Operator: My name is Mike and I’ll be your conference operator today. At this time, I would like to welcome everyone to the IntelGenx Reports Second Quarter 2018 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] I will now turn the call over to Stephen Kilmer, Investor Relations. You may begin your conference.

Stephen Kilmer: Thanks, Mike. 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 U.S. dollars unless otherwise indicated 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 and assumptions can be found in our filings with the U.S. and Canadian Securities Commissions. I’ll now turn the call over to Dr. Zerbe.

Horst Zerbe: Thank you, Steve. Good afternoon and welcome to the IntelGenx’s 2018 second quarter 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 Q2 2018 financial results then we’ll open up the line for your questions. This quarter we continued to make stride to financing the development of our various drug products. I will start with highlighting some recent patent achievements and then I will discuss updates on our pipeline. I thought that some recent patent used on Loxapine VersaFilm, the first oral thin film product loxapine – of loxapine for the treatment of agitation in schizophrenia or bipolar 1 disorder patients. We’ve received a Notice of Allowance from the Canadian Patent Office for a patent covering the use of loxapine in an oral mucosa – transmucosal film for the treatment of these two indications. This patent is the Company’s first Canadian patent for its VersaFilm technology. Loxapine is still currently in early development thus the importance of this patent is that it serves to confirm our leading approach in helping schizophrenia and bipolar 1 disorder patients while protecting our intellectual property with x facility protection in parallel. Moving on to Rizaport, the European patent office issued a notice of intention, to grant the patent, covering the versatile technology applied to Rizaport in various European Countries. Since the product would eventually be sold in a number of European countries it is important for us to have broad IP coverage in Europe. With prospect to the Spanish application or partner Grupo Juste now Exeltis recently learned that the committee for medicinal products for human use which does not equivalent to the FDA has included Rizaport in the list of medicines within the informative note from its July 2018 meeting indicating that your priority is satisfied with the application was submitted and amended and intends to issue the market authorization following approval of the labeling. Once status issued we will be able to move forward with the site change for the manufacture of the product at IntelGenx. Regarding the status of the U.S. application based on an initial review 505(b)(2) resubmission for Rizaport in milligrams, FDA required additional information related to our transfer of manufacturing to the IntelGenx site in order to proceed for further review of NDA resubmission. But finalizing our response with the intent to resubmit next month meaning this coming September, since this is a six months review we believe that we are still on course for FDA approval of Rizaport in the U.S. in the first half of 2019. IntelGenx already has licensing agreements with Grupo Juste and Pharmatronic in Korea to commercialize Rizaport in Spain and South Korea and we are continuing dialogue with respected additional commercial partners for Rizaport in Europe and other territories for example Italy. We are also advancing our partnering discussions with a number of candidates in the U.S. Moving now onto Suboxone in other recent patent news this quarter, we announced the settlement of all Suboxone related patent litigation between the Company, Par Pharmaceutical, Indivior, Indivior UK and Aquestive Therapeutics. Suboxone as you all – as you know is indicated for the treatment of opioid dependency. Par is IntelGenx’s commercial and development partner for a generic version of Suboxone specifically in oral films. We are very happy with the outcome of this headwind which now paves the path to sales of Suboxone in the near to mid-term future. Hence the litigation surrounding the product and can show us that Par and IntelGenx can market the product without any risk of being sued by individual question or infringement of their Orange Book patents. However, the IP situation is still fluid, there are IPRs pending that were filed by other generic filers that may have a significant impact on the launch date. Nevertheless with the uncertainty resulting from the ongoing patent litigation now removed. We are reviewing our manufacturing capacities we have to make sure we will able to meet Par’s demands for commercial product quantities. According to our MS data, the oral film market, opioid dependence in the United States was worth more than 1.8 billion last year and is expected to continue to grow significantly up to the time of Suboxone film hits the market. Few comments now on tadalafil. Tadalafil is indicated for the treatment of erectile dysfunction and pulmonary hypertension. Our film pursues the erectile dysfunction indication and the product is fully bioequivalent to the similar products we have established. IntelGenx has an exclusive license from Eli Lilly for their 166 dosing patent which is listed in the Orange Book and this exclusivity allows IntelGenx a clear path to product launch, now that the subsequent patent has expired. At the last update call, I have mentioned that we are working with a partner towards a Q4 launch, these discussions are ongoing. With the attractiveness of the multi-billion dollar erectile dysfunction market and with strong competitive forces at play, we are exploring other options as well in an attempt to find the right commercial pipeline, who can provide the best market positioning and best resources for our tadalafil product. Few comment now on cannabinol. We are developing an oral mucoadhesive tablet as well as we are active in the medical cannabis space more broadly. Cannabinol is the synthetic form of THC, the active constituent in cannabis and acts as an adjunct therapy for opioid reduction in patients with chronic pain. Ability testing for our Cannabinol, at first the product is currently ongoing. And together with our partner Tetra, we are doing a pre-clinical testing. In that context, Tetra has recently announced that they have received two meeting granted letters from U.S. FDA for Type B and C meetings to discuss requirements for obtaining marketing approval and 505(b)(2) NDA regulatory pathway for the product. Alongside of these meetings, Tetra and IntelGenx are working together to finalize the clinical trial applications for the upcoming comparative pharmacokinetic and opioid sparing trials. Tetra is managing the FDA filing, expects to file the CTAs with health data in the third quarter of 2018. As for the application of our VersaFilmTM technology to cannabinoid, we continue to see the recreational and medical cannabis market as a high demand opportunity and demonstrated by the conversations IntelGenx has had with several leading companies in this space. Our Business Development team, led by Dr. Matzen has been in active partnership discussions, continues to promote main benefits of our VersaFilm technology at key industry events, also recently at the O’Cannabiz Conference & Expo in Toronto. Few comments now Montelukast. This is our major drug repurposing opportunity indicated for the treatment of degenerative diseases of the brain, like Alzheimer’s disease, cognitive impairment and other similar diseases. The addressable market of that product is in excess of $5 billion and is expected to grow very significantly over the next years. We recently came across a peer-reviewed scientific paper entitled 2018 Alzheimer’s Disease Facts and Figures published in the March 2018 issue of Alzheimer’s & Dementia Journal of the Alzheimer’s Association, which highlighted that damage to areas of the brain that controls swallowing makes it difficult to eat and drink. This difficulty in swallowing represents a significant unmet medical need that may be addressed by IntelGenx’s Montelukast VersaFilm product candidate. Addressing this unmet need, that drives additional opportunities for Montelukast project. At the beginning of this year, IntelGenx initiates a Phase 2a clinical trial to evaluate the tolerability, efficacy and safety of Montelukast bucket with VersaFilm in patients with mild-to-moderate Alzheimer’s disease. To carry out the study, we retained the services of the Contract Research – Research Organizations Cogstate and JSS Medical Research. IntelGenx has already manufactured the clinical Montelukast supplies required for the study. We realized that our initial target dates for patient enrollment were too optimistic. The delays that we were facing were mainly caused by longer-than-expected reviews of the study protocol by the various local ethical review boards, as well as unforeseen delays in the training of a clinical staff; unfortunately, all areas – that are completely outside of our control. By this, IntelGenx, along with Cogstate and JSS Medical Research have been very persistent in continued discussions with all our testing sites for us to work on ethics, submissions and executing site contracts. With this we now anticipate patient screening to start very soon; very soon, certainly, meaning, within the next few weeks. As is common practice, we don’t plan on announcing the commencement of screening, but we will issue a press release when the first patient is in. And with that, I would now like to turn the call over to our CFO, Andre Godin, who will review our financial results. 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 2018 second quarter ended June 30, 2018. For the second quarter of 2018, total revenue amounted to $234,000 compared to $1.1 million the same period last year. The decrease is mainly attributable to the decrease in deferred revenue on monetization of $915,000 that is now fully amortized. If we look at cash-based revenue only for the quarter, there’s actually an increase of $12,000 in revenue. Operating costs and expenses were $2.4 million for Q2 2018 versus $1.7 million for the corresponding three-month period of 2017. The increase is mainly attributable to increase in R&D and G&A expense of $203,000 and $496,000 respectively compared to the same period last year. Also for Q2 2018, the Company had an operating loss of $2.1 million, compared to an operating loss of $613,000 for the comparable period of 2017. Adjusted EBITDA was negative $1.9 million for Q2 2018, compared to negative $390,000 in the same period last year. The net comprehensive loss was $2.4 million, or $0.04 on a basic and diluted per share basis for Q2 2018, compared to net comprehensive loss of $550,000, or $0.01 per share the comparable period of 2017. As of June 30, 2018, the Company’s cash and short-term investments totaled $3.7 million. I’ll now turn the call back to Dr. Zerbe to conclude our remarks.

Horst Zerbe: Thanks, Andre. I would like to close by thanking the support of our Board, our shareholders and most importantly the ongoing hard work and dedication of our staff, for that thanks to all of them. I’ll now turn the call over for questions.

Operator: [Operator Instructions] Your first question comes from Jason McCarthy from Maxim Group.

Joanne Lee: Hi there, my name is Joanne Lee. I’m calling on behalf of Jason McCarthy from Maxim. Thank you for taking our questions. So the first question we had was, can you discuss and around the development of Cialis VersaFilm for erectile dysfunction particularly around the potential timing for commercialization. And the patent protection around when our Cialis with pending patent expires.

Horst Zerbe: Yes. The first one – the first question was for Tadalafil…

Andre Godin: I think there are both for Tadalafil.

Horst Zerbe: Yes. So I missed part of the question. Would you be so kind to repeat?

Joanne Lee: Yes, of course. Sorry about that. So the first question was if you could discuss plans around the development of the Cialis VersaFilm for erectile dysfunction, particularly around the potential timing for commercialization and the patent protection around brand of Cialis with pending patent expires.

Horst Zerbe: Yes. As far as development patent, I have mentioned at the previous call, and in that respect we nothing has changed. That we’re in very advanced discussions with partner or a commercialization of patent also as early as late this year. Since this is a discussion with a partner, we are not solely in control, that’s one aspect that I need to mention and the other aspect I need to mention is that we have to observe very strict confidentiality obligations for this particular negotiation. So really, all I can comment in that respect is – that is partnering discussions are ongoing the target of having product available for commercialization in the very near future as change.

Joanne Lee: Okay. Well, thank you for that. My second question involves around the fact that significant activity in the past several weeks in Alzheimer’s space has been occurring, especially around companies like Biogen and amyloid hypothesis. Montelukast is in early stage development, but it’s believe to target upstream of amyloid and tau. Can you walk us through the proposed mechanism of action, where Montelukast to say in the treatment paradigm and what the next steps for the AD program are following readout of the Phase 2a.

Horst Zerbe: Yes. I’ll try to do that in relatively broad-strokes. Montelukast essentially prevents the occurrence of inflammation in the brain. Inflammatory processes are responsible for the formation of plaques. And so the mechanism of Montelukast in the context of preventing and healing regenerative diseases of the brain, like essentially in its potential of avoiding the formation of amyloid base of more precisely data amyloid based plaques in the brain that are known to be essential in the development of degenerative disease of the brain. I hope that was not too specific.

Joanne Lee: No, that was fine. Thank you so much for answering my question.

Operator: Your next question comes from Sean Lee from H.C. WainWright.

Sean Lee: Hi, thanks. Just two quick questions. First is on the Tadalafil program. You mentioned that you expect to have U.S. commercialization next quarter, could you provide a little more color on what steps needs to be done before that.

Horst Zerbe: Really what needs to be done in the ramp up to that is, finalizing the negotiation – I’m sorry, commercialization and development partner, terms have been discussed and when backend forth and waiting for the product to receive approval.

Sean Lee: So all the backend, like this year, maybe the initial batches are already.

Horst Zerbe: Sorry, Sean, I didn’t fully get the question.

Sean Lee: What I mean is like, all the manufacturing and potentially the initial launch batches are already there are more CMC work to be done before that.

Horst Zerbe: That is happening in cooperation with the partner to the best of my knowledge.

Sean Lee: Okay. Thank you. And then could you remind us a little more on the Phase 2a study of multiple trends, what’s the expected timeline for the study and how much is expected to cost?

Horst Zerbe: On the cost, I’ll let Andre comment. As far as anticipated timeline, enrollment is really imminent, we expect an intermediate evaluation, we refer to it as a midpoint evaluation, which point have 50% of the patients will have been treated. At around the second quarter of next quarter and the study is expected to be completed results available by the end of Q4 of 2019.

Sean Lee: Great. And your cost of that?

Horst Zerbe: The cost is, in total it will be approximately $5 million. But we’ve already started obviously, spending on the study. So but it should in total costs above $5 million.

Sean Lee: Okay. I see. And what’s the interim analysis that could potentially come up in the second quarter next year. What exactly would that entail? Is it just a suitable feasible for your analysis? Are you going to disclose before the dataset at that point.

Horst Zerbe: No. There won’t be no data disclosure. What we will do is we look at the data – at blinded data. Nothing will be unlined it. We look at the blinded data and see if any trend becomes inherent. That is very common actually in studies of that nature and it would allow us, for example, and that’s why this midpoint evaluation is so relevant for us. It would allow us to – for example, make any necessary adjustments to the study dosing during the interim analysis.

Sean Lee: Okay. So it will be more of a go, no-go. Sorry.

Horst Zerbe: No. We don’t expect at this point that. It will – the study is expected to be go over the full length. There could be adjustments.

Sean Lee: All right. Are there predefined criteria for another determination for efficacy or do we expect the study to go through the following regardless?

Horst Zerbe: Well, we have to look at the protocol again to be honest on that. As far as, I understand, there are no early determination privateers included in the study protocol.

Sean Lee: Okay. Thank you. Thank you for the additional color. That’s all I have.

Operator: The next question comes from Patrick Tully from Endeavor Asset Management.

Patrick Tully: Hi. Two quick questions from Andre. One is do you have any updates on the Quebec government loan and secondarily, if you could – just tell us what a typical manufacturing relationship in terms or margin percentage might look like a percentage in margins for just the manufacturing and not including the warranty license.

Andre Godin: Okay. On your first question, I am expecting new by the end of this month, so hopefully it’s going to positive, I mean the process has been extremely long and because of the defecation time, I mean the government here is – it’s taking more time than usual, and it’s not usual is also not the fastest, so – but the qualification of IntelGenx for that new program is obvious, so I’m expecting good news by the end of this month. So on the manufacturing, so your question was, what typically is margin on manufacturing film. I just want to make sure that…

Patrick Tully: Yes.

Andre Godin: Yes. Okay, it does depend quite a bit, and it could vary, because sometimes when we have an agreement, let’s say with profit sharing at the end, then the margin will be lower because at the end of the day, we get such a large amount of money coming back to us that we agree with the partners that will have a cost plus in place, so it could be cost plus 20 or cost plus 25 if we sell through with a transfer price then the gross margin is much greater, could go easily 50% to 50% to 60%, 70% depending on the transfer pricing, so it varies. But most of the time when we have a royalty base agreement, it will be at higher gross margin in a share profit agreement it will be with a smaller margin on the manufacturing.

Patrick Tully: Okay, thanks.

Andre Godin: Thank you.

Operator: Your next question comes from Stan Robeski from SCR Asset Management.

Stan Robeski: Yes, good afternoon, Horst. We met probably 10 years ago, and you’ve been busy creating all this science and all this technology. and I’m looking at the balance sheet at this point and we have – at this June 30th, we have a limited – we have a cash of $2.3 million short-term investments, $1.362 million and stockholders’ equity of $1.675 million. Do we need to raise more funds? What is our – how do we get through the next six months to do all the work we’re doing considering the losses we’ve achieved?

Andre Godin: Okay. Let me answer that question. I mean we have multiple source, non-dilutive source of funds that we are looking to bring in the next several months I would say. I mean the government loan that I just described or just discussed with absolute question. The $2 million we have warrant exercise or warrant I should say that will expire by the end of this year that could bring in close $2 million and it is now $2 million and there is obviously, in all our discussion with all the programs that we have presently ongoing upfront money that we – that we should be receiving and since some of the discussions are quite advanced. We’re expecting or hoping that we would get some money coming from those programs before the end of 2018. So, I’m not concerned in the short-term, in the mid-term at all. I mean obviously it all depends on what CapEx, If we need to invest in CapEx in the future or if we need to do a strategic move or acquisition, then it would – it could change a picture, but for the company’s day-to-day operation, we should be fine, we’re not looking at raising money in very short-term.

Stan Robeski: So, we won’t be doing things they’re anti-dilutive and you feel you have enough money for the next year or six months, or you expect some kind of transaction to happen in the next six months that will produce more funds for IntelGenx.

Andre Godin: Yes. I mean a year, we’d be pushing it, but like you just said, it depends on upfront money will get and but we are – I mean the warrants like I said before they’re in the money, so I don’t see why they wouldn’t be excited and the government loan is looking good, but there is always – we’re always looking at opportunities to expand the operation as well as maybe doing a strategic acquisition and we did discuss that in the past with the GMP lab result. That could change the picture exactly, but – so I want to emphasize that if we were to dilute it would be most like them at a much higher price and also for strategic reason.

Stan Robeski: Thank you very much. Good luck, hopefully, you achieve your goals.

Andre Godin: Thank you

Operator: Your next question comes from [indiscernible] Private Investor.

Unidentified Analyst: Thank you for taking my call. I was just couple minutes laid on a call and you maybe just alluded to in our last call you talked about your expected chemo or whatever some of those to file NDA share in the third quarter. Are you still on target for those? Or and on the fourth quarter what’s happening with those chemo and other programs next year?

Andre Godin: We are on target to file an ANDA for – I can’t disclose. It’s a FDA, ANDA filing in October. We’re still more or less on the protected the timeline.

Unidentified Analyst: So that’s just one of the four or more than one?

Horst Zerbe: Right now we’re focusing on this one. First to file opportunity, so we’re really concentrating on that one. Others will follow relatively soon there are.

Unidentified Analyst: Okay. Thanks you.

Horst Zerbe: Welcome.

Operator: Your last question comes from [indiscernible] Private Investor.

Unidentified Analyst: Hello?