SOFTOX SOLUTIONS AS: FINAL REPORT REAFFIRMS POSITIVE TOP LINE PHASE 1 RESULTS FOR SOFTOX BIOFILM ERADICATOR

This first-in-human clinical study demonstrated that SoftOx Biofilm Eradicator (SBE) applied on chronic leg wounds was safe and well-tolerated There were no statistically significant differences in the evaluation of pain during and after the wound cleaning procedure comparing SBE with placebo (Saline). Treatment with all SBE formulations consistently reduced the absolute number of bacteria in the wound compared with pre-treatment A dose-dependent reduction in wound size was observed in the multiple-dosing SBE treatment groups OSLO – December 15, 2022 – SoftOx Solutions AS (“SoftOx” or the “Company”), a clinical-stage pharmaceutical and MedTech company based in Norway, announces that the Company has received the final report and analysis of its Phase 1 study evaluating the safety and tolerability of SoftOx Biofilm Eradicator (SBE-01) (EudraCT no. 2021-000314-42), SoftOx’s antimicrobial solution for the treatment of chronic wounds. SBE-01 is a first-in-human study investigating the safety, tolerability, and antimicrobial efficacy of single and multiple doses of SBE in patients with chronic leg wounds. The Phase 1 study was divided into two parts: a randomized, blinded, Single Ascending Dose (SAD) phase, followed by an open label, Multiple Ascending Dose (MAD) phase, where patients were treated once-daily or twice-daily over five days. Key findings The final report reaffirms previous findings that SBE is safe and well-tolerated by patients suffering from chronic leg wounds. There were no statistically significant differences in the evaluation of pain during and after the wound cleaning procedure comparing SBE with placebo. The study found that formulations of SBE consistently reduced the bacterial burden in the wound compared with pre-treatment. There was also evidence of wound healing with a reduction in wound area of between 24 to 36% after just 5 days’ treatment. Thomas Bjarnsholt, Chief Scientific Officer at SoftOx, said: “ According to the World Health Organization, antimicrobial resistance is one of the largest threats to human health, which is why it is critical to develop new and innovative ways to tackle bacterial infections. These results clearly suggest that the SBE solution is safe and well-tolerated by patients and can significantly reduce the overall bacterial burden in wounds, ultimately promoting wound healing. Taken together with previous clinical studies, these data are early proof-of-concept for the technology as a potential treatment candidate for patients suffering from chronic wounds worldwide .” Next steps Having demonstrated early proof-of-concept for the SBE project and in accordance with the Company’s corporate strategy, SoftOx will seek a strategic partner to further develop and advance its wound care segment within acute and chronic indications. For further information, please contact: Geir Almås, CEO of SoftOx Solutions AS, or Christopher Burton, CMO of SoftOx Solutions AS Mail: [email protected] Phone: Front Desk: (+47) 948-59-599 About SoftOx Solutions AS SoftOx Solutions AS (SoftOx, listed on Euronext Growth Oslo) is a Norwegian biopharmaceutical and MedTech company based in Oslo, with the goal of reducing the spread of infection and emergence of antimicrobial resistance. For more information on SoftOx, visit www.soft-ox.com About biofilm and antimicrobial resistance Biofilm in chronic wounds is a cluster of bacteria within a matrix, which makes it difficult for today’s antibiotics to effectively eradicate the infection in chronic wounds. Up to 2 per cent of the population of developed countries are projected to experience a chronic wound during their lifetime. Within organized biofilms, bacteria are more resistant to antibiotics and immune responses, making clinical treatment of biofilm infection difficult. Antimicrobial resistance – significant unmet need Combination antibiotic therapy and physical removal of biofilms are commonly used forms of treatment for biofilm-associated infections. Still, there remains a significant unmet need for new and innovative approaches to tackling biofilm and multidrug-resistant bacteria. Previous studies have shown that antimicrobial-resistant bacteria are present in more than 50 per cent of chronic wounds. According to the World Health Organization (WHO), antimicrobial resistance is one of the largest threats to human health. In 2019 alone, antimicrobial-resistant bacteria contributed to 4.95 million deaths worldwide. More information: Access the news on Oslo Bors NewsWeb site

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