NeuroVive’s core R&D assets in genetic mitochondrial diseases have made steady progress over the past several months. Notable newsflow includes KL1333 proceeding to the second part of its study and NeuroSTAT receiving the FDA’s fast track designation. Potential near-term milestones include initial results from KL1333 Phase Ia/b, a non-dilutive financing solution to enable the start of the NeuroSTAT Phase II clinical trial and an out-licensing of NV556. Our updated valuation is slightly higher at SEK1.63bn or SEK8.8/share.
In July 2019, NeuroVive announced it had initiated the second part of the Phase Ia/b study ongoing in the UK with KL1333 in genetic mitochondrial diseases such as MELAS, PEO, KSS and Pearson’s syndrome. Healthy volunteers in this study will now receive repeated doses of KL1333. This followed the successful completion of the first part of the study, where healthy volunteers received single doses of KL1333 and the effect of food intake on the drug’s absorption was measured. Healthy volunteer safety data should be released later this year.
With its Q219 report, NeuroVive described progress with its other two projects in the core R&D portfolio. NV354, a succinate prodrug targeting complex I deficiency, should enter clinical development in 2020. NeuroVive expects to select a drug candidate from its earliest mitochondrial disease programme, NVP025, targeting mitochondrial myopathies.
Another significant recent announcement was that NeuroSTAT has received fast track designation from the FDA. This designation has benefits such as more frequent meetings and communication with the FDA, continuous feedback on the New Drug Application and the possibility of a shorter review period than the typical 10 months. This designation was received after the FDA approved the Investigational New Drug application for NeuroSTAT in May 2019.
Our updated, risk-adjusted NPV valuation of NeuroVive has increased slightly to SEK1.58bn or SEK8.5/share due to rolling our model forward and a positive foreign exchange rate effect, which was partially offset by a lower net cash position. We leave our financial forecasts and R&D assumptions virtually unchanged. On 9 October 2019, NeuroVive will host a capital markets day in Stockholm.