- In January 2016, Sage raised approximately $140.4 million in net proceeds, after underwriters' discounts and commissions and offering expenses, through a follow-on public offering of 3,157,894 shares of its common stock at a price of $47.50 per share.
- Sage presented data from five abstracts at the 68 th American Academy of Neurology (AAN) Annual Meeting on April 15-21, 2016 in Vancouver, Canada, including an oral platform presentation:
- Presented detailed data regarding effects of underlying disorders, and treatment approaches from the open-label Phase 1/2 study of SAGE-547 in SRSE in a peer-reviewed setting for first time.
- Demonstrated that the key efficacy endpoint response rate in the Phase 1/2 SRSE study was not related to age, gender, ethnicity, co-morbid medical condition, underlying medical condition, or previous antiepileptic or third line agent treatment; identified additional treatment characteristics subsequently incorporated into the Phase 3 STATUS Trial protocol.
- Identified an exploratory pharmacodynamic biomarker that was significantly correlated with the plasma concentration of SAGE-547 during Phase 1/2 study.
- Estimated the health economic burden of illness of SRSE in the U.S. through analysis of cases classified as SRSE using a treatment algorithm applied to a database of certain patient-level demographics and resource utilization data from 2012, highlighting significant morbidity, lengthy hospitalizations and significant utilization of ICU and overall hospital resources.
- Presented data from a proof-of-concept study using SAGE-547 in 25 patients to evaluate the GABA mechanism as a potential treatment for essential tremor, and informing assessment and statistical methodology for the anticipated Phase 2 trial with next-generation GABA A modulator, SAGE-217, later this year.
- In April 2016, Sage was awarded Most Innovative Clinical Trial Design for the Phase 1/2 clinical trial of SAGE-547 in SRSE at Informa's 1st Annual Clinical & Research Excellence (CARE) Awards. Sage was a finalist in three award categories.
- Sage was announced as a finalist for the Most Valuable HCP or Healthcare Initiative for the Phase 3 STATUS Trial app at the 2nd Annual eyeforpharma Philadelphia Awards 2016.
- Upcoming data presentations at the Society of Biological Psychiatry (SOBP) 71st Annual Scientific Meeting on May 12-14 in Atlanta, GA.
- Detailed data from the open-label, proof-of-concept study for SAGE-547 in four PPD patients.
- Late-breaking abstract highlighting pre-clinical data from the first NMDA positive allosteric modulator candidate, SAGE-718, showing effects in established animal models of psychosis and cerebrosterol deficit disorders.
- Top-line results for the Phase 2 placebo-controlled, proof-of-concept clinical trial of SAGE-547 in severe PPD is expected during the second quarter of 2016.
- Top-line results for the Phase 1 clinical program of SAGE-217 is expected during the second quarter of 2016.
- Top-line results for the Phase 3 STATUS Trial of SAGE-547 in SRSE is expected during the second half of 2016.
- Phase 2 clinical trial initiations for SAGE-217 in at least two indications, among essential tremor, orphan epilepsies and possibly, severe PPD, planned for the second half of 2016, assuming successful completion of Phase 1 and, in the case of severe PPD, positive data from the ongoing SAGE-547 proof-of-concept trial.
- Initiation of the Phase 1 development program for SAGE-689, a next generation positive allosteric modulator of GABA A receptors, expected during the second half of 2016, assuming additional non-clinical data is satisfactory to the FDA.
- Clinical development with the first NMDA candidate, SAGE-718, planned to begin in 2017.
- Society of Biological Psychiatry 71st Annual Scientific Meeting, Atlanta, May 12-14
- 2 nd Congress of the European Academy of Neurology (EAN), Copenhagen, May 28-May 31
- American Society of Clinical Psychopharmacology (ASCP) 2016 Annual Meeting, Scottsdale, May 30-June 3
- Goldman Sachs Global Healthcare Conference, Rancho Palos Verdes, June 7-9
- Eilat Conference on New Antiepileptic Drugs (Eilat XIII), Madrid, June 26-29
- Cash Position: Cash and cash equivalents as of March 31, 2016 were $299.7 million, compared with $186.8 million at December 31, 2015. In January 2016, Sage completed an underwritten public offering resulting in net proceeds of $140.4 million.
- R&D Expenses: Research and development expenses in the first quarter of 2016 were $23.6 million, including $1.6 million of non-cash stock-based compensation expense, compared to $12.9 million, including $0.5 million of non-cash stock-based compensation expense, for the same period of 2015. The increase in R&D expense was primarily due to increased spending on clinical activities related to the continued advancement of the SAGE-547 Phase 3 development program, the Phase 2 proof-of-concept trial of SAGE-547 in severe PPD, and the SAGE-217 Phase 1 development program; increased personnel-related R&D expenses supporting the advancement of Sage's pipeline of product candidates; and increased non-cash stock-based compensation expense.
- G&A Expenses: General and administrative expenses in the first quarter of 2016 were $7.1 million, including $2.1 million of non-cash stock-based compensation expense, compared to $4.0 million, including $0.8 million of non-cash stock-based compensation expense, for the same period of 2015. The increase in G&A expenses was primarily due to an increase in personnel-related costs to support general operations.
- Net Loss: Net loss was $30.5 million for the first quarter of 2016 compared to net loss of $16.9 million for the same period of 2015.
- Financial Guidance: Sage reiterates its expectation that its existing cash and cash equivalents will be sufficient to fund operations into the beginning of 2018 based on its current operating plans.
|Sage Therapeutics, Inc. and Subsidiaries Condensed Consolidated Balance Sheets(in thousands)(unaudited)|
|March 31, 2016||December 31, 2015|
|Cash and cash equivalents||$||299,680||$||186,753|
|Prepaid expenses and other current assets||2,926||1,738|
|Total current assets||302,606||188,491|
|Property and equipment and other long-term assets||904||525|
|Liabilities and Stockholders' Equity|
|Total current liabilities||15,970||15,307|
|Total Stockholders' Equity||287,500||173,695|
|Total liabilities and stockholders' equity||$||303,510||$||189,016|
|Sage Therapeutics, Inc. and Subsidiaries Condensed Consolidated Statements of Operations and Comprehensive Loss(in thousands, except share and per share data)(unaudited)|
|Three Months Ended March 31,|
|Research and development||$||23,581||$||12,900|
|General and administrative||7,133||3,997|
|Total operating expenses||30,714||16,897|
|Loss from operations||(30,714||)||(16,897||)|
|Interest income, net||175||21|
|Other income (expense), net||(4||)||5|
|Net loss and comprehensive loss||$||(30,543||)||$||(16,871||)|
|Net loss per share - basic and diluted||$||(0.97||)||$||(0.66||)|
|Weighted-average shares outstanding - basic and diluted||31,643,216||25,655,883|