Saniona AB (publ) ($SANION)

Hello, and welcome to Redeye and today's live queue with Saniona. And first off, CEO, Thomas Feldthus; and CFO, Johnny Stilou will present the report. And after that, we will do a Q&A. [Operator Instructions] So without further ado, please, Saniona go ahead with your presentation.

Thank you. So good morning, everyone, and thank you for joining us our Q1 2026 update. So the first quarter reflects continued disciplined execution. The rising 3 proprietary programs towards the clinic, progressing our partner programs and strengthening engagement potentially from partners and the investment community. Today, we will walk you through pipeline progress, upcoming catalysts and financial performance. I'm Thomas Feldthus, CEO and Co-Founder, Saniona. And with me is our CFO, Johnny Stilou, who will walk you through the financial data in the presentation. So before we begin, please note that this presentation contains forward-looking statements, and these are based on current expectation and involve risks and uncertainties could cause actual results to differ materially. With that, let's move to the agenda. Today, we will cover Q1 highlights and strategic positioning, pipeline progress and upcoming catalysts and financial performance and outlook and then after that go for Q&A. So Saniona stands on 3 pivots, first, deep iron channel expertise validated through multiple partnerships. And second, a partnership-driven business model that strengthen our financial position by preserving long-term upsides. And finally, 3 differentiated CNS assets entering clinic development. So in summary, we combine a validated size, strong partnerships and the pipeline approaching value inflection points. So our recent partnerships by Acadia and Jazz provide validation and substantial potential value. We received $70.5 million of fund and have $17.5 million in near-term milestone potential and the total potential payment exceeds $1.6 billion. So these agreements provide meaningful non-dilutive upsides while we advance our internal pipeline. And they allow us to operate partly self-financed while building long-term value internally. So this slide puts our business into context. Recent multiple CNS transaction demonstrate renewed strategic interest in differentiated neurological assets like ours. Our ambition is to advance 1 to 2 assays into late-stage development over time through a combination of milestones, partnerships and disciplined capital allocation. Q1 was about execution. On the external pipeline, we have completed [indiscernible] material for all 3 internal programs with precision for Phase I starts in late 2026 and early 2027. All compounds are newly discovered and protected into the 40s. Also, a brief comment on SAN903, which is the Phase I-ready asset position for partnering as it sits outside our focus. Here, we continue repositioning it towards lung fibrosis and are currently conducting additional preclinical studies to further strengthen in partnering profile. On partnerships, Jazz and Acadia are progressing towards clinical studies taking milestone of $7.5 million and $10 million, respectively. Our research with Prader-Willi, AstronauTx and Cephagenix continue to progress. The next key milestones for BI and is candidate selection. Regarding business development and engagement in international We significantly increased visibility during the quarter. We had more than 40 meetings at JPMorgan and continuing engagement thereafter with pharmaceutical companies, investors, banks and analysts. And this reflects the growing awareness and interest in our platform and pipeline for our recent collaborations. Finally, we maintain a strong cash position. Our strategy remains partly self-financed through our outline with them based to partner at least one internal assay in the near to midterm. At the same time, we continue building relationships with the international investment community to support long-term strategic flexibility. So with that, let me turn you to next to the 3 internal programs and what you can expect in 2026 and beyond. So this slide provides a high-level development plan for our Phase I and Phase II studies. The Phase I studies will include single ascending dose and multiple ascending dose components. And following that phase, we plan to conduct PET studies to measure receptor occupancy in the brain enabling rational Phase II dose selection. In parallel, we will collect quality radiative EEG biomarkers providing objective readout related to [indiscernible], supporting our differentiation basis. For SAN2668, we are also planning our photosensitive epilepsy challenge studies in patients during 2027. This study will provide early proof of mechanism and efficacy data in adults. This will support regulatory dialogue and facilitate requirements, recruitment when we initiate Phase II studies in pediatric patients. If execution proceeds as planned, we expect substantial clinical and biomarker data flow in the second half of 2027. So as mentioned our corporation continue to progress and several partners may move into the next development phase over the coming year. Acadia's Phase II start for ACPV11 in essential tremor would provide a $10 million milestone payment. Jazz Phase I start for [ SAN2355 ] in epilepsy will provide a $7.5 million milestone payment. And to this, we have potential option fee from AstronauTx and a resource milestone on preparing in-time when they reach candidate selection. Regimedics regulatory dialogue continues. And while a potential pool we could generate royalties. Our core value driver remains our CNS pipeline. Overall, core-basis provide non-dilutive capture and strategic flexibility. So in summary, we see multiple inflection points over the next 24 months, including clinical initiation, Phase I and biomarker readouts, proof of mechanism and early efficacy data for our lead assets of 2668 and partner milestones and potential license opportunities. And I will now hand you over to Jonny for review of our financial performance.

Thank you, Thomas. As you can see here, our financial result for the first quarter was a loss of SEK 46 million, which is in line with our expectations as we continue to progress our 3 internal programs towards initiation of clinical Phase I trials. Personnel costs in the quarter increased due to head count growth. 43 employees in March '26 compared to '23 almost half a year earlier. This buildup also reflects preparation for the clinical execution. Next slide. Here, you find an overview of our operating expenses for the past 8 quarters. Operating expenses of OpEx was realized at SEK 61 million in the quarter. This is an increase of SEK 10 million compared to the previous quarter. As mentioned, the increase in cost quarter-over-quarter is both expected and planned as we progress our free internal programs towards initiation of the clinical Phase I trials. As informed at our last call, we expect up to a 50% increase in OpEx in '26 compared to '25. So increases in costs will continue during the year. They will fluctuate over quarters as we progress toward the planned clinical Phase I initiation. Next slide, please. At the end of March, we held SEK 532 million in cash. We expect to receive an additional USD 17.5 million equal to SEK 165 million in near-term milestones payments when Acadia start the Phase II trial and Jazz start their Phase I trial. We also maintain the option of making a sale and leaseback of our headquarter, which we acquired for SEK 70 million. This will further bolster our cash position and provides us with a strong cash runway to progress the free internal program through Phase I clinical trials. With that, I'll give the word back to Thomas for final remarks.

So thank you, Johnny. And to summarize, we have 3 internal assets advising towards clinics, near-term milestone catalysts from partners. We have strengthened engagement with pharma investors. We have a strong financial position, and we have a clear path toward multiple Phase II proof-of-content value inflection point. We are advancing with discipline and strategic flexibility. With that, we are happy to take questions. Thank you.

Thank you for that presentation. So I will try to answer -- ask so many questions that I can from investors. So the first one was about external R&D costs in Q1, but they are higher than before and on the same level as almost the full year 2025. And you discussed this a bit on, but maybe if you can elaborate a bit on these R&D costs? And if it's one program in particular or quite broad or yes, or can you say?

As I mentioned, we have indeed seen an increase in cost over quarters. It reflects 2 aspects. As I mentioned, it is the personnel cost going up as we are increasing our headcount driven by the build of our clinical organization. That compared with the development cost increasing as we are preparing for the execution of all 3 programs. The cost is not related to -- specifically to any of the 3 programs. They are broadly distributed to all programs. As mentioned, all the free internal programs, they are basically running towards clinical initiation in parallel. So costs are therefore also kind of in parallel. As also mentioned, cost will continue to increase during '26 the quarters. It will obviously fluctuate over quarters, but the general trend is that as we get closer to Phase I initiation, cost will also increase.

Got it. And another question was about the clinical plans for designing these 2 trials with your internal programs, if you can -- what are you currently doing to prepare for [indiscernible], although it's a while to do that.

Yes.

Just a minute.

So depressive disorder and the epilepsy to remain our key area of focus. We have -- our clinical team has a deep expertise in this therapeutic area. And we continue to engage with the network -- established network of key collaborator investigators and we are really encouraged by the strong support that we continue to receive regarding both the value proposition for our asset and the ultimate goal to get this drug patient. We are actively involved in these key opinion leaders in the design of our clinical studies. And then those far away, we still have a good plans and visibility in time. In addition, we plan to feature some of the opinion leaders in our webinar series that we are preparing for this present in our prioritized asset in a webinar later this summer.

Thank you for that. I hope that could hear and sorry for the mix up in the under So the next question was about the Phase I trial for SAN2219. It has been pushed a bit into 2027. Could you elaborate a bit on this delay?

Well, yes, I mean, when we -- when you conduct these preclinical studies, CMC and toxicology are the most difficult to estimate time-wise. And it's really first in this point in time where you have some more solid plants. And yes, 2019, we have a delay for one quarter. We expect now to start it in around March, April. And on the other hand, 2668 is actually advancing a quarter. So this is the way the situation is. And we are quite happy with this because 2668 is our leader.

Got it. And one question here was about the status of SAN903 that you mentioned that we might get an update this spring. And also if you can discuss this preclinical study in IPF a bit.

Yes. I mean the thing is we conducted certain studies here in the first quarter, and they came out favorable. And now we are moving forward and making some studies in animal model of IPF at what you consider realistic doses and within the therapeutic window for the trial. And this was straightens the partner position. We cannot go into further details because there may be some IP potential -- potentially profiting some in relation to this. And therefore, we will wait with further details.

Got it. And another question was about -- also about SAN903 here about Bridge biotherapeutics and that passed the program in IPF for BBT301, which is, as I understand, cannot peer drug and how is San differentiated? And can you discuss the competitive landscape a bit in IPF?

It's a very dense area and other companies involved in clinical studies, is one of them in Phase II. And some companies are getting listed in U.S. for a Phase II program only. So it's really complicated and a busy area. There's a significant also a great yard. We don't think there are any direct competitors to our program out there.

Okay. Got it. And one question was about, what can you tell us about Acadia's progress with SP711, including studies conducted before commencing Phase II, kind of what did...

So we have completed all the Phase I work and also other things in relation to Acadia. And they are understanding progressing towards Phase II. They have previously announced that they expect to start Phase II this year. We have not seen that they're going out and changing that at this time. And we have not seen anything we should delay so far. So this is what I can say.

Got it. And another question was about partnering. You mentioned at least one more licensing deal and I've stated that you intend to keep SAN2668 in-house is SAN2465 or SAN2219, more likely to bolt license. And is this 2026 or 2027 event?

I cannot comment on time line on this. But we see significant interest in all 3 assets. And we would prefer to keep 2668 in-house because it's addressing rare diseases, and it's much easier for us to run late-stage clinical studies in this indication in these indications. And this is the reason for us mentioning that it's more likely to outline in the MDD product for depression product as well as [ 2021 ].

And another question was about Tesomet. Are there any discussions when it comes to Tesomet. And also another question was about a dose finding study in PWS, how that -- how such a trial with Tesomet and PLS to look like? And if it's anything that you are thinking about in-house or if it's strictly for a partner to decide?

Okay. We have positioned these proprieties outside CMS in our view. And although there is some synergy issues related to this. But the -- but this is not a price as from our side this time. We are positioned for partnering. And we have during the corner connected with some of the companies interested in this space and are in dialogue with a few companies. On generally say that we see some more interest in our Sines assets potation partners.

Got it. And yes, what is the status of the collaborations with Boehringer Ingelheim, AstronauTx and Safiennics? Do you have any time lines for the expected progress?

I mean, Boehringer is conducted is moving towards candidate selection under the extended research agreement. And AstronauTx is also moving forward to candidate selection where they will take the system for exercise of their option. And as mentioned in my presentation, we see the potential for face shift for both companies in the coming 12 months period.

Clear enough. And another question from an investor was have you freed up any resources to work on generating new compounds from the ion channel platform?

Yes. We have one full order research program internally, ongoing. And then which get significant resources right now. It could actually lead to not only on comp, but maybe 2. And this is going very well. So we have an internal research problem and which is important for us because we want to build a balanced pipeline and we hope for candidates election sometimes in '27.

And how would you prioritize between those assets and your prioritized current Phase I ready assets, for example, in terms of financing?

As I mean, the thing is that we are currently prioritizing our 3 internal assets towards Phase I and bring them into ready for Phase II and the intention from our side is to make a collaboration agreement with one of these 3 assets in near to midterm and then build a balanced pipeline. So it will be prioritized. But obviously, cost in relation to the really preclaim development is less than for running Phase I studies to prepare for Phase II.

Got it. And when it comes to tesofensine in Mexico, one Western was asking, is there anything more new you can share about the regulatory progress?

I mean, there's nothing material for us to report this time. I can understand that there is some patient and our shareholders in relation to days. Having said that, our -- if it gets approved, we will be legal for royalties, but the core value in this company is still our CNS assets.

And another was about, you have previously mentioned certain legal options has Medix explore this further?

Yes, Cofepris and the process is extremely challenging for not only Medix but for all companies involved the coverage these days. And Medix facing chance from bids. They're not following the rules. They are using nonvalid arguments for rejections and so on. And many companies, including mass acetic, has file lawsuits and go through the legal rule in order to ensure that corporate base is sticking to what they're supposed to do. And this has been also the case for Medix during this process.

Got it.

And we cannot rule out that they may come additional legal filings. But when you are in lose, you don't want to speak about it in partly and it's also extremely complicated, we say.

And another question regarding to tesofensine was about, is there any impact from Medix collaborating with Biocon regarding GLP-1 drug -- generic GLP-1, if that has impacted Magic's interest into basin.

Not at this time. I mean provides similar way closes vehicles commence tablets, it's much more convenient to use and would be competitive once approved. So they are still very interested in getting this product. And they have invested quite a lot on this. They are not only for finish a Phase III study. They have also produced material for commercial use for several years on the market. So they have a keen interest in continuing this.

Sounds good. And another question was about you have a strong preclinical pipeline, strong financial position and the share price does not seem to reflect this. Have you considered hosting Capital Markets Day or new IR initiatives?

Yes, absolutely. So we are planning SCA or webinars around our product assets starting with 2668 over the summer, sometimes in June, the press release well in advance the last couple of weeks ahead of the planned date. Currently, we are planning for around 17th of June, we'll see whether the go up in the time line. As I said, we will place release that at least 2 weeks ahead of that.

And another question was about, you have asked the AGM for the right to issue 20% new shares, but you currently do not intend to do capital raise. Can you explain this and why you want the permission?

Yes. Certainly, that is correct. And as you also stated, correctly, it doesn't mean that we are planning on right now to raise any funds. This is just to have the authorization as we have had basically all years. So a 20% authorization to issue new shares, that's very normal for a biotech company and completely in line with market standards. The authorization is imperative for our ability to attract institutional investors and secure future funds when needed. An investor meaning an institutional investor, will not accept that we have to call a general meeting to approve their investment. And at all the meetings we have with institutional investors, we all the time get the question if we have an authorization to issue shares at hand and what the size of this authorization is -- so it is a deal breaker for institutional investors if we cannot confirm positively to this question. The alternative to doing a ducted issue towards institutional investors is to raise capital through a highly dilutive rights issue, which I think we can all agree, we definitely want to avoid.

Sounds reasonable. And yes, so you mentioned that the directed issue could be possible. And you also mentioned in the report that the interest has been high when you have been to, for example, JPMorgan and talked about the company. Maybe if you can elaborate a bit but is more about what's the pros of getting institutional investors aboard? And do you have any demands on them, for example, to be long-term oriented and things like that, what type of investors they want?

Absolutely. So I mean, just to clarify this. We are not out in a capital raise mode right now. But as Johnny said, we're getting this question all the time. And we really would like to engage with high qualified institution investors to select, we call them specialists in this context. And they will primarily only spend time in companies where they could potentially come into a transaction someday. They to be when you -- when we had the first meeting, they say, well, we like this company, we find it interesting. We'd like to follow you. And they tend to follow you for a year or 2 in order to see whether we're developing according to our plans, and the company is progressing nicely. And in this context, it's very important that we can have some possible of this despite that we may not utilize it this coming 12 months, as similar as we did last year, and this is the reason for putting this in. When it comes to the quality, yes, it is major investors interested in this space, so-called specialist investors who can make their own evaluation on our preclinical assets.

And Yes. And you mentioned this also a bit about my question about clinical plans. Maybe if you can discuss a bit how we interact with key opinion leaders a bit more in the field to which is also impacting.

So, yes, so [indiscernible], he's taking care of this, maybe you can join and how you work on this. He's coming in here okay?

Yes. So we do one-to-one interaction peer to discuss the details, but we also participate in conferences later this month, and we are engaged in the research round table for epilepsy that include also a major sponsor investing in epilepsy. We also participated at the conference where we redid the entire pipeline on the epilepsy programs. And those are ground where we can collaborate or strengthen our collaboration with clear to discuss our plans and be also abreast of the competitive landscape and what other companies are doing. So we are very engaged in all these events and key collaborators.

Thank you for that. And final...

It's also a great opportunity to meet potential partners at these conferences because they are interested in the same space, so.

Got it. And another final investor question was about, can you give us your best elevator pitch, why should I invest in Saniona today?

Well, I said initially, we are standing on 3 pillars and we lead in and drug discovery. This platform has been validated through multiple partnerships lately with 2 significant deals with Jazz Pharmaceuticals and Acadia Pharmaceuticals. And this business plan that this plan, you could say, is based on a partnering model. But at the same time, it allows us to progress our own and secure long-term value. And we have 3 highly differentiated assets, which we are bonding into start a Phase I. So today, we have validated this cover platform. We have strong partnerships. And third, we have 3 different assets as we moving forward internally.

And my own follow-up there. From a kind of share price perspective, what would be the key catalyst the coming year or so? Would more licensing deals or initiating clinical trials? Or what would you...

So there is initiating the Phase I study as we come into Phase I and we make the company ready for Phase II will bring this company forward to a complete different level in my view. And then, of course, if we are succeeding and making a large deal 1 more likely, it could be a major triggering part.

Yes, I think that's all the questions that we have received. So thank you all very much for this live queue and talk to you soon.

Thank you.