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Sage Therapeutics Announces Second Quarter 2022 Financial Results and Highlights Pipeline and Business ProgressPharma & Healthcare Monitor Worldwide Sage Therapeutics Announces Second Quarter 2022 Financial Results and Highlights Pipeline and Business ProgressSage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, today reported business highlights and financial results for the second quarter ended June 30, 2022. The first half of 2022 has been marked by important clinical and regulatory achievements across our entire pipeline, paving the way for continued focused execution throughout the remainder of the year, said Barry Greene, Chief Executive Officer at Sage Therapeutics. We are making progress on the NDA submission for zuranolone and building our organization to support a potential launch. Based on the consistent clinical profile of zuranolone, we believe it has the potential, if approved, to address the significant unmet need for people suffering from MDD and PPD and we are working with a sense of urgency toward our goal of bringing zuranolone to them. Beyond zuranolone, we are continuing to advance our pipeline, with the presentation of multiple data sets at key upcoming scientific congresses. I believe our progress this year, combined with the strong foundation weve built, supports our growth as a leader in brain health and a top-tier biopharmaceutical company. Second Quarter 2022 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 Sages depression franchise features zuranolone, Sages 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 Association (FDA) as the first treatment specifically indicated for postpartum depression (PPD). Zuranolone has received Breakthrough Therapy and Fast Track Designation for the treatment of major depressive disorder (MDD) and Fast Track Designation for the treatment of PPD from the FDA. Zuranolone is being evaluated as a potential rapid-acting, once-daily, oral two-week treatment for MDD and PPD in the LANDSCAPE and NEST clinical development programs, respectively. Across seven positive clinical trials, zuranolone has demonstrated rapid and sustained relief of depressive symptoms in people with MDD and PPD. In the second quarter of this year, Sage and its collaborator, Biogen, announced that the SKYLARK Study of zuranolone in PPD met its primary and all key secondary endpoints. In June 2022, Sage and Biogen announced that the rolling NDA submission that was previously initiated will seek approval for both MDD and PPD in one filing. The Companies plan to complete submission of the single NDA for zuranolone for the treatment of both MDD and PPD to the FDA in the second half of this year, accelerating previously planned timelines for PPD. The Company also shared insights from the terminated RAINFOREST and REDWOOD Studies today. The RAINFOREST Study was designed to investigate the efficacy and safety of 30 mg zuranolone in comorbid MDD and insomnia. The REDWOOD Study was designed to study fixed schedule intermittent dosing of 30 mg zuranolone throughout the course of a year. Both studies were terminated in 2020 based on the Companys plans to advance the program with the 50 mg dose of zuranolone. The RAINFOREST Study, which enrolled 87 patients, was terminated prior to achieving the planned sample size. As the study was not fully enrolled, the statistical analysis plan was invalid. The study directionality showed that zuranolone may benefit sleep efficiency, with numerical improvement in objective measures of quality of sleep, including wake after sleep onset, total sleep time, latency to persistent sleep, median number of awakenings, and mean duration of awakenings, and differences on endpoints involving REM sleep. The REDWOOD Study did not enroll enough patients for efficacy analyses to be performed. There were no new safety findings from the study. In the open-label SHORELINE Study, a large naturalistic study in the zuranolone development program, 80% of patients who responded to initial treatment with zuranolone 50 mg received only 1 or 2 treatment courses during their time in the year-long study, with a median time to the second treatment course of 249 days also with no new safety findings. Additionally, Sage today announced that the SUNBIRD Study evaluating the safe-use administration of ZULRESSO as a treatment for PPD in a womans home has completed enrollment. Sage does not plan any label changes from this study. The Company expects to achieve the following milestones across its depression franchise in 2022: Late 2022: Complete NDA submission for zuranolone in MDD and PPD (2H 2022). Present additional zuranolone data throughout 2022. Neuropsychiatry Franchise Sages neuropsychiatry franchise features SAGE-718, the Companys first-in-class NMDA receptor PAM and lead neuropsychiatric drug candidate, in development as a potential oral therapy for cognitive disorders associated with NMDA receptor dysfunction, potentially including Huntingtons disease (HD), Parkinsons disease (PD) and Alzheimers disease (AD). SAGE-718 received Fast Track Designation from the FDA for development as a potential treatment for HD. Sage is advancing a robust clinical program for SAGE-718 with multiple ongoing or planned Phase 2 studies, including the DIMENSION and SURVEYOR Studies in people with HD cognitive impairment, the lead indication for SAGE-718, the PRECEDENT Study in people with mild cognitive impairment (MCI) associated with PD and a Phase 2 study in people with MCI and mild dementia due to AD. DIMENSION (CIH-201) Study: Sage is currently enrolling the Phase 2 DIMENSION Study, a double-blind, placebo-controlled study in people with HD cognitive impairment. The study is designed to evaluate the efficacy of once-daily dosed SAGE-718 over three months, with a target enrollment of approximately 178 people. Sage expects the DIMENSION Study to include more than 40 clinical sites. SURVEYOR (CIH-202) Study: The SURVEYOR Study is a placebo-controlled Phase 2 study in people with HD cognitive impairment and healthy volunteers, with the goal of generating evidence linking efficacy signals on cognitive performance to domains of real-world functioning. PRECEDENT (CNP-202) Study: The Phase 2 PRECEDENT Study is a double-blind, placebo-controlled study in people with MCI due to PD. The study is designed to evaluate the safety and efficacy of SAGE-718 in people with MCI due to PD over 42 days, followed by a controlled follow-up period. The Company expects to achieve the following milestones across its neuropsychiatry franchise in 2022: Late 2022: Phase 3 Study in HD (CIH-301): Initiate a Phase 3 safety study of SAGE-718 in people with HD cognitive impairment. Phase 2 Study in AD (CNA-202): Initiate a placebo-controlled Phase 2 study of SAGE-718 in people with mild cognitive impairment and mild dementia due to AD. Present additional SAGE-718 data throughout 2022. Neurology Franchise Sages neurology franchise features SAGE-324 and SAGE-689. SAGE-324, a next-generation PAM of GABAA receptors and Sages lead neurology program, is in development as a potential oral therapy for neurological conditions, such as essential tremor (ET), epilepsy and PD. SAGE-689 is an intramuscular GABAA receptor PAM in development as a potential therapy for disorders associated with acute GABA hypofunction. Sage and its collaborator, Biogen, are currently enrolling people in the Phase 2b KINETIC 2 placebo-controlled study of SAGE-324 in ET following positive results from the KINETIC Study. The KINETIC 2 Study is a Phase 2b dose-ranging study with the primary goal of defining the dose and frequency for SAGE-324 in ET with a good tolerability profile and a dosing schedule to maintain plasma concentrations needed for sustained tremor symptom control in treating ET. Sage also recently initiated a Phase 2 long-term open label safety study with SAGE-324, designed to evaluate the long-term safety and tolerability of SAGE-324 in ET, with incidence of treatment-emergent adverse events as the primary endpoint. SAGE-689 continues in Phase 1 development. The Company expects to achieve the following milestones across its neurology franchise in 2022: Late 2022: Complete enrollment in KINETIC 2 Study of SAGE-324 in ET. Present additional SAGE-324 data throughout 2022. Early Development Sage is progressing its early development programs with IND-enabling work underway for SAGE-319 and SAGE-421. SAGE-319: an oral, extrasynaptic GABAA receptor preferring PAM that Sage plans to study for potential use in disorders of social interaction. SAGE-421: an oral, NMDA receptor PAM that Sage plans to study for potential use in neurodevelopmental disorders and cognitive recovery and rehabilitation. FINANCIAL RESULTS FOR THE SECOND QUARTER 2022 Cash Position: Cash, cash equivalents and marketable securities as of June 30, 2022 were $1.5 billion compared to $1.6 billion at March 31, 2022. Revenue: Net revenue from sales of ZULRESSO was $1.5 million in the second quarter of 2022, compared to $1.6 million in the same period of 2021. R&D Expenses: Research and development expenses were $77.3 million, including $6.5 million of non-cash stock-based compensation expense, in the second quarter of 2022 compared to $66.2 million, including $13.5 million of non-cash stock-based compensation expense, for the same period in 2021. The increase in R&D expenses was primarily due to increased spending on SAGE-324 and Sages wholly owned pipeline, including SAGE-718 and other programs. The reimbursement from Biogen pursuant to the Sage/Biogen Col |
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