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: August 2015
Commission file number: 001-35932
ALCOBRA LTD.
(Translation of registrant's name into English)
Amot Investment Building
2 Weizman St. 9th Floor
Tel Aviv 6423902 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 August 13, 2015, announcing its financial results for the second quarter ended June 30, 2015.
The GAAP financial statements in the press release attached to this Form 6-K of the Registrant are incorporated by reference into the Registration Statements on Form F-3 (File No. 333-197411) and Form S-8 (File No. 333-194875) 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and Exchange Commission, to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.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 August 13, 2015, announcing its financial results for the second quarter ended June 30, 2015. |
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.
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Alcobra Ltd.
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| Name: Dr. Yaron Daniely | ||
| Chief Executive Officer and President |
Date: August 13, 2015
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 | 773-463-4211 | +972-72 2204661 |
| mrice@lifesciadvisors.com | mikebeyer@sambrown.com | debbie@alcobra-pharma.com |
ALCOBRA ANNOUNCES SECOND QUARTER 2015 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE
| · | Conference Call & Webcast today at 8:30 a.m. Eastern Time/5:30 a.m. Pacific Time |
Tel Aviv, Israel – August 13, 2015 – Alcobra Ltd. (NasdaqGM: ADHD), an emerging pharmaceutical company focused on the development of new medications to help patients with cognitive disorders, including Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome, today announced financial results for the three and six months ended June 30, 2015, and provided a corporate update.
Second Quarter Ended June 30, 2015 Financial Results:
| · | Total operating expenses were $5.2 million, similar to the first quarter of 2015, compared with $7.8 million in the second quarter of 2014. Operating expenses included non-cash stock based compensation of $0.4 million in the second quarter of 2015 and $0.9 million in the same quarter of 2014. |
| · | Research and development (R&D) expenses were $3.7 million, compared with $5.9 million in the second quarter of 2014. R&D expenses in the second quarter of 2015 consisted primarily of costs associated with the completion of the Phase II Fragile X study and the initiation of the Phase III pivotal study in adult ADHD. |
| · | General and administrative (G&A) expenses were $1.2 million in the second quarter of 2015, compared with $1.3 million in the same quarter of 2014. Pre-commercialization expenses were $0.3 million, compared with $0.6 million in the second quarter of 2014. |
| · | Cash, cash equivalents and bank deposits totaled $41.1 million at June 30, 2015, compared with $45.0 million at March 31, 2015. Net cash used in operating activities was $3.9 million in the second quarter of 2015, compared with $5.5 million in the second quarter of 2014. In future periods, we expect our cash used in operating activities to increase, as we continue to advance our adult ADHD phase III pivotal study. |
Second Quarter and Recent Corporate Updates:
| · | The company began patient enrollment in the MEASURE study (MDX Evaluation in Adults – StUdy of Response and Efficacy). The MEASURE study is Alcobra’s second, pivotal Phase III study of MDX in adults with ADHD. The study includes design and operational elements to mitigate placebo response and reduce response variability. |
| · | On June 24, 2015, the company reported that its Phase II exploratory study of MDX in adolescent and adult patients with Fragile X Syndrome did not achieve statistical significance on the primary endpoint, yet demonstrated significant improvements in certain clinically meaningful behavioral and cognitive endpoints. Alcobra plans to discuss these trial results with the U.S. Food and Drug Administration (FDA) later in 2015. |
| · | The company announced the election of Dr. Joao Siffert to its Board of Directors. Dr. Siffert currently serves as the Executive Vice President of Research and Development and Chief Medical Officer of Avanir Pharmaceuticals Inc. (a subsidiary of Otsuka Pharmaceutical Co. Ltd.). |
| · | The company believes that it has sufficient capital to fund the company’s activities through 2016, including the completion of the MEASURE study. |
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Conference Call & Webcast
Thursday, August 13 @ 8:30am Eastern Time/5:30am Pacific Time
Domestic: 855-469-0611
International: 484-756-4341
Passcode: 82123051
Webcast: http://www.alcobra-pharma.com/indexInvestor.cfm
Replays available through August 27, 2015
Domestic: 855-859-2056
International: 404-537-3406
Passcode: 82123051
About Alcobra Ltd.
Alcobra Ltd. is an emerging pharmaceutical company primarily focused on the development and commercialization of a proprietary drug candidate, MDX, 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 contains 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 Alcobra’s ability to better design clinical studies and reduce high placebo response and response variability, the content and timing of future discussions with the FDA and statements regarding future use of cash and the sufficiency of the company's financial resources. In addition, historic results of scientific research do not guarantee that the conclusions of future research would not suggest different conclusions or that historic results referred to in this press release would not be interpreted differently in light of additional research or otherwise. Also, while the FDA has indicated to Alcobra that positive efficacy results from certain clinical studies may be sufficient to demonstrate efficacy for approval of MDX, the FDA is not bound by these communications and accordingly may change its position in the future due to reasons within or outside the control of Alcobra. 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, 2014, 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 hereof, whether as a result of new information, future events or circumstances or otherwise.
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Alcobra Pharma Ltd.
Consolidated Statements of Operation
(In thousands, except per share amounts)
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||||||
| (unaudited) | (unaudited) | (unaudited) | (unaudited) | |||||||||||||
| Research and development | $ | 3,683 | $ | 5,918 | $ | 7,273 | $ | 11,440 | ||||||||
| Pre commercialization expenses | 288 | 565 | 637 | 1,089 | ||||||||||||
| General and administrative | 1,202 | 1,348 | 2,491 | 3,137 | ||||||||||||
| Total operating expenses | 5,173 | 7,831 | 10,401 | 15,666 | ||||||||||||
| Financial income, net | (64 | ) | (57 | ) | (128 | ) | (135 | ) | ||||||||
| Loss before taxes on income | 5,109 | 7,774 | 10,273 | 15,531 | ||||||||||||
| Tax on income | 14 | 6 | 27 | 15 | ||||||||||||
| Net loss attributable to holders of Ordinary shares | $ | 5,123 | $ | 7,780 | $ | 10,300 | $ | 15,546 | ||||||||
| Net basic and diluted loss per share | $ | (0.24 | ) | $ | (0.57 | ) | $ | (0.50 | ) | $ | (1.14 | ) | ||||
| Weighted average number of Ordinary shares used in computing basic and diluted net loss per share | 21,179,233 | 13,662,146 | 20,677,364 | 13,649,427 | ||||||||||||
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Alcobra Pharma Ltd.
Consolidated Balance Sheets
(In thousands)
ASSETS
| June 30, | December 31, | |||||||
| 2015 | 2014 | |||||||
| (unaudited) | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 8,570 | $ | 2,176 | ||||
| Short-term bank deposits | 32,523 | 19,522 | ||||||
| Prepaid expenses and other current assets | 334 | 428 | ||||||
| Total current assets | 41,427 | 22,126 | ||||||
| Long-term assets: | ||||||||
| Other long-term assets | 85 | 95 | ||||||
| Property and equipment, net | 112 | 97 | ||||||
| Total long-term assets | 197 | 192 | ||||||
| Total assets | $ | 41,624 | $ | 22,318 | ||||
LIABILITIES AND
SHAREHOLDERS’ EQUITY
| Current liabilities: | ||||||||
| Trade payables | $ | 161 | $ | 305 | ||||
| Accrued expenses and other liabilities | 2,703 | 2,070 | ||||||
| Total current liabilities | 2,864 | 2,375 | ||||||
| Shareholders’ equity: | ||||||||
| Ordinary shares | 58 | 39 | ||||||
| Additional paid-in capital | 100,570 | 71,472 | ||||||
| Accumulated deficit | (61,868 | ) | (51,568 | ) | ||||
| Total shareholders’ equity | 38,760 | 19,943 | ||||||
| Total liabilities and shareholders’ equity | $ | 41,624 | $ | 22,318 |
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Alcobra Pharma Ltd.
Consolidated Cash Flows
(In thousands)
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||||||
| (unaudited) | (unaudited) | (unaudited) | (unaudited) | |||||||||||||
| Cash flow from operating activities: | ||||||||||||||||
| Net loss | $ | (5,123 | ) | $ | (7,780 | ) | $ | (10,300 | ) | $ | (15,546 | ) | ||||
| Adjustments to reconcile net income to net cash used in operating activities: | ||||||||||||||||
| Depreciation | 11 | 8 | 21 | 14 | ||||||||||||
| Stock based compensation | 418 | 941 | 1,201 | 2,276 | ||||||||||||
| Loss from sale of property, and equipment | (1 | ) | - | (1 | ) | - | ||||||||||
| Change in operating assets and liabilities: | ||||||||||||||||
| Prepaid expenses and other current assets | (86 | ) | (31 | ) | 94 | (907 | ) | |||||||||
| Other long-term assets | 22 | (13 | ) | 10 | (50 | ) | ||||||||||
| Trade payables | 106 | 48 | (144 | ) | 1,410 | |||||||||||
| Accrued expenses and other liabilities | 762 | 1,359 | 633 | 1,707 | ||||||||||||
| Net cash used in operating activities | (3,891 | ) | (5,468 | ) | (8,486 | ) | (11,096 | ) | ||||||||
| Cash flow from investing activities: | ||||||||||||||||
| Purchase of property and equipment | (24 | ) | (20 | ) | (36 | ) | (70 | ) | ||||||||
| Decrease in long-term deposit | 13,000 | - | - | - | ||||||||||||
| Proceeds from (investment in) short-term bank deposit | (8,000 | ) | 2,008 | (13,000 | ) | (4,017 | ) | |||||||||
| Net cash provided by (used in) investing activities | 4,976 | 1,988 | (13,036 | ) | (4,087 | ) | ||||||||||
| Cash flow from financing activities: | ||||||||||||||||
| Issuance of share capital upon public offering, net | - | - | 27,903 | - | ||||||||||||
| Exercise of options | 13 | - | 13 | - | ||||||||||||
| Net cash provided by financing activities | 13 | - | 27,916 | - | ||||||||||||
| Increase (decrease) in cash and cash equivalents | 1,098 | (3,480 | ) | 6,394 | (15,183 | ) | ||||||||||
| Cash and cash equivalents at the beginning of the period | 7,472 | 10,392 | 2,176 | 22,095 | ||||||||||||
| Cash and cash equivalents at the end of the period | $ | 8,570 | $ | 6,912 | $ | 8,570 | $ | 6,912 | ||||||||
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