| Three Months Ended September 30, 2024 (2023) | Nine Months Ended September 30, 2024 (2023) |
| Revenue was SEK 7.2 M (5.5 M) | Revenue was SEK 21.3 M (11.5 M) |
| Operating profit/loss was SEK -18.9 M (-18.4 M) | Operating profit/loss was SEK -48.5 M (-61.3 M) |
| Net profit/loss was SEK -29.5 M (-24.1 M) | Net profit/loss was SEK -58.4 M (-67.1 M) |
| Cash and cash equivalent SEK 41.3 M (49.3) | Cash and cash equivalent SEK 41.3 M (49.3) |
| Basic earnings/loss per share was SEK -0.26 (-0.38) | Basic earnings/loss per share was SEK -0.53 (-1.05) |
| Diluted earnings/loss per share were SEK -0.26 (-0.38) | Diluted earnings/loss per share were SEK -0.53 (-1.05) |
Business highlights in Q3 2024
- September 18, Saniona receives regulatory approval for SAN711 Biomarker Study.
Significant events after the reporting period
- October 1, Saniona provides update on major progress for SAN2355. The company has identified a stable solid form of the substance and completed the synthesis optimization.
- October 7, Saniona initiates SAN711 Biomarker study.
- October 14, Saniona Ion Channel Research Collaborations with Boehringer Ingelheim Reaches Milestone, resulting in a research milestone payment of €500,000 (approximately SEK 5.7 million).
- October 23, Fenja Capital II A/S (previously Formue Nord Fokus A/S) requested conversion of outstanding convertibles for a total nominal amount of SEK 2 million.
- November 6, Saniona's partner, Productus Medix, did not receive approval from Mexican regulatory agency (COFEPRIS) for tesofensine for obesity. Medix is entering a dialogue with the agency regarding the path forward as it appears that the decision by COFEPRIS has not been based on the full data package submitted by Medix.
- November 12, Saniona comments on Medix's recent regulatory submission for tesofensine in obesity.
- November 26, Saniona Announces Licensing Agreement with Acadia Pharmaceuticals for SAN711 in Neurological Diseases.
Comments from the CEO
"The deal with Acadia Pharmaceuticals is transformational for Saniona, as it validates our R&D approach, secures progress of one of our lead assets, and provides a strong cash position allowing us to bring several pipeline assets to key value-inflection points over the next years".
For more information, please contact
Thomas Feldthus, CEO, +45 22109957; thomas.feldthus@saniona.com
About Saniona
Saniona (OMX: SANION) is a clinical-stage biopharmaceutical company leading the way in ion channel modulation for the treatment of epilepsy and other neurological disorders. Saniona's epilepsy pipeline includes SAN2219, targeting acute repetitive seizures; and SAN2355, addressing refractory focal onset seizures. Beyond epilepsy, Saniona oversees four clinical programs poised for collaboration. Tesofensine for obesity is Saniona's most advanced candidate and is out licensed to Medix in Mexico and Argentina. Tesomet is ready for Phase 2b, targeting rare eating disorders, while SAN903 is ready for Phase 1 for inflammatory bowel disease and SAN2465 is set for preclinical development for major depressive disorder. Saniona partners include Acadia Pharmaceuticals, Boehringer Ingelheim GmbH, Productos Medix S.A de S.V, AstronauTx Limited, and Cephagenix ApS. Saniona is based in Copenhagen and listed on Nasdaq Stockholm Main Market.
For more information, visit www.saniona.com.
This information is information that Saniona AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2024-11-28 08:00 CET.
