Saniona publishes its interim report for the first quarter 2020

PRESS RELEASE

May 6, 2020

Financial highlights

Business highlights in Q1 2020

• In January, Saniona appointed Rami Levin as its President and Chief Executive Officer. Rami Levin will oversee the transformation of Saniona to a fully integrated rare disease biopharmaceutical company. He has extensive commercial experience in CNS and rare diseases, both in U.S. and globally. Jørgen Drejer, previous CEO, was appointed Chief Scientific Officer.
• In January, Saniona completed a private placement of SEK 25 million and proposed a financing of up to SEK 158 million comprising a combination of the directed issue and rights issue of warrants totaling SEK 111 million – 133 million at a strike price of SEK 25 – 30 per share as well as a loan facility of SEK 25 million.
• On February 18, 2020, Saniona co-founded new migraine therapy company Cephagenix.
• CFO Thomas Feldthus has left the company and Saniona has initiated a search for a new, U.S.-based CFO. Anita Milland, the current VP of Finance and Administration, was appointed interim CFO and Head of IR, and Jørgen Drejer assumed the role of Deputy CEO.
• On 18 March 2020, Saniona announced the completion of its the six-month double-blind Phase 2 trial of Tesomet in hypothalamic obesity.
• In March, Saniona signed a second research collaboration agreement with Boehringer Ingelheim in schizophrenia.

Significant events after the reporting period

• In April, Saniona reported positive topline results from its Phase 2 Trial of Tesomet in Hypothalamic Obesity. The double-blind placebo controlled results showed that Tesomet was safe and well tolerated and on its main efficacy end points it showed that Tesomet was statistically significantly different than placebo.
• Saniona reported the appointment of Rudolf Baumgartner, M.D., as Chief Medical Officer and Head of Clinical Development. Dr. Baumgartner will be based in the US, along with CEO Rami Levin.

Comments from the CEO                                    

"Saniona has continued to execute on its strategic milestones over the last quarter. Our focus has been on two main areas: To advance our clinical development program both in early stage and mid/late development, and to build our presence in the US market. We have completed our double-blind placebo controlled Phase 2 trial of Tesomet in patients with hypothalamic obesity (HO). The positive results of this study and the sustained progress of our Prader-Willi Syndrome (PWS) program have brought us closer to our goal of bringing Tesomet to the market to address the significant unmet need of patients affected by these diseases. By leveraging the continued progress of these drug programs and our strategic partnerships and out licensing agreements in other areas, along with the initiation of building out our presence in the US have positioned ourselves to emerge as a leading U.S.-based rare disease company focused on the central nervous system,” says Rami Levin, President & CEO of Saniona.

For more information, please contact

Rami Levin, CEO, Saniona. Mobile: +1 781 987 3144. Email: rami.levin@saniona.com 

Anita Milland, Interim CFO & Head of IR. Mobile +45-20163432. Email: anita.milland@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 10:00 CET on May 6, 2020.

About Saniona

Saniona is a rare disease biopharmaceutical company focused on research, development and commercialization of treatments for the central nervous system. The company has four programs in clinical development. Saniona intends to develop and commercialize treatments for rare disease 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 also has out-licensing agreements with Boehringer Ingelheim GmbH, Productos Medix, S.A de S.V and Cadent Therapeutics. Saniona is based in Copenhagen, Denmark, and in Boston, US. The company’s shares are listed on Nasdaq Stockholm Small Cap (OMX: SANION). Read more at www.saniona.com.

Attachment

• 20200506 - Saniona Q1 Report 2020 - UK