On 13 November, the application to start a phase II trial was submitted to the Swedish medical authority. The intention is to start the trial in Q1 2024 and to complete the study within one year. This is a slight delay compared to the original plans, but the company has a decent cash position and several funding possibilities (including the warrants TO2 and TO3), which should not be a problem. However, this has an effect on our valuation model as we now have to assume the drug reaches the market slightly later.

Yesterday, Lipigon reported new biomarker data, a 29% reduction in ANGPTL-4 which was statistically significant (previously 24%); a tendency for a treatment effect for the higher doses was also seen, which is positive for the upcoming phase II study. In October, Lipisense obtained a patent in the US for the treatment of cardiometabolic diseases, including dyslipidemia, valid until 20239. This is important for future business development. During the quarter, the competitor Ionis presented strong phase III data in familial familial chylomicronemia syndrome, which we discuss below.

Due to the slight delay, we push the development time of Lipisense forward by one year (we cannot add just half a year in our model), which has an impact due to discounting; we also make some minor changes. We increase the WACC by 0.5% and the USD/SEK to 10.5. This results in a base case of SEK2.5 (SEK2.9).