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Earnings call: IntelGenx reports Q3 2023 results, announces new partnerships and upcoming product launches

EditorPollock Mondal
Published 10/11/2023, 11:08
© Reuters.

IntelGenx Corp. recently held its Q3 2023 conference call, during which it revealed a series of significant developments, including new partnerships, upcoming product launches, and regulatory approvals. The pharmaceutical company received its first purchase order for RIZAFILM from Gensco Pharma, triggering an upfront payment and a milestone payment. The shipment of the product is expected in Q1 2024. The company is also in discussions for an animal health partnership to be announced later this year. IntelGenx reported total revenues of $318,000 for Q3 2023, with an operating loss of $2.4 million.

Key takeaways from the call include:

  • First purchase order for RIZAFILM from Gensco Pharma, with shipment expected in Q1 2024.
  • A priority review from the FDA for the Buprenorphine Buccal Film program, with a goal date of March 8, 2024.
  • A settlement agreement with Tilray (NASDAQ:TLRY), including a purchase order for three new product offerings.
  • Expansion of the CDMO offering and engagement with an R&D customer.
  • Progress on R&D programs, including completion of enrollment for the Phase 2a BUENA clinical trial.
  • A private placement of units from atai Life Sciences for $3 million.

IntelGenx also highlighted its partnership with Exeltis, which received regulatory approval in Spain for a new strategy to boost sales of RIZAPORT. The company is also in discussions with Gensco for RIZAFILM distribution in China and Exeltis for distribution in Spain. IntelGenx noted that pediatric RIZAFILM is still in development, with expected availability in 2025.

The company also revealed it had entered a settlement agreement with Tilray, which included a purchase order for three new product offerings. An initial order of $400,000 has been placed, and the settlement was described as a positive outcome that allows for a partnership and potential future products.

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IntelGenx also discussed the support from investors, including a term loan and a significant investment from atai Life Sciences, which currently owns 21% of IntelGenx. The company indicated that atai Life Sciences could potentially own more than 50% with further investment.

IntelGenx CEO Dwight Gorham expressed confidence in the company's future, stating that executing their business plan and moving closer to commercialization would positively impact the stock price in 2024. He also acknowledged past missteps with approved drugs and expressed the hope that future approvals would be successful. The call concluded with Gorham expressing gratitude to the IntelGenx team, board, and investors for their support.

InvestingPro Insights

According to the latest data from InvestingPro, IntelGenx Corp. (IGXT (OTC:IGXT)) has a market capitalization of $29.34 million. The company's P/E ratio stands at -2.07, reflecting its recent lack of profitability. This is further underscored by a P/E ratio of -2.61 for the last twelve months as of Q2 2023. However, the company's revenue for the same period was $0.61 million, indicating some level of financial activity despite the challenges.

The InvestingPro Tips suggest that the company's net income is expected to grow this year, and analysts anticipate sales growth in the current year. These predictions align with the company's recent announcements of new partnerships and upcoming product launches. However, it's important to note that the company has been quickly burning through cash, and its stock has taken a big hit over the last week.

InvestingPro's comprehensive platform offers numerous additional tips and insights for investors interested in IGXT. With more than 10 additional tips available, users can gain a deeper understanding of the company's financial health and potential investment risks and rewards.

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Full transcript - IGXT Q3 2023:

Operator: Greetings. 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. [Operator Instructions] Please note this call is being recorded. I will now turn the conference over to your host Stephen Kilmer, Investor Relations at IntelGenx. You may begin.

Stephen Kilmer: 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. 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 all that amounts mentioned today are in U.S. 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 U.S. and Canadian securities laws. A number of assumptions were made by us in preparing these forward-looking statements, which are subject to risks and results may differ materially. Details on these risks and assumptions can be found in our filings with the U.S. and Canadian Securities Commissions. I would now like to turn the call over to Mr. Gorham. Dwight?

Dwight Gorham: Thank 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 on 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. I will now update you on our key programs beginning with RIZAPORT. During the quarter, we received the first purchase order for RIZAFILM, the U.S. market name for RIZAPORT, from our U.S. commercial 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 to RIZAFILM product to Gensco in Q1 2024 for immediate launch to market. Production of the RIZAFILM is expected to commence in December 2023. Also Exeltis, our 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 Exeltis 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 Buprenorphine Buccal Film program, Xiromed, 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 a Generic Drug User Fee Act or GDUFA goal date of March 8, 2024. However, if the agency determines that an inspection is required, the GDUFA date is July 8, 2024. But given the March 2023 preapproval 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 three new product CBD20, THC10, and a 10:10 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 non-exclusive for both parties. Clearly, this represents a new stage in our relationship with Tilray. However, we have worked hard this year to develop these three 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 and license agreement for an animal health product using our VetaFilm 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.S. IntelGenx will package the product at our GMP manufacturing facility in Montreal. Moving on to R&D, and specifically turning to our Montelukast program. We have completed enrollment of 52 patients in our Phase 2a BUENA 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. We are looking forward to completing the BUENA trial dosing in the first quarter 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 multi-center, randomized, double-blinded, placebo-controlled trial will be conducted at the Karolinska University Hospital in collaboration with principal investigator Dr. Per Svenningsson, who will sponsor the study through a Swedish Research Council grant worth approximately US$2 million USD. The planned study will assess Montelukast VersaFilm 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. Lastly, we also engaged an R&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?

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Andre Godin: Thank you, Dwight. Good afternoon, everyone. As Dwight mentioned, I’ll take a few minutes to discuss the company’s financial performance for the third quarter ended September 30, 2023. The total revenues for the 2023 third quarter amounted to $318,000 compared to $142,000 in the same period last year. The change is mainly attributable to increase in R&D revenue of $128,000 and R&D milestone revenues of $125,000. Operating costs and expenses were $2.7 million for Q3 2023 compared to $2.5 million in the same period last year. For Q3 2023, the company had an operating loss of $2.4 million, consistent with Q3 2022. Adjusted EBITDA was negative $2.1 million for Q3 2023 compared to negative $2.2 million for the corresponding three-month period of 2022. Our net comprehensive loss was $2.5 million or $0.01 on a basic and diluted per share basis for Q3 2023, down from a net comprehensive loss of $3 million or $0.02 per share for the comparable period of 2022. As of September 30, 2023, the company’s cash and short-term investment totaled $2.1 million. In August, our parent company closed the first tranche of a non-broker private placement of units from atai Life Sciences for an aggregate gross proceeds of approximately US$3 million, including 750,000 in a subsequent atai subscription upon shareholders approval. We intend to use the proceed of the offering to fund the formulation and development efforts related to our collaboration with atai for working capital purposes and to cover costs related to the offering. IntelGenx will 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. I will now turn the call back to Dwight.

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Dwight Gorham: Thanks, 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. Finally, we indicated that our partner Xiromed would respond to the latest CRL in a timely manner, and such response was submitted in Q3. All of this to say, since joining IntelGenx’s 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 health partnership in Q4 2023, the launch of RIZAFILM in Q1 2024, and the fulfillment of the cannabid 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 highlighting the fact that the progress we have made in our key projects has opened the door within our R&D Group for additional projects. We 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&D organization into a full service R&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&A. Thank you.

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Operator: Thank you. At this time, we will be conducting a question-and-answer session. [Operator Instructions] We did have a question come from Hugh Kelly. Hugh is a private investor. Hugh, your line is live.

Hugh Kelly: Thank you. Thank you, Dwight and Andre for the update. Question on the RIZAFILM, the shipment is going to go in the fourth quarter 2024 – first quarter, excuse me. Is that any idea? Can you share? Is that going to pharmacies, hospitals or any light on the distribution and rollout plan like CVS or anything like that.

Dwight Gorham: Yes, 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 it’ll go to Gensco and Gensco has set that already in motion and they expect to have CVS as a large customer.

Hugh Kelly: That’s good, because I’ve seen on there, Dwight has seen it following this closely. It 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 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. under Gensco?

Andre Godin: I can answer that if you want. I mean, Gensco is also looking at China. And I mean, we also have obviously Exeltis distributing in Spain. Hopefully, the sales should pick up based on what Dwight just mentioned and they’re looking at…

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Hugh Kelly: Congratulations on getting that resolve, Andre, congratulations with Exeltis getting that shelving issue, resupply issue resolved. So regarding that one, is there discussions on the way? What countries in the EU would be next in line or they’re just going to wait to see how Spain goes?

Andre Godin: I 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 exeltis, 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 RIZAFILM or RIZAPORT can be very successful. It’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.

Dwight Gorham: Yes, it’s Dwight back online. I’m sorry, I got cut off. We definitely as late as two weeks ago were speaking with exeltis about monitoring progress in Spain and looking to move that into other large markets in the EU, directly adjacent to Spain.

Hugh Kelly: Okay, that’s good. Last thing with the FDA and the pediatric RIZAFILM, is that still – is that ways off to be developed or do you see that in first half of next year, the end of the year or for the one of the year.

Andre Godin: That 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 25 line item.

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Hugh Kelly: Okay. And then the new products that were introduced with Tilray, I know from a prior call 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 less excitement of the cannabis market. Do you think those will have an attractive peel in the marketplace with Tilray?

Andre Godin: I think that’s an open question, Hugh. I mean, we 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. The 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.

Hugh Kelly: And I was just wondering with their prior arrangement with rapid dose, 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 I track these…

Andre Godin: Hugh, they did drop rapid though, they’re dealing with us now.

Hugh Kelly: Okay, thank you, Andre. No, thank you for that. I didn’t get 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 resolved to both companies satisfactory expectations. Would that be done in Q4 or that go into 2024?

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Dwight Gorham: That’ll likely be early in 2024, Hugh. It’s not stopped us from progressing. The machine parts, which are the critical path item 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, et cetera, to get the line commissioned and run stability lots. So the definitive agreement I suspect will be completed sometime in Q1 2024.

Hugh Kelly: Okay, that’s a good answer, Dwight. And I was going to ask you about on the other products like that, DisinteQ or transdermal, before I bring up VetaFilm, does any of those – have any potential interest in the marketplace with new partners?

Dwight Gorham: Our focus and our conversations have all been on the film products, not transdermal.

Hugh Kelly: Okay. And then would 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 conclusion with a contract or is it just one for the present time for VetaFilm?

Dwight Gorham: It’s one. But there are other conversations on other pharmaceutical ingredients that might be good targets for conversion from the current dosing regime to VetaFilm.

Hugh Kelly: All right, one last question.

Dwight Gorham: Those are early conversations.

Hugh Kelly: Yes. Okay. No, I accept that. The discussions prior calls we had with the status of the power product, maybe the partner – 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?

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Dwight Gorham: I would say, the latter potential product that you may get news on. There’s discussions, but they’re in early stages.

Hugh Kelly: Okay, thank you. I’ll go back into the queue. Thank you, Dwight and Andre.

Dwight Gorham: Yes. My apologies for getting cut off, Hugh.

Operator: Thank you. The next question is coming from Abraham Shapiro [ph]. Abraham is a private investor.

Unidentified Analyst: Good afternoon, everybody, Andre, Horst, Dwight. I got the Tilray order. I didn’t hear any revenue numbers. What kind of revenue we expecting? Is IntelGenx expecting from that initial order?

Dwight Gorham: Okay, go ahead.

Andre Godin: The initial order is for $400,000.

Unidentified Analyst: $400,000. All right.

Andre Godin: That’s just an initial order.

Unidentified Analyst: That’s what kind of revenue. Okay. Being that it’s a medical product, is it allowed to export to the United States?

Andre Godin: No, they cannot.

Dwight Gorham: They cannot. And in general, exports to the U.S. are still problematic on cannabis.

Unidentified Analyst: Okay. I thought perhaps because it was a medical that might be a little lesser. So other than that, it’s high finance. It’s always my concern that you guys won’t get to the finish line. You’re getting so close. What other revenue borrowing, financing, do you have in line, if any?

Dwight Gorham: Andre, can you take that one?

Andre Godin: 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’s also other revenue that might come 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 been and always will be very concerned about dilution. So we’re trying to find ways so that the dilution is not too dramatic. But there’s – 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 launched as expected and that we’re getting new programs in and new programs approved in order to generate revenue.

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Unidentified Analyst: All right, thanks. Congratulations. To me, it looked like the Tilray’s settlement was a good settlement. It took a long time and moving along and I’m a longtime shareholder and I’m waiting for the price to reflect all these great things going on. So thank you.

Andre Godin: Thank you.

Operator: Thank you. The next question is coming from Brent Geikie [ph]. Brent is a private investor. Brent, your line is live.

Unidentified Analyst: Yes. Good afternoon, guys. So the first CDMO contract that you’ll have – that’s just a 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 to come in on that?

Andre Godin: That is a binding term sheet that is signed. The definitive agreement, as I told Hugh, is expected to be in the first quarter of 2024. There’s some registration work to be done and it should be late 2024, early 2025 revenue.

Unidentified Analyst: Okay. 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?

Dwight Gorham: I don’t recall what was said in the last meeting. So 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 Buprenorphine going to come out of the FDA. And those are the major events I see in the next six to nine months.

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Unidentified Analyst: Okay. And as far as atai, 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 $0.11 or $0.12 or $0.13, is it still going to be $0.18?

Andre Godin: Yes, it’s going to be $0.185 for – that’s the conversion price on their convertible note. And the warrant that is attached to it is US$0.26 and that won’t change.

Unidentified Analyst: Okay, thank you guys.

Andre Godin: Thank you.

Dwight Gorham: Operator?

Operator: Yes. Apologies, I lost my line for a moment. The next question is coming from Bobby Zanetti [ph], who’s a private investor.

Unidentified Analyst: Yes, 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 IntelGenx is moving forward at a very fast pace. So congrats on that. My first question is in regards to the atai 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?

Andre Godin: Dwight, you want me to answer this one?

Dwight Gorham: Yes, please do.

Andre Godin: Yes. 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 a fact. And they could potentially at some point own more than 50%. So anywhere between 50% and 60%. But to get there, they would have to invest about $30 million, $35 million. So the reality is they own 21%. And as long as they don’t invest any further money into IntelGenx, it will remain at 21%.

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Unidentified Analyst: Okay. Okay. And the other question that I have is, in regards to the settlement with Tilray, 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?

Tommy Kenny: Do you want me to take that, Dwight?

Dwight Gorham: Yes.

Tommy Kenny: Hi, 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 three products and we’re hoping that this will be a continuing product. They have told us that their patients are expecting those products. So there is some expectation there.

Unidentified Analyst: Okay. And just to clarify, Andre, you had mentioned that their atai’s with rapid dose, there is no manufacturing by rapid dose for Tilray as far as the film goes.

Andre Godin: Yes.

Tommy Kenny: As 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 sell to someone else, we’re authorized right now.

Unidentified Analyst: Okay. And are there any other companies like from the big players that have approached you in regards to the CBD or THC products?

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Tommy Kenny: At 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.

Dwight Gorham: Yes. This agreement was just signed. And we’ve activated our sales department and marketing department to take a look at other potential targets for these products.

Unidentified Analyst: Okay. 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 time frame? Is it going to be Q1 of 2024 or this year?

Dwight Gorham: No. Well, based on the orderly times of the base for all materials, it’ll be early Q2.

Unidentified Analyst: Okay. All right. And going to the Buprenorphine, you said March 8 was the GDUFA date, correct?

Dwight Gorham: Provided that they don’t push a facility inspection. Yes.

Unidentified Analyst: For an 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?

Tommy Kenny: I can take that, Dwight.

Dwight Gorham: Yes. Go ahead, Tommy.

Tommy Kenny: Yes. I mean, it’s Tommy here. There is ongoing litigation with the product. So I mean, we cannot make any statement as to when the product will be available because it will depend on when we get the court date and we get in front of a judge. Unfortunately, this is the situation. We’re looking forward to approval, and we’ll push as much as we can to get the product as soon as possible to the market.

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Unidentified Analyst: Okay. And is there any milestone payment that IntelGenx will be receiving upon approval?

Tommy Kenny: Yes. There is one milestone upon approval.

Unidentified Analyst: Okay. And can you shed light on like is it like a six figure or…?

Tommy Kenny: Low six figure.

Unidentified Analyst: Okay. All right. That’s all for me, gentlemen. And again, congratulations to you guys and the whole team. God bless.

Dwight Gorham: Thank you.

Operator: Thank you. And the next question we had was Hugh Kelly with a follow-up. Hugh, your line is live.

Hugh Kelly: Okay. Thank you. And I apologize, Dwight, Andre, and Dr. Zerbe, and Tommy, for and Frank for not congratulating on their great progress with the company so far in 2023. I have a question with atai’s, any other programs in the work besides the one that’s moving right along? Any new molecules that they’re interested in having your company, our company, develop for them?

Dwight Gorham: We’re really focused on getting their clinical Phase 2 work done for them. As recently as two 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’s been ruled out.

Hugh Kelly: Okay. And is it follow on to that with the your business development team evaluating different molecules? Is there anything in the background that’s being worked on developed that we could learn news on that may be attractive for the oral film market?

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Dwight Gorham: I think I said that we’ve reached – we’ve opened up some space in the R&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 with the shareholders, but it’s premature for me to say right now.

Hugh Kelly: Yes. Okay, I accept that. Thank you. And last question, last two questions. Is – with the progress of Montelukast and soon with the Parkinson study over there in Sweden, any potential partners on the horizon for either one of those programs? I know I ask at every conference call, but always got an keen eye out for that.

Dwight Gorham: Well, there’s certainly Dr. Zerbe and I had a lot of conversations at the recent trade show we were at with several potential partners. But everything comes down to getting the readout in the second quarter. If the readout is good, then I don’t think there’s a lack of partners.

Hugh Kelly: Okay. That’s a good answer. And then that would be the same for both products or just the Alzheimer’s film?

Dwight Gorham: I 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 though.

Hugh Kelly: Okay. And it wasn’t brought up on [indiscernible] but I’ll ask, is any update on the progress on Tadalafil?

Dwight Gorham: Yes. Tadalafil is – excuse me. We’re – we’ve got the lots 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 three months to six months.

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Hugh Kelly: Okay.

Dwight Gorham: And that’s not commercial, but there’s other project milestones in there.

Hugh Kelly: Yes. That’s a good report. All right. That takes care of my questions. Dwight, Frank, Andre and Dr. Zerbe and if I missed anyone else, I apologize.

Dwight Gorham: Well, [indiscernible] as well. Yes.

Hugh Kelly: One question, I did – sorry, this one. In the past, there’s 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 houses that may issue a report with the success of the approval of RIZAPORT and the other progress the company has made?

Dwight Gorham: To my knowledge at this point you know, would we like to engage with that? The answer would be yes.

Hugh Kelly: Okay. All right. Thank you, Dwight. Thank you.

Operator: Thank you. [Operator Instructions] The next question is a follow-up coming from Brent Geikie [ph]. Brent, your line is live.

Unidentified Analyst: Yes. Do you all expect or have any indication that Tilray will put out any communication, press release or anything on these three products.

Dwight Gorham: Tommy, can you answer that one?

Tommy Kenny: I mean they will probably – if they issue anything, they will probably only issue it upon receiving the product because they don’t want to create expectation from their patient or customer before the product is actually available.

Unidentified Analyst: Okay. And if the share price continues to wane down where it is now, do you all have any indication or idea if atai would purchase shares on the open market?

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Andre Godin: I can answer that. I think that atai has warrants and available. I doubt that their business model allow them to purchase shares on the open market, but they could bring in money by exercising either more convert that they have or warrants that they have. But they are there to support us. Obviously, the – 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 six months and that continues towards 2024 will 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. But 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.

Unidentified Analyst: Okay. Thank you.

Operator: Thank you. And the next question is going to be from David Nguyen, who’s a Private Investor. David, your line is live.

David Nguyen: Thank 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 that there’s been some hiccups in 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.

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Dwight Gorham: That’s a great question. Thank you very much. The – from a criteria perspective, I think if the Monte [ph] hits, there’ll 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. So for me, it’s mostly going to be scale and size to the enterprise to make this happen. With some of the other products, we were – we had partners and 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 Monte hits, I don’t think there’s a lack of partners. It’ll be significantly into their choosing and scale and the credibility organization will be key attributes we’d look at.

David Nguyen: I appreciate that answer there. I just hope that the – 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.

Dwight Gorham: Yes. Thank you as well for the question.

Operator: Thank you. And we would now like to hand the call back to Mr. Gorham for closing remarks.

Dwight Gorham: Yes. Thank you very much. Well, this concludes our third quarter 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 the continuing belief in and supporting us. The quality of the questions was excellent today. Thank you very much. Thank you, and goodbye.

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Operator: Thank you. 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.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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