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NeuroVive Pharmaceutical

Licensing deal and R&D pipeline progress

Outlook | Pharmaceutical & healthcare | 05 Oct 2018

On 18 June 2018, NeuroVive announced that it had out-licensed a subset of compounds from its NVP015 programme (succinate prodrugs) to BridgeBio, a private biotech based in California, targeting Leber’s Hereditary Optic Neuropathy (LHON) under new subsidiary Fortify Therapeutics. The upfront payment was limited, but the total deal value could reach $60m. NeuroVive is about to initiate a Phase Ib trial with the second lead drug candidate, KL1333 (NAD+ modulator), while both the EMA and FDA have provided positive views on the lead NeuroSTAT Phase IIb programme (TBI). We value NeuroVive at SEK1.64bn or SEK17.9/share.

NeuroVive Pharmaceutical

KL1333 Ph I positive; rights issue oversubscribed

Update | Pharmaceutical & healthcare | 04 Jun 2018

On 27 April 2018, NeuroVive announced that the planned rights issue was oversubscribed (104%), delivering SEK78.5m in gross proceeds and funding the operations into 2019. The fundraise allows NeuroVive to focus on the initiation of the NeuroSTAT (traumatic brain injury) Phase IIb trial (H218/H119) and the Phase Ib KL1333 (genetic mitochondrial diseases) trial in Europe (H218). The latter project was bolstered by the recent news from the South Korean partner, Yungjin Pharm, which reported a positive outcome in its own locally run Phase I trial with KL1333. Our updated valuation is SEK1.62bn or SEK17.7/share (SEK18.0/share previously).

NeuroVive Pharmaceutical

Bitesize briefing - NeuroVive Pharmaceutical

Edison TV: | Pharmaceutical & healthcare | 24 Apr 2018

Mitochondrial disease is an umbrella term that includes a diverse set of conditions where the function of the mitochondria is failing. The diversity of the clinical presentation, low incidence rates and high unmet need make this an interesting area for specialist orphan drug developers. Here, healthcare analyst Dr Jonas Peciulis presents an overview of mitochondrial medicine, the competitive landscape in drug development and discusses one of the companies covered by Edison, specialising in the field, NeuroVive Pharmaceutical.

NeuroVive Pharmaceutical

Rights issue to reach several R&D events

Update | Pharmaceutical & healthcare | 05 Mar 2018

NeuroVive's planned rights issue (subject to approval at the EGM) is expected to bring in a minimum guaranteed amount of at least SEK55m (gross), which would extend the cash reach to 2019 and past several R&D events. Namely, the company will be able to initiate two new clinical trials with both leading assets KL1333 (Phase I) for genetic mitochondrial diseases and NeuroSTAT (Phase II) for traumatic brain injury (TBI). In addition, the company will advance its broad preclinical portfolio, aiming to out-license one of the assets, NV556, for NASH. Our updated valuation is SEK1.44bn or SEK18.0/share compared to SEK1.38bn or SEK26.3/share previously.

NeuroVive Pharmaceutical

Two new trials and likely out-licensing in 2018

Update | Pharmaceutical & healthcare | 14 Dec 2017

NeuroVive has made progress on multiple fronts over the past few months with both its core asset portfolio and non-core projects for out-licensing. Notable developments in the core portfolio include positive feedback from the EMA on the next Phase IIb trial with NeuroSTAT (traumatic brain injury, TBI) and orphan drug designation for KL1333 (genetic mitochondrial diseases) in Europe. Also, the lead compound has been selected in the NVP015 programme for genetic mitochondrial diseases with complex I dysfunction. In addition, investors had a first glimpse of the preclinical data on NVP022, which, together with NV556, targets NASH and both are in portfolio for out-licensing. Our valuation is SEK1.38bn or SEK26.3/share (vs SEK27.0/share previously).

NeuroVive Pharmaceutical

R&D progress on track; new investor on board

Update | Pharmaceutical & healthcare | 25 Aug 2017

NeuroVive’s recent Q217 report described R&D activities progressing according to plan. The company is preparing for the next clinical studies with the two most advanced assets – NeuroSTAT for traumatic brain injury and KL1333 for genetic mitochondrial disorders. With regard to the portfolio for out-licensing, NeuroVive indicated that discussions with potential partners for NV556 (NASH and liver tumours) will be initiated in the autumn, although partnering is usually a rather lengthy process. We value NeuroVive at SEK1.4bn (SEK27.0/share) vs SEK1.5bn previously.

NeuroVive Pharmaceutical

Mitochondrial medicine specialist

Initiation | Pharmaceutical & healthcare | 29 Jun 2017

NeuroVive Pharmaceutical is a mitochondrial medicine specialist with a diversified asset portfolio. It employs a two-pronged strategy and has a portfolio of drug candidates for orphan mitochondrial diseases, which it aims to develop internally; more recently, it has also identified in-house assets suitable to tackle larger indications, which NeuroVive aims to out-license in pre-clinical development. The most advanced projects are Phase IIb ready NeuroSTAT for traumatic brain injury and KL1333 in Phase I for various mitochondrial diseases. We value NeuroVive at SEK1.5bn.