Operator: And the next question is coming from Hugh Kelly, Hugh is a Private Investor. Hugh, your line is live.
Hugh Kelly: Thank you. Good afternoon, folks, and welcome David to IntelGenx. Hey, one question I have I didn’t minute say hey, I apologize. On the Tadalafil, is that getting with the API issues that you believe resolved? Would that be we have a timeline for resubmission to the FDA?
Horst Zerbe: For the current timeline is that’s our partner Aquestive repeats the positive experiments or the experiments with the positive outcome that we conducted here IntelGenx and that led to the resolution of the problems that they encountered. They need to repeat that, which they’re currently doing. And once they have repeated that at the lab bench level, then they will proceed with manufacturing the clinical batch required for the irritation study. At this point, the expectation is that the study will be completed late summer, and that we submit our response to FDA in most probably Q4 of this year.
Hugh Kelly: Okay. And the anticipated date of announcing the undisclosed partner Dr. Zerbe?
Horst Zerbe: I’m sorry. I missed that acoustically.
Hugh Kelly: The anticipated date to disclose the partner?
Andre Godin: I think it would be upon approval.
Hugh Kelly: Okay.
Horst Zerbe: That’s what I believe, yes.
Andre Godin: Yes. Okay. So as soon as we get an approval, we’ll be able to disclose. Obviously, it’s a very credible and reputable partner, so we’re all anxious to be unable to announce it.
Hugh Kelly: Okay. And moving on to Montelukast, can you give us an update on the number of patients wrote for your clinical trial?
Horst Zerbe: Yes. For that, we brought Dr. Pietrantonio in our Clinical Director. And Frank, do you want to comment on that?
Frank Pietrantonio: Sure, sure. As of the March 29, 2023, we’ve screened over 105 patients. 44 have been randomized, and six are pendings. And a week or two, we should have another six randomized. Under the single dose regimen with the 10 milligram, we had about 25, and with the higher dose, the 60 milligram dose, we have over 20 subjects.
Hugh Kelly: Okay. And Frank, thanks for joining the call. The best guest and the completion of the study, I know it’s a moving target next year.
Frank Pietrantonio: Yes. So we were somewhat penalized with I guess from January when we started in 2022 because of, as I call post-pandemic syndrome, a lot of the sites did lose a lot of their staff. So there’s been a lot of retraining hesitancy from patients going to the hospitals after in fear of getting COVID. And so a lot of that activity, I would say, instead of starting January 2022 started I would say around April. So in terms of ameliorating the enrollment rate, so what we did is we opened new sites, and so based on that and we’re looking at ending, I guess, recruitment around June 2023 and hopefully by the end of the year of 2023. Yes.
Hugh Kelly: Okay. Thank you, Frank. And that is €“ any update on the status of the Par program? Is that going to go forward or is that postponed?
Horst Zerbe: Well, sorry, which Par is in I’m assuming you’re talking about Suboxone that’s what I €“ it has been penetrated into the public, Par is in bankruptcy proceedings. So Par, that program has discontinued with Par, we have seen interest right now, there are concrete discussions ongoing between Par and a company that’s interested in acquiring the end, but I can obviously not disclose any names or any details. I just want to send a message that while the program with Par has been discontinued, that does not necessarily mean that the program itself is that we are working very hard to progress it. But inevitably because of the unfortunate Par and Endo situation, there is a pretty significant delay. But we’re hopeful and actually confident that, that the program will continue.
Hugh Kelly: Okay. That’s you €“ that’s I anticipated and then the other quick question is on the recent patent announcement of Loxapine how does that €“ would that program become active in the future? Or is that still on hold due to other priorities?
Horst Zerbe: And there are €“ we are discussing the opportunity with actually at this point a European company, but nothing is concrete in terms of entering into an agreement. We’ve seen interest and we continue promoting the program because we really believe in that.
Hugh Kelly: A very sizable market if I’m €“ my facts right, and then I’ll go back in the queue. There’s on the atai programs is, did I hear you say they’re in discussions with the third program or did I misunderstand that?
Horst Zerbe: They are discussing internally and two more potential candidates and then €“ and we hope that at least one of them will make it and evolve to an active program. But at this point, the discussion about those candidates is being held internally at atai. We just know information €“ internal information that discussion is proceeding.
Hugh Kelly: All right. Then my €“ before I go back in the queue, on the products that were developed €“ that were not co-developed with two-way with your €“ whether announcements with your new patents or new platforms, is your potential to introduce with other partners, other cannabis THC film products? Or is that still locked up with the arbitration?
Horst Zerbe: That is certainly the case. So we definitely plan to proceed with our forms. Tommy, since it’s
Tommy Kenny: Yes, I can answer that. So
Horst Zerbe: Since legal is heavily involved. Maybe Tommy you should comment on that.
Tommy Kenny: So we’re continuing to develop product and we’re €“ the arbitration is still ongoing, but we hope to be able to announce the resolution in the coming months to investor. Right now everything is confidential, but we’re still working on the cannabis franchise, because we still pretty much believe in the product, whether it’s with Tilray or with a future partner that should be clarified in the coming month.
Hugh Kelly: Okay. I guess, but if there was €“ I guess the question was asked Tommy, would the development that with other products after the €“ it would develop without the participation too? Are you free to launch them or is that locked up? Was my
Tommy Kenny: This is not something I want to comment too clearly. I guess, there are to be €“ because it’s under the arbitration, there’s things to be clarified, but rest assure that we’re doing everything we can and we’re planning to launch those product in the future.
Hugh Kelly: All right. And any penetration with the cannabis film over there? And I know you had on your web, on your presentation, Germany, Israel, Spain, Portugal, Mexico, any opportunities presenting himself for the countries?
Horst Zerbe: Not at this point. That would require a footprint in the U.S. because of certain legal reasons with our footprint right now only in Canada. We would’ve problems, at least with THC with CBD, but there are at this point no active leads.
Hugh Kelly: Okay. And penetrating two into the U.S., is that on the horizon or is that still legal challenges with cannabis in the U.S.?
Horst Zerbe: It’s €“ it would be too.
