PRESS RELEASE
February 21, 2019
Financial highlights
Jan - Dec 2018 (Jan - Dec 2017)
- Net revenues were SEK 54.9 M (20.7 M)
- EBIT was SEK -54.2 M (-57.2 M)
- Net profit/loss was SEK -41.1 M (-49.2)
- Earnings per share were SEK -1.84 (-2.30)
- Diluted earnings per share were SEK -1.84 (-2.30)
Q4 2018 (Q4 2017)
- Net revenues were SEK 2.2 M (4.6 M)
- EBIT was SEK -34.3 M (-16.6 M)
- Net profit/loss was SEK -23.3 M (-14.8)
- Earnings per share were SEK -1.02 (-0.68)
- Diluted earnings per share were SEK -1.02 (-0.68)
Business highlights in Q4 2018
- Saniona completed recruitment of adolescents for the second part of its Phase 2a study of Tesomet in patients with Prader Willi Syndrome (PWS). The trial is expected to be completed in early 2019.
- Saniona's partner Medix successfully completed a Phase 3 registration trial for tesofensine in obesity. The trial met its primary endpoints with a statically and clinically significant weight loss for both doses of tesofensine compared to placebo. Patients achieved an average weight loss of ten percent in the highest dose group and more than half of the patients lost more than ten percent in weight. The trial also met other secondary endpoints with statistically significant reduction in key obesity-related risk factors.
- Saniona's partner Cadent Therapeutics secured USD 40 million financing anchored by Atlas Ventures, a leading US-based investor, and initiated a Phase 2 study for its lead compound, CAD-1883, in essential tremor, which was discovered under the collaboration with Saniona.
- Saniona's spin-out company Scandion Oncology was listed on the Spotlight Stock Market on November 8, 2018 and received total proceeds of SEK 26 million before issuance costs through an Initial Public Offering.
- Saniona entered into a 1-year option agreement with Initiator Pharma A/S, where Initiator Pharma obtains the right to acquire the AN788 program under certain conditions.
Significant events after the reporting period
- In January, Saniona initiated an open label extension study in the second part of its Phase 2a study of Tesomet comprising nine adolescent patients with PWS. The treatment with a dose of 0.125 mg/day appeared to be well tolerated but did not achieve sufficient plasma levels known to be efficacious in previous Phase 2 and Phase 3 studies. Saniona has now filed and received approval to increase the dose to 0.25 mg/day in the Czech Republic; approval in Hungary is pending. The first patients are expected to be switched to the 0.25 mg dose in March and the study is scheduled to continue until the end of June.
- Saniona's partner University of Pennsylvania Treatment Research Center plans to continue the investigator-initiated study with NS2359 for cocaine addiction at a higher dose following their interim analysis.
- Saniona successfully completed a full regulatory toxicological program for its first in class compound, SAN711, which offers a new treatment paradigm for itching and neuropathic pain. Saniona has scaled-up the manufacturing process, produced the material for clinical studies and the program is now ready for Phase 1 studies.
Comments from the CEO
"Our partner Medix successfully completed a Phase 3 registration trial of tesofensine, paving the way for a regulatory filing in Mexico and supporting our fully-owned program with Tesomet. We made significant progress at Saniona in the fourth quarter with our pipeline in rare eating disorders, moving towards the market to provide help to patients with these debilitating diseases," 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 CET on February 21, 2019.
About Saniona
Saniona is a research and development company focused on drugs for diseases of the central nervous system and eating disorders. The company has four 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 preclinical 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
- 20190221 - Saniona Q4 Report 2018 - UK (https://ml-eu.globenewswire.com/Resource/Download/8f857ae8-0d0f-4ea0-a25d-9888dbe63c7b)
