Form 8-K Neuralstem, Inc. For: Nov 14

 

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): November 15, 2019 (November 14, 2019)

________________________________

 

Seneca Biopharma, Inc.

(Exact name of registrant as specified in Charter)

 

 

Delaware		001-33672		52-2007292
(State or other jurisdiction of incorporation or organization)		(Commission File No.)		(IRS Employee Identification No.)

 

20271 Goldenrod Lane, 2 ^nd Floor, Germantown, Maryland 20876

(Address of Principal Executive Offices)

 

(301) 366-4960

(Issuer Telephone number)

 

 

(Former Name or Former address, if changed since last report):

 

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 (see General Instruction A.2. below):

 

	¨	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))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of Class		Trading Symbol		Name of Each Exchange on Which Registered
Common stock, par value $0.01 per share		SNCA		NASDAQ Capital Market

 

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 November 14, 2019, Seneca Biopharma, Inc. (the “Company”) reported financial results for the quarter ended September 30, 2019. A copy of the press release is attached hereto 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 November 14, 2019

 

 

 

  

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Report on Form 8-K to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

Date:	November 15, 2019	Seneca Biopharma, Inc.
		/s/ Kenneth Carter
		By: Kenneth Carter
		Executive Chairman

 

 

 

 

 

INDEX OF EXHIBITS

 

Exhibit No.		Description
99.01		Press Release dated November 14, 2019

 

Exhibit 99.01

 

 

 

 

Seneca Biopharma Reports Third Quarter 2019 Fiscal Results

 

GERMANTOWN, Md., November 14, 2019 – Seneca Biopharma, Inc. (Nasdaq: SNCA), a clinical-stage biopharmaceutical company developing novel treatments for various diseases of high unmet medical need, reported its financial results for the three and nine months ended September 30, 2019.

 

RECENT HIGHLIGHTS & ACCOMPLISHMENTS:

 

·

Name change to Seneca Biopharma, Inc. (SNCA) in October 2019;

·

Signed non-binding term sheet for an exclusive license to a pipeline of monoclonal antibody product candidates for a range of auto-immune and other diseases;

·

Completed $7.5 million underwritten public offering; and

·

Regained compliance with the NASDAQ listing requirements.

 

“We are pleased at the progress we have made to reshape our company. Changing our name to Seneca Biopharma, Inc. is symbolic of our new focus and direction. Additionally, with our recently announced non-binding term sheet with Jiangsu QYuns Therapeutics Co., Ltd., we have accomplished one of our primary objectives in moving forward with the transformation of the Company” said Ken Carter, Executive Chairman of Seneca.

 

Financial Results for the Quarter Ended September 30, 2019

 

Research and Development Expenses: R&D expenses for the quarter ended September 30, 2019 decreased to $0.8 million versus the comparable period of 2018 of $0.9 million. The decrease reflects reduced clinical activities offset by increases in costs of identification and evaluation of strategic program opportunities.

 

R&D expenses for the nine months ended September 30, 2019 increased by $0.2 million, 7%, to $3.3 million from $3.1 million over the comparable period of 2018. This increase was primarily attributable to increases in costs of identification and evaluation of strategic program opportunities, a $0.5 million write-off related to an employee payable in connection with such employee’s termination, and partially offset by a decrease in clinical costs.

General and Administrative Expenses: G&A expenses for the quarter ended September 30, 2019 increased by $0.1 million to $1.3 million, or 10%, over the $1.2 million reflected in the comparable period of 2018. This increase primarily relates to an increase in non-cash compensation expense which was partially offset by a decrease in tax expense.

 

G&A expenses for the nine months ended September 30, 2019 decreased by $0.4 million to $3.2 million, or 13%, from $3.6 million reflected in the comparable period of 2018. This decrease is the result of general expense reduction efforts across multiple areas including consulting, outside services, tax and insurance expense as well as an increase in non-cash compensation expense.

 

Net Loss: Net loss for the quarter ended September 30, 2019 was $1.8 million, or $0.59 per share, compared to a loss of $1.8 million, or $2.41 per share, for the comparable period of 2018. Weighted average shares outstanding were 3.0 million shares at September 30, 2019 compared to 0.76 million shares at September 30, 2018.

 

Net loss for the nine months ended September 30, 2019 was $6.3 million, or $4.80 per share, compared to a loss of $4.6 million, or $6.08 per share, for the comparable period of 2018. Weighted average shares outstanding were 1.3 million shares at September 30, 2019 compared to 0.76 million shares at September 30, 2018.

 

All per share numbers have been retroactively adjusted for our 1-for-20 reverse stock split.

 

The net loss in the three and nine-month periods of 2018 were positively impacted by reductions in the derivative liabilities related to outstanding warrants reflected on the September 30, 2018 statement of operations of $0.2 and $1.8 million, respectively. The corresponding 2019 three- and nine-month periods also reflect reduced derivative liabilities with the impact reflected on the statement of operations in the amounts of $0.3 and $0.4 million, respectively.

 

Cash Position and Liquidity: At September 30, 2019, cash, cash equivalents and short-term investments were $7.3 million as compared to $5.8 million at December 31, 2018. The Company anticipates its existing cash, cash equivalents to fund its operations, based on its current operating plans, into the third quarter of 2020.

 

Seneca Biopharma, Inc.
Unaudited Condensed Consolidated Balance Sheets
			September 30,				December 31,
			2019				2018
ASSETS
CURRENT ASSETS
Cash and cash equivalents		$	7,299,836			$	5,787,110
Trade and other receivables			61,154				294,057
Current portion of related party receivable, net of discount			-				63,938
Prepaid expenses			605,312				363,288
Total current assets			7,966,302				6,508,393
Property and equipment, net			51,943				90,311
Patents, net			688,127				763,543
Related party receivable, net of discount and current portion			-				298,238
ROU and other assets			237,141				23,965
Total assets		$	8,943,513			$	7,684,450
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES
Accounts payable and accrued expenses		$	1,181,364			$	832,564
Short term note and other current liabilities			400,016				218,602
Total current liabilities			1,581,380				1,051,166
Warrant liabilities, at fair value			166,938				583,734
Lease liability, net of current portion			152,632				-
Total liabilities			1,900,950				1,634,900
STOCKHOLDERS' EQUITY
Preferred stock, 7,000,000 shares authorized, $0.01 par value; 200,000 and 1,000,000 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively			2,000				10,000
Common stock, $0.01 par value; 300,000,000 shares authorized, 2,818,291 and 910,253 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively			28,183				9,103
Additional paid-in capital			226,957,990				219,654,753
Accumulated other comprehensive loss			(7,670	)			(413	)
Accumulated deficit			(219,937,940	)			(213,623,893	)
Total stockholders' equity			7,042,563				6,049,550
Total liabilities and stockholders' equity		$	8,943,513			$	7,684,450

 

Seneca Biopharma, Inc.
Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss
		Three Months Ended September 30,								Nine Months Ended September 30,
		2019				2018				2019				2018
Revenues		$	2,500			$	2,500			$	12,894			$	257,500
Operating expenses:
Research and development expenses			825,486				897,098				3,294,402				3,081,319
General and administrative expenses			1,301,189				1,188,076				3,217,613				3,630,822
Total operating expenses			2,126,675				2,085,174				6,512,015				6,712,141
Operating loss			(2,124,175	)			(2,082,674	)			(6,499,121	)			(6,454,641	)
Other income (expense):
Interest income			15,234				17,619				55,086				54,882
Interest expense			(1,913	)			(1,498	)			(4,437	)			(4,190	)
Change in fair value of derivative instruments			320,785				236,270				416,796				1,805,319
Other income (expense)			26,935				-				(282,371	)			(5,667	)
Total other income			361,041				252,391				185,074				1,850,344
Net loss		$	(1,763,134	)		$	(1,830,283	)		$	(6,314,047	)		$	(4,604,297	)
Net loss per share - basic and diluted		$	(0.59	)		$	(2.41	)		$	(4.80	)		$	(6.08	)
Weighted average common shares outstanding - basic and diluted			2,975,779				758,575				1,316,597				757,221
Comprehensive loss:
Net loss		$	(1,763,134	)		$	(1,830,283	)		$	(6,314,047	)		$	(4,604,297	)
Foreign currency translation adjustment			(4,501	)			(512	)			(7,257	)			(2,001	)
Comprehensive loss		$	(1,767,635	)		$	(1,830,795	)		$	(6,321,304	)		$	(4,606,298	)

 

About Seneca Biopharma, Inc.

 

Seneca Biopharma, Inc., is a clinical-stage biopharmaceutical company developing novel treatments for various diseases of high unmet medical need. The Company is in the process of transforming the organization through the acquisition or in-licensing of new science and technologies, to develop with the goal of providing meaningful therapies for patients.

 

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 Seneca’s periodic reports, including its Annual Report on Form 10-K for the year ended December 31, 2018, as well as our Quarterly Reports on Form 10-Q, 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:

 

Hibiscus Bioventures

[email protected]

 

 

 

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