SoftOx Solutions (SOFTX) Investor Update summary

Strategic Focus and Clinical Development

• The lead stabilized hypochlorous acid inhalation solution targets chronic lung infections, with cystic fibrosis (CF) as the initial proof-of-concept population due to its homogeneous patient group and clear efficacy endpoints.

• The solution demonstrates broad-spectrum antimicrobial activity, including against antibiotic-resistant and dormant bacteria, with no observed resistance or systemic side effects in preclinical and early human studies.

• A Phase IIa proof-of-concept study in CF is planned, with dose escalation in healthy volunteers followed by CF patients; study initiation is expected in Q1 2026, with results anticipated by mid-2027.

• The clinical trial application is scheduled for submission by September 2025, with a €7-8 million investment allocated for the study.

• Success in CF could enable expansion into non-cystic fibrosis bronchiectasis (NCFB) and other chronic airway infections, supporting broader clinical development and partnership opportunities.

Market Opportunity and Financial Strategy

• The addressable market for CF in major Western countries is estimated at $600 million annually, with a realistic initial market share target of 15%, equating to $90 million in annual turnover.

• NCFB represents a larger opportunity, with a potential market size up to $5 billion in annual turnover, depending on market penetration.

• Pricing benchmarks for inhaled antibiotics and new therapies support high annual treatment costs ($75,000 in the US, €20,000 in the EU).

• An equity facility provides up to NOK 50 million over 24 months, extendable to NOK 80 million over 36 months, offering financial flexibility and control over drawdowns.

• The facility is structured as an equity line of credit with market-based pricing, no obligation to use the full amount, and additional funding options will be considered as needed.

Partnership, Execution, and Operational Outlook

• The company aims to generate strong proof-of-concept data to attract global pharma partners by 2027, rather than commercializing the product alone.

• All current resources are focused on the CF proof-of-concept study, with future expansion into other indications dependent on results and partner interest.

• The European Defence Fund project remains on track, with synergies between civilian and defense applications of the technology.

• The equity facility ensures operational continuity through 2027, with dilution managed through market-based issuance and potential alternative funding.

• Regular investor updates will be provided as key milestones are reached, rather than on a fixed quarterly schedule.