Company Announcement, Helsinki, 23 December 2025 at 9 AM (EET)
Inside information: Nexstim Plc Agrees on Next Phase of Exclusivity Agreement with Sinaptica Therapeutics, Inc.
Nexstim Plc ("Nexstim" or "Company") announces that it is moving into the next phase of its exclusivity agreement ("Exclusivity agreement") with Sinaptica Therapeutics, Inc. ("Sinaptica") regarding their planned collaboration in the field of Alzheimer's disease. Nexstim previously announced having signed the Exclusivity agreement on 30 June 2025.
The agreement reached now will complete payment obligations by Sinaptica contemplated under the Exclusivity agreement, allowing Sinaptica and Nexstim to move the partnership forward in 2026. The term of exclusivity extending past 2026 is subject to the definitive agreement ("Definitive agreement"), planned to be completed and signed before the end of the year 2026.
As background, on 7 June 2024, Nexstim announced having signed a non-binding Letter of Intent ("LOI") with Sinaptica regarding the development, manufacturing, and supply of Sinaptica's patented precision neuromodulation system custom-built upon the Nexstim NBS 6 system with its advanced TMS-EEG and precision neuronavigation capabilities, integrated with Sinaptica's proprietary MAINTAIN cloud-based personalization engine, for the treatment of Alzheimer's Disease and MCI (mild cognitive impairment).
As part of the current agreements in place with Nexstim, Sinaptica commits to ordering future research systems needed for their clinical trials from Nexstim, and Nexstim will not proceed to commercialize its technology in the field of Alzheimer's treatment alone or with partners other than Sinaptica. As announced on 30 June 2025, the exclusivity agreed was conditional on payments of EUR 1.5 million to Nexstim. The partners have now agreed that Nexstim will accept EUR 0.5 million in cash and EUR 1 million in the form of convertible debt to satisfy these obligations. Nexstim has already received EUR 0.2 million signing fee in cash, recognized as revenue in H1 2025, and will receive another EUR 0.3 million cash due now upon signing. Nexstim estimates a further positive cash impact of EUR 0.3 million and an earnings impact of EUR 0.1 million in H2 2025. The exclusivity fee will be recognized over time.
The planned partnership would be a worldwide, 10-year exclusive arrangement. The financial structure of the collaboration consists of an upfront Exclusivity agreement signing fee, a milestone-based development project, and clinical & commercial system sales. The milestone-based development project and clinical system sales are defined in more detail in the Definitive agreements subject to changes during the negotiations. The long-term exclusive arrangement depends on the signing of the Definitive agreements before the end of 2026.
Ken Mariash, CEO of Sinaptica, comments: "This fulfilment of Sinaptica's exclusivity payments and expansion of our partnership with Nexstim reflects the strong progress of our collaboration and our shared confidence in the long-term potential of our novel neuromodulation approach in Alzheimer's disease. We believe this is a positive forward step in aligning both organizations as we work towards building a scalable solution based on our very promising phase 2 trial results."
Mikko Karvinen, CEO of Nexstim, comments: "We have worked closely with the Sinaptica team this year and have been successful in delivering the first research systems to them. At Nexstim, we're committed to collaborating with Sinaptica and supporting them with research system validation and deliveries on their way to new clinical trials. With the investment announced we strengthen our strategic collaboration with Sinaptica. Our expectations for the collaboration have remained positive, and we will continue our active work towards the partnership."
Further information is available on the website www.nexstim.com, or by contacting:
Mikko Karvinen, CEO
+358 50 326 4101
mikko.karvinen@nexstim.com
The Company's Certified Adviser is DNB Carnegie Investment Bank AB.
About the SinaptiStim® System
The SinaptiStim® System is an investigational new approach to treating Alzheimer's disease using non-invasive personalized precision neuromodulation. Calibrated to each individual's brain, the therapy is delivered in weekly 20-minute sessions in a recliner. The SinaptiStim system delivers safe, painless, customized neurostimulation technology targeting the Default Mode Network (DMN), an important brain network associated with episodic memory, introspection, and other cognitive functions. The technology was granted Breakthrough Device Designation by the FDA in 2022.
The company is preparing for a pivotal randomized controlled clinical trial in mild-to-moderate Alzheimer's, based on validated global measures of dementia encompassing cognition and function. In this trial, the treatment will be calibrated quarterly using TMS and EEG concurrently in combination with MRI-guided neuronavigation, which enables the SinaptiStim System to achieve customized precise repeatable targeting and safe-yet-effective dosage for each patient, tracking progress and adjusting over time to achieve the best possible individualized outcomes with its nDMN therapy. The pivotal trial will also be designed to determine the effects of SinaptiStim® System on several biomarkers measuring beta amyloid, phosphorylated tau, neuroinflammation, and synaptic dysfunction.
About Sinaptica Therapeutics
Sinaptica Therapeutics is a clinical-stage neuromodulation therapeutics company leading the development of a new class of novel personalized therapeutics to revolutionize the treatment of Alzheimer's and other primary neurodegenerative diseases. The company utilizes a patented non-invasive approach to treating Alzheimer's via precision neurostimulation of a key brain network involved in memory, the Default Mode Network. Sinaptica's scientific co-founders pioneered research on this novel approach which a growing body of evidence indicates can slow disease progression. Sinaptica's mission is to bring a safe, effective, and non-invasive neuromodulation therapy to Alzheimer's patients that can help to significantly slow the progression of cognitive, functional, and behavioral decline. Learn more at sinapticatx.com and follow us on LinkedIn and X @SinapticaTX.
The SinaptiStim® System is for investigational use only. It has not been approved by the U.S. Food and Drug Administration and is not available for commercial sale in any geography.
About Nexstim Plc
Nexstim is a Finnish, globally operating growth-oriented medical technology company. Our mission is to enable personalized and effective diagnostics and therapies for challenging brain diseases and disorders.
Nexstim has developed a world-leading non-invasive brain stimulation technology for navigated transcranial magnetic stimulation (nTMS) with highly sophisticated 3D navigation providing accurate and personalized targeting of the TMS to the specific area of the brain.
Nexstim's Diagnostics Business focuses on commercialization of the NBS System 6, which is the only FDA-cleared and CE-marked navigated TMS system for pre-surgical mapping of the speech and motor cortices of the brain.
Nexstim's Therapy Business markets and sells the NBS System 6 which is FDA-cleared for marketing and commercial distribution for the treatment of major depressive disorder (MDD) in the United States. In Europe, the NBS 6 system is CE-marked for the treatment of major depression and chronic neuropathic pain.
Nexstim shares are listed on Nasdaq First North Growth Market Finland.
For more information, please visit www.nexstim.com
