Exhibit 99.01

Neuralstem Provides Business Update and Reports Second Quarter 2018 Fiscal Results

- Phase 2 clinical trial initiated to further evaluate NSI-566 as treatment for ischemic stroke -
- NSI-189 Granted Orphan Drug Designation for the Treatment of Angelman Syndrome -
- Jim Scully appointed interim chief executive officer -

GERMANTOWN, Md., Aug. 15, 2018 (GLOBE NEWSWIRE) -- Neuralstem, Inc. (Nasdaq:CUR), a biopharmaceutical company focused on the development of nervous system therapies based on its neural stem cell and small molecule compound technologies, provides a business update and reported its financial results for the second quarter ended June 30, 2018. 

“We are pleased to report a productive second quarter of 2018 as we continue to advance our pipeline of innovative neural stem cell and small molecule therapies,” said Jim Scully, interim Chief Executive Officer of Neuralstem. “We are especially excited about the advancement of our lead stem cell therapy candidate, NSI-566, into a Phase 2 trial in ischemic stroke, as well as its potential application to other areas of unmet medical need. Additionally, based on encouraging preclinical data, we look forward to exploring our small molecule NSI-189’s potential treatment applications, including Angelman Syndrome and Alzheimer’s Disease.”

Clinical Highlights

NSI-566, is a spinal cord-derived neural stem cell line that is being evaluated to treat paralysis associated with stroke, Amyotrophic Lateral Sclerosis (ALS) and chronic spinal cord injury (cSCI). NSI-566 is Neuralstem’s lead stem cell therapy candidate.

NSI-189, is a small molecule benzylpiperazine-aminopyridine, in clinical development for MDD and in preclinical development for Angelman syndrome, irradiation-induced cognitive impairment, Type 1 and Type 2 diabetes, and stroke.

Corporate Highlights

Financial Results for the Quarter Ended June 30, 2018

Cash Position and Liquidity:  At June 30, 2018, cash and investments was $7.1 million as compared to $9.7 million at March 31, 2018.  The $2.6 million decrease reflects a $0.6 million loss for the period adjusted for certain non-cash items including a $1.4 million gain related to the change in fair value of our liability classified warrants, $760,000 net cash outflows related to changes in operating assets and liabilities, and $200,000 of share-based compensation. The Company expects its existing cash, cash equivalents and short-term investments to fund its operations based on its current operating plans, into the first quarter of 2019.

Operating Loss: Operating loss for the second quarter ended June 30, 2018 was $2.0 million compared to a loss of $4.2 million for the comparable period of 2017.  Operating loss for the six months ended June 30, 2018 was $4.4 million compared to a loss of $8.5 million for comparable period of 2017. 

The decrease in operating loss for both the three- and six-month periods was primarily related to decreases in clinical trial and related costs due to the completion of the NSI-189 Phase 2 clinical trial, decreases in personnel, facility and related expenses due to ongoing corporate restructuring and cost reduction efforts offset by revenues from a milestone-based royalty and reimbursements under a National Institute of Health (NIH) grant.

Net Loss:  Net loss for the second quarter ended June 30, 2018 was $0.6 million, or $0.04 per share (basic), compared to a loss of $4.6 million, or $0.39 per share (basic), for the comparable period of 2017.  The decrease in net loss was primarily due to a decrease in operating loss and the non-cash charges related to the change in the fair value of liability classified warrants.

Net loss for the six months ended June 30, 2018 was $2.8 million, or $0.18 per share (basic), compared to a loss of $12.2 million, or $1.06 per share (basic), for the comparable period of 2017.  The decrease in net loss was primarily due to a decrease in operating loss and the non-cash charges related to the change in the fair value of liability classified warrants and warrant inducement expenses in the 2017 period and a decrease in interest expense related to our long-term debt which matured in April 2017.

Research and Development Expenses: The $1.0 million of research and development expenses for the quarter ended June 30, 2018 represents a $1.6 million, or 61% decrease over the comparable period of 2017.  This decrease was primarily attributable to a $710,000 decrease in personnel and facility expenses due to ongoing corporate restructuring and cost reduction efforts, a $310,000 decrease in clinical trial and related costs due to the completion of our NSI-189 Phase 2 clinical trial and a $410,000 decrease in non-cash share-based compensation expense along with $90,000 of reimbursements under a NIH grant.

The $2.2 million of research and development expenses for the six months ended June 30, 2018 represents a $3.3 million, or 60% decrease over the comparable period of 2017.  This decrease was primarily attributable to a $1.8 million decrease in personnel and facility expenses due to ongoing corporate restructuring and cost reduction efforts, a $540,000 decrease in clinical trial and related costs due to the completion of the NSI-189 Phase 2 clinical trial, a $720, 000 decrease in our non-cash share-based compensation expense along with $180,000 of reimbursements under a NIH grant.

General and Administrative Expenses:  The $1.3 million of general and administrative expenses for the second quarter ended June 30, 2018 represents a $380,000, or 23% decrease over the comparable period of 2017.  This decrease was primarily attributable to a $400,000 decrease in payroll and related expenses due to corporate restructuring and cost reduction efforts coupled with a $40,000 decrease in non-cash share-based compensation expense partially offset by a $70,000 increase in tax and insurance expenses.

The $2.4 million of general and administrative expenses for the six months ended June 30, 2018 represents a $530,000, or 18% decrease over the comparable period of 2017.  This decrease was primarily attributable to a $560,000 decrease in payroll and related expenses coupled with a $40,000 decrease in consulting and professional service expenses due to corporate restructuring and cost reduction efforts partially offset by a $90,000 increase in our tax and insurance expenses.

 
Neuralstem, Inc.
    
Unaudited Condensed Consolidated Balance Sheets
    
 June 30, December 31,
 2018 2017
    
ASSETS   
CURRENT ASSETS   
Cash and cash equivalents$7,092,832  $6,674,940 
Short-term investments -   5,000,000 
Trade and other receivables 478,722   312,802 
Current portion of related party receivable, net of discount -   58,784 
Prepaid expenses 343,428   402,273 
Total current assets 7,914,982   12,448,799 
    
Property and equipment, net 128,017   172,886 
Patents, net 814,023   883,462 
Related party receivable, net of discount and current portion 343,281   365,456 
Other assets 33,004   13,853 
Total assets$9,233,307  $13,884,456 
    
LIABILITIES AND STOCKHOLDERS' EQUITY   
CURRENT LIABILITIES   
Accounts payable and accrued expenses$713,068  $875,065 
Accrued bonuses -   418,625 
Other current liabilities 52,933   220,879 
Total current liabilities 766,001   1,514,569 
    
Warrant liabilities 2,283,833   3,852,882 
Other long term liabilities 8,270   1,876 
Total liabilities 3,058,104   5,369,327 
    
STOCKHOLDERS' EQUITY   
Preferred stock, 7,000,000 shares authorized, $0.01 par value; 1,000,000 shares issued and outstanding at both June 30, 2018 and December 31, 2017 10,000   10,000 
Common stock, $0.01 par value; 300,000,000 shares authorized, 15,160,014 shares issued and outstanding at both June 30, 2018 and December 31, 2017 151,600   151,600 
Additional paid-in capital 217,485,751   217,050,174 
Accumulated other comprehensive income 1,142   2,631 
Accumulated deficit (211,473,290)  (208,699,276)
Total stockholders' equity 6,175,203   8,515,129 
Total liabilities and stockholders' equity$9,233,307  $13,884,456 
        


 
Neuralstem, Inc.
        
Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss
    
 Three Months Ended June 30, Six Months Ended June 30,
 2018 2017 2018 2017
        
Revenues$252,500  $2,500  $255,000  $5,000 
        
Operating expenses:       
Research and development expenses 1,014,780   2,585,079   2,184,221   5,487,165 
General and administrative expenses 1,260,692   1,635,652   2,442,746   2,968,073 
Total operating expenses 2,275,472   4,220,731   4,626,967   8,455,238 
Operating loss (2,022,972)  (4,218,231)  (4,371,967)  (8,450,238)
        
Other income (expense):       
Interest income 19,514   14,013   37,263   34,896 
Interest expense (772)  (15,728)  (2,692)  (154,460)
Change in fair value of derivative instruments 1,378,830   (341,611)  1,569,049   (3,082,925)
Fees related to issuance of inducement warrants and other expenses (1,646)  (87,635)  (5,667)  (563,719)
Total other income (expense) 1,395,926   (430,961)  1,597,953   (3,766,208)
        
Net loss$(627,046) $(4,649,192) $(2,774,014) $(12,216,446)
        
Net loss per share - basic and diluted$(0.04) $(0.39) $(0.18) $(1.06)
        
Weighted average common shares outstanding - basic and diluted 15,144,243   11,906,334   15,130,666   11,525,730 
        
Comprehensive loss:       
Net loss$(627,046) $(4,649,192) $(2,774,014) $(12,216,446)
Foreign currency translation adjustment (1,604)  (384)  (1,489)  (555)
Comprehensive loss$(628,650) $(4,649,576) $(2,775,503) $(12,217,001)
                

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 its Annual Report on Form 10-K for the year ended December 31, 2017, and its Quarterly Report on Form 10-Q for the three months ended March 31, 2018, 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.

Contact:

Argot Partners (Investor Relations)
212-600-1902
neuralstem@argotpartners.com