Full Press Release Details
SAGE Therapeutics Reports Third Quarter 2014 Results
SAGE-547 Phase 1/2 Study Meets Primary Efficacy and Safety Endpoints
Cambridge, Mass. November 12, 2014 SAGE Therapeutics (NASDAQ: SAGE), a clinical-stage biopharmaceutical company developing novel
medicines to treat life-threatening, rare central nervous system (CNS) disorders, today reported pipeline updates and reported business and financial results for the quarter ended September 30, 2014.
So far this year, we have made great progress towards our mission to improve the lives of patients living with rare and severe CNS disorders, said
Jeff Jonas, M.D., chief executive officer of SAGE. Financial results were in line with expectations and we recently announced that we met both the primary efficacy and safety endpoints for our Phase 1/2 clinical trial of SAGE-547 in patients
with super-refractory status epilepticus (SRSE). Based on the activity of SAGE-547 in this trial combined with the observed ability of SAGE-547 to halt status epilepticus in emergency-use cases, we are focusing our efforts on initiating our pivotal
trial for treatment of this disorder in the first half of 2015 pending our discussions with the FDA. We are excited about the potential for SAGE-547, as well as our earlier stage programs, to treat multiple orphan genetic epilepsies and other rare
disorders for which there are few to no approved treatment options.
In addition, in September, SAGE strengthened its leadership team with the
addition of Michael F. Cola to its Board of Directors.
About SAGE Therapeutics
SAGE Therapeutics (NASDAQ: SAGE)
is a clinical-stage biopharmaceutical company committed to developing and commercializing novel medicines to treat life-threatening, rare central nervous system, or CNS disorders. SAGE s lead program, SAGE-547, is in clinical development for
super-refractory status epilepticus, or SRSE, and is the first of several compounds the company is developing in its portfolio of potential seizure medicines. The active pharmaceutical ingredient, treatment IND and support for emergency-use patients
have been contributed under agreement by the Regents of the University of California and the University of California Davis. SAGE s proprietary chemistry platform has generated multiple new compounds that target GABAA and NMDA receptors, which are broadly accepted as impacting many psychiatric and neurological disorders. For more information, please visit www.sagerx.com.
Forward-Looking Statement
This release contains
forward-looking statements and information. The use of words such as may, might, will, should, expect, plan, anticipate, believe, estimate,
project, intend, future, potential, or continue, and other similar expressions are intended to identify forward looking statements. For example SAGE s future expectations, plans and
prospects, including without limitation, SAGE s expectations regarding the potential safety, pharmacological effect and efficacy of SAGE-547 as a treatment for SRSE and essential tremor, the expected development pathway for its other product
candidates and its expectations with respect to the timing and success of its clinical trials, in particular a new clinical trial for SAGE-547 as a treatment for SRSE and whether such trial will be deemed by FDA to be a pivotal trial, constitute
forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. In particular it should be noted that the initial data reported from the ongoing
Phase 1/2 clinical trial of SAGE-547 are preliminary in nature and that the SAGE-547 clinical trial has not been completed. The preliminary data may change as additional data is released and such preliminary data may not be repeated or observed in
ongoing or future studies involving SAGE-547 or our other product candidates. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation,
SAGE s ability to successfully demonstrate the efficacy and safety of its product candidates, the pre-clinical and clinical results for its product candidates, which may not support further development of product candidates, actions of
regulatory agencies, which may affect the initiation, timing and progress of clinical trials, obtaining, maintaining and protecting intellectual property, SAGE s ability to enforce its patents against infringers and defend its patent portfolio
against challenges from third parties, competition from others developing products for similar uses, SAGE s ability to manage operating expenses, SAGE s ability to obtain
additional funding to support its business activities and establish and maintain strategic business alliances and new business initiatives, SAGE s dependence on third parties for
development, manufacture, marketing, sales and distribution of products, the outcome of litigation, and unexpected expenditures, as well as those risks more fully discussed in the section entitled Risk Factors in the final prospectus
related to SAGE s initial public offering filed with the Securities and Exchange Commission pursuant to Rule 424(b) of the Securities Act of 1933, as amended, as well as discussions of potential risks, uncertainties, and other important factors
in SAGE s subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent SAGE s views only as of today and should not be relied upon as representing its views as of any subsequent
date. SAGE explicitly disclaims any obligation to update any forward-looking statements.
Dan Budwick, Pure Communications
Monique Allaire Lyons, Pure
Sage Therapeutics, Inc.
thousands, except share and per share data)
| September 30, 2014 | December 31, 2013 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 136,727 | $ | 8,066 | ||||
| Prepaid expenses and other current assets | 1,063 | 341 | ||||||
| Total current assets | 137,790 | 8,407 | ||||||
| Property and equipment, net | 134 | 86 | ||||||
| Restricted cash | 39 | 39 | ||||||
| Total assets | $ | 137,963 | $ | 8,532 | ||||
| Liabilities, Redeemable Convertible Preferred Stock and Stockholders Equity (Deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,157 | $ | 1,988 | ||||
| Accrued expenses | 2,853 | 327 | ||||||
| Total current liabilities | 5,010 | 2,315 | ||||||
| Other liabilities: | 34 | 44 | ||||||
| Total liabilities | 5,044 | 2,359 | ||||||
| Redeemable convertible preferred stock (Series A, B and C), $0.0001 par value; 0 and 37,750,000 shares authorized at September 30, 2014 and December 31, 2013, respectively; 0 and 37,750,000 shares issued and outstanding at September 30, 2014 and December 31, 2013, respectively; liquidation preference of $0 and $40,663 at September 30, 2014 and December 31, 2013, respectively | 37,709 | |||||||
| Stockholders equity (deficit): | ||||||||
| Common stock, $0.0001 par value; 70,623,905 and 66,000,000 shares authorized at September 30, 2014 and December 31, 2013, respectively; 25,586,295 and 1,622,761 shares issued and outstanding at September 30, 2014 and December 31, 2013, respectively | 3 | |||||||
| Additional paid-in capital | 187,400 | 139 | ||||||
| Accumulated deficit | (54,484 | ) | (31,675 | ) | ||||
| Total stockholders equity (deficit) | 132,919 | (31,536 | ) | |||||
| Total liabilities, redeemable convertible preferred stock and stockholders equity (deficit) | $ | 137,963 | $ | 8,532 |
The accompanying notes are an integral part of these financial statements.
Sage Therapeutics, Inc.
Statements of Operations and Comprehensive Loss
(in thousands, except share and per share data)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2014 | 2013 | 2014 | 2013 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 6,601 | $ | 3,408 | $ | 15,155 | $ | 9,845 | ||||||||
| General and administrative | 2,869 | 1,111 | 6,294 | 2,719 | ||||||||||||
| Total operating expenses | 9,470 | 4,519 | 21,449 | 12,564 | ||||||||||||
| Loss from operations | (9,470 | ) | (4,519 | ) | (21,449 | ) | (12,564 | ) | ||||||||
| Interest income (expense), net | 3 | 4 | ||||||||||||||
| Other income (expense), net | (1 | ) | (5 | ) | 1 | |||||||||||
| Net loss and comprehensive loss | (9,468 | ) | (4,519 | ) | (21,450 | ) | (12,563 | ) | ||||||||
| Accretion of redeemable convertible preferred stock to redemption value | (391 | ) | (2,294 | ) | ||||||||||||
| Net loss attributable to common stockholders | $ | (9,859 | ) | $ | (4,519 | ) | $ | (23,744 | ) | $ | (12,563 | ) | ||||
| Net loss per share attributable to common stockholders basic and diluted | $ | (0.50 | ) | $ | (2.98 | ) | $ | (3.08 | ) | $ | (8.56 | ) | ||||
| Weighted average number of common shares used in net loss per share attributable to common stockholders basic and diluted | 19,581,624 | 1,514,838 | 7,711,038 | 1,467,387 |
The accompanying notes are an integral part of these financial statements.