Full Press Release Details
SAGE Therapeutics Reports Second Quarter 2014 Financial Results
Successfully Completed Initial Public Offering and Reported Preliminary Results for SAGE-547 in Super-Refractory Status Epilepticus
Cambridge, Mass. August 14, 2014 SAGE Therapeutics (NASDAQ: SAGE), a clinical-stage biopharmaceutical company developing novel
medicines to treat life-threatening, rare central nervous system (CNS) disorders, today provided business updates and reported financial results for the quarter ended June 30, 2014.
This has been a great year for SAGE in several areas, stated Jeff Jonas, M.D., chief executive officer at SAGE. We ve made great
progress with our lead product candidate, SAGE-547, having reported preliminary results from the first four patients with super-refractory status epilepticus in our ongoing Phase 1/2 clinical trial. The data, to date, demonstrated both clinically
relevant activity and safety with SAGE-547. We completed a successful initial public offering, and we also made significant progress in several of our pipeline programs. With the proceeds from the IPO, we are in a strong position to invest in new
SAGE-547 trials and complete the work necessary to advance two additional product candidates towards the clinic. We look forward to reporting further progress this year.
Recent Business Highlights
About SAGE Therapeutics
SAGE Therapeutics 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. 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, the expected development pathway for its other product candidates and its expectations with respect to the timing and success of its clinical trials, 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, Pure Communications
Sage Therapeutics, Inc.
Statements of Operations and Comprehensive Loss
(in thousands, except share and per share data)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2014 | 2013 | 2014 | 2013 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 4,381 | $ | 3,854 | $ | 8,554 | $ | 6,437 | ||||||||
| General and administrative | 1,807 | 801 | 3,424 | 1,607 | ||||||||||||
| Total operating expenses | 6,188 | 4,655 | 11,978 | 8,044 | ||||||||||||
| Loss from operations | (6,188 | ) | (4,655 | ) | (11,978 | ) | (8,044 | ) | ||||||||
| Interest income (expense), net | 1 | 1 | ||||||||||||||
| Other income (expense), net | (5 | ) | (5 | ) | ||||||||||||
| Net loss and comprehensive loss | (6,192 | ) | (4,655 | ) | (11,982 | ) | (8,044 | ) | ||||||||
| Accretion of redeemable convertible preferred stock to redemption value | (1,577 | ) | (1,903 | ) | ||||||||||||
| Net loss attributable to common stockholders | $ | (7,769 | ) | $ | (4,655 | ) | $ | (13,885 | ) | $ | (8,044 | ) | ||||
| Net loss per share attributable to common stockholders basic and diluted | $ | (4.57 | ) | $ | (3.18 | ) | $ | (8.28 | ) | $ | (5.58 | ) | ||||
| Weighted average number of common shares used in net loss per share attributable to common stockholders basic and diluted | 1,700,517 | 1,464,419 | 1,676,864 | 1,442,774 |
Sage Therapeutics, Inc.
(in thousands, except share and per share data)
| June 30, 2014 | December 31, 2013 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 49,127 | $ | 8,066 | ||||
| Prepaid expenses and other current assets | 2,416 | 341 | ||||||
| Total current assets | 51,543 | 8,407 | ||||||
| Property and equipment, net | 69 | 86 | ||||||
| Restricted cash | 39 | 39 | ||||||
| Total assets | $ | 51,651 | $ | 8,532 | ||||
| Liabilities, Redeemable Convertible Preferred Stock and Stockholders Deficit | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,862 | $ | 1,988 | ||||
| Accrued expenses | 2,069 | 327 | ||||||
| Total current liabilities | 3,931 | 2,315 | ||||||
| Other liabilities: | 40 | 44 | ||||||
| Total liabilities | 3,971 | 2,359 | ||||||
| Redeemable convertible preferred stock (Series A, B and C), $0.0001 par value; 56,723,905 and 37,750,000 shares authorized at June 30, 2014 and December 31, 2013, respectively; 56,723,904 and 37,750,000 shares issued and outstanding at June 30, 2014 and December 31, 2013, respectively; liquidation preference of $96,615 and $40,663 at June 30, 2014 and December 31, 2013, respectively | 92,472 | 37,709 | ||||||
| Stockholders deficit: | ||||||||
| Common stock, $0.0001 par value; 70,623,905 and 66,000,000 shares authorized at June 30, 2014 and December 31, 2013, respectively; 1,714,248 and 1,622,761 shares issued and outstanding at June 30, 2014 and December 31, 2013, respectively | ||||||||
| Additional paid-in capital | 139 | |||||||
| Accumulated deficit | (44,792 | ) | (31,675 | ) | ||||
| Total stockholders deficit | (44,792 | ) | (31,536 | ) | ||||
| Total liabilities, redeemable convertible preferred stock and stockholders deficit | $ | 51,651 | $ | 8,532 |