- Conference Call & Webcast at 8:30 a.m. Eastern Time/5:30 a.m. Pacific Time
TEL AVIV, Israel, Feb. 12, 2015 (GLOBE NEWSWIRE) -- Alcobra Ltd. (Nasdaq: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 fourth quarter and fiscal year ended December 31, 2014, and provided a business update.
Fourth Quarter and Fiscal Year Ended December 31, 2014 Financial Results:
- Total operating expenses in the fourth quarter and fiscal year 2014 were $6.8 million and $33.1 million, respectively, compared with $5.6 million and $10.3 million in the fourth quarter and fiscal year 2013.
- Net operating expenses, excluding non-cash stock based compensation, in the fourth quarter and fiscal year 2014 were $6.0 million and $29.0 million, respectively, compared with $5.1 million and $8.8 million in the fourth quarter and fiscal year 2013.
- Research and development (R&D) expenses in the fourth quarter and fiscal year 2014 were $4.9 million and $25.1 million, respectively, compared with $4.6 million and $7.1 million in the fourth quarter and fiscal year 2013. R&D expenses consist primarily of costs associated with the conduct of our clinical studies.
- Cash, cash equivalents and short-term deposits totaled $21.7 million at December 31, 2014, compared with $29.4 million at September 30, 2014 and $50.1 million at December 31, 2013. The reported cash, cash equivalents and short-term deposits balance as of December 31, 2014 does not include net proceeds of $27.9 million from our equity financing completed on January 14, 2015.
Fourth Quarter and Recent Corporate Updates:
- On January 14, 2015, the company completed a public equity financing with net proceeds of $27.9 million. The financing was led by healthcare-dedicated institutional investors.
- The company is scheduled to meet with the FDA in the first quarter of 2015 to discuss the results of its first phase III study reported in October 2014, and the protocol of the second adult Phase III study which is expected to launch in the second quarter of 2015. The company's second phase III study will include design elements that may provide rigorous controls over the magnitude of placebo responses and response variability.
- The company completed patient recruitment into AL015, its Phase II study in adolescents with ADHD, and expects to report data by the end of the first quarter of 2015.
- The company is also recruiting patients into AL014, its Phase IIb study in adolescents and adults with Fragile X Syndrome. Completion of enrollment is expected in the first quarter of 2015 and the company expects to report data in the second quarter of 2015.
- The company believes that it has sufficient capital to complete the Phase II trials in pediatric ADHD and Fragile X Syndrome, and fund the company's activities through 2016, including the completion of its second Phase III study in adult ADHD.
| Conference Call & Webcast | |
| Thursday, February 12 @ 8:30am Eastern Time/5:30am Pacific Time | |
| Domestic: | 855-469-0611 |
| International: | 484-756-4341 |
| Passcode: | 74833931 |
| Webcast: | http://www.alcobra-pharma.com/indexInvestor.cfm |
| Replays available through February 26, 2015 | |
| Domestic: | 855-859-2056 |
| International: | 404-537-3406 |
| Passcode: | 74833931 |
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 Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome. MDX has completed multiple Phase II studies and a Phase III study in adults with ADHD. The company is conducting separate Phase II trials in pediatric 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, design, expected enrollment, completion and reporting results of clinical studies, timing of meeting with the FDA and statements regarding Alcobra's future use of cash and the sufficiency of the company's financial resources to meet certain milestones and whether such milestones may be achieved at all. 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. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the "Risk Factors" section of Alcobra Ltd.'s Prospectus Supplement dated January 9, 2015, and the heading "Risk Factors" in Alcobra Ltd.'s Annual Report on Form 20-F for the fiscal year ended December 31, 2013, 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. | ||||
| CONSOLIDATED STATEMENTS OF OPERATIONS | ||||
| (In thousands, except per share amounts) | ||||
| Three Months Ended | Year ended | |||
| December 31, | December 31, | |||
| 2014 | 2013 | 2014 | 2013 | |
| Research and development expenses | $ 4,908 | $ 4,603 | $ 25,105 | $ 7,066 |
| Pre commercialization expenses | 483 | -- | 2,134 | -- |
| General and administrative expenses | 1,436 | 1,040 | 5,839 | 3,224 |
| Operating loss | 6,827 | 5,643 | 33,078 | 10,290 |
| Financial expenses (income), net | (33) | --*) | (227) | 197 |
| Loss before taxes on income | 6,794 | 5,643 | 32,851 | 10,487 |
| 8 | 61 | (17) | 61 | |
| Taxes on income | ||||
| Net loss attributable to holders of ordinary shares | $ 6,802 | $ 5,704 | $ 32,834 | $ 10,548 |
| Net basic and diluted loss per share | $ (0.50) | $ (0.45) | $ (2.40) | $ (1.04) |
| Weighted average number of ordinary shares used in computing basic and diluted net loss per share | 13,702,440 | 12,756,506 | 13,674,818 | 10,177,786 |
| *) Represents an amount lower than $1. | ||||
| ALCOBRA PHARMA LTD. | ||
| CONSOLIDATED BALANCE SHEETS DATA | ||
| (In thousands) | ||
| ASSETS | ||
| December 31, | ||
| 2014 | 2013 | |
| Current assets: | ||
| Cash and cash equivalents | $ 2,176 | $ 22,095 |
| Short-term bank deposit | 19,522 | 28,008 |
| Receivables and prepaid expenses | 428 | 115 |
| Total current assets | 22,126 | 50,218 |
| LONG-TERM ASSETS: | ||
| Other long-term assets | 95 | 57 |
| Property and equipment, net | 97 | 49 |
| Total long-term assets | 192 | 106 |
| TOTAL ASSETS | $ 22,318 | $ 50,324 |
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||
| Current liabilities: | ||
| Trade payables | $ 305 | $ 47 |
| Accrued expenses and other liabilities | 2,070 | 1,589 |
| Total current liabilities | 2,375 | 1,636 |
| SHAREHOLDERS' EQUITY: | ||
| Ordinary shares | 39 | 39 |
| Additional paid- in capital | 71,472 | 67,383 |
| Accumulated deficit | (51,568) | (18,734) |
| Total shareholders' equity | 19,943 | 48,688 |
| TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ 22,318 | $ 50,324 |
| ALCOBRA PHARMA LTD. | ||||
| CONSOLIDATED CASH FLOWS DATA | ||||
| (In thousands) | ||||
| Three Months Ended | Year ended | |||
| December 31, | December 31, | |||
| 2014 | 2013 | 2014 | 2013 | |
| Cash flows from operating activities | ||||
| Net loss | $ (6,802) | $ (5,704) | $ (32,834) | $ (10,548) |
| Adjustments to reconcile net income to net cash used in operating activities: | ||||
| Depreciation | 10 | 3 | 31 | 8 |
| Interest on convertible notes | -- | -- | -- | 203 |
| Stock based compensation | 787 | 505 | 4,089 | 1,540 |
| Gain from sale of property and equipment | -- | -- | -- | 1 |
| Change in operating assets and liabilities: | ||||
| Receivables and prepaid expenses | 786 | 64 | (313) | (32) |
| Other long-term assets | 9 | (2) | (38) | (54) |
| Trade payables | (1,227) | 16 | 258 | 24 |
| Accrued expenses and other liabilities | (1,303) | 338 | 481 | 1,505 |
| Net cash used in operating activities | (7,740) | (4,780) | (28,326) | (7,353) |
| Cash flows from investing activities | ||||
| Purchase of property and equipment | -- | (19) | (79) | (39) |
| Investment in (proceeds from) short-term bank deposit | 7,202 | (13,008) | 8,486 | (28,008) |
| Net cash provided by (used in) investing activities | 7,202 | (13,027) | 8,407 | (28,047) |
| Cash flows from financing activities | ||||
| Proceeds from issuance of convertible notes | -- | -- | -- | 115 |
| Issuance of share capital upon public offering | -- | 35,334 | -- | 57,254 |
| Exercise of options | -- | 29 | -- | 29 |
| Net cash provided by financing activities | -- | 35,363 | -- | 57,398 |
| Increase (decrease) in cash and cash equivalents | (538) | 17,556 | (19,919) | 21,998 |
| Cash and cash equivalents at the beginning of the period | 2,714 | 4,539 | 22,095 | 97 |
| Cash and cash equivalents at the end of the period | $ 2,176 | $ 22,095 | $ 2,176 | $ 22,095 |
| Supplemental disclosure of non-cash investing and financing activities: | ||||
| Issuance of ordinary shares upon conversion of convertible notes | $ -- | $ -- | $ -- | $ 980 |