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spk08: Greetings and welcome to the Intelligenix fourth quarter and full year 2022 financial results conference call. At this time, all participants are in listen-only mode. A question and answer session will follow the formal presentation. If you wish to enter the queue to ask a question, please press star 1 on your phone at any time. If anyone should require operator assistance during the conference, please press star 0 on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to your host, Stephen Kilmer, Investor Relations at Intelligenix. You may begin.
spk05: Thank you. Good afternoon, everyone, and thank you for joining us on today's call. With me on the line is Dr. Horst Hubei, Intelligenix's CEO, Andre Godin, our President and CFO, Dr. David Kadeko, the company's Head of Corporate Development and Strategic Alliances, Dr. Frank Pietrantonio, our Director of Clinical Research, and Tommy Kenney, 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 those 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. Dubey. Horst?
spk12: Thank you, Steve.
spk06: Good afternoon, everyone. And thank you for joining us for the Intelligenix fourth quarter and full year 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 financial results. Following that, we will open up the line for your questions. Before launching into an update, I would like to take this opportunity to welcome David Kedekel, to our team and to his inaugural Intelligenix investor call. David succeeds Dana Madsen, who recently left Intelligenix, to pursue another opportunity. David has nearly 20 years of combined industry and capital markets experience, most recently managing his own advisory group. Before that, he was a managing director, senior institutional equity research analyst at ATV Capital Markets, David's industry experience spans several senior healthcare and biotechnology executive roles, including at Johnson & Johnson Inc. and Alexion Pharmaceuticals. David has a PhD in neuroscience from the University of Toronto. While he's just getting up to speed, David has volunteered to join us today on the call, and he will be available to participate in the Q&A session following our introductory remarks. With that, I will now update you on our key programs. First, on the ATAI partnership, as many of you will recall, in September, we shipped a clinical trial batch of our previously undisclosed candidate, Buccal VLS01, to ATAI. VLS01 is a pharmaceutical-grade psychedelic buccal film containing a synthetic form of NL-dimethyltryptamine, or DMT. ATAI is developing the product as a novel therapy for treatment-resistant depression in combination with its digital therapeutic designed to provide contextual mindset and setting support to patients prior to dosing. In October, ATAI announced that it had dosed the first subject in its Phase I clinical trial of buccal VLS01, the first ever in human clinical study evaluating an oral thin film psychedelic drug candidate with top line results expected in the first half of 2023. The PK study was delayed due to flooding in New Zealand and is still ongoing. Atai is also evaluating potential new candidates, which obviously I cannot disclose yet. Sorry, moving on to ResaPort now. In November, the FDA accepted for review our Class 2 response to the 2020 Complete Response Letter for our 505 P2 NDA for Resafilm. We believe the Class 2 response provided all of the additional chemistry manufacturing controls information that the FDA requires. FDA has assigned a PDUFA goal date of April 17, 2023, for completion of the review of the Rizafilm NDA. We look forward to their decision and to hopefully making Rizafilm available to acute migraine patients in the United States. Regarding the OUS, an update there. Recently, we met with Exceltis, our partner for Rizapod in Spain. They reported great feedback from prescribing doctors and patients, but have been struggling with significant product substitution at the pharmacy level. They are now working on a strategy to overcome the loss in sales, and Exceltis is waiting for regulatory approval to implement that new strategy, which is basically revolving around modifying the packaging format, which would then make a generic substitution no longer possible. In January, we entered into an exclusive supply agreement for resupport with R1 pharmaceuticals industries, Lebanon, SAL, in various countries in the MENA region. I will not mention all these countries, but I can tell you it's a total of 22 countries spanning that region. R1 knows the MENA marketplace intimately and has a successful track record. We're looking forward to working with them. Moving on to Tadalafil, as we reported last quarter, there was a slight delay as our partner, Questiv, has encountered some API-related issues for Tadalafil. However, the R&D teams from both companies worked diligently and formed a task force to address the issue. We believe that we have now solved this API issue and we are preparing for manufacturing of the clinical batch. Moving on to cannabis films, we are planning a PK study to demonstrate the superiority of our GHC sublingual film over conventional applications like gummy bears and so on. We also recently received a US patent for our novel cannabis emulsion based film technology. Now some words on Montelukast. While enrollment in the ongoing Phase IIa Buenas clinical trial in patients with mild to moderate Alzheimer's disease or AD is continuing, we are also now expanding the Montelukast repurposing program to include another major neurodegenerative disorder, Parkinson's disease or PD. We believe and there's sufficient scientific evidence that Montelukas Versafilm has the potential to be disease-modifying in both AD and PD. In February, we announced a research collaboration with Dr. Piers Wenigsen of the Karolinska Institute to plan and conduct a multicenter randomized double-blind placebo-controlled clinical study to investigate the use of Montelukas Versafilm or the treatment of PD. Dr. Svenningson will serve as the principal investigator for the planned study and will sponsor it through a grant awarded by the Swedish Research Council. It's a grant in excess of $2 million. Intergenics will supply Dr. Svenningson with both active and placebo films to be used in the 18 months treatment regimen for study participants. Upon completion of the study, Intergenix will retain the intellectual property rights and use the findings to further develop this program for PD treatment. We currently expect the study to commence in Q3 2023, and we'll provide more details on its design at that time. Now some comments on Zaromet. In October, we announced that buprenorphine buccal film received an FDA Generic Drug User Act, or GDUFA, date of April 28th, 2023. We partner with Chemo, part of the INSUD Pharma Group, on the development of buprenorphine buccal film in September of 2016, and we co-developed the candidate's ANDA that was filed through Zaromet and is currently under review by the FDA. Buprenorphine buccal film is a generic version of Belbuca, an opioid that is used to manage pain severe enough to require daily around-the-clock long-term treatment with an opioid when other pain treatments are inadequate. Belbuca was approved by the FDA in 2015 and is applied to the oral or buccal mucosa every 12 hours. Buprenorphine buccal film incorporates our Versafilm technology in a novel formulation and is designed to be a bioequivalent, lower-cost alternative for patients. According to IMS Health, global annual sales of Belbuca were $315 million as of July 2022. We're looking forward to the FDA's decision and assuming a positive decision by the FDA We're looking forward to the commercialization of buprenorphine buccal film as soon as possible. Last but not least, animal health. In December, we announced a research collaboration with the University of Prince Edward Island, PI, to assess palatability, owner-perceived acceptability, and ease of administration of vetafilm, of our vetafilm platform in dogs and cats. The University of Prince Island-Edward is one of North America's leading veterinary universities. So, we are very much looking forward to the results of this assessment as we continue to advance our drug delivery technology into the animal health space. Earlier in the fourth quarter, we entered into a new vetafilm feasibility and development agreement with an undisclosed animal health company for a VetaFilm-based oral film formulation containing CBD for use in companion animals. The results from the CBD study are expected in Q2. With that, I would now like to turn the call over to André for a review of our financial results. André?
spk11: Thank you, Urs. Good afternoon, everyone. As Ors mentioned, I'll take a few minutes to discuss the company's financial performance for the fourth quarter, as well as the full fiscal year ended December 31st, 2022. For the fourth quarter, the total revenue amounted to $173,000 compared to $494,000 the same period last year. The change is mainly attributable to a decrease in revenue from licensing agreements of $249,000, R&D revenue of $43,000, and product revenue of $36,000. That was offset partially by an increase in royalty on product sales of $7,000. The main difference comes from the one-time licensing fee we received last year for Pedality. Operating costs and expenses were $2.7 million for Q4 2022. versus for the corresponding three-month period of 2021, just like year-over-year reduction. For Q4 2022, the company had an operating loss of $2.5 million, essentially in Q4 2021, as well as adjusted EBITDA, which was negative $2.3 million for Q4 2022. Again, essentially unchanged from Q4 2021. Our net comprehensive loss was improved to 2.3 million or one cent on a basic and diluted per share basis for Q4 2022 compared to a net comprehensive loss of 2.9 million or two cents per share for the comparable period of 2021. For the full year, total revenue for the 12 months amounted to $1 million compared to $1.5 million in 2021. Again, the main difference coming from the one-time licensing fee we received last year for Tadalafil. The full-year operating costs were $10.4 million for 2022 versus $9.5 million for 2021. For the full year 2022, the company had an operating loss of $9.4 million compared to an operating loss of $8 million for the comparable period of 2021. Net comprehensive loss was $11.6 million, or $0.07 per share, per basic and diluted share for a 12-month of 2022 compared to a net comprehensive loss of $9.8 million, or again $0.07, per basic and deluded share for the comparable period of 2021. As of December 31st, 2021, 2022, sorry, the company's cash and short-term investments totaled $2.5 million, which does not include the $3 million secured loan granted to Intelligenix by a tie that we received in January of 2023, nor the $1 million in Canadian dollars in gross proceeds from the private placement offering of the convertible mode, which we closed just earlier this month. I will pass it back to Dr. Zerbe.
spk12: Thank you, André.
spk06: In closing, 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'd like to remind you that our forward-looking statements apply to both our prepared remarks and the following QA. Thank you.
spk08: Thank you. At this time, we will be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Once again, please press star 1 if you wish to enter the Q&A queue at this time. Please hold while we poll for questions. It looks like we did have a few questions come in. The first question is coming from Brent Gake, who is a private investor. Brent, your line is live.
spk09: Good afternoon, guys. We have a couple of questions. So if if either of these products are approved later this or in April, are you all ready for production? How soon would production start?
spk12: The current plan of our commercialization partners is to
spk06: commence with the launch preparation, meaning manufacturing of validation batches later in the year. In the case of buprenorphine, I can tell you that the launch timeline is driven by litigation, Paragraph 4 litigation. If you want more information on that and to the extent that that is public domain, Tommy can certainly comment on that. And our partner for RezaFilm also targets for manufacturing of validation batches, which would be the first saleable product for later in the year, I think Q3 or probably Q4. Both would then be lined up for commercialization in early 2024.
spk09: Okay, so it sounds like you're still a ways off from revenues, any significant revenues. I mean, how long can the company survive without any revenues? I mean, you plan to just keep diluting or what?
spk06: I think what we have to do with that, Andre, do you want to comment?
spk11: Yeah, I think that, you know, it's not um defined uh i mean or obviously just mentioned that uh you know what what the partners are planning to do but obviously when you after we get these approvals it would be much clearer as to when the both launch could take place we're expecting to get obviously some momentum with those with those approvals and we have other things in the pipeline so At some point, we might have to raise money, but at a much higher valuation as we are presently. So that's why we were very conservative with the offering we did earlier this month. Those were investors that were already shareholders of the company. So we limited that offering. but we're expecting to have great momentum and probably raise money, you know, to secure, you know, all the necessary steps to be able to launch commercially these two products. But it could be Q3, Q4, Q1, but it will be, I guess, a little bit clearer when we get these approvals.
spk08: Okay. Thank you, guys. Welcome. Thank you. The next question is coming from Steve Geo. Steve is a private investor. Save your line of life.
spk13: Hello, fellas. If April 17th, April 28th dates with this PDU doesn't come through, what happens next?
spk12: What's the game plan there? Do you want to comment?
spk06: Yeah, I can certainly comment. I mean, that's a very theoretical question. Our game plan depends on what the response is. At this point, we assume that the products will be approved. Should FDA require further information, then we will deal with that. That's really all I can say at the moment. I simply, nobody knows at this point what the, what FDA's response will be at the, at or around the GDUFA dates. We are in constant contact with FDA. They come regularly with requests, which indicates to us that they're progressing well with the review. And at this point, we have not seen any showstoppers. But that's really all I can say there. I cannot speculate on the outcome.
spk13: Okay, because in the past, you know, you talk about this, and we get dates set, and then next thing you know, it's more paperwork. It didn't get this. It didn't get that. You know, I'm in two public offerings there. One of them was five years ago, and my warrants expired, so I lost money on that. and now the second one ends at the end of this year, and I'm wondering what's going to happen come April 17th, 28th, if we don't get the approval. That was my question.
spk12: No, I understand that.
spk06: We are as anxious as everybody else to get the approvals, and we worked really hard to submit...
spk11: satisfactory responses to fda that's that's all i can say okay and now andre just stated to the last question was uh you're going to do another another offering soon he said andre um yeah it will depend on uh yeah that's probably the plan yes but uh it will depend on uh the valuation and the term that we might might be able to get um you know after april um i mean we we need if we get these approval like we think we will uh we will need to build inventory we will need to get ready uh to get commercial ready so there's some investment there and until we actually get the benefit from the product launch it will take a few months so that's why we need to fund the company but i'm expecting the terms to be much better than the previous raise. And, you know, but as Ors mentioned, you know, we don't know the outcome, but we'll soon find out. All right. Okay.
spk12: Thank you. Thank you.
spk08: You're welcome. The next question is coming from Hugh Kiley. Hugh is a private investor. Hugh, your line is live.
spk04: Thank you. Good afternoon, folks. and welcome, David, to Intelligenix. Hey, one question I have, let me say, I apologize, on the data, Phil, is that getting with the API issues that you believe resolved, would that be, do we have a timeline for resubmission to the FDA?
spk12: The current timeline is that our partner, Equestiv,
spk06: repeats the positive experiments or the experiments with a positive outcome that we conducted here at Intergenics and that led to the resolution of the problems that they encountered. They need to repeat that, which they are 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.
spk04: Okay, and the anticipated date of announcing the undisclosed partner?
spk12: I'm sorry, I missed that acoustically. The anticipated date to disclose the partner? I think it would be upon approval.
spk11: That's what I believe, yeah. 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 able to announce it.
spk04: Okay. And moving on to Monte Lucas, can you give us an update on the number of patients enrolled for your clinical trial?
spk06: Yeah. For that, we brought Dr. Pietro Antonio in, our clinical director. Frank, do you want to comment on that?
spk07: Sure, sure. As of the 29th of March 2023, we've screened over 105 patients. 44 have been randomized, and six are pending. 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 randomized.
spk04: Okay, and Frank, thanks for joining the call, your best guess on the completion of the study. I know it's a moving target next year.
spk07: Yeah, 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... of their staff. So, um, there's been a lot of retraining, uh, hesitancy from, from patients going to the hospitals, uh, uh, after, you know, in fear of getting COVID. And, uh, so a lot, a lot of that activity, I would say, instead of starting January, 2022 started, uh, um, I would say around April. So, um, in terms of, uh, ameliorating the enrollment rate. So what we did is we opened new sites. And so based on that, and, um, we're looking at, uh, ending, I guess, recruitment around, um, June, 2023. And hopefully by the end of the year of 2023. Yeah.
spk04: Okay. Thank you, Frank. And, uh, uh, that deserves any update on, uh, the status of the PAH program? Is that going to go forward or is that postponed?
spk06: Well, PAH is in, I'm assuming you're talking about Suboxone, that's what I think has been penetrated into the public. PAH is in bankruptcy proceedings, so PAH 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 ANDA, 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 dead. 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 the program will
spk04: continue okay that's you that's uh anticipated and then the other quick question is on the uh recent patent announcement of loxapine or how does that with that program become active in the future or is that still one hold due to other priorities there are we are just we're discussing the opportunity with um actually at this point a european
spk06: 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.
spk04: A very sizable market, if I have my facts right. And then I'll go back in the queue. On the Atai programs, there's Did I hear you say they're in discussions with the third program or did I misunderstand that?
spk06: They are discussing internally two more potential candidates 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 from information, internal information, that discussion is proceeding.
spk04: All right. Then before I go back in the queue, on the products that were developed that were not co-developed with Tilray, were there announcements with your new patents and new platforms? Is there potential to introduce with the other partners, other cannabis THC film products? Or is that still locked up with the arbitration?
spk06: That is certainly the case. We definitely plan to proceed with those forms. Tommy, since it's... Yes, I can answer that. Since legal is heavily involved, maybe Tommy should comment on that.
spk10: We're continuing to develop product and the arbitration is still ongoing, but we hope to be able to announce a resolution in the coming months to investors. 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 months.
spk04: Okay. I guess the question was asked, tell me, with the development that, uh, with other products after the, that would develop without the participation too, are you free to launch them or is that locked up? That was my question.
spk10: 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 assured that we're doing everything we can and we're planning to launch those products in the future.
spk04: And any penetration with the cannabis film over there? And I know you had on your presentation Germany, Israel, Spain, Portugal, Mexico. Any opportunities presenting themselves for other countries?
spk06: Not at this point. That would require a footprint in the U.S. because of certain legal reasons. with our footprint right now in Canada, we would have problems at least with THC. We're good with CBD. But there are, at this point, no active leads.
spk04: Okay. And penetrating into the U.S., is that on the horizon or is that still legal challenges with cannabis in the U.S.? It
spk10: Maybe I can answer that, Horst. Currently, it's the Canadian legislation that prevents us from exporting cannabis products. Unless there is a change in legislation, we're permitted under certain exceptions for medical purposes, but since the U.S. has a very undefined line between medical and consumer, it's not something that's permitted for us to export to the U.S. There would be a possibility that we work with a U.S. partner to manufacture it in the U.S. under our brand, but this is not something we can comment on at this point. Okay, thank you, Tony.
spk04: And one last question, then I'll be quiet. Are you partnering with three different animal health care companies, or is it the original two?
spk06: At this point, we have two firm contracts and a third one, is being worked on.
spk04: Okay. Okay. Thank you. I'll go back into queue. Thank you all.
spk06: You're welcome.
spk08: Thank you. And just a reminder, ladies and gentlemen, if you do wish to enter the Q&A queue, please press star one on your phone. And the next question is coming from Trevor Lee. Trevor is a private investor. Trevor, your line is live.
spk03: Hey, how's it going? I had a quick few questions for you today. Thanks for taking the call. I heard you had a vetafilm study with the results Q2. Will there be any more studies necessary after that one before commercialization or would that be the last one?
spk06: That is a the study that we were that I was discussing or mentioning is a palatability study.
spk12: We expect for the key programs that we are working on that further studies will be necessary.
spk06: Those are just regulatory requirements. Without those studies, the product wouldn't be approvable.
spk03: Okay. Yes. I was just wondering if there'd be more studies after that one. Is that a yes? Yes, for sure. Okay. So, I wonder if you can give an update on, like, any sort of specific sales numbers for Resupport Spain or CBD products. Like, are you seeing any sort of consistent growth in the CBD, or is it kind of leveled off? What is that looking like there?
spk11: André, do you want to comment? Yeah, but I mean, for Resupport in Spain, I think that Urs mentioned that in the introduction that, you know, Ex-Healthis is working on avoiding generic substitution. So that should probably increase the level of sales over there. But there was a peak at first, but now it has declined. So they're looking at ways to go back, you know, on a growing path so for the CBD we had a nice order in q1 and we're expecting the the growth to continue but you know we're not seeing extreme growth at this point and that's why we've been working on this THC formulation because we all believe that THC might be more suitable for our technology. Uh, but for the time being, um, it's pretty steady, but we don't see that much growth into these, uh, products. Yeah.
spk03: And then I think Tommy for the, for the, uh, THC Tilray thing, did you say the coming months singular or months plural?
spk10: So right now the arbitration is ongoing. Uh, I cannot really comment on it. Uh, it's the coming months, several months before we can announce something, but it's like, it takes the life of itself. You never know when there could be a resolution earlier, but, uh, to manage expectation, we're looking at several months to, to be able to announce a resolution and hopefully we'll be successful in, in announcing that.
spk03: Okay. Has there been any talks with Atai about any further loans or any sort of share purchasing as part of the original deal or any additional capital coming in from that route?
spk06: Not at the moment, no.
spk10: Okay. But Atai still has their option. Just to be clear, their options are good for three years. So to some extent, it will also depend on the share price.
spk03: Okay. And then Dr. Cadeckel, is he on the call? I was just curious what maybe Horst, if you could clarify what made you guys choose him and what does he plan to focus on?
spk06: Well, I let David speak for himself. Okay. David, why don't you introduce yourself?
spk02: Sure, thanks. Yeah, so I just joined last week to Intel GenX to lead the corporate development department and really in tandem with the executive team, we're going to be spearheading an initiative to look for new business development opportunities while also maintaining the existing business development portfolio, which is why the title actually includes strategic alliances. But just quickly to give you a quick background, What I bring to the table is approximately 20 years of combined experience between pharmaceuticals and biotechnology, coupled with capital markets and finance experience. So it's that really unique blend of the two different worlds, all within life sciences and pharmaceuticals, to be able to what we hope will drive shareholder value for Intelligenix.
spk03: Is there any other, like any kind of strategies that you think Intelligenix has been missing out on or anything different that you would do, I guess?
spk02: You know, I think this strategy is sound. Again, I've only been in the role for about a week now, so I'm coming up to speed. But I think, you know, with the oral film technology and looking at the generic market, One strategy in particular, I think, you know, going after those companies, looking at innovator companies and seeing which products will be going into generic over the next couple of years or so. So, so-called low-hanging fruit, I think that's an area that we could more further develop to target moving forward. And that's just one example, but there will be others.
spk06: Maybe I can add to that. We, not too long ago, maybe half a year ago, hired another business development person specifically focusing on our CDMO business. That person, Mihaly, has initiated a systematic outreach campaign, has contacted in excess of I think 130 or so companies where we think that our CDMO services could be used and he has in fact received pretty interesting feedback. He has initiated concrete program discussions with right now three companies. So that is a direction that we will keep pursuing with some priority, you know, applying our existing manufacturing and R&D technologies and capabilities to businesses interested in our CDMO services. And just as a side effect, I think I've mentioned in the past that our film equipment is also capable of handling transdermal products. And so one of these CDMO contacts is actually concretely discussing a transdermal program with us. So that's certainly one focal area in our business development efforts. a second person in David's group is looking more closely into animal health. We mentioned two opportunities and we do see ever increasing interest in applying our film technology to the animal health space.
spk03: Okay, nice. I just have a couple more For the Monte Lucas enrollment, maybe June and then study, would that be study results by the end of the year? Or would that be the last dosing by the end of the year?
spk06: It's a yes, but I'll let Frank comment.
spk07: Yeah, in terms of the results, so we're targeting the remaining recruitment would end, we're estimating in June. And then you have to tack on, the patients have to be dosed for six months. So that's why we're looking at an estimate at the end of 2023. And at that point, close the database. And then you take a look at all the data.
spk03: But the results... How long would the data, like how long do you think that would take? Another few months or...
spk07: Yeah, typically the turnaround time is about one to three months. So we close the database and then we do the analysis and then create a report, study report based on those reports.
spk03: Okay. And then do you guys have like a rough plan for after that? Would it be a phase three trial or when would that begin?
spk06: Our strategy there is very clear. we will commit our own money only to completing this phase two exploratory study, proof of concept study. The feedback that we are receiving from the market, from interested potential partners is such that they would contemplate entering into an agreement once we've been able to show the results of this proof of concept study. But we would not ourselves enter into any full-blown phase two study. That would be the responsibility of any future partner.
spk03: Okay. But it would be another phase two?
spk12: That would have to be the case, yeah. Okay. Yeah, I think that's all I had. Yeah, I think that's all I have for today. I appreciate it.
spk08: Thank you. Thank you. And we did have a follow-up come in from Hugh Kiley. Hugh, your line is live.
spk04: Thank you. Regarding the Matthew Lucas... release at the end of the year, Frank. Any feedback or intelligence? I think Emory's been about five months since they completed their study. Any insights if they made progress? I know the expectations were low from prior calls, but are you hearing anything on that?
spk07: Good question. We've been actively trying to get access to that information. I do know, however, that they initially were targeting 150 patients and then reduced that to 37. And most likely the reason is because of the pandemic, which imposed two years. We have not seen any of those results. which, uh, would be interesting. Um, and, uh, it would be, um, nice, nice, nice, nice to look at and share as well. So, but I have not yet, uh, seen anything.
spk04: Okay. As a follow-up to that, would, uh, appreciate that Frank.
spk12: Okay. Sorry. Go ahead.
spk04: I was just following up to the other gentleman's questions. Uh, Once the data is reduced and 24 presented, if it looks good, that's when you open up the discussions with potential partners for Monte Lucas?
spk06: Yes.
spk04: Okay, and then my last question would be on the cannabis side, would the other film or film companies that do not have the breadth or depth of Intelligenix Do you see any of those emerging as potential competitors to our products?
spk12: Not really.
spk06: What we see is and what we're hearing in this space is that there is a, at this point, still relatively small a patient population that is firmly committed to the films and that are certainly repeat consumers. And so the objective in the industry is to systematically grow that patient base. And that's what we're targeting.
spk12: Okay.
spk04: And then with the adverse product that's on your technology on the website, is there any interest in any partners entering in any collaborations in that product?
spk06: We have more or less discontinued that. Tommy, maybe you want to comment on, to the extent we can comment on, what happened with ADVERSA, with the ADVERSA program?
spk10: The ADVERSA program was divested, so we sold this program and we still have a residual royalty to Tetra BioPharma, so that's the microadhesives still. They own the IP for Canada and the US at the moment. If they're not doing anything in the future, we might want to see if there is anything we can do, but at this point, we're not pursuing anything. To be fair, we're really focusing our business on film, and since this was not related to film, we decided to divest it at that time, and we still believe it was the best decision.
spk06: To add to that, if we were contemplating any expansion of our technology portfolio, it would go into the trans-thermal space, where we are where we have actual conversations because that is a natural extension of what we do with the films. It does essentially require the same manufacturing equipment. So that's what we would be looking at if we contemplated our diversification of our technology portfolio.
spk10: Also, if I can add, we are always developing new film platforms, so although for investors or for the outside world, sometimes it seems like a plug-and-play, but every active is a new platform and a new technology, and we're constantly filing new applications and patents to expand our technology portfolio for films and in the future, transdermal.
spk04: And the... with the two dates before the FDA get approval, is there milestone payments anticipated for the two products on approval?
spk10: Yes, there is one milestone upon approval for Rizoport, which is now Rizoport, which I think is due 60 days, but I don't have the specific time, but there is, I believe, a $100,000 milestone, but... there is one milestone for Resupport for sure.
spk04: Okay. All right. Thank you. Thank you. Take care, too.
spk08: Thank you. And the next question is coming from Lindsay Murphy. Lindsay is a private investor. Lindsay, your line is live.
spk01: Hi. Thank you for taking my call. I just had a quick question and was wondering if there was any update on the Veriderm.
spk12: Which one? I missed that acoustically.
spk01: It was the Veriderm. If there was any update with the Veriderm.
spk10: I think she means Vivaderm, which is our trademark for transdermal.
spk06: Oh, okay. Yeah, I briefly commented on that before. We are in active discussions with a European company about two transdermal programs. So we have determined that the transdermal space, and that's where Vivaderm, the name comes from, is an attractive technology and an attractive market for us, so we're actively pursuing that. Like I said, we're discussing two opportunities. However, that's early stage, so it'll be a while until we can, until we'll be able to present any more tangible or advanced project. But principally speaking, there is definite activity in that space.
spk01: Okay, thank you. I really appreciate it. I apologize I missed that earlier.
spk08: No problem. Thank you. And we have a follow-up coming from Trevor Lee. Trevor, your line is live.
spk03: Hey, I just had one more thing I was just thinking of while listening. I know in the past, Horst, you said, like, you don't want to, you know, you're not about releasing fluff news or anything that's not concrete. Have you considered you know, just doing more to bring awareness to the company. Like, you know, if we need to raise capital in the future, I think bringing in investors or just bringing in awareness to the company couldn't hurt. Like, you know, having more of a social media presence or on Twitter with just, you know, leading people to the company via information about Alzheimer's or you know, some of the causes that we're looking to help. Is that anything that you might be interested in?
spk06: We definitely are. That is actually a subject that we're discussing very often and regularly. I mean, as far as outreach to investors is concerned, that is in Andre's domain. He's doing that, I think, going forward, and that was One of the many reasons as to why we brought David in, he will be supported by David, who has pretty significant capital markets expertise beside his BD background. We also have a communications group that regularly discusses what we can do in terms of bringing our message to investors. So we're trying to be more active in that space. It is recognized as an area that we need to step up our efforts. Tommy, with you being a member of that group, If you want to add anything, feel free.
spk10: Yeah, we know that we need to improve on the social media front. As for the hard news, the press releases, I mean, what you said is consistent. We want to only release things that are material, and we don't want to release press releases about nothing. So we will work as hard as we can to improve our social media presence, but the press release will remain hard news as the investor would expect it and not those press release that means nothing.
spk03: That sounds good. Yeah, I think the company could definitely benefit from just more of a presence just to bring awareness. The power of the retail investors has definitely grown as well in the past couple of years. I get to piggyback off that, you know, maybe more presence at conferences and stuff like that. I was curious if there was any sort of anything happened at the Roth conference on the West Coast.
spk11: Yeah, that's all day. Yeah, I mean, that was actually a very good conference. I met a lot of investors as well as, you know, Roth analysts. So we're expecting to to get some good feedback from that. There is, obviously, since we're on the Bolton board in the U.S., sometimes it might be a little bit difficult to attract a lot of health care institution. But I think that being on the big board in Toronto, that has improved our ability to attract health care institution from the U.S. But yes, there was good meeting and we're expecting more coverage too. We were present also at JP Morgan, not at the big conference, and there was a lot of interest from different banks and different analysts. So we're pushing towards that direction to get more coverage. We have one coverage right now from Canada, but I think that we're expecting and hoping to get a few more from the U.S.
spk03: Yeah, I think that would go a long way, like more analyst coverage and stuff. Yeah. Yeah, that's all I had for today. Thank you, guys. Thank you. Thank you.
spk08: Thank you. And we had a question from James Larkham from Ontario Limited. James, your line is live.
spk14: Hello, folks. Yeah, good to speak with you. This is my first time calling into one of your investor relations, but I've been invested long for a little while. I'm actually quite optimistic. David, you joining our team. You're, if I understand correctly, Rotman from University of Toronto Rotman. Is that correct?
spk09: Yeah, I did.
spk02: Uh, hi, thanks for the question. Uh, PhD university of Toronto and then an MBA at Ed Rotman at university of Toronto as well. Yep.
spk14: Amazing. Okay. Cause I, I, I did some work with CDL a few years back and, and in the quantum space. So seeing, um, what may be to the American market, uh, not necessarily the, the visible heavy hitter come onto the team. You may be here. Uh, can you tell me, um, When you were first approached by Intelligenix, what excited you about joining the team?
spk02: Yeah, I think that's a really good question. I think we're at a pivotal stage right now. You know, you have a company that's been around for quite some time now, you know, around 20 years in the oral film markets. And then the types of drugs that we're actually targeting, generics in particular, and I felt, you know, I'm a former analyst as well. You know, we've talked about my capital markets experience, but I mean, I was a former analyst. So, you know, the former investors question too around increased presence. I mean, I completely get it because I've worn that hat before. So I think, you know, just to go back to your question here, what excited me was the opportunities that we have, the markets that Intel GenX is competing in. are are quite large and the technology is second to none when you look at the technology itself you know the the only oral film uh type of technology within canada there are others obviously you know in other parts of the world but i think yep um with horse expertise and really the entire management teams here i think now's the time for intelgenics to really make inroads so I'm certainly counting on that and betting on it as I put my career on the line to join the company and move forward here. So I'm excited to see how, you know, things will turn, not just with, you know, FDA's upcoming decisions, but also more specifically and more practically around how business development is going to aid in further developments here.
spk14: Okay, I'm really excited that you're talking about generics, because I don't think everybody on this call really understands the lay of the land in Canada with regards to generic patents and drugs, because in the US, they have like longer term patents for research and development. But in Canada, we have, is it correct, five years on generic transfer?
spk12: Tommy, can you respond to that?
spk10: I don't know any specific. I know that patents have a 20-year lifespan, and I think this is the same in Canada as well. But to be fair, we haven't.
spk14: My understanding was part of the big reason why American pharmaceutical mail-order drugs were destabilized in the late 90s, early 2000s was because of the Canadian generics laws. But I could be misremembering. Regardless, I do think that there's a really big opportunity here in generic. So I'm glad to hear that that's the play. When you guys talk about taking on a $3 million cash infusion at an interesting time, I can't remember who talked about this, but I got the impression that you were saying, you know, this is a bridge towards something larger. We've got like something in the background and we don't want to take on like a, a $9 million infusion and, and give up like three, 5% of the company when, when that $9 million may be worth like one to 3% of the company in the near future is, is, is, I know that may be in the realm of speculation, but what kind of burndown are we looking at for 3 million when we, when we've just increased, uh, we've just added a, a, a headcount of, uh, 300,000 for, I hope, a successful position. But we're talking about a company of 20 to 40 people, right?
spk11: Close to 50. We're about 50 people.
spk14: About 50. Okay, excellent. Cool. I am sorry. I have tried to do my research as much as possible on Intelligenix. I'm really excited about the company. But so that $3 million across 50 people, that's looking like at most six months rundown, right?
spk11: I'm not too sure where you're taking that $3 million from.
spk14: I'm talking about the new note that you guys negotiated.
spk11: No, the note was $1 million that we closed earlier this month. And the $3 million that I referred to, no, the $3 million I referred to was a loan from a tie, our partners. Right. Okay. I am getting these two mixed up. Yeah. You're right. So we got that $3 million in January, and we closed. That's what's $3 million U.S., and we closed $1 million Canadian on a convertible note earlier this month.
spk14: Got it. Okay, I understand that. Then that $1 million is actually closer to what I was thinking about because that won't really last very long, would it?
spk11: No, I mean, the plan was not to fund the company long term. I mean, you know, we were planning initially. Sure.
spk14: So one could speculate that I think there was some rumblings earlier on in the call where, oh, you're going to have to draw in money again soon. And I just want other investors to realize that that's actually part of the game. But the idea is to, like, get as little as possible now so that you can get more later at a lower valuation. I guess that's just what I'm saying. Yeah. Yeah. Yep. Yep. That's the plan. Excellent. I'm happy to hear that. Really, that's all my questions, and I'm going to pass the floor and thank David for joining the team.
spk12: Thank you very much.
spk08: Thank you. There were no other questions in queue. I would now like to hand the call back to Dr. Harst Zerbe for closing remarks.
spk06: Thank you. This concludes our fourth quarter and full year 2022 investor update call. As always, I would Once again, I'd like to thank the entire Intergenics team for its hard work and dedication, our board of directors for their continued support of the management team, and finally, our investors for continuing to believe in and supporting us. Thank you all, and goodbye.
spk08: Thank you. This does conclude today's conference. You may disconnect your lines at this time. Have a wonderful day. Thank you for your participation.
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