Abliva - KL1333 ready for pivotal Phase II/III trial

Just a few months in, Abliva’s new CEO has already spearheaded a successful private placement (SEK80m gross in March 2021), which will now support the preparations for the pivotal KL1333 trial in primary mitochondrial diseases (PMDs). The R&D plan is focused on a single randomised, placebo-controlled Phase II/III trial with an adaptive design, which should start in H221. The newly released clinical dataset from the Phase Ia/b study also support such a strategy. The Phase II/III trial is envisioned undergo an interim futility analysis in H222 and the final results should be available by end-2023. Abliva’s second lead asset NV354, a succinate prodrug for complex I disorders, should complete preclinical development this year. Our valuation is SEK1.21bn or SEK3.01 per share.