Saniona AB (publ) (STO:SANION)
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May 4, 2026, 5:29 PM CET
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Life Science-dagen 2026

Mar 4, 2026

Johnny Stilou
CFO, Saniona

Taksamika. I will be doing my presentation is English. I hope that's okay. The slides are also in English. When we get to the Q&A, you're certainly welcome to ask questions in Swedish. I will understand it, I will do the presentation in English. Before I go to the presentation, here's the usual disclaimer saying that I will be making forward-looking statements during my presentation. Saniona is a clinical stage biotech company. We are in the disease areas of psychiatric and neurological diseases. We are listed at Nasdaq Stockholm . Our market cap today, I just looked before I came up here. The share prices are volatile these days, due to the geopolitical situation. Our market cap is today, I think around SEK 2.2 billion.

As you can see at the year-end, it was higher, SEK 2.9. The share price was SEK 21. Today it's SEK 16. This compares with when we did the Jazz deal in August last year. The share price was SEK 8, and then it rose since then. It has been higher, as you can see. We have in the recent months seen some short selling and profit-taking due to, we expect that due to the significant increase in the share price. Over the recent days, obviously due to the Middle East. Saniona has a very strong cash position. At year-end, we had SEK 581 million in cash in the bank. On top of that, I can look into receiving additional funds this year.

We expect through our two partner deals with Jazz and Acadia to receive an additional almost SEK 170 million, and we have the option to do a sale and leaseback of our headquarter, which we own. That will give us approximately SEK 70 million. In total, we have SEK 800 million plus krona to progress our three internal programs according to our plan, which I will describe in more details. A few highlights. It is still the beginning of 2026, so a few highlights of the year that's behind us, 2025. We did the significant partnering agreement with Jazz in August last year, where they acquired one of our preclinical assets, and they paid an upfront payment of $42.5 million

The other deal we had from the year before with Acadia, they concluded the phase I trial and are now ready to move into phase II during 2026. Our other partnership agreements with AstronauTx, Boehringer Ingelheim, and Cephagenix, they all progress according to plan. Medix, our partner in Mexico , they have resubmitted tesofensine to COFEPRIS. COFEPRIS is the Mexican authorities. Discussions are ongoing. We will obviously, if when there are material news, update the market about it. Further, as I mentioned, we did acquire the headquarter last year. This you can ask you is kind of atypical for a biotech company to use its funds to buy buildings. Indeed, it is. Saniona is located in an industrial area which has been laid out, the whole area, to residential area.

All tenants are being moved out as developers move in to build residential condos. We had the option to buy our headquarter to avoid the issue of moving the disturbance to our operations, the cost of moving, the cost of building new research labs. We decided to acquire our headquarter. As mentioned, over the next 10- 15 years, the whole area will be residential. We do expect that the price will increase. Having said that, it also means that we do have the option to make a sale and leaseback of the property if, when we so choose. Right now we don't have any need for the money, but obviously, when we get to a point where we need funding, this is definitely something for us to consider.

We expanded our organization, quite significantly last year, and we will continue to do so in 2026. We expect to reach approximately 50 employees by the end of this year. This is derived from us building our clinical development team, enabling us to progress our three internal programs into the clinic later this year. Saniona builds on a former company. In the 90s and the 00s, there was the largest biotech company in Denmark, called NeuroSearch. They were in the CNS space, and in 2012, Saniona acquired all their assets, all their library of molecules, all the data they had. Along with that, most of their research team joined Saniona.

The combination of the backlog, the library, and the data that we have from NeuroSearch, along with world-class researchers who has decades of experience within the CNS space, that actually enables us to continuously progress molecules into development. Over the past four years, we have moved forward four molecules, three of them which are currently our internal pipeline and one which we have partnered. This partnership model has provided us, as I mentioned today, with a very strong cash position that enables us to progress our three internal programs into clinical trials. Our internal programs are in two big disease areas, epilepsy and depression. Epilepsy is a big market. Both of them have high commercial value, and there is a high medical unmet need.

For epilepsy, we see that 30% of patients have a drug resistance and therefore account for more than 80% of all cost to society related to those diseases. For depression, which is a significantly higher market, as you can see here, the total cost related to depression exceeds EUR 100 billion within the EU on an annual basis. We see that more than 50% of total mental health care related cost relates to depression. On top of that, it is a severe disease. It comes with high mortality, and we see that 60% of all suicides relates to depression. This is an overview of our CNS pipeline. We have our two partner programs with Acadia and Jazz that I mentioned.

We have our three internal programs, SAN2668 and SAN2219 in epilepsy, and then SAN2465 within depression. All of those are at a stage where we are progressing them towards start of clinical phase I, to be initiated in the second half of this year, by the end of the year, and one of them most likely in the beginning of 2027. To build, just showing a slide, talking a little about what is it that we are trying to build at Saniona. We have our three internal programs, and we have secured funding through two partner deals to progress them into the clinic. The plan is to progress all three programs into phase I.

At the same time, prepare them for at-risk for phase II, meaning doing a CMC, and tox and production, making them ready for phase II, and take one or two of them into phase II while making them phase III ready. This is the plan until the next five years. By 2030, our plan is that Saniona will be a clinical company with one or two products, ready for phase III. One new product not announced yet, probably in phase I, and then with some preclinical assets. I show here some comparisons of companies that were in the same space as us, CNS, and that were acquired in 2024. Longboard, a U.S. company, they had one asset, one molecule in epilepsy, in pediatric epilepsies.

They had a phase II study in 52 patients where they did a basket trial, meaning that they did a trial in a number of severe pediatric epilepsy diseases with positive data. Lundbeck acquired this company with one asset, phase II, for $2.6 billion. As I mentioned, our market cap today is approximately SEK 2.2 million or $200 million. Our one product, SAN2668, resembles very much, I'll get back to that, the Longboard drug they have here. That is not, as I mentioned, the vision for Saniona by 2030. It is to build a broader pipeline, much more in line with what you see in Karuna and Cerevel when then were acquired by BMS and AbbVie in 2024. That is the plan.

That is the aim for us to develop Saniona into a similar company. If we just briefly talk about our two partnered programs. The first ACP711, in November of 2024, we partnered that with Acadia. It was a phase I, ongoing phase I, when they acquired it. Since then, phase I is completed with demonstrating safety and tolerability, and Acadia are getting ready to move into phase II during this year. In 2024, they paid $28 million upfront. When they move into phase II, we will receive an additional milestone of $10 million expected later this year. Total deal values are approximately $150 million in development milestones and $435 million in commercial milestones.

The Jazz deal that we made August last year, that was a preclinical asset, and Jazz paid, as I mentioned, $42.5 million upfront. Total deal value is approximately $1 billion, $192 million in development and $800 million in commercial milestones. We expect that they will move into phase I later this year, and that will give us an additional $7.5 million. Hence, in the beginning, I mentioned that approximately SEK 170 million we will receive in milestones payments during this year as those two partners programs progress further into the clinic.

Here's just an overview of the total deal flow mentioned, should they go all the way, $1.6 billion, and tiered royalties, low double-digit is single-digit, royalties. Important to state about those two deals is that besides, the significant value, the significant cash we have received, it validates our technology, it validates what we are doing. We are hearing from investors and also from pharma companies, that those two deals have put us on the radar, that two significant companies have made those deals at high prices. The value, the validation should not be underestimated. Touching on our three internal programs, they are all GABA programs, as you can see here.

GABA is the main inhibitory signal within the brain, and it comes in five subtypes, A one, two, three, four, five, and they work in different ways. They work in different areas of the brain, and that means that they come with different benefits and also with different side effects, some quite significant. The most used drugs, families of drugs, is the benzodiazepines, who works really good, but the problem is they have significant side effects. This is because they target, they are not selective.

They also target, if you look over here, they also target the GABA a1 receptors, which you kind of want to avoid Its, the green one, you want seizure control, you can affect anxiety, well-being, when we talk depression, the feeling of happiness, and also pain. The side effects are, and this is a general problem, is that you see sedation, you see cognitive impairment, and you see a significant abuse liabilities, which is obviously a huge issue, all of them, driven by the GABA a1 . I'll get more into this. It's important to develop selective drugs, which is what we're doing and which I will be presenting. Our clinical plan path forward is for the three programs, all three of them. We will, as I mentioned, initiate phase I by the end of this year, early next year.

We will have readout, phase I readout for all three programs in the second half of 2027. This is important to mention because our current funds, the SEK 800 million I mentioned, they will sustain operations expected with our current execution plan into the second half of 2028, meaning that we can self-fund the three phase I programs and also have data readout. What we cannot do is with the 2030 plan vision I mentioned, we cannot fund all the way into 2030. There we will need additional funds in the amount of $60 million-$100 million. This can come from doing a partner deal on one of the programs here, similar to the Jazz Pharmaceuticals and Acadia Pharmaceuticals, that will give us some upfront payments. It can come from additional milestones payments from the two deals, Jazz Pharmaceuticals, Acadia Pharmaceuticals.

We can do a directed issue towards big institutional investors, getting some anchor investors into the company, or a combination of all three. We can also do. What's important is we don't have any imminent need to secure additional funding quickly. SAN2668 is in pediatric epilepsies. As I mentioned, it's for kids. It is a selective GABA a 2, a3 modulator, which is as efficacious, if not more, than the benzodiazepines. Since it's selective, you don't see the significant side effects on sedation, cognitive impairment, and potential abuse liabilities. We will start in a disease ESES, which is a severe epilepsy in kids, which is debilitating for them, and the kids end up in homes. We do have the option to...

The aim to expand it into a basket of DEE, similar to, as I mentioned, to what Longboard did. We are in discussions with Cure Leukaemia and authorities on the design of this. This is a very potent molecule that has a significant potential within epilepsy in the area that we saw Longboard also addressing. Here the graph over here, it compares with the benzodiazepine. Here's a diazepam, a drug there. It goes up to 100. It's important to say that the benzodiazepines, as said, they had the side effects, they cannot dose higher than approximately 20% because then the patients will be completely sedated. As we don't have the same side effects, we can't dose higher.

You can hear that the GABA a 3, the blue one, goes up very high. We have a very potent anti-seizure effect here, similar with the GABA a 2. We also see additional anti-seizure control on the GABA a 1, but it's low, so we don't expect to see any significant side effects on sedation. There might be a little sedation, but that is acceptable in the pediatric areas because the diseases here ESES is something that the kids re-have when they are asleep, so they will need the medications when they are supposed to sleep anyway. Here is the clinical plan for SAN2668. In phase I we will do several things. We will look for EEG biomarkers. You can see that the patients is healthy patients in phase I.

They get the helmet on. Thereby we can measure the various brainwaves when we administer the drug. Similar, we will do PET scans of the brain, which will give us a receptor occupancy and help us to select the right dosing when we move into phase II, which is in patients. If you look in phase I there, just below there's a blue box, photosensitivity. We have the option. We would like do this in parallel with the phase I in healthy patients. We can do a small study in sick patients, the photosensitivity. It is known that if you flash a light into the eyes of epilepsy patients, it will... You can measure the brain, specific brainwaves start in the brain, which will eventually cause a seizure.

What we'll do here is that we will do that, flash the light and monitor the brainwaves, and then we will administer 1 dose of our drug to see how it works against the brainwaves. The patients, we will stop the patients don't get seizures, but it gives us significant information about how the drug works in patients actually prior to starting any phase II. This is a very strong early signal that we get here. SAN2219, this is also in epilepsy. This is in focal epilepsies. This is adults typically who have that. That is the most common, the usual one where you get seizures during the day. This is a significant market. It is again a GABA a 2, a3 modulator.

Similar to the benzodiazepines but without the side effect profile. Here we see that 30% of patients remain uncontrolled despite getting 2, 3, 4 known medications in combination. So there is a significant unmet need here. We believe that SAN2219 in itself can address this, but we see in data that SAN2219 has a significant synergetic effect. So our belief is that we may be able to specifically address this 30% of the market where there is no treatment available today for those patients. Here, showing the same graph again, you can see the alpha 2 and 3. It spikes there. Importantly, you can see that GABA a 1, the red one is flat, so no side effects here

This is important as we're talking about adult people who work, sedation is a problem, cognitive impairment is a problem. You don't want sedation because then you're not allowed to drive. You would like to drive to get around. Cognitive impairment, you want to be able to do your daily stuff and maintain your job and work abilities. This is the same again. This is similar how we will be doing the phase I study. Finally, quickly, SAN2465 in depression. This is a GABA a5 modulator. It is for fast onset mechanism. We see that 30% of patients do not respond to standard of care.

Importantly, standard of care takes typically 6 to 8 weeks before you have the full effect, which is a huge problem as we're talking about sick patients who are at high risk of committing suicide. You want something that works fast like esketamine. Here you have the graph showing that it is a negative, so it is a GABA a2 negative modulator, which targets specifically the GABA a5 in the brain. It works very well. Does the ketamine. Just to show how it is, it is known that by targeting in hippocampus, that's where emotions, feelings are. If we can increase the activity in hippocampus, then you get more joy, you get more well-being. That's what the ketamines can do. Works very well, very fast.

The problem is that it hits all the GABAs in the brain. Hippocampus is the small area down here. That's what you want to target. The ketamines, they also do that, but you can see the entire brain lights up, so you have the massive side effects and abuse liabilities. With our drug, highly selective GABA a5 is solely represented in hippocampus. If you target that, which we're doing, then you can see that we can target specifically hippocampus. With that, good work for Q&A. Thank you.

Operator

We don't have a lot of time, but I think we'll make some time for two questions here. Saniona has a lot of several programs in neurological diseases. How do you prioritize between those projects?

Johnny Stilou
CFO, Saniona

Yes. Well, we certainly have our internal favorites. For sure we do. It's also looking at what is the commercial value, what is the options there. SAN2668 is a very potent molecule it seems like, and it is a molecule where we can probably progress it quite far ourselves. Similar, SAN2465 in depression is also really good, and we can progress it. Let's be honest, to phase III studies in depression, that is really big, costly studies to be done. In reality, company like Saniona, we can take it until phase III, but in reality, we will need a partner eventually to go into phase III.

Operator

Yeah. Partnership seems to be an important part of your strategy. What is the ideal partner for Saniona?

Johnny Stilou
CFO, Saniona

Well, the ideal partner for Saniona is one where obviously we are here to create shareholder value, so obviously a partner which is willing to pay for the value of the molecules which we believe it has, but also a partner where we believe they have the strength to develop the assets quickly and commercialize it to get the highest market value. Because we both receive development, commercial milestones, but also royalties. Obviously we want someone who's strong and can take it all the way fast and has the muscles to do it and who will pay for the value that we believe it has.

Operator

Thank you. Time flies, so I think that's all the time we have for questions. If you in the audience have a question here for John, maybe you can grab him after. Thank you so much.

Johnny Stilou
CFO, Saniona

Thank you.

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