TEL AVIV, Israel, Feb. 13, 2014 (GLOBE NEWSWIRE) -- Alcobra Ltd. (Nasdaq:ADHD), an emerging biopharmaceutical company primarily focused on the development and commercialization of its proprietary drug candidate, MG01CI (Metadoxine extended-release), to treat cognitive dysfunctions, such as Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome, today announced its financial results for the quarter and year-ended December 31, 2013.
4th Quarter and FY 2013 Financial Results:
- Total operating expenses for the three-month period ended December 31, 2013 were $5.6 million, compared to $0.2 million in the same period of 2012.
- Net loss attributable to common shareholders for the three-month period ended December 31, 2013 was $5.7 million, or $0.45 per basic and diluted share. This compares to a net loss of $0.3 million, or $0.04 per basic and diluted share in the same period of 2012.
- Total operating expenses for the year ended December 31, 2013 were $10.3 million, compared to $1.5 million for the year ended December 31, 2012. Net loss attributable to common shareholders was $10.5 million, or $1.04 per basic and diluted share.
- As of December 31, 2013, the Company had cash & cash equivalents of approximately $50 million.
- Announced highly statistically significant positive results with lead product candidate MG01CI in a Phase IIb clinical trial in adults with Predominantly Inattentive Attention Deficit Hyperactivity Disorder (PI-ADHD).
- Announced results from a preclinical abuse liability study demonstrating Metadoxine has substantially less potential for abuse than methylphenidate, a common stimulant ADHD medication.
- The U.S. Food & Drug Administration (FDA) granted "Orphan Drug" designation for Metadoxine in the treatment of Fragile X Syndrome.
- Filed an IND with the FDA to initiate a Phase III clinical trial with MG01CI in Adults with ADHD.
- Completed a successful public offering of shares, netting the Company approximately $35 million.
* Provides the Company with the necessary resources to fund the MG01CI ADHD and Fragile X programs through FDA approvals for each indication.
- Strengthened Executive Management team with the addition of industry veteran David Baker as the Company's Chief Commercial Officer.
- Announced the appointment of Howard Rosen as the Company's Chairman of the Board of Directors.
"We have made excellent progress on clinical, operational and financial fronts, and as a result significantly enhanced shareholders value. Our main focus continues to be on the development and commercialization of our lead drug candidate MG01CI to treat cognitive dysfunctions such as Attention Deficit/Hyperactivity Disorder," said Dr. Yaron Daniely, President and CEO of Alcobra. "We achieved an important milestone in December when we announced positive results in our second Phase IIb trial in adults with predominantly inattentive ADHD. We now have two placebo-controlled Phase II studies that show the substantial efficacy and tolerability attributes of MG01CI in adults with ADHD. These trials demonstrate what we believe are key differentiating attributes of MG01CI in the treatment of ADHD. We have filed an IND which will allow us to proceed with clinical trials in the US for all MG01CI uses. We expect to begin enrolling patients into the first of two large Phase III clinical trials during the first quarter of 2014."
"The public financing we completed during the fourth quarter puts us in a very strong position financially," added Dr. Daniely. "Together with the capital we raised in the IPO last year, we now have the necessary cash to fund the expansion of our clinical research programs into new indications beyond the adult ADHD program. The funds raised are expected to allow us to proceed with the planned pediatric clinical trials for MG01CI in ADHD both this year and in 2015, as well as the Fragile X programs in adults and children through expected approvals."
|Conference Call & Webcast|
|Thursday, February 13, 2014 @ 8:30am Eastern Time/5:30am Pacific Time|
About Alcobra Ltd.
Alcobra Ltd. is an emerging biopharmaceutical company primarily focused on the development and commercialization of a proprietary drug candidate, MG01CI, to treat cognitive dysfunctions including Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome. MG01CI has completed Phase II studies to treat Attention Deficit Hyperactivity Disorder. The company was founded in 2008 and is headquartered in Tel Aviv, Israel. 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 may contain 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 that imply that MG01CI may be helpful to treat cognitive dysfunctions such as ADHD, including PI-ADHD, and Fragile X or that we will receive favorable results in clinical trials in MG01CI, statements regarding the timing of initiation of enrollment to our Phase III trials, if such trials, or other trials, are commenced at all as well as statements regarding the sufficiency of our 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 be interpreted differently in light of additional research. 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 registration statement on Form F-1/A filed with the Securities and Exchange Commission ("SEC") on October 22, 2013 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 Operation|
|(In thousands, except per share amounts)|
|Three Months Ended||Year ended|
|December 31,||December 31,|
|Research and development||$4,603||$67||$7,066||$818|
|General and administrative||1,040||182||3,224||683|
|Total operating expenses||5,643||249||10,290||1,501|
|Financial expenses, net||--||46||197||78|
|Net comprehensive loss||5,704||295||10,548||1,579|
|Net loss attributable to holders of Ordinary shares||$5,704||$295||$10,548||$1,579|
|Net basic and diluted (gain) loss per share||$(0.45)||$(0.04)||$(1.04)||$(0.20)|
|Weighted average number of Ordinary shares used in computing basic and diluted net loss per share||12,756,506||7,791,785||10,177,786||7,791,934|
|Alcobra Pharma Ltd Consolidated.|
|Balance Sheet Data|
|December 31,||December 31,|
|Cash and cash equivalents||$22,095||$97|
|Short-term bank deposits||28,008||--|
|Receivables and prepaid expenses||115||83|
|Total current assets||50,218||180|
|Property and equipment, net||49||18|
|Other long-term assets||57||3|
|Total long-term assets||106||21|
|SHAREHOLDERS' EQUITY (DEFICIENCY)|
|Accrued expenses and other liabilities||1,589||83|
|Total current liabilities||1,636||768|
|Additional paid-in capital||67,383||7,615|
|Deficit accumulated during the development stage||(18,734)||(8,186)|
|Total shareholders' equity (deficiency)||48,688||(567)|
|Total liabilities and shareholders' equity (deficiency)||$50,324||$201|
|Alcobra Pharma Ltd Consolidated.|
|Cash Flow Data|
|Three Months Ended||Year Ended|
|December 31,||December 31,|
|Cash flow from operating activities:|
|Adjustments to reconcile net loss to net cash used in operating activities:|
|Gain from sale of property, plant and equipment||--||--||1||--|
|Decrease (increase) in receivables and prepaid expenses||64||(51)||(32)||12|
|Decrease (increase) in other long-term assets||(2)||--||(54)||2|
|Increase (decrease) in trade payables||16||16||24||(101)|
|Increase in accrued expenses and other liabilities||338||(6)||1,505||(12)|
|Interest on convertible notes||--||62||203||62|
|Stock based compensation||505||4||1,540||26|
|Net cash used in operating activities||(4,780)||(269)||(7,353)||(1,583)|
|Cash flow from investing activities:|
|Purchase of property and equipment||(19)||--||(39)||--|
|Investment in (proceeds from) short-term bank deposit||(13,008)||--||(28,008)||517|
|Investment in restricted bank deposit||--||--||--||507|
|Net cash provided by (used in) investing activities||(13,027)||--||(28,047)||1,024|
|Cash flow from financing activities:|
|Issuance of shares, net||--||1||--||1|
|Issuance of share capital upon public offering||35,334||--||57,254||--|
|Exercise of options||29||--||29||--|
|Proceeds from issuance of convertible notes||--||333||115||600|
|Net cash provided by financing activities||35,363||334||57,398||601|
|Increase in cash and cash equivalents||17,556||65||21,998||42|
|Cash and cash equivalents at the beginning of the period||4,539||32||97||55|
|Cash and cash equivalents at the end of the period||$22,095||$97||$22,095||$97|
|Supplemental disclosure of non-cash activities:|
|Issuance of ordinary shares upon conversion of convertible notes||--||--||$980||--|
CONTACT: U.S. Investor Contacts: LifeSci Advisors, LLC Michael Rice 646-597-6979 firstname.lastname@example.org Israel Investor Contact: Alcobra Investor Relations Debbie Kaye +972-72 2204661 email@example.com