Flerie increases its shareholding in Xspray Pharma and comments on FDA feedback on Dasynoc

Flerie has today purchased 111'276 shares in Xspray Pharma for approx. SEK 5.6 million and now owns 17.5 % of the shares in the company.
 
As the largest shareholder in Xspray Pharma, Flerie has carefully followed the recent news from the
company regarding the FDA’s Complete Response Letter (CRL). Whilst the content of the CRL will cause a disappointing delay, Flerie remains firm in the belief that there is significant commercial potential in Xspray and its technology platform. The delayed launch is unfortunate, but we are convinced that the new questions raised can be answered by Xspray in a timely manner as the FDA has not requested additional clinical studies nor queried the submitted stability or clinical data.
 
The future launch of Dasynoc in the US is clearly an important milestone for Xspray and the fee for service commercialisation model that the company has chosen is well suited to achieve this in a cost-effective manner. The company also has a pipeline of promising programs, including XS003 nilotinib, XS008 axitinib and XS015 cabozantinib, which Flerie believes will add great value when fully exploited.
 
Furthermore, Xspray has clearly shown in clinical studies with both dasatinib and nilotinib that their unique technology can be used to develop improved versions of important oncology products. The results presented by Xspray, in a press release on 9th July 2024 on XS003 nilotinib, demonstrate that the company has developed a potentially improved version of Tasigna® which we see as a key step forward.
 
As such, Flerie remains fully committed to Xspray and we are confident that the company will be able to reach the US market with Dasynoc, whilst also further developing the other programs.