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SAGE Therapeutics Reports Third Quarter 2014 Results
"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
Pipeline Updates
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Primary Efficacy and Safety Endpoints Met in Phase 1/2 Trial of SAGE-547 in Super-Refractory Status Epilepticus (SRSE): Top-line data reported from 12 patients enrolled in the trial show that all 12 patients met the primary endpoint, safety and tolerability. Of the 11 patients evaluable for efficacy, eight patients met the key efficacy endpoint of being successfully weaned off their anesthetic agents while SAGE-547 was being administered, and eight patients were successfully weaned off SAGE-547 without recurrence of SRSE. SAGE-547 was generally well tolerated and no drug-related serious adverse events, as determined by the Safety Review Committee, were reported in treated patients. SAGE is continuing to enroll patients in this trial in an expansion cohort. This expansion will include pediatric patients as young as two years old and enable increased dosing of SAGE-547
per a recently approved protocol amendment.
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Emergency-use Experience with SAGE-547 Consistent with Clinical Data: To date, seven patients have been treated with SAGE-547 by independent centers under emergency-use Investigational New Drug Applications. Five of these patients treated with SAGE-547 achieved resolution of SRSE either during the course of or soon after SAGE-547 treatment.
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Phase 2a Trial of SAGE-547 for the Treatment of Essential Tremor Initiated: SAGE recently began patient enrollment in an exploratory, single-center Phase 2a clinical trial of SAGE-547 in patients with essential tremor, a debilitating neurological disorder that causes involuntary, rhythmic shaking with no known cause. This trial is designed to evaluate the safety, tolerability, pharmacokinetics and activity of SAGE-547 in patients with essential tremor. The company plans to use data from this exploratory study to help guide the design of a second-generation molecule for the chronic treatment of this disease.
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SAGE-217 Non-clinical Data Suggest Improved Clinical Profile of Second-Generation Neuroactive Steroids: At the
Twelfth Eilat Conference on New Anti-Epileptic Drugs , SAGE presented non-clinical data on its second-generation neuroactive steroid, SAGE-217. The data suggest improved activity for SAGE-217 versus other first-generation neuroactive steroids in development, as well as favorable selectivity and pharmacokinetic profile, of the drug candidate. SAGE-217 is designed to be administered orally, in addition to intramuscular and intravenous dosing. This may make the compound suitable as a maintenance or chronic treatment for status epilepticus, as well as for other orphan genetic seizure disorders.
- SAGE-217 Advanced to be Second Development Program: Based on the non-clinical data and pharmacokinetic profile observed with SAGE-217, combined with the potential for multiple routes of administration, the company has elected to prioritize the development of SAGE-217 as its second clinical candidate. The company intends to file an IND for SAGE-217 in late 2015 and initiate Phase 1 development thereafter, which would be followed by clinical development of SAGE-689.
In addition, in September, SAGE strengthened its leadership team with the addition of Michael F. Cola to its Board of Directors.
Financial Results
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Cash Position: Cash, cash equivalents and marketable securities as of
Sept. 30, 2014 , were$136.7 million compared with$8.1 million atDec. 31, 2013 . The increase was primarily driven by net proceeds of$94.0 million from the company's initial public offering completed in July, offset by cash used to fund its operations.
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R&D Expenses: Research and development expenses were
$6.6 million in the third quarter of 2014 compared to$3.4 million in the third quarter of 2013. The increase in R&D expenses was primarily due to increased spending on clinical activities as SAGE-547 continued enrollment in its Phase 1/2 trial, increased personnel-related R&D expenses to support the advancement of SAGE's pipeline of programs, and expenses associated with the non-clinical development of SAGE-689 and SAGE-217.
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G&A Expenses: General and administrative expenses were
$2.9 million in the third quarter of 2014 compared to$1.1 million for the third quarter of 2013. The increase in G&A expenses was largely due to personnel-related costs to support the activities associated with becoming a public company.
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Net Loss: Net loss was
$9.5 million for the third quarter of 2014 compared to net loss of$4.5 million for the third quarter of 2013.
About
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
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Balance Sheets | ||
(in thousands, except share and per share data) | ||
(Unaudited) | ||
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2014 | 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), |
-- | 37,709 |
Stockholders' equity (deficit): | ||
Common stock, |
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. |
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Statements of Operations and Comprehensive Loss | ||||
(in thousands, except share and per share data) | ||||
(Unaudited) | ||||
Three Months Ended |
Nine Months Ended |
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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. |
CONTACT: Media Contact:Source:Dan Budwick ,Pure Communications dan@purecommunicationsinc.com 973-271-6085 Investor Contact:Monique Allaire Lyons ,Pure Communications monique@purecommunicationsinc.com 781-631-0759
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