Saniona has strengthened its financial position and clinical development strategy through strategic partnerships and successful fundraising, positioning the neurological drug developer to advance multiple programs toward Phase 2 trials. The company reported SEK 261 million in cash and cash equivalents in Q1 2025, up from SEK 71 million in the same period last year, following a SEK 115 million warrant exercise.
Financial Strengthening Supports Pipeline Advancement
The Danish biotech's improved financial position builds on its partnership with Acadia Pharmaceuticals, which included a $28 million upfront payment and potential milestone payments totaling up to $582 million. CEO Thomas Feldthus stated that "this financing builds on the strength of our agreement with Acadia" and enables the company to "independently advance all three internal development programs to key clinical milestones."
Saniona's Q1 2025 results showed revenue increasing to SEK 10 million from SEK 6 million year-over-year, while the company achieved a net profit of SEK 19 million compared to a SEK 9 million loss in Q1 2024.
Strategic Pipeline Development
The company's neurological pipeline includes SAN711, now designated ACP-711 under the Acadia partnership and Phase II-ready for essential tremor treatment. CFO Johnny Stilou explained that Acadia has positioned the compound for essential tremor, which "typically affects the elderly population," with Phase 2 preparation including formulation work and clinical studies in elderly volunteers to optimize dosing strategy.
For acute repetitive seizures, SAN2219 remains under Saniona's internal development, with the company expecting to finalize its CTA/IND-enabling package in the first half of 2026. SAN2355, targeting focal onset seizures from the Kv7 program, is scheduled for regulatory package completion by end-2025.
Validation Through Strategic Partnerships
The extension of Saniona's collaboration with Boehringer Ingelheim for schizophrenia research and the Cephagenix joint venture in migraine represent "a strong endorsement of our ion channel expertise and discovery engine," according to Stilou. The Cephagenix venture secured up to €9 million in seed funding from AdBio Partners and AbbVie Ventures.
Additionally, partner Medix resubmitted its regulatory application for tesofensine to COFEPRIS in Mexico following feedback, with a clear path toward potential approval for obesity treatment in 2025.
Clinical Development Timeline
Saniona expects to initiate Phase 1 clinical trials for its three internal programs next year, with all programs currently in preclinical development. The company has initiated GMP manufacturing and toxicology studies for SAN2355 and begun scale-up activities for SAN2219.
For SAN2465, another compound from the GABA platform, Stilou indicated the company expects to start Phase 1 clinical trials in the second half of 2026. The next milestone payment of $10 million from Acadia is expected upon the start of Phase 2 trials in 2026.
Near-Term Catalysts
Over the next six months, Saniona anticipates several developments including preclinical milestones for SAN2219, SAN2355, and SAN2465, along with preparations for regulatory submissions. The company also expects updates from existing partnerships and potential new collaborations, while awaiting clarification on tesofensine's regulatory submission status in Mexico.
