Galmed Pharmaceuticals Provides Business Update and Reports Fourth Quarter and Year End 2019 Financial Results

TEL AVIV, Israel, March 12, 2020 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of Aramchol, a liver targeted, oral, SCD1 modulator, currently in a Phase 3 clinical trial for the treatment of nonalcoholic steatohepatitis (NASH) and fibrosis provides today a business update and reports financial results for the three and twelve months ended December 31, 2019. The Company will host a conference call and webcast at 08:30 ET today.

Financial Summary - Full Year 2019 vs. Full Year 2018; 4Q19 vs. 4Q18:

    --  For the three and twelve months ended December 31, 2019, the Company
        recorded a net loss of $8.3 and $20.5 million or $0.39 and $0.97 per
        share, respectively, compared with a net loss of $3.7 million and $9.9
        million, or $0.18 and $0.54 per share, for the three and twelve months
        ended December 31, 2018.

    --  Research and development expenses were $18.2 million for the twelve
        months ended December 31, 2019, compared with $8.3 million for the
        twelve months ended December 31, 2018. For the three months ended
        December 31, 2019, research and development expenses totaled $7.4
        million, which compares with $2.7 million for the same period in 2018.
        The increase during the three and twelve months is mainly due to the
        preparation and initiation of the ARMOR study.

    --  The Company incurred general and administrative expenses of $4.2 million
        for the twelve months ended December 31, 2019, compared with $4.4
        million for the twelve months ended December 31, 2018. For the three
        months ended December 31, 2018, general and administrative expenses
        totaled $1.3 million, which compares with $1.5 million for the same
        period in 2018. The decrease primarily resulted from a decrease in
        salaries and benefits expenses of approximately $0.5 million due to
        lower year-end bonuses.

    --  During the three and twelve months ended December 31, 2019, the Company
        recognized a net financial income of $0.3 million and $1.9 million,
        respectively, compared with $0.5 and $0.9 million, respectively, during
        2018. The increase during the twelve months ended December 31, 2019 is
        mainly due to an increase in interest income from marketable debt
        securities and short-term deposits, as compared to such income in 2018.
    --  Cash and cash equivalents, restricted cash, short-term deposits and
        marketable debt securities totaled $75.6 million as of December 31,
        2019, compared with $90.2 million as of December 31, 2018. The decrease
        is mainly attributable to our $14.9 million negative cash flow from
        operations during the twelve months ended December 31, 2019.

Conference Call & Webcast:

Thursday, March 12(th) @ 8:30am Eastern Time.

     Toll Free:          


     Israel Toll Free:   

     Conference ID:                                                           13699345


Replay Dial-In Numbers

     Toll Free:          


     Replay Pin Number:                     13699345

     Replay Start:         Thursday, March 12, 2020,
                             11:30 AM ET

     Replay Expiry:        Thursday, March 26, 2020,
                             11:59 PM ET

About Aramchol and Non-alcoholic Steatohepatitis (NASH)
Aramchol (arachidyl amido cholanoic acid) is a novel fatty acid bile acid conjugate, inducing beneficial modulation of intra-hepatic lipid metabolism. Aramchol's ability to modulate hepatic lipid metabolism was discovered and validated in animal models, demonstrating downregulation of the three key pathologies of NASH: steatosis, inflammation and fibrosis. The effect of Aramchol on fibrosis is mediated by downregulation of steatosis and directly on human collagen producing cells. Aramchol has been granted Fast Track designation status by the FDA for the treatment of NASH.

NASH is an emerging world crisis impacting an estimated 3% to 5% of the U.S. population and an estimated 2% to 4% globally. It is the fastest growing cause of liver cancer and liver transplant in the U.S. due to the rise in obesity. NASH is the progressive form of non-alcoholic fatty liver disease that can lead to cardiovascular disease, cirrhosis and liver-related mortality.

About Galmed Pharmaceuticals Ltd.
Galmed Pharmaceuticals Ltd. is a clinical stage drug development biopharmaceutical company for liver, metabolic and inflammatory diseases. Our lead compound, Aramchol(TM), a backbone drug candidate for the treatment of NASH and fibrosis is currently in a Phase 3 registrational study.

Forward-Looking Statements:
his press release may include forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to Galmed's objectives, plans and strategies, as well as statements, other than historical facts, that address activities, events or developments that Galmed intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as "believes," "hopes," "may," "anticipates," "should," "intends," "plans," "will," "expects," "estimates," "projects," "positioned," "strategy" and similar expressions and are based on assumptions and assessments made in light of management's experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Many factors could cause Galmed's actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the following: the timing and cost of Galmed's pivotal Phase 3 ARMOR trial, or the ARMOR Study; completion and receiving favorable results of the ARMOR Study for Aramchol or any other pre-clinical or clinical trial; regulatory action with respect to Aramchol by the FDA or the EMA; the commercial launch and future sales of Aramchol or any other future products or product candidates; Galmed's ability to comply with all applicable post-market regulatory requirements for Aramchol in the countries in which it seeks to market the product; Galmed's ability to achieve favorable pricing for Aramchol; Galmed's expectations regarding the commercial market for NASH patients; third-party payor reimbursement for Aramchol; Galmed's estimates regarding anticipated capital requirements and Galmed's needs for additional financing; market adoption of Aramchol by physicians and patients; the timing, cost or other aspects of the commercial launch of Aramchol; the development and approval of the use of Aramchol for additional indications or in combination therapy; and Galmed's expectations regarding licensing, acquisitions and strategic operations. More detailed information about the risks and uncertainties affecting Galmed is contained under the heading "Risk Factors" included in Galmed's most recent Annual Report on Form 20-F filed with the SEC on March 12, 2020, and in other filings that Galmed has made and may make with the SEC in the future. The forward-looking statements contained in this press release are made as of the date of this press release and reflect Galmed's current views with respect to future events, and Galmed does not undertake and specifically disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.


                Consolidated Balance Sheets (Audited)


                U.S. Dollars in thousands, except share data and per share data

     As of December 31,

                                                                                                              2019                 2018


                Current assets

              Cash and cash equivalents                                                                           $
           15,931          $

              Restricted cash                                                                                                 112

              Short-term deposits                                                                                          27,938                  6,067

              Marketable debt securities                                                                                   31,622                 59,962

              Other accounts receivable                                                                                       827                    218

                Total current assets                                                                            76,430                 90,406

              Right of use assets                                                                                             538

              Property and equipment, net                                                                                     171                    194

                Total non-current assets                                                                           709                    194

                Total assets                                                                           $
           77,139          $

                Liabilities and stockholders' equity

                Current liabilities

              Trade payables                                                                                       $
           5,999           $

              Other accounts payable                                                                                          935                    892

                Total current liabilities                                                                        6,934                  2,706

                Non-current liabilities

              Lease obligation                                                                                       $

                Total non-current liabilities                                                                      352

                Stockholders' equity

              Ordinary shares, par value NIS 0.01 per share; Authorized                                                        58                     58
    50,000,000 shares; Issued and outstanding: 21,139,385 shares
    as of December 31, 2019; 21,018,919 shares as of December
    31, 2018

              Additional paid-in capital                                                                                  176,696                174,322

              Accumulated other comprehensive income (loss)                                                                    35                   (11)

              Accumulated deficit                                                                                       (106,936)              (86,475)

                Total stockholders' equity                                                                      69,853                 87,894

                Total liabilities and stockholders' equity                                             $
           77,139          $


                Consolidated Statements of Operations (Audited)


                U.S. Dollars in thousands, except share data and per share data

          Year ended December 31,

                                                                                              2019                                2018                   2017

        $                                     $
             2,038       $

              Research and development expenses                                                              18,180                             8,313                  9,650

              General and administrative expenses                                                             4,196                             4,440                  3,799

                Total operating loss                                                              22,376                            10,715                 12,364

              Financial income, net                                                                         (1,915)                            (934)                  (65)

                Loss before income taxes                                                          20,461                             9,781                 12,299

              Income taxes                                                                                                                        75

                Net loss                                                                 $
             20,461                  $
             9,856      $

              Basic and diluted net loss per share                                                    $
             0.97                   $
             0.54        $

              Weighted-average number of shares outstanding                                              21,114,399                        18,137,689             12,487,349
    used in computing basic and diluted net loss per share


                Consolidated Statements of Cash Flows (Audited)


                U.S. Dollars in thousands

             Year ended December 31,

                                                                                                           2019                                   2018                       2017

                Cash flow from operating activities

              Net loss for the year                                                                              $
           (20,461)                        $
           (9,856)           $

                Adjustments required to reconcile net loss to net cash used in
    operating activities:

              Depreciation and amortization                                                                                     35                                      387                           239

              Amortization of discount/premium on marketable debt securities                                                 (105)                                   (144)                           21

              Loss (gain) on sale of marketable debt securities                                                                (9)                                      12                           143

              Linked difference of marketable debt securities                                                                                                                                     (167)

              Interest income from short-term deposits                                                                        (63)

              Stock-based compensation expense                                                                               2,231                                    1,783                         1,394

                Changes in operating assets and liabilities:

              Decrease in deferred revenue from collaboration agreement                                                                                              (538)                      (1,085)

              Decrease (increase) in other accounts receivable                                                               (609)                                    (63)                          129

              Increase (decrease) in trade payables                                                                          4,185                                    (462)                        (846)

              Increase (decrease) in other accounts payable                                                                  (141)                                   (142)                          671

              Increase (decrease) in related party                                                                                                                                                (267)

                Net cash used in operating activities                                                          (14,937)                                 (9,023)                     (12,067)

                Cash flow from investing activities

              Purchase of property and equipment                                                                              (12)                                    (90)                         (12)

              Investment in securities, available for sale                                                                (72,600)                                (92,279)                      (3,869)

              Proceeds from sale of securities, available for sale                                                         101,098                                   38,421                        10,325

              Investment in short-term deposits, net                                                                      (21,808)                                 (6,067)                  

                Net cash provided by (used in) investing activities                                               6,678                                 (60,015)                        6,444

                Cash flow from financing activities

              Issuance of ordinary shares and warrants, net of issuance costs (*)                                                                                   79,149                        15,017

              Proceeds from exercise of options                                                                                143                                    1,027                           530

                Net cash provided by financing activities                                                           143                                   80,176                        15,547

                Increase (decrease) in cash and cash equivalents and restricted cash                            (8,116)                                  11,138                         9,924

                Cash and cash equivalents and restricted cash at the beginning of the year                       24,159                                   13,021                         3,097

                Cash and cash equivalents and restricted cash at the end of the year                    $
           16,043                          $
           24,159             $

                Supplemental disclosure of cash flow information:

              Cash received from interest                                                                           $
           1,953                             $
           865                $

              Cash paid for taxes                                                                     
          $                                                 $

                Non-cash transactions:

              Recognition of right-of-use asset and lease liabilities from adoption of ASU 2016-02                    $

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SOURCE Galmed Pharmaceuticals Ltd.