Q2 2026 Saniona AB (publ) Earnings Call

August 27, 2026

Speaker #1: Okay. Hello, and welcome to this live Q&A with Saniona. First off, there will be a presentation from the management team, and after that we will try to answer as many questions as possible from you investors. We have received quite a lot of questions, so we will make some time for that.

Operator: Okay. Hello, and welcome to this live Q with Saniona. First off, there will be a presentation from the management team. After that, we will try to ask as many questions as possible from you investors. We have received quite a lot of questions, so we will make some time for that. Please, Saniona, do your presentation first.

Speaker #1: So please, Saniona, do your presentation first.

Speaker #2: Do you want me to start? Okay, thank you. Good morning, everyone, and thank you for joining our Q2 update. The quarter was marked by continued execution across our proprietary and partner programs.

Thomas Feldthus: Do you want me to start? Okay. Thank you. Good morning, everyone, and thank you for joining our Q2 update. The quarter was marked by continued execution across our proprietary and partnered programs. More recently, we decided to focus our internal development resources on SAN-2668 and SAN-2465 as our two lead proprietary programs. Today, we will focus on that decision, our progress toward the clinic, upcoming catalysts, and our financial position. With me today, I have our CMO, Pierandrea Muglia, and our CSO, Karin Sandager Nielsen, as well as our CFO, Johnny Stilou. Pierandrea and Karin will take you through the clinical strategy and new data for our prioritized pipeline. Johnny will cover the financials. Before we begin, please note that today's presentation contains forward-looking statement based on current expectation and subject to risk and uncertainties. I will start with the Q2 highlights, our recent strategic prioritization.

Speaker #2: More recently, we decided to focus our internal development resources on SAT-2668 and SAT-2465 as our two lead proprietary programs. Today, we will focus on that decision, our progress toward the clinic, upcoming catalysts, and our financial position.

Speaker #2: So with me today I have our CMO, Pierre-André Amouclier, and our CSO, Karin Sania, as well as our CFO, Johnny Steelo. Pierre-André and Karin will take you through the clinical strategy and new data for our prioritized pipeline.

Speaker #2: And Johnny will cover the financials. So before we begin, please note that today's presentation contains forward-looking statements based on current expectations and subject to risks and uncertainties.

Speaker #2: I will start with the Q2 highlights and our recent strategic prioritization. Pierre-André and Karin will then cover our development plans and the new SAT-2668 data.

Thomas Feldthus: Pierandrea and Karin will then cover our development plans and new SAN-2668 data, followed by Johnny on the financials before we open for questions. Let me briefly remind you of our long-term ambition. We aim to build a balanced CNS pipeline with programs across early, mid, and late-stage clinical development, similar to companies like Arvelle and Cerevel before acquired in 2024. We believe we have three strong pillars supporting that ambition. First, a validated drug discovery platform that has delivered five clinical candidates in the last five years. Second, a proven partnership model that provides validation, potential non-dilutive funding, and substantial downstream value. Third, our proprietary pipeline, where SAN-2668 and SAN-2465 are now approaching clinical development. Q2 was another quarter of execution, followed by a sharpening of our strategic focus. We continued the IND and CTA-enabling work for SAN-2668 and SAN-2465.

Speaker #2: Followed by Johnny on the financials, before we open for questions. So let me briefly remind you of our long-term ambition. We aim to build a balanced CNS pipeline with programs across early, mid, and late-stage clinical development, similar to companies like Aruna and Serval before they were acquired in 2024.

Speaker #2: We believe we have three strong pillars supporting that ambition. First, a validated drug discovery platform that has delivered five clinical candidates in the last five years.

Speaker #2: Second, a proven partnership model that provides validation, potential non-dilutive funding, and substantial downstream value. And third, our proprietary pipeline, where SAT-2668 and SAT-2465 are now approaching clinical development.

Speaker #2: Q2 was another quarter of execution, followed by a sharpening of our strategic focus. We continue the R&D and CTA-enabling work for SAT-2668 and SAT-2465.

Thomas Feldthus: SAN-2465 is expected to enter phase I around year-end, while SAN-2668, we expect CTA submission around year-end and first dosing in the first quarter of 2027. The prioritization of these two programs also extend our expected runway into 2029 and give us greater capacity to invest in our clinical development and early proof-of-concept studies. Our partner portfolio continue to progress. AstronauTx exercised its option to ATX-0926 after quarter end, providing us with share value at $5 million and significant future milestones and royalty potential. Jazz Pharmaceuticals is preparing the first phase I study of SAN-2355, while Acadia now expects its ACP-711 phase II study to start in 2027. We also continued active business development and investor engagement, including around 25 partnering meetings at BIO International Convention in San Diego and with institutional investors in the US and Europe over the summer.

Speaker #2: SAT-2465 is expected to enter Phase I around year-end, while for SAT-2668, we expect CTA submission around year-end and first dosing in the first quarter of 2027.

Speaker #2: The prioritization of these two programs also extends our expected runway into 2029 and gives us greater capacity to invest in our clinical development and early proof-of-concept studies.

Speaker #2: Our partner portfolio continues to progress. As a Nordics TX, exercised its option to ATX 0926. Arthur quarter end, providing us with share value at $5 million.

Speaker #2: And significant future milestones and royalty potential. JAS is preparing the first Phase 1 study of SAT-2355, while Acadia now expects its ACP-711 Phase 2 study to start in 2027.

Speaker #2: We also continue active business development and investor engagement, including around 25 partnering meetings at BIO in San Diego, and with institutional investors in the US and Europe over the summer.

Speaker #2: As our programs have matured, we have gained greater clarity on both their development opportunities and the resources required to take them through clinical proof of concept.

Thomas Feldthus: As our programs have matured, we have gained greater clarity on both their development opportunities and the resources required to take them through clinical proof of concept. We therefore recently decided to concentrate our internal development resources on SAN-2668 and SAN-2465. This focus is expected to extend our financial runway into 2029 and gives us flexibility to invest further in the programs where we see the greatest value. In particular, we may allocate capital to generate early proof of concept with SAN-2668 in DEE patients in 2028, following the planned proof of mechanism study in photosensitive epilepsy in 2027. SAN-2668 combines a strong preclinical profile with a compelling rare disease development path and the potential for Saniona to retain the program through late-stage development and potential commercialization. SAN-2465 gives us a differentiated opportunity in major depressive disorders, with significant unmet need and substantial commercial potential.

Speaker #2: We have therefore recently decided to concentrate our internal development resources on SAT-2668 and SAT-2465. This focus is expected to extend our financial runway into 2029 and gives us flexibility to invest further in the programs where we see the greatest value.

Speaker #2: In particular, we may allocate capital to generate early proof of concept with SAT-2668 in DEE patients in 2028, following the planned proof-of-mechanism study in photosensitive epilepsy in 2027.

Speaker #2: SAT-2668 combines a strong regional profile with a compelling rare disease development path, and the potential for Saniona to retain the program through late-stage development and potential commercialization.

Speaker #2: SAT-2465 gives us a differentiated opportunity in major depressive disorders, with significant unmet need and substantial commercial potential. We believe these two programs provide the strongest opportunities for value creation as we enter the more resource-intensive clinical stage.

Thomas Feldthus: We believe these two programs provide the strongest opportunities for value creation as we enter the more resource-intensive clinical states. As part of this discussion, we will pause SAN2219. The program has demonstrated an attractive preclinical profile and will be retained for potential future development or partnering opportunities. There is a significant unmet medical need in pediatric epilepsy and DEEs, and we have seen substantial strategic interest in this area. The transactions on this slide range from commercial-stage projects from GW and Zogenix, to Longboard with a phase III asset, and most recently, Actio, which was acquired by Jazz for up to $1.6 billion with its lead epilepsy program in phase I-B/II-A. The Actio transaction is particularly interesting from our perspective. If our development proceeds as planned, SAN-2668 could reach a comparable stage of clinical development in 2028, when we aim to generate early proof of concept in DEE patients.

Speaker #2: As part of this discussion, we will pause SAT-2219. The program has demonstrated an attractive preclinical profile and will be retained for potential future development or partnering opportunities.

Speaker #2: There is a significant unmet medical need in PDR epilepsy and DEEs, and we have seen substantial strategic interest in this area. The transactions on this slide range from commercial-stage projects from GW and Syngenics to Longboard with a Phase 3 asset.

Thomas Feldthus: The transactions on this slide range from commercial-stage projects from GW and Zogenix, to Longboard with a phase III asset, and most recently, Actio, which was acquired by Jazz for up to $1.6 billion with its lead epilepsy program in phase I-B/II-A. The Actio transaction is particularly interesting from our perspective. If our development proceeds as planned, SAN-2668 could reach a comparable stage of clinical development in 2028, when we aim to generate early proof of concept in DEE patients.

Speaker #2: And most recently, Accu, which was acquired by Jazz for up to $1.6 billion, with its lead epilepsy program in phase 1b/2a.

Speaker #2: The Accu transaction is particularly interesting from our perspective. If our development proceeds as planned, SAT-2668 could reach a comparable stage of clinical development in 2028.

Speaker #2: When we aim to generate early proof of concept in DEE patients, SAT-2668 also has the potential for DEEs rather than a single genetically defined indication.

Thomas Feldthus: SAN-2668 also has the potential to address multiple DEEs rather than a single genetic defined indication, providing an opportunity for broader development over time. These transactions are not directly comparable, but they illustrate the significant strategic value that can be created by differentiating therapies in this field. We see similar strong strategic interest in major depressive disorders and treatment-resistant depression. SAN-2465 offers a differentiated approach with the potential for rapid antidepressant efficacy in all treatment without the in-clinic administration and monitoring required by some newer rapid-acting therapies. Our two prioritized programs provide complementary opportunities, a focused rare disease strategy with SAN-2668 and a large neuropsychiatric opportunity with SAN-2465. With that, I will hand you over to Pierandrea.

Speaker #2: Providing an opportunity for the board of development over time. These transactions are not directly comparable, but they illustrate the significant strategic value that can be created by differentiating therapies in this field.

Speaker #2: We see similar strong strategic interest in major depressive disorders and treatment-resistant depression. SAN2465 offers a differentiated approach with the potential for rapid antidepressant efficacy in all treatment, without the in-clinic administration and monitoring required by some newer rapid-action therapies.

Speaker #2: So, our two prioritized programs provide complementary opportunities: a focused rare disease strategy with SAT-2668, and a large neuropsychiatric opportunity with SAT-2465. And with that, I would hand you over to Pier Andrea.

Speaker #1: Thank you, Thomas. I'm going to give you a highlight of our clinical programs, and how we are planning to translate the properties of our compound in humans and in patients.

Pierandrea Muglia: Thank you, Thomas. I am going to give you a highlight of our clinical programs and how we are planning to translate the properties of our compounds in humans and in patients. Both programs have phase I studies that with a rich biomarker for target engagement and proof of pharmacology, and they are aiming to start toward the end of this year or early next year. Starting with 2668 in the next slide. Since the candidate selection, we are building the preclinical package and demonstrating evidence in a number of animal models, and Karin will show you that. In essence, what we are learning is that our compound has strong and broad effect on seizures and multiple type of seizures, but also on non-seizure endpoints. This give us the confidence to broaden our value proposition and the potential impact of our compound.

Speaker #1: Both programs have a phase one study, where we then reach biomarker for target engagement and proof of pharmacology. They are aiming to start toward the end of this year or early next year.

Speaker #1: So, starting with 2668 in the next slide. Since candidate selection, we are building the preclinical package and demonstrating evidence in a number of animal models, and currently I will show you that.

Speaker #1: And in essence, what we are learning is that our compound has a strong and broad effect on seizures, and on multiple types of seizures, but also on non-seizure endpoints.

Speaker #1: This gives us the confidence to broaden our value proposition and the potential impact on our compound. And as a consequence, we have refined our clinical development plan that we recently presented at the webinar.

Pierandrea Muglia: As a consequence, we have refined our clinical development plan that we recently presented at the webinar. I will suggest you for more details to look at our webinar. Now, in essence, I am going to walk you through the key points of our plan and value proposition. If you go to the next slide, I borrowed this slide from our opinion leader that was presented at the webinar that shows that the DEEs are complex multifactorial disorders. It is not only about seizures that give a great burden, but there is a number of non-seizure endpoints. Some of these might be indirectly improved with the improvement of seizure or reduction of seizure burden. Others can be additionally improved with the pharmacology of our compounds. This is based on our evidence on non-seizure endpoint and specifically behavior. Karin is going to show you those data.

Speaker #1: So I will suggest you, for more details, to look at our webinar. But now, in essence, I'm going to walk you through the key points of our plan and value proposition.

Speaker #1: If you go into the next slide, I borrowed this slide from our opinion leader that was presented at the webinar. It shows that DEEs are complex, multifactorial disorders.

Speaker #1: It's not only about seizures that give a great burden, but there's a number of non-seizure endpoints. Some of these might be indirectly improved with the improvement or reduction of seizure burden.

Speaker #1: Others, like Q2, can be additionally improved with the pharmacology of our compounds. And this is based on our evidence on non-seizure endpoints, and specifically behavior.

Speaker #1: And Karen is going to show you those data. So on that, we have refined our value proposition that you see in the next slide, where we see a clear, strong potential effect on seizures and multiple seizure types.

Pierandrea Muglia: On that, we have refined our value proposition that you see in the next slide, where we see a clear strong potential effect on seizures and multiple seizure types. We see the potential of reducing the impaired EEG and electrical abnormalities that impair development in these kids. In addition to that, as I said, the non-seizure endpoint is specifically behaviors that are really impacting the disease and families, like aggressivity and irritability. With that, and a reduced tolerability profile given by the selective for GABA, we think to have a unique differentiating potential for these compounds. Now, without further ado, I will give the work to Karin, so we will explain in details the data that we recently acquired. Karin?

Speaker #1: We see the potential of reducing the impaired EEG and electrical abnormalities that impair development in these kids. And in addition to that, as I said, the non-seizure endpoints—specifically behaviors that are really impacting the disease and families, like aggressivity and irritability.

Speaker #1: So with that, and its reduced tolerability profile given by the selective pharmacological GABA, we think we have a unique differentiating potential for this compound.

Speaker #1: So now, without further ado, I'll give the word to Karen, who will explain in detail the data that we recently acquired. Karen?

Speaker #3: Thank you. Thank you, Pier Andrea. And hi, everyone. So, as Pier Andrea alluded to, spike-wave activity is quite common across the DEEs, and it's believed to contribute not only to seizures but also to negatively impact cognition and behavior by disrupting the normal information processes in the brain.

Karin Sandager Nielsen: Thank you, Pierandrea, and hi, everyone. As Pierandrea alluded to, spike wave activities is quite common across the DEEs, and it is believed to contribute not only to seizures but also to negatively impact cognition and behavior by disrupting the normal information processes in the brain. At our webinar in June, I showed in one monogenetic DEE, namely the SYNGAP1 model. Since then, we have produced data in two additional genetically defined DEEs, namely the STXBP1 and the CHD2. As you see in the figure here, besides the strong suppression of spike waves in SYNGAP1 that you saw early on in our webinar, SAN-2668 also strongly suppresses spike wave activity in the two other genetically defined DEEs.

Speaker #3: At our webinar in June, I showed one monogenetic DEE, namely the SYNGAP1 model. Since then, we have produced data in two additional genetically defined DEEs, namely the SGXBP1 and the CHD2.

Speaker #3: And as you see in the figure here, besides the strong suppression of spike waves in SYNGAP1 that you saw early on in our webinar, 2668 also strongly suppresses spike wave activity in the two other genetically defined DEEs.

Speaker #3: What I find particularly encouraging about these data is the consistency we see across the different genetically defined DEEs. This supports the potential for 2668 to have activity across multiple DEEs, rather than being limited to one specific genetic disorder.

Karin Sandager Nielsen: What I find particularly encouraging by these data is the consistency we see across the different genetically defined DEEs, because this supports the potential for SAN-2668 to have activity across multiple DEEs, rather than just being limited to one specific genetic disorder. Next slide, please. As the DEEs are much more than seizure, it is quite important to investigate whether SAN-2668 can affect non-seizure symptoms. Here on this figure, we demonstrate that SAN-2668 improves multiple non-seizure endpoints, including cognitive impairment and aggression-like behavior in the SYNGAP1 model, and also improves social functioning in the CHD2 model. Of course, this is preclinical findings, and we should be cautious about that translation to patients. I think they are particularly interesting, given the significant non-seizure burden that is experienced by children with DEEs. Next slide.

Speaker #3: Next slide, please. As the DEEs are much more than seizures, it's quite important to investigate whether 2668 can affect non-seizure symptoms. And here on this figure, we demonstrate that 2668 improves multiple non-seizure endpoints, including cognitive impairment and aggression-like behavior in the SYNGAP1 model, and also improves social functioning in the CHD2 model.

Speaker #3: Of course, these are preclinical findings and we should be cautious about their translation to patients. But I think they are particularly interesting, given the significant non-seizure burden experienced by children with DEEs.

Speaker #3: Next slide. Now, aggressive symptoms have been reported by the caregivers to be among the most troublesome behavioral symptoms. So, to further support the beneficial effects of 2668 on aggression-related behaviors, we have replicated the zebrafish findings in an established rodent model, namely the resident intruder model of aggression.

Karin Sandager Nielsen: Now, aggressive symptoms have been reported by the caregiver to be among the most troublesome behavioral symptoms. To further support the beneficial effects of SAN-2668 on aggression-related behaviors, we have replicated the Zebrafish findings in an established rodent model, namely the resident-intruder model of aggression. As you reasonably can see in the figure, SAN-2668 reduced aggressive behavior, both by delaying the first attack but also in reducing attack duration. Importantly, this was not just caused by some kind of unspecific effects because locomotor activity was not affected. So it suggests that the effect was not simply caused by sedative effect or other unspecific effects. Together, these data clearly strengthen our confidence in the potential broader clinical profile of SAN-2668. With that, I will hand it back to Pierandrea to take you through how we plan to evaluate the compound clinically.

Speaker #3: And as you readily can see in the figure, 2668 reduced aggressive behavior both by delaying the first attack and by reducing the attack duration.

Speaker #3: And importantly, this was not just caused by some kind of unspecific effects because locomotor activity was not affected. So, it suggests that the effect was not simply due to a sedative effect or other unspecific effects.

Speaker #3: So together, these data clearly strengthen our confidence in the potential broader clinical profile of 2668. And with that, I will hand it back to Pier Andrea to take you through how we plan to evaluate the compound clinically.

Speaker #1: Thank you, Karen. As I said, we are finalizing the package that will allow us to submit for first-in-human studies toward the end of this year.

Pierandrea Muglia: Thank you, Karin. As I said, we are finalizing the package that will allow us to submit for first-in-human studies toward the end of this year. On these slides, you should focus on the lower part, where you see the key deliverable of our clinical plan. We are fortunate to have a number of validated biomarkers for test differentiated pharmacology that we are developing, in addition to be fortunate to have a PET tracer that will allow us to measure target occupancy at different levels. So the early program is rich biomarker will allow us to deliver phase I data in conjunction with this clear evidence of differentiated pharmacology, and that will be around the end of 2027, beginning of 2028.

Speaker #1: On this slide, you should focus on the lower part where you see the key deliverable of our clinical plan. We are fortunate to have a number of validated biomarkers for test-differentiated pharmacology that we are developing, in addition to being fortunate to have the PET tracer that will allow us to measure target occupancy at different levels.

Speaker #1: So, the early program is rich in biomarkers, which will allow us to deliver Phase I data in conjunction with this clear evidence of differentiated pharmacology. That will be around the end of 2027 or the beginning of 2028.

Pierandrea Muglia: In parallel to the phase I, we have designed a study to test the effects of our compound in an established and translatable model that is widely used in epilepsy. That is the photosensitivity model, where susceptible patients are exposed to flickering lights, and we will test, evaluate the effect of compound will suppress this epileptic form activity. That will eventually will be the information will be used to select a dose and design and finalize the study that will test the effect efficacy in the relevant population, the broad DEE in a basket study composed of a number of orphan disease. So that would be the delivery of the proof of concept data that you see later on in the plan. So that is in essence our SAN-2668 early clinical plan that will generate evidence at different time points with the specific deliverables.

Speaker #1: In parallel to the Phase One, we have designed a study to test the effect of our compound in an established and translational model that is widely used in epilepsy—that is, the photosensitivity model.

Speaker #1: Where susceptible patients are exposed to flickering light, and we will test and evaluate the effect of compounds used to suppress this epileptic form activity. That information will eventually be used to select a dose and design, finalizing the study that will test the effect and efficacy in the relevant population, the broad DEE, in a basket study composed of a number of orphan diseases.

Speaker #1: And so that will be the delivery of the proof-of-concept data that you see later on in the plan. So that's kind of, in essence, our 2668 early clinical plan that will generate evidence at different time points with specific deliverables.

Speaker #1: So, without further ado, on 2668, I will just now transition to the next slide and give you a few highlights on the other program, the 2465.

Pierandrea Muglia: Without further ado on SAN-2668, I will just now transition to the next slide and give you a few highlights on the other program, the SAN-2465, our alpha-5 GABA A selective compound that is in development for depression. There is no question that depression constitutes one of the major burden, overall and specifically for CNS disorders. The majority of the burden is given by patients that do not respond to first-line therapy like SSRIs. A demonstration of the burden and also how you can alleviate the burden with the pharmacology is demonstrated by esketamine, approved to treat the most refractory patients. As you can see here, in term of revenues, it is generating a lot of value for the company that develop it, but a lot of value for this very severe patient.

Speaker #1: You know, our alpha-5 GABA A selective compound that is in development for depression. So, there is no question that depression constitutes one of the major burdens overall, and specifically for CNS disorders.

Speaker #1: And the major burden, the majority of the burden, is given by patients that do not respond to first-line therapy like SSRIs. And the demonstration of the burden, and also how you can alleviate the burden with pharmacology, is demonstrated by esketamine, proven to treat the most refractory patients.

Speaker #1: And as you can see here, in terms of revenues, it's generating a lot of value for the company that developed it, but also a lot of value for these very severe patients.

Speaker #1: And this is in spite of complexity that is related to the administration of this compound in clinic under monitoring. Our proposition with our compound is to target this type of patient, but be devoid of this in-clinic administration, because we don't expect any similarity on the pharmacology of some aspects that are given by esketamine administration.

Pierandrea Muglia: This is in spite of complexity that is related to the administration of this compound in clinic under monitoring. Our proposition of our compound is to target this type of patient, but being devoid of this in-clinic administration, because we do not expect any similarity on the pharmacology of some aspect that are given by esketamine administration. In essence, our program is expected to give a faster onset of action with potential on cognition. We are making good progress here as well to submit for an IND approval October in this fall. If you go on the next slide, I wanted to provide you just key highlights on the program. The good progress include the testing of the compound in non-human primates, where we are demonstrating again with a specific tracer, that brain penetration and different exposure of our target occupancy.

Speaker #1: So in essence, our program is expected to give a fast onset of action with potential on cognition. And we're making good progress here as well to submit for an IND approval toward this fall.

Speaker #1: And if you go to the next slide, I wanted to provide you with just key highlights on the program. The good progress includes the testing of the compound in non-human primates, where we have demonstrated again with a specific PET tracer that pain presentation and different exposure of target occupancy.

Speaker #1: This will inform our dosing strategy for Phase One and eventually for our Phase Two. And so, if you go to the next slide, you can see the value proposition again summarized on 24-65.

Pierandrea Muglia: This will inform our dosing strategy for phase I and eventually for our phase II. If you go on the next slide, you can see the value proposition again, summarized on SAN-2465. We expect a rapid onset of action and comparable to ketamine, and we expect based on the pharmacology and the data on this pharmacology, a cognitive benefit for these patients, where cognitive impairment is quite common and is also a negative prognostic factor for improvement of the overall symptomatology. Together with that, as I said, it is easy to use at home administration without any complexity of in-clinic and esketamine. With that, we expect to address a key unmet need in major depression, and we have delineated the clinical plan again in phase I. You can see next slide at the timeline of the deliverable.

Speaker #1: We expect a rapid onset of action, comparable to ketamine. And we expect, based on the pharmacology and the data on this pharmacology, a cognitive benefit for this patient.

Speaker #1: Cognitive impairment is quite common and is also a negative prognostic factor for improvement of the overall symptomatology. Together with that, as I said, it's easy to use at-home administration without any complexity of in-clinic and esketamine.

Speaker #1: So, with that, we expect to address the key unmet need in measured depression. And we have delineated the clinical plan again in Phase 1.

Speaker #1: You can see on the next slide the timeline of the deliverable. Phase one was reached with the biomarker for target engagement and proof of pharmacology, and that will allow us to enable a phase two study in the relevant population with the standard design and a lot of learning from past experience in this area that we have already discussed with the key opinion leaders, who are behind our program.

Pierandrea Muglia: A phase I reach with a biomarker for target engagement and proof of pharmacology. That will allow us to enable a phase II study in the relevant population with the standard design and a lot of learning from the past experience in this area that we have already discussed with the key opinion leaders that are behind our program. With that, I have concluded the clinical part and hand over to Pierandrea Muglia.

Speaker #1: And with that, I conclude the clinical part, and over to John Haggis.

Speaker #3: Yes, thank you, Pierre-André. Next slide, please. Our net result for the second quarter was a loss of SEK 58 million, which continued to be in line with our expectations.

Johnny Stilou: Yes. Thank you, Pierandrea. Next slide. Our net results for Q2 was a loss of 58 million SEK, which continued to be in line with our expectations. The increase in cost is driven by the progression of our 2 internal assets, SAN-2668 and SAN-2465, as we progress them towards initiation of clinical phase I trials around year-end. Personnel costs increased due to headcount growth with 44 employees in June this year versus 29 a year earlier. This buildup again reflects preparations for the clinical execution. The buildup in our organization needed to initiate the clinical trials is complete for now, and we do not plan to continue the growth in headcount near term. Next slide. Here you find an overview of our operating expenses for the past 8 quarters. Operating expenses or OpEx was realized at 65 million SEK in the quarter.

Speaker #3: The increase in cost is driven by the progression of our two internal assets, SAN2668 and SAN2465, as we move them towards initiation of clinical Phase 1 trials around year-end.

Speaker #3: Personnel costs increased due to headcount growth, with 44 employees in June this year versus 29 a year earlier. This buildup again reflects preparations for clinical execution.

Speaker #3: The buildup in our organization needed to initiate the clinical trials is complete for now, and we do not plan to continue the growth in headcount in the near term.

Speaker #3: Next slide. Here you find an overview of our operating expenses for the past eight quarters. Operating expenses, or OPEX, were realized at 65 million kronor in the quarter.

Speaker #3: This is an increase in kronor compared to the previous quarter. As mentioned, the increase in cost quarter over quarter is both expected and planned as we progress our two internal programs toward the initiation of the clinical Phase One trials around year-end.

Johnny Stilou: This is an increase of SEK 4 million compared to the previous quarter. As mentioned, the increase in cost quarter-over-quarter is both expected and planned as we progress our two internal programs towards the initiation of the clinical phase I trials around year-end. Next slide. At the end of June, we held SEK 486 million in cash, equal to approximately $50 million. We expect to receive an additional $17.5 million, equal to approximately SEK 165 million in near-term milestone payments when Acadia start their phase II trial and Jazz start their phase I trial. We also maintain the option of making a sale and lease back of our headquarter, which we acquired for SEK 70 million last year. Including the near-term milestones, our current funding can sustain our planned operations into 2029.

Speaker #3: Next slide. At the end of June, we held 486 million Swedish kronor in cash, equal to approximately $50 million US dollars. We expect to receive an additional $17.5 million US dollars, equal to approximately 165 million Swedish kronor, in near-term milestone payments when Acadia starts their Phase 2 trial and JAS starts their Phase 1 trial.

Speaker #3: We also maintain the option of making a sale and lease-back of our headquarters, which we acquired for 70 million kronor last year. Including the near-term milestones, our current funding can sustain our planned operations into 2029.

Speaker #3: This means that current cash can fund clinical Phase 1 programs for both SAN2668 and SAN2465 through to data readout and early proof of concept in DEEs for SAN2668 in 2028.

Johnny Stilou: This means that current cash can fund clinical phase I programs for both SAN-2668 and SAN-2465 through to data readout and early proof of concept in DEEs for SAN-2668 in 2028. Next slide. Over the next 24 months, we see multiple inflection points, including clinical initiation, phase I and biomarker readouts, proof of mechanism and early efficacy data for our lead asset, partner milestones, and potential licensing opportunities. Next slide. As mentioned, our collaborations continue to progress, latest with AstronauTx, who exercised their option and paid us $5 million in milestone, which we received in shares. Several partners may move into next development phase over the coming year. Acadia's phase II start for ACP-711 in essential tremors will provide a $10 million milestone payment. Jazz's phase I start for SAN2355 in epilepsy will provide $7.5 million in milestone payment.

Speaker #3: Next slide. Over the next 24 months, we see multiple inflection points, including clinical initiation, Phase 1 and biomarker readouts, proof of mechanism, and early efficacy data for our lead asset.

Speaker #3: Partner milestones and potential licensing opportunities. Next slide. As mentioned, our collaborations continue to progress. Most recently with Astronautics, who exercised their option and paid us $5 million in a milestone, which we received in shares.

Speaker #3: And several partners may move into the next development phase over the coming year. Acadia's phase two start for ACP-San 11 in essential tremors will provide a $10 million milestone payment.

Speaker #3: And JAS's Phase 1 start for SAN2355 in epilepsy will provide $7.5 million in milestone payment. In addition, we have a potential research milestone from Boehringer Ingelheim when they reach candidate selection.

Johnny Stilou: In addition, we have a potential research milestone from Boehringer Ingelheim when they reach candidate selection. Regarding Medix and tesofensine, regulatory dialogue is ongoing, and Medix is increasing their actions and push towards COFEPRIS. While potential approval could generate royalties, our core value driver remains our CNS pipeline. Overall, collaborations provide non-dilutive capital and strategic flexibility. With that, I will give the word back to Thomas for final remarks.

Speaker #3: Regarding Medix and tesofensine, regulatory dialogue is ongoing, and Medix is increasing their actions and push towards coverage. While potential approval could generate royalties, our core value driver remains our CNS pipeline.

Speaker #3: Overall, collaborations provide non-dilutive capital and strategic flexibility. With that, I will give the word back to Thomas for final remarks.

Thomas Feldthus: Thank you, Johnny. Let me just summarize before we open for questions. We are entering an important new phase for Saniona. We have sharpened our focus around SAN-2668 and SAN-2465, the two proprietary programs we believe offer the strongest opportunity for value creation. Both our approach in the clinics and our priorities give us the financial flexibility to take these programs further, including the potential to generate early proof of concept with SAN2668 in DEE patients in 2028. At the same time, our partner programs continue to advance and provide opportunities for both near-term milestones and significant long-term value. The strong financial position and focused proprietary pipeline, multiple potential value inflection points ahead, we believe Saniona is well-positioned for the next phase of development. With that, we are happy to take questions. Thank you.

Speaker #1: So, thank you, Johnny. Let me just summarize before we open for questions. We are entering an important new phase for Saniona. We have sharpened our focus around 2668 and 2465.

Speaker #1: The two proprietary programs we believe offer the strongest opportunity for value creation. Both are approaching the clinic, and our private give us the financial flexibility to take these programs further, including the potential to generate early proof of concept with SAN2688 in DEE patients in 2028.

Speaker #1: At the same time, our partner programs continue to advance and provide opportunities for both near term milestones as a significant long term value. The strong financial position and focus proprietary pipeline multiple potential value inflection points ahead we believe Saniona is well positioned for the next phase of development.

Speaker #1: And with that, we are happy to take questions. Thank you.

Operator: Okay, thank you for that presentation. The first question was, and this is an investor question, and we got quite a few variations of this, but if you can elaborate a bit more about prioritizing SAN2668 and SAN2465 over SAN2219, and if you can discuss that and whether it has anything to do with a SAN2219 molecule in a cell, or if it is just a capital allocation or develop a bit more.

Speaker #2: Okay, thank you for that presentation. So the first question was—and this is an investor question, and we got quite a few variations of this—but if you can elaborate a bit more about the prioritizing of 2668 and 2465 over 2219, and, yeah, if you can discuss that and whether it has anything to do with the 2219 molecule in a cell, or if it's just a capital allocation, or, yeah, develop a bit more.

Speaker #1: Yeah, so this is clearly a decision based on focus and not something about 2219. So SAN2668 has had the top priority since we selected it in August last year, followed by SAN2465 and 2219.

Thomas Feldthus: Yeah. This is clearly a decision based on focus and not something about SAN2219. SAN2668 has had the top priority since we selected it in August last year, followed by SAN2465 and SAN2219. What is new is that we have narrowed our focus for development on SAN2668 and SAN2465. We have been in a similar situation before. In 2024, we focused all our internal development resources on SAN711 and SAN2355, partly because we saw a significant industry interest. Within 18 months, those programs were licensed to Acadia and Jazz. Today, we see significant interest in SAN2668 and SAN2465. Within epilepsy, SAN2219 stands somewhat in shadow of SAN2668 because efficacy is critically important, particularly in severe pediatric epilepsies. SAN2668 has exceptional strong preclinical efficacy profile. The difference this time is that we want to take SAN2668 further ourselves and capture more of the potential value.

Speaker #1: What is new is that we have narrowed our focus for development on 2668 and 2465. We have been in a similar situation before. In 2024, we focused all our internal development resources on SAN711 and SAN2365, partly because we saw significant industry interest.

Speaker #1: Within 18 months, those programs were licensed to Acadia and JAS. And today, we see significant interest in SAN2668 and SAN2465. Within epilepsy, SAN2219 stands somewhat in the shadow of SAN2668 because efficacy is critically important, particularly in severe pediatric epilepsies.

Speaker #1: And SAN2668 has an exceptionally strong preclinical efficacy profile. The difference this time is that we want to take SAN2668 further ourselves and capture more of the potential value.

Speaker #1: Our financial position gives us now the opportunity to generate early proof of concept in DEE patients, and recent transactions clearly illustrate the value that can be created at that stage of development.

Thomas Feldthus: Our financial position gives us now the opportunity to generate early proof of concept in DEE patients, and recent transactions clearly illustrate the value that can be created at that stage of development.

Speaker #2: And you mentioned the focus here, and is it also about extending the cash runway, or is it also partly because of internal constraints in terms of capacity and so on? Or is it—yeah, why do you need to focus, I guess, is the question?

Operator: You mentioned the focus here, and is it also about extending the cash runway, or is it also partly because of internal constraints in terms of capacity and so on? Why do you need to focus, I guess, is the question.

Thomas Feldthus: This is about extending runway to a meaningful inflection point and to be able to create proof of concept studies for SAN2668. This is part of it, but it is also because we think that we can create more value in these two assets at this point in time based on our current financial situation.

Speaker #1: This is about extending runway to reach a meaningful inflection point and to be able to create proof-of-concept studies for SAN2668. This is part of it.

Speaker #1: But it's also because we think that we can create more value in these two assets at this point in time, based on our current financial situation.

Speaker #2: Makes sense. And another investor question here was about whether you still plan to pursue a partnering strategy for 2019. Do you still have meetings regarding it, and so on, or how should we see it?

Operator: Makes sense. Another investor question here was about, do you still plan to pursue a partnering strategy for SAN2219? Do you still have meetings regarding it and so on? How should we see it? Is it paused?

Speaker #2: Should it be, "Is it paused," or just...?

Speaker #1: So, we retain SAN2219 for potential further development and partnering. If our resources and priorities change, we could certainly pick it up again.

Thomas Feldthus: We retain SAN2219 for potential further development and partnering. If our resources and priorities change, we could certainly pick it up again, but it is primarily for partnering at this point in time.

Speaker #1: But with this, it's primarily for partnering at this point in time.

Speaker #2: And another question that I think you mostly answered here about which internally developed asset is currently closest to a partnering transaction. And it sounded like it's the other two, then maybe.

Operator: Another question that I think you mostly answered here about which internally developed asset is currently closest to a partnering transaction. It sounded like it is the other two then, maybe.

Speaker #1: I didn't—sorry, I didn't understand that question.

Thomas Feldthus: Sorry, I did not understand that question.

Speaker #2: So, basically, which of your assets is most likely to land a deal soon?

Operator: Basically, which of your assets is most likely to land a deal?

Thomas Feldthus: As mentioned, among these three assets, we see stronger interest in SAN2668 and SAN2465. Within epilepsy, SAN2668 tends to attract more attention because it is very strong efficacy profile and the opportunity in severe pediatric epilepsies. So it is in the shadow, as I mentioned before, of that asset. Very often when we speak with partners about SAN2219, the conversation go very quickly into that direction.

Speaker #1: As mentioned, we see among our three these three assets, we see stronger interest in San 2668 and San 2465. Within epilepsy, San 2668 tends to attract more attention because it's very strong efficacy profile.

Speaker #1: And the opportunity in severe pediatric epilepsies. So it is in the shadow, as I mentioned before, of that asset. And very often, when we speak with partners about 2219, the conversation goes very quickly in that direction.

Speaker #2: Got it. And you have previously referred to 'near to midterm' when it comes to future licensing deals. Is there anything more precise on that, or has it changed in any way?

Operator: Got it. You have previously referred to near to midterm when it comes to future licensing deals. Can you say anything more precise on that? Has it changed in any way? Maybe you can tell us a bit about your plans for the autumn in terms of partnering meetings and so on.

Speaker #2: And yeah, maybe you can tell us a bit about your plans for the autumn in terms of partnering meetings and so on.

Speaker #1: So, as we are speaking, we are entering into—we have had 25 meetings, for instance, at BIO in San Diego in early summer. And we are speaking with companies across our pipeline, including 903 into Sumed, and also the three assets we are developing internally.

Thomas Feldthus: We have had 25 meetings, for instance, at BIO in San Diego, early summer. We are speaking with companies across our pipeline, including SAN903 into Tesomet, and also the three assets we are developing internally. I cannot go into details about specific conversations about that at this time.

Speaker #1: I cannot go into details about specific conversations regarding that at this time.

Speaker #2: It's an active schedule, I presume, for the autumn in terms of meetings and...

Operator: It's an active schedule, I presume, for the autumn, in terms of meetings and-

Speaker #1: What was that? Sorry.

Thomas Feldthus: What was that? Sorry.

Speaker #2: No, no, just—it seems that it will be an eventful autumn in terms of meetings, going to partnering meetings and so on, but you just...

Operator: No, just it seems that it will be an eventful autumn in terms of meetings going to partnering meetings and so on, but you just-

Thomas Feldthus: Yeah. After the two deals we did with Jazz and Takeda, we have also seen a lot of inbound coming to us wanting to speak about our pipeline and see what we have. We see great interest in general in the company and across our pipeline.

Speaker #1: Yeah, we have. So, after the two deals we did with JAS and Acadia, we've also seen a lot of inbound coming to us, wanting to speak about our partner and see what we have.

Speaker #1: So, we see great interest in general in the company and across our pipeline.

Speaker #2: So there was one question about the finances. And I think you mentioned this a bit, Jon, about the burn rate has increased and if it was expected, but you told us basically it was expected.

Operator: There was one question about the finances, and I think you mentioned this a bit, John, about the burn rate has increased and if it was expected, but you told us basically that it was expected. The next question was a bit about your cash position and why is the return on cash relatively low beyond the FX? What actions are you taking to get a better yield from the cash position?

Speaker #2: So the next question was a bit about your cash position and why the return on cash is relatively low. Beyond the FX, what actions are you taking to get a better yield from the cash position?

Speaker #3: So yes, as you correctly mentioned, I stated that our increase in cost over the past quarters is, as I mentioned, both expected and planned.

Johnny Stilou: Yes. As you correctly mentioned, I stated that our increase in cost over the past quarters is, as I mentioned, both expected and planned, and it is as we transition towards our clinical execution. Our funds, we do not take a speculative approach. We have funds to progress our programs and to execute our planned operation. Our funds, we place those in a short to medium long cash deposits and or in other short-term assets without any risk, so bonds, short-term bonds. We are risk-averse in that context. You did not ask the question, similar on currency exposure, we hedge our currency exposures through operational hedges as we forecast what currencies are needed from a Euro, US dollar, Swedish, Danish kroner perspective, and hence we hedge that way.

Speaker #3: And it is as we transition towards our clinical execution. With our funds, we do not take a speculative approach. We have funds to progress our programs and to execute our planned operations.

Speaker #3: So our funds—we place those in short- to medium-term cash deposits and/or in other short-term assets without any risk, such as short-term bonds. So, we are risk-averse in that context.

Speaker #3: Similar to the next question, regarding currency exposure, we hedge our currency exposures through operational hedges as we forecast what currencies are needed from a euro, US dollar, Swedish krona, and Danish krone perspective.

Speaker #3: And hence, we hedge that way.

Speaker #2: And you mentioned that you are risk-averse when it comes to the cash position, and of course, I assume that's because you expect to use the cash in the coming years.

Operator: You mentioned that you are risk-averse when it comes to the cash position, and of course, I assume that it is because you expect to use the cash in the coming years.

Johnny Stilou: Exactly.

Speaker #3: Exactly. Yes. Yes. Exactly. So that is exactly why we have a risk averse approach and have the funds in a short to medium-term cash deposits as we will be utilizing the funds similar to having short to mid-term bonds similar where the interest rates may be highest at any given time.

Operator: Yeah.

Johnny Stilou: Yes, exactly. So that is exactly why we have a risk-averse approach and have the funds in a short to medium-term cash deposits as we will be utilizing the funds similar to having short to midterm bonds, where the interest rates may be highest at any given time.

Speaker #2: Got it. And another question was about your large cash position. Many investors regard this as meaning you have a low enterprise value.

Operator: Got it. Another question was about, again, you have a large cash position and many investors regard it that you have a low enterprise value. Has the board evaluated a minor share buyback program or other capital allocation strategies? Of course, you are not the board, but maybe can you say the view in the company?

Speaker #2: Has the board evaluated a minor share buyback program or other capital allocation strategies? And of course, you're not the board, but maybe you can share the view within the company?

Speaker #3: Yeah. So the funds we have are to progress our pipeline to create value. As Thomas mentioned, as we go through the clinical stages and get readouts—you saw the slides about the transaction that has taken place.

Johnny Stilou: Well, the funds we have is to progress our pipeline to create value, as Thomas mentioned, as we go through the clinical stages and get readouts. You saw the slides about the transaction that has taken place. So that is our focus. Being biotech, this is clearly costly to progress the programs. Hence, we do not have any plans to do any share buybacks.

Speaker #3: So that is our focus. Being in biotech, this is clearly costly to progress the programs. Hence, we do not have any plans to do any share buybacks.

Speaker #2: Yeah, makes sense. And another question was about where you want to be in terms of ramping up the organization or the expected future hires.

Operator: Yeah. Makes sense. Another question was about are you where you want to be in terms of ramping up the organization or the expected future hires?

Speaker #3: Again, as I mentioned in the presentation, at the end of the quarter—end of June—we were 44 employees. As of today, as we speak right now, we are 47.

Johnny Stilou: Again, as I mentioned in the presentation, at the end of the quarter, end of June, we were 44 employees. As of today, as we speak right now, we are 47. That is basically the organization that we need for now. We have the clinical organization in place to execute into the phase I trials as planned. As mentioned, we do not have any near-term plans to increase our organization significantly. Therefore, the cost item personal cost, I do not foresee the continued increase in that cost line in the coming quarters.

Speaker #3: That is basically the organization that we need for now. We have the clinical organization in place to execute into the Phase 1 trials as planned.

Speaker #3: As mentioned, we do not have any near-term plans to significantly increase our organization. Therefore, for the personnel cost item, I do not foresee a continued increase in that cost line in the coming quarters.

Speaker #2: Got it. And another question was about the fact that the astronautics exercised their option in your collaboration there. If that frees up any resources internally, both cash and personnel.

Operator: Got it. Another question was about the fact that AstronauTx exercised their option in your collaboration there, if that frees up any resources internally, both cash and personnel.

Johnny Stilou: Well, I would. Go ahead, Ken. Oh, please go ahead, Ken. Just saying that, cash-wise, as we stated, the $5 million, they are paid in shares, so there is no cash impact directly from that milestone payment. On the draw on our resources, AstronauTx will be using a limited amount of our resources, so these resources will be allocated to internal research allocations.

Speaker #3: Well, go ahead, Ken.

Speaker #1: Oh, please go ahead, Jon.

Speaker #3: Now, I'm just saying that, cash-wise, as we stated, the $5 million are paid in shares. So, there is no cash impact directly from that milestone payment.

Speaker #3: On the draw on our resources, astronautics will be using a limited amount of our resources. So, these resources will be allocated to internal research allocations.

Operator: Sounds good. Maybe if you can just say shortly, you got an investment in AstronauTx. Maybe you can explain why that is a good thing for Saniona. What do you get out of the investment, I guess? What programs do they have? At least my interpretation was that you get exposure to some other programs that you obviously don't have internally.

Speaker #2: Sounds good. And yeah, maybe if you can just say shortly—I mean, you got an investment in Astronautics. Maybe you can explain why that is a good thing for Saniona.

Speaker #2: What you get out of the investment, I guess. What programs do they have? At least my interpretation was that you—you get exposure to some other programs that you obviously don't have internally.

Speaker #1: So for our internal resources, on that piece, I think that over the last year, we have not spent a lot of resources on this program because the candidate has been quite advanced for a while.

Thomas Feldthus: As for our internal resources on that piece, I think that over the last year, we have not spent a lot of resource on this program because candidate date has been quite advanced for a while. We do not see much difference in our internal research allocation. From a financial perspective, then, of course, shares is not cash, but we see significant downstream milestone payments coming into the company when they approach the clinics. They have, as we mentioned in the recent press release, informed that the preclinical development starts shortly. Coming to that, it typically takes around 18 months if things are moving smoothly, before it will be phase I ready. But again, this is AstronauTx which is controlling this timeline, and they will progress, and we will comment on or make a release about it when the time is appropriate.

Speaker #1: So, we don't see much difference in our internal research allocation. From a financial perspective, then, of course, shares are not cash. But we do see significant downstream milestone payments.

Speaker #1: Coming into the company, when they approach the clinics, they have—as we mentioned in the original press release—informed that the pre-term development will start shortly.

Speaker #1: And coming to that, it typically takes around 18 months if things are moving smoothly before it will be phase one ready. But again, this is Astronautics which is controlling this timeline, and they will progress, and we will comment on it or make a release about it when the time is appropriate.

Speaker #2: Yeah, I was thinking more like, I mean, indirectly, investors in Saniona get a share of Astronautics as well. So what do they get exposure to beyond your collaboration?

Operator: Yeah, I was thinking more like, indirectly investors in Saniona want to get a share of AstronauTx as well. So what do they get exposure to beyond your collaboration? Because it was a valuation that was from a previous round, right? Maybe also the valuation could be attractive in AstronauTx.

Speaker #2: And because it was a validation that was from a previous round, right? So maybe also, the validation could be attractive in astronautics.

Speaker #1: Yes, this is a price according to around several years ago, just after we made the deal with Astronautics. And they basically raised financing based on that deal.

Thomas Feldthus: Yes, this is a price according to around seven years ago, just after we made the deal with AstronauTx. They basically raised financing based on that deal. Some of the investors even were part of the due diligence process on this asset. Then it was priced, and we got it that priced within more than three years ago, I think. So we believe this could be a potential attraction for Saniona going forward.

Speaker #1: Some of the investors were even part of the due diligence process on this asset. And when it was priced and we got it, that price was set more than three years ago, I think.

Speaker #1: So, we believe it could be a potential attraction for Saniona going forward.

Speaker #2: It will be interesting to follow. And another question was about whether you will inform the market when you file INDs or CTA applications on the internal pipeline?

Operator: Will be interesting to follow. Another question was about will you inform the market when you file INDs or CTA applications on the internal pipeline?

Thomas Feldthus: This must be you, Pietro, isn't it?

Thomas Feldthus: This must be you, Pierandrea, isn't it?

Speaker #1: This was the European there, isn't it?

Speaker #3: Yeah, sure. Yeah. No, as I said, we expect to submit an IND toward the end of the year for 2465, and we will, you know—we will, of course, make it informational, and similar for 2668.

Pierandrea Muglia: Yeah, sure. As I said, we expected to submit an IND toward the end of the year for SAN-2465, and we will make it, of course, information about it, and similar for SAN-2668. There will be a CTA application in Europe coming along, and we will inform the public.

Speaker #3: There will be a CTS application in Europe coming along, and we will inform the public.

Operator: One of the other questions from an investor was your position, the SAN-2668 for indications that may qualify for Rare Pediatric Disease Designation and Orphan Drug Designation. When would it be sensible to apply for this?

Speaker #2: And yeah, one other question from an investor was your position with the 2668 for indications that may qualify for rare pediatric disease designation and orphan drug designation.

Speaker #2: When will it be sensible to apply for this?

Speaker #3: Yeah, absolutely. 2,668 properties in these indications qualify for both rare pediatric designation and orphan disease designation. The essence to obtain the designation for orphan disease is to have a proof of value of the pharmacology in the specific disease.

Johnny Stilou: Yeah, absolutely. SAN-2668 properties in these indications qualify for both a Rare Pediatric Disease Designation and Orphan Drug Designation. The essence to obtain the designation for orphan disease is to have

Pierandrea Muglia: Yeah, absolutely. SAN-2668 properties in these indications qualify for both a Rare Pediatric Disease Designation and Orphan Drug Designation. The essence to obtain the designation for orphan disease is to have

Pierandrea Muglia: A proof of the value of the pharmacology in the specific disease, other in patients, but also in specific preclinical models. We have some of this data. As soon as we have the sufficient package, we will make a submission. The Rare Pediatric Disease Designation goes along with the Orphan Drug Designation. That will be sufficient for the disease to be of a severe pediatric concern. Those both apply to the property of SAN2668. When we will do that, we will inform about our submission and eventual obtaining the designation.

Speaker #3: Other patients, but also in specific preclinical models. So, we have some of this data. As soon as we have the sufficient packet, we'll make a submission.

Speaker #3: The rare pediatric disease designation goes along with the orphan designation. That will be sufficient for the disease to be of severe pediatric concern. So both of those apply to the property of 2668, and when we do that, we will inform about our submission and eventual obtaining of the designation.

Speaker #2: And another question was about your R&D days. If you can share updates on when you might hold them for your other internal programs.

Operator: Another question was about your R&D days, if you can share updates on when you might hold them for your other internal programs.

Speaker #1: So we currently expect to hold an R&D day for 2465 in the fourth quarter, around Phase One initiation. We will provide further details in due course.

Thomas Feldthus: We currently expect to hold an R&D day for SAN2465 in Q4 around phase I initiation. We will provide further details in due course through a press release.

Speaker #1: Through a press release.

Speaker #2: And you also mentioned last time that you expect to select one or two new compounds from your research efforts. How is that progressing?

Operator: You also mentioned last time that you expect to select one or two new compounds from your research efforts. How is that progressing?

Karin Sandager Nielsen: Really good, actually. I think the expectation is unchanged. Discovery efforts are continuing in parallel with our prioritized programs. In this regard, I think it is worth mentioning that our discovery organization has actually delivered five clinical candidates over the past five years, and that includes SAN2355 that we licensed to Jazz, and also recently one of the molecules that AstronauTx has now taken forward. I think that is a huge endeavor, and I think it is a strong validation of our platform, and it also testifies to the focused productivity of our people. So we are continuing working on generating the next clinical candidate. Our ambition is to select at least one new candidate next year.

Speaker #3: Really good, actually. I think the expectation is unchanged. Discovery efforts are continuing in parallel with our prioritized programs. And maybe in this regard, I think it's worth mentioning that our discovery organization has actually delivered five clinical candidates over the past five years.

Speaker #3: And that includes some 2,355 that we licensed to Jess, and also recently, one of the molecules that Astronautics has now taken forward. I think that's a huge endeavor, and I think it's a strong validation of our platform. It also testifies to the focus and productivity of our people.

Speaker #3: So we are continuing to work on generating the next clinical candidate, and our ambition is to select at least one new candidate next year.

Operator: Sounds good. Can you also share your thoughts a bit about Acadia delaying their phase II start to explore high doses, what it means, and if it is

Speaker #2: Sounds good. And yeah, can you also share your thoughts a bit about Acadia delaying their Phase 2 start to explore high doses? What it means, and if it's—

Thomas Feldthus: Yeah.

Speaker #1: Yeah.

Speaker #3: Yeah. I mean, I can take this please. Yeah, no, as you stated, Acadia, you know, this is part of the phase one program, you know, and giving the best option to the compound because the safety tolerability that we observe in our phase one are quite good that they're going higher in those is and that will kind of delay the phase two start.

Pierandrea Muglia: I can take this.

Thomas Feldthus: I am going at the end. Pienaar, please.

Thomas Feldthus: I am going at the end. Pierandrea, please.

Pierandrea Muglia: Yeah. As you stated, Acadia, this is part of the phase I program, and giving the best option to the compound because of the safety tolerability that we observe in our phase I are quite good that they are going higher in the doses, and that will delay the phase II start. We do not see any issue. This is standard phase I approach, to do a variety of phase I study that enable the best phase II option for success, I guess.

Speaker #3: We don't see any issue. There's a kind of standard Phase 1 approach to do a variety of Phase 1 studies that enable the best Phase 2 option for success, I guess.

Speaker #2: And a few investors pointed out as well that we have seen a few transactions in the ion channel space lately. For example, YAS and Actio, and Biohaven and SK Biopharma, I believe.

Operator: A few investors pointed out as well about we have seen a few transactions in the ion channel space lately. For example, Jazz and Actio, Biohaven and SK Biopharmaceuticals, I believe. How do you look at these deals? You discussed it a bit, but maybe a bit more on what it means for the value of your own platform.

Speaker #2: How do you look at these deals? You discussed it a bit, but maybe you could elaborate a bit more and discuss what it means for the value of your own platform.

Speaker #3: Yeah, we see both transactions validating well. It's emphasizing the unmet need of this population and, as a related interest, in the existing pharma, both for adults and for pediatric, as we keep stating ourselves.

Pierandrea Muglia: Yeah. We see both transaction validating, well, emphasizing the magnitude of this population, and as a related interest in that existing pharma, both for adults and for pediatric as we keep stating ourselves. They are also validating the approach with ion channel pharmacology that also is the heart of our platform and compounds. So that is confidence that what we are doing is going to be of interest and generate value for patients. Obviously, that comes with a concern, but with the fact that we will face competition. Our program, however, is quite differentiated in term of pharmacology and properties from other compounds. So we are very mindful of other activities, and we are also very confident that our pharmacology is quite unique, and has the properties that are differentiating from these other companies. Some of this, the recent transaction was for a specific monogenic disorder.

Speaker #3: They are also validating the approach with ion channel pharmacology, which is also at the heart of our compounds. So that's, you know, confidence that what we're doing is going to be of interest and generate value for patients.

Speaker #3: Of course, that comes with, you know, a concern, but with the fact that, you know, we will face competition. Our program, however, is quite differentiated in terms of pharmacology and properties from other compounds.

Speaker #3: So we were very mindful of other activities, and we are also very confident that our pharmacologist is quite thick and has properties that are differentiating from these other companies.

Speaker #3: Some of this—that, you know, the recent transaction was for a specific monogenic disorder. Our ambition, based on the properties, is to go much broader, including orphan, but will be broader DEE, and so with other specificity that we are illustrating.

Pierandrea Muglia: Our ambition, based on the properties, is to go much broader, including orphan, but will be broader DEE. So with other specificity that we illustrate.

Speaker #2: It's so good to have some external validation, but now you have a competitive edge as well, so to speak. So the next question was about the Boehringer Ingelheim collaboration: could potential milestones be settled in cash or in stock?

Operator: So good to have some external validation, but you have a competitive edge as well, so to say. The next question was about the Boehringer Ingelheim collaboration. Will potential milestones be settled in cash or in stock?

Karin Sandager Nielsen: That will be in cash. Milestones from this collaboration will be in cash. With Boehringer, we have a long-standing relationship with them. This is the second collaboration we have with them. So we are fully committed to continue to support the program, and milestones will be paid out in cash.

Speaker #3: That will be in cash. Milestones from this collaboration will be in cash. With Bearing, we have a longstanding relationship with them. This is the second collaboration we have with them.

Speaker #3: So we are fully committed to continuing to support the program, and milestones will be paid out in cash.

Operator: The next question was about when can we expect the candidate selection and hence the milestone? You touched upon this a bit in the presentation, but I am not sure if there is anything more to say there.

Speaker #2: So, the next question was about when we can expect candidate selection, and hence a milestone. You touched upon this a bit in the presentation, but I'm not sure.

Speaker #2: If there's anything more to say there.

Speaker #3: Yeah, well, we have we have several programs that are in lead optimization. Either internally or with partners. So we are as a touched on before, we have a pretty good track record in identifying candidates.

Karin Sandager Nielsen: Well, we have several programs that are in need optimization, either internally or with partners. As I touched on before, we have a pretty good track record in identifying candidates. So we are still committed to and our aim is to select a candidate by next year.

Speaker #3: So, we are still committed to, and our aim is to select, the candidate by next year.

Speaker #2: Got it. And another question was about SAN903, and are you seeing any increased interest following the change of indication? Is running a Phase I yourself still not relevant?

Operator: Got it. Another question was about SAN903. Are you seeing any increased interest following the change of indication? Is running a phase I yourself still not relevant?

Speaker #1: As we are currently conducting a non-clinical study for set 903 in an additional indication to support partnering discussions. And this indication is outside our CNS focus.

Thomas Feldthus: We are currently conducting a non-clinical study for SAN903 in an additional indication to support partnering discussions. This indication is outside our CNS focus, so it does not change our strategy. Our internal development focus is on SAN2668 and SAN2465, and we continue to view SAN903 as a partnering opportunity.

Speaker #1: So it doesn't change our strategy. Our internal development focus is on San 2668 and San 2465. And we continue to view it view San 903 as a partnering opportunity.

Speaker #2: But you mentioned before, at least, that you have conversations about 903 partnering discussions, for example.

Operator: But you mentioned before, at least, that you have conversations about SAN903, partnering discussions, for example.

Thomas Feldthus: We have partnering discussions. It is available, but we cannot comment on specific discussions in relation to this.

Speaker #1: We have partnering discussions. It is available, but we cannot comment on specific discussions or in relation to this.

Operator: Done. Another was about Tesomet. If there is anything more to say about Tesomet in terms of partnering, maybe the same answer there?

Speaker #2: And another was about Tesomet. If there is anything more to say about Tesomet in terms of partnering, and maybe the same answer applies there.

Speaker #1: It will be the same questions and answers. So, Tesomet remains available for partnering, and we cannot comment on internal discussions. There are ongoing business development activities in relation to this as well.

Thomas Feldthus: It would be the same answer. Tesomet remains available for partnering, we cannot comment on individual discussions on ongoing business development activities in relation to this asset either.

Speaker #2: Yes. And we also got a few questions about Tesofensine in Mexico. And John, I think you mentioned a bit that Medix is increasing their activities towards coffee prescribers, and maybe if you can elaborate a bit on that and what is happening.

Operator: Yes. We also got a few questions about tesofensine in Mexico. Jon, I think you mentioned a bit that Medix is increasing their activities towards COFEPRIS. Maybe if you can elaborate a bit on that, what is happening.

Pierandrea Muglia: Yeah. Thomas?

Johnny Stilou: Yeah. Thomas?

Speaker #3: Yeah. Well, yeah, Thomas.

Speaker #1: Hello, Johnny. Please.

Thomas Feldthus: No, Jon, please.

Thomas Feldthus: No, Johnny, please.

Johnny Stilou: Yeah, just saying Medix continue dialogue with COFEPRIS, as I said, they are pushing COFEPRIS on their various obligations regarding the program.

Speaker #3: Yeah, just saying, yeah, I said, yeah, medics continue dialogue with Coffee Priests, and they are, as I said, they are pushing Coffee Priests on their various obligations regarding the program.

Operator: Got it. Yes, I am not sure if I asked this, but the SAN-2465 studies is still going to be conducted in the US, was a question from an investor.

Speaker #2: Got it. And let's see. Yes, also, I'm not sure if I asked this, but the 2465 studies are still going to be conducted in the US, wasn't—question from my investor.

Pierandrea Muglia: Yeah, the phase I, we have a US study in the making. We will submit an IND, as I stated. So will be US phase I.

Speaker #1: Yeah, for Phase One, we have a US study in the making. We will submit an IND, as I stated before, so it will be a US Phase One.

Speaker #2: And the 2668 will be done in Europe, right?

Operator: And SAN-2668 will be done in Europe, right?

Pierandrea Muglia: Indeed. It will be done in Europe in a highly specialized phase I unit for CNS that will provide a comprehensive biomarker as they have done previously for similar pharmacology. We selected them with that goal in mind.

Speaker #1: Indeed. It will be done in Europe in a highly specialized phase one unit for CNS. That will provide a comprehensive biomarker, as they've done previously for similar pharmacology.

Speaker #1: So we selected them for that purpose, without a goal in mind.

Operator: Yes. I think I have asked most questions here. Can you inform on the PK data in animals with your two compounds? That is my final question.

Speaker #2: Yes, so I think you have asked most of the questions here. Can you provide information on the PK data in animals with your two compounds? Final question.

Pierandrea Muglia: Maybe I can take it. We have the PK data. We take a very serious approach to dosing in humans and equivalent to what we see in animal. We have adopted modeling to come up with the expected dose. As I said, for SAN-2465, we will add the imaging PET in monkeys that will provide further information about how to dose a human equivalent. We consider it a very important approach. The PK properties are, as expected, quite a good profile, so we do not see any issue of translating those in humans for now.

Speaker #1: Maybe I can take it. Yeah, we have the PK data. We take a very serious approach to dosing in humans, and it's equivalent to what we see in animals.

Speaker #1: We have adopted modeling to come up with the expected dose. As I said, for 2465, we'll add the imaging PET in monkeys. They will provide further information about how to dose a human equivalent.

Speaker #1: And you know, so we consider a very important approach to the PK properties, which are as expected, quite a good profile. So we don't see any issue translating those in humans for now.

Speaker #2: I think that's all the questions. Do you have anything more to add from your side? Otherwise, we will end it.

Operator: I think that is all the questions. Do you have anything more to add from your side? Otherwise, we will end it.

Thomas Feldthus: I will say thank you for the attention, for the shares, and for the good pricing. It is highly appreciated. Thank you.

Speaker #1: I would say thank you for the interesting questions forwarded this year. I will send forward the good questions. It's highly appreciated. Thank you.

Speaker #2: I agree. Thank you.

Operator: I agree. Thank you.

Pierandrea Muglia: Thank you.

Thomas Feldthus: Thank you.

Karin Sandager Nielsen: Thank you.

Browse all earnings call transcripts

Q2 2026 Saniona AB (publ) Earnings Call

Request TrialDemo

Saniona

Earnings