Alcobra Announces Second Quarter 2016 Financial Results and Provides Corporate Update

TEL AVIV, Israel, Aug. 30, 2016 (GLOBE NEWSWIRE) -- Alcobra Ltd. (Nasdaq: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, today announced financial results for the three and six months ended June 30, 2016, and provided a corporate update.

Second Quarter Ended June 30, 2016 Financial Results:

  • Total operating expenses in the second quarter 2016 were $5.9 million, compared to $5.2 million in the second quarter 2015.
  • Net operating expenses, excluding non-cash stock based compensation of $0.6 million, in the second quarter 2016 were $5.3 million, compared with $4.8 million in the second quarter 2015.
  • Research and development (R&D) expenses in the second quarter 2016 were $4.2 million, compared with $3.7 million in the second quarter 2015. R&D expenses consist primarily of costs associated with the conduct of Alcobra’s Phase III Adult ADHD clinical study named MEASURE.
  • General and administrative (G&A) expenses in the second quarter 2016 were $1.4 million, compared with $1.2 million in the second quarter 2015.
  • Cash, marketable securities, and deposits totaled $61.1 million at June 30, 2016, compared with $65.2 million at March 31, 2016 and $69.7 million at the end of 2015.

Second Quarter and Recent Corporate Updates:

  • Alcobra is currently enrolling subjects into the MEASURE study (MDX Evaluation in Adults – Study of Response and Efficacy). The MEASURE study is Alcobra’s second Phase III study of Metadoxine Extended Release (MDX) in 750 adults with ADHD.
  • 718 subjects have been screened to date in the MEASURE study, with 474 subjects already enrolled or at a post-screening visit. With a current rate of close to 150 screenings per month, Alcobra expects to complete enrollment in this study in 2016 and release data in the first quarter of 2017.
  • Alcobra expects to begin enrollment in the first of two registration studies with MDX in pediatric ADHD in the fourth quarter of 2016.
  • Alcobra is continuing discussions with the FDA on a pivotal Phase III study in adolescents and adult subjects with Fragile X Syndrome. MDX has previously shown a benefit on Daily Living Skills in a placebo-controlled Phase II study in this population. The European Commission recently granted orphan drug designation to MDX for the treatment of Fragile X. The FDA previously granted orphan drug designation and Fast Track designation to MDX for the treatment of Fragile X Syndrome.

Conference Call & Webcast
Tuesday, August 30, 2016 @ 8:30 a.m. Eastern Time
Domestic: 855-469-0611
International: 484-756-4341
Passcode: 22966106
Webcast: http://www.alcobra-pharma.com/events.cfm

Replays available through September 13, 2016
Domestic: 855-859-2056
International: 404-537-3406
Passcode: 22966106

About Alcobra Ltd.
Alcobra Ltd. is an emerging pharmaceutical company primarily focused on the development and commercialization of MDX, a proprietary drug candidate, 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 enrollment of subjects to its clinical studies and expected timing of reporting results of such studies, design of future clinical studies and content of discussions with the FDA and possible positive outcomes of such discussions. 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 Alcobra has received Fast Track designation for MDX for the treatment of Fragile X Syndrome, the company cannot guarantee that it will be able to maintain such designation due to reasons within or outside of its control. 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, 2015, 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 Ltd.
Consolidated Statements of Comprehensive Loss
(In thousands, except share and per share amounts)
Three Months Ended Six Months Ended
June 30, June 30,
2016 2015 2016 2015
(unaudited) (unaudited) (unaudited) (unaudited)
Research and development$ 4,182 $ 3,683 $ 7,544 $ 7,273
Pre commercialization expenses 334 288 746 637
General and administrative 1,402 1,202 2,860 2,491
Total operating expenses 5,918 5,173 11,150 10,401
Financial income, net (152) (64) (324) (128)
Loss before taxes on income 5,766 5,109 10,826 10,273
Tax on income 22 14 48 27
Net loss attributable to holders of Ordinary shares 5,788 5,123 10,874 10,300
Unrealized gain on available-for-sale marketable securities 5 - 5 -
Total comprehensive loss$ 5,783 $ 5,123 $ 10,869 $ 10,300
Net basic and diluted loss per share$ (0.21) $ (0.24) $ (0.39) $ (0.50)
Weighted average number of Ordinary shares used in computing basic and diluted net loss per share 27,562,795 21,179,233 27,562,517 20,677,364


Alcobra Ltd.
Consolidated Balance Sheet Data
(In thousands)
ASSETS
June 30,
2016
December 31,
2015
(Unaudited)
Current assets:
Cash and cash equivalents $ 15,093 $ 16,658
Short-term bank deposits 24,000 34,022
Available-for-sale marketable securities 13,989 -
Prepaid expenses and other receivables 1,276 1,666
Total current assets 54,358 52,346
Long-term assets:
Long-term bank deposits 8,000 19,000
Other long-term assets 112 110
Property and equipment, net 219 227
Total long-term assets 8,331 19,337
Total assets $ 62,689 $ 71,683


LIABILITIES AND
SHAREHOLDERS’ EQUITY
Current liabilities:
Trade payables $ 138 $ 57
Accrued expenses and other liabilities 2,769 2,295
Total current liabilities 2,907 2,352
Shareholders’ equity:
Ordinary shares 74 74
Additional paid-in capital 141,594 140,274
Accumulated other comprehensive income 5 -
Accumulated deficit (81,891) (71,017)
Total shareholders’ equity 59,782 69,331
Total liabilities and shareholders’ equity $ 62,689 $ 71,683



Alcobra Ltd.
Consolidated Cash Flow Data
(In thousands)
Three Months Ended Six Months Ended
June 30, June 30,
2016 2015 2016 2015
(unaudited) (unaudited) (unaudited) (unaudited)
Cash flow from operating activities:
Net loss$ (5,788) $ (5,123) $ (10,874) $ (10,300)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation 18 11 33 21
Amortization of premium on marketable securities 41 - 41 -
Stock based compensation 578 418 1,314 1,201
Loss from sale of property, and equipment - (1) - (1)
Change in operating assets and liabilities:
Prepaid expenses and other receivables 261 (86) 448 94
Other long-term assets (13) 22 (60) 10
Trade payables 27 106 81 (144)
Accrued expenses and other liabilities 770 762 474 633

Net cash used in operating activities
(4,106) (3,891) (8,543) (8,486)
Cash flow from investing activities:
Purchase of property and equipment (2) (24) (25) (36)
Investment in marketable securities (10,676) - (14,415) -
Proceeds from maturity of marketable securities 145 - 145 -
Proceeds from call redemption of marketable securities 245 - 245 -
Decrease in long-term deposit - - - -
Proceeds from (investment in) short-term bank deposit 16,000 5,000 21,022 (13,000)

Net cash provided by (used in) investing activities
5,712 4,976 6,972
(13,036

)
Cash flow from financing activities:
Issuance of share capital upon public offering, net - - - 27,903
Exercise of options - 13 6 13

Net cash provided by financing activities

-

13
6 27,916
Increase (decrease) in cash and cash equivalents 1,606 1,098 (1,565) 6,394
Cash and cash equivalents at the beginning of the period 13,487 7,472 16,658 2,176
Cash and cash equivalents at the end of the period$ 15,093 $ 8,570 $ 15,093 $ 8,570


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.