Saniona publishes its interim report for the third quarter 2019

PRESS RELEASE

November 13, 2019

Financial highlights

Jan – Sep 2019 (Jan – Sep 2018)

• Net revenues were SEK 2.7 M (52.7 M)
• EBIT was SEK -75.8 M (-19.9 M)
• Net profit/loss was SEK -72.3 M (-17.7)
• Earnings per share were SEK -2.89 (-0.80)
• Diluted earnings per share were SEK -2.89 (-0.80)

Q3 2019 (Q3 2018)

• Net revenues were SEK 0.3 M (44.6 M)
• EBIT was SEK -26.0 M (19.9 M)
• Net profit/loss was SEK -27.7 (15.3 M)
• Earnings per share were SEK -1.00 (0.68)
• Diluted earnings per share were SEK -1.00 (0.68)

Business highlights in Q3 2019

• Saniona reported positive Tesomet Phase 2a clinical results in adolescent patients with Prader-Willi syndrome. Tesomet was safe and well tolerated in growing adolescent patients with PWS at both tested doses. Reduction in body weight and improvement of BMI observed at the high dose with hyperphagia score reduced to low single digits. Data provides additional guidance for the Phase 2b and Phase 3 studies now in planning.
• Saniona selected a development candidate, SAN903, in the IK program. Based on work done to date, Saniona has elected to focus SAN903 initially on the treatment of Crohn’s disease and colitis.
• In July Saniona received the gross proceeds of SEK 66.5 million (SEK 53.7 million after transaction costs) from the Rights Issue, which was completed in June.

Significant events after the reporting period

• Saniona recruited the last patient in the Phase 2a clinical study for Tesomet in hypothalamic obesity. Patients will receive either Tesomet or matching placebo for 24 weeks followed by an open-label extension study where all patients will receive Tesomet for 24 weeks resulting in a total treatment period of 48 weeks. Saniona expects to report top line results from double-blind part of the study in Q2 2020

Comments from the CEO         

"The results from our Phase 2a study in PWS provide strong de-risking and guidance for the pivotal Phase 2b/3 studies that we are now planning in PWS and other rare eating disorders, including hypothalamic obesity. Tesomet has the potential to significantly reduce weight and body mass index (BMI), and treat debilitating hyperphagia in these severe, rare and highly underserved eating disorders. By pursuing such orphan indications, we are creating a unique opportunity to develop and bring our own product to the market,” says Jørgen Drejer, CEO of Saniona.

Read the complete Interim Report attached below.

For more information, please contact

Thomas Feldthus, EVP and CFO, Saniona, Mobile: +45 2210 9957, E-mail: tf@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 08:00 a.m. CET on November 13, 2019.

About Saniona

Saniona is a research and development company focused on drugs for treatment of eating disorders and diseases of the central nervous system. The company has five programs in clinical development. Saniona intends to develop and commercialize treatments for orphan indications such as Prader-Willi syndrome and hypothalamic obesity on its own. The research is focused on ion channels and the company has a broad portfolio of research programs. Saniona has partnerships with Boehringer Ingelheim GmbH, Productos Medix, S.A de S.V and Cadent Therapeutics. Saniona is based in Copenhagen, Denmark, and the company’s shares are listed at Nasdaq Stockholm Small Cap (OMX: SANION). Read more at www.saniona.com.

Attachment

• 20191113 - Saniona Q3 Report 2019 - UK