Research, Charts & Company Announcements
Research Tree provides access to ongoing research coverage, media content and regulatory news on NEXSTIM OYJ. We currently have 6 research reports from 1 professional analysts.
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Funded and back on stroke trial track
07 Mar 17
A key uncertainty for Nexstim was removed in December as the FDA confirmed that only one additional stroke rehabilitation trial in 60 patients will be required to seek de novo 510(k) regulatory approval for the NBT system. US approval might be obtained during Q418. Nexstim has used €8.8m from the Bracknor/Sitra funding arrangement and had €8.2m in cash in December. A further €3.2m can be raised from the arrangement. Excluding 30m issued warrants, this could fund Nexstim until late 2018. The NBS system achieved €2.5m in sales in 2016, with modest increases anticipated by Nexstim for 2017; new US distributors have been appointed.
More data please
29 Sep 16
The FDA has told Nexstim it may accept a “limited-sized” further trial plus additional analysis of the Phase III (NICHE) study. While this is positive for Nexstim – the FDA did not reject the application – it delays any approval to at least 2019. The new design is unlikely to be confirmed before H117. In our view, the uncertainty decreases the probability of success from 55% to 50%. Including the likely 2016 dilution, this decreases the indicative value from €0.96/share to €0.58/share. Nexstim should be funded until early 2018 on the current arrangements with Bracknor, but will then require further capital.
Sham surprise shows stroke success
25 Apr 16
The partly unblinded Phase III data, stopped after a futility analysis, show that two-thirds of treated patients showed meaningful clinical improvements, but also that the ‘active’ sham patients had similar responses. Nexstim will unblind the study, giving 138+ patients worth of data in Q2. The company aims to file an FDA de novo 510(k) application in Q316, which might give some US sales from mid-2017 if the FDA agrees. The system can already be sold in the EU. Extra trials to secure reimbursement are likely to be needed and indications such as depression could be developed. Nexstim has cash to last until Q316. The CEO left on 20 April; the chairman is acting as CEO.
NICHE stroke rehab trial fails its primary endpoint
01 Mar 16
The pivotal trial of Nexstim’s Navigated Brain Therapy (NBT) System in treating stroke patients has failed to meet its primary endpoint. We suspend our financial forecasts and valuation while Nexstim reviews its next strategic steps. It estimates its cash reach until Q316.
First hurdle cleared in pivotal trial
01 Oct 15
An independent committee’s interim analysis of the pivotal trial using Nexstim’s Navigated Brain Therapy System in the treatment of hemiplegic stroke patients recommended that it continue. A positive readout of the full trial in Q316 may enable a US launch in late 2017. We expect the NBT System to gradually capture a third of the €1.6bn market opportunity and we continue to value Nexstim at €112m based on a 70% probability of success.
Game-changing stroke treatment
10 Sep 15
Nexstim’s Navigated Brain Therapy System could transform the rehabilitation of hemiplegic stroke patients. Success in the ongoing Phase III trial may enable a US launch in late 2017. We expect the NBT system to gradually capture a third of the €1.6bn market opportunity and value Nexstim at €112m based on a 70% probability of success.
20 Apr 17
Although the last two months have seen a broadly neutral performance from the UK healthcare sector compared to a significantly more volatile 6 months prior, we continue to expect macro-events and increased geo-political risk to result in an overall neutral performance from the sector over the next period. However, company specific news is likely to drive a strong outperformance from selected mid-market companies. We retain our neutral sector stance whilst highlighting those we expect to outperform.
N+1 Singer - Morning Song 24-04-2017
24 Apr 17
First Derivatives (FDP LN) FY slightly ahead as strong trading momentum continues | Goals Soccer Centres (GOAL LN) A potentially exciting corporate development | mporium Group (MPM LN) 2016 results: course set for exciting 2017 | Vectura Group (VEC LN) VR315 risk outweighs longer-term potential
Positive top-line results in first iclaprim phase III clinical trial (REVIVE-1)
18 Apr 17
Motif Bio (LSE: MTFB, NASDAQ: MTFB), a late clinical stage antibiotic development company, announced positive results this morning in the first of its two iclaprim phase III clinical trials, REVIVE-1, comparing iclaprim to vancomycin in the treatment of acute bacterial skin and skin structure infections (ABSSSI). Iclaprim, a next-generation antibiotic targeting an underutilised mechanism of action which causes rapid killing of bacteria, is being developed for the treatment of serious and life threatening bacterial infections. On the key primary endpoint in the study, early clinical response at 48-72 hours after drug treatment began, 80.9% of patients on iclaprim achieved a positive response compared to 81.0% of patients on vancomycin, well within the 10% non-inferiority margin required by the FDA. Iclaprim was also shown to be safe and well-tolerated compared to vancomycin. With these positive results from REVIVE-1 we have increased the probability of success for the iclaprim development program from 65% to 75% raising our risk-adjusted NPV for Motif Bio to almost £240m or 122p per share (previously £210m and 107p per share).
N+1 Singer - Sinclair Pharma - EBITDA upgrade for 2017, but lower TP due to warranty claim and costs
19 Apr 17
We have updated product-level forecasts and included the £10m SVB debt facility and £5m warranty claim settlement with Alliance Pharma in our forecasts. The 6.3% upgrade to our FY2017 sales estimate (from £46.0m to £48.9m) brings expected EBITDA profitability forward by one year (to FY2017 from FY2018). We remain positive on the ongoing rollout of Silhouette Instalift® in particular and retain our Buy recommendation. However, higher expected sales & marketing costs and the warranty claim weigh on our valuation: we downgrade our target price from 42p to 37p.
24 Apr 17
Lok’nStore* (LOK): Growth supported by a strong balance sheet (CORP) | Mortice* (MORT): UK acquisition (CORP) | Avacta* (AVCT): Another milestone – 1st non-therapeutics licence (CORP) | Petra Diamonds (PDF): Trading update and Q3 results (BUY) | Nasstar* (NASA): Growth and margin focus (CORP)