Subsequent to the end of the quarter, on November 3, 2014 we announced the successful completion of a pilot clinical study for INT0036 that demonstrated a significantly improved pharmacokinetic profile against the reference product. The study data confirm that buccal absorption of the drug from the INT0036 film product results in a significantly higher bioavailability of the drug compared to oral tablets. Therapeutically relevant plasma concentrations are therefore reached significantly faster with the VersaFilm product compared to conventional tablets. We also announced that the product, INT0036, is indicated for the treatment of schizophrenia.

In order to maintain our competitive advantage, we are unable to disclose further details related to this project at this time.

Erectile Dysfunction VersaFilm™ product

On February 24, 2014 we announced the completion of a pilot biostudy with our proprietary VersaFilm™ tadalafil product for erectile dysfunction that indicated bioequivalence with the leading brand reference listed drug tadalafil product.

The successful outcome of this study enables us to finalize the optimization of the formulation and subsequently move on to pivotal activities.

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.

About IntelGenx:

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.

CONTACT:

Paul A. Simmons
Chief Financial Officer
IntelGenx Technologies Corp.
T: +1 514-331-7440
F: +1 514-331-0436
www.intelgenx.com