Sage Therapeutics Announces Third Quarter 2018 Financial Results and Highlights Pipeline and Business Progress
FDA Advisory Committee Meeting outcome supports approval of ZULRESSO™ (brexanolone) injection asthe first medicine specifically indicated for the treatment of postpartum depression (PPD)
Continuing to execute commercial strategy for ZULRESSO in PPD ahead
of PDUFA target date of
Completion of enrollment in Phase 3 clinical trial of SAGE-217 in PPD
– top-line results expected in
Expansion of depression franchise with initiation of Phase 2 clinical trial of SAGE-217 in bipolar depression and multiple near-term trial initiations expected in major depressive disorder
Continued progress for SAGE-324 and SAGE-718 in early clinical pipeline
Conference call today at
“At Sage, our approach to scientific discovery and development is
focused on transforming the lives of people with life-altering CNS
disorders. Our first program, in PPD, exemplifies this philosophy.
Members of the PPD patient advocacy community and healthcare providers
across the country have shared their sense of urgency with us – they are
seeking a new way of thinking about PPD and an opportunity to rapidly
alleviate suffering from this condition. If approved, ZULRESSO has the
potential to meet these needs and to be an important new tool that
healthcare providers can use to ease the burden of PPD for patients and
their families,” said
ZULRESSO™ (brexanolone) Injection Regulatory and Pre-Launch Activities Updates:
November 2nd, the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee(PDAC) and Drug Safety and Risk Management Advisory Committee(DSaRM) jointly voted (17 yes, 1 no) that data support the favorable benefit-risk profile of ZULRESSO™ (brexanolone) injection for the treatment of postpartum depression (PPD) when administered by qualified staff in a facility that has been certified under a Risk Evaluation and Mitigation Strategies (REMS) program. The joint committee based their joint recommendation on the safety and efficacy data from three placebo-controlled clinical studies.
The New Drug Application (NDA) for ZULRESSO for the treatment of PPD
has been accepted for Priority Review by the
FDA. The FDAhas assigned a Prescription Drug User Fee Act (PDUFA) target date of December 19, 2018.
If approved, ZULRESSO is expected to be scheduled by the
U.S. Drug Enforcement Administration(DEA), consistent with other approved GABAergic therapies. The DEA is required to issue an interim final rule controlling the drug within 90 days of approval.
Preparations continue for a potential U.S. commercial launch of
ZULRESSO for the treatment of PPD in late
March 2019, if the NDA is approved and post-DEA scheduling.
Sage is continuing discussions with the
European Medicines Agency(EMA) to determine the European regulatory pathway for a marketing authorization application (MAA) filing for brexanolone injection for PPD. Sage plans to seek additional Scientific Advice to help determine what additional data or information will be needed prior to filing, as is permissible under the PRIority MEdicines (PRIME) designation program.
Beyond ZULRESSO, Sage is advancing a portfolio of novel CNS product candidates targeting the GABA and NMDA receptor systems. Dysfunction in these systems is known to be at the core of numerous psychiatric and neurological disorders.
SAGE-217 in Major Depressive Disorder (MDD) and PPD:
PPD Phase 3 trial enrollment completed: Enrollment was recently
completed for the Phase 3 placebo-controlled trial evaluating
SAGE-217 in patients with PPD, and Sage plans to announce top-line
- MDD Phase 3 trial initiated: Plans are on-track for enrollment to begin in a Phase 3 placebo-controlled trial of SAGE-217 in MDD in 4Q 2018. The trial will evaluate the potential of episodic treatment through a protocol including two weeks of 20mg or 30mg SAGE-217 treatment compared to placebo in approximately 450 patients with MDD, with four weeks of additional follow-up.
- Long-term retreatment study: Additional data regarding patient safety and potential treatment of recurrent or new major depressive episodes will be acquired through a long-term retreatment study evaluating SAGE-217 treatment and episodic retreatment as needed.
- PPD Phase 3 trial enrollment completed: Enrollment was recently completed for the Phase 3 placebo-controlled trial evaluating SAGE-217 in patients with PPD, and Sage plans to announce top-line results in
SAGE-217 in Other Psychiatric Indications:
- Bipolar depression: Dosing of patients is underway in Part A of a two-part Phase 2 clinical trial evaluating open-label SAGE-217 treatment in up to 30 patients with bipolar I/II disorder with a current major depressive episode. If Part A is successful, the Company plans to progress to a randomized, placebo-controlled Part B study. The Part A trial is intended to evaluate the safety and tolerability of SAGE-217 and secondary endpoints, including efficacy in improving depressive symptoms and sleep. The top-line results from Part A are planned to be announced in 1H 2019.
Sleep disorders: Additional data from a placebo-controlled trial
in a model of insomnia demonstrating an encouraging impact of
SAGE-217 on sleep architecture was recently presented at the 31st
European College of Neuropsychopharmacology Congress. Sage plans to initiate a Phase 3 placebo-controlled polysomnography trial of SAGE-217 in MDD patients with co-morbid insomnia in 4Q 2018, and also plans to seek feedback in 2019 from the FDAon potential development plans for SAGE-217 for the treatment of sleep disorders and other indications.
SAGE-324 in Neurological Indications:
- Phase 1 program: A Phase 1 single-ascending dose trial of SAGE-324 in healthy volunteers, which is intended to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic profile of SAGE-324, is ongoing, and Sage plans to complete this trial in 4Q 2018. Based on initial findings from this trial, Sage plans to initiate a Phase 1 multiple-ascending dose trial of SAGE-324 in healthy volunteers in 4Q 2018. SAGE-324 is being developed as a potential treatment for patients impacted by neurological conditions such as epileptiform disorders, essential tremor, and Parkinson’s disease.
- SAGE-718: The healthy volunteer portion of the Phase 1 multiple ascending dose trial of SAGE-718 has been completed. As part of the Phase 1 program, Sage has initiated target engagement biomarker studies, focusing on electrophysiology and imaging, to evaluate SAGE-718 in healthy volunteers, and is considering plans to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic profile of SAGE-718 in a patient cohort.
- SAGE-904 is currently in IND-enabling studies.
- Trial Enrollment Initiations:
- SAGE-217 Phase 3 placebo-controlled trial in MDD (4Q 2018)
- SAGE-217 Phase 3 placebo-controlled polysomnography trial in MDD patients with co-morbid insomnia (4Q 2018)
- SAGE-324 Phase 1 multiple ascending dose trial (4Q 2018)
- Data Readouts:
SAGE-217 Phase 3 placebo-controlled trial in PPD (
- SAGE-217 Phase 2 trial in bipolar depression (1H 2019)
- SAGE-718 Phase 1 target engagement studies (1H 2019)
- SAGE-324 Phase 1 multiple ascending dose trial (1H 2019)
- SAGE-217 Phase 3 placebo-controlled trial in PPD (
- Regulatory and Commercial:
ZULRESSO in PPD PDUFA target date (
December 19, 2018)
ZULRESSO in PPD commercial launch, if approved (late
- ZULRESSO in PPD PDUFA target date (
Financial Results for the Third Quarter of 2018
- R&D Expenses: Research and development expenses were
$75.1 million, including $14.0 millionof non-cash stock-based compensation expense, in the third quarter of 2018, compared to $58.3 million, including $5.4 millionof non-cash stock-based compensation expense, for the same period of 2017. The increase in R&D expenses was primarily due to increases in expenses related to ongoing R&D programs and discovery efforts focused on identifying new clinical candidates and additional indications of interest and investments in R&D headcount to support the growth in Sage's pipeline and operations, offset by decreases in expenses due to the completion of Phase 3 clinical development of ZULRESSO.
- G&A Expenses: General and administrative expenses were
$53.7 million, including $11.5 millionof non-cash stock-based compensation expense, in the third quarter of 2018, compared to $16.1 million, including $4.3 millionof non-cash stock-based compensation expense, for the same period of 2017. The increase in G&A expenses was primarily due to the increase in personnel-related expenses, professional fees to support expanding operations, costs related to continued preparations for a potential commercial launch, and facilities-related costs to support expanding operations.
- Net Loss: Net loss was
$122.9 millionfor the third quarter of 2018 compared to a net loss of $73.7 millionfor the comparable period of 2017.
- Cash Position: Cash, cash equivalents, and marketable
securities as of
September 30, 2018were $1.0 billion, compared with $518.8 millionat December 31, 2017. The increase was primarily due to net proceeds of $631.2 millionfrom Sage's follow-on public offering completed in February 2018, and an upfront milestone payment from Shionogi & Co., Ltd.related to the strategic collaboration that was entered in June 2018.
Based on its current operating plan, Sage anticipates that its
existing cash, cash equivalents and marketable securities as of
September 30, 2018will enable Sage to fund its operating expenses and capital expenditure requirements into 2020.
- Sage expects that its operating expenses will increase year-over-year in 2018 to support continued pipeline advancement, including ongoing Phase 3 development of SAGE-217, and potential commercialization of ZULRESSO in PPD, if approved.
Conference Call Information
Sage will host a conference call and webcast on
Various statements in this release concern Sage's future expectations, plans and prospects, including without limitation: our expectations regarding the potential for approval of our NDA for ZULRESSO in the treatment of PPD, including the target timing of a decision by the
Sage Therapeutics, Inc. and Subsidiaries
|Three Months Ended September 30,||Nine Months Ended September 30,|
|Research and development||75,052||58,286||193,302||159,386|
|General and administrative||53,693||16,087||125,709||43,320|
|Total operating expenses||128,745||74,373||319,011||202,706|
|Loss from operations||(128,745||)||(74,373||)||(229,011||)||(202,706||)|
Interest income, net
Other income (expense), net
|Net loss per share - basic and diluted||$||(2.63||)||$||(1.97||)||$||(4.68||)||$||(5.37||)|
|Weighted average shares outstanding - basic and diluted||46,706,770||37,470,912||45,866,676||37,367,802|
Sage Therapeutics, Inc. and Subsidiaries
September 30, 2018
|December 31, 2017|
|Cash and cash equivalents||$||253,123||$||306,235|
|Prepaid expenses and other current assets||18,511||6,227|
|Total current assets||1,039,912||525,075|
|Property and equipment and other long-term assets||7,087||4,862|
|Liabilities and Stockholders' Equity|
|Total current liabilities||54,526||51,951|
|Total stockholders' equity||988,505||475,475|
|Total liabilities and stockholders' equity||$||1,046,999||$||529,937|