Financial Guidance
Based on its current operating plan and assumptions with respect to future plans and resource allocation decisions, Sage anticipates that its balance of cash, cash equivalents, restricted cash, and marketable securities of approximately $1.0 billion as of December 31, 2019, will support operations into 2022. The Company is currentlyre-assessing its resource allocation and prioritization strategy in light of the development of zuranolone, the uptake of ZULRESSO™ (brexanolone) CIV injection, and factoring in the potential impact on its business of the unprecedented global public health crisis. The Company plans to share its updated resource allocation strategy during its first quarter earnings call.
About Zuranolone
Zuranolone(SAGE-217) is a once-daily,two-week therapy in development for the treatment of major depressive disorder (MDD) and postpartum depression (PPD). Zuranolone is an investigational oral neuroactive steroid (NAS) GABAA receptor positive allosteric modulator (PAM). The GABA system is the major inhibitory signaling pathway of the brain and central nervous system and contributes significantly to regulating brain function. Zuranolone has been granted Breakthrough Therapy Designation by the U.S. Food & Drug Administration.
About Major Depressive Disorder
Major depressive disorder (MDD), commonly referred to as depression, is a brain health disorder that affects an estimated 17 million adults in the U.S. each year. It is one of the largest contributors to disability in the U.S. and worldwide and is characterized by symptoms of depressed mood and/or loss of interest in pleasurable activities. MDD causes significant impairment in daily life and can limit a person’s ability to fulfill work, school, family, or social responsibilities; enjoy leisure activities; or maintain health and hygiene. While antidepressants are widely used to treat MDD, large-scale studies have demonstrated that there is an unmet need in the treatment of MDD, including during the weeks between initiation of treatment and onset of effect, as well as the need for new therapeutic options.
About Postpartum Depression
Postpartum depression (PPD) is one of the most common medical complications during and after pregnancy. PPD can have a serious negative impact on a woman, including significant functional impairment, depressed mood and/or loss of interest in her newborn, and associated symptoms of depression such as loss of appetite, difficulty sleeping, motor challenges, lack of concentration, loss of energy and poor self-esteem. PPD is estimated to affect approximately one in nine women who have given birth in the U.S. or approximately 400,000 women annually.
About Sage Therapeutics
Sage Therapeutics is a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with debilitating disorders of the brain. We are pursuing new pathways with the goal of improving brain health, and our depression, neurology and neuropsychiatry franchise programs aim to change how brain disorders are thought about and treated. Our mission is to make medicines that matter so people can get better, sooner. For more information, please visit www.sagerx.com.
Forward Looking Statements
Various statements in this release concern Sage’s future expectations, plans and prospects, including without limitation, our statements as to the various potential development and regulatory pathways for zuranolone in MDD and PPD; our expectations as to the timing of initiation of clinical trials and reporting of results; our expectations regarding the potential sufficiency of the planned development program, if successful, to support regulatory filings and