Nov 13, 2017 Market Comments Off on Neuralstem Reports Third Quarter 2017 Fiscal Results and Provides Clinical and Business Update
GERMANTOWN, Md., Nov. 13, 2017 (GLOBE NEWSWIRE) — Neuralstem, Inc. (NASDAQ:CUR), a biopharmaceutical company focused on the development of nervous system therapies based on its neural stem cell technology, reported its financial results for the three and nine month periods ended September 30, 2017.
“We continue to evaluate the full Phase 2 data set for NSI-189 to determine the optimal development path in major depressive disorder and for other conditions, including Angelman’s Syndrome following highly encouraging preclinical data in that setting. We expect to provide a detailed update on our corporate strategy, including development and regulatory plans, after our post-phase 2 meeting with the FDA in the first half of 2018,” commented Rich Daly, Chairman and CEO.
“Our recent financing has further extended the company’s cash runway to sufficiently support continued research on NSI-189 and to support operations. We are encouraged by the emerging clinical profile of NSI-189 and look forward to presenting additional clinical data at the upcoming American College of Neuropsychopharmacology in December.”
Recent Corporate & Clinical Highlights & Milestones
Financial Results for the Third Quarter Ended September 30, 2017
Cash Position and Liquidity: At September 30, 2017, cash and investments was $14.1 million as compared to $11.4 million at June 30, 2017. The $2.6 million increase is due to proceeds of $5.4 million, net, from a public offering of common stock and warrants. On August 1, 2017, the Company closed a public offering of 3,000,000 shares of common stock and 2,250,000 common stock purchase warrants at a public purchase price of $2.00 per share and accompanying warrant. Gross proceeds were $6.0 million and approximately $5.4 million, net.
Operating Loss: Operating loss for the quarter ended September 30, 2017 was $2.6 million compared to a loss of $4.9 million for the same period of 2016. The decrease in operating loss for the third quarter 2017 was primarily due to a decrease in clinical trial expenses related to the completion of the Phase 2 clinical trial of NSI-189 in MDD coupled with ongoing corporate restructuring and cost reduction efforts.
Operating loss for the nine months ended September 30, 2017 was $11.0 million compared to a loss of $15.0 million for the same period of 2016. The decrease in operating loss for the nine-month period was primarily due to ongoing corporate restructuring and cost reduction efforts partially offset by increases in clinical trial expenses as the Company completed the Phase 2 clinical trial of NSI-189.
Net Loss: Net loss for the quarter ended September 30, 2017 was $0.1 million, or $0.01 per share (basic) compared to a loss of $5.2 million, or $0.59 per share (basic), on a split adjusted basis for the same period of 2016. The decrease in net loss was primarily due to a decrease in operating expenses along with a $2.7 million non-cash, gain resulting from the fair value adjustment of outstanding liability classified stock purchase warrants.
Net loss for the nine months ended September 30, 2017 was $12.4 million, or $1.00 per share (basic), compared to a loss of $15.7 million, or $1.96 per share (basic), on a split adjusted basis for the same period of 2016. The decrease in net loss was primarily due to a decrease in operating expenses and interest expense due to the maturity of long-term debt in April 2017.
R&D Expenses: The $2.2 million, or 61% decrease, in research and development expenses for the quarter ended September 30, 2017, as compared to the comparable period of 2016, was primarily attributable to a $1.7 million decrease in clinical trial expenses due to the completion of NSI-189 Phase 2 clinical trial, a $0.3 million decrease in personnel, facility and other expenses related to ongoing corporate restructuring and cost reduction efforts and a $0.2 million decrease in non-cash stock based compensation expense.
The $2.3 million, or 25% decrease, in research and development expenses for the nine months ended September 30, 2017, as compared to the comparable period of 2016, was primarily attributable to a $2.2 million decrease in personnel, facility and other expenses related to ongoing corporate restructuring and cost reduction efforts and a $0.4 million decrease in non-cash stock based compensation expense partially offset by a $0.3 million increase in clinical trial expenses related to the completion of the Phase 2 clinical trial of NSI-189.
G&A Expenses: The $0.1 million, or 9% decrease, in general and administrative expenses for the quarter ended September 30, 2017, as compared to the comparable period of 2016, was primarily attributable to a decrease in cash based board of directors fees.
The $1.7 million, or 29% decrease, in general and administrative expenses for the nine months ended September 30, 2017 as compared to the comparable period of 2016 was primarily attributable to a $1.0 million decrease in non-cash stock based compensation expense coupled with a $0.8 million decrease in personnel related expense as a result of headcount reductions.
|Unaudited Condensed Consolidated Balance Sheets|
|September 30, 2017||December 31, 2016|
|Cash and cash equivalents||$||9,063,710||$||15,194,949|
|Trade and other receivables||37,458||10,491|
|Current portion of related party receivable, net of discount||57,291||53,081|
|Total current assets||14,707,225||20,904,716|
|Property and equipment, net||196,191||269,557|
|Related party receivable, net of discount and current portion||356,174||424,240|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accounts payable and accrued expenses||$||1,476,683||$||2,343,936|
|Current portion of long-term debt, net of fees and discount||–||3,705,787|
|Other current liabilities||358,044||430,738|
|Total current liabilities||1,834,727||7,333,424|
|Other long-term liabilities||3,400||18,209|
|Convertible preferred stock, 7,000,000 shares authorized, $0.01 par value; 1,000,000 shares issued and outstanding at September 30, 2017 and December 31, 2016, respectively||10,000||10,000|
|Common stock, $0.01 par value; 300 million shares authorized, 15,146,027 and 11,032,858 shares issued and outstanding at September 30, 2017 and December 31, 2016, respectively||151,460||110,329|
|Additional paid-in capital||216,784,493||204,239,837|
|Accumulated other comprehensive income||2,345||3,905|
|Total stockholders’ equity||11,564,776||11,330,778|
|Total liabilities and stockholders’ equity||$||16,188,766||$||22,604,328|
|Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss|
|Three Months Ended September 30,||Nine Months Ended September 30,|
|Research and development expenses||1,383,863||3,589,793||6,871,028||9,130,012|
|General and administrative expenses||1,206,510||1,329,712||4,174,583||5,862,374|
|Total operating expenses||2,590,373||4,919,505||11,045,611||14,992,386|
|Other income (expense):|
|Change in fair value of derivative instruments||2,679,770||(538,261||)||(403,155||)||219,014|
|Gain on related party settlement||–||458,608||–||458,608|
|Fees related to issuance of derivative liabilities, warrant inducement and other expenses||(242,396||)||(456||)||(806,115||)||(463,798||)|
|Total other income (expense)||2,454,090||(303,278||)||(1,312,118||)||(693,689||)|
|Net loss per share – basic||$||(0.01||)||$||(0.59||)||$||(1.00||)||$||(1.96||)|
|Net loss per share – diluted||$||(0.18||)||$||(0.59||)||$||(1.00||)||$||(1.96||)|
|Weighted average common shares outstanding – basic||14,060,844||8,835,045||12,380,054||8,019,153|
|Weighted average common shares outstanding – diluted||14,163,072||8,835,045||12,380,054||8,019,153|
|Foreign currency translation adjustment||(1,005||)||21||(1,560||)||1,516|
Neuralstem is a clinical-stage biopharmaceutical company developing novel treatments for nervous system diseases of high unmet medical need. NSI-189 is a small molecule in clinical development for major depressive disorder (MDD) and in preclinical development for Angelman syndrome, irradiation-induced cognitive impairment, Type 1 and Type 2 diabetes, and stroke.
NSI-566 is a stem cell therapy being tested for treatment of paralysis in stroke, chronic spinal cord injury (cSCI) and Amyotrophic Lateral Sclerosis (ALS). Neuralstem’s diversified portfolio of product candidates is based on its proprietary neural stem cell technology.
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, 2016, and Form 10-Q for the three and nine months ended September 30, 2017, filed with the Securities and Exchange Commission (SEC), and in other reports filed with the SEC. We do not assume any obligation to update any forward-looking statements.
Argot Partners (Investor Relations)