Operator: Good afternoon. My name is Christine and I'll be your conference operator today. At this time, I would like to welcome everyone to the IntelGenx Q3 2017 Financial Results Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers’ remarks, there will be a question-and-answer session. [Operator Instructions] Thank you. Mr. Stephen Kilmer, you may begin your conference.

Stephen Kilmer: Thank you, Christine. Good afternoon, everyone and thank you for joining us on today’s call. With me on the line are Dr. Horst Zerbe, IntelGenx’s President and CEO, and Andre Godin, our Executive Vice President and CFO. Before we begin, I would like to remind you that all amounts mentioned today are in US dollars and today’s call may contain forward-looking information that represents our expectations as of today and accordingly are subject to change. We do not undertake any obligation to update any forward-looking statements, except as maybe required by US and Canadian securities laws. A number of assumptions were made by us in preparing these forward-looking statements, which are subject to risks and results may differ materially. Details on these risks and assumptions can be found in our filings with the US and Canadian Securities Commissions. I’ll now turn the call over to Dr. Zerbe. Horst?

Horst Zerbe: Thank you, Steve. Good afternoon and welcome to IntelGenx's third quarter 2017 conference call. I will begin by providing a corporate update and just stress the key developments in the quarter. Following that, Andre will review our Q3 financial results before we open up the line for your questions. Some of the key updates for the quarter include, first, the resubmission of the NDA to the US Food and Drug Administration for our RIZAPORT 10 milligrams film. Along with RedHill Biopharma, we resubmitted the 505(b)(2) NDA for our RIZAPORT 10 milligram film. For new investors, let me provide a little background. Following the original RIZAPORT NDA submission to the FDA, IntelGenx and RedHill received a complete response from the agency. Great response was prompted by the fact that FDA had imposed an import ban on the API supplier listed in the application. The import ban was issued because of multiple GMP violations. IntelGenx therefore had to identify and qualify a new API supplier. Since the stability data in the application were generated with product containing API from the old supplier, we had to manufacture new submission batches, that for your information, three batches per strength and perform stability testing on those batches. These batches also support the manufacturing site change of the product from the original German contract manufacturer to IntelGenx’s old manufacturing facility. This site change was necessary because at the time of the submission of the original NDA, the company did not have its own manufacturing plant and the initial submission batches therefore had to be manufactured at a contract manufacturer. PDUFA date, a new PDUFA date I should say is expected to be set by the agency for the first half of 2018. This resubmission was a key milestone for the team. We're very excited to move closer to bringing this product to the US market and provide migraine sufferers a convenient and unique migraine relief alternative. The European application is on the National Review in Spain. A response to questions from the Spanish authority was recently submitted. Approval of the Spanish application is expected for November or December of this year, to be precise. Once the product has been approved in Spain, as I mentioned before, we will submit an application for the manufacturing site change. The product is expected to be launched in Spain by mid-2018. Regarding the South Korean filing, with our Korean partner, Pharmatronics, we will transfer the FDA dossier to Pharmatronics upon acceptance of the file for review by FDA, which is expected to be received in late November of this year. A few comments on Tadalafil. Tadalafil as you know is indicated for the treatment of erectile dysfunction and pulmonary hypertension. IntelGenx is only pursuing the erectile dysfunction indication. The film that we developed is fully equivalent with the brand product Cialis. The filing of the 505(b)(2) NDA is now on track for a Q4 submission. We expect an 8 to 12 month review by FDA and correspondingly a launch in the United States is targeted for the second half of 2018. A few comments on the Suboxone patent litigation. As we have pointed out previously, our Par project for the indication of opioid dependency is entirely driven by litigation. In September of this year, the Delaware Court determined that the process used to manufacture the product does not infringe on Monosol's so-called 497 patent. This is a really positive outcome for IntelGenx, confirming that our process for making the product does not infringe on the process and culmination disclosed in the 497 patent. The same court has previously ruled on Monosol's so called 514 patent, Par and IntelGenx who have found to infringe on this patent. However, we did not agree with that decision and decided to appeal the ruling. Shortly thereafter, TEVA which had also been sued in a separate court case by Indivior and Monosol for infringement of that same 514 patent received a claim construction stating that they were not infringing on this patent. In order to address this obvious contradiction, Par and IntelGenx filed a motion to reopen our case and asked the judge to reconsider our ruling arguing that another infringement ruling issued in the TEVA case should be applied to our case as well. However, the court argued that the motion was filed too late and it was rejected. I would like to point out that the rejection was not based on merits, but simply on formal grounds. As I just mentioned, the court decided that we filed the motion too late. Par and IntelGenx will now move forward through the appeal process as initially planned. Moving onto Montelukast, Montelukast is IntelGenx’s most important and advanced drug repurposing opportunity. The drug is approved by FDA for the treatment of asthma. IntelGenx has established a drug repurposing project with the objective to obtain approval for the treatment of degenerative disease of the brain. The decision to take on the project was initially based on animal experiments conducted by the Austrian researcher Professor Aigner who published those results in Nature. Recently, an epidemiological study was published by Norwegian Research group which found that asthma patients treated with Montelukast are less likely to develop dementia compared with patients taking conventional inhalation asthma medicine. The conclusion of the article was, and I quote, "The present results suggest that Montelukast may alleviate the cognitive decline associated with human aging." Obviously, the conclusion of this epidemiological review needs to be confirmed by controlled clinical trial. As previously reported, we successfully completed the Phase 1 clinical study with Montelukast. The results represented at the recent ADDS Congress in London and show a significantly improved pharmacokinetic profile of the drug when given as an oral film. The bioavailability increased by 52% against reference product and there is clear evidence that the drug crosses the blood brain barrier. With the assistance of leading Alzheimer's experts, we designed a Phase II so called proof of concept study, which will be supervised by the C5R which is the Canadian Governing Body of Alzheimer’s and Dementia Studies. The study protocol has been agreed upon with the above mentioned clinical experts and a clinical trial application has been submitted to Health Canada. The study will be conducted in patients suffering from mild to moderate Alzheimer's dementia. Eight study sites with approximately 70 patients, have been secured in Canada to conduct the study. Study enrollment will commence in the first quarter of 2018, as we expect intermediary study results to be available by mid-2018. Besides the projects I just discussed, we have four projects ongoing with the chemo group and one additional project with Endo. Because of contractual confidentiality obligations, we are not at liberty to disclose any details of these projects. I can qualitatively state that all five projects are progressing according to redeployed budget plans and regulatory submissions for all five projects are scheduled for 2018. With that, I would now like to turn the call over to our CFO, Andre Godin who will review our Q3, 2017 financial results. Andre?

Andre Godin: Thank you, Horst and good afternoon everyone. As Horst just mentioned, I will take a few minutes to discuss the company's financial performance for Q3. Let's start with the revenue. The total revenue for the three month period ended September 30, 2017 amounted to 1.3 million, compared to 1.8 million last year for the same period. The decrease for the three-month period September 30, 2017, compared to last year is mainly attributable to the decrease in license and other revenue following the signing of several agreements in Q3 of last year. Operating costs and expenses were 1.8 million for 2017 third quarter versus 1.7 million for the corresponding period last year. Let's point out that SG&A expenses decreased by 100,000 for the three months period and by 150,000 for the nine-month period compared to 2016. In terms of EBITDA, adjusted EBITDA was minus 340,000 for the three month period compared to 311,000 last year. For the nine month period though, there was an improvement of 60,000 in the EBITDA compared to 2016. For Q3 2017, the company had an operating loss of 569,000 compared to an operating income of 88,000 for the comparable period in 2016. Net comprehensive loss was 586,000 or $0.01 on a basic and diluted per share basis for the three month period of 2017 compared to a net comprehensive income of 62,000 for last year. As of December 30, 2017, the company's cash and short-term investment totaled 6.9 million. This includes the net proceeds from the prospectus offering of the convertible unsecured subordinated debenture that was completed in early August. I would like now to turn the call back to Dr. Zerbe to conclude our remarks.

Horst Zerbe: Thank you, Andre. I would like to conclude the call by thanking our team and everybody at IntelGenx for their dedication and hard work, and to everyone on the call, thank you once again for your interest in IntelGenx and for your participation today. With that, I now turn to call over for questions.

Operator: [Operator Instructions] Your first question comes from the line of Anthony Cantone from Cantone Research. Your line is open.

Anthony Cantone: Hello, Horst. I wanted to ask about any update you can give us on the progress of potentially, I know that it's hard to discuss partnership negotiations, but are you thinking that we're going to get something in the near term regarding the potential marketing of Cialis. I mean, it's still in the works that we should have Cialis on the market hopefully by next year I assume, and I just wanted to ask about any progress that you can comment on.

Horst Zerbe: Thanks for the question, Anthony. It's certainly not unexpected. I cannot provide any specifics. What I can tell you qualitatively is that there are very active discussions ongoing with respect to a licensing deal, but as I mentioned at this point, I'm not at liberty to disclose any details, but just to restate there are ongoing very active discussions with interested parties.

Anthony Cantone: Okay, fair enough. And could you comment about the progress of the Montelukast, is there -- are we getting close to enrolling patients yet?

Horst Zerbe: Yes. As I mentioned in the update, the clinical trial application has been submitted to Health Canada, and we also by the way disclosed that in a press release. That is more or less a formality. We expect the clinical trial to be approved by Health Canada later this year and enrollment to be commencing in the first quarter of next year. When exactly, we don't know, because this depends on the time that the clinical sites that we have at this point, eight clinical sites committed, the time that the clinical sites require for the preparation of the trial. Keep in mind this is not a Phase 1 trial, it's an efficacy trial and so therefore the clinical sites need to hire and train nurses and there's a lot of preparation at the clinical end to be completed before the first enrolment can start. We were told that within six weeks to roughly a quarter after Health Canada has approved the clinical trial application, we can expect commencement of enrolment.

Anthony Cantone: Okay, so that's good news. All right. So do you expect to enroll 50 people or more than 60 people? Can you give us a general idea and what the cost is going to be roughly speaking?

Horst Zerbe: At this point, 70 patients have been committed. I cannot finally comment on the study cost. That's an ongoing discussion and we will know more once the clinical sites have completed their preparations. We will update our investors accordingly.

Anthony Cantone: Okay. And regarding Cialis, did we get the bioequivalency done and have we -- what about the shelf life study, has that been completed yet, or is it to be completed early next year?

Horst Zerbe: The bio study has been completed quite a while ago, long, long time ago, but we are looking at wrapping up stability studies, and as I mentioned in the update, we are geared up for a submission later this quarter.

Anthony Cantone: Okay, good. Do you think that's going to require press release or an 8-K filing?

Horst Zerbe: Upon submission, we will issue a press release, yes.

Anthony Cantone: Okay, good. Okay, that’s good. That keeps everybody informed. All right, that’s good. Now right now, we have about nine drugs in the pipeline, do you expect to have anything more than that in the near term?

Horst Zerbe: I think we have more than nine. If I remember correctly, we have 11 projects in our pipeline, but it's a good question and the answer is the short answer, again I cannot provide any details. Yes, we're in very active negotiations for a couple of other programs.

Anthony Cantone: Okay. And last question is always about money. Do we have enough money to carry out all the strategic initiatives that we have with Montelukast being a pretty significant burden I would think, even though you couldn’t mention how much it's going to be, and do we have enough cash or do you think there'll be something, I mean maybe next year, we're going to have to raise some more money.

Horst Zerbe: Andre will address that question.

Andre Godin: Yes. At this point, we have sufficient cash. Like Horst said, we're still working on the Montelukast budget so that will be important to know what will be the final cost of the study, but keep in mind that we also -- always looking for strategic opportunities so in which case, there could be a potential raise, but for the day to day, we don't need to raise any money for the time being.

Anthony Cantone: Okay. We have enough cash from the most recent raise and not looking to raise money, at least in the near term.

Horst Zerbe: Yes, exactly. Correct.

Operator: Your next question comes from the line of Peter Maza, a Private Investor. Your line is open.

Unidentified Analyst: When do you expect to get the approval of your production facility by the Canadian regulatory agency?

Horst Zerbe: We expect to receive that by the end of this year or later this year. We are in active communication with the Canadian Authority. A site inspection has been scheduled, but at this time, I cannot comment any further, but qualitatively speaking, we assume that later this year we will obtain the approval.

Operator: There are no further questions at this time. Dr. Zerbe, I turn the call back over to you.

Horst Zerbe: Okay. So as there are no further questions, I would again like to thank everybody attending the call, for their continued interest in the company. Thank you very much and have an enjoyable reset of the day.

Andre Godin: Thank you.

Operator: This concludes today's conference call. You may now disconnect.