Announcement • Jun 05
SoftOx Solutions AS Enrolls First Participant In SIS-02 Phase 1 Clinical Study SoftOx Solutions AS announced that the first participant has been enrolled in the SIS-02 Phase 1 clinical study in Ireland. The enrollment follows the previously announced approval of the SIS-02 clinical trial application by Ireland’s Health Products Regulatory Authority (HPRA) and marks the formal initiation of the study. The SIS-02 Phase 1 study is designed to evaluate the safety, tolerability, and pulmonary exposure profile of SoftOx Inhalation Solution (“SIS”) following inhaled administration in healthy volunteers and supports the continued development of SIS for defence and biological countermeasure applications. The initiation of SIS-2 represents an important operational milestone for SoftOx and expands the Company’s clinical trial pipeline from one to two ongoing clinical studies. SIS-02 is separate from, and independent of, the Company’s SIS-03 study in chronic lung infections in patients, including cystic fibrosis. Together, the two SIS programs support SoftOx’s strategy to develop SIS as an inhaled anti-infective therapy with potential relevance in both civilian healthcare and defence-related biological preparedness. The SIS-02 program is formally conducted through SoftOx’s wholly owned subsidiary, SoftOx Defense Solutions AS, and is grant-funded through SoftOx’s participation in the COUNTERACT Consortium, which is funded by the European Defence Fund and includes universities, public research institutes, and companies across Europe. The program is also supported by the Norwegian Ministry of Defence. The SIS-02 study is intended to add to the clinical evidence base for SIS and support the planning of subsequent development activities. SoftOx will provide further updates on SIS-02 as the study progresses and when relevant data reviews have been completed. SoftOx Solutions AS is developing SIS, a novel inhaled anti-infective therapy for respiratory infections in the airways and lungs. Delivered by nebulizer, SIS is being developed to address bacterial, viral, and fungal pathogens through local delivery directly at the site of infection, without systemic exposure to the remainder of the human body. Its broad pathogen relevance positions SIS as a distinct therapeutic in respiratory infections. New Risk • Mar 26
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -kr19m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr19m free cash flow). Share price has been highly volatile over the past 3 months (21% average weekly change). Minor Risks Revenue is less than US$5m (kr16m revenue, or US$1.6m). Market cap is less than US$100m (kr174.4m market cap, or US$18.1m). 
