SoftOx Solutions AS: ANNOUNCES POSITIVE PHASE 1 RESULTS FOR SOFTOX INHALATION SOLUTION (SIS)

OSLO – May 19, 2022: SoftOx Solutions AS (“SoftOx” or the “Company”), a clinical-stage pharmaceutical and medtech company based in Norway, today announced top line results from its Phase 1 study evaluating SoftOx Inhalation Solution (SIS). SIS is a novel aqueous formulation of hypochlorous acid (HOCl), a biological oxidant with broad spectrum antimicrobial (antiviral and antibacterial) properties. In this Phase 1, first-in-human study, nebulised SIS achieved the primary objective of safety and tolerability in healthy subjects. There were no observed local tolerability issues, no adverse effects on pulmonary function, and no serious adverse events. “ We are highly encouraged by these Phase 1 results demonstrating an acceptable safety and tolerability profile for a potential future inhaled antiviral treatment ”, says Dr Christopher Burton, Chief Medical Officer for SIS. “ This study paves the way forward for the future clinical development of SIS within infectious disease indications in the upper and lower respiratory tract .” SIS-01 is a first-in-human study investigating the safety and tolerability of single and multiple ascending doses of nebulised SIS to healthy subjects. The randomized, double-blind trial was the first systematic, placebo-controlled study investigating the safety and tolerability of inhaled HOCl in humans. A total of 57 healthy volunteers were randomised to receive SIS formulations of up to 100 µg/ml HOCl, four times daily for five days, or a matching placebo regimen. “ SIS has the potential to be a breakthrough in respiratory treatment ”, stated CEO Geir Almås of SoftOx, “ the broad spectrum antimicrobial effect of SIS obviates the need for expensive diagnostic testing which can also delay the start of treatment, and would represent a paradigm shift in the management of respiratory infections .” Data from the study demonstrates that an aqueous formulation of HOCl can be administered to the respiratory tract as an aerosol, as evidenced by dose-response effects on safety parameters, which were predominantly mild, even in the most intensive dosing regimen. With these positive results from the Phase 1 study, SoftOx will continue Phase 2 clinical development of SIS. The company is already in the process of preparing Phase 2 documentation and is engaged in dialogue with the European Medical Association. For more information about the SIS-01 study, please visit clinicaltrials.gov and reference identifier: NCT05188638. For further information, please contact: Geir Almås, CEO of SoftOx Solutions AS, or Christopher Burton, CMO, SIS, SoftOx Solutions AS Mail: [email protected] Phone: Front Desk: (+47) 948-59-599 The information included in this announcement is defined as inside information pursuant to MAR article 7 and is publicly disclosed in accordance with MAR article 17. The announcement is made by the IR responsible. About SoftOx Solutions AS SoftOx Solutions AS (SoftOx, listed on Euronext Growth Oslo) is a Norwegian pharmaceutical/medtech company based in Oslo with the aim of helping to combat major threats to human health, namely the emergence of antimicrobial resistance (AMR), biofilm infections in chronic wounds and the spread of viruses. For more information on SoftOx, visit www.soft-ox.com More information: Access the news on Oslo Bors NewsWeb site

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