1. 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 the appointment of Chris Benecchi as Chief Commercial Officer. In his new role, Mr. Benecchi will lead Sage's global commercial efforts across all Sage programs, new product planning, strategy, and competitive intelligence.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210921005386/en/

    Chris Benecchi, Chief Commercial Officer, Sage Therapeutics (Photo: Business Wire)

    Chris Benecchi, Chief Commercial Officer, Sage Therapeutics (Photo: Business Wire)

    "Chris Benecchi is an innovator, a transformative global commercial leader and a strategic launch expert…

    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 the appointment of Chris Benecchi as Chief Commercial Officer. In his new role, Mr. Benecchi will lead Sage's global commercial efforts across all Sage programs, new product planning, strategy, and competitive intelligence.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210921005386/en/

    Chris Benecchi, Chief Commercial Officer, Sage Therapeutics (Photo: Business Wire)

    Chris Benecchi, Chief Commercial Officer, Sage Therapeutics (Photo: Business Wire)

    "Chris Benecchi is an innovator, a transformative global commercial leader and a strategic launch expert," said Barry Greene, Chief Executive Officer at Sage Therapeutics. "He has a track record of designing winning commercial strategies and launching novel therapies that have sustained long-term growth in highly competitive markets. I am confident that Chris will provide the vision, leadership and strategic thinking needed to drive the commercialization efforts across Sage's portfolio and with our partners as we continue on our mission to successfully build a top tier biopharmaceutical company."

    As a highly engaged, cross-functional leader, Mr. Benecchi will work in collaboration with internal partners to create a shared, mission-driven, launch vision that reflects the input we receive from external stakeholders. Among his responsibilities will be to ensure smooth working relationships with Sage's partners and an integrated commercialization plan for zuranolone – a once-daily, two-week therapy in Phase 3 clinical development for the treatment of major depressive disorder (MDD) and postpartum depression (PPD). Mr. Benecchi will also lead commercialization strategies across the company's leading portfolio of treatments for brain health disorders.

    "With a robust pipeline of differentiated products being studied for their potential to improve brain health, it is an exciting time to join Sage and help execute plans to accelerate development of innovative treatments on a global level with a potential impact, if we are successful, on several hundred million people around the world," said Chris Benecchi. "It is an honor to join Sage's world-class team at such a pivotal moment in the advancement of multiple programs across the company's depression, neurology, and neuropsychiatric franchises."

    Chris Benecchi joins Sage from Alexion, where he served as Vice President, Global Head of Commercial Excellence. Previously, he spent eight years at UCB in commercial roles of increasing responsibility including Global Launch Head, Commercial and Medical Affairs, Immunology and Global Commercial Strategy Lead, Immunology. He began his career in sales at J&J and held sales leadership and senior marketing roles at Takeda as well. Mr. Benecchi received an MBA from Duke University and a BA from Colby College.

    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 success of our development-stage products; the potential for future launch and commercialization of any such products, if successfully developed; the potential profile and benefit of the products we are developing; the number of people who may benefit from our products, if successfully developed and approved; the mission, vision, strategies, plans and goals for our business; and the potential for value creation. 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 successfully complete 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 non-clinical studies or in earlier clinical trials or at interim time periods 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; the results of completed, ongoing and future studies may not be sufficient to file for or gain regulatory approval to market a product without further development work; unexpected concerns may arise from additional data, analysis or results from any of our completed studies; we may encounter adverse events at any stage that negatively impact further development, our ability to seek or obtain regulatory approval or commercialization of such product; we may encounter delays in initiation, conduct or completion of our ongoing and planned clinical trials; the FDA and other regulatory agencies may ultimately decide that the design or results of our completed, ongoing and planned clinical trials, even if positive, are not sufficient to file for or obtain regulatory approval in the indications that are the focus of our development plans even if we have had prior discussions with the agency supporting our approach; other decisions or actions of the FDA or other regulatory agencies may affect the initiation, timing, design, size, and progress of clinical trials and our ability to proceed with further development or our ability to obtain approval; even if we obtain regulatory approval of a new product, our launch efforts may not be successful and we may never be able to generate meaningful revenues from sales of such product at levels we expect or at levels necessary to justify our investment; the number of patients with the diseases or disorders for which our products are developed, the unmet need for additional treatment options and the potential market for our current or future products may be significantly smaller than we expect; and we may encounter technical and other unexpected hurdles in the development or manufacture of our product candidates or the manufacture, distribution or commercialization of our marketed product which may delay our timing or change our plans or otherwise negatively impact our business; as well as those risks more fully discussed in the section entitled "Risk Factors" in our most recent Quarterly Report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent our views only as of today, and should not be relied upon as representing our views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.

    View Full Article Hide Full Article
  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 that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to SAGE-718 for development as a potential treatment for Huntington's disease (HD). Fast Track is a process designed to facilitate the development and review of new treatments for serious conditions with unmet medical need such as HD.

    "HD is an autosomal dominant genetic disorder that impacts the brain and by nature numerous generations of a family. Cognitive decline is often one of the earliest signs of the disease and this decline, in addition…

    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 U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to SAGE-718 for development as a potential treatment for Huntington's disease (HD). Fast Track is a process designed to facilitate the development and review of new treatments for serious conditions with unmet medical need such as HD.

    "HD is an autosomal dominant genetic disorder that impacts the brain and by nature numerous generations of a family. Cognitive decline is often one of the earliest signs of the disease and this decline, in addition to other symptoms, results in a devastating impact on independence, general functioning, and quality of life. We believe that improving cognitive function is one of the core paths to maintaining quality of life in HD and remains an area of significant unmet medical need," said Jim Doherty, Ph.D., chief research officer at Sage Therapeutics. "In studies to date, treatment with SAGE-718 has been associated with improved cognitive performance, particularly in the domain of executive functioning. The FDA Fast Track Designation is an important milestone in the development of SAGE-718, as it provides opportunities to engage collaboratively with the FDA to further clinical development and future regulatory review of SAGE-718 for the treatment of HD."

    About Fast Track Designation

    Fast Track is a process designed to facilitate the development, and expedite the review, of drugs to treat serious conditions and fill an unmet medical need. Drugs that receive Fast Track designation may be eligible to be the subject of more frequent communications and meetings with FDA to review the drug's development plan including the design of the proposed clinical trials, use of biomarkers and the extent of data needed for approval. Drugs with Fast Track Designation may also qualify for priority review to expedite the FDA review process, if relevant criteria are met.

    The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions. For more information about Fast Track, please visit: https://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm.

    About SAGE-718

    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). Ongoing studies aim to evaluate whether SAGE-718 may have the potential to improve cognitive symptoms for these difficult-to-treat disorders. Sage expects to initiate a placebo-controlled Phase 2 trial with SAGE-718 in early to moderate HD in late 2021.

    About Huntington's Disease

    Huntington's disease (HD) is a rare, inherited neurodegenerative disease that progresses over time. Up to 30,000 adults are diagnosed with HD in the U.S. each year. Symptoms usually appear between ages 30–45, worsen over the following 15–20 years, and ultimately lead to death. Psychiatric and cognitive symptoms can severely affect people with HD.

    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 expectations regarding the potential benefit of Fast Track designation; our plans and expected timelines for development of SAGE-718; our view of the potential profile and benefit of SAGE-718 and potential indications; our expectations as to the unmet need in the treatment of Huntington's disease; and our other statements as to the potential opportunity 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: Fast Track designation from the FDA may not lead to a faster or successful development of SAGE-718 and, even if development is successful, may not result in a faster or successful regulatory review process; the FDA may withdraw Fast Track designation at any time; we may not be successful in our development of SAGE-718 or any of our other product candidates in any indication we are currently pursuing or may in the future pursue; success in non-clinical studies or in earlier clinical trials or at interim time periods may not be repeated or observed in ongoing or future studies or in studies in other indications, 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 delays in initiation, conduct or completion of our ongoing and planned clinical trials, including as a result of slower than expected site initiation or enrollment, the need or decision to expand the trials or other changes, that may impact our ability to meet our expected timelines; the FDA may not agree that the design or results of our nonclinical studies and clinical trials for SAGE-718 or any of our other product candidates, even if positive, are sufficient to file for or obtain regulatory approval in the indications that are the focus of our development plans even if we have had prior discussions with the agency supporting our approach; 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 unmet need for additional treatment options for Huntington's disease or any other indications we are studying or may study in the future with SAGE-718 or any of our other product candidates may be significantly smaller than we expect; and we may encounter technical and other unexpected hurdles in the development and manufacture of SAGE-718 or any of our other product candidates which may delay our timing or change our plans, increase our costs or otherwise negatively impact our business; as well as those risks more fully discussed in the section entitled "Risk Factors" in our most recent Quarterly Report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent our views only as of today, and should not be relied upon as representing our views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.

    View Full Article Hide Full Article
  3. 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 today that the Company will participate in a fireside chat at the Morgan Stanley Global Healthcare Conference on September 10 at 12:30pm ET.

    A live webcast of the fireside chat 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, announced today that the Company will participate in a fireside chat at the Morgan Stanley Global Healthcare Conference on September 10 at 12:30pm ET.

    A live webcast of the fireside chat 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
  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, announced today that the Company will present at the following upcoming investor conferences in August:

    • 2021 Wedbush PacGrow Healthcare Virtual Conference: Barry Greene, Chief Executive Officer of Sage Therapeutics, will be a featured speaker on the panel, The Brains of the Operation - Novel Approaches in Neuro, on Tuesday, August 10, 2021 at 12:00 p.m. ET.
    • Canaccord Genuity 41st Annual Growth Conference: fireside chat on Wednesday, August 11, 2021 at 8:00 a.m. ET.

    A live webcast of each event can be accessed on the investor page of Sage's…

    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 today that the Company will present at the following upcoming investor conferences in August:

    • 2021 Wedbush PacGrow Healthcare Virtual Conference: Barry Greene, Chief Executive Officer of Sage Therapeutics, will be a featured speaker on the panel, The Brains of the Operation - Novel Approaches in Neuro, on Tuesday, August 10, 2021 at 12:00 p.m. ET.
    • Canaccord Genuity 41st Annual Growth Conference: fireside chat on Wednesday, August 11, 2021 at 8:00 a.m. ET.

    A live webcast of each event can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcasts 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
  5. Announced positive topline data from pivotal WATERFALL Study of zuranolone in patients with MDD showing statistically significant and clinically meaningful reduction in depressive symptoms at Day 15, primary endpoint

    Continued pipeline expansion and acceleration advancing all three brain health franchises, including first patient dosed in SAGE-718 PARADIGM Parkinson's disease Study Part B and initiation of Phase 1 program for SAGE-689

    Updated enrollment guidance for Phase 3 SKYLARK Study of zuranolone in women with PPD with topline data now expected mid-2022

    Company announces REDWOOD and RAINFOREST Studies not expected to be required for a potential zuranolone NDA submission

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

    Today, Sage Therapeutics…

    Announced positive topline data from pivotal WATERFALL Study of zuranolone in patients with MDD showing statistically significant and clinically meaningful reduction in depressive symptoms at Day 15, primary endpoint

    Continued pipeline expansion and acceleration advancing all three brain health franchises, including first patient dosed in SAGE-718 PARADIGM Parkinson's disease Study Part B and initiation of Phase 1 program for SAGE-689

    Updated enrollment guidance for Phase 3 SKYLARK Study of zuranolone in women with PPD with topline data now expected mid-2022

    Company announces REDWOOD and RAINFOREST Studies not expected to be required for a potential zuranolone NDA submission

    Conference call today at 8:00 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, reported business highlights and financial results for the second quarter ended June 30, 2021.

    "Sage has made incredible progress on our mission to become the leader in brain health in the first half of 2021, setting us up for multiple near-mid and long-term catalysts," said Barry Greene, chief executive officer, Sage Therapeutics. "Our goal of making medicines that matter for people with brain health disorders is more important than ever, and we are committed to delivering innovative therapies. The LANDSCAPE and NEST programs for zuranolone are examples of Sage's unique approach to designing integrated clinical development strategies that we believe will enable us to bring paradigm shifting treatments to market and address the greatest unmet needs for patients. I look forward to providing further updates on zuranolone and the rest of Sage's robust pipeline in the second half of the year."

    Second Quarter 2021 and Recent Portfolio Updates

    Sage is advancing a portfolio of clinical programs featuring internally discovered novel 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 postpartum depression (PPD). Zuranolone has received breakthrough therapy designation from the FDA for the treatment of major depressive disorder (MDD).

    Zuranolone is being evaluating as a potential rapid-acting, durable, two-week treatment for PPD and MDD in the NEST and LANDSCAPE clinical trial programs.

    Sage and Biogen, its collaborator on zuranolone and SAGE-324, recently announced that the WATERFALL Study, a pivotal, Phase 3, double-blind, randomized, placebo-controlled study evaluating the efficacy and safety of zuranolone 50 mg in adults 18 to 64 years with MDD, met its primary endpoint demonstrating statistically significant and clinically meaningful improvement in depressive symptoms compared with placebo at Day 15 as assessed by the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score.

    • The WATERFALL Study enrolled 543 patients with MDD; patients were treated with zuranolone 50 mg or placebo once nightly for 14 days.
    • The mean (SD) baseline HAMD-17 score at entry into the study was 26.8 (2.60) in the zuranolone 50 mg treatment group (n=268) and 26.9 (2.67) in the placebo group (n=269).
    • 90.3% of patients who received zuranolone, and 87.4% of patients who received placebo, completed the study.
    • The LS means (SE) change from baseline in HAMD-17 total score at Day 15 for patients who received zuranolone 50 mg was -14.1 (0.51) compared with -12.3 (0.50) for patients who received placebo (LS mean difference -1.7 points; p=0.0141).
    • Rapid and significant onset of treatment effect was also seen in HAMD-17 results at Days 3, 8, and 12.
    • Patients with a response to zuranolone at Day 15 retained on average 86% of their HAMD-17 improvement at Day 42 (4 weeks after dosing ended).
    • Zuranolone was generally well-tolerated in the WATERFALL Study and demonstrated a safety profile consistent with previous clinical studies. The most common treatment-emergent adverse events (TEAEs) that were ≥ 5% in patients treated with zuranolone (rates vs placebo) included somnolence 15.3% (vs 3.0%), dizziness 13.8% (vs 2.2%), headache 10.8% (vs 7.8%), and sedation 7.5% (vs 0.4%); these events predominantly occurred during the 14-day treatment period.
      • There were no reports of weight gain, sexual dysfunction, euphoria or nausea typically associated with most, if not all, antidepressant drugs

    Zuranolone has been granted Breakthrough Therapy Designation by the FDA, and Sage and Biogen plan to discuss next steps with the Agency. Additional analysis and full data from the WATERFALL Study will be shared at future scientific forums.

    Additionally, the Company is formally terminating the REDWOOD and RAINFOREST Studies, which were suspended in the first quarter of 2020. After discussions with the FDA, Sage does not believe that these studies will be required for a potential NDA submission.

    The Company expects the following zuranolone data readouts in 2021 and 2022:

    • Late 2021:
      • CORAL (MDD-305) Study: A placebo-controlled Phase 3 trial evaluating a two-week course of zuranolone 50 mg, when co-initiated with a new antidepressant, in patients with MDD, with additional short-term follow-up.
      • SHORELINE (MDD-303) Study 50 mg Cohort (1-year data cut): An open-label Phase 3 trial designed to naturalistically follow patients with MDD and evaluate the safety and tolerability of zuranolone 50 mg in adults for up to one year. The Company announced interim data from the 50 mg treatment cohort in March 2021.
    • Mid-2022:
      • SKYLARK (PPD-301) Study: A placebo-controlled Phase 3 trial evaluating a two-week course of zuranolone 50 mg in women with PPD, with additional short-term follow-up.
        • Sage now expects topline data for the SKYLARK Study in mid-2022, because of a slower than anticipated pace of enrollment in the study, due to a lower number of women seeking care for PPD and a lower rate of childbirth during the pandemic.

    Sage today announced topline data from the Phase 3 CHICKADEE Study evaluating the safety of ZULRESSO treatment in adolescent females aged 15 to 17 with postpartum depression. This study was conducted as a post-marketing requirement to investigate ZULRESSO in an adolescent population diagnosed with PPD. In the study, the safety and pharmacokinetic profile of ZULRESSO in this population was consistent with prior studies in adults and the FDA-approved product label. While not the primary endpoint, efficacy results were positive and consistent with previous studies.

    Neurology Franchise

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

    In the second quarter, Sage and Biogen announced that the KINETIC Study, a Phase 2 multicenter, randomized, double-blind, placebo-controlled study of SAGE-324 in ET, met its primary endpoint.

    • In the study, SAGE-324 demonstrated a statistically significant reduction from baseline in the TETRAS Item 4 upper limb tremor score at Day 29 in the total studied population compared to placebo.
    • Also in the study, SAGE-324 demonstrated a statistically significant correlation between TETRAS tremor score and activities of daily living at all measured time points.
    • Sage and Biogen anticipate initiating a Phase 2 dose-ranging study in late 2021, with the goal of optimizing the dose and frequency, including to maintain plasma concentrations that translate into sustained tremor symptom control.

    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), PD and Alzheimer's disease (AD).

    This quarter, Sage dosed the first patient in the 4-week dosing cohort, or part B, of the PARADIGM Study to gather additional data on SAGE-718 in the PD patient population. The PARADIGM study is a Phase 2a open-label study in patients aged 50 to 75 years old with mild cognitive impairment due to PD. Additionally, the LUMINARY Study, a Phase 2a open-label trial evaluating SAGE-718 in patients with AD mild cognitive impairment and mild dementia is ongoing.

    The following milestones are expected for the neuropsychiatry franchise in 2021:

    • Late 2021:
      • LUMINARY (718-CNA-201) Study: The Company anticipates topline data from the LUMINARY Study in late 2021.
      • Phase 2 Study in HD: The Company expects to initiate a placebo-controlled Phase 2 trial with SAGE-718 in early to moderate HD in late 2021.

    Early Development

    Sage expects to complete certain ongoing Phase 1 clinical studies for two programs in its early development pipeline in late 2021, SAGE-689 (single ascending dose) and SAGE-904 (single ascending dose and multiple ascending dose). Results from the Phase 1 studies will inform further development of these programs.

    • SAGE-689: an intramuscular GABAA receptor PAM in development as a potential therapy for disorders associated with acute GABA hypofunction. In the second quarter, the first patient was dosed in the SAGE-689 Phase 1 SAD study.
    • SAGE-904: Sage's second NMDA receptor PAM product candidate in development as a potential oral therapy for disorders associated with NMDA hypofunction. In the second quarter, the first patient was dosed in the continued SAGE-904 Phase 1 studies.

    Additionally, IND-enabling work is underway for SAGE-319.

    • SAGE-319: an oral, extrasynaptic GABAA receptor preferring PAM that Sage plans to study for potential use in disorders of social interaction.

    The Company plans to advance SAGE-421 to preclinical studies.

    • SAGE-421: an oral, NMDA receptor PAM that Sage plans to study for potential use in neurodevelopmental disorders and cognitive recovery and rehabilitation.

    Other Development Opportunities

    Sage's Phase 3 trial with brexanolone in ventilated intensive care unit patients with advanced COVID-19 related acute respiratory distress syndrome (ARDS) did not meet enrollment expectations and was closed to enrollment this quarter. Sage has terminated the study.

    ANTICIPATED 2021 MILESTONES

    Late 2021:

    • Zuranolone:
      • Report topline data from Phase 3 CORAL Study
      • Report topline data cut from Phase 3 SHORELINE Study 50 mg cohort
    • SAGE-324:
      • Initiate Phase 2 dose-ranging study in ET
    • SAGE-718:
      • Report topline data from Phase 2a LUMINARY open-label, signal finding study in patients with AD mild cognitive impairment and mild dementia
      • Initiate placebo-controlled Phase 2 study in early to moderate HD
    • SAGE-689 & SAGE-904:
      • Complete ongoing Phase 1 studies (SAD for SAGE-689 and SAD/MAD for SAGE-904)

    FINANCIAL RESULTS FOR THE SECOND QUARTER 2021

    • Cash Position: Cash, cash equivalents and marketable securities as of June 30, 2021 were $1.9 billion compared to $2.0 billion at March 31, 2021.
    • Revenue: Net revenue from sales of ZULRESSO was $1.6 million in the second quarter of 2021 compared to $1.1 million in the same period of 2020.
    • R&D Expenses: Research and development expenses were $66.2 million, including $13.5 million of non-cash stock-based compensation expense, in the second quarter of 2021 compared to $73.3 million, including $10.1 million of non-cash stock-based compensation expense, for the same period in 2020, a decrease of $7.1 million. The amount for the second quarter of 2021 reflects an increase in expenses of $13.0 million and a reduction in expenses of $20.1 million due to reimbursement from Biogen pursuant to the Sage/Biogen Collaboration and License Agreement. The primary reasons for the increase in expenses were clinical pharmacology studies that began in 2021 and non-cash stock-based compensation expense from the achievement of a milestone for certain outstanding performance restricted stock units.
    • SG&A Expenses: Selling, general and administrative expenses were $43.3 million, including $14.2 million of non-cash stock-based compensation expense, in the second quarter of 2021 compared to $38.2 million, including $12.1 million of non-cash stock-based compensation expense, for the same period in 2020, an increase of $5.1 million. The amount for the second quarter of 2021 reflects an increase in expenses of $8.6 million and a reduction in expenses of $3.5 million due to reimbursement from Biogen pursuant to the Sage/Biogen Collaboration and License Agreement. The primary reasons for the increase in expenses were an increase in activities focused on disease awareness, increased launch readiness activities for a potential product launch, if our zuranolone development efforts are successful, and non-cash stock-based compensation expense from the achievement of a milestone for certain outstanding performance restricted stock units.
    • Restructuring Expenses: Sage had no restructuring expenses in the second quarter of 2021 compared to $28.4 million in the second quarter of 2020.
    • Net Loss: Net loss was $107.2 million for the second quarter of 2021 compared to a net loss of $136.3 million for the same period in 2020.

    FINANCIAL GUIDANCE

    • Sage anticipates cash, cash equivalents, and marketable securities of more than $1.7 billion at end of 2021.
    • The Company does not anticipate receipt of any milestone payments from collaborations in 2021.

    Conference Call Information

    Sage will host a conference call and webcast today, Tuesday, August 3, at 8:00 am ET to discuss its second quarter 2021 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 planned research and development activities and related timelines, including anticipated timelines for reporting clinical trial results, commencement of trials, and initiation of new activities; our plans for advancement of our pipeline; our belief in the potential profile and benefit of our product candidates, the potential for our programs, and the opportunity to help patients in various indications; our belief and expectations as to the potential regulatory pathways and requirements for filing a potential new drug application for zuranolone and for possible approval; potential indications for our product candidates; the mission and goals for our business and potential value creation opportunities; and our expectations with respect to 2021 year-end cash. These statements constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, which could cause actual results to differ materially from those contemplated in these forward-looking statements, including the risks that: success in non-clinical studies or in earlier clinical trials or at interim time periods 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; unexpected concerns may arise from additional data, analysis or results from any of our completed studies; 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 delays in initiation, conduct or completion of our ongoing and planned clinical trials, including as a result of slower than expected site initiation or enrollment, the need or decision to expand the trials or other changes, that may impact our ability to meet our expected timelines and increase our costs; the impact of the COVID-19 pandemic on our clinical development efforts may be more significant than we expect if new surges continue; the FDA may ultimately decide that the design or results of our completed, ongoing and planned clinical trials for zuranolone or any of our other product candidates, even if positive, are not sufficient to file for or obtain regulatory approval in the indications that are the focus of our development plans even if we have had prior discussions with the agency supporting our approach; 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 anticipated benefits of our ongoing collaborations may never be achieved and the need to align with our collaborators may hamper or delay our development and commercialization efforts or increase our costs; our business may be adversely affected and our costs may increase if any of our key collaborators fails to perform its obligations or terminates our collaboration; 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; we may never be able to generate meaningful revenues from sales of ZULRESSO or to generate revenues at levels we expect or at levels necessary to justify our investment; 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; our expectations as to year-end cash 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; additional funding may not be available on acceptable terms when we need it; the number of patients with the diseases or disorders for which our products are developed, the unmet need for additional treatment options and the potential market for our current or future products may be significantly smaller than we expect; and we may encounter technical and other unexpected hurdles in the development and manufacture of our product candidates or the commercialization of our marketed product which may delay our timing or change our plans, increase our costs or otherwise negatively impact our business; as well as those risks more fully discussed in the section entitled "Risk Factors" in our most recent Quarterly Report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent our views only as of today, and should not be relied upon as representing our views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.

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

    Three Months Ended June 30,

    Six Months Ended June 30,

     

    2021

     

     

    2020

     

     

    2021

     

     

    2020

     

    Product revenue, net

    $

    1,643

     

    $

    1,089

     

    $

    3,226

     

    $

    3,375

     

     
    Operating costs and expenses:
    Cost of goods sold

     

    148

     

     

    110

     

     

    335

     

     

    280

     

    Research and development

     

    66,170

     

     

    73,320

     

     

    124,226

     

     

    136,930

     

    Selling, general and administrative

     

    43,346

     

     

    38,224

     

     

    83,193

     

     

    108,355

     

    Restructuring

     

    -

     

     

    28,402

     

     

    -

     

     

    28,402

     

    Total operating costs and expenses

     

    109,664

     

     

    140,056

     

     

    207,754

     

     

    273,967

     

    Loss from operations

     

    (108,021

    )

     

    (138,967

    )

     

    (204,528

    )

     

    (270,592

    )

     
    Interest income, net

     

    732

     

     

    2,686

     

     

    1,440

     

     

    7,416

     

    Other income (expense), net

     

    44

     

     

    (66

    )

     

    79

     

     

    89

     

    Net loss

    $

    (107,245

    )

    $

    (136,347

    )

    $

    (203,009

    )

    $

    (263,087

    )

    Net loss per share - basic and diluted

    $

    (1.83

    )

    $

    (2.63

    )

    $

    (3.47

    )

    $

    (5.07

    )

    Weighted average shares outstanding - basic and diluted

     

    58,582,569

     

     

    51,926,074

     

     

    58,478,970

     

     

    51,917,417

     

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

    2021
    December 31,

    2020
    Cash, cash equivalents and marketable securities

    $

    1,911,315

    $

    2,099,549

    Total assets

    $

    2,015,475

    $

    2,159,246

    Total liabilities

    $

    85,963

    $

    86,912

    Total stockholders' equity

    $

    1,929,512

    $

    2,072,334

    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 until your 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.

    View Full Article Hide Full Article
  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 it will host a live webcast on Tuesday, August 3, 2021 at 8:00 a.m. ET to announce second quarter 2021 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 Tuesday, August 3, 2021 at 8:00 a.m. ET to announce second quarter 2021 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
  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 the Company will participate in a fireside chat at Cowen's Psychedelics & Novel Mechanisms in Neuropsychiatry Summit on July 13th at 2:25pm 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 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, 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 participate in a fireside chat at Cowen's Psychedelics & Novel Mechanisms in Neuropsychiatry Summit on July 13th at 2:25pm 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 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
  8. 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 participate in a fireside chat at SVB Leerink's 3rd Annual CNS Forum on June 29th at 4:15pm ET.

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

    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 participate in a fireside chat at SVB Leerink's 3rd Annual CNS Forum on June 29th at 4:15pm ET.

    A live webcast of each presentation can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcasts 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
  9. Announcing Positive Phase 3 Results for Zuranolone, an Investigational Two-Week, Once Daily Therapeutic Being Evaluated for Major Depressive Disorder

    Webcast scheduled for 8:00a.m. ET on Tuesday, June 15

    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 this morning, June 15, 2021 at 8:00 a.m. ET to review topline results from the Phase 3 WATERFALL Study evaluating zuranolone for major depressive disorder.

    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…

    Announcing Positive Phase 3 Results for Zuranolone, an Investigational Two-Week, Once Daily Therapeutic Being Evaluated for Major Depressive Disorder

    Webcast scheduled for 8:00a.m. ET on Tuesday, June 15

    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 this morning, June 15, 2021 at 8:00 a.m. ET to review topline results from the Phase 3 WATERFALL Study evaluating zuranolone for major depressive disorder.

    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.

    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
    • At the Day 15 primary endpoint, zuranolone 50 mg showed a statistically significant and clinically meaningful reduction in depressive symptoms as measured by HAMD-17 (p=0.0141) compared to placebo
    • Rapid onset of treatment effect was seen in HAMD-17 results at Days 3, 8, and 12
    • Patients with a response at Day 15 to zuranolone retained on average 86% of their HAMD-17 improvement at Day 42 (4 weeks after dosing ended)
    • Zuranolone was generally well-tolerated and demonstrated a safety profile consistent with previous clinical studies; trial completion rate was 90.3% in the zuranolone group
    • Zuranolone is an investigational two-week, once-daily oral drug for MDD that represents a potential new class of drug for the management of this common but serious
    • At the Day 15 primary endpoint, zuranolone 50 mg showed a statistically significant and clinically meaningful reduction in depressive symptoms as measured by HAMD-17 (p=0.0141) compared to placebo

    • Rapid onset of treatment effect was seen in HAMD-17 results at Days 3, 8, and 12
    • Patients with a response at Day 15 to zuranolone retained on average 86% of their HAMD-17 improvement at Day 42 (4 weeks after dosing ended)
    • Zuranolone was generally well-tolerated and demonstrated a safety profile consistent with previous clinical studies; trial completion rate was 90.3% in the zuranolone group
    • Zuranolone is an investigational two-week, once-daily oral drug for MDD that represents a potential new class of drug for the management of this common but serious mental health disorder

    CAMBRIDGE, Mass., June 15, 2021 (GLOBE NEWSWIRE) -- Sage Therapeutics, Inc. (NASDAQ:SAGE) and Biogen Inc. (NASDAQ:BIIB) today announced that the WATERFALL Study in patients with MDD met its primary endpoint with zuranolone (SAGE-217/BIIB125) 50 mg showing statistically significant improvement in depressive symptoms compared with placebo at Day 15 as assessed by the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score. LS means (SE) change from baseline in HAMD-17 total score at Day 15 for patients who received zuranolone 50 mg was -14.1 (0.51) compared with -12.3 (0.50) for patients who received placebo (LS mean difference -1.7 points; p=0.0141).

    Monoamine-based antidepressants have been the standard of care for chronic treatment of MDD for the past 60 years. They are treatments administered daily, which require sufficient exposure and continuous use to maintain effect. Zuranolone is a two-week, once-daily oral drug under investigation for the treatment of MDD. It is a molecule that is designed to potentially provide a rapid-acting, sustainable treatment option, and could represent a breakthrough in the current management of depression.

    The WATERFALL Study was a pivotal, Phase 3, double-blind, randomized, placebo-controlled study evaluating the efficacy and safety of zuranolone 50 mg in adults 18 to 64 years with MDD (N=543). The WATERFALL Study enrolled patients who had MDD with a HAMD-17 total score ≥24 at screening and Day 1 prior to dosing.

    "Sage's expertise in the modulation of the GABA receptor pathway in the brain, coupled with insights on the treatment wants and needs of clinicians and patients, has resulted in our targeting a unique benefit/risk profile with the development of zuranolone supported to date by the data generated in the WATERFALL Study and the broader Landscape and NEST programs," said Barry Greene, Chief Executive Officer at Sage Therapeutics. "We dared to imagine a different future for the treatment of MDD where patients have the potential to experience a rapid response that is well-tolerated and that may enable them to stay better with long periods free from depression symptoms, and free from daily chronic treatments and related side effects. In doing so, we aspire to help eliminate stigma associated with brain health disorders so that we can move beyond brain health awareness to brain health action."

    "Together with our collaboration partners at Sage, we are proud to announce highly encouraging results from the Phase 3 WATERFALL Study of zuranolone in major depressive disorder. These results represent hope and positive progress for the more than 250 million patients worldwide who are estimated to live with depression," said Alfred Sandrock, Jr., M.D., Ph.D., Head of Research and Development at Biogen. "Major depressive disorder is a common co-morbidity of many diseases represented in Biogen's neuroscience portfolio. We believe zuranolone has the potential to offer a unique, first-in-class therapeutic for depression with a distinct benefit-risk profile to people living with this common but serious mental health condition."

    Zuranolone was generally well-tolerated in the WATERFALL Study and demonstrated a safety profile consistent with previous clinical studies. The rate of treatment emergent adverse events (TEAEs) in the zuranolone group was 60.1% (161/268) vs the placebo group at 44.6% (120/269). The majority of the TEAEs were mild to moderate. The most common TEAEs that were ≥ 5% in patients treated with zuranolone (rates vs placebo) included somnolence 15.3% (vs 3.0%), dizziness 13.8% (vs 2.2%), headache 10.8% (vs 7.8%), and sedation 7.5% (vs 0.4%); these events predominantly occurred during the 14-day treatment period. Throughout the study, a total of two patients each (0.7%) reported serious adverse events (SAEs) in the zuranolone and placebo groups; no death occurred in the study. The percent of patients reporting TEAEs leading to drug discontinuation was 3.4% (9/268) and 1.5% (4/269), in the zuranolone and placebo groups, respectively. No signal for withdrawal symptoms as assessed by the 20-item Physician Withdrawal Checklist (PWC-20), or for increased suicidal ideation or behavior as per the Columbia-Suicide Severity Rating Scale (C-SSRS) were identified.

    "I'm really excited about these breakthrough data: we know MDD is episodic and zuranolone has the potential to treat episodically. The LANDSCAPE clinical studies are all helpful taken together because they provide data on both short- and long-term use of zuranolone," said Anita H. Clayton, M.D., Chair of Psychiatry and Neurobehavioral Sciences, University of Virginia School of Medicine. "These data suggest that this treatment, if approved, has the potential to work fast with a short-course of therapy that is well-tolerated, with the effect maintained over the long-term. This will empower my patients to think differently about their depression and treatment, and to rapidly return to their life. Depression is not an identity, it's an episodic disorder that we hope in the future to be able to treat quickly with treatments that are well-tolerated and with benefits that last."

    "MDD is a pressing mental health concern and, unlike physical health concerns where innovation is commonplace, many of the treatments for MDD were first approved more than two decades ago," said Paul Gionfriddo, President and CEO of Mental Health America (MHA). "We welcome today's news, and the potential for a new and innovative treatment that could change the way we treat depression."

    Zuranolone has been granted Breakthrough Therapy Designation by the U.S. Food & Drug Administration, and the Companies intend to discuss next steps with the Agency. Full data from the WATERFALL Study will be shared at future scientific forums.

    Detailed Topline Results from the WATERFALL Study

    • The WATERFALL Study enrolled 543 patients with MDD. The patients were treated with zuranolone 50 mg or placebo once nightly for 14 days.
    • The primary endpoint of the study was the change from baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D) total score at Day 15; the first secondary endpoint was the change from baseline in the Clinical Global Impression-Severity of Illness (CGI-S) at Day 15
    • The mean (SD) baseline HAMD-17 score at entry into the study was 26.8 (2.60) in the zuranolone 50 mg treatment group (n=268) and 26.9 (2.67) in the placebo group (n=269).
    • 90.3% of patients who received zuranolone, and 87.4% of patients who received placebo, completed the study
    • Results for the primary endpoint and several topline secondary efficacy endpoints during the treatment period are outlined in the following table and all favor zuranolone:



    Outcome*Day 3Day 8Day 12Day 15
    HAMD-17: LS mean difference (p value)-3.0 (<0.0001)^-2.6 (<0.0001)^-2.5 (0.0003)-1.7 (0.0141)*
    CGI-Severity: LS mean difference (p value)-0.4 (<0.0001)-0.4 (0.0001)-0.3 (0.0014)-0.2 (0.1193)^
    CGI-Improvement Response:

    Odds ratio (p value)
    1.8 (0.0032)1.9 (0.0005)1.6 (0.0101)1.5 (0.0191)
    MADRS: LS mean difference (p value)Not measured

    per protocol
    -3.4 (0.0003)Not measured

    per protocol
    -2.4 (0.0238)
    HAM-A: LS mean difference (p value)Not measured

    per protocol
    -1.7 (0.0011)Not measured

    per protocol
    -1.4 (0.0199)

    Except for HAMD-17 at Day 15 (primary) which was statistically significant and CGI-S (first secondary endpoint) which was not significant at Day 15, all p-values in the table are nominal and not adjusted for multiple comparisons.

    *Pre-specified primary endpoint

    ^Pre-specified key secondary endpoints

    LS = least squares; LS mean difference = difference in LS means of change from baseline between zuranolone and placebo groups

    Patients with a response at Day 15 in the zuranolone group retained on average 86.1% of their HAMD-17 improvement at Day 42 (4 weeks after dosing ended). A similar maintenance of response was also observed with the MADRS scale, where people who responded to zuranolone at Day 15 maintained 87.6% of that response at Day 42. While not statistically significant, a numerical advantage in favor of zuranolone was demonstrated at Day 42.

    Safety and tolerability:

    • Adverse events were consistent with the safety profile of zuranolone seen to date in clinical studies.
    • The incidence of treatment emergent adverse events (TEAEs) in the zuranolone group was 60.1% (161/268) vs the placebo group at 44.6% (120/269).
    • The majority of the TEAEs were mild to moderate, with 8 (3.0%) and 3 (1.1%) being severe in the zuranolone and placebo groups respectively.
    • The most common TEAEs observed in ≥5% of patients in either treatment group are listed below and occurred predominantly during the 14-day treatment period. These events were non-serious, and most were mild to moderate.
     AE (≥5%) Zuranolone 50 mg Placebo
     Somnolence, n (%) 41 (15.3) 8 (3.0)
     Dizziness, n (%) 37 (13.8) 6 (2.2)
     Headache, n (%) 29 (10.8) 21 (7.8)
     Sedation, n (%) 20 (7.5) 1 (0.4)
     Diarrhea, n (%) 8 (3.0) 14 (5.2)
    • Discontinuation rates of the study drug due to AEs in patients receiving zuranolone were 3.4% (9/268) compared to 1.5% (4/269) in those receiving placebo.
    • Throughout the study, a total number of 4 patients reported serious adverse events (SAEs), 2 (0.7%) each in the zuranolone and placebo groups.
    • No deaths occurred in the study.
    • No signal in increased suicidal ideation or behavior, as assessed by the C-SSRS, was observed throughout the study in patients receiving zuranolone 50 mg or placebo.
    • No signal in withdrawal effects, as assessed by the PWC-20, was observed after discontinuation of zuranolone.
    • No loss of consciousness, or adverse effects such as weight gain, sexual dysfunction, or euphoria were reported.

    About the WATERFALL Study

    The WATERFALL Study was a double-blind, placebo-controlled pivotal Phase 3 study evaluating the efficacy and safety of zuranolone in adults with major depressive disorder. In the study, 543 patients were enrolled. Patients were randomized to receive zuranolone 50 mg, or placebo, once-nightly for two weeks. The primary endpoint of the study was the change from baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D) total score at Day 15. Secondary endpoints included 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 Zuranolone

    Zuranolone (SAGE-217/BIIB125) is a once-daily, two-week drug in development for the treatment of major depressive disorder (MDD) and postpartum depression (PPD). Zuranolone is an investigational oral neuroactive steroid (NAS) GABA-A 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.

    Zuranolone is being evaluated as a potential rapid-acting, 2-week treatment for PPD and MDD in the NEST and LANDSCAPE clinical trial programs. The programs are designed to generate data to support a potential NDA filing as efficiently as possible. If successful, LANDSCAPE and NEST may support paths to approval with three distinct opportunities to address patient needs: PPD, acute rapid response therapy (RRT) in MDD when co-initiated with a new standard antidepressant, and as-needed treatment of MDD.

    Zuranolone is being evaluated as a potential rapid-acting, 2-week treatment for PPD and MDD in the NEST and LANDSCAPE clinical trial programs. The two development programs include multiple studies examining use of zuranolone in several thousand patients with a variety of dosing, clinical endpoints, and treatment paradigms. The LANDSCAPE Program includes six studies of zuranolone in patients with MDD. Data have been reported from three studies of zuranolone 30 mg in patients with MDD (MDD-201, MOUNTAIN Study and the 30 mg cohort from the ongoing SHORELINE Study), and one study of zuranolone 50 mg in patients with MDD (WATERFALL Study). Two additional studies evaluating zuranolone 50 mg in patients with MDD are expected to read out by the end of 2021 (CORAL Study and a 50mg cohort of the SHORELINE Study).

    The NEST Program includes two placebo-controlled studies of zuranolone in patients with PPD. Positive data from the ROBIN Study (zuranolone 30 mg) have been previously reported. The SKYLARK Study (zuranolone 50 mg) is anticipated to readout by the end of 2021.

    About Major Depressive Disorder (MDD)

    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. and more than 250 million people worldwide suffer from MDD each year. While antidepressants are widely used to treat MDD, large-scale studies have demonstrated the need for additional therapies with a differentiated profile.

    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.

    About Biogen

    At Biogen, our mission is clear: we are pioneers in neuroscience. Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. One of the world's first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp. Today Biogen has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, commercializes biosimilars of advanced biologics and is focused on advancing research programs in multiple sclerosis and neuroimmunology, Alzheimer's disease and dementia, neuromuscular disorders, movement disorders, ophthalmology, neuropsychiatry, immunology, acute neurology and neuropathic pain.

    We routinely post information that may be important to investors on our website at www.biogen.com. Follow us on social media – Twitter, LinkedIn, Facebook, YouTube.

    Forward-Looking Statements

    Sage Therapeutics Safe Harbor

    Various statements in this release concern Sage's future expectations, plans and prospects, including without limitation statements regarding: the potential for future regulatory approval of zuranolone; our planned timing for reporting of data from ongoing clinical trials; the potential profile and benefit of zuranolone in MDD and PPD; plans for discussions of next steps with the FDA; regulatory filing plans and potential pathways and opportunities; planned next steps for the program; our estimates as to the number of patients with MDD; and the goals, opportunity and potential for zuranolone and 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 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; unexpected concerns may arise from additional data, analysis or results from any of our completed studies; 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 delays in conduct of our clinical trials, including slower than expected site initiation or enrollment, that may impact our ability to meet our expected time-lines; the FDA may ultimately decide that the design, conduct or results of our completed and planned clinical trials for zuranolone, even if positive, are not sufficient for regulatory filing or approval in the indications that are the focus of our development plan and may require additional trials or data which may significantly delay our efforts to obtain approval and may not be successful; other decisions or actions of the FDA or other regulatory agencies may affect the zuranolone program and our plans, progress or results; the actual size of the MDD patient population may be significantly lower than our estimates and, even if zuranolone is approved, it may 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 zuranolone or our other product candidates which may delay our timing or change our plans; 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.

    Biogen Safe Harbor

    This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, relating to the potential, benefits, safety and efficacy of zuranolone (SAGE-217/BIIB125); the potential clinical effects of zuranolone; results from the Phase 3 WATERFALL Study of zuranolone; the clinical development program for zuranolone; clinical development programs, clinical trials and data readouts and presentations for zuranolone; the potential treatment of MDD and PPD; the potential of Biogen's commercial business and pipeline programs, including zuranolone; the anticipated benefits and potential of Biogen's collaboration arrangement with Sage; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "potential," "possible," "will," "would" and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements, or the scientific data presented.

    These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation, uncertainty of success in the development and potential commercialization of zuranolone; unexpected concerns may arise from additional data, analysis or results obtained during the WATERFALL Study or the other clinical studies of zuranolone; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of Biogen's drug candidates, including zuranolone; the occurrence of adverse safety events; the risks of other unexpected hurdles, costs or delays; failure to protect and enforce data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; third party collaboration risks; and the direct and indirect impacts of the ongoing COVID-19 pandemic on our business, results of operations and financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen's expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in Biogen's most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements are based on Biogen's current beliefs and expectations and speak only as of the date of this news release. Biogen does not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

    SAGE MEDIA CONTACT:

    Maureen L. Suda

    Sage Therapeutics

    Tel: (617) 949-4289

    Email: Maureen.Suda@sagerx.com
    SAGE INVESTOR CONTACT:

    Jeff Boyle

    Sage Therapeutics

    Tel: (617) 949-4256

    Email: Jeff.Boyle@sagerx.com



    BIOGEN MEDIA CONTACT:        

    Allison Parks  

    +1 781-464-3260

    public.affairs@biogen.com

    BIOGEN INVESTOR CONTACT:

    Mike Hencke

    +1 781 464 2442

    IR@biogen.com



    Primary Logo

    View Full Article Hide Full Article
  10. Creating a movement from the inside out – to break the stigma of mental health conditions and empower employees to be champions of brain health

    Learn more at www.MentalHealthActionDay.org

    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 participation in the first-ever Mental Health Action Day, on May 20, convened by MTV Entertainment Group and including more than 1,300 leading brands, nonprofits, government agencies and cultural leaders. Mental Health Action Day is an open-source movement of brands, organizations, and cultural leaders to turn mental health awareness into the appropriate…

    Creating a movement from the inside out – to break the stigma of mental health conditions and empower employees to be champions of brain health

    Learn more at www.MentalHealthActionDay.org

    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 participation in the first-ever Mental Health Action Day, on May 20, convened by MTV Entertainment Group and including more than 1,300 leading brands, nonprofits, government agencies and cultural leaders. Mental Health Action Day is an open-source movement of brands, organizations, and cultural leaders to turn mental health awareness into the appropriate mental health action. On May 20 and throughout the month of May, Sage will be focusing on inspiring employees to take mental health action for themselves, their friends, family, or for their community. "Sageans" are encouraged to break the stigma by talking about mental health, understanding mental health and the impact it can have, and importantly asking for help when needed, even in the workplace.

    "As we pass the one-year mark of the unprecedented public health crisis created by the COVID-19 pandemic, I am optimistic we are turning the corner in containing the devastating impact the virus has had on society. However, there is a hidden pandemic, the brain health pandemic, represented by an estimated four-fold increase in the rates of depression symptoms in the U.S. alone with a near doubling of adult suicidality," said Barry Greene, CEO of Sage Therapeutics. "There is hope, however, when people and organizations join together to create positive change. We are proud to be an inaugural partner in Mental Health Action Day – collectively we can move from awareness to appropriate action, to create a brain health movement with the potential to transform the lives of millions of people."

    Putting people first is a Sage Core Value. The mental and emotional well-being of employees is important and that includes fostering a safe and inclusive environment free of stigma. To support the mental health and wellness of employees, Sage offers a broad array of resources, benefits, and educational programs to enable employees to support themselves and one another and serve as advocates of brain health. Sage supports the vision of a future where brain health disorders are taken seriously and treated with urgency, integrated with physical health, made a priority, destigmatized, de-mystified and managed with a more people-focused and empowering mindset.

    "As a company focused on brain health, we are on a mission to break the stigma around mental health so people can get the right help – and it starts within Sage first," said Erin Lanciani, Senior Vice President, People and Organizational Strategy, Sage Therapeutics. "We put people first and seek to foster a safe and inclusive environment where our employees feel supported and can be comfortable sharing their mental health experiences, including seeking the appropriate help, if needed. To make a difference for patients, our people need to be at their best. Our long-standing commitment to the emotional well-being of our employees is now more important than ever before."

    More information about Mental Health Action Day and a current list of partners can be found at www.MentalHealthActionDay.org.

    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. Debut webcast to provide deep dive on SAGE-718, the company's lead neuropsychiatry product candidate being studied for cognitive disorders associated with NMDA receptor dysfunction, including Huntington's, Parkinson's, and Alzheimer's diseases

    Webcast scheduled for 8:30 a.m. ET on Thursday, May 20

    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 the first Sage Science Spotlight webcast focused on an in-depth review of SAGE-718.

    Sage will provide details on its progress with SAGE-718, the company's lead neuropsychiatry product candidate being explored for the potential…

    Debut webcast to provide deep dive on SAGE-718, the company's lead neuropsychiatry product candidate being studied for cognitive disorders associated with NMDA receptor dysfunction, including Huntington's, Parkinson's, and Alzheimer's diseases

    Webcast scheduled for 8:30 a.m. ET on Thursday, May 20

    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 the first Sage Science Spotlight webcast focused on an in-depth review of SAGE-718.

    Sage will provide details on its progress with SAGE-718, the company's lead neuropsychiatry product candidate being explored for the potential treatment of cognitive disorders associated with NMDA receptor dysfunction, including Huntington's disease, Alzheimer's disease, and Parkinson's disease. Sage will also share additional details on the recently announced data from the PARADIGM Study of SAGE-718 in patients with mild cognitive impairment due to Parkinson's disease and the planned initiation of a Phase 2 placebo-controlled study in Huntington's disease. Additionally, the Company will discuss the unmet need in Huntington's disease, with participation and perspectives from a leading neurologist and a patient advocate.

    The Sage Science Spotlight is a new webcast series designed to take a deeper look at Sage's work in brain health. It will complement Sage's annual FutureCast event, which provides an update on the company's overall research and development strategy and clinical progress in its key depression, neurology and neuropsychiatry franchise programs.

    Speakers on the May 20th webcast will include:

    • Jim Doherty, Chief Research Officer, Sage Therapeutics
    • Mike Quirk, Vice President, Pharmacology, Sage Therapeutics
    • Aaron Koenig, Executive Medical Director, Early Development, Sage Therapeutics
    • Dr. Samuel Frank, Associate Professor of Neurology, Beth Israel Deaconess Medical Center
    • Seth Rotberg, Patient Advocate (Huntington's Disease)

    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.

    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: statements regarding our planned research and development activities and the opportunity to help patients in various indications. 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 hurdles and delays in initiation, conduct or completion of our planned clinical trials, including as a result of slower than expected site initiation or enrollment; decisions or actions of the FDA may affect the initiation and timing of clinical trials and our ability to proceed with further development; ongoing and future non-clinical and clinical results may not meet their primary or key secondary endpoints or support further development; 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; and 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 otherwise negatively impact our business; as well as those risks more fully discussed in the section entitled "Risk Factors" in our most recent Quarterly Report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent our views only as of today, and should not be relied upon as representing our views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.

    View Full Article Hide Full Article
  12. Company on-track to initiate placebo-controlled Phase 2 trial with SAGE-718 in Huntington's disease in late 2021, as the target for the first indication for SAGE-718, following encouraging signals in Phase 1 data

    PARADIGM Study with SAGE-718 showed improved performance from baseline on multiple tests of executive function over 14 days of treatment in patients with Parkinson's disease cognitive impairment, further supporting development in disorders associated with cognitive dysfunction

    Positive topline data from Phase 2 KINETIC Study showed statistically significant reduction in tremor score with SAGE-324 compared to placebo at Day 29 in adults with essential tremor

    Continued positive data demonstrated for the 30 and 50 mg doses of zuranolone

    Company on-track to initiate placebo-controlled Phase 2 trial with SAGE-718 in Huntington's disease in late 2021, as the target for the first indication for SAGE-718, following encouraging signals in Phase 1 data

    PARADIGM Study with SAGE-718 showed improved performance from baseline on multiple tests of executive function over 14 days of treatment in patients with Parkinson's disease cognitive impairment, further supporting development in disorders associated with cognitive dysfunction

    Positive topline data from Phase 2 KINETIC Study showed statistically significant reduction in tremor score with SAGE-324 compared to placebo at Day 29 in adults with essential tremor

    Continued positive data demonstrated for the 30 and 50 mg doses of zuranolone in open-label SHORELINE Study of zuranolone in patients with major depressive disorder

    Conference call today at 8:00 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, reported business highlights and financial results for the first quarter ended March 31, 2021.

    "Sage started 2021 with significant advances across our depression, neurology and neuropsychiatry franchises, and the progress we've made so far this year sets us up for near-, medium- and long-term value creation opportunities as we further advance our deep organic pipeline," said Barry Greene, chief executive officer at Sage Therapeutics. "In the first quarter alone, we demonstrated the significant potential of our innovative development-stage therapeutics that modulate the GABA and NMDA pathways, through the positive clinical data demonstrated in studies of zuranolone, SAGE-324 and now SAGE-718. We are making great progress toward our goal of becoming the leading brain health company and a top-tier biopharmaceutical company, with multiple upcoming catalysts that I believe represent important steps on our mission of delivering medicines that matter to address the ongoing crisis in brain health."

    First Quarter 2021 and Recent Portfolio Updates

    Sage is advancing a portfolio of clinical programs featuring internally discovered novel 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 brain health 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 postpartum depression (PPD). Zuranolone has received breakthrough therapy designation from the FDA for the treatment of major depressive disorder (MDD). Sage is jointly developing zuranolone in the U.S. with Biogen.

    Zuranolone is being evaluated as a potential rapid-acting, short-course treatment for PPD and MDD in the NEST and LANDSCAPE clinical trial programs. Four Phase 3 clinical studies with zuranolone are ongoing. If successful, these programs may support paths to approval with three distinct opportunities to address patient needs: PPD, acute rapid response therapy (RRT) in MDD when co-initiated with a new standard antidepressant, and as-needed treatment of MDD.

    • In March 2021, Sage reported complete, topline 12-month data from the 30 mg cohort and interim topline data from the 50 mg cohort of the ongoing Phase 3 open-label SHORELINE Study. The SHORELINE Study is designed to evaluate the safety and tolerability of zuranolone in adults for up to one year. Data reported showed:
      • After the initial 2-week zuranolone treatment, more than 70% of patients who received 30 mg and 80% of patients who received 50 mg achieved positive response at Day 15.
      • In the 30 mg zuranolone cohort, approximately 70% of participants with positive response to an initial 2-week treatment required at most one additional zuranolone treatment during the 12-month study.
        • Of the 489 patients continuing in the study, 210 (42.9%) patients used only the single initial zuranolone course, while 125 (25.6%) used a total of two courses, 58 (11.9%) used a total of three courses, 53 (10.8%) used a total of four courses, and 43 (8.8%) used a total of five courses.
      • In the 199 patients who received zuranolone 50 mg only, approximately 80% achieved response and 43.2% achieved remission after the initial 2-week treatment period.
        • In this cohort the adverse event (AE) profile was similar to that seen in patients who received 30 mg zuranolone.
      • In both 30 mg and 50 mg cohorts, zuranolone was generally well-tolerated with an AE profile consistent with data reported earlier.
        • 30 mg cohort: 368 (51%) patients reported at least one adverse event. The most common treatment emergent adverse events (TEAEs) (reported ≥5%) were somnolence (86; 11.9%), headache (103; 14.2%), and dizziness (54; 7.4%). Most adverse events were mild or moderate.
        • Retreatment: The overall incidence rates of TEAEs during the second, third, fourth, and fifth treatment courses were, 42% (120/286), 28.6% (45/157), 29% (28/96), and 27.9% (12/43), respectively. The incidence of TEAEs in the first treatment course was 51% (368/725). The safety profile on treatment, off-treatment, and in between treatments has shown a consistent pattern to date in AE presentation across treatment courses.
        • 50 mg cohort: 62.8% (125/199) subjects reported at least one AE. Events >5% of somnolence, dizziness, and sedation 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.
    • The Company plans to reopen enrollment in the 50 mg cohort of the open-label SHORELINE Study, increasing the target enrollment to 500 patients. Additionally, the Company plans to offer patients from the CORAL Study the ability to roll-over into the SHORELINE Study following completion of the CORAL Study. These extensions of the SHORELINE Study will allow Sage to collect additional long-term data on patients treated with zuranolone 50 mg.

    The Company expects the following zuranolone data readouts in 2021:

    • 1H 2021:
      • WATERFALL (MDD-301B) Study: A placebo-controlled Phase 3 trial evaluating a two-week course of zuranolone 50 mg in patients with MDD, with additional short-term follow-up. In February 2021 the Company announced the WATERFALL Study was closed to enrollment.
    • Late 2021:
      • CORAL (MDD-305) Study: A placebo-controlled Phase 3 trial evaluating a two-week course of zuranolone 50 mg, when co-initiated with a new antidepressant, in patients with MDD, with additional short-term follow-up.
      • SHORELINE (MDD-303) Study 50 mg Cohort (1-year data): An open-label Phase 3 trial designed to naturalistically follow patients with MDD and evaluate the safety and tolerability of zuranolone 50 mg in adults for up to one year.
      • SKYLARK (PPD-301) Study: A placebo-controlled Phase 3 trial evaluating a two-week course of zuranolone 50 mg in women with PPD, with additional short-term follow-up.

    Sage plans to align with the FDA on data to support a potential future new drug application (NDA). Additional development plans for zuranolone in indications beyond MDD and PPD will be determined as part of the Company's strategic collaboration with Biogen.

    Neurology Franchise

    SAGE-324, a next-generation PAM of GABAA receptors and Sage's lead neurology program, is in development as a potential oral therapy for neurological conditions, such as essential tremor (ET), epilepsy and Parkinson's disease (PD). Sage is jointly developing SAGE-324 in the U.S. with Biogen.

    • In April 2021, Sage reported topline data from the KINETIC Study evaluating SAGE-324 in the treatment of people with ET. The KINETIC Study is a Phase 2 study that evaluated the efficacy, safety, and tolerability of SAGE-324 60 mg in patients with ET aged 18 to 80 years old.
      • In the full analysis set (ITT), patients receiving SAGE-324 experienced a statistically significant reduction from baseline in TETRAS Performance Subscale Item 4 compared to placebo at Day 29 (P=0.049), corresponding to a 36% reduction in upper limb tremor amplitude from baseline in the SAGE-324 group compared to a 21% reduction in the placebo group.
      • In a pre-specified subgroup analysis, patients with a more severe tremor at baseline (TETRAS ≥12) demonstrated a statistically significant reduction from baseline in the TETRAS Item 4 upper limb tremor score at Day 29 (p=0.007) which corresponded to a 41% reduction in upper limb tremor amplitude compared to an 18% reduction for placebo.
      • Safety and Tolerability: Patients were randomized 1:1 to receive SAGE-324 (60 mg) or matched placebo once daily in the morning. The trial evaluated treatment of SAGE-324 at the higher end of the dose range and the daily dose could be down-titrated to 45 mg or 30 mg if 60 mg was not well tolerated. Down-titration of dose occurred in 62% of patients who received SAGE-324 and discontinuations were noted in 38% of patients receiving SAGE-324. AEs were generally consistent with the safety profile of SAGE-324 seen to date. The most common TEAEs that occurred in ≥10% of patients in the SAGE-324 treatment group and at a rate at least twice as high as that of patients in the placebo group were: somnolence 68%; dizziness 38%; balance disorder 15%; diplopia 12%; dysarthria 12%; and gait disturbance 12%.
      • Activities of Daily Living (ADL) Scores: ADL scores showed a statistically significant correlation with upper limb tremor score at all timepoints. While not powered to fully examine TETRAS ADL, SAGE-324 was also numerically superior to placebo at all time points during treatment.

    The following milestones are expected for the neurology franchise in late 2021:

    • Sage anticipates initiating a dose-ranging Phase 2 clinical trial with SAGE-324.

    Additional development plans for SAGE-324 will be determined as part of the Company's strategic collaboration with Biogen.

    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), PD and Alzheimer's disease (AD).

    In the Phase 2a open-label PARADIGM Study, eight patients aged 50 to 75 years old with mild cognitive impairment due to PD received SAGE-718 3 mg daily for two-weeks.

    • Patients showed performance improvements from baseline on multiple tests in the cognitive domain of executive function during the 14 days of treatment.
    • Emerging signals on several measures also suggested improved performance from baseline on additional cognitive tests in the domains of learning and memory over a similar timeframe.
    • SAGE-718 was generally well tolerated; there were no serious AEs and no TEAEs were determined to be related to SAGE-718.
    • As expected, and due to its potentially unique profile, in certain tests of attention and psychomotor speed, SAGE-718 demonstrated neutral results. Other classes of medicines, including amphetamines, have been shown to alter simple attention or reaction time but not improve cognitive attributes.

    Findings from the PARADIGM Study extend Sage's understanding of the potential impact of SAGE-718 on multiple domains of cognition. To date, SAGE-718 has demonstrated improvements in executive function in phase 1 and phase 2a studies and these findings add to the Company's confidence in the potential for SAGE-718 to become an important treatment for disorders associated with cognitive dysfunction, including HD, PD and AD.

    Based on data generated with SAGE-718 to date, the Company intends to pursue several paths forward for SAGE-718 in parallel:

    • HD
      • Initiate a placebo-controlled Phase 2 trial with SAGE-718 in early to moderate HD in late 2021. If the overall HD development program is successful, the Company believes HD could be the lead indication pursued for SAGE-718.
    • PD
      • Activate a new 4-week dosing cohort in the PARADIGM Study to gather additional data in the PD patient population.

    The following milestones are expected for the neuropsychiatry franchise in late 2021:

    • LUMINARY (718-CNA-201) Study: The Company anticipates topline data from the LUMINARY Study, a Phase 2a open-label trial evaluating SAGE-718 in patients with AD mild cognitive impairment and mild dementia. The Company initiated enrollment and dosing in this study in early 2021.
    • Phase 2 Study in HD: The Company expects to initiate a placebo-controlled Phase 2 trial with SAGE-718 in early to moderate HD.

    Early Development

    Sage expects to complete certain Phase 1 clinical studies for two programs in its early development pipeline in 2021, SAGE-689 (single ascending dose) and SAGE-904 (single ascending dose and multiple ascending dose).

    • SAGE-689: is an intramuscular GABAA receptor PAM in development as a potential therapy for disorders associated with acute GABA hypofunction.
    • SAGE-904: is Sage's second NMDA receptor PAM product candidate in development as a potential oral therapy for disorders associated with NMDA hypofunction.

    Results from the planned Phase 1 studies will inform further development of these programs.

    Additionally, the Company recently announced plans to advance SAGE-319 and SAGE-421 to preclinical studies.

    • SAGE-319: is an oral, extrasynaptic GABAA receptor preferring PAM that Sage plans to study for potential use in disorders of social interaction.
    • SAGE-421: is an oral, NMDA receptor PAM that Sage plans to study for potential use in neurodevelopmental disorders and cognitive recovery and rehabilitation.

    Other Development Opportunities

    Sage's Phase 3 trial with brexanolone in patients with advanced COVID-19 related acute respiratory distress syndrome (ARDS) is ongoing. The Company expects data from this trial in 2021.

    ANTICIPATED 2021 MILESTONES

    1H21:

    • Zuranolone:
      • Report topline data from Phase 3 WATERFALL Study

    Late 2021:

    • Zuranolone:
      • 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 cohort
    • SAGE-324:
      • Initiate Phase 2 dose-ranging study in ET
    • SAGE-718:
      • Report topline data from Phase 2a LUMINARY open-label, signal finding study in patients with AD mild cognitive impairment and mild dementia
      • Initiate placebo-controlled Phase 2 study in early to moderate HD
    • Brexanolone:
      • Report data from Phase 3 study in patients with advanced COVID-19 related ARDS
    • SAGE-689 & SAGE-904:
      • Complete planned Phase 1 studies (SAD for SAGE-689 and SAD/MAD for SAGE-904)

    FINANCIAL RESULTS FOR THE FIRST QUARTER 2021

    • Cash Position: Cash, cash equivalents and marketable securities as of March 31, 2021 were $2.0 billion compared to $2.1 billion at December 31, 2020.
    • Revenue: Net revenue from sales of ZULRESSO was $1.6 million in the first quarter of 2021 compared to $2.3 million in the same period of 2020.
    • R&D Expenses: Research and development expenses were $58.1 million, including $9.3 million of non-cash stock-based compensation expense, in the first quarter of 2021 compared to $63.6 million, including $12.2 million of non-cash stock-based compensation expense, for the same period in 2020, a decrease of $5.5 million. The amount for the first quarter of 2021 reflects an increase in expenses of $16.6 million and a reduction in expenses of $22.1 million due to reimbursement from Biogen pursuant to the Biogen Collaboration and License Agreement. The primary reasons for the increase in expenses were spending on the WATERFALL Study and the CORAL Study.
    • SG&A Expenses: Selling, general and administrative expenses were $39.8 million, including $12.7 million of non-cash stock-based compensation expense, in the first quarter of 2021 compared to $70.1 million, including $18.9 million of non-cash stock-based compensation expense, for the same period in 2020, a decrease of $30.3 million. The amount for the first quarter of 2021 reflects a decrease in expenses of $27.6 million, and a reduction in expenses of $2.7 million due to reimbursement from Biogen pursuant to the Biogen Collaboration and License Agreement. The primary reason for the decrease in expenses was the impact of the restructuring that the Company announced during the second quarter of 2020.
    • Net Loss: Net loss was $95.8 million for the first quarter of 2021 compared to a net loss of $126.7 million for the same period in 2020.

    FINANCIAL GUIDANCE

    • Sage anticipates cash, cash equivalents, and marketable securities of more than $1.7 billion at end of 2021.
    • The Company does not anticipate receipt of any milestone payments from collaborations in 2021.

    Conference Call Information

    Sage will host a conference call and webcast today, Tuesday, May 4, at 8:00 a.m. ET to discuss its first quarter 2021 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 planned research and development activities and related timelines, including plans for reporting data, initiation of new activities, and advancement of our pipeline; our belief in the potential profile and benefit of our product candidates, and the opportunity to help patients in various indications; the potential regulatory pathways for our product candidates and potential lead indications; our goal to deliver medicines that we hope will help patients; our mission to become the leading brain health company and top-tier bio-pharmaceutical company; our statements regarding the vision, opportunity and potential for our business and potential value creation opportunities; and our expectations with respect to 2021 year-end cash. These statements constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, which could cause actual results to differ materially from those contemplated in these forward-looking statements, including the risks that: success in non-clinical studies or in earlier clinical trials or at interim time periods 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 studying in our ongoing trials; we may encounter issues with the efficacy or durability of short-term treatment, or co-initiated treatment with zuranolone or safety and efficacy concerns with respect to retreatment that require additional studies be conducted; the impact of the COVID-19 pandemic on our clinical development timelines 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 timelines 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; we may encounter other delays in initiation, conduct or completion of our ongoing and planned clinical trials, including as a result of slower than expected site initiation or enrollment, the need or decision to expand the trials or other changes, that may impact our ability to meet our expected timelines and increase our costs; 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 plans; 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 anticipated benefits of our ongoing collaborations may never be achieved and the need to align with our collaborators may hamper or delay our development and commercialization efforts or increase our costs; our business may be adversely affected and our costs may increase if any of our key collaborators fails to perform its obligations or terminates our collaboration; 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; we may never be able to generate meaningful revenues from sales of ZULRESSO or to generate revenues at levels we expect or at levels necessary to justify our investment; 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; our expectations as to year-end cash 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; the number of patients with the diseases or disorders for which our products are developed or the unmet need for additional treatment options may be significantly smaller than we expect; and we may encounter technical and other unexpected hurdles in the development and manufacture of our product candidates or the commercialization of our marketed product which may delay our timing or change our plans, increase our costs or otherwise negatively impact our business; as well as those risks more fully discussed in the section entitled "Risk Factors" in our most recent Quarterly Report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent our views only as of today, and should not be relied upon as representing our views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.

     

    Sage Therapeutics, Inc. and Subsidiaries

    Condensed Consolidated Statements of Operations

    (in thousands, except share and per share data)

    (unaudited)

     

    Three Months Ended March 31,

    2021

     

    2020

    Product revenue, net

    $

    1,583

     

    $

    2,286

     

     
    Operating costs and expenses:
    Cost of goods sold

     

    187

     

     

    170

     

    Research and development

     

    58,056

     

     

    63,610

     

    Selling, general and administrative

     

    39,847

     

     

    70,130

     

    Total operating costs and expenses

     

    98,090

     

     

    133,910

     

    Loss from operations

     

    (96,507

    )

     

    (131,624

    )

     
    Interest income, net

     

    708

     

     

    4,729

     

    Other income, net

     

    35

     

     

    155

     

    Net loss

    $

    (95,764

    )

    $

    (126,740

    )

    Net loss per share - basic and diluted

    $

    (1.64

    )

    $

    (2.44

    )

    Weighted average shares outstanding - basic and diluted

     

    58,374,219

     

     

    51,908,760

     

     

    Sage Therapeutics, Inc. and Subsidiaries

    Condensed Consolidated Balance Sheets

    (in thousands)

    (unaudited)

     

    March 31,

    2021

    December 31,

    2020

    Cash, cash equivalents and marketable securities

    $

    2,004,017

    $

    2,099,549

    Total assets

    $

    2,080,698

    $

    2,159,246

    Total liabilities

    $

    77,422

    $

    86,912

    Total stockholders' equity

    $

    2,003,276

    $

    2,072,334

     

    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 until your 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.

    View Full Article Hide Full Article
  13. 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 following upcoming investor conferences in May:

    • Bank of America Health Care Conference: fireside chat on Tuesday, May 11, 2021 at 10:15 am ET.
    • RBC Capital Markets Global Healthcare Conference: fireside chat on Tuesday, May 18, 2021 at 8:35 am ET.

    A live webcast of each presentation can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcasts will be available approximately two hours after the completion of the event and will be archived for 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 that the Company will present at the following upcoming investor conferences in May:

    • Bank of America Health Care Conference: fireside chat on Tuesday, May 11, 2021 at 10:15 am ET.
    • RBC Capital Markets Global Healthcare Conference: fireside chat on Tuesday, May 18, 2021 at 8:35 am ET.

    A live webcast of each presentation can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcasts 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
  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 Tuesday, May 4, 2021 at 8:00 a.m. ET to announce first quarter 2021 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…

    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 Tuesday, May 4, 2021 at 8:00 a.m. ET to announce first quarter 2021 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. Statistically significant reduction in tremor score compared to placebo at Day 29 in adults with essential tremor

    SAGE-324 demonstrated a 36% reduction in upper limb tremor amplitude from baseline at Day 29 in the total studied population; in a more severe population (baseline TETRAS Upper Limb Item 4 &gt;12), SAGE-324 demonstrated a 41% reduction in upper limb tremor amplitude compared to baseline

    SAGE-324 demonstrated a safety profile generally consistent with previously reported data

    Sage Therapeutics to host conference call today at 8 a.m. ET

    Sage Therapeutics, Inc. (NASDAQ:SAGE) and Biogen Inc. (NASDAQ:BIIB) today reported topline results from the Phase 2 KINETIC Study evaluating SAGE-324 in the treatment of people with essential tremor…

    Statistically significant reduction in tremor score compared to placebo at Day 29 in adults with essential tremor

    SAGE-324 demonstrated a 36% reduction in upper limb tremor amplitude from baseline at Day 29 in the total studied population; in a more severe population (baseline TETRAS Upper Limb Item 4 >12), SAGE-324 demonstrated a 41% reduction in upper limb tremor amplitude compared to baseline

    SAGE-324 demonstrated a safety profile generally consistent with previously reported data

    Sage Therapeutics to host conference call today at 8 a.m. ET

    Sage Therapeutics, Inc. (NASDAQ:SAGE) and Biogen Inc. (NASDAQ:BIIB) today reported topline results from the Phase 2 KINETIC Study evaluating SAGE-324 in the treatment of people with essential tremor (ET). The study (n=67 full analysis set) achieved its primary endpoint of a statistically significant reduction from baseline compared to placebo in The Essential Tremor Rating Assessment Scale (TETRAS) Performance Subscale Item 4 upper limb tremor score on Day 29 (P=0.049), which corresponded to a 36% reduction from baseline in upper limb tremor amplitude in patients receiving SAGE-324 compared to a 21% reduction in patients receiving placebo. Activities of daily living (ADL) scores showed a statistically significant correlation with upper limb tremor score at all timepoints. While not powered to fully examine TETRAS ADL, SAGE-324 was numerically superior to placebo at all time points. Reported treatment-emergent adverse events (TEAEs) were generally consistent with the safety profile of SAGE-324 to date.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210412005277/en/

    In the KINETIC Study, patients (n=47) with a more severe tremor at baseline (at or above the median TETRAS Performance Subscale upper limb tremor Item 4 score of 12) who received SAGE-324, demonstrated a statistically significant reduction (P=0.007) from baseline in TETRAS Performance Subscale Item 4 upper limb tremor score compared to placebo at Day 29, corresponding to a 41% reduction from baseline in upper limb tremor amplitude in patients receiving SAGE-324 compared to an 18% reduction for placebo. Study patients were not taking other medications for ET during the 28-day treatment period.

    The collaboration partners are pleased with the progress to date and are planning next steps for development of SAGE-324.

    "In the design of the KINETIC Study, we set a high bar and believe we exceeded it. SAGE-324 met the primary endpoint in the trial and demonstrated a safety profile generally consistent with previously reported data. The strong correlation observed in this study between TETRAS performance scale – measuring reduction of upper limb tremor, a disabling symptom experienced by more than 90% of people suffering from essential tremor -- and improvement on the ADL score provides suggestive evidence that these findings have the potential to be truly impactful for people with essential tremor," said Barry Greene, chief executive officer at Sage Therapeutics. "We believe the data announced today provide clear support and insights for the continued development of SAGE-324 in an area of significant unmet medical need. People with brain health disorders have been conditioned to accept the status quo due to limited innovation or the lack of truly transformative medicines in recent years – and that's certainly been the case with essential tremor. However, at Sage, we believe that people suffering from brain health disorders deserve better and we aim to help achieve that."

    "We are encouraged by the positive results of the KINETIC Study, which indicate that SAGE-324 may provide relief in people suffering with essential tremor, a movement disorder that affects an estimated 6.4 million people – and is one of the most common movement disorders – in the United States," said Alfred Sandrock, Jr., M.D., Ph.D., Head of Research and Development at Biogen. "For people with essential tremor, uncontrollable shaking of the hands, head, voice, or legs can create difficulty eating, dressing, writing, and pursuing other day-to-day tasks. It is our hope that, in collaboration with Sage, we will be able to deliver an innovative and meaningful new treatment option for these patients. The positive results of the KINETIC Study represent one step further towards that goal, and also underscore Biogen's commitment to delivering new therapeutic options to patients living with movement disorders that have high medical unmet need, including essential tremor."

    "There is an extraordinary unmet need for people suffering with essential tremor, a condition that can cause significant disability in patients," said Dr. Rodger Elble, M.D., a neurologist at the Southern Illinois University School of Medicine. "The only approved medicine was developed more than 50 years ago, and most medicines used for ET were developed for other conditions, and their benefits to people with ET were only discovered serendipitously. Current investigational drugs like SAGE-324, if successful, may offer potential for new treatment options for tremor management, as more than 50% of people with ET do not respond optimally to the current standard of care."

    Full data from the KINETIC Study will be shared at future scientific forums and in publications.

    Summary of Topline Results from KINETIC Study

    In the KINETIC Study, SAGE-324 taken orally, once daily in the morning, showed a statistically significant reduction from baseline in upper limb tremor score as measured by Item 4 of TETRAS Performance Subscale on Day 29 compared to placebo. TETRAS Scale includes two subscales: the Performance Subscale and the Activities of Daily Living (ADL) Subscale. The TETRAS Performance Subscale is a validated, physician-administered scale designed to provide an accurate, comprehensive assessment of ET motor symptoms and has been shown to correlate with TETRAS ADL. The Performance Subscale includes Item 4, which measures upper limb tremor.

    Primary Endpoint

    Patients receiving SAGE-324 experienced a statistically significant reduction from baseline in TETRAS Performance Subscale Item 4 compared to placebo at Day 29 (P=0.049), corresponding to a 36% reduction in upper limb tremor amplitude from baseline in the SAGE-324 group compared to a 21% reduction in the placebo group. The analysis is based on the prespecified Full Analysis Set.

    Safety and Tolerability

    Patients were randomized 1:1 to receive SAGE-324 (60 mg) or matched placebo once daily in the morning. The trial evaluated treatment of SAGE-324 at the higher end of the dose range and the daily dose could be down-titrated to 45 mg or 30 mg if 60 mg was not well tolerated. Down-titration of dose occurred in 62% of patients who received SAGE-324 and discontinuations were noted in 38% of patients receiving SAGE-324. Adverse events were generally consistent with the safety profile of SAGE-324 seen to date. The most common TEAEs that occurred in ≥10% of patients in the SAGE-324 treatment group and at a rate at least twice as high as that of patients in the placebo group were: somnolence 68%; dizziness 38%; balance disorder 15%; diplopia 12%; dysarthria 12%; and gait disturbance 12%.

    Sage Therapeutics Conference Call Information

    Sage will host a conference call and webcast today, Monday, April 12, at 8:00 a.m. ET to discuss the KINETIC Study topline results. 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 the KINETIC Study

    The KINETIC Study is a Phase 2 study that evaluated the efficacy, safety, and tolerability of SAGE-324 60 mg in 69 patients with essential tremor aged 18 to 80 years old. The primary endpoint of the multicenter, randomized, double-blind, placebo-controlled study was change from baseline compared to placebo on Day 29 in upper limb tremor score as measured by Item 4 of the TETRAS Performance Subscale.

    About Essential Tremor

    Essential Tremor (ET) is one of the most common movement disorders in the United States, affecting an estimated 6.4 million Americans. For ET patients, uncontrollable shaking of the hands, head, voice, or legs creates difficulty eating, dressing, writing, and pursuing other day-to-day tasks. While ET is often associated with aging populations, ET can begin much earlier in life, with a progressive disease course that can eventually necessitate a care partner. Social anxiety and depressive symptoms can manifest in patients with ET as tremor severity increases and may negatively impact a patient's ability to work and engage in hobbies. The only U.S. Food and Drug Administration (FDA) approved pharmacological treatment for ET was approved more than 50 years ago, and more than 50% of patients with ET experience a sub-optimal response with standard-of-care treatments, highlighting a significant unmet need in care.

    About SAGE-324

    SAGE-324 is an investigational oral neuroactive steroid (NAS) GABAA receptor positive allosteric modulator (PAM). NAS GABAA receptor PAMs bind to both synaptic and extrasynaptic GABAA receptors, enhancing inhibitory activity of the GABAergic system, the major inhibitory neurotransmission system in the brain. GABA is the primary inhibitory neurotransmitter in the central nervous system and plays a critical role in maintaining balanced neuronal activity in the brain. GABA dysregulation has been implicated in the pathophysiology of ET.

    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.

    About Biogen

    At Biogen, our mission is clear: we are pioneers in neuroscience. Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. One of the world's first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp. Today Biogen has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, commercializes biosimilars of advanced biologics and is focused on advancing research programs in multiple sclerosis and neuroimmunology, Alzheimer's disease and dementia, neuromuscular disorders, movement disorders, ophthalmology, neuropsychiatry, immunology, acute neurology and neuropathic pain.

    We routinely post information that may be important to investors on our website at www.biogen.com. Follow us on social media – Twitter, LinkedIn, Facebook, YouTube.

    Sage Therapeutics Safe Harbor

    Various statements in this release concern future expectations, plans and prospects, including without limitation statements regarding: Sage's belief and confidence in the potential profile and benefit of SAGE-324 and the potential impact of the findings from the KINETIC Study; our goals and plans for further development of SAGE-324 and the potential for successful development; estimates as to the number of patients with ET; Sage's belief in the need for new treatment options for ET; and the goals, opportunity and potential for the SAGE-324 program and for Sage's 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: the positive results of the KINETIC Study may not be repeated in future studies, and future clinical results may not meet their primary or key secondary endpoints; clinical and nonclinical data we generate may not be sufficient to file for or gain regulatory approval to market SAGE-324 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 delays in initiation, conduct or completion of future clinical trials that may impact our ability to meet our expected time-lines; the FDA may not agree with our view of the data we generate from our development efforts at any stage; decisions or actions of the FDA or other regulatory agencies may affect the initiation, timing, design, size, or progress of future clinical trials and our ability to proceed with further development; the FDA may ultimately decide that the design or results of completed and planned clinical trials, even if positive, are not sufficient for regulatory approval of SAGE-324 in ET or of any of our product candidates in any indications that are the focus of our development programs and plans; the actual size of the ET patient population and unmet need may be significantly lower than our estimates and, even if SAGE-324 is approved to treat ET, it may only be approved or used to treat a subset of the relevant patient population; we may encounter technical and other unexpected hurdles in the development and manufacture of SAGE-324 or our other product candidates which may delay our timing or change our plans; as well as those risks more fully discussed in the section entitled "Risk Factors" in Sage's most recent Annual Report on Form 10-K, and 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 Sage's views only as of today, and should not be relied upon as representing Sage's views as of any subsequent date. Sage explicitly disclaims any obligation to update any forward-looking statements.

    Biogen Safe Harbor

    This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, relating to the potential, benefits, safety and efficacy of SAGE-324; the potential clinical effects of SAGE-324; results from the Phase 1/2 studies of SAGE-324; the clinical development program, clinical trials, data readouts and presentations related to SAGE-324; the treatment of essential tremor; the potential of Biogen's commercial business and pipeline programs, including SAGE-324; the anticipated benefits and potential of Biogen's collaboration arrangements with Sage; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "hope," "intend," "may," "plan," "potential," "possible," "will," "would" and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements, or the scientific data presented.

    These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation, uncertainty of success in the development and potential commercialization of SAGE-324; unexpected concerns may arise from additional data, analysis or results obtained during the KINETIC Study; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of Biogen's drug candidates, including SAGE-324; the occurrence of adverse safety events; the risks of other unexpected hurdles, costs or delays; uncertainty of success in the development of SAGE-324; failure to protect and enforce data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; the direct and indirect impacts of the ongoing COVID-19 pandemic on Biogen's business, results of operations and financial condition; product liability claims; and third party collaboration risks. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen's expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in Biogen's most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements are based on Biogen's current beliefs and expectations and speak only as of the date of this news release. Biogen does not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

    View Full Article Hide Full Article
  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 the Company will participate in a fireside chat at the Stifel 3rd Annual CNS Day on Wednesday, March 31, 2021 at 8:00am ET.

    A live webcast of the fireside chat 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…

    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 participate in a fireside chat at the Stifel 3rd Annual CNS Day on Wednesday, March 31, 2021 at 8:00am ET.

    A live webcast of the fireside chat 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
  17. In the now completed 30 mg zuranolone cohort, approximately 70% of participants with positive response to an initial 2-week treatment required at most one additional zuranolone treatment during the 12-month study

    After the initial 2-week zuranolone treatment, more than 70% of patients who received 30 mg and 80% of patients who received 50 mg achieved positive response at Day 15

    In both 30 mg and 50 mg cohorts, zuranolone was generally well-tolerated with an adverse event profile consistent with data reported earlier

    Sage Therapeutics, Inc. (NASDAQ:SAGE) today reported complete 12-month data from the 30 mg cohort and interim data from the 50 mg cohort of the ongoing Phase 3 open-label SHORELINE Study. This clinical study was designed to naturalistically…

    In the now completed 30 mg zuranolone cohort, approximately 70% of participants with positive response to an initial 2-week treatment required at most one additional zuranolone treatment during the 12-month study

    After the initial 2-week zuranolone treatment, more than 70% of patients who received 30 mg and 80% of patients who received 50 mg achieved positive response at Day 15

    In both 30 mg and 50 mg cohorts, zuranolone was generally well-tolerated with an adverse event profile consistent with data reported earlier

    Sage Therapeutics, Inc. (NASDAQ:SAGE) today reported complete 12-month data from the 30 mg cohort and interim data from the 50 mg cohort 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 and 50 mg in adults for up to one year. For the primary endpoint of safety and tolerability, the data analyzed to date show that zuranolone was generally well-tolerated in both the 30 mg and 50 mg dose cohorts. Adverse events reported in the trial during the period analyzed were generally consistent with results seen in previous zuranolone 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. Patients with a clinical response (decrease in HAMD-17 baseline score of ≥50%) to the initial 14-day course of zuranolone 30 mg required a mean of 2.2 treatments in the 12-month study. 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 to date. The Company plans to report additional data from patients in the 50 mg dose cohort in late 2021. Additionally, the Company plans to present additional data from the SHORELINE Study at medical and scientific conferences and in peer-reviewed journal articles.

    "Sage embarked on the LANDSCAPE clinical program to evaluate the safety and efficacy of zuranolone with the ambition of reimagining the treatment for depression with the goal of a rapid-acting, durable, treat-as-needed option in a disease where innovation is lacking and the incidence rate has unfortunately increased exponentially in the last 20 years," said Barry Greene, Chief Executive Officer at Sage Therapeutics. "Today we are announcing additional positive data from the SHORELINE Study that demonstrate continued strong results from the 30 mg dose and strengthens our confidence in the potential of the 50 mg dose. Designed as a naturalistic study, these data approximate real-world evidence of use of zuranolone at 30 mg and 50 mg doses. We look forward to the results of the WATERFALL and CORAL Phase 3 pivotal data readouts in MDD this year."

    Zuranolone 30 mg: Summary of Complete 12-Month Results from SHORELINE Study

    The Phase 3 SHORELINE Study is evaluating the safety and tolerability of zuranolone 30 mg and 50 mg in adults 18-75 who have MDD with a baseline HAMD-17 total score ≥20.

    • 725 people with MDD (HAM-D ≥20 and Montgomery Asberg Depression Rating Scale (MADRS) ≥28) were treated with a first dose of zuranolone 30 mg once nightly for 14 days.
    • The mean baseline HAM-D score (± SD) at entry into the study was 25.3 ± 4.1 (n=725).
    • 173 (23.9%) 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, the mean change from baseline was -15.2 ± 7.1 (n=687); 505 (73.5%) patients achieved response and 276 (40.2%) 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 the first course of treatment (n=725), the adverse events reported were similar in nature and frequency to those previously reported for completed zuranolone studies, with 368 (51%) patients reporting at least one adverse event.
    • The most common treatment emergent adverse events (TEAEs) (reported ≥5%) were somnolence (86; 11.9%), headache (103; 14.2%), and dizziness (54; 7.4%). 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. The overall rate of study drug discontinuation due to TEAEs was 2.6%.
    • No events of loss of consciousness were reported at any time during the study.

    Retreatment:

    489 patients were responders to initial 30 mg treatment and continued in the study beyond the first treatment course.

    • Of the 489 patients continuing in the study, 210 (42.9%) patients used only the single initial zuranolone course, while 125 (25.6%) used a total of two courses, 58 (11.9%) used a total of three courses, 53 (10.8%) used a total of four courses, and 43 (8.8%) used a total of five courses.
    • The number of zuranolone retreatments used were similar regardless of the presence or absence of ADT.
    • The overall incidence rates of TEAEs during the second, third, fourth, and fifth treatment courses were, 42% (120/286), 28.6% (45/157), 29% (28/96), and 27.9% (12/43), respectively. The incidence of TEAEs in the first treatment course was 51% (368/725). The TEAEs were observed to decrease in frequency through the first three courses and remained stable over the next two courses.
    • Safety on treatment, off-treatment, and in between treatments has shown a consistent pattern to date, in AE presentation across treatment courses.
    • No signal on suicidality was identified during or in between treatment courses.
    • Outcomes on efficacy measures and safety events were similar to those observed in the initial treatment course; and the presence or absence of ADT did not change the results.

    Zuranolone 50 mg Dosing Cohort Initial Treatment Course:

    Since May 2020, all newly enrolled patients in the SHORELINE Study received zuranolone 50 mg.

    • In the 199 patients who received zuranolone 50 mg only (n=199), the mean HAM-D baseline score was 25.1 ± 3.3.
    • At Day 15 of the initial treatment course in this group, the mean HAM-D change from baseline was -16 ± 6.0; 149/185 (80.5%) achieved response and 80/185 (43.2%) achieved remission.
    • In this cohort the adverse event profile was similar to that seen in patients who received 30 mg zuranolone, with 62.8% (125/199) subjects reporting at least one AE. Events >5% of somnolence, dizziness, and sedation 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.
    • The 50 mg cohort completed course one and is due for completion of the full 12-month follow-up in late 2021.

    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 12-month study 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.

    We are jointly developing zuranolone in the U.S. with Biogen under a Collaboration and License Agreement that became effective in December 2020, and will jointly commercialize zuranolone with Biogen in the U.S. if our development efforts are successful and it is approved in the U.S. We have granted Biogen sole rights to develop and commercialize zuranolone outside the U.S., other than in Japan, South Korea and Taiwan where we have granted rights to Shionogi.

    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 statements regarding: our belief and confidence in the potential profile and benefit of zuranolone and in future results; the potential for successful development and approval of zuranolone; our planned timing for reporting of data from ongoing clinical trials; our estimates as to the number of patients with MDD; and the goals, opportunity and potential for zuranolone and 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 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 dose of zuranolone we are studying in our ongoing trials; we may encounter issues with the efficacy or durability of short-term treatment, or co-initiated treatment with zuranolone or safety and efficacy concerns with respect to retreatment that require additional studies be conducted; we may encounter delays in conduct of our clinical trials, including slower than expected site initiation or enrollment, that may impact our ability to meet our expected time-lines; 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 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 zuranolone or our other product candidates which may delay our timing or change our plans; 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.

    View Full Article Hide Full Article
  18. 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 Mike Cloonan, Sage's Chief Operating Officer, is leaving the company effective May 3, 2021 to pursue other opportunities.

    "Mike has made significant contributions to Sage over the past four years. We extend our thanks for his leadership and wish him nothing but success in his future endeavors," said Barry Greene, chief executive officer at Sage. "While Mike will be missed, Sage will continue to execute on a data rich 2021, and we plan to grow our team to support efforts across our multiple brain health programs."

    "I made the decision…

    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 Mike Cloonan, Sage's Chief Operating Officer, is leaving the company effective May 3, 2021 to pursue other opportunities.

    "Mike has made significant contributions to Sage over the past four years. We extend our thanks for his leadership and wish him nothing but success in his future endeavors," said Barry Greene, chief executive officer at Sage. "While Mike will be missed, Sage will continue to execute on a data rich 2021, and we plan to grow our team to support efforts across our multiple brain health programs."

    "I made the decision that it is the right time in my career to pursue a Chief Executive Officer position in the biopharmaceutical industry, and Barry and the leadership team were very supportive of my aspirations. I am proud of what we have accomplished at Sage, and I am convinced that Sage will become the leader in brain health and build a top tier biopharmaceutical company," said Mike Cloonan.

    The Company will not seek to immediately fill the position. Mike's responsibilities will be assumed by the CEO, with Mike's support during the transition, as Sage continues planned expansion and acceleration initiatives on its mission to deliver innovative medicines for brain health 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: views and expectations regarding our planned growth; planned expansion and acceleration initiatives; expected data read-outs; Sage's mission to become the leading brain health company and a top tier biotechnology company delivering innovative medicines for brain health disorders; and other goals and opportunities. 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 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 or at interim time periods 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; 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 plans; 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 number of patients with the diseases or disorders for which our products are developed or the unmet need for additional treatment options may be significantly smaller than we expect; and 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.

    View Full Article Hide Full Article
  19. Reported positive interim data from Phase 3 open-label SHORELINE Study showing that more than 70% of patients successfully treated with zuranolone 30 mg needed two or fewer treatment courses over one year

    Progressed WATERFALL Study – now closed to enrollment – investigating zuranolone for as needed treatment of major depressive disorder with data anticipated in the first half of 2021

    Entered into global collaboration with Biogen worth up to $3.1 billion, enabling planned expansion and acceleration of the Sage pipeline and increasing the potential patient reach to more than 450 million, if successful

    Initiated six late-stage clinical trials in 2020, including four Phase 3 trials

    Ended 2020 with cash balance of $2.1 billion

    Conference call

    Reported positive interim data from Phase 3 open-label SHORELINE Study showing that more than 70% of patients successfully treated with zuranolone 30 mg needed two or fewer treatment courses over one year

    Progressed WATERFALL Study – now closed to enrollment – investigating zuranolone for as needed treatment of major depressive disorder with data anticipated in the first half of 2021

    Entered into global collaboration with Biogen worth up to $3.1 billion, enabling planned expansion and acceleration of the Sage pipeline and increasing the potential patient reach to more than 450 million, if successful

    Initiated six late-stage clinical trials in 2020, including four Phase 3 trials

    Ended 2020 with cash balance of $2.1 billion

    Conference call today at 8:00 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, reported business highlights and financial results for the fourth quarter and full year ended December 31, 2020.

    "Although 2020 was a challenging year, Sage's commitment to rigorous science, innovation and disciplined execution resulted in significant progress across all of our brain health franchises, strongly positioning us in our efforts to deliver revolutionary medicines to millions of patients," said Barry Greene, chief executive officer at Sage Therapeutics. "Our collaboration with Biogen enhances our strategic, financial, and operational flexibility, enabling our plans to expand and accelerate our pipeline and extending the potential impact of our product candidates, if we're successful, to more than 450 million patients worldwide. In the first months of 2021, we've already begun to realize this expansion and acceleration with the progression of multiple early-stage programs. I believe 2021, with 10 expected data readouts, will be a transformational year for Sage in our mission to become the leading brain health company in the next five years."

    KEY 2020 UPDATES

    Collaboration with Biogen:
    In November 2020, Sage and Biogen entered into a global collaboration and license agreement to jointly develop and commercialize zuranolone (SAGE-217) for major depressive disorder (MDD), postpartum depression (PPD) and other disorders, and SAGE-324 for essential tremor (ET) and other disorders.

    • Total potential value of the collaboration is $3.1 billion, including $1.5 billion received at closing on December 31, 2020, comprised of an upfront payment of $875 million and a $650 million equity investment, and $1.6 billion in potential milestone payments.
    • Transaction included purchase by Biogen of 6,241,473 shares of Sage common stock at a 40% premium.
    • Sage and Biogen are jointly developing, and, if successful, will jointly commercialize, zuranolone and SAGE-324 in the U.S. Biogen has an exclusive license to develop and commercialize zuranolone and SAGE-324 outside of the U.S., excluding rights to zuranolone in Japan, Taiwan and South Korea.

    Zuranolone SHORELINE Study data: In October 2020, Sage reported positive, interim topline results from a July data cut of the ongoing Phase 3 open-label SHORELINE Study of zuranolone in MDD. The SHORELINE Study is designed to evaluate the safety and tolerability of zuranolone in adults for up to one year.

    Interim topline data from the SHORELINE Study showed:

    • 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 a positive response to the initial 14-day course of zuranolone 30 mg did not need an additional zuranolone treatment course and more than 70% needed two or fewer zuranolone treatment courses.
      • In the 30 mg cohort, 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.
    • At Day 15 of the first course of zuranolone in the initial group of patients who only received 50 mg in the study (n=52), ~75% achieved response (decrease in HAMD-17 baseline score of ≥50%) and ~48% achieved remission (HAM-D ≤7).
      • Safety data available from the 50 mg cohort 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. In patients who received zuranolone 50 mg after having received 30 mg previously, higher rates and levels of intensity with AEs of >5% (sedation, somnolence) were noted.

    Corporate restructuring: In April 2020, Sage completed a restructuring intended to enable the Company to advance its corporate strategy and pipeline throughout the COVID-19 pandemic and beyond.

    PORTFOLIO UPDATES

    Sage is advancing a portfolio of clinical programs featuring internally discovered novel 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 has received breakthrough therapy designation from the FDA for the treatment of MDD.

    Zuranolone is being evaluating as a potential rapid-acting, short-course treatment for PPD and MDD in the NEST and LANDSCAPE clinical trial programs. Sage initiated three Phase 3 clinical studies in 2020. If successful, these studies, along with the rest of the program, may support paths to approval with three distinct opportunities to address patient needs: PPD, acute rapid response therapy (RRT) in MDD when co-initiated with a new standard antidepressant, and as-needed treatment of MDD.

    The Company expects the following zuranolone data readouts in 2021:

    • 1H 2021:
      • WATERFALL (MDD-301B) Study: A placebo-controlled Phase 3 trial evaluating a two-week course of zuranolone 50 mg in patients with MDD, with additional short-term follow-up. Today the Company announced the WATERFALL Study is closed to enrollment, with more than 525 patients expected to be randomized in the study. Data are anticipated in the first half of 2021.
    • Mid-2021:
      • SHORELINE (MDD-303) Study 30 mg Cohort - Full Data: An open-label Phase 3 trial designed to naturalistically follow patients with MDD and evaluate the safety and tolerability of zuranolone 30 mg in adults for up to one year. The Company announced positive interim topline data from this cohort in October 2020.
    • Late 2021:
      • SKYLARK (PPD-301) Study: A placebo-controlled Phase 3 trial evaluating a two-week course of zuranolone 50 mg in women with PPD, with additional short-term follow-up.
      • CORAL (MDD-305) Study: A placebo-controlled Phase 3 trial evaluating a two-week course of zuranolone 50 mg, when co-initiated with a new antidepressant, in patients with MDD, with additional short-term follow-up.
      • SHORELINE (MDD-303) Study 50 mg Cohort: An open-label Phase 3 trial designed to naturalistically follow patients with MDD and evaluate the safety and tolerability of zuranolone 50 mg in adults for up to one year.

    Sage is also evaluating the ongoing zuranolone clinical pharmacology and safety program and plans to align with FDA on data to support a potential future new drug application (NDA) with the FDA. Additional development plans for zuranolone will be confirmed and announced as part of the Company's strategic collaboration with Biogen.

    Additionally, Sage's collaboration with Shionogi & Co., Ltd. is progressing. In 2020, Shionogi initiated a Phase 2 trial with zuranolone in Japan for the treatment of MDD. Shionogi anticipates that this Phase 2 study will finish in the third quarter of 2021. Under the terms of the 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.

    Neurology Franchise

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

    The following milestones are expected for the neurology franchise in 2021:

    • Early 2021:
      • KINETIC (324-ETD-201) Study: The Company expects topline data from the KINETIC Study, a placebo-controlled Phase 2 trial evaluating the safety and efficacy of SAGE-324 in patients with ET to readout in early 2021.
    • Late 2021:
      • If data from the KINETIC Study support further development, Sage anticipates initiating a placebo-controlled Phase 2b trial with SAGE-324 in ET in late 2021 to explore dose and frequency, including potential formulations.

    Additional development plans for SAGE-324 will be confirmed and announced as part of the Company's strategic collaboration with Biogen.

    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), PD and Alzheimer's disease (AD).

    Positive data with SAGE-718 to date include results from a Phase 1 open-label study evaluating the safety and pharmacokinetics of SAGE-718 in a cohort of patients with early HD. In that study, SAGE-718 was well tolerated with no serious adverse events or adverse events leading to treatment discontinuation and patients demonstrated improved performance, compared to baseline, on assessments of executive functioning, a core feature of early HD.

    Ongoing trials with SAGE-718:

    • PARADIGM Study: Phase 2a open-label trial evaluating SAGE-718 in patients with PD cognitive dysfunction. The Company initiated enrollment and dosing in September 2020.
    • LUMINARY Study: Phase 2a open-label trial evaluating SAGE-718 in patients with AD mild cognitive impairment and mild dementia. The Company initiated enrollment and dosing in early 2021.

    The following milestones are expected for the neuropsychiatry franchise in 2021:

    • Early 2021:
      • PARADIGM (718-CNP-201) Study: The Company anticipates topline data from the PARADIGM Study in early 2021.
    • Late 2021:
      • LUMINARY (718-CNA-201) Study: The Company anticipates topline data from the LUMINARY Study in late 2021.

    Additionally, the Company expects to initiate a placebo-controlled Phase 2 trial with SAGE-718 in late 2021. Details of this trial will be informed by results from the Phase 2a studies and earlier work.

    Early Development

    Sage expects to complete certain Phase 1 clinical studies for two programs in its early development pipeline in 2021, SAGE-689 (single ascending dose) and SAGE-904 (single ascending dose and multiple ascending dose).

    • SAGE-689: is an intramuscular GABAA receptor PAM in development as a potential therapy for disorders associated with acute GABA hypofunction.
    • SAGE-904: is Sage's second NMDA receptor PAM product candidate in development as a potential oral therapy for disorders associated with NMDA hypofunction.

    Results from the Phase 1 studies will inform further development of these programs.

    Additionally, the Company recently announced plans to advance SAGE-319 and SAGE-421 to preclinical studies.

    • SAGE-319: is an oral, extrasynaptic GABAA receptor preferring PAM that Sage plans to study for potential use in disorders of social interaction.
    • SAGE-421: is an oral, NMDA receptor PAM that Sage plans to study for potential use in neurodevelopmental disorders and cognitive recovery and rehabilitation.

    Other Development Opportunities

    Sage initiated a Phase 3 trial with brexanolone in patients with advanced COVID-19 related acute respiratory distress syndrome (ARDS) in the fourth quarter of 2020 under the Coronavirus Treatment Acceleration Program (CTAP). The Company expects topline data from this trial in 2021.

    ANTICIPATED 2021 MILESTONES

    Early 2021:

    • SAGE-324:
      • Report topline data from Phase 2 placebo-controlled KINETIC Study in ET
    • SAGE-718:
      • Report topline data from Phase 2a PARADIGM open-label, signal finding study in patients with PD cognitive dysfunction

    Mid-2021:

    • Zuranolone:
      • Report topline data from Phase 3 WATERFALL Study (1H21)
      • Report full data from Phase 3 SHORELINE Study 30mg cohort

    Late 2021:

    • Zuranolone:
      • Report topline data from Phase 3 SKYLARK Study
      • Report topline data from Phase 3 CORAL Study
      • Report topline data from Phase 3 SHORELINE Study 50mg cohort
    • SAGE-324:
      • Initiate Phase 2b study in ET
    • SAGE-718:
      • Report topline data from Phase 2a LUMINARY open-label, signal finding study in patients with AD mild cognitive impairment and mild dementia
      • Initiate placebo-controlled Phase 2 study
    • Brexanolone:
      • Report topline data from Phase 3 study in patients with advanced COVID-19 related ARDS
    • SAGE-689 & SAGE-904:
      • Complete planned Phase 1 studies (SAD for SAGE-689 and SAD/MAD for SAGE-904)

    FINANCIAL RESULTS FOR THE FOURTH QUARTER AND FULL YEAR 2020

    • Cash Position: Cash, cash equivalents, restricted cash, and marketable securities as of December 31, 2020 were $2.1 billion compared to $0.7 billion at September 30, 2020. The increase is from the receipt of cash from Biogen for the upfront under the collaboration and license agreement of $875 million and the stock purchase of $650 million.
    • Revenue: Sage recorded $1.1 billion in net revenue in the fourth quarter of 2020, comprised of $1.1 billion of collaboration revenue from Biogen and $1.7 million from sales of ZULRESSO, compared to $2.0 million for the same period in 2019, which consisted of revenue from sales of ZULRESSO. For the year ended December 31, 2020, Sage recorded $1.1 billion in net revenue comprised of $1.1 billion of collaboration revenue from Biogen and $6.7 million from sales of ZULRESSO, compared to $6.9 million for the same period in 2019, which consisted of $4.0 million in revenue from sales of ZULRESSO and $2.9 million of collaboration revenue from Shionogi. The collaboration revenue of $1.1 billion from Biogen recorded in the fourth quarter of 2020 consisted of an upfront payment of $875 million plus $232.5 million in excess proceeds from the equity investment under the stock purchase agreement.
    • R&D Expenses: Research and development expenses were $81.7 million, including $10.1 million of non-cash stock-based compensation expense, in the fourth quarter of 2020 compared to $91.3 million, including $11.4 million of non-cash stock-based compensation expense, for the same period in 2019. For the year ended December 31, 2020, R&D expenses were $292.7 million, including $42.4 million of non-cash stock-based compensation expense, compared to $368.8 million, including $62.9 million of non-cash stock-based compensation expense, for the same period in 2019. The decreases in R&D expenses were primarily due to a decrease of $30.2 million in expenses for zuranolone, primarily as a result of completion of the MOUNTAIN Study and decreased spending for clinical pharmacology studies, partially offset by an increase in spending for the WATERFALL Study and the SKYLARK Study. For the year, non-cash stock-based compensation expense decreased because the Company incurred no expense in 2020 for performance-based grants, and incurred $14.0 million of expense for such grants as R&D expenses in 2019.
    • SG&A Expenses: Selling, general and administrative expenses were $53.5 million, including $10.6 million of non-cash stock-based compensation expense, in the fourth quarter of 2020 compared to $85.1 million, including $19.3 million of non-cash stock-based compensation expense, for the same period in 2019. For the year ended December 31, 2020, SG&A expenses were $197.0 million, including $51.8 million of non-cash stock-based compensation expense, compared to $345.8 million, including $90.3 million of non-cash stock-based compensation expense, for the same period in 2019. The decreases in SG&A expenses were primarily due to the restructuring that the Company announced during the second quarter of 2020. For the year, non-cash stock-based compensation expense decreased because the Company incurred no expense in 2020 for performance-based grants, and incurred $13.2 million of expense for such grants as SG&A expenses in 2019.
    • Net Income (loss): Net income was $974.9 million for the fourth quarter of 2020, compared a net loss of $168.7 million for the same period in 2019. For the year ended December 31, 2020, net income was $606.1 million, compared to a net loss of $680.2 million for the same period in 2019. In both periods, the increase was due to the collaboration revenue from Biogen.

    FINANCIAL GUIDANCE

    • Sage anticipates cash, cash equivalents, restricted cash, and marketable securities of more than $1.7 billion at end of 2021.
    • The Company does not anticipate receipt of any milestone payments from collaborations in 2021.

    Conference Call Information

    Sage will host a conference call and webcast today, Wednesday, February 24, at 8:00 am ET to discuss its fourth quarter and full year 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 our planned research and development activities and related timelines, including plans for reporting data, initiation of new activities, and acceleration and expansion of our pipeline; our belief in the potential profile and benefit of our product candidates, and the opportunity to help patients, in various indications; the potential benefit and success of our collaborations; our goal to deliver medicines that we hope will help patients and the number of patients we hope our medicines will help; our mission to become the leading brain health company; our statements regarding the vision, opportunity and potential for our business; and our expectations with respect to 2021 year-end cash. These statements constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, which could cause actual results to differ materially from those contemplated in these forward-looking statements, including the risks that: success in non-clinical studies or in earlier clinical trials or at interim time periods 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 studying in our ongoing trials; we may encounter issues with the efficacy or durability of short-term treatment, or co-initiated treatment with zuranolone or safety and efficacy concerns with respect to retreatment that require additional studies be conducted; the impact of the COVID-19 pandemic on our clinical development timelines 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 timelines 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; we may encounter other delays in initiation, conduct or completion of our ongoing and planned clinical trials, including as a result of slower than expected site initiation or enrollment, the need or decision to expand the trials or other changes, that may impact our ability to meet our expected timelines and increase our costs; 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 anticipated benefits of our ongoing collaborations may never be achieved; 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; we may never be able to generate meaningful revenues from sales of ZULRESSO or to generate revenues at levels we expect or at levels necessary to justify our investment; 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; our expectations as to year-end cash 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; the number of patients with the diseases or disorders for which our products are developed or the unmet need for additional treatment options may be significantly smaller than we expect; and 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.

    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,

    2020

     

     

    2019

     

     

    2020

     

     

    2019

    Product revenue, net

    $

    1,686

     

    $

    1,960

     

    $

    6,700

    $

    3,957

     

    Collaboration revenue

     

    1,107,500

     

     

    -

     

     

    1,107,500

     

    2,911

     

    Total revenue

     

    1,109,186

     

     

    1,960

     

     

    1,114,200

     

    6,868

     

     
    Operating costs and expenses:
    Cost of goods sold

     

    136

     

     

    219

     

     

    565

     

    400

     

    Research and development

     

    81,706

     

     

    91,250

     

     

    292,714

     

    368,815

     

    Selling, general and administrative

     

    53,498

     

     

    85,129

     

     

    196,952

     

    345,777

     

    Restructuring

     

    (130

    )

     

    -

     

     

    27,743

     

    -

     

    Total operating costs and expenses

     

    135,210

     

     

    176,598

     

     

    517,974

     

    714,992

     

    Income (loss) from operations

     

    973,976

     

     

    (174,638

    )

     

    596,226

     

    (708,124

    )

     
    Interest income, net

     

    834

     

     

    5,915

     

     

    9,597

     

    27,804

     

    Other income, net

     

    85

     

     

    70

     

     

    250

     

    82

     

    Net income (loss)

    $

    974,895

     

    $

    (168,653

    )

    $

    606,073

    $

    (680,238

    )

    Net loss per share - basic

    $

    18.71

     

    $

    (3.25

    )

    $

    11.66

    $

    (13.38

    )

    Net loss per share - diluted

    $

    18.19

     

    $

    (3.25

    )

    $

    11.43

    $

    (13.38

    )

    Weighted average shares outstanding - basic

     

    52,115,022

     

     

    51,834,880

     

     

    51,983,188

     

    50,833,837

     

    Weighted average shares outstanding - diluted

     

    53,594,637

     

     

    51,834,880

     

     

    53,003,115

     

    50,833,837

     

     

    Sage Therapeutics, Inc. and Subsidiaries

    Condensed Consolidated Balance Sheets

    (in thousands)

    (unaudited)

     

    December 31,

     

     

    December 31,

    2020

     

     

    2019

    Cash, cash equivalents, restricted cash and investments

    $

    2,101,265

    $

    1,010,760

    Total assets

    $

    2,159,246

    $

    1,084,150

    Total liabilities

    $

    86,912

    $

    139,495

    Total stockholders' equity

    $

    2,072,334

    $

    944,655

    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 until your 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.

    View Full Article Hide Full Article
  20. 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 following upcoming investor conferences:

    • SVB Leerink Partners 10th Annual Global Healthcare Conference: on Thursday, February 25, 2021 at 8:00 am ET.
    • Cowen & Co. 41st Annual Health Care Conference: on Monday, March 1, 2021 at 4:00 pm ET.

    A live webcast of each presentation can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcasts will be available approximately two hours after the completion of the event and will be archived for up to 30 days…

    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 following upcoming investor conferences:

    • SVB Leerink Partners 10th Annual Global Healthcare Conference: on Thursday, February 25, 2021 at 8:00 am ET.
    • Cowen & Co. 41st Annual Health Care Conference: on Monday, March 1, 2021 at 4:00 pm ET.

    A live webcast of each presentation can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcasts 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
  21. 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 Wednesday, February 24, 2021 at 8:00 a.m. ET to announce fourth quarter and full year 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…

    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 Wednesday, February 24, 2021 at 8:00 a.m. ET to announce fourth quarter and full year 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
  22. Catalyst rich 2021 includes expected topline readouts from ten clinical trials across the Company's depression, neurology and neuropsychiatry franchises and in COVID-related ARDS

    Company committed to accelerating pipeline and expanding product engine with goal of delivering at least two IND-enabling product candidates per year by 2023

    Sage to present at J.P. Morgan Healthcare Conference on January 12, 2021 at 10:50 am ET

    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 Chief Executive Officer, Barry Greene, will discuss the Company's progress in becoming a leader in brain…

    Catalyst rich 2021 includes expected topline readouts from ten clinical trials across the Company's depression, neurology and neuropsychiatry franchises and in COVID-related ARDS

    Company committed to accelerating pipeline and expanding product engine with goal of delivering at least two IND-enabling product candidates per year by 2023

    Sage to present at J.P. Morgan Healthcare Conference on January 12, 2021 at 10:50 am ET

    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 Chief Executive Officer, Barry Greene, will discuss the Company's progress in becoming a leader in brain health in a corporate presentation at the 39th Annual J.P. Morgan Healthcare Conference. As part of the presentation, Mr. Greene will highlight the Company's planned portfolio expansion and acceleration in 2021, including the anticipated advancement of SAGE-718, SAGE-689 and SAGE-904 into further phases of development. Today Sage also announced plans to advance two of its early development product candidates, SAGE-319 and SAGE-421, to preclinical studies.

    "This year will be transformational for Sage, with numerous catalysts expected in early, mid and late 2021," said Barry Greene, Chief Executive Officer at Sage Therapeutics. "Brain health disorders represent one of the biggest challenges we face today, and with the planned expansion and acceleration of both our partnered and internal clinical pipeline this year, we are well-positioned in our efforts to deliver innovation to the millions of patients with these debilitating disorders. I believe that the upcoming milestones in 2021 will support our mission to bring medicines that matter to patients and propel us further on our journey to become the leading brain health company."

    During his presentation, Mr. Greene will discuss the following corporate updates and milestones anticipated in the next 12-18 months:

    Corporate Updates

    Sage and Biogen recently announced that they have executed a global collaboration and license agreement to jointly develop and commercialize zuranolone (SAGE-217) for major depressive disorder (MDD), postpartum depression (PPD) and other disorders, and SAGE-324 for essential tremor and other disorders. The transaction, including the related purchase by Biogen of 6,241,473 shares of Sage Common Stock, closed in December 2020, following completion of review under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 in the U.S., and other customary closing conditions. In conjunction with the closing, Sage received $1.525 billion comprised of an $875 million up-front payment and $650 million for the equity investment. As of December 31, 2020, the Company had a cash balance of $2.1 billion (unaudited).

    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 postpartum depression (PPD). Zuranolone has received breakthrough therapy designation from the FDA for the treatment of MDD.

    The Company expects the following pivotal data readouts from the LANDSCAPE clinical program evaluating zuranolone in MDD and PPD in 2021:

    • 1H 2021:
      • WATERFALL (MDD-301B) Study: A placebo-controlled Phase 3 trial evaluating a two-week course of zuranolone 50 mg in patients with MDD, with additional short-term follow-up.
    • Mid 2021:
      • SHORELINE (MDD-303) Study 30 mg Cohort - Full Data: An open-label Phase 3 trial designed to naturalistically follow patients with MDD and evaluate the safety and tolerability of zuranolone 30 mg in adults for up to one year. The company announced topline interim data from this cohort in October 2020.
    • Late 2021:
      • SKYLARK (PPD-301) Study: A placebo-controlled Phase 3 trial evaluating a two-week course of zuranolone 50 mg in women with PPD, with additional short-term follow-up.

      • CORAL (MDD-305) Study: A placebo-controlled Phase 3 trial evaluating a two-week course of zuranolone 50 mg, when co-initiated with a new open-label antidepressant, in patients with MDD, with additional short-term follow-up.

      • SHORELINE (MDD-303) Study 50 mg Cohort: An open-label Phase 3 trial designed to naturalistically follow patients with MDD and evaluate the safety and tolerability of zuranolone 50 mg in adults for up to one year.

    Additional development plans for zuranolone will be confirmed as part of the Company's strategic collaboration with Biogen.

    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 (PD).

    • Early 2021:
      • KINETIC (324-ETD-201) Study: The Company expects topline data from the KINETIC Study, a placebo-controlled Phase 2 trial evaluating the safety and efficacy of SAGE-324 in patients with ET to read out in early 2021.
    • Late 2021:
      • Sage expects to initiate the next placebo-controlled Phase 2 trial with SAGE-324 in ET in late 2021.

    Additional development plans for SAGE-324 will be confirmed as part of the Company's strategic collaboration with Biogen.

    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), PD and Alzheimer's disease (AD).

    • Early 2021:
      • PARADIGM (718-CNP-201) Study: The Company anticipates topline data from the PARADIGM Study, a Phase 2a open-label trial evaluating SAGE-718 in patients with PD cognitive dysfunction in early 2021.
    • Late 2021:
      • LUMINARY (718-CNA-201) Study: The Company expects to initiate dosing in the LUMINARY Study, a Phase 2a open-label trial evaluating SAGE-718 in patients with AD cognitive dysfunction and mild dementia in early 2021. Topline data from this trial are expected in late 2021.

    Additionally, the Company expects to initiate a placebo-controlled Phase 2 trial with SAGE-718 in late 2021. Details of this trial will be informed by results from the Phase 2a studies.

    Early Development

    Sage expects to complete certain Phase 1 clinical studies for two compounds in its early development pipeline in 2021, SAGE-689 (single ascending dose) and SAGE-904 (single ascending dose and multiple ascending dose).

    • SAGE-689: is an intramuscular GABAA receptor PAM in development as a potential therapy for disorders associated with acute GABA hypofunction.
    • SAGE-904: is Sage's second NMDA receptor PAM product candidate in development as a potential oral therapy for disorders associated with NMDA hypofunction.

    Results from the Phase 1 studies will inform further development of these compounds.

    The company also announced plans to advance SAGE-319 and SAGE-421 to preclinical studies.

    • SAGE-319: is an oral, extrasynaptic GABAA receptor preferring PAM that will be studied for potential use in disorders of social interaction.
    • SAGE-421: is an oral, NMDA receptor PAM that will be studied for potential use in neurodevelopmental disorders and cognitive recovery and rehabilitation.

    Other Development Opportunities

    Sage initiated a Phase 3 trial with brexanolone in patients with advanced COVID-19 related acute respiratory distress syndrome (ARDS) in the fourth quarter of 2020 under the Coronavirus Treatment Acceleration Program (CTAP). The Company expects topline data from this trial in late 2021.

    Webcast Information

    Sage is scheduled to present at the 39th Annual J.P. Morgan Healthcare Conference on Tuesday, January 12, 2021 at 10:50 am ET. A live webcast of the presentation can be accessed on the investor page of Sage's website at investor.sagerx.com. A 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.

    Forward-Looking Statements

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

    View Full Article Hide Full Article
  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 the Company will present at the 39th Annual J.P. Morgan Healthcare Conference on Tuesday, January 12, 2021 at 10:50 a.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 39th Annual J.P. Morgan Healthcare Conference on Tuesday, January 12, 2021 at 10:50 a.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
  24. Barry Greene, a world-class leader with global experience and a significant track record of success in R&D and commercialization, joins as part of plan to accelerate the Sage mission to deliver truly transformational medicines for people with brain health disorders

    Jeff Jonas to assume new role of Chief Innovation Officer, Chair of the Science and Technology Forum, remaining a member of the Board and bolstering plans for further expansion of pipeline opportunities

    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, as part of the Company's plan to accelerate growth and leverage the talents…

    Barry Greene, a world-class leader with global experience and a significant track record of success in R&D and commercialization, joins as part of plan to accelerate the Sage mission to deliver truly transformational medicines for people with brain health disorders

    Jeff Jonas to assume new role of Chief Innovation Officer, Chair of the Science and Technology Forum, remaining a member of the Board and bolstering plans for further expansion of pipeline opportunities

    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, as part of the Company's plan to accelerate growth and leverage the talents of the leaders in the brain health space, Barry Greene has been appointed chief executive officer. Mr. Greene, who most recently served as president of Alnylam Pharmaceuticals, Inc., from 2007 to September 2020, and as its chief operating officer from 2003 to 2016, will also continue as a member of Sage's board of directors.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201216005269/en/

    Barry Greene (Photo: Business Wire)

    Barry Greene (Photo: Business Wire)

    "Sage is taking on one of the biggest challenges we face today with the urgent and escalating need for more options to transform the lives of millions of patients with debilitating brain health disorders," said Barry Greene, chief executive officer at Sage. "I am impressed by the groundbreaking and relentless pursuit that Jeff has spearheaded, and one that the entire organization has embraced, to bring a new way of thinking about how we can treat brain health disorders differently. Together, Jeff with his unique neuroscience expertise, and I, along with the talented team at Sage, can leverage our collective strengths in our efforts to bring new options to patients in areas that have been lacking innovation for a very long time. I look forward to being part of such a passionate and committed team as we advance Sage's multi-franchise strategy and work to deliver on our mission to bring positive impact to the lives of many patients and their families."

    Dr. Jonas will continue to advance the Company's mission in the new role of chief innovation officer. In this capacity, he will bring his thought leadership and the creative, innovative thinking for which Sage is known. He will remain a member of the board and will chair Sage's Science & Technology Forum of the Board. As chief innovation officer, Jeff will focus on his well-recognized expertise — neuroscience, development, and pipeline expansion — bringing to bear in the role his creative thinking and extensive drug development experience.

    "I am optimistic about what we have done to advance breakthrough science with the goal of delivering truly different approaches to treat brain health disorders. We always had the vision of upending the conventional wisdom of how to think about and how to treat these disorders," said Jeff Jonas, M.D. chief innovation officer and formerly chief executive officer at Sage. "I am proud of the progress we have made on this journey — we took the company from a research organization to a fully integrated biopharmaceutical company with the first approved product for postpartum depression and one of the strongest brain health pipelines in the industry. Our ability to attract Barry's caliber of talent as our next CEO is a testament to these efforts and he's committed to continuing to make progress on our journey to provide groundbreaking options for people with brain health disorders. I look forward to working with Barry and the Sage team moving forward and continuing to contribute to Sage's advancement in my new role."

    "I've known and worked with Barry for 20 years," said Kevin Starr, chairman of the board at Sage. "His appointment as CEO is the result of thoughtful succession discussions with the Board, with the aim of augmenting the executive bench with a world-class leader committed to moving Sage to the next stage of growth and commercialization. Barry is ideal to lead this mission: he has a significant track record of successfully executing on R&D and commercialization strategies. He has built and grown a multiproduct company and is very familiar with Sage's business and culture. Having Barry as CEO and Jeff as CInO strengthens Sage for its next evolution."

    About Barry Greene:

    Barry E. Greene joined the Sage Board of Directors in October 2020 bringing more than 30 years of experience to this position. Prior to Sage, he served as president of Alnylam Pharmaceuticals, Inc., since 2007 and 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, including strategic business direction and execution, 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 multiple leadership positions at AstraZeneca (formerly AstraMerck), and was a partner of Andersen Consulting, where he was responsible for the pharmaceutical/biotechnology marketing and sales practice.

    He received his B.S. in Industrial Engineering from the University of Pittsburgh and served as a Senior Scholar at Duke University's Fuqua School of Business.

    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 goals, opportunity, plans, mission and potential for our products, 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: success in our earlier clinical trials or non-clinical studies may not be repeated or observed in ongoing or future studies, and ongoing and future clinical and non-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; the FDA may ultimately decide that the design or results of our completed, ongoing and planned clinical trials for any of our product candidates, even if positive, are not sufficient for regulatory approval in the indications that are the focus of our development plan; other decisions or actions of the FDA or other regulatory agencies may affect the initiation, timing, design, size, progress and cost of clinical trials and our ability to proceed with further development; we may encounter technical and other unexpected hurdles in the development and manufacture of our product candidates which may delay our timing or change our plans or increase our costs; as well as those risks more fully discussed in the section entitled "Risk Factors" in our most recent Quarterly Report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.

    View Full Article Hide Full Article
  25. 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 BMO 2020 Growth & ESG Conference on Wednesday, December 9, 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…

    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 BMO 2020 Growth & ESG Conference on Wednesday, December 9, 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
    • Biogen and Sage enter into an agreement to jointly develop and commercialize zuranolone and SAGE-324 in the U.S.
    • Biogen to receive exclusive license to develop and commercialize zuranolone and SAGE-324 outside of the U.S., excluding rights to zuranolone in Japan, Taiwan and South Korea
    • Sage Therapeutics to receive $1.525 billion in cash comprised of an upfront payment of $875 million and a $650 million equity investment as well as potential milestone payments, profit sharing and royalties
    • Sage to host conference call Monday, November 30 at 8:00 a.m. ET
    • Biogen to host conference call Monday, November 30 at 9:00 a.m. ET

    CAMBRIDGE, Mass., Nov. 27, 2020 (GLOBE NEWSWIRE) -- Biogen Inc. (NASDAQ:BIIB) and Sage Therapeutics, Inc. (NASDAQ:SAGE) announced…

    • Biogen and Sage enter into an agreement to jointly develop and commercialize zuranolone and SAGE-324 in the U.S.

    • Biogen to receive exclusive license to develop and commercialize zuranolone and SAGE-324 outside of the U.S., excluding rights to zuranolone in Japan, Taiwan and South Korea
    • Sage Therapeutics to receive $1.525 billion in cash comprised of an upfront payment of $875 million and a $650 million equity investment as well as potential milestone payments, profit sharing and royalties
    • Sage to host conference call Monday, November 30 at 8:00 a.m. ET
    • Biogen to host conference call Monday, November 30 at 9:00 a.m. ET

    CAMBRIDGE, Mass., Nov. 27, 2020 (GLOBE NEWSWIRE) -- Biogen Inc. (NASDAQ:BIIB) and Sage Therapeutics, Inc. (NASDAQ:SAGE) announced that they have executed a global collaboration and license agreement to jointly develop and commercialize zuranolone (SAGE-217) for major depressive disorder (MDD), postpartum depression (PPD) and other psychiatric disorders and SAGE-324 for essential tremor and other neurological disorders.

    "We are excited about the potential to bring together Biogen's leading capabilities in neuroscience with Sage's deep expertise in psychiatry," said Michel Vounatsos, Biogen's Chief Executive Officer. "Major depressive disorder affects approximately 17 million people in the U.S. alone, and is a common co-morbidity of multiple neurological disorders in Biogen's core therapeutic areas. There is a tremendous unmet medical need in depression, and we are optimistic about the potential for zuranolone to help transform the treatment of depression and address the stigma often associated with chronic use of antidepressants."

    "With the recent and pending data outputs for zuranolone and SAGE-324, the timing is right for a collaboration between two like-minded companies committed to patients and driven by a passion for neuroscience and brain health," said Mike Cloonan, Chief Operating Officer at Sage Therapeutics. "Through this collaboration, Sage and Biogen have the potential to build something greater together than either could have done alone. We will leverage each other's existing expertise while continuing to build new capabilities in our efforts to create paradigm shifts in the treatment of depression, PPD and essential tremor -- disorders that have gone too long with few treatment innovations. Additionally, the cash from the collaboration is expected to enable Sage to accelerate and expand value potential for its pipeline and will enhance Sage's strategic, financial and operational flexibility as well as strengthening our multi-franchise approach."

    Zuranolone, a potential first-in-class, two-week, once-daily oral therapy in development for the treatment of MDD and PPD, is currently in Phase 3 development as part of the LANDSCAPE and NEST clinical programs. Zuranolone has breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) for MDD and, if successfully developed and approved, has the potential to be a novel treatment paradigm in depression.

    The vision for zuranolone in MDD and PPD is based on its potential, being evaluated in the LANDSCAPE and NEST development programs, to work rapidly and to continue providing sustained benefit beyond the period of dosing. Together, these two features, if supported by positive clinical efficacy and safety data, could provide an alternative option to how depression is treated today based on a target profile of an "as-needed" short course of treatment for a depressive episode, with rapid and sustained efficacy and favorable tolerability. The development of an "as-needed" treatment for depression may help ease the difficulties associated with chronic use of antidepressants and may enhance quality of life and patient adherence.

    An estimated 17 million Americans experience symptoms of MDD each year. Additionally, a September 2020 Journal of the American Medical Association article found that, in the U.S., depression symptoms are more than three times higher during the COVID-19 pandemic than before. MDD is one of the largest contributors to disability in the U.S. and worldwide.

    Postpartum depression is a major depressive episode that can occur during pregnancy or postpartum and is one of the most common medical complications during and after pregnancy. In the U.S., an estimated 1 in 8 mothers experience symptoms of PPD which equates to approximately 500,000 annual cases.

    If approved, zuranolone would also be highly complementary to several of Biogen's therapeutic areas of focus, including multiple sclerosis (MS), Alzheimer's disease (AD), spinal muscular atrophy (SMA), amyotrophic lateral sclerosis (ALS) and Parkinson's disease (PD). Depression is a common co-morbidity in patients with these neurological disorders and their caregivers. Biogen estimates that ~ 50 percent of patients with MS, ~ 40 percent of patients with AD, ~ 50 percent of patients with PD, ~ 30 percent of patients with ALS and ~ 60 percent of SMA caregivers experience depression. In addition, many patients with AD see psychiatrists as part of their diagnostic and/or treatment journey.

    Zuranolone is a next-generation positive allosteric modulator of the gamma-aminobutyric acid (GABAA) receptor. The GABAA system is the major inhibitory signaling pathway of the brain and central nervous system (CNS), and contributes significantly to regulating CNS function. This mechanism of action is a novel approach that may enable a new class of antidepressants.

    To date, two positive pivotal studies have been completed with zuranolone 30 mg, one in MDD (MDD-201) and one in PPD (ROBIN Study). Additionally, while the Phase 3 MOUNTAIN Study of zuranolone in MDD did not meet its primary endpoint, the encouraging data from the recently announced MOUNTAIN six-month follow-up period and the topline interim SHORELINE Study analysis, suggest the potential for zuranolone, if successfully developed and approved, to be uniquely positioned as a disruptive, distinct and novel treatment approach for patients. Biogen and Sage believe that zuranolone is clinically active in MDD based on the data compiled to date and look forward to planned data readouts in 2021.

    Sage is pursuing three development pathways for zuranolone in the U.S.: PPD; acute rapid response therapy (RRT) in MDD when co-initiated with new standard antidepressant therapy; and "as-needed," or episodic, treatment of MDD. As a result, Sage is advancing four additional pivotal studies evaluating a 50 mg dose of zuranolone: a Phase 3 study in PPD (SKYLARK, PPD-301), a Phase 3 study of use as an acute RRT in patients with MDD when co-initiated with new standard antidepressant therapy (CORAL, MDD-305), a Phase 3 study in the acute treatment of MDD (WATERFALL, MDD-301B) and an open label Phase 3 study evaluating the long-term safety, tolerability and efficacy of "as-needed" repeat treatment (SHORELINE, MDD-303). Data from these studies are expected in 2021.

    Upon closing of the transaction, Biogen and Sage will collaborate to further define the development and commercialization strategy for zuranolone. Beyond PPD and MDD, zuranolone may also have potential in other psychiatric disorders including bipolar disorder and generalized anxiety disorder.

    SAGE-324 is a next-generation positive allosteric modulator of GABAA receptors in Phase 2 development for essential tremor with potential in other neurological conditions such as epilepsy and PD. Essential tremor is one of the most common movement disorders estimated to affect over six million patients in the U.S., and current standard of care may be inadequate for many. Following encouraging results from a Phase 1 open-label study in essential tremor, Sage advanced SAGE-324 to the Phase 2a KINETIC Study, which Sage is currently conducting. The KINETIC Study is a 28-day placebo-controlled study in patients with essential tremor expected to read out in 2021. Upon closing of the transaction, Biogen and Sage will collaborate to further define the development and commercialization strategy for SAGE-324 in essential tremor and, as appropriate, for potential expansion into other neurological disorders.

    Terms of the Collaboration

    The strategic collaboration is global in scope and under the terms of the agreement, Sage will receive $1.525 billion in cash to be comprised of an upfront payment of $875 million and a $650 million equity investment in Sage from the purchase of approximately 6.2 million newly issued shares of Sage common stock at a price of $104.14 per share, representing a premium of 40 percent over the 30-day volume-weighted average share price of $74.39 per share as of November 25, 2020.

    Should the zuranolone and SAGE-324 programs achieve certain development and commercial milestones, Sage will be eligible to receive up to approximately $1.6 billion in potential milestone payments.

    Biogen and Sage will share responsibility and costs for development as well as profits and losses for commercialization in the U.S. (50 percent Biogen; 50 percent Sage). Outside the U.S., Biogen will be responsible for development and commercialization, excluding Japan, Taiwan and South Korea with respect to zuranolone, and will pay Sage tiered royalties in the high teens to low twenties.

    Closing of the transaction is contingent on completion of review under antitrust laws, including the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 in the U.S., and other customary closing conditions. The transaction is expected to close by the end of January 2021.

    BofA Securities and Guggenheim Securities acted as financial advisors to Biogen. Goldman Sachs & Co. LLC is acting as the exclusive financial advisor to Sage.

    Conference Call Information

    Sage will host a conference call to discuss the collaboration Monday, November 30 at 8:00 a.m. ET. 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.

    On Monday, November 30 at 9:00 a.m. ET, Biogen will host a live conference call to discuss the collaboration, which will be accessible through the Investors section of Biogen's website, www.biogen.com.

    About Biogen

    At Biogen, our mission is clear: we are pioneers in neuroscience. Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. One of the world's first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp. Today Biogen has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, commercializes biosimilars of advanced biologics and is focused on advancing research programs in multiple sclerosis and neuroimmunology, Alzheimer's disease and dementia, neuromuscular disorders, movement disorders, ophthalmology, immunology, neurocognitive disorders, acute neurology and pain.

    We routinely post information that may be important to investors on our website at www.biogen.com. Follow us on social media – Twitter, LinkedIn, Facebook, YouTube.

    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.

    Biogen Safe Harbor

    This news release contains forward-looking statements, made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements relating to the potential benefits and results that may be achieved through Biogen's proposed collaboration with Sage; the anticipated completion and timing of the proposed transaction; the potential benefits, safety and efficacy of zuranolone and SAGE-324; the clinical development program and data readouts for zuranolone and SAGE-324; the potential treatment of depression, including MDD and PPD, essential tremor and other neurological disorders; the potential of Biogen's commercial business and pipeline programs; Biogen's strategy and plans; risks and uncertainties associated with drug development and commercialization; and Biogen's future financial and operating results. These forward-looking statements may be accompanied by words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "intend," "may," "plan," "potential," "possible," "will," "would" and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or the scientific data presented.

    These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including, without limitation: risks that the proposed transaction will not be completed in a timely manner or at all; the possibility that certain closing conditions to the proposed transaction will not be satisfied; uncertainty as to whether the anticipated benefits of the proposed collaboration can be achieved; risks of unexpected hurdles, costs or delays; uncertainty of success in the development and potential commercialization of zuranolone and SAGE-324, which may be impacted by, among other things, unexpected concerns that may arise from additional data or analysis, the occurrence of adverse safety events, failure to obtain regulatory approvals in certain jurisdictions, failure to protect and enforce data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; third party collaboration risks; and the direct and indirect impacts of the ongoing COVID-19 pandemic on Biogen's business, results of operations and financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen's expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risks factors identified in Biogen's most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements are based on Biogen's current beliefs and expectations and speak only as of the date of this news release. Biogen does not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

    Sage Therapeutics Safe Harbor

    This news release contains forward-looking statements, made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements relating to: the potential benefits and results that may be achieved through Sage's proposed collaboration with Biogen; the anticipated completion of the proposed transaction; the anticipated payments that may be received if all milestones under the agreement with Biogen are met; the potential benefits, safety and efficacy of zuranolone and SAGE-324, and the potential of the product candidates, if successful, to change the way certain diseases and disorders are treated; the planned clinical development program and expected timing of data readouts for zuranolone and SAGE-324; the potential for successful development and approval of zuranolone and SAGE-324 and the potential for future commercialization; estimates as to the number of patients with MDD, PPD and essential tremor; and the goals, opportunity and potential for Sage's 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 Sage's control, which could cause actual results to differ materially from those contemplated in these forward-looking statements, including the risks that: the proposed transaction may not be completed in a timely manner or at all; certain closing conditions to the proposed transaction may not be satisfied; the anticipated benefits of the proposed collaboration may never be achieved; 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 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; adverse results may occur at any stage of development that negatively impact further development or that require additional nonclinical and clinical work which may not yield positive results; different or more severe adverse events may occur at the higher doses of zuranolone or SAGE-324 currently being studied; issues may arise with the efficacy or durability of short-term treatment, or co-initiated treatment with zuranolone or there may be safety and efficacy concerns with respect to retreatment with zuranolone or chronic treatment with SAGE-324 that require additional nonclinical studies or clinical trials be conducted; delays in initiation of dosing or conduct or completion of ongoing and planned clinical trials may occur that may impact expected timelines; COVID-19 may impact clinical development timelines; the FDA may ultimately decide that the design or results of completed and planned clinical trials for zuranolone or SAGE-324, even if positive, are not sufficient for regulatory approval in the indications that are the focus of our development plan; the actual size of the MDD, PPD and essential tremor patient populations may be significantly lower than estimates; Sage may not obtain the operational, strategic or financial flexibility or value creation opportunities it expects from the collaboration with Biogen; there may be other unexpected hurdles in the development and manufacture of zuranolone or SAGE-324 which may delay or impact planned activities or results; as well as those risks more fully discussed in the section entitled "Risk Factors" in Sage's 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 Sage's views only as of today, and should not be relied upon as representing Sage's views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.

    BIOGEN MEDIA CONTACT:BIOGEN INVESTOR CONTACT:
    David CaouetteJoe Mara
    Biogen Inc.Biogen Inc.
    Tel: (781) 464-3260Tel: (781) 464-2442
      
    SAGE MEDIA CONTACT:SAGE INVESTOR CONTACT:
    Maureen L. SudaJeff Boyle
    Sage TherapeuticsSage Therapeutics
    Tel: (617) 949-4289Tel: (617) 949-4256
    Email: Maureen.Suda@sagerx.comEmail: Jeff.Boyle@sagerx.com


    Primary Logo

    View Full Article Hide Full Article
  26. Ongoing zuranolone Phase 3 pivotal trials in major depression and postpartum depression progressing well; expect to initiate dosing in CORAL Study in 4Q 2020

    Continued execution across brain health franchises highlighted during 2nd annual FutureCast event

    First patient dosed in PARADIGM Study investigating SAGE-718 in patients with Parkinson's disease cognitive dysfunction

    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 third quarter ended September 30, 2020.

    "Today I'm pleased to report…

    Ongoing zuranolone Phase 3 pivotal trials in major depression and postpartum depression progressing well; expect to initiate dosing in CORAL Study in 4Q 2020

    Continued execution across brain health franchises highlighted during 2nd annual FutureCast event

    First patient dosed in PARADIGM Study investigating SAGE-718 in patients with Parkinson's disease cognitive dysfunction

    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 third quarter ended September 30, 2020.

    "Today I'm pleased to report that our clinical programs across three franchises remain on track, with a series of key milestones anticipated over the next 12 to 18 months," said Mike Cloonan, chief operating officer at Sage Therapeutics. "During the third quarter, we continued progress across our deep and robust clinical pipeline, a pipeline that spans multiple disease states with programs in early, mid and late stage development. The Sage team continues to execute well during the COVID-19 pandemic and remains determined to provide much needed options to patients suffering with debilitating brain health disorders."

    Recent updates

    Sage recently reported positive, interim topline results from a July data cut of the ongoing Phase 3 open-label SHORELINE Study of zuranolone in major depressive disorder (MDD). 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 zuranolone clinical trials.

    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 of the SHORELINE Study in the first half of 2021 and will include additional analyses of the data set.

    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 postpartum depression (PPD). Zuranolone has received breakthrough therapy designation from the 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 along with the rest of the program, if successful, to support 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 are anticipated in 2021.



      • WATERFALL (MDD-301B) Study investigating zuranolone for the as-needed, or episodic, treatment of 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 are anticipated in the first half of 2021.

    Sage expects to initiate 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 a new open-label antidepressant, in patients with MDD, with additional short-term follow-up.
      • Topline data from this study are anticipated in 2021.
    • Sage 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.
    • ZULRESSO® (brexanolone) CIV injection:
      • Revenue in the third quarter of 2020 from sales of ZULRESSO was $1.6 million, compared to $1.5 million in the third quarter of 2019. As previously announced, due to the ongoing impact of the COVID-19 pandemic, the Company expects de minimis revenue for the balance of 2020, and expects future revenue growth to be limited even after the pandemic as a result of the significant barriers to treatment and the refocus of Sage's commercialization efforts after the April 2020 restructuring.
      • The Company has received clearance from the 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). The Company expects to initiate patient dosing in this study in the fourth quarter of 2020.
        • Topline data from this study are anticipated in 2021.

    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 (PD).

    • KINETIC Study: The KINETIC Study (324-ETD-201), a placebo-controlled Phase 2 study evaluating the safety and efficacy of SAGE-324 in patients with ET is ongoing. Patients in the study receive a once-daily, four-week course of SAGE-324 60 mg or placebo.
      • Topline data from this study are now anticipated in 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), PD and Alzheimer's disease (AD).

    • PARADIGM Study: The Company initiated enrollment and dosing in the PARADIGM Study (718-CNP-201), a Phase 2a open-label study evaluating SAGE-718 in patients with PD cognitive dysfunction.
      • Topline data from this study are now anticipated in the first quarter of 2021.
    • LUMINARY Study: The Company expects to initiate dosing in the LUMINARY Study (718-CNP-201), a Phase 2a open-label study evaluating SAGE-718 in patients with AD cognitive dysfunction and mild dementia in the fourth quarter of 2020.

    Results from these studies will inform potential advancement of SAGE-718 into further development.

    Corporate Updates

    During the third quarter, the Company strengthened its leadership with two key additions:

    • Barry Greene was appointed to Sage's Board of Directors. He was most recently President of Alnylam Pharmaceuticals, Inc.
    • Tammy Phinney joined the Company's management team as senior vice president, regulatory affairs. Her extensive experience leading regulatory functions in the neurology therapeutic area over the last 15 years is well-aligned with Sage's significant regulatory needs as the Company is anticipating several potential FDA engagements as its pipeline advances. Most recently, she served as Vice President, Head of US, Regulatory Affairs at EMD Serono.

    The Company also hosted the 2nd annual "FutureCast: An R&D Portfolio Review" in the third quarter to review the Company's research and development strategy, and clinical progress in its key depression, neurology, and neuropsychiatry franchise programs.

    Anticipated Upcoming Milestones

    Q4 2020

    • Zuranolone:
      • Initiate dosing in Phase 3 CORAL Study (MDD-305) evaluating zuranolone 50 mg, when co-initiated with a new open-label antidepressant, as an acute rapid response therapy in patients with MDD.
    • Brexanolone:
      • Initiate dosing in Phase 3 study in patients with advanced COVID-19 related acute respiratory distress syndrome (ARDS).
    • SAGE-718
      • Initiate dosing in Phase 2a LUMINARY open-label, signal finding study in patients with Alzheimer's disease cognitive dysfunction and mild dementia.

    2021

    • Zuranolone:
      • Report topline data from Phase 3 WATERFALL Study (1H 2021).
      • Report topline data from Phase 3 SKYLARK Study.
      • Report topline data from Phase 3 CORAL Study.
      • Report topline data from Phase 3 SHORELINE Study (30 mg full data set – 1H 2021; 50 mg topline data – 2H 2021).
    • SAGE-324:
      • Report topline data from Phase 2 placebo-controlled KINETIC Study in essential tremor (1Q 2021).
    • SAGE-718:
      • Report topline data from Phase 2a PARADIGM open-label, signal finding study in patients with Parkinson's disease cognitive dysfunction (1Q 2021).
    • Brexanolone:
      • Report topline data from Phase 3 study in patients with advanced COVID-19 related ARDS.

    Financial Results for the Third Quarter 2020

    • Revenue: Sage recorded $1.6 million in net revenue in the third quarter of 2020 from sales of ZULRESSO, compared to $1.5 million for the same period in 2019. Sage recorded no collaboration revenue in the third quarter of 2020 compared to $2.1 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 September 30, 2020 were $671 million compared to $759 million at June 30, 2020.
    • R&D Expenses: Research and development expenses were $74.1 million, including $9.9 million of non-cash stock-based compensation expense, in the third quarter of 2020 compared to $102.1 million, including $17.1 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; the decrease in non-cash stock-based compensation expense and decreased spending for clinical pharmacology studies, partially offset by an increase in spending for the WATERFALL Study, a Phase 3 clinical trial of zuranolone in MDD.
    • SG&A Expenses: Selling, general and administrative expenses were $35.1 million, including $10.2 million of non-cash stock-based compensation expense, in the third quarter of 2020 compared to $88.5 million, including $26.6 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.
    • Net Loss: Net loss was $105.7 million for the third quarter of 2020, compared to $180.0 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, Thursday, November 5, at 8:30 a.m. ET to discuss its third 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; 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 patients with the diseases or disorders for which our products are developed or the unmet need for additional treatment options may be significantly smaller than we expect; we may encounter delays in initiation, conduct or completion of our ongoing and planned clinical trials, including as a result of slower than expected site initiation or enrollment, the need or decision to expand the trials or other changes, that may impact our ability to meet our expected time-lines 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 or at interim time periods 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 studying 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 September 30,

     

    Nine Months Ended September 30,

    2020

     

    2019

     

    2020

     

    2019

    Product revenue, net

    $

    1,639

     

    $

    1,478

     

    $

    5,014

     

    $

    1,997

     

    Collaboration revenue

     

    -

     

     

    2,092

     

     

    -

     

     

    2,911

     

    Total revenue

     

    1,639

     

     

    3,570

     

     

    5,014

     

     

    4,908

     

     
    Operating costs and expenses:
    Cost of goods sold

     

    149

     

     

    137

     

     

    429

     

     

    181

     

    Research and development

     

    74,078

     

     

    102,108

     

     

    211,008

     

     

    277,565

     

    Selling, general and administrative

     

    35,099

     

     

    88,502

     

     

    143,454

     

     

    260,648

     

    Restructuring

     

    (529

    )

     

    -

     

     

    27,873

     

     

    -

     

    Total operating costs and expenses

     

    108,797

     

     

    190,747

     

     

    382,764

     

     

    538,394

     

    Loss from operations

     

    (107,158

    )

     

    (187,177

    )

     

    (377,750

    )

     

    (533,486

    )

     
    Interest income, net

     

    1,347

     

     

    7,227

     

     

    8,763

     

     

    21,889

     

    Other income (expense), net

     

    76

     

     

    (8

    )

     

    165

     

     

    12

     

    Net loss

    $

    (105,735

    )

    $

    (179,958

    )

    $

    (368,822

    )

    $

    (511,585

    )

    Net loss per share - basic and diluted

    $

    (2.03

    )

    $

    (3.48

    )

    $

    (7.10

    )

    $

    (10.13

    )

    Weighted average shares outstanding - basic and diluted

     

    51,981,468

     

     

    51,704,687

     

     

    51,938,923

     

     

    50,496,489

     

    Sage Therapeutics, Inc. and Subsidiaries

    Condensed Consolidated Balance Sheets

    (in thousands)

    (unaudited)

     

    September 30,

    2020

    December 31,

    2019

    Cash, cash equivalents, restricted cash and investments

    $

    670,904

    $

    1,010,760

    Total assets

    $

    738,628

    $

    1,084,150

    Total liabilities

    $

    81,047

    $

    139,495

    Total stockholders' equity

    $

    657,581

    $

    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 until your 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.

    View Full Article Hide Full Article
  27. 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 following investor conferences in November:

    • Stifel Virtual Healthcare Conference: fireside chat on Monday, November 16, 2020 at 8:40 am ET.
    • Wolfe Research Virtual Healthcare Conference: fireside chat on Thursday, November 19, 2020 at 4:05 pm ET.

    A live webcast of each presentation can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcasts will be available approximately two hours after the completion of the event and will be archived for up to…

    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 following investor conferences in November:

    • Stifel Virtual Healthcare Conference: fireside chat on Monday, November 16, 2020 at 8:40 am ET.
    • Wolfe Research Virtual Healthcare Conference: fireside chat on Thursday, November 19, 2020 at 4:05 pm ET.

    A live webcast of each presentation can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcasts 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
  28. 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.

    View Full Article Hide Full Article
  29. 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.

    View Full Article Hide Full Article
  30. 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.

    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 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.

    View Full Article Hide Full Article
  32. 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.

    View Full Article Hide Full Article
  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 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.

    View Full Article Hide Full Article
  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 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.

    View Full Article Hide Full Article
  35. 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.

    View Full Article Hide Full Article
  36. 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
  37. 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
  38. 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
  39. 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.

    View Full Article Hide Full Article
  40. 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