Announcement • Jul 01
SciBase Holding AB Submits FDA 510(k) to Expand Nevisense Indication for Non-Melanoma Skin Cancer Assessment SciBase Holding AB submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) seeking to expand the U.S. indication for Nevisense to include the assessment of Non-Melanoma Skin Cancers (keratinocyte skin cancers). Nevisense is currently the only FDA-approved AI-driven technology in dermatology for the assessment and early detection of melanoma. If cleared, the expanded indication would extend the clinical utility of the existing Nevisense platform to include non-melanoma skin cancers, representing a significant expansion of its addressable U.S. market. More than 5,400,000 cases of basal cell carcinoma and squamous cell carcinoma are diagnosed annually in the United States, making keratinocyte skin cancer the most common form of cancer. Delayed diagnosis can lead to, in the case of squamous cell carcinoma, metastatic disease, highlighting the need for objective technologies that support earlier clinical assessment and more informed biopsy decisions. The submitted 510(k) premarket notification seeks to expand Nevisense's indication to include lesions with characteristics of keratinocyte skin cancer. In Europe, Nevisense is already CE marked for use in both melanoma and keratinocyte skin cancer, making the U.S. submission an important milestone in SciBase's strategy to broaden the clinical application of its technology. New Risk • Jun 17
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Swedish stocks, typically moving 9.4% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. 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 (-kr85m free cash flow). Shareholders have been substantially diluted in the past year (202% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (kr5.6m net loss in 3 years). Share price has been volatile over the past 3 months (9.4% average weekly change). Revenue is less than US$5m (kr46m revenue, or US$4.8m). Market cap is less than US$100m (kr433.0m market cap, or US$45.5m). Announcement • Jun 12
SciBase Holding AB Publishes Study Demonstrating Nevisense as Early Biomarker for Atopic Dermatitis SciBase Holding AB announced the publication of a study in the peer-reviewed journal Allergy demonstrating that results from Nevisense measurements obtained shortly after birth identified children who subsequentially developed atopic dermatitis. The study was conducted by researchers at the Icahn School of Medicine at Mount Sinai and assessed neonatal skin barrier integrity using Nevisense within the first days of life. Infants who developed atopic dermatitis during their first year had significantly higher neonatal measurements than those who remained disease-free, suggesting that Nevisense may serve as a non-invasive early biomarker of skin barrier dysfunction associated with future atopic dermatitis risk. Conclusion from the study was “Higher EIS scores, suggestive of impaired skin barrier, within the first week of life were significantly associated with development of AD in the first year of life.” The publication adds to a growing body of evidence supporting Nevisense as a non-invasive technology platform for assessing skin barrier integrity and dysfunction. Together with previous studies, these findings further strengthen the potential role of Nevisense in earlier risk assessment, prevention strategies, disease monitoring, and future therapeutic development in atopic dermatitis and other skin barrier disorders. The authors conclude that reliable, non-invasive technologies for assessing skin barrier integrity remain an important unmet need. Their findings demonstrate the potential of Nevisense to detect early skin barrier dysfunction and identify infants at elevated risk for atopic dermatitis before disease onset. 
