Välkomna alla. Som ni kan höra, svenska är inte mitt modersmål, så om det är okej så kommer jag att köra själva presentationen på engelska. Men alla Q&A eller frågor efter det är såklart på svenska. Jag har bott i Sverige ganska lång tid, men alla slides är faktiskt på engelska, och några nyckelord är också på engelska, så vokabuläret är scientific English, so I'm going to change over to English right away. It's nice to be able to present Gabather, a small Swedish biotech company. We work in the general area of mental health disorders and developing therapies in the area of mental health disorders. We work with one particular neurotransmitter system in the brain that's governed by a compound called GABA. As the name comes from GABA Therapeutics. An ultra-short agenda of what I'm going to talk about today. Gabather itself, as I said, Swedish biotech.
We're listed in Nasdaq First North since 2018. Our research and our compounds, our molecules come from actually research at Lund University and Sankt Hans Hospital in Denmark many years ago. They were then patented and taken over by the Swedish Innovation System. We have developed a track record in CNS drug development and clinical trials. We've run quite a number of them. Today I'm going to present one key asset actually in our therapy pipeline, GT002, and talk a little bit about the clinical trial we are about to start together with the partners in Denmark and our plans for a licensing deal within the next year. Just to take one step back here, what are the issues in neuropsychiatry and the therapies that are available? First of all, the unmet medical need is absolutely staggeringly big actually regarding CNS disorders.
We must remember that many CNS disorders, i.e., neurology, psychiatry, are age-related, and we have an aging population worldwide. There are many people that suffer from severe mental health disorders in their lifeline. I think we all know, at least I heard of somebody. There are actually no adequate treatments, and those treatments that are around, certainly there's a lot of room for improvement, for innovation, and that's where Gabather comes in. Many of the treatments either have no effect at all. There's things like autism, for example, as the neuropsychiatric disorders. All the ones where you have treatments, they are actually severe side effects in some of the therapies.
The market opportunity within this area, I'm going to go into a little bit more detail later, is absolutely enormous, both regarding what can be done when licensing agreement, but also, of course, the impact in society in general and socioeconomic. What we have done over the last, yeah, soon 10 years, we've developed a pipeline of GABA A receptor modulators. This is a receptor in the brain that keeps actually the balance in the brain. The compounds that we have are small molecular compounds. Again, a technical term. It's just a nice technical term for the simple molecules. Think aspirin or paracetamol. This is not an antibody, and it's not a gene therapy. Very simple compounds, which has quite a lot of advantages, in my opinion at least. The compounds are very potent.
You need very little of the medicine in order to see an effect, and they're very selective. That means they only target this particular receptor combination actually in the brain that we are interested in modulating. That means that they don't have any side effects. We have shown in many animal models that it improves learning and memory, which makes this compound very, very interesting because deficits in learning and memory you have in many situations in neuropsychiatry in particular. The classical hallmark, I think, of a memory and learning and memory deficit is Alzheimer's disease. This is very interesting for us: schizophrenia, depression, stress, ADHD, autism. All these disorders have some component of learning and memory deficits, i.e., cognition. We've also shown that we have positive safety results. This is a safe, well-tolerated drug. This is very, very important for us.
CNS drug discovery development is a risky business. You have to be careful with compounds that are potent and selective. We're starting a phase two clinical trial. I'm going to do a little bit more about it. We're going to present it actually yesterday. Society for Neuroscience, w e're starting to release some of our data that we have on something that is just a neural fingerprint. With imaging techniques, actually, we've shown that GT002 affects the brain in a very, very particular and I think very promising and interesting manner. The drug development process we've done at Gabather, it's very, you would see the same kind of process, gun chart or pipeline in any drug company.
I want to just highlight here is that we have focused very much on one compound, which we have driven all the way from discovery into phase II now, where we want to see if we can achieve a licensing deal. The indications I'm indicating, I'm suggesting here is the indication we're working on now in a clinical trial in patients that suffer from schizophrenia is one indication. There are other indications possible with GT002. Phase III is still beyond us. This is still quite a time away, and we actually would be very happy to find a partner to push it to phase three. I also want to highlight that we do have a pipeline of compounds which we have not been able to push through all these phases, but they're in discovery. They're literally in the laboratory here in our headquarters here in Södertälje.
They have been tested, and they have the potential for being developed. We have actually released some of the initial data on our pipeline in our presentation at the Neurosciences meeting yesterday. The poster for that presentation is on our website and was on the press release that we had. Status of GT002, t his is three successful phase I studies. That means healthy volunteers. We have developed an orally available daily dosing drug. This is safe, well-tolerated. This is non-sedative. It does not slow you down or make you sleepy, drowsy. It is a very stable compound. It has a very low cost of goods. This is, again, very important. If you do a drug discovery and you have a compound that is either expensive to produce or unstable, once you have produced it, you are in trouble. We do not have any of these issues.
In fact, last month we got the stability data, and this compound has been stable for four years now, and it's looking very, very good. We got a strong IP. We have IP consultants based in the U.S. And they give very good advice with all composition of matter patents, formulation patents, synthesis patents, and we're working on patents on looking at the neural fingerprints too. It modulates the brain activity. We've shown that in imaging techniques, and it has a unique signature how it modulates the brain. To go there, I have to again apologize. This is very technical, but all I want to point out is that our approach to developing a new drug has been very much focused on imaging techniques, i.e., EEG and fMRI. Within imaging techniques, we've looked very much at what is the effect of these two parameters in relation to cognition.
Cognition is a mental process involved in, again, learning and memory, thinking, language, all the information that we get, process, and then put out back into the world. That has been quite unique because, of course, EEG and fMRI, you need quite unique competence in order to develop a drug using this as biomarkers, i.e., as indicators of the effect of your drug. The neural fingerprint, what we want to achieve with this is actually very straightforward. A disease state, say schizophrenia, has a certain neural fingerprint. There is a certain pattern in the brain activity. Our drug induces also its own pattern, of course, and if you move from left to right, but we want to apply the drug to a disease and in that way, normalize the fingerprint, the activity pattern in the brain to a healthy condition. This is quite advanced.
We're looking at network activity in the brain, how different areas of the brain talk to each other in a drug discovery setting, which is, at least in my experience, and I've been working with this for 30-something years, as advanced as you can get as a readout of what your drug actually does to the brain. The EEG findings and the fMRI engineering behind this, this non-sedative and pro-cognitive, and with signature is that I mean a fingerprint. If the brain has a certain network engagement when you do cognitive processes, the brain has a certain activity pattern signature. GT002 induces that kind of pattern in the healthy volunteers. It drives the brain towards a cognitive state, if you can put it that way.
That's why we think it's actually very, very interesting, both as a biomarker, but also it suggests that if it can do the same in people that suffer from a disease from an altered signature, that you can actually correct that one. If you look at then, what are the potential if you have that kind of profile? It's not only schizophrenia, which we're working on now, but of course, very interesting. I got a lot of questions about this. What about Alzheimer's, mild cognitive impairment if you had a stroke, for example? What about ADHD, PTSD? All these neuropsychiatric disorders have a cognitive component. What about Gabather? What triggers can you expect if you're interested in joining the journey of Gabather here? In Q4, we know we're reaching the end of it. We have the publication of the TOTEMS study. It's already done.
We presented it to the neurosciences yesterday. That poster is actually going to be up all the way until December. We were going to initiate the trial at the CNSR in Denmark. A little bit more about the details of that, I think it's very important a little bit later on. We will submit the publication and we'll do a press release if we do that on the neural fingerprint issue. We are still working on preclinical compounds. We have a lot of data on that that we're going to release. I think if you look at the bigger picture of Gabather, we have sort of neglected a little bit the pipeline compounds, which could be interesting. It is a question of time and resources. We have to show that we have a drug that works in the clinic, of course.
Of course, the next steps are GMP tox studies with the next clinical candidate as we go through 2026. The idea for Gabather is, of course, to reach a licensing agreement with GT002. We're given an example of what potential licensing agreements have in this relationship. This can be partnering, can be co-development, it can be an MTA that people actually acquire our drug because we have a clinical material now and do their own studies together with Gabather. To come to the core of what is actually starting now, the trial I meant, this is a clinical trial where we look at cognitive impairment in schizophrenia. It is a trial we do together with the CNRS, there's a group in Denmark at the hospital in Glostrup. The trial is funded for its entirety by the Innovation Fund Denmark for the duration of two years.
We are looking at 25 patients and 25 healthy volunteers. We're looking at modulation and cognition tests and in the EEG pattern after application of GT002 compared to classical benzodiazepine. This is a little bit more concrete. What can you expect of deliverables on a clinical trial in the TOTEMS trial in schizophrenia over the next three, four quarters? Site initiation is actually ongoing. The team in Denmark is in place and waiting for the clinical trial material, which should be over in Denmark actually next week, being produced today. We had some issues with this material. We've solved all that. We're marching forward. In Q1, we see the EEG, fMRI data. We'll confirm what we've seen in the healthy volunteers. Hopefully, this data will also have an effect in the patients because now we do a patient trial.
I think the first pharmacodynamic observations, this is only at the observation level, but it's very, very interesting for us when the first feedback will come on how does the effect of the drug actually look like. Marching through Q2 and Q3 next year, we'll be doing both an analysis and the safety data in the biomarker data, sorry, in Q3 and in Q4. This is what one can reliably predict as deliverables for this particular project. Of course, everybody wants to see patient data, efficacy data as quick as possible. I think this is a realistic thing. I think Q1, by the end of Q1, we should have a good idea if this program is going to work. To wait for QA interim reports, you will have to wait until Q2, Q3, 2026.
Having said that, Gabather is actually chairing the committee that runs this particular trial because Gabather delivers the clinical trial material and the expertise how to run clinical trials because we've done so many. We have actually firsthand and direct information on the progress of the trial that we then can communicate, which is actually nice. We're not only sponsors, but we are literally on the driving seat there. Regarding what can we do then once we have the trial going, hopefully good data coming in, whom can we partner and license to? They have the usual suspects on the right-hand side, big pharma and medium-sized pharma, of course. Many of these companies we've already talked to. We're already in discussions with them. They've followed Gabather for a long time, some more than others, but AbbVie, for example, we've exchanged the CDAs and so on.
What can we do? We can do co-development. We can do preclinical development and licensing opportunities for material transfer agreement or clinical collaborations in general. I think it's quite an asset to have clinical trial material of a new drug that is actually safe and well tolerated that targets the trial. There is also interest in clinics in general in other indications than the ones that we're doing now, which is cognitive impairment and schizophrenia. I have one example. I was thinking a lot about this example. This is a company listed also on Nasdaq First North. They also work with GABA A receptors, small molecules. They have an indication which is called essential tremor, which is shaking of the hand. They made a deal with Arcadia Pharmaceuticals in the U.S. The deal is, I have the details there on the slide.
I think it was published $28 million upfront, but total depending on what milestones you achieve, up to $580 million milestones in the overall deal, royalties in double digits, which is all very nice. I just want to point out that this particular compound is in clinical phase I, and they published this data in October 2023, last month. If you compare this as a comparator to GT002, we have three clinical trials for safety and tolerability and one imaging and biomarker trial in healthy volunteers. We are starting a phase II trial in patients. I think if you look at the value, what can you expect from a GT002 agreement? I think these are sort of the minimum figures that are sort of fair to compare with Gabather. It should start in this area and then actually move upwards regarding the volume and the numbers.
Finally, I just want to put on GT002 itself. If we look a little bit beyond, and in particular with the funding of the company that we're doing right now, what else can you do with GT002 in the sense of innovation? What I've talked a lot about is Alzheimer's disease and cognition and cognitive enhancers. There, of course, there are no really good, in my opinion, no really good treatment for Alzheimer's disease, certainly not disease-modifying. Even if you have it with GT002, with a safe and fast-acting cognition enhancer, potentially, because we know that GT002 enters the brain rapidly, it also leaves the brain in a reasonable time for daily dosing. That will be very interesting to look at in all areas, Alzheimer's and dementia, for example, within the GABAergic therapies, comparators.
If you look at compounds like neurosteroids, which are also working on the GABA A receptor, the same mechanism, but they have not really that impact on cognition, but they do have an impact on mood, and they're actually used for the treatment of depression, postpartum depression, actually, with the Sage Therapeutics and Biogen deal a couple of years ago, quite significant. Finally, of course, in cognitive impairment and schizophrenia, which is what we're addressing right now. There is quite simply no treatment for this particular disease right now. That is where GT002 really has the first and very big impact. We would be the first biomarker-driven drug that can address this particular condition. I think we are both from an indication therapy area point of view and from our approach, very innovative. I think we're well positioned in this area.
I think this is, if not the last, then the next to last slide. Yeah, this is just the team. I mean, I just want to show that we are all rather experienced, to put it politely, in this area. Myself, I've worked like 30 plus years in drug discovery, both in big pharma and small pharma, my own company and so on, Gabather for the last eight years, and I've been CEO for the last seven. The team that we have is actually well- positioned. We got the founder with us. We got the scientific expertise, and we also got the legal expertise if we're looking into negotiations for agreements. I think this is the Gabather story in brief. I hope I have given you a little bit of an overview. I think this is all I had to say for today.
There's a lot of info on our homepage. There are a lot of interviews, question-and-answer sessions, videos. If you want to know about Gabather, the Gabather story, our philosophy of working, actually. At the end of the day, you're always welcome to contact me at Gabather. I'm here on duty 24/7. Having said that, I think I will switch both back to Swedish and back to Björn.
Yep. Hi, Michael-Robin. This is Pavelan, a colleague of Björn Andersson, who unfortunately had to step out of the meeting.
Oh, okay, okay. I didn't notice that. So sorry.
Björn had to leave the meeting for a personal acute matter that he had to attend to. You and I know each other really well also.
Yes, that's right.
I'm not quite sure if the question that has been posted in the chat function has been asked to you.
If not, I will read it out.
Okay.
Hi, Michael. Given your small team and constrained financial resources, what strategies and operational frameworks will you use to prioritize development, manage risk, and ensure successful execution?
The only thing, yeah, of course. The team is very small, but we have a huge network, which makes things both very easy, but also it's a certain risk. The problem is that there are many parts of the operational aspect that you refer to, which I cannot really control. For example, production of clinical trial material is done by a third party. Production of the API is also done by a third party. The key thing for us is that we have good control over the way the clinical trial in Denmark is managed because we are part of the team and actually chairing that.
We will also, of course, get support, in particular for third-party support for investor relation/business development as an expertise from outside, which we're going to fund with the resources that we're getting in now because that is the one that is which is not really the area of expertise of Gabather management right now. My area of expertise, I'm a neuroscientist, and we can drive the clinical and the scientific part forward on our own. For that, we don't need. For the business development and the investor relations, we definitely upgrade to third-party expertise from outside in form of consultancy.
Thank you, Michael. I have no further questions at this time. If there is one last question, please be quick to post it. Otherwise, I will, on behalf of Westerhamnen and on behalf of Gabather, thank all of you for participating today.
Thank you, Michael, for a good presentation.
Thank you.
Bye.