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 2015 (Report No. 2)
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 12, 2015, announcing its financial results for the third quarter ended September 30, 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and Exchange Commission, to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.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
| 99.1 | Press release issued by Alcobra Ltd. on November 12, 2015, announcing its financial results for the third quarter ended September 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.
| Alcobra Ltd. | ||
| (Registrant) | ||
| By | /s/ Dr. Yaron Daniely | |
| Name: Dr. Yaron Daniely | ||
| Chief Executive Officer and President | ||
Date: November 12, 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+972-72 2204661 |
| 646-597-6979 | 773-463-4211 | |
| mrice@lifesciadvisors.com | mikebeyer@sambrown.com | debbie@alcobra-pharma.com |
ALCOBRA ANNOUNCES THIRD QUARTER 2015 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE
| · | Conference Call & Webcast November 17th at 8:30 a.m. Eastern Time/5:30 a.m. Pacific Time |
| · | The company provides an update on its Fragile X Syndrome development program |
Tel Aviv, Israel – November 12, 2015 – 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 nine months ended September 30, 2015, and provided a corporate update.
Third Quarter Ended September 30, 2015 Financial Results:
| · | Total operating expenses were $4.3 million, compared with $5.2 million in the second quarter of 2015 and $10.6 million in the third quarter of 2014. Operating expenses included non-cash stock based compensation of $0.6 million in the third quarter of 2015 and $1.0 million in the same quarter of 2014. |
| · | Research and development (R&D) expenses were $2.9 million, compared with $8.8 million in the third quarter of 2014. R&D expenses in the third quarter of 2015 consisted primarily of costs associated with the Phase III pivotal study in adult ADHD. |
| · | General and administrative (G&A) expenses were $1.2 million in the third 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 third quarter of 2014. |
| · | Cash, cash equivalents and bank deposits totaled $35.5 million at September 30, 2015, compared with $41.1 million at June 30, 2015. Net cash used in operating activities was $5.4 million in the third quarter of 2015, compared with $9.5 million in the third quarter of 2014. |
Third Quarter and Recent Corporate Updates:
| · | In October 2015, the company held a meeting with the U.S. Food and Drug Administration (FDA) to discuss the results of the company’s Phase II study in Fragile X and the requirements for new drug application (NDA) submission of MDX in this therapeutic indication. |
| · | The FDA concurred that results from a single short-term, adequate and well-controlled, efficacy study in adolescents and adult patients with Fragile X may be sufficient to support a claim of efficacy for approval of MDX in this indication. The FDA further confirmed that the Vineland-II Daily Living Skills Assessment, which was statistically significant in Alcobra’s Phase II study on the intent-to-treat population, could serve as the primary endpoint in the pivotal trial. The study is scheduled to begin in 2016. |
| · | The company announced that the FDA has granted Fast Track designation to MDX for the treatment of Fragile X on September 21, 2015. |
| · | In the second quarter of 2015, we launched the MEASURE study (MDX Evaluation in Adults – StUdy of Response and Efficacy). The MEASURE study is our second Phase 3 study of MDX in adults with ADHD. The study includes design and operational elements to potentially mitigate placebo response and reduce response variability. Data from the study is expected mid-2016. |
| · | The company expects to launch the first of two adequate, well-controlled, short-term efficacy studies in children with ADHD in 2016 after receiving comments from the FDA on its Pediatric Study Plan for the indication of ADHD. The study will be a multi-center, Phase II, placebo-controlled, short-term efficacy study. |
Conference Call & Webcast
Tuesday, November 17 @ 8:30a.m. Eastern Time/5:30a.m. Pacific Time
| Domestic: | 855-469-0611 |
| International: | 484-756-4341 |
| Passcode: | 56489875 |
| Webcast: | http://www.alcobra-pharma.com/events.cfm |
| Replays available through December 1, 2015 | |
| Domestic: | 855-859-2056 |
| International: | 404-537-3406 |
| Passcode: | 56489875 |
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 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, initiating future clinical studies and the content and timing of future discussions with the FDA. 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 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 | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||||||
| (unaudited) | (unaudited) | (unaudited) | (unaudited) | |||||||||||||
| Research and development | $ | 2,853 | $ | 8,757 | $ | 10,126 | $ | 20,197 | ||||||||
| Pre-commercialization expenses | 294 | 562 | 931 | 1,651 | ||||||||||||
| General and administrative | 1,176 | 1,266 | 3,667 | 4,403 | ||||||||||||
| Total operating expenses | 4,323 | 10,585 | 14,724 | 26,251 | ||||||||||||
| Financial income, net | (68 | ) | (59 | ) | (196 | ) | (194 | ) | ||||||||
| Loss before taxes on income | 4,255 | 10,526 | 14,528 | 26,057 | ||||||||||||
| Tax on income | 7 | (40 | ) | 34 | (25 | ) | ||||||||||
| Net loss attributable to holders of Ordinary shares | $ | 4,262 | $ | 10,486 | $ | 14,562 | $ | 26,032 | ||||||||
| Net basic and diluted loss per share | $ | (0.20 | ) | $ | (0.77 | ) | $ | (0.70 | ) | $ | (1.90 | ) | ||||
| Weighted average number of Ordinary shares used in computing basic and diluted net loss per share | 21,181,722 | 13,696,525 | 20,796,235 | 13,665,459 | ||||||||||||
Alcobra Pharma Ltd.
Consolidated Balance Sheets
(In thousands)
ASSETS
| September 30, | December 31, | |||||||
| 2015 | 2014 | |||||||
| (unaudited) | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 9,970 | $ | 2,176 | ||||
| Short-term bank deposits | 25,537 | 19,522 | ||||||
| Prepaid expenses and other current assets | 1,856 | 428 | ||||||
| Total current assets | 37,363 | 22,126 | ||||||
| Long-term assets: | ||||||||
| Other long-term assets | 87 | 95 | ||||||
| Property and equipment, net | 197 | 97 | ||||||
| Total long-term assets | 284 | 192 | ||||||
| Total assets | $ | 37,647 | $ | 22,318 | ||||
LIABILITIES AND
SHAREHOLDERS’ EQUITY
| Current liabilities: | ||||||||
| Trade payables | $ | 527 | $ | 305 | ||||
| Accrued expenses and other liabilities | 2,037 | 2,070 | ||||||
| Total current liabilities | 2,564 | 2,375 | ||||||
| Shareholders’ equity: | ||||||||
| Ordinary shares | 58 | 39 | ||||||
| Additional paid-in capital | 101,155 | 71,472 | ||||||
| Accumulated deficit | (66,130 | ) | (51,568 | ) | ||||
| Total shareholders’ equity | 35,083 | 19,943 | ||||||
| Total liabilities and shareholders’ equity | $ | 37,647 | $ | 22,318 |
Alcobra Pharma Ltd.
Consolidated Cash Flows
(In thousands)
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||||||
| (unaudited) | (unaudited) | (unaudited) | (unaudited) | |||||||||||||
| Cash flow from operating activities: | ||||||||||||||||
| Net loss | $ | (4,262 | ) | $ | (10,486 | ) | $ | (14,562 | ) | $ | (26,032 | ) | ||||
| Adjustments to reconcile net income to net cash used in operating activities: | ||||||||||||||||
| Depreciation | 16 | 8 | 37 | 22 | ||||||||||||
| Stock based compensation | 585 | 1,026 | 1,786 | 3,302 | ||||||||||||
| Loss from sale of property and equipment | 3 | - | 2 | - | ||||||||||||
| Change in operating assets and liabilities: | ||||||||||||||||
| Prepaid expenses and other current assets | (1,376 | ) | (193 | ) | (1,282 | ) | (1,099 | ) | ||||||||
| Other long-term assets | (2 | ) | 3 | 8 | (47 | ) | ||||||||||
| Trade payables | 366 | 74 | 222 | 1,485 | ||||||||||||
| Accrued expenses and other liabilities | (713 | ) | 77 | (80 | ) | 1,784 | ||||||||||
| Net cash used in operating activities | (5,383 | ) | (9,491 | ) | (13,869 | ) | (20,585 | ) | ||||||||
| Cash flow from investing activities: | ||||||||||||||||
| Purchase of property and equipment, net | (56 | ) | (8 | ) | (92 | ) | (80 | ) | ||||||||
| Proceeds from (investment in) short-term bank deposit | 6,985 | 5,301 | (6,015 | ) | 1,284 | |||||||||||
| Change in restricted cash | (146 | ) | - | (146 | ) | - | ||||||||||
| Net cash provided by (used in) investing activities | 6,783 | 5,293 | (6,253 | ) | 1,204 | |||||||||||
| Cash flow from financing activities: | ||||||||||||||||
| Issuance of share capital upon public offering, net | - | - | 27,903 | - | ||||||||||||
| Exercise of options | - | - | 13 | - | ||||||||||||
| Net cash provided by financing activities | - | - | 27,916 | - | ||||||||||||
| Increase (decrease) in cash and cash equivalents | 1,400 | (4,198 | ) | 7,794 | (19,381 | ) | ||||||||||
| Cash and cash equivalents at the beginning of the period | 8,570 | 6,912 | 2,176 | 22,095 | ||||||||||||
| Cash and cash equivalents at the end of the period | 9,970 | 2,714 | 9,970 | 2,714 | ||||||||||||
| Non-cash transactions: | ||||||||||||||||
| Purchase of property and equipment | 47 | - | 47 | - | ||||||||||||
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