Alcobra Ltd. Reports Third Quarter 2013 Results


The following excerpt is from the company's SEC filing.

Tel Aviv, Israel (November 7, 2013) – Alcobra Ltd. (NASDAQCM: ADHD) (the “Company”), 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 ADHD and Fragile X Syndrome, today reported its results for the quarter ended September 30, 2013.

-Received positive pre-clinical results showing significant improvement in cognitive and social functioning following treatment with Metadoxine (MG01CI) in a Fragile X syndrome study

-Enrolled first patient in a 36-patient placebo-controlled Phase II clinical study comparing the efficacy of varied dosage levels of MG01CI to treat and improve cognitive dysfunctions in adult patients with Predominantly Inattentive Attention Deficit Disorder (PI-ADHD)

-Selected Premier Research as its Clinical Research Organization (CRO) to conduct a Phase III clinical study of MG01CI in adults with ADHD

“During the third quarter we made steady progress advancing the pre-clinical and clinical research of our primary drug candidate, MG01CI, which included expanding our research beyond ADHD to include other cognitive disorders such as Fragile X Syndrome,” stated Dr. Yaron Daniely, President and CEO of Alcobra. “In addition, we enrolled our first patient in a Phase II clinical study to compare the efficacy of varied dosage levels of MGO1CI to potentially treat and improve cognitive dysfunctions in adult patients with PI-ADHD.”

Dr. Daniely continued, “Our primary focus over the past several months has been preparing for our first U.S. Phase III clinical study for MG01CI in adults with ADHD. Most recently, we named Premier Research as the Clinical Research Organization to conduct this trial. With our CRO now in place, we are preparing to launch this multi-site study in nearly 20 select clinical sites in the USA and Israel.”

“The more we learn about MG01CI, the more confident we become about the potential for the drug to safely and effectively address a wide array of cognitive dysfunctions without some of the adverse characteristics of approved drugs. To support this expanded clinical research program and to deliver additional potential in the form of new clinical programs, we recently completed an approximately $38 million follow-on offering,” concluded Dr. Daniely.

Operating expenses for the third quarter of 2013 were $3.1 million, of which $0.3 million was non-cash charges from stock based compensation. Excluding stock based compensation, operating expenses for the third quarter of 2013 were $2.8 million. The Company expects quarterly operating expenses to increase over the next few quarters due to an acceleration of its clinical development activities.

Net loss for the third quarter of 2013 was $3.1 million, or $0.28 per basic and diluted share, compared to $0.3 million, or $0.04 per basic and diluted share, for the same period of 2012.

As of September 30, 2013, cash, cash equivalents and short-term deposits totaled $19.5 million, compared with $21.6 million as of June 30, 2013.

On October 30th, the Company completed a public offering of 2,300,000 ordinary shares, including shares issued pursuant to the underwriters' over-allotment option, at an offering price of $16.50 per share. The gross proceeds to Alcobra from the offering, including the exercise of the over-allotment option, were approximately $38.0 million, before underwriting discounts and commissions and other offering expenses.

Alcobra will hold a conference call today, November 7th, at 9 a.m. EST to discuss events that occurred during the quarter and provide an update on the business. The call will be available via webcast and can be accessed through the Alcobra website, http://www.alcobra-pharma.com/events.cfm. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. To dial into the conference call, please dial 1-877-375-4189 (U.S. and Canada) or 1-973-935-2046 (International); and use the passcode: 95351389.

For those unable to listen to the live event, an archive of the conference call will be available on the Alcobra website, http://www.alcobra-pharma.com/events.cfm. A telephonic playback of the conference call will be available for one week after the call by calling 1-855-859-2056 (U.S. and Canada) and 1-404-537-3406 (Internationally); and use the passcode: 95351389.

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 ADHD. 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 does not form a part of this press release.

The above information was disclosed in a filing to the SEC. To see this filing in its entirety, click here.

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Other recent filings from the company include the following:

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