NEWPORT BEACH, Calif., April 07, 2022 (GLOBE NEWSWIRE) — GABA Therapeutics, Inc, (“GABA”) a clinical-stage biotechnology company developing novel therapies for anxiety, depression and other neurological disorders, and part of the atai Life Sciences (“atai”) platform, announces the appointment of Mario David Saltarelli M.D., Ph.D. as Chief Executive Officer (CEO) and Chief Medical Officer (CMO) effective April 4, 2022. He joins GABA with more than 25 years of experience in the biopharmaceutical industry, primarily in senior executive roles at several market-leading companies including Pfizer, Abbott (AbbVie), Annexon, and Syntimmune. He succeeds former CEO and co-founder, Dr. Ian J. Massey.
“Mario has extensive experience in anxiety, depression and other CNS disorders, and has led companies through all aspects of clinical development, regulatory approvals, strategic planning and major capital raises and mergers / acquisitions,” said Dr. Massey. “Mario is the ideal leader to support GABA in advancing its lead compound, GRX-917, into phase 2 efficacy studies in anxiety, depression and other neurological indications, and in progressing GABA’s earlier stage, novel small molecule Rapid Acting Antidepressant (RAAD) program.”
About GABA Therapeutics
GABA Therapeutics, an atai Life Sciences platform company, is a clinical stage biotechnology company focused on addressing the growing, unmet medical need in serious psychiatric and neurological disorders, including depression, anxiety, epilepsy, and essential tremor.
GABA’s flagship product, GRX-917, is an improved, patent protected, deuterated version of an approved European anxiety medication (etifoxine) with comparable speed of onset and anxiolytic efficacy as the top two selling benzodiazepines, lorazepam and alprazolam, but without the side effects of sedation, amnesia, ataxia, and dependence associated with benzodiazepines. GRX-917, which has composition of matter patent protection through 2036, has an identical mechanism of action, biology and pharmacology as etifoxine, but with improved pharmacokinetics, resulting in superior bioavailability and lower dosage requirements. The company is on-track to complete the Phase 1 single and multiple ascending dose study of GRX-917 in the Q2/3 2022 and the initiation of a Phase 2a proof-of-concept trial is anticipated to follow in the second half of this year.
About atai Life Sciences
atai Life Sciences is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. Founded in 2018 as a response to the significant unmet need and lack of innovation in the mental health treatment landscape, atai is dedicated to acquiring, incubating, and efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders.
atai’s business model combines funding, technology, scientific, and regulatory expertise with a focus on innovative compounds, including psychedelic therapy and other drugs with differentiated safety profiles and therapeutic potential. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies to achieve clinically meaningful and sustained behavioral change in mental health patients.
atai’s vision is to heal mental health disorders so that everyone, everywhere can live a more fulfilled life. atai has offices in New York, San Diego, Boston, London and Berlin. For more information, please visit www.atai.life.
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. GABA Therapeutics, Inc. (“GABA”), an atai Life Sciences N.V. (“atai”) platform company and atai, intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “anticipate,” “initiate,” “could,” “would,” “project,” “plan,” “potentially,” “preliminary,” “likely,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these words. All references in these Forward-Looking Statements to “we,” and “our,” refer to GABA and atai, as applicable. In addition, all statements contained in this news release other than statements of historical fact, including statements regarding the success, cost and timing of development of GRX-917, including the progress of related preclinical studies and clinical trials and related milestones, are forward-looking statements. The forward-looking statements in this news release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond our control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.
We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including without limitation: statements regarding the success, cost and timing of development of our product candidates, including the progress of preclinical studies and clinical trials and related milestones. Other risk factors include the important factors described in the section titled “Risk Factors” in atai’s most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”), as updated by atai’s subsequent filings with the SEC, that may cause our actual results, performance or achievements to differ materially and adversely from those expressed or implied by the forward-looking statements.
Any forward-looking statements made herein speak only as of the date of this news release, and you should not rely on forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, performance, or achievements reflected in the forward-looking statements will be achieved or will occur. Except as required by applicable law, we undertake no obligation to update any of these forward-looking statements for any reason after the date of this news release or to conform these statements to actual results or revised expectations.
Richard G. Farrell – Chief Financial Officer
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