SoftOx Solutions AS: Danish Medicines Agency Approves Phase 2a Trial for SoftOx Inhalation Solution

29 Dec 2025 09:33 CET

Oslo / Copenhagen – SoftOx Solutions AS (“SoftOx”) today announces that the
Danish Medicines Agency has approved the Company’s clinical trial application
for a combined Phase 2a dose-escalation and proof-of-concept (PoC) study of the
SoftOx Inhalation Solution (SIS). This regulatory clearance marks a significant
de-risking milestone for the program and materially increases the visibility and
value of the SIS development pathway.

The approved Phase 2a trial includes:
A dose-escalation study in healthy volunteers, designed to confirm safety and
tolerability at increasing dose levels.
A proof-of-concept (PoC) study in people with cystic fibrosis (CF), aimed at
assessing safety at higher doses and generating key data on bacterial load
reduction in the CF airway environment.

This combined study structure marks a critical advancement in SoftOx’s clinical
program and represents the Company’s first human efficacy-oriented assessment of
SIS in a target patient population.

Material de-risking and value creation
Regulatory approval removes the key uncertainty heading into Phase 2a and
transitions SIS into a stage where execution is now the primary remaining risk
ahead of clinical readouts. This milestone meaningfully increases the program’s
probability of technical and regulatory success, aligning SoftOx’s clinical
roadmap with industry-standard development trajectories. For investors, this
represents a clear value inflection point, as SIS can now advance to human
testing on a well-defined development plan and timeline.

Large commercial opportunity
SIS targets biofilm-associated infections through a patented, non-antibiotic
mechanism designed to avoid resistance. In CF alone, an estimated 13,000
patients across the US and EU4+UK receive chronic inhaled antibiotic therapy,
representing a market of >USD 600 million annually.
The same mechanism is relevant to non-CF bronchiectasis, a significantly larger
indication affecting ~445,000 patients with a potential market opportunity
exceeding USD 5 billion.

Upcoming value-driving milestones
1H 2026: Dose-escalation topline data – a key validation point and gating event
for initiating PoC testing
Q1 2027: Final Phase 2a PoC readout – expected to be the next major value
inflection point for the SIS platform

These milestones will provide critical human safety and early patient-based
signals, shaping the regulatory and partnering strategy for SIS.

CEO Thomas Bjarnsholt comments:
“Regulatory approval of our Phase 2a trial is a transformative step for SoftOx.
This milestone substantially de-risks the program and gives us a clear,
predictable path into human testing. The upcoming dose-escalation readout in 1H
2026 and the PoC results expected in Q1 2027 are major catalysts for the Company
as we advance SIS toward later-stage development.”

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.

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