Saniona is focused on developing innovative therapies for neurological and psychiatric disorders. Its pipeline features SAN711 (Phase II-ready for essential tremor), SAN2219 (acute repetitive seizures), and SAN2355 (focal onset seizures from the Kv7 program). In addition, the company has outlicensed tesofensine to Medix, targeting obesity, with potential market approval in Mexico in 2025.
The company has also demonstrated success in forming strategic partnerships, including collaborations with Acadia Pharmaceuticals, Boehringer Ingelheim, and Productos Medix, that are instrumental in advancing its therapies in key markets.
Milestones so far in 2025
During the first quarter of 2025, Saniona achieved several milestones. The company secured seed funding for its joint venture, Cephagenix, with up to EUR 9 million from AdBio Partners and AbbVie Ventures. Progress with tesofensine continued as partner Medix resubmitted its regulatory application to COFEPRIS in Mexico, following feedback, with a clear path to potential approval.
Saniona also initiated GMP manufacturing and toxicology studies for SAN2355 and began scale-up for SAN2219, both aimed at clinical trial applications by year-end. Additionally, the collaboration with Boehringer Ingelheim was extended for another year, and positive phase I results for SAN711 were announced with Acadia Pharmaceuticals. Post-quarter, the full exercise of TO4 warrants brought in SEK 115 million, reinforcing Saniona’s financial runway to support its pipeline goals.
In the report, CEO Thomas Feldthus stated:
– This financing builds on the strength of our agreement with Acadia, which included a USD 28 million upfront payment and the potential for up to USD 582 million in future milestone payments. The next milestone payment – USD10 million – is expected upon the start of phase II in 2026. Combined, these proceeds enable us to independently advance all three internal development programs to key clinical milestones.
Saniona’s Q1 2025 financials show a strengthened position with SEK 261 million in cash and cash equivalents, up from SEK 71 million in Q1 2024. Revenue increased to SEK 10 million from SEK 6 million, while net profit reached SEK 19 million, compared to a SEK 9 million loss last year, supporting the company’s clinical advancement.
Sealing the Deal
At the recent BioStock Global Forum 2025, held on May 20–21 in Lund, Thomas Feldthus participated in the panel “Sealing the Deal: Lessons from Partnering with Big Pharma”, alongside experts from Genmab, Novo Nordisk, AstraZeneca, the Nordic Pharma Licensing Group and Lykkesfeldt. The discussion offered insights into forging successful partnerships with global pharmaceutical leaders. Watch the panel discussion here.
Comments from the CFO
We spoke with Saniona’s CFO, Johnny Stilou, for a comment.
How will the current financing be allocated to advance SAN711, SAN2219 and SAN2355 and SAN2465 toward their clinical milestones?
– Following the partnership with Arcadia we are leveraging the upfront proceeds to advance all three internal development programs to start of Phase 2 clinical trials. The three programs are in preclinical development and scheduled to start Phase 1 clinical trials next year. We expect to finalize the CTA/IND-enabling package for the start of the Phase 1 clinical trials by the end of 2025 for SAN2355 and for SAN2219 in the first half of 2026. For SAN2465 we expect to start phase 1 clinical trails in the second half of 2026.
What specific clinical milestones are you targeting for SAN711 in its phase II-ready stage for essential tremor?
– Acadia has positioned ACP-711 (SAN711) for essential tremor, which typical affects the elderly population. The preparation for Phase 2 comprises several activities including formulation work suitable for this patient population, clinical studies in elderly volunteers and human pharmacokinetic studies to secure that the new formulation is optimal for this patient population. These are critical steps in optimizing the dosing strategy for essential tremor. Once this extension is complete, the aim is to initiate a Phase 2 clinical trial focused on demonstrating efficacy and safety in patients with essential tremor.
How does the Acadia partnership enhance Saniona’s ability to develop SAN2219 for acute repetitive seizures?
– While SAN2219 is not directly part of the Acadia partnership, the collaboration with Acadia on ACP-711 significantly strengthens our overall capabilities. The collaboration provides financing and frees up internal resources to focus on internal programs including SAN2219 It provides validation of our ion channel platform and in particular our GABA platform, which also have delivered SAN2219 and SAN2465. The success of ACP-711 under the Acadia collaboration also demonstrates the scalability of our model, showing that we can develop high-potential assets internally and advancing them through strategic partnerships.
How does the extension of the Boehringer Ingelheim collaboration and Cephagenix joint venture strengthen Saniona’s position in neurological drug development?
– The extension of our collaboration with Boehringer Ingelheim for schizophrenia and our Cephagenix joint venture in migraine is a strong endorsement of our ion channel expertise and discovery engine as well as its applicability in diseases outside neurological diseases.
What can we expect from Saniona in the coming six months?
– In the next six months, we anticipate several important developments:
- Preclinical milestones for SAN2219. SAN2355 and SAN2465, including preparations for CTA/IND submissions.
- Updates from our partnerships, including potential new collaborations and/or progress within existing ones like Boehringer Ingelheim and Cephagenix.
- Clarification about the regulatory submission for approval of tesofensine in Mexico.
- We also expect Acadia to advance ACP-711 towards start of Phase 2.
Also read: Saniona’s new CFO: ”More deals are definitely on the horizon”
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