Helsinki, 29 February 2016 at 2:00 PM
Company Highlights, July – December 2015
NBS revenues increased by 4.9% to EUR 1.9 million (2014: EUR 1.8 million)
Phase III multi-centre trial in the US for stroke therapy receives positive first interim analysis in September 2015
Key US technology patent granted adding further global protection of unique E-field navigation
Company completed a EUR 5.3 million private placement
Appointment of Martin Jamieson as Chairman of the Board of Directors
Post period end highlight
The DSMB second interim analysis of Phase III Stroke Therapy Trial concluded that trial will not meet its primary endpoint
No safety concerns were observed
Status of clinical development
The Company has been building clinical evidence by conducting a clinical Phase III multi-centre clinical trial to demonstrate the effectiveness of Nexstim’s Navigated Brain Therapy NBT® System in post-acute stroke therapy. In September 2015 Nexstim received a positive recommendation from the Data Safety Monitoring Board (DSMB), an independent committee of experts monitoring the trial, to continue the Phase III stroke therapy trial without any modifications towards the goal of achieving its primary endpoint. This first interim analysis was performed after 81 patients reached their primary safety outcome assessment, on track, at six months post-treatment. The clinical trial was fully enrolled in December 2015, ahead of schedule.
The second interim analysis on the Phase III stroke therapy trial using Nexstim’s Navigated Brain Therapy (NBT®) was performed for 138 patients as well as safety data was reviewed for all 199 patients recruited to-date. No safety concerns were observed. On 28 February 2016 the company announced that it had received the second set of interim analysis information from the DSMB that the study’s pre-specified stopping criteria for futility had been met and the trial would not meet its primary endpoint. The DSMB recommended that the study team and subjects remain blinded and data collection be completed. Nexstim will analyse the DSMB recommendation further before deciding upon the continuation of the Phase III trial. With treatment on all patients now complete the next phase of the trial would be to receive results from the third and final cohort’s six month follow-up assessment.
CEO Janne Huhtala’s review
Our validated technology and software continues to gain international recognition from both industry and the medical community.
Nexstim has been selling its diagnostic NBS (Navigated Brain Stimulation) system to strategic customers in neurosurgery such as teaching hospitals and universities that have a strong Key Opinion Leader presence. The NBS system is the first and only FDA-cleared and CE-marked navigated Transcranial Magnetic Stimulation (nTMS) device for pre-surgical mapping of the motor and speech cortices. Nexstim has been using a capital equipment investment sales model. Clinical research from these important centres continues to be published by affiliates in high quality journals internationally, commending the benefits of NBS mapping in neurosurgery and neurosurgical planning, and demonstrating the value of NBS in neurosurgery outcomes and workflows, supporting the wider adoption of Nexstim’s technology and software.
Revenues in the second half of the year increased by 4.9% to EUR 1.9 million compared to the equivalent period in 2014 (EUR 1.8 million). Sales of NBS systems in the US was lower than expected, causing a consequential lumpiness in revenue expectations. We estimate that the sales pipeline will remain strong and expect NBS sales growth in the full financial year of 2016.
Following a successful private placement amounting to a total subscription of EUR 5.3 million, Nexstim ended 2015 with a cash position of EUR 6.9 million. The current cash and cash generated from sales is estimated to be sufficient to finance the Company’s existing clinical development trials until the final results in September 2016.
Having now received the DSMB’s recommendation on the second interim analysis of the Phase III trial, Nexstim is conducting a review of the future strategy for NBT® as part of the company’s wider strategy and an update announcement will be made in due course.
Nexstim was pleased to announce the appointment of Martin Jamieson as Chairman of the Board of Directors, at the Extraordinary General Meeting, adding strength to the Board and aligning it to Nexstim’s international growth strategy.
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*The number of Shares and subscription price have been adjusted to take account the effect of the merging of the share classes and share split on 29 September 2014, where the number of Shares was increased 14-fold
Based on its business forecast the Company estimates its net sales to grow during financial year 2016 and a loss is expected for the financial year.
Nexstim will now conduct a review of the future strategy for NBT® as part of the company’s wider strategy and an update announcement will be made in due course. The Company estimates that more detailed information related to its long-term financial and commercial goals will be given as part of the update.
Board of Directors’ Proposal on the Dividend
During its existence the Company's operations have been unprofitable and no dividend has been distributed. In the forthcoming years, the Company will focus on financing the growth and the development of its business and the Company will adhere to a very stringent dividend policy, tied to the Company's results and financial standing. The Company does not expect to be able to distribute dividends in the near future. Further, the Company has reduced its share capital for loss coverage on 29 September 2014. Therefore, pursuant to the Finnish Companies Act, all distributions of unrestricted equity to the shareholders by the Company are subject to a three months' public summons to the creditors until 3 October 2017. In the event dividends are distributed, all Shares entitle to equal dividends
At the end of the financial period of 2015, the distributable assets of the group’s parent company were EUR 12,148, 284.77. The Board of Directors proposes that Nexstim Plc should not pay any dividend for the financial period of 2015.
Helsinki 29 February 2016
Board of Directors
Janne Huhtala, Chief Executive Officer
+358 40 8615046
UB Securities Ltd (Certified Adviser)
+358 9 2538 0246
Consilium Strategic Communications
Mary-Jane Elliott / Ivar Milligan / Laura Thornton
+44 (0)20 3709 5700
Half-Yearly Report January-June 2016 (H1) will be published on Wednesday, August 17, 2016.
Nexstim Annual Report 2015 (Report of the Board of Directors, the Financial Statements and Consolidated Financial Statements and the Auditor's Report) will be published on company web pages on Wednesday, March 9, 2016.
The Annual General Meeting will be held on Thursday, March 31, 2016 beginning at 12:00 noon.
About Nexstim Plc
Nexstim is a medical technology company aiming to improve rehabilitation for stroke patients. Nexstim has pioneered its technology in brain diagnostics with the Navigated Brain Stimulation (NBS) system as the first and only FDA-cleared and CE-marked navigated Transcranial Magnetic Stimulation (nTMS) device for pre-surgical mapping of the motor and speech cortices. Based on the same technology platform, the company has developed a device for stroke therapy called Navigated Brain Therapy (NBT®). In H1 2014, Nexstim initiated a two-year pivotal Phase III study at 12 sites in the US aiming to demonstrate the effectiveness of NBT® and gain FDA clearance for commercialisation in post-acute stroke therapy in the US. Nexstim's shares are listed on Nasdaq First North Finland and Nasdaq First North Sweden. For more information please visit www.nexstim.com.