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 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 August 30, 2016, announcing its financial results for the second quarter ended June 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and Exchange Commission, to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.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 August 30, 2016, announcing its financial results for the second quarter ended June 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: August 30, 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 SECOND QUARTER 2016 FINANCIAL RESULTS AND
PROVIDES CORPORATE UPDATE
· Conference Call & Webcast August 30th at 8:30 a.m. Eastern Time/5:30 a.m. Pacific Time
Tel Aviv, Israel – August 30, 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 six months ended June 30, 2016, and provided a corporate update.
Second Quarter Ended June 30, 2016 Financial Results:
| · | Total operating expenses in the second quarter 2016 were $5.9 million, compared to $5.2 million in the second quarter 2015. |
| · | Net operating expenses, excluding non-cash stock based compensation of $0.6 million, in the second quarter 2016 were $5.3 million, compared with $4.8 million in the second quarter 2015. |
| · | Research and development (R&D) expenses in the second quarter 2016 were $4.2 million, compared with $3.7 million in the second quarter 2015. R&D expenses consist primarily of costs associated with the conduct of Alcobra’s Phase III Adult ADHD clinical study named MEASURE. |
| · | General and administrative (G&A) expenses in the second quarter 2016 were $1.4 million, compared with $1.2 million in the second quarter 2015. |
| · | Cash, marketable securities, and deposits totaled $61.1 million at June 30, 2016, compared with $65.2 million at March 31, 2016 and $69.7 million at the end of 2015. |
Second Quarter and Recent Corporate Updates:
| · | Alcobra is currently enrolling subjects into the MEASURE study (MDX Evaluation in Adults – Study of Response and Efficacy). The MEASURE study is Alcobra’s second Phase III study of Metadoxine Extended Release (MDX) in 750 adults with ADHD. |
| · | 718 subjects have been screened to date in the MEASURE study, with 474 subjects already enrolled or at a post-screening visit. With a current rate of close to 150 screenings per month, Alcobra expects to complete enrollment in this study in 2016 and release data in the first quarter of 2017. |
| · | Alcobra expects to begin enrollment in the first of two registration studies with MDX in pediatric ADHD in the fourth quarter of 2016. |
| · | Alcobra is continuing discussions with the FDA on a pivotal Phase III study in adolescents and adult subjects with Fragile X Syndrome. MDX has previously shown a benefit on Daily Living Skills in a placebo-controlled Phase II study in this population. The European Commission recently granted orphan drug designation to MDX for the treatment of Fragile X. The FDA previously granted orphan drug designation and Fast Track designation to MDX for the treatment of Fragile X Syndrome. |
Conference Call & Webcast
Tuesday, August 30, 2016 @ 8:30 a.m. Eastern Time
Domestic: 855-469-0611
International: 484-756-4341
Passcode: 22966106
Webcast: http://www.alcobra-pharma.com/events.cfm
Replays available through September 13, 2016
Domestic: 855-859-2056
International: 404-537-3406
Passcode: 22966106
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 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 the enrollment of subjects to its clinical studies and expected timing of reporting results of such studies, design of future clinical studies and content of discussions with the FDA and possible positive outcomes of such discussions. 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 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 share and per share amounts)
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| (unaudited) | (unaudited) | (unaudited) | (unaudited) | |||||||||||||
| Research and development | $ | 4,182 | $ | 3,683 | $ | 7,544 | $ | 7,273 | ||||||||
| Pre commercialization expenses | 334 | 288 | 746 | 637 | ||||||||||||
| General and administrative | 1,402 | 1,202 | 2,860 | 2,491 | ||||||||||||
| Total operating expenses | 5,918 | 5,173 | 11,150 | 10,401 | ||||||||||||
| Financial income, net | (152 | ) | (64 | ) | (324 | ) | (128 | ) | ||||||||
| Loss before taxes on income | 5,766 | 5,109 | 10,826 | 10,273 | ||||||||||||
| Tax on income | 22 | 14 | 48 | 27 | ||||||||||||
| Net loss attributable to holders of Ordinary shares | 5,788 | 5,123 | 10,874 | 10,300 | ||||||||||||
| Unrealized gain on available-for-sale marketable securities | 5 | - | 5 | - | ||||||||||||
| Total comprehensive loss | $ | 5,783 | $ | 5,123 | $ | 10,869 | $ | 10,300 | ||||||||
| Net basic and diluted loss per share | $ | (0.21 | ) | $ | (0.24 | ) | $ | (0.39 | ) | $ | (0.50 | ) | ||||
| Weighted average number of Ordinary shares used in computing basic and diluted net loss per share | 27,562,795 | 21,179,233 | 27,562,517 | 20,677,364 | ||||||||||||
Alcobra Ltd.
Consolidated Balance Sheet Data
(In thousands)
ASSETS
| June 30, 2016 | December 31, 2015 | |||||||
| (Unaudited) | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 15,093 | $ | 16,658 | ||||
| Short-term bank deposits | 24,000 | 34,022 | ||||||
| Available-for-sale marketable securities | 13,989 | - | ||||||
| Prepaid expenses and other receivables | 1,276 | 1,666 | ||||||
| Total current assets | 54,358 | 52,346 | ||||||
| Long-term assets: | ||||||||
| Long-term bank deposits | 8,000 | 19,000 | ||||||
| Other long-term assets | 112 | 110 | ||||||
| Property and equipment, net | 219 | 227 | ||||||
| Total long-term assets | 8,331 | 19,337 | ||||||
| Total assets | $ | 62,689 | $ | 71,683 | ||||
LIABILITIES AND
SHAREHOLDERS’ EQUITY
| Current liabilities: | ||||||||
| Trade payables | $ | 138 | $ | 57 | ||||
| Accrued expenses and other liabilities | 2,769 | 2,295 | ||||||
| Total current liabilities | 2,907 | 2,352 | ||||||
| Shareholders’ equity: | ||||||||
| Ordinary shares | 74 | 74 | ||||||
| Additional paid-in capital | 141,594 | 140,274 | ||||||
| Accumulated other comprehensive income | 5 | - | ||||||
| Accumulated deficit | (81,891 | ) | (71,017 | ) | ||||
| Total shareholders’ equity | 59,782 | 69,331 | ||||||
| Total liabilities and shareholders’ equity | $ | 62,689 | $ | 71,683 | ||||
Alcobra Ltd.
Consolidated Cash Flow Data
(In thousands)
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| (unaudited) | (unaudited) | (unaudited) | (unaudited) | |||||||||||||
| Cash flow from operating activities: | ||||||||||||||||
| Net loss | $ | (5,788 | ) | $ | (5,123 | ) | $ | (10,874 | ) | $ | (10,300 | ) | ||||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||||||||
| Depreciation | 18 | 11 | 33 | 21 | ||||||||||||
| Amortization of premium on marketable securities | 41 | - | 41 | - | ||||||||||||
| Stock based compensation | 578 | 418 | 1,314 | 1,201 | ||||||||||||
| Loss from sale of property, and equipment | - | (1 | ) | - | (1 | ) | ||||||||||
| Change in operating assets and liabilities: | ||||||||||||||||
| Prepaid expenses and other receivables | 261 | (86 | ) | 448 | 94 | |||||||||||
| Other long-term assets | (13 | ) | 22 | (60 | ) | 10 | ||||||||||
| Trade payables | 27 | 106 | 81 | (144 | ) | |||||||||||
| Accrued expenses and other liabilities | 770 | 762 | 474 | 633 | ||||||||||||
| Net cash used in operating activities | (4,106 | ) | (3,891 | ) | (8,543 | ) | (8,486 | ) | ||||||||
| Cash flow from investing activities: | ||||||||||||||||
| Purchase of property and equipment | (2 | ) | (24 | ) | (25 | ) | (36 | ) | ||||||||
| Investment in marketable securities | (10,676 | ) | - | (14,415 | ) | - | ||||||||||
| Proceeds from maturity of marketable securities | 145 | - | 145 | - | ||||||||||||
| Proceeds from call redemption of marketable securities | 245 | - | 245 | - | ||||||||||||
| Decrease in long-term deposit | - | - | - | - | ||||||||||||
| Proceeds from (investment in) short-term bank deposit | 16,000 | 5,000 | 21,022 | (13,000 | ) | |||||||||||
| Net cash provided by (used in) investing activities | 5,712 | 4,976 | 6,972 | (13,036 | ) | |||||||||||
| Cash flow from financing activities: | ||||||||||||||||
| Issuance of share capital upon public offering, net | - | - | - | 27,903 | ||||||||||||
| Exercise of options | - | 13 | 6 | 13 | ||||||||||||
| Net cash provided by financing activities | - | 13 | 6 | 27,916 | ||||||||||||
| Increase (decrease) in cash and cash equivalents | 1,606 | 1,098 | (1,565 | ) | 6,394 | |||||||||||
| Cash and cash equivalents at the beginning of the period | 13,487 | 7,472 | 16,658 | 2,176 | ||||||||||||
| Cash and cash equivalents at the end of the period | $ | 15,093 | $ | 8,570 | $ | 15,093 | $ | 8,570 | ||||||||