Santhera Announces Half-Year 2022 Financial Results and

Ad hoc announcement pursuant to Art. 53 LR

A conference call will be held on November 7, 2022, at 14:30 CET, 13:30 GMT, 08:30 EST. Details are at the end of this news release.

• Revenue from contracts with customers of CHF 6.3 million (H1-2021: CHF 4.5 million)
• Operating result of CHF -25.5 million (H1-2021: CHF -19.5 million) and net result of CHF -29.7 million (H1-2021: CHF -20.5 million)
• Cash and cash equivalents of CHF 12.7 million (June 30, 2022), together with existing facilities enabling cash reach into Q1-2023
• Key milestones reached with U.S. and EU regulatory submissions (NDA, MAA) for vamorolone in Duchenne muscular dystrophy (DMD)
• Financing initiatives ongoing to support vamorolone launch and other ongoing activities

Pratteln, Switzerland, October 31, 2022 – Santhera Pharmaceuticals (SIX: SANN) announces the Company’s financial results for the six months ended June 30, 2022, reports on the regulatory and clinical progress with its lead drug candidate vamorolone for the treatment of DMD in the U.S. and Europe, and provides updates on its financing initiatives.

“The year 2022 to date was fully geared towards registration and approval of vamorolone in Duchenne muscular dystrophy (DMD) and I am delighted that, over the last month, we submitted and received validation for a marketing authorization application (MAA) in the EU followed by completion of the rolling submission of a new drug application (NDA) in the U.S. This represents a tremendous achievement for Santhera and a major step towards our goal of bringing this investigational therapy to patients living with DMD,” said Dario Eklund, CEO of Santhera. “With equally high priority, we are pursuing additional near-term financing, primarily to allow us to fund market entry preparations for vamorolone. We are evaluating various non-dilutive options including but not limited to licensing agreements and monetization of assets in addition to debt and royalty financing and,…