Thinking differently about thinking – Development plans for SAGE-718 focused on executive function across multiple indications

Early learnings from studies of other compounds created multi-faceted insights for SAGE-324 program in essential tremor

Interview with investigator from SHORELINE study highlights potential for multiple approaches in the treatment of MDD

Additional details about Phase 3 trial with brexanolone in COVID-19 related ARDS

Webcast today at 9:00 a.m. ET

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sep. 10, 2020-- Today, Sage Therapeutics, Inc. (NASDAQ: SAGE), a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with debilitating disorders of the brain, will host “FutureCast: An R&D Portfolio Review” to discuss the Company’s research and development strategy, and clinical progress in its key depression, neurology, and neuropsychiatry franchise programs.

“The team at Sage continues to follow the science with a fundamentally different approach, using our strong medicinal chemistry and focus on translational data to efficiently approach drug development,” said Jeff Jonas, M.D., chief executive officer at Sage Therapeutics. “We continue to focus on areas where our early clinical data suggest the potential for meaningful patient benefit, not just incremental change. With this approach, we’ve generated compelling data. I believe we are one of the few companies developing new chemical equity with a goal of making true advances in brain health.”

Clinical Program Updates:
Sage is advancing a portfolio of novel and differentiated product candidates designed to improve brain health by targeting the GABA and NMDA receptor systems. Dysfunction in these systems is known to be at the core of numerous disorders.

FutureCast will feature the following topics and speakers:

Sage’s approach to exploratory clinical research and the questions we ask

• Jim Doherty, Ph.D., Chief Research Officer

Sage’s NMDA Discovery Efforts: An emerging platform of NMDAr modulators

• Mike Quirk, Ph.D., Vice President, Pharmacology
• Aaron Koenig, M.D., Senior Medical Director, Early Development

SAGE-324: Novel potential treatment for chronic neurological conditions

• Helen Colquhoun, M.D., Vice President, Early Development

Zuranolone: Exploring the fundamentals of an ‘as needed’ treatment in major depressive disorder (MDD)

• Rob Lasser, M.D., Vice President, Late Development
• Greg Mattingly, M.D., Associate Clinical Professor at Washington University

Brexanolone and COVID-19 related acute respiratory distress syndrome (ARDS)

• Steve Kanes, M.D., Ph.D., Chief Medical Officer

Webcast Information
FutureCast: An R&D Portfolio Review, begins at 9:00 a.m. ET today, Thursday, September 10, 2020. The live webcast can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcast will be available on Sage's website approximately two hours after the completion of the event and will be archived for up to 30 days.

About Sage Therapeutics
Sage Therapeutics is a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with debilitating disorders of the brain. We are pursuing new pathways with the goal of improving brain health, and our depression, neurology and neuropsychiatry franchise programs aim to change how brain disorders are thought about and treated. Our mission is to make medicines that matter so people can get better, sooner. For more information, please visit www.sagerx.com.

Forward-Looking Statements
Various statements in this release concern Sage's future expectations, plans and prospects, including without limitation: our views and expectations regarding the potential of our product candidates in various indications, the potential profile and benefit of our product candidates, and the goals, opportunity and potential for our business. These statements constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, which could cause actual results to differ materially from those contemplated in these forward-looking statements, including the risks that: success in our non-clinical studies or in earlier clinical trials may not be repeated or observed in ongoing or future studies, and ongoing and future non-clinical and clinical results may not meet their primary or key secondary endpoints or be sufficient to file for or gain regulatory approval to market a product without further development work or may not support further development at all; we may encounter adverse results or adverse events at any stage of development that negatively impact further development or that require additional nonclinical and clinical work which may not yield positive results; we may encounter different or more severe adverse events at the higher doses we are studying in our new trials; we may encounter issues with the efficacy or durability of short-term treatment, or co-initiated treatment with zuranolone or safety and efficacy concerns with respect to retreatment that require additional studies be conducted; we may encounter delays in initiation or conduct of our ongoing and planned clinical trials, including slower than expected site initiation or enrollment, that may impact our ability to meet our expected time-lines and increase our costs; we may not be able to mitigate the impact of COVID-19 on our clinical development timelines and the impact may be more significant than we expect and may negatively impact expected site initiation, enrollment or conduct in our clinical trials, or cause us to pause trials or not be able to use data, in each case which may significantly impact our ability to meet our expected time-lines or may significantly impact the integrity or sufficiency of the data from our trials or increase our costs or cause us to have to change our plans; the FDA may ultimately decide that the design or results of our completed and planned clinical trials for any of our product candidates, even if positive, are not sufficient for regulatory approval in the indications that are the focus of our development plan; other decisions or actions of the FDA or other regulatory agencies may affect the initiation, timing, design, size, progress and cost of clinical trials and our ability to proceed with further development; we may encounter technical and other unexpected hurdles in the development and manufacture of our product candidates which may delay our timing or change our plans or increase our costs; as well as those risks more fully discussed in the section entitled "Risk Factors" in our most recent Quarterly Report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent our views only as of today, and should not be relied upon as representing our views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200910005195/en/

Investor Contact
Jeff Boyle
617-949-4256
Jeff.Boyle@sagerx.com

Media Contact
Maureen L. Suda
617-949-4289
maureen.suda@sagerx.com

Source: Sage Therapeutics, Inc.