Operator: Ladies and gentlemen, thank you for standing by. And welcome to the IntelGenx 2019 Third Quarter Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. [Operator Instructions] I would now like to hand the conference over to your speaker today, Mr. Steve Kilmer with Investor Relations. Sir, please begin.

Steve Kilmer: Thank you. Good afternoon, everyone. And thank you for joining us on today's call. With me on the line are Dr. Horst Zerbe, IntelGenx's CEO; and Andre Godin, our President and CFO. Before we begin, I would like to remind you that all amounts mentioned today are in U.S. dollars unless otherwise mentioned. And today’s call may contain forward-looking information that represent 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 may be 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 of these risks and assumptions could be found in our filings with the U.S. and Canadian Securities Commissions. I'd now -- I would now like to turn the call over to Dr. Zerbe. Horst?

Horst Zerbe: Thank you, Steve. Good afternoon, everyone. And thank you for joining us for the IntelGenx 2019 third quarter conference call. On today's call, I will provide a corporate update and discuss the project progress we’ve made on our key pipeline projects. Following that, Andre will review our Q3 2019 financial results. Then we will open up the line for your questions. Before I update you on recent developments of our pipeline projects, I’d like to start out with a general remark. Since the beginning of this year and more specifically, since we received the CRL for RIZAPORT, we’ve given our near term opportunities RIZAPORT and the cannabis-infused film highest priority. Knowing that our stakeholders expect us to demonstrate that we're able to deliver on our promise to bring high quality products to the market, most of my remarks will focus on these two lead programs. So first, the cannabis-infused films, which is our newest term commercial opportunity. As I discussed on our last call, we received the first shipment of cannabis extract from Tilray in May and have since been developing various medical use and adult use formulation prototypes that comply with the Canadian cannabis market. A prototype which aligns with both company's goals to provide innovative, high quality cannabis-infused VersaFilm products has now been approved by Tilray. As a result of that product approval by Tilray, and in order to ensure that we avoid any unnecessary delays of the commercial product launch, we have initiated manufacturing scale up and process development activities in our manufacturing facility. While new classes of cannabis products including cannabis-infused oral films are authorized for sale, these products due to certain procedural requirements will not be available before mid December at the earliest. We believe that we have developed an exciting product that will certainly need if not exceed consumer expectations, and we therefore, think that we're well positioned to become a significant player in this expanding market. Just as new products formats come online. We're looking forward to providing more details on the product as we get closer to commercial launch. That said cannabis is also regulated at a provincial level in Canada. Connect for instance, has taken a particularly hard stance against edibles by proposing new regulations to ban the sale of any cannabis product that is attractive to minors, which would essentially prevent the sale of brownies, chocolate, gummies, and so on. We believe such restrictions on available edible products for sale in Quebec, could potentially – could be potentially beneficial for the cannabis-infused film market. As these products are by design, not attractive to minors. Moving onto RIZAPORT, we are pleased to announce that our RIZAPORT new drug application or NDA was accepted by the FDA last month. The agency assigned a March 26, 2020 Prescription Drug User Fee Act, PDUFA Act goal date for completion of the review. I'd like to thank the IntelGenx team for their hard work that enabled us to address all of the FDA questions for a timely NDAs resubmission. We are very much looking forward to the FDA decision early next year. Moving on to Tadalafil, we're looking at finalizing an irritation study protocol in the coming days, once finalized this will be sent to the FDA for review an input, the costing exercise with Siro [ph] and selection completed and approval from IntelGenx and requested has been granted. Montelukast. Moving on to Montelukast now we were pleased to announce that an independent Data Safety Monitoring Board, or DSMB, completed its first interim analysis for ongoing Phase 2a BUENA trial last month. The DSMB reviewed compiled safety data from 25 enrolled Alzheimer's disease patients, 13 of which have completed 26 weeks of daily treatment. I recommended that the trial continue. Recently recent studies of Montelukast in the mouse model of Alzheimer's disease conducted by Dr. Aigner's group demonstrated that Montelukast treatment effect is those dependent with higher doses of Montelukast, significantly increasing cognition, meaning spatial memory and learning in two behavioral tests. Based on these findings, and the accumulated safety data from studies in humans exposed to doses many times higher than what we are proposing. We plan to continue the BUENA clinical trial at an increased daily dose subject to healthcare approval. We expect to submit the application before years end and to receive regulatory authorization to proceed by the first quarter of 2020. We still plan to report intermediate results, primarily safety data along with any early indications of the therapeutic trend when 28 subjects have completed, 26 weeks of treatment. We currently estimate this will be in the second half of next year. With respect to trial sites, that Peterborough Ontario site has been activated as of last week. And we're planning on activating the Ottawa site at the end of December. That will bring us to a total of eight sites. We also continue to work to generate, invest investigated interest and increase awareness of this trial. As part of this effort, we are planning to present a Montelukast poster on the 12th edition of clinical trials on Alzheimer's disease in Sanyo, California next month. Finally, we are continuing our discussions with those involved in Emory University's Montelukast tablet study in Alzheimer's disease to explore how we might work together. With that, I would now like to turn the call over to our President and 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 of the third quarter. So for this three month period ended September 30th 2019, total revenue amounted to 61,000, compared to 700,000, in the same period of last year. The decrease is mainly attributable to a decrease in R&D revenues. Also on operating costs and expenses were lowered than last year to $2.6 million for Q3 versus $3.3 million for the corresponding three month period of 2018. The decrease is mainly attributable to increase 610,000 in R&D expenses and 153,000 in SG&A compared to the same period of last year. Also for Q3 2019, the company had reduced operating loss of 2.5 million from 2.6 for the comparable period of 2018. On the year ever adjusted EBITDA was negative $2.2 million which is consistent with the same period last year. Net comprehensive loss was $2.9 million or $0.03 on a basic and diluted per share basis for Q3, 2019 compared to a net comprehensive loss of $3 million or $0.04 per share for the comparable period of 2018. As of December 30th, 2019, the company's cash and short-term investment total $4.3 million. I will now turn the call back to Dr. Zerbe to conclude our remarks.

Horst Zerbe: Thanks, Andre. In closing, I would like to thank our Board of Directors for their ongoing guidance, our shareholders for their loyalty and most importantly, our staff whose dedication will drive our success. I would like to add another comment. A few years ago, we had an opportunity to build a much stronger business, one, able to drive significant and sustainable growth over both, the mid and long-terms. So, we made a strategic decision to transform IntelGenx into a full service, global leader of innovative pharmaceutical, or film development, and manufacturing. Of course, to get there would require investment, hard work and patience. We're now approaching the realization of that strategy, the starting line, if you will with the anticipated commercialization of our two league products, cannabis infused VersaFilm and RIZAPORT and I would like to thank those stakeholders for their patience and support needed to get to that point. I will now turn the call over for questions. I would like to remind you that our forward-looking statements apply to both of prepared remarks and the following Q&A. Thank you.

Operator: [Operator Instructions] And your first question comes from the line Doug Loe with Echelon Wealth Partners. Sir, you may go ahead. Mr. Loe, you may go ahead.

Doug Loe: Hi. Sorry operator, I was on mute. Andre, Horst thanks very much for the update on the quarter. And I kind of wanted to focus specifically on the Montelukast cognition BUENA study, if I could. I mean, I'm sure, no doubt you're aware that Emory is conducting its own even larger and longer term study similar to yours, though using Montelukast tablet formulation. Just no doubt you are aware of that study, you know, I was just wondering if there any insights into study design that might be infused in BUENA, if you're collaborating with that group through in any substantive way. And if you think there, you know, there might be any insights that you could garner from the -- ways in which cognition is being measured in that study as it might relate to your VersaFilm formulation?

Horst Zerbe: Yeah, Doug, its Horst here. Thank you very much for the question. We are, I believe, I had mentioned that on the previous call -- we are in contact with the Emory Group and with the study coordinator, Dr. Hajjar. We have some information about the design, it's a crossover placebo controlled studies design. Say population is larger than ours, I believe, they're targeting under 150 patients. The key difference is that they dosing the tablet instead of our film. It is – the study in those dose escalation, they are setting at a low level of 10 milligrams per day, then stepping up to 20 and ending up with 40 milligrams daily dose. They are looking at cognitive effects. In addition to that, they are looking at biomarkers as well. So the study is from that standpoint, a little more involved. They are of course, and obviously aware of the study that we're conducting and are very interested in our study to the extent that. And I believe I had mentioned that before as well to the extent that they are interested in becoming a steady sight of our ongoing BUENA study and our clinical Research Director Frank is currently in negotiations with Dr. Hajjar and other people involved in that Emory study to discuss details concerning their participation. Those would be the comments I would be able to make at this point Doug.

Doug Loe: Great. That's great color. Thanks a lot.

Horst Zerbe: You're welcome.

Andre Godin: Thanks, Doug.

Operator: And your next question comes line of Patrick Tully with Endeavor Asset Management.

Patrick Tully: Good afternoon. Posted the Wainwright conference you had forecasts some revenues for the cannabis product. And now that you're closer to launch, I'm just wondering if you're still comfortable with those projections that you made. I believe it was $4 million in manufacturing revenue for the first year and three to four times that for royalties, I'm just wondering if you're still comfortable with those numbers?

Horst Zerbe: But I don't want to speculate on what might come from royalties, because that's really not in our control pricing, it has not been finalized yet and things like that. The $4 million based on what we initially received from them in terms of that, I need to emphasize that non-binding forecast or unit forecasts, I should say and then from that, we derived that number. I'd like to emphasize that this is very speculative Tilray has no idea as to how the market will respond and how the film product will be perceived. We think that they projected that the unit forecast was rather on the defensive side. But I'm somewhat reluctant to speculate numbers of that nature at this point in the gain, because we really have no reference that we could base any more reliable or defendable projection on. I hope you understand that.

Patrick Tully: Okay. So, if you can give revenue projections at this time, what about -- can you discuss about the rollout of additional products and maybe give a range of time as to what -- when additional products will be rolled out?

Horst Zerbe: I could talk about whole migraine film.

Patrick Tully: No, I'm just referring to cannabis.

Horst Zerbe: You're referring to cannabis?

Patrick Tully: Yes.

Horst Zerbe: At this point, I can really only comment on the recreational -- on the adult use film product. That's the one that we're concretely working on. Our agreement with Tilray provides that we will eventually also provide them with the film for medical applications, but we have no idea of the timing of those products. So, I couldn't even speculate at this point. We know -- and then I can tell qualitatively, we know from recent meetings with Tilray Executive Management that the interest in cannabis films for medicinal applications has risen sharply. But again, I'm not comfortable going beyond this qualitative statement.

Patrick Tully: Okay. And finally are you tied to Tilray on pet? Any future pet products in cannabis? Or are you in discussion with other parties regarding any cannabis for pets?

Horst Zerbe: Our agreement with the Tilray covers films for human applications. We are free to deal with other partners on cannabis films for veterinary applications.

Patrick Tully: And are you in discussions with anybody on those applications?

Horst Zerbe: Yes, there are preliminary discussions going on. Our business development group is conducting those.

Patrick Tully: Okay. Thank you.

Horst Zerbe: You're welcome.

Operator: [Operator Instructions] And your last question comes from the line of Fadi [Indiscernible], a Private Investor.

Unidentified Analyst: Yeah. Good afternoon gentlemen. I have a question for Andre. So, the cash on hand right now as of the end of September was $4.3 million. And with the anticipated launch of the cannabis VersaFilm with Tilray, do you see like the company bridging it until you become cash flow positive without a dilution?

Andre Godin: So, that's a good question. It is, I mean, obviously the launch is accelerated launch since they're providing the API, which is the most costly, most expensive cost in the manufacturing and it allows us to read a little bit better. But having said that, I mean, there is multiple projects, ongoing projects, Montelukast being one of them. There is right now some opportunity that I'm looking at for non-diluted or less diluted instrument. So, I'm really focusing on that, trying to bridge a certain figure, so we -- until we actually get cash flow positive. And we're always looking at the market valuation of the company and share price. There's price that we wouldn't go under to dilutive company. So, but I mean, we're extremely concerned, not concerns, but looking at these -- all these factors and obviously putting a lot of emphasis on non dilutive or less dilutive instrument, but I mean, I think that the reality is that we will need at some point, some kind of bridge until we get cash flow positive. And we're definitely looking at that right now.

Unidentified Analyst: And just a couple more questions in regards to this like, what kind of a runway guidance can you give us at this point for the company? And the other question is, in regards to raising funds, is that something that you see like this year or towards next year, if you can share a little bit more based on that?

Andre Godin: Yeah, so the run rate -- I mean is a little bit difficult right now, but we know that we're probably burning anywhere between $1.5 million and $2 million per quarter. But since we don't have formal forecast from Tilray, but we're expecting those soon. So, at which point, we'll be in a better position to look at our run rate for 2020. And also in March, obviously with our potential approval of RIZAPORT, a launch will take place after that in the U.S. and our partner is very confident that that would generate good revenues, so that's also going to be helping me to determine, what's going to be the run rate, but -- and in order to for -- so that's for your first question. Your second question, it depends. I mean, I can't say whether it's going to be this year and next year. If I have the right terms at the right time then I'll do it. It's a non dilutive instrument then it would be as soon as possible. If it's dilutive, then it would have to be -- we would have to be looking at the share price of the market response, so that it would have to be -- all elements would have to be positive basically for us to finance the company, but we’ll need to do it at some point. That’s for sure.

Unidentified Analyst: Okay. And Dr. Zerbe, I have a question for you. If you can touch base again on the Tadalafil, if you can shed more light on that?

Horst Zerbe: Yes. As I mentioned in my introductory comments, we are planning to conduct a safety study. And just to shed a little light on that, as we indicated on earlier calls, the CRL that FDA issued for this product and requests us to conduct a safety study, which is what we are -- what we did plan with our development partner requested. We requested and received quotes from CRLs that the study will be awarded to a Canadian CRL. I want to be open, this steady start has been delayed a little, which was not due to -- that were not caused by IntelGenx but rather by our development partner who for a short period of time went through a difficult time and had a problem to commit to that study that has now resolved. We spoke with some other people just a few days ago. So, we know that they continue to fully support the study. To make a long story short, this study -- I cannot give you an exact date, but this study will start sometime in the first quarter and should be completed most probably in the third quarter. So we expect the product to be launched in early 2021.

Unidentified Analyst: Okay, and my last question for you is in regards to the Suboxone, it’s like a while back on like a couple of culprits called the back, you had mentioned that it was one of the highly active products currently at IntelGenx, and can you touch base on Suboxone and Par, and where that project is going?

Horst Zerbe: Yeah. I spoke with Par earlier today, and that product was brought up, and it’s continues to be an important program at Par. And Par had problems at their -- at one of their analytical sites that was involved in some of the analytical work associated with the Par which caused a bit of a delay. The companies are now -- both companies Par and IntelGenx are, as we speak, working on putting together a response to the complete response letter that FDA issued a while ago and that is currently pending. I’m at this point not able to give you a precise answer as to the target resubmission date. It should be sometime in either late Q2 of next year or Q3 of next year to do the best. That's my best recollection at this point. Well, that's the status to this and that's are my comment on the current status.

Unidentified Analyst: Okay. That's fair. Thank you so much. And we're looking forward to the launch of cannabis VersaFilm in December.

Horst Zerbe: Thank you very much.

Unidentified Analyst: All right. Thank you.

Operator: That concludes the Q&A session. I would now like to turn the call back to Dr. Zerbe for closing remarks.

Horst Zerbe: Thank you. And I would again like to thank all the Board of Directors for their support our staff for their dedicated work, and most importantly, our shareholders for their loyalty and continued support. And with that, I'd like to conclude this call. Thank you all very much.

Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.