Company Announcement, Helsinki, 30 June 2025 at 9 AM (EEST)
Nexstim Plc Signs Exclusivity Agreement with Sinaptica Therapeutics, Inc. as Part of Planned Alzheimer's Collaboration
Nexstim Plc (NXTMH:HEX) ("Nexstim" or "Company") announces that it has signed an exclusivity agreement ("Exclusivity agreement") with Sinaptica Therapeutics, Inc. ("Sinaptica") regarding the companies' planned collaboration in the field of Alzheimer's disease. The agreement signed concerns activity in 2025 ahead of the planned completion of the definitive agreement ("Definitive agreement") before the end of the year.
On June 7, 2024, Nexstim announced having signed a non-binding Letter of Intent ("LOI") with Sinaptica regarding the development, manufacturing and supplying of Sinaptica's patented precision neuromodulation system custom-based upon the Nexstim NBS 6 system with its advanced TMS-EEG and precision neuronavigation capabilities for the treatment of Alzheimer's Disease and MCI (mild cognitive impairment).
In January 2025, it was announced that the delivery of the first investigational system unit was underway in preparation for Sinaptica's clinical trials. Sinaptica has since then ordered additional similar investigational systems from Nexstim, which are now being finalized for delivery.
As part of the exclusivity agreement signed, 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. The exclusivity agreed is conditional to payments of EUR 1.5 million for Nexstim, to be paid in multiple instalments during the year 2025.
The planned partnership contemplates a worldwide, 10-year exclusive arrangement. The financial structure of the collaboration consists of an upfront exclusivity signing fee announced today, 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 also depends on the payments completed by Sinaptica during 2025 as well as the signing of the definitive agreements before the end of 2025.
Ken Mariash, CEO of Sinaptica, comments: "We are very pleased with the progress working with Nexstim, and the excellent performance seen to date of the prototype SinaptiStim® devices, which are now being sent to various sites worldwide for use in clinical trials. This agreement is another tangible step furthering our partnership as we work towards a future scalable TMS-EEG commercial system powered by Sinaptica's MAINTAIN protocol via our cloud-based personalization engine."
Mikko Karvinen, CEO of Nexstim, comments: "Nexstim is excited to be part of such a promising treatment method for a disease that touches so many people. We hosted the Sinaptica team in Helsinki in the spring for the testing of the first prototype of the clinical trial system, and the opportunity to get together to know each other better and to share know-how was extremely valuable to both teams. After discussions with Sinaptica, we have found bringing the agreement into force in stages the most suitable arrangement, and we will keep on working hard towards advancing this valuable collaboration further."
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. 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 Navigated Brain Stimulation (NBS) system. The NBS System 5 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
