SoftOx Solutions AS (SoftOx), a clinical-stage biopharmaceutical company based
in Norway, announced today the end of the Phase 1 clinical study of the SoftOx
Biofilm Eradicator (SBE-01) (EudraCT no. 2021-000314-42), SoftOx's antimicrobial
solution for treatment of chronic wounds.

"We would like to thank our study participants and the staff at DanTrials ApS.
SoftOx is looking forward to announcing the top line results in Q4 2022," said
Glenn Gundersen, Sr Medical Director of SoftOx. 

SBE-01 is a first-in-human study investigating the safety, tolerability, and
antimicrobial efficacy of single and multiple doses of the SoftOx Biofilm
Eradicator (SBE) in patients with venous leg ulcers. In Phase 1b the company
treated the wounds once and twice daily over 5 days. The original study design
included three times daily administration for five days; however, the company
expects that data from the two first groups are sufficient to document safety,
tolerability, and antimicrobial efficacy in clinically relevant treatment
schedules in chronic wounds. 

"With the closure of Phase 1 study, we can turn our attention towards analysing
the data and complete our preparations for the Phase 2 study investigating the
effect of SBE on wound closure in venous leg ulcers," said Gundersen.

Co-funded by the US Naval Medical Research Center
The study is co-funded by the US Naval Medical Research Center (NMRC) under the
Medical Technology Enterprise Consortium (MTEC), a biomedical technology
consortium that collaborates under a transaction agreement (OTA) with the US
Army Medical Research and Development Command.

"The Phase 2 study will also be co-funded by the United States Naval Medical
Research Center, and we are confident that the SBE-01 results will support
selection of an optimal SBE formulation and dosing schedule for treating
patients with chronic wounds in both hospital and long-term community care
settings," said Gundersen.

SBE is in clinical development as an anti-infective treatment for chronic
wounds, designed specifically to penetrate and kill pathogens within biofilms.
Due to the broad spectrum and multi-targeted antimicrobial effects, SBE has been
shown to kill antibiotic resistant bacteria in biofilms without inducing new
antimicrobial resistance in vitro. SoftOx has previously published clinical data
supporting the association between reduced bacterial burden and improved wound
healing. These associations will be further investigated in the planned SBE
Phase 2 (SBE-02) study.

As previously reported, SBE-01 recruitment was delayed in the early stages of
the trial due to the Danish nursing strike in 2021. To maintain overall clinical
development timelines, SoftOx has taken the decision to omit the three times
daily treatment, stop further patient recruitment and to end the trial.

Facts about biofilm:
Biofilm in chronic wounds is a cluster of bacteria covered by a matrix, which
makes it difficult for today's antibiotics to effectively eradicate the
infection in chronic wounds. 1-2 % of the population are projected to experience
a chronic wound during their lifetime in develop countries. Under the protection
of biofilm, microbial cells in biofilm become tolerant and resistant to
antibiotics and the immune responses, which increases the difficulties for the
clinical treatment of biofilm infection.

For further information, please contact:
Geir Almås, CEO of SoftOx Solutions AS, or
Glenn Gundersen, Senior Medical Director of SoftOx Solutions AS
Mail: ir@soft-ox.com
Phone: Front Desk: (+47) 948-59-599

About SoftOx Solutions AS
SoftOx Solutions AS (SoftOx, listed on Euronext Growth Oslo) is a Norwegian
BioTech 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

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