IntelGenx Technologies Corp’s (IGXT) CEO Horst Zerbe on Q2 2022 Results – Earnings Call Transcript

IntelGenx Technologies Corp. (OTCQB:IGXT) Q2 2022 Earnings Conference Call August 11, 2022 4:30 PM ET

Company Participants

Stephen Kilmer – Investor Relations

Horst Zerbe – Chief Executive Officer

André Godin – President and Chief Financail Officer

Dana Matzen – Vice President-Business and Corporate Development

Tommy Kenny – Vice President-Intellectual Property, Legal Affairs and General Counsel

Conference Call Participants

Hugh Kelly – Private Investor

Adam Tubero – Psychedelic Invest

Lindsey Murphy – Private Investor

Operator

Good day everyone and welcome to today’s IntelGenx Second Quarter 2022 Financial Results Call. At this time all participants are in a listen-only mode. Later you will have an opportunity to ask questions during the question-and-answer session. [Operator Instructions]

And it is now my pleasure to turn today’s program over to Stephen Kilmer, Investor Relations.

Stephen Kilmer

Thank you. Good afternoon, everyone, and thank you for joining us on today’s call. With me on the line are Dr. Horst Zerbe, IntelGenx’s CEO; André Godin, our President and CFO; and Dr. Dana Matzen, the company’s Vice President of Business and Corporate Development; and Tommy Kenny, our VP, Legal Affairs and Intellectual Property and General Counsel.

Before we begin, I would like to remind you that all amounts mentioned today are in U.S. dollars, unless otherwise mentioned, 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’d now like to turn the call over to Dr. Zerbe. Horst?

Horst Zerbe

Thank you, Steve. Good afternoon everyone and thank you for joining us for the IntelGenx second quarter 2022 conference call. On today’s call, I will provide a corporate update and discuss the progress we’ve made on our key pipeline projects. Then André will review our second quarter 2022 financial results. Following that we will open up the line for our questions. Although we continue to progress each of our development programs during the second quarter, today’s corporate update will be brief. Our material news flow, which we expect will be heavier as we enter the four months, was relatively light this quarter.

So let me begin with ATAI. We completed the manufacturing of a clinical trial batch for one of the partner programs. The study materials will be shipped in September and we anticipate the start of the study later this year, most likely still in the third quarter. We report in May, we met with Exeltis to discuss the potential for the commercialization of RIZAPORT in additional countries. The call was positive with Exeltis indicating that there was a strong interest for certain Eastern European countries. In addition, we are in discussions with other distribution partners of licensing rights for [indiscernible].

Moving on to Tadalafil, IntelGenx and Aquestive have formed a joint task force to work on the response to the CRL that Aquestive had received for the product. Now, moving on to the – to our cannabis films, we are working to fulfill Heritage’s purchase order for their resale of our CB4 Control film containing CBD to one of the top three license producers in Canada that is expected to happen in early September. Accordingly, we expect the related revenue to be reflected in our Q4 2022 results. Our partner Heritage continues to rush CBD distribution in Canada and recently got the product listing – listed on the Shoppers drug Mart website. We continue to push distribution in Canada and recently met with the Nova Scotia Liquor Corporation to discuss the products. And finally as per two-way [ph] litigation, Tommy will be available for questions during the Q&A session.

Now moving on to montelukast and initially regarding the BUENA study, as we reported earlier in the year, the study and correspondingly our recruitment efforts have resumed. Recruitment is ongoing with six sites activated. As of now a total of 33 patients have been randomized, 22 of which have completed treatment. We’re working diligently to improve the recruitment rate and have now launched a Facebook awareness campaign to attract more study participants and accelerate enrollment. With these currently ongoing activities, we expect to complete enrollment later in Q4 of 2022. Final study results are thus expected to be available in Q2 of 2023.

Finally, on animal health, we delivered a better film based clinical trial batch to our undisclosed animal health partner for a study in dogs in the U.S. We recently received partial study results and are waiting for the full report to be issued. Once available, we will discuss a tailored program to further develop the product. In addition, we are in discussions with several animal health companies regarding our better film platform. Again, the progress we continue to make is not – at least not fully reflected by this quarter despite a new slow, which we expect will be a short term trend. We look forward to updating you on our progress in the coming quarters.

And with that, I would now like to turn the call over to André for a review of our financial results. André?

André Godin

Thank you, Horst. Good afternoon, everyone. As Horst mentioned, I’ll take a few minutes to discuss the company’s financial performance for the second quarter ended June 30, 2022. For the second quarter, total revenue amounted to $398,000, up 146% from $162,000 in the same period last year. The change is mainly attributable to an increase in R&D revenues of $210,000 and royalties of $28,000. Operating costs and expenses were $2.6 million for Q2 2022 versus $2.1 million for the corresponding three month period of 2021. For Q2 2022, the company had an operating loss of $2.2 million compared to an operating loss of $1.9 million for the comparable period of 2021. Adjusted EBITDA was negative $2 million for Q2 2022 compared to $1.7 million for the same period last year. The net comprehensive loss was $3.2 million or $0.02 on the basic and diluted per share basis for Q2 2022, compared to net comprehensive loss of $2.5 million or $0.02 per share for the comparable period of 2021.

I will now turn the call back to Dr. Zerbe. Horst?

Horst Zerbe

So, thanks, André. Before we proceed to the Q&A section, I’d like to once again recognize our team for executing on our long-term strategy. And with that, I will now turn the call over for questions. I would like to remind you that our forward-looking statements applied to both our prepared remarks and the following Q&A. Thank you.

Question-and-Answer Session

Operator

[Operator Instructions] We’ll go ahead to our first question that comes from [indiscernible]. Please go ahead. Your line is open.

Unidentified Analyst

Hi, good afternoon. Can you please tell me what is happening with RIZAPORT and Tadalafil that’s been on hold for too long.

Horst Zerbe

Okay, Dana, I’d like to turn over to you or…

Dana Matzen

Yes, for sure. So for RIZAPORT the product is launched in Spain. And as you know, we launched the product with our partner Exeltis about a year ago. Product is doing well. As you might know, Rizatriptan is the number one prescribed migraine molecule in Spain and off those products RIZAPORT is the first alternative to Maxzide, which is the brand. So we’re waiting for the four, 12 months to be completed to see how the product really performed in the first 12 months, but so far we are quite happy with the success story there.

On the U.S. side, we are preparing with the submission or with our response to the CRL, which we will be doing later this year and then meeting with the FDA to really accelerate this probe. So it is coming, there were some questions on the FDA before that took us a little bit longer to prepare batches at some issues with some APIs, and now it’s all resolved and we should be on our way by the end of the year. Talking about Tadalafil this program is partnered with Aquestive. And as we released recently that we have a partner for the U.S. So the partner Aquestive and us, we are preparing to respond to the CRL. We have a joint project team to really work through the last details and the plan as well here is to be ready and to submit early next year. That’s our response.

Horst Zerbe

And let me – can I just add one comment, which is really brand new and not even Dana is aware because he’s currently not in the office. We have decided to not even waste time by initially going to the FDA and discuss our approach to the response to the CRL, but rather submit our response directly that will save us a couple of months. The reason for this being that upon review of our data package, our external consultant decided that we have a very solid case and do not need to waste any additional time by applying for meeting and then meeting with FDA who will submit directly.

Like I said, that will save us a few months.

Dana Matzen

Yes, that’s responding to [indiscernible].

Horst Zerbe

And sorry, interrupt. We’ve been mean trying to get Rizaport into the market for, I think, over 10 years now, or at least eight years. And we’ve lost an opportunity with [indiscernible] in the last three years because we partner with Aquestive. When will we actually start monetizing our assets and are we ever going to? And how does it even justify raising funds and not bringing a product to fruition despite so many years, why are we always stuck in the lab?

Horst Zerbe

Well on Rizaport I understand your frustration. We have not always been happy with the time slow progress ourselves, either. As far as Rizaport we’ve stepped it up very significantly, as you just heard from Dana. And the addition that I made. We’re moving now very rapidly and the product will be besides Spain, where it is already on the market will be on the market in the U.S. next year.

On Tadalafil, the decision to cooperate with Aquestive was made a few years ago under the impression that this would accelerate our path-to-market. And that was at the time to the best of our knowledge, the best decision we could make. What we did not know was, and could not possibly know was that FDA came back with a pretty significant complete response letter to Aquestive’s 505(b)(2) NDA which we are now responding to jointly with Aquestive we formed a joined task force that is working very diligently on clearing the path towards resubmission. Our formulators here are involved in that work.

So I acknowledge that Tadalafil has, or the path-to-market for Tadalafil has had and has seen some bumps, but undoubtedly we’re now on the right path and are moving very swiftly. So as Tadalafil, we’re expecting the product to be on the market. And if I’m not mistaken early 2024, right.

Operator

We’ll take our next question from Hugh Kelly [Private Investor]. Your line is open.

Hugh Kelly

Yes, good afternoon, everyone. Thank you for taking my questions on the visit for resubmission Dr. Zerbe when you resubmit that to the FDA, do they have to then go through and do another plant inspection after you send in the new ANDA?,

Horst Zerbe

It’s not a new – it’s not an ANDA to begin with, it’s a 505(b)(2) ANDA.

Hugh Kelly

That was my mistake. You’re right. Sorry about that.

Horst Zerbe

Yes, no problem. I’m not quite sure they may or may not conduct another preapproval inspection. The wrecks are not quite clear. They do not have to come mandatorily, but they might very well, even though they recently inspected our facility. So honestly, I cannot answer that question with certainty. There is certainly a very good chance that they will come and we will be prepared, but whether or not they actually do come that we don’t know.

Hugh Kelly

Okay. And follow-on to that was the stability testing with your three batches, all the data looking good on that.

Horst Zerbe

They look really excellent. And that is the main reason as to why I had mentioned before in, in the prepared remarks that we have decided to move directly towards responding to this area and not bothering a meeting with the FDA. We have very, very convincing data that do not raise or cannot possibly raise even the slightest stability concern. The data are, as we say, squeaky clean.

Hugh Kelly

That is a very good news. And then if when the submission goes through, would the facility, would that be prepared for – once it’s approved by the FDA, does it take is a long lead time to get the plant ready for the U.S. and Canada production?

Horst Zerbe

We are gearing up for production. At this point, I cannot give you a precise timeline that would really be very speculative and a little premature,

André Godin

Hey look, it’s only for the U.S. there is no file was submitted in Canada.

Horst Zerbe

Yes, that’s right.

André Godin

Just to clarify.

Hugh Kelly

Okay. And then I will go back in the queue. Thank you.

André Godin

You are welcome.

Operator

Next two Adam Tubero with Psychedelic Invest. Your line is open.

Adam Tubero

Hey, thank you for letting me ask the question. The first question is how many different strips do you guys have the capabilities of manufacturing at the same time? So let’s say for example, you guys are manufacturing Rizaport. Can you manufacture any other strips at the same time? What are the capabilities of your manufacturing of those strips? Do you just focus on one strip at a time or like one formulation at a time?

Horst Zerbe

Yes, that is typically what we do. We have one commercial size quarter and the GMT clients, we would make one product at a time.

Adam Tubero

Okay. Thank you. The next question is in regards to atai, what are the – I know there are two already confirmed things that you are working with them. Can you just – are you at liberty that say what they are, because I’ve read them on the pipeline before, but I just want to get confirmation from you guys.

Horst Zerbe

I don’t think we can disclose to compound, right now, unfortunately not.

Adam Tubero

Okay. No problem. My last question is, is there any type of update you can give on Tilray because you guys have been in arbitration with them for quite a long time now. And we’ve heard nothing. Is there anything that you are at liberty to say anything at all?

Horst Zerbe

Sure. So I turn over to Tommy, Tommy will comment.

Tommy Kenny

Yes, I hear you. And although it might seem like a long time for you from the outside perspective, it’s still a little time if you compare to the actual court timing. We’ve been actually the – it’s not even a year since we initiated arbitration. And at this point I cannot comment on the process and we don’t have anything to share. We’re pushing as much as we can. The timeline is not necessarily in our control. It’s the arbitrator that decides everything, but right now we don’t have anything. I cannot comment any further than that, but as soon as we get a decision on the case that we can update, the investor will be very happy to do so.

Adam Tubero

Okay. And my last two questions are, have you guys been approached by any other marijuana companies? You don’t have to say who or anything, but have you guys been approached by other marijuana companies in regards to showing interest in the strips?

Horst Zerbe

We have been in the past, but Dana, maybe you want to comment.

Dana Matzen

Yes. No, of course we have many times. So either while we were still with our current partners, some of them we can’t do because we are bound under exclusivity, but yes, we have been approached many times.

Adam Tubero

And sorry, the last question is, so I feel – I’m not sure if I read this somewhere or not, but does atai have the first right of refusal in terms of getting access to montelukast when that’s possible?

Horst Zerbe

I don’t believe so. I know they have no right of first refusal. What they have is as part of the strategic partnership agreement, they are on our board. So they are involved in it. And maybe to give you a little more context, they didn’t really want us to let’s say divest this opportunity before them being aware of it. So they don’t have a right of first refusal. What they have is the right to be considered and to be at the table when we make those decisions. But by default, they are on our board. So they are involved.

Adam Tubero

Awesome. Thank you very much. I’ll get back in line.

Horst Zerbe

You’re welcome

Operator

We’ll take our next question from David [indiscernible]. Your line is open.

Unidentified Analyst

Thank you for the call today. In regards to the BUENA trial Dr. Zerbe, you mentioned that 32 patients have completed, I’m sorry, 32 patients are enrolled. The 22 are completed the treatment. Can you share [Technical Difficulty]

Horst Zerbe

I’m sorry. You, you broke off. We didn’t really get your question. Yes, I understand the question about montelukast.

Unidentified Analyst

Yes. Can you hear me okay?

Horst Zerbe

Yes. Now I can. Well, okay. So of the 22 patients who’ve completed the trial. Can you share any data on those 22 patients?

Horst Zerbe

No, not. Because the study is fully blinded and we would only be able to look into details by breaking the randomization code. So the answer is, no.

Unidentified Analyst

Okay. Thank you very much for that. I’ll go back in queue.

Horst Zerbe

You’re welcome.

Operator

We’ll now to Lindsey Murphy [Private Investor]. Your line is open.

Lindsey Murphy

Hi. Yes. Thank you for taking my call. My first question actually is just about the montelukast, just when that is or when it is through with the discussions. Are there any other discussions with any large pharmaceutical companies about montelukast?

Horst Zerbe

We have those in the past before we started the program, and we saw a very significant interest in a number of very significant or by a number of very significant companies, but ever since we have commenced the study, we have discontinued those efforts, because the comment we received from every single contact we ever made was we are interested, but we would need to see the results from your proof-of-concepts study before we can go any further. And so we’ll waiting now to – for the completion of the study and results being available before we – before Dana hits the road, and reaches out to potential partners.

Lindsey Murphy

Got it. Understand. Thank you. And one other question for the Heritage order, can you share how large that order was?

Horst Zerbe

Quarter million.

Lindsey Murphy

A quarter million. Okay. Thank you so much. I will go back in the queue.

Operator

We’ll go now to [indiscernible]. Your line is open.

Unidentified Analyst

Good afternoon, Dr. Zerbe. Couple quick questions. You said the Riz timeline or not having that meeting was going save you all a few months. So, what exactly is the timeline now? I mean, when are you – I know you said next year, I think, but when next year do you think the product will be available?

Horst Zerbe

I believe second quarter is, say I’m…

André Godin

Third quarter.

Horst Zerbe

Third quarter. Yes. Would be the safe bed.

Unidentified Analyst

Okay.

Horst Zerbe

Review time is six months. So, we submit, over the next weeks, review time is six months and then come large preparation. So Q3.

Unidentified Analyst

Okay. My next question, if once that happens, if you’re still receiving additional orders from Heritage, can you produce those and RIZAPORT?

Horst Zerbe

Yes. There shouldn’t be a problem.

Unidentified Analyst

Okay. And my last question, when do you expect to be cash flow positive?

Horst Zerbe

That’s a question for André. So André, if you want to comment?

André Godin

Yes. We are expecting to launch two products next year. One generic product that we have partnered with Exeltis and RIZAPORT. So if those two products are launched as scheduled we should be cash flow positive probably by, I would say Q3 or Q4 next year.

Unidentified Analyst

Okay. Thank you guys.

André Godin

You’re welcome.

Operator

Our next question comes from [indiscernible]. Your line is open.

Unidentified Analyst

Yes. Good afternoon, Dr. Zerbe. My first question for you is in regards to the CRL that you guys received, I believe in May for the buprenorphine, could you shed some light on the resubmission progress and timeline of resubmission?

Horst Zerbe

So first of all, I can’t confirm the molecule that is confidential. I don’t know where you got that information from. But I don’t want to confirm that we have pretty significant or pretty severe confidentiality obligations. What I can say is that the response has recently been submitted for that generic product.

Unidentified Analyst

Okay. So it has been submitted to the FDA?

Horst Zerbe

Yes.

Unidentified Analyst

Okay. And is there any, like timeframe on the review after your review submission? Is it a six month review?

Horst Zerbe

I’m sorry.

Unidentified Analyst

That’s fine.

Horst Zerbe

Six months review. That’s what we’re expecting, six months review.

Unidentified Analyst

Okay. And the next question is in regards to the RIZAPORT U.S. resubmission, when do you anticipate to submit the batches? I know you said that you’re going to avoid the meeting with the FDA to save time, but when are you looking at resubmitting?

Horst Zerbe

We haven’t defined a precise date, but it’ll certainly be within the next three months from what I can see. Right. So within the next three months, for sure.

Unidentified Analyst

Okay. And my last question is for Tommy. Well, actually I have two more questions. Sorry. This question is for Tommy. It’s in regards to the litigation with Tilray. I know you said you can’t like shed some light on the progress, but the question that I would like to ask is since Tilray has breached the agreement that you had with them is the company possibly considering taking back the exclusivity on the THC as well. So they don’t have any rights for the THC. So this way will be free and clear of Tilray to be able to make possibly, you know, business agreements with other companies.

Tommy Kenny

Without commenting on the arbitration. I think from what it looks right now it looks right now, it’s very hard to see a past where there’s a relationship between the company, meaning IntelGenx and Tilray going forward, but I don’t know what the outcome of the arbitration will be, but this is a clear assessment at this point.

Horst Zerbe

For both companies actually.

Unidentified Analyst

Yes.

Horst Zerbe

Yeah.

Unidentified Analyst

Okay. And my last question is for Dana, it’s in regards to the [indiscernible] film batch that you guys submitted to that company. When do you see, like, I mean, when do you think, like timeframe wise, would we be able to know, like or when would you guys be signing an agreement with that company and like kind of going public, about it as to which company you’re dealing with in the United States and so forth?

Dana Matzen

Well, first of all the try we submitted the product that, can do the clinical trial, we’re waiting for the full data readout to see if the goal that they wanted to achieve is the firm has been met. And once that’s clear and we define the path forward, how a full clinical trial program looks like, then we will find the full agreement that this moment, it’s a little bit of crystal ball. I don’t have to full data set, and there are a lot of assumptions, but there is a timeframe that we are trying to do this. And we said, within, probably in reasonable couple of months, we should know if this has worked. If our film delivers the product to the way that it it’s supposed to deliver it. And then we will go into contract stage. I’m, we would see something this year.

Unidentified Analyst

Okay. Okay. That sounds great. And I’m sorry, this is the last question. In regards to the montelukast Emery University is also doing a study and they’re supposed to be having their final results coming out in October of 2022, if they yield positive results, how do you think that would affect IntelGenx? I mean, because we IntelGenx has a more superior delivery platform for that molecule. So, do you think like how do you think that would affect if they come out and say that they did achieve for example, significant positive results? How would that affects?

Horst Zerbe

Yes, first of all, I mean, we’re monitoring their progress. Of course. Also, first of all, they’re also delayed. I mean, they announced about a year ago or whenever it was that they expect results to be available in October. I think that’s at this point, wishful thinking they, they’re also pretty serious setbacks in their enrollment. Just like we did mostly due to COVID, I mean, we know very well what they’re doing. We know the dose level, and we know the bioavailability of the product that they’re dosing. I’m not so sure to be honest with you that there will be meaningful results coming from that study much before our study will have been completed.

Unidentified Analyst

And IntelGenx does hold the Orange Book patent for that, right?

Horst Zerbe

Yes. For once I tell you that they’re dosing lower than we do. Now knowing that, that we have a 50% higher bioavailability or the film then the tablet, I mean, they dose effectively less than half of what we are dosing. And we know that the response and the efficacy on neuroinflammation is related to the dose level. So with that, I see the IntelGenx study and the IntelGenx product to be at a significant advantage, but these are admittedly qualitative comments, but again to coming back to the initial part of your question, I don’t believe that they will be able to announce results from their study at least significantly earlier than we will.

Unidentified Analyst

Okay. Okay. And I mean, as far as I see it with the dosing that IntelGenx is currently doing at 30 milligrams twice a day, and with the 50% higher bioavailability, I think the chances for IntelGenx are extremely, extremely high to achieve successful results with this medication?

Horst Zerbe

Yes. That’s what we are strongly believing. The only question is the study population large enough? I think it is the study was planned in conjunction with the biostatistician. So we didn’t come up with the 70 patients number clinician and biostatistician assisted us with that, but we have yet to see.

Unidentified Analyst

Okay. And I just want to say thank you so much for taking my questions. And I think the company is doing amazing progress over the years, so keep going forward and God bless you guys.

Horst Zerbe

Thank you very much.

Unidentified Analyst

All right.

Operator

[Operator Instructions] We’ll go now to [indiscernible]. Your line is open.

Unidentified Analyst

Hello, Dr. Zerbe, can you hear me?

Horst Zerbe

Yes. Good afternoon. Yes, I hear you.

Unidentified Analyst

Okay, fine. This question is for André. End of June the company showed a cash on hand of $7 million; it appears that we have a cash burn rate of $2 million a quarter. Most of the products that were discussed today have a longer time horizon before they begin to generate any income. So how does the company look at the need for additional capital cash to close the gap between what appears to be the amount of cash on hand versus when income will start coming into the company?

André Godin

Yes. Thanks for your question. We have a loan with a tie that is scheduled to come in January of 2023. So that was part of the amendment that we signed with them several months back. So we had one coming in 2022 – January of 2022 and another one in 2023, a $3 million. And that should be sufficient for us to be able to get to commercial products. Like I said earlier, if everything is aligned and on schedule, we’re scheduled to launch two products next year Rizatriptan and a generic product. So if that takes place – takes place as schedule, we should be fine. Because as you mentioned, yes, we’re burning about that $2 million a quarter. But since we are going to get $3 million in January and we’re expecting to launch in Q2 and Q3 of next year it should be fine.

Unidentified Analyst

Okay. Thank you.

Operator

We’ll go now to Tom [indiscernible]. Your line is open.

Unidentified Analyst

Yes. Thank you for taking my call. During the last call, I believe there was going to be a meeting with our Spanish partner regarding expanding marketing into other countries. I wondered if you had any updates on that?

Horst Zerbe

Okay, Dana?

Dana Matzen

Horst, do you want me to take that. Yes.

Horst Zerbe

Yes.

Dana Matzen

So as Horst already mentioned we did have a meeting with them. There is quite an interest from Eastern European countries. So we’re looking into how the timeline would work and how we expand into that. So that’s the update for now.

Unidentified Analyst

Okay. Thank you very much. I’m sorry. I got on the call late. I didn’t hear that was mentioned earlier. Thank you.

Dana Matzen

It’s okay. No worries. You’re welcome.

Operator

We’ll take a follow up from Adams Tobero. Your line is open,

Unidentified Analyst

Hey, thank you so much. Okay. So the first thing I wanted to ask was based on what André just said and what was said in the call so far between a tie and the deals coming through in 2024 we should be good enough to get to profitability without having to worry too much. Let’s say on more dilution in something like that, unless it’s deals with a tie? Is that safe to assume?

Horst Zerbe

Yes. That’s safe to assume. There’s always – you never have too much cash. So, I mean, it doesn’t mean necessarily that we wouldn’t raise money, but at this point, at this level, at this stock price it’s not a consideration.

Unidentified Analyst

All right, cool. Alright, my next question is going to be for Dr. Zerbe. It’s going to be two questions for you. So the first question is, so what would be the advantages of putting a psychedelic like psilocybin on a strip that IGXT has? If you can break that down for me.

Horst Zerbe

Yes. Just in broad strokes psilocybin is not easy to be administered because if you administered it orally you need to at the same time administer a so-called monoamine oxidase inhibitor in order to yes, let me put it in like this. In order to extend the lifetime – the presence of the active metabolite psilocybin in the bloodstream that makes it complicated. Nobody likes to concomitant administer medication just to make the first medication work. You would avoid that by administering psilocybin or psilocin via a film.

Unidentified Analyst

And through let’s say putting it on the film, what type of things can you tweak in regards to, I know the onset would be faster. But what about something like the duration of the effect? If that’s something you guys would be able to tweak?

Horst Zerbe

Again generally speaking, what you control with your delivery system is the delivery of the drug to the bloodstream. And obviously in drug delivery, what you always attempt is to increase or optimize – increase the amount that you deliver to the bloodstream. Once it’s there the elimination occurs completely independent from the delivery system. So what the film does is it optimizes the rate and extent to which the drug is delivered to the bloodstream. Once it’s there, it’s out of our control. The elimination occurs is completely independent from the delivery system.

Unidentified Analyst

Okay. Understood. Understood. And so the last one would be in terms of, so in a lot of times now there’s many companies now that are looking into sort of [indiscernible] molecules. So I would ask like, is there – is it fair to compare these strips to due duration or is it just completely different where it wouldn’t even matter?

Horst Zerbe

I didn’t really.

André Godin

[indiscernible] I don’t know enough about that to comment let’s say intelligently on that question, so, sorry, I have to pass on that one.

Unidentified Analyst

All right. Thank you for answering my questions doctor.

Horst Zerbe

Yes. You’re welcome.

Operator

We’ll take a follow up from you Kylie. Your line is open

Unidentified Analyst

A few more questions for me would be submitting the, response to the CRL to the FDA, once report gets approved in the past was always a desire to do all the manufacturing at your Canadian facility for the global marketplace, the RIZAPORT. Is that still the intent?

Horst Zerbe

Yes, it is.

Hugh Kelly

Okay. That’s okay. And then the last, my next question would be, or the – and your last presentation, which was outstanding Dr. Zerbe at the Bloom Conference, any update on the potential for COVID and Parkinson’s any initiatives in that arena?

Horst Zerbe

At the moment, we’ve put this on hold. I certainly do see potential to be honest with you regarding montelukast for COVID, but we have to be realistic. Our montelukast program is, at least for a company of our size, quite aggressive with the BUENA study. So at this time we’re not pursuing COVID as far as Parkinson we have discussions, but I would, at this point leave it at that and not go further into that. Let me say there are discussions regarding Parkinson’s.

Hugh Kelly

Okay. And in the past André you indicated about some updating the investor relations program. I was just wondering, we had research reports coming out from Leede Jones, any other investment houses researching or inquiring about your progress that would issue a research report.

Horst Zerbe

At this point there’s nothing actively ongoing regarding a research report. I would like to turn over to André. André is in charge of IR and related activities. André, do you want to further comment on this?

André Godin

Yes. As Horst just mentioned there’s nothing active at this moment, but we’ve been in discussion with several banks for coverage. We don’t really pursue any paid coverage because, we feel they’re useless, but we’re actively in discussion with several banks and probably planning a roadshow in the fall or in the spring at which point you get involved with banks and you can expect some coverage. So it is on the radar. But there’s nothing that, that is definitive in the short term.

Hugh Kelly

Okay. And last question would be, is the addition of the 15,000 square foot storage. It’s quite an addition to your facility.

André Godin

Yes, it is. Okay. But

Horst Zerbe

Okay, Andre, go ahead.

André Godin

Yes, it is, but there is an expansion plan for the future. So we couldn’t let go that, that space for the time being, yes, we’re using it for storage, but eventually if everything goes as planned, we would expand our production capacity in that space.

Hugh Kelly

And that’s in addition to the other 11,000 square with production space, André?

André Godin

Yes.

Hugh Kelly

Wow. Okay.

André Godin

The entire space, it’s a big project. I’m not saying that it’s something that we’re going to do tomorrow. But it’s something that we are considering for the future and we needed that space to eventually being able to move forward with that expansion program.

Hugh Kelly

Okay. Thank you.

André Godin

You’re welcome.

Operator

We’ll take a follow up from Jeremy Levin [ph]. Your line is open.

Unidentified Analyst

Yes. Good afternoon. And thanks for taking my questions. I appreciate it. I wanted to ask, first of all just more about what’s going on with free support in Europe. I know you don’t want to say too much, and I don’t want to you to say anything you can’t be held to, but why has there been, no, you haven’t been able to give, tell us anything about the sales in the last nine months since it sort of went live in Europe. So that’s the first question I had. Is there anything you can tell us at all about it?

Dana Matzen

Horst let me take that question. So, first of all, the product launch in September, and it’s very typically that you get from a commercial partner after the first 12 month of marketing review, how the product performed, it takes time to list the product and order pharmacy staff it available to start with the marketing campaign. And we will meet with the partner again, after September. So far all I can tell you is that the product is doing well. It is the number one first alternative after maxsize. The maxi size is the brand that there’s great campaigns running in Spain about the product. But at the end of day, and we receiving variety reports, we see that that the, the product is performing, but how is it performing compared to the market? Is it taking kind of a leadership position that I can only answer after we have that meeting this partner, if you know, right now it’s August, most companies close down for, in August in Spain.

So I would only get an update probably mostly in, at the end of September, beginning of October. So it’s not a lack of communication. It’s really uncommon to provide an overall view of the product before the full year has lapsed, because there’s so many activities that take time to see how the product is responding to certain marketing initiatives. And you can’t just look at the first couple of months to predict how the product will be performing.

Unidentified Analyst

Okay. Well, okay. Thank you. I appreciate that. The other question I had just more technical thing. How long does it take you to make a batch of trips? Like the order you just fulfilled, for example is that a number of just a couple of weeks, or is it more of more, most of a quarter? How long did it take you to manufacture that batch?

Horst Zerbe

If we look at, at the CBD batch, that’s a concrete example. Two weeks to manufacture then a week to analyze and then we ship it.

Unidentified Analyst

So it’s a, within a month you turnaround is about a month or so

Horst Zerbe

Less than a month. Yeah.

Unidentified Analyst

Less. Okay. Within a month. Less than a month. Okay. So, and, but you said that you can only manufacture sort of one product at a time, is that what I do? Okay. So is that going to pose any kind of problem for you, or how do you plan to deal with that as you ramp up?

Horst Zerbe

At the moment? Not and I would explain why, because that timeframe that I just gave you does not mean that, we will be tied up for three or four weeks with one part and then move on to the next, if you breakdown the process, we leave out, it starts out with dispensing the materials and preparing the, the blend. That’s a few days, let’s say the better part of a week. And then it goes onto the coding machine. We code that’s again about a week, and then it goes into packaging another week.

So we can typically work in one week increments because, if once the dispensing and blending has been completed and the material has been moved into coding, we can move the next pilot. Of course we have to clean, but then we can move the next product into the dispensing and blending area and start preparing the next blend.

Unidentified Analyst

I see.

Horst Zerbe

There’s a certain breakdown that, and if we do that intelligently, then we can really compress.

Unidentified Analyst

Okay. So within the same month, you can be working on two or three different orders. If you had to, you could fit that in

Horst Zerbe

Yes. Certainly too.

Unidentified Analyst

Right. Okay. Perfect. Okay. Thank you. I appreciate that.

Horst Zerbe

Yes. You’re welcome.

Operator

We are approaching the end of our program at this time. I’d like to turn it back over to Dr. Zerbe for any additional or closing remarks.

Horst Zerbe

Yes. Thank you very much. And so thank you for all your questions. So this concludes now our Q2 2022 Investor Update call. Again, I would like to thank the entire IntelGenx team. It’s hard work and dedication, our board of directors for the continuous support of the management team. Finally, our investors for continuing to believe in and in supporting us. Thank you and goodbye.

Operator

This does conclude today’s program. Thank you for your participation. You may disconnect at any time.

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