Greetings. Welcome to the IntelGenx First Quarter 2023 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to your host, Stephen Kilmer. You may begin. Good afternoon, thank you for joining us on today's call. With me on the line are Dr. Horst G. Zerbe, IntelGenx's Chairman and Former CEO, Dwight Gorham, IntelGenx's newly appointed 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 Senior Vice President 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 Commissions. I would now like to turn the call over to Dr. Zerbe. Horst? Thank you, Steve. Good afternoon, everyone, thank you for joining us for the IntelGenx first quarter 2023 conference call. On today's call, I will provide a corporate update and discuss the progress we have made on our key pipeline projects. Andre will review our financial results. Following that, we will open up the line for all your questions. Before launching into an update, I would like to take this opportunity to welcome our newly appointed CEO, Dwight Gorham, to our team and to his inaugural IntelGenx investor call. About a year ago, I informed the Board of Directors of my intent to retire as CEO of the company. The board subsequently appointed a succession committee chaired by Bernard Boudreau, which after thorough search that was conducted with the help of the Montreal-based executive search firm Heidrick & Struggles, recommended that the board appoint Dwight Gorham as the new CEO of the company. On March thirteenth, the board accepted my resignation and unanimously appointed Dwight Gorham as the new CEO, effective upon my resignation. I will continue to serve on the board and remain available to help the new CEO during the transition. Dwight is exceptionally well qualified to lead IntelGenx through and beyond its transformation from an R&D company to a successful commercial manufacturing operation. Dwight is an engineer by training. Most recently, Dwight served as president and CEO of Pillar 5 Pharma, a pharmaceutical contract manufacturing organization with a specialty in sterile ophthalmic products. Before joining Pillar 5 in 2015, he served as senior vice president and general manager of global operations of Pharmascience. Prior to that, he held a variety of senior roles, including president and CEO at Accucaps Industries, a leading North American supplier of soft gelatin capsules, a variety of management assignments at the Burroughs Wellcome facility in Montreal, president of Draxis Pharma, a Montreal-based CMO, and supplier of parental and lyophilization products, general manager of Baker Cummings, and director of operations at the Canadian arm of Glaxo, which is now GSK. During each of these assignments, he managed to significantly improve the financial performance of the company or the unit he was responsible for. While he's still just getting up to speed, Dwight has agreed 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 on our key programs. First, on atai. A phase I PK and dose escalation. PK, meaning pharmacokinetics, and dose escalation study using DMT buccal film is ongoing. Activities have also commenced to proceed with the next phase of the development, which is a phase II study. Moving on to RIZAPORT. Last month, the FDA approved our 505(b)(2) NDA for RizaFilm, the U.S. market name for RIZAPORT. Importantly, this followed a successful pre-approval inspection by the agency of our Montreal manufacturing facility in March of this year. This was a major milestone achievement for IntelGenx, as it was our first FDA approval for a film product that is based on our proprietary VersaFilm technology and that was fully developed in-house. We certainly view this as an important validation of our VersaFilm technology and will communicate this accordingly to our partners and investors. According to the American Migraine Foundation, 39 million or 12% of Americans suffer from migraine, which is the second leading cause of disability nationwide. Our partner for VersaFilm in the U.S., Gensco Pharma, is targeting the manufacturing of validation batches, which would be the first available product for later in the year, and then full commercialization in early 2024. I should also mention that the FDA approval came with the request to develop and submit within two years to FDA for re-review and approval of 5-milligram pediatric version of the film. Recently, we met with Exeltis, our partner for RIZAPORT in Spain. They reported great feedback from prescribing doctors and patients that 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. In January, we entered into an exclusive supply agreement for VeraPort with R1 Pharmaceuticals Industries Lebanon SAL in various countries in the MENA region. Moving on to tadalafil. As we reported last quarter, there was a slight delay as our partner, Aquestive, had 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 the API issue and are preparing for manufacturing of the clinical batch. As to cannabis, the arbitration process involving Tilray is currently in progress. Arbitration proceedings are confidential, we are unable to provide further details regarding this dispute at this time. We will promptly update our investors as soon as a resolution has been reached. Two words on montelukast. We were able to add five more sites to the study, and as a result, we've seen an increase in patient enrollment, especially in the last two months. We're targeting to end enrollment by July, possibly even earlier, if the rate of enrollment has been as active as it as in the past two months. While enrollment in the ongoing phase II 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 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 Institute to 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 lead principal investigator for the planned study and was sponsored through a grant awarded by the Swedish Research Council in the amount 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. On 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 QC 2023, we'll provide more details on its design at that time. Moving on to Xiromed. In April, we announced that Chemo Research, through its agent and affiliate, Xiromed, received a Complete Response Letter from the FDA regarding the submitted Abbreviated New Drug Application of Buprenorphine Buccal Film. Buprenorphine Buccal Film is the 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 I'm sorry, designed to be a bioequivalent lower-cost alternative for patients. Xiromed's CRL response is expected in the current quarter. Lastly, animal health. In the fourth quarter, we entered into a new VetaFilm feasibility and development agreement with an undisclosed animal health company for a VetaFilm-based oral formulation containing CBD for use in companion animals. The results from the CBD study are expected in the current quarter. As the newly appointed head of corporate development and strategic alliances, Dr. David Kideckel is also engaged in discussions with potential major animal health partners. 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 just mentioned, it's a few minutes to discuss the company's financial performance for the first quarter ending March 31st, 2023. On the revenue front, total revenue for 2023 first quarter amounted to $162,000, compared to $237,000 in the same period last year. The change is mainly attributable to decreases in R&D revenues of $63,000 and royalty on product sales of $12,000. Operating costs and expenses were $2.8 million for Q1 2023 versus $2.5 million for the corresponding three-month period of 2022. For Q1 2023, the company had an operating loss of $2.6 million compared to $2.3 million in Q1 2022. Adjusted EBITDA was negative $2.4 million for Q1, 2023, compared to negative $2.1 million in Q1, 2022. Our net comprehensive loss was $2.9 million or $0.02 on a basic and diluted per share basis for Q1, 2023, down slightly from a net comprehensive loss of $3 million or $0.02 per share for the comparable period of 2022. As of March 31, 2023, the company's cash and short-term investment totaled $3.8 million. I will now turn the call back to Dr. Zerbe. Horst? Thanks, 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. 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 that your line is in the question queue. You may press star two 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 key. One moment, please, while we poll for questions. We have a first question in the queue from David Nguyen, a private investigator or a private investor. See revenue. Have we gone to the PBMs? Have we gone to the wholesalers? I mean, I just wanna understand the marketing plan or the commercialization plan for this product moving forward. David, we missed the first part of the question. Apparently, you should just go. Could you please repeat the question? Basically, I'm sorry. Thank you again for allowing this. RIZAPORT's been approved. We have a, I just wanna understand the commercialization plan of IGXT for this product because it's pretty significant to gain an FDA approval, even though it's a 505(b)(2) drug. I'm just trying to understand, has the company contacted PBMs, you know, wholesalers, how are we gonna distribute this product? How are we gonna make it aware that's on the market compared to the oral option that's out there? David, do you want to respond to that? Yeah, happy to. Hi, David. Thanks for the question. David Kideckel here, SVP, Head of Corporate Development and Strategic Alliances. We do have a commercial partner in the U.S. that we've had for quite some time. That commercial partner is Gensco. We are in active discussions as we have been since the inception or the execution of the contract, to finalize commercialization plan. All planning for this is well underway for the launch of the product in the U.S. Are there any details you can give to how they're going to get this out to the wholesalers and make, also like physician awareness, channels which they're gonna market this product? I think it'll be more traditional type of sales and marketing efforts here. We're unable to really give more final details at this point in time with Gensco. Mainly because we're still finalizing the commercialization plans for the product. Yeah. I should-- Okay. David, I should probably add, because it's relevant for the timing of the launch, that. We still have to conduct the process validation, so we have to manufacture three batches, and undergo a full process validation exercise with those. That's a requirement by the agency. During that time, we will finalize with our partner, Gensco, in detail the launch and marketing activities. A final question on RIZAPORT. Could we expect a 2023 launch? David, do you want to respond? I would say it's highly unlikely that we'll see a 2023 launch. It is possible, but just given all the planning that's involved to launch a product, you know, once approved by the FDA, I would say we're looking at sometime in 2024. Okay. Thank you for that. In regards to montelukast, Dr. Zerbe, you've talked about the enrollment speed. It sounds very favorable. Say that you stop enrollment in July, when could we have the first set of data? Frank, do you want to respond to that? Frank is our clinical director or director of clinical research. Frank, you have to unmute yourself. Frank, can you unmute yourself? Maybe it's in. Can anyone speak to the data? Yeah, I guess. Horst, do you want to do it or you want me to do it? No, go ahead. Basically, if enrollment is finalized by June, July, since it's a six-month treatment, then you know, we're expecting the trial to be over by year-end or early Q1. Data should be available late Q1 or early Q2 of next year. All right. Thank you so much. I don't have any more questions. Thank you. Our next questioner comes from Abraham Shapiro. Yeah. Hi. Good afternoon, Andre and Horst. I like the news of the product development, the past quarter. Congratulations on the FDA approval. My concern is cash on hand. You know, what can we expect for a raise? That's Andre. Hi, Abe. Thanks for your question. I think, you know, we're very cautious and patient because, you know, of the stock price obviously. We have multiple option. We're looking at multiple options. We will have to raise money at some point. Right now, you know, we're managing the cash very carefully. I wouldn't worry. We'll We always find ways, and we'll find ways again. We're expecting some good catalysts to come in the near future. Hopefully that can give some momentum to the stock, and we can raise money at a higher level because as you can see, the stock price is pretty depressed right now. I mean, the entire market, but especially small cap. You know, we're being cautious. you know, we have a plan, and we have multiple options. Okay. Because I saw, you know, your partner, Aquestive, its stock has risen nicely the past quarter. You know, I'm looking forward to that happening to IntelGenx. I have a couple other questions. Gensco, your partner, are they gonna make some sort of announcement, some sort of public relations announcement, put something on their website? That's a good question. I mean, Gensco is a private company. There's likely no press release issued. As far as products available on their website, I mean, yeah. I mean, that's not a bad idea either. Yeah. Because we go on there's no mention of, you know, of IntelGenx at all. You know? Yeah. I mean, you know, to their defense, however, I mean, the product was just approved, you know, two to three weeks ago. We'll let them breathe a bit. We have regular communications with them, and I think that's a good idea. Thank you. That would be good. You know, the-- That's a welcome to IntelGenx. Best of luck and, you know. Dr. Zerbe, you know, enjoy your extra time. That's all I got for now. Thank you. Thank you, Abe. Thank you. We now hear from Hugh Kiley. A reminder, if you would like to pose a question, please press star one. Just to follow up. Good afternoon, everyone, welcome to the new members that joined the IntelGenx family. Excited to have you on board. Just a couple of follow-up questions, and I'll go back in the queue, is regarding the Gensco rollout and with the comment that David made is the normal sales process. Any idea of the number of salespeople that they have in that organization? I know it's private, so the information is limited in scope. Just wondering how they're gonna tackle the major U.S. Yeah, no, thanks for the question. I mean, it is a fairly smaller organization. I'm not sure the number of employees that work there. That wouldn't be considered public information. I would say it's not necessarily even the number of salespeople they or any organization would have in commercialization. It's where is the product gonna be positioned as far as effort allocation is concerned. This will become one of their top priorities as an organization. We're very much looking forward to working with Gensco at this point. As far as-- Again, I don't know if I would be focused so much on solely at least the number of salespeople. Just, you know, back to effort allocation. Okay. The follow-up to that one is, the other countries that have partnered with IntelGenx for the RIZAPORT. Any update on South Korea or the other territories? Yeah, the R1-- There's no-- I'm sorry. Go ahead, David. I was just gonna say, there's no real update to R1. All I can say is that there are ongoing negotiations and discussions with all the above that you just mentioned. Okay. Consistent with the RIZAPORT, any details of the product substitution and packaging that there are Exeltis experience in Spain, and do we have an estimated timeframe? Everyone was pretty excited with the rollout and, you know, 18 months ago, just do they see a light at the end of the tunnel on that, David? I'll Horst, I'll leave that one with you. What Exeltis has done there is change the packaging format in such a way that it would prevent substitution at the pharmacy level. They submitted that a few months ago to the Spanish regulatory authority. They're waiting currently as we speak for approval. When the approval will be issued, obviously, I can't tell you. I know it's pending. Exeltis is waiting for a response from the authority. Once immediately after that, they will transfer that into the market. All right. With that issue that was in Spain, Dr. Zerbe, would that be a challenge in the other countries that Exeltis has the right to commercialize in Europe? I would think so. We don't have any specific knowledge about that, but I would certainly think so. I mean, Exeltis has been around for some years, so I think that they will learn from past experience and not do and not commit similar mistakes in other jurisdictions. That is speculation on my part. We haven't discussed that specifically, with them. Okay. Thank you for that response. Follow up on the fourth quarter call was any update on the discussions with the company that would be potentially replacing Par for Suboxone? That discussion and, I know what you're talking about. I don't want to. Actually, I can't disclose that potential partner. That discussion is currently on hold because bankruptcy proceedings have still not been completed. We have to wait until that process has come to a closure in full, because only then will the asset become available. We have in the meantime and our potential partner for that has in the meantime confirmed with Par that the asset would be available. I assume that once the process has come to a conclusion that those negotiations will resume. Okay. It'll be hard to put a timeframe on that, I'd imagine. All right. With the same as the Endo project that we discussed on the last, fourth quarter, the undisclosed with Endo, is that still terminated or tabled or ended? that was the second program that we had with Endo/Par. That program unfortunately at this point is on hold. We have not at this point anyways, found an alternative partner to continue that program. Is it still a potential product that would be attractive to somebody, do you believe? Or is that maybe shelved? It depends on how the sales of the reference product develop. Until a few months ago, the sales of the reference product, the brand, were lagging behind expectations. I haven't checked recently as to whether there has been any, at least a significant improvement. That's really all I can say on-- or comment on that one. Two more then I'll go back in the queue. The transdermal patches discussion still going on in that unique product? That is still going on, and it is the likelihood that that negotiation will come to fruition has increased. We have received a provisional informal notice of acceptance by our partner. There, I'm very confident that this will come to a positive result. David, if you want to comment further, but that would be the extent of my comment. Thank you, Dr. Zerbe, as always. Thank you. Yeah. Okay. Did you-- No comment, David? Was it ended? Yeah. No, I thought we were moving on. Yeah, I did wanna make a comment. That that is something from a business development side, that is something we're pitching to potential clients. I know that there is interest just in it. You know, in my short time that I've been here, it's come up several time with potential partners. The transdermal technology is definitely a positive asset that we have within our tool bag at IntelGenx for future potential partners. The other one that's in your tool bag, David, is Loxapine. The last call, there was potential discussions going on with an interested partner. Is that still active or? I'll put this one back to Horst again. Yeah. On Loxapine, there's no progress to report since last quarter. We will reach out, but quite frankly, because of obvious reasons, you know, for the past couple of months and the focus has really more been on the Xiromed activity, on RIZAPORT and related aspects. Loxapine has not been pushed to the side, but it has not received much attention over the past quarter. It continues to be an important and as we think, very valuable asset. As soon as BD finds the time, they will proactively continue to reach out. All right. One last one, then I'll go in the queue. The Belbuca with the CRL and then with the, you know, the challenges with the other company, followed up pretty closely with the legal issues. Is there still four indications on the with your partner for the that would be developed for the marketplace for the four dosage or has it changed? No, that hasn't changed at this point. Okay. That's still the case. I mean, eventually the partner plans to commercialize all strengths, but for the moment the focus is on those four strengths. I mean, the reality is the sales volume of those two strengths that we are not actively pursuing at this point is in the 10% range, so it really wouldn't make much of a difference. Those two low strengths are mostly used in the initial phase to titrate patients up to their final maintenance level. That's why they don't play any significant role sales-wise. All right. Last, I'll go in the queue on the VersaFilm. Is it three companies that we're in partnership with or just two with multiple programs? Yeah. David, I'll pass that on to you. I'm sorry. Can you repeat the question? On the VersaFilm, partnership, David, is it three companies or just two companies with multiple of, programs? All right. Well, there's multiple programs ongoing right now. There's a couple of them what that we're deep in discussions with, and hope to have an update for you once if they become public over the next little while. Okay. Is it two, are you still two companies or more than two that are under a partnership or a contract for trials? Yeah. We have University of PEI, Prince Edward Island in Canada. I believe there's another one, and I'm not sure if that's been made public, and that would be for CBD in dogs. There are two I can confirm that it's Horst. To confirm what David said, we're actively talking to two companies. In addition to that, we are conducting a study with University of Prince Edward Island. Okay, I'll go back in a queue. Thank you for your responses and taking my questions. You're welcome. We now hear from Brett Giggy. Yes. I was wondering, I think Andre had mentioned some catalysts coming up that he thought would boost the share price. I mean, if an FDA approval wasn't a catalyst to boost the share price, I mean, what do y'all have coming up that you think is gonna do some good to the share price? We have significant catalysts coming up. I can only confirm what Andre said, but for obvious reasons, we cannot provide any details. I apologize for that. Andre, if you want to add to that. These are in 2023? Oh, yeah. In the near term. Yeah. One more question. Take this. Yeah, go ahead. Have you guys entertained at all a reverse split or anything to try to get the share price up to maybe attract investors? I'm sure at a barely over 10% share price, you know, there's a lot of investors are not attracted at that. Not seriously. I mean, the stock is being. Andre, you're welcome to comment further, we think the share price is right now massively manipulated. We're not contemplating a reverse split at this point. Andre, feel free to add to that. Yeah. I don't think that the reverse split would be an answer. If we were to, at some point, uplist on Nasdaq, that could be helpful. But at this level, I think that what we need to do is really, you know, execute, you know, on all front. Like I said earlier, there's some catalysts coming, work with Xiromed, with our Buprenorphine program to get it approved, launch product on the market. I think that that will definitely make the stock appreciate. Since there's a lot of short on the stock right now, we basically need to squeeze the short and the only way to squeeze the short is by executing properly and that, and announcing, you know, very tangible news. That's what we're working on right now. And increase volume with that. Yeah. Right. Okay. I guess I just would've expected the RIS announcement to have done that a little more than obviously it didn't do it at all as we've gone backwards. I appreciate you guys' information. Thank you. You're welcome. Our next questioner is Bedi Ozdeniz. Hi, good afternoon, gentlemen. My first question is in regards to the CRL that was received by Chemo. Per your press release, you said that Chemo received the CRL. Is it fair to assume that the CRL has nothing to do with the actual film and stability and more of like a packaging technicality on the partner's end? If you can shed some light on the CRL. There is a-- Let me just think how to properly respond to that. There is one talks related question that our partner, Hollister, needs to be able to respond to within an acceptable period of time. Then there was another comment that we quite frankly don't understand because we believe that we provided the information to the agency. That's, you know, a main reason as to why our partner has filed a request for reconsideration. It's just to sum it up, the CRL had nothing to do with, for example, the stability of the film or anything to do with its manufacturing part of it. Is that safe to say? It has got nothing to do with the manufacturing, and/or the stability. That is correct. Okay. The next question that I have is in regards to Heritage and your CBD film. Any update on that with like new orders from Heritage? How is that whole process going, like from sales and so forth? Yeah. David, I would prefer if you responded to that. You met with them just a few days ago. Please. Yeah. The Heritage agreement is still proceeding. The purchase orders we hope and expect will come in short order. I mean, if you follow the Canadian market at all, where this, where the deal is for at this time, the Canadian markets in general within cannabis is just not produced to the level of expectations that a lot of investors and analysts had initially predicted. Moving forward, while we're optimistic that Heritage will continue to place additional orders, it's not. We, we don't necessarily hold the same level of grandiose expectations for the Canadian cannabis market as potentially historically some of my predecessors did. Okay. All right. The next question that I have is in regards to the RIZAPORT, VersaFilm approval that you recently got. Was IntelGenx expecting any, like, sort of like royalty payment upon FDA approval from Gensco? Was that like in the contract? There's a payment due upon shipping first commercial batch, if I remember correctly. Is that correct, David? There's actually a payment due, from the time of FDA approval. Yes, that's contractual. Okay. Right now, but, yeah, exactly. This will be reflected in Q2? In Q2. Yeah. Yeah. Okay. Is there any way that you can shed light on roughly like, is it like a six-figure, seven-figure royalty payment or? It's six figures. Six figures. Okay. My last question is in regards to the Awan Pharmaceuticals and that whole contract that you have with them. Since the RIZAPORT just got FDA approval, are you going to be supplying the RIZAPORT to those nations directly from your manufacturing facility in Canada? Horst, I'll give this to you, but my understanding is that we're currently assessing different parts of the agreement. If you have other information, Horst, please feel free to chime in. Yeah. The deal was negotiated on the basis of the European approval. For the most part, the product would be manufactured by our manufacturing partner in Europe, and we would receive royalties. However, we do have under the agreement the option of online manufacturing the product ourselves. Okay. All right. I just wanted to touch base on one thing that was mentioned by a previous caller and what Andre was saying in regards to the possibility. Sorry, in regards to possibly considering a reverse split. I just want to say that I think IntelGenx has come a long way on its own, and I highly don't entertain the idea of a reverse split. I think the results and the execution of this company will speak for itself, and it will eventually, you know, get the company to the fair valuation where it needs to be because it's like highly undervalued right now. I think with, you know, the company what you guys are doing, focusing on execution and not just, you know, manipulating the stock price just to make the company look appealing. I think what you're doing is an amazing job, and we've been supporting you for all these years. I've been with IntelGenx for like 11+ years, and I believe in the company, and I think, you know, we're at the finish line. First of all, I really appreciate the comment. Thank you so much. What I really want to stress, we're fully on board with your assessment. I mean, we have discussed a reverse split several times, and we have every single time come to the same conclusion. This is nothing that we would seriously entertain. Going forward, I cannot see that to be changing at all. If Andre, if you want to add to that, you know, please go ahead. My position on this is very clear. I mean, if I may add, you know, I already commented on that. I think that we're fully aligned with your comment here. The only way that we would contemplate that is if the stock was much higher and it would be to migrate to Nasdaq. Right now, it's totally out of the question to contemplate any reverse split. I got you. I got you. Congratulations to you guys on the RIZAPORT approval. Welcome to Dwight to the company. We are supporting you. We are fully behind you. We believe in the vision that IntelGenx has. Oh, thank you very much for your support. Thank you so much. You got it. Thank you. We have Hugh Kiley back on the line. Dr. Zerbe, first of all, my apologies for not recognizing you and the company on the successful FDA approval of RIZAPORT. I dropped the ball on that one. Congratulations to you and all your team members on the continued long focus on that successful journey. Couple questions I have. Thank you. A couple of follow-up questions on the cannabis film. With the market acceptance of the film and the slowing down on that, is the intent still to focus on the adult use or the medical cannabis? Where do you see the biggest market opportunity? Yeah, I'll take this one. I mean, without question-- Go ahead, David. The bigger opportunity, is within adult use in Canada as opposed to medical. That said, there's a much higher price point in medical too. We're, we're opportunistic, as to which market to target. To be honest with you, Hugh, this isn't so much around what IntelGenx is gonna be focused on. It's more a matter of, what Heritage is gonna be focused on, our commercialization partner. They deal in both the sectors within the Canadian cannabis market, both medical and adult use. Okay. The expansion, I know we've been in Australia and Canada. Is there any other countries with, you know, Heritage on the horizon or, and/or other partners, you know, just taking the same five countries outlined on the investor presentation? I don't know which countries or when that investor presentation was compiled. Like I said, I, you know, as I just started a month or two ago, I'm in the process of reevaluating a lot of previous business opportunities and where we're gonna invest, business development's time and effort. Cannabis is certainly one of those areas that I'm keeping a close eye on. That said, keep in mind we do have the potential arrangement with Tilray subject to the outcome of our dealings with them. Okay. Okay. As far as additional countries, you know, the U.S. right now is likely not gonna happen just because of the legality there. Australia is still relatively small markets, certainly maybe parts of Europe. Canada is really the focus, at least for right now. Okay. Thank you, for that one, David. Just on the, the oral cannabis oral film, there's a, you know, a handful of other companies out there. Any of them you see as a strong competitor to IntelGenx product? To be honest, I haven't seen any oral film strips in cannabis. Even if I would have to do some more due diligence if others exist. To my knowledge, I don't know of any others, at least not in Canada. In other areas of the world that could be a different story. Yeah. I'll leave it at that for now. That was a very good answer. The, pardon my humor. Dr. Zerbe, any interest in partnership with anybody with your major repurposing effort, montelukast? We're waiting until we have initial results. A ctually from both studies. The BUENA study is nearing its end, so early next year, second quarter, first, second quarter, we will know the outcome and will then in earnest start our outreach. We had in the past discussions with a number of companies, big pharma certainly amongst them, and with no exception, the message that we received was, "We're interested, but show us the data." With that in mind, we haven't seriously entertained any outreach activities, you know, while the BUENA study is still ongoing. I suspect that with the Parkinson's study, it has not even begun. It will be similar. The situation is different in so far as Professor Sveinbjörn Gizurarson, the lead investigator of that study, already conducted an efficacy study with Montelukast in 40 patients and found a significant level of efficacy, which prompted him to design this much larger study, and if I recall correctly, in 170 patients. There we have very good evidence that the molecules is in fact effective in Parkinson's patients. There, the outreach might start sooner. That's very good news. That would be very good. Last question, Andre, regarding some of the prior questions on the catalysts in the air. Are the catalysts you were indicating over and above RIZAPORT and Belbuca, or is there something else maybe in horizon? Yeah, it's something else. I mean, obviously, we're working on multiple fronts. BD is very active. I mean, you know, of course, we want this Buprenorphine film to be approved and launched. That's a priority because it represents a, you know, great volume, great revenue for us. You know, the focus is also on other things, as you can see on the corporate presentation, and hopefully we can have some catalyst there as well in the near term. Okay. That's all for me. Thank you all. Thank you. You're welcome. David Wynn. Yeah, thank you. Just one more quick question. You know, it's great that we have a new management team in place. Is it safe to assume for the next earnings call that they will be up to speed on all the company's operations? I know Mr. Kideckel, you mentioned that you're gonna look at past programs. Will there be an update on, you know, future programs based on what you'll be seeing in the past and maybe some of what Andre said, what are the programs you're looking at in terms of business development? I mean, I just wanna make sure that when we come to this next call, it's clear-cut, it's not a lot of going back and forth, and we have our new CEO speaking to the investors. Yeah. I think, you know-- That one I can confirm. The new CEO will be actively running the next investor call. That I can say. I would have mentioned that in my concluding comments, but since you asked me that I can confirm. Thank you. Abraham Shapiro. Yeah, just, one last thing. I just wanna mention that I'm really, happy of the results this past quarter, and, congratulations. Certainly, the share price is way undervalued, in my opinion. You know, I went in as I nibbled for some more at this price. I'm 110% behind not doing reverse split. I think a reverse split plays into the hands of the shorts, and I'm with you 110%. Please do not do a reverse split. Best of luck to, all. Thank you. No worries, Abe. No worries. Thank you, Abe. Yeah. Dustin Foster. Hi, gentlemen. A quick question and quick comment. The question is about the arbitration with Tilray, and I understand you can't say anything in terms of substance content. Can you give any color on timing? Either what would be agreed to going in, when a decision would come or anything else without violating your oaths to give us a little idea on progress or timing? I mean, the only thing I can tell you is that the most likely decision would come in the fall. This is as far as we can go. This is highly confidential, that's the reason why companies decide arbitration instead of court processes. If we were in court, I could give you the full picture, now I just don't want to hamper our position. Of course. That's fine. That, that is helpful, and thank you. Finally, I was a shareholder many a year ago and have just recently joined you guys again. At that time, several years ago, I think a reverse split, you actually had authority for it from the shareholders and decided not to do it. I think that was one of the boldest and wisest things you gentlemen did because most small cap money-losing crump companies think that that's the answer. Of course, as we know, the original share price after a reverse split goes right back down within 8 months or 10 months to where it was. The market cap is 1/10 of what it was. Even being part of the Nasdaq is overrated because the dark pool trading, off exchange trading is there too. I just wanna congratulate you on that decision years ago and affirm that your ongoing decision not to entertain it or even contemplate it is smart and wise, and at that time, bold. Thank you again. I look forward to good things this time, although I lost a little money with you guys years ago. Thank you again. Thank you. Thank you. Doug Bistler. Hello. I just want to thank Horst for being accessible and congratulating on his retirement and leadership and vision over the years, and welcome to the new management team. I have a question. What product or products in the pipeline has the most potential to generate the revenue that's needed to place the company in a break-even position the quickest? David, I think that's one for you. Yeah, I was gonna take that. That's a good question. That's part of our exercise in defining which of the business segments we should be targeting with a priority basis. What I can tell you is that Riza with launch into the U.S. is likely not gonna be the highest potential revenue-generating opportunities. That's not to say it's, I mean, it's still a major priority for the company, one of our top priorities. As far as drugs that are approved, you know, if and when we address the CRL and with our partner with Xiromed, between that and Rizafilm, those are gonna be two of the most important products to the company. You look at other potential products as well that we have within our pipeline, Tadalafil being a very important product used for ED. Another area, you know, when you talk about profitability, it's one thing to talk about revenue, but it's another thing to talk about margin. That's something that we have to be very shrewd and careful with in defining what are the highest margin types of segments and businesses we target. One of those areas is our CDMO opportunity. That's a pivot that was undertaken several months ago where we hired another business development member as part of my team. He's really mostly focused on CDMO outreach and generating new business from that avenue. Moving forward, I expect you'll be hearing more and more about that on the next and subsequent conference calls. Okay. Thank you. One other question, you may or may not be able to answer. With regard to legal expenses, on the litigation, regarding Tilray, have those expenses been high, and does the company have the ability to recapture any legal expenses should they be successful in the arbitration settlement? Maybe I can answer that. Arbitration, contrary to court, is a process where you can normally recoup legal expenses. That means at the end, the arbitrator will rule on legal fees as much as the substance of the case. Thank you. That's all I have. Thank you. Kiley. A quick question for Tommy regarding your comment, with Tilray, you know, somewhere potentially in the fall. Is there potential that could be sooner than that, Tommy, if an agreement is worked out or settled? We always hope that something can happen sooner. To be to answer the question, we don't have any anything that would give us any indication other than something sometime in the fall. Okay. Okay, that's it for me. We have reached the end of the question and answer session. I will now turn the call over to Horst G. Zerbe for closing remarks. Thank you. This concludes our first quarter 2023 investor update call. 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. On a personal note, I would like to reiterate what a pleasure it has been steering this company to this pivotal stage, and I look forward to continuing to contribute to its success as champ. Naturally, going forward and in future quarters, as I previously mentioned, Dwight will lead these calls instead of me. As my last comment, there is really no doubt in my mind that I'm passing the torch into the right hands. Thanks to everybody and goodbye. This concludes today's conference, and you may disconnect your lines at this time. Thank you for your participation
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