E-FIT stroke trial results disappoint

Update | 4 September 2018

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Nexstim has reported that the pivotal E-FIT stroke trial did not show a clinically significant difference between active and sham treatment groups. The disappointment is particularly marked as the approach was technically so promising. A positive outcome would have led to the FDA approving Nexstim’s proven proprietary rTMS platform for the rehabilitation of stroke patients. Management intends to focus resources on commercialising the depression indication in the US and Europe. Whilst the strategic options are evaluated we are suspending our forecasts and valuation.

Year-end: December 3120172018E2019E2020E
Sales (€m)2.6---
PBT (€m)(7.4)---
Net Income (€m)(7.3)---
EPS (€)(0.09)---
Cash (€m)8.5---
EBITDA (€m)(5.3)---
Source: Trinity Delta
  • No material difference in stroke indication The top-line results of the E-FIT study showed no statistical difference in clinical improvement between the active and sham groups, with 60% and 50% positive responses respectively (p=0.62). Clearly, combining the results of this 60-patient trial with the existing results from the active arm of the NICHE study, as requested by the FDA for approval, also results in no statistical difference. The results are disappointing as the approach is technically elegant and the NBT platform was particularly well suited to this application.
  • Stroke was a major indication for the NBT platform The efficacy and safety of the NBT platform has been validated by its FDA approval in pre-surgery brain mapping and its therapeutic use in Major Depressive Disease (MDD). The US MMD launch took place in May and commercialisation is progressing well, with the system’s ability to navigate precisely, reliably, and reproducibly achieving clear differentiation from other technologies. However, we viewed the FDA approval for stroke as a key inflection point that could, in our view, transform Nexstim’s outlook.
  • Focus shifts to commercialising MDD indication Management intends to maximise the commercial opportunity of the depression indication, a sizeable market in both the US and Europe (detailed in our Initiation note in June 2018). Nexstim had cash of €10.3m in June, which we estimate is sufficient for c 12 months at current burn rates. The trial failure means funding requirements are lower (the majority of the expected fund raise was directed to exploiting the stroke indication) but we believe additional funding is still needed to achieve these more modest near-term goals.
  • There is still inherent value present Nexstim’s rTMS platform has demonstrated its worth in several indications but today’s set back impacts Nexstim’s valuation materially. Until there is greater visibility on the possible strategic options, and their funding needs, we have to suspend our forecasts and valuation.


4 September 2018

Market Cap€6.4m
Enterprise Value€3.6m
Shares in issue97.5m
12 month range€0.05-0.40
Free float85.8%
Primary exchangeHelsinki
Other exchangesStockholm
Company CodesNXTMH/NXTMS
Corporate clientYes

Company description

Nexstim has developed a proprietary navigated rTMS platform that is used in planning brain surgery (NBS) and has therapeutic uses (NBT) in stroke, depression, and chronic pain. FDA approval for depression was given in 2017; the stroke indication has suffered from disappointing results in the pivotal E-FIT Phase III study.


Mick Cooper PhD
+44 (0) 20 3637 5042

Lala Gregorek
+44 20 3637 5041


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