UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_____________________
Form 8-K
_____________________
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event Reported): May 12, 2017 (May 10, 2017)
Neuralstem, Inc.
(Exact Name of Registrant as Specified in Charter)
Delaware | 001-33672 | 52-2007292 |
(State or Other Jurisdiction of Incorporation) | (Commission File Number) | (I.R.S. Employer Identification Number) |
20271 Goldenrod Lane, 2nd Floor, Germantown, Maryland 20876 |
(Address of Principal Executive Offices) (Zip Code) |
301-366-4960
(Registrant's telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: | ||
[ ] | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |
[ ] | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |
[ ] | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |
[ ] | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). Emerging growth company [ ]
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [ ]
Item 2.02. Results of Operations and Financial Condition.
On May 10, 2017, Neuralstem, Inc. (the “Company”) reported financial results for the three months ended March 31, 2107 and provided an update on clinical programs and business highlights. The press release is attached as Exhibit 99.01 and is incorporated herein by reference. The information furnished under Items 2.02, including the accompanying Exhibit 99.01 shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”), or otherwise subject to the liability of such section, nor shall such information be deemed to be incorporated by reference in any subsequent filing by the Company under the Securities Act of 1933 or the Exchange Act, regardless of the general incorporation language of such filing, except as specifically stated in such filing.
Item 9.01. Financial Statements and Exhibits.
Exhibit
No. Description 99.01 Press Release Dated May 10, 2017
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Neuralstem, Inc. | ||
Date: May 12, 2017 | By: | /s/ Richard Daly |
Richard Daly | ||
Chief Executive Officer | ||
INDEX OF EXHIBITS
Exhibit No. | Description | |
99.01 | Press Release Dated May 10, 2017 |
Exhibit 99.01
Neuralstem Reports First Quarter 2017 Fiscal Results Provides Clinical and Business Update
Phase 2 MDD clinical trial results expected in 3Q17, Extended runway of cash into 3Q18
GERMANTOWN, Md., May 10, 2017 (GLOBE NEWSWIRE) -- Neuralstem, Inc. (Nasdaq:CUR), a biopharmaceutical company developing next generation treatments for nervous system diseases, reported its financial results for the quarter ended March 31, 2017.
“This is an exciting time for the company as we approach a large clinical milestone of NSI-189 Phase 2 major depressive disorder (MDD) study results, which remain ahead of schedule for the third quarter of this year,” commented Rich Daly, chairman and CEO. “We also continue to strengthen our balance sheet and have extended our cash runway an additional quarter into late 2018.”
Clinical Highlights
Corporate Highlights
Financial Results for the Quarter Ended March 31, 2017
Cash Position: Cash, cash equivalents and short-term investments on hand was approximately $16.7 million at March 31, 2017, compared to approximately $20.2 million at December 31, 2016. The decrease resulted from use of cash to fund our NSI-189 clinical programs and to meet our debt repayment obligations partially offset by cash raised of approximately $2.2 million, net primarily from the exercise of warrants in March 2017. As of March 31, 2017 we had approximately $2.58 million of debt outstanding as compared to $3.8 million at December 31, 2016.
Net Loss: In the quarter ended March 31, 2017, we reported a net loss of approximately $7.6 million or $0.68 per share, compared to a loss of approximately $6.6 million or $0.93 per share on a split adjusted basis in the quarter ended March 31, 2016. Our operating loss in the quarter ended March 31, 2017 was approximately $4.2 million, compared to a loss of approximately $6.2 million in the quarter ended March 31, 2016.
R&D Expenses: Research and development expenditures, at $2.9 million, decreased by approximately $0.2 million in the quarter ended March 31, 2017 as compared to expenditures of $3.1 million in the quarter ended March 31, 2016. The decrease in research and development expenses was primarily attributable to a $1.8 million reduction in employment costs, internal and external research expenditures associated with our May, 2016 restructuring partially offset by a $1.6 million increase in clinical trial costs associated with our ongoing Phase 2 MDD study.
G&A Expenses: General and administrative expenses decreased by approximately $1.8 million dollars to $1.3 million in the quarter ended March 31, 2017 as compared to $3.2 million for the quarter ended March 31, 2016. The decrease was primarily attributable to employment costs savings associated with our May, 2016 restructuring.
Equity and Reverse Stock Split: The Board of Directors approved a 1-for-13 reverse stock split of the Company’s common stock effective January 6, 2017. Stockholders' equity and all references to share and per share amounts in the accompanying consolidated financial statements have been retroactively adjusted to reflect the 1-for-13 reverse stock split for all periods presented.
We had 11.7 million and 7.1 million common shares issued and outstanding on a reverse split adjusted basis and 1.0 million and no preferred shares issued and outstanding at March 31, 2017 and 2016, respectively.
Liquidity: We expect that our existing cash, cash equivalents and short-term investments will fund our anticipated level of operations based on our current operating plans, into the second half of 2018.
Neuralstem, Inc. | |||||||
Unaudited Condensed Consolidated Balance Sheets | |||||||
March 31, 2017 | December 31, 2016 | ||||||
ASSETS | |||||||
CURRENT ASSETS | |||||||
Cash and cash equivalents | $ | 11,680,499 | $ | 15,194,949 | |||
Short-term investments | 5,000,000 | 5,000,000 | |||||
Trade and other receivables | 14,715 | 10,491 | |||||
Current portion of related party receivable, net of discount | - | 53,081 | |||||
Prepaid expenses | 477,072 | 646,195 | |||||
Total current assets | 17,172,286 | 20,904,716 | |||||
Property and equipment, net | 242,810 | 269,557 | |||||
Patents, net | 904,732 | 990,153 | |||||
Related party receivable, net of discount and current portion | 392,840 | 424,240 | |||||
Other assets | 15,824 | 15,662 | |||||
Total assets | $ | 18,728,492 | $ | 22,604,328 | |||
LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||
CURRENT LIABILITIES | |||||||
Accounts payable and accrued expenses | $ | 2,167,615 | $ | 2,343,936 | |||
Accrued bonuses | - | 852,963 | |||||
Current portion of long-term debt, net of fees and discount | 2,530,922 | 3,705,787 | |||||
Other current liabilities | 349,087 | 430,738 | |||||
Total current liabilities | 5,047,624 | 7,333,424 | |||||
Derivative instruments | 3,884,972 | 3,921,917 | |||||
Other long-term liabilities | 16,129 | 18,209 | |||||
Total liabilities | 8,948,725 | 11,273,550 | |||||
STOCKHOLDERS' EQUITY | |||||||
Convertible preferred stock, 7,000,000 shares authorized, $0.01 par value; 1,000,000 shares issued and outstanding at March 31, 2017 and December 31, 2016 respectively | 10,000 | 10,000 | |||||
Common stock, $0.01 par value; 300 million shares authorized, 11,743,244 and 11,032,858 shares outstandingat March 31, 2017 and December 31, 2016 respectively | 117,432 | 110,329 | |||||
Additional paid-in capital | 210,249,148 | 204,239,837 | |||||
Accumulated other comprehensive income | 3,734 | 3,905 | |||||
Accumulated deficit | (200,600,547 | ) | (193,033,293 | ) | |||
Total stockholders' equity | 9,779,767 | 11,330,778 | |||||
Total liabilities and stockholders' equity | $ | 18,728,492 | $ | 22,604,328 | |||
Neuralstem, Inc. | |||||||||
Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss | |||||||||
Three Months Ended March 31, | |||||||||
2017 | 2016 | ||||||||
Revenues | $ | 2,500 | $ | 2,500 | |||||
Operating expenses: | |||||||||
Research and development expenses | 2,902,086 | 3,065,590 | |||||||
General and administrative expenses | 1,332,421 | 3,170,522 | |||||||
Total operating expenses | 4,234,507 | 6,236,112 | |||||||
Operating loss | (4,232,007 | ) | (6,233,612 | ) | |||||
Other income (expense): | |||||||||
Interest income | 20,883 | 11,136 | |||||||
Interest expense | (138,732 | ) | (386,506 | ) | |||||
Change in fair value of derivative instruments | (2,741,314 | ) | - | ||||||
Warrant inducement and other expenses | (476,084 | ) | 3,199 | ||||||
Total other income (expense) | (3,335,247 | ) | (372,171 | ) | |||||
Net loss | $ | (7,567,254 | ) | $ | (6,605,783 | ) | |||
Net loss per share - basic and diluted | $ | (0.68 | ) | $ | (0.93 | ) | |||
Weighted average common shares outstanding - basic and diluted | 11,140,898 | 7,077,676 | |||||||
Comprehensive loss: | |||||||||
Net loss | $ | (7,567,254 | ) | $ | (6,605,783 | ) | |||
Foreign currency translation adjustment | (171 | ) | (1,773 | ) | |||||
Comprehensive loss | $ | (7,567,425 | ) | $ | (6,607,556 | ) | |||
About Neuralstem
Neuralstem is a clinical-stage biopharmaceutical company developing next-generation treatments for nervous system diseases of high unmet medical need. Neuralstem’s lead asset, NSI-189, is an oral antidepressant in Phase 2 clinical development for major depressive disorder (MDD). NSI-566 is a stem cell therapy being tested 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, filed with the Securities and Exchange Commission (SEC) on March 23, 2017, and in other reports filed with the SEC. We do not assume any obligation to update any forward-looking statements.
Contact:
Danielle Spangler
Neuralstem, Director of Investor Relations
301.366.1481
dspangler@neuralstem.com
Kimberly Minarovich
Argot Partners, Investor Relations
212-600-1902
kimberly@argotpartners.com
Lori Rosen
LDR Communications
Public Relations
917.553.6808
lori@ldrcommunications.com