GERMANTOWN, Md., Aug. 11, 2016 (GLOBE NEWSWIRE) -- Neuralstem, Inc. (Nasdaq:CUR), a biopharmaceutical company focused on the development of central nervous system therapies based on its neural stem cell technology, reported its financial results and provided business and clinical updates for the three and six months periods ended June 30, 2016.
“During the quarter, we have taken measures to improve the Company’s cost structure and completed initiatives to strengthen the organization, particularly with the formation of a new Scientific Policy Committee,” commented Rich Daly, President and Chief Executive Officer. “This quarter brought clinical advancements with our lead compound, NSI-189, and we are pleased with progression of the enrollment the ongoing Phase 2 MDD trial, with results expected in the second half of 2017. Additionally, the preclinical long-term potentiation data announced in June, provided insight to NSI-189’s mechanism of action and the possible therapeutic benefit of improvement in cognitive function, further supporting the validity of our proprietary novel technology.”
Recent Business Highlights
Pre-Clinical Development Pipeline
Results of Operations for the Six Months Ended June 30, 2016
|Unaudited Condensed Consolidated Balance Sheets|
|June 30, 2016||December 31, 2015|
|Cash and cash equivalents||$||11,128,763||$||4,716,533|
|Trade and other receivables||5,085||37,316|
|Total current assets||11,839,688||13,431,084|
|Property and equipment, net||363,192||343,200|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accounts payable and accrued expenses||$||2,501,518||$||1,455,826|
|Current portion of long-term debt, net of fees and discount||5,905,672||4,545,180|
|Other current liabilities||204,464||263,104|
|Total current liabilities||8,611,654||6,425,472|
|Long-term debt, net of fees, discount and current portion||-||3,382,654|
|Other long-term liabilities||21,825||174,144|
|Preferred stock, 7,000,000 shares authorized, zero shares issued and outstanding||-||-|
|Common stock, $0.01 par value; 300 million shares authorized, 114,760,960 and 92,005,705 shares outstanding in 2016 and 2015, respectively||1,147,610||920,057|
|Additional paid-in capital||182,101,289||176,002,832|
|Accumulated other comprehensive income||4,566||3,071|
|Total stockholders' equity||836,491||4,967,278|
|Total liabilities and stockholders' equity||$||13,294,865||$||14,949,548|
|Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss|
|Three Months Ended June 30,||Six Months Ended June 30,|
|Research and development expenses||2,474,629||3,312,841||5,540,219||6,495,664|
|General and administrative expenses||1,362,140||1,684,381||4,532,662||3,117,455|
|Total operating expenses||3,836,769||4,997,222||10,072,881||9,613,119|
|Other income (expense):|
|Change in fair value of derivative instruments||757,275||-||757,275||-|
|Fees related to issuance of derivative instrument and other expenses||(466,541||)||(10,326||)||(463,342||)||(10,326||)|
|Total other income (expense)||(18,240||)||(453,315||)||(390,411||)||(893,480||)|
|Net loss per share - basic and diluted||$||(0.04||)||$||(0.06||)||$||(0.11||)||$||(0.12||)|
|Weighted average common shares outstanding - basic and diluted||105,835,578||90,791,285||98,887,421||90,004,597|
|Foreign currency translation adjustment||3,268||(18||)||1,495||(5||)|
Neuralstem's patented technology enables the commercial-scale production of multiple types of central nervous system stem cells, which are being developed as potential therapies for multiple central nervous system diseases and conditions.
Neuralstem's ability to generate neural stem cell lines from human hippocampus, which were used for systematic chemical screening for neurogenesis effect, led to the discovery and patenting of molecules that Neuralstem believes may stimulate the brain's capacity to generate new neurons, potentially reversing pathophysiologies associated with certain central nervous system (CNS) conditions.
The Company has completed Phase 1a and 1b trials evaluating NSI-189, its first neurogenic small molecule product candidate, for the treatment of major depressive disorder (MDD), and is currently conducting a Phase 2 efficacy study for MDD.
Neuralstem's first stem cell product candidate, NSI-566, a spinal cord-derived neural stem cell line, is under development for treatment of amyotrophic lateral sclerosis (ALS). Neuralstem has completed two clinical studies, in a total of 30 patients, which met primary safety endpoints.
In addition to ALS, NSI-566 is also in a Phase 1 study to treat paralysis due to chronic spinal cord injury, as well as in a Phase 1 study to treat paralysis from ischemic stroke.
Cautionary Statement Regarding Forward Looking Information:
This news release contains "forward-looking statements" made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements relate to future, not past, events and may often be identified by words such as "expect," "anticipate," "intend," "plan," "believe," "seek" or "will." Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Specific risks and uncertainties that could cause our actual results to differ materially from those expressed in our forward-looking statements include risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Neuralstem's periodic reports, including the Annual Report on Form 10-K for the year ended December 31, 2015, and filed with the Securities and Exchange Commission (SEC) on March 14, 2016, Form 10-Q for the period ended June 30, 2016, and in other reports filed with the SEC.
Neuralstem Contact: Danielle Spangler Director, Investor Relations 301.366.1481 Media Contact: Eliza Schleifstein Argot Partners Managing Director, Media 973.361.1546