Galmed Pharmaceuticals Reports First Quarter 2022 Financial Results

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    <br /> Galmed Pharmaceuticals Reports First Quarter 2022 Financial Results<br />

    PR Newswire



    TEL AVIV, Israel


    ,


    May 17, 2022


    /PRNewswire/ —Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) (“Galmed” or the “Company”), a clinical-stage biopharmaceutical company for liver, metabolic, fibrosis and inflammatory diseases reports financial results for the three months ended

    March 31, 2022

    .

    Galmed Pharmaceuticals Logo


    Recent Developments

    • Announced that Company’s clinical development strategy will expand into new anti-fibrotic indications to maximize the potential of its lead compound, Aramchol while at the same time discontinuing the Open Label Part of the Armor Study having reached its objectives.
    • Company evaluating its strategic alternatives and its structuring to best enhance shareholder value and achieve its goals.


    Financial Summary – First Quarter 2022 vs. First Quarter 2021:

    • Cash and cash equivalents, restricted cash and marketable debt securities totaled

      $28.9 million

      as of

      March 31, 2022

      , compared to

      $34.9 million

      at

      December 31, 2021

      .
    • Net loss amounted to

      $6.1 million

      , or

      $0.24

      per share, for the three months ended

      March 31, 2022

      , compared to a net loss of

      $8.9 million

      , or

      $0.38

      per share, for the three months ended

      March 31, 2021

      .
    • Research and development expenses amounted to approximately

      $4.8 million

      for the three months ended

      March 31, 2022

      , compared to approximately

      $7.4 million

      for the three months ended

      March 31, 2021

      . The decrease resulted primarily from a decrease in drug development expenses.
    • General and administrative expenses amounted to approximately

      $1.3 million

      for the three months ended

      March 31, 2022

      , compared to approximately

      $1.8 million

      for the three months ended

      March 31, 2021

      . The decrease in general and administrative expenses for the three months ended

      March 31, 2021

      resulted primarily from a decrease in salaries and benefits.
    • Financial expense, net amounted to

      $0.05 million

      for the three months ended

      March 31, 2022

      , compared to financial income, net of

      $0.2 million

      for the three months ended

      March 31, 2021

      .



    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™, a backbone drug candidate for the treatment of NASH and fibrosis is currently in a Phase 3 registrational study. We are also collaborating with the

    Hebrew University

    in the development of Amilo-5MER, a 5 amino acid synthetic peptide and recently initiated a first in human study.



    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 pivotal Phase 3 ARMOR trial, or the ARMOR Study or any other pre-clinical or clinical trials; completion and receiving favorable results of the ARMOR Study for Aramchol or any other pre-clinical or clinical trial; the impact of the COVID-19 pandemic; regulatory action with respect to Aramchol or any other product candidate 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 or any other product candidate in the countries in which it seeks to market the product; Galmed’s ability to achieve favorable pricing for Aramchol or any other product candidate; Galmed’s expectations regarding the commercial market for NASH patients or any other indication; third-party payor reimbursement for Aramchol or any other product candidate; Galmed’s estimates regarding anticipated capital requirements and Galmed’s needs for additional financing; market adoption of Aramchol or any other product candidate by physicians and patients; the timing, cost or other aspects of the commercial launch of Aramchol or any other product candidate; the development and approval of the use of Aramchol or any other product candidate for additional indications or in combination therapy; Galmed’s expectations regarding licensing, acquisitions and strategic operations; and the outcome of any evaluation of Galmed’s strategic alternatives. 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

    May 2, 2022

    , 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



    March 31,



    December 31,



    2022



    2021



    Unaudited



    Audited



    Assets



    Current assets


    Cash and cash equivalents


    $


    3,741


    $


    2,884


    Restricted Cash


    114


    114


    Marketable debt securities


    25,001


    31,931


    Other receivable


    843


    1,125



    Total current assets


    29,699


    36,054


    Right of use assets


    361


    406


    Property and equipment, net


    136


    145



    Total non-current assets


    497


    551



    Total assets


    $


    30,196


    $


    36,605



    Liabilities and stockholders’ equity



    Current liabilities


    Trade payables


    $


    4,835


    $


    4,871


    Other payables


    812


    1,008



    Total current liabilities


    5,647


    5,879



    Non-current liabilities


    Lease obligation


    $


    183


    $


    229



    Total non-current liabilities


    183


    229


    Ordinary shares par value NIS 0.01 per share; Authorized 50,000,000; Issued and outstanding:


    25,088,414 shares as of March 31, 2022 and December 31, 2021


    70


    70


    Additional paid-in capital


    199,229


    198,772


    Accumulated other comprehensive loss


    (616)


    (171)


    Accumulated deficit


    (174,317)


    (168,174)



    Total stockholders’ equity


    24,366


    30,497



    Total liabilities and stockholders’ equity


    $


    30,196


    $


    36,605


    The accompanying notes are an integral part of the interim consolidated financial statements.



    GALMED PHARMACEUTICALS LTD.



    Consolidated Statements of Operations (Unaudited)



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



    Three months ended



    March 31,



    2022



    2021


    Research and development expenses


    $


    4,796


    $


    7,380


    General and administrative expenses


    1,296


    1,752



    Total operating expenses


    6,092


    9,132


    Financial expense (income), net


    51


    (227)



    Net loss


    $


    6,143


    $


    8,905


    Basic and diluted net loss per share


    $


    0.24


    $


    0.38


    Weighted-average number of shares outstanding used in computing basic and diluted net loss per

    share


    25,088,414


    23,374,061



    GALMED PHARMACEUTICALS LTD.



    Consolidated Statements of Cash Flows (Unaudited)



    U.S. Dollars in thousands



    Three months ended



    March 31,



    2022



    2022



    Cash flow from operating activities


    Net loss


    $


    (6,143)


    $


    (8,905)



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


    Depreciation and amortization


    9


    11


    Stock-based compensation expense


    457


    471


    Amortization of premium on marketable debt securities


    31


    21


    Interest income from short-term deposits


    –


    (4)


    Loss (Gain) from realization of marketable debt securities


    145


    15


    Finance expenses


    (10)


    –



    Changes in operating assets and liabilities:


    Decrease in other accounts receivable


    282


    28


    Decrease in trade payables


    (36)


    (1,243)


    Increase (decrease) in other accounts payable


    (187)


    320



    Net cash used in operating activities


    (5,452)


    (9,286)



    Cash flow from investing activities


    Purchase of property and equipment


    –


    (1)


    Investment in available for sale securities


    –


    (10,007)


    Sale (investment) in short term deposits, net


    –


    2,005


    Consideration from sale of available for sale securities


    6,309


    6,359



    Net cash provided by (used in) investing activities


    6,309


    (1,644)



    Cash flow from financing activities


    Proceeds from exercise of options (*)


    –


    (*)


    Issuance of Ordinary shares, net of issuance cost


    –


    17,368



    Net cash provided in financing activities


    –


    17,368



    Increase (decrease) in cash and cash equivalents and restricted cash


    857


    6,438



    Cash and cash equivalents and restricted cash at the beginning of the period


    2,998


    7,060



    Cash and cash equivalents and restricted cash at the end of the period


    $


    3,855


    $


    13,498



    Supplemental disclosure of cash flow information:


    Cash received from interest


    $


    77


    $


    179



    Non-cash transactions:


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


    $


    –


    $


    497


    (*) Represents amount less than $1.

    Cision
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    SOURCE Galmed Pharmaceuticals Ltd.

    PR Newswire
    May 17, 2022 – 5:00 AM PDT