Sinaptica Completes Scientific Advisory Board with Final Expert Appointment as Company Advances to Pivotal Trial in Alzheimer's

Sinaptica Therapeutics, Inc., a clinical-stage company leading the development of a new class of personalized neuromodulation therapeutics to treat Alzheimer's (AD) and other neurodegenerative diseases, announces the appointment of Giovanni Frisoni, MD to complete the company's Scientific Advisory Board.

Comprised of internationally renowned experts in a range of fields including Alzheimer's, neuromodulation, and neurology, the SAB provides strategic oversight and guidance for the global development of Sinaptica's investigational precision network neuromodulation therapy for Alzheimer's Disease as the company prepares for a pivotal Phase 3 clinical trial this year.

"With a breakthrough of this magnitude, we knew we needed to surround ourselves with the best advisors from across the scientific continuum?from AD pathology and biomarkers to neuro-electrophysiology and clinical trial design?to help guide Sinaptica as we develop this groundbreaking neuromodulation therapy," said Sinaptica CEO Ken Mariash. "We're honored to have Prof. Frisoni, an international leader in the field of clinical and translational Alzheimer's research, join our esteemed board of scientific and clinical experts."

"I'm pleased to join Sinaptica's SAB at a time when Precision Medicine, AI/ML, and the emerging field of ?perturbation-based biomarkers' are for the first time making it possible to decode brain signals at the individual's connectome level, allowing personalized modulation of entire functional networks?not just stimulating simple anatomical targets," said Professor Frisoni.

Sinaptica is building on unprecedented positive Phase 2 data in Alzheimer's published by the company's scientific co-founders, showing greater than 80% disease slowing on all four gold-standard cognitive and functional clinical endpoints, in the peer-reviewed Oxford University Press journal, Brain. Sinaptica's technology has been granted FDA Breakthrough Device Designation.

Giovanni Frisoni, MD, is a clinical neurologist, Full Professor of Clinical Neuroscience at the University of Geneva, Switzerland, and Director of the Memory Clinic at Geneva University Hospital where he is leading a team of 40 clinicians and scientists. Formerly the Director at the National Alzheimer's Centre in Bresca, Italy, Prof. Frisoni is author of about 700 scientific papers listed in PubMed, imaging editor for Neurobiology of Aging, and founding editorial board member of The Lancet Neurology. He has led national and international projects funded by the European Commission, the Alzheimer's Association, Italian and Swiss Ministries of Health, and industry. He is currently a leading figure worldwide in microbiota studies in dementia, has taken active part in the IWG initiative for the definition of global diagnostic criteria for Alzheimer's disease, and is leading a European working group of experts tasked with developing protocols and procedures for the memory clinics of the future (brain health services for dementia prevention).

Other members of Sinaptica's Scientific Advisory Board include:

Jeffrey L. Cummings, MD, ScD_(HC), Joy Chambers-Grundy Professor of Brain Science at UNLV School of Integrated Health Sciences and Director of the Chambers-Grundy Center for Transformative Neuroscience. Prior to UNLV, Dr. Cummings served as founding director of the Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas, and as director of the Mary S. Easton Center for Alzheimer's Disease Research, and director of the Deane F. Johnson Center for Neurotherapeutics, both at UCLA. A world-renowned Alzheimer's researcher and leader of clinical trials, Dr. Cummings has been recognized with many awards for his scientific and leadership contributions. He has published over 900 articles and 44 books devoted to neuroscience, Alzheimer's disease, and clinical trials.

Casey Lynch, MS, CEO of Lighthouse Pharmaceuticals and Managing Partner of Sonoma Bioventures, an investment and advisory firm, with more than 25 years of experience as an entrepreneur, executive and director with a focus on development of treatments for neurological disorders. Lynch is a member of the board of directors of Longboard Pharmaceuticals (LBPH), a public company developing the next wave of neuropharmaceuticals, and a member of the review board of the Alzheimer's Drug Development Foundation. She previously co-founded and served as President, CEO and member of the board of directors of Cortexyme, Inc., serving as Chairman from November 2018 through January 2022. She was a member of the board of directors of the California Life Science Association, a trade association representing California's life science industry, from 2019 to 2021. Prior to co-founding Cortexyme, Ms. Lynch co-founded various companies and organizations in the biotechnology industry, including Aspira Biosystems and NeuroInsights.

Ana Pereira, MD, neurologist at the Barbara and Maurice Deane Center for Wellness and Cognitive Health at The Mount Sinai Hospital, New York. Dr. Pereira completed her neurology residency at Harvard University, with sub-specialty trainings in Cognitive Neurology at Columbia University, Post-Doctoral Research Fellowship at Columbia University and Translational and Clinical Investigation at Rockefeller University in New York City, where she was an Assistant Professor of Clinical Investigation before moving to Mount Sinai. Clinically, Dr. Pereira evaluates patients at the Barbara and Maurice Deane Center for Wellness and Cognitive Health at The Mount Sinai Hospital, having expertise in diagnosing and treating neurodegenerative disorders and other cognitive syndromes. Dr. Pereira's research focuses on furthering knowledge of the neurobiology of aging and Alzheimer's disease, taking into account the selective vulnerability of glutamatergic neural circuits to synaptic changes in aging and neuronal loss in Alzheimer's disease. She seeks to explore mechanisms underlying these susceptibilities along with effective therapeutic interventions.

Simone Rossi, MD, PhD, Professor of Neurology, clinical neurophysiologist, leading the Brain Investigation & Neuromodulation Lab (Si-BIN Lab) at the Department of Medicine, Surgery and Neuroscience, Neurology and Clinical Neurophysiology Unit, University of Siena, where he also leads the Parkinson's disease clinical activity. He is the author of popular books as "Il Cervello Elettrico" [The Electric Brain], "Il corpo artificiale. Neuroscienze e robot da indossare" [The Artificial Body. Neuroscience and wearable robots], Raffaello Cortina Ed. And "IO & IA. Mente, Cervello e GPT [I and AI. Mind, brain and GPT], Rubbettino Ed. Dr. Rossi is an international leader in the field of noninvasive brain stimulation, where his contributions include: technical developments (a new sham coil for TMS); use and developments of noninvasive brain stimulation techniques (TMS, tDCS, tACS) as neuroimaging procedures in cognitive neuroscience, with a focus on memory, therapeutic neuromodulatory tools in neuropsychiatry, and neuroehnancement (including ethical issues); individuation of neurophysiological markers of psychiatric diseases; noninvasive investigation of neural plasticity mechanisms and brain connectivity, studied with EEG, TMS-EEG combination and rsFMRI. Dr. Rossi has authored 250 full text publications on peer-reviewed scientific journals and has more than 30,000 citations.

About Sinaptica Therapeutics

Sinaptica Therapeutics is a clinical-stage neuromodulation therapeutics company leading the development of a new class of personalized therapeutics to revolutionize the treatment of Alzheimer's and neurodegenerative diseases. The company utilizes a novel, noninvasive approach to treating Alzheimer's via precision neurostimulation of a key brain network involved in memory, the Default Mode Network. This novel approach slowed disease progression by >80% on all four gold-standard cognitive and functional clinical endpoints in a placebo-controlled Phase 2 clinical study, with results published in the peer-reviewed Oxford University Press journal, Brain. The technology was granted Breakthrough Device Designation by the FDA in 2022 and the company is preparing for a pivotal randomized controlled clinical trial in early 2025. Sinaptica's mission is to bring a safe, effective, and noninvasive neuromodulation therapy to Alzheimer's patients that can help to significantly slow the progression of both cognitive and functional decline. Learn more at sinapticatx.com and follow us on LinkedIn and Twitter @SinapticaTX.

The SinaptiStimtm 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.