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CURRENT REPORT
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Item 7.01. Regulation FD Disclosure.
On January 9, 2023, Sage Therapeutics, Inc. (the “Company”) made available an updated corporate presentation, which it plans to use for meetings with investors and analysts at the 41st Annual J.P. Morgan Healthcare Conference. A copy of the presentation is being furnished hereto as Exhibit 99.1 and is incorporated herein by reference.
The information in Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 8.01. Other Events.
On January 8, 2023, the Company issued a press release titled “Sage Therapeutics to Provide Update on 2023 Key Initiatives at J.P. Morgan Healthcare Conference.” A copy of the press release is filed as Exhibit 99.2 hereto and is incorporated by reference herein.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. |
Description | |
| 99.1 | Corporate Presentation dated January 2023. | |
| 99.2 | Press release issued by Sage Therapeutics, Inc. on January 8, 2023. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: January 9, 2023 | SAGE THERAPEUTICS, INC. | |||||
| By: | /s/ Jennifer Fitzpatrick | |||||
| Jennifer Fitzpatrick | ||||||
| Vice President, Corporate Counsel | ||||||
Exhibit 99.1 J.P. Morgan Healthcare Conference January 2023
Safe Harbor Statement • The slides presented today and the accompanying oral presentations contain forward-looking – At any stage, regulatory authorities may ask for additional clinical trials, nonclinical studies or other data in order for us to proceed further in development or to file for or obtain regulatory statements, which may be identified by the use of words such as “may,” “might,” “will,” “should,” “can,”,“expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “opportunity”, approval. Other decisions or actions of the FDA or other regulatory authorities may affect the “goal”, “mission”, “potential,” “target”, or “continue,” and other similar expressions. initiation, timing, design, size, progress and cost of clinical trials and our ability to proceed with further development. • Forward-looking statements in this presentation include statements regarding: our clinical development plans, including expected timelines for activities and our expectations as to potential – Even if zuranolone is approved, we may not achieve market acceptance or use of zuranolone in results; our belief that our NDA for zuranolone will be accepted and the possibility of priority the MDD and PPD patient types we expect and we may not achieve reimbursement review; the potential for approval and launch of zuranolone and potential timelines; our belief in the of zuranolone at the levels or with the type of access we expect. The benefit and safety profile of potential benefit and profile of zuranolone and in its potential to be successful and to meet an unmet zuranolone in clinical practice, if approved, may not meet our expectations. We may not need in the treatment of MDD and PPD; the potential for commercialization of zuranolone and our be successful in execution of our planned commercialization activities or we may change our commercialization plans, including plans to help enable access; our expectations as to the types of plans. We may never be successful or achieve our goals with respect to commercialization MDD patients who may benefit from zuranolone, if approved; the potential for success of our other of zuranolone, if approved. product candidates in various indications, including the potential profile and benefit of our other product candidates; our estimates as to the number of patients with disorders and diseases of – Even if zuranolone or our other product candidates are successfully developed and approved, the number of patients with the diseases or disorders our products treat or the subset of such interest to us and that we hope to help and the potential market for our product candidates, if approved; the goals, opportunity, mission and vision for business; and our views with respect our patients we believe will use our products, the need for new treatment options, and the actual financial strength and potential value creation opportunities. market for such products may be smaller than our current estimates. – The anticipated benefits of our collaborations, including our collaboration with Biogen, may never • 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 be achieved. 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 could cause actual results to differ materially from those contemplated in these forward-looking statements, including the risk that: costs may increase if any of our key collaborators fails to perform its obligations or terminates our collaboration. – The FDA may not accept our NDA for zuranolone for review or may accept the filing for review – We may not be able to obtain and maintain adequate intellectual property protection or other but not grant approval or may grant approval for a narrower indication than we expect or with unexpected limitations. The FDA may ask for additional clinical trials, nonclinical studies or forms of data and marketing exclusivity for our products, or to defend our patent portfolio against challenges from third parties. other data in order for us to file for or obtain regulatory approval of zuranolone. The FDA may not grant priority review of our NDA for zuranolone. Our expectations for timing of review of our NDA and of launch of zuranolone, if approved, may not be accurate. The FDA may ultimately – We may face competition from others developing products or with approved products for similar uses as those for which our product candidates are being developed. decide that the design or results of our clinical trials for our product candidates are not sufficient to successfully file for or obtain regulatory approval. – Our operating expenses may be higher than forecasted, our revenues may be lower than we expect, or we may face unexpected expenditures, which could cause us to change our – Our clinical trials may not meet their primary endpoints or key secondary endpoints. Success in plans. We may need or choose to raise additional funding, which may not be available on non-clinical studies or in prior clinical trials of our product candidates may not be repeated or observed in ongoing, planned or future studies involving the same compound or other product acceptable terms, or at all. candidates. Non-clinical and clinical results from ongoing or future trials may not support further – We may not be able to establish and maintain key business relationships with third parties on development of the product candidate or filing for or obtaining regulatory approval on the acceptable terms or we may encounter problems with the performance of such third parties. timelines we expect or at all and we may be required to conduct additional clinical trials or nonclinical studies which may not be successful. – We may encounter technical and other unexpected hurdles in the manufacture, development or commercialization of our products. – We may experience slower than expected enrollment in our clinical trials or may encounter other delays or problems, including in analyzing data or requiring the need for additional analysis, data – Any of the foregoing or other factors may negatively impact our ability to achieve our goals, or patients, and such issues with any trial could cause delay in completion of the trial, availability mission, opportunities, plans or expectations for our business. of results and timing of future activities. • For additional disclosure regarding these and other risks Sage faces, see the disclosure contained – We may encounter unexpected safety or tolerability issues with respect to any of our product in the Risk Factors section of our most recent report, and in our other public filings, with the candidates or marketed products; we may encounter different or more severe adverse events at Securities and Exchange Commission, available on the SEC's website at http://www.sec.gov. Any the higher doses, different frequency or length of dosing or in new indications we are studying or forward-looking statement represent our views only as of today, and should not be relied upon as may study in ongoing or planned trials. representing our views as of any subsequent date. We undertake no obligation to update or revise the information contained in this presentation, whether as a result of new information, future events or circumstances or otherwise. 2 Sage Therapeutics © 2023
The time is now… Kay Lynn Seth Postpartum Huntington’s Essential Depression (PPD) Disease (HD) Tremor (ET) Sheante Dan Kirsten Major Depressive Parkinson’s Alzheimer’s Disorder (MDD) Disease (PD) Disease (AD) Brain health is fundamental to good health 3 Sage Therapeutics © 2023
Building impact and scale Millions of people have been Patients, providers, and society Relentless focus on developing waiting decades for new can and must be better served new and effective treatments to treatment options address brain health disorders The time is now… 4 Sage Therapeutics © 2023
Challenge scientific convention Starting with our work on GABA and NMDA, we are pursuing breakthroughs that have the potential to advance the treatment of a wide range of brain health disorders. 5 Sage Therapeutics © 2023
Building a business for the future Rich innovative pipeline/product engine Deep expertise in brain circuitry Significant potential patient impact Strong cash position to fuel growth Exciting business momentum into 2023 6 Sage Therapeutics © 2023
Sage has a leading brain health portfolio PRECLINICAL REGISTRATION MARKETED COMPOUND PARTNER INDICATIONS PHASE 1 PHASE 2 PHASE 3 DEPRESSION ® ZULRESSO Postpartum Depression (brexanolone) CIV injection Major Depressive Disorder Postpartum Depression Zuranolone Treatment Resistant Depression (SAGE-217) Generalized Anxiety Disorder Bipolar Depression NEUROLOGY Essential Tremor Epileptiform Disorders SAGE-324 Parkinson’s Disease SAGE-689 Acute GABA Hypofunction NEUROPSYCHIATRY Huntington’s Disease Cognitive Dysfunction Parkinson’s Disease Cognitive SAGE-718 Dysfunction Alzheimer’s Disease Mild Cognitive Impairment and Mild Dementia EARLY DEVELOPMENT SAGE-319 GABA Hypofunction NMDA Hypofunction SAGE-421 7 Sage Therapeutics © 2023 Light shades indicate trials in the planning or evaluation stage
Significant unmet needs remain in the treatment of depression Unmet Needs In a survey of MDD patients (n=583) STAR*D Analysis shows that patients The economic burden of MDD in the conducted by Sage, 75% of MDD who achieve later remission have a United States is an estimated $326 2 patients asked about the impact of 1.5 times higher risk of relapse than billion in 2018 1 switching medications reported being those who remit early frustrated or feeling that no medication 1 was going to work for them 1 2 3 MDD = major depressive disorder 8 Sage Therapeutics © 2023 1. Sage Therapeutics. Data on file. 2. Greenberg PE, et al. PharmacoEconomics. 2021; 39: 653-665.
Zuranolone clinical data supports its potential to fulfill unmet needs for people with MDD and PPD Rapid & Sustained Short Course • Rapid symptom reduction observed • As-needed oral therapy • Sustained effects lasted beyond • 2-week treatment course completion of treatment Well-Tolerated Novel MOA • Selectively modulates GABA R • Well-tolerated profile* A • May help neuronal networks • Differentiated side effect profile with no 1 rebalance evidence of increased sexual dysfunction, weight gain or sleep disruption Flexible Approach Improved Feel/Functioning • Improvement seen in • Improvements seen across depressive symptoms in domains of quality of life MDD/PPD patients when used • Measured benefits that patients as mono or adjunctive therapy are looking for from depression • Improvements seen in treatment MDD/PPD patients with or *Zuranolone was generally well-tolerated across clinical studies. The most common adverse events associated with zuranolone included headache, somnolence, dizziness and sedation. without elevated anxiety Profile based on data demonstrated in clinical studies with zuranolone to date Note: Success of zuranolone and the product profile depend on the clinical development program and regulatory approval. 1 Antonoudiou, P. et al. Allopregnanolone mediates affective switching through modulation of oscillatory states in the basolateral amygdala. Biological Psychiatry, 2021.2003.2008.434156, doi:10.1016/j.biopsych.2021.07.017 (2021). Sage Therapeutics © 2023 9 MDD = major depressive disorder, PPD = postpartum depression Zuranolone is being developed in collaboration with Biogen.
In an integrated analysis of zuranolone data, patients reported overall † improvement in functioning and well-being * Mental Health * Clinically meaningful * improvements were observed Role-Emotional * across mental health, physical * * Social Functioning and general health domains * Vitality * of SF-36 * * General Health * Bodily Pain * Role-Physical * * Physical Functioning 0 3 6 9 12 15 18 Day 42 Day 15 Zuranolone Day 42 Zuranolone Day 15 Placebo Day 42 Placebo Day 15 † *LSM treatment difference p-value <0.05 (nominal); Integrated analyses combine doses from the ROBIN Study, MDD- ‡ 201B Study, MOUNTAIN Study (≥24 HAMD-17 subgroup), and WATERFALL Study. For the ROBIN study, data were 10 collected at Day 45.; SF-36 = 36-Item Short Form Health Survey (version 2). Sage Therapeutics © 2023 Zuranolone is being developed in collaboration with Biogen.
Selected responder interviews from SHORELINE Study in MDD Examples of quotes from surveyed patients who responded to initial treatment cycle of 50 mg zuranolone in the open-label SHORELINE Study (n=32) “Very satisfied because “...almost like an afterglow of “It was really impressive it’s helping me. I feel better the two week course of that the results happened about myself now than I did treatment, that then it was just “I felt better both times… so quickly, and it was so when I first started. I know it’s working for several months. I started feeling better right dramatic. It wasn’t just a slight good…I’m doing more than I I didn’t have to think about it away…and I wasn’t as bad improvement, it was night and used to. I’m getting up. I’m going constantly. I didn’t have to take when I took it the second time day. It was a 180 degree turn to church. Before, I wouldn’t be medication...I wasn’t having as I had been before the study.” from how I’d been feeling anywhere, I wouldn’t go outside, to think about my depression even just the day before.” I would just look outside the and try to manage it.” door. It has helped me.” Rapid Onset Durability Retreatment Satisfaction A substantial majority of interviewed Most interviewed patients reported A significant majority of interviewed All interviewed patients reported patients noticed improvements within being satisfied with duration of patients who received retreatment being moderately, quite, or very the first week improvements reported feeling fine, positive, or satisfied with zuranolone neutral about needing to be retreated Among patients treated in the ongoing open-label Phase 3 SHORELINE Study, the most common TEAEs (>5%) observed in the 30 and 50 mg cohorts were headache, somnolence, dizziness, and sedation. Patient experiences are provided solely to help illustrate the data collected from the SHORELINE Study interviews. Patient experiences in the SHORELINE Study differed patient-to-patient. Results of the survey are not intended to make claims about zuranolone's potential benefit. Survey information does not represent all patients who took zuranolone. Interviews conducted with patients who responded to the first 50 mg zuranolone treatment cycle and had been participants in the SHORELINE Study for at least six months. Interviews were conducted at various timepoints for each patient. Based on SHORELINE Study design, patients were allowed to be on background therapy. Sample size of interviewed patients n = 32. 11 Sage Therapeutics © 2023 MDD = major depressive disorder Zuranolone is being developed in collaboration with Biogen.
Goal of the planned zuranolone launch strategy is to transform the way MDD and PPD are treated MDD – MDD Partial with Elevated If zuranolone is approved, plan to focus on: Response Anxiety Priority MDD and PPD patient segments Target High Volume HCPs • Psychiatrists • NPs / PAs • PCPs MDD – Adherence PPD • OBGYNs Challenged Collaborate with Payers Lead with Value Sage and Biogen Zuranolone Webcast [December 6, 2022]. Accessible via: https://investor.sagerx.com/events/event-details/sage-therapeutics-and-biogen-webcast-discuss- potential-commercialization-plans MDD = major depressive disorder, PPD = postpartum depression, NP = nurse practitioner, PA = physician assistant, PCP = primary care provider 12 Sage Therapeutics © 2023 Zuranolone is being developed in collaboration with Biogen.
Cognitive impairment is prevalent and impacts people across the lifespan Executive Function Learning & Memory Attention Language Visuospatial Planning, decision- Recall, recognition. Sustained attention, Object naming, word Visual perception. making, working long-term memory, divided attention, finding, fluency, Visuo-constructional memory, multitasking, implicit learning selective attention, grammar and syntax, reasoning, perceptual- flexibility processing speed receptive language motor coordination DAILY LIFE Cooking Driving Lists Working Finances Sources: SSM Popul Health. 2020 Aug; 11: 100577. Published online 2020 Mar 31. doi: 10.1016/j.ssmph.2020.100577 https://altoida.com/blog/defining-the-6-key-domains-of-cognitive-function/ 13 Sage Therapeutics © 2023
Sage’s first-in-class NMDA receptor PAM Novel starting point for understanding NMDA receptor modulation Emerging Science SAGE-718: NMDA Positive Drives New Thinking Allosteric Modulator (PAM) • The neuroactive steroid, 24S- • SAGE-718 is a novel, positive hydroxycholesterol (24S-HC), is an allosteric modulator derived from our endogenous modulator of NMDA pharmacological understanding of receptors 24S-HC • NMDA receptors play a major role in • SAGE-718 is believed to bind to a excitatory transmission in the brain novel neurosteroid site on the NMDA and influence cognition and other receptor key brain functions • SAGE-718 has the potential to • NMDA receptor hypofunction has restore NMDA activity and improve been implicated in cognitive cognitive functioning impairment associated with disorders such as Huntington’s disease, Parkinson’s disease and Alzheimer’s disease 14 Sage Therapeutics © 2023
Globally, disorders involving cognitive impairment continue to increase Cognitive impairment has devastating impacts on patients, families, and society ~188K ~8.8M ~134M Huntington’s Disease Parkinson’s Disease Alzheimer’s Disease 1 2 3 Global Prevalence Global Prevalence Global Prevalence Cognitive Impairment in HD can Mild cognitive impairment (MCI) is Up to 50% of people with MCI due occur up to 15 years before motor diagnosed in nearly half of people to AD progress to Alzheimer’s manifestation & is highly associated with PD and causes poorer treatment dementia within 5-10 years with overall functional decline outcomes, greater medical costs, and caregiver distress HD = Huntington’s disease, PD = Parkinson’s disease, AD = Alzheimer’s disease 1. Pringsheim T, Wiltshire K, Day L, Dykeman J, Steeves T, Jette N. The incidence and prevalence of Huntington's disease: a systematic review and meta-analysis. Mov Disord. 2012 Aug;27(9):1083-91. doi: 10.1002/mds.25075. Epub 15 Sage Therapeutics © 2023 2012 Jun 12. PMID: 22692795. 2. Sage Therapeutics, Inc. Data on file. 3. Sage Therapeutics, Inc. Data on file.
SAGE-718 has demonstrated consistent beneficial effects on cognitive performance in clinical studies to date Placebo-controlled Two Back Test Performance on Executive Functioning Tasks Across SAGE-718 Studies Digital Symbol Substitution Test Z-Transformed Change from Baseline to Last Assessment* (Mean change from baseline plotted) Spatial Working Memory Test IMPROVEMENT 1.2 Healthy Volunteers Huntington’s Parkinson’s Disease Alzheimer’s Disease w/ Ketamine Disease PARADIGM Study LUMINARY Study Challenge CLP-102B 1.0 EXM-103 0.8 0.6 0.4 0.2 NO CHANGE HV on Ketamine n = 6 n = 13 n = 16 n = 17 n = 23 n = 24 n = 25 & SAGE-718 -0.2 n = 18 -0.4 HV on Ketamine WORSENING & Placebo n = 19 HV = healthy volunteers 16 Sage Therapeutics © 2023
SAGE-718 clinical development program in Huntington’s disease DIMENSION (CIH-201) | 3-month study • Description: Robust RCT in patients with HD cognitive impairment, designed to evaluate efficacy • Objective: Demonstrate difference on cognitive performance between drug and placebo at month 3 • Target enrollment: 178 ENROLLING Huntington’s SURVEYOR (CIH-202) | 1 month study • Description: Placebo-controlled RCT to demonstrate the clinical meaningfulness of improving cognition in HD Disease • Objective: Generate evidence linking change in cognitive performance to real-world patient functioning, benchmarked against performance of healthy volunteers • Target enrollment: 40 people with HD, 40 healthy volunteers (assessment-only HV arm) ENROLLING FDA Fast-track Designation PURVIEW (CIH-301) | 13-month study • Description: Open-label safety study, enrolling participants from DIMENSION, SURVEYOR, and an additional de novo cohort • Objective: Designed to evaluate the long-term safety profile and benchmark performance against HD natural history studies • Target enrollment: 300 ENROLLING 17 Sage Therapeutics © 2023
Sage’s robust portfolio features NCEs with differentiated target profiles that may be suited for study across the lifespan ® ZULRESSO (brexanolone) CIV zuranolone (Oral) SAGE-324 (Oral) SAGE-718 (Oral) SAGE-319 (Oral) SAGE-689 (Parenteral) SAGE-421 (Oral) GABA NMDA 18 Sage Therapeutics © 2023
Anticipated 2023 Milestones Early Mid Late *Early:Q1-Q2; Mid:Q2-Q3; Late: Q3-Q4 DEPRESSION FDA acceptance of rolling NDA submission for zuranolone in MDD and PPD l Present additional data from SHORELINE Study l PDUFA date for zuranolone in MDD and PPD, if accepted for review by the FDA l Zuranolone (SAGE-217) Commercial availability of zuranolone in MDD and PPD, if priority review is granted and l zuranolone is approved Initiate a lifecycle innovation study with zuranolone l Present additional analyses of data from LANDSCAPE and NEST clinical programs, including lll health economics and patient reported outcomes NEUROLOGY Complete enrollment in Phase 2b KINETIC 2 Study l SAGE-324 Present additional analyses of data from clinical development program as well as disease state lll and burden of disease research in ET NEUROPSYCHIATRY Progress recruitment in the ongoing DIMENSION, SURVEYOR, PURVIEW, PRECEDENT, and lll LIGHTWAVE Studies SAGE-718 Present additional analyses of data from clinical development program as well as disease state lll and burden of disease research in HD, PD and AD ADDITIONAL CLINICAL PROGRAMS & MILESTONES Additional Pipeline Programs Provide update on next steps for pipeline programs (e.g., SAGE-319) l Maintain strong balance sheet Cash Balance lll MDD = major depressive disorder, PPD = postpartum depression, ET = essential tremor, HD = Huntington’s disease, PD = Parkinson’s disease, AD = Alzheimer’s disease 19 Sage Therapeutics © 2023
The time is now… Kay Lynn Seth Postpartum Huntington’s Essential Depression (PPD) Disease (HD) Tremor (ET) Sheante Dan Kirsten Major Depressive Parkinson’s Alzheimer’s Disorder (MDD) Disease (PD) Disease (AD) Brain health is fundamental to good health 20 Sage Therapeutics © 2023
Seeing the brain differently makes a world of difference 21 Sage Therapeutics © 2023
Exhibit 99.2
Sage Therapeutics to Provide Update on 2023 Key Initiatives at 41st Annual J.P. Morgan Healthcare Conference
Robust pipeline provides potential for long-term value creation, establishing Sage as a leader in brain health
Rolling New Drug Application (NDA) submission for zuranolone in MDD and PPD complete, with potential for PDUFA date as early as the third quarter of 2023 if priority review is received and other timelines meet expectations
Progressing nine ongoing studies across zuranolone, SAGE-718, SAGE-324 and early pipeline programs
CAMBRIDGE, Mass. – January 8, 2023 – Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, today announced that Chief Executive Officer, Barry Greene, will discuss the Company’s progress in developing a leading brain health pipeline at the 41st Annual J.P. Morgan Healthcare Conference in San Francisco, California.
As part of this presentation, Mr. Greene will provide key updates on programs across Sage’s depression, neuropsychiatry and neurology portfolios. 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.
“It’s time to begin a new era in the treatment of brain health disorders. We at Sage have a tremendous sense of urgency to create innovative medicines that address what matters most for people who currently lack adequate treatment options,” said Barry Greene, Chief Executive Officer at Sage Therapeutics. “We enter 2023 having completed the submission of the rolling NDA for zuranolone in the treatment of major depressive disorder and postpartum depression with our collaborator Biogen. We’ve also made progress in initiating multiple studies across our pipeline, including SAGE-718 and SAGE-324. We believe that this momentum will help us achieve our mission to improve the lives of millions of people and advance the way brain health is viewed and treated.”
Sage and its collaborator Biogen recently announced the submission of the zuranolone New Drug Application to the FDA for the treatment of major depressive disorder (MDD) and postpartum depression (PPD). Zuranolone, Sage’s next-generation positive allosteric modulator (PAM) of GABAA receptors, is being evaluated as a potential rapid-acting treatment for MDD and PPD. If approved, zuranolone could represent the first oral, short course (14-day) medication for these indications. In the clinical development program to date, zuranolone has shown rapid and sustained improvement of depressive symptoms with a generally well-tolerated and consistent safety profile.
Sage and Biogen are focused on preparing for a potential launch of zuranolone for both MDD and PPD in 2023, if approved, with the ultimate goal of transforming the way depression is treated. Current efforts are focused on disease state education in MDD and PPD, scientific exchange and permitted interactions with payers. Sage expects these efforts and other permitted pre-launch activities to continue to broaden and ramp up in the coming year.
Sage continues to advance a robust clinical program for SAGE-718, the Company’s first-in-class NMDA receptor PAM and lead neuropsychiatric drug candidate. SAGE-718 is in development as a potential oral therapy for cognitive disorders associated with NMDA receptor dysfunction, with multiple ongoing or planned Phase 2 studies across multiple disease areas, including its potential lead indication, Huntington’s disease (HD), as well as Alzheimer’s (AD) and Parkinson’s diseases (PD). The company recently initiated LIGHTWAVE (CNA-202), a Phase 2 study of SAGE-718 in people with mild cognitive impairment and mild dementia due to AD and PURVIEW (CIH-301), a Phase 3 extension study in people with HD.
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“We are proud of the progress we’ve made in advancing the SAGE-718 development program as we work to address impaired cognition, a main driver of disability in the indications we are studying, including Huntington’s, Alzheimer’s and Parkinson’s diseases,” said Laura Gault, M.D., Ph.D., Chief Medical Officer at Sage. “Our goal with SAGE-718 is to provide rapid, meaningful, and sustained symptomatic improvement in cognitive function early in disease so that patients can maintain independence longer.”
Anticipated 2023 Key Milestones
The Company anticipates the following key milestones in 2023:
| • | Zuranolone: |
| • | Early: |
| • | FDA acceptance of rolling NDA submission for zuranolone in MDD and PPD |
| • | Mid: |
| • | Present additional data from the SHORELINE Study |
| • | Late: |
| • | PDUFA date for zuranolone in MDD and PPD, if accepted for review by the FDA |
| • | Commercial availability of zuranolone in MDD and PPD, if priority review is granted and zuranolone is approved |
| • | Initiate a lifecycle innovation study with zuranolone |
| • | Present additional analyses of data from LANDSCAPE and NEST clinical programs, including health economics and patient reported outcomes |
| • | SAGE-718: |
| • | Progress recruitment in the ongoing DIMENSION, SURVEYOR, PURVIEW, PRECEDENT, and LIGHTWAVE Studies |
| • | Present additional analyses of data from clinical development program as well as disease state and burden of disease research in Huntington’s, Parkinson’s and Alzheimer’s diseases |
| • | SAGE-324: |
| • | Late: |
| • | Complete enrollment in the Phase 2b KINETIC 2 Study |
| • | Present additional analyses of data from clinical development program as well as disease state and burden of disease research in ET |
About Sage Therapeutics
Sage Therapeutics is a biopharmaceutical company fearlessly leading the way to create a world with better brain health. Our mission is to pioneer solutions to deliver life-changing brain health medicines, so every person can thrive. For more information, please visit http://www.sagerx.com.
Forward-Looking Statements
Various statements in this release concern Sage’s future expectations, plans and prospects, including without limitation our statements regarding: the potential for our NDA for zuranolone in MDD and PPD to be accepted and the possibility of priority review; the potential for approval and launch of zuranolone and potential timelines; our belief in the potential benefit and profile of zuranolone and in its potential to be successful and to meet an unmet need in the treatment of MDD and PPD; the potential for commercialization of zuranolone and our commercialization strategy and plans, including plans to help enable access; our expectations as to the types of MDD patients who may benefit from zuranolone, if approved; other planned activities and next steps for the zuranolone program; anticipated timelines for commencement of trials, completion of dosing, initiation of new activities and other plans for our other programs and early stage pipeline; our belief in the potential profile and benefit of our product candidates; potential indications for our product candidates; the potential for success of our programs, and the opportunity to help patients in various indications; the number of patients with the indications we are pursuing or may in the future pursue and the unmet need; and the mission and goals for our business and potential for long-term value creation.
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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 FDA may find inadequacies and deficiencies in our NDA for zuranolone, including in the data we submit, despite prior discussions, and may decide not to accept the NDA for filing; even if the FDA accepts the NDA for filing, the FDA may find that the data included in the NDA are not sufficient for approval and may not approve the NDA in MDD or PPD, or both; the FDA may decide that the design, conduct or results of our completed and ongoing clinical trials for zuranolone, even if positive, are not sufficient for approval in MDD or PPD and may require additional trials or data which may significantly delay and put at risk our efforts to obtain approval and may not be successful; even if our NDA is successfully filed and accepted, the FDA may not grant priority review or meet expected review timelines for our NDA which would delay our launch timelines if zuranolone is approved; other decisions or actions of the FDA may affect our efforts with respect to zuranolone and our plans, progress, results and expected timelines; our expectations for timing of review of our NDA and of launch of zuranolone, if approved, may not be accurate; results of ongoing or future studies may impact our ability to obtain approval of zuranolone or impair the potential profile of zuranolone; success in earlier clinical trials of any of our other product candidates may not be repeated or observed in ongoing or future studies, and ongoing and future clinical trials may not meet their primary or key secondary endpoints which may substantially impair development; unexpected concerns may arise from additional data, analysis or results from any of our completed studies; we may encounter adverse events at any stage for any of product candidates that negatively impact further development, the potential for approval or the potential for successful commercialization or that require additional nonclinical and clinical work which may not yield positive results; we may encounter delays in initiation, conduct, completion of enrollment or completion of our ongoing and planned clinical trials, including as a result of slower than expected site initiation, slower than expected 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; 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 or may impair the potential for successful development; we may not be successful in our efforts to gain regulatory approval of any products, even if successfully developed and approved; we may not achieve revenues from any future products, including zuranolone, if approved, at the levels we expect; the number of patients with the diseases or disorders for which our product candidates are being developed, the unmet need for additional treatment options and the potential use cases and market for our current or future products, including zuranolone, if approved, may be significantly smaller than we expect; zuranolone, if approved, or any of our other products that may be approved in the future, may not have the profile we expect in clinical practice after launch or may not achieve market acceptance for other reasons or we may encounter reimbursement-related or other market-related issues that impact the success of our commercialization efforts; the anticipated benefits of our ongoing collaborations, including the achievement of events tied to milestone payments or the successful development or commercialization of products and generation of revenue, may never be achieved; 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 our marketed product or to generate revenues at levels we expect or at levels necessary to justify our investment; our expectations as to sufficiency of cash to fund future operations and expense levels may prove not to be correct for these and 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; and we may encounter technical and other unexpected hurdles in the development and manufacture of our product candidates or the commercialization of any marketed product which may delay our timing or change our plans, increase our costs or otherwise negatively impact our business; any of the foregoing or other issues may negatively impact our value creation opportunity, as well as those risks more fully discussed in the section entitled “Risk Factors” in our most
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recent quarterly report, 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.
| Investor Contact | Media Contact | |
| Helen Rubinstein | Matthew Henson | |
| 315-382-3979 | 917-930-7147 | |
| helen.rubinstein@sagerx.com | matthew.henson@sagerx.com |
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