Oslo/Copenhagen, September 2nd, 2025 - SoftOx Solutions AS ("SoftOx" or "the
Company" - TICKER: SOFTX) today announces a shift in its initial clinical focus
towards chronic lung diseases in the upcoming proof-of-concept (POC) trial. It
will evaluate the safety of SoftOx Inhalation Solution (SIS) across escalating
doses and its effects on pulmonary bacterial load, thereby establishing a
foundation for additional clinical advancements. The change will not negatively
impact previously announced budgets and timelines. Expected readouts from dose
escalation in H1 2026, and PoC study concluded in Q1 2027. 

Rationale for clinical refocusing 
Over the recent quarters, the board and leadership, assisted by external
experts, have carefully evaluated the strategic options for advancing SoftOx's
inhaled pharmaceutical platform. Following this review, the Company has decided
to refine the initial clinical focus by initiating its first PoC study in
chronic lung disease, focusing on people with cystic fibrosis (pwCF), rather
than ventilator-associated pneumonia (VAP). The chronic lung disease indication
offers a tangible and feasible development path, and positive outcomes will
demonstrate the ability of SoftOx's technology to broadly eradicate bacteria in
lung infections. Such results will represent a major value inflection point and
be a solid foundation for broader clinical development, either by SoftOx or in
partnership, including additional chronic indications such as non-cystic
fibrosis bronchiectasis (NCFB), as well as acute indications such as VAP. 

Despite the availability of recent advances in the treatment of pwCF restoring
the gene defect, treatment of chronic infection remains an unmet need, leading
to an attractive opportunity for SIS in CF. Similarly, there is a strong
clinical rationale for SIS in NCFB, given the high rate of bacterial infection
within the patient population. Both of these indications are characterized by
strong commercial potential due to significant addressable markets and likely
favorable pricing and reimbursement modalities. The addressable market for SIS
in CF is estimated to be above   $600 million, and for NCFB, it could be as much
as ~$5 billion, subject to market developments in this emerging therapeutic
indication. SoftOx believes that SIS in these indications will be attractive
partnering candidates for global pharmaceutical companies, once positive data
from the forthcoming clinical trial becomes available.   

Patient Population and Study Design 
"The patients we are targeting for the PoC study live with infections and attend
hospitals frequently for treatment. While there are differences amongst them,
they form a relatively homogeneous group accessible through established
networks. They are familiar with hospitalization, can reliably convey potential
adverse events, treatment effects, and provide test samples, directly linked to
trial endpoints. These traits are pivotal for generating convincing PoC results
within viable timelines, and the revised setup of this initial patient trial
allows us to document a larger dosing headroom than would have been possible in
VAP," says CEO Thomas Bjarnsholt.  

About the POC trial 
The trial is designed in two stages: first to evaluate the safety of SIS in
healthy volunteers at higher dose levels than previously tested, and then to
demonstrate proof-of-concept by measuring reductions in lung bacterial load
among patients with chronic airway infections. The study will be set up at the
same site as SoftOx's Phase I study, ensuring that the previously communicated
timelines and budgets will not be affected. The clinical trial application will
be submitted at the end of September 2025, and study initiation is planned for
Q1 2026 with a 12-month duration, which will require a EUR7-8 million investment. 

Focus on Value Creation
"Due to the unique mode of action of SIS, SoftOx believes it may be applied
effectively in several pulmonary indications. Therefore, the stronger and
broader applicable PoC foundation we can generate, the better. Consequently,
proving the platform in CF and expanding the therapeutic window makes compelling
sense both scientifically and commercially. Although orphan, CF is a highly
relevant, tangible, and commercially attractive opportunity, but equally
important, results here will directly enable us to pursue NCFB, and the PoC
safety and efficacy data will document the broader applicability of SIS as an
inhaled pan-microbial pharmaceutical in both chronic and acute settings. We
truly believe this new approach to reducing pulmonary infections has the
potential to positively impact the lives of thousands of patients and their
families", stated COB Ulrik Spork. 

Investor Update Invitation 
SoftOx invites to an investor update on September 8th at 10:00 regarding the
refined clinical focus and the upcoming PoC trial in detail. 

Link to the investor update: 
https://investorweb.no/ir-channel/SOFTX/event/bb11f388-9ecb-4022-a43a-74c202b54c
f9 

Applications 
SoftOx is initiating a proof-of-concept trial of its inhaled pan-antimicrobial
pharmaceutical candidate (SIS) in patients with chronic lung diseases. In
parallel, the Company is advancing early-stage development of the same
technology as a countermeasure against biological warfare threats, under a
European Defence Fund (EDF) contract in collaboration with the Norwegian Defence
Research Establishment (FFI) and other European partners. 

About Cystic Fibrosis (CF):
Cystic fibrosis (CF) is a genetic disorder caused by mutations in the CFTR gene
that primarily affects the lungs and digestive system. It is characterized by
the production of thick, sticky mucus, which leads to chronic respiratory
infections, impaired lung function, and difficulties with nutrient absorption.
Advances in treatment, such as CFTR corrector drugs, have increased life
expectancy, but their effects are variable, and they do not eliminate the need
for anti-infective therapy. Chronic bacterial infections and inflammation remain
the main drivers of disease progression and premature mortality, underscoring
the continued unmet need for effective supplementary treatments. Globally, tens
of thousands of individuals are affected by CF, with the highest prevalence in
North America and Europe. 

Beyond its direct unmet needs, CF is also considered a model disease for
studying chronic airway infections in general. The pathogens, host-response
mechanisms, and treatment challenges seen in CF overlap with those in other
respiratory conditions, including non-CF bronchiectasis and even acute viral
infections such as COVID-19, where secondary bacterial infections are a major
complication. Demonstrating efficacy in CF could therefore provide
proof-of-concept (PoC) for broader application of SoftOx's technology across a
spectrum of airway infections.  

About Non-Cystic Fibrosis Bronchiectasis (NCFB): 
Non-Cystic Fibrosis Bronchiectasis (NCFB) is a debilitating, progressive
respiratory disease characterized by permanent bronchial dilatation, chronic
infection, excessive sputum production, and recurrent lung infections. The
disease follows a "vicious cycle" in which infection, structural lung changes,
inflammation, and deterioration in mucociliary clearance (i.e., the way that the
body clears the lung of mucus) perpetuate one another. NCFB can be triggered by
various underlying conditions and external insults, resulting in a heterogeneous
population that is difficult to treat. Like pwCF, those with NCFB (pwNCFB) are
frequently infected with pathogens such as Pseudomonas aeruginosa. These chronic
lung infections drive lung function decline, repeated hospitalizations, and
impaired quality of life, underscoring the urgent need for new intervention
strategies. 

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 

About SoftOx Solutions AS 
SoftOx Solutions AS (ticker: SOFTX) is a clinical-stage pharmaceutical company
listed on Euronext Growth Oslo. The company is developing highly effective
pan-antimicrobial pharmaceuticals targeting bacteria, viruses, and fungi. The
Technology is based on extensive research and development in partnership with
leading Nordic research institutes.