Saniona achieved orphan drug designation (ODD) from the FDA for Tesomet for the treatment of hypothalamic obesity (HO).
Three Months Ended September 30, 2021 (2020)
Revenue was SEK 2.3 M (2.2 M)
Operating loss was SEK -88.2 M (-37.3 M)
Net loss was SEK -93.7 M (-48.3 M)
Basic loss per share was SEK -1.50 (-1.14)
Diluted loss per share was SEK -1.50 (-1.14)
Nine Months Ended September 30, 2021 (2020)
Revenue was SEK 7.6 M (6.6 M)
Operating loss was SEK -286.7 M (-90.8 M)
Net loss was SEK -281.8 M (-29.0 M)
Basic loss per share was SEK -4.52 (-0.86)
Diluted loss per share was SEK -4.52 (-0.86)
Business highlights in Q32021
- Saniona achieved orphan drug designation (ODD) from the FDA for Tesomet for the treatment of hypothalamic obesity (HO). Tesomet is the first and only investigational treatment for HO to receive ODD, and it previously received ODD for Prader-Willi syndrome (PWS). ODD qualifies Saniona for certain benefits including tax credits, elimination of certain FDA license application fees, and seven years of market exclusivity in the U.S. following approval.
- Saniona entered into a non-dilutive term loan agreement for SEK 87 million ($10 million) with Formue Nord Fokus A/S to support new activities aimed at accelerating clinical development programs.
- Saniona appointed Wendy Dwyer as Chief Business Officer to focus on out-licensing of assets in non-core markets and/or non-core therapeutic areas in order to generate non-dilutive capital while expanding the potential reach of Saniona’s medicines globally.
- Finance veteran Robert E. Hoffman was appointed as a member of the board of directors and Chairman of the Audit Committee, as resolved at an extraordinary shareholders’ meeting.
Significant events after the reporting period
- 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.
- Saniona initiated a Phase 2b clinical trial of Tesomet in patients with HO. The company also confirmed, and continues to confirm, that it remains on track to initiate its Phase 2b clinical trial of Tesomet for PWS before the end of 2021, as planned.
Comments from the CEO
“With two clinical trials now underway and a third poised to begin before the end of this year, Saniona has made significant progress on our mission to discover, develop and ultimately commercialize our medicines to treat rare diseases,” said Rami Levin, President & Chief Executive Officer of Saniona. “This progress is a direct result of the hard work by the talented and experienced team we have hired, and it positions us well to continue to achieve important milestones in the fourth quarter of 2021 as well as throughout 2022 and 2023.”
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 Regulationand the Securities Markets Act. The information was submitted for publication, through the agency of the contact person set out above, at 08:00 CET on November18, 2021.
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, Saniona’s 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
