Saniona publishes its interim report for the first quarter of 2022

Business highlights in Q1 2022

• Saniona initiated the Multiple Ascending Dose (MAD) stage and the Positron Emission Tomography (PET) stage of its Phase 1 trial of SAN711; The ongoing Phase 1 trial is placebo-controlled, and the data remain blinded. Saniona continues to expect data from the trial by mid-2022.
• Saniona received SEK 7.3 million (US$0.8 million) from Novartis related to Novartis’s January 2021 acquisition of Cadent Therapeutics, in which Saniona held a 3% ownership stake. This payment, in addition to the previously received SEK 24.2 million (US$2.9 million), together complete Saniona’s portion of the upfront payment connected to the acquisition. Saniona may also receive a portion of the remaining SEK 5.1 billion (US$560 million) in contingent payments associated with the achievement of undisclosed future milestones relative to its previous ownership stake, when and if these milestones are achieved.
• Saniona and Boehringer Ingelheim advanced the ongoing research collaboration into the "hit-to-lead” stage. The collaboration is focused on a novel, undisclosed CNS ion channel target for schizophrenia. Saniona receives ongoing research funding and may receive up to €76.5 million in milestone payments as well as royalties on worldwide net sales.
• On March 29, 2022, Saniona announced a program reprioritization and restructuring comprising a voluntary pause of the Phase 2b clinical trials of Tesomet™ for hypothalamic obesity (HO) and Prader-Willi syndrome (PWS) and a workforce reduction of approximately 30%. The decision to voluntarily pause the Phase 2b clinical trials of Tesomet^TM is not related to the safety or efficacy of Tesomet^TM and is entirely due to funding limitations.

Significant events after the reporting period

• On April 30, 2022, Saniona appointed Thomas Feldthus as Chief Executive Officer and Anita Milland as Chief Financial Officer. Thomas Feldthus will oversee Saniona’s refocused strategy on ion channel research and development and explore partnering opportunities to advance its lead assets. The Board of Directors elected Jørgen Drejer as interim Chairman until the Annual General Meeting (AGM) to be held on May 25, 2022. In connection with this refocused strategy, the company terminated its plans to list its shares in the U.S., closed its U.S. operations and terminated the positions of all U.S. personnel, including the U.S. executive management team. These restructuring actions are anticipated to reduce future annual operating expenses by approximately 70-75%.

Comments from the CEO        
"We are transforming the company into a more focused and cost-effective organization that leverages our core strengths within ion channel drug discovery and development. We have closed our operation in the United States and are seeking strategic partnerships in order to maximize the value of Tesomet^TM and SAN711. By improving our operational efficiency and targeting business development efforts, we aim to fully leverage the value of our most advanced assets and develop new ion channel-based therapies through 2022 and beyond.”

For more information, please contact
Thomas Feldthus, CEO, +45 22109957; thomas.feldthus@saniona.com

This information is such information as Saniona AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation and the Securities Markets Act. The information was submitted for publication, through the agency of the contact person set out above, at 8.00 CEST on 25 May 2022.

About Saniona
Saniona is a clinical-stage biopharmaceutical company with a mission to leverage its ion channel targeting expertise to discover, develop and deliver innovative rare disease treatments. The company’s most advanced product candidate, Tesomet™, has been progressed into mid-stage clinical trials for hypothalamic obesity and Prader-Willi syndrome, serious rare disorders characterized by severe weight gain, disturbances of metabolic functions and uncontrollable hunger. These clinical trials are voluntarily paused due to funding limitations and Saniona is actively exploring partnering opportunities. Saniona has developed a proprietary ion channel drug discovery engine anchored by IONBASE™, a database of more than 130,000 compounds, of which more than 20,000 are Saniona’s proprietary ion channel modulators. Through its ion channel expertise, Saniona is advancing two wholly-owned ion channel modulators, SAN711 and SAN903. SAN711 is in a Phase 1 clinical trial and is positioned for the treatment of neuropathic pain conditions, and SAN903 is in preclinical development for rare inflammatory, fibrotic and hematological disorders. Saniona is based in the Copenhagen area, Denmark, and is listed on Nasdaq Stockholm Small Cap (OMX: SANION). Read more at http://www.saniona.com.

Attachment

• 20220525 Saniona Q1 (UK)