Saniona publishes its year-end report for 2021

PRESS RELEASE

February 24, 2022

Three Months Ended December 31, 2021 (2020)

Revenue was SEK 2.9 M (1.6 M)
Operating loss was SEK -125.7 M (-68.6 M)
Net loss was SEK -129.9 M (-44.4 M)
Basic loss per share was SEK -2.08 (-0.71)
Diluted loss per share was SEK -2.08 (-0.71)

Twelve Months Ended December 31, 2021 (2020)
Revenue was SEK 10.5 M (8.2 M)
Operating loss was SEK -411.6 M (-159.4 M)
Net loss was SEK -410.9 M (-73.4 M)
Basic loss per share was SEK -6.59 (-1.79)
Diluted loss per share was SEK -6.59 (-1.79)

Business highlights in Q4 2021

• Saniona initiated a Phase 2b clinical trial of Tesomet in patients with Prader-Willi syndrome (PWS); data are expected in the first half of 2023.
• Saniona initiated a Phase 2b clinical trial of Tesomet in patients with hypothalamic obesity (HO); data are expected in the second half of 2023.
• Saniona completed the submission of all information previously requested by the U.S. Food and Drug Administration (FDA) regarding its chemistry, manufacturing and controls program for Tesomet capsules. Tesomet capsules are being utilized in both ongoing Phase 2b trials.
• Saniona's Chairman and the CEO, as well as additional members of the Board of Directors and executive management team, purchased shares of the company in the open market.

Significant events after the reporting period

• Saniona initiated the Multiple Ascending Dose stage of its Phase 1 trial of SAN711; data are expected by the end of the first half of 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 and class of shares held, when and if these milestones are achieved.

Comments from the CEO        
"In 2021, we significantly strengthened the fundamentals of our business. We initiated three rare disease clinical trials: two Phase 2b trials of our lead candidate Tesomet for HO and PWS, and a Phase 1 trial of SAN711 for rare neuropathic disorders. We also secured orphan drug designation from the FDA for Tesomet in both HO (the first time ever granted for this indication) and PWS, and we reduced manufacturing risks by completing the transition to Tesomet capsules,” said Rami Levin, President & Chief Executive Officer of Saniona. "As we enter 2022, we look forward to continuing to advance our pipeline: delivering Phase 1 data for SAN711, advancing SAN903 into the clinic, and selecting a new ion channel modulator for our pipeline. We will also continue to focus on business development opportunities to generate non-dilutive capital and continuing to ensure Saniona is well-positioned for the future.”

Read the full report attached below.

For more information, please contact
Trista Morrison, Chief Communications Officer, Saniona. Office: + 1 (781) 810-9227. Email: trista.morrison@saniona.com

This information is such information as 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 person set out above, at 8.00 CET on 24 February 2022.

About Saniona
Saniona is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing innovative therapies for patients suffering from rare diseases for which there are a lack of available treatment options. The company’s lead product candidate, Tesomet™, is in 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. 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 may be applicable in the treatment of rare neuropathic disorders, and SAN903 is in preclinical development for rare inflammatory, fibrotic and hematological disorders. Led by an experienced scientific and operational team, Saniona has an established research organization in the Copenhagen area, Denmark, and a corporate office in the Boston, Massachusetts area, U.S. The company’s shares are listed on Nasdaq Stockholm Small Cap (OMX: SANION). Read more at http://www.saniona.com.

Attachment

• Saniona-12.31.21-6F (UK) vFinal