Galmed Pharmaceuticals Provides Business Update and Reports Fourth Quarter and Year End 2021 Financial Results

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    <br /> Galmed Pharmaceuticals Provides Business Update and Reports Fourth Quarter and Year End 2021 Financial Results<br />

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    TEL AVIV, Israel

    ,

    May 2, 2022

    /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™, an oral therapy for the treatment of nonalcoholic steatohepatitis, or NASH and fibrosis, provides today updated information on the Company’s scientific and clinical development programs and reports financial results for the three and twelve months ended December 31, 2021.

    Galmed Pharmaceuticals Logo


    Recent Clinical & Scientific Developments

    • Announced positive interim results from Open-Label part of the ARMOR study showing that treatment with Aramchol 300mg BID resulted in a high rate of fibrosis improvement using three separate biopsy reading methodologies (NASH CRN, Ranked paired reading and a Quantitative Digital Pathology image analysis and artificial intelligence (AI) method), with a larger treatment effect with longer duration of therapy.
    • Results of post baseline biopsies performed either at 24 weeks or at 48 weeks from 46 subjects with NASH and F1-3 that received Aramchol showed greater histological improvement at week 48 in both paired and AI evaluations (65% and 100% respectively) compared to NASH CRN scoring (40%).


    Financial Summary – Full Year 2021 vs. Full Year 2020; 4Q21 vs. 4Q20:

    For the three and twelve months ended

    December 31, 2021

    , the Company recorded a net loss of

    $7.5 million

    and

    $32.5 million

    or

    $0.30

    and

    $1.32

    per share, respectively, compared with a net loss of

    $10.3 million

    and

    $28.8 million

    , or

    $0.48

    and

    $1.35

    per share, for the three and twelve months ended

    December 31, 2020

    .

    Research and development expenses were

    $27.2 million

    for the twelve months ended

    December 31, 2021

    , compared with

    $26.1 million

    for the twelve months ended

    December 31, 2020

    . The increase for the twelve months resulted primarily from an increase in clinical trial expenses in connection with the Company’s ongoing ARMOR study, partially offset by a decrease in expenses related to CMC and formulation expenses.

    For the three months ended

    December 31, 2021

    , research and development expenses totaled

    $6.3 million

    , which compares with

    $9.0 million

    for the same period in 2020. The decrease for the three months resulted primarily from a decrease in clinical trial expenses and a decrease in expenses related to CMC and formulation expenses.

    The Company incurred general and administrative expenses of

    $5.7 million

    for the twelve months ended

    December 31, 2021

    , compared with

    $4.1 million

    for the twelve months ended

    December 31, 2020

    . The increase for the twelve months primarily resulted from an increase in salaries and benefits expenses, and as well from an increase in the cost of the Company’s D&O insurance policy premium.

    For the three months ended

    December 31, 2021

    , general and administrative expenses totalled

    $1.2 million

    , which compares with

    $1.3 million

    for the same period in 2020.

    Financial income, net amounted to

    $0.4 million

    for the twelve months ended

    December 31, 2021

    , compared with

    $1.4 million

    for the twelve months ended

    December 31, 2020

    . For the three months ended

    December 31, 2021

    , financial income, net totalled

    $0.04 million

    , which compares with

    $0.07 million

    for the same period in 2020.

    • Cash and cash equivalents, restricted cash, short-term deposits, and marketable debt securities totaled

      $34.9 million

      as of

      December 31, 2021

      , compared with

      $51.0 million

      as of

      December 31, 2020

      .

    More detailed information can be found in the Company’s Annual Report on Form 20-F, a copy of which has been filed with the Securities and Exchange Commission and posted on the Company’s website at

    www.galmedpharma.com

    . You may request a copy of the Company’s Form 20-F, at no cost to you, by writing to the Chief Financial Officer of the Company at 16 Tiomkin Street,

    Tel Aviv, Israel

    , 6578317 or by calling +972-3-693-8448.



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    May 2, 2022

    ,

    8:30 AM ET




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    Toll/International: 1-201-389-0878


    Israel Toll Free

    : 1 809 406 247

    Conference ID: 13727793

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    Replay Dial-In Numbers




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    Replay Pin Number:  13727793

    Replay Start:

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    Replay Expiry:

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    11:59 PM ET


    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.


    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; 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

    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 (Audited)



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



    As of December 31,



    2021



    2020



    Assets



    Current assets


    Cash and cash equivalents


    $


    2,884


    $


    6,947


    Restricted cash


    114


    113


    Short-term deposits


    –


    3,807


    Marketable debt securities


    31,931


    40,132


    Other accounts receivable


    1,125


    812



    Total current assets


    36,054


    51,811


    Operating lease right-of-use assets


    406


    394


    Property and equipment, net


    145


    176



    Total non-current assets


    551


    570



    Total assets


    $


    36,605


    $


    52,381



    Liabilities and stockholders’ equity



    Current liabilities


    Trade payables


    $


    4,871


    $


    7,046


    Other accounts payable


    1,008


    966



    Total current liabilities


    5,879


    8,012



    Non-current liabilities


    Operating lease liabilities, net of current portion


    $


    229


    $


    216



    Total non-current liabilities


    229


    216



    Stockholders’ equity


    Ordinary shares, par value NIS 0.01 per share; Authorized 50,000,000 shares;

    Issued and outstanding: 25,088,414 shares as of December 31, 2021; 21,325,975

    shares as of December 31, 2020


    70


    58


    Additional paid-in capital


    198,772


    179,530


    Accumulated other comprehensive income (loss)


    (171)


    272


    Accumulated deficit


    (168,174)


    (135,707)



    Total stockholders’ equity


    30,497


    44,153



    Total liabilities and stockholders’ equity


    $


    36,605


    $


    52,381



    GALMED PHARMACEUTICALS LTD.



    Consolidated Statements of Operations (Audited)



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



    Year ended December 31,



    2021



    2020



    2019


    Research and development expenses


    27,220


    26,082


    18,180


    General and administrative expenses


    5,661


    4,128


    4,196



    Total operating loss


    32,881


    30,210


    22,376


    Financial income, net


    (414)


    (1,439)


    (1,915)



    Net loss


    $


    32,467


    $


    28,771


    $


    20,461


    Basic and diluted net loss per share


    $


    1.32


    $


    1.35


    $


    0.97


    Weighted-average number of shares outstanding used in

    computing basic and diluted net loss per share


    24,597,638


    21,280,787


    21,114,399



    GALMED PHARMACEUTICALS LTD.



    Consolidated Statements of Cash Flows (Audited)



    U.S. Dollars in thousands



    Year ended December 31,



    2021



    2020



    2019



    Cash flow from operating activities


    Net loss for the year


    $


    (32,467)


    $


    (28,771)


    $


    (20,461)



    Adjustments required to reconcile net loss to net cash used in

    operating activities:


    Depreciation and amortization


    42


    39


    35


    Amortization of discount (premium) on marketable debt securities


    121


    90


    (105)


    Gain on sale of marketable debt securities


    (37)


    (527)


    (9)


    Finance expenses


    6


    31


    3


    Interest income from short-term deposits


    7


    (285)


    (63)


    Stock-based compensation expense


    1,886


    2,066


    2,231



    Changes in operating assets and liabilities:


    Decrease (increase) in other accounts receivable


    (313)


    15


    (609)


    Increase (decrease) in trade payables


    (2,175)


    1,047


    4,185


    Increase (decrease) in other accounts payable


    38


    8


    (144)



    Net cash used in operating activities


    (32,892)


    (26,287)


    (14,937)



    Cash flow from investing activities


    Purchase of property and equipment


    (11)


    (44)


    (12)


    Increase in restricted deposit


    (1)


    –


    –


    Investment in securities, available for sale


    (13,569)


    (55,034)


    (72,600)


    Proceeds from sale of securities, available for sale


    21,243


    47,198


    101,098


    Proceeds from (investment in) short-term deposits, net


    3,800


    24,416


    (21,808)



    Net cash provided by investing activities


    11,462


    16,536


    6,678



    Cash flow from financing activities


    Issuance of ordinary shares in at-the-market offering, net of

    issuance costs


    8,147


    –


    –


    Issuance of ordinary shares, net of issuance costs

    (**)


    9,221


    707


    –


    Proceeds from exercise of options


    (*)


    61


    143



    Net cash provided by financing activities


    17,368


    768


    143



    Decrease in cash, cash equivalents and restricted cash


    (4,062)


    (8,983)


    (8,116)



    Cash and cash equivalents and restricted cash at the

    beginning of the year


    7,060


    16,043


    24,159



    Cash, cash equivalents and restricted cash at the end of the year


    $


    2,998


    $


    7,060


    $


    16,043



    Supplemental disclosure of cash flow information:


    Cash received from interest


    $


    562


    $


    1,192


    $


    1,953



    Non-cash transactions:


    Recognition of right-of-use asset and lease liabilities from

    adoption of ASU 2016-02, net


    $


    –


    $


    –


    $


    653


    Right-of-use assets obtained in exchange for new operating lease liabilities, net


    $


    199


    $


    35


    $


    –


    (*) Represents amount less than $1


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    May 2, 2022 – 4:00 AM PDT