PRESS RELEASE
May 29, 2019
Financial highlights
Q1 2019 (Q1 2018)
- Net revenues were SEK 1.7 M (4.3 M)
- EBIT was SEK -29.1 M (-15.7 M)
- Net profit/loss was SEK -24.8 M (-13.5)
- Earnings per share were SEK -1.06 (-0.62)
- Diluted earnings per share were SEK -1.06 (-0.62)
Business highlights in Q1 2019
- 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 obesity studies. Saniona has increased the dose to 0.25 mg/day in March and the final open label study is scheduled to continue until July.
- In March, Saniona recruited the first patient in a Phase 2a clinical study of Tesomet to treat the rare eating disorder hypothalamic obesity. The trial comprises a total of up to 25 patients and is conducted at Rigshospitalet in Copenhagen, Denmark.
- Following the interim analysis, 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.
- 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.
- Selection of ABG Sundal Collier As a financial advisor.
Significant events after the reporting period
- Saniona announced a Rights Issue of SEK 78 MSEK. The intention with this Rights Issue is to secure Saniona’s financing requirement and thereby replace potential future tranches under the existing funding agreement with Nice & Green.
- Saniona established a Scientific Advisory Board for the development of Tesomet in PWS.
Comments from the CEO
"Saniona continued development of its promising portfolio of new drugs in the first quarter, making further progress as a leading biotech company focusing on treatment of eating disorders and diseases of the central nervous system. In particular, we advanced the clinical trials of our lead product Tesomet. In further positive news for Saniona, our partner Medix remain confident about launching tesofensine in Mexico in 2020, which would be the first program from our portfolio to reach the market. At the same time, we continue the development of our business and have engaged with several leading biopharmaceutical companies regarding partnering of assets”, 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
The information was submitted for publication, through the agency of the contact person set out above, at 08:00 a.m. CEST on May 29, 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 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.
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