PRESS RELEASE
Financial highlights
Jan - Dec 2020 (Jan - Dec 2019 restated)
Revenue was SEK 8.2 M (7.2 M)
Operating loss was SEK -159.4 (-93.6 M)
Net loss was SEK -73.4 M (-68.8 M)
Earnings per share were SEK -1.79 (-2.67)
Diluted earnings per share were SEK -1.75 (-2.67)
Q4 2020 (Q4 2019 restated)
Revenue was SEK 1.6 M (0.0 M)
Operating loss was SEK -68.8 M (-28.2 M)
Net loss was SEK -45.6 M (-6.8 M)
Earnings per share were SEK -0.73 (-0.24)
Diluted earnings per share were SEK -0.73 (-0.24)
Business highlights in Q4 2020
- Saniona achieved positive top-line Phase 2 results from the open-label extension study of Tesomet in patients with HO. Patients treated with Tesomet for nearly one year (24 weeks in a double-blind trial followed by a 24-week open label extension) demonstrated statistically significant and clinically meaningful reductions in body weight and waist circumference, as well as improvements in glycemic control. Tesomet was well tolerated, and no clinically meaningful differences in heart rate or blood pressure were observed over the course of the 48-week trial.
- Saniona received written feedback from the U.S. Food and Drug Administration (FDA) regarding pre-Investigational New Drug (IND) submissions for Tesomet in Prader-Willi syndrome (PWS) and HO. In both indications, the FDA recommended that the clinical development program include a supportive Phase 2b study followed by a Phase 3 study. Saniona anticipates initiating both Phase 2b studies in the first half of 2021.
- Saniona refined its pipeline, regaining exclusive, global rights to its GABAa5 negative allosteric modulator program from Boehringer Ingelheim, which terminated this collaboration for strategic reasons. This does not impact the 2020 collaboration between Saniona and Boehringer Ingelheim, which remains ongoing. Separately, Saniona and the Treatment Research Center (TRC) at the University of Pennsylvania jointly discontinued their collaboration to develop NS2359 for cocaine addiction. Saniona will evaluate the applicability of both programs in rare diseases.
- Saniona further strengthened its executive team with the addition of Denelle Waynick as Chief Legal Officer and Kyle Haraldsen as Chief Technical Operations Officer.
Significant events after the reporting period
- Saniona received an upfront payment of approximately USD 2.9 million (SEK 24.2 million) relating to Novartis's acquisition of Cadent Therapeutics, in which Saniona holds an ownership stake of approximately 3%. The acquisition may result in additional contingent consideration upon the achievement of future milestones.
- The U.S. FDA granted orphan drug designation to Tesomet for the treatment of PWS. This designation qualifies Saniona for certain development benefits, including tax credits, elimination of certain FDA license application fees, and seven years of market exclusivity in the U.S. following approval.
- The U.S. FDA provided further clarity on a regulatory path for Tesomet in the treatment of HO. The FDA indicated overall agreement with Saniona's Risk Evaluation and Mitigation Strategy (REMS) proposal and cardiovascular monitoring proposal. Based on this feedback, Saniona is proceeding with plans to initiate a Phase 2b study in HO in the first half of this year.
Comments from the CEO
"Throughout 2020, Saniona continued to execute on our strategy of discovering, developing and delivering innovative rare disease treatments: we generated positive data with Tesomet in both the double-blind and open-label extension periods of our Phase 2 study for hypothalamic obesity, we established our executive team and infrastructure in the U.S., and we attracted some of the most respected institutional investors in healthcare with the ability to support Saniona's long-term growth prospects," said Rami Levin, President & Chief Executive Officer of Saniona. "We are currently in the strongest cash position of Saniona's history, which will allow us to conduct three clinical trials simultaneously: two Phase 2b trials for Tesomet in hypothalamic obesity and Prader-Willi syndrome and a Phase 1 trial of SAN711 for rare neuropathic disorders. We are well-positioned to continue with our transformation in 2021 as we advance our pipeline and position Saniona to access the U.S. patients, physicians and financial market which will be critical to realize our potential."
As part of its evaluation of a potential U.S. listing, Saniona completed a company-initiated restatement of prior period financial statements and a subsequent audit of these financial statements under U.S. Public Company Accounting Oversight Board (PCAOB) audit standards. The restatements are included in the year-end report. The restatements relate to accounting adjustments and do not impact Saniona's cash position, forecast, operating plan or the conduct of our clinical trials.
Read the full report attached below.
For more information, please contact
Trista Morrison, Chief Communications Officer, Saniona. Office: + 1
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 CET on March 17, 2021.
About Saniona
Saniona is a biopharmaceutical company focused on discovering, developing, and delivering innovative treatments for rare disease patients around the world. The company's lead product candidate, Tesomet, is in mid-stage clinical trials for hypothalamic obesity and Prader-Willi syndrome, severe rare disorders characterized by uncontrollable hunger and intractable weight gain. Saniona's robust drug discovery engine has generated a library now consisting of more than 20,000 proprietary modulators of ion channels, a significantly untapped drug class that is scientifically validated. Lead candidate SAN711 is entering Phase 1 for rare neuropathic disorders, with SAN903 for rare inflammatory and fibrotic disorders advancing through preclinical studies. Led by an experienced scientific and operational team, Saniona has an established research organization in Copenhagen, Denmark and is building its corporate office in the Boston, Massachusetts area, U.S. The company's shares are listed on Nasdaq Stockholm Small Cap.
Attachment
- 20210316 - Saniona Q4 Report UK vFINAL (https://ml-eu.globenewswire.com/Resource/Download/888c92f9-665f-4f3a-b2e9-6c525396f6c7)
