New Risk • Jun 05
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: kr844.0m (US$89.1m) This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 23% per year over the past 5 years. Revenue is less than US$1m (kr2.5m revenue, or US$260k). Minor Risks Share price has been volatile over the past 3 months (12% average weekly change). Shareholders have been diluted in the past year (28% increase in shares outstanding). Market cap is less than US$100m (kr844.0m market cap, or US$89.1m). Announcement • Jun 05
Xspray Pharma Receives Complete Response Letter From FDA For Nilopki Xspray Pharma has announced that the FDA is currently unable to approve the New Drug Application for Nilopki. Xspray Pharma is now analysing the response in detail and intends, together with its partners, to address the agency’s comments as soon as possible. Nilopki is an improved formulation of nilotinib for the treatment of chronic myeloid leukaemia (CML). In a Complete Response Letter (CRL) to Xspray Pharma, the FDA has raised three issues: a requirement for dose correspondence with Tasigna, a request for additional manufacturing data at commercial scale, and GMP observations at the contract manufacturer that need to be addressed. Xspray Pharma’s overall strategy and pipeline remain unchanged. The company has a further product candidate under FDA review, Dasynoc, an improved formulation of dasatinib for the treatment of CML and ALL, with a PDUFA date of 25 August 2026. Flerie’s holding in Xspray Pharma amounts to 17%. Chronic myeloid leukemia (CML) is a blood cancer that is a chronic, manageable disease thanks to tyrosine kinase inhibitors (TKIs). An estimated 300,000 people are living with CML in Europe and the United States, and globally the prevalence is estimated to potentially reach up to 10 million. Despite the efficacy of existing TKI therapies, challenges around tolerability and adherence remain, creating a significant market opportunity for improved formulations with lower development risk and shorter time to market. New Risk • May 12
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 28% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 23% per year over the past 5 years. Revenue is less than US$1m (kr2.5m revenue, or US$266k). Minor Risks Share price has been volatile over the past 3 months (9.4% average weekly change). Shareholders have been diluted in the past year (28% increase in shares outstanding). 
