Seneca Biopharma Reports 2020 Third Quarter Results

GERMANTOWN, Md., Nov. 10, 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 September 30, 2020.

Business Highlights for 2020 to date.

During 2020, the Company achieved the following business milestones:

    --  Completed offerings resulting in net proceeds of over $14.7 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 Matthew W. Kalnik, Ph.D. as President and Chief Operating
        Officer and Dane R. Saglio as Chief Financial Officer.

    --  Announced the completion of the last subject's follow-up assessment in
        the Company's non-GCP Phase II trial evaluating NSI-566, for the
        treatment of chronic ischemic stroke.

    --  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 September 30, 2020

Cash Position and Liquidity: At September 30, 2020, cash was approximately $12.7 million as compared to approximately $15.8 million at June 30, 2020.

Operating Loss: Operating loss for the quarter ended September 30, 2020 was $2.3 million compared to a loss of $2.1 million for the comparable 2019 period. For the nine-month period ended September 30, 2020, the operating loss was $6.3 million versus $6.5 million for the nine months ended September 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 September 30, 2020 was $2.3 million, or $0.13 per share, compared to a loss of $1.8 million, or $0.59 per share on a post-reverse stock-split basis, for the same period in 2019. For the 2020 nine-month period the net loss was $11.8 million, or $0.93 per share versus a net loss of $6.3 million, or $4.80 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

              September 30,                 
     December 31,

                                                                                 2020                              2019


              CURRENT ASSETS

      Cash and cash equivalents                                           $12,651,728                        $5,114,917

      Trade and other receivables                                               8,779                            21,064

     Prepaid expenses                                                      1,431,398                           510,900

     Assets held for sale                                                    899,538                                 -

                 Total current assets                                      14,991,443                         5,646,881

      Property and equipment, net                                              15,040                            41,036

     Patents, net                                                            152,625                           668,936

     ROU and other assets                                                     10,439                           227,036

                 Total assets                                             $15,169,547                        $6,583,889




      Accounts payable and accrued
       expenses                                                              $577,558                          $824,406

     Accrued bonuses                                                          98,750                           135,686

      Short-term note and other
       current liabilities                                                          -                          264,665

      Liabilities associated with
       assets held for sale                                                   325,812

                 Total current liabilities                                  1,002,120                         1,224,757

      Warrant liabilities, at fair
       value                                                                   44,954                            84,596

      Lease liability, net of
       current portion                                                              -                          148,543


                 Total liabilities                                          1,047,074                         1,457,896


      Preferred stock, 7,000,000
       shares authorized, $0.01 par
       value; 200,000 shares issued
       and outstanding at September
       30, 2020 and December 31,
       2019                                                                     2,000                             2,000

      Common stock, $0.01 par value;
       authorized, 17,295,703 and
       3,866,457 shares issued and
       outstanding at September 30,
       2020 and December 31, 2019,
       respectively                                                           172,957                            38,665

      Additional paid-in capital                                          247,775,027                       227,067,058

      Accumulated other
       comprehensive loss                                                     (3,986)                          (6,186)

     Accumulated deficit                                               (233,823,525)                    (221,975,544)

                 Total stockholders' equity                                14,122,473                         5,125,993

                 Total liabilities and
                  stockholders' equity                                    $15,169,547                        $6,583,889


                Seneca Biopharma, Inc.
               Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss

                                                             Three Months Ended September
                                                              30,                                            Nine Months Ended September 30,

                                              2020                         2019                          2020                         2019

     Revenues                              $2,500                       $2,500                       $11,020                      $12,894

      Operating expenses:

      Research and
       development expenses                466,014                      825,486                     1,608,935                    3,294,402

      General and
       expenses                          1,880,122                    1,301,189                     4,683,539                    3,217,613

      Total operating
       expenses                          2,346,136                    2,126,675                     6,292,474                    6,512,015

      Operating loss                   (2,343,636)                 (2,124,175)                  (6,281,454)                 (6,499,121)

      Other income (expense):

      Interest income                        7,731                       15,234                        27,935                       55,086

      Interest expense                     (3,586)                     (1,913)                     (14,015)                     (4,437)

      Warrant inducement
       expense                                                                                  (5,620,089)

      Gain on fair value of
       liability classified
       warrants                             17,669                      320,785                        39,642                      416,796

      Other income (expense)                                            26,935                                                 (282,371)

      Total other income
       (expense)                            21,814                      361,041                   (5,566,527)                     185,074

     Net loss                        $(2,321,822)                $(1,763,134)                $(11,847,981)                $(6,314,047)

      Net loss per share -
       basic and diluted                   $(0.13)                     $(0.59)                      $(0.93)                     $(4.80)

      Weighted average common
       shares outstanding -
       basic and diluted                17,306,672                    2,975,779                    12,713,094                    1,316,597

      Comprehensive loss:

     Net loss                        $(2,321,822)                $(1,763,134)                $(11,847,981)                $(6,314,047)

      Foreign currency
       translation adjustment                3,180                      (4,501)                        2,200                      (7,257)

      Comprehensive loss              $(2,318,642)                $(1,767,635)                $(11,845,781)                $(6,321,304)

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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