×

Alcobra Announces Third Quarter 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, Nov. 17, 2014 (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 third quarter ended September 30, 2014 and provided a business update.

Third Quarter Ended September 30, 2014 Financial Results:

  • Total operating expenses were $10.6 million, compared with $7.8 million in the second quarter of 2014 and $3.1 million in the third quarter of 2013.
  • Net operating expenses, excluding non-cash stock based compensation, were $9.6 million, compared with $6.9 million in the second quarter of 2014 and $2.8 million in the third quarter of 2013.
  • Research and development (R&D) expenses were $8.8 million, compared with $5.9 million in the second quarter of 2014 and $2.1 million in the third quarter of 2013. R&D expenses in the third quarter of 2014 consist primarily of costs associated with the conduct of 3 advanced clinical studies, including the first Phase III study which was recently completed.
  • Pre-commercialization expenses were $0.6 million, similar to the second quarter of 2014. Pre-commercialization expenses consist primarily of costs associated with market research and analysis as well as business development.
  • Cash, cash equivalents and short-term deposits totaled $29.4 million at September 30, 2014, compared with $38.9 million at June 30, 2014.

Third Quarter and Recent Corporate Updates:

  • In October, the company announced topline data from its first Phase III trial of MDX in adult subjects with ADHD. The results did not show a statistically significant outcome on the Intent to Treat (ITT) population evaluated on the primary endpoint.
  • A collection of pre-specified as well as post-hoc analyses presented at the time and subsequently at a major conference provided a consistent signal of efficacy.
  • MDX was well-tolerated in the trial, in line with the company's prior studies.
  • The company plans to meet with FDA and launch a second adult Phase III study in 2015. The company is currently evaluating changes to the design and monitoring of the second trial to control the unusually high placebo response and wide response variability observed in the first Phase III study.
  • The company is currently recruiting patients into AL015, its Phase IIb study in adolescents with ADHD. Enrollment is expected to be completed by the end of 2014.
  • 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.

"While we obviously are disappointed with the results of the first Phase III study, we strongly believe in the potential of MDX based on our clinical experience to date," said Dr. Yaron Daniely, President and Chief Executive Officer of Alcobra. "We remain encouraged by the signals of efficacy and the safety profile of the drug, and are confident in our ability to improve the design and execution of future trials."

Conference Call & Webcast
Monday, November 17 @ 8:30am Eastern Time/5:30am Pacific Time
Domestic: 855-469-0611
International: 484-756-4341
Passcode: 23967565
Webcast: http://www.alcobra-pharma.com/indexInvestor.cfm
Replays
Domestic: 855-859-2056
International: 404-537-3406
Passcode: 23967565

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 IIb 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 expected enrollment and completion of clinical studies, as well as timing of providing data analysis, timing of meeting with the FDA and launch of a second Phase III study, if such meeting and launch actually occur, and our ability to better design future studies and reduce high placebo response. 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 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 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 Ltd.
Consolidated Statement of Operations
(In thousands, except share and per share amounts)
Three Months Ended Nine Months Ended
September 30, September 30,
2014 2013 2014 2013
(unaudited) (unaudited) (unaudited) (unaudited)
Research and development expenses 8,757 2,067 20,197 2,463
Pre commercialization expenses 562 -- 1,651 --
General and administrative 1,266 1,069 4,403 2,183
Operating loss 10,585 3,136 26,251 4,646
Financial expenses (income), net (59) (8) (194) 198
Loss before taxes on income 10,526 3,128 26,057 4,844
Taxes on income (40) -- (25) --
Net loss attributable to holders of Ordinary shares 10,486 3,128 26,032 4,844
Net basic and diluted loss per share $ (0.77) $ (0.28) $ (1.90) $ (0.52)
Weighted average number of Ordinary shares used in computing basic and diluted net loss per share 13,696,525 11,128,001 13,665,459 9,320,696
Alcobra Ltd.
Consolidated Balance Sheet
(In thousands)
ASSETS
September 30, December 31,
2014 2013
(unaudited)
Current assets:
Cash and cash equivalents $ 2,714 $ 22,095
Short-term bank deposits 26,724 28,008
Receivables and prepaid expenses 1,214 115
Total current assets 30,652 50,218
Long-term assets:
Other long-term assets 104 57
Property and equipment, net 107 49
Total long-term assets 211 106
Total assets $ 30,863 $ 50,324
LIABILITIES AND
SHAREHOLDERS' EQUITY
Current liabilities:
Trade payables $ 1,532 $ 47
Accrued expenses and other liabilities 3,373 1,589
Total current liabilities 4,905 1,636
Shareholders' equity:
Ordinary shares 39 39
Additional paid-in capital 70,685 67,383
Accumulated deficit (44,766) (18,734)
Total shareholders' equity 25,958 48,688
Total liabilities and shareholders' equity $ 30,863 $ 50,324
Alcobra Ltd.
Consolidated Cash Flow
(In thousands)
Three Months Ended Nine Months Ended
September 30, September 30,
2014 2013 2014 2013
(unaudited) (unaudited) (unaudited) (unaudited)
Cash flow from operating activities:
Net loss $ (10,486) $ (3,128) $ (26,032) $ (4,844)
Adjustments to reconcile net income to net cash used in operating activities:
Depreciation 8 1 22 4
Interest on convertible notes -- -- -- 203
Stock based compensation 1,026 292 3,302 1,036
Gain from sale of property and equipment -- -- -- 1
Change in operating assets and liabilities:
Receivables and prepaid expenses (193) (95) (1,099) (99)
Other long-term assets 3 -- (47) --
Trade payables 74 (36) 1,485 8
Accrued expenses and other liabilities 77 974 1,784 1,167

Net cash used in operating activities
(9,491) (1,992)
(20,585)

(2,524)
Cash flow from investing activities:
Purchase of property and equipment (8) (17) (80) (20)
Decrease in long-term deposit -- (44) -- (48)
Investment in (proceeds from) short-term bank deposit 5,301 (11,000) 1,284 (15,000)

Net cash (used in) provided by investing activities
5,293 (11,061)
1,204

(15,068)
Cash flow from financing activities:
Issuance of share capital upon initial public offering -- -- -- 21,920
Proceeds from issuance of convertible notes -- -- -- 115

Net cash provided by financing activities

--

--

--

22,035
Increase (decrease) in cash and cash equivalents (4,198) (13,053) (19,381) 4,443
Cash and cash equivalents at the beginning of the period 6,912 17,593 22,095 97
Cash and cash equivalents at the end of the period $ 2,714 $ 4,540 $ 2,714 $ 4,540
Supplemental disclosure of non-cash activities:
Issuance of ordinary shares upon conversion of convertible notes -- --
--

979

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.