In February, the Swedish Medical Authority approved Lipigon’s phase IIa application. 26 patients (of which 13 in the placebo group) will be recruited in 3-4 centres, the plan being to have the first patient treated in March and the last patient treated by H2 2024. Patients will have more than 5mmol/l of triglycerides (which is almost 500 mg/dL) and 5-10 higher levels of ANGPTL4 than normal. While this is, first and foremost, a safety study in patients (phase I was in healthy volunteers), several efficacy measures will also be investigated, including triglycerides, remnant cholesterol and glucose levels. This is essential to position Lipisense in the cardio-metabolic space, where a drug should show more than just triglyceride lowering to have a good chance of reaching the market. This is a cost-effective trial since Lipisense material from phase I can be used resulting in a cost for the trial similar to the proceeds from the rights issue in 2023 (cSEK23m). Lipigon is also preparing the phase I report which should be available in H1 2024.

In February, Combigene terminated its licensing agreement for the lipodystrophy project (P2). We remove it from our valuation, but its value was negligible compared to Lipisense, being in a very early stage, so it does not impact our valuation of the Lipigon share. P3, the LPL project in dyslipidaemia, is continuing with the goal of having a stop/go decision by the summer of 2024. Management thinks this project could be out-licensed at an early stage, even before preclinical development. P4, targeting ANGPTLA4 in lung conditions (ARDS), is also active; Lipigon could find a lead candidate this year. It is discussing a further potential collaboration in the US.

Lipigon received cSEK13m net from TO2 in December, with a 91% subscription rate, and is thus comparatively well-funded with a cash position of SEK32m. A further milestone payment should be due when Leaderna initiates phase I. Further proceeds should be obtained from TO3 in May-June. We maintain our fully diluted base case of SEK2.5.