- Alcobra Provides Update on Results of FDA Meeting
- Conference Call & Webcast at 8:30 a.m. Eastern Time/5:30 a.m. Pacific Time
TEL AVIV, Israel, May 6, 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 first quarter ended March 31, 2015, and provided a business update.
First Quarter Ended March 31, 2015 Financial Results:
- Total operating expenses were $5.2 million, compared with $6.8 million in the fourth quarter of 2014 and $7.8 million in the first quarter of 2014.
- Net operating expenses, excluding non-cash stock based compensation, were $4.4 million, compared with $6.0 million in the fourth quarter of 2014 and $6.5 million in the first quarter of 2014.
- Research and development (R&D) expenses were $3.6 million, compared with $4.9 million in the fourth quarter of 2014 and $5.5 million in the first quarter of 2014. R&D expenses consist primarily of costs associated with the conduct of 2 clinical studies, namely, the Phase II Fragile X study and the Phase II adolescent ADHD safety and tolerability study.
- Pre-commercialization expenses were $0.3 million, compared with $0.5 million in the fourth quarter of 2014 and $0.5 million in the first quarter of 2014.
- Cash, cash equivalents and bank deposits totaled $45.0 million at March 31, 2015, compared with $21.7 million at December 31, 2014. Net cash used in operating activities was $4.6 million in the first quarter of 2015, compared with $7.8 million in the fourth quarter of 2014 and $5.7 million in the first quarter of 2014.
First 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.
- On March 10, 2015, the company reported that its Phase II safety and tolerability study of a single administration of MDX in adolescent patients with ADHD achieved its primary endpoint.
- The company met with the FDA in the first quarter of 2015 to obtain the FDA's feedback regarding the previously completed Phase III study in adult subjects with ADHD and discuss the future development path for MDX in adult and pediatric ADHD.
- The FDA concurred that positive efficacy results from a single additional short-term, well-controlled, efficacy study in adult ADHD, and two pediatric studies (a single Phase II and a single Phase III), will be sufficient to demonstrate efficacy for approval of MDX in these populations. Standard ICH E1 guideline will be followed for safety database.
- Alcobra's second Phase III adult ADHD trial is expected to launch in the second quarter of 2015, and will include elements to control placebo response and reduce response variability.
- The company expects to submit for FDA's review a Pediatric Study Plan, per FDA published guidance, in the second quarter of 2015.
- The company expects to report data from AL014, its Phase IIb study in adolescents and adults with Fragile X Syndrome, in the second quarter of 2015.
- The company believes that it has sufficient capital to fund the company's activities through 2016, including the completion of its second Phase III study in adult ADHD.
Conference Call & Webcast
Wednesday, May 6 @ 8:30am Eastern Time/5:30am Pacific Time
| Domestic: | 855-469-0611 |
| International: | 484-756-4341 |
| Passcode: | 29527840 |
| Webcast: | http://www.alcobra-pharma.com/indexInvestor.cfm |
Replays available through May 20, 2015
| Domestic: | 855-859-2056 |
| International: | 404-537-3406 |
| Passcode: | 29527840 |
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. MDX has completed multiple Phase II studies in adults and adolescents with ADHD and has completed a Phase III study in adults with ADHD. The company is conducting a Phase II trial in adolescents and adults with 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, completion and reporting results of clinical studies, Alcobra's ability to better design future studies and reduce high placebo response, reaching the milestones required for FDA approval, timing of submitting a Pediatric Study Plan to the FDA and statements regarding 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. 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 hereof, whether as a result of new information, future events or circumstances or otherwise.
| Alcobra Pharma Ltd. | ||
| Consolidated Statement of Operation | ||
| (In thousands, except per share amounts) | ||
| Three Months Ended | ||
| March 31, | ||
| 2015 | 2014 | |
| (Unaudited) | (Unaudited) | |
| Research and development | $3,590 | $5,522 |
| Pre commercialization expenses | 349 | 524 |
| General and administrative | 1,289 | 1,789 |
| Total operating expenses | 5,228 | 7,835 |
| Financial income, net | (64) | (78) |
| Net comprehensive loss | 5,164 | 7,757 |
| Income tax | 13 | 9 |
| Net loss attributable to holders of Ordinary shares | $5,177 | $7,766 |
| Net basic and diluted loss per share | $(0.26) | $(0.57) |
| Weighted average number of Ordinary shares used in computing basic and diluted net loss per share | 20,158,404 | 13,636,709 |
| Alcobra Pharma Ltd. | ||
| Consolidated Balance Sheet Data | ||
| (In thousands) | ||
| ASSETS | ||
|
March 31, 2015 |
December 31, 2014 |
|
| (Unaudited) | ||
| Current assets: | ||
| Cash and cash equivalents | $7,472 | $2,176 |
| Short-term bank deposits | 24,522 | 19,522 |
| Receivables and prepaid expenses | 248 | 428 |
| Total current assets | 32,242 | 22,126 |
| LONG-TERM ASSETS: | ||
| Long-term bank deposits | 13,000 | -- |
| Other long-term assets | 107 | 95 |
| Property and equipment, net | 99 | 97 |
| Total long-term assets | 13,206 | 192 |
| TOTAL ASSETS | $45,448 | $22,318 |
|
LIABILITIES AND SHAREHOLDERS' EQUITY |
||
| Current liabilities: | ||
| Trade payables | $55 | $305 |
| Accrued expenses and other liabilities | 1,941 | 2,070 |
| Total current liabilities | 1,996 | 2,375 |
| SHAREHOLDERS' EQUITY: | ||
| Ordinary shares | 58 | 39 |
| Additional paid- in capital | 100,139 | 71,472 |
| Accumulated deficit | (56,745) | (51,568) |
| Total shareholders' equity | 43,452 | 19,943 |
| TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $45,448 | $22,318 |
| Alcobra Pharma Ltd. | ||
| Consolidated Cash Flow Data | ||
| (In thousands) | ||
| Three Months Ended | ||
| March 31, | ||
| 2015 | 2014 | |
| (Unaudited) | (Unaudited) | |
| Cash flow from operating activities: | ||
| Net loss | $(5,177) | $(7,766) |
| Adjustments to reconcile net loss to net cash used in operating activities: | ||
| Depreciation | 10 | 6 |
| Decrease (increase) in receivables and prepaid expenses | 180 | (876) |
| Increase in other long-term assets | (12) | (37) |
| Increase (decrease) in trade payables | (250) | 1,362 |
| Increase (decrease) in other accounts payable | (129) | 348 |
| Stock based compensation | 783 | 1,335 |
| Net cash used in operating activities | (4,595) | (5,628) |
| Cash flow from investing activities: | ||
| Purchase of property and equipment | (12) | (50) |
| Investment in bank deposits | (18,000) | (6,025) |
| Net cash used in investing activities | (18,012) | (6,075) |
| Cash flow from financing activities: | ||
| Issuance of share capital upon public offering, net | 27,903 | -- |
| Net cash provided by financing activities | 27,903 | -- |
| Increase (decrease) in cash and cash equivalents | 5,296 | (11,703) |
| Cash and cash equivalents at the beginning of the period | 2,176 | 22,095 |
| Cash and cash equivalents at the end of the period | $7,472 | $10,392 |