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: February 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 February 17, 2016, announcing its financial results for the fourth quarter ended December 31, 2015.
The GAAP financial statements in this Form 6-K of the registrant are incorporated by reference into the Registration Statements on Form F-3 (File No. 333-197411) and Forms S-8 (File No. 333-194875 and File No. 333-202394) 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and Exchange Commission, to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.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 February 17, 2016, announcing its financial results for the fourth quarter ended December 31, 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.
| Alcobra Ltd. | ||
| (Registrant) | ||
| By | /s/ Dr. Yaron Daniely | |
| Name: Dr. Yaron Daniely | ||
| Chief Executive Officer and President | ||
Date: February 17, 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 | 773-463-4211 | +972-72 2204661 |
| mrice@lifesciadvisors.com | mikebeyer@sambrown.com | debbie@alcobra-pharma.com |
ALCOBRA ANNOUNCES FOURTH QUARTER AND
FISCAL 2015 FINANCIAL
RESULTS AND PROVIDES CORPORATE UPDATE
| · | Conference Call & Webcast February 17th at 8:30 a.m. Eastern Time/5:30 a.m. Pacific Time |
Tel Aviv, Israel – February 17, 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 (Fragile X), today announced financial results for the three and twelve months ended December 31, 2015, and provided a corporate update.
Fourth Quarter and Fiscal Year Ended December 31, 2015 Financial Results:
| · | Total operating expenses in the fourth quarter and fiscal year 2015 were $5.0 million and $19.7 million, respectively, compared with $6.8 million and $33.1 million in the fourth quarter and fiscal year 2014. |
| · | Net operating expenses, excluding non-cash stock based compensation of $0.6 million and $2.4 million, respectively, in the fourth quarter and fiscal year 2015 were $4.4 million and $17.3 million, respectively, compared with $6.0 million and $29.0 million in the fourth quarter and fiscal year 2014. |
| · | Research and development (R&D) expenses in the fourth quarter and fiscal year 2015 were $3.3 million and $13.5 million, respectively, compared with $4.9 million and $25.1 million in the fourth quarter and fiscal year 2014. R&D expenses consist primarily of costs associated with the conduct of our clinical studies. |
| · | General and administrative (G&A) expenses in the fourth quarter and fiscal year 2015 were $1.3 million and $5.0 million, respectively, compared with $1.4 million and $5.8 million in the fourth quarter and fiscal year 2014. Pre-commercialization expenses in the fourth quarter and fiscal year 2015 were $0.3 million and $1.2 million, respectively, compared with $0.5 million and $2.1 million in the fourth quarter and fiscal year 2014. |
| · | Cash, cash equivalents and short-term and long-term deposits totaled $69.7 million at December 31, 2015, compared with $35.5 million at September 30, 2015 and $21.7 million at December 31, 2014. |
Fourth Quarter and Recent Corporate Updates:
| · | On November 13, 2015, Alcobra completed a public equity financing with net proceeds of $38.6 million. The financing was led by healthcare-dedicated institutional investors, and provides the company with sufficient capital to execute its development programs through the end of 2017. |
| · | The company is currently enrolling patients into the MEASURE study (MDX Evaluation in Adults – Study of Response and Efficacy). The MEASURE study is the company’s second Phase III study of Metadoxine Extended Release (MDX) in adults with ADHD. The study includes design and operational elements to potentially mitigate a placebo response and reduce response variability. Based on trends in recent enrollment rates, the company now expects data from the study by year end 2016. |
| · | The company is preparing to launch the first of two registration studies with MDX in children with ADHD. This multi-center, Phase II, short-term efficacy study will be placebo-controlled. |
| · | The company is completing analyses and plans for a Phase III study in adolescents and adult patients with Fragile X, following the November 2015 meeting with the U.S. Food and Drug Administration (FDA). The FDA has previously granted an orphan drug designation and Fast Track designation to MDX for the treatment of Fragile X. |
| · | Dr. Tomer Berkovitz, Alcobra’s Chief Financial Officer since May 2014, was appointed to the additional position of Chief Operating Officer, effective January 1, 2016. |
Conference Call & Webcast
Wednesday, February 17, 2016 at 8:30 a.m. Eastern
| Domestic: | 855-469-0611 |
| International: | 484-756-4341 |
| Passcode: | 34475008 |
| Webcast: | http://www.alcobra-pharma.com/events.cfm |
| Replays available through March 2, 2016 | |
| Domestic: | 855-859-2056 |
| International: | 404-537-3406 |
| Passcode: | 34475008 |
About Alcobra Ltd.
Alcobra Ltd. is an emerging pharmaceutical company primarily focused on the development and commercialization of MDX, a proprietary drug candidate, to treat cognitive disorders including ADHD and Fragile X. 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 sufficiency of capital resources, the timing of launching and reporting results of clinical studies, design of future clinical studies and Alcobra’s ability to better design clinical studies and reduce high placebo response and response variability. 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 Alcobra has received Fast Track designation for MDX for the treatment of Fragile X, 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, 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 they were made, whether as a result of new information, future events or circumstances or otherwise.
Alcobra Pharma Ltd.
Consolidated Statements of Operation
(In thousands, except share and per share amounts)
| Three Months Ended | Year Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||||||
| Research and development | $ | 3,335 | $ | 4,908 | $ | 13,461 | $ | 25,105 | ||||||||
| Pre commercialization expenses | 314 | 483 | 1,245 | 2,134 | ||||||||||||
| General and administrative | 1,325 | 1,436 | 4,992 | 5,839 | ||||||||||||
| Total operating expenses | 4,974 | 6,827 | 19,698 | 33,078 | ||||||||||||
| Financial income, net | (104 | ) | (33 | ) | (300 | ) | (227 | ) | ||||||||
| Loss before taxes on income | 4,870 | 6,794 | 19,398 | 32,851 | ||||||||||||
| Tax on income | 17 | 8 | 51 | (17 | ) | |||||||||||
| Net loss attributable to holders of Ordinary shares | $ | 4,887 | $ | 6,802 | $ | 19,449 | $ | 32,834 | ||||||||
| Net basic and diluted loss per share | (0.20 | ) | $ | (0.50 | ) | (0.90 | ) | $ | (2.40 | ) | ||||||
| Weighted average number of Ordinary shares used in computing basic and diluted net loss per share | 24,136,669 | 13,702,440 | 21,638,207 | 13,674,818 | ||||||||||||
Alcobra Pharma Ltd.
Consolidated Balance Sheet Data
(In thousands)
ASSETS
| December 31, | ||||||||
| 2015 | 2014 | |||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 16,658 | $ | 2,176 | ||||
| Short-term bank deposits | 34,022 | 19,522 | ||||||
| Prepaid expenses and other current assets | 1,666 | 428 | ||||||
| Total current assets | 52,346 | 22,126 | ||||||
| Long-term assets: | ||||||||
| Long term bank deposits | 19,000 | - | ||||||
| Other long-term assets | 110 | 95 | ||||||
| Property and equipment, net | 227 | 97 | ||||||
| Total long-term assets | 19,337 | 192 | ||||||
| Total assets | $ | 71,683 | $ | 22,318 | ||||
LIABILITIES AND
SHAREHOLDERS’ EQUITY
| Current liabilities: | ||||||||
| Trade payables | $ | 57 | $ | 305 | ||||
| Accrued expenses and other liabilities | 2,295 | 2,070 | ||||||
| Total current liabilities | 2,352 | 2,375 | ||||||
| Shareholders’ equity: | ||||||||
| Ordinary shares | 74 | 39 | ||||||
| Additional paid-in capital | 140,274 | 71,472 | ||||||
| Accumulated deficit | (71,017 | ) | (51,568 | ) | ||||
| Total shareholders’ equity | 69,331 | 19,943 | ||||||
| Total liabilities and shareholders’ equity | $ | 71,683 | $ | 22,318 |
Alcobra Pharma Ltd.
Consolidated Cash Flow Data
(In thousands)
| Three Months Ended | Year Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||||||
| Cash flow from operating activities: | ||||||||||||||||
| Net loss | $ | (4,887 | ) | $ | (6,802 | ) | $ | (19,449 | ) | $ | (32,834 | ) | ||||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||||||||
| Depreciation | 12 | 10 | 51 | 31 | ||||||||||||
| Stock based compensation | 579 | 787 | 2,365 | 4,089 | ||||||||||||
| Change in operating assets and liabilities: | ||||||||||||||||
| Prepaid expenses and other current assets | 205 | 786 | (1,077 | ) | (313 | ) | ||||||||||
| Other long-term assets | (23 | ) | 9 | (15 | ) | (38 | ) | |||||||||
| Trade payables | (470 | ) | (1,227 | ) | (248 | ) | 258 | |||||||||
| Accrued expenses and other liabilities | 305 | (1,303 | ) | 225 | 481 | |||||||||||
| Net cash used in operating activities | (4,279 | ) | (7,740 | ) | (18,148 | ) | (28,326 | ) | ||||||||
| Cash flow from investing activities: | ||||||||||||||||
| Purchase of property and equipment, net | (89 | ) | - | (181 | ) | (79 | ) | |||||||||
| Proceeds from (investment in) short-term bank deposit, net | (8,485 | ) | 7,202 | (14,500 | ) | 8,486 | ||||||||||
| Investment in long-term bank deposit | (19,000 | ) | - | (19,000 | ) | - | ||||||||||
| Change in restricted cash | (15 | ) | - | (161 | ) | - | ||||||||||
| Net cash provided by (used in) investing activities | (27,589 | ) | 7,202 | (33,842 | ) | 8,407 | ||||||||||
| Cash flow from financing activities: | ||||||||||||||||
| Issuance of shares upon public offering, net | 38,556 | - | 66,459 | - | ||||||||||||
| Exercise of options | - | - | 13 | - | ||||||||||||
| Net cash provided by financing activities | 38,556 | - | 66,472 | - | ||||||||||||
| Increase (decrease) in cash and cash equivalents | 6,688 | (538 | ) | 14,482 | (19,919 | ) | ||||||||||
| Cash and cash equivalents at the beginning of the period | 9,970 | 2,714 | 2,176 | 22,095 | ||||||||||||
| Cash and cash equivalents at the end of the period | $ | 16,658 | $ | 2,176 | $ | 16,658 | $ | 2,176 | ||||||||
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