Saniona develops treatments for neurological and psychiatric diseases. The pipeline includes SAN711 (Phase II ready in essential tremor), SAN2219 (acute repetitive seizures) and SAN2355 (focal seizures, from the Kv7 program). In addition, the company has out-licensed tesofensine to Medix, which targets obesity, with potential market approval in Mexico in 2025.
The company has also been successful in creating strategic partnerships with Acadia Pharmaceuticals, Boehringer Ingelheim and Medix Products, which are crucial for introducing Saniona's therapies in key markets.
Milestones so far in 2025
In the first quarter of 2025, the Saniona several milestones. The company secured seed funding for its joint venture, Cephagenix, with up to €9 million from AdBio Partners and AbbVie VenturesIn addition, partner Medix, following feedback, submitted a regulatory application for tesofensine to COFEPRIS in Mexico with a clear path towards potential approval.
Saniona also initiated GMP manufacturing and toxicology studies for SAN2355 and started scale-up for SAN2219, both with a view to filing for regulatory approvals before the end of the year. In addition, the collaboration with Boehringer Ingelheim was extended for another year, and positive Phase I results for SAN711 was announced together with Acadia Pharmaceuticals. After the quarter, a full exercise of series TO4 warrants brought in SEK 115 million, strengthening Saniona's financial capacity to achieve its pipeline goals.
In the report, the CEO says Thomas Feldthus:
– This financing builds on the strength of our agreement with Acadia, which included an initial payment of $28 million and the possibility of an additional $582 million in future milestone payments. The next milestone payment – $10 million – is expected in connection with the start of Phase 2 in 2026. Together, these proceeds will enable us to independently drive all three internal development programs to key clinical milestones.
Saniona's financial results for the first quarter of 2025 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 amounted to SEK 19 million, compared to a loss of SEK 9 million the previous year, supporting the company's clinical development.
Sealing the Deal
At 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”, together with experts from Genmab, Novo Nordisk, AstraZeneca, Nordic Pharma Licensing Group and Happiness Field. The discussion offered important lessons about building strong alliances with global pharmaceutical companies. Watch the panel discussion here.
CFO comment
We contacted Saniona's CFO, Johnny Stilou, for a comment.
How will the current financing be allocated to advance SAN711, SAN2219 and SAN2355 and SAN2465 towards their clinical milestones?
– Following the partnership with Arcadia we are leveraging the upfront proceeds to advance all three internal development programs to the 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 typically 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 ensure 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 the start of Phase 2.
Read also: Saniona's new CFO: "More deals are definitely on the horizon"
The content of BioStock's news and analysis is independent, but BioStock's operations are to some extent financed by companies in the industry. This post refers to a company from which BioStock has received funding.
