Saniona AB (SANION) Q1 2026 Earnings Call Transcript

Hello and welcome to RedEye and today's live queue with Sanjona. First off, CEO Thomas Feldhus and CFO Jonny Stillo will present the report. And after that, we will do a Q&A. And as a reminder, please continue to ask questions through our website. And I will try to ask as many questions as possible. So without further ado, please, Sanjona, go ahead with your presentation.

Thank you, Audrey. So good morning, everyone, and thank you for joining us for our Q1 2026 update. So the first quarter reflects continued discipline execution. We are advancing fleet proprietary CNS programs towards the clinic, progressing our partner programs, and strengthening engagement with potential pharmaceutical partners and the investment community today we will walk you through pipeline progress upcoming catalyst and financial performance i'm thomas felt the ceo and co-founder of san jona and with me is our cfo johnny stila who will walk you through the finances later in the presentation so before we begin please note that this presentation contains forward looking statements and these are based on current expectation and involves widths and uncertainties that 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, open for Q&A. So, Sanyona stands on three pillars. First, First, deep iron-channel expertise validated through multiple partnerships. And second, a partnership-driven business model that strengthens our financial position by preserving long-term upsides. And finally, three differentiated CNS assets entering clinic development. So in summary, we combine a validated science, strong partnerships, and a pipeline approaching value inflection points. So, our recent partnerships with Acadia and Jazz provide validation at substantial potential value. We've received $70.5 million off-front 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-diluted 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 ambition into context. Recent multiple-dollar CNS transactions demonstrate renewed strategic interest in differentiated neurological assets like ours. Our ambition is to advance one to two assets 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 GLP-TOX material for all three internal programs, which position us for Phase I starts in late 2026 and early 2027. All compounds are newly discovered and projected into the 40s. Also, a brief comment on SANT903, which is the Phase I ready asset position for partnering as it sits outside of our core CNS focus. Here we continue repositioning toward long fibrosis and are currently conducting additional pre-tanker studies to further strengthen in partnering pool firefly. On partnerships, JAS and Arcadia are progressing toward clinical studies triggering milestones of $7.5 million and $10 million respectively. Our research collaboration with Program Inline And astronautics and cyphrogenics continue to progress. The next key milestones for PI and astronautics is candidate selection. Regarding business development and engagement international investors, we significantly increased visibility during the quarter. We had more than 40 meetings at J.P. Morgan and continuing engagement thereafter with pharmaceutical companies, investors, banks and others. 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 out-lighting, with the ambition to partner at least one internal asset in the near to mid-term. At the same time, we continue building relationships with the international investment community to support long-term strategic flexibility. So with that all, let me turn you to the three internal programs and what you can expect in 2026 and by on. So this slide provides a high-level development plan for our Phase 1 and Phase 2 studies. The phase 1 studies will include single ascending dose and multiple ascending dose components. And following the SAT phase, we plan to conduct PIT studies to measure receptor occupancy in the brain, enabling rational phase 2 dose selection. In parallel, we will collect quantitative EEG biomarkers, providing objectives readouts related to sedation, vigliance and cognitive effects, supporting our differentiation basis. For CENT 2668, we are also planning for 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 for recruitment when we initiate phase two studies in pediatric patients. If execution proceeds are spent, we expect substantial clinical and biomarker data flow in the second half of 2027. So, as mentioned, our collaboration continues to progress, and several partners may move into the next development phase over the coming year. A cadence Phase 2 start for ACP711 in the Accenture Tramer would provide a $10 million milestone payment. Just phase one start, percent 23.55 in epilepsy, will provide a $7.5 million milestone payment. And to this, we have potential option exercise fee from astronautics and a research milestone from Bering-Einstein when they reach candidate selection. Regarding MEVICS and TESA-FANCEN, regulatory dialogue continues. And while a potential approval could generate royalties, our core value driver remains our CNS pipeline. Overall, collaborations provide non-dilutive data and strategic flexibility. So in summary, we see multiple inflection points over the next 24 months, including clinical initiation, phase one and biomarker readouts, proof of mechanism and early efficacy data for our leader assets, 2668, and partner milestones and potential license opportunities. And I will now hand you over to Johnny for a review of our financial performance.

Thank you, Thomas. As you can see here, our financial result for the first quarter was a loss of 46 million Swedish kronor, which is in line with our expectations as we continue to progress our free internal programs towards initiation of clinical phase one trials. Personal cost in the quarter increased due to headcount 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 eight quarters. Operating expenses, or OPEX, was realized at 61 million sec in the quarter. This is an increase of 10 million sec 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 one trials. As informed at our last call, we expect up to a 50% increase in OPEX in 26 compared to 25. So increases in cost will continue during the year. They will fluctuate over quarters as we progress toward the planned clinical phase one initiation. Next slide, please. At the end of March, we held 532 million Swedish kronor in cash. We expect to receive an additional 17.5 million US dollars, equal to 165 million Swedish kroner in near-term milestones payments when Arcadia's start the phase two trial and just start their phase one trial. We also maintain the option of making a sale and lease back of our headquarter, which we acquired for 70 million Swedish kroner. This will further bolster our cash position and provides us with a strong cash runway to progress the free internal program through phase one clinical trials. With that, I'll give the word back to Thomas for final remarks.

Thank you, Johnny. And to summarize, we have free internal assets advising towards clinics. Near-term milestone catalysts from partners.

We have strengthened engagement with pharma and investors. we have a strong financial position and we have a clear path toward multiple phase two proof of concept value inflection points we are advancing with discipline and strategic flexibility with that we are happy to take questions thank you thank you for that presentation so so i'll try to try to answer or ask so many questions that i can from from investors so the The first one was about external R&D costs in Q1, that they are higher than before and on the same level as almost a full year 2025. And you discussed this a bit, Jonny, 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, yeah, what can you say?

So, as I mentioned, we have indeed seen an increase in cost over quarters. It reflects two aspects. As I mentioned, it is the personal 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 free programs. The cost is not related specifically to any of the free 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 one initiation, cost will also increase.

Got it. and another question was about the clinical plans for designing phase two trials with your internal internal programs if you can what what are you currently doing to prepare for phase two although it's so major depressive disorder and epilepsy 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, principal investigators. And we are really encouraged by the strong support and enthusiasm that we continue to receive regarding both the value proposition for our assets and the ultimate goal to get this drug patient. We are actively involving these key opinion leaders in the design of our clinical studies and that there are those far away we still have a good plans on feasibility and design in addition we plan to feature some of disability ko opinion key opinion leaders in our webinar series that we are preparing for this presenting our prioritized asset in the webinar later this summer so the next question was about the phase one trial for san 2219 it has been pushed a bit into 2027 uh could you elaborate a bit on this uh this delay well yeah i mean you know

um when we when you conduct these pre-clinical studies um cmc and toxicology uh are the most difficult to estimate time wise and it's really first in this point in time where you have some more salt-type plants. And yes, 22-19, we're having a delay for one quarter. We expect now to start it around March, April. And on the other hand, 26-68 is actually advancing a quarter. So, you know, this is the way the situation is. And we are quite happy with this because 26-68 is our leaders. got it and and one question here was about the status of san 903 that you mentioned that we might get an update this spring um and also if we can discuss this uh this uh pre-clinical study in ipf a bit yeah as i mean the thing 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 an animal model of ipf at what you consider realistic doses and within the therapeutic window for the drop and this was strengthening you say the partner position we cannot go into further details because there may be some ip potential potential profile getting some ip in relation to this and therefore we will wait with further details got it and another question was about also about san 903 here about bridge biotherapeutics and that post their their program in ipf for bbt 301 which is i i understand a kind of a peer peer drug and how is san 903 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 aquamap is one of them in phase two and some companies are getting listed in us for a phase two program only um so it's really complicated and a busy area and there's a significant interest it's also a graveyard we don't think there are any direct competitors to our program out there okay got it and um one question was about what can you tell us about acadia's progress with

ACP 7-11 including studies conducted before commencing phase 2. What are they done lately?

We have completed all the phase 1 work and also other things in relation to a creature and they are progressing towards phase 2. They have previously announced that they expect to start phase 2 this year.

We have not seen that they're going out and and and changing that at this time um and we have not seen anything we should delay it so far so this is what i can say got it and another question was about about partnering you have mentioned at least one more licensing deal and i've stated that you intend to keep SAN 2668 in-house? Is SAN 2465 or SAN 2219 more likely to belt license? And is this a 2026 or 2027 event?

I cannot comment on timeline on this. But I've received significantly interest in all three 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 and in these indications. And this is the reason for us mentioning that it's more likely to outline the MDD product for depression as well as 2219.

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 such a trial with TESOMET in PWS could look like and if it's anything that you are thinking about in-house Also, if it's strictly for a partner to decide.

We are positioned as for partners outside CNS in our view. And although there are some CNS issues related to this. But it's not a priority as from our side at this time. We are positioned for partnering. And we have, during the quarter, connected with some of the companies interested in this space and are in dialogue with a few companies. But in general, I'll say that we see some more interest in our CNS assets from potential partners than the TSM-ed partners.

Got it. And yes, what is the status of the collaborations with Beringer Ingelheim, Astronautics and Sephagenics? Do you have any timelines for the expected progress?

I mean, Beringer Ingel is is moving towards candidate selection under an extended research agreement. And And Astronautis is also moving forward to its candidate selection, where they will take the decision for exercise of their option. And as mentioned in my presentation, we see the potential for phase 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 Iron Channel platform?

Yeah, we have one full support of research program internally, ongoing. And then we get significant resources right now. It could actually lead to not only one compound, but maybe two. and this is going very well so we have an internal research program which is important for us because we want to build a balanced pipeline and we hope for candidate selection sometimes in 2017 and how would you prioritize between those assets and your prioritized current phase one ready assets for example in terms of financing um as i mean the thing is that as we are currently uh prioritizing our free internal assets towards phase one and bring them into ready for phase two and the intention from our side is to make a collaboration agreement with one of these three assets in in the near to midterm and then build a balanced pipeline so it will be prioritized but obviously the cost relation to the early pre-clin development is is less than than for face around in phase one studies prepare for phase two got it and when it comes to tesofensin in in mexico one investor was asking is there anything more new you can share about the regulatory progress I mean, there is nothing material for us to report this time I can understand that there is some patient and our share who is in relation to this having said that if it gets approved we will be illegal for royalties but the core value in this company is still our CNS assets and then it was about But you have previously mentioned certain legal options.

Has Medix explored this further?

Yeah. Yeah, Co-Fapris and the process is extremely challenging for not only Medix but for all companies involved in Co-Fapris these days. and medics are facing China's pump copper bits you know following the they are using non-valid arguments for rejections and so on and many companies including medics has filed lawsuits and go legal rule in order ensure copper is sticking to what they're supposed to do. And this has been also the case for medics during this process.

Got it.

And we cannot rule out that there may come additional legal filings, but when you are in a lawsuit, you don't want to speak about it in public. And it's also extremely complicated, I would say.

And another question regarding Tesefelsin was about, is there any impact from medics collaborating with biocon regarding a glp1 drug a generic glp1 if that has impacted medics interest in tesefacine not at this time i just mean tesemed provides similar weight loss as vehicle which comes in tablets it's much more convenient to use and would be competitive once approved.

So they are still very interested in getting this product approved. And they have invested quite a lot on this. They're not only financed a phase three study, they have also produced material for commercial use for several years uh on the market so they have a keen interest in continuing this sounds good and another investor question was about you have a strong pre-clinical pipeline strong financial position and the share price does not seem to reflect this have you considered hosting a capital markets day or new ir initiatives yes absolutely so so we are planning a series of webinars around our prior assets starting with 2668 over the summer, sometimes in June, and we will press release it well in advance a couple of weeks ahead of the planned date. Currently, we are planning for around 17 of June. Let's see whether the math goes up in the timeline. As I said, we will press release that at least two weeks ahead of that.

Another question was about, you have asked the ADM for the right to issue 20% new shares, but you currently do not intend to do a capital raise. Can you explain this and why you want 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 funding 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 directed 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 interest has been high when you have been to, for example, JP Morgan and talked about the company. Maybe if you can elaborate a bit about this 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 do you want?

Absolutely. Just to clarify this, we are not in a capital race mode right now. But as Johnny said, we're getting this question all the time. And, you know, we really would like to engage with high qualified institution investors, select, we call them specialists in this context. And they will primarily only spend time on companies where they could potentially come into a transaction someday. they typically you know when you when we have the first meeting they 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 two in order to see whether you're developing according to our plans and the company is progressing nicely and in this context it's very important that we can put as a process of this despite that we may not utilize it in the 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.

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

Yeah, so we do one-to-one interaction with key opinion leaders to discuss the details, but we also participate in conferences later this month. we engage in the research roundtable for epilepsy that include also the FDA, a major sponsor investing in epilepsy. We also participated at the conference where we reviewed the entire pipeline of the epilepsy programs. And those are, you know, grounds where we can we can collaborate, you know, strengthen our collaboration with care, you know, need to discuss our plans and be also abreast of the competitive landscape and what other companies are doing. So we are heavily engaged in all these events and collaborators.

Thank you for that.

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

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

Well, I've said initially we are standing on three pillars and we are a leader in iron chain drug discovery. This platform has been validated through multiple partnerships, more lately with two significant deals with JASP pharmaceuticals and Arcadia 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 progress our own and secure long-term value and we have three highly differentiated assets which we are booming into startup phase two so today we have validated discovery platform we have strong strong partnerships and third we have three different shares different share that has been moving forward internally thank you uh and as my own follow-up there um from a kind of share price um perspective what would be the key catalyst the coming year or so would it be more licensing deals or initiating clinical trials or what would you so so there is you know initiating the phase one studies we come into phase one and we make the company ready for phase two will bring this company forward to a complete different level in my view and then of course if you are succeeding and making a life if you deal one more license it could be a major triggering

part yes i think that's that's all the questions that we have received so uh thank thank you all very much for this live queue and talk to you soon.

Thank you.