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LandNorge
ListaEuronext Growth Oslo
SektorHälsovård
IndustriMedicinteknik
SoftOx Solutions är ett norskt medicintekniskt bolag. Bolaget har utvecklat en egenpatenterad lösning baserad på ättiksyra för behandling av kroniska sår hos patienter. Lösningen används för att eliminera infektioner i samband med biofilmer, vilket består av olika kluster av bakterier. En del av läkemedelsutvecklingen sker i samarbete med övriga forskningsinstitut. SoftOx Solutions grundades år 2012 och har sitt huvudkontor i Oslo, Norge.

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SoftOx Solutions AS: FIRST PATIENT DOSED IN SIS-03 PROOF-OF-CONCEPT PATIENT TRIAL

2026-08-11 10:35:35
First  patient with chronic airway infection dosed, marking initiation of the
proof-of-concept phase

Oslo, Norway - SoftOx Solutions AS ("SoftOx"), a clinical-stage pharmaceutical
company developing a novel anti-infective therapy for airway infections, today
announces that the first patient has been dosed in the proof-of-concept (PoC)
patient phase of the SIS-03 clinical program. This Phase 2a patient phase of the
trial is evaluating SoftOx Inhalation Solution ("SIS") as an inhaled
anti-infective therapy for chronic airway infections.

The dosing of the first patient follows the previously announced completion of
the SIS-03 dose-escalation phase in healthy volunteers and the positive topline
safety review, which reported no serious adverse events and no severe
tolerability issues. The PoC patient phase is designed to assess clinical and
microbiological signals relevant to establishing proof-of-concept for SIS,
including data on bacterial load reduction in patients' airways.

"Dosing the first patient in the SIS-03 proof-of-concept phase is a very
important moment for SoftOx. For the first time, we are evaluating SIS directly
in patients suffering from chronic airway infections - a population where
existing therapies often fall short due to antimicrobial resistance. We look
forward to generating clinical data that will help us understand the potential
of SIS in this setting," stated Thomas Bjarnsholt, CEO of SoftOx.

The SIS-03 clinical trial program is being conducted in collaboration with
Rigshospitalet in Copenhagen, Denmark. The Company expects to dose between 15
and 25 patients in this phase of the program, which is expected to conclude in
H1 2027. SIS-03 remains separate from the Company's other ongoing SIS-02
clinical program, which is evaluating SIS in healthy volunteers in a biodefence
context.

The Company will provide further updates on SIS-03 as relevant milestones are
reached.

Potential commercial relevance:
Based on Company estimates, approximately 13,000 patients with cystic fibrosis
across the US and EU4+UK receive chronic inhaled antibiotic therapy,
representing a market of more than USD 600 million annually. SoftOx believes
SIS's mechanism may also be relevant to non-CF bronchiectasis, a significantly
larger indication affecting approximately 445,000 patients, with a potential
market opportunity exceeding USD 5 billion.

About SIS:
SoftOx Solutions AS is developing SIS, a novel inhaled anti-infective therapy
for respiratory infections in the airways and lungs. SIS targets
biofilm-associated infections through a patented, non-antibiotic mechanism
designed to reduce the risk of resistance development. Delivered by nebulizer,
SIS is being developed to address bacterial, viral, and fungal pathogens through
local delivery directly at the site of infection, without systemic exposure to
the remainder of the human body. Its broad pathogen relevance positions SIS as a
distinct therapeutic in respiratory infections.

About SoftOx Solutions AS:
SoftOx Solutions AS (ticker: SOFTX) is a clinical-stage pharmaceutical company
developing SIS (SoftOx Inhalation Solution), a novel inhaled anti-infective
therapy for the treatment of respiratory infections in the airways and lungs.
The Company is also exploring the potential dual-use relevance of SIS within
civilian health security and biological preparedness. SoftOx is listed on
Euronext Growth Oslo.

For more information, please contact:
Ulrik Spork, Chairman of the Board, SoftOx Solutions AS, +45 31 38 83 87
Thomas Bjarnsholt, CEO, SoftOx Solutions AS, +45 20 65 98 88
Mail: ir@soft-ox.com

This information is subject to the disclosure requirements pursuant to section
5-12 of the Norwegian Securities Trading Act.
to the disclosure requirements pursuant to section\
5-12 of the Norwegian Securities Trading Act. \