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 2013
ALCOBRA LTD.
(Translation of registrant's name into English)
35 Ehad Ha-Am Street
Tel-Aviv, Israel 65202
(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):_____
Indicate by check mark, whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes ¨ No x
If "Yes" is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): ___
Attached hereto and incorporated by reference herein is the registrant's press release issued on August 6, 2013.
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: August 6, 2013
News Release
| U.S. Investor Contacts: | Israel Investor Contact: |
| KCSA Strategic Communications | Investor Relations Ltd. |
| Garth Russell / Jeffrey Goldberger | Moran Meir-Beres |
| +1 212.896.1250 / +1 212.896.1249 | +011972-3-5167620 |
| grussell@kcsa.com / jgoldberger@kcsa.com | moran@km-ir.co.il |
ALCOBRA LTD. REPORTS SECOND QUARTER 2013 RESULTS
- - -
Raised $25 million in recent IPO and listed on the NASDAQ on May 21, 2013
- - -
Tel Aviv, Israel (August 6, 2013) – Alcobra Ltd. (NASDAQCM: ADHD) (the “Company”), an emerging biopharmaceutical company primarily focused on the development and commercialization of its proprietary drug, MG01CI, to treat Attention Deficit Hyperactivity Disorder (ADHD), today reported its results for the fiscal quarter ended June 30, 2013.
Recent Highlights:
| - | Received U.S. Patent 8,476,304, which protects the Company’s lead drug candidate modified release Metadoxine (MG01CI) |
| - | Appointed Dr. Jonathan Rubin as the Company’s Chief Medical Officer to further accelerate and aid in the development of MG01CI as it advances into Phase III U.S. trials |
| - | Published positive results from secondary analysis of the Phase IIb trial comparing the effect of MG01CI with placebo on ADHD subsets |
| o | Data shows that MG01CI is highly efficacious for treating adults with ADHD-PI and inattention symptoms |
| o | Analysis was published in the July 2013 issue of Postgraduate Medicine Journal |
| - | Scheduled to start a placebo-controlled clinical study further establishing the immediate onset and magnitude of the effect of several doses of MG01CI in patients with ADHD-PI in August 2013. |
“Since our successful IPO in May and listing on the NASDAQ, we have achieved a number of significant milestones which have advanced our efforts to further develop our proprietary drug, MG01CI,” stated Dr. Yaron Daniely, President and CEO of Alcobra.
“To help guide our expanding clinical work, we recently appointed Dr. Jonathan Rubin as our Chief Medical Officer. With tremendous experience within the ADHD arena, Dr. Rubin will directly oversee our research and clinical activities and help accelerate the development of MG01CI for potential commercialization in this large and underpenetrated market, as well as other cognitive indications,” continued Dr. Daniely.
“We strongly believe that MG01CI may represent a safer and more efficacious, non-stimulant treatment for ADHD, especially compared to today’s leading stimulant ADHD drugs such as Vyvanse, Concerta and Adderall, as well as the non-stimulant ADHD medication, Strattera. Our proprietary drug features an immediate onset of action, and presents no addictive features and is extremely well-tolerated. As a result, we are excited by the potential MG01CI has to revolutionize the ADHD market,” concluded Dr. Daniely.
Financial Overview:
Operating expenses for the second quarter of 2013 were $1.2 million, of which $0.7 million was non cash charges from stock based compensation mainly related to the completion of the Company's IPO in late-May. Excluding the stock based compensation, operating expenses for the second quarter of 2013 were $0.3 million. The Company expects quarterly operating expenses to increase from the $0.3 million throughout the remainder of 2013 due to the hiring of experienced and senior personnel and the advancement of the Company’s clinical development plan.
Financial expenses for the second quarter of 2013 were $0.1 million, of which $0.1 million were related to the convertible loan that was converted to equity upon the IPO.
Net loss for the second quarter of 2013 was $1.3 million, or $0.15 per basic and diluted share, compared to $0.4 million, or $0.06 per basic and diluted share, for the same period of 2012. The net loss attributable to holders of ordinary shares for the second quarter of 2013 includes approximately $0.7 million in stock base compensation and $0.1 million of interest on convertible notes.
As of June 30, 2013, cash, cash equivalents and short-term deposits totaled $21.6 million, compared with $0.1 million as of December 31, 2012.
Conference Call
Alcobra will hold a conference call today, August 6th, at 9 a.m. EDT to discuss events that occurred during the quarter and provide an update on the business. The call will be available via webcast and can be accessed through the Alcobra website, http://www.alcobra-pharma.com/events.cfm. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. To dial into the conference call, please dial 1-877-375-4189 (U.S. and Canada) or 1-973-935-2046 (Internationally); and use the passcode: 20461839.
For those unable to listen to the live event, an archive of the conference call will be available on the Alcobra website, http://www.alcobra-pharma.com/events.cfm. A telephonic playback of the conference call will be available for one week after the call by calling 1-855-859-2056 (U.S. and Canada) and 1-404-537-3406 (Internationally); and use the passcode: 20461839.
About Alcobra Ltd.
Alcobra Ltd. is an emerging biopharmaceutical company primarily focused on the development and commercialization of a proprietary drug, MG01CI, to treat Attention Deficit Hyperactivity Disorder. MG01CI has completed Phase II studies to treat Attention Deficit Hyperactivity Disorder. The company was founded in 2008 and is headquartered in Tel Aviv, Israel.
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 commencement, timing of commencement and advancement of clinical trials, the possible future effect of the MG01CI product on the ADHD market and change in levels of expenses. 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 registration statement on Form F-1 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.
# # #
Alcobra Pharma Ltd.
Statement of Operation
(In thousands, except per share amounts)
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2013 | 2012 | 2013 | 2012 | |||||||||||||
| (unaudited) | (unaudited) | (unaudited) | (unaudited) | |||||||||||||
| Research and development | $ | 321 | $ | 231 | $ | 396 | $ | 632 | ||||||||
| General and administrative | 875 | 198 | 1,114 | 356 | ||||||||||||
| Total operating expenses | 1,196 | 429 | 1,510 | 988 | ||||||||||||
| Financial expenses, net | 143 | 11 | 206 | 13 | ||||||||||||
| Net comprehensive loss | 1,339 | 440 | 1,716 | 1,001 | ||||||||||||
| Net loss attributable to holders of Ordinary shares | $ | 1,339 | $ | 440 | $ | 1,716 | $ | 1,001 | ||||||||
| Net basic and diluted loss per share | $ | (0.15 | ) | $ | (0.06 | ) | $ | (0.20 | ) | $ | (0.13 | ) | ||||
| Weighted average number of Ordinary shares used in computing basic and diluted net loss per share | 9,016,628 | 7,791,785 | 8,397,070 | 7,791,785 | ||||||||||||
Alcobra Pharma Ltd.
Statement of Operation
Balance Sheet Data
(In thousands)
ASSETS
| June 30, | December 31, | |||||||
| 2013 | 2012 | |||||||
| (unaudited) | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 17,593 | $ | 97 | ||||
| Short-term deposits | 4,000 | - | ||||||
| Receivables and prepaid expenses | 87 | 83 | ||||||
| Total current assets | 21,680 | 180 | ||||||
| Long-term assets: | ||||||||
| Long-term deposit | 7 | 3 | ||||||
| Property and equipment, net | 17 | 18 | ||||||
| Total long-term assets | 24 | 21 | ||||||
| Total assets | $ | 21,704 | $ | 201 | ||||
LIABILITIES AND
SHAREHOLDERS’ EQUITY
| Current liabilities: | ||||||||
| Trade payables | $ | 67 | $ | 23 | ||||
| Other accounts payable | 276 | 83 | ||||||
| Convertible Notes | - | 662 | ||||||
| Total current liabilities | 343 | 768 | ||||||
| Shareholders’ equity: | ||||||||
| Share capital | 32 | 4 | ||||||
| Additional paid-in capital | 31,231 | 7,615 | ||||||
| Retained earnings | (9,902 | ) | (8,186 | ) | ||||
| Total shareholders’ equity | 21,361 | (567 | ) | |||||
| Total liabilities and shareholders’ equity | $ | 21,704 | $ | 201 |
Alcobra Pharma Ltd.
Cash Flow Data
(In thousands)
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2013 | 2012 | 2013 | 2012 | |||||||||||||
| (unaudited) | (unaudited) | (unaudited) | (unaudited) | |||||||||||||
| Cash flow from operating activities: | ||||||||||||||||
| Net loss | $ | (1,339 | ) | $ | (440 | ) | $ | (1,716 | ) | $ | (1,001 | ) | ||||
| Adjustments to reconcile net income to net cash used in operating activities: | ||||||||||||||||
| Depreciation | 2 | 2 | 3 | 4 | ||||||||||||
| Gain from sale of property, plant and equipment | - | - | 1 | - | ||||||||||||
| Decrease (increase) in receivables and prepaid expenses | 41 | 72 | (4 | ) | 56 | |||||||||||
| Increase (decrease) in trade payables | 46 | 4 | 44 | (102 | ) | |||||||||||
| Increase in other accounts payable | 20 | 48 | 193 | 41 | ||||||||||||
| Interest on convertible notes | 142 | - | 203 | - | ||||||||||||
| Stock base compensation | 739 | 7 | 744 | 16 | ||||||||||||
| Net cash used in operating activities | (349 | ) | (307 | ) | (532 | ) | (986 | ) | ||||||||
| Cash flow from investing activities: | ||||||||||||||||
| Purchase of property and equipment | (3 | ) | - | (3 | ) | - | ||||||||||
| Decrease (increase) in long-term deposit | (6 | ) | 2 | (4 | ) | 2 | ||||||||||
| Investment in (proceeds from) short-term bank deposit | (4,000 | ) | 294 | (4,000 | ) | 465 | ||||||||||
| Investment in (proceeds from) restricted bank deposit | - | - | - | 507 | ||||||||||||
| Net cash (used in) provided by investing activities | (4,009 | ) | 296 | (4,007 | ) | 974 | ||||||||||
| Cash flow from financing activities: | ||||||||||||||||
| Issuance of share capital upon initial public offering | 21,920 | - | 21,920 | - | ||||||||||||
| Proceeds from issuance of convertible notes | - | - | 115 | - | ||||||||||||
| Net cash provided by financing activities | 21,920 | - | 22,035 | - | ||||||||||||
| Increase (decrease) in cash and cash equivalents | 17,562 | (11 | ) | 17,496 | (12 | ) | ||||||||||
| Cash and cash equivalents at the beginning of the period | 31 | 54 | 97 | 55 | ||||||||||||
| Cash and cash equivalents at the end of the period | $ | 17,593 | $ | 43 | $ | 17,593 | $ | 43 | ||||||||
| Supplemental disclosure of non-cash activities: | ||||||||||||||||
| Issuance of ordinary shares upon conversion of convertible notes | $ | 979 | - | $ | 979 | - | ||||||||||