Galmed Pharmaceuticals Provides Business Update and Reports Second Quarter 2018 Financial Results

Published: Aug 02, 2018

 

- Conference Call and Webcast Today at 8:30 a.m. EST / 5:30 a.m. PST -

TEL AVIV, Israel, Aug. 2, 2018 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of the liver targeted SCD1 modulator Aramchol, a once-daily, oral therapy for the treatment of nonalcoholic steatohepatitis, or NASH, today provides business update and reports financial results for the three and six months ended June 30, 2018. The Company will host a conference call and webcast at 08:30 ET today.

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Business Update

  • In June 2018, the Company reported top line results in its global, 52 week, Phase IIb ARREST study on 247 NASH patients demonstrating that Aramchol™ 600 mg achieved a regulatory approvable endpoint showing NASH resolution without worsening of fibrosis. Full top line results can be viewed in the Company's press release dated June 12, 2018 and in a corporate presentation dated June 2018, both of which are available on the Company's website and in the Company's filings with the SEC. The Company is preparing for an end of Phase IIb meeting with the FDA to discuss the results of the ARREST study and the design of a pivotal study.
  • In June 2018, the Company completed an underwritten public offering of 5,000,000 ordinary shares, at a price of $15.00 per share. Net proceeds, after deducting underwriting discounts and commissions and offering expenses, were $70.3 million.
  • In April 2018, the Company sold to Biotechnology Value Fund, L.P. and certain of its affiliates 1,000,000 ordinary shares for a purchase price of $6.00 per share, and one-year warrants to purchase an additional 1,000,000 ordinary shares, with an exercise price of $15.00 per share. Net proceeds to the Company were $5.9 million.

Financial Summary - First Quarter 2018 vs. First Quarter 2017:

  • Cash and cash equivalents and marketable securities totaled $94.1 million as of June 30, 2018, compared to $19.0 million at December 31, 2017. The increase is mainly attributable to the approximately $70.3 million in net proceeds raised in an underwritten public offering that was completed in June 2018, together with $5.9 million in net proceeds raised in a registered direct offering during April 2018.
  • Net loss of $2.7 million, or ($0.17) per share, for the three months ended June 30, 2018, compared to a net loss of $2.7 million, or ($0.22) per share, for the three months ended June 30, 2018.
  • The Company recognized $0.3 million of revenue for the three months ended June 30, 2018, the same amount as in the corresponding quarter in 2017. The revenue relates to the amortization of the up-front payments under the license agreement with Samil Pharma.
  • Research and development expenses amounted to approximately $1.9 million for the three months ended June 30, 2018, compared to approximately $2.3 million for the three months ended June 30, 2017. The decrease resulted primarily from a decrease in expenses in connection with clinical studies.
  • General and administrative expenses amounted to approximately $1.1 million for the three months ended June 30, 2018, compared to approximately $0.6 million for the three months ended June 30, 2017. The increase in general and administrative expenses for the three months ended June 30, 2018 resulted primarily from a provision for employees' year-end compensation, as well as an increase in professional services.
  • Financial expenses amounted to $0.1 million for the three months ended June 30, 2018, compared to financial income of $0.01 million for the three months ended June 30, 2017.

Conference Call & Webcast:

    Thursday, August 2 @ 8:30am Eastern Time
    ----------------------------------------

    Within the US:                           888-394-8218

    Outside the US:                          323-701-0225

    From Israel:                                                                          1809 212 883

    Conference ID:                                                                             5856233

    Webcast:                                 http://public.viavid.com/index.php?id=130659


    Replays, Available through August 16:

    Domestic:                                844-512-2921

    International:                           412-317-6671

    Replay PIN:                                                                                5856233

 

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 is a clinical-stage biopharmaceutical company focused on the development of Aramchol, a first in class, novel, once-daily, oral therapy for the treatment of NASH for variable populations. Galmed recently announced top-line results of the ARREST Study, a multicenter, randomized, double blind, placebo-controlled Phase IIb clinical study designed to evaluate the efficacy and safety of Aramchol in subjects with NASH, who are overweight or obese, and who are pre-diabetic or type-II-diabetic. Galmed is currently preparing for an end of Phase IIb meeting with the FDA to discuss the results of the ARREST Study and a Phase III study protocol, with a view to initiating a Phase III clinical study of Aramchol in 2019.

Forward-Looking Statements:

This 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 planned Phase III trial for Aramchol, or whether a Phase III trial will be conducted at all; completion and receiving favorable results of a Phase III trial 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; 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 13, 2018, 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.

 

    GALMED PHARMACEUTICALS LTD.

    Consolidated Balance Sheets
    ---------------------------

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


                                                               As of                As of
                                                             June 30,           December 31,
                                                                  2018                   2017
                                                                  ----                   ----

                                                            Unaudited              Audited
                                                            ---------              -------

    Assets

    Current assets

    Cash and cash
     equivalents                                                         $6,151                 $13,021

    Marketable securities                                                87,954                   5,976

    Other accounts
     receivable                                                             368                     155
                                                                            ---                     ---

    Total current assets                                                 94,473                  19,152
                                                                         ------                  ------


    Property and
     equipment, net                                                         374                     491
                                                                            ---                     ---


    Total assets                                                        $94,847                 $19,643
                                                                        =======                 =======


    Liabilities and
     stockholders' equity


    Current liabilities

    Trade payables                                                       $2,346                  $2,276

    Other accounts payable                                                1,458                   1,034

    Short-term portion of
     deferred revenue                                                         -                    538
                                                                            ---                    ---

    Total current
     liabilities                                                          3,804                   3,848
                                                                          -----                   -----


    Stockholders' equity:

    Ordinary shares par
     value NIS 0.01 per
     share; Authorized
     50,000,000;                                                             58                      40
    Issued and
     outstanding:
     20,912,754 shares as
     of June 30, 2018;
    14,435,161 shares as
     of December 31, 2017

    Additional paid-in
     capital                                                            172,824                  92,381

    Accumulated other
     comprehensive loss                                                    (29)                    (7)

    Accumulated deficit                                                (81,810)               (76,619)
                                                                        -------                 -------

    Total stockholders'
     equity                                                              91,043                  15,795
                                                                         ------                  ------


    Total liabilities and
     stockholders' equity                                               $94,847                 $19,643
                                                                        =======                 =======

 

 

    GALMED PHARMACEUTICALS LTD.

    Consolidated Statements of Operations (Unaudited)
    ------------------------------------------------

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


                                                                        Three months ended             Six months ended

                                                                           June 30,                  June 30,
                                                                           --------                  --------

                                                                    2018                   2017                    2018        2017
                                                                    ----                   ----                    ----        ----

    Revenue                                                                        $270               $270                    $538        $538


    Research and development expenses                                             1,940              2,347                   3,884       5,090


    General and administrative expenses                                           1,105                624                   1,988       1,413
                                                                                  -----                ---                   -----       -----


    Total operating expenses                                                      2,775              2,701                   5,334       5,965


    Financial expenses (income), net                                               (90)               (9)                  (143)      (111)
                                                                                    ---                ---                    ----        ----


    Loss before income taxes                                                      2,685              2,692                   5,191       5,854


    Taxes on Income                                                                   -                 -                      -          -
                                                                                    ---               ---                    ---        ---


    Net loss                                                                     $2,685             $2,692                  $5,191      $5,854
                                                                                 ======             ======                  ======      ======


    Basic and diluted net loss per share                                          $0.17              $0.22                   $0.34       $0.48
                                                                                  =====              =====                   =====       =====


    Weighted-average number of shares outstanding                            15,711,736         12,175,147              15,243,785  12,171,668
    used in computing basic and diluted net loss per share

 

 

 

    GALMED PHARMACEUTICALS LTD.

    Consolidated Statements of Cash Flows (Unaudited)
    ------------------------------------------------

    U.S. Dollars in thousands




                                                         Six months ended
                                                             June 30,
                                                             --------

                                                      2018                         2017
                                                      ----                         ----

    Cash flow from operating
     activities


    Net loss                                                              $(5,191)      $(5,854)


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

    Depreciation and
     amortization                                                              118            120

    Stock-based compensation
     expense                                                                   417            709

    Amortization of discount/
     premium on marketable
     securities                                                                (4)         (207)

    Loss from Realization of
     marketable securities                                                       5            115

    Changes in operating
     assets and liabilities:

    Decrease (increase) in
     other accounts
     receivable                                                              (213)            18

    Increase (decrease) in
     trade payables                                                             70          (757)

    Increase (decrease) in
     other accounts payable                                                    424          (178)

    Decrease in related party                                                    -         (117)

    Decrease in deferred
     revenue                                                                 (538)         (538)
                                                                              ----           ----

    Net cash used in
     operating activities                                                  (4,912)       (6,689)
                                                                            ------         ------


    Cash flow from investing
     activities

    Purchase of property and
     equipment                                                                 (1)           (8)

    Investment in available
     for sale securities                                                  (85,174)             -

    Consideration from sale
     of available for sale
     securities                                                              3,173          5,100
                                                                             -----          -----

    Net cash provided in
     (used in) investing
     activities                                                           (82,002)         5,092
                                                                           -------          -----


    Cash flow from financing
     activities

    Issuance of Ordinary
     Shares                                                                 79,164              -

    Proceeds from exercise of
     options                                                                   880            247
                                                                               ---            ---

    Net cash provided in
     financing activities                                                   80,044            247
                                                                            ------            ---


    Decrease in cash and cash
     equivalents                                                           (6,870)       (1,350)

    Cash and cash equivalents
     at the beginning of the
     period                                                                 13,021          3,097
                                                                            ------          -----

    Cash and cash equivalents
     at the end of the period                                               $6,151         $1,747
                                                                            ======         ======


    Supplemental disclosure
     of cash flow
     information:

    Cash received from
     interest                                                                 $171            136
                                                                              ----            ---

 

 

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SOURCE Galmed Pharmaceuticals Ltd.

Company Codes: Berlin:GPH, NASDAQ-SMALL:GLMD, Frankfurt:GPH, Stuttgart:GPH

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