Strategic Shift & Clinical Focus - SoftOx Solutions AS is refining its clinical focus towards chronic lung infections, particularly Cystic Fibrosis (CF), with SIS 003 as a Proof of Concept (PoC) [9, 15] - The Cystic Fibrosis (CF) pathway is a commercially valid and strategic first step, creating a foundation for long-term value creation in the inhaled pan-microbial pharmaceuticals space [17] - The company aims to transform antimicrobial therapy and combat antibiotic resistance with a novel mode of action that eradicates bacteria independent of metabolism [22] Market Opportunity & Commercial Potential - The Cystic Fibrosis (CF) addressable market is estimated to be greater than $600 million, with approximately 13,000 addressable patients in the US & EU4+UK, based on an annual treatment cost of $75,000/€20,000 [25, 53, 55] - The Non-Cystic Fibrosis Bronchiectasis (NCFB) addressable market is estimated to be greater than $5 billion, with approximately 445,000 addressable patients in the US & EU4+UK [31, 58] - Assuming a feasible market share of 15% in CF, the annual turnover potential is $90 million [55] Clinical Development & Investment - SoftOx plans to invest 7-8 million EUR to conclude Phase IIa and conduct partnership processes [45] - The company plans to submit a Clinical Trial Application (CTA) by the end of September 2025 for a Phase IIa PoC study in CF [45, 49] - The PoC study is designed to demonstrate a reduction in lung bacterial load in CF patients, with a primary endpoint of ≥ 2 log10 CFU/g reduction in bacterial load in expectorated sputum [41, 42, 51] Financial Flexibility - SoftOx has a financing facility with Long State Investment for a total commitment of NOK 50 million over 24 months, with the option to extend to NOK 80 million over 36 months [68]