\nSage 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, today announced that Chief Executive Officer, Barry Greene, will discuss the Company\u2019s progress in becoming a leader in brain health in a corporate presentation at the 39th<\/sup> Annual J.P. Morgan Healthcare Conference. As part of the presentation, Mr. Greene will highlight the Company\u2019s planned portfolio expansion and acceleration in 2021, including the anticipated advancement of SAGE-718, SAGE-689 and SAGE-904 into further phases of development. Today Sage also announced plans to advance two of its early development product candidates, SAGE-319 and SAGE-421, to preclinical studies.\n<\/p>\n
\n\u201cThis year will be transformational for Sage, with numerous catalysts expected in early, mid and late 2021,\u201d said Barry Greene, Chief Executive Officer at Sage Therapeutics. \u201cBrain health disorders represent one of the biggest challenges we face today, and with the planned expansion and acceleration of both our partnered and internal clinical pipeline this year, we are well-positioned in our efforts to deliver innovation to the millions of patients with these debilitating disorders. I believe that the upcoming milestones in 2021 will support our mission to bring medicines that matter to patients and propel us further on our journey to become the leading brain health company.\u201d\n<\/p>\n
\nDuring his presentation, Mr. Greene will discuss the following corporate updates and milestones anticipated in the next 12-18 months:\n<\/p>\n
Corporate Updates<\/span><\/b><\/p>\n \nSage and Biogen recently announced that they have executed a global collaboration and license agreement to jointly develop and commercialize zuranolone (SAGE-217) for major depressive disorder (MDD), postpartum depression (PPD) and other disorders, and SAGE-324 for essential tremor and other disorders. The transaction, including the related purchase by Biogen of 6,241,473 shares of Sage Common Stock, closed in December 2020, following completion of review under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 in the U.S., and other customary closing conditions. In conjunction with the closing, Sage received $1.525 billion comprised of an $875 million up-front payment and $650 million for the equity investment. As of December 31, 2020, the Company had a cash balance of $2.1 billion (unaudited).\n<\/p>\n Depression Franchise<\/span><\/b><\/p>\n Sage\u2019s depression franchise features zuranolone, Sage\u2019s next-generation positive allosteric modulator (PAM) of GABAA<\/sub> receptors being evaluated in clinical development as a treatment for various affective disorders, and ZULRESSO\u00ae<\/sup> (brexanolone) CIV injection, approved by the U.S. Food and Drug Administration (FDA) as the first treatment specifically indicated for postpartum depression (PPD). Zuranolone has received breakthrough therapy designation from the FDA for the treatment of MDD.<\/i><\/p>\n \nThe Company expects the following pivotal data readouts from the LANDSCAPE clinical program evaluating zuranolone in MDD and PPD in 2021:\n<\/p>\n \nAdditional development plans for zuranolone will be confirmed as part of the Company\u2019s strategic collaboration with Biogen.\n<\/p>\n Neurology Franchise<\/span><\/b><\/p>\n SAGE-324, a next-generation PAM of GABAA<\/sub> receptors and Sage\u2019s lead neurology asset, is in development as a potential oral therapy for neurological conditions, such as essential tremor (ET), epilepsy and Parkinson\u2019s disease (PD).<\/i><\/p>\n \nAdditional development plans for SAGE-324 will be confirmed as part of the Company\u2019s strategic collaboration with Biogen.\n<\/p>\n Neuropsychiatry Franchise<\/span><\/b><\/p>\n SAGE-718, Sage\u2019s first-in-class NMDA receptor PAM and lead neuropsychiatric drug candidate, is in development as a potential oral therapy for cognitive disorders associated with NMDA receptor dysfunction, potentially including Huntington\u2019s disease (HD), PD and Alzheimer\u2019s disease (AD).<\/i><\/p>\n \nAdditionally, the Company expects to initiate a placebo-controlled Phase 2 trial with SAGE-718 in late 2021. Details of this trial will be informed by results from the Phase 2a studies.\n<\/p>\n Early Development<\/span><\/b><\/p>\n \nSage expects to complete certain Phase 1 clinical studies for two compounds in its early development pipeline in 2021, SAGE-689 (single ascending dose) and SAGE-904 (single ascending dose and multiple ascending dose).\n<\/p>\n \nResults from the Phase 1 studies will inform further development of these compounds.\n<\/p>\n \nThe company also announced plans to advance SAGE-319 and SAGE-421 to preclinical studies.\n<\/p>\n Other Development Opportunities<\/span><\/b><\/p>\n \nSage initiated a Phase 3 trial with brexanolone in patients with advanced COVID-19 related acute respiratory distress syndrome (ARDS) in the fourth quarter of 2020 under the Coronavirus Treatment Acceleration Program (CTAP). The Company expects topline data from this trial in late 2021.\n<\/p>\n Webcast Information<\/b><\/p>\n \nSage is scheduled to present at the 39th<\/sup> Annual J.P. Morgan Healthcare Conference on Tuesday, January 12, 2021 at 10:50 am ET. A live webcast of the presentation can be accessed on the investor page of Sage’s website at investor.sagerx.com<\/a><\/span>. A replay of the webcast will also be archived for up to 30 days on Sage’s website following the conference.\n<\/p>\n About Sage Therapeutics<\/b><\/p>\n \nSage 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<\/a><\/span>.\n<\/p>\n Forward-Looking Statements<\/b><\/p>\n Various statements in this release concern Sage’s future expectations, plans and prospects, including without limitation: our expectations regarding timelines for initiation and completion of certain clinical trials and data read-outs; our plans for advancing, accelerating and expanding our development efforts and our product engine; our belief in the potential for upcoming catalysts and milestones to be transformational and to support our mission of bringing innovative medicines to patients; our views as to the potential profile and benefit of our product candidates; and our statements regarding the mission, 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: we may encounter delays in initiation, conduct, completion, or data analysis with respect to our ongoing and planned clinical trials, including as a result of slower than expected site initiation or enrollment, the need or decision to expand the trials or other changes, that may impact our ability to meet our expected time-lines; we may not be able to mitigate the impact of the COVID-19 pandemic 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 of our clinical trials, or cause us to pause trials or not to 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 cause us to have to change our plans; our clinical trials may not meeting their primary endpoints or key secondary endpoints; success in non-clinical studies or in earlier clinical trials or at interim time periods may not be repeated or observed in ongoing or future studies; ongoing and future non-clinical and clinical trial results may not support further development at all or may not be sufficient to move to the next stage of development or to file for or gain regulatory approval to market the product without further development work; we may encounter 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 ongoing 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; 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 not be successful in our development of any of our product candidates in any indication we are currently pursuing or may in the future pursue; 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.<\/i><\/p>\n View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20210107005221\/en\/<\/a><\/span><\/p>\n Investor: Media: KEYWORDS:<\/b> Massachusetts United States North America<\/p>\n INDUSTRY KEYWORDS:<\/b> Biotechnology Pharmaceutical Health<\/p>\n\n
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Jeff Boyle
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617-949-4256
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Jeff.Boyle@sagerx.com<\/a><\/p>\n
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<\/b>Maureen L. Suda
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617-949-4289
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maureen.suda@sagerx.com<\/a><\/p>\n
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