[Foreign language] Björn Andersson. [Foreign language] Gabather [Foreign language] Michael- Robin Witt [Foreign language] Michael- Robin [Foreign language] Michael- Robin [Foreign language] Michael- Robin.
[Foreign language] Björn. [Foreign language] Björn [Foreign language] via Björn. [Foreign language] Gabather, [Foreign language] mental health disorders, drug development and drug discovery within mental health disorders. Gabather has been around for more than 10 years now. We are a classical Swedish biotech company started from research at university, actually University of Lund. We are a classical story of bench to bedside. The drugs that we work and develop, originally actually invented at the university levels, have gone through the innovation and commercialization system in Sweden. We've gone through different share platforms, public trading platforms, and now we are actually traded at Nasdaq.
This is a little bit the story about Gabather and the opportunity at Gabather right now.
Michael- Robin, I think you are on mute now.
Sorry, I guess you can hear me now. This is just a disclaimer to say that what I'm saying is a lot about information about things that can happen in the future. I'll try to be as concrete and forward-looking as I can. This disclaimer, I don't know. Sorry, I got to. Gabather opportunity, what will I show today in the next 25-30 minutes or so? I will show you that we got a track record in drug development and clinical trials, that we are about to start a Phase II clinical trial in patients, a very important step for a small biotech company, that we are trying to get a licensing deal. We will work towards this in 2025. I'll give some examples of licensing deals, both the ones that are very relevant and very close to our heart, like Saniona.
We will also show a little bit what triggers and news flow you can expect from us during 2025. A little bit one step back, what problem are we actually addressing and working with? We are working within the area of mental health, neuropsychiatric disorders. The unmet medical need in this particular indications, which in neuropsychiatry is enormous. If you think that one in four people will actually experience mental health issues and problems in their lifetime, not all of them very serious, but many of them are actually, the societal impact is enormous. The treatments that are currently available, there are treatments available, not for all of the disorders actually. All of the treatments that are available do have some serious side effects, limitations, not all patient groups can be reached. There is an actual need for an innovative step, a new medicines.
This is an ongoing process, of course, that many players in this field, that they're working in and developing new candidate drugs, in particular in the area of neuropsychiatry, which is actually a very, very challenging and difficult area. You need a lot of expertise in order to succeed in this area. The market still is enormous. It is actually expanding. If you think that many of the diseases we are working with, we try to address, target, and actually alleviate, let's say, an increasing market because many diseases are age-related. World population is getting older worldwide. Many of the CNS disorders follow that, of course. We're talking about close to one billion people that are impacted by some form of CNS disorders. I think we have developed interesting candidates, which we try to develop into the market together with a potential big pharma partner.
For that, we're looking for funding for during this emission specifically. The candidate drugs that we develop are innovative. They are new. We are one of the few actors. There are not so many in the CNS area. Of course, Sweden with AstraZeneca. AstraZeneca now stopped the research in R&D. Gabather is actually literally sitting in the old facilities of AstraZeneca developing CNS drugs. We have developed an entire pipeline of GABA-A. GABA-A is a neuromodulator, neurotransmitter. We developed a pipeline of drugs targeting this receptor system. Our main candidate I'm going to talk about most of is a drug called GT-002. It's a very interesting candidate. It's very potent, which is very good because you need to give very little of the compound. It's very selective for a particular subset of the GABA-A receptor system.
That means that you have very few side effects. Actually, in our case, in the clinical trials that we have done, no side effects so far observed, which is excellent. We have done this, our due diligence here. We put our compound through three Phase I studies in order to make 100% sure that this is a potentially interesting drug candidate once we go into patients, which is what we are doing now together with a study I am going to present later. In those three Phase I studies, we have not seen any side effects or any issues or concerns. If you look at the classical drug discovery pipeline here, if you go from left to right from discovery to Phase III, we have pushed the GT-002 compound. Our indication is cognitive impairment in mental disorders. Cognitive impairment means basically deficits in learning and deficits in memory.
Deficits in learning and memory are actually part of many, many disorders. They are also part of a normal stress reaction of healthy aging. It is an absolutely key component and a symptom component in many mental disorders. In our case, we have driven GT-002 from the bench in discovery in our own lab to Phase II now. The interesting thing is, and that is why I have indication one, two, three, just to show that because we are targeting and GT-002 has beneficial effect on cognition, we are targeting other indications also in the future. It is not only schizophrenia, which I am going to talk about later, but of course, all areas where we touch dementia, Alzheimer's, healthy aging. Anywhere we have cognitive impairment, GT-002 could have an interesting profile.
Also in this slide, I want to show you that we do have, of course, a pipeline of compounds and molecules similar to GT-002, which because of resources and limitations, since we are a very small biotech company, we do have those compounds in the pipeline, but we have not been able to develop them further than into potential CD selection, which we could do this year for a next follow-up drug. We've very much pushed GT-002 forward into the clinic, which is what everybody in drug discovery wants to see. It's very good to have a lot of preclinical data, but at the end of the day, you're trying to develop a medicine. The proof is actually not in the pudding, but the proof is to push it through to Phase I, show that it's safe and well tolerated. We've done that.
Now we have to prove in Phase II that it actually does help, is beneficial in a patient setting. You actually can say to yourself, it accomplished the mission that we wanted to do. The way there for Gabather, at least, has been a number of Phase I studies, so-called SAD, which is a single ascending dose, followed by a MAD study, multiple ascending doses, where we take different doses up to a certain level to see if it's tolerated. We've done studies looking at so-called target engagement, which just means that does your drug, when given orally, actually penetrate the brain? There's a brain-blood barrier. Once it's in the brain, does it modulate the brain activity in the way that you want it? That we've shown with EEG, with data which we already have published.
We're going to show it with fMRI data very soon too. In Q1, relevant for the discussion now, is the start of the clinical phase study in schizophrenia patients together with a center in Denmark and Glostrup, actually. I will underline more than once in this presentation that this is a fully funded study, where the logistics, patients, clinical trial material, ethical approval, practical approval is all in place. It will start in Q1. A little bit of background for those people who are interested, what is our specific approach? Gabather has put a lot of emphasis on biomarkers using EEG, electroencephalography, and neuroimaging, i.e., fMRI. The data that we present on GT-002 are on exactly EEG and fMRI.
We've done the studies because we believe that it's the functional connectivity in the brain that's a relevant biomarker to see if your drug actually modulates the brain activity in the way that you want. On the cartoon on the left, you can see I put GT-002 in the middle. If you think the effects in cognition, learning, and memory, they are present in all the disorders around the circle of GT-002, be it substance abuse, cognitive impairment, dementia, Alzheimer's disease, or schizophrenia. They all have a component of cognitive impairment, which is the one that we hope and we're targeting GT-002 to address, actually. The potential for GT-002, in my opinion, is a very, very interesting one.
Since we have clinical trial material and we have just received approval from the Danish authorities to run trials in patients, of course, now people are approaching us and asking if GT-002 can be also interesting. In other diseases that we, for example, have never thought when we started this project, one of the things I must not forget to mention is long-term COVID, which has definitely a component of learning and memory deficits. Could GT-002 be interested, for example, in treating this kind of disorders? I think it's an interesting thing, something that we, of course, when we started the project, never really thought about. I'm going to repeat myself a little bit and say a little bit of being proud of being to this step, at least. Three successful Phase I studies is quite unique.
We wanted to be 100% sure that this drug, knowing how potent it is, that it is safe. That was number one, our number one goal. That was proven, we've proven also. Bullet point number one, it's orally available. This is not a trivial characteristic of any drug. This is a drug that is orally available and has a pharmacokinetics, i.e., a metabolism that gives us to once daily treatments, which is a fantastic good logistic way in a medical setting that you don't have to do any infusion or any advanced and very expensive and very resource-consuming treatment. There's literally a capsule. It's on the right-hand side of this cartoon. That is actually GT-002 capsule that you can give once daily. It's well tolerated and safe in multiple dosing settings also.
That means that you can give this drug over a number of days, two, three weeks to start seeing the effects. It's a drug and a chemical component that you can upscale, which is also not trivial without problems. We've actually done lots of progress on this. We have developed our first product form, and we've also shown that it reaches the brain. We've also shown that it modulates the brain activity in the right direction that we wanted to do. Basically, we've set up everything up that the clinical Phase II study should be as positive as possible for the results of this trial that can be expected. This is as good as it gets prior to a clinical Phase II study to have this kind of a profile of a pharmaceutical agent, in my opinion.
Here, in this cartoon, it's just to show because there's a lot of focus on the Phase II trial, of course, everybody's interested in. As I said, this is a trial that is funded by the Innovation Fund Denmark, which is a competitive bid. Actually, well done, Gabather, to actually participate in this together with the Center for Neuropsychiatric Schizophrenia Research in Denmark. I have just shown these two slides that the approach, that's why it's innovative, and that's why we get funded by an innovation fund, that our approach to treating schizophrenia and the cognitive impairment on the right-hand slide is actually different to the standard approaches of treating schizophrenia, which target two other neurotransmitter systems, the dopamine and the glutamate systems.
Ours is a new, literally a new way of treating cognitive impairment in schizophrenia with modulators of the GABA-A receptor that are different to benzodiazepines and do not show sedation and do not show drowsiness and actually improve cognition and do not show cognitive impairment like the benzodiazepines. Of course, we have no issues with dependence and addiction whatsoever. That is where the innovation part actually comes in. This is for those people that are really interested. All I want to highlight, I will put this presentation on our website later on. Link will follow later on. All I wanted to say is that the design of this particular trial, the TOTEM trial with GT-002, in my opinion, is very, very good. It is very, very interesting.
There's a so-called crossover design where the same patient is treated with three different agents, a placebo, GT-002, and a reference compound. What you then actually do is you compare the effect of these three agents within the same person. Every participant in the trial, every patient, is its own control. I think it's very important to mention we are not comparing one huge group of people, A, treated with one agent and group of people, B, treated with another agent. We're comparing it in the same person. That way, you get rid of the differences between individual people. In my opinion, crossover design is extremely good. The data that comes out just has quite high quality.
It's, of course, challenging because logistically, you have to make sure that the same patient comes in to three different settings, three different measurements with a time in between to wash out the drug. I think it's a very good design, actually. The publication of the design alone is already on the way and will be presented at the end of this month already at a meeting in the U.S. I'm going to come back to that later. What triggers can you expect from us? The approval of the TOTEM, we have already done that. We do the refinement of the EEG and the start of the TOTEM trial, which should happen in March, Q1. We'll hold this deadline. We got preclinical data from the pipeline compounds. This I talked before that we have these compounds in the pipeline ready to go further with them.
What will happen is once the TOTEM trial starts in Denmark, the clinical trial material is delivered and the patients start coming in, we can go back to our own work. At the same time that the Phase II trial is going on, we can push our other candidates in the pipeline here. This we can do at our own speed. The trial is, of course, happening in Denmark, so it's not so much that we can do hands-on, but hands-on we can do here getting new candidates in other than GT-002, which we already tested, actually. We will start getting the preliminary data from the clinical trial in Q3 this year. Once the patients are in, the first patients have gone through the three different kinds of trials.
Just to underline what will the information flow, remember that this is we're working together with an academic group, and they are more than eager to publish the results as quickly as possible as they come out during the trial within the constraints, of course, that you have to perform the experiments first, get the data in, get the analysis out. I also want to say that we've been working together with the National Institute on Drug Abuse in the United States for a couple of years now. They were interested in GT-002 in the treatment of opioid addiction, in particular, opioid addiction withdrawal symptoms. We expect them to have a summary of our collaboration in Q3 2025.
This has nothing to do with the clinical trial in Denmark, but it's relevant to mention because NIDA definitely thinks that GT-002 has an interesting profile for them, of course, since the Institute for Drug Abuse, in particular, to opioid addiction. Who knows? We'll see once the data is compiled and presentable. I expect this to be in Q3 2025. Our goal, and I'm going to go a little bit more in detail on this for 2025, very ambitious. If we take about one year, we are already into Q1 2025, Q4 2025 to go into the licensing agreement with GT-002. The licensing partner would most probably be medium or large-sized pharma that are working with CNS. I'm going to give some examples of what kind of agreements you can expect.
We are very opportunistic regarding who we want to partner and how we want to partner. This can be an out-licensing deal. This can be a co-development deal if somebody wants to look at GT-002. Another indication that what we are working on can be somebody that's interested in running clinical trials in their particular indication. Of course, it can be also people or potential partners that are interested in preclinical work because, again, we do have a pipeline of these compounds. Again, we are not an in-licensing, out-licensing exercise. We literally create the molecules, and we know how to create more of them in our lab. We have put them, at least in the case of GT-002, all the way in the clinic. I think that's actually a little bit of an achievement.
I'll give you some examples over the last years and give you some more interesting recent ones. These are agreements between small pharma and big-side pharma in areas relevant to cognition and/or schizophrenia with different partners. You can see roughly the numbers we are talking about. They are all in the two- up to three-digit million U.S. dollars in this kind of agreements at different levels. Of course, this can be Phase II, Phase III clinical trials just to show you who are the players in here. There is one company that's been our reference. It's Sage Therapeutics in the U.S. That is because their molecule also targets the GABA-A receptor system. It's a completely different chemical structure than ours.
Just to show you what kind of potential there is in compounds that target the GABA-A receptor in particular, and to highlight SAGE-217 , which was used in depression, actually, and not in cognitive impairment. They made a very significant agreement with Biogen. The data on the pharmaceutical properties, for example, of this drug, I think GT-002 compares very positively if you think that GT-002 is a drug that's already available for once daily treatment. This is the arena we are in and very much closer to home. Again, an example, what are the potential in this kind of project? On the left-hand side, you see an agreement between Acadia Pharmaceuticals in the U.S. and Saniona. Saniona also works in the area of CNS, of course. They're also on Nasdaq First North Growth in Stockholm.
They do small molecule development on GABA-A receptor modulators like we do. They made an agreement with Acadia Pharmaceuticals with $28 million upfront, three digits in U.S. dollars, million dollars in milestones. Here, I just want to highlight that they are actually starting the Phase II clinical trials, Phase II clinical in 2026, i.e., next year. We are starting Phase II clinical trials in 2025, now in March. It is an example of these are the kind of agreements we are working towards.
Just on the right-hand side, I just very briefly want to show that the need for innovation in the treatment in schizophrenia, in our case, we're treating the addressing the cognitive impairment, of course, is enormously big because the big news was actually that the FDA approved, I think this was from the end of last year, a new treatment regime for the treatment of schizophrenia. It was the first of these approaches within decades. Many of the drugs are actually not only old, but the innovation step is very low. The threshold to actually getting something exciting and new is relatively low, but it's, of course, very difficult to reach. These are the partners we are targeting in partner meetings, flyers, business opportunities that we mentioned. Some of them we've already talked to. We are certainly on the radar of most of them.
Just want to highlight here that companies like Takeda and Lundbeck, for example, they're very active in particular in cognitive impairment in schizophrenia. Developed a collaboration, a lot of drugs and companies like AbbVie, Johnson & Johnson. I'm going to give some examples in a second there, of course, active in the partnering arena within the CNS area. Here I've given you some recent transactions in the CNS area from March to January 2025. Of course, the partners of big pharma on the left-hand side, BMS, AbbVie, and J&J, they're, of course, companies. They are bigger than Gabather. Maybe it's not 100% fair and relevant. I think I just wanted to show you what kind of agreements.
In the case of the third example, J&J, if you would look at the link, the agreement they made with Intra-Cellular, now we're talking actually billions of U.S. dollars, which is, of course, not what we can expect. Smaller companies like AbbVie and Cerevel, AbbVie and Karuna, these are CNS deals. They are definitely something that are roughly in our league, so to speak, and reachable. For Gabather, if we can succeed in getting the runway, starting with the Phase II clinical trial, keep up the news flow, and go towards the idea, the milestone for us, or the goal for us to achieve a licensing agreement for Gabather. I think, more or less, the summary of what I've done, repeating what I already said, I think I've shown focus very much on what deals are being done.
I think Gabather has shown that we can do our work. We've got a compound into Phase II clinical trials, a funded trial. This trial duration is a minimum of two years, and it's funded for these two years. The largest part of the logistic effort isn't actually in Denmark. The whole project group is more than 12 people, actually. It's, of course, based on GT-002 and the innovation step in the treatment of schizophrenia. We have more compounds in our pipeline we can develop. I've shown you a little bit what news flow, what triggers we can expect in 2025. I want to also highlight not only that the clinical Phase II trial is funded, but also that the runway extension we are asking for is actually based on a very low burn rate.
We have actually adapted Gabather for 2025 to be able to focus on a licensing agreement for which we, of course, we can't do everything ourselves. We definitely will get consultants and business development people in 2025 to achieve that goal. With that, I'm about to give back to Björn, but not without saying that first presentation of GT-002 is already in a couple of weeks at the end of March, the annual Congress on schizophrenia research, where the group in Denmark will be presenting GT-002. Of course, people track us and follow, and they already got some questions about GT-002 regarding this poster presentation. We have been invited to join also the Innovation in Psychosis Therapeutic Summit in Boston in June. All the information I've given you, I would put it up. We will put it up on our website. Website link is here.
If you want to know all the nitty-gritty and the presentations that I've given and the background or some of the info, it's all on the Gabather Investors site regarding this particular rights issue in 2025. Anyway, any specific information is my email address, of course, there. It's also on the website. With that, I say thanks for your attention. [Foreign language] Back to, not headquarter, back to Björn.
[Foreign language] Michael- Robin. [Foreign language] Michael- Robin. [Foreign language] Gabather [Foreign language]
Gabather [Foreign language] GT-002, [Foreign language] clinical trial material.
[Foreign language] Gabather. [Foreign language]
[Foreign language] 2025, [Foreign language] 2026, [Foreign language] EEG [Foreign language] 25 [Foreign language] 25 [Foreign language] crossover design [Foreign language]
[Foreign language] 2026.
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[Foreign language] EEG fMRI [Foreign language] fMRI, EEG, [Foreign language] fMRI data [Foreign language] EEG-fMRI [Foreign language] EEG [Foreign language] fMRI [Foreign language] med EEG, [Foreign language] fMRI data [Foreign language] functional connectivity.
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[Foreign language] Michael -Robin. [Foreign language] GT-002 [Foreign language] med GT-002?
[Foreign language] med GT-002. [Foreign language] Plus [Foreign language] GT-002 [Foreign language]
[Foreign language] GT-002 [Foreign language] GT-002 [Foreign language] GT-002 [Foreign language]
[Foreign language] GT-002. [Foreign language] Gabather's pipeline. [Foreign language] GT-002. [Foreign language] pipeline [Foreign language] GT-002, [Foreign language] GT-002 [Foreign language]
[Foreign language] pipeline. [Foreign language]
[Foreign language] Gabather [Foreign language]
[Foreign language] SEK 400,000 [Foreign language] SEK 5 million [Foreign language] Gabather. [Foreign language] licensing agreement. [Foreign language] fully funded. [Foreign language] å Gabather.
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[Foreign language] information [Foreign language] all information [Foreign language]
[Foreign language] Michael -Robin. [Foreign language] Gabather [Foreign language]
[Foreign language] Gabather [Foreign language]
[Foreign language] partnering [Foreign language] GT-002 just [Foreign language] Gabather [Foreign language] target engagement. [Foreign language] lean organisation.
[Foreign language] Gabather just [Foreign language] opportunity.
[Foreign language] Michael -Robin. [Foreign language] Gabather [Foreign language] Gabather [Foreign language]