SAN-2465

Saniona (OMX: SANION), a clinical-stage biopharmaceutical company, today announces significant progress in the preclinical development of SAN2355, a new generation Kv7.2/Kv7.3 activator aimed at treating focal onset seizures. The company has identified a stable solid form of the compound and completed synthesis optimization, enabling a robust, scalable manufacturing process. As a result, Saniona has successfully produced 4 kg of SAN2355 for GLP toxicology studies. “We are delighted to have completed the analytical development, synthesis optimization, and production of the GLP toxicology batch. We expect the remaining preclinical work to take about nine months, which means that SAN2355 could enter Phase 1 clinical trials by Q3 2025,” said Janus Schreiber Larsen, Chief Development Officer at Saniona. “SAN2355 is a key asset in our epilepsy portfolio. Kv7 activators have previously been clinically and commercially validated for treating refractory focal onset epilepsy, but no products are currently available on the market. SAN2355 stands out due to its unique selectivity profile and has the potential to become best in class, addressing significant unmet needs in the epilepsy market,” added Thomas Feldthus, CEO of Saniona. The GLP toxicology batch was produced with assistance from the Danish firm Niels Clauson-Kaas, and the project is now ready for preclinical toxicity and safety studies, in compliance with GLP standards. About Kv7 Channels and Epilepsy Epilepsy is a neurological disorder characterized by recurrent seizures, affecting millions globally. Around 30% of patients do not respond to existing treatments, highlighting a critical unmet need. Kv7 channels are crucial for regulating potassium ion transport across neuronal membranes, helping to prevent uncontrolled nerve impulses. Kv7.2 and Kv7.3 subunits, primarily expressed in the brain, play a key role in dampening overactive neurons, thus preventing seizures. While the non-selective Kv7 activator retigabine demonstrated proof-of-concept for treating resistant focal onset seizures, it was withdrawn from the market due to side effects unrelated to its target. About SanionaSaniona (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.

Saniona (OMX: SANION), a clinical-stage biopharmaceutical company, today announces that it has been granted approval to begin a Phase 1 multiple ascending dose (MAD)/biomarker study in adults for SAN711. This study is a key step towards launching a clinical proof-of-concept study in children with absence seizures, scheduled for 2025. The Phase 1 MAD/biomarker study will assess the safety, tolerability, and pharmacokinetics of higher SAN711 doses in a multiple-dose setting. It will also gather data on food interactions and the drug's pharmacodynamic effects on EEG during both awake and sleep states in healthy volunteers. The biomarker data can provide evidence of SAN711's central pharmacological activity, aiding in defining the dosing strategy for future patient studies. This information, combined with receptor occupancy data from a prior PET study, will guide the next steps. Saniona is conducting this study in collaboration with Evotec at the Clinical Research Centre (CRC) of the University Hospital in Verona, Italy. Evotec and CRC bring extensive experience in neurological and psychiatric clinical research, enhancing the study's execution. “We are thrilled with our collaborations with Evotec and CRC. Despite the tight timelines, all three teams have worked efficiently to move this complex process forward quickly. We expect to begin dosing patients within the next few weeks,” said Janus S. Larsen, Chief Development Officer at Saniona. Additionally, Saniona is conducting a preclinical juvenile toxicity study and physiologically based pharmacokinetic modeling to translate adult Phase 1 data into appropriate dosing for children. About SanionaSaniona (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.