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Alcobra Announces Fourth Quarter and Fiscal Year 2014 Financial Results and Provides Corporate Update

  • 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

CONTACT: U.S. Investor Contacts LifeSci Advisors, LLC Michael Rice 646-597-6979 mrice@lifesciadvisors.com Media Inquiries Sam Brown, Inc. Mike Beyer 773-463-4211 mikebeyer@sambrown.com Israel Investor Contact: Alcobra Investor Relations Debbie Kaye +972-72 2204661 debbie@alcobra-pharma.com

Source:Alcobra Ltd.