1. 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, announced that Jeff Jonas, M.D., chief executive officer, will undergo a scheduled surgical procedure today. The Company anticipates he will make a full recovery and return to his role full-time in December 2020. While Dr. Jonas is recuperating, he will be available as needed, and during this time, the Sage leadership team will direct business operations. In addition, Sage's experienced Board of Directors will continue to serve as a resource.

    About Sage Therapeutics

    Sage Therapeutics is a biopharmaceutical company committed to developing…

    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, announced that Jeff Jonas, M.D., chief executive officer, will undergo a scheduled surgical procedure today. The Company anticipates he will make a full recovery and return to his role full-time in December 2020. While Dr. Jonas is recuperating, he will be available as needed, and during this time, the Sage leadership team will direct business operations. In addition, Sage's experienced Board of Directors will continue to serve as a resource.

    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.

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  2. 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, today announced it will host a live webcast on Thursday, November 5, 2020, at 8:30 a.m. ET to announce third quarter 2020 financial results and discuss recent business updates.

    The webcast can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcast will be available 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…

    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, today announced it will host a live webcast on Thursday, November 5, 2020, at 8:30 a.m. ET to announce third quarter 2020 financial results and discuss recent business updates.

    The webcast can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcast will be available 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.

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  3. Zuranolone was generally well-tolerated at the 30 mg dose and by the initial patients treated with the 50 mg dose with an adverse event profile consistent with that seen in earlier trials

    Nearly half of trial participants with positive response to initial 14-day course of zuranolone 30 mg did not need an additional zuranolone treatment course

    For those who needed retreatment with the 30 mg dose, safety, tolerability and efficacy results were similar to those seen in the initial treatment course

    Sage Therapeutics, Inc. (NASDAQ:SAGE), a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with debilitating brain disorders, today reported interim, topline results from a July…

    Zuranolone was generally well-tolerated at the 30 mg dose and by the initial patients treated with the 50 mg dose with an adverse event profile consistent with that seen in earlier trials

    Nearly half of trial participants with positive response to initial 14-day course of zuranolone 30 mg did not need an additional zuranolone treatment course

    For those who needed retreatment with the 30 mg dose, safety, tolerability and efficacy results were similar to those seen in the initial treatment course

    Sage Therapeutics, Inc. (NASDAQ:SAGE), a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with debilitating brain disorders, today reported interim, topline results from a July data cut of the ongoing Phase 3 open-label SHORELINE Study. This clinical study was designed to naturalistically follow patients with major depressive disorder (MDD) and evaluate the safety and tolerability of zuranolone 30 mg in adults for up to one year. In May 2020, the protocol was amended to include a 50 mg dose of zuranolone. For the primary endpoint of safety and tolerability, the data analyzed to date show that zuranolone was generally well-tolerated in the 30 mg dose and among the initial patients treated with the 50 mg dose. Adverse events reported in the trial during the period analyzed were generally consistent with results seen in previous clinical trials.

    Secondary endpoints included response and remission as evaluated by the 17-item Hamilton Rating Scale for Depression (HAMD-17) and the number of times a patient received retreatment. At the time of this analysis, patients with a clinical response (decrease in HAMD-17 baseline score of ≥50%) to the initial 14-day course of zuranolone 30 mg used a mean number of 1.9 treatments per year. As the first naturalistic, longitudinal, clinical development trial conducted in MDD, the SHORELINE Study provides real world insight into the potential use of zuranolone, if successfully developed and approved as an as-needed treatment for MDD, and builds on the data assembled in the LANDSCAPE clinical program. The Company plans to report comprehensive data from the 30 mg dose in the first half of 2021 and will include additional subsets of data within the primary and secondary endpoints. Select data will be reserved for presentation at medical and scientific conferences and in peer-reviewed journal articles.

    "This data from the SHORELINE Study show that medically-oriented, as needed treatment for depression has the potential to be a compelling option for many patients diagnosed with MDD," said Jeff Jonas, M.D., chief executive officer at Sage Therapeutics. "Approximately 70% of patients who participated in the study only needed one or two treatment courses, a total of two to four weeks of treatment with zuranolone 30 mg, which we believe will be the minimally effective dose, if our development efforts are successful."

    Zuranolone 30 mg: Summary of July Results from SHORELINE Study

    Sage's Phase 3 SHORELINE Study is evaluating the safety and tolerability of zuranolone 30 mg and 50 mg in adults 18-75 who have MDD as defined by a baseline HAMD-17 total score ≥20. The original study design included a zuranolone 30 mg dose administered once nightly for 14 days.

    • 725 people with MDD (HAM-D ≥ 20) were treated with a first dose of zuranolone 30 mg once daily for 14 days.
    • The mean baseline HAM-D score (± SD) at entry into the study was 25.3 ± 4.1 (n=725).
    • Of the 725 patients treated, 143 (19.7%) did not achieve response to the first course and exited the study. Subjects were required by protocol to achieve response to continue into the naturalistic follow-up period.
      • At Day 15 of the initial course of patients who only received 30 mg in the study, the mean change from baseline was -14.9 ± 7.1 (n=640); 458 (71.6%) patients achieved response and 255 (39.8%) achieved remission (HAM-D ≤ 7).
      • 304 (42%) patients were on pre-existing antidepressant therapy (ADT) which was continued, while 421 (58%) were on no ADT; there were no meaningful differences in efficacy outcomes between the two groups.

    Safety and tolerability of initial treatment:

    • In this first course of treatment with zuranolone 30 mg, the adverse events experienced by patients were similar in nature and frequency to those previously reported for completed zuranolone studies, with 447 (61.7%) patients reporting at least one adverse event.
    • The most common adverse events (reported ≥ 5%) were: somnolence (69; 9.5%), headache (63; 8.7%), and dizziness (39; 5.4%). Most adverse events were mild or moderate.
    • Similar adverse events were reported regardless of the presence or absence of ADT.
    • Causes of adverse event-related discontinuations during the 14-day course of treatment were varied, with the most common being dizziness, anxiety, or nausea (n=2 each). The overall rate of discontinuation due to treatment-emergent adverse events was 2.2%
    • No events of loss of consciousness were reported at any time during the study.

    Retreatment:

    Among the 494 patient responders from the initial treatment cycle continuing in the study, 274 (55.5%) of patients used zuranolone in retreatment one or more times, while the remaining 220 (44.5%) were not retreated during their participation in the study.

    • Of the 494 patients continuing in the study, 220 (44.5%) patients used only the single initial zuranolone course, while 132 (26.7%) used a total of 2 courses, 66 (13.4%) used a total of 3 courses, 51 (10.3%) used a total of 4 courses, and 27 (5.5%) used a total of 5 courses.
    • The number of zuranolone retreatments used were similar regardless of the presence or absence of ADT.
    • For patients using one or more retreatments with zuranolone, overall AE rates in treatment courses with greater than 50 patients were 151 (53.7%), 56 (38.1%), and 28 (35.9%) for the second, third, and fourth treatment courses, respectively.
    • For those patients that used one or more retreatments, outcomes on efficacy measures and safety events were similar to those observed in the initial treatment course; and the presence or absence of ADTs did not change the results.

    Initial Experience with Zuranolone 50 mg Dosing:

    In May 2020, standard dosing with zuranolone in the SHORELINE Study was increased to 50 mg. Patients who started treatment at the 30 mg dose and were retreated after May 2020 started receiving zuranolone 50 mg rather than 30 mg. A new cohort of patients starting treatment at 50 mg was also initiated in May 2020.

    • In this interim sample of patients who received zuranolone 50 mg after having received 30 mg previously (n=48), higher rates and levels of intensity with AEs of >5% (sedation, somnolence) were noted. Most adverse events were mild or moderate.
    • In the 76 (38%) patients with safety data available from the 50 mg cohort, the adverse event profile was similar to that seen in patients who received 30 mg zuranolone. Events >5% of somnolence, dizziness, sedation, headache and tremor were observed to be more frequent in the 50 mg cohort, but were similar in severity to the events seen with 30 mg. Most adverse events were mild or moderate.
    • For new 50 mg cohort (n=52) the mean HAM-D baseline score was 25.1 ± 3.1.
    • At Day 15 of the initial course in this group, the mean HAM-D change from baseline was -15.9 ± 6.6; 39 (75.0%) achieved response and 25 (48.1%) achieved remission.

    About the SHORELINE Study

    The SHORELINE Study (217-MDD-303) is a Phase 3, open-label, 1-year longitudinal study evaluating the safety, tolerability, and need for repeat dosing with zuranolone in adults with MDD. The study comprises two cohorts, one with zuranolone 30 mg as a starting dose and one with zuranolone 50 mg as a starting dose both administered once nightly for 14 days. The need for repeated dosing is assessed every 14 days based on the results of a patient-reported PHQ-9 (≥10) and HAMD-17 (≥20) assessment. There was a minimum of 56 days between zuranolone 14-day courses, to allow for a maximum of five treatments for the follow-up period.

    About Major Depressive Disorder

    Major depressive disorder (MDD) is a common but serious mood disorder in which people experience depressive symptoms that impair their social, occupational, educational or other important functioning, such as a depressed mood or loss of interest or pleasure in daily activities, consistently for at least a two-week period. It is estimated that approximately 17 million people in the U.S. suffer from MDD each year. While antidepressants are widely used to treat MDD, large-scale studies have demonstrated the need for additional therapies.

    About Zuranolone

    Zuranolone (SAGE-217) is a once-daily, two-week therapy in development for the treatment of major depressive disorder (MDD) and postpartum depression (PPD). Zuranolone is an investigational oral neuroactive steroid (NAS) GABAA receptor positive allosteric modulator (PAM). The GABA system is the major inhibitory signaling pathway of the brain and central nervous system and contributes significantly to regulating brain function. Zuranolone has been granted Breakthrough Therapy Designation by the U.S. Food & Drug Administration.

    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: our plans and expected timelines; our belief in the potential profile and benefit of zuranolone, and the potential for successful development and approval;; our estimates as to the number of patients with MDD; the potential of our other 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: results from interim data cuts from a clinical study may not be reflective of the results that will be achieved in the full study once completed; 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; the actual size of the MDD patient population may be significantly lower than our estimates and, even if zuranolone is approved, it will only be approved or used to treat a subset of the relevant patient populations; 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.

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  4. 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, today announced the addition of Barry Greene to the company's board of directors.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201001005353/en/

    Barry Greene (Photo: Business Wire)

    Barry Greene (Photo: Business Wire)

    "We are honored to have Barry Greene join the Board at Sage. Barry's history of achievements and leadership are well-recognized and will complement Sage's vision to innovate treatment and medical care, as our goal is nothing less than to offer disruptive, distinct and novel treatment approaches for patients…

    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, today announced the addition of Barry Greene to the company's board of directors.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201001005353/en/

    Barry Greene (Photo: Business Wire)

    Barry Greene (Photo: Business Wire)

    "We are honored to have Barry Greene join the Board at Sage. Barry's history of achievements and leadership are well-recognized and will complement Sage's vision to innovate treatment and medical care, as our goal is nothing less than to offer disruptive, distinct and novel treatment approaches for patients. Barry shares this sense of purpose and focus on operational excellence," said Jeff Jonas, M.D., chief executive officer of Sage. "His proven leadership, decades of experience building and growing businesses, and his commitment to changing the lives of patients for the better will be invaluable as we aim to continue advancing programs across our depression, neurology, and neuropsychiatry franchises."

    Barry Greene recently served as President of Alnylam Pharmaceuticals, Inc., since 2007. He previously held the position of Chief Operating Officer when he first joined the company in 2003. Prior to his 17 year tenure at Alnylam, Mr. Greene was the General Manager of Oncology at Millennium Pharmaceuticals, Inc., where he led the company's global strategy and execution for its oncology business, culminating in the successful U.S. Food and Drug Administration approval and launch of VELCADE® (bortezomib) in mid-2003. Prior to joining Millennium in 2001, Mr. Greene served as Executive Vice President and Chief Business Officer for Mediconsult.com, a healthcare consulting company. Earlier in Mr. Greene's career, he held such leadership positions as Vice President of Marketing and Customer Services for AstraZeneca (formerly AstraMerck); Vice President, Strategic Integration with responsibility for the AstraZeneca North American post-merger integration; and as a partner of Andersen Consulting.

    "I am pleased to be joining the Board at Sage at such a monumental time in their evolution as a brain health leader. I believe the best drug companies are grounded in a collective pursuit of innovative science and where the organization believes in the vision, mission and core values – with a commitment to employees, a sense of urgency on behalf of patients and a passion for excellence. I see all of this at Sage," said Mr. Greene. "Disorders of the central nervous system are in desperate need of novel, science-based, game-changing treatment options. It's an exciting opportunity to collaborate with the outstanding leadership team and Board at Sage as they aim to expand those options for potentially millions of patients."

    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.

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  5. 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

    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…

    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

    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.

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  6. 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, today announced that the Company will present at the Morgan Stanley 18th Annual Global Healthcare Conference on Tuesday, September 15, 2020 at 2:45 p.m. ET.

    A live webcast of the presentation can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcast will also be archived for up to 30 days on Sage's website following the conference.

    About Sage Therapeutics

    Sage Therapeutics is a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people…

    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, today announced that the Company will present at the Morgan Stanley 18th Annual Global Healthcare Conference on Tuesday, September 15, 2020 at 2:45 p.m. ET.

    A live webcast of the presentation can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcast will also be archived for up to 30 days on Sage's website following the conference.

    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.

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  7. 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, today announced that it will host Sage FutureCast: An R&D and Portfolio Review on Thursday, September 10, 2020 from 9:00 a.m. to 11:00 a.m. ET.

    Sage FutureCast will discuss the Company's research and development strategy, and review clinical progress in programs throughout the depression, neurology and neuropsychiatric franchises, including zuranolone, SAGE-324 and SAGE-718, respectively.

    A live webcast of the presentation can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcast will also be archived…

    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, today announced that it will host Sage FutureCast: An R&D and Portfolio Review on Thursday, September 10, 2020 from 9:00 a.m. to 11:00 a.m. ET.

    Sage FutureCast will discuss the Company's research and development strategy, and review clinical progress in programs throughout the depression, neurology and neuropsychiatric franchises, including zuranolone, SAGE-324 and SAGE-718, respectively.

    A live webcast of the presentation can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcast will also be archived for up to 30 days on Sage's website following the conference.

    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.

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  8. Pipeline progress continues with first patient dosed and ongoing enrollment in multiple clinical trials across the depression and neurology franchises

    Durability of response was observed in patients with MDD who responded to a 2-week treatment with zuranolone in MOUNTAIN Study six-month follow-up period

    Conference call today at 8:30 a.m. ET

    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, reported business highlights and financial results for the second quarter ended June 30, 2020.

    During the quarter, Sage initiated enrollment and dosing in two new trials with zuranolone 50 mg…

    Pipeline progress continues with first patient dosed and ongoing enrollment in multiple clinical trials across the depression and neurology franchises

    Durability of response was observed in patients with MDD who responded to a 2-week treatment with zuranolone in MOUNTAIN Study six-month follow-up period

    Conference call today at 8:30 a.m. ET

    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, reported business highlights and financial results for the second quarter ended June 30, 2020.

    During the quarter, Sage initiated enrollment and dosing in two new trials with zuranolone 50 mg:

    • Phase 3 SKYLARK Study (PPD-301) in postpartum depression (PPD)
    • Phase 3 WATERFALL Study (MDD-301B) in major depressive disorder (MDD)
      • Based on strong enrollment to date, topline data from this study is now anticipated in first half of 2021

    In addition, Sage initiated dosing in the 50 mg cohort of the open-label Phase 3 SHORELINE Study and is on-track to initiate dosing in 2H 2020 in the Phase 3 CORAL Study (MDD-305) investigating zuranolone 50 mg as an acute rapid response therapy (RRT) in patients with MDD when co-initiated with a newly administered standard antidepressant therapy. The Company also initiated dosing in the Phase 2 KINETIC Study evaluating SAGE-324 in patients with essential tremor and is on-track to initiate the Phase 2 PARADIGM Study in the second half of 2020 evaluating SAGE-718 in patients with Parkinson's disease (PD) with impaired cognitive function.

    Sage also reported results from the 6-month follow-up cohort with zuranolone 30 mg from the MOUNTAIN study. There were no symptoms of withdrawal observed after discontinuation of zuranolone (Day 14) and 74.5% of patients who responded to zuranolone maintained their response at the last follow-up at Day 182. Zuranolone was generally well-tolerated and showed a similar safety profile as seen in earlier studies.

    "We have created a novel drug company successfully able to convert our chemical equity into a rich pipeline of clinical assets that are new chemical entities, not repurposed molecules," said Jeff Jonas, M.D., chief executive officer at Sage Therapeutics. "Even in the face of the difficulties currently challenging the world, I'm pleased to report that the team at Sage is executing across all three brain health franchises and we expect to report on numerous catalysts in the next 18 months."

    Portfolio Updates

    Sage is advancing a portfolio of novel, new chemical entities with the potential to become differentiated products designed to improve brain health by targeting the GABAA and NMDA receptor systems. Dysfunction in these systems is thought to be at the core of numerous neurological and neuropsychiatric disorders.

    Depression Franchise

    Sage's depression franchise features zuranolone, Sage's next-generation positive allosteric modulator (PAM) of GABAA receptors being evaluated in clinical development as a treatment for various affective disorders and ZULRESSO™ (brexanolone) CIV injection, approved by the U.S. Food and Drug Administration (FDA) as the first treatment specifically indicated for PPD. Zuranolone received breakthrough therapy designation from the U.S. FDA for the treatment of MDD.

    • Zuranolone ongoing studies: Sage is evaluating the potential of zuranolone as a rapid-acting, short-course treatment for PPD and MDD. Sage recently initiated three new short-term clinical studies in 2020, with the potential, if successful, for three distinct indications: PPD, acute rapid response therapy (RRT) in MDD when co-initiated with a new standard antidepressant, and as-needed, or episodic, treatment of MDD. Enrollment and dosing are now ongoing in two of these trials:
      • SKYLARK (PPD-301) Study investigating zuranolone as an oral therapy in women with PPD:
        • Placebo-controlled trial evaluating a two-week course of zuranolone 50 mg in women with PPD, with additional short-term follow-up.
        • Topline data from this study is anticipated in 2021.
      • WATERFALL (MDD-301B) Study investigating zuranolone for as-needed, or episodic, treatment in MDD:
        • Placebo-controlled trial evaluating a two-week course of zuranolone 50 mg in patients with MDD, with additional short-term follow-up.
        • Based on strong enrollment to date, with more than 50% enrolled, topline data from this study is now anticipated in the first half of 2021.

    Sage is on-track to commence dosing of the third new zuranolone Phase 3 trial in 2020:

    • CORAL (MDD-305) Study investigating zuranolone for acute RRT in patients with MDD when co-initiated with a newly administered standard antidepressant therapy:
      • Placebo-controlled trial evaluating a two-week course of zuranolone 50 mg, when co-initiated with an open-label antidepressant, in patients with MDD, with additional short-term follow-up.
      • Topline data from this study is anticipated in 2021.

    Additional study updates:

    • SHORELINE Study (MDD-303): The Company is on track to report topline data in the second half of 2020 from patients with MDD who received zuranolone 30 mg in the SHORELINE Study, designed to evaluate safety and tolerability of as-needed repeat treatment over a 1-year period.
      • Patient dosing has begun in a new 50 mg cohort of patients with MDD; enrollment is ongoing.
    • MOUNTAIN Study 6-month follow-up data: As part of the MOUNTAIN Study, subjects were offered the opportunity to participate in a 6-month, blinded follow-up to assess durability of response. The study was not powered to detect statistical significance beyond the Day 15 endpoint. More detailed data will be prepared for presentation and publication.
      • Of the subjects who were dosed in the MOUNTAIN Study, approximately 50% agreed to join the 6-month follow-up period and nearly 75% of patients who responded to zuranolone 30 mg at Day 15 maintained their response rate at the last follow-up on Day 182.

    Safety:

    • No drug-related adverse events, changes in laboratories, ECG measures, vital signs, or suicidality ratings were present over the long-term following exposure to zuranolone. Zuranolone was generally well-tolerated and showed a similar safety profile as seen in earlier studies.
    • There were no signals of withdrawal or rebound after treatment with zuranolone was completed.

    Durability of treatment:

    • In subjects with response after the 14-day treatment period (Day 15), a large majority maintained this response throughout the 6-month follow-up regardless of arm.
      • Out of responders to zuranolone 30 mg at Day 15 (N=77), a large majority (74.5%) maintained their response rate at the last follow up at Day 182.
      • This continued benefit was seen with all efficacy measures over the 6-month follow-up period: (17-item Hamilton Rating Scale for Depression (HAM-D), Clinician Global Impression – Improvement (CGI-I), Clinician Global Impression – Severity (CGI-S).
    • Sage's collaboration with Shionogi & Co., Ltd. is progressing, with Shionogi initiating a Phase 2 trial with zuranolone in Japan for the treatment of MDD. Under terms of collaboration, Shionogi is responsible for all clinical development, regulatory filings and commercialization of zuranolone for MDD, and potentially other indications, in Japan, Taiwan and South Korea.
    • Sage is also currently evaluating the ongoing zuranolone clinical pharmacology and safety program and plans to finalize requirements to support a potential future NDA with the FDA.
    • ZULRESSO™ (brexanolone) CIV injection:
      • Revenue in the second quarter of 2020 from sales of ZULRESSO was $1.1 million, compared to $2.3 million in the first quarter of 2020. In April 2020, as a part of the Company's restructuring, Sage downsized commercial efforts, including elimination of its entire salesforce. The Company now has a small commercial team with a primary focus on working with healthcare providers and supporting women with PPD in geographies with active, ZULRESSO treating sites.
      • The rapid spread of COVID-19 in the U.S. resulted in multiple sites of care pausing treatment of new patients with ZULRESSO during the quarter. Concerns about exposure to the virus have also caused a significant reduction in the number of women with PPD seeking treatment with ZULRESSO and in physicians willing to prescribe it. Given the ongoing surge in the number of cases of COVID-19 in the U.S. and continuing concerns about the pandemic across the country, the Company expects the significant adverse impact of the pandemic on ZULRESSO revenues to continue. The Company does not plan to provide revenue guidance for the balance of 2020.
      • The Company has received clearance from the U.S. FDA, under the Coronavirus Treatment Acceleration Program (CTAP), to initiate a Phase 3 study with brexanolone in patients with advanced COVID-19 related acute respiratory distress syndrome (ARDS).
        • Additional information about this program will be provided during Sage's upcoming FutureCast investor day planned for September.

    Neurology Franchise

    SAGE-324, a next-generation PAM of GABAA receptors and Sage's lead neurology asset, is in development as a potential oral therapy for neurological conditions, such as essential tremor (ET), epilepsy and Parkinson's disease.

    • SAGE-324: Sage initiated enrollment and dosing in the KINETIC Study (324-ETD-201), a placebo-controlled Phase 2 study evaluating the safety and efficacy of SAGE-324 in patients with ET. Patients will receive a once-daily, four-week course of SAGE-324 60 mg or placebo.
      • Topline data from this study is anticipated in 4Q 2020/1Q 2021.

    Neuropsychiatry Franchise

    SAGE-718, Sage's 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's disease (HD), Parkinson's disease (PD) and Alzheimer's disease (AD).

    • SAGE-718: The Company is on-track to initiate the PARADIGM Study (718-CNP-201), a Phase 2a open-label study in 2020 evaluating SAGE-718 in patients with PD cognitive dysfunction.
      • Results from this study will inform potential advancement of SAGE-718 into further development.
      • Topline data from this study is anticipated in 2H 2020.

    Anticipated Upcoming Milestones

    2H 2020

    • Zuranolone:
      • Initiate dosing in Phase 3 CORAL (MDD-305) Study evaluating a two-week course of zuranolone 50 mg, when co-initiated with an open-label anti-depressant, as an acute rapid response therapy in patients with MDD.
      • Report topline data from Phase 3 SHORELINE (MDD-303 – 30 mg) Study.
    • Brexanolone:
      • Initiate Phase 3 study in patients with advanced COVID-19 related acute respiratory distress syndrome (ARDS).
    • SAGE-718:
      • Report topline data from Phase 2a study in patients with Parkinson's disease cognitive dysfunction.
    • SAGE-324:
      • Report topline data from Phase 2 placebo-controlled study in ET (4Q 2020/1Q 2021).

    2021

    • Zuranolone:
      • Report topline data from Phase 3 WATERFALL Study (1H 21).
      • Report topline data from Phase 3 SKYLARK Study.
      • Report topline data from Phase 3 CORAL Study.
      • Report topline data from Phase 3 SHORELINE Study (50 mg).

    Financial Results for the Second Quarter 2020

    • Revenue: Sage recorded $1.1 million in net revenue in the second quarter of 2020 from sales of ZULRESSO, compared to $0.5 million for the same period in 2019. Sage recorded no collaboration revenue in the second quarter of 2020 compared to $0.4 million in collaboration revenue from Shionogi & Co., Ltd. related to reimbursement of product expense for the same period in 2019.
    • Cash Position: Cash, cash equivalents, restricted cash, and marketable securities as of June 30, 2020 were $759 million compared to $875 million at March 31, 2020.
    • R&D Expenses: Research and development expenses were $73.3 million, including $10.1 million of non-cash stock-based compensation expense, in the second quarter of 2020 compared to $89.1 million, including $13.7 million of non-cash stock-based compensation expense, for the same period in 2019. The decrease in R&D expenses was primarily related to the completion of the MOUNTAIN Study, a Phase 3 clinical trial of zuranolone in MDD and the decrease in non-cash stock-based compensation expense.
    • SG&A Expenses: Selling, general and administrative expenses were $38.2 million, including $12.1 million of non-cash stock-based compensation expense, in the second quarter of 2020 compared to $88.2 million, including $21.1 million of non-cash stock-based compensation expense, for the same period in 2019. The decrease in SG&A expenses was primarily due to the restructuring that the Company announced during the second quarter of 2020.
    • Restructuring Expenses: Restructuring expenses were $28.4 million in the second quarter of 2020 compared to none for the same period in 2019.
    • Net Loss: Net loss was $136.3 million for the second quarter of 2020, compared to $168.2 million for the same period in 2019.

    Financial Guidance

    • Sage anticipates a cash balance of at least $550 million at end of 2020, which the Company anticipates will support operations into 2022 based on current operating plans. 

    Conference Call Information

    Sage will host a conference call and webcast today, Monday, August 10, 2020, at 8:30 a.m. ET to discuss its second quarter 2020 financial results and recent corporate updates. 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 revenues from sales of ZULRESSO and the expected continuing impact of the COVID-19 pandemic on ZULRESSO revenues; our clinical development plans and expected timelines; our expectations with respect to 2020 operating expenses and year-end cash; our belief that existing cash will support operations into 2022; our belief in 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: we may never be able to generate meaningful revenues from sales of ZULRESSO or to generate revenues at levels necessary to justify our investment; the impact of the COVID-19 pandemic on sales of ZULRESSO may last longer than we expect or may reoccur in waves; our post-restructuring focus on geographies where there are existing, active ZULRESSO treating sites may not be sufficient for us to achieve success from the sale of ZULRESSO or to generate revenues at meaningful levels or at levels necessary to justify our investment even after the impact of the COVID-19 pandemic lessens; we may not be able to overcome the barriers to treatment with ZULRESSO or we may continue to encounter other issues or challenges in commercializing ZULRESSO which could further limit the potential of ZULRESSO and the timing and amount of future revenues; results achieved with use of ZULRESSO in the treatment of PPD in commercial use may be different than observed in clinical trials, and may vary among patients; the number of women with PPD or the unmet need for additional treatment options may be significantly smaller than we expect; 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 internal and external costs required for our ongoing and planned activities, and the resulting impact on expense and use of cash, may be higher than expected which may cause us to use cash more quickly than we expect or change or curtail some of our plans or both; our expectations as to expenses, year-end cash and cash needs may prove not to be correct for other reasons such as changes in plans or actual events being different than our assumptions; we may be opportunistic in our future financing plans even if available cash is sufficient; 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; 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 the product without further development work or may not support further development at all; 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 planning to study in 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; 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.

    Sage Therapeutics, Inc. and Subsidiaries
    Condensed Consolidated Statements of Operations
    (in thousands, except share and per share data)
    (unaudited)
                   
      Three Months Ended March 31,   Six Months Ended June 30,
     

    2020

     

    2019

     

    2020

     

    2019

    Product revenue, net

     $

                    1,089

     

     

     $

                       519

     

     

     $

               3,375

     

     

     $

                       519

     

    Collaboration revenue

     

                            -

     

     

     

                          354

     

     

     

                       -

     

     

     

                          819

    Total revenue

     

                       1,089

     

     

     

                          873

     

     

     

                  3,375

     

     

     

                       1,338

     

                   
    Operating costs and expenses:              
    Cost of goods sold

     

                          110

     

     

     

                            44

     

     

     

                     280

     

     

     

                            44

     

    Research and development

     

                     73,320

     

     

     

                      89,059

     

     

     

              136,930

     

     

     

                    175,457

     

    Selling, general and administrative

     

                     38,224

     

     

     

                      88,227

     

     

     

              108,355

     

     

     

                    172,146

     

    Restructuring

     

                     28,402

     

     

     

                              -

     

     

     

                28,402

     

     

     

                              -

     

    Total operating costs and expenses

     

                   140,056

     

     

     

                    177,330

     

     

     

              273,967

     

     

     

                    347,647

     

    Loss from operations

     

                  (138,967

    )

     

     

                  (176,457

    )

     

     

             (270,592

    )

     

     

                  (346,309

    )

                   
    Interest income, net

     

                       2,686

     

     

     

                       8,220

     

     

     

                  7,416

     

     

     

                      14,662

     

    Other income (expense), net

     

                          (66

    )

     

     

                            16

     

     

     

                       89

     

     

     

                            20

     

    Net loss 

     $

               (136,347

    )

     

     $

                (168,221

    )

     

     $

          (263,087

    )

     

     $

                (331,627

    )

    Net loss per share - basic and diluted

     $

                    (2.63

    )

     

     $

                     (3.28

    )

     

     $

                (5.07

    )

     

     $

                     (6.65

    )

    Weighted average shares outstanding - basic and diluted

     

               51,926,074

     

     

     

               51,257,640

     

     

     

          51,917,417

     

     

     

               49,882,377

     

    Sage Therapeutics, Inc. and Subsidiaries
    Condensed Consolidated Balance Sheets 
    (in thousands)
    (unaudited)
             
        June 30,

    2020
      December 31,

    2019
    Cash, cash equivalents, restricted cash and investments  

     $

                758,889

     

     $

              1,010,760

    Total assets  

     $

                827,242

     

     $

              1,084,150

    Total liabilities  

     $

                  87,327

     

     $

                 139,495

    Total stockholders' equity  

     $

                739,915

     

     $

                 944,655

    About ZULRESSO™ (brexanolone) CIV injection

    ZULRESSO, the first medicine specifically approved by the U.S. Food and Drug Administration (FDA) for the treatment of postpartum depression (PPD) in adults, is a positive allosteric modulator of both synaptic and extrasynaptic GABAA receptors. Allosteric modulation of neurotransmitter receptor activity results in varying degrees of desired activity rather than complete activation or inhibition of the receptor.

    SELECT IMPORTANT SAFETY INFORMATION

    These are not all the side effects of ZULRESSO.

    ZULRESSO can cause serious side effects, including:

    • Excessive sedation and sudden loss of consciousness. ZULRESSO may cause you to feel very sleepy (excessive sedation) or pass out (loss of consciousness). Your healthcare provider should check you for symptoms of excessive sleepiness every 2 hours while you are awake.
      • During your infusion, tell your healthcare provider right away if you feel like you cannot stay awake during the time you are normally awake or if you feel like you are going to pass out. Your healthcare provider may lower your dose or stop the infusion until symptoms go away
      • You must have a caregiver or family member with you to help care for your child(ren) during your infusion
    • Because of the risk of serious harm resulting from excessive sedation or sudden loss of consciousness, ZULRESSO is only available through a restricted program called the ZULRESSO REMS.

    ZULRESSO can cause other serious side effects, including:

    • Increased risk of suicidal thoughts or actions. ZULRESSO and other antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger. Pay close attention to and tell your healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you:
      • Attempts to commit suicide, thoughts about suicide or dying, new or worse depression, other unusual or sudden changes in behavior or mood
      • Keep all follow-up visits and call your healthcare provider between visits as needed, especially if you have concerns about symptoms.

    The most common side effects of ZULRESSO include:

    • Sleepiness, dry mouth, passing out, flushing of the skin or face.

    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Before receiving ZULRESSO, tell your healthcare provider about all your medical conditions including if you drink alcohol, have kidney problems, are pregnant or think you may be pregnant, or are breastfeeding or plan to breastfeed. It is not known if ZULRESSO will harm your unborn baby. If you become pregnant during treatment, talk with your healthcare provider about enrolling with the National Pregnancy Registry for Antidepressants at 1-844-405-6185.

    While receiving ZULRESSO, avoid the following:

    • Driving a car or doing other dangerous activities after your ZULRESSO infusion untilyour feeling of sleepiness has completely gone away
    • Do not drink alcohol

    Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ZULRESSO and some medicines may interact with each other and cause serious side effects.

    Especially tell your healthcare provider if you take other antidepressants, opioids, or Central Nervous System (CNS) depressants (such as benzodiazepines).

    Please see the patient Medication Guide, including information about serious side effects, for Zulresso in the full Prescribing Information.

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  9. 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, today announced that the Company will present at the 2020 Wedbush PacGrow Healthcare Virtual Conference on Wednesday, August 12, 2020 at 1:45 p.m. ET.

    A live webcast of the presentation can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcast will also be archived for up to 30 days on Sage's website following the conference.

    About Sage Therapeutics

    Sage Therapeutics is a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with…

    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, today announced that the Company will present at the 2020 Wedbush PacGrow Healthcare Virtual Conference on Wednesday, August 12, 2020 at 1:45 p.m. ET.

    A live webcast of the presentation can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcast will also be archived for up to 30 days on Sage's website following the conference.

    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.

    View Full Article Hide Full Article
  10. 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, today announced it will host a live webcast on Monday, August 10, 2020, at 8:30 a.m. ET to announce second quarter 2020 financial results and discuss recent business updates.

    The webcast can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcast will be available 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…

    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, today announced it will host a live webcast on Monday, August 10, 2020, at 8:30 a.m. ET to announce second quarter 2020 financial results and discuss recent business updates.

    The webcast can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcast will be available 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.

    View Full Article Hide Full Article
  11. 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, today announced that the Company will present at the Goldman Sachs 41st Annual Global Healthcare Conference on Wednesday, June 10, 2020 at 3:00 p.m. ET.

    A live webcast of the presentation can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcast will also be archived for up to 30 days on Sage's website following the conference.

    About Sage Therapeutics

    Sage Therapeutics is a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with…

    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, today announced that the Company will present at the Goldman Sachs 41st Annual Global Healthcare Conference on Wednesday, June 10, 2020 at 3:00 p.m. ET.

    A live webcast of the presentation can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcast will also be archived for up to 30 days on Sage's website following the conference.

    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.

    View Full Article Hide Full Article
  12. 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, today announced that the Company will present at the Bank of America Health Care Conference 2020 on Wednesday, May 13, 2020 at 1:40 p.m. ET.

    A live webcast of the presentation can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcast will also be archived for up to 30 days on Sage's website following the conference.

    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…

    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, today announced that the Company will present at the Bank of America Health Care Conference 2020 on Wednesday, May 13, 2020 at 1:40 p.m. ET.

    A live webcast of the presentation can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcast will also be archived for up to 30 days on Sage's website following the conference.

    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.

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  13. Expected initiation of three new short-term zuranolone clinical studies in 2020, with the potential for three distinct indications

    April restructuring to advance corporate strategy and pipeline expected to result in approximate annualized cost savings of $170M, with significant portion related to ZULRESSO commercial and G&A support

    Progress continues in neurology and neuropsychiatry franchises with planned initiation of Phase 2 clinical trials of SAGE-324 in 1H and SAGE-718 in 2H, 2020

    Mike Cloonan elevated to chief operating officer

    Conference call today at 4:30 p.m. ET

    Today, Sage Therapeutics, Inc. (NASDAQ:SAGE), a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people…

    Expected initiation of three new short-term zuranolone clinical studies in 2020, with the potential for three distinct indications

    April restructuring to advance corporate strategy and pipeline expected to result in approximate annualized cost savings of $170M, with significant portion related to ZULRESSO commercial and G&A support

    Progress continues in neurology and neuropsychiatry franchises with planned initiation of Phase 2 clinical trials of SAGE-324 in 1H and SAGE-718 in 2H, 2020

    Mike Cloonan elevated to chief operating officer

    Conference call today at 4:30 p.m. ET

    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, reported business highlights and financial results for the first quarter ended March 31, 2020. The Company also announced the promotion of Mike Cloonan to chief operating officer; he will continue to report into Jeff Jonas, Sage's chief executive officer. In the newly created role, Mr. Cloonan will strategically align the business functions to support the ongoing development and commercialization of Sage's brain health portfolio.

    "I want to take a moment to acknowledge the challenges resulting from the global COVID-19 pandemic. I'm proud of the way our employees, partners, and the community have responded in this unprecedented time," said Jeff Jonas, M.D., chief executive officer at Sage Therapeutics. "The teams at Sage are handling virtual work well, and progress across our pipeline remains strong. Our mission is more important than ever as mental health issues are coming to the forefront and will continue to have significant impact even after the current phase of the COVID-19 pandemic is over. The strategic decisions we made in the first quarter, and the promotion of Mike to chief operating officer, have us on the right track, we believe, to continue developing medicines that matter for people with brain health disorders."

    Portfolio Updates

    Sage is advancing a portfolio of novel and differentiated product candidates designed to improve brain health by targeting the GABAA and NMDA receptor systems. Dysfunction in these systems is thought to be at the core of numerous neurological and neuropsychiatric disorders.

    Depression Franchise

    The Depression Franchise includes zuranolone (SAGE-217), Sage's next-generation positive allosteric modulator (PAM) of GABAA receptors, being evaluated in clinical development as a treatment for various affective disorders, and ZULRESSO™ (brexanolone) CIV injection, the first treatment approved by the U.S. Food and Drug Administration (FDA) specifically for postpartum depression (PPD). Zuranolone has received breakthrough therapy designation from the FDA for the treatment of major depressive disorder (MDD).

    • Zuranolone: Sage is evaluating the potential of zuranolone as a rapid-acting, short-course treatment for PPD and MDD. Following discussions with the FDA, Sage plans to initiate three new short-term clinical studies in 2020, with the potential, if successful, for three distinct indications: PPD, acute rapid response therapy (RRT) in MDD when co-initiated with a newly administered standard antidepressant, and episodic treatment of MDD. These planned studies include:
      • Oral therapy in women with PPD: Placebo-controlled trial evaluating a two-week course of zuranolone 50 mg in women with PPD, with additional short-term follow-up.
        • Topline data from this study is anticipated in 2021.
      • RRT in patients with MDD when co-initiated with a newly administered standard antidepressant therapy: Placebo-controlled trial evaluating a two-week course of zuranolone 50 mg, when co-initiated with an open-label SSRI, in patients with MDD, with additional short-term follow-up.
        • Topline data from this study is anticipated in 2021.
      • Episodic therapy in patients with MDD: Placebo-controlled trial evaluating a two-week course of zuranolone 50 mg in patients with MDD, with additional short-term follow-up.
        • Topline data from this study is anticipated in 2021.
        • Long-term safety data, including data from REDWOOD (MDD-302), are expected to be required to support a new drug application (NDA) filing for episodic treatment of depression.
      • Ongoing study updates:
      • SHORELINE Study (MDD-303): The Company is on track to report topline data in 2020 from patients with MDD who received zuranolone 30 mg in the SHORELINE Study.
        • The protocol has been amended to allow currently enrolled patients to receive retreatment with zuranolone 50 mg.
        • The Company expects to enroll a new cohort of patients with MDD who will receive zuranolone 50 mg.
      • REDWOOD Study (MDD-302) and RAINFOREST Study (MDD-304): The Company has paused enrollment in the REDWOOD and RAINFOREST Studies, and is in the process of closing active sites, to focus resources and activities on enrollment in the three new planned Phase 3 clinical studies. The Company plans to reevaluate whether and when to reinitiate the REDWOOD and RAINFOREST studies at a later date.
    • The Company is also currently evaluating the ongoing zuranolone clinical pharmacology and safety program and plans to finalize requirements to support a potential future NDA with the FDA.
    • ZULRESSOTM (brexanolone) CIV injection:
      • Revenue for Q1 2020 was $2.3 million, a 17% increase over Q4 2019. The Company continued focusing its efforts on navigating the barriers to treatment with ZULRESSO. The number of patients infused in the first quarter increased by more than 20% compared to the previous quarter. The Company received approximately 320 start forms and 12 new treating sites of care were added in the first quarter, increasing the total number of sites that have treated patients with ZULRESSO to 41 since launch.
      • The recent rapid spread of COVID-19 in the U.S. has resulted in a significant reduction in patient demand as well as sites of care starting to pause treatment of new patients with ZULRESSO during March 2020, and in increasing numbers since then. As a result of the pandemic only approximately 15% of sites active in the first quarter remained active in April. Concerns about exposure to the virus have also caused a reduction in the number of women with PPD seeking treatment with ZULRESSO, as evidenced by the approximately 75% decline in the monthly start form volume in April compared to the average monthly volume for the first quarter of 2020.
      • Sage recently executed a corporate restructuring. As a part of the restructuring, Sage downsized commercial efforts, including elimination of its entire salesforce. The Company now has a small account management field-based team with a primary focus on working with healthcare providers and supporting women with PPD in geographies with active, ZULRESSO treating sites.
      • Given the ongoing impact of the COVID-19 pandemic in the U.S., the Company expects de minimis revenues from sales of ZULRESSO in the second quarter of 2020. The Company does not plan to provide revenue guidance for the balance of 2020. The Company anticipates, however, that the COVID-19 pandemic will continue to have an adverse impact on sales of ZULRESSO even after pandemic-related restrictions are eased as sites of care adjust to new processes and address ongoing concerns as the situation evolves.

    Neurology Franchise

    SAGE-324, a next-generation PAM of GABAA receptors and Sage's lead neurology asset, is in development as a potential oral therapy for neurological conditions, such as essential tremor (ET), epilepsy and Parkinson's disease.

    • SAGE-324: The Company plans to initiate a placebo-controlled Phase 2 study evaluating the safety and efficacy of SAGE-324 in patients with ET in the first half of 2020. Patients will receive a once-daily, four-week course of SAGE-324 60 mg or placebo.

      ‒ The planned progression of SAGE-324 in ET is based on results from a Phase 1 open-label study evaluating the safety and pharmacokinetics of SAGE-324 in patients with ET. Data from the study will be presented in 2020.

    Neuropsychiatry Franchise

    SAGE-718, Sage's 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, including Huntington's disease (HD).

    • SAGE-718: The Company plans to initiate one or more Phase 2a open-label studies in 2020 evaluating SAGE-718 in patients with impaired cognitive function, which may include Parkinson's disease, Alzheimer's disease, and other neuropsychiatric disorders. Results from these studies will inform potential advancement of SAGE-718 into further Phase 2 development.

      ‒ The planned progression of SAGE-718 in disorders associated with impaired cognitive function is based on results from a Phase 1 open-label study evaluating the safety and pharmacokinetics of SAGE-718 in a cohort of patients with early HD. Results from the study were presented at the CHDI Foundation annual meeting in February 2020.

    Anticipated Upcoming Milestones and Potential Impact of COVID-19

    Sage has implemented business continuity policies and practices intended to safeguard employees and help reduce the spread of COVID-19, including initiating a work from home policy for all employees. Sage is working closely with clinical development teams to develop strategies to help mitigate potential disruptions caused by COVID-19 and at this time the Company does not anticipate there will be a significant impact to timelines for its planned or ongoing clinical programs.

    1H2020

    • SAGE-324:

      ‒ Initiate Phase 2 placebo-controlled study in ET

    2H 2020

    • Zuranolone:

      ‒ Initiate Phase 3 trial evaluating a two-week course of zuranolone 50 mg in women with PPD

      ‒ Initiate Phase 3 trial evaluating a two-week course of zuranolone 50 mg, when co-initiated with an open-label SSRI, as an acute rapid response therapy in patients with MDD

      ‒ Initiate Phase 3 trial evaluating a two-week course of zuranolone 50 mg in patients with MDD (acute study intended to support episodic indication)

      ‒ Report topline data from Phase 3 MDD SHORELINE Study (30 mg)
    • SAGE-718:

      ‒ Initiate Phase 2a open-label study or studies in various disorders associated with cognitive dysfunction

    2021

    • Zuranolone:

      ‒ Report topline data from Phase 3 trials in PPD, RRT, and MDD
    • SAGE-324:

      ‒ Report topline data from Phase 2 placebo-controlled study in ET
    • SAGE-718:

      ‒ Report topline data from Phase 2a open-label study or studies in various disorders associated with cognitive dysfunction

    Financial Results for the First Quarter 2020

    • Revenues: Sage recorded $2.3 million in net revenues in the first quarter of 2020 from sales of ZULRESSO. Sage recorded $0.5 million in collaboration revenues from Shionogi & Co., Ltd. related to reimbursement of product expense for the same period of 2019.
    • Cash Position: Cash, cash equivalents, restricted cash, and marketable securities as of March 31, 2020 were approximately $0.9 billion compared to $1.0 billion at December 31, 2019.
    • R&D Expenses: Research and development expenses were $63.6 million, including $12.2 million of non-cash stock-based compensation expense, in the first quarter of 2020, compared to $86.4 million, including $20.7 million of non-cash stock-based compensation expense, for the same period of 2019. The decrease in R&D expenses was primarily related to pauses in enrollment of certain Phase 3 clinical trials of zuranolone in MDD and the completion of the MOUNTAIN Study, a Phase 3 clinical trial of zuranolone in MDD.
    • SG&A Expenses: Selling, general and administrative expenses were $70.1 million, including $18.9 million of non-cash stock-based compensation expense, in the first quarter of 2020, compared to $83.9 million, including $23.4 million of non-cash stock-based compensation expense, for the same period in 2019. The decrease in SG&A expenses was primarily due to a decrease in professional fees, primarily due to costs incurred in the three months ended March 31, 2019, related to preparations for the commercial launch of ZULRESSO in the U.S., which commenced on June 24, 2019.
    • Net Loss: Net loss was $126.7 million for the first quarter of 2020, compared to a net loss of $163.4 million for the comparable period of 2019.

    Financial Guidance

    • Sage anticipates a cash balance of at least $550 million at end of 2020, which the Company anticipates will support operations into 2022 based on current operating plans.

    Conference Call Information

    Sage will host a conference call and webcast today, Thursday, May 7, 2020, at 4:30 p.m. ET to discuss its first quarter 2020 financial results and recent corporate updates. 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 revenues from sales of ZULRESSO and factors that may impact revenues, including the expected impact of the COVID-19 pandemic on ZULRESSO revenues; our clinical development plans and expected timelines, including our belief as to our ability to mitigate the possible impact of the COVID-19 pandemic on our clinical development timelines; the amount of the expected one-time cost associated with our restructuring; expected reductions in external expenses; our expectations with respect to 2020 operating expenses and year-end cash; our belief that existing cash will support operations into 2022; our belief in 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: we may never be able to generate meaningful revenues from sales of ZULRESSO or to generate revenues at levels necessary to justify our investment; the impact of the COVID-19 pandemic on sales of ZULRESSO may last longer than we expect or may reoccur in waves; our post-restructuring focus on geographies where there are existing, active ZULRESSO treating sites may not be sufficient for us to achieve success from the sale of ZULRESSO or to generate revenues at meaningful levels or at levels necessary to justify our investment even after the impact of the COVID-19 pandemic lessens; we may not be able to overcome the barriers to treatment with ZULRESSO or we may continue to encounter other issues or challenges in commercializing ZULRESSO which could further limit the potential of ZULRESSO and the timing and amount of future revenues; results achieved with use of ZULRESSO in the treatment of PPD in commercial use may be different than observed in clinical trials, and may vary among patients; the number of women with PPD or the unmet need for additional treatment options may be significantly smaller than we expect; we may not realize expected cost savings from our restructuring, including the anticipated decrease in external spend, at the levels we expect; we may encounter delays in initiation or conduct of our 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 or enrollment 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 internal and external costs required for our ongoing and planned activities, and the resulting impact on expense and use of cash, may be higher than expected which may cause us to use cash more quickly than we expect or change or curtail some of our plans or both; our expectations as to expenses, year-end cash and cash needs may prove not to be correct for other reasons such as changes in plans or actual events being different than our assumptions; we may be opportunistic in our future financing plans even if available cash is sufficient; 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; 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 the product without further development work or may not support further development at all; 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 planning to study in 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; 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.

    Sage Therapeutics, Inc. and Subsidiaries
    Condensed Consolidated Statements of Operations
    (in thousands, except share and per share data)
    (unaudited)
     

    Three Months Ended March 31,

    2020

     

    2019

    Product revenue, net

    $

    2,286

     

    $

    -

     

    Collaboration revenue

     

    -

     

     

    465

     

    Total revenue

     

    2,286

     

     

    465

     

     
    Operating costs and expenses:
    Cost of goods sold

     

    170

     

     

    -

     

    Research and development

     

    63,610

     

     

    86,398

     

    Selling, general and administrative

     

    70,130

     

     

    83,919

     

    Total operating costs and expenses

     

    133,910

     

     

    170,317

     

     
    Loss from operations

     

    (131,624

    )

     

    (169,852

    )

    Interest income, net

     

    4,729

     

     

    6,442

     

    Other income, net

     

    155

     

     

    4

     

    Net loss

    $

    (126,740

    )

    $

    (163,406

    )

    Net loss per share - basic and diluted

    $

    (2.44

    )

    $

    (3.37

    )

    Weighted average shares outstanding - basic and diluted

     

    51,908,760

     

     

    48,491,834

     

    Sage Therapeutics, Inc. and Subsidiaries
    Condensed Consolidated Balance Sheets
    (in thousands)
    (unaudited)
     
    March 31,
    2020
    December 31,
    2019
    Cash, cash equivalents, restricted cash and investments

    $

    875,124

    $

    1,010,760

    Total assets

    $

    944,973

    $

    1,084,150

    Total liabilities

    $

    95,767

    $

    139,495

    Total stockholders' equity

    $

    849,206

    $

    944,655

    About ZULRESSO™ (brexanolone) CIV injection

    ZULRESSO, the first medicine specifically approved by the U.S. Food and Drug Administration (FDA) for the treatment of postpartum depression (PPD) in adults, is a positive allosteric modulator of both synaptic and extrasynaptic GABAA receptors. Allosteric modulation of neurotransmitter receptor activity results in varying degrees of desired activity rather than complete activation or inhibition of the receptor.

    IMPORTANT SAFETY INFORMATION

    What is the most important information I should know about ZULRESSO?

    ZULRESSO can cause serious side effects, including:

    • Excessive sedation and sudden loss of consciousness. ZULRESSO may cause you to feel very sleepy (excessive sedation) or pass out (loss of consciousness). Your healthcare provider should check you for symptoms of excessive sleepiness every 2 hours while you are awake.

      - During your ZULRESSO infusion, tell your healthcare provider right away if you feel like you cannot stay awake during the time you are normally awake or if you feel like you are going to pass out. Your healthcare provider may lower your dose or stop the infusion until symptoms go away.

      - You must have a caregiver or family member with you to help care for your child(ren) during your ZULRESSO infusion.
    • Because of the risk of serious harm resulting from excessive sedation or sudden loss of consciousness, ZULRESSO is only available through a restricted program called the ZULRESSO REMS.

    Before receiving ZULRESSO, tell your healthcare provider about all your medical conditions, including if you:

    • drink alcohol
    • have kidney problems
    • are pregnant or think you may be pregnant. It is not known if ZULRESSO will harm your unborn baby.

      - There is a pregnancy registry for females who are exposed to ZULRESSO during pregnancy. The purpose of the registry is to collect information about the health of females exposed to ZULRESSO and their baby. If you become pregnant during treatment with ZULRESSO, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visit https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/
    • are breastfeeding or plan to breastfeed. ZULRESSO passes into breast milk. Talk to your healthcare provider about the risks and benefits of breastfeeding and about the best way to feed your baby while receiving ZULRESSO.

    Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

    ZULRESSO and some medicines may interact with each other and cause serious side effects.

    Especially tell your healthcare provider if you take other antidepressants, opioids, or Central Nervous System (CNS) depressants (such as benzodiazepines).

    Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. Your healthcare provider will decide if other medicines can be taken with ZULRESSO.

    How will I receive ZULRESSO?

    ZULRESSO is given to you by continuous intravenous (IV) infusion into your vein. The infusion will last for a total of 60 hours (2.5 days).

    What should I avoid while receiving ZULRESSO?

    • ZULRESSO may make you feel dizzy and sleepy. Do not drive a car or do other dangerous activities after your ZULRESSO infusion until your feeling of sleepiness has completely gone away. See "What is the most important information I should know about ZULRESSO?"
    • Do not drink alcohol while receiving ZULRESSO.

    What are the possible side effects of ZULRESSO?

    ZULRESSO can cause serious side effects, including:

    • See "What is the most important information I should know about ZULRESSO?"
    • Increased risk of suicidal thoughts or actions. ZULRESSO and other antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger. Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.

    How can I watch for and try to prevent suicidal thoughts and actions?

    - Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions.

    - Tell your healthcare provider right away if you have any new or sudden changes in mood, behavior, thoughts, or feelings.

    - Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.

    Tell your healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you:

    - Attempts to commit suicide, thoughts about suicide or dying, new or worse depression, other unusual changes in behavior or mood

    The most common side effects of ZULRESSO include:

    • Sleepiness, dry mouth, passing out, flushing of the skin or face.

    These are not all the side effects of ZULRESSO.

    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Please see Full Prescribing Information including Boxed Warning and Medication Guide for ZULRESSO and discuss any questions you may have with your healthcare provider.

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  14. 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, today announced it will host a live webcast on Thursday, May 7, 2020, at 4:30 p.m. EDT to announce first quarter 2020 financial results and discuss recent business updates.

    The webcast can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcast will be available 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…

    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, today announced it will host a live webcast on Thursday, May 7, 2020, at 4:30 p.m. EDT to announce first quarter 2020 financial results and discuss recent business updates.

    The webcast can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcast will be available 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.

    View Full Article Hide Full Article
  15. Changes are expected to result in annualized cost savings of approximately $170 million, including SG&A savings of $150 million

    Headcount reduction of 340 – approximately 53 percent of workforce

    Current balance of cash, cash equivalents, restricted cash, and marketable securities expected to support operations into 2022

    Based on current information, anticipated 2020 and 2021 R&D milestones remain unchanged

    Conference call today at 4:30 p.m. EDT

    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, today announced a restructuring intended to enable the Company to advance its corporate strategy…

    Changes are expected to result in annualized cost savings of approximately $170 million, including SG&A savings of $150 million

    Headcount reduction of 340 – approximately 53 percent of workforce

    Current balance of cash, cash equivalents, restricted cash, and marketable securities expected to support operations into 2022

    Based on current information, anticipated 2020 and 2021 R&D milestones remain unchanged

    Conference call today at 4:30 p.m. EDT

    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, today announced a restructuring intended to enable the Company to advance its corporate strategy and pipeline. The resulting cost savings are comprised of a reduction in the workforce of approximately 53 percent, in addition to an expected decrease in external expenses that together are anticipated to result in annualized savings of approximately $170 million, of which $150 million is related to SG&A. The workforce reduction will primarily affect the ZULRESSO™ (brexanolone) CIV injection commercial operation and related SG&A support functions. The Company remains committed to working with healthcare providers and patients seeking access to ZULRESSO, but commercial efforts will be focused on geographies that have existing, active ZULRESSO treating sites.

    "The headwinds we are facing individually and collectively, along with a recognition of our need to move forward as a company, have led to this difficult decision. We believe this cost reduction and reallocation of resources will help Sage advance our portfolio in a way that is consistent with our mission of delivering medicines that matter to people with serious brain health disorders," said Jeff Jonas, M.D., chief executive officer at Sage Therapeutics. "Unfortunately, we will be saying goodbye to some of our valued colleagues and I want to thank them for their dedication to always doing what's best for patients. Moving forward, we are confident that we have a great team that will continue to execute on our multi-franchise strategy. We believe Sage's mission is more important than ever, especially as mental health issues are coming to the forefront and will continue to have significant impact, even after the current phase of the pandemic."

    Based on the current operating plan and assumptions, Sage expects that its balance of cash, cash equivalents, restricted cash, and marketable securities of approximately $1.0 billion at the end of 2019 will support operations into 2022. Sage expects to incur a one-time cost of approximately $31 million, associated with the reduction in workforce, primarily in the second quarter of 2020. The Company anticipates operating expenses in 2020 will be lower than the previous year; additional financial guidance will be provided on the Company's 1Q 2020 quarterly earnings update in May.

    The Company continues to focus on its three brain health franchises – depression, neurology and neuropsychiatry – and anticipated 2020 and 2021 R&D milestones remain unchanged.

    Strategic focus areas

    The restructuring will enable the Company to focus on key strategic areas and supporting ongoing development activity, including:

    • Planned initiation and completion of three new zuranolone pivotal studies; completion of the 30 mg arm of zuranolone SHORELINE Study in major depressive disorder (MDD)
    • Efforts to meet clinical timelines goals, including those related to SAGE-324 and SAGE-718
    • Maintain a level of access to ZULRESSO by focusing on geographies with existing treating sites that administer this innovative treatment

    2020 planned trial initiations

    • Zuranolone (topline data anticipated in 2021)
      • Initiate Phase 3 study evaluating zuranolone 50 mg in women with postpartum depression (PPD)
      • Initiate Phase 3 study evaluating zuranolone 50 mg in patients with MDD
      • Initiate Phase 3 study evaluating zuranolone 50 mg in patients with MDD as an acute rapid response treatment (RRT) when co-initiated with an SSRI
      • Add cohort to Phase 3 SHORELINE Study evaluating zuranolone 50 mg in patients with MDD
    • SAGE-324
      • Initiate Phase 2 study evaluating SAGE-324 60 mg in essential tremor (ET) (1H 2020)
    • SAGE-718
      • Initiate Phase 2a open-label study or studies evaluating SAGE-718 in one or more disorders associated with cognitive dysfunction (2020)

    Conference Call/Webcast Information:

    Sage will host a conference call and webcast today, Tuesday, April 7, 2020, at 4:30 p.m. EDT to discuss the recent corporate updates. 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 statements as to: the potential cost savings from our restructuring; expected reductions in external expenses; the amount of the expected one-time cost associated with our restructuring; our expectations that the cost savings from the restructuring will help advance our programs and our mission; our expectations with respect to 2020 operating expenses and our belief that existing cash will support operations into 2022; our clinical development plans and expected timelines; and the goals, opportunity and potential for our business. 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 not realize expected cost savings from the restructuring, including the anticipated decrease in external spend, at the levels we expect; we may encounter delays in initiation or conduct of our 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; the internal and external costs required for our ongoing and planned activities, and the resulting impact on expense and use of cash, may be higher than expected which may cause us to use cash more quickly than we expect or change or curtail some of our plans or both; our expectations as to expenses, cash usage and cash needs may prove not to be correct for other reasons such as changes in plans or actual events being different than our assumptions; we may be opportunistic in our future financing plans even if available cash is sufficient; 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; 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 the product without further development work or may not support further development at all; 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 planning to study in 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; 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; the spread of the COVID-19 pandemic and related fears in the U.S. and outside the U.S., measures taken to curb the spread of the virus, and avoidance of healthcare settings and public interactions as a result of the foregoing may negatively impact expected site initiation or enrollment in our clinical trials, or cause us to pause trials, in each case which may significantly impact our ability to meet our expected time-lines or may significantly impact our costs or other aspects of our business or cause us to have to change our plans; 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 Annual Report on Form 10-K, 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.

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  16. 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, today announced that on April 1, 2020, the Compensation Committee of Sage's Board of Directors granted non-qualified stock options to purchase an aggregate of 540 shares of its common stock, and 90 performance restricted stock units (PSUs) to one new employee under Sage's 2016 Inducement Equity Plan.

    The 2016 Inducement Equity Plan is used exclusively for the grant of equity awards to individuals who were not previously an employee or non-employee director of Sage (or following a bona fide period of non-employment), as an inducement material…

    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, today announced that on April 1, 2020, the Compensation Committee of Sage's Board of Directors granted non-qualified stock options to purchase an aggregate of 540 shares of its common stock, and 90 performance restricted stock units (PSUs) to one new employee under Sage's 2016 Inducement Equity Plan.

    The 2016 Inducement Equity Plan is used exclusively for the grant of equity awards to individuals who were not previously an employee or non-employee director of Sage (or following a bona fide period of non-employment), as an inducement material to such individual's entering into employment with Sage, pursuant to Rule 5635(c)(4) of the NASDAQ Listing Rules.

    The options have an exercise price of $26.75 per share, which is equal to the closing price of Sage's common stock on April 1, 2020. Each option will vest and become exercisable as to 25% of the shares on the first anniversary of the recipient's start date and will vest and become exercisable as to the remaining 75% of the shares in 36 equal monthly installments following the first anniversary, in each case, subject to such employee's continued employment with Sage on such vesting dates. The PSUs will vest in increments if pre-established performance milestones are achieved, subject to the employee's continued employment with Sage on such vesting dates.

    The equity awards are subject to the terms and conditions of Sage's 2016 Inducement Equity Plan, and the terms and conditions of equity award agreements covering the grants.

    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.

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  17. Expected regulatory pathway for episodic treatment of major depression remains unchanged with plan for one new additional efficacy study

    Pursuing two additional pathways with the goal of accelerating patient access to zuranolone while continuing development for the episodic treatment of depression

    Plans to pursue novel development and filing pathway for acute, rapid treatment of major depressive episodes when co-initiated with new antidepressant with one additional short-term pivotal study

    Filing pathway for postpartum depression anticipated to require one additional study without long-term follow-up

    Sage Therapeutics, Inc. (NASDAQ:SAGE), a biopharmaceutical company committed to developing novel therapies with the potential to transform…

    Expected regulatory pathway for episodic treatment of major depression remains unchanged with plan for one new additional efficacy study

    Pursuing two additional pathways with the goal of accelerating patient access to zuranolone while continuing development for the episodic treatment of depression

    Plans to pursue novel development and filing pathway for acute, rapid treatment of major depressive episodes when co-initiated with new antidepressant with one additional short-term pivotal study

    Filing pathway for postpartum depression anticipated to require one additional study without long-term follow-up

    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, today announced next steps in the Landscape Program, the clinical program evaluating zuranolone (SAGE-217) for the treatment of postpartum depression (PPD) and major depressive disorder (MDD), following a Breakthrough Therapy guidance meeting with the U.S. Food and Drug Administration (FDA). Sage has identified three potential pathways intended, if successful, to support a possible filing for approval of zuranolone in the U.S. in two novel indications – PPD and acute treatment of MDD when co-initiated with a new antidepressant – along with the previously disclosed development plan for the treatment of MDD as an episodic therapy.

    "Following FDA guidance, Sage has several potential pathways to bring zuranolone to patients, if we are successful, with two pathways that would represent unique indications that we believe we can progress quickly and efficiently, while in tandem we pursue our original approach to develop zuranolone for the episodic treatment of depression," said Jeff Jonas, M.D., chief executive officer of Sage Therapeutics. "The development program for zuranolone is an example of Sage's ability to think differently about depression, with the goal of providing treatment options that help people with depression get better, sooner. Sage is well-positioned for the path forward, and to continue advancing our multi-franchise strategy."

    Zuranolone Landscape Program

    The Landscape Program is evaluating the potential of zuranolone as a rapid-acting, short-course oral treatment for PPD and MDD. It includes three completed pivotal efficacy studies evaluating zuranolone 30 mg in PPD (ROBIN Study) and MDD (MDD-201, MOUNTAIN Study), the results of which have been previously reported.

    Planned studies to support multiple filing pathways

    Following discussions with the FDA, Sage plans to initiate three new short-term clinical studies in 2020, with the potential, if successful, for three distinct indications: PPD, acute rapid response therapy in MDD when co-initiated with a new standard antidepressant, and episodic treatment of MDD. These planned studies include:

    1. For use as an oral therapy in women with PPD: one additional positive pivotal trial, along with data from previously completed studies, is expected to be required to support an efficacy claim in PPD. No additional long-term follow-up is expected to be required to support an efficacy claim in this indication:

    • Placebo-controlled trial evaluating a two-week course of zuranolone 50 mg in women with PPD, with additional short-term follow-up. Topline data from this study is anticipated in 2021.

    2. For use as an acute rapid response therapy (RRT) in patients with MDD when co-initiated with new standard antidepressant therapy: one additional positive treatment study, along with data from previously completed acute treatment studies, is expected to be required to support an efficacy claim in this indication:

    • Placebo-controlled trial evaluating a two-week course of zuranolone 50 mg, when co-initiated with an open-label SSRI, in patients with MDD, with additional short-term follow-up. Topline data from this study is anticipated in 2021.

    3. For use as an episodic therapy in patients with MDD: one additional positive pivotal trial, along with previously completed acute treatment studies and long-term safety data, including data from REDWOOD (MDD-302), are expected to be required to support an NDA filing for episodic treatment of depression:

    • Placebo-controlled trial evaluating a two-week course of zuranolone 50 mg in patients with MDD, with additional short-term follow-up. Topline data from this study is anticipated in 2021.

    Updates to three ongoing or paused studies:

    • SHORELINE Study (MDD-303): The Company is on track to report topline data in 2020 from patients with MDD who received zuranolone 30 mg in the SHORELINE Study.
      • The protocol has been amended to allow currently enrolled patients to receive retreatment with zuranolone 50 mg. Additionally, the Company expects to enroll a new cohort of patients with MDD who will receive zuranolone 50 mg.
    • REDWOOD Study (MDD-302): The Company paused enrollment in the REDWOOD study in the fourth quarter of 2019 and plans to reevaluate timing for reinitiating the study while resources and activities focus on enrollment in the three new planned Phase 3 clinical studies.
    • RAINFOREST Study (MDD-304): The Company paused enrollment in the RAINFOREST study in the fourth quarter of 2019. The Company plans to evaluate data from ongoing and planned short-term studies prior to reinitiating enrollment.

    The updated development plan is expected to create flexibility, if successful, to pursue an efficient and expedited pathway to filing based on data from an additional positive efficacy study (e.g. in MDD when co-initiated with a new antidepressant or in PPD), which the Company believes can be achieved without further long-term follow-up data.

    The Company is also currently evaluating the ongoing zuranolone clinical pharmacology and safety program and plans to finalize requirements to support a potential future new drug application (NDA) with the FDA.

    Financial Guidance

    Based on its current operating plan and assumptions with respect to future plans and resource allocation decisions, Sage anticipates that its balance of cash, cash equivalents, restricted cash, and marketable securities of approximately $1.0 billion as of December 31, 2019, will support operations into 2022. The Company is currently re-assessing its resource allocation and prioritization strategy in light of the development of zuranolone, the uptake of ZULRESSO™ (brexanolone) CIV injection, and factoring in the potential impact on its business of the unprecedented global public health crisis. The Company plans to share its updated resource allocation strategy during its first quarter earnings call.

    About Zuranolone

    Zuranolone (SAGE-217) is a once-daily, two-week therapy in development for the treatment of major depressive disorder (MDD) and postpartum depression (PPD). Zuranolone is an investigational oral neuroactive steroid (NAS) GABAA receptor positive allosteric modulator (PAM). The GABA system is the major inhibitory signaling pathway of the brain and central nervous system and contributes significantly to regulating brain function. Zuranolone has been granted Breakthrough Therapy Designation by the U.S. Food & Drug Administration.

    About Major Depressive Disorder

    Major depressive disorder (MDD), commonly referred to as depression, is a brain health disorder that affects an estimated 17 million adults in the U.S. each year. It is one of the largest contributors to disability in the U.S. and worldwide and is characterized by symptoms of depressed mood and/or loss of interest in pleasurable activities. MDD causes significant impairment in daily life and can limit a person's ability to fulfill work, school, family, or social responsibilities; enjoy leisure activities; or maintain health and hygiene. While antidepressants are widely used to treat MDD, large-scale studies have demonstrated that there is an unmet need in the treatment of MDD, including during the weeks between initiation of treatment and onset of effect, as well as the need for new therapeutic options.

    About Postpartum Depression

    Postpartum depression (PPD) is one of the most common medical complications during and after pregnancy. PPD can have a serious negative impact on a woman, including significant functional impairment, depressed mood and/or loss of interest in her newborn, and associated symptoms of depression such as loss of appetite, difficulty sleeping, motor challenges, lack of concentration, loss of energy and poor self-esteem. PPD is estimated to affect approximately one in nine women who have given birth in the U.S. or approximately 400,000 women annually.

    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 statements as to the various potential development and regulatory pathways for zuranolone in MDD and PPD; our expectations as to the timing of initiation of clinical trials and reporting of results; our expectations regarding the potential sufficiency of the planned development program, if successful, to support regulatory filings and approvals of zuranolone in MDD and PPD; our estimates as to the number of patients with MDD and PPD; our statements regarding the potential for efficient and expedited development of zuranolone and being well-positioned for the path forward; the potential profile and benefit of zuranolone and our other product candidates; our expectations with respect to use of cash based on the current operating plan and assumptions as to future decisions and plans; and the goals, opportunity and potential for our business. 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 or conduct of our planned clinical trials, including slower than expected site initiation or enrollment, that may impact our ability to meet our expected time-lines; we may not be successful in our development of zuranolone in MDD or PPD or in our development of any of our other product candidates in any indication we are currently pursuing or may in the future pursue; success in our non-clinical studies or in earlier stage 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 the product without further development work or may not support further development at all; 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 planning to study in new trials; we may encounter issues with the efficacy or durability of short-term treatment, or co-initiated treatment 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 zuranolone, 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; the actual size of the MDD and PPD patient populations may be significantly lower than our estimates and, even if zuranolone is approved, it will only be approved or used to treat a subset of the relevant patient populations; the spread of the coronavirus and related fears in the U.S. and outside the U.S., measures taken to curb the spread of the virus, and avoidance of healthcare settings and public interactions as a result of the foregoing may impact expected site initiation or enrollment in our clinical trials and our ability to meet our expected time-lines or may significantly impact other aspects of our business causing us to have to change our plans; we may encounter technical and other unexpected hurdles in the development and manufacture of zuranolone or any of our other products which may delay our timing or change our plans; the internal and external costs required for our ongoing and planned activities, and the resulting impact on expense and use of cash, may be higher than expected which may cause us to change or curtail some of our plans; and our expectations as to cash usage and cash needs may prove not to be correct for other reasons such as changes in plans or actual events being different than our assumptions; as well as those risks more fully discussed in the section entitled "Risk Factors" in our most recent Annual Report on Form 10-K, 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.

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  18. DURHAM, N.C., March 11, 2020 (GLOBE NEWSWIRE) -- Precision BioSciences, Inc. (NASDAQ:DTIL), a life sciences company dedicated to improving life through the application of its pioneering, proprietary ARCUS® genome editing platform, announced today that Geno Germano, President and CEO of Elucida Oncology, has been appointed to the company's Board of Directors.

    "Over the course of his career, Geno has been a leader at some of the world's most innovative companies, including Intrexon, Pfizer, Wyeth and Johnson & Johnson. This experience, together with his expertise in oncology as CEO of Elucida, will be invaluable to Precision as we work to deliver on the promise of genome editing to improve human health and wellness," commented Matt Kane, CEO…

    DURHAM, N.C., March 11, 2020 (GLOBE NEWSWIRE) -- Precision BioSciences, Inc. (NASDAQ:DTIL), a life sciences company dedicated to improving life through the application of its pioneering, proprietary ARCUS® genome editing platform, announced today that Geno Germano, President and CEO of Elucida Oncology, has been appointed to the company's Board of Directors.

    "Over the course of his career, Geno has been a leader at some of the world's most innovative companies, including Intrexon, Pfizer, Wyeth and Johnson & Johnson. This experience, together with his expertise in oncology as CEO of Elucida, will be invaluable to Precision as we work to deliver on the promise of genome editing to improve human health and wellness," commented Matt Kane, CEO and co-founder of Precision BioSciences. "We welcome him and look forward to working together."

    "I am excited to join Precision BioSciences at this important time, as they continue to advance multiple innovative programs in allogeneic cell therapy and in vivo gene correction into clinical trials," said Mr. Germano. "My personal goal is to work with innovative companies who are driving real therapeutic benefit for patients in need. Precision's differentiated approach to genome editing through ARCUS, along with its expanding clinical portfolio, has tremendous potential to deliver transformative advancements in medicine across multiple different diseases."

    Mr. Germano is a 30-year veteran of the pharmaceutical and life sciences industry who, prior to joining Elucida Oncology, served as President of Intrexon, a leader in the application of synthetic biology. He has also held multiple senior roles at major pharmaceutical corporations including Pfizer, Wyeth and Johnson & Johnson. At Pfizer, he led the Global Innovative Pharmaceutical business, cultivating a $14 billion operation and guiding the development of an extensive portfolio of products in the cardiovascular, immunology, metabolic disease, neuroscience and rare disease areas. He also served as Pfizer's President and General Manager of the Specialty Care, Vaccines and Oncology business units. At Wyeth Pharmaceuticals, Mr. Germano served as President of Wyeth U.S., President of the Global Pharmaceutical and Women's Healthcare business and as Executive Vice President of the Vaccines. He has been a member of the Group of Fifty (G50) and served on the Board of the Biotechnology Innovation Organization (BIO), where he was a member of the Executive Committee. Mr. Germano has also served on the Advisory Board of the Healthcare Businesswomen's Association, and he currently serves on the board of directors at Sage Therapeutics (NASDAQ:SAGE). He received his Bachelor of Science degree at the Albany College of Pharmacy and Health Sciences.

    About Precision BioSciences, Inc.
    Precision BioSciences is dedicated to improving life (DTIL) through its proprietary genome editing platform, ARCUS. Precision leverages ARCUS in the development of its product candidates, which are designed to treat human diseases and create healthy and sustainable food and agriculture solutions. Precision is actively developing product candidates in three innovative areas: allogeneic CAR T immunotherapy, in vivo gene correction, and food. For more information regarding Precision, please visit www.precisionbiosciences.com.

    Investor Contact:
    Nick Riddle
    Precision BioSciences
    Tel. (919) 314-5512

    Media Contact:
    Cory Tromblee
    Scient Public Relations
    Tel. (617) 571-7220


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  19. 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, today announced that on March 2, 2020, the Compensation Committee of Sage's Board of Directors granted non-qualified stock options to purchase an aggregate of 4,500 shares of its common stock, and 750 performance restricted stock units (PSUs) to 1 new employee under Sage's 2016 Inducement Equity Plan.

    The 2016 Inducement Equity Plan is used exclusively for the grant of equity awards to individuals who were not previously an employee or non-employee director of Sage (or following a bona fide period of non-employment), as an inducement material…

    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, today announced that on March 2, 2020, the Compensation Committee of Sage's Board of Directors granted non-qualified stock options to purchase an aggregate of 4,500 shares of its common stock, and 750 performance restricted stock units (PSUs) to 1 new employee under Sage's 2016 Inducement Equity Plan.

    The 2016 Inducement Equity Plan is used exclusively for the grant of equity awards to individuals who were not previously an employee or non-employee director of Sage (or following a bona fide period of non-employment), as an inducement material to such individual's entering into employment with Sage, pursuant to Rule 5635(c)(4) of the NASDAQ Listing Rules.

    The options have an exercise price of $53.36 per share, which is equal to the closing price of Sage's common stock on March 2, 2020. Each option will vest and become exercisable as to 25% of the shares on the first anniversary of the recipient's start date and will vest and become exercisable as to the remaining 75% of the shares in 36 equal monthly installments following the first anniversary, in each case, subject to each such employee's continued employment with Sage on such vesting dates. The PSUs will vest in increments if pre-established performance milestones are achieved, subject to the employee's continued employment with Sage on such vesting dates.

    The equity awards are subject to the terms and conditions of Sage's 2016 Inducement Equity Plan, and the terms and conditions of equity award agreements covering the grants.

    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.

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  20. ZULRESSO™ (brexanolone) CIV injection net revenues of $2M and $4M for fourth quarter and full year 2019, respectively

    Evaluating path forward for the zuranolone (SAGE-217) Landscape Program

    Continued expansion of Neurology and Neuropsychiatry franchises with planned initiation of additional SAGE-324 and SAGE-718 studies in 2020

    Conference call today at 8:00 a.m. EST

    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, reported business highlights and financial results for the fourth quarter and full year ended December 31, 2019.

    This press release features multimedia. View the full…

    ZULRESSO™ (brexanolone) CIV injection net revenues of $2M and $4M for fourth quarter and full year 2019, respectively

    Evaluating path forward for the zuranolone (SAGE-217) Landscape Program

    Continued expansion of Neurology and Neuropsychiatry franchises with planned initiation of additional SAGE-324 and SAGE-718 studies in 2020

    Conference call today at 8:00 a.m. EST

    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, reported business highlights and financial results for the fourth quarter and full year ended December 31, 2019.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200227005220/en/

    "The progress we made in 2019 across our depression, neuropsych and neurology franchises supports our vision to make medicines that matter," said Jeff Jonas, chief executive officer of Sage Therapeutics. "Our focus in 2020 will be guided by perseverance, disciplined execution and rigorous prioritization designed to achieve an optimal pace of innovation for what we believe is a leading, novel portfolio of NCEs dedicated to treating brain health disorders. Our most immediate goal is to find the most efficient pathway to bring new treatments to patients as quickly as possible."

    Portfolio 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 thought to be at the core of numerous neurological and neuropsychiatric disorders.

    Depression Franchise

    The Depression Franchise is led by ZULRESSO™ (brexanolone) CIV injection, approved by the U.S. Food and Drug Administration (FDA) as the first treatment specifically indicated for postpartum depression (PPD), and zuranolone (SAGE-217), Sage's next-generation positive allosteric modulator (PAM) of GABAA receptors, being evaluated in clinical development as a treatment for various affective disorders. Zuranolone has received breakthrough therapy designation from the FDA for the treatment of major depressive disorder (MDD).

    • ZULRESSOTM (brexanolone) CIV injection: Enabling broad access to ZULRESSO for women with PPD and helping to activate treatment-ready sites of care remain the key focus in the launch of ZULRESSO. The Company continues to see positive indicators suggesting the long-term potential of ZULRESSO, including strong patient and health care provider (HCP) demand, as well as broad and favorable payor coverage.
      • Sites of care
        • Sage continues to help sites of care advance through the actions required to be treatment-ready to ensure women with PPD have access to a healthcare setting capable of administering ZULRESSO.
        • Based on experience during the initial six months of the ZULRESSO launch, Sage now anticipates the majority of interested sites will take nine months or longer to complete the actions required to be treatment ready. Many large hospital and healthcare systems are estimated to take 12 months or longer.
        • As of December 31, 2019, more than 175 healthcare facilities were ZULRESSO REMS certified across 75 of the top 140 Metropolitan Statistical Areas in the U.S., compared to 140 healthcare facilities as of the end of the third quarter of 2019. Of these healthcare facilities, 29 have completed all of the steps required to be treatment-ready and infused patients with ZULRESSO by the end of the year 2019, compared to 11 sites as of the end of the third quarter of 2019.
      • Payor coverage & reimbursement
        • As of December 31, 2019, plans representing in aggregate 80 percent of all covered lives have committed to favorable coverage with either light or no restrictions.
        • Sites must often negotiate the reimbursement amount for each payor under commercial coverage. Availability and sufficiency of Medicaid reimbursement varies by state and often depends on whether the state treats the ZULRESSO infusion as an outpatient or inpatient administration.
        • The Centers for Medicare & Medicaid Services assigned ZULRESSO an HCPCS C-code in January 2020. The C-code is being adopted by commercial and state Medicaid plans and is available for use on qualifying claims reflecting ZULRESSO utilization to treat women with PPD through the hospital out-patient department. Sage anticipates activation by the end of the first quarter of 2020, which could improve reimbursement transparency.
      • Patient demand & support
        • Sage continues to see strong patient demand with more than 300 start forms in the fourth quarter of 2019 compared to more than 200 in the third quarter of 2019, bringing the total to more than 500 start forms by end of year 2019. Additionally, the number of referring HCPs more than doubled in the fourth quarter of 2019 compared to the third quarter of 2019, bringing the total to more than 300 referring HCPs by the end of year 2019.
        • Sage Central, Sage's patient support center, continues to provide a range of patient resources to assist women with PPD and their families in the treatment journey. As of December 31, 2019, more than 95% of referred patients used Sage Central's resources.
      • Revenue
        • Sage expects ZULRESSO revenue growth will be modest over the next couple of quarters with an increase in the rate of growth of ZULRESSO revenue anticipated in the second half of 2020, assuming an increase in the number of treatment-ready sites, including larger hospitals administering ZULRESSO to treat women with PPD, and an increase in the volume of patients treated at existing sites. To accomplish this objective, Sage is guiding large sites through the steps necessary to become treatment-ready and supporting hospital administrations' efforts to reduce the complexity of those steps.
    • Zuranolone: The Landscape Program, the clinical program evaluating the potential of zuranolone as a rapid-acting, durable, short-course treatment for MDD and PPD, currently includes three completed pivotal efficacy studies, one in PPD (ROBIN Study) and two in MDD (MDD-201, MOUNTAIN Study), and three other initiated Phase 3 pivotal studies (REDWOOD, SHORELINE, RAINFOREST).
      • Study updates
        • MOUNTAIN Study (MDD-301): The Company announced topline data from the pivotal Phase 3 study in December 2019.
          • The MOUNTAIN study did not meet its primary endpoint of a statistically significant reduction from baseline compared to placebo in the 17-item Hamilton Rating Scale for Depression (HAM-D) total score at Day 15. Patients in the zuranolone 30 mg group achieved statistically significant reductions in the HAM-D total score at Days 3, 8 and 12.
          • Zuranolone was generally well-tolerated and showed a similar safety profile as seen in earlier studies.
        • REDWOOD Study (MDD-302): The study is a placebo-controlled pivotal trial evaluating the efficacy – time to first relapse – and long-term safety of fixed interval zuranolone 30 mg monotherapy maintenance treatment. Randomized patients receive a two-week course of zuranolone 30 mg or placebo every two months until the first relapse for up to one year.
          • The Company paused enrollment in the study in the fourth quarter of 2019 and is evaluating potential study amendments as the Company determines next steps in the Landscape Program.
        • SHORELINE Study (MDD-303): The study is an open-label, long-term pivotal trial evaluating the safety of as-needed repeat treatment with zuranolone. Patients receive an initial two-week course of zuranolone 30 mg and as needed retreatment. Patients are assessed for potential relapse of depressive symptoms for up to one year.
          • The Company anticipates reporting topline data from the SHORELINE Study in 2020.
          • The Company is also assessing the potential of adding an additional cohort to the study evaluating a higher dose of zuranolone in patients with MDD.
        • RAINFOREST Study (MDD-304): The study is a placebo-controlled pivotal trial evaluating zuranolone 30 mg in patients with comorbid MDD and insomnia. The primary endpoint of the study is change from baseline in sleep efficiency as assessed by polysomnography.
          • The Company paused enrollment in the study in the fourth quarter of 2019 and is evaluating potential study amendments as the Company determines next steps in the Landscape Program.
      • Program next steps
        • Sage previously announced that a meeting with the FDA to discuss zuranolone would occur in the first quarter of 2020. The Company continues to evaluate data from the MOUNTAIN Study and will announce next steps in the Landscape Program upon completion of relevant correspondence with the FDA, including receipt of meeting minutes, and the determination of the development and regulatory path forward.

    Neurology Franchise

    SAGE-324, a next-generation PAM of GABAA receptors and Sage's lead neurology asset, is in development as a potential oral therapy for neurological conditions, such as essential tremor (ET), epilepsy and Parkinson's disease.

    • SAGE-324: The Company plans to initiate a placebo-controlled Phase 2 study evaluating the safety and efficacy of SAGE-324 in patients with ET in the first half of 2020. Patients will receive a once-daily, four-week course of SAGE-324 60 mg or placebo.
      • The planned progression of SAGE-324 in ET is based on results from a Phase 1 open-label study evaluating the safety and pharmacokinetics of SAGE-324 in patients with ET. Data from the study will be presented in 2020.

    Neuropsychiatry Franchise

    SAGE-718, Sage's 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, including Huntington's disease (HD).

    • SAGE-718: The Company reported data from a Phase 1 open-label study evaluating the safety and pharmacokinetics of SAGE-718 in a cohort of patients with early HD in December 2019.
      • Study results
        • SAGE-718 was well tolerated, with no serious adverse events or adverse events leading to treatment discontinuation.
        • Patients demonstrated improved performance, compared to baseline, on assessments of executive functioning; executive dysfunction is a core feature of early HD. Additional data will be presented at an upcoming medical meeting.
      • Next steps
        • SAGE-718 is being developed as a potential treatment for disorders where cognitive function is impaired. In 2020, the Company plans to initiate one or more Phase 2a open-label studies evaluating SAGE-718 in patients with impaired cognitive function, which may include Parkinson's disease, Alzheimer's disease, and other neuropsychiatric disorders. Results from these studies will inform advancement of SAGE-718 into further Phase 2 development.

    Anticipated Upcoming Milestones

    • Regulatory Updates
      • The Company previously announced that a meeting with the FDA to discuss zuranolone would occur in the first quarter of 2020. The Company continues to evaluate data from the MOUNTAIN Study and will announce next steps in the Landscape Program upon completion of relevant correspondence with the FDA, including receipt of meeting minutes, and determination of the development and regulatory path forward (2020)
    • Topline Data
      • Zuranolone Phase 3 MDD SHORELINE Study (2020)
    • Planned Clinical Trial Initiations
      • SAGE-324 Phase 2 placebo-controlled study in ET (1H 2020)
      • SAGE-718 Phase 2a open-label study or studies in various disorders associated with cognitive dysfunction (2020)

    Financial Results for the Fourth Quarter and Full Year 2019

    • Revenues: Sage recorded $2.0 million in revenues in the fourth quarter of 2019 from sales of ZULRESSO. Sage recorded $0.3 million in collaboration revenues from Shionogi & Co., Ltd. related to reimbursement of product expense for the same period of 2018. For the year ended December 31, 2019, revenues were $6.9 million, including $4.0 million of net product revenues related to sales of ZULRESSO and $2.9 million in collaboration revenues from Shionogi & Co., Ltd. related to reimbursement of product expense, compared to $90.3 million in collaboration revenues from Shionogi & Co., Ltd., for the year ended December 31, 2018.
    • Cash Position: Cash, cash equivalents, restricted cash, and marketable securities as of December 31, 2019 were approximately $1.0 billion compared to $925.1 million at December 31, 2018.
    • R&D Expenses: Research and development expenses were $91.3 million, including $11.4 million of non-cash stock-based compensation expense, in the fourth quarter of 2019, compared to $88.8 million, including $15.9 million of non-cash stock-based compensation expense, for the same period of 2018. For the year ended December 31, 2019, research and development expenses were $368.8 million, including $62.9 million of non-cash stock-based compensation expense, compared to $282.1 million, including $50.9 million of non-cash stock-based compensation expense, for the year ended December 31, 2018. The increase in R&D expenses was primarily due to the advancement of the pivotal program for zuranolone in MDD and continued research and development efforts across the Company's early-stage clinical and discovery pipeline.
    • SG&A Expenses: Selling, general and administrative expenses were $85.1 million, including $19.3 million of non-cash stock-based compensation expense, in the fourth quarter of 2019, compared to $75.7 million, including $15.8 million of non-cash stock-based compensation expense, for the same period in 2018. For the year ended December 31, 2019, SG&A expenses were $345.8 million, including $90.3 million of non-cash stock-based compensation expense, compared to $201.4 million, including $51.1 million of non-cash stock-based compensation expense, for the year ended December 31, 2018. The increase in SG&A expenses was primarily due to an increase in personnel-related expenses, along with facilities and corporate infrastructure costs to support expanding operations and the ZULRESSO commercial launch.
    • Net Loss: Net loss was $168.7 million for the fourth quarter of 2019 and $680.2 million for the year ended December 31, 2019, compared to a net loss of $158.4 million and $372.9 million, respectively, for the comparable periods of 2018.

    Financial Guidance

    • Sage expects ZULRESSO revenue growth will be modest over the next couple of quarters with an increase in the rate of growth of ZULRESSO revenue anticipated in the second half of 2020.

    Conference Call Information

    Sage will host a conference call and webcast today, Thursday, February 27, 2020, at 8:00 a.m. EST to discuss its fourth quarter and full year 2019 financial results and recent corporate updates. 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 our commercial launch of ZULRESSO and its long-term potential, including the potential timing for sites to become ready to administer ZULRESSO and expectations regarding an increase in the number of activated sites, the potential timing of revenue growth, an increase in the volume of treated patients at existing sites, and the potential for favorable reimbursement of ZULRESSO; our development plans, goals and strategy and the potential timing and results of our development efforts; our plans to determine next steps with respect to the development and regulatory path forward for zuranolone and the Landscape Program, including any potential amendments to our clinical trials of zuranolone; our belief in 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: we may encounter issues or other challenges in commercializing ZULRESSO, including issues related to market acceptance by healthcare providers, healthcare settings and women with PPD, issues related to the willingness of sites to administer ZULRESSO, issues related to reimbursement, issues related to the requirements of the REMS, and challenges associated with execution of our sales and patient support activities, which in each case could limit the potential of ZULRESSO and the timing and amount of future revenues; results achieved with use of ZULRESSO in the treatment of PPD in commercial use may be different than observed in clinical trials, and may vary among patients; the number of women with PPD or the unmet need for additional treatment options may be significantly smaller than we expect; we may encounter unexpected safety or tolerability issues with ZULRESSO or any of our product candidates, including, for zuranolone or other product candidates, as a result of any increase in dosing in our clinical trials; we may not be successful in our development of any of our current or future product candidates in any indication we are currently pursuing or may in the future pursue; success in prior clinical trials or nonclinical studies may not be repeated or observed in ongoing or future studies of any of our product candidates; ongoing and future clinical or nonclinical results for our product candidates may generate results that are different than we expect or may not support further development of the product candidate or be sufficient to gain regulatory approval of our product candidates on the timelines we expect or at all, or may require additional clinical trials or nonclinical studies; we may decide that a development pathway for one of our product candidates in one or more indications is no longer feasible or advisable or that the unmet need no longer exists; the FDA may decide that the development program for any of our product candidates, even if positive, is not sufficient for a new drug application filing or approval; 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 experience slower than expected initiation or enrollment in ongoing or future clinical trials; the internal and external costs required for our ongoing and planned research and development efforts, and to manage our organization in connection with such activities, and the resulting expense increases and use of cash, may be higher than expected which may cause us to change or curtail some of our plans; we may change our plans for other business reasons; and we may encounter technical and other unexpected hurdles in the development of our product candidates; as well as those risks more fully discussed in the section entitled "Risk Factors" in our most recent annual report filed with the Securities and Exchange Commission (SEC), and discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the SEC. 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.

       
    Sage Therapeutics, Inc. and Subsidiaries  
    Condensed Consolidated Statements of Operations  
    (in thousands, except share and per share data)  
    (unaudited)  
             
      Three Months Ended December 31,     Year Ended December 31,  
     

    2019

    2018

       

    2019

    2018

     
    Product revenue, net  

    $

    1,960

     

    $

    -

     

       

    $

    3,957

     

    $

    -

     

     
    Collaboration revenue  

     

    -

     

     

    273

     

       

     

    2,911

     

     

    90,273

     

     
    Total revenue  

     

    1,960

     

     

    273

     

       

     

    6,868

     

     

    90,273

     

     
             
    Operating costs and expenses:        
    Cost of goods sold  

     

    219

     

     

    -

     

       

     

    400

     

     

    -

     

     
    Research and development  

     

    91,250

     

     

    88,805

     

       

     

    368,815

     

     

    282,107

     

     
    Selling, general and administrative  

     

    85,129

     

     

    75,695

     

       

     

    345,777

     

     

    201,404

     

     
    Total operating costs and expenses  

     

    176,598

     

     

    164,500

     

       

     

    714,992

     

     

    483,511

     

     
             
    Loss from operations  

     

    (174,638

    )

     

    (164,227

    )

       

     

    (708,124

    )

     

    (393,238

    )

     
    Interest income, net  

     

    5,915

     

     

    5,851

     

       

     

    27,804

     

     

    20,334

     

     
    Other income (expense), net  

     

    70

     

     

    (12

    )

       

     

    82

     

     

    22

     

     
    Net loss  

    $

    (168,653

    )

    $

    (158,388

    )

       

    $

    (680,238

    )

    $

    (372,882

    )

     
    Net loss per share - basic and diluted  

    $

    (3.25

    )

    $

    (3.38

    )

       

    $

    (13.38

    )

    $

    (8.08

    )

     
    Weighted average shares outstanding - basic and diluted  

     

    51,834,880

     

     

    46,876,452

     

       

     

    50,833,837

     

     

    46,121,194

     

     
    Sage Therapeutics, Inc. and Subsidiaries  
    Condensed Consolidated Balance Sheets   
    (in thousands)  
    (unaudited)  
                   
        December 31,
    2019
          December 31,
    2018
     
    Cash, cash equivalents, restricted cash and investments  

     $

             1,010,760

         

     $

                925,143

     
    Total assets  

     $

             1,084,150

         

     $

                952,705

     
    Total liabilities  

     $

                139,495

         

     $

                  89,734

     
    Total stockholders' equity  

     $

                944,655

         

     $

                862,971

     

    About ZULRESSO™ (brexanolone) CIV injection

    ZULRESSO, the first medicine specifically approved by the U.S. Food and Drug Administration (FDA) for the treatment of postpartum depression (PPD) in adults, is a positive allosteric modulator of both synaptic and extrasynaptic GABAA receptors. Allosteric modulation of neurotransmitter receptor activity results in varying degrees of desired activity rather than complete activation or inhibition of the receptor.

    IMPORTANT SAFETY INFORMATION

    What is the most important information I should know about ZULRESSO?

    ZULRESSO can cause serious side effects, including:

    • Excessive sedation and sudden loss of consciousness. ZULRESSO may cause you to feel very sleepy (excessive sedation) or pass out (loss of consciousness). Your healthcare provider should check you for symptoms of excessive sleepiness every 2 hours while you are awake.
      • During your ZULRESSO infusion, tell your healthcare provider right away if you feel like you cannot stay awake during the time you are normally awake or if you feel like you are going to pass out. Your healthcare provider may lower your dose or stop the infusion until symptoms go away.
      • You must have a caregiver or family member with you to help care for your child(ren) during your ZULRESSO infusion.
    • Because of the risk of serious harm resulting from excessive sedation or sudden loss of consciousness, ZULRESSO is only available through a restricted program called the ZULRESSO REMS.

    Before receiving ZULRESSO, tell your healthcare provider about all your medical conditions, including if you:

    • drink alcohol
    • have kidney problems
    • are pregnant or think you may be pregnant. It is not known if ZULRESSO will harm your unborn baby.
      • There is a pregnancy registry for females who are exposed to ZULRESSO during pregnancy. The purpose of the registry is to collect information about the health of females exposed to ZULRESSO and their baby. If you become pregnant during treatment with ZULRESSO, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visit https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/
    • are breastfeeding or plan to breastfeed. ZULRESSO passes into breast milk. Talk to your healthcare provider about the risks and benefits of breastfeeding and about the best way to feed your baby while receiving ZULRESSO.

    Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

    ZULRESSO and some medicines may interact with each other and cause serious side effects.

    Especially tell your healthcare provider if you take other antidepressants, opioids, or Central Nervous System (CNS) depressants (such as benzodiazepines).

    Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. Your healthcare provider will decide if other medicines can be taken with ZULRESSO.

    How will I receive ZULRESSO?

    ZULRESSO is given to you by continuous intravenous (IV) infusion into your vein. The infusion will last for a total of 60 hours (2.5 days).

    What should I avoid while receiving ZULRESSO?

    • ZULRESSO may make you feel dizzy and sleepy. Do not drive a car or do other dangerous activities after your ZULRESSO infusion until your feeling of sleepiness has completely gone away. See "What is the most important information I should know about ZULRESSO?"
    • Do not drink alcohol while receiving ZULRESSO.

    What are the possible side effects of ZULRESSO?

    ZULRESSO can cause serious side effects, including:

    • See "What is the most important information I should know about ZULRESSO?"
    • Increased risk of suicidal thoughts or actions. ZULRESSO and other antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger. Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.

    How can I watch for and try to prevent suicidal thoughts and actions?

    • Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions.
    • Tell your healthcare provider right away if you have any new or sudden changes in mood, behavior, thoughts, or feelings.
    • Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.

    Tell your healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you:

    • Attempts to commit suicide, thoughts about suicide or dying, new or worse depression, other unusual changes in behavior or mood

    The most common side effects of ZULRESSO include:

    • Sleepiness, dry mouth, passing out, flushing of the skin or face.

    These are not all the side effects of ZULRESSO.

    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Please see Full Prescribing Information including Boxed Warning and Medication Guide for ZULRESSO and discuss any questions you may have with your healthcare provider.

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  21. Sage Therapeutics (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 the Company will present at the Cowen & Co. 40th Annual Health Care Conference on Monday, March 2, 2020, at 12:00 p.m. EST in Boston, Mass.

    A live webcast of the presentation can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcast will also be archived for up to 30 days on Sage's website following the conference.

    About Sage Therapeutics

    Sage Therapeutics is a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with…

    Sage Therapeutics (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 the Company will present at the Cowen & Co. 40th Annual Health Care Conference on Monday, March 2, 2020, at 12:00 p.m. EST in Boston, Mass.

    A live webcast of the presentation can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcast will also be archived for up to 30 days on Sage's website following the conference.

    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.

    View Full Article Hide Full Article
  22. Sage Therapeutics (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 it will host a live webcast on Thursday, February 27, 2020 at 8:00 a.m. EST to report its fourth quarter and full year 2019 financial results and discuss recent business updates.

    The webcast can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcast will be available 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…

    Sage Therapeutics (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 it will host a live webcast on Thursday, February 27, 2020 at 8:00 a.m. EST to report its fourth quarter and full year 2019 financial results and discuss recent business updates.

    The webcast can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcast will be available 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.

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  23. 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, today announced that on Monday, February 3, 2020, the Compensation Committee of Sage's Board of Directors granted non-qualified stock options to purchase an aggregate of 13,950 shares of its common stock, and 6,325 performance restricted stock units (PSUs) to four new employees under Sage's 2016 Inducement Equity Plan.

    The 2016 Inducement Equity Plan is used exclusively for the grant of equity awards to individuals who were not previously an employee or non-employee director of Sage (or following a bona fide period of non-employment), as an…

    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, today announced that on Monday, February 3, 2020, the Compensation Committee of Sage's Board of Directors granted non-qualified stock options to purchase an aggregate of 13,950 shares of its common stock, and 6,325 performance restricted stock units (PSUs) to four new employees under Sage's 2016 Inducement Equity Plan.

    The 2016 Inducement Equity Plan is used exclusively for the grant of equity awards to individuals who were not previously an employee or non-employee director of Sage (or following a bona fide period of non-employment), as an inducement material to such individual's entering into employment with Sage, pursuant to Rule 5635(c)(4) of the NASDAQ Listing Rules. The options have an exercise price of $67.40 per share, which is equal to the closing price of Sage's common stock on February 3, 2020. Each option will vest and become exercisable as to 25% of the shares on the first anniversary of the recipient's start date and will vest and become exercisable as to the remaining 75% of the shares in 36 equal monthly installments following the first anniversary, in each case, subject to each such employee's continued employment with Sage on such vesting dates. The PSUs will vest in increments if pre-established performance milestones are achieved, subject to the employee's continued employment with Sage on such vesting dates.

    The equity awards are subject to the terms and conditions of Sage's 2016 Inducement Equity Plan, and the terms and conditions of equity award agreements covering the grants.

    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.

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  24. 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, today announced that on Thursday, January 2, 2020, the Compensation Committee of Sage's Board of Directors granted non-qualified stock options to purchase an aggregate of 11,850 shares of its common stock, and 1,975 performance restricted stock units (PSUs) to four new employees under Sage's 2016 Inducement Equity Plan.

    The 2016 Inducement Equity Plan is used exclusively for the grant of equity awards to individuals who were not previously an employee or non-employee director of Sage (or following a bona fide period of non-employment), as an…

    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, today announced that on Thursday, January 2, 2020, the Compensation Committee of Sage's Board of Directors granted non-qualified stock options to purchase an aggregate of 11,850 shares of its common stock, and 1,975 performance restricted stock units (PSUs) to four new employees under Sage's 2016 Inducement Equity Plan.

    The 2016 Inducement Equity Plan is used exclusively for the grant of equity awards to individuals who were not previously an employee or non-employee director of Sage (or following a bona fide period of non-employment), as an inducement material to such individual's entering into employment with Sage, pursuant to Rule 5635(c)(4) of the NASDAQ Listing Rules. The options have an exercise price of $73.16 per share, which is equal to the closing price of Sage's common stock on January 2, 2020. Each option will vest and become exercisable as to 25% of the shares on the first anniversary of the recipient's start date and will vest and become exercisable as to the remaining 75% of the shares in 36 equal monthly installments following the first anniversary, in each case, subject to each such employee's continued employment with Sage on such vesting dates. The PSUs will vest in increments if pre-established performance milestones are achieved, subject to the employee's continued employment with Sage on such vesting dates.

    The equity awards are subject to the terms and conditions of Sage's 2016 Inducement Equity Plan, and the terms and conditions of equity award agreements covering the grants.

    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.

    View Full Article Hide Full Article
  25. Sage Therapeutics (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 the Company will present at the J.P. Morgan 2020 Healthcare Conference in San Francisco, Calif. on Monday, January 13, 2020 at 1:30 p.m. PST (4:30 p.m. EST), followed by a Q&A session.

    A live webcast of the presentation and Q&A session can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcast will also be archived for up to 30 days on Sage's website following the conference.

    About Sage Therapeutics

    Sage Therapeutics is a biopharmaceutical company committed to developing novel therapies…

    Sage Therapeutics (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 the Company will present at the J.P. Morgan 2020 Healthcare Conference in San Francisco, Calif. on Monday, January 13, 2020 at 1:30 p.m. PST (4:30 p.m. EST), followed by a Q&A session.

    A live webcast of the presentation and Q&A session can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcast will also be archived for up to 30 days on Sage's website following the conference.

    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.

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  26. Three poster presentations highlight the role of NMDA receptor dysfunction in Huntington's Disease related cognitive impairment and potential for positive cognitive effects with SAGE-718

    Sage Therapeutics (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 it plans to advance SAGE-718, a novel, first-in-class, oxysterol-based positive allosteric modulator (PAM) of N-methyl-D-aspartate (NMDA) receptors, to a Phase 2 placebo-controlled clinical trial in patients with Huntington's disease (HD). The planned progression of SAGE-718 is based on results from Phase 1 studies evaluating the safety and tolerability…

    Three poster presentations highlight the role of NMDA receptor dysfunction in Huntington's Disease related cognitive impairment and potential for positive cognitive effects with SAGE-718

    Sage Therapeutics (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 it plans to advance SAGE-718, a novel, first-in-class, oxysterol-based positive allosteric modulator (PAM) of N-methyl-D-aspartate (NMDA) receptors, to a Phase 2 placebo-controlled clinical trial in patients with Huntington's disease (HD). The planned progression of SAGE-718 is based on results from Phase 1 studies evaluating the safety and tolerability of SAGE-718, including an open-label cohort of patients with HD.

    In the 14-day open-label study of patients with HD, the safety, tolerability, and pharmacokinetic profile of daily SAGE-718 oral solution were evaluated in six patients with early HD. In the study, SAGE-718 was well tolerated, with no serious adverse events or adverse events leading to treatment discontinuation. In addition, patients demonstrated improved performance, compared to baseline, on assessments of executive functioning, with measures relevant to the core cognitive decline seen in people with HD. These results are comparable to improvements in measures of executive function observed in an earlier Phase 1 cohort of individuals without HD. Additional data from the Phase 1 open-label cohort study on the safety and tolerability of SAGE-718 in patients with early HD will be presented at a future congress in 2020.

    In addition, the Company is presenting data from three other non-clinical and Phase 1 studies with SAGE-718 at the 58th Annual Meeting of the American College of Neuropsychopharmacology (ACNP). The poster presentations provide supportive evidence for the role of NMDA receptor dysfunction in Huntington's Disease-related cognitive impairment, as well as functional target engagement of SAGE-718, including positive cognitive effects in healthy volunteers.

    "There is a critical need for better therapeutics to help patients with cognitive decline, particularly those suffering from conditions such as Huntington's disease," said Mike Quirk, vice president, pharmacology at Sage. "Discovering and developing treatments with the potential to quickly and meaningfully improve the lives of patients is a significant driver of our growing neuropsychiatry franchise. The SAGE-718 data presented at ACNP, together with Phase 1 data from patients with Huntington's Disease, marks an important achievement for our NMDA platform, and supports the progression of SAGE-718 to Phase 2."

    Data presentations at ACNP focus on additional studies in HD, including SAGE-718 data:

    Poster [M-147]: Cognitive Deficits in Huntington's Disease and Altered 24(S)-hydroxycholesterol

    24(S)-hydroxycholesterol (24(S)-HC) is an endogenous, brain-specific, cholesterol metabolite that acts as a PAM of the NMDA receptor. Previous work has established that levels of 24(S)-HC are decreased in the plasma and brain in people with HD.

    • In this study, plasma samples from the TRACK-HD study, a longitudinal observational study of biological and clinical manifestations of HD, were analyzed.
    • Results demonstrated levels of 24(S)-HC declined during the transition from pre-manifest to manifest HD, and that levels correlated with performance on tests of executive dysfunction and emotional processing.
    • These data support a role for 24(S)-HC in cognitive changes in HD and suggest that NMDA hypofunction may contribute to cognitive impairment in HD.

    Poster [M-144]: Using a Multimodal Biomarker Approach to Identify Functional Target Engagement of the Novel NMDA Positive Allosteric Modulator SAGE-718

    A suite of three clinical studies was designed to evaluate CNS-target engagement of SAGE-718 by electrophysiology and magnetic resonance imaging (MRI), using a low-dose ketamine challenge paradigm in healthy adults in a placebo controlled cross-over design.

    • In these studies, SAGE-718 was generally well tolerated with no serious adverse events or adverse events leading to treatment discontinuation.
    • A single dose administration of SAGE-718 (3 mg oral solution) attenuated ketamine-induced changes in functional MRI-derived alterations of blood oxygenation levels (BOLD), including attenuation of ketamine-induced increases of BOLD observed in posterior brain regions and decreases observed in anterior brain regions (n=13).
    • In a single-click, auditory evoked potential paradigm, the N100-P200 potential waveform was significantly reduced by ketamine under placebo conditions, but not after administration of SAGE-718 (n=18).
    • Results from these studies demonstrate that SAGE-718 had effects on functional imaging in healthy volunteers. SAGE-718 also modulated the effects of ketamine on regional and global measures of resting brain activity. These effects are in line with the presumed mechanism of action of SAGE-718 as an NMDA PAM, which supports the hypothesis of functional engagement of the NMDA receptor.

    Poster [M-143]: Cognitive Performance After Repeated Administration of the NMDA Positive Allosteric Modulator SAGE-718 in Healthy Volunteers

    In a double-blind, placebo-controlled study, the effects of 10-day repeated exposure of SAGE-718 on core cognitive battery were investigated in healthy volunteers. Healthy volunteers (n=40) were randomized to receive either SAGE-718 1 mg (n=19) plus ketamine or placebo (n=21) plus ketamine, and computerized testing was used to measure performance on key cognitive domains, including attention, working memory, processing speed, executive function, and motor reaction time.

    • Statistically significant improvements were observed compared to placebo on tests of higher-order working memory (Two-Back Test) and complex problem solving (Groton Maze Test).
    • SAGE-718 was generally well tolerated with no serious adverse events or adverse events leading to study withdrawal or discontinuation.
    • Improvements in executive performance, as reflected by significant improvements on the Two-Back and Groton Maze tests, suggest that SAGE-718 is potentially distinct from other cognitive-enhancing compounds and supports further investigation of SAGE-718 for the treatment of conditions characterized by states of relative NMDA hypofunction, particularly those manifesting with executive deficits.

    About SAGE-718 and NMDA Receptors

    SAGE-718 is a novel, oral, first-in-class, oxysterol-based positive allosteric modulator (PAM) of N-methyl-D-aspartate (NMDA) receptors. SAGE-718 is the lead compound from Sage's NMDA modulator platform.

    NMDA receptors are glutamate-gated cation channels that play a critical role in the health and regulation of neurons, and are involved in learning, memory and neuroplasticity. Positive modulation of NMDA receptors may have potential benefit in the treatment of conditions associated with NMDA hypofunction and disorders associated with a high prevalence of anti-NMDA antibodies, as well as in disorders associated with reductions in plasma cerebrosterol, such as Huntington's disease and Alzheimer's disease.

    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 our development plans for SAGE-718; our belief in the potential of SAGE-718 in various indications; the potential profile and benefit of SAGE-718; and the goals, opportunity and potential for our other product candidates and 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 not be successful in our development of SAGE-718 or any of our other current or future product candidates in any indication we are currently pursuing or may in the future pursue; success in earlier clinical trials or nonclinical studies may not be repeated or observed in ongoing or future studies of SAGE-718 or any of our other product candidates; ongoing and future clinical or nonclinical results may generate results that are different than we expect or may not support further development; we may decide that a development pathway for SAGE-718 or any of our other product candidates in one or more indications is no longer feasible or advisable or that the unmet need no longer exists; decisions or actions of the FDA or other regulatory agencies may affect our plans for development of SAGE-718, including the initiation, timing, design, size, progress and cost of clinical trials and our ability to proceed with further development; we may experience slower than expected initiation or enrollment in ongoing or future clinical trials; we may encounter unexpected safety or tolerability issues with SAGE-718 or any of our other product candidates; the internal and external costs required for our ongoing and planned research and development efforts, and to build our organization in connection with such activities, and the resulting expense increases and use of cash, may be higher than expected which may cause us to change or curtail some of our plans; and we may encounter technical and other unexpected hurdles in the development of SAGE-718 or our other product candidates; as well as those risks more fully discussed in the section entitled "Risk Factors" in our most recent quarterly report filed with the Securities and Exchange Commission (SEC), and discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the SEC. 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.

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  27. MOUNTAIN Study did not meet primary endpoint at Day 15

    Statistical significance on HAM-D scale achieved at Days 3, 8 and 12; preliminary data from long-term follow-up suggest maintenance of effect on depressive symptoms

    Statistical significance achieved at Days 3, 8, 12 and 15 in patients with measurable drug concentration levels of SAGE-217

    Statistical significance achieved in patients comparable to those studied in earlier trials with SAGE-217 (HAM-D>24)

    SAGE-217 was generally well-tolerated with safety profile comparable to placebo

    Conference call scheduled at 8:30 a.m. EST

    Sage Therapeutics (NASDAQ:SAGE), a biopharmaceutical company developing novel therapies for people with debilitating brain disorders, today reported topline…

    MOUNTAIN Study did not meet primary endpoint at Day 15

    Statistical significance on HAM-D scale achieved at Days 3, 8 and 12; preliminary data from long-term follow-up suggest maintenance of effect on depressive symptoms

    Statistical significance achieved at Days 3, 8, 12 and 15 in patients with measurable drug concentration levels of SAGE-217

    Statistical significance achieved in patients comparable to those studied in earlier trials with SAGE-217 (HAM-D>24)

    SAGE-217 was generally well-tolerated with safety profile comparable to placebo

    Conference call scheduled at 8:30 a.m. EST

    Sage Therapeutics (NASDAQ:SAGE), a biopharmaceutical company developing novel therapies for people with debilitating brain disorders, today reported topline results from the pivotal Phase 3 MOUNTAIN Study evaluating the effect of SAGE-217 on depressive symptoms in adults with major depressive disorder (MDD). The MOUNTAIN Study did not meet its primary endpoint of a statistically significant reduction from baseline compared to placebo in the 17-item Hamilton Rating Scale for Depression (HAM-D) total score at Day 15. SAGE-217 30 mg, given once-daily as an oral treatment, was associated with a mean reduction of 12.6 in HAM-D total score compared to 11.2 for placebo (p=0.115). Patients in the SAGE-217 30 mg group achieved statistically significant reductions in the HAM-D total score at Days 3, 8 and 12 (p<0.018 for each timepoint). The SAGE-217 development program includes five other pivotal studies, two of which have reported positive data, one in MDD and one in postpartum depression (PPD), and three of which are ongoing.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20191205005375/en/

    Post-hoc analysis revealed that in the MOUNTAIN Study, approximately 9% of patients in the SAGE-217 30 mg group had no measurable drug concentration, consistent with non-compliance in taking SAGE-217. Excluding these patients from the primary analysis set (SAGE-217 30 mg vs. placebo) resulted in statistical significance at all timepoints through, and including, Day 15 (p<0.048).

    The study enrolled more patients with an overall distribution of milder severity of symptoms than previous studies of SAGE-217. When including only patients with a HAM-D>24 (n=124 for SAGE-217 30 mg), a post-hoc analysis demonstrated statistical significance at all timepoints through, and including, Day 15 (p<0.032). Analyses utilizing a HAM-D cutoff of 25 or 26 were also statistically significant.

    SAGE-217 was generally well-tolerated and showed a similar safety profile as seen in earlier studies. Overall reports of adverse events (AEs) during the 14-day treatment period and 28-day follow-up were similar between SAGE-217 and placebo (30 mg 54.2%, 20 mg 50.0%, placebo 48.9%). The most common AEs (≥5%) in either SAGE-217 group were headache, dizziness, somnolence, fatigue, diarrhea, sedation and nausea.

    "This study did not meet the primary endpoint. With that, the data are supportive of the activity of SAGE-217 in MDD given the statistical significance at the majority of timepoints, and in relevant populations," said Jeff Jonas, M.D., chief executive officer at Sage. "Notwithstanding the finding on the primary endpoint, the drug displays good activity on most measures. We understand that drug development is an iterative process. In this study, we've gathered new data on SAGE-217, data we believe support our hypothesis that SAGE-217 has a unique profile with the potential for rapid and robust onset with durable effect."

    "These study results reinforce that we have an active drug with safety data that are consistent with the two earlier pivotal trials in MDD and PPD," said Steve Kanes, M.D., Ph.D., chief medical officer at Sage. "As a designated breakthrough therapy, we are evaluating the path forward to more fully inform a potentially expedited pathway to approval, and any amendments we might consider to the ongoing SAGE-217 pivotal program."

    Summary of topline results from the MOUNTAIN Study

    Sage's Phase 3 MOUNTAIN Study evaluated the efficacy, safety and pharmacokinetics of SAGE-217 in adult patients diagnosed with MDD (MADRS total score ≥32 and a HAM-D total score ≥22).

    Effect on depressive symptoms through end of treatment and follow-up

    At Day 15, the primary endpoint and end of dosing, patients randomized to SAGE-217 30 mg demonstrated a reduction in depressive symptoms of 12.6 in the HAM-D total score compared with 11.2 in patients who received placebo (LS Mean Difference from placebo -1.4, p=0.115).

    Rapid onset of effect for SAGE-217 30 mg (n=166) was noted beginning at Day 3 and statistical significance from placebo (n=157) was noted at all visits during the treatment period leading up to Day 15 (LS Mean Difference from placebo, p-value): Day 3 (-1.6, p=0.016), Day 8 (-2.1, p=0.008) and Day 12 (-2.1, p=0.018).

    Improvements in depressive symptoms were sustained in all treatment groups through Day 42 of the double-blind portion of the study. Change from baseline in HAM-D total score at Day 42 for SAGE-217 30 mg was -11.9 and for placebo was -11.7 (LS Mean Difference from placebo -0.5, p=0.807). Preliminary data suggest maintenance of improvement in depressive symptoms in those patients who have completed long-term follow-up up to 6 months. These data will continue to be collected in the coming months.

    The 20 mg dose of SAGE-217 did not separate from placebo in this dose-ranging study.

    Effect on depressive symptoms by performance factors

    Post-hoc analyses were conducted to evaluate the effects of performance factors on the primary outcome at Day 15.

    Change from baseline in HAM-D total score at Day 15, SAGE-217 30 mg vs. placebo:

    • Patients with SAGE-217 measurable drug concentrations (n=151) (excluding 30 mg patients with no measurable drug concentration consistent with noncompliance): SAGE-217 30 mg (-13.0) vs. placebo (-11.2); LS Mean Difference -1.8, p=0.048.
    • Patients with HAM-D≥24 (n=124): SAGE-217 30 mg (-13.7) vs. placebo (-11.4); LS Mean Difference -2.3, p=0.032.
    • Patients with SAGE-217 measurable drug concentrations and HAM-D≥24 (n=115): SAGE-217 30 mg (-14.0) vs. placebo (-11.4); LS Mean Difference -2.6; p=0.017.

    Safety and tolerability

    SAGE-217 was generally well tolerated in the trial. The overall incidence of patients who experienced AEs during the 14-day treatment period and 28-day follow up was 54.2% for SAGE-217 30 mg, 50.0% for SAGE-217 20 mg and 48.9% for placebo.

    • Two patients receiving SAGE-217 30 mg experienced serious adverse events (SAEs) during treatment: one suicide attempt on Day 5 in a patient with a longstanding history of MDD and a past suicide attempt, and one report of a bile duct stone after Day 2 requiring removal in a patient with a prior bile duct repair. In addition, three patients, one in each treatment group, reported SAEs during follow-up, all occurring at least one week following cessation of treatment: syncope and associated injuries which occurred with dehydration and orthostatic hypotension during exercise in a patient with a history of bradycardia (SAGE-217 30 mg, Day 28), multiple SAEs related to medical complications of cocaine ingestion (SAGE-217 20 mg, Day 39) and suicidal ideation (placebo, Day 22).
    • The number of subjects having treatment emergent AEs leading to study drug discontinuation were similar in each treatment group (SAGE-217 30 mg 2.1%, SAGE-217 20 mg 1.6% and placebo 3.2%).
    • The most common AEs (≥5%) in any group (SAGE-217 30 mg, SAGE-217 20 mg and placebo) during the 14-day treatment period and the 28-day follow up were:
      • Headache (30 mg 6.3%, 20 mg 11.2%, placebo 7.4%)
      • Dizziness (30 mg 5.7%, 20 mg 7.4%, placebo 3.7%)
      • Somnolence (30 mg 6.8%, 20 mg 5.9%, placebo 4.2%)
      • Fatigue (30 mg 6.8%, 20 mg 1.6%, placebo 2.6%)
      • Diarrhea (30 mg 6.3%, 20 mg 5.9%, placebo 5.3%)
      • Sedation (30 mg 4.7%, 20 mg 5.9%, placebo 3.2%)
      • Nausea (30 mg 3.6%, 20 mg 5.3%, placebo 4.7%)
    • There were no AEs of loss of consciousness.
    • There was no signal for increased suicidal ideation or suicidal behavior compared to baseline, as measured by Columbia Suicide Severity Rating Scale (C-SSRS).

    Sage plans to present additional results from the MOUNTAIN Study at an upcoming medical congress.

    About the MOUNTAIN Study

    The MOUNTAIN Study is a double-blind, placebo-controlled pivotal Phase 3 study evaluating the efficacy and safety of SAGE-217 in adults with major depressive disorder (MDD). In the study, 581 patients were randomized to receive SAGE-217, 20 mg or 30 mg, or placebo, once-nightly for two-weeks. The primary endpoint of the study is the change from baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D) total score at Day 15. Secondary endpoints include the change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) and the Hamilton Anxiety Rating Scale (HAM-A) total score, among others.

    About Major Depressive Disorder

    Major depressive disorder (MDD), commonly referred to as depression, is a brain health disorder that affects an estimated 17 million adults in the U.S. each year. It is one of the largest contributors to disability in the U.S. and worldwide and is characterized by symptoms of depressed mood and/or loss of interest in pleasurable activities. MDD causes significant impairment in daily life and can limit a person's ability to fulfill work, school, family, or social responsibilities; enjoy leisure activities; or maintain health and hygiene. While antidepressants are widely used to treat MDD, large-scale studies have demonstrated that there is an unmet need in the treatment of MDD as well as the need for new therapeutic options.

    About SAGE-217

    SAGE-217 is an investigational, oral, novel medicine in development for depression. SAGE-217 is an investigational oral neuroactive steroid (NAS) GABAA receptor positive allosteric modulator (PAM). The GABA system is the major inhibitory signaling pathway of the brain and central nervous system (CNS), and contributes significantly to regulating CNS function.

    The clinical program evaluating SAGE-217 in depression is progressing. To date, two positive pivotal studies have been completed, one in MDD (MDD-201) and one in postpartum depression (ROBIN Study). Ongoing studies include the REDWOOD, SHORELINE and RAINFOREST studies.

    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 SAGE-217 in the treatment of depression; our views as to the potential profile and benefit of SAGE-217; our plans and expectations related to ongoing development of SAGE-217, the potential pathway for approval and next steps; and our plans, goals, opportunity and potential for our programs and 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 not be successful in our development of SAGE-217 in depression or of any of our other current or future product candidates in any indication we are currently pursuing or may in the future pursue; success in earlier clinical trials or nonclinical studies may not be repeated or observed in ongoing or future studies; ongoing and future clinical or nonclinical results may generate results that are different than we expect or may not support further development or be sufficient to gain regulatory approval of SAGE-217 or any of our other product candidates; the FDA may decide that the development program for SAGE-217, or any of our product candidates, is not sufficient for a new drug application filing or approval and may require completion of additional clinical trials or nonclinical studies; we may decide that a development pathway for one of our product candidates in one or more indications is no longer feasible or advisable or that the unmet need no longer exists; 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 experience slower than expected initiation or enrollment in ongoing or future clinical trials; we may encounter unexpected safety or tolerability issues; the internal and external costs required for our ongoing and planned research and development efforts, and to build our organization in connection with such activities, and the resulting expense increases and use of cash, may be higher than expected which may cause us to change or curtail some of our plans; and we may encounter technical and other unexpected hurdles in the development of SAGE-217 or any of our other product candidates; as well as those risks more fully discussed in the section entitled "Risk Factors" in our most recent quarterly report filed with the Securities and Exchange Commission (SEC), and discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the SEC. 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.

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  28. 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, today announced that on Monday, December 2, 2019, the Compensation Committee of Sage's Board of Directors granted non-qualified stock options to purchase an aggregate of 4,200 shares of its common stock, and 700 performance restricted stock units (PSUs) to two new employees under Sage's 2016 Inducement Equity Plan.

    The 2016 Inducement Equity Plan is used exclusively for the grant of equity awards to individuals who were not previously an employee or non-employee director of Sage (or following a bona fide period of non-employment), as an inducement…

    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, today announced that on Monday, December 2, 2019, the Compensation Committee of Sage's Board of Directors granted non-qualified stock options to purchase an aggregate of 4,200 shares of its common stock, and 700 performance restricted stock units (PSUs) to two new employees under Sage's 2016 Inducement Equity Plan.

    The 2016 Inducement Equity Plan is used exclusively for the grant of equity awards to individuals who were not previously an employee or non-employee director of Sage (or following a bona fide period of non-employment), as an inducement material to such individual's entering into employment with Sage, pursuant to Rule 5635(c)(4) of the NASDAQ Listing Rules. The options have an exercise price of $152.21 per share, which is equal to the closing price of Sage's common stock on December 2, 2019. Each option will vest and become exercisable as to 25% of the shares on the first anniversary of the recipient's start date and will vest and become exercisable as to the remaining 75% of the shares in 36 equal monthly installments following the first anniversary, in each case, subject to each such employee's continued employment with Sage on such vesting dates. The PSUs will vest in increments if pre-established performance milestones are achieved, subject to the employee's continued employment with Sage on such vesting dates.

    The equity awards are subject to the terms and conditions of Sage's 2016 Inducement Equity Plan, and the terms and conditions of equity award agreements covering the grants.

    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.

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  29. ZULRESSO™ (brexanolone) CIV injection revenues of $1.5M in third quarter

    Enrollment completed in SAGE-217 Phase 3 MOUNTAIN and SHORELINE studies with topline data expected in 4Q 2019 and 2020, respectively

    Planning to expand pipeline with two new GABA and NMDA clinical-stage assets

    Conference call today at 8:00 a.m. EST

    Today, Sage Therapeutics (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, reported business highlights and financial results for the third quarter ended September 30, 2019.

    "Sage's approach to drug discovery and development has led to the significant progress we have made during the third…

    ZULRESSO™ (brexanolone) CIV injection revenues of $1.5M in third quarter

    Enrollment completed in SAGE-217 Phase 3 MOUNTAIN and SHORELINE studies with topline data expected in 4Q 2019 and 2020, respectively

    Planning to expand pipeline with two new GABA and NMDA clinical-stage assets

    Conference call today at 8:00 a.m. EST

    Today, Sage Therapeutics (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, reported business highlights and financial results for the third quarter ended September 30, 2019.

    "Sage's approach to drug discovery and development has led to the significant progress we have made during the third quarter," said Jeff Jonas, M.D., chief executive officer of Sage Therapeutics. "We are pleased with the execution by our teams at Sage. Our Depression Franchise continues to advance, our SAGE-217 studies are progressing well, and the launch of ZULRESSO in postpartum depression is yet another step towards upending conventional wisdom about treating psychiatric disorders. On top of this, our early stage pipeline continues to expand. We are looking forward to the upcoming data readout for SAGE-217, and we are excited by the possibilities in front of us."

    Portfolio 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 thought to be at the core of numerous neurological and neuropsychiatric disorders.

    Depression Franchise

    Sage's Depression Franchise includes ZULRESSO™ (brexanolone) CIV injection, the first treatment specifically approved by the U.S. Food and Drug Administration (FDA) for postpartum depression (PPD), and SAGE-217, Sage's investigational oral neuroactive steroid GABAA receptor positive allosteric modulator (PAM), that is being evaluated as a treatment for various affective disorders. SAGE-217 received breakthrough therapy designation from the FDA for the treatment of major depressive disorder (MDD).

    • ZULRESSO: Following the U.S. commercial launch of ZULRESSO on June 24, 2019, Sage remains focused on enabling broad access to ZULRESSO for women with PPD and establishing treatment-ready sites of care. The Company is encouraged by positive indicators in the first few months that suggest the long-term potential of ZULRESSO, including patient demand, interest from HCPs, and favorable payer coverage.
      • Sites of Care
        • Sage continues to focus on helping sites of care advance through the actions required to be treatment-ready to ensure women with PPD have access to a healthcare setting capable of administering ZULRESSO. Sage continues to expect the majority of healthcare sites will take an estimated six to nine months or more to complete the actions required to be treatment-ready, which include:
          • establishing protocols for administering ZULRESSO;
          • certifying under the ZULRESSO REMS (Risk Evaluation and Mitigation Strategy);
          • achieving formulary approval; and
          • securing satisfactory reimbursement from payers.
        • Sage expects some treatment-ready sites to wait to gain familiarity with the clinical profile of ZULRESSO and to secure direct experience with reimbursement prior to increasing patient intake. As a result, Sage expects that revenue momentum may lag the expected increase in site of care activation.
        • As of September 30, 2019, more than 140 healthcare facilities, including hospitals, infusion centers, wellness centers, and fertility centers were ZULRESSO REMS certified across 66 of the top 140 Metropolitan Statistical Areas in the U.S. Of these healthcare facilities, 11 sites were able to accelerate the activation process for treatment-readiness and infused patients with ZULRESSO in the third quarter of 2019.
      • Payer Coverage & Reimbursement
        • As of September 30, 2019, plans representing in aggregate more than 75 percent of all covered lives have committed to favorable coverage with either light or no restrictions.
        • The Company has made progress with coverage and reimbursement across national commercial payers and several state Medicaid plans.
      • Patient Support
        • Sage Central, Sage's patient support center, continues to provide a range of patient resources to assist women with PPD and their families in the treatment journey. In the third quarter of 2019, more than 90% of referred patients have used Sage Central's resources.
    • SAGE-217: The clinical program evaluating the potential of SAGE-217 as a rapid-acting, durable, short-course treatment for MDD and PPD is progressing. In addition to the two completed positive pivotal studies, one in MDD (MDD-201) and one in PPD (ROBIN Study), ongoing or planned Phase 3 studies include:
      • MOUNTAIN Study (MDD-301): Placebo-controlled pivotal trial evaluating the safety and efficacy of SAGE-217 in patients with MDD. Patients received a two-week course of SAGE-217, 20mg or 30mg, or placebo, with four weeks of blinded follow-up and will have up to six months of open-label follow-up.
        • Enrollment completed in September 2019. The Company anticipates reporting topline data in 4Q 2019.
      • REDWOOD Study (MDD-302): Placebo-controlled pivotal trial evaluating the efficacy – time to first relapse – and long-term safety of fixed interval SAGE-217 monotherapy maintenance treatment. Randomized patients receive a two-week course of SAGE-217 or placebo every two months until the first relapse for up to one year.
        • Dosing in the study commenced in 3Q 2019.
      • SHORELINE Study (MDD-303): Open-label, long-term pivotal trial evaluating the safety of as needed repeat treatment with SAGE-217. Patients receive an initial two-week course of therapy and as needed retreatment and are assessed for potential relapse of depressive symptoms for up to one year.
        • Enrollment completed in October 2019. The Company anticipates reporting topline data in 2020.
      • RAINFOREST Study (MDD-304): Placebo-controlled pivotal trial evaluating SAGE-217 in patients with comorbid MDD and insomnia. The study will evaluate the effects on sleep as measured by polysomnography.
        • The Company anticipates reporting topline data in 2020.
      • Treatment-resistant depression (TRD): Planned placebo-controlled pivotal trial evaluating SAGE-217 as a potential therapy for TRD.
        • The Company is in the process of evaluating the design and timing of the study.

    Neurology Franchise

    SAGE-324, a next-generation PAM of GABAA receptors and Sage's lead neurology asset, is in development as a potential oral therapy for neurological conditions, such as essential tremor (ET), epilepsy and Parkinson's disease.

    • SAGE-324: The Company plans to initiate study-related activities for a Phase 2 study evaluating SAGE-324 as a potential therapy for ET in 4Q 2019.

    Neuropsychiatry Franchise

    SAGE-718, Sage's 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, including Huntington's Disease. SAGE-718 represents a new and complementary set of opportunities for the Sage portfolio.

    • SAGE-718: The Company expects to report data from a Phase 1 clinical trial evaluating the safety and pharmacokinetics of SAGE-718 in a cohort of patients with early Huntington's Disease in 4Q 2019.

    Early Development

    • SAGE-904: Sage's second NMDA receptor PAM product-candidate is in development as a potential oral therapy for disorders associated with NMDA hypofunction. Dosing in a Phase 1 clinical trial of SAGE-904 in healthy volunteers commenced in 3Q 2019.
    • SAGE-689: Sage is developing an intramuscular GABAA receptor PAM, SAGE-689, as a potential therapy for disorders associated with GABA hypofunction. The IND for SAGE-689 was cleared by the FDA and the Company expects to commence dosing in a Phase 1 clinical trial in healthy volunteers in 2020.

    Anticipated Upcoming Milestones

    • Top-line Data Readouts:
      • SAGE-217 Phase 3 MDD MOUNTAIN Study (4Q 2019)
      • SAGE-718 Phase 1 cohort data in early Huntington's disease (4Q 2019)
      • SAGE-217 Phase 3 MDD SHORELINE Study (2020)
      • SAGE-217 Phase 3 MDD and Comorbid Insomnia RAINFOREST Study (2020)

    • Planned Clinical Trial Initiations:
      • SAGE-324 Phase 2 placebo-controlled study in ET (4Q 2019 for study-related activities; 1H 2020 for dosing)
      • SAGE-689 Phase 1 study in healthy volunteers (2020)

    Financial Results for the Third Quarter of 2019

    • Revenues: Sage recorded $3.6 million in revenues in the third quarter of 2019, including $1.5 million of net revenues from sales of ZULRESSO and $2.1 million in collaboration revenues from Shionogi & Co., Ltd. related to reimbursement of product expense. Sage recorded no revenue for the same period in 2018.
    • Cash Position: Cash, cash equivalents, restricted cash, and marketable securities as of September 30, 2019 were approximately $1.1 billion compared to $925.1 million at December 31, 2018. The increase was primarily due to proceeds from Sage's follow-on public offering completed in February 2019.
    • R&D Expenses: Research and development expenses were $102.1 million, including $17.1 million of non-cash stock-based compensation expense in the third quarter of 2019, compared to $75.1 million, including $14.0 million of non-cash stock-based compensation expense, for the same period in 2018. The increase in R&D expenses was primarily due to advancement of the pivotal program for SAGE-217 in MDD and continued research efforts across the Company's early-stage clinical and discovery pipeline.
    • SG&A Expenses: Selling, general and administrative expenses were $88.5 million, including $26.6 million of non-cash stock-based compensation expense in the third quarter of 2019, compared to $53.7 million, including $11.5 million of non-cash stock-based compensation expense, for the same period in 2018. The increase in SG&A expenses was primarily due to an increase in personnel-related expenses, along with facilities and corporate infrastructure costs to support expanding operations and the ZULRESSO commercial launch.
    • Net Loss: Net loss was $180.0 million for the third quarter of 2019 compared to a net loss of $122.9 million for the same period in 2018.

    Financial Guidance

    • Based on its current operating plan, Sage anticipates that its balance of cash, cash equivalents, restricted cash, and marketable securities will be at least $950 million at the end of 2019.
    • Sage expects ZULRESSO revenue growth will be modest over the next few quarters and anticipates a meaningful increase in ZULRESSO revenue in the second half of 2020.

    Conference Call Information

    Sage will host a conference call and webcast today, Tuesday, November 12, 2019, at 8:00 a.m. EST to discuss its third quarter 2019 financial results and recent corporate updates. 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 our commercial launch of ZULRESSO and its long-term potential, including the potential timing for sites to become ready to administer ZULRESSO and expectations regarding an increase in the number of activated sites, the potential timing of revenue momentum and the potential for favorable reimbursement of ZULRESSO; our development plans, goals and strategy and the potential timing and results of our development efforts; our belief in the potential of our product candidates in various indications; the potential profile and benefit of our product candidates; the goals, opportunity and potential for our business; and our expectations regarding our cash position at year-end and increases in operating expense. 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 issues or other challenges in commercializing ZULRESSO, including issues related to market acceptance by healthcare providers, healthcare settings and women with PPD, issues related to the willingness of sites to administer ZULRESSO, issues related to reimbursement, issues related to the requirements of the REMS, and challenges associated with execution of our sales and patient support activities, which in each case could limit the potential of ZULRESSO and the timing and amount of future revenues; results achieved with use of ZULRESSO in the treatment of PPD in commercial use may be different than observed in clinical trials, and may vary among patients; the number of women with PPD or the unmet need for additional treatment options may be significantly smaller than we expect; we may encounter unexpected safety or tolerability issues with ZULRESSO or any of our product candidates; we may not be successful in our development of any of our current or future product candidates in any indication we are currently pursuing or may in the future pursue; success in prior clinical trials or nonclinical studies may not be repeated or observed in ongoing or future studies of any of our product candidates; ongoing and future clinical or nonclinical results may generate results that are different than we expect or may not support further development or be sufficient to gain regulatory approval of our product candidates; we may decide that a development pathway for one of our product candidates in one or more indications is no longer feasible or advisable or that the unmet need no longer exists; the FDA may decide that the development program for any of our product candidates, even if positive, is not sufficient for a new drug application filing or approval; 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 experience slower than expected initiation or enrollment in ongoing or future clinical trials; we may encounter unexpected safety or tolerability issues with our product candidates; the internal and external costs required for our ongoing and planned research and development efforts, and to build our organization in connection with such activities, and the resulting expense increases and use of cash, may be higher than expected which may cause us to change or curtail some of our plans; we may change our plans for other business reasons; and we may encounter technical and other unexpected hurdles in the development of our product candidates; as well as those risks more fully discussed in the section entitled "Risk Factors" in our most recent quarterly report filed with the Securities and Exchange Commission (SEC), and discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the SEC. 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.

     
    Sage Therapeutics, Inc. and Subsidiaries
    Condensed Consolidated Statements of Operations
    (in thousands, except share and per share data)
    (unaudited)
     
    Three Months Ended September 30, Nine Months Ended September 30,

     

    2019

     

     

    2018

     

     

    2019

     

     

    2018

     

    Product revenue, net

    $

    1,478

     

    $

    -

     

    $

    1,997

     

    $

    -

     

    Collaboration revenue

     

    2,092

     

     

    -

     

     

    2,911

     

     

    90,000

     

    Total revenue

     

    3,570

     

     

    -

     

     

    4,908

     

     

    90,000

     

     
    Operating costs and expenses:
    Cost of goods sold

     

    137

     

     

    -

     

     

    181

     

     

    -

     

    Research and development

     

    102,108

     

     

    75,052

     

     

    277,565

     

     

    193,302

     

    Selling, general and administrative

     

    88,502

     

     

    53,693

     

     

    260,648

     

     

    125,709

     

    Total operating costs and expenses

     

    190,747

     

     

    128,745

     

     

    538,394

     

     

    319,011

     

     
    Loss from operations

     

    (187,177

    )

     

    (128,745

    )

     

    (533,486

    )

     

    (229,011

    )

    Interest income, net

     

    7,227

     

     

    5,817

     

     

    21,889

     

     

    14,483

     

    Other income (expense), net

     

    (8

    )

     

    10

     

     

    12

     

     

    34

     

    Net loss

    $

    (179,958

    )

    $

    (122,918

    )

    $

    (511,585

    )

    $

    (214,494

    )

    Net loss per share - basic and diluted

    $

    (3.48

    )

    $

    (2.63

    )

    $

    (10.13

    )

    $

    (4.68

    )

    Weighted average shares outstanding - basic and diluted

     

    51,704,687

     

     

    46,706,770

     

     

    50,496,489

     

     

    45,866,676

     

    Sage Therapeutics, Inc. and Subsidiaries
    Condensed Consolidated Balance Sheets
    (in thousands)
    (unaudited)
     
    September 30,
    2019
    December 31,
    2018
    Cash, cash equivalents, restricted cash and investments

    $

    1,124,617

    $

    925,143

    Total assets

    $

    1,203,727

    $

    952,705

    Total liabilities

    $

    122,656

    $

    89,734

    Total stockholders' equity

    $

    1,081,071

    $

    862,971

    About ZULRESSO™ (brexanolone) injection CIV

    ZULRESSO, the first medicine specifically approved by the U.S. Food and Drug Administration (FDA) for the treatment of postpartum depression (PDD) in adults, is a positive allosteric modulator of both synaptic and extrasynaptic GABAA receptors. Allosteric modulation of neurotransmitter receptor activity results in varying degrees of desired activity rather than complete activation or inhibition of the receptor.

    What is ZULRESSO?

    ZULRESSO™ (brexanolone) CIV is a prescription medicine used in adults to treat a certain type of depression called Postpartum Depression.

    IMPORTANT SAFETY INFORMATION

    What is the most important information I should know about ZULRESSO?

    ZULRESSO can cause serious side effects, including:

    Excessive sedation and sudden loss of consciousness. ZULRESSO may cause you to feel very sleepy (excessive sedation) or pass out (loss of consciousness). Your healthcare provider should check you for symptoms of excessive sleepiness every 2 hours while you are awake.

    During your ZULRESSO infusion, tell your healthcare provider right away if you feel like you cannot stay awake during the time you are normally awake or if you feel like you are going to pass out. Your healthcare provider may lower your dose or stop the infusion until symptoms go away.

    You must have a caregiver or family member with you to help care for your child(ren) during your ZULRESSO infusion.

    Because of the risk of serious harm resulting from excessive sedation or sudden loss of consciousness, ZULRESSO is only available through a restricted program called the ZULRESSO REMS.

    Before receiving ZULRESSO, tell your healthcare provider about all your medical conditions, including if you:

    drink alcohol

    have kidney problems

    are pregnant or think you may be pregnant. It is not known if ZULRESSO will harm your unborn baby.

    There is a pregnancy registry for females who are exposed to ZULRESSO during pregnancy. The purpose of the registry is to collect information about the health of females exposed to ZULRESSO and their baby. If you become pregnant during treatment with ZULRESSO, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visit https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/

    are breastfeeding or plan to breastfeed. ZULRESSO passes into breast milk. Talk to your healthcare provider about the risks and benefits of breastfeeding and about the best way to feed your baby while receiving ZULRESSO.

    Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

    ZULRESSO and some medicines may interact with each other and cause serious side effects.

    Especially tell your healthcare provider if you take other antidepressants, opioids, or Central Nervous System (CNS) depressants (such as benzodiazepines).

    Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. Your healthcare provider will decide if other medicines can be taken with ZULRESSO.

    How will I receive ZULRESSO?

    ZULRESSO is given to you by continuous intravenous (IV) infusion into your vein. The infusion will last for a total of 60 hours (2.5 days).

    What should I avoid while receiving ZULRESSO?

    ZULRESSO may make you feel dizzy and sleepy. Do not drive a car or do other dangerous activities after your ZULRESSO infusion until your feeling of sleepiness has completely gone away. See "What is the most important information I should know about ZULRESSO?"

    Do not drink alcohol while receiving ZULRESSO.

    What are the possible side effects of ZULRESSO?

    ZULRESSO can cause serious side effects, including:

    See "What is the most important information I should know about ZULRESSO?"

    Increased risk of suicidal thoughts or actions. ZULRESSO and other antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger. Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.

    How can I watch for and try to prevent suicidal thoughts and actions?

    Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions.

    Tell your healthcare provider right away if you have any new or sudden changes in mood, behavior, thoughts, or feelings.

    Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.

    Tell your healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you:

    Attempts to commit suicide, thoughts about suicide or dying, new or worse depression, other unusual changes in behavior or mood

    The most common side effects of ZULRESSO include:

    Sleepiness, dry mouth, passing out, flushing of the skin or face.

    These are not all the side effects of ZULRESSO.

    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Please see Full Prescribing Information including Boxed Warning and Medication Guide for ZULRESSO™ and discuss any questions you may have with your healthcare provider.

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  30. Sage Therapeutics (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 the Company will present at the Stifel 2019 Healthcare Conference on Tuesday, November 19, 2019, at 10:20 a.m. EST in New York, NY.

    A live webcast of the presentation can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcast will also be archived for up to 30 days on Sage's website following the conference.

    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…

    Sage Therapeutics (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 the Company will present at the Stifel 2019 Healthcare Conference on Tuesday, November 19, 2019, at 10:20 a.m. EST in New York, NY.

    A live webcast of the presentation can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcast will also be archived for up to 30 days on Sage's website following the conference.

    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.

    View Full Article Hide Full Article
  31. 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, today announced that on November 1, 2019, the Compensation Committee of Sage's Board of Directors granted non-qualified stock options to purchase an aggregate of 7,350 shares of its common stock, and 1,225 performance restricted stock units (PSUs) to three new employees under Sage's 2016 Inducement Equity Plan.

    The 2016 Inducement Equity Plan is used exclusively for the grant of equity awards to individuals who were not previously an employee or non-employee director of Sage (or following a bona fide period of non-employment), as an inducement…

    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, today announced that on November 1, 2019, the Compensation Committee of Sage's Board of Directors granted non-qualified stock options to purchase an aggregate of 7,350 shares of its common stock, and 1,225 performance restricted stock units (PSUs) to three new employees under Sage's 2016 Inducement Equity Plan.

    The 2016 Inducement Equity Plan is used exclusively for the grant of equity awards to individuals who were not previously an employee or non-employee director of Sage (or following a bona fide period of non-employment), as an inducement material to such individual's entering into employment with Sage, pursuant to Rule 5635(c)(4) of the NASDAQ Listing Rules. The options have an exercise price of $143.95 per share, which is equal to the closing price of Sage's common stock on November 1, 2019. Each option will vest and become exercisable as to 25% of the shares on the first anniversary of the recipient's start date and will vest and become exercisable as to the remaining 75% of the shares in 36 equal monthly installments following the first anniversary, in each case, subject to each such employee's continued employment with Sage on such vesting dates. The PSUs will vest in increments if pre-established performance milestones are achieved, subject to the employee's continued employment with Sage on such vesting dates.

    The equity awards are subject to the terms and conditions of Sage's 2016 Inducement Equity Plan, and the terms and conditions of equity award agreements covering the grants.

    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.

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  32. Sage Therapeutics (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 it will host a live webcast on Tuesday, November 12, 2019 at 8:00 a.m. EST to report its third quarter 2019 financial results and discuss recent business updates.

    The webcast can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcast will be available 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…

    Sage Therapeutics (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 it will host a live webcast on Tuesday, November 12, 2019 at 8:00 a.m. EST to report its third quarter 2019 financial results and discuss recent business updates.

    The webcast can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcast will be available 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.

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  33. 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, today announced that on October 1, 2019, the Compensation Committee of Sage's Board of Directors granted non-qualified stock options to purchase an aggregate of 8,100 shares of its common stock, and 1,350 performance restricted stock units (PSUs) to four new employees under Sage's 2016 Inducement Equity Plan.

    The 2016 Inducement Equity Plan is used exclusively for the grant of equity awards to individuals who were not previously an employee or non-employee director of Sage (or following a bona fide period of non-employment), as an inducement…

    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, today announced that on October 1, 2019, the Compensation Committee of Sage's Board of Directors granted non-qualified stock options to purchase an aggregate of 8,100 shares of its common stock, and 1,350 performance restricted stock units (PSUs) to four new employees under Sage's 2016 Inducement Equity Plan.

    The 2016 Inducement Equity Plan is used exclusively for the grant of equity awards to individuals who were not previously an employee or non-employee director of Sage (or following a bona fide period of non-employment), as an inducement material to such individual's entering into employment with Sage, pursuant to Rule 5635(c)(4) of the NASDAQ Listing Rules.

    The options have an exercise price of $136.28 per share, which is equal to the closing price of Sage's common stock on October 1, 2019. Each option will vest and become exercisable as to 25% of the shares on the first anniversary of the recipient's start date and will vest and become exercisable as to the remaining 75% of the shares in 36 equal monthly installments following the first anniversary, in each case, subject to each such employee's continued employment with Sage on such vesting dates. The PSUs will vest in increments if pre-established performance milestones are achieved, subject to the employee's continued employment with Sage on such vesting dates.

    The equity awards are subject to the terms and conditions of Sage's 2016 Inducement Equity Plan, and the terms and conditions of equity award agreements covering the grants.

    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.

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  34. 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, today announced that on September 3, 2019, the Compensation Committee of Sage's Board of Directors granted non-qualified stock options to purchase an aggregate of 12,300 shares of its common stock, and 2,050 performance restricted stock units (PSUs) to four new employees under Sage's 2016 Inducement Equity Plan.

    The 2016 Inducement Equity Plan is used exclusively for the grant of equity awards to individuals who were not previously an employee or non-employee director of Sage (or following a bona fide period of non-employment), as an inducement…

    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, today announced that on September 3, 2019, the Compensation Committee of Sage's Board of Directors granted non-qualified stock options to purchase an aggregate of 12,300 shares of its common stock, and 2,050 performance restricted stock units (PSUs) to four new employees under Sage's 2016 Inducement Equity Plan.

    The 2016 Inducement Equity Plan is used exclusively for the grant of equity awards to individuals who were not previously an employee or non-employee director of Sage (or following a bona fide period of non-employment), as an inducement material to such individual's entering into employment with Sage, pursuant to Rule 5635(c)(4) of the NASDAQ Listing Rules.

    The options have an exercise price of $160.79 per share, which is equal to the closing price of Sage's common stock on Sept. 3, 2019. Each option will vest and become exercisable as to 25% of the shares on the first anniversary of the recipient's start date and will vest and become exercisable as to the remaining 75% of the shares in 36 equal monthly installments following the first anniversary, in each case, subject to each such employee's continued employment with Sage on such vesting dates. The PSUs will vest in increments if pre-established performance milestones are achieved, subject to the employee's continued employment with Sage on such vesting dates.

    The equity awards are subject to the terms and conditions of Sage's 2016 Inducement Equity Plan, and the terms and conditions of equity award agreements covering the grants.

    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.

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  35. Results from pivotal trial showed treatment with SAGE-217 resulted in rapid, clinically meaningful improvement in major depressive disorder (MDD) symptoms across multiple measures and time points

    SAGE-217 is currently being investigated in the Phase 3 MOUNTAIN trial for the treatment of MDD, with results expected in Q4 2019 or Q1 2020

    Sage Therapeutics (NASDAQ:SAGE), a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with debilitating brain disorders, today announced that the New England Journal of Medicine (NEJM) published full results from the double-blind, randomized, placebo-controlled Phase 2 study evaluating SAGE-217 as a treatment for major depressive disorder (MDD…

    Results from pivotal trial showed treatment with SAGE-217 resulted in rapid, clinically meaningful improvement in major depressive disorder (MDD) symptoms across multiple measures and time points

    SAGE-217 is currently being investigated in the Phase 3 MOUNTAIN trial for the treatment of MDD, with results expected in Q4 2019 or Q1 2020

    Sage Therapeutics (NASDAQ:SAGE), a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with debilitating brain disorders, today announced that the New England Journal of Medicine (NEJM) published full results from the double-blind, randomized, placebo-controlled Phase 2 study evaluating SAGE-217 as a treatment for major depressive disorder (MDD). In the study, SAGE-217, taken orally, once daily, showed a rapid, statistically significant reduction in Hamilton Rating Scale for Depression (HAM-D) total scores versus placebo beginning the morning following the first dose (Day 2) and sustained through the primary endpoint of Day 15 (-7.1 difference, p<0.001). At Day 15, 64% of patients who received SAGE-217 achieved remission, defined as a score of 7 or less on the HAM-D scale, compared with 26% of patients who received placebo. Additionally, at Day 15 the HAM-D response rates were 78.6% versus 40.5% in the SAGE-217 and placebo groups, respectively.

    Results published in NEJM also include additional data from multiple secondary endpoints, all of which generally favored SAGE-217 at the end of treatment (Day 15). In the study, SAGE-217 was generally well tolerated with a safety profile consistent with that seen in earlier SAGE-217 trials. Overall reports of treatment emergent adverse events (TEAEs) were 53.3% in the SAGE-217 group and 45.5% in the placebo group. No serious adverse events or deaths occurred during the trial.

    "The findings published in the New England Journal of Medicine suggest the potential for SAGE-217 to be developed as a novel treatment option for people living with major depressive disorder," said Anthony J. Rothschild, M.D., Irving S. and Betty Brudnick Endowed Chair of Psychiatry, professor of psychiatry and psychiatry department vice chair for research at the University of Massachusetts Medical School and an author on the manuscript. "Current treatments can take many weeks to work yet patients often experience side effects almost immediately. The significant and rapid improvements in depression and anxiety symptoms observed with SAGE-217 in this trial, combined with the response, remission and safety data, are extremely encouraging for a clinical disorder that can have such debilitating effects on people's lives."

    Major depressive disorder causes a persistent feeling of sadness and loss of interest in daily activities, often affecting how a person feels, thinks and behaves, and can lead to a variety of emotional and physical problems. It affects more than 17 million American adults, or about 6.8% of the U.S. population age 18 and older in a given year, and is one of the most common, but serious, mood disorders impacting people of all ages, races, and socioeconomic status.

    "Our ongoing research into the treatment and management of depression, and other mood disorders, is driven by an ultimate goal of transforming the lives of people suffering from these conditions," said Steve Kanes, M.D., Ph.D., chief medical officer of Sage Therapeutics. "The Phase 2 results suggest SAGE-217, if successfully developed, may offer a rapid-acting, well-tolerated, and durable therapy, which could change the way depression is treated. The ongoing clinical program for SAGE-217 in major depressive disorder and postpartum depression is intended to generate key efficacy and safety information needed to support a submission for regulatory approval and to further inform use if the drug is approved."

    About the placebo-controlled pivotal Phase 2 trial of SAGE-217 in MDD

    In the randomized, double-blind, parallel-group, placebo-controlled trial, 89 eligible patients (with a minimum total score of 22 on the Hamilton Rating Scale for Depression at baseline) were randomized in a 1:1 ratio to receive SAGE-217 capsules (30 mg) (n=45) or matching placebo (n=44). All doses of study drug were administered at night with food. The study consisted of a 14-day treatment period and a 4-week follow-up period. The mean HAM-D total scores at baseline were 25.2 for the SAGE-217 group and 25.7 for the placebo group (overall range 22-33), representing patients with moderate to severe MDD. Approximately 90% of patients in each group completed the study. The most common treatment emergent adverse events (≥5%) in the SAGE-217 group included headache (17.8%), nausea (11.1%), dizziness (11.1%), and somnolence (6.7%).

    About Major Depressive Disorder

    Major depressive disorder (MDD) is a common but serious mood disorder in which people experience depressive symptoms that impair their social, occupational, educational or other important functioning, such as a depressed mood or loss of interest or pleasure in daily activities, consistently for at least a two-week period. It is estimated that approximately 17 million people in the U.S. suffer from MDD each year. While antidepressants are widely used to treat MDD, large-scale studies have demonstrated the need for additional therapies.

    About SAGE-217

    SAGE-217 is a next generation positive allosteric modulator that has been optimized for selectivity to synaptic and extrasynaptic GABAA receptors and has a pharmacokinetic profile intended for periods of daily oral dosing. The GABA system is the major inhibitory signaling pathway of the brain and central nervous system (CNS), and contributes significantly to regulating CNS function. SAGE-217 is currently being developed for major depressive disorder, postpartum depression, and certain other mood disorders.

    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, statements and expectations regarding: the potential timing for reporting results from the MOUNTAIN study; the goals of our development program for SAGE-217, and the potential to generate data sufficient to file for regulatory approval; the potential of SAGE-217 as a future treatment option in the treatment of MDD and PPD, and the potential to change treatment paradigms and benefit patients, if SAGE-217 is successfully developed and approved; our estimates as to the number of people in the U.S. who suffer from MDD; and the goals and vision for our programs and potential of 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 not be successful in our development of SAGE-217 or any of our other current or future product candidates in any indication we are currently pursuing or may in the future pursue; success in earlier clinical trials or nonclinical studies may not be repeated or observed in ongoing or future studies; ongoing and future clinical or nonclinical results may generate negative results or results that are otherwise different than we expect which may cause a delay or curtailment of future development efforts or may not support further development or be sufficient to file for or gain regulatory approval; we may decide that a development pathway in one or more indications is no longer feasible or advisable or that the unmet need no longer exists; the FDA may decide that a development program, even if positive, is not sufficient for a new drug application filing or approval; 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 experience slower than expected initiation or enrollment in ongoing or future clinical trials or issues with sites or data collection or generation; we may encounter unexpected safety or tolerability issues; the number of people suffering from MDD or the unmet need for additional treatment options may be significantly smaller than we expect and our results may not be sufficient to meet the unmet need or to change treatment paradigms, even if we are successful in our development efforts; the internal and external costs required for our ongoing and planned activities, and to build our organization in connection with such activities, and the resulting use of cash, may be higher than expected which may cause us to change or curtail some of our plans; and we may encounter technical and other unexpected hurdles in our development efforts; as well as those risks more fully discussed in the section entitled "Risk Factors" in our most recent quarterly report filed with the Securities and Exchange Commission (SEC), and discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the SEC. 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.

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  36. Sage Therapeutics (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 the Company will present at the Morgan Stanley Global Healthcare Conference on Wednesday, September 11, 2019 at 11:05 a.m. EDT in New York, NY.

    A live webcast of the presentation can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcast will also be archived for up to 30 days on Sage's website following the conference.

    About Sage Therapeutics

    Sage Therapeutics is a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people…

    Sage Therapeutics (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 the Company will present at the Morgan Stanley Global Healthcare Conference on Wednesday, September 11, 2019 at 11:05 a.m. EDT in New York, NY.

    A live webcast of the presentation can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcast will also be archived for up to 30 days on Sage's website following the conference.

    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.

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