Operator: My name is Jody and I’ll be your conference operator today. At this time, I would like to welcome everyone to the IntelGenx Third Quarter 2018 Earnings Conference Call. [Operator Instructions] Thank you. Stephen Kilmer, Investor Relations. You may begin your conference.

Stephen Kilmer: Thanks Jody. 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 all that amounts mentioned today are in U.S. dollars unless otherwise mentioned 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 U.S. 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 factors and assumptions can be found in our filings with the U.S. and Canadian Securities Commissions. I’ll now like to turn the call over to Dr. Zerbe. Horst?

Horst Zerbe: Thank you, Steve. Good afternoon and welcome to the IntelGenx’s third quarter 2018 conference call. On today’s call, I will provide a corporate update and discuss the progress we have made in our pipeline projects. Following that, Andre will review our Q3 2018 financial results and discuss the recent equity offering, then we’ll open up the lines for your questions. This quarter we have continued to make significant strides in advancing the development of our various products. Let's start with RIZAPORT a proprietary oral thin-film formulation of rizatriptan for the treatment of acute migraines which is the most advanced product. This past September we announced successful results from a bioequivalence study demonstrating that RIZAPORT is bioequivalent to the U.S. reference Maxalt-MTL and the European reference, Maxalt-Lingua. The bioequivalence study was single-dose, randomized, three-way crossover, pivotal, comparative bioavailability study of RIZAPORT 10 mg Maxalt-MLT 10 mg orally disintegrating tablets and Maxalt-Lingua 10 mg oro-dispersible tablets in 30 healthy volunteers. The study was conducted under the direction of Biopharma Services in Toronto, Ontario. The study results fulfilled FDA’s request for additional information related to the transfer of manufacturing to IntelGenx new GMP complaint manufacturing plant to allow for a full review of the Company’s 505(b)(2) NDA resubmission for RIZAPORT. We continue to look for U.S. approval of RIZAPORT before the end of first half of 2019. As for Europe the study will be used to support applications in additional European countries. It may also be required to support the transfer of the manufacturing of RIZAPORT from the European contract manufacturing listed in the initial application to IntelGenx. In late October the Spanish Agency of Medicines and Medical Devices AEMPS granted national marketing authorization for RIZAPORT 10 mg in Spain. This marketing authorization was received by our marketing partner Grupo Juste who is now a part of Exceltis Healthcare. Once the site transfer of RIZAPORT to IntelGenx new GMP facility is approved. This marketing authorization will enable IntelGenx commercialization Exceltis Healthcare to commercialize the product in Spain. Now let’s touch on tadalafil which is indicated for erectile dysfunction and pulmonary hypertension treatment. Other application pursues the erectile dysfunction indication only it is fully bioequivalent with the brand product Cialis tablets. IntelGenx has an exclusive license from Eli Lilly for their Orange Book listed 166 dosing patent and this exclusivity allows IntelGenx a clear path to product launch, now that the substance patent has expired. I would like to take the opportunity to update you on the current status and to provide some context without violating strict, contractual, confidentiality obligations. Earlier this year we entered into negotiations with a company that has a tadalafil NDA pending at the FDA with the intent to jointly commercialize that product under our exclusive license from Lilly. These negotiations have been put on hold for some time and have recently resumed. Yes an agreement can be reached we could foresee that under certain circumstances a product launch in the near future. Although we believe that the potential partnership is in our best business interests we have throughout the entire negotiation period continue to pursue our own independent 505(b)(2) NDA. In the absence of an agreement with our potential partner before the end of this year we are on track to file our own 505(b)(2) NDA before the end of this year. It is important to understand that our partnering discussions were and continue to be subject to strict contractual confidentiality provisions that admittedly cause some confusion and frankly frustration. However, as I have pointed out on past calls for competitive and other reasons we are often required to maintain strict confidentiality. I hope you will all agree that our intentions always are to get the best possible deal and thereby maximize the benefit of our shareholders. At the same time, we are committed to being as transparent as we possibly can. Moving onto cannabis news, earlier this week we executed a definitive licensing development and supply agreement with Tilray Inc. a global leader in medical and adult-only cannabis research, cultivation, production and distribution. The two companies will co-develop and commercialize cannabis-infused oral film products for adult-only and medical use in anticipation of the amended cannabis regulations allowing the sale of edible cannabis product in Canada for adult-only consumers. Under the agreement - IntelGenx and Tilray will fund 20% and 80% respectively of the cost associated with the development of the cannabis-infused VersaFilm products. IntelGenx will have exclusive rights to manufacture and supply the co-developed products to Tilray and will also receive a fixed single-digit royalty on net product sales. Tilray will have the exclusive worldwide marketing and distribution rights for the co-developed products. Partnering with Tilray is an important and exciting development in our endeavor to enter the cannabis markets. Longer films are highly unique and highly relevant approach to consuming cannabis appealing to both medicinal and adult-only markets. We believe that a significant portion of those likely to use cannabis will find the dissolvable film appealing due to its ease of use, discreteness and lack of harmful smoke, precise dosing and child-resistant packaging. We’re also pleased to welcome Tilray as a strategic shareholder of IntelGenx in connection with this transaction. The market for cannabis is expected to see significant growth under the new Canadian legal regime both in terms of number of participants and dollar value. PIBC analysts forecast the EBITDA of the private sector of the cannabis industry it worked about $1 billion in 2020. In other partnership news in October, we announced that ANDA and for a generic buccal film product that IntelGenx co-developed with Insud, which is the former chemo group, had been submitted to the FDA. This is the first submission for a product co-developed under our partnership with Insud and marks the achievement of the major milestone. Let's now move on to Montelukast. Montelukast is our major drug repurposing opportunity indicated for the treatment of certain degenerative diseases of the brain, such as Alzheimer's, cognitive impairment, and other similar diseases. The addressable market of that product is in excess of $5 billion and expected to grow very significantly over the next years. At the beginning of this year, IntelGenx initiated a Phase 2 clinical trial to evaluate the tolerability, efficacy, and safety of Montelukast buccal film in patients with mild-to-moderate Alzheimer's disease. To carry out this study we retained the services of the Contract Research Organizations Cogstate and JSS Medical Research. With again patient screening in September, and we are pleased to announce that seven of our eight testing sites have now been activated and are recruiting patients. As of earlier this week, the first patient has been entered in the electronic data capture system and two other sites are actively prescreening patients. For the patients - selected patients that has been entered, test all results come positive in terms of meeting entry criteria, the patient will then be enrolled into this study. With that I would now like to turn the call over to our CFO, Andre Godin, who will review our financial results and briefly discuss the recent equity offering. Andre?

Andre Godin: Thank you, Horst. Good afternoon, everyone. As Horst mentioned, I'll take a few minutes to discuss the Company's financial performance for the third quarter ended September 30, 2018. For the third quarter 2018, total revenue amounted to $700,000 compared to $1.3 million in the same period last year. The decrease is mainly attributable to the decrease in deferred revenue on the monetization of [indiscernible] for $972,000 that was offset by an increase in R&D revenue of $418,000. Operating costs and expenses were $3.3 million for Q3, 2018, versus $1.8 million for the corresponding three month period of 2017. The increase is mainly attributable to increase in R&D and SG&A expenses of $874,000 and $750,000 respectively compared to the same period last year. It is for, in terms of R&D it is mostly to increase in study costs and for SG&A is mainly attributable to increase in manufacturing expenses due to all scale-up activities and validation on our different projects. Also for Q3 2018, the Company had operating loss of $2.6 million compared to an operating loss of $569,000 for the comparable period of 2017. Adjusted EBITDA was negative $2.3 million for Q3, compared to negative $340,000 for the same period last year. Net comprehensive loss was $2.9 million or $0.04 on a basic and diluted per share basis, for Q3 of this year compared to $586,000 or $0.01 per share for the comparable period of 2017. As at September 30, 2018, the Company's cash and short-term investments totaled $2.2 million, which obviously does not include $0.5 million in proceeds from the exercise of previously issued common share purchase warrants, nor the gross proceeds of $12 million raised by the Company in its October 2018 equity offering and the gross proceeds of $633,000 from the exercise of the over-allotment options. Finally, it does not include as well the Tilray $1 million private placement which should be closing tomorrow. Now let's talk a few words on the latest financings. We're pleased that the outcome of this financing allows us to be in a much stronger financial position now so knowing that we don't need to return to the market in time soon. This financing allows the Company to pursue it's key program. While the terms were not necessarily the ones we were totally satisfied with, we were able to limit the issuance of warrant compared to what is now more common. And we believe that the Company is in much better cash flow position now than it was pre-financing. I will now turn the call back to Dr. Zerbe, to conclude our remarks.

Horst Zerbe: Thank you, Andre. A few years IntelGenx made the strategic decision to move away from being a development company limited to royalty as licensed revenues and to move towards becoming a full service global leader in oral films by owning both the development and manufacturing processes. While that decision temporarily impacted on the Company's profitability due to the need to make significant new investments in plant and people, we firmly believed that we had an opportunity to build a much stronger business and able to drive significant and sustainable growth over both mid and long term. In anyways, anticipated approvals to manufacture RIZAPORT at IntelGenx site, a Letter of Itent with Tilray and the agreement with ANDA which gives us all manufacturing rights for two significant products will serve to help validate that choice. We look forward to updating all of our stakeholders as we progress. I would like to close acknowledging the support of our Board, our shareholders, and most importantly the ongoing hard work and dedication of our staff. Heartfelt thank you to all of them. I will now turn the call over for questions. Thank you.

Operator: [Operator Instructions] Your first question comes from the line of Sean Lee from H.C. WainWright. Please go ahead.

Sean Lee: Could you provide a little more color on the Tilray agreement? Has the parties committed to develop a number of products? And also following the legalization of cannabis in Canada, what's the regulatory process like there?

Horst Zerbe: Regarding the first part of your question, definitive agreement that we executed earlier this week includes a relatively detailed development plan for at least first product and the development costs associated with that, the Company is happy intend to turn this into a multi-product relationship but obviously for good reasons. At this point we've been a little more specific only for the first product. As far as the second part of your question goes, we don't know much yet about the further development of the legal environment that will eventually lead to the full legalization of adult-only cannabis. We know the time frame, the assumption - actually we know for a fact that in about a year these products will be legalized but above and beyond that I can't really comment much more on this.

Operator: Your next question comes from the line of [indiscernible] a Private Investor. Please go ahead.

Unidentified Analyst: My first question is in regards to the RIZAPORT you had mentioned that a Grupo Juste got the marketing authorization in Spain and now they're working on transferring the manufacturing site to Montreal. What timeframe do you guys anticipate this to be completed at?

Horst Zerbe: It’s Horst speaking that is extremely difficult to answer because the Spain authority is absolutely unpredictable. To give you an example our Spanish partner that expected a six month’s review period for the initial application it took well over a year for the site change. And they expect a three to six months review period but that is their best guess only I obviously do not commit to that. But that is the information that were receiving from our Spain partner.

Unidentified Analyst: And my next question is in regards to the product that IntelGenx is manufacturing are there any products that you are currently manufacturing because you showed that there is a manufacturing expense on this Q3 report?

Horst Zerbe: Not a stellarable product yet at this point we are manufacturing transfer batches meaning batches that are intended to validate our manufacturing site or several products and submission batches. And we are not yet manufacturing any commercial product, we expect that to commence in 2019.

Unidentified Analyst: And another question in regards to the FDA inspection the facility Andre had mentioned in the last meeting at the Rodman & Renshaw that you guys are waiting on the FDA to inspect your facility. Is that going to be happening this year?

Horst Zerbe: Typically I'm sure that or I'm assuming that Andre referred to the preapproval inspection for our RIZAPORT resubmission. Typically the agency schedules the preapproval inspection for about two months post notification of acceptance for review. The notice for acceptance – for review hasn’t been received yet it's overdue which is actually in our interpretation a good sign so to be concrete it is more likely that the preapproval inspection will occur early next year January at the latest in my estimation in early February that is the more likely timeframe.

Unidentified Analyst: And this is in reference to the bioequivalence study results that you guys resubmitted for that additional information that the FDA was requiring from you correct?

Horst Zerbe: Yes, the resubmission included a lot more information and data but part of that you are absolutely right it was the bio study that FDA required to support the switch our manufacturing site.

Operator: [Operator Instructions] Your next question comes from the line of Patrick Tully of Endeavor Asset Management. Please go ahead.

Patrick Tully: Just a follow-up on the prior question regarding the transferring of the Spanish review of the transfer. When did the clock start running on the three to six months period?

Horst Zerbe: This month, first of all thanks Pat for the question this month.

Patrick Tully: Okay.

Horst Zerbe: Let me correct myself we said the resubmission occurred in October so technically it was last month that the clock started running.

Patrick Tully: So three to six months from last month is when your partner expects to receive the transfer approval?

Horst Zerbe: Yes.

Patrick Tully: Can you put anymore color on the tadalafil negotiations in terms of whether or not you think you're in a better negotiating position or any other color whatsoever and am I correct that now when that the negotiations are back on that there's a chance that marketing could begin in the fourth quarter?

Horst Zerbe: To respond to the last part of your question that is possible other than that I'm very sorry, but I have quiet to be as forthcoming as possible with any new information on the current tadalafil situation. I cannot disclose any further details without violating the confidentiality obligations so I have to apologize for that.

Operator: Our next question comes from the line of Collin Taylor a Private Investor. Please go ahead. Collin your line is open. And your next question comes from the line of Sean Rao a Private Investor. So please go ahead.

Unidentified Analyst: So I had two questions and seems so far as so let me ask some questions to Andre to begin with. Andre last conference call you indicated that you’re not looking at diluting in the short to the medium term. So what led the company to tell us that there will be no dilution and then you go to a dilution which effectively is of priced lower than where it has been trading in the last couple of months?

Andre Godin: Yes it was the intent to keep the dilution as minimal as possible and unfortunately I mean we like I said earlier we issued only as a warrant as opposed to previous financing or whatever you see on the market right now it's often a unit of common and for warrant. But there was need for our key program like Montelukast like the expansion so we were hoping and expecting the price of the issue to be at a much higher price. And at some point it was, but when you start the process sometimes you lose control of the stock price and that's really what happened. And but having waited - we could have been in a worst position. So we basically decided to close on that that number. The good thing is that we were expecting to raise more and we didn’t for multiple reasons but at the end of the day it could have been even more dilutive if we were - had raised the total amount that we were initially looking for. So at the end of the day, we don't need to go back to the market anytime soon like I mentioned but when you have cash needs, you don't want to be in a situation where you become vulnerable and that just stop - could get damaged even more. So that's why we went ahead and closed that financing.

Operator: Your next question comes from the line of [Steven Sloman], a Private Investor. Please go ahead.

Unidentified Analyst: My question refers from the previous question, I think the previous question I was getting out initially was that he was very concerned is that Andre had possibly misled investors if only inadvertently, and this I think is something that has concerned a number of investors. Of particular concern was Dr. Zerbe's response to a question put to him on previous conference call when he was asked whether Tadalafil had been - Tadalafil application had been filed and he answered unequivocally yes. And following that a number of shareholders sought clarification and none was forthcoming, it now seems to be the case that at the time when that answer was given, no such finding had taken place. If that is indeed the case, it is a matter of grave concern and I would like to ask Dr. Zerbe whether his answer was in fact actually correct and generally to comment on the context.

Horst Zerbe : Thank you for your question, I'm very happy to clarify because of course I noticed that there had been confusion, people were upset and so forth. We have been very careful never to state explicitly that our own 505(b)(2) NDA that we have been working on - are still working on had been filed with the FDA. I have been referring on previous calls you're absolutely correct to an NDA pending at FDA and as I tried to explain today that is an NDA that was filed by a different company and which we are currently negotiating for a full commercialization agreement under our license from Lilly.

Unidentified Analyst: Dr. Zerbe, may I interrupt you. I've been a shareholder of IntelGenx for a long time and I'm still a shareholder, the fact that I'm still a shareholder says something. I would like to say this though, when I invest in a company, one of my principal criteria is the extent to which I can trust management. And I do very much hope that going forward disclosure from you and your colleagues will be less ambiguous than it has been in the past. I do think shareholders would value that. That's all I have to say.

Horst Zerbe: Again, thanks for the comments and we'll take it.

Operator: Our next question comes from the line of [Tom Nicolino], a Private Investor. Please go ahead.

Unidentified Analyst: First of all, can you give us some information as to if the interest free loan is still in play?

Horst Zerbe : The interest free loan from the Quebec government is probably 25% alive. There's been a critical in the account manager so everything has been taking a little bit more time. It's not totally dead but there is less I guess the chance to get at this probably a little bit less than it was a few months ago.

Unidentified Analyst: Can you give us some update on Suboxone. I noticed that in one of the preliminary prospectus' filed that money was earmarked to pay Health Canada to begin manufacturing at the facility and then in the final prospectus that was gone. So is Suboxone put on hold indefinitely pending funding or is there any - are you still moving ahead with that?

Horst Zerbe: I can say this much, Suboxone is a generic Suboxone -

Unidentified Analyst: Yes, I'm sorry, the generic term. You're absolutely correct.

Horst Zerbe: It is anything but on hold. It is very active. Unfortunately I cannot provide any details. I had a conversation with our partner, I'm sure you know who the partner is, what can be disclosed and what not. And I have to observe strict confidentiality obligations. But what I can say qualitative speaking is that the program is at this point in time probably the most active at our facility.

Unidentified Analyst: So the removal of this $1.7 million from the prospectus to initiate manufacturing the product at your facility will not impact the timeline?

Andre Godin: No, it will not. It's a question of allocation of funds and use of proceeds but there's always flexibility and it will not affect the timeline with generic Suboxone

Unidentified Analyst: Regarding the cannabis, both recreational medicinal, at this point in time do you have all the equipment required to begin producing this or will there be special build out required to enter into that field?

Horst Zerbe: We are at this point fully equipped to develop and commercially manufacture that product. Let me emphasize again, we are the only film manufacturer in Canada that is fully licensed. I don't know if anybody else is equipped but we are the only film company in Canada that is fully licensed and qualified by Health Canada to manufacture commercial supplies of cannabis infused films.

Unidentified Analyst: And one more question if I may, I'm getting myself confused with RIZAPORT, it is just - it's been going on forever. When you received the letter from FDA stating they needed more information, did the clock reset so we'd be looking at another year or was it - did we have to put in a new submission and are we looking at an approval? I know you said the inspection will probably come in January. Do you think the approval will be forthcoming in the first quarter?

Horst Zerbe: I can only - thanks for the question, it's an important one. I can only refer to what the guidelines are and what is common practice. In our determination and under current FDA guidelines we're talking about a two to three months review. It's not even a six months review. So it's not that the clock restarts from new, that is not the case. But again a word of caution, FDA to quite some extent is a black box and they are at liberty to extend - to prolong their response time else or reasons that they don't have to testify with us.

Unidentified Analyst: But all the information they've requested has now been resubmitted, is that correct?

Horst Zerbe: Yes.

Unidentified Analyst: Some day it will be approved gentleman. Still a long haul but some day it will be approved. That’s the end of my questions. Thank you very much for your time.

Operator: Thank you for your questions. We have met our time requirements for the earnings conference call. I will now turn the call back over to Horst Zerbe for final remarks.

End of Q&A:

Horst Zerbe: At this time I'd like to thank again everybody on the call and thanks to all our investors for their continued support of the Company. And I wish you a good evening, thanks and goodbye.

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