SoftOx Solutions AS: SoftOx builds momentum: CF trial strategy reinforced by HOCl stability breakthrough

23 Sep 2025 08:00 CEST

Following its strategic decision to initiate the first proof-of-concept (PoC)
trial in people with cystic fibrosis, SoftOx announces published breakthrough
data on the stability of hypochlorous acid (HOCl), the core component of its
inhaled therapy (SIS).

The preformulation study, published in the Journal of Drug Delivery Science and
Technology (Pham et al., 2025), demonstrates that storing HOCl as a solid
precursor and generating it only when needed overcomes the long-standing
stability barrier that has limited higher-strength HOCl formulations. The powder
was highly stable for ≥24 months at ~23 °C when stored dry (≈≤5% degradation)
and showed near-instant conversion on activation (≥99% within seconds).

CEO Thomas Bjarnsholt: “These findings validate the foundation of our inhaled
SIS program. Combined with our focused clinical path in cystic fibrosis, they
mark a pivotal moment for SoftOx.”

The upcoming PoC trial, planned for Q1 2026, will evaluate safety at higher
doses in healthy volunteers and demonstrate bacterial load reduction in pwCF.
Positive results would open the way to broader indications, including non-CF
bronchiectasis (NCFB).

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.

Reference: Pham AK, Hiorth M, Rongved P. A novel and stable formulation of
powdered high-assay calcium hypochlorite as a solid precursor of the
antimicrobial compound hypochlorous acid: a preformulation study. Journal of
Drug Delivery Science and Technology 113 (2025) 107292.
https://doi.org/10.1016/j.jddst.2025.107292

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655939_Pham AK, Hiorth M, Rongved P. A novel and stable formulation of powdered high-assay calcium hypochlorite.pdf