Home - Gate Neurosciences

Directly Enhancing Synaptic Function

Synaptic dysfunction is the biological basis for a number of CNS disorders, including depression. Our next-generation therapeutic candidates are designed to restore healthy and balanced brain signaling by enhancing underlying synaptic function using a novel, direct mechanism that modulates the NMDA receptor without causing the dissociative effects seen in other emerging therapies.

Powered by Precision

Our precision development approach includes objective EEG biomarkers, targeted patient subpopulations, and robust translational modeling combined with clinical trial experience in thousands of patients to position our therapeutic candidates for long-term success.

Pipeline

Our lead program, zelquistinel, is a novel oral NMDAR PAM that has demonstrated a differentiated, well-tolerated safety profile and statistically significant rapid-acting antidepressant effects in a Phase 2a study in Major Depressive Disorder.

*Next Phase 2 study to be initiated in 2023.

CNS Is In Our DNA

Our team has devoted decades to researching CNS disease biology and improving the treatment of CNS disorders, giving us the deep expertise necessary for meaningful innovation.

Leadership

Michael G. McCully

President & CEO
Mike is the President and CEO of Gate Neurosciences. An experienced biopharma executive, investor, and entrepreneur, Mike has spent the past 20 years contributing to the development of dozens of successful biotech companies. Mike established his career in the biotech industry in the early 2000s at Recombinant Capital, Inc, a boutique strategic advisory firm, where he served as an advisor to over 100 companies, including emerging and established biopharma, and had a role in more than $4 billion in partnering transactions. In 2008, Recombinant Capital was acquired by Deloitte and Mike became a leader in the Deloitte Life Sciences Practice based in San Francisco.

Since his time at Deloitte, Mike has held operating roles at several emerging and established biopharma companies, notably serving as Head of Business Development, BioNeurology at Elan Pharmaceuticals, Head of Financial Strategy at Coherus Biosciences (CHRS), and Chief Business Officer of the pain-focused specialty pharma Charleston Laboratories where he led the $650M US partnership with Daiichi Sankyo. Most recently, Mike was the Chief Executive Officer of Anagin, Inc., an emerging biotech developing first-in-class novel targeted therapies for addressing pathologies associated with disrupted synaptic plasticity in the central nervous system.

Mike received his BS from Purdue University and a hybrid Masters from Northwestern University.
Ronald M. Burch, M.D., Ph.D.

Chief Medical Officer
Ronald Burch is the Chief Medical Officer of Gate Neurosciences. With more than 30 years of experience in the pharmaceutical industry, Dr. Burch’s expertise spans discovery research, preclinical safety, clinical research, regulatory affairs, and company formation. He has participated in more than 20 IND submissions from which 7 investigational products have become marketed products and 2 are currently in phase 3 clinical trials.

Previously, Dr. Burch served as the Director of Pain & Inflammation at Nova Pharmaceutical Corporation where he led programs from lead identification into clinical trials for a range of indications including pain and asthma. He was also Head of US Biosciences at Zeneca Pharmaceuticals Group where he led the CNS Therapeutic Area team that developed the antipsychotic agent Seroquel. And at Purdue Pharma LP, Dr. Burch was Vice President, Scientific Evaluations and a member of development teams that introduced Tramadol CR, Norspan, and hydromorphone ER, and headed the discovery teams that identified and took V11294 (PDE4 inhibitor) into phase 2 for asthma as well as LABD (long-acting bupivacaine injectable) into phase 2 for pain.

Dr. Burch then founded and was CEO of AlgoRx until its reverse merger with Corgentech, developing Zingo (nanoparticle lidocaine transdermal) to NDA for procedural pain in children and ALGX-4975 (capsaicin injection) to phase 2 for analgesia in total knee replacement, Morton’s neuroma, and bunionectomy (currently in Phase 3 fast track development as CTNX-4975 by Centrexion). Following AlgoRx, Dr. Burch oversaw the phase 2 and phase 3 of long-acting bupivacaine injection at Pacira, now approved as Exparel. Dr. Burch then left Pacira to join the founding team of Naurex where he oversaw the regulatory strategy and clinical trials programs for the NMDA receptor modulators GLYX-13 (through phase 2b) and NRX-1074 (through phase 2a) for depression prior to being acquired by Allergan.

Dr. Burch obtained his Ph.D. in Pharmacology and M.D. from the Medical University of South Carolina and BS in chemistry and marine biology from the College of Charleston. Dr. Burch was a researcher at the National Institutes of Health, performing research involving neuroreceptor regulation with Nobel Laureate Dr. Julius Axelrod.
Anantha Shekhar, M.D., Ph.D.,

Chief Scientific Officer
Anantha Shekhar is the Chief Scientific Officer of Gate Neurosciences, a nationally recognized leader in neuropsychiatry, and currently serves as the Dean of the Medical School and Senior Vice Chancellor for Health Sciences at the University of Pittsburgh. Previously, Dr. Shekhar was the Associate Vice President for University Clinical Affairs & Research and Executive Dean for Research at the Indiana University School of Medicine. Dr. Shekhar is also the Founding Director of the Indiana Clinical and Translational Sciences Institute (Indiana CTSI), a statewide institute within the Indiana University School of Medicine supported by a grant from the US National Institutes of Health and established in 2008 as a joint partnership between Indiana University, Purdue University, the University of Notre Dame, life sciences businesses and community organizations.

Dr. Shekhar has conducted groundbreaking research in the innovative psychiatric therapeutics, bench to bedside neuroscience discovery and translation, and recognized for his work with biotech and entrepreneurship. Currently, he provides visionary leadership to Pitt’s large academic medical center, encompassing six health sciences schools: medicine, dentistry, nursing, public health, pharmacy and rehabilitation sciences. His innovation highlights include first to demonstrate the following: that Muscarinic receptor 1/4 agonist is effective in schizophrenia (Karuna Therapeutics); Role of the neuropeptide orexin and orexin 1 receptor in human panic disorder; Role of NMDA-PSD95-nNOS pathway in regulating fear (co-founded Anagin); Role of Metabotropic glutamate 2 receptors and amygdala NMDA plasticity in anxiety and mood disorders. He is a member of the National Academies Forum on Drug Discovery and Development (2019-2023); Co-Chair, and co-author National Academies Workshop on Innovation in Drug Research and Development for Prevalent Chronic Diseases.

Prior to Gate Neurosciences, Dr. Shekhar was the founder, CSO and CMO of Anagin, Inc., a neuroscience company developing first-in-class nNOS agonists for PTSD and neuropathic pain. Dr. Shekhar completed his psychiatry residency, psychopharmacology fellowship, and obtained his Ph.D. in Neuroscience from Indiana University. He received an M.D. from St. John’s Medical College.

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Board of directors

Michael G. McCully

Director, CEO
Mike is the President and CEO of Gate Neurosciences. An experienced biopharma executive, investor, and entrepreneur, Mike has spent the past 20 years contributing to the development of dozens of successful biotech companies. Mike established his career in the biotech industry in the early 2000s at Recombinant Capital, Inc, a boutique strategic advisory firm, where he served as an advisor to over 100 companies, including emerging and established biopharma, and had a role in more than $4 billion in partnering transactions. In 2008, Recombinant Capital was acquired by Deloitte and Mike became a leader in the Deloitte Life Sciences Practice based in San Francisco.

Since his time at Deloitte, Mike has held operating roles at several emerging and established biopharma companies, notably serving as Head of Business Development, BioNeurology at Elan Pharmaceuticals, Head of Financial Strategy at Coherus Biosciences (CHRS), and Chief Business Officer of the pain-focused specialty pharma Charleston Laboratories where he led the $650M US partnership with Daiichi Sankyo. Most recently, Mike was the Chief Executive Officer of Anagin, Inc., an emerging biotech developing first-in-class novel targeted therapies for addressing pathologies associated with disrupted synaptic plasticity in the central nervous system.

Mike received his BS from Purdue University and a hybrid Masters from Northwestern University.
Derek A. Small

Executive Chairman
Derek is the Founder and Executive Chairman of Gate Neurosciences, a Luson Bioventures portfolio company. He is also the Founding Managing Director of Luson Bioventures, a venture creation firm founded in 2007, and has been launching new biotech companies and developing innovative drugs for more than 20 years. Derek was the Co-Founder and CEO of Assembly Biosciences, Founder and GM of Assembly China, Founding CEO of Naurex (acquired by Allergan in 2015 leading to the spin out of Aptinyx) and numerous other Luson Bioventures portfolio companies. In these roles he has overseen the development of more than 10 novel and innovative drug candidates to address the unmet needs of patients living with diseases of the central nervous system (CNS). Derek has helped to raise upwards of $1 billion from top-tier life science investors, established global and regional partnerships totaling more than $3 billion, and, to date, three of the companies have achieved greater than $1 billion in market value.

Derek received his BS in Business and Marketing at Franklin College and studied Global Business and International Marketing in England at Harlaxton College.
Sarah J. Schlesinger, M.D.

Director
Dr. Schlesinger has served as a member of the board of directors of Innoviva since February 2018 and the board of directors of Armata Pharmaceuticals since February 2020. She is currently Chair of Innoviva’s Nominating/Corporate Governance Committee and Compensation Committee. Dr. Schlesinger is an Associate Professor of Clinical Investigation at Rockefeller University and Senior Attending Physician at Rockefeller University Hospital. Dr. Schlesinger led the Dendritic Cell section of the Division of Retrovirology at the Walter Reed Army Institute of Research and was also a member of the Division of Infectious and Parasitic Disease Pathology at the Armed Forces Institute of Pathology from 1994 to 2002. In 2002, Dr. Schlesinger rejoined Rockefeller University and began working with the International AIDS Vaccine Initiative as a Scientist in Vaccine Research and Design. Dr. Schlesinger has been a member of Rockefeller University Hospital’s Institutional Review Board (“IRB”) (Ethics Committee) since 2003 and previously served as IRB’s vice-chairperson. In 2017 she assumed the position of chairperson of the IRB. She is currently the director of the education and training programs at Rockefeller University Center for Clinical and Translational Science and serves on the Medical Staff Executive Committee of Rockefeller University Hospital. Dr. Schlesinger currently serves on the board of three non-profit organizations: the AIDS Vaccines Advocacy Coalition, Global Viral and The Hastings Center, the pre-eminent center for the study of bioethics. Dr. Schlesinger served as an independent corporate director of Ariad Pharmaceuticals from 2013 until its sale to Takeda Pharmaceutical Company Limited in 2017. Dr. Schlesinger has a B.A. from Wellesley College and a M.D. from Rush Medical College in Chicago, Illinois.