SoftOx Solutions AS: FIRST PARTICIPANT ENROLLED IN BIODEFENCE-FOCUSED SIS-02 PHASE 1 CLINICAL STUDY

05 Jun 2026 09:44 CEST

First participant enrolled, marking the initiation of SIS-02 and supporting the
Company’s respiratory infection and dual-use preparedness strategy.

Oslo/Dublin: SoftOx Solutions AS (“SoftOx”), a clinical-stage pharmaceutical
company developing a novel anti-infective therapy for airway infections, today
announces that the first participant has been enrolled in the SIS-02 Phase 1
clinical study in Ireland. The enrollment follows the previously announced
approval of the SIS-02 clinical trial application by Ireland’s Health Products
Regulatory Authority (HPRA) and marks the formal initiation of the study.

TWO ONGOING CLINICAL TRIALS ARE NOW ADVANCING IN PARALLEL
The SIS-02 Phase 1 study is designed to evaluate the safety, tolerability, and
pulmonary exposure profile of SoftOx Inhalation Solution (“SIS”) following
inhaled administration in healthy volunteers and supports the continued
development of SIS for defence and biological countermeasure applications.

The initiation of SIS-2 represents an important operational milestone for SoftOx
and expands the Company’s clinical trial pipeline from one to two ongoing
clinical studies. SIS-02 is separate from, and independent of, the Company’s
SIS-03 study in chronic lung infections in patients, including cystic fibrosis.
Together, the two SIS programs support SoftOx’s strategy to develop SIS as an
inhaled anti-infective therapy with potential relevance in both civilian
healthcare and defence-related biological preparedness.

“The initiation of SIS-02 is an important milestone for SoftOx. With trials now
underway in both SIS-02 and SIS-03, we are continuing to build the human safety
and exposure foundation for SIS as a novel inhaled anti-infective therapy. In
parallel with its potential clinical relevance in respiratory infections, we
believe SIS may have a role to play in future national biological preparedness
and health security strategies,” stated Thomas Bjarnsholt, CEO of SoftOx.

SUPPORTED THROUGH THE EUROPEAN DEFENCE FUND COUNTERACT PROGRAM
The SIS-02 program is formally conducted through SoftOx’s wholly owned
subsidiary, SoftOx Defense Solutions AS, and is grant-funded through SoftOx’s
participation in the COUNTERACT Consortium, which is funded by the European
Defence Fund and includes universities, public research institutes, and
companies across Europe. The program is also supported by the Norwegian Ministry
of Defence.

The SIS-02 study is intended to add to the clinical evidence base for SIS and
support the planning of subsequent development activities.

SoftOx will provide further updates on SIS-02 as the study progresses and when
relevant data reviews have been completed.

About SIS:
SoftOx Solutions AS is developing SIS, a novel inhaled anti-infective therapy
for respiratory infections in the airways and lungs. 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.

More information:
Access the news on Oslo Bors NewsWeb site

675497_Press Release FSFV SIS-02 (1).pdf