GERMANTOWN, Md., Aug. 13, 2020 /PRNewswire/ -- Seneca Biopharma, Inc. (Nasdaq: SNCA), a biopharmaceutical company focused on developing novel treatments for diseases of high unmet medical need, today reported its financial results for the quarter ended June 30, 2020.

Business Highlights for 2020 to date.

During the First Half of 2020, the Company achieved the following business milestones:

  • Completed offerings resulting in net proceeds of over $14.8 million.   
  • Continued progress on both the Company's out-licensing effort to partner NSI-566 and NSI-189 programs and initiative to in-license or acquire novel therapeutics.
  • Appointed of Matthew W. Kalnik, Ph.D. as President and Chief Operating Officer and Dane R. Saglio as Chief Financial Officer.
  • Affirmed guidance that data readout from the Company's non-GCP Phase II trial evaluating NSI-566, for the treatment of chronic ischemic stroke, is expected during the second half of 2020.
  • Announced that as a result of feedback received from the FDA, Seneca believes that the existing Phase 1 and 2 trial results support moving into a Phase 3 clinical study for ALS.
  • Completion of the Company's stem cell manufacturing facility in Suzhou, China which will be used to manufacture NSI-566 for clinical trials within China.

Financial Results for the Quarter Ended June 30, 2020

Cash Position and Liquidity:  At June 30, 2020, cash was approximately $15.8 million as compared to approximately $10 million at March 31, 2020.  The increase in cash is attributed to the May 2020 warrant exercises and registered direct offering.

Operating Loss:  Operating loss for the quarter ended June 30, 2020 was $1.9 million compared to a loss of $1.9 million for the comparable 2019 period.  For the six-month period ended June 30, 2020, the operating loss was $3.9 million versus $4.4 million for the six months ended June 30, 2019.  The decrease in operating loss for 2020 was primarily due to a decrease in R&D expenses as we continue to wind down the clinical programs. This decrease was partially offset by an increase in G&A expenses which reflects an enhanced management structure to support corporate objectives as compared to the same period of 2019.

Net Loss:  Net loss for the quarter ended June 30, 2020 was $2.0 million, or $0.15 per share, compared to a loss of $1.4 million, or $1.45 per share on a post-reverse stock-split basis, for the same period in 2019.  For the 2020 six-month period the net loss was $9.5 million, or $0.92 per share versus a net loss of $4.6 million, or $4.78 per share for the same period in 2019.  The 2020 increase in net loss was primarily attributed to a non-cash expense of $5.6 million related to the January 2020 warrant inducement transaction.

Seneca Biopharma, Inc.

Unaudited Condensed Consolidated Balance Sheets






June 30,


December 31,


2020


2019





ASSETS




CURRENT ASSETS




Cash and cash equivalents

$         15,834,832


$          5,114,917

Trade and other receivables

16,938


21,064

Prepaid expenses

390,646


510,900

Total current assets

16,242,416


5,646,881





Property and equipment, net

21,698


41,036

Patents, net

630,554


668,936

ROU and other assets

206,994


227,036

Total assets

$         17,101,662


$          6,583,889





LIABILITIES AND STOCKHOLDERS' EQUITY




CURRENT LIABILITIES




Accounts payable and accrued expenses 

$              542,976


$             824,406

Accrued bonuses

98,750


135,686

Short-term note and other current liabilities

34,250


264,665

Total current liabilities

675,976


1,224,757





Warrant liabilities, at fair value

62,623


84,596

Lease liability, net of current portion

128,770


148,543

Total liabilities

867,369


1,457,896





STOCKHOLDERS' EQUITY




Preferred stock, 7,000,000 shares authorized, $0.01 par value; 200,000 shares
issued and outstanding at June 30, 2020 and December 31, 2019

2,000


2,000

Common stock, $0.01 par value; 300,000,000 shares authorized, 17,295,703 and
3,866,457 shares issued and outstanding at June 30, 2020 and December 31, 2019,
respectively

172,957


38,665

Additional paid-in capital

247,568,205


227,067,058

Accumulated other comprehensive loss

(7,166)


(6,186)

Accumulated deficit

(231,501,703)


(221,975,544)

Total stockholders' equity

16,234,293


5,125,993

Total liabilities and stockholders' equity

$         17,101,662


$          6,583,889

 

Seneca Biopharma, Inc.

 Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss



Three Months Ended June 30,


Six Months Ended June 30,


2020


2019


2020


2019









Revenues

$                         2,500


$                         7,894


$                         8,520


$                       10,394









Operating expenses:








Research and development expenses

446,032


954,453


1,142,921


2,468,916

General and administrative expenses

1,503,822


971,822


2,803,417


1,916,424

Total operating expenses

1,949,854


1,926,275


3,946,338


4,385,340

Operating loss

(1,947,354)


(1,918,381)


(3,937,818)


(4,374,946)









Other income (expense):








Interest income

6,915


10,852


20,204


39,852

Interest expense

(7,850)


(507)


(10,429)


(2,524)

Warrant inducement expense

-


-


(5,620,089)


-

Gain (loss) on fair value of liability classified warrants

(2,652)


436,126


21,973


96,011

Other income (expense)

-


34,989


-


(309,306)

Total other income (expense)

(3,587)


481,460


(5,588,341)


(175,967)









Net loss

$                 (1,950,941)


$                 (1,436,921)


$                 (9,526,159)


$                 (4,550,913)









Net loss per share - basic and diluted

$                          (0.15)


$                          (1.45)


$                          (0.92)


$                          (4.78)









Weighted average common shares outstanding - basic
and diluted

12,642,972


993,854


10,391,065


952,567









Comprehensive loss:








Net loss

$                 (1,950,941)


$                 (1,436,921)


$                 (9,526,159)


$                 (4,550,913)

Foreign currency translation adjustment

(18)


(1,013)


(980)


(2,756)

Comprehensive loss

$                 (1,950,959)


$                 (1,437,934)


$                 (9,527,139)


$                 (4,553,669)

About Seneca Biopharma, Inc.

Seneca Biopharma, Inc., is a clinical-stage biopharmaceutical company developing novel treatments for 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 filed with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2019, its Quarterly Reports on Form 10-Q as well as and in other reports filed with the SEC. We do not assume any obligation to update any forward-looking statements.

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SOURCE Seneca Biopharma, Inc.

Copyright 2020 PR Newswire

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