Greetings, welcome to the IntelGenx Second 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 0 on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to your host, Mr. Stephen Kilmer, Investor Relations at IntelGenx. Steven, you may begin. Thank you. Good afternoon, everyone, and thank you for joining us on today's call. With me on the line are Dwight Gorham, IntelGenx's CEO; Andre Godin, our President and CFO; Dr. David Kideckel, the company's SVP and Head of Corporate Development and Strategic Alliances; Dr. Frank Pietrantonio, our Director of Clinical Research; Tommy Kenny, our Senior Vice President and General Counsel; and Dr. Horst Zerbe, IntelGenx's Chairman. Before we begin, I would like to remind you that all amounts mentioned today are in US dollars, unless otherwise mentioned, and today's call may contain forward-looking information that represents our expectations as of today and accordingly are subject to change. We do not undertake any obligation to update any forward-looking statements except as may be required by the 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 US and Canadian Securities Commissions. I would now like to turn the call over to Mr. Gorham. Dwight? Thank you, Steve. Good afternoon, everyone, thank you for joining us for the IntelGenx Second Quarter 2023 conference call. On today's call, I will provide a corporate update and discuss 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. To start, I will now update you on one of our key programs, beginning with RIZAPORT. The FDA approval of our 505(b)(2) new drug application for RIZAFILM, the U.S. market name for RIZAPORT, marked a major milestone achievement for the company. It is IntelGenx's first FDA approval for a film product developed in-house using proprietary VersaFilm technology. Importantly, the FDA approval included a request that within 2 years, we develop a 5 milligram pediatric version of the film and submit an application for the agency's review and approval. According to a recent issue of Practical Neurology, migraine affects up to 7 million children and adolescents in the US. In addition to reflecting the remarkable, remarkable impact migraine has on younger individuals, the FDA's request affirms our belief that a film-delivered migraine treatment will be valuable to younger patients that have difficulty swallowing pills due to nausea and other factors. The commercialization of RIZAFILM in the USA, as well as in Spain, is one of our 3 short-term commercial objectives we unveiled in May. Our US commercialization partner for RIZAFILM, Gensco Pharma, is planning to achieve the first saleable product later this year, with full commercialization in early 2024. Exeltis, our partner for RIZAPORT in Spain, continues to await regulatory approval to implement a new strategy to enable product substitution at the pharmacy level. Based on the positive feedback they have received from prescribing doctors and patients, we believe, if approved, Exeltis' new strategy will boost product sales. We are also pleased to announce that the work of our CDMO business development team has resulted in a binding term sheet with a CDMO customer for the packaging of pharmaceutical oral film produced that they're, they are planning to commercialize in the United States. The expected agreement is estimated to generate approximately $9 million in revenue over 3 years, and we look forward to providing updates as we work to finalize such, such agreement with them. Turning to our other CMO, CDMO business, we received in May an amended Drug Establishment Licence from Health Canada that allows us to provide third-party testing services, further supporting our short-term commercial objective to expand this part of the business. Also, on our CDMO business and subsequent to quarter end, we just signed up a customer to engage on an R&D project with the objective of advancing commercial output. We are extremely excited to embark on this new piece of immediate revenue generating business. Changing the subject and turning to our Montelukast program, we are thrilled to announce completion of enrollment in our phase 2a BUENA clinical trial in patients with mild to moderate Alzheimer's disease or AD. As you may recall, the COVID-19 pandemic effectively halted the BUENA, BUENA trial's recruitment for a year and a half, and the post-pandemic restrictions imposed by hospitals posed an additional challenge to trial recruitment. With the intention of avoiding any further delay in achieving the program's goal, we engaged our statistical consultant, Cogstate Ltd., and determined that we could just decrease enrollment while still providing a basis to determine which drug effect size, sizes are statistically significant by adjusting the p-values to less than 0.1. The study design modifications received a no objection letter from Health Canada, we've completed study enrollment with 52 patients, which is 18 fewer than initially planned. We are confident that this Health Canada authorized study design modification will enable us to utilize data from fewer patients while optimizing the power of the study to detect the effects of Montelukast VersaFilm compared to placebo. We are looking forward to completing the BUENA trial in the first quarter of 2024, to report initial trial results the following quarter. Believing that Montelukast VersaFilm has the potential to be disease-modifying, not only in AD, but as is being currently investigated in BUENA trial, but also in Parkinson's disease, we've expanded the program. In conjunction with that, we recently announced that manufacturing both active and placebo films are underway in preparation for a multicenter, randomized, double-blind, placebo-controlled clinical study to investigate the use of Montelukast VersaFilm for the treatment of PD or Parkinson's disease. The study will be conducted at the Karolinska University Hospital under our previously announced research collaboration with Dr. Per Svenningsson, who will serve as the study's principal investigator. Dr. Svenningsson previously conducted a clinical trial study utilizing the tablet form of Montelukast for the treatment of PD, where 2 tablets of 10 milligram Montelukast were administered twice daily for a total dose of 40 milligrams. The planned study will assess Montelukast in doses exceeding 40 milligrams. The Montelukast VersaFilm offers study participants an attractive dosing alternative to tablets, which would have them required administration of multiple tablets several times per day. Dr. Svenningsson will sponsor the study through a Swedish research grant worth approximately $2 million. IntelGenx has the option to acquire developed IP and study data for a potential further development of Montelukast VersaFilm for the treatment of PD. We are currently expected the study to commence in Q3 2023, and will provide more details on its design when they are available. Xiromed. In April, we announced that Chemo Research, through its agent and affiliate, Xiromed, received a Complete Response Letter from the FDA regarding. They submitted an abbreviated new drug application for buprenorphine buccal film. 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 bioequivalent, lower-cost alternative for patients. Xiromed's CRL response is expected in the current quarter. Animal health. As mentioned on our previous earnings call, our newly appointed Senior VP and Head of Corporate Development Strategy, Dr. David Gidicco, is in advanced discussions to engage a potential major animal health partner over a multi-year period. We expect to be able to announce more details on this during the next quarter. With that, I would like to now turn the call over to Andre for a review of our financial results. Andre? Thank you, Dwight. Good afternoon, everyone. As Dwight mentioned, I'll take a few minutes to discuss the company's financial performance for the second quarter, ended June 2023. Let's start with the revenue. The total revenue for the second quarter amounted to $133,000, compared to $398,000 in the same period last year. The change is mainly attributable to decrease in R&D revenue of $260,000 and royalty on product sales of $5,000. Operating costs and expenses were $2.7 million for Q2 2023, similar to last year, $2.6 million. For Q2 2023, the company had an operating loss of $2.5 million, compared to $2.2 million in Q2 2022. The adjusted EBITDA was -$2.2 million for Q2 2023... compared to -$2 million for the corresponding three-month period of 2022. Our net comprehensive loss was $3 million or $0.02 on a basic and diluted per share basis for this quarter, down slightly, slightly from a net comprehensive loss of $3.2 million or $0.02 per share for their comparable period of 2022. As at June 30, 2023, the company cash and short-term investment total, $1.3 million. I would like to also add that, I'm presently working on a financing, so, and the news should be out shortly. There's not much detail I can mention at this time, but, the cash runway of the company has been taken care of. Right now, I will now turn the call back to Dwight. Dwight? 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 would like to remind you that our forward-looking statements apply to both our prepared remarks and the following Q&A. Thank you. Thank you very much. At this time, we are opening the floor up for questions. If you would like to ask a question, please press star one on your phone keypad now. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For anyone using speaker equipment, it might be necessary to pick up your handset before you press the keys. Please pause a moment while we poll for questions. Thank you. Your first question is coming from Brent Gakey, who is a private investor. Brent, your line is live. Yeah, good afternoon, guys. On the last call, I had asked a question to you guys, and Horst and someone else were very confident you guys had some short, which they indicated were short-term catalysts that were going to increase the share price. Maybe we have a different definition of short term, but I would have assumed that would have meant during the last quarter, and nothing seemed to have happened. Are those no longer in the hopper, or y'all just thinking they just haven't hit yet? What's the deal with that? Yes, Brent, it's Andre here. I think that, there were some, an announcement last week, obviously, about, and, Dwight, covered that, you know, that new, CDMO, partnership. That obviously generated a lot of volume. We did mention last quarter that we were gonna hit, several catalysts. It is still true, but sometimes it takes a little bit more time to materialize. We're, expecting, some more news flow in the current quarter and in Q4. I guess everybody has to be patient, but it, it's coming. It's just like sometimes, we think that it might go faster than, than it actually, is. It's coming. There's nothing that is any different from the last, quarter. Okay, thank you. Thank you very much. Your next question is coming from Doug Distler, who is a private investor. Doug, your line is live. Yes, thank you. If I may, I'd like to ask 2 questions. My first question is: What is the status of the Tilray arbitration? Unfortunately, the answer is similar to last time. The arbitration is confidential by its nature, so we're hoping to have a resolution to, to this arbitration by the end of the year. That's all I can say at the moment. Yeah, okay. Well, it seems like it keeps getting pushed back every time we have an earnings call, but I, I can appreciate the answer. Also, what happened to the joint venture with Aquestive Therapeutics on tadalafil? This joint venture was first announced, I think, several years ago. Aquestive does never provide any updates on the progress on this drug getting through the FDA. Is this a dead project, or where does this stand? Because it seems like this is a real lost opportunity. Hi, this is David. I'll, I'll take this. No, thanks for your question. The project is still very much alive. In fact, we're working with Aquestive right now to embark on the final stages of the project. That will still take some time. We have a commercial partner set as well for in the UK. By no means is the project dead. Because I am newer to the team, I don't know what was disclosed for timelines, so I'm a little reluctant to give timelines because they're all still being worked out. I would say, you know, investors should really consider the tadalafil project more medium to longer term in nature right now, as far as FDA approvals and actual sales are concerned. As far as project development and moving forward to getting, you know, submission towards the FDA? That is one of the organization's top priorities as we speak. Yeah. It seems like IntelGenx is more optimistic about it than what Aquestive is, 'cause Aquestive, you would think with the potential it has, it would be more in the forefront. I mean, it's they, they just never mention it. We can't comment on other companies. At the end... I understand. Go ahead. Just to clarify. Go ahead. The commercial, the commercial partner is from U.S., I think they're just to, to avoid confusion. It's not, Aquestive Therapeutics? No, no, but I mean, Yeah, Aquestive is based in the U.S., but the commercial partner that we signed up is also based in the U.S. Okay. Thank you, Andre. Andre, just to, just to clarify, the commercial partner, that we've signed up through Aquestive, it's a NASDAQ-listed company, but for sales to commercialize, they have, rights for the U.K. That's what the point was. Yeah. Thank you. U.S. U.K., yeah. Again, to reiterate David's point, this is a medium to longer term project. And it's, it's in the 2-3-year horizon that the commercialization would, would take place. It just seems like it's been out there forever. Yeah, I understand that. Okay, thank you so much. Your next question is coming from Stephen Gee of Wedbush. Steve, your line is live. Hello, fellas. All right. I've been a public offering three times with the now out of business Fantone financials. Are you guys looking to raise money again to another, another company? Yeah. As I mentioned in my intro, we're working on something actually, right now as we speak, and we're expecting to announce something shortly. There's no issue in terms of cash runway for the company. This money go on the research, or this money go on the salaries and bonuses for you guys and wives and girlfriends and anybody else that you hire in that company. You know, me personally, I don't think it's fair that you guys are getting bonuses, and I've been in this stock for six years, and out of the three public offerings that I'm into, two of them, I lost my warrants now. You guys are taking so long trying to manufacture stuff from, you know, marijuana strips to cancer strips, to headache medicine, to dog strips. You guys, you know, smoke and mirrors again, and I hope everybody's listening to this. It's the same old, same old stuff. The only announcements we get is, this guy's retiring, we're hiring somebody new. He comes from 30 years experience from so and so company, it's still the same. 6 years already, I'm still sitting in this stock. No, but sir- I mean, everything is, everything is quarter, year, next year. I never hear minutes, days, weeks, or... I mean, go ahead, I'm listening. Sir, by the way, we haven't had bonus in 2 years. We have reduced our salary right now. I don't know what you're referring to. Well, why, why, why don't you take that then? I don't see none of that. I don't think anybody sees none of that. Okay. I mean, what do you think is gonna happen to the stock price after, after today's, after your call with the smoke and mirror thing? What do you think is gonna happen? You think it's gonna drop from $0.14 down into single digits? Nothing. No crickets there, huh? Just crickets. I don't hear nothing. No answer on that, huh? You guys don't seem optimistic about this stock. I didn't get the question. Yeah, I'm not sure- What was that? I understood exactly what the question was. Well, the question is, I've been sitting on the stock for six years with three public offerings that I'm in. Two of them, I lost their warrants. Now I'm sitting on... I'm all over the place, $0.40, $0.80. We're, we're down to $0.14 today. I'm asking, what do you, what do you think, since you guys work for the company and you have all the big titles, do you think this stock is gonna move anytime soon, or are we gonna sit on it for another six years? I'm just curious, because I think after today's smoke and mirror conference call that you guys just pulled again, it's gonna drop down to the teeth. Nothing positive came out of this, what I heard from you guys at all. Everything is next quarter, next- Thank you very much. If anyone has any remaining questions, please press star one on your phone handset now. Our next question is coming from Justin Foster, who's a private investor. Justin, your line is live. Thanks. Good afternoon, gentlemen. On the financing that you remarked upon, I know that you cannot expand upon it at great length. However, could you, since you have confidence that it will be accomplished, give us an idea, does it involve issuing of new shares, warrants? Is it dilutive? Is it internal people forwarding some loan to the company? Can you give us a little bit of direction there without compromising your need for restriction of information at this moment? Yeah, there's not much I can say, but, what I can say is that, yes, there will be some dilution, but, it will be in, most of it, will be in very strong hands. For the long term, that is very clear, in the, in the process. The terms, obviously, I cannot disclose because they haven't been announced publicly. You know, we're trying to avoid as much as possible dilution, but, we, we need the money. We're going commercial, you know, next year, you know, maybe the end of this year or, for sure, next year. We need to get there, and that's what we're doing. We're getting a bridge to get us to, the next year. Okay. Thank you for that. Thanks, much appreciated. I think the good part of all of that is you're starting out with not a lot of shares, so that investors can afford a little bit of dilution, and you've been wonderfully adamant about not reversing shares just to increase the share price in order to get financing. That whatever the disappointments out there, both those things are certainly appreciated by your shareholders, and I think it evinces integrity on all of your parts. I, for one, thank you for that, and good luck next quarter. Thank you. Thank you. Thank you very much. Your next question is coming from Tom Miglino, who's also a private investor. Tom, your line is live. Thank you very much. Thank you for taking my calls, I think congratulations are in order. I think this was a very exciting quarter. I've been in this stock for probably eight or nine years, and it's the most exciting quarter I've seen. Keep the good news coming. I was wondering if you could give us an update on the PEI project and how that testing is going with the non-humans. Yeah, I can. This is David Kideckel here. The PEI project is underway. In fact, I was out there not too long ago to meet the individual researcher, who was just starting testing in both dogs and, and eventually cats, or the other way around. We have just commenced that actual R&D or almost clinical trial in animals on that front. There's, there hasn't been any data received to date. Oh, I'm sorry. How, when do you expect that you might hear results? Is it something that's imminent? No, that's something more to bridge our longer-term entrance into the animal health space. I don't know off the top of my head what the exact timelines are for any data coming through. What I can tell you, too, that in Mr. Gorham's prepared remarks, he also mentioned another project that I've taken over since joining the company not too long ago. That, if, if approved and if it goes through, we'll have a lot of legs and potentially material upside to the company. We hope to give, you know, give investors in the markets an update on that as soon as we have one, which we hope will be within the next quarter. The two animal health projects are not related? The one isn't contingent upon the other? No, the... That's correct. They're completely unrelated. One is more of an R&D type study, and the other would be R&D going into commercial. Like you mentioned at the outside of your, your questions here, sir, this was at the University of Prince Edward Island or, or PEI, out in eastern Canada. The other- Yeah. That's a university-based. The other project, which is more commercial and, and R&D in nature, at least at the outset, that's with an actual company. Well, thank you very much, David. Also, has there been any movement in getting RIZAPORT into other European countries? I know a while ago they were talking about entry into some of the other big four. I know that they're stalled currently in Spain, and I'm sure in August, not much gets done in Spain. I wondered if there was any movement on entering other European markets with that product. Yeah, no, thanks for the question. David here again. I'll take this. The short answer is nothing material to report. Even Spain, as you heard in Mr. Gorham's prepared remarks, has been delayed to some extent. In fact, we reported no sales this quarter. We hope that some of the regulatory issues on the ground in Spain will be rectified, but there certainly are other European markets that, as part of the corporate development and business development team, we're actively listening to potential opportunities, but nothing right now that we can report that's material. Terrific. Well, thank you all very much for taking my call. Again, congratulations. Thank you. Thank you. Thank you very much. Your next question is coming from Hugh Kyle, who's a private investor. Hugh, your line is live. Yes, good afternoon, everyone. First question I have on the, to follow up the gentleman's question with Spain, and was there any... I know on the last call, they thought they were submitting a new application to the authorities to resolve that packaging or substitution issue, but that's not resolved as of yet? That's correct. That's not resolved, as of yet. I mean, the sales has shown it. I mean, there's essentially zero sales in, in rest of world, for RIZA. At the end of the day as well, I mean, Spain, it, it's not even one of the, the top four markets in Europe. We are keeping a very close eye on that and speak with our partners, Exeltis, for Spain. If there's any material updates, as, as always, we would share that with investors in the market. The same issues that affect the online pharmaceutical and the other partner, I think it's Jarvis? ARWAN? No. Package- Yeah, no, that would be separate. ARWAN is more for the Middle East and Lebanon in particular. Yep. With the goal to, as a gateway to other parts of the Middle East, but those are completely unrelated right now. We're dealing with ARWAN, too, with a number of other, I guess, hiccups that we're trying to work through our contractual agreements. Again, I would focus, if I'm you and an investor, I think the biggest opportunity, you know, having crunched the numbers and doing this on a near weekly, if not daily basis, you know, Riza USA is by far one of the company's largest opportunities. That's what we're putting a lot of our efforts into right now, and we, and we have been for the past several months. Okay. The, the, validation batches, they completed, they going through the testing, or they still need to be manufactured? We still need to have those manufactured. Correct. Okay, thanks. Is that David speaking? That's David. Yep. Okay, David, thank you. I'm sure I'll be back in a moment. Question for Andre. It was brought up before regarding the last conference call and the catalyst near term. Could we, you know, peel that back a little bit? Is the catalyst regarding oral film, transdermal, VetaFilm, or the CDMO? I mean, there's, like I said earlier, I, I think we have a few things coming up, and all of the above that you mentioned. You know, those are ongoing, you know, agreements that we are, you know, are working on. You know, David is obviously involved, Dwight, everybody's involved. It's just taking a little bit longer than we expected. It will happen. It, it's coming, you know, if not in the current quarter, it's gonna be in the fourth quarter for sure. Okay. Would they fall into the, that name of a, a significant catalyst, Andre? Uh- That was used in the last call. They're good catalysts. Everything is, is, is good when, you know, you announce a new partnership or you're a settlement or a CMO contract like we just announced last week. We're working hard on getting these things done. Yeah. I think the bigger part of that rests in the human, the human films and the VetaFilms. The CBD, not CBT, I, I don't believe we'll see major announcements on, but there'll be announcements. The big ones will be in the human, in the human side. Okay. Thank you, Dwight. I don't know if it was covered, any new programs with the Tilray? Not at this time. I mean, the we're working on DMT. That's their main, you know. Yep ... program with us. You know, there's discussion, but nothing new on that front. Okay. On the, and the transdermal front, I know the last call and the one before there was this potential opportunities with some discussions going on with a partner for transdermal. Yes. I mean, those conversations are ongoing. However, the focus of the organization is really making sure we bring to market Reza, which is approved, and we get the proper partnership agreement with that, and then resolving the buprenorphine issue and getting it resubmitted to the agency so we can get that to the market as well. Those are the two focus. However, we do have conversations on transdermal. Okay. The resubmission for the Belbuca is, I believe in the last call, there was two items, one for, you know, Xiromed and one that was a clarification issue for IntelGenx. Is that one been resolved, do you believe? It'll be a resubmission to the agency. It is next week. Okay. All right. The anticipated announcement for the CBD for animal health, is that study completed? Is that still going on? I didn't catch your comments on that, David. Yeah. I would say right now, we have 2 active animal health programs, both of which I just mentioned, the one at the University of PEI, the second being with the, the company. The other project that I think you're referring to, last quarter call or the quarterly call, I believe we, we had 3 ongoing projects. There was a third, and the recent CBD data in dogs, as reviewed by our R&D team, was not as promising as we thought. There might have been a few experimental errors. We're not exactly sure, but we've decided to pull the plug on that one. The 2 projects that we have right now in animal health are, again, the one in PEI, which is not material from a business standpoint, just to be very clear. That's more gonna feed into what data we can present for other potential partners down the road. What the most important projects, and revenue-generating opportunity that we have existing now is the one, that I was referring to with a, a company that, we believe we could be in a position to announce, over the coming months. Yeah. Would that be, associated with cats, maybe? It could be. It's mostly dogs, but it's also, just to be clear, it doesn't have anything to do with CBD or- Okay. any cannabinoid-derived medicine. Was there a prior study or, maybe some type of a effort with a undisclosed partner on cats? Is that one still active, or? I'm not sure which one that's actually referring to. I don't recall any undisclosed partner with cats. It was, BD, before David, you know? It could have been. Yeah. To my knowledge, there is. The only one that we're looking at cats in, again, is the one in, in the University of PEI. Yeah. That's more clinical and, and R&D in nature, as opposed to anything commercial. Okay. There's a, a product that's in your, you know, SEC filing. It's called DisinteQ, if I'm saying that. I hope I'm saying it properly, David. Some controlled all release film. Is that one active at all with any discussions? I'm sorry, can you repeat that? Did you say DisinteQ? I think it's, yeah. Yeah. D-I-S-I-N, DisinteQ. Yeah, this, this is correct. This is a platform that we have established. We filed IP on it. Right now, there are no current discussion on the, with the existing partner with that. It's a platform that we still believe in. We're trying to protect it from an IP standpoint as much as we can. The hope is to offer it to a future partner in, in the near to mid-future. Okay, and last question for you. Nothing going on with the... I have 2 questions. With Heritage, is that kind of panned out? Yeah, maybe, first of all, let me, let me talk about Heritage, and then maybe Dwight wants to comment on our overall cannabinoid program. Heritage, the sales have been very low, and I wouldn't put this on Heritage, but it's more just the Canadian market, in particular, has been quite lower in results than most people have thought. Heritage is, while, while not saying, you know, by any means, is the program terminated, I would say that it's not forming a focal point to this company by any shape or form, just with the effort and resource allocation, and ultimately with material sales, which just aren't panning out. It's not something that we believe firmly in at this point, for all of cannabis, not specifically Heritage, again. The THC platform, if I could use that terminology, David, is that still an attractive opportunity for IntelGenx? I, I personally don't think so. Okay. It's not just for IntelGenx. I think the market in Canada as a whole is very saturated, and I don't see where incremental business will come to the company. But we never know, too. We're also very opportunistic. If, you know, another partner comes to IntelGenx and asks us to develop, as part of our CDMO business, a particular products, I mean, we'd be very open to such an arrangement. The, the, horizon for medical THC and cannabis looks a little bit, soft, if I can use that acronym. Yeah or description. Yeah, the market's very soft. Yeah. Okay. All right, last question, how was, Andre, you, you said before about the plant build-out, that you needed some funds to complete the, or expand the plant for production. Is that going all right? I mean, as Dwight mentioned, you know, right now, the focus of the company is really short-term revenue, and that should, you know, start unfolding early next year. But we have sufficient capacity right now to support the product launch. But at some point, we will have to definitely look at expanding, because based on the projections that we have for the product that will be launched next year, we'll run out of capacity at some point. But right now, I would say we're fine for at least, you know, 18-24 months Correct with the current capacity. Right. I mean, it, it's an ongoing project to look at, and we run capacity utilization models on a regular basis. We should be good through till mid-2025, if not till the end of 2025. We will need to talk about this perhaps in some more length at the end of the 1st quarter in 2024. Okay. The, any update, any discussions on Par, Andre, is that still tabled pending the Endo bankruptcy? That's on hold. That program- It's on hold. Is on hold. Okay. All right. That's all for me. Thank you, gentlemen, and welcome aboard, Dwight. Yeah, thank you. Thank you very much. Your next question is coming from Abraham Shapiro, who's a private investor. Abraham, your line is live. Hey, good evening, Andre. Good evening to Dwight and David. I was hoping that, you know, you guys is down to $1 billion. I was hoping that there would be some sort of financial financing news during the earnings, but, time is of the essence, you know? I'm gonna hold you guys, that you're gonna announce something shortly. What did catch my ear is, you know, first of all, congratulations, congratulations on getting the CDMO deal. It's about time some revenue starts coming in. Even though $3 million a year is not what we're looking for, it's certainly a start in the right direction to get some revenue. You mentioned that Riza is where you guys are going, right? For the money. You said you're looking for the right partner. What happened with the partnership with the firm in Florida? Well, let me clarify. It's David here. When we're saying we're looking for the right partner, the question was more referring in context to those in Europe. We, we still, we have our agreement, our partnership. Our U.S. commercial partner is Gensco Pharma, based in Florida, so that... There's been no change there. My comment, again, was more based on other markets, within Europe. What is Gensco doing in regards to the partnership lately? Well, we have regular update meetings with Gensco. You know, to launch a product, I'm sure, as you can appreciate, Abraham, is no easy feat, and we're preparing for a launch. That's what we're doing, as we speak. I, I mentioned it last, quarter, you know, conference call, that, you know, there's silence from them. You know, maybe the partner, you know, could announce something on occasion. I, I know that, you know, Aquestive doesn't say anything. Gensco doesn't say anything. I'm, I'm looking for, you know, some word from some of the, partners. Again, you, you can't control other companies, but certainly you can recommend, some sort of announcements. Yeah. Yeah, I mean, I hear you. Again, we can't really speak for other companies, but Gensco is a private company. There'd be real not a lot of incentive for them to announce anything. I don't even know if that's part of their standard business. I can't comment on them at all, but, I mean, all we can control is what's in our purview at IntelGenx. I can tell you, Riza USA is one of the pillars of the company. Okay. When can we expect? I missed the first part, I apologize. When do we think commercialization is gonna happen with some revenue with Riza? We expect any time from the end of 2023 up until the beginning parts of 2024. The reason why there's a, a bit of a, a kind of a goalpost there, it's, it's really just due to some, some moving parts that we're trying to work through right now. I would say latest, we hope, is going to be the first half of 2024. Okay. There was, I think it was, she had left, one of your colleagues, and she had mentioned a cat product. I know that that's, you know, we didn't pull it out of thin air. You know, we have been hearing that a, you know, some cat or dog product soon. I hope so. Listen, I'm, I'm happy that we're seeing some revenue and, you know, good job to bring some money in. I think that you don't want to, you know, you don't want to sell it so cheap, you guys got to stay in business, so you got to raise the money, right? You know, if you have to, dilute, you know, somewhat, I'm fine with it, you know? Get to the goalpost. Yeah. Abe, Abe, I would've, I would've, obviously expected, you know, to talk about a little bit more, about the financing, but, unfortunately, I can't. I can tell you that it, it's really coming, you know, so. All right. I'm, I'm looking forward because you guys are gonna, you know, you're, you're, you're cutting it to the wire here. You know. Good luck. Thanks, Abe. I'm rooting. Shareholder for many years, and I'm, you know, I, I like the new mousetrap, and I'm rooting, and, hopefully, you know, we'll all become winners one of these days. Yeah. Thanks, Abe. Thank you. Thank you very much. Your next question is coming from Adam Viverito, who's a private investor. Adam, your line is live. Hey, how are you? I'm on a, on a headset with a microphone. How's the audio on your side? Great. Thank you. Good. Excellent. All right. Gentlemen, good work on the pending contract for $9 million over the next 3 years. Wonderful. Hope things are going well. Just a quick question, been a holder for a few years and, you know, I don't, I don't want to, I don't want to share the frustration of, I don't know, 3 or 4 callers ago, on the revenue front, it is what it is. We don't need to use negative descriptive adjectives and whatnot. I just did a little research, and, I mean, my blue sky thinking may be ridiculous, the TAM of the vitamin and supplement market is $39.4 billion. I think that's US. I don't know about worldwide. It was as of 2022. Real quick, you know, going back as a little kid, I remember, you know, there were chewable vitamins. As we grew older, we swallowed the vitamins, and then within the last decade, there was, like, a huge, let's say, emergence marketing of, of, like, gummy type of vitamins. Your technology, it's not novel. I mean, I remember Listerine strips back in the day, but I don't know if there are like, film vitamins. I think it's an exceptional idea, and, you know, if you, if you capture a, a, a de minimis amount of the TAM of 40 billion, that would be huge. I, I'll, I'll stop and ask: Has there ever been any discussions, thoughts, you know, about supplements and, and using your, your very technology? Okay, it's David here. I'll, I'll take a stab at this one. I mean, it's a fair point. Since Dwight and myself joined at roughly the same time points, and to take really right, why Dwight was brought on to take the organization from R&D to commercial, I mean, the sky's the limit here, in my opinion. What we have to do to execute is be laser-focused. And with our plan to focus on, you know, two to three products, and really do well with them, then we can start talking about where do we go from there from a very strategic perspective. You know, to rewrite the strategy and pivot to an altogether different area with, with, you know, one that we'd have to come fully up to speed on, I think that could actually take longer than pursuing our very laser-focused strategy right now. Thanks, David, for the answer, but I, I don't I'm not saying to deviate from your laser-focused strategy. I'm saying to augment your strategy. If you think about supplements, they're not, you, you don't have to go through an FDA process, approval process. There may be, you know, other, other certifications, whatnot, that you have to go through, but it, it seems like a much easier lift, so to speak. Once again, with a, with a TAM of just under $40 billion, if you capture hardly any of it, you're gonna, you're gonna make a ton more money than, than you're making. You know, that, that other caller's frustrations are, are valid. If you've been a shareholder for five, 10 years, it, it's pretty much the same old, same old. I mean, if you look at the revenues, there's not much there. I'm not saying to take your eye off the ball. I, I think you, you should be laser-focused on your strategy, but there's nothing wrong with diversifying your strategy, pulling in a new team, seeing what it takes to get a supplement on the market, even if it's a small test batch, what have you. Once again, I mean, it's so much easier than going through all these approvals and whatnot. It, it just seems like we're jumping through myriad hoops all the time, if you hit it out of the park, wonderful, it's going to be a bonanza. Why not diversify your, your, your revenue stream with something that may be very achievable? I mean, you go in any grocery, supermarket, drugstore, I, I mean, shelf space, shelf space may be difficult to come by, but, you know, the supplement's a huge business. $40 billion is, is $40 billion. Once again, if you capture a, a small 0.1%, I mean, you can do the math, that's more revenues than you've probably earned in, you know, for the duration of the, of, of the business thus far. I'm not saying to take your eye off the ball. I'm not saying to remove the strategy or pivot from the strategy. I'm saying to add to the strategy. There's no FDA approval for supplements, to my knowledge, vitamin C, what have you. It just, just food for thought. If you implement it, you hit on it, you, you could send me a, a free pack of vitamins or a small finder's fee. Thanks. No, thank you. Point noted. All right, cool. Thanks. I won't, I won't go on and on. Hopefully, we'll see a press release soon. Thank you, Adam. Thanks. Thank you, Adam. Your next question is coming from Brent Gakey, who's a private investor. Brent, your line is live. Yeah, guys. Y'all are talking about RIZ and how it's the pillar of the company. Do y'all have, I'm assuming you do, but I'm not sure if you can tell us. Do y'all have any... I mean, what are y'all projecting revenue-wise, and do you think it's in 2024 or 2025? I mean, what are y'all, what are y'all thinking, and is RIZ, I mean, is RIZ gonna, you know, make the company cash flow positive? Hi, David. I'll take. Okay, someone else want to take that? Yeah, I think I should take it. David, I'll. Okay, you take it. Yeah. I mean, we, we've never given guidance, but it will take more than Riza, obviously. buprenorphine, if, if approved and launched, will be probably the biggest contributor. It's hard to say when we will be cash flow positive. It depends on the performance of these, of, you know, Riza and buprenorphine. Some, next year would probably be a stretch, but, you know, maybe 12 to 15 months to 18 months, and we, we should be there. Okay, thank you. Thank you very much. If anyone has any remaining questions, please press star one on your phone keypad now. Your next question is coming from-... You okay? Yeah, no, I'm fine, thank you. Okay, our next question is coming from Hugh Kyle, who's a private investor. Hugh, your line is live. Okay, thank you. One question for Dwight. In your announcement, you put down out, you want to do a top-down or complete review of the, where IGXT was, the product, the focus. Any redirection of the company, is this going to be the status quo on the products that are under development and under commercial considerations? Yeah, that might be a, that's a great question. You know, I've, and David said it a couple of times, but I'll reiterate, there's some, some players with, there's some products with the agency that we need to bring to market. If we bring them to market with, with, with the, the, CDMO business that was announced last week, then we have a business that's EBITDA positive, likely. In the next quarter to 1.5 quarters, there's a full strategy review I need to go through. The other gentleman obviously brought, brought the vitamins and something we're not going to discount. In the short-term operation, we're going to really focus on making, hitting the bogeys and changing it from promising and not delivering to the, to the promising and delivering. In the maybe not the next conference, not the next call, but the one after, we can talk about potential strategic changes of direction. On the short term bogeys, you're addressing be RIZAPORT, potentially, if you get Belbuca approved in the CDMO arena? Bupivacaine, yeah. Bupivacaine, Riza, and the CDMO for the CDMO volume. Those, those three products, when mature, late in 2024, if the FDA approves the bupivacaine by then, as we go into 25 for the company, then cash flow, EBITDA positive. Okay. That's the game we're playing right now, that's the focus in the business. Stay myopically focused. All right. So the, is VELTROM still in that arena, too? Absolutely. We talked about it. I talked in my remarks about the work that David's doing. It's more R&D focus. It's pipeline, commercial sales beyond 25. R&D, there's significant R&D revenues in the next 3 to 9 months. Okay. Okay. That's my end of my question. Thank you, Dwight. You're welcome. Thank you very much. That appears to be the end of our question and answer session. I will now turn the call back over to Mr. Gorham for any closing remarks. All right. I want to thank everybody for their patience and their time. Clearly, we've come a long way over the last five years, and there's a significant amount of frustration in our jobs to clean that up and make it clear to everybody directionally where we're going. I just ask that people hang in there for the next three, six, nine months, and you start to see a progression of positive news out the business. Thank you very much for your confidence, and I look forward to our next call in three months and the one after that in six. Thank you very much. This does conclude today's conference call. You may disconnect your phone lines at this time and have a wonderful day. Thank you for your participation. Thank you. Thank you.