Shall I mention, my name is Thomas Feldthus. I'm CEO of Saniona, which is a clinical-stage biopharmaceutical company, focused on neurological and psychiatric diseases. We are centered around a quite successful partnership business model. Here are some reservations for forward-looking statements. In the last two years, we have entered into two major deals. A licensing agreement with Acadia in 2024, a total deal value of $600 million. Then last year in August, we announced a collaboration with Jazz in a total deal value of $1 billion. Those two deals generated upfront payments of about DKK 700 million. It has been driving our revenues quite significantly and also profitability in the company in the last two financial years.
At the end of February, we had a market cap about DKK 2.6 billion, and we are quite strong financial position thanks to these collaborations with about DKK 580 million in cash at the year-end. If you're looking for planning purpose, then we have, in our view, DKK 820 million crowns available for internal development because we have some two milestones coming up soon from Acadia and Jazz, these companies when they start the first clinical study after signing the deals. We acquired our headquarters last year, and we plan to, at some point, make a sale-leaseback transaction in order to get the money back.
Saniona is a leader in ion channel drug discovery, which is relevant for CNS diseases. I think I can say that we have been validating this. We have been doing numerous collaboration agreements around this platform with major pharmaceutical companies and biotech companies, and more recently by out-licensing some of our assets coming out of this platform. This partnership model has, you know, been very good for us. It has generated a strong cash position and enabled us to partially self-finance growth. This means that we now are in a situation where we can both develop products in collaboration with partners and internally in order to capture more long-term value in the programs.
Today, the situation is this, that we have a validated platform, we have strong partnerships, and we have a CNS, differentiated CNS pipeline entering clinical development. Our internal programs address two areas, epilepsy and treatment-resistant depression. In both diseases, about one-third of the patients do not respond properly to the existing therapies. This create a significant unmet medical need in these severe diseases, and good opportunities for differentiated product to bring forward. This is exactly what our platform is developed for. This bring us to my internal pipeline. Our lead compound is SAN2668. It is persistent for severe pediatric epilepsies. It has shown very high efficacy similar to benzodiazepines, which are the most effective drugs on the market, but not used that often, because of side effects.
They are kind of reserved for rescue medication in hospitals. This compound is just as effective, but do not have the same side effects at all. We have SAN2465 for major depressive disorders. It is designed to have a rapid onset for treatment of depression, but without the side effects seen with esketamine, which it will compete with in the market. Finally, SAN2219 for which we are proceeding for refractory focal onset seizures. Here we have no sedation at all, so this is very helpful for this type of patients. We have two partnerships, Acadia and Jazz. Acadia is now developing an ACP-711 towards phase II clinical studies for essential tremor.
Jazz has got a license to SAN2355, which they will take into phase one soon for epilepsy. These two deals I said they have a significant milestone payment, so they will create a lot of value for the company in the coming years. We got $70.5 million up front. We will get $340 million in development and regulatory milestone payments, bringing the total to $410 million. After commercialization, we have commercial milestones of about $1.2 billion, so the total deal value will be go up in $1.6 billion of those deals. We have royalties on net sales.
While we are developing our internal pipeline, we have some meaningful non-dilutive income coming out of this, these collaborations, in terms of development, which we cannot count on, but will be helpful during the process. Going to our internal pipeline a little bit more about them. SAN2668 is a GABA alpha 2/3 modulator with a balanced activity of alpha one activity. It is a first-in-class compound coming out with this profile of anything, I think, in clinical development. We have targeted it for developmental epileptic encephalopathies with ESES as the lead indication. This is an epilepsy in children, which is diagnosed typically in the age of one to four years of age. They are very severe. They cause harm to the brain. They have mental development delays.
Some of them also have it prior to that from some underlying disease. In ESES, it's very difficult. There's no approved therapies, and some of them are. They cannot learn anything. They can't remember what happened the day before. Sometimes they even are losing the skills they already acquired before the disease came, such as they are losing their language. It's a very severe disease. We think that this compound has some very interesting elements, not only because it's controlled seizures. In animal models, we have tested in numerous animal models and we think actually it's more effective than the best which exist on the market now. But it also has some characteristics which address the underlying problems for these children causing the mental delays.
That makes it very interesting for these types of patients. We both have something controlling the seizures, which will be very helpful to stopping it, but it may also actually improve cognition in these kids. This is something which we're looking very well forward to develop. We take it to start with ESES, but we also conduct a basket study, we think, over time, so we move into other indications. The ESES by itself is a meaningful market, but it would become a billion-dollar product if we go into a broader indications in DE indications. SAN 2465 is a GABA alpha five modulator. It's a negative allosteric modulator. Alpha five is only making up 5% of the GABA ion channels in the brain, and they are all located in areas where you control mod.
It's a very selective mechanism. It goes into the same pathway as esketamine, which is used when nothing else is used in these type of patients. It has to be given in the hospital setting. It's something which was developed many years ago to as an anesthetic to horses. Now it also is used in humans for depression, but it comes with a lot of side effects. This one drug swipes into the same pathway, but through a much safer and much better tolerated mechanism. We have seen in this model, in animal models, that it takes away the symptoms typically seen in epilepsy just as fast as esketamine. It lasts for several days after the drug has left the body, indicating plastic changes going on.
It's a very interesting concept to bring forward. The risk is higher here compared to the other drug, but so is the rewards. It's a huge market. Finally, SAN2219, which is a little bit similar to the first product, but this one is designed differently, only addressing two, three, nothing on alpha one. It has shown very strong efficacy in epileptic models. It has perfect PK, and we don't see any sign of sedation at all, and we therefore position it for focal onset seizures. It means adult epilepsies, where people need to go and work and have a daily life, and we think that would be very suitable for this drug. These are the three we are investing in.
What we plan is to start phase I clinical studies around year-end 2022 this year, and one early 2027. These will be done in healthy volunteers as the yellow color here. We have here a standard single ascending dose study in humans, and then it goes over to multiple ascending dose. After the single ascending dose, we will conduct a so-called PET studies . We have PET ligands on all these three drug candidates, meaning that we can dose patients with radiolabeled ligands and then put on our drug afterwards, and then we can see exactly how in a scanner, how many of receptors have been covered by the drug at a given dose. Is it 60%, 70%, and 80% of the receptors?
This way, we have a rational dose and a rational arguments for what dose selection we should use in phase II and phase III studies. On top of this, we also collect quantitative EEG readouts. It's similar to ECG, just in the brain, where we see the wave signal, brain signals, wave signals, and it tells our scientists a lot about how this drug is working in the brain. Does it work as expected? We have basically a neutral or you could say a way to see whether they cause sedation, whether it has cognitive improvement and vigilance and so on. This is helping us to differentiate and get some data into how to differentiate the product compared to competition and any other types of drugs out there.
This we can do for all three compounds through 2027. On top of this, what we plan to do is to make a small study in patients after we have done the single ascending dose study. These are patients with photosensitive epilepsy. It means that they get epilepsy once they are out in sunlight and the lights get into the eyes, then they get epilepsy, seizures in the brain. They need to walk around with sunglasses all the time when they're outside. What we do here is that we take them into the hospital, and then we activate the seizures with a flashlight. Then we give a drug and see whether we can stop it.
Many of the recent drugs developed in epilepsy, they have done that with this model. There's a very strong correlation between the efficacy of the drug in this model and what you see later in other types of epilepsies. One reason why we do it is, of course, that we would like to see some proof-of-concept patients very early, as soon as possible with this drug, and we can get that already in 2027. Because it can be done while we do the multiple ascending dose study, because they only need one dose in such a model. But the second part of it is that next time we want to go into children, and it's very good to have data in adults first and show efficacy in adults when you want to enter children.
It makes the regulatory pathway easier, and also it helps recruitment down the road when you're showing it's effective in other indications. That's why, the other reason for doing this one. You see in 2027, there were a lot of data come out. Phase I safety data. We will have qEEG, PET scanning data for dose ascending, and then finally some patient data at the end coming out in 2027. Then we are ready to phase II studies. Near-term inflection points, we will have.
We're starting phase 1 in the second half of this year, and then we will have the PET and qEEG data coming out, and then we will have, you know, data from this, call it, challenge study in photosensitive epilepsy patients. Then on top of that, we have potential near-term milestones from Acadia and Jazz. There will also come potential research milestones from Boehringer Ingelheim and AstronauTx, which, where we have one for schizophrenia with Boehringer Ingelheim, and we actually work with Alzheimer's disease together with AstronauTx. We have a spin-off with Cephagenix, where there could be some movement. We can conduct a potential license deal again, with one of our CNS assets or our non-CNS assets.
We also have some non-CNS which we have put for sale. Finally, we also have tesofensine, which is under regulatory approval for obesity in Mexico, which could potentially be approved and then lead to royalty income to Saniona. There's a lot of other intake income potentially coming in through all these things, activities. What is it in the long term? Our mission is to take one or two programs ready to late-stage clinical development. We are looking at some companies here who have done that very successfully in the CNS space. If you look, the first one is Longboard, which were acquired by Lundbeck for $2.6 billion in 2024, after they have just finished a phase II study in 52 Developmental and Epileptic Encephalopathies patients in children with epilepsies.
So they... and then they got support from FDA to have a broad label in this area. They run in a little bit different indication than we are planning, but this is exactly what we want to do with SAN2668. We start at ESES, and then we broaden it out in a basket study to other indications where they will have similar problems. We have more assets, and then we have our validated platform which to keep on generating new drugs. I foresee then in about 2009 to [2930], we will have one or two late-stage programs. We probably sold some of them as we go. We will have something in phase 1, something in preclinical development.
We look like a company like BMS, Karuna and Cerevel, who were acquired for quite substantial amount of money by BMS and AbbVie at the time in 2024. This is our lighthouses, and this is what we do wanna do with our company. We have $90 million in cash to do this. We need to double it, I believe. Some of this will come with making new deals. We have money we actually made through deals. Or milestones from existing deals we have talked about before. And potential royalties from Medix also it could be. That's the different revenues will come in. Finally, there's also, I think, the potential to make some capital market activity.
I think there are investors who would like to invest in this story out there. Before going to questions, just summing up. We have our business model has been validated and has created a very fortunate situation for the company, now allowing us to develop our internal candidates. We have three very interesting candidates which we are taking forward into the clinical development. They will be supported by PET ligands and PET and quantitative EEG biomarkers, which will secure or improve, increase the successful, the story in development in phase two. From now on, I think that the strategy is quite clear. We are in execution mode.
We are taking these programs into clinical phase I now, and then we will bring some of them forward into to late stage development, while selling the others. While we're doing this, we will advance our programs in partnership with Acadia, Jazz, Boehringer Ingelheim, Medix, AstronauTx, and Cephagenix. Thank you for your attention.
Oh, wow. Now it's full of questions here. I think we have four from the web. Okay, I'll just read one of them. Have you seen the data Acadia released the other day from the phase I in ACP-711? It looks like they can go for other things than essential tremor, also pain. Is this new info?
Is that Seagen you're referring to or?
Acadia, the deal you did with Acadia. Acadia has just-
Yeah
...said that they are going outside of essential tremor.
Yeah.
Did you see that?
No, I didn't see that.
Oh, okay.
That's news to me. It's true. I say if it is with ACP- 711.
Yes
They can do that.
Yeah.
I mean, originally with this compound, we developed for pain, but we couldn't sell it for pain because nobody were interested in pain four years ago. Therefore, we reposition for epilepsy, for certain type of epilepsy. We also generate data in essential tremor. When we make the deal, they were interested in essential tremor. They were also saying we want secondary indications, so we also will go for epilepsy at the time. Actually, I think this drug is SAN903, is a very unique, it's a very interesting drug in the way that it only hits a so-called benzodiazepine site, which is supposed to modulate four different ion channels, but it's only modulating one of them. It's called GABAA alpha 3.
This alpha three receptor is sitting certain area in brain which is gatekeeping in the brain for the pain signaling and also for rash. It's a perfect drug for this. Apparently it works better than but then comes with broader pharmacology in pain, in our pain models. That's why we liked it for pain. That's pretty obvious. I didn't know that, but that's interesting.
Well, they obviously just released, right?
Yeah.
Yeah, apparently.
Yeah. Okay.
We have a really long question, but basically, it's about SAN903-
Yeah
...your obesity drugs.
Yeah.
Can you say something about how developments are going there?
As in SAN903?
Yes.
This one was developed originally for inflammatory bowel diseases, and it's outside the brain. It's not really something which is our core anymore. It is clearly positioned for partnering. What we learned was that this perfect drug for IBD is no longer relevant because the biologics has basically solved a lot of the medical need there. We are then in the process of repositioning it for other indications. It's a little early for me to comment on that at this point, but I think it's moving forward, and I guess sometime in spring we'll be ready to inform the market about it. Yeah.
We'll look at your current portfolio. If you could please take out where you have the three, your internal pipeline.
Yeah.
Maybe it's easier for people to see when you answer.
Yeah.
I'm wondering, how are you thinking about licensing these?
Yeah.
Which do you think you will license first and to whom?
I mean, I think.
Which type of area?
Yeah. Now if you look at ourselves first, right?
Yeah.
If you're taking pediatric epilepsies, which is a rare diseases, where we only need to make a study of 52 patients, phase III studies, the pivotal phase II studies like this one, if you see a little bit more basically. Phase II, this would be a phase 1, B/IIb, that could translate into a phase II, phase III study. It could be 200-300 patients. That would be an overlay. We're starting running while we're doing this, where people are invited in as soon as they've been there. You want this patient data. That's enough. This is something we can do. This is something which a company like Saniona will be able to do with 50, 60, 70 people in the company.
This one is difficult, as a b ecause depression is, you need about five or six phase III studies running parallel. 200-300 patients in each. Different types of depression. There's a huge placebo effect, that's why you need so many patients. Esketamine, which we are comparing to, they ran five or six of those, and they failed two or three of them. Still they got approved and they sell for more than a $1 billion product now. You can see what happens with Saniona's stock now if you've just failed one. Our shareholders would not understand it. This is not an area for a small company. It's it. You need a lot of dollars to do these things.
When can you license that? After phase II?
Yeah. That is one which we really I think would be good to find a partner for.
Yeah. After phase II?
Before we enter into this phase.
Mm.
Maybe we can make a mechanistic study to make people more interested. We can also make a phase II study, but it's risky.
Yeah.
Yeah.
The last one.
It's easier, but it still is too big a study to do in focal seizures. I think this one is the best one for Saniona to keep. That's why we call it a lead program.
Please.
Mm.
I must admit that I am not in-depth knowledgeable about the different epilepsy programs.
Mm.
Isn't there a competition between the one you have out-licensed to Jazz and the two programs, your internal programs that you have retrieved?
Yeah. Absolutely. There is. As Jazz go for this focal onset seizures. Got a Xenon and it's a really interesting mechanism. It's called Kv7 channels. Xenon, X-E-N-O-N, came out with phase III data two weeks ago. Strong data. Showing basically repeating their phase II study. They provided the proof, which is probably the best study done in epilepsy so far, best data seen in any epilepsy studies. It's probably right. They had 60% efficacy of the patients, which is very high compared to 10% and 15% in placebo. Very good data. It would be a proof and get a billion-dollar sales in epilepsy. It doesn't change the story for Saniona and doesn't change the story for Jazz.
We knew that. We still think that we have best in class. We have really made a fantastic compound, extremely selective. You go up at higher doses than Xenon, and we think we can create better data. Yes, we would compete with them, but we think that, for instance, a drug like 2668 is very interesting. Jazz thinks probably the same when they see the data. They want differentiated assets, that's why they paid. They acquired, they bought, paid $1 billion and $42 million up front for our Kv7 assets. They may do something similar again. Okay. Yeah.
We saw that Acadia might be repositioning for pain. Do you see that these could be repositioned from what you do today?
Yeah. I think actually we are looking for this one because as people getting how many epilepsy products can you have in one company? We are looking for this one and saying, "Which other indication would be relevant?" There are many. There are several indications which we could potentially go for. Also, some which is not mentioned already. But pain is always there, for these types of drugs. You know, normally when you look at this, on this area with the GABA channels, and it's basically the major brake in the brain. If things go too fast, you need something to slow it down. Epilepsy is an obvious example because the neurons are simply firing completely uncontrolled, and that's why people get these convulsions.
If you have anxiety, then your certain parts of your brain is just moving too fast. You need to slow it down. If you have pain, if you're neuropathic pain neurons, then it's actually the neurons who cause the pain. This perception of pain is something which is going on, not supposed to go on. You need to slow it down. The major break in the brain is the so-called GABAergic neurons. This is those we are modeling with our technologies here, which we have a lot of experience in. We're not done. Even these, all these three compounds basically are based on GABAergic neurons. We're not even done yet. We still have some research going on in this space.
One last question on the financing. You said that you are eligible for $410 million in development and regulatory milestones-
Yeah
...from Jazz and Acadia. Do you have any timeline on that? Is it like three years or is it 10 years out?
I'd say Acadia have informed the market. I don't know whether they've been in the last press release. Until that point, they intend to start a phase two study this year. This will result in a $10 million milestone to Saniona. The Jazz, when they start phase one, we will receive $7.5 million. They have not informed the market, but it's the same status we are. It was handed last summer. Of the other programs there, we expected to start phase one around Christmas. When we start talking with Jazz, they said, "Now you stop working. We wanna take it over right where it is. You put down the pen. Don't do any studies." Then we were negotiating. We did that at risk, of course.
We closed the deal in August, and then we had a tech transfer. There has been. It will take a little longer. They have not announced anything, and I'm not allowed to make a prediction on another company. Not a. I can hope.
The type of studies they do.
I have reason to believe that it's not gonna fall forever. It should be this year-
No
in my view.
Yeah.
All right. Yeah. Yeah.
Okay.
Yeah.
Okay. Thank you very much, Thomas.
Okay.
Good luck with finding your DKK 990 million.