| Three Months Ended December 31, 2023 (2022 restated) | Twelve Months Ended December 31, 2023 (2022 restated) |
| Revenue was SEK 5.4 M (3.3 M) | Revenue was SEK 16.8 M (15.3 M) |
| Operating profit/loss was SEK -19.8 M (-22.6 M) | Operating profit/loss was SEK -81.1 M (-225.7 M) |
| Net profit/loss was SEK -28.7 M (-7.2 M) | Net profit/loss was SEK -95.8 M (-211.6 M) |
| Cash and cash equivalent SEK 31.0 M (111.7 M) | Cash and cash equivalent SEK 31.0 M (111.7 M) |
| Basic earnings/loss per share was SEK -0.45 (-0.11) | Basic earnings/loss per share was SEK -1.49 (-3.39) |
| Diluted earnings/loss per share were SEK -0.45 (-0.11) | Diluted earnings/loss per share were SEK -1.49 (-3.39) |
Business highlights in Q4 2023
- In October, Saniona's partner, AstronauTx, closed a $61 million financing led by the Novartis Venture Fund.
- In November, Professor Vincenzo Crunelli presented preclinical data at the annual meeting of the Society for Neuroscience demonstrating that SAN711 represents a novel precision approach for treatment of absence seizures.
- In November, Saniona announced that it has initiated the candidate selection phase with a frontrunner molecule from its Kv7 program for epilepsy.
- In December, Saniona announced that it plans to carry out a right issue of units.
- In December, Saniona announced that the research collaboration with Boehringer Ingelheim has been extended with up to two years.
- In December, Saniona strengthened its epilepsy pipeline with selection of SAN2355 as the first preclinical candidate from the Kv7 program.
Significant events after the reporting period
- In January, Saniona announced selection of SAN2465 as a preclinical candidate for major depressive disorder.
- In January, the board of directors resolved on an issue of units consisting of shares and warrants with preferential rights for the existing shareholders, which was approved at the extraordinary general meeting on January 16, 2024.
- In January, Saniona announced the preliminary 2023 financials.
- In February, Saniona announced outcome in rights issue of a proceed of approximately SEK 88.9 million before issue costs and a directed issue of units to guarantors in the rights issue as well as convertibles of SEK 10 million to Formue Nord.
Comments from the CEO
"Since the beginning of 2023 we have established a new and fully funded research collaboration, selected two new unique development candidates, reduced our debt with about 45%, and developed a sustainable and coherent business strategy for creating value with a focus on epilepsy. Our development pipeline is stronger than ever comprising three epilepsy assets and four non-epilepsy assets of which the most advanced program has progressed to final regulatory evaluation together with a partner. Our research activities are now fully funded through three partnerships and cover a fair share of our operating overheads. In February we completed a rights issue. The proceeds will be used to progress our epilepsy assets, including SAN711 and SAN2355, as well as to support our business development efforts. With a potential market approval on tesofensine and new potential partnerships underway, I am looking forward to providing further updates in the coming year."
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 features SAN711, a Phase 2-ready candidate drug targeting absence seizures, SAN2219 for acute repetitive seizures, and SAN2355, addressing refractory focal onset seizures. Beyond epilepsy, Saniona oversees four clinical programs poised for collaboration. Tesofensine, Saniona's most advanced candidate, is progressing towards regulatory approval for obesity in Mexico through a partnership with Medix. 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 has esteemed partners, including 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, please visit www.saniona.com.
