Saniona carves path to disrupt the epilepsy market
Saniona’s expertise in ion channel modulation has resulted in a vast pipeline of drug candidates targeting a number of central nervous system disorders. However, the company’s main focus is epilepsy, where the medical need and market potential are quite significant. The lead candidate in the epilepsy programme, SAN711, is poised for proof-of-concept studies. To secure its development, and to bring forward other epilepsy candidates towards the clinic, Saniona is carrying out a SEK 140 million rights issue.
With more than 50 million affected worldwide and with five million new diagnosed cases each year, epilepsy is one of the most severe neurological diseases. Curative treatments are still lacking, and today’s symptom-relieving treatments often lead to overwhelming side effects. Moreover, only about 30 per cent of patients respond to conventional medicines, thus speaking to the significant medical need in this area.
Seizure candidate SAN711 towards proof-of-concept
Danish biotech Saniona is putting a good portion of its innovation efforts towards answering the call for new therapies. The company’s drug development revolves around the modulation of ion channels in the brain – proteins that plan a major role in signal transmission between brain cells. Through this concept, Saniona has developed several drug candidates, including SAN711, which has successfully completed phase I of development where positive target engagement biomarker data has been reported.
According to Saniona’s CEO Thomas Feldthus, who recently spoke to BioStock about Saniona’s business development plans in this interview, SAN711 will be positioned for childhood absence seizures, which qualify for an orphan drug designation. Feldthus also mentioned that this can be extended to, e.g. juvenile absence seizures and myoclonic absence seizures, both of which also qualify for orphan drug designation. SAN711 has first-in-class potential, based on highly differentiated profile, and it is now being readied for proof-of-concept studies.
Two other epilepsy candidates towards the clinic
Besides SAN711, Saniona has compounds SAN2219 and SAN2355, as well as a compound from the GABA programme, in early stage development for targeting epilepsy.
SAN2355 was recently selected from Saniona’s Kv7 programme. Read more. Kv7 channels are part of a subfamily of K+ (potassium) ion channels in the brain, and they have been shown to play a significant role in certain types of epilepsy. Notably, SAN2355 has best-in-class potential for the treatment of refractory focal onset seizure. This compound addresses concerns like urinary retention, a potentially life-threatening side effect, and CNS side effects associated with non-selective Kv7 activators.
Partnerships are key to Saniona’s business
While epilepsy is Saniona’s main focus, the company has other pipeline programmes that are either being developed through a partnership or are positioned for partnering. This reliance on partnerships and investing the proceeds from such partnerships is a key to building shareholder value for the Danish biotech. The goal is long-term success and being less reliant on conventional financing routes.
Tesofensine, Saniona’s most advanced candidate, is progressing towards regulatory approval in Mexico through a partnership with Medix as a treatment for obesity. According to the company, we could see a market launch of this product already this year if regulators are pleased with the data.
Meanwhile, three additional programmes are positioned for partnering. Tesomet is phase IIb-ready for rare eating disorders, while SAN903 is phase I-ready for inflammatory bowel disease and SAN2465 is ready for preclinical development as a treatment for severe depressive disorder.
Besides the collaboration with Medix, Saniona has research collaborations with other reputable partners, including Boehringer Ingelheim, AstronauTx and Cephagenix. The collaboration with Boehringer alone has the potential to bring in EUR 76.5 million in milestone payments as well as royalties on worldwide net sales of resulting products.
Rights issue for continued development
To advance its epilepsy assets further and bring the company closer to strategic partnerships, Saniona is now conducting a share issue of units of approximately SEK 140 million. The capital raise, which runs from January 22 to February 5, 2024, is covered by subscription undertakings and guarantee commitments of SEK 84 million, corresponding to approximately 60 per cent of the rights issue.
BioStock recently spoke with Saniona’s CEO Thomas Feldthus about the capital raise and the company’s plans moving forward. He makes it clear that he strongly believes in Saniona’s pipeline and business strategy, and that SAN711 can have a significant impact on the epilepsy treatment landscape. Read the full interview here.
The offering in summary
| Terms | Existing shareholders will receive eight unit rights for each existing share. 15 unit rights entitle the holder to subscribe for one unit. Each unit consists of two shares and one series TO 4 warrant. | |
| Subscription period | January 22 – February 5, 2024 | |
| Subscription price | SEK 4.12 per unit | |
| Issue volume | SEK 140 million + proceeds from warrants (a minimum of SEK 1.7 million, but potentially up to SEK 171 million) | |
| Dilution | 51.6 per cent upon full subscription in the rights issue only. A further dilution of 20.5 per cent upon full subscription in the rights issue with the addition of TO 4 series warrants. | |
Documents
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To the offer at Avanza |
This material has been prepared for marketing purposes and is not and shall not be deemed to constitute a prospectus under applicable laws and regulations. The complete terms and conditions of the rights issue and more information about the company have been presented in an issue prospectus that was published on Saniona.com on 18 January 2024.
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