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.

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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.

 

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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 

 

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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)

 

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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

josh@hibiscusbio.com

 

 

 

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