SoftOx Solutions AS: GMP Drug Substance Successfully Manufactured – Key Milestone for CF and EDF Clinical Programs

14 Nov 2025 08:35 CET

SoftOx Solutions AS (“SoftOx”) is pleased to announce that it has successfully
manufactured and released its first Good Manufacturing Practice (GMP) batch of
the SoftOx Inhalation Solution (SIS) Drug Substance, marking a significant step
forward in the Company’s clinical and technological development.

The newly manufactured GMP-grade salt represents the core drug substance for the
next generation of SoftOx products and will be used in both the upcoming Cystic
Fibrosis (CF) Phase 2a trial and the European Defence Fund (EDF) Phase 1 trial.

This milestone demonstrates SoftOx’s ability to scale from research to
GMP-compliant clinical manufacturing, ensuring quality, stability, and
reproducibility in line with international pharmaceutical standards. The
development also reinforces SoftOx’s role in creating medical countermeasures
against biological threats under the EDF framework, combining healthcare
innovation with defense preparedness.

Head of CMC Charlotte Pinholt comments:
“Having successfully manufactured and released the GMP drug substance, we are
now finalizing preparations for GMP drug product manufacturing. This progress
highlights the robustness of our CMC strategy and ensures that we can supply
high-quality, reliable material for our upcoming clinical studies.”

CEO Thomas Bjarnsholt comments:
“The successful GMP manufacturing of our drug substance marks a significant
milestone for SoftOx. It validates our technology’s maturity and readiness for
clinical deployment in both healthcare and defense applications. This step also
strengthens our foundation for future partnerships and commercialization
opportunities.”

By achieving GMP manufacturing readiness, SoftOx significantly advances its
position in the clinical pipeline, demonstrating operational capability,
regulatory compliance, and increasing investor value as the company moves closer
to trial execution and long-term product commercialization.

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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