Greetings, and welcome to the IntelGenx fourth quarter and full year 2022 financial results conference call. At this time, all participants are in listen-only mode. A question and answer session will follow the formal presentation. If you wish to enter the queue to ask a question, please press star 1 on your phone at any time. If anyone should require operator assistance during the conference, please press star 0 on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to your host, Stephen Kilmer, Investor Relations at IntelGenx. You may begin. Thank you. Good afternoon, everyone, thank you for joining us on today's call. With me on the line is Dr. Horst Zerbe, IntelGenx CEO, Andre Godin, our President and CFO, Dr. David Kideckel, the company's Head of Corporate Development and Strategic Alliances, Dr. Frank Pietrantonio, our Director of Clinical Research, and Tommy Kenny, our VP, Legal Affairs and Intellectual Property, and General Counsel. Before we begin, I would like to remind you that all amounts mentioned today are in U.S. dollars unless otherwise mentioned, 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 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 on these risks and assumptions can be found in our filings with the U.S. and Canadian Securities Administrators. I'd now like to turn the call over to Dr. Zerbe. Horst. Thank you, Steve. Good afternoon, everyone, and thank you for joining us for the IntelGenx fourth quarter and full year 2022 conference call. On today's call, I will provide you with a corporate update and discuss the progress we've made on our key pipeline projects. Andre will review our financial results. Following that, we will open up the line for your questions. Before launching into an update, I would like to take this opportunity to welcome David Kideckel to our team and to his inaugural IntelGenx investor call. Excuse me. David succeeds Dana Matson, who recently left IntelGenx to pursue another opportunity. David has nearly 20 years of combined industry and capital markets experience, most recently managing his own advisory group. Before that, he was a managing director, senior institutional equity research analyst at ATB Capital Markets. David's industry experience spans several senior healthcare and biotechnology executive roles, including at Johnson & Johnson Inc. and Alexion Pharmaceuticals. David has a PhD in neuroscience from the University of Toronto. While he's just getting up to speed, David has volunteered to join us today on the call, and he will be available to participate in the Q&A session following our introductory remarks. With that, I will now update you on our key programs. First, on the atai partnership. As many of you will recall, in September, we shipped a clinical trial batch of our previously undisclosed candidate, buccal VLS-01, to atai. VLS-01 is a pharmaceutical-grade psychedelic buccal film containing a synthetic form of N,N-dimethyltryptamine, or DMT. Atai is developing the product as a novel therapy for treatment-resistant depression in combination with its digital therapeutic design to provide contextual mindset and setting support to patients prior to dosing. In October, Atai announced that it had dosed the first subject in its phase 1 clinical trial of buccal VLS-01, the first ever in-human clinical study evaluating an oral thin film psychedelic drug candidate with top-line results expected in the first half of 2023. The PK study was delayed due to flooding in New Zealand and is still ongoing. Atai is also evaluating potential new candidates, which obviously I cannot disclose yet. Sorry. Moving on to RIZAPORT now. In November, the FDA accepted for review our Class 2 response to the 2020 Complete Response Letter for our 505(b)(2) NDA for RIZAFILM. We believe the Class II response provided all of the additional chemistry manufacturing controls information that the FDA requires. FDA has assigned a PDUFA goal date of April 17, 2023, for completion of the review of the RIZAFILM NDA. We look forward to their decision and to hopefully making RIZAFILM available to acute migraine patients in the United States. Regarding the OUS, an update there. Recently, we met with Exeltis, our partner for RIZAPORT in Spain. They reported great feedback from prescribing doctors and patients but have been struggling with significant product substitution at the pharmacy level. They are now working on a strategy to overcome the loss in sales. Exeltis is waiting for regulatory approval to implement that new strategy, which is basically revolving around modifying the packaging format, which would then make a generic substitution no longer possible. In January, we entered into an exclusive supply agreement for RIZAPORT with Arwan Pharmaceutical Industries Lebanon s.a.l. in various countries in the MENA region. I will not mention all these countries, but I can tell you it's a total of 22 countries spanning that region. Arwan knows the MENA marketplace intimately and has a successful track record. We're looking forward to working with them. Moving on to tadalafil. As we reported last quarter, there was a slight delay as our partner, Aquestive, has encountered some API-related issues for tadalafil. The R&D teams from both companies worked diligently and formed a task force to address the issue. We believe that we have now solved this API issue, and we are preparing for manufacturing of the clinical batch. Moving on to cannabis films. We are planning a PK study to demonstrate the superiority of our THC sublingual film over conventional applications like gummy bears and so on. We also recently received a U.S. patent for our novel cannabis emulsion base film technology. Some words on montelukast. While enrollment in the ongoing Phase 2A BUENA clinical trial in patients with mild to moderate Alzheimer's disease or AD is continuing, we are also now expanding the montelukast repurposing program to include another major neurodegenerative disorder, Parkinson's disease or PD. We believe, and there's sufficient scientific evidence that montelukast VersaFilm has the potential to be disease modifying in both AD and PD. In February, we announced a research collaboration with Dr. Per Svenningsson of the Karolinska Institutet to plan and conduct a multicenter randomized double-blind placebo-controlled clinical study to investigate the use of montelukast VersaFilm for the treatment of PD. Dr. Svenningsson will serve as the principal investigator for the planned study and will sponsor it through a grant awarded by the Swedish Research Council. It's a grant in excess of $2 million. IntelGenx will supply Dr. Svenningsson with both active and placebo films to be used in the 18-months treatment regimen for study participants. Upon completion of the study, IntelGenx will retain the intellectual property rights and use the findings to further develop this program for PD treatment. We currently expect the study to commence in Q3 2023, and we'll provide more details on its design at that time. Some comments on Xaramet. In October, we announced that buprenorphine buccal film received an FDA Generic Drug User Fee Act or GDUFA date of April 28, 2023. We partnered with Chemo, part of the Insud Pharma Group, on the development of buprenorphine buccal film in September of 2016, and we co-developed the candidate's ANDA that was filed through Xaramet and is currently under review by the FDA. Buprenorphine buccal film is a generic version of Belbuca, an opioid that is used to manage pain severe enough to require daily around-the-clock long-term treatment with an opioid when other pain treatments are inadequate. Belbuca was approved by the FDA in 2015 and is applied to the oral or buccal mucosa every 12 hours. Buprenorphine buccal film incorporates our VersaFilm technology in a novel formulation and is designed to be a bioequivalent lower-cost alternative for patients. According to IMS Health, global annual sales of Belbuca were $315 million as of July 2022. We're looking forward to the FDA's decision and, assuming a positive decision by the FDA, we're looking forward to the commercialization of buprenorphine buccal film as soon as possible. Last but not least, animal health. In December, we announced a research collaboration with the University of Prince Edward Island, PEI, to assess palatability, owner-perceived acceptability, and ease of administration of our VetaFilm platform in dogs and cats. The University of Prince Edward Island is one of North America's leading veterinary universities, we are very much looking forward to the results of this assessment as we continue to advance our drug delivery technology into the animal health space. Earlier in the 4th quarter, we entered into a new VetaFilm feasibility and development agreement with an undisclosed animal health company. For a VetaFilm based oral film formulation containing CBD for use in companion animals. The results from the CBD study are expected in Q2. With that, I would now like to turn the call over to Andre for a review of our financial results. Andre. Thank you, Horst. Good afternoon everyone. As Horst mentioned, I'll take a few minutes to discuss the company's financial performance for the fourth quarter, as well as the full fiscal year ended December 31st, 2022. For the fourth quarter, the total revenue amounted to $173,000 compared to $494,000 the same period last year. The change is mainly attributable to a decrease in revenue from licensing agreement of $249,000, R&D revenue of $43,000, and product revenue of $36,000. That was offset partially by an increase in royalty on product sales of $7,000. The main difference comes from the one-time licensing fee we received last year for tadalafil. Operating costs and expenses were $2.7 million for Q4, 2022 versus $3 million for the corresponding three-month period of 2021. A slight year-over-year reduction. For Q4 2022, the company had an operating loss of $2.5 million, especially in Q4 2021, as well as adjusted EBITDA, which was -$2.3 million for Q4 2022. Essentially unchanged from Q4 2021. Our net comprehensive loss was improved to $2.3 million or $0.01 on a basic and diluted per share basis for Q4 2022, compared to a net comprehensive loss of $2.9 million or $0.02 per share for the comparable period of 2021. For the full year, total revenue for the 12 month amounted to $1 million compared to $1.5 million in 2021. The main difference coming from the one-time licensing fee we received last year for tadalafil. The full year operating costs were $10.4 million for 2022 versus $9.5 million for 2021. For the full year 2022, the company had an operating loss of $9.4 million compared to an operating loss of $8 million for the comparable period of 2021. Net comprehensive loss was $11.6 million or $0.07 per share for basic and diluted share for the 12 months of 2022 compared to a net comprehensive loss of $9.8 million or again $0.07 per basic and diluted share for the comparable period of 2021. As at December 31, 2021, 2022, sorry, the company's cash and short-term investments totaled $2.5 million, which does not include the $3 million secured loan granted to IntelGenx by atai that we received in January 2023, nor the CAD 1 million in Canadian dollar in gross proceeds from the private placement offering of the convertible note, which we closed just earlier this month. I will turn it all back to Dr. Zerbe. Horst. Yeah. Thank you, Andre. In closing, I'd like to once again recognize our team for executing on our long-term strategy. With that, I will now turn the call over for questions. I'd like to remind you that our forward-looking statements apply to both our prepared remarks and the following QA. Thank you. Thank you. At this time, we will be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Once again, please press star 1 if you wish to enter the Q&A queue at this time. Please hold while we poll for questions. It looks like we did have a few questions come in. The first question is coming from Brent Gake, who is a private investor. Brent, your line is live. Good afternoon, guys. We had a couple of questions. If either of these products are approved later this or in April, are you all ready for production? How soon would production start? The current plan of our commercialization partners is to commence with the launch preparation, meaning manufacturing of validation batches later in the year. In the case of buprenorphine, I can tell you that the launch timeline is driven by litigation, Paragraph IV litigation. If you want more information on that and to the extent that that is public domain, Tommy can certainly comment on that. Our partner for the RIZAFILM also targets for manufacturing of validation batches, which would be the first saleable product for later in the year, I think Q3 or probably Q4. Both would then be lined up for actual commercialization in early 2024. Okay. It sounds like you're still a ways off from revenues, any significant revenues. I mean, how long can the company survive without any revenues? I mean, do you plan to just keep diluting or what? I think what we have to do with that, Andre, do you want to comment? I think that, you know, it's not defined. I mean, Horst obviously just mentioned that, you know, what the partners are planning to do, but obviously after we get these approval, it would be much clearer as to when the both launch could take place. We're expecting to get obviously some momentum with those, with those approval. We have other things in the pipeline. At some point we might have to raise money, but at a much higher valuation as we are presently. That's why we were very conservative with the offering we did earlier this month. Those were investors that, you know, were already shareholders of the company. We limited that offering. We're expecting to have great momentum and probably raise money, you know, to secure, you know, all the necessary step to be able to launch commercially these two products. It could be Q3, Q4, Q1, but it will be, I guess, a little bit clearer when we get these approval. Okay. Thank you, guys. Welcome. Thank you. The next question is coming from Steve Gio. Steve is a private investor. Steve, your line is live. Hello, fellas. If these April 17th, April 28th dates with this PDUFA doesn't come through, what happens next? What's the game plan there? Horst, you wanna comment or? We will see. I can certainly comment. I mean, that's a very theoretical question. Our game plan depends on what the response is. At this point, we assume that we will that the products will be approved. Should FDA require further information, we will deal with that. That's really all I can say at the moment. It's. Nobody knows at this point what the what FDA's response will be at the at or around the PDUFA dates. We, we are in constant contact with FDA. They, they come regularly with requests, which indicates to us that they're progressing well with the review. At this point, we have not seen any showstoppers, that's really all I can say there. I cannot speculate on the outcome. Okay. 'Cause in the past, you know, you talked about this then next thing you know, it's more paperwork. It didn't get this, it didn't get that. You know, I'm in two private, two public offerings there. One of them was five years ago, and my warrants expired, so I lost money on that. Now the second one ends at the end of this year. I'm wondering what's gonna happen come April 17, 2028 if we don't get the approval. That's That was my question. I understand that. We are as anxious as everybody else to get the approvals, and we worked really hard to submit satisfactory responses to FDA. That's all I can say. Okay. Now Andre just stated to the last question was, you're gonna do another offering soon, he said. Andre? Yeah, it will depend on, yeah, that's probably the plan, yes. It will depend on the valuation and the terms that we might be able to get, you know, after April. I mean, we need If we get these approval like we think we will, we will need to build inventory. We will need to get ready to get commercial ready. There's some investment there. Until we actually get the benefit from the product launch, it will take a few months. That's why we need to fund the company. I'm expecting the terms to be much better than the previous raise. You know, but as Horst mentioned, you know, we don't know the outcome, we'll soon find out. Right. Okay. Thank you. Thank you. Thank you. You're welcome. The next question is coming from Hugh Kelly. Hugh is a private investor. Hugh, your line is live. Thank you. Good afternoon, folks, and welcome David to IntelGenx. One question I have, let me say, I apologize. On the tadalafil, is that getting with the API issues that you believe resolved, would that be, do we have a timeline for resubmission to the FDA? The current timeline is that our partner, Aquestive repeats the positive experiments or the experiments with a positive outcome that we conducted here at IntelGenx, and that led to the resolution of the problems that they encountered. They need to repeat that, which they are currently doing. Once they have re-repeated that at the lab bench level, then they will proceed with manufacturing the clinical batch required for the irritation study. At this point, the expectation is that the study will be completed late summer and that we submit our response to FDA in most probably Q4 of this year. Okay. The anticipated date of announcing the undisclosed partner, Dr. Zerbe? I'm sorry. I missed that acoustically. The anticipated date to disclose the partner. I think it would be upon approval, Hugh. Okay. That's what I believe. Yeah. Yeah. Okay. As soon as we get an approval, we'll be able to disclose. Obviously, it's a very credible and reputable partner, so we're all anxious to be able to announce it. Okay. Moving on to montelukast, can you give us an update on the number of patients enrolled for your clinical trial? For that, we brought Dr. Pietrantonio in, our Clinical Director. Frank, do you want to comment on that? Sure. Sure. As of the 29th of March 2023, we screened over 105 patients. 44 have been randomized and six are pending. In a week or two, we should have another six randomized. Under the single-dose regimen with the 10 milligram, we had about 25. With the higher dose, the 60 milligram dose, we have over 20 subjects. Okay. Frank, thanks for joining the call. The, you know, best guess on the completion of the study. I know, it's a moving target. Next year? Yeah. We were, somewhat penalized with, I guess from January when we started in 2022, 'cause of, as I call, post-pandemic syndrome. Yep ... A lot of the sites did lose a lot of their staff. There's been a lot of retraining, hesitancy from patients going to the hospitals after, you know, in fear of getting COVID. Yeah. A lot of that activity, I would say, instead of starting January 2022, started, I would say around April. In terms of ameliorating the enrollment rates, what we did is we opened new sites. Based on that and, we're looking at ending, I guess, recruitment around June 2023. Yep. hopefully by the end of the year. Okay of 2023. Okay. Yeah. Okay. Thank you, Frank. Dr. Zerbe, is there any update on the status of the Par program? Is that gonna go forward? Is that postponed? Well- Sorry. Par is in... I'm assuming, you're talking about Suboxone. That's what I. Yes ... It has been penetrated into the public. Par is in bankruptcy proceedings. That program has discontinued with Par. We have seen interest. Right now, there are concrete discussions ongoing between Par and a company that's interested in acquiring the ANDA, but I can obviously not disclose. Yep ...... Any names or any details. I just want to send a message that while the program with Par has been discontinued, that does not necessarily mean that the program itself is dead. We are working very hard to progress it. Inevitably, because of the unfortunate, Par and Endo situation, there is a pretty significant delay. We're hopeful and actually confident that the program will continue. Okay. That's really anticipated. The other quick question is on the recent patent announcement on loxapine. Will that program become active in the future, or is that still on hold due to other priorities? We're discussing the opportunity with, actually, at this point, a European company, but nothing is concrete in terms of entering into an agreement. We've seen interest, and we continue promoting the program because we really believe in that. A very sizable market if I'm, if I have my facts right. Then I'll go back in the queue. There's on the ATAI programs, is did I hear you say they're in discussions with a third program, or did I misunderstand that? They are discussing internally, two more potential candidates. You know, we hope that, at least one of them will make it and evolve to an active program. At this point, the discussion about those candidates. Yeah. Is being held internally at ATAI. We just know from- Yep. -Information, internal information that discussion is proceeding. All right. My, before I go back in the queue, on the products that were developed, that were not co-developed with Tilray, would your, you know, were there announcements with your new patents and new platforms? Is there potential to introduce with the other partners, other cannabis THC film products, or is that still locked up with the arbitration? That is certainly the case. We definitely plan to proceed with those films. Tommy, since it's. Yes. I can answer that. Since legal is heavily involved, maybe Tommy should comment on that. Yes. We're continuing to develop product, and the arbitration is still ongoing, but we hope to be able to announce a resolution in the coming months to investor. Right now everything is confidential, but we're still working on the cannabis franchise because we still very much believe in the product. Whether it's with Tilray or with a future partner, that should be clarified in the coming months. Okay. I guess, but if there was I guess the question I was asked, Tommy, would the development that with other products after the that were developed without the participation of Tilray, are you free to launch them, or is that locked up? This is not something I wanna comment too clearly. Okay. All right. Because it's under the arbitration, there's things to be clarified. Rest assured that we're doing everything we can, and we're planning to launch those products in the future. All right. Any penetration with the cannabis film or over there in, I know you had on your web, on your presentation, Germany, Israel, Spain, Portugal, Mexico. Any opportunities presenting themselves for other countries? Not at this point. Understood. That would require a footprint in the U.S. because of certain legal reasons, with our footprint right now only in Canada. We would have problems, at least with THC. We're good with. Yep. With CBD. There are, at this point, no active leads. Okay. Penetrating too into the U.S., is that on the horizon, or is that still legal challenges with cannabis in the U.S.? It would be too speculative... Maybe I can answer that, Horst. Currently, it's the Canadian legislation that prevents us from exporting cannabis products. Okay. Unless there is a change in legislation. We're permitted under certain exception for medical purposes. Since the U.S. has a very undefined line between medical and consumer, it's not something that's permitted for us to export to the U.S. There would be a possibility that we work with a U.S. partner to manufacture it in the U.S. under our brand. This is not something we can comment on at this point. Yeah. Okay. Thank you, Tommy. One last question, then I'll be quiet. Are you partnering with three different animal healthcare companies, or is it the original two? At this point, we have 2 firm contracts, and a third one is being worked on. Okay. Okay. Thank you. I'll go back in the queue. Thank you, all. You're welcome. Thank you. Just a reminder, ladies and gentlemen, if you do wish to enter the Q&A queue, please press star one on your phone. The next question is coming from Trevor Lee. Trevor is a private investor. Trevor, your line is live. Hey, how's it going? I had a quick few questions for you today. Thanks for taking the call. I heard you had a VetaFilm study with results Q2. Will there be any more studies necessary after that one before commercialization, or would that be the last one? That is the study that we were that I was discussing or mentioning is a palatability study. We expect for the key programs that we are working on that further studies will be necessary. Those are just regulatory requirements. Without those studies the product wouldn't be approvable. Okay. Yeah. I was just wondering if there'd be more studies after that one. That is, that's a yes? Yes. For sure. I wonder if you can give an update on like any sort of specific sales numbers for RIZAPORT Spain or CBD products. Are you seeing any sort of consistent growth in the CBD, or is it kind of leveled off? What is that looking like there? Andre, do you want to comment? I mean, for RIZAPORT in Spain, I think that Horst mentioned that in the introduction, that Exeltis is working on avoiding generic substitution. That should probably increase the level of sales over there. There was a peak at first, but now it has declined, so they're looking at ways to go back on a growing path. For the CBD, we had a nice order in Q1, and we're expecting the growth to continue. We're not seeing extreme growth at this point, and that's why we've been working on this THC formulation because we all believe that THC might be more suitable for our technology. For the time being, it's pretty steady, but we don't see that much growth into the, these, product. Yeah. Then I think, Tommy, for the THC Tilray thing, did you say the coming month singular or months plural? Right now the arbitration is ongoing. I cannot really comment on it. It's the coming months, several months before we can announce something. Okay. It's like it takes a life of itself. You never know when there could be a resolution earlier. To manage expectation, we're looking at several months to be able to announce a resolution and hopefully we'll be successful in announcing that. Okay. Has there been any talks with atai about any further loans or any sort of share purchasing as part of the original deal or any additional capital coming in from that route? Not at the moment, no. Okay. Atai still has their option, like just to be clear. Their option are good for three years. Yeah. To some extent it will also depend on the share price. Okay. Dr. David Kideckel, is he on the call? I was just curious what maybe Horst, if you could clarify what made you guys choose him, and what does he plan to focus on? I let David speak for himself. Okay. David, why don't you introduce yourself? Sure. Thanks. Yeah. I just joined last week to IntelGenx to lead the corporate development department. Really in tandem with the executive team, we're going to be spearheading an initiative to look for new business development opportunities while also maintaining the existing business development portfolio, which is why the title actually includes strategic alliances. Just quickly to give you a quick background, what I bring to the table is approximately 20 years of combined experience between pharmaceuticals and biotechnology, coupled with capital markets and finance experience. It's that really unique blend of the two different worlds all within life sciences and pharmaceuticals to be able to what we hope will drive shareholder value for IntelGenx. Yeah. Is there any other... like, any kind of strategies that you think, IntelGenx has been missing out on or anything different that you would do, I guess in the future? You know, I think the strategy is sound. Again, I've only been in the role for about a week now, so I'm coming up to speed. But I think, you know, with the oral film technology and looking at the generic market, one strategy in particular, I think, you know, going after those companies, looking at innovator companies and seeing which products will be going into generic over the next couple of years or so-called low-hanging fruit. I think that's an area that we could more further develop to target moving forward. That's just one example, but there will be others as I... Maybe- Yeah. I can add to that. Mm-hmm. We, not too long ago, maybe half a year ago, hired another business development person specifically focusing on our CDMO business. That person, Mihai, has initiated a systematic outreach campaign, has contacted, you know, in excess of 100, I think, 130 or so companies, where we think that our CDMO services, you know, could be used. He has, in fact, received pretty interesting feedback. He has initiated concrete program discussions with right now three companies. That is a direction that we will keep pursuing with some priority. You know, it's applying our existing manufacturing and R&D technologies and capabilities to businesses interested in our CDMO services. Just as a side effect, I've, I think I've mentioned in the past that our film equipment is also capable of handling transdermal products. One of these CDMO contacts is actually concretely discussing a transdermal program with us. That's certainly one focal area in our business development efforts. A second person in David's group is looking more closely into animal health. We mentioned two opportunities, and we do see ever-increasing interest in applying our film technology to the animal health space. Okay. Nice. I just have a couple more. For the Montelukast, you said enrollment may be June. Would that be study results by the end of the year? Or that's be the last dosing by the end of the year? It's a yes, but, I'll let Frank comment. Mm-hmm. Yeah, in terms of the results of. We're targeting the remaining recruitment would end, we're estimating in June. Yeah. You have to tack on, the patients have to be dosed for 6 months. We're looking at an estimate at the end of 2023. At that point, close the database, and then you take a look at all the data. The results are. How long would the data, like, how long do you think that would take? Another few months, or? Yeah. Typically, the turnaround time is about, one month to three months. We close the database and then, we do the analysis and then, create a report, a study report based on those results. Okay. Do you guys have, like, a rough plan for after that? Would it be a phase three trial, or when would that begin? Our strategy there is very clear. We will commit our own money only to completing this phase two exploratory study, proof of concept study. The feedback that we are receiving from the market, from interested potential partners, is such that they would contemplate entering into an agreement once we've been able to show the results of this proof of concept study. We would not ourselves enter into any full-blown phase two study. That would be the responsibility of any future partner. Okay. It would be another phase two? That would have to be the case, yeah. Okay. Yeah, I think that's all I had. Yeah, I think that's all I have for today. I appreciate it. Thank you. Thank you. Thank you. We did have a follow-up come in from Hugh Kelly. Hugh, your line is live. Thank you. Regarding the Montelukast data release at the end of the year, Frank, is any feedback or intelligence? I think Emery's been about five months since they completed their study. Any insights if they made progress or is that... I know the expectations were low on complier calls, but are you hearing anything on that? I, good question, Hugh. We've been actively trying to get access to that information. I do know, however, that they initially were targeting 150 patients and then reduced that to 37. Most likely the reason is because of the pandemic, which imposed two years. We have not seen any of those results, which would be interesting, and would be. Nice to look at and share as well. Okay. I have not yet seen anything. Okay. As a follow-up to that would. Appreciate that, Frank. Follow-up with. Okay. Sorry. Go ahead, Hugh. I was just following up to the other gentleman's questions. Once the data is reduced in 2024, presented, if it looks good, that's when you open up the discussions with potential partners for Montelukast? Yes. Okay. My last question would be on the cannabis side with the other oral film companies that do not have the breadth and depth of IntelGenx, do you see them any of those emerging as potential competitors to our products? Not really. What we see is, and what we're hearing, in this space is that there is a at this point still relatively small patient population that is firmly committed to the films and that are certainly repeat consumers. So the objective in the industry is to systematically grow that patient base. That's what we're targeting. Okay. Then the, with the AdVersa product that's on your technology on the website, is there any interest in any partners, you know, entering in any collaborations in that product? We have more or less discontinued that. Tommy, maybe you want to comment on, to the extent we can comment, on what happened with AdVersa, with the AdVersa program. Yeah. The AdVersa program was divested. We sold this program, and we still have a residual royalty to Tetra Bio-Pharma. That's the mucoadhesive pill. They own the IP for Canada and the U.S. at the moment. Okay. If they're not doing anything in the future, we might wanna see if there is anything we can do, but at this point we're not pursuing anything. To be fair, we're really focusing our business on film. Since this was not related to film, we decided to divest it at that time, and we still believe it was the best decision. Okay. Thank you. Tom- Yeah. To Yeah. To add to that, to add to that, Hugh, if we were contemplating any expansion of our technology portfolio, it would go into the transdermal space where we have actual conversations, because that is a natural extension of what we do with the films. It does essentially require the same manufacturing equipment. That's what we would be looking at if we contemplated or a diversification of our technology portfolio. Okay. And, Also if I can add, like, we are always developing new film platforms. Although for investor or for the outside world, sometime it seems like it's plug and play, but every active is a new platform and a new technology, and we're constantly filing new application and patents to expand our technology portfolio for films and in the future, transdermal. The, if, with the 2 dates before the FDA get approval, is there milestone payments anticipated for the 2 products on approval? No. Not for these. I wouldn't know that there is one. Yes, there is one milestone upon approval for RIZA, for RIZAFILM, RIZAPORT, which is now RIZAFILM. Oh, sorry. Yeah. Yeah. Which is I think is due 60 days, but I don't have the specific time, but there is, I believe a $100,000 milestone. There is one milestone for RIZAPORT for sure. Okay. All right. Thank you. Thank you. Take care, Hugh. Thank you. Thank you. The next question is coming from Lindsey Murphy. Lindsey is a private investor. Lindsey, your line is live. Hi. Thank you for taking my call. I just had a quick question and was wondering if there was any update on the Vivaderm. Which one? I missed that acoustically. It was the VivaDerm. If there was any update with the VivaDerm? I think she mean VivaDerm, which is our trademark for transdermal. Okay. Yeah, I briefly commented on that before. We are in active discussions with a European company about two transdermal programs. We have determined that the transdermal space, and that's where VivaDerm, the name comes from, is an attractive technology and an attractive market for us, so we're actively pursuing that. Like I said, two. We're discussing two opportunities. That's early stage, so it'll be a while until we can until we'll be able to present any more tangible or advanced project. Principally speaking, there is definite activity in that space. Okay. Thank you. I really appreciate it. I apologize I missed that earlier. No problem. Thank you. We have a follow-up coming from Trevor Lee. Trevor, your line is live. Hey, I just had one more thing I was just thinking of while listening. I know in the past, Horst, you said, like, you don't wanna, you know, you're not about releasing fluff news or anything that's not concrete. Have you considered, you know, just doing more to bring awareness to the company? Like, you know, if we need to raise capital in the future, I think bringing in investors or just bringing in awareness to the company couldn't hurt. Like, you know, either having more of a social media presence or on Twitter with just, you know, leading people to the company via information about Alzheimer's or, you know, some of the causes that we're looking to help. Is that anything that you might be interested in? Yes. We definitely are. That is actually a subject that we're discussing very often and regularly. I mean, as far as outreach to investors is concerned, that is in Andre's domain. He's doing that. I think going forward, and that was one of the many reasons as to why we brought David in, he will be supported by David, who has a pretty significant capital markets expertise beside his BD background. We also have a communications group that regularly discusses what we can do in terms of bringing our message to investors. We're trying to be more active in that space. It is recognized as an area that we need to step up our efforts. Tommy, you know, with you, being a member of that group, if you want to add anything, feel free. Yeah, we know that we need to improve on the social media front. As for the hard news, the press releases, I mean, what you said is consistent. We want to only release things that are material, and we don't want to release press release about nothing. We will work as hard as we can to improve our social media presence, but the press release will remain hard news as the investor would expect it and not those press release that means nothing. That sounds good. I think, you know, I think the company could definitely benefit from just more of a presence just to bring awareness. You know, power of the retail investors has definitely grown as well in past couple of years. I guess to piggyback off that, you know, maybe more presence at conferences and stuff like that. I was curious if there was any sort of anything happened at the ROTH Conference on the West Coast. Yeah. Andre was out there. That's Andre's area. Mm-hmm. I mean, that was actually a very good conference. I met a lot of investors as well as you know, ROTH analysts. We're expecting to get some good feedback from that. There is. Obviously, since we're on the bulletin board in U.S., sometimes it's it might be a little bit difficult to attract a lot of healthcare institution. I think that being on the big board in Toronto, that has improved our ability to attract healthcare institution from the U.S. Yes, there was good meeting and we're expecting more coverage too. We were present at also at JPMorgan, not at the big conference, but and there was a lot of interest from different banks and different analysts. We're pushing towards that direction to get more coverage. We have 1 coverage right now from Canada, but I think that we're expecting and hoping to get a few more from the U.S. Yeah. I think that would go a long way, like more analyst coverage and stuff but. Yeah, definitely. Yeah. That's all I had for today. Thank you, guys. Thank you. Thank you. Thank you. We had a question from James Larkham from Ontario Limited. James, your line is live. Hello, folks. yeah, good to speak with you. This is my first time calling into one of your investor relations, but I've been invested long for a little while. I'm actually quite optimistic. David, you joining our team. you're, if I understand correctly, Rotman from University of Toronto Rotman. Is that correct? Yeah, I. Is that you? Hi. Thanks for the question. PhD, University of Toronto, and then an MBA at Rotman at University of Toronto as well. Yep. Amazing. Okay. Cause I did some work with CDL a few years back and in the quantum space. Seeing what may be to the American market, not necessarily the visible heavy hitter come onto the team you may be here. Can you tell me when you were first approached by IntelGenx, what excited you about joining the team? Yeah. I think That's a really good question. I think we're at a pivotal stage right now. You know, you have a company that's been around for quite some time now, you know, around 20 years, in the oral film markets. The types of drugs that we're actually targeting, generics in particular, You know, I'm a former analyst as well, you know, we talked about my capital markets experience, I mean, I was a former analyst, you know, the former investor's question too around increased presence, I mean, I completely get it 'cause I've worn that hat before. I think you know, just to go back to your question here, what excited me was the opportunities that we have. The markets that IntelGenx is competing in are quite large and the technology is second to none. When you look at the technology itself, you know, the only oral film type of technology within Canada. There are others obviously, you know, in other parts of the world, but I think- Yep. With Horst's expertise and really the entire management teams here, I think now's the time for IntelGenx to really make inroads. I'm certainly counting on that and betting on it as I put my career on the line to join the company and move forward here. I'm excited to see how, you know, things will turn not just with, you know, FDA's upcoming decisions, but also more specifically and more practically around how business development is gonna aid in further developments here. I'm really excited that you're talking about generics because I don't think everybody on this call really understands the lay of the land in Canada with regards to generics, patents and drugs. In the US they have like longer term patents for research and development, but in Canada we have, is it correct, five years on generic transfer? Tommy, can you respond to that? Perhaps. I don't know. I don't know any specific. I know that there's patents have a 20-year lifespan and I think this is the same in Canada as well. Okay. To be fair, we haven't. There's nothing. My understanding was part of the big reason why American pharmaceutical like mail order drugs were destabilized in the like late 1990s, early 2000s was because of the Canadian generics laws, but I could be misremembering. Regardless, I do think that there's a really big opportunity here in generics, so I'm glad to hear that that's the play. When you guys talk about taking on a $3 million cash infusion at an interesting time, I can't remember who talked about this, but I got the impression that you were saying, you know, this is a bridge towards something larger. We've got like something in the background, and we don't want to take on like a $9 million infusion and give up like 3%-5% of the company when that $9 million may be worth like 1%-3% of the company in the near future. Is I know that may be in the realm of speculation, but what kind of burn down are we looking at for $3 million when we've just added a headcount of $300,000 for I hope a successful position? We're talking about a company of 20 people-40 people, right? Close to 50. We're about, 50 people. About 50. Okay, excellent. Cool. I am sorry. I have tried to do my research as much as possible on IntelGenx. I am really excited about the company. That $3 million across 50 people, that's looking like at most 6 months run down, right? Yeah. I'm not too sure where you're taking that $3 million from. I'm talking about the new note that you guys negotiated. No, the note was $1 million dollar that we closed earlier this month. The $3 million that I referred to. I thought- No. The $3 million I referred to was a loan from atai, our partners. Right. Okay. We got- I am getting these two mixed up. Yeah. You're right. Yeah. We got that $3 million in January, and we closed. Yeah. That's was $3 million, and we closed CAD 1 million on a convertible note earlier this month. Got it. Okay, I understand that. That CAD 1 million is actually closer to what I was thinking about because that won't really last very long, would it? No. I mean, the plan was not to fund the company long term. Right. It's, you know, we were planning initially... So one- Sure. Yeah. One could speculate that, it... I think there was some rumblings earlier on in the call where, "Oh, you're gonna have to draw in money again soon." I just want other investors to realize that that's actually part of the game. The idea is to like get as little as possible now so that you can get more later at a lower valuation. I guess that's just what I'm trying to. That's right. Yeah. Yeah. I know. Yeah. Yep. Yeah. That's the plan. Excellent. I'm happy to hear that. Really, that's all my questions then. I'm gonna pass the floor and thank David for joining the team. You're welcome. Thank you very much. Thanks for the question. Thank you. There were no other questions in queue. I would now like to hand the call back to Dr. Horst Zerbe for closing remarks. Thank you. This concludes our fourth quarter and full year 2022 investor update call. As always, I would once again like to thank the entire IntelGenx team for its hard work and dedication, our board of directors for their continued support of the management team, and finally, our investors for continuing to believe in and supporting us. Thank you all and goodbye. Thank you. This does conclude today's conference. You may disconnect your lines at this time. Have a wonderful day. Thank you for your participation.
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