OTCMKTS:IGXT IntelGenx Technologies Q3 2023 Earnings Report $0.17 0.00 (0.00%) As of 04/25/2025 Earnings History IntelGenx Technologies EPS ResultsActual EPS-$0.01Consensus EPS N/ABeat/MissN/AOne Year Ago EPSN/AIntelGenx Technologies Revenue ResultsActual Revenue$0.32 millionExpected RevenueN/ABeat/MissN/AYoY Revenue GrowthN/AIntelGenx Technologies Announcement DetailsQuarterQ3 2023Date11/9/2023TimeN/AConference Call DateThursday, November 9, 2023Conference Call Time4:30PM ETUpcoming EarningsIntelGenx Technologies' next earnings date is estimated for Tuesday, May 13, 2025, based on past reporting schedules. Conference Call ResourcesConference Call AudioConference Call TranscriptInterim ReportEarnings HistoryCompany ProfilePowered by IntelGenx Technologies Q3 2023 Earnings Call TranscriptProvided by QuartrNovember 9, 2023 ShareLink copied to clipboard.There are 10 speakers on the call. Operator00:00:00Greetings. Welcome to IntelGenx's Third 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. Please note this call is being recorded. Operator00:00:22I will now turn the conference over to your host, Stephen Kummer, Investor Relations at IntelGenx. You may begin. Speaker 100:00:31Good afternoon, everyone, and thank you for joining us on today's call. With me on the line are Dwight Gorham, IntelGenx's CEO Andre Golben, our President and CFO Doctor. Frank Piantantonio, our Director of Clinical Research Tom McKemney, our Senior Vice President and General Counsel and Doctor. Horst Nabe, Intelligent Experts' Chairman. Before we begin, I would like to remind you all that amounts mentioned today are in U. Speaker 100:00:56S. Dollars unless otherwise mentioned, and today's call may contain forward looking information that represents our expectations 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 Commission. Speaker 100:01:26I would now like to turn the call over to Mr. Gorham. Dwight? Speaker 200:01:30Thank you, Steve. Good afternoon, everyone, and thank you for joining us For the IntelGenx Third Quarter 2023 Conference Call. On today's call, I will provide a corporate update and discuss the progress we've made Our key pipeline projects consistent with what we had previously committed to shareholders. Then Andre will review our financial results. Following that, we will open up the line for your questions. Speaker 200:01:58I will now update you on our key programs beginning with RIZAPORT. During the quarter, we received the 1st purchase order for RIZAFILM, the U. S. Market name for RIZAPORT from our U. S. Speaker 200:02:08Commercial partner Gensco Pharma. This represents a significant milestone for the company as it is our first purchase order for commercial supply of a pharmaceutical oral film. The purchase order triggered both an upfront order deposit payment as well as a pre specified milestone payment, both of which are reflected in our Q3 2023 financial results. We expect to ship the order of Riza Film products to Genesco in Q1 2024 For immediate launch to market, production of the Riza film is expected to commence in December 2023. Speaker 100:02:46Also, Axaltis, Speaker 200:02:49our partner for RIZAPORT in Spain, received This week, the regulatory approval to implement a new strategy that enables product substitution at the pharmacy level. Based on the positive feedback they received from prescribing doctors and patients, we believe Axaltic's new strategy will ultimately boost product sales. We are eager to see this new strategy implemented to increase product substitution at the pharmacy level and the corresponding increase in RIZAPORT sales in Spain. Turning to our bupinephrine buccal film program, Xyromed, the agent and affiliate of our co development partner Chemo Research Submitted to the FDA an amendment to the abbreviated new drug application requesting priority review. The FDA granted priority review with the Generic Drug User Fee Act or GDUFA goal date of March 8, 2024. Speaker 200:03:44However, if the agency determines an inspection is required, The GDUFA date is July 8, 2024. But given the March 2023 pre approval inspection of our facility And the subsequent approval of rizatriptan oral film, we are relatively confident that the FDA will decide to review this amendment without the need for an additional inspection. Now turning to our cannabis business, we are happy to have entered into a settlement agreement with Tilray. The settlement agreement includes a purchase order for 3 new product, CBD-twenty, THC-ten and a ten-ten combined CBD THC and was entered into concurrently with an amendment to our licensing and development and supply agreement with Tilray That renders the relationship nonexclusive for both parties. Clearly, this represents a new stage in our relationship with Tilray. Speaker 200:04:46However, we have worked hard this year to develop these 3 products and are looking forward to having them available to medical cannabis patients. Next, turning to Animal Health. We have discussed during the previous call that we are under discussions with a potential partner for an important development License agreement for an animal health product using our Vethafilm technology. These discussions are still ongoing And with the substantial progress we have made to date, we anticipate being able to announce this Animal Health Partnership later this year. Finally, with respect to our commercial activities, we expanded our CDMO offering by signing a binding term sheet For the packaging of a pharmaceutical oral film product that an undisclosed CDMO customer is planning to commercialize in the U. Speaker 200:05:39S. IntelGenx will package the product at our GMP manufacturing facility in Montreal. Moving on to R and D and specifically turning to our Montelukast program, we have completed enrollment of 52 patients in our Phase 2a Buna Clinical trial in patients with mild to moderate Alzheimer's disease. With the intention of efficiently achieving The program's goal, we've made a Health Canada authorized study design modification where we adjust the P value to less than 0.1. This modification enabled us to decrease enrollment while optimizing the power of the study to detect the effects of Montelukast Versafilm compared to placebo. Speaker 200:06:24We are looking forward to completing the BUNUS trial dosing in the Q1 of 2024 and to report initial trial results the following quarter. Additionally, manufacturing of both placebo and active Films are ongoing in preparation for a clinical study to investigate the use of montelukast Versafilm for the treatment of Parkinson's disease or PD. The multicenter, randomized, double blinded, placebo controlled trial We'll be conducted at the Karolinska University Hospital in collaboration with Principal Investigator, Doctor. Per Sievingsson, We will sponsor the study through a Swedish Research Council grant worth approximately $2,000,000 The planned study will assess the Montelukast 1st film as an alternate to the tablet form of Montelukast. We currently expect the study to commence in Q4 2023 with dosing to be initiated in Q1 2024 and we will provide more details on its design when they are available. Speaker 200:07:35Lastly, We also engaged an R and D customer to advance their product to commercial output and are proud to have secured the immediate albeit small revenue generating business. With that, I would like now to turn the call over to Andre for a review of our financial results. Andre? Speaker 300:07:55Thank you, Dwight. Good afternoon, everyone. As Dwight mentioned, I'll take a few minutes to discuss the company's financial performance For the Q3 ended September 30, 2023, the total revenues for the 2023 Q3 amounted to $318,000 compared to $142,000 in the same period last year. The change is mainly attributable to increase in R and D revenue of 128,000 And R and D milestone revenues of $125,000 Operating costs and expenses were $2,700,000 for Q3 2023 compared to $2,500,000 in the same period last year. For Q3 2023, the company had an operating loss of $2,400,000 consistent with Q3 2022. Speaker 300:09:01Adjusted EBITDA was negative $2,100,000 for Q3 2023 compared to negative $2,200,000 for the corresponding 3 month period of 2022. Our net comprehensive loss was $2,500,000 or $0.01 on a basic and diluted per share basis For Q3 2023, down from a net comprehensive loss of 3,000,000 or $0.02 per share for the comparable period of 2022. As at September 30, 2023, The company's cash and short term investments totaled $2,100,000 In August, Our parent company closed the 1st tranche of a non brokered private placement of units from Ittai Life Sciences For an aggregate gross proceeds of approximately US3 $1,000,000 including $750,000 in a subsequent the Thai subscription upon shareholders approval. We intend to use the proceeds of the offering to fund the formulation and development efforts related to our collaboration with Itai For working capital purposes and to cover costs related to the offering, IntelGenx We'll seek to obtain shareholders' approval at a special meeting of shareholders taking place on November 28, 2023. In addition to shareholders' approval, the offering is subject to final TSX approval and the satisfaction of customary closing conditions. Speaker 300:10:53I will now turn the call back to Dwight. Speaker 200:10:57Thanks, Andre. At this point, I'd like to review our track record of delivering on our promises. During the previous Q2 call, we indicated we would soon advance RIZAFILM in the U. S, which we have done in Q3. We also told investors that we are expecting to resolve the Tilray arbitration by the end of the year, which was also recently accomplished in an outcome that is favorable to both the company and its partner. Speaker 200:11:26Finally, We indicated that our partner Xyremend will respond to the latest CRL in a timely manner and such response was submitted in Q3. All of this to say, since joining IntelGenx as CEO, the company has kept its commitment to the investment community and executed on key programs in line with commitments made. We are looking forward to continue to execute and deliver on our upcoming milestones such as the signature of our Animal partnership in Q4 2023, the launch of RezaFilm in Q1 2024 and the Filming of the cannabinoid infused Versafilm order from Tilray. We are also looking forward to receiving the latest tranche of our recent financing in Q4, assuming we receive shareholder approval. I would like to end my introductory remarks by The fact that the progress we have made in our key projects has not opened the door within our R and D group for additional projects. Speaker 200:12:27We look forward to updating everyone on future calls on how we successfully capitalize on that. In closing, I'd like to once again recognize our team for executing our long term strategy and the team's commitment and focus on the company's transformation From solely an R and D organization into a full service R and D and commercial operation. 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 and A. Thank you. Operator00:13:03Thank you. At this time, we will be conducting a question and answer A confirmation tone will indicate your line is in the question We did have a question come from Hugh Kiley. Hugh is a Private Investor. Hugh, your line is live. Speaker 400:13:56Thank you, Duane and Andre for the update. Question on the RIZZIP film, The shipment is going to go in the Q4 2024 Q1, excuse me. Is there any idea, can you share that going to Pharmacies, hospitals, any light on the distribution and rollout plan Like CVS or anything like Speaker 200:14:24Yes, Hugh. This is Dwight. The product when it's shipped from our warehouse will be immediately available for shipment And CVS is a lead one of the customers. So they'll go to Gensco and Gensco has set that already in motion And they expect to have CVS as a large customer. Speaker 400:14:51That's good because I've seen on there, Dwight, I've seen it following this closely that was highlighted on the website. There's more info to come about arrival on their shelves. With the Gensco relationship, I know they have, I believe, I may hopefully I say it correctly, first right to China, is there any Thoughts of expanding that or is that just further down the road? More specifically, just wondering about other countries besides the U. S. Speaker 400:15:24And the Gensco. Speaker 300:15:29I can answer that if you want more. I mean, Telco is also looking at China. And I mean, We also have, obviously, Axaltis, distributing in Spain. Hopefully, the sales should pick up Based on what Dwight just mentioned and they're looking at others. Speaker 400:15:53Congratulations on getting that resolved, Andre. Congratulations with Excelsior is getting that shelving issue, resupply issue resolved. So regarding that one, is there Discussions underway, what countries in the EU would be next in line or they're just going to wait to see how Spain goes? Speaker 300:16:14I think in the first place, they will wait to see how Spain goes. But there has been discussion for EU countries in the past with Axeltis. So we'll see how that goes. But we also have discussion with other countries, But this is really preliminary in terms of discussion. But obviously, we are Fully aware how this RIZAPORT can be very successful. Speaker 300:16:45It's the first migraine film In the U. S, and it will be in other countries. So, I think we're very excited about this launch. And we're definitely ongoing discussion for other countries. Speaker 200:17:00Hey, Dave. It's Dwight back in line. Sorry, I got Cut off. We definitely, as late as 2 weeks ago, were speaking with Exaltis about Monitoring progress in Spain and looking to move that into other large markets in the EU Adjacent directly adjacent to Spain. Speaker 400:17:25Okay. That's good. And lastly, with the FDA and the pediatric risofilm, is that still is that ways off to be developed? Do you see that In the first half of next year, the end of the year or for the year or the one at the end? Speaker 200:17:45That is in development And we have studies to do, so it's not likely to be part of the sales line in 2024. It's more likely a 2025 line item. Speaker 400:17:57Okay. And then the new products that were introduced with Tilray, I know from a prior call, I was talking to Tommy, there was a lot of development effort for cannabis, cannabis THC and whatever other products are. Do you see those last call, there was some, let's say, less excitement of the cannabis market. Do you think Those who have an attractive feel in the marketplace with Tilray? Speaker 200:18:27I think that's an open question here. Speaker 500:18:30I mean, Speaker 200:18:30we all know that the cannabis market has been problematic for most. This is medical cannabis. So the limitations will be a little bit more will be a little tighter. And I think it's a wait and see. The good news is We're making commercial product. Speaker 200:18:48The commercial product is going to market. So there's some return on that investment. And they are Very clear that they expect that they'll make some traction with this, although I would say cautiously optimistic Would be the expression I would use. Speaker 400:19:08And I was just wondering with their prior arrangement with Raptidose, is that Still active as a competitor or is it basically aligned with IntelGenx? I don't know if you're allowed to say that, but Yes. Speaker 300:19:24Hugh, these are rapidly. They're dealing with us now. Speaker 400:19:29Okay. Thank you, Andrei. Speaker 600:19:31Thanks, Andrei. Speaker 400:19:33No, thank you for that. And on the I didn't get on I got on a little late there, Dwight. On the CDMO, This is the contract that was revealed before. Is it close to being finalized? I know you got the binding term sheet and some other Issues to work out resolve to both companies' satisfactory expectations, would that be done in Q4 or is that going to 2024? Speaker 200:20:00That will likely be early in 2024, It's not stopped us from progressing. The machine parts, which are the critical path items, are on order and they're Subject to the vagrancies of some of the subcontractors, but are expected to be in January. And we will then start doing Line trials, etcetera, to get the line commissioned and run stability lots. So the Definitive agreement, I suspect, will be completed sometime in Q1 'twenty four. Speaker 400:20:35Okay. That's Good answer Dwight. And I was going to ask you about And any of the other products like the Dsyntek or Transdermal before I bring up Vetafilm, was any of those Have any potential interest in the marketplace with new partners? Speaker 200:20:58Our focus and our conversations have all been on the Speaker 400:21:06Okay. And then the did you say you have potentially one partner For Vetafilm, is there any behind that, the first company that you may be able to bring to a conclusion with a contract? There is just one for the present time for Vetafilm. Speaker 200:21:25It's one, but there are other conversations on other Pharmaceutical ingredients that might be good targets for conversion From the current dosing regime to Vitafil. Speaker 400:21:42All right. And one last question Speaker 200:21:44on that. Those are early conversations. Yes. Speaker 400:21:47Okay. No, accept that. And on the discussions, prior calls we had With the status of the power product maybe being the power partnership being replaced, Is that still on hold with the Endo bankruptcy? Or is that a potential future product that could be news on? Speaker 200:22:12I would say the latter potential product that you may get news on. There's discussions, but they're in early stages. Speaker 400:22:21Okay. Thank you. I'll go into the I'll go back into the queue. Thank you, Dwight and Andre. Speaker 200:22:27Yes, my apologies for getting cut off. Operator00:22:32Thank you. The next question is coming from Abraham Shapiro. Abraham is a Private Investor. Speaker 700:22:38Good afternoon, everybody. Andre Horace, please. I got the Tilray order. I didn't hear any revenue numbers. What kind of revenue We expecting is IntelGen is expecting from that initial order? Speaker 200:22:57The initial order It's for $400,000 Speaker 700:23:09$400,000 All right. Speaker 200:23:13That's just an initial order. Speaker 700:23:15That's what kind of revenue. Okay. Being that it's a medical product, is it allowed to export to the United States? Speaker 300:23:30No, they cannot. Speaker 200:23:33They cannot. They cannot. And in general, exports to the U. S. Are still problematic on cannabinoids. Speaker 700:23:43Okay. I thought perhaps because it was a medical that might be a little lesser. So Other than that, it's high financing. It's always my concern that you guys won't get you need to get to the finish line, you get it so close. What other revenue, borrowing, financing do you have in line, If Speaker 200:24:10there any? Andre, can Speaker 300:24:12you take that one? Yes. We're looking at multiple options, There is another 750,000 coming in on November 28 Upon shareholders' approval and based on what we know or see At this point, we will get that money. There is also other revenue That might come in, in 2023 that we cannot really be specific on, but that are most likely to happen. But having said that, there is always Options that we're looking at to fund or well capitalize the company, but we are always And always been and always will be very concerned about dilution. Speaker 300:25:15So we're trying to find Way so that the dilution is not too dramatic, But there is I wouldn't be worried. I think that we have money And we'll find the money like we always did to make sure that all our programs are Launch as expected and that we're getting new programs in and new programs approved in order to generate Operator00:25:52revenue. All Speaker 700:25:53right. Thanks. Congratulations. It looked like To me, it looks like the utility settlement was a good settlement. It took a long time and moving along. Speaker 700:26:04And I'm a long time shareholder and I'm waiting for the price to reflect all these great things going on. So Thank you. Speaker 300:26:16Thank you, Ed. Operator00:26:19Thank you. The next question is coming from Brandt Dike. Brent is a Private Investor. Brent, your line Speaker 800:26:28is open. Speaker 900:26:28Yes. Good afternoon, guys. So the first CDMO contract that you all have, that's just the term sheet signed right now? Or do you all have Is that a contract signed and ready to go? Or when do you expect that to be done, revenue Speaker 200:26:52That is a binding term sheet that is signed. The definitive agreement, As I told Hugh, it's expected to be in the Q1 of 'twenty four. There's some Registration work to be done and it should be late 'twenty four, early 'twenty five revenue. Speaker 900:27:16Okay. And what about I think on the last call, you all had mentioned a second deal would be coming soon. Is that still the case? And if so, When do you expect that? Speaker 200:27:32I don't recall what was said in the last I'm sorry, my age is getting to me, I guess. However, at this point, I don't see another CDMO customer on the horizon. I see FDA Approvals for Riza and I see a lot of volume coming with Riza and I see bupinephrine going to Come out of the FDA. Okay. And those are the major events I see in the next 6 to 9 months. Speaker 900:28:09Okay. And as far as Itay, I believe the press release had indicated that Their shares would be at $0.18 Is that going to be the case even if when this gets approved, if we're at 11 or 12 or 13, is it still going to be 18? Speaker 300:28:31On the You want to yield that one, please? Yes. It's going to be $0.185 for their current that's the conversion price on their convertible note And the warrant that is attached to it is $0.26 and that won't change. Speaker 900:28:53Okay. Okay. Thank you, guys. Speaker 300:28:56Thank you. Speaker 400:29:25Operator? Speaker 300:29:32Thank you, operator. Operator00:29:36The next question is coming from Bobby Zanetti, Please provide an Speaker 200:29:40update. Speaker 500:29:42Yes. Hi. Good afternoon, gentlemen. First of all, I'd like to congratulate you on all the accomplishments for this quarter. It's really nice to see that Antoniax is moving forward at a very fast pace. Speaker 500:29:54So congrats on that. My first question In regards to the Atay Life Sciences announcing the filing of an early warning report on October 10, Could you shed some light on that with them owning 66% shares in the company? Speaker 300:30:16Dwight, do you want me to answer this one? Speaker 200:30:19Yes, please do. Speaker 300:30:21Yes. This is the it's kind of unfortunate, but this number is wrong to start with. But, Atai owns 21% of the company, and that's the fact. And they could potentially, at some point, own more than 50%, So anywhere between 50% 60%. But to get there, they would have to invest about $30,000,000 $35,000,000 So the reality is they own 21%. Speaker 300:31:03And As long as they don't invest any further money into IntelGenx, it will remain at 21%. Speaker 500:31:14Okay. Okay. And the other question that I have is in regards to the settlements with Hilary, a lot of investors were anticipating a payout for you guys. Was there a payout on the table or a partnership deal? Or was it only a partnership deal with amendment of the other part of the deal concerning exclusivity? Speaker 600:31:39Do you want me to take that, Dwight? Speaker 200:31:42We should be there. Speaker 600:31:45Hi, it's Tommy here. Unfortunately, settlement discussions are confidential and it's not something that we can bring up. I can just tell you that the outcome is probably the best thing Both company could have expected. We're moving forward as partners, and we're hoping that the future will bring additional product. But at least right now, there are 3 products and we're hoping that this will be a continuing product. Speaker 600:32:09They have told us that their patients are expecting those products. So there is some expectation there. Okay. Speaker 500:32:16And just to clarify, Andre, you had mentioned that there are ties with rapid dose. There is no manufacturing by rapid dose for Tilray as far as the film goes? Speaker 600:32:26As far as we're informed that's the case, but again, the agreement is non exclusive. We believe they will Get the film from us, but it's the same thing with us. If we want to Speaker 300:32:35sell to someone else, we're authorized right now. Speaker 500:32:38Okay. And are there any other companies like from the big Players that have approached you in regards to the CBD or THC products? Speaker 600:32:48At this point, we haven't shopped anything around because we were in litigation. The game has significantly changed now that this is open to us to market if we see an opportunity. So At this point, we were not entertaining any discussion with the current partner in Canada. Speaker 200:33:04Yes. This agreement was just signed. And we will we have activated our sales department and marketing department to Take a look at other potential targets for these products. Speaker 500:33:18Okay. And just I wanted to ask about the launch of these products or when they will be Possibly delivered to Tilray and distributed to the patients. Do you have like some sort of like a timeframe? Is it going to be Q1 of 2024 or this year? Speaker 200:33:38No. Well, based on The orderly times of the base for raw materials, it will be early Q2. Speaker 500:33:45Okay. All right. And going to the buprenorphine, you said March 8 Was the GDUFA day, correct? Speaker 200:34:00Provided that they don't push a facility inspection, yes. Speaker 500:34:04For inspection, okay. So when are we expecting if, God willing, you get the approval on March 8, when are we expecting this product to be launched? Speaker 200:34:22Yes, I mean, it's Donnie here. Speaker 600:34:24There is ongoing litigation with the product. So I mean, we cannot make any statement as to when the product will be available because it We'll depend on when we get the court date and we get in front of the judge. Unfortunately, this is the situation. We're looking forward to approval and we'll push as much as we can Get the product as soon as possible to the market. Speaker 500:34:44Okay. And is there any milestone payment that IntelGenius will be receiving upon approval? Speaker 600:34:50Yes, there is one milestone upon approval. Speaker 500:34:53Okay. And can you shed light on like is it like a 6 figure or? Speaker 600:34:59Low 6 figure. Speaker 500:35:01Okay. All right. That's all for me, gentlemen. And again, congratulations to you guys and the whole team. God bless. Speaker 200:35:08Thank you. Operator00:35:11Thank you. And the next question we had was Hugh Kiley with a follow-up. Hugh, your line is live. Speaker 400:35:17Okay. Thank you. And I apologize, Dwight, Andre and Doctor. Dhirby and Tommy for and Frank for not congratulating on their Great progress with the company so far in 2023. I have a question with the tires, any other programs in the work Besides the one that's moving right along, any new molecules that they're interesting having Your company or our company developed for them? Speaker 200:35:50We're Really focused on getting their clinical Phase 2 work done for them. As recently as 2 weeks ago, I had extended conversations with their CEO in Berlin. And at this point, it's a focus on what we've got on the table, Although nothing has been ruled out. Speaker 400:36:10Okay. And as a follow on to that, would Your business development team is evaluating different molecules. Is there anything in The background that's being worked and developed that we could learn news on that it may be attractive for the oral film market? Speaker 200:36:31I think I said that we've reached we've opened up some space in the R and D area. We're looking to capitalize on that. And as soon as we've got that nailed down, I would love to be able to share that Okay. With the shareholders. But it's premature for me to say right now. Speaker 400:36:51Yes. Okay. And I accept it, Dwight. Thank you. And last question last two questions is, with the progress of Montelukastin soon With the Parkinson's study over there in Sweden, any potential partners on the horizon for either one of those programs? Speaker 400:37:10I know I ask at Speaker 200:37:17Well, there's certainly Doctor. Zuber and I had a lot of conversations at the recent trade show with several potential partners. But everything comes down to getting the readout in the Q2. Okay. If the readout is good, then I don't think there's a lack of partners. Speaker 400:37:38Okay. That's a good answer. And then that would be the same for both products or just the Alzheimer's film? Speaker 200:37:50I don't think I think if the data is good on all of them, then there's partners to be had. The first one will be the Alzheimer's. Okay. Speaker 400:38:00And it wasn't brought up in the call, but I'll ask is Any update on the progress on tadalafil? Speaker 200:38:09Yes. So, Alastair is excuse me, we are we've got the last of The development work understood and we're back on track for with that to Complete the work we need to move forward probably within the next 3 to 6 months. Okay. And that's not commercial, but there's other project milestones in there. Speaker 400:38:41Yes. That's a good report. All right. That takes care of my questions, White, Frank, Condrey, and Doctor. Zerbe. Speaker 400:38:49And If I missed anyone else, I apologize. Speaker 200:38:56Thank you. All the gentlemen, both in Amin Speaker 100:38:59as well. Speaker 400:39:01One question I did sorry, this one. In the past, there have been research reports about The progress of the company and investors research report, is there anything in there with your discussion with investors, any research Which houses, they may issue a report with the success of the approval of RIZAPORT and the other progress the company is being made has made. Speaker 200:39:29To my knowledge, at this point, no. Would we like to engage with that? The answer would be yes. Speaker 400:39:37Okay. All right. Thank you, Dwight. Thank you. Operator00:39:44Thank you. The next question is a follow-up coming from Brent Caike. Brent, your line is live. Speaker 900:39:57Yes. Do you all expect or have any indication that Tilray will put out any communication, press release or anything on these three products? Speaker 200:40:09Tommy, can you answer that one? Speaker 600:40:12I mean, they will probably if they issue anything, they will probably only Upon receiving the product because they don't want to create expectations from their patient or customer before the product is actually available. Speaker 900:40:27Okay. And if the share price continues to wane down where it is now, do you all have any Indication or idea if Atay would purchase shares on the open market? Speaker 300:40:44I can answer that. I think that Itay has warrants and available. I doubt that their business model allow them to purchase shares on the open market. But like they could bring in money by exercising Speaker 500:41:13either more Speaker 300:41:16Convert that they have or warrants that they have, but they are there to support us. Obviously, they as you Probably know they have supported us through a term loan as well. But one of the objectives of the company with all the Execution that has taken place the last 6 months and that continues towards 2024 We'll be out there road showing. I just came back from a road show in South Florida, and that will continue. So Unfortunately, small cap has been hit quite a bit in the market, especially life science. Speaker 300:42:01But as long as we execute on our business plan And that we get closer and closer to being commercial, I think that the stock price will reflect that at some point In 2024, I'm not worried. Speaker 900:42:21Okay. Thank you. Operator00:42:27Thank you. And the next question is going to be from David Nain, who is a Private Investor. David, your line is live. Speaker 800:42:36Thank you. Gentlemen, thank you for the update and your progress. It's good to see that Real progress is being made. But being that said, we have a couple of products that have already been approved in various countries, including the United States. And I think it's fair to say Speaker 500:42:53that there have been some hiccups Speaker 800:42:54in commercialization. Moving forward with Montelukast being probably the jewel of the company, are there any basic Criteria for choosing a commercialization partner because God willing, that drug gets approved for AZ and maybe PD, What is the criteria for choosing a commercialization partner? Because obviously with prior approved products, we haven't seen real revenues from that. Speaker 200:43:25That's a great question. Thank you very much. From a criteria perspective, I think if the Monti hits, There will be much more mature companies, much larger scale companies involved In the bidding for the product, and certainly, some of the criteria will be scale, Others will be international reach and others will be specifically focused to reach into the U. S. And to Europe. Speaker 200:44:00So for me, it's mostly going to be scale and size of the enterprise to make this happen. With some of the other products, we were we had partners and they were we didn't quite understand Some of the logistics associated with holding their hands to get to market, and that's been cleared up, and I think we've fixed that. And if Monty hits, I don't think there's a lack of partners. It will be significantly into their choosing and scale and the credibility organization will be key attributes we look at. Speaker 800:44:41I appreciate that answer there. I just hope that the company I know you've only been here for a short time, but I just hope the company can learn from the missteps With already approved drugs and maybe make the next few drugs that we get approved huge successes. So thank you for your time. Speaker 200:44:58Thank you as well for the question. Thank you. Operator00:45:10And we would now like to hand the call back to Mr. Gorham for closing remarks. Speaker 200:45:21Yes. Thank you very much. Well, this concludes our Q3 2023 investor call. I'd once again like to thank the entire IntelGenx team for its hard work and dedication, Our Board of Directors for the continued support of the management team and finally, our investors for your continued belief in and supporting us. The quality of the questions was excellent today. Speaker 200:45:45Thank you very much. Thank you and goodbye. Thank you. This does conclude today's conference call. You may disconnect your phone lines at this time andRead morePowered by Conference Call Audio Live Call not available Earnings Conference CallIntelGenx Technologies Q3 202300:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsInterim report IntelGenx Technologies Earnings HeadlinesIntelgenx Technologies (OTC:IGXT) Stock Quotes, Forecast and News SummaryAugust 18, 2024 | benzinga.comIntelGenx Technologies Corp.: IntelGenx Provides Update on Previously Announced Sale and Investment Solicitation ProcessJuly 20, 2024 | finanznachrichten.deSilicon Valley Gold RushA new technology has sparked a modern-day gold rush in Silicon Valley. OpenAI’s Sam Altman invested $375M. Bill Gates has backed four companies in this space. The World Economic Forum calls it “the most exciting human discovery since fire.” Whitney Tilson believes this trend could mint a new class of wealthy investors—and he’s sharing one stock to watch now, for free.April 26, 2025 | Stansberry Research (Ad)IntelGenx Provides Update on Previously Announced Sale and Investment Solicitation ProcessJuly 19, 2024 | globenewswire.comIntelGenx Obtains Preliminary Efficacy Results for the ‘BUENA' Montelukast VersaFilm® Phase 2a Clinical Trial in Patients with Mild to Moderate Alzheimer's DiseaseJuly 3, 2024 | globenewswire.comIntelGenx Announces Initiation of the Sale and Investment Solicitation ProcessJune 11, 2024 | globenewswire.comSee More IntelGenx Technologies Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like IntelGenx Technologies? Sign up for Earnings360's daily newsletter to receive timely earnings updates on IntelGenx Technologies and other key companies, straight to your email. Email Address About IntelGenx TechnologiesIntelGenx Technologies (OTCMKTS:IGXT), a drug delivery company, focuses on the development and manufacturing of novel oral thin film products for the pharmaceutical market. It offers INT0008/2008, a Rizatriptan oral film product for the treatment of migraine; INT0046/2018 and INT0055/2021 are for adult use; INT0007/2006, an oral film product for treatment of erectile dysfunction; INT0043/2015, an oral film containing montelukast for treatment of Alzheimer and Parkinsons; INT0027/2011 to treat opioid addition; INT0010/2006 for treatment of neuropathic pain and nausea in cancer patients undergoing chemotherapy; INT0036/2013, an oral film product for schizophrenia or bipolar 1 disorder; and INT0048/2020 for animal health. It is also develops INT0039/2013 for pain; and INT0053/2020 for the treatment of resistant depression. The company has licensing, development, and supply agreement with Tilray, Inc.; and development agreement with Cynapsus Therapeutics Inc. IntelGenx Technologies Corp. was founded in 2003 and is headquartered in Montreal, Canada.View IntelGenx Technologies ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Markets Think Robinhood Earnings Could Send the Stock UpIs the Floor in for Lam Research After Bullish Earnings?Market Anticipation Builds: Joby Stock Climbs Ahead of EarningsIs Intuitive Surgical a Buy After Volatile Reaction to Earnings?Seismic Shift at Intel: Massive Layoffs Precede Crucial EarningsRocket Lab Lands New Contract, Builds Momentum Ahead of EarningsAmazon's Earnings Could Fuel a Rapid Breakout Upcoming Earnings Cadence Design Systems (4/28/2025)Welltower (4/28/2025)Waste Management (4/28/2025)AstraZeneca (4/29/2025)Mondelez International (4/29/2025)PayPal (4/29/2025)Starbucks (4/29/2025)DoorDash (4/29/2025)Honeywell International (4/29/2025)Regeneron Pharmaceuticals (4/29/2025) Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. 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There are 10 speakers on the call. Operator00:00:00Greetings. Welcome to IntelGenx's Third 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. Please note this call is being recorded. Operator00:00:22I will now turn the conference over to your host, Stephen Kummer, Investor Relations at IntelGenx. You may begin. Speaker 100:00:31Good afternoon, everyone, and thank you for joining us on today's call. With me on the line are Dwight Gorham, IntelGenx's CEO Andre Golben, our President and CFO Doctor. Frank Piantantonio, our Director of Clinical Research Tom McKemney, our Senior Vice President and General Counsel and Doctor. Horst Nabe, Intelligent Experts' Chairman. Before we begin, I would like to remind you all that amounts mentioned today are in U. Speaker 100:00:56S. Dollars unless otherwise mentioned, and today's call may contain forward looking information that represents our expectations 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 Commission. Speaker 100:01:26I would now like to turn the call over to Mr. Gorham. Dwight? Speaker 200:01:30Thank you, Steve. Good afternoon, everyone, and thank you for joining us For the IntelGenx Third Quarter 2023 Conference Call. On today's call, I will provide a corporate update and discuss the progress we've made Our key pipeline projects consistent with what we had previously committed to shareholders. Then Andre will review our financial results. Following that, we will open up the line for your questions. Speaker 200:01:58I will now update you on our key programs beginning with RIZAPORT. During the quarter, we received the 1st purchase order for RIZAFILM, the U. S. Market name for RIZAPORT from our U. S. Speaker 200:02:08Commercial partner Gensco Pharma. This represents a significant milestone for the company as it is our first purchase order for commercial supply of a pharmaceutical oral film. The purchase order triggered both an upfront order deposit payment as well as a pre specified milestone payment, both of which are reflected in our Q3 2023 financial results. We expect to ship the order of Riza Film products to Genesco in Q1 2024 For immediate launch to market, production of the Riza film is expected to commence in December 2023. Speaker 100:02:46Also, Axaltis, Speaker 200:02:49our partner for RIZAPORT in Spain, received This week, the regulatory approval to implement a new strategy that enables product substitution at the pharmacy level. Based on the positive feedback they received from prescribing doctors and patients, we believe Axaltic's new strategy will ultimately boost product sales. We are eager to see this new strategy implemented to increase product substitution at the pharmacy level and the corresponding increase in RIZAPORT sales in Spain. Turning to our bupinephrine buccal film program, Xyromed, the agent and affiliate of our co development partner Chemo Research Submitted to the FDA an amendment to the abbreviated new drug application requesting priority review. The FDA granted priority review with the Generic Drug User Fee Act or GDUFA goal date of March 8, 2024. Speaker 200:03:44However, if the agency determines an inspection is required, The GDUFA date is July 8, 2024. But given the March 2023 pre approval inspection of our facility And the subsequent approval of rizatriptan oral film, we are relatively confident that the FDA will decide to review this amendment without the need for an additional inspection. Now turning to our cannabis business, we are happy to have entered into a settlement agreement with Tilray. The settlement agreement includes a purchase order for 3 new product, CBD-twenty, THC-ten and a ten-ten combined CBD THC and was entered into concurrently with an amendment to our licensing and development and supply agreement with Tilray That renders the relationship nonexclusive for both parties. Clearly, this represents a new stage in our relationship with Tilray. Speaker 200:04:46However, we have worked hard this year to develop these 3 products and are looking forward to having them available to medical cannabis patients. Next, turning to Animal Health. We have discussed during the previous call that we are under discussions with a potential partner for an important development License agreement for an animal health product using our Vethafilm technology. These discussions are still ongoing And with the substantial progress we have made to date, we anticipate being able to announce this Animal Health Partnership later this year. Finally, with respect to our commercial activities, we expanded our CDMO offering by signing a binding term sheet For the packaging of a pharmaceutical oral film product that an undisclosed CDMO customer is planning to commercialize in the U. Speaker 200:05:39S. IntelGenx will package the product at our GMP manufacturing facility in Montreal. Moving on to R and D and specifically turning to our Montelukast program, we have completed enrollment of 52 patients in our Phase 2a Buna Clinical trial in patients with mild to moderate Alzheimer's disease. With the intention of efficiently achieving The program's goal, we've made a Health Canada authorized study design modification where we adjust the P value to less than 0.1. This modification enabled us to decrease enrollment while optimizing the power of the study to detect the effects of Montelukast Versafilm compared to placebo. Speaker 200:06:24We are looking forward to completing the BUNUS trial dosing in the Q1 of 2024 and to report initial trial results the following quarter. Additionally, manufacturing of both placebo and active Films are ongoing in preparation for a clinical study to investigate the use of montelukast Versafilm for the treatment of Parkinson's disease or PD. The multicenter, randomized, double blinded, placebo controlled trial We'll be conducted at the Karolinska University Hospital in collaboration with Principal Investigator, Doctor. Per Sievingsson, We will sponsor the study through a Swedish Research Council grant worth approximately $2,000,000 The planned study will assess the Montelukast 1st film as an alternate to the tablet form of Montelukast. We currently expect the study to commence in Q4 2023 with dosing to be initiated in Q1 2024 and we will provide more details on its design when they are available. Speaker 200:07:35Lastly, We also engaged an R and D customer to advance their product to commercial output and are proud to have secured the immediate albeit small revenue generating business. With that, I would like now to turn the call over to Andre for a review of our financial results. Andre? Speaker 300:07:55Thank you, Dwight. Good afternoon, everyone. As Dwight mentioned, I'll take a few minutes to discuss the company's financial performance For the Q3 ended September 30, 2023, the total revenues for the 2023 Q3 amounted to $318,000 compared to $142,000 in the same period last year. The change is mainly attributable to increase in R and D revenue of 128,000 And R and D milestone revenues of $125,000 Operating costs and expenses were $2,700,000 for Q3 2023 compared to $2,500,000 in the same period last year. For Q3 2023, the company had an operating loss of $2,400,000 consistent with Q3 2022. Speaker 300:09:01Adjusted EBITDA was negative $2,100,000 for Q3 2023 compared to negative $2,200,000 for the corresponding 3 month period of 2022. Our net comprehensive loss was $2,500,000 or $0.01 on a basic and diluted per share basis For Q3 2023, down from a net comprehensive loss of 3,000,000 or $0.02 per share for the comparable period of 2022. As at September 30, 2023, The company's cash and short term investments totaled $2,100,000 In August, Our parent company closed the 1st tranche of a non brokered private placement of units from Ittai Life Sciences For an aggregate gross proceeds of approximately US3 $1,000,000 including $750,000 in a subsequent the Thai subscription upon shareholders approval. We intend to use the proceeds of the offering to fund the formulation and development efforts related to our collaboration with Itai For working capital purposes and to cover costs related to the offering, IntelGenx We'll seek to obtain shareholders' approval at a special meeting of shareholders taking place on November 28, 2023. In addition to shareholders' approval, the offering is subject to final TSX approval and the satisfaction of customary closing conditions. Speaker 300:10:53I will now turn the call back to Dwight. Speaker 200:10:57Thanks, Andre. At this point, I'd like to review our track record of delivering on our promises. During the previous Q2 call, we indicated we would soon advance RIZAFILM in the U. S, which we have done in Q3. We also told investors that we are expecting to resolve the Tilray arbitration by the end of the year, which was also recently accomplished in an outcome that is favorable to both the company and its partner. Speaker 200:11:26Finally, We indicated that our partner Xyremend will respond to the latest CRL in a timely manner and such response was submitted in Q3. All of this to say, since joining IntelGenx as CEO, the company has kept its commitment to the investment community and executed on key programs in line with commitments made. We are looking forward to continue to execute and deliver on our upcoming milestones such as the signature of our Animal partnership in Q4 2023, the launch of RezaFilm in Q1 2024 and the Filming of the cannabinoid infused Versafilm order from Tilray. We are also looking forward to receiving the latest tranche of our recent financing in Q4, assuming we receive shareholder approval. I would like to end my introductory remarks by The fact that the progress we have made in our key projects has not opened the door within our R and D group for additional projects. Speaker 200:12:27We look forward to updating everyone on future calls on how we successfully capitalize on that. In closing, I'd like to once again recognize our team for executing our long term strategy and the team's commitment and focus on the company's transformation From solely an R and D organization into a full service R and D and commercial operation. 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 and A. Thank you. Operator00:13:03Thank you. At this time, we will be conducting a question and answer A confirmation tone will indicate your line is in the question We did have a question come from Hugh Kiley. Hugh is a Private Investor. Hugh, your line is live. Speaker 400:13:56Thank you, Duane and Andre for the update. Question on the RIZZIP film, The shipment is going to go in the Q4 2024 Q1, excuse me. Is there any idea, can you share that going to Pharmacies, hospitals, any light on the distribution and rollout plan Like CVS or anything like Speaker 200:14:24Yes, Hugh. This is Dwight. The product when it's shipped from our warehouse will be immediately available for shipment And CVS is a lead one of the customers. So they'll go to Gensco and Gensco has set that already in motion And they expect to have CVS as a large customer. Speaker 400:14:51That's good because I've seen on there, Dwight, I've seen it following this closely that was highlighted on the website. There's more info to come about arrival on their shelves. With the Gensco relationship, I know they have, I believe, I may hopefully I say it correctly, first right to China, is there any Thoughts of expanding that or is that just further down the road? More specifically, just wondering about other countries besides the U. S. Speaker 400:15:24And the Gensco. Speaker 300:15:29I can answer that if you want more. I mean, Telco is also looking at China. And I mean, We also have, obviously, Axaltis, distributing in Spain. Hopefully, the sales should pick up Based on what Dwight just mentioned and they're looking at others. Speaker 400:15:53Congratulations on getting that resolved, Andre. Congratulations with Excelsior is getting that shelving issue, resupply issue resolved. So regarding that one, is there Discussions underway, what countries in the EU would be next in line or they're just going to wait to see how Spain goes? Speaker 300:16:14I think in the first place, they will wait to see how Spain goes. But there has been discussion for EU countries in the past with Axeltis. So we'll see how that goes. But we also have discussion with other countries, But this is really preliminary in terms of discussion. But obviously, we are Fully aware how this RIZAPORT can be very successful. Speaker 300:16:45It's the first migraine film In the U. S, and it will be in other countries. So, I think we're very excited about this launch. And we're definitely ongoing discussion for other countries. Speaker 200:17:00Hey, Dave. It's Dwight back in line. Sorry, I got Cut off. We definitely, as late as 2 weeks ago, were speaking with Exaltis about Monitoring progress in Spain and looking to move that into other large markets in the EU Adjacent directly adjacent to Spain. Speaker 400:17:25Okay. That's good. And lastly, with the FDA and the pediatric risofilm, is that still is that ways off to be developed? Do you see that In the first half of next year, the end of the year or for the year or the one at the end? Speaker 200:17:45That is in development And we have studies to do, so it's not likely to be part of the sales line in 2024. It's more likely a 2025 line item. Speaker 400:17:57Okay. And then the new products that were introduced with Tilray, I know from a prior call, I was talking to Tommy, there was a lot of development effort for cannabis, cannabis THC and whatever other products are. Do you see those last call, there was some, let's say, less excitement of the cannabis market. Do you think Those who have an attractive feel in the marketplace with Tilray? Speaker 200:18:27I think that's an open question here. Speaker 500:18:30I mean, Speaker 200:18:30we all know that the cannabis market has been problematic for most. This is medical cannabis. So the limitations will be a little bit more will be a little tighter. And I think it's a wait and see. The good news is We're making commercial product. Speaker 200:18:48The commercial product is going to market. So there's some return on that investment. And they are Very clear that they expect that they'll make some traction with this, although I would say cautiously optimistic Would be the expression I would use. Speaker 400:19:08And I was just wondering with their prior arrangement with Raptidose, is that Still active as a competitor or is it basically aligned with IntelGenx? I don't know if you're allowed to say that, but Yes. Speaker 300:19:24Hugh, these are rapidly. They're dealing with us now. Speaker 400:19:29Okay. Thank you, Andrei. Speaker 600:19:31Thanks, Andrei. Speaker 400:19:33No, thank you for that. And on the I didn't get on I got on a little late there, Dwight. On the CDMO, This is the contract that was revealed before. Is it close to being finalized? I know you got the binding term sheet and some other Issues to work out resolve to both companies' satisfactory expectations, would that be done in Q4 or is that going to 2024? Speaker 200:20:00That will likely be early in 2024, It's not stopped us from progressing. The machine parts, which are the critical path items, are on order and they're Subject to the vagrancies of some of the subcontractors, but are expected to be in January. And we will then start doing Line trials, etcetera, to get the line commissioned and run stability lots. So the Definitive agreement, I suspect, will be completed sometime in Q1 'twenty four. Speaker 400:20:35Okay. That's Good answer Dwight. And I was going to ask you about And any of the other products like the Dsyntek or Transdermal before I bring up Vetafilm, was any of those Have any potential interest in the marketplace with new partners? Speaker 200:20:58Our focus and our conversations have all been on the Speaker 400:21:06Okay. And then the did you say you have potentially one partner For Vetafilm, is there any behind that, the first company that you may be able to bring to a conclusion with a contract? There is just one for the present time for Vetafilm. Speaker 200:21:25It's one, but there are other conversations on other Pharmaceutical ingredients that might be good targets for conversion From the current dosing regime to Vitafil. Speaker 400:21:42All right. And one last question Speaker 200:21:44on that. Those are early conversations. Yes. Speaker 400:21:47Okay. No, accept that. And on the discussions, prior calls we had With the status of the power product maybe being the power partnership being replaced, Is that still on hold with the Endo bankruptcy? Or is that a potential future product that could be news on? Speaker 200:22:12I would say the latter potential product that you may get news on. There's discussions, but they're in early stages. Speaker 400:22:21Okay. Thank you. I'll go into the I'll go back into the queue. Thank you, Dwight and Andre. Speaker 200:22:27Yes, my apologies for getting cut off. Operator00:22:32Thank you. The next question is coming from Abraham Shapiro. Abraham is a Private Investor. Speaker 700:22:38Good afternoon, everybody. Andre Horace, please. I got the Tilray order. I didn't hear any revenue numbers. What kind of revenue We expecting is IntelGen is expecting from that initial order? Speaker 200:22:57The initial order It's for $400,000 Speaker 700:23:09$400,000 All right. Speaker 200:23:13That's just an initial order. Speaker 700:23:15That's what kind of revenue. Okay. Being that it's a medical product, is it allowed to export to the United States? Speaker 300:23:30No, they cannot. Speaker 200:23:33They cannot. They cannot. And in general, exports to the U. S. Are still problematic on cannabinoids. Speaker 700:23:43Okay. I thought perhaps because it was a medical that might be a little lesser. So Other than that, it's high financing. It's always my concern that you guys won't get you need to get to the finish line, you get it so close. What other revenue, borrowing, financing do you have in line, If Speaker 200:24:10there any? Andre, can Speaker 300:24:12you take that one? Yes. We're looking at multiple options, There is another 750,000 coming in on November 28 Upon shareholders' approval and based on what we know or see At this point, we will get that money. There is also other revenue That might come in, in 2023 that we cannot really be specific on, but that are most likely to happen. But having said that, there is always Options that we're looking at to fund or well capitalize the company, but we are always And always been and always will be very concerned about dilution. Speaker 300:25:15So we're trying to find Way so that the dilution is not too dramatic, But there is I wouldn't be worried. I think that we have money And we'll find the money like we always did to make sure that all our programs are Launch as expected and that we're getting new programs in and new programs approved in order to generate Operator00:25:52revenue. All Speaker 700:25:53right. Thanks. Congratulations. It looked like To me, it looks like the utility settlement was a good settlement. It took a long time and moving along. Speaker 700:26:04And I'm a long time shareholder and I'm waiting for the price to reflect all these great things going on. So Thank you. Speaker 300:26:16Thank you, Ed. Operator00:26:19Thank you. The next question is coming from Brandt Dike. Brent is a Private Investor. Brent, your line Speaker 800:26:28is open. Speaker 900:26:28Yes. Good afternoon, guys. So the first CDMO contract that you all have, that's just the term sheet signed right now? Or do you all have Is that a contract signed and ready to go? Or when do you expect that to be done, revenue Speaker 200:26:52That is a binding term sheet that is signed. The definitive agreement, As I told Hugh, it's expected to be in the Q1 of 'twenty four. There's some Registration work to be done and it should be late 'twenty four, early 'twenty five revenue. Speaker 900:27:16Okay. And what about I think on the last call, you all had mentioned a second deal would be coming soon. Is that still the case? And if so, When do you expect that? Speaker 200:27:32I don't recall what was said in the last I'm sorry, my age is getting to me, I guess. However, at this point, I don't see another CDMO customer on the horizon. I see FDA Approvals for Riza and I see a lot of volume coming with Riza and I see bupinephrine going to Come out of the FDA. Okay. And those are the major events I see in the next 6 to 9 months. Speaker 900:28:09Okay. And as far as Itay, I believe the press release had indicated that Their shares would be at $0.18 Is that going to be the case even if when this gets approved, if we're at 11 or 12 or 13, is it still going to be 18? Speaker 300:28:31On the You want to yield that one, please? Yes. It's going to be $0.185 for their current that's the conversion price on their convertible note And the warrant that is attached to it is $0.26 and that won't change. Speaker 900:28:53Okay. Okay. Thank you, guys. Speaker 300:28:56Thank you. Speaker 400:29:25Operator? Speaker 300:29:32Thank you, operator. Operator00:29:36The next question is coming from Bobby Zanetti, Please provide an Speaker 200:29:40update. Speaker 500:29:42Yes. Hi. Good afternoon, gentlemen. First of all, I'd like to congratulate you on all the accomplishments for this quarter. It's really nice to see that Antoniax is moving forward at a very fast pace. Speaker 500:29:54So congrats on that. My first question In regards to the Atay Life Sciences announcing the filing of an early warning report on October 10, Could you shed some light on that with them owning 66% shares in the company? Speaker 300:30:16Dwight, do you want me to answer this one? Speaker 200:30:19Yes, please do. Speaker 300:30:21Yes. This is the it's kind of unfortunate, but this number is wrong to start with. But, Atai owns 21% of the company, and that's the fact. And they could potentially, at some point, own more than 50%, So anywhere between 50% 60%. But to get there, they would have to invest about $30,000,000 $35,000,000 So the reality is they own 21%. Speaker 300:31:03And As long as they don't invest any further money into IntelGenx, it will remain at 21%. Speaker 500:31:14Okay. Okay. And the other question that I have is in regards to the settlements with Hilary, a lot of investors were anticipating a payout for you guys. Was there a payout on the table or a partnership deal? Or was it only a partnership deal with amendment of the other part of the deal concerning exclusivity? Speaker 600:31:39Do you want me to take that, Dwight? Speaker 200:31:42We should be there. Speaker 600:31:45Hi, it's Tommy here. Unfortunately, settlement discussions are confidential and it's not something that we can bring up. I can just tell you that the outcome is probably the best thing Both company could have expected. We're moving forward as partners, and we're hoping that the future will bring additional product. But at least right now, there are 3 products and we're hoping that this will be a continuing product. Speaker 600:32:09They have told us that their patients are expecting those products. So there is some expectation there. Okay. Speaker 500:32:16And just to clarify, Andre, you had mentioned that there are ties with rapid dose. There is no manufacturing by rapid dose for Tilray as far as the film goes? Speaker 600:32:26As far as we're informed that's the case, but again, the agreement is non exclusive. We believe they will Get the film from us, but it's the same thing with us. If we want to Speaker 300:32:35sell to someone else, we're authorized right now. Speaker 500:32:38Okay. And are there any other companies like from the big Players that have approached you in regards to the CBD or THC products? Speaker 600:32:48At this point, we haven't shopped anything around because we were in litigation. The game has significantly changed now that this is open to us to market if we see an opportunity. So At this point, we were not entertaining any discussion with the current partner in Canada. Speaker 200:33:04Yes. This agreement was just signed. And we will we have activated our sales department and marketing department to Take a look at other potential targets for these products. Speaker 500:33:18Okay. And just I wanted to ask about the launch of these products or when they will be Possibly delivered to Tilray and distributed to the patients. Do you have like some sort of like a timeframe? Is it going to be Q1 of 2024 or this year? Speaker 200:33:38No. Well, based on The orderly times of the base for raw materials, it will be early Q2. Speaker 500:33:45Okay. All right. And going to the buprenorphine, you said March 8 Was the GDUFA day, correct? Speaker 200:34:00Provided that they don't push a facility inspection, yes. Speaker 500:34:04For inspection, okay. So when are we expecting if, God willing, you get the approval on March 8, when are we expecting this product to be launched? Speaker 200:34:22Yes, I mean, it's Donnie here. Speaker 600:34:24There is ongoing litigation with the product. So I mean, we cannot make any statement as to when the product will be available because it We'll depend on when we get the court date and we get in front of the judge. Unfortunately, this is the situation. We're looking forward to approval and we'll push as much as we can Get the product as soon as possible to the market. Speaker 500:34:44Okay. And is there any milestone payment that IntelGenius will be receiving upon approval? Speaker 600:34:50Yes, there is one milestone upon approval. Speaker 500:34:53Okay. And can you shed light on like is it like a 6 figure or? Speaker 600:34:59Low 6 figure. Speaker 500:35:01Okay. All right. That's all for me, gentlemen. And again, congratulations to you guys and the whole team. God bless. Speaker 200:35:08Thank you. Operator00:35:11Thank you. And the next question we had was Hugh Kiley with a follow-up. Hugh, your line is live. Speaker 400:35:17Okay. Thank you. And I apologize, Dwight, Andre and Doctor. Dhirby and Tommy for and Frank for not congratulating on their Great progress with the company so far in 2023. I have a question with the tires, any other programs in the work Besides the one that's moving right along, any new molecules that they're interesting having Your company or our company developed for them? Speaker 200:35:50We're Really focused on getting their clinical Phase 2 work done for them. As recently as 2 weeks ago, I had extended conversations with their CEO in Berlin. And at this point, it's a focus on what we've got on the table, Although nothing has been ruled out. Speaker 400:36:10Okay. And as a follow on to that, would Your business development team is evaluating different molecules. Is there anything in The background that's being worked and developed that we could learn news on that it may be attractive for the oral film market? Speaker 200:36:31I think I said that we've reached we've opened up some space in the R and D area. We're looking to capitalize on that. And as soon as we've got that nailed down, I would love to be able to share that Okay. With the shareholders. But it's premature for me to say right now. Speaker 400:36:51Yes. Okay. And I accept it, Dwight. Thank you. And last question last two questions is, with the progress of Montelukastin soon With the Parkinson's study over there in Sweden, any potential partners on the horizon for either one of those programs? Speaker 400:37:10I know I ask at Speaker 200:37:17Well, there's certainly Doctor. Zuber and I had a lot of conversations at the recent trade show with several potential partners. But everything comes down to getting the readout in the Q2. Okay. If the readout is good, then I don't think there's a lack of partners. Speaker 400:37:38Okay. That's a good answer. And then that would be the same for both products or just the Alzheimer's film? Speaker 200:37:50I don't think I think if the data is good on all of them, then there's partners to be had. The first one will be the Alzheimer's. Okay. Speaker 400:38:00And it wasn't brought up in the call, but I'll ask is Any update on the progress on tadalafil? Speaker 200:38:09Yes. So, Alastair is excuse me, we are we've got the last of The development work understood and we're back on track for with that to Complete the work we need to move forward probably within the next 3 to 6 months. Okay. And that's not commercial, but there's other project milestones in there. Speaker 400:38:41Yes. That's a good report. All right. That takes care of my questions, White, Frank, Condrey, and Doctor. Zerbe. Speaker 400:38:49And If I missed anyone else, I apologize. Speaker 200:38:56Thank you. All the gentlemen, both in Amin Speaker 100:38:59as well. Speaker 400:39:01One question I did sorry, this one. In the past, there have been research reports about The progress of the company and investors research report, is there anything in there with your discussion with investors, any research Which houses, they may issue a report with the success of the approval of RIZAPORT and the other progress the company is being made has made. Speaker 200:39:29To my knowledge, at this point, no. Would we like to engage with that? The answer would be yes. Speaker 400:39:37Okay. All right. Thank you, Dwight. Thank you. Operator00:39:44Thank you. The next question is a follow-up coming from Brent Caike. Brent, your line is live. Speaker 900:39:57Yes. Do you all expect or have any indication that Tilray will put out any communication, press release or anything on these three products? Speaker 200:40:09Tommy, can you answer that one? Speaker 600:40:12I mean, they will probably if they issue anything, they will probably only Upon receiving the product because they don't want to create expectations from their patient or customer before the product is actually available. Speaker 900:40:27Okay. And if the share price continues to wane down where it is now, do you all have any Indication or idea if Atay would purchase shares on the open market? Speaker 300:40:44I can answer that. I think that Itay has warrants and available. I doubt that their business model allow them to purchase shares on the open market. But like they could bring in money by exercising Speaker 500:41:13either more Speaker 300:41:16Convert that they have or warrants that they have, but they are there to support us. Obviously, they as you Probably know they have supported us through a term loan as well. But one of the objectives of the company with all the Execution that has taken place the last 6 months and that continues towards 2024 We'll be out there road showing. I just came back from a road show in South Florida, and that will continue. So Unfortunately, small cap has been hit quite a bit in the market, especially life science. Speaker 300:42:01But as long as we execute on our business plan And that we get closer and closer to being commercial, I think that the stock price will reflect that at some point In 2024, I'm not worried. Speaker 900:42:21Okay. Thank you. Operator00:42:27Thank you. And the next question is going to be from David Nain, who is a Private Investor. David, your line is live. Speaker 800:42:36Thank you. Gentlemen, thank you for the update and your progress. It's good to see that Real progress is being made. But being that said, we have a couple of products that have already been approved in various countries, including the United States. And I think it's fair to say Speaker 500:42:53that there have been some hiccups Speaker 800:42:54in commercialization. Moving forward with Montelukast being probably the jewel of the company, are there any basic Criteria for choosing a commercialization partner because God willing, that drug gets approved for AZ and maybe PD, What is the criteria for choosing a commercialization partner? Because obviously with prior approved products, we haven't seen real revenues from that. Speaker 200:43:25That's a great question. Thank you very much. From a criteria perspective, I think if the Monti hits, There will be much more mature companies, much larger scale companies involved In the bidding for the product, and certainly, some of the criteria will be scale, Others will be international reach and others will be specifically focused to reach into the U. S. And to Europe. Speaker 200:44:00So for me, it's mostly going to be scale and size of the enterprise to make this happen. With some of the other products, we were we had partners and they were we didn't quite understand Some of the logistics associated with holding their hands to get to market, and that's been cleared up, and I think we've fixed that. And if Monty hits, I don't think there's a lack of partners. It will be significantly into their choosing and scale and the credibility organization will be key attributes we look at. Speaker 800:44:41I appreciate that answer there. I just hope that the company I know you've only been here for a short time, but I just hope the company can learn from the missteps With already approved drugs and maybe make the next few drugs that we get approved huge successes. So thank you for your time. Speaker 200:44:58Thank you as well for the question. Thank you. Operator00:45:10And we would now like to hand the call back to Mr. Gorham for closing remarks. Speaker 200:45:21Yes. Thank you very much. Well, this concludes our Q3 2023 investor call. I'd once again like to thank the entire IntelGenx team for its hard work and dedication, Our Board of Directors for the continued support of the management team and finally, our investors for your continued belief in and supporting us. The quality of the questions was excellent today. Speaker 200:45:45Thank you very much. Thank you and goodbye. Thank you. This does conclude today's conference call. You may disconnect your phone lines at this time andRead morePowered by