- The SoftOx Biofilm Eradicator (SBE) was shown to be safe and well tolerated.
- Treatment with SBE consistently reduced bacterial burden in chronic leg
ulcers. 
- The SBE-01 study demonstrates further proof-of-concept for the company's wound
care technology platform.
- SoftOx wound care formulations tailored to treatment of wounds in the presence
or absence of biofilms.

OSLO - October 4, 2022
SoftOx Solutions AS ("SoftOx" or the "Company"), a clinical-stage
biopharmaceutical company based in Norway, announces top line results from its
Phase 1 clinical 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. In addition, the company provides
an update on its financial situation. 

"A large proportion of chronic wounds, like venous leg ulcers and diabetic foot
ulcers, are colonised by multiple species of bacteria organised in biofilms.
These biofilms are detrimental to the wound healing process and are difficult to
treat with conventional antiseptics and antibiotics," says Dr Christopher
Burton, Chief Medical Officer of SoftOx. "The SBE formulation has been
specifically designed to penetrate the biofilm and exhibit an antimicrobial
effect throughout the wound bed, to improve subsequent wound healing. The
results of the SBE-01 trial are another important step towards realising a
product that is expected to greatly improve quality of life for a large group of
people suffering from chronic wounds of variable causes." 

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.

Data from the SBE-01 study demonstrate that SBE 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.
Treatment with all SBE formulations consistently reduced the absolute number of
bacteria (bacterial burden) in the wound compared with pre-treatment (baseline).
 A dose dependent reduction in wound size was also observed in the multiple dose
SBE treatment groups.   

"These positive results add to our growing body of clinical evidence supporting
the company's wound care technology platform. There are around 40 million 
people with chronic wounds worldwide, where drug and medical device treatment
costs are estimated to be $600  for each infection. The SoftOx technology
promises to be a cost-effective wound care treatment, that can also be an
effective solution to the treatment of multidrug-resistant bacteria, such as
Methicillin Resistant Staphylococcus Aureus or MRSA," said Geir Almås, CEO of
SoftOx. "Moving forward, we are excited to explore potential strategic partners
to advance this promising asset through the clinical development."

Proof of concept
The SoftOx technology platform is highly versatile, new generation antimicrobial
agent with the potential to treat different types of wounds, from infection
prevention in acute surgical or non-surgical wounds to infection removal in
wounds typically associated with biofilm such as chronic leg ulcers and
traumatic penetrating injuries.

SoftOx has previously published clinical data supporting the association between
the use of SoftOx technology and improved wound healing in acute wounds. Taken
together with the results from the SBE-01 study of antimicrobial effects in
chronic leg wounds over a safe and tolerable dose range, these combined results
are early proof of concept for the SoftOx wound care technology platform for a
range of potential acute and chronic wound care indications. 

Klaus Kirketerp-Møller, MD, PhD, from Copenhagen Wound Healing Center at
Bispebjerg Hospital, Denmark commented: "We are encouraged by these results,
which speak to the potential of SBE as a treatment of chronic wounds as well as
aiding in the fight against antimicrobial resistance as a possible alternative
to antibiotics." 

Significant unmet need
Combination antibiotic therapy and physical removal of biofilms are the commonly
used forms of treatment of biofilm-associated infections today, but 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 . 

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. 

The clinical development of SBE is co-funded by the US Naval Medical Research
Center (NMRC) through 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.

For more information about the study, please visit the European Union Drug
Regulating Authorities Clinical Trials Database and reference identifier:
EudraCT no. 2021-000314-42.

About biofilm and antimicrobial resistance
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. Up to 2 per cent of the population of developed
countries are projected to experience a chronic wound during their lifetime.
Within organised biofilms, bacteria are more resistant to antibiotics and the
immune responses, making clinical treatment of biofilm infection difficult.
According to the WHO, antimicrobial resistance is considered as a global crisis
that threatens a century of progress in health. Presently, deaths linked to
multidrug-resistant bacteria are already higher than those related to HIV/AIDS
or malaria . 

Update on the company's financial situation
As reported at the end of the previous quarter, the company has a limited cash
position, and there is a need to financially strengthen the company and its
liquidity in the short and long term. The company is working actively with
different solutions in this respect, both financially and strategically. Amongst
others, the proof-of-concept data for the SBE are expected to play a vital role
in securing future partnering investments and collaborations, and if successful,
the company believes that a sale or partnership will provide the company with a
good foundation to support the company's financial situation and activities in
the long term. 

To strengthen the liquidity situation in the shorter term, the company has
initiated a cost improvement plan to defer noncritical R&D activities, reduce
future overhead and infrastructure expenditures and prioritize its ongoing
development projects. On the basis of this plan, the company estimates that a
cash injection of up to NOK 50 million is sufficient to fund the company to June
2023. An underwritten rights issue is one of the alternatives being evaluated. 
The estimated capital need does not take into account that approximately NOK 25
million of the previous announced grants on the SoftOx inhalation solution (SIS)
is expected to be pre-paid at the time of signing the research agreement (as
SoftOx is defined as a SMB company). 

The company will provide an update as soon as a solution has materialized and
thus also indicate the financial and accounting effects on the same.

For further information, please contact:
Geir Almås, CEO of SoftOx Solutions AS, or
Christopher Burton, CMO of SoftOx Solutions AS
Mail: ir@soft-ox.com
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
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



References:
  MedMarket Diligence (2011). Wound prevalence and wound management: 2012-2020
  MedValue & Radboud University (2019). Decision Modeling Assessment. 
  IACG (2019). No Time to Wait, WHO.
https://www.who.int/antimicrobial-resistance/interagency-coordination- 
  group/IACG_final_report_EN.pdf?ua=1
 
https://www.ox.ac.uk/news/2022-01-20-estimated-12-million-people-died-2019-antib
iotic-resistant-bacterial- 
 
infections#:~:text=First%20comprehensive%20analysis%20of%20global,role%20in%204.
95%20million%20deaths.