Sage Therapeutics’ Third Annual FutureCast Showcases Data from All Three Brain Health Franchises

Rhea-AI Summary

Sage Therapeutics recently announced progress in clinical studies, highlighting that SAGE-718 showed improved cognitive function in patients with Alzheimer’s disease. Additionally, they are enrolling patients for the KINETIC 2 study, focusing on SAGE-324 for essential tremor. The company will host its annual FutureCast event today to review its R&D strategy, showcasing advancements in depression and neurology programs. With a focus on GABA and NMDA receptor pathways, Sage aims to address significant brain health disorders.

Positive

• SAGE-718 demonstrated improved cognitive function in Alzheimer's patients, showing promise for other brain disorders.
• Enrollment for KINETIC 2 study of SAGE-324 in essential tremor is underway.

Negative

• None.

In the open-label LUMINARY Study, SAGE-718 improved performance from baseline on multiple tests of cognitive function in patients with Alzheimer’s disease mild cognitive impairment and mild dementia, consistent with positive signals seen in Parkinson’s disease and Huntington’s disease

Now enrolling patients in KINETIC 2, a Phase 2b dose-ranging study evaluating SAGE-324 in essential tremor

Webcast today at 8:00 a.m. ET

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- 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 its third annual “FutureCast: An R&D Portfolio Review” to showcase the Company’s research and development strategy, and clinical progress in its depression, neurology, and neuropsychiatry franchise programs.

“Sage’s expertise in brain circuitry, including our deep understanding of the GABA_A and NMDA receptor pathways, has resulted in a rich portfolio that includes multiple opportunities to deliver life-changing brain health medicines, if we’re successful,” said Barry Greene, Chief Executive Officer at Sage Therapeutics. “Over the last decade, the devastating impact of brain health disorders and the absence of innovation have resulted in significant costs to individuals, families, and society. We believe our productive, proactive, predictive, and patient-focused approach to drug development may enable us to deliver innovative treatments that meet patient needs. We look forward to advancing this work in 2022.”

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:

Science of Sage: Expanding Our Leading Brain Health Portfolio

• Barry Greene, Chief Executive Officer

Zuranolone: Program Overview

• Rob Lasser, M.D., Vice President, Late Development

SAGE-324: Patient-led Drug Development to Address the Unmet Need in Essential Tremor

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

SAGE-718 CogNEXT Platform: An Evolution of Sage’s Early-Stage Clinical Signal-Finding Strategy

• Aaron Koenig, M.D., Vice President, Medical Lead Neuropsychiatry

Advancing Our Differentiated Approach to Development

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

Webcast Information
FutureCast: An R&D Portfolio Review, begins at 8:00 a.m. ET today, Tuesday, December 14, 2021. 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, the potential of our drug development approach to lead to innovative treatments, 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 non-clinical studies or in prior clinical trials of our product candidates may not be repeated or observed in ongoing, planned or future studies; ongoing, planned and future clinical trials may not meet their primary endpoints or key secondary endpoints; non-clinical and clinical results from ongoing or future trials may not support further development of the product candidate or filing for or obtaining regulatory approval on the timelines we expect or at all and we may be required to conduct additional clinical trials or nonclinical studies which may not be successful; we may experience slower than expected enrollment in our clinical trials or may encounter other delays or problems, including in analyzing data or requiring the need for additional analysis, data or patients, and such issues with any trial could cause delay in completion of the trial, availability of results and timing of future activities; we may encounter unexpected safety or tolerability issues with respect to any of our product candidates; we may encounter different or more severe adverse events at the higher doses, different frequency or length of dosing or in new indications we are studying or may study in ongoing or planned trials; the FDA and other regulatory authorities may ultimately decide that the design or results of our completed, ongoing or planned clinical trials for zuranolone or any of our other product candidates, even if positive, are not sufficient to file for or obtain regulatory approval in the indications that are the focus of our development plans despite prior regulatory advice; at any stage, regulatory authorities may ask for additional clinical trials, nonclinical studies or other data in order for us to proceed further in development or to file for or obtain regulatory approval; other decisions or actions of the FDA or other regulatory authorities may affect the initiation, timing, design, size, progress and cost of clinical trials and our ability to proceed with further development; we may never achieve the rate of new product candidates from our research engine that we expect in the future; even if our products are successfully developed and approved, the number of patients with the diseases or disorders our products treat, and the actual market for such products may be smaller than our current estimates; or we may not achieve the anticipated benefit of our product candidates or market acceptance at acceptable levels; we may never be successful or achieve the goals and opportunity of our business, 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/20211213006006/en/

Investors

Helen Rubenstein

315-382-3919

helen.rubenstein@sagerx.com

Media

Maureen L. Suda

617-949-4289

maureen.suda@sagerx.com

Source: Sage Therapeutics, Inc.

FAQ

What were the results of the SAGE-718 study for Alzheimer's disease?

The open-label LUMINARY Study showed that SAGE-718 improved cognitive function in patients with Alzheimer’s disease mild cognitive impairment and mild dementia.

What is the KINETIC 2 study about?

The KINETIC 2 is a Phase 2b dose-ranging study evaluating SAGE-324 for treating essential tremor.

When is the FutureCast event hosted by Sage Therapeutics?

The FutureCast event is being held today at 8:00 a.m. ET.

What are the focuses of Sage Therapeutics' R&D strategy?

Sage Therapeutics' R&D strategy focuses on developing therapies for depression, neurology, and neuropsychiatry.

What is Sage Therapeutics' approach to drug development?

Sage Therapeutics combines a productive, proactive, predictive, and patient-focused approach to drug development targeting brain health disorders.