UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
under the Securities Exchange Act of 1934
For the month of: November 2016
Commission file number: 001-35932
ALCOBRA LTD.
(Translation of registrant's name into English)
Azrieli Triangle Building
132 Derech Menachem Begin 39th Floor
Tel Aviv 6701101 Israel
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F x Form 40-F ¨
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulations S-T Rule 101(b)(1):_____
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulations S-T Rule 101(b)(7):_____
Attached hereto and incorporated by reference herein is the registrant's press release issued on November 15, 2016, announcing its financial results for the third quarter ended September 30, 2016.
The GAAP financial statements in this Form 6-K of the registrant are incorporated by reference into the Registration Statement on Forms F-3 (File No. 333-209960) and Forms S-8 (File Nos. 333-194875, 333-202394 and 333-209947) of the registrant, filed with the Securities and Exchange Commission, to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.
Exhibit No.
| 99.1 | Press release issued by Alcobra Ltd. on November 15, 2016, announcing its financial results for the third quarter ended September 30, 2016. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| Alcobra Ltd. | |||
| (Registrant) | |||
| By: | /s/ Dr. Tomer Berkovitz | ||
| Name: | Dr. Tomer Berkovitz | ||
| Chief Financial Officer and Chief Operating Officer | |||
Date: November 15, 2016
Exhibit 99.1
| U.S. Investor Contacts | Media Inquiries | Israel Investor Contact: | ||
| LifeSci Advisors, LLC | Sam Brown, Inc. | Alcobra Investor Relations | ||
| Michael Rice | Mike Beyer | Debbie Kaye | ||
| 646-597-6979 | 312-961-2502 | +972-72 2204661 | ||
| mrice@lifesciadvisors.com | mikebeyer@sambrown.com | debbie@alcobra-pharma.com |
ALCOBRA ANNOUNCES THIRD QUARTER 2016 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE
| · | Conference Call & Webcast November 15th at 8:30 a.m. Eastern Time/5:30 a.m. Pacific Time |
Tel Aviv, Israel – November 15, 2016 – Alcobra Ltd. (NasdaqGM: ADHD), an emerging pharmaceutical company focused on the development of new medications to treat patients with cognitive disorders, including Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome, today announced financial results for the three and nine months ended September 30, 2016, and provided a corporate update.&&&
Third Quarter Ended September 30, 2016 Financial Results:
| · | Total operating expenses in the third quarter 2016 were $7.9 million, compared to $4.3 million in the third quarter 2015. |
| · | Net operating expenses, excluding non-cash stock based compensation of $0.6 million, in the third quarter 2016 were $7.3 million, compared with $3.7 million in the third quarter 2015. |
| · | Research and development (R&D) expenses in the third quarter 2016 were $6.4 million, compared with $2.9 million in the third quarter 2015. R&D expenses consisted primarily of costs associated with the conduct of our Phase III Adult ADHD clinical study named MEASURE. |
| · | General and administrative (G&A) expenses in the third quarter 2016 were $1.2 million, similar to the third quarter 2015. |
| · | Cash, marketable securities, and deposits totaled $54.3 million at September 30, 2016 compared with $61.1 million at June 30, 2016 and $69.7 million at the end of 2015. |
Third Quarter and Recent Corporate Updates:
| · | Alcobra paused enrollment and treatment in its MEASURE study following the placement of a full clinical hold by the Division of Psychiatry Products (DPP) of the U.S. Food and Drug Administration. The DPP stated concerns over adverse neurophysiological findings in animal studies and recommended the scheduling of a meeting to discuss human safety data collection in the MDX development program. The DPP did not cite any clinical safety data observed in the MEASURE study or previous clinical studies involving MDX as the basis for their action. |
| · | Alcobra will hold a meeting with the DPP next month to present its proposals to collect additional safety data in its previously planned long-term clinical safety study as well as the MEASURE study. |
| · | Alcobra will also seek guidance on the possibility of conducting certain analyses of the efficacy data already collected in the MEASURE study. The number of evaluable subjects (n=281) in the MEASURE dataset is comparable to other Phase III adult ADHD studies with approved medications. |
Conference Call & Webcast
Tuesday, November 15, 2016 @ 8:30a.m. Eastern Time
| Domestic: | 855-469-0611 | |
| International: | 484-756-4341 | |
| Passcode: | 9001229 | |
| Webcast: | http://www.alcobra-pharma.com/events.cfm | |
| Replays available through November 29, 2016 | ||
| Domestic: | 855-859-2056 | |
| International: | 404-537-3406 | |
| Passcode: | 9001229 | |
About Alcobra Ltd.
Alcobra Ltd. is an emerging pharmaceutical company primarily focused on the development and commercialization of MDX (Metadoxine Extended Release), a proprietary drug candidate to treat cognitive disorders including ADHD and Fragile X Syndrome. For more information, please visit the Company's website, www.alcobra-pharma.com, the content of which is not incorporated herein by reference.
Forward Looking Statements
This press release as well as the content of the Alcobra conference call scheduled for today contain forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Because such statements deal with future events and are based on Alcobra's current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Alcobra could differ materially from those described in or implied by the statements in this press release. For example, forward-looking statements include statements regarding the MEASURE study, the removal of any safety concerns and any basis thereto, the potential clinical benefit of MDX, expected expenses and sufficiency of capital resources, timing and design of future preclinical and clinical studies and content and timing of discussions with the U.S. Food and Drug Administration and possible positive outcomes of such discussions. In addition, historic results of scientific research do not guarantee that the conclusions of future research would suggest similar conclusions or that historic results referred to in this press release would be interpreted similarly in light of additional research or otherwise. Also, while Alcobra has received Fast Track designation for MDX for the treatment of Fragile X Syndrome, the company cannot guarantee that it will be able to maintain such designation due to reasons within or outside of its control. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading "Risk Factors" in Alcobra Ltd.'s Annual Report on Form 20-F for the fiscal year ended December 31, 2015, filed with the Securities and Exchange Commission (SEC) and in subsequent filings with the SEC. Except as otherwise required by law, Alcobra disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.
Alcobra Ltd.
Consolidated Statements of Comprehensive Loss
(In thousands, except per share amounts)
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| (unaudited) | (unaudited) | (unaudited) | (unaudited) | |||||||||||||
| Research and development | $ | 6,400 | $ | 2,853 | $ | 13,944 | $ | 10,126 | ||||||||
| Pre commercialization expenses | 313 | 294 | 1,059 | 931 | ||||||||||||
| General and administrative | 1,211 | 1,176 | 4,071 | 3,667 | ||||||||||||
| Total operating expenses | 7,924 | 4,323 | 19,074 | 14,724 | ||||||||||||
| Financial income, net | (137 | ) | (68 | ) | (461 | ) | (196 | ) | ||||||||
| Loss before taxes on income | 7,787 | 4,255 | 18,613 | 14,528 | ||||||||||||
| Tax on income | 15 | 7 | 63 | 34 | ||||||||||||
| Net loss attributable to holders of Ordinary shares | $ | 7,802 | $ | 4,262 | $ | 18,676 | $ | 14,562 | ||||||||
| Unrealized loss on available-for-sale marketable securities | (8 | ) | - | (3 | ) | - | ||||||||||
| Total comprehensive loss | $ | 7,810 | $ | 4,262 | $ | 18,679 | $ | 14,562 | ||||||||
| Net basic and diluted loss per share | $ | (0.28 | ) | $ | (0.20 | ) | $ | (0.68 | ) | $ | (0.70 | ) | ||||
| Weighted average number of Ordinary shares used in computing basic and diluted net loss per share | 27,562,795 | 21,181,722 | 27,562,610 | 20,796,235 | ||||||||||||
Alcobra Ltd.
Consolidated Balance Sheet Data
(In thousands)
ASSETS
| September 30, 2016 | December 31, 2015 | |||||||
| (Unaudited) | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 4,375 | $ | 16,658 | ||||
| Short-term bank deposits | 32,000 | 34,022 | ||||||
| Available-for-sale marketable securities | 14,972 | - | ||||||
| Prepaid expenses and other receivables | 1,279 | 1,666 | ||||||
| Total current assets | 52,626 | 52,346 | ||||||
| Long-term assets: | ||||||||
| Long-term bank deposits | 3,000 | 19,000 | ||||||
| Other long-term assets | 74 | 110 | ||||||
| Property and equipment, net | 212 | 227 | ||||||
| Total long-term assets | 3,286 | 19,337 | ||||||
| Total assets | $ | 55,912 | $ | 71,683 | ||||
LIABILITIES AND
SHAREHOLDERS’ EQUITY
| Current liabilities: | ||||||||
| Trade payables | $ | 152 | $ | 57 | ||||
| Accrued expenses and other liabilities | 3,143 | 2,295 | ||||||
| Total current liabilities | 3,295 | 2,352 | ||||||
| Shareholders’ equity: | ||||||||
| Ordinary shares | 74 | 74 | ||||||
| Additional paid-in capital | 142,239 | 140,274 | ||||||
| Accumulated other comprehensive loss | (3 | ) | - | |||||
| Accumulated deficit | (89,693 | ) | (71,017 | ) | ||||
| Total shareholders’ equity | 52,617 | 69,331 | ||||||
| Total liabilities and shareholders’ equity | $ | 55,912 | $ | 71,683 | ||||
Alcobra Ltd.
Consolidated Cash Flow Data
(In thousands)
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| (unaudited) | (unaudited) | (unaudited) | (unaudited) | |||||||||||||
| Cash flow from operating activities: | ||||||||||||||||
| Net loss | $ | (7,802 | ) | $ | (4,262 | ) | $ | (18,676 | ) | $ | (14,562 | ) | ||||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||||||||
| Depreciation | 14 | 16 | 47 | 37 | ||||||||||||
| Amortization of premium on marketable securities | 45 | - | 86 | - | ||||||||||||
| Stock-based compensation | 645 | 585 | 1,959 | 1,786 | ||||||||||||
| Loss from sale of property and equipment | - | 3 | - | 2 | ||||||||||||
| Change in operating assets and liabilities: | ||||||||||||||||
| Prepaid expenses and other receivables | (3 | ) | (1,376 | ) | 445 | (1,282 | ) | |||||||||
| Other long-term assets | 38 | (2 | ) | (22 | ) | 8 | ||||||||||
| Trade payables | 14 | 366 | 95 | 222 | ||||||||||||
| Accrued expenses and other liabilities | 374 | (713 | ) | 848 | (80 | ) | ||||||||||
| Net cash used in operating activities | (6,675 | ) | (5,383 | ) | (15,218 | ) | (13,869 | ) | ||||||||
| Cash flow from investing activities: | ||||||||||||||||
| Purchase of property and equipment, net | (7 | ) | (56 | ) | (32 | ) | (92 | ) | ||||||||
| Change in restricted cash | - | (146 | ) | - | (146 | ) | ||||||||||
| Investment in marketable securities | (1,912 | ) | - | (16,327 | ) | - | ||||||||||
| Proceeds from maturity of marketable securities | 876 | 1,021 | ||||||||||||||
| Proceeds from call redemption of marketable securities | - | 245 | ||||||||||||||
| Proceeds from (investment in) short-term bank deposit | (3,000 | ) | 6,985 | 18,022 | (6,015 | ) | ||||||||||
| Net cash provided by (used in) investing activities | (4,043 | ) | 6,783 | 2,929 | (6,253 | ) | ||||||||||
| Cash flow from financing activities: | ||||||||||||||||
| Issuance of share capital upon public offering, net | - | - | - | 27,903 | ||||||||||||
| Exercise of options | - | - | 6 | 13 | ||||||||||||
| Net cash provided by financing activities | - | - | 6 | 27,916 | ||||||||||||
| Increase (decrease) in cash and cash equivalents | (10,718 | ) | 1,400 | (12,283 | ) | 7,794 | ||||||||||
| Cash and cash equivalents at the beginning of the period | 15,093 | 8,570 | 16,658 | 2,176 | ||||||||||||
| Cash and cash equivalents at the end of the period | 4,375 | 9,970 | 4,375 | 9,970 | ||||||||||||
| Non-cash transactions: | ||||||||||||||||
| Purchase of property and equipment | - | 47 | - | 47 | ||||||||||||