Softox Solutions

Analyst Group initiates coverage today, the 23rd of September 2026, of SoftOx Solutions AS (”SoftOx” or ”the Company”), which includes an equity research report with quarterly updates as well as analyst comments on press releases.

About SoftOx

SoftOx Solutions AS is a Norwegian clinical-stage pharmaceutical company developing SoftOx Inhalation Solution (”SIS”), an inhaled, non-antibiotic anti-infective for chronic airway infection. SIS is built on the Company’s platform for stabilizing hypochlorous acid, an oxidizing molecule produced by the body’s own neutrophils as part of the innate immune response, and is delivered by nebulizer directly into the lungs together with acetic acid. The acetic acid acts as a stabilizer. while hypochlorous acid oxidizes multiple microbial components simultaneously, including membranes, proteins, lipids and enzymes. The mechanism depends neither on a single molecular target nor on the bacteria being metabolically active, two conditions that limit the effect of conventional inhaled antibiotics within biofilm. Preclinical studies have shown activity against bacteria, viruses, fungi and biofilms, with no evidence that SIS contributes to antimicrobial resistance, and local delivery enables high concentrations in the lungs with low systemic exposure.

The lead indication is cystic fibrosis (”CF”), where the Phase IIa study SIS-03 is ongoing at Rigshospitalet in Copenhagen with readout expected during H1-27, while non-CF bronchiectasis (”NCFB”) constitutes the principal expansion opportunity. A second clinical programme, SIS-02, applies the same technology as a medical countermeasure against biological threats and is funded through the European Defence Fund and the Norwegian Ministry of Defence.

SoftOx’s business model is to advance SIS through clinical proof of concept and thereafter out-license the asset to a partner for later-stage development and commercialization, while retaining the option to advance the programme independently.

The Company is led by CEO and Chief Scientific Officer Thomas Bjarnsholt, professor at the Costerton Biofilm Center at the University of Copenhagen and among the most cited researchers globally within biofilm science, with Ulrik Spork as Chairman.

Analyst Group View on SoftOx

Analyst Group considers SoftOx to address a treatment gap that current therapy has yet not closed. In CF, CFTR modulators have transformed treatment but do not eliminate bacteria already established within the airways, and chronic inhaled antibiotics remain the standard of care, with approximately 12,400 patients across the US and EU4+UK receiving such treatment, corresponding to a market of approximately USD 600m. Within NCFB, an addressable market of approximately USD 5bn, the first therapy approved specifically for the indication reached the market in August 2025 and has been guided to USD 1.25bn – 1.4bn in revenue in its first full year, validating the commercial opportunity. The approved therapy addresses inflammation rather than infection, and no antimicrobial therapy has been approved specifically for NCFB in the US or Europe. SIS thereby targets the bacterial component of both diseases, in markets where reimbursement at specialty pricing is already established.

In our view, the combination of a non-antibiotic mechanism with broad antimicrobial activity, local delivery to the site of infection and a safety profile established across two studies positions SoftOx well ahead of the proof-of-concept readout during H1-27, and Analyst Group expects partnering discussions to advance following the readout. Beyond CF and NCFB, the mechanism is also relevant in acute respiratory infections such as hospital-acquired and ventilator-associated pneumonia, while the externally funded biodefense programme adds human clinical data and illustrates the breadth of the platform.

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SoftOx published its interim report for the first half of 2026 on the 23rd of September 2026. The following are key points we have chosen to highlight in connection with the report:

• Dose escalation completed without serious adverse events and first patient dosed in the proof-of-concept phase, with readout expected during H1-27
• SIS-02 entered clinical execution with the first participant dosed in June 2026, externally funded through the European Defence Fund and the Norwegian Ministry of Defence
• Operating expenses of NOK 19.5m (9.5) reflect two clinical programmes running in parallel, with approximately 70% directed toward R&D
• Cash of NOK 21.4m and a flexible financing facility, estimated to fund the Company into the H1-27 readout

SIS-03 Has Moved from Healthy Volunteers into Patients

The dose escalation part of the Phase IIa study SIS-03 was completed in June 2026 with all planned dose levels evaluated. The topline safety review reported no serious adverse events, no severe tolerability issues and no impact on lung function or oxygenation, which follows a first-in-human study in which adverse events occurred in 27.9% of participants receiving SIS against 21.4% receiving placebo, all of which were mild. SIS has thereby established a safety and tolerability profile across two studies in healthy volunteers before entering patients. The patient proof-of-concept phase began in August 2026 at Rigshospitalet in Copenhagen and is planned to enroll 15 to 25  patients with chronic airway infection, with reduction in bacterial load in expectorated sputum as the primary endpoint. The study is conducted through the Copenhagen Cystic Fibrosis Center, one of the largest CF centres in Europe with more than 300 patients under care and an established collaboration with the Danish CF registry, which Analyst Group considers a material advantage for recruitment in a rare disease. Readout is expected during H1-27.

Analyst Group regards the readout as the most important near-term value driver for SoftOx. A consistent reduction in bacterial burden would establish that the activity observed preclinically translates into infected human airways and would, in our view, constitute the central element in partnering discussions. Since bacterial load is measured directly and objectively rather than through symptom-based scales, the outcome is less open to interpretation than in many proof-of-concept studies and directly readable by a prospective partner. Additional GMP drug product was manufactured during the period and clinical supply for the study has been secured, which means that manufacturing, one of the elements a licensee evaluates alongside clinical data, is already in place.

SIS-02 Broadens the Human Dataset Without Shareholder Capital

In parallel, the Phase I study SIS-02 within biological preparedness entered clinical execution, with the first participant dosed at the University of Galway in June 2026 following approval by the Irish Health Products Regulatory Authority. The study evaluates safety, tolerability and pulmonary exposure in healthy volunteers and is conducted within the EDF COUNTERACT consortium together with the Norwegian Defence Research Establishment, with readout expected during H1-27. We view the programme as a complement to the two chronic respiratory indications that is expected to strengthen the human clinical evidence base for SIS without drawing on shareholder capital, while positioning SIS within a field where governments are prioritizing medical countermeasures against biological threats.

Cost Base Reflects Two Studies in Execution

Operating revenue amounted to NOK 5.8m (7.5) and consists of project funding from the European Defence Fund, recognized as project costs are incurred. Total operating expenses amounted to NOK 19.5m (9.5) during the first half, of which NOK 10.4m (7.6) in the second quarter. The comparison with the corresponding period is affected by a low base in Q1-25, when other operating expenses were reported at NOK -0.3m, and relative to H2-25 operating expenses increased by approximately 12%. The increase is driven by other operating expenses of NOK 15.2m (4.7), attributable to execution of SIS-03 and SIS-02, while personnel expenses decreased to NOK 2.5m (3.2). That personnel costs fall while two clinical programmes run in parallel illustrates the operating model, where a small internal organization executes through contract research organizations, contract manufacturers and academic collaborations. Approximately 70% of operating costs were directed toward R&D. Given that dose escalation in SIS-03 was completed, SIS-02 initiated and additional GMP drug product manufactured during the period, Analyst Group considers the cost development consistent with the level of clinical activity and the capital allocation to be disciplined. The pre-tax loss amounted to NOK 13.6m (1.4).

Financing Facility Bridges the Company to the Readout

Cash amounted to NOK 21.4m at the end of the period (19.8m at year-end). Cash flow from operating activities amounted to NOK -17.7m, of which NOK -5.9m was attributable to changes in working capital, primarily a reduction in other current liabilities, while net proceeds from equity issues amounted to NOK 20.1m. Funding has been drawn under the financing facility with Long State Investments of up to NOK 80m, entered into in August 2025, under which approximately NOK 30m has been drawn to date. After the period, a direct placement of 54.8m shares at NOK 0.105 added gross proceeds of approximately NOK 5.75m. The Board states that the Company has sufficient flexibility through existing financing arrangements, the facility and the cash position to support planned operations in the near term. Considering the cash position, the July placement and the remaining capacity under the facility, Analyst Group estimates that SoftOx is funded through the patient phase and into the H1-27 readout. We consider the facility a flexible instrument in that it allows the Company to draw capital at its own discretion depending on market conditions and is not accompanied by any obligation to draw, which in our view enables SoftOx to enter partnering discussions after the readout with financial flexibility intact.

Summary

In summary, Analyst Group considers the first half of 2026 to mark SoftOx’s transition from clinical preparation into execution, with dose escalation in SIS-03 completed without serious adverse events, SIS-02 initiated through external funding and, after the period, the first patient dosed in the proof-of-concept phase. The cost base reflects the higher level of clinical activity while the internal organization remains lean, and the financing facility together with the July placement is estimated to carry the Company to the proof-of-concept readout expected during H1-27. SIS addresses the bacterial component of chronic airway infection that neither CFTR modulators in CF nor the first approved therapy in NCFB resolve, in markets where willingness to pay is established, and positive proof-of-concept data would in our view form the basis for partnering discussions during 2027. With a differentiated, broad-spectrum mechanism, an established safety profile, two clinical readouts during H1-27 and a platform with potential beyond the two lead indications, Analyst Group assesses that SoftOx offers an attractive risk/reward profile ahead of the upcoming value inflection points.

Analyst Group will return with an equity research report on SoftOx.