Cover
Cover | 12 Months Ended |
Dec. 31, 2021shares | |
Entity Addresses [Line Items] | |
Document Type | 20-F |
Amendment Flag | false |
Document Registration Statement | false |
Document Annual Report | true |
Document Transition Report | false |
Document Shell Company Report | false |
Document Period End Date | Dec. 31, 2021 |
Document Fiscal Period Focus | FY |
Document Fiscal Year Focus | 2021 |
Current Fiscal Year End Date | --12-31 |
Entity File Number | 001-36345 |
Entity Registrant Name | GALMED PHARMACEUTICALS LTD. |
Entity Central Index Key | 0001595353 |
Entity Incorporation, State or Country Code | L3 |
Entity Address, Address Line One | 16 Tiomkin Street |
Entity Address, City or Town | Tel Aviv |
Entity Address, Country | IL |
Entity Address, Postal Zip Code | 6578317 |
Title of 12(b) Security | Ordinary shares, par value NIS 0.01 per share |
Trading Symbol | GLMD |
Security Exchange Name | NASDAQ |
Entity Well-known Seasoned Issuer | No |
Entity Voluntary Filers | No |
Entity Current Reporting Status | Yes |
Entity Interactive Data Current | Yes |
Entity Filer Category | Non-accelerated Filer |
Entity Emerging Growth Company | false |
Document Accounting Standard | U.S. GAAP |
Entity Shell Company | false |
Entity Common Stock, Shares Outstanding | 25,088,414 |
Contact Personnel Email Address | ab@galmedpharma.com |
ICFR Auditor Attestation Flag | true |
Auditor Firm ID | 1197 |
Auditor Name | Brightman Almagor Zohar & Co |
Auditor Location | Tel Aviv, Israel |
Business Contact [Member] | |
Entity Addresses [Line Items] | |
Entity Address, Address Line One | 16 Tiomkin Street |
Entity Address, City or Town | Tel Aviv |
Entity Address, Country | IL |
Entity Address, Postal Zip Code | 6578317 |
City Area Code | +972.3 |
Local Phone Number | 693.8448 |
Contact Personnel Name | Allen Baharaff |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
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 |
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 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - ₪ / shares | Dec. 31, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Ordinary shares, price per share | ₪ 0.01 | ₪ 0.01 |
Ordinary shares, authorized | 50,000,000 | 50,000,000 |
Ordinary shares, Issued | 25,088,414 | 21,325,975 |
Ordinary shares, Outstanding | 25,088,414 | 21,325,975 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Statement [Abstract] | |||
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 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Statement [Abstract] | |||
Net loss | $ 32,467 | $ 28,771 | $ 20,461 |
Other comprehensive loss: | |||
Net unrealized loss (gain) on available for sale securities | 443 | (237) | (46) |
Comprehensive loss | $ 32,910 | $ 28,534 | $ 20,415 |
Statements of Changes in Stockh
Statements of Changes in Stockholders' Equity - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid-in Capital [Member] | AOCI Attributable to Parent [Member] | Retained Earnings [Member] | Total |
Balance - December 31, 2020 at Dec. 31, 2019 | $ 58 | $ 176,696 | $ 35 | $ (106,936) | $ 69,853 |
Beginning balance, shares at Dec. 31, 2019 | 21,139,385 | ||||
Stock-based compensation | 2,066 | 2,066 | |||
Exercise of options and vesting of restricted stock units | 61 | $ 61 | |||
Exercise of options and vesting of restricted stock units, shares | 50,290 | 47,509 | |||
Issuance of ordinary shares in at-the-market (“ATM”) offering, net of $73 issuance costs | 707 | $ 707 | |||
Issuance of ordinary shares in at the market offering, net of issuance costs,shares | 136,300 | ||||
Unrealized loss on marketable debt securities | 237 | 237 | |||
Net loss | (28,771) | (28,771) | |||
Balance - December 31, 2021 at Dec. 31, 2020 | $ 58 | 179,530 | 272 | (135,707) | 44,153 |
Ending balance, shares at Dec. 31, 2020 | 21,325,975 | ||||
Stock-based compensation | 1,886 | 1,886 | |||
Exercise of options and vesting of restricted stock units | |||||
Exercise of options and vesting of restricted stock units, shares | 23,236 | ||||
Issuance of ordinary shares in at-the-market (“ATM”) offering, net of $73 issuance costs | $ 5 | 8,142 | 8,147 | ||
Issuance of ordinary shares in at the market offering, net of issuance costs,shares | 1,541,400 | ||||
Unrealized loss on marketable debt securities | (443) | (443) | |||
Net loss | (32,467) | (32,467) | |||
Stock Issued During Period, Value, New Issues | $ 7 | 9,214 | 9,221 | ||
Issuance of ordinary shares under underwritten public offering agreement, net of issuance costs, shares | 2,197,803 | ||||
Balance - December 31, 2021 at Dec. 31, 2021 | $ 70 | $ 198,772 | $ (171) | $ (168,174) | $ 30,497 |
Ending balance, shares at Dec. 31, 2021 | 25,088,414 |
Statements of Changes in Stoc_2
Statements of Changes in Stockholders' Equity (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Subsidiary, Sale of Stock [Line Items] | ||
Stock Issued During Period, Value, Issued for Services | $ 73 | |
Atthemarket Offering [Member] | ||
Subsidiary, Sale of Stock [Line Items] | ||
Stock issuance cost | $ 295 | |
Underwritten Public Offering [Member] | ||
Subsidiary, Sale of Stock [Line Items] | ||
Stock issuance cost | $ 786 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 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 | |||
Proceeds from Issuance Initial Public Offering | 8,147 | ||
Proceeds from Issuance of Common Stock | 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 |
General
General | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
General | Note 1 – General Galmed Pharmaceuticals Ltd. (the “Company”) was incorporated in Israel on July 31, 2013 February 2, 2014 The Company holds a wholly-owned subsidiary, Galmed International Ltd., which was incorporated in Malta. Galmed International Ltd. previously held a wholly-owned subsidiary, Galmed Medical Research Ltd., which was incorporated in Israel, and had been an inactive company since 2015 and was liquidated in February 2019. The Company also holds two additional wholly-owned subsidiaries, Galmed Research and Development Ltd and Galtopa Therapeutics Ltd., both of which are incorporated in Israel. The Company is a clinical-stage biopharmaceutical company primarily focused on the development of therapeutics for the treatment of liver diseases. The Company has an operating history limited to pre-clinical and clinical drug development. To date, the Company has focused almost exclusively on developing its product candidates, Aramchol and Amilo-5MER. The Company funded its research and development programs and operations to date primarily through proceeds from private placements and public offerings. The Company currently has no products approved for marketing and has not generated any revenue from product sales to date. As of December 31, 2021, the Company had cash and cash equivalents of $ 2.8 0.1 31.9 The Company has incurred operating losses in each year since inception. The Company’s loss attributable to holders of its ordinary shares for the years ended December 31, 2019, 2020, and 2021 was approximately $ 20.5 28.8 32.4 168.2 The Company will need to raise substantial, additional capital to fund its operations and to develop Aramchol for, and beyond its current development stage and any future commercialization, as well as any additional indications. Based on the Company’s current operating plan, the Company’s management currently estimates that its cash position will support its current clinical trials and operations as currently conducted for more than 12 months from the date of issuance of these financial statements. |
Significant Accounting Policies
Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies | Note 2 – Significant Accounting Policies A. Basis of presentation The consolidated financial statements have been prepared in accordance with United States Generally Accepted Accounting Principles (“U.S. GAAP”). B. Use of estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities as of the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. GALMED PHARMACEUTICALS LTD. Notes to Consolidated Financial Statements Note 2 – Significant Accounting Policies (Cont.) C. Financial statement in U.S. dollars The functional currency of the Company and its subsidiaries is in U.S dollar (the “dollar”), because the dollar is the currency of the primary economic environment in which the Company and its subsidiaries operate, and expect to continue operating in the foreseeable future. Transactions and balances denominated in dollars are presented in their original amounts. Non-dollar denominated transactions and balances have been re-measured to dollars in accordance with the provisions of ASC 830-10, “Foreign Currency Translation.” All transaction gains and losses from re-measurement of monetary balance sheet items denominated in non-dollar currencies are reflected in the statement of operations as financial income or expenses, as appropriate. D. Principles of consolidation The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries: Galmed Research and Development Ltd., Galmed International Ltd. and Galtopa Therapeutics Ltd. All intercompany balances and transactions have been eliminated upon consolidation. E. Cash and cash equivalents Cash equivalents are short-term, highly liquid investments that are readily convertible into cash with maturities of three months or less as of the date acquired. F. Restricted Cash Cash that is held for a specific purpose and is not available for immediate or general business use due to external restrictions is classified in our consolidated balance sheets as restricted cash. G. Marketable debt securities The Company invests most of its excess cash primarily in debt securities. The Company accounts for its investments in investment grade debt securities in accordance with ASC 320 “Investments - Debt and Equity Securities”. Management determines the appropriate classification of its investments in debt securities at the time of purchase and re-evaluates such determinations at each balance sheet date. Marketable debt securities are considered to be available for sale and are carried at fair value on the consolidated balance sheet. Unrealized gains and losses net of tax, if any, are reported in a separate component of shareholders’ equity in accumulated other comprehensive income (“OCI”). Gains and losses are recognized when realized, on a specific identification basis, in the Company’s consolidated statements of operations. Following the adoption of ASC 326 in January 2020, current expected credit losses on the Company’s marketable grade debt securities are recorded, if expected, through an allowance for current expected credit losses. The amount of allowance for current expected credit losses is limited to the amount that the fair value is less than the amortized cost basis. Any remaining unrealized losses are included in accumulated other comprehensive loss in shareholders’ equity. If the Company intends to sell the debt security (that is, it has decided to sell the security), or more likely than not will be required to sell the security before recovery of its amortized cost basis, any allowance for current expected credit losses is written off and the amortized cost basis shall be written down to the debt security’s fair value at the reporting date with any incremental impairment reported in earnings. Based on management’s assessment, the Company does not intend to sell its securities for less than amortized cost; therefore, an allowance for current expected credit losses has not been recorded as of December 31, 2021 and 2020. GALMED PHARMACEUTICALS LTD. Notes to Consolidated Financial Statements Note 2 – Significant Accounting Policies (Cont.) H. Concentrations of credit risk Financial instruments which potentially subject the Company to credit risk consist primarily of cash, cash equivalents, marketable securities and short-term deposits. The Company hold these investments in highly-rated financial institutions, and, by policy, limit the amounts of credit exposure to any one financial institution. These amounts at times may exceed federally insured limits. The Company has not experienced any credit losses in such accounts and do not believe we are exposed to any significant credit risk on these funds. The Company has no off-balance sheet concentrations of credit risk, such as foreign currency exchange contracts, option contracts, or other hedging arrangements. I. Property and equipment Property and equipment are stated at cost, less accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the assets. The annual depreciation rates are as follows: Schedule of Depreciation Rates for Property, Plant and Equipment % Office furniture and equipment 7 16 Computer software and electronic equipment 15 33 Leasehold improvements Shorter of lease term or useful life J. Impairment of long-lived assets The Company’s and its subsidiaries’ long-lived assets are reviewed for impairment in accordance with ASC 360-10, “Accounting for the Impairment or Disposal of Long-Lived Assets,” whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of the assets to the future undiscounted cash flows expected to be generated by the assets. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds their fair value. During 2021 and 2020, no impairment losses were recorded. K. Severance pay The Company employees are included under section 14 of the Severance Compensation Act, 1963 (“Section 14”) in Israel for a portion of their salaries. According to Section 14, these employees are entitled to monthly deposits at a rate of 8.33% GALMED PHARMACEUTICALS LTD. Notes to Consolidated Financial Statements Note 2 – Significant Accounting Policies (Cont.) L. Fair value of financial instruments The estimated fair value of financial instruments was determined by the Company using available market information and valuation methodologies. Considerable judgment is required in estimating fair values. Accordingly, the estimates may not be indicative of the amounts the Company could realize in a current market exchange. The following methods and assumptions were used by the Company in estimating its fair value disclosures for financial instruments: The carrying amounts of cash and cash equivalents, short-term bank deposits, other accounts receivables, trade payables and other trade payables approximate their fair value due to the short-term maturity of such instruments. Fair value is an exit price representing the amount that would be received upon selling an asset or that would be paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions used by market participants in pricing an asset or a liability. A three-tier fair-value hierarchy was established as a basis for considering such assumptions and for inputs used in the valuation methodologies in measuring fair value: ● Level 1 - Observable inputs that reflect quoted prices (unadjusted) for identical assets or liabilities in active markets ● Level 2 - Other inputs that are directly or indirectly observable in the marketplace; and ● Level 3 - Unobservable inputs that are supported by little or no market activity The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The Company’s marketable debt securities are measured at fair value on a recurring basis by level within the fair value hierarchy. Other than the marketable debt securities, which includes corporate bonds and mutual funds as of December 31, 2021, the Company does not have any other financial assets or financial liabilities marked to market at fair value. The fair value of the Company’s marketable debt securities measured at fair value on a recurring basis by level within the fair value hierarchy are as follows (in thousands): Schedule of Marketable Debt Securities December 31, 2021 Fair Level 1 Level 2 Level 3 Value Marketable debt securities $ 26,467 $ 5,464 — $ 31,931 December 31, 2020 Fair Level 1 Level 2 Level 3 Value Marketable debt securities $ 25,449 $ 14,683 — 40,132 M. Accounting for stock-based compensation The Company applies ASC 718-10, “Share-Based Payment,” which requires the measurement and recognition of compensation expense for all share-based payment awards made to employees and directors, including employee stock options under the Company’s stock plans, based on estimated fair values. ASC 718-10 requires companies to estimate the fair value of equity-based payment awards on the date of grant using an option-pricing model. The value of the portion of the award that is ultimately expected to vest is recognized as expense over the requisite service periods in the Company’s consolidated statement of operations. GALMED PHARMACEUTICALS LTD. Notes to Consolidated Financial Statements Note 2 – Significant Accounting Policies (Cont.) M. Accounting for stock-based compensation (Cont.) All issuances of stock options or other equity instruments to non-employees as consideration for goods or services received by the Company are accounted for based on the fair value of the equity instruments issued. The Company estimates the fair value of restricted shares based on the market price of the shares at the grant date and estimates the fair value of stock options granted using a Black-Scholes option-pricing model . The option-pricing model requires a number of assumptions, the most significant of which are the expected stock-price volatility and the expected option term (the time from the grant date until the options are exercised or expire). The Company’s calculations of the expected volatility were based upon actual historical stock-price movements over the period, which was equal to the expected option term. The expected option term was calculated for options granted to employees and directors in accordance with ASC-718-10-S99, using the “simplified” method, and grants to non-employees were based on the contractual term. Historically, the Company has not paid dividends, and has no foreseeable plans to do so. The risk-free interest rate is based on the yield from U.S. Treasury zero-coupon bonds with an equivalent term. N. Revenue Recognition The Company only has one license agreement for which it has recognized revenues to date, from a license agreement with Samil Pharm. Co., Ltd. (“Samil” or “Samil Agreement”). The Samil Agreement was signed on July 28, 2016, for an exclusive, royalty-bearing license for the commercialization of Aramchol (with an option to manufacture) for the treatment of fatty liver indications including NASH in the Republic of Korea. Additionally, following the ARREST Study, Samil has an option to extend the License to Vietnam, which, if exercised, would increase the clinical- and regulatory-based milestone payments. Under the terms of the Samil Agreement, the Company received an up-front payment of approximately $ 2.1 1.5 4.5 In accordance with ASC 606 the Company determined that the Agreement included a combined performance obligation representing the delivery of the exclusive license and completion of the ARREST study. As of December 31, 2021, management evaluated the remaining clinical and regulatory milestones and determined that the variable consideration should not be recorded as revenue for the period ended December 31, 2021. The Company will re-evaluate the transaction price in each reporting period when events whose outcomes are resolved or other changes in circumstances occur that would indicate it is appropriate to recognize variable consideration as revenue. GALMED PHARMACEUTICALS LTD. Notes to Consolidated Financial Statements Note 2 – Significant Accounting Policies (Cont.) O. Research and development expenses Research and development expenses are charged to the statement of operations as incurred. P. Income taxes The Company accounts for income taxes utilizing the asset and liability method in accordance with ASC 740, “Income Taxes.” Current tax liabilities are recognized for the estimated taxes payable on tax returns for the current year. Deferred tax liabilities or assets are recognized for the estimated future tax effects attributable to temporary differences between the income-tax bases of assets and liabilities and their reported amounts in the financial statements and for tax loss carry forwards. Measurement of current and deferred tax liabilities and assets is based on provisions of enacted tax laws, and deferred tax assets are reduced, if necessary, by the amount of tax benefits, the realization of which is not considered more likely than not based on available evidence. As of December 31, 2021, and 2020, the Company had a full valuation allowance against deferred tax assets. The Company is subject to the provisions of ASC 740-10-25, “Income Taxes” (“ASC 740”). ASC 740 prescribes a more likely-than-not threshold for the financial statement recognition of uncertain tax positions. ASC 740 clarifies the accounting for income taxes by prescribing a minimum recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. On a yearly basis, the Company undergoes a process to evaluate whether income tax accruals are in accordance with ASC 740 guidance on uncertain tax positions. The Company has not recorded any liability for uncertain tax positions for the years ended December 31, 2021 and 2020. Q. Basic and diluted net loss per share Basic net loss per share is computed based on the weighted-average number of shares outstanding during each year. Diluted net loss per share is computed based on the weighted-average number of shares outstanding during each year, plus the dilutive potential of the ordinary shares considered outstanding during the year, in accordance with ASC 260-10, “Earnings Per Share.” All outstanding stock options and warrants were excluded from the calculation of the diluted loss per share for the years ended December 31, 2021, 2020 and 2019, because all such securities have an anti-dilutive effect. GALMED PHARMACEUTICALS LTD. Notes to Consolidated Financial Statements Note 2 – Significant Accounting Policies (Cont.) R. Segment Reporting The chief operating decision maker for the Company is the Chief Executive Officer. The Chief Executive Officer reviews financial information presented on a consolidated basis for purposes of allocating resources and evaluating financial performance. Accordingly, management has determined that the Company operates in one reportable segment. S. Comprehensive Loss The purpose of reporting comprehensive income is to report a measure of all changes in equity of an entity that result from recognized transactions and other economic events of the period resulting from transactions from non-owner sources. T. Leases Under Accounting Standards Update, “Leases” (“ASC 842”), the Company determines if an arrangement is a lease at inception. Upon initial recognition, the Company recognizes a liability at the present value of the lease payments to be made over the lease term, and concurrently recognizes a right-of-use asset at the same amount of the liability, adjusted for any prepaid or accrued lease payments, plus initial direct costs incurred in respect of the lease. The Company uses its incremental borrowing rate based on the information available at the commencement date to determine the present value of the lease payments. The subsequent measurement depends on whether the lease is classified as a finance lease or an operating lease. During the reporting periods, the Company has only operating leases. Lease terms include options to extend the lease when it is reasonably certain that the Company will exercise that option. Lease expenses for operating leases are recognized on a straight-line basis over the lease term. The Company has made a policy election not to capitalize leases with a term of 12 months or less. In accordance with ASC 360-10, management reviews operating lease assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable based on estimated future undiscounted cash flows. If so indicated, an impairment loss would be recognized for the difference between the carrying amount of the asset and its fair value. U. Recently adopted accounting pronouncements From time to time, new accounting pronouncements are issued by FASB, or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the impact of recently issued standards that are not yet effective will not have a material impact on our financial position or results of operations upon adoption. GALMED PHARMACEUTICALS LTD. Notes to Consolidated Financial Statements Note 2 – Significant Accounting Policies (Cont.) U. Recently adopted accounting pronouncements (Cont.) In December 2019, the FASB issued ASU 2019-12, “Simplifying the Accounting for Income Taxes”, which will simplify the accounting for income taxes to improve consistency of accounting methods and remove certain exceptions. The amendment is effective for the Company beginning January 1, 2021. The adoption did not have a significant impact on the Company’s consolidated financial statements. V. Recently issued accounting pronouncements In May 2021, the FASB issued Update 2021-04, Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options (a consensus of the FASB Emerging Issues Task Force). The amendments in this Update affect all entities that issue freestanding written call options that are classified in equity. Specifically, the amendments affect those entities when a freestanding equity-classified written call option is modified or exchanged and remains equity classified after the modification or exchange. The amendments that relate to the recognition and measurement of EPS for certain modifications or exchanges of freestanding equity-classified written call options affect entities that present EPS in accordance with the guidance in Topic 260, Earnings Per Share. The effect of implementing this ASU is immaterial. GALMED PHARMACEUTICALS LTD. Notes to Consolidated Financial Statements |
Marketable debt securities
Marketable debt securities | 12 Months Ended |
Dec. 31, 2021 | |
Cash and Cash Equivalents [Abstract] | |
Marketable debt securities | Note 3 – Marketable debt securities The following table summarizes the Company’s marketable debt securities as of December 31, 2021 and 2020. Summary of Marketable Debt Securities As of December 31, 2021 Gross Gross Amortized Unrealized Unrealized Estimated Cost Gains Losses Fair Value (in thousands) Corporate bonds $ 5,505 $ 9 $ (50 ) $ 5,464 Mutual funds 26,597 58 (188 ) 26,467 Total short-term investments $ 32,102 $ 67 $ (238 ) $ 31,931 As of December 31, 2020 Gross Gross Amortized Unrealized Unrealized Estimated Cost Gains Losses Fair Value (in thousands) Corporate bonds $ 14,575 $ 124 $ (16 ) $ 14,683 Commercial papers 25,285 $ 181 $ (17 ) $ 25,449 Total short-term investments $ 39,860 $ 305 $ (33 ) $ 40,132 The contractual maturity of the aforementioned marketable securities varies between less than one year to two years. |
Other Accounts Receivable
Other Accounts Receivable | 12 Months Ended |
Dec. 31, 2021 | |
Receivables [Abstract] | |
Other Accounts Receivable | Note 4– Other Accounts Receivable Schedule of Accounts, Notes, Loans and Financing Receivable 2021 2020 As of December 31, 2021 2020 (in thousands) Prepaid expenses $ 1,046 $ 746 Government institutions 79 66 Total $ 1,125 $ 812 |
Leases
Leases | 12 Months Ended |
Dec. 31, 2021 | |
Leases | |
Leases | Note 5– Leases The Company leases, approximately 590 two additional options to extend until March 22, 2023. The Company elected not to exercise its options to extend the lease and in March 2021, signed a new lease extension agreement to its corporate headquarters for a period of two 134,508 144,476 50 In addition, the Company leases vehicles under various operating lease agreements. GALMED PHARMACEUTICALS LTD. Notes to Consolidated Financial Statements Note 5 – Leases (Cont.) At December 31, 2021, the Company’s operating lease assets and lease liabilities (both the current and non-current portion) for operating leases totaled $ 406 435 394 419 The Company uses its incremental borrowing rate as the discount rate for its leases, as the implicit rate in the lease is not readily determinable. As of December 31, 2021, the Company’s operating leases had a weighted average remaining lease term of 2.12 2.3 The following table summarizes the Company’s significant contractual lease obligations at December 31, 2021: Summary of Company's significant contractual lease obligations Less than Total 1 year 1-3 years (in thousands) Facility leases $ 376 $ 161 $ 215 Car leases 41 24 17 Total $ 417 $ 185 $ 232 |
Property and equipment, net
Property and equipment, net | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
Property and equipment, net | Note 6 – Property and equipment, net Schedule of Property and Equipment, Net 2021 2020 As of December 31, 2021 2020 (in thousands) Medical equipment $ 737 $ 737 Office furniture and equipment 56 56 Computer software and electronic equipment 78 78 Leasehold improvements 231 221 Property and equipment, gross 1,102 1,092 Less - Accumulated depreciation 957 916 Net book value $ 145 $ 176 GALMED PHARMACEUTICALS LTD. Notes to Consolidated Financial Statements |
Related Parties
Related Parties | 12 Months Ended |
Dec. 31, 2021 | |
Related Party Transactions [Abstract] | |
Related Parties | Note 7 – Related Parties 1. As of December 31, 2021, and 2020, the Company had an accrual in the amount of approximately $ 0.6 0.5 2. During 2021, 2020 and 2019, the Company recorded salary expenses, stock-based compensation expenses and directors’ fee to its related parties in the amount of $ 4.1 3.5 3.6 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 8 – Commitments and Contingencies 1. As of December 31, 2021, the Company recorded a pledge on its short-term deposit in favor of its bank in the amount of approximately $ 114 54 2. The Company enters into contracts in the ordinary course of business with contract research organizations for clinical trials and clinical supply manufacturing and with vendors for non-clinical research studies and other services and products for operating purposes, which generally provide for termination upon 30 to 90 days’ notice or less, and therefore are cancelable contracts and not considered as commitment or purchase obligations. 3. For information regarding the Company’s leases commitments, see note 5. 4. On June 28, 2021, the Company entered into a license agreement with Yissum Research Development Company of the Hebrew University of Jerusalem (“Yissum”) pursuant to which Yissum granted to the Company a worldwide, exclusive and irrevocable license to develop and commercialize Amilo-5Mer. Under the license agreement, the Company is responsible for carrying out the development and commercialization of Amilo-5Mer and the prosecution and maintenance of the licensed patents under the license agreement. In consideration for the grant of the license, the Company paid Yissum an upfront license fee of $ 100 950 5. Other than as described above, the Company did not have any material commitments, including any anticipated material acquisition of plant and equipment or interests in other companies, as of December 31, 2021 and 2020. GALMED PHARMACEUTICALS LTD. Notes to Consolidated Financial Statements |
Shareholders_ Equity
Shareholders’ Equity | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
Shareholders’ Equity | Note 9– Shareholders’ Equity A. Ordinary shares 1. Ordinary shares confer upon the holders the right to receive notice to participate and vote in general meetings of the Company and the right to receive dividends, if declared. 2. On December 22, 2017, the Company entered into an At-the-Market Equity Offering Sales Agreement (the “Stifel Sales Agreement”) with Stifel, Nicolaus & Company, Incorporated, as the Company’s sales agent (“Stifel”). Pursuant to the prospectus relating to the Company’s shelf registration statement on Form F-3 filed with the SEC on March 26, 2018 the Company may offer and sell, from time to time through Stifel, its ordinary shares having an aggregate offering price of up to $ 35 31.9 136,300 0.8 1,541,400 8.2 3. During February 2021, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with Cantor Fitzgerald & Co. (the “Underwriter”) in connection with an underwritten public offering (the “Underwritten Public Offering”) of 2,197,803 4.3258 9.2 Under the terms of the Underwriting Agreement, the Company granted the Underwriter an option, exercisable for 30 329,670 4. On March 26, 2021, the Company entered into a new Sales Agreement with Cantor Fitzgerald & Co. and Canaccord Genuity LLC, as sales agents, pursuant to which the Company may offer and sell ordinary shares “at the market” having an aggregate offering price of up to $ 50.0 5. In November 2021, the Company issued an additional 4,500 GALMED PHARMACEUTICALS LTD. Notes to Consolidated Financial Statements Note 9– Shareholders’ Equity (Cont.) B. Stock-based compensation 1. The Company has an equity-based incentive plan, the 2013 Incentive Share Option Plan (the “2013 Plan”). As of December 31, 2021, a total of 375,743 2. During the year ended December 31, 2020, certain current and former office holders exercised options into 47,509 61 3. During the year ended December 31, 2020, restricted stock units held by certain officers, employees and former employees vested resulting in the issuance of 2,781 4. In March 2020, the Company granted options to purchase 67,500 4.21 10 four years 0.2 5. In August 2020, the Company granted options to purchase 30,000 4.77 10 four years 0.1 220,000 5.12 10 four years 0.8 6. In November 2020, the Company granted options to purchase 267,500 3.33 10 four years 0.6 220,000 3.33 10 four years 0.5 7. During February 2021, certain office holders exercised options into 18,736 Ordinary shares of the Company for a total amount of less than $ 1 thousand. 8. In March 2021, the Company granted options to purchase 45,000 4.16 10 four years 0.1 9. In July, 2021, the Company granted options to purchase 100,000 3.10 10 three years 0.2 10. In August, 2021, the Company granted options to purchase 37,500 2.83 10 three years 0.01 GALMED PHARMACEUTICALS LTD. Notes to Consolidated Financial Statements Note 9– Shareholders’ Equity (Cont.) B. Stock-based compensation (Cont.) 7. A summary of the status of the Company’s option plans as of December 31, 2021 and 2020 and changes during the years then ended are presented below: Summary of Status of Company's Option Plans and Changes 2021 2020 Weighted Weighted Number of average Number of average share options exercise price share options exercise price Options outstanding at beginning of year 2,723,011 $ 5.70 2,393,715 $ 6.12 Granted 402,500 $ 3.32 585,000 $ 4.18 Forfeited (253,100 ) $ 5.25 (208,195 ) $ 7.49 Exercised (18,736 ) $ 0.01 (47,509 ) $ 1.27 Outstanding at end of year 2,853,675 $ 5.42 2,723,011 $ 5.70 Options exercisable at year end $ 2,027,431 $ 5.67 1,754,261 $ 5.42 The following assumptions were used for the fiscal year 2021, 2020 and 2019 grants: - dividend yield of 0.00 - risk-free interest rate between 0.42 2.35 0.42 0.74 0.80 1.34 - an expected life between 5 6.25 - and a volatility rate ranging between 87 95 83 88 64 81 As of December 31, 2021, and 2020, the weighted-average remaining contractual term of the outstanding options, excluding the 38,637 5.90 6.60 The weighted average grant date fair value of the options granted during the years ended December 31, 2021, 2020 and 2019 is $ 2.19 2.76 4.85 As of December 31, 2021, a total of the 333,532 0.6 390,905 1.1 The unrecognized compensation expense calculated under the fair-value method for stock options expected to vest as of December 31, 2021, 2020 and 2019 is approximately $ 3.4 4.0 5.5 1.75 2.9 3.1 For the years ended 2021, 2020 and 2019, the Company recorded a total of $ 1.9 2.1 2.2 GALMED PHARMACEUTICALS LTD. Notes to Consolidated Financial Statements Note 9– Shareholders’ Equity (Cont.) B. Stock-based compensation (Cont.) During 2016, the Company issued a total of 78,750 four years 59,528 0 5 70 no |
Research and Development Expens
Research and Development Expenses | 12 Months Ended |
Dec. 31, 2021 | |
Research and Development [Abstract] | |
Research and Development Expenses | Note 10 – Research and Development Expenses Schedule of Research and Development Expenses Year ended December 31, 2021 2020 2019 (in thousands) Chemistry and formulation studies $ 5,009 $ 5,856 $ 3,439 Salaries 2,963 2,570 2,283 Stock-based compensation 660 871 883 Research and preclinical studies 2,163 1,873 1,962 Clinical studies 14,937 13,225 8,346 Regulatory and other expenses 1,488 1,687 1,267 $ 27,220 $ 26,082 $ 18,180 |
General and Administrative Expe
General and Administrative Expenses | 12 Months Ended |
Dec. 31, 2021 | |
General And Administrative Expenses | |
General and Administrative Expenses | Note 11 – General and Administrative Expenses Schedule of General and Administrative Expenses Year ended December 31, 2021 2020 2019 (in thousands) Stock-based compensation $ 1,225 $ 1,194 $ 1,349 Professional fees 897 796 877 Salaries and benefits 1,617 828 856 Rent and office-maintenance fees 530 430 482 Investor relations and business development expenses 242 293 364 Insurance and other expenses 1,150 587 268 $ 5,661 $ 4,128 $ 4,196 GALMED PHARMACEUTICALS LTD. Notes to Consolidated Financial Statements |
Financial income, net
Financial income, net | 12 Months Ended |
Dec. 31, 2021 | |
Revenue from Contract with Customer [Abstract] | |
Financial income, net | Note 12 – Financial income, net Schedule of Financial Income, Net 2021 2020 2019 Year ended December 31, 2021 2020 2019 (in thousands) Bank fees $ 43 $ 31 $ 33 Interest income (562 ) (1,192 ) (1,953 ) Loss (gain) from sale of marketable debt securities 80 (397 ) (106 ) Foreign currency losses 25 119 111 Financial income net $ (414 ) $ (1,439 ) $ (1,915 ) |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Note 13 – Income Taxes A. General The Company is assessed for tax purposes on an unconsolidated basis. Each of the Company’s subsidiaries is subject to the tax rules prevailing in its country of incorporation. B. Corporate Taxation Ihe Israeli corporate income tax rate is 23 On February 7, 2018, the Israeli Tax Authority issued a ruling granting the Company’s Israeli subsidiary, Galmed Research and Development Ltd, a “Preferred Technological Enterprise” status as defined under the Encouragement of Capital Investment Law -1959 (the “Approval”). The grant of the status means that the Company’s Israeli subsidiary will be subject to a reduced Israeli corporate tax rate that will range between 6 12 Maltese subsidiary: Taxable income of Maltese companies was subject to tax at the rate of 35 C. Net Operating Loss Carry forward As of December 31, 2021, the Company had approximately $ 137.9 11.7 126.2 1.9 GALMED PHARMACEUTICALS LTD. Notes to Consolidated Financial Statements Note 13 – Income Taxes (Cont.) D. Deferred income taxes As of December 31, 2021, the significant components of the Company’s deferred tax assets are net operating loss carryforward in the amount of $ 126 37 E. Tax assessment The Israeli subsidiaries received final tax assessments through the year ended December 31, 2016. F. Effective tax expense A reconciliation of the Company’s effective tax expense to the Company’s theoretical statutory tax benefit is as follows: Schedule of Effective Income Tax Rate Reconciliation 2020 2021 2019 Year ended December 31, 2021 2020 2019 (in thousands) Loss before taxes on income, as reported in the consolidated statements of operations $ 32,467 $ 28,771 $ 20,461 Statutory tax rate 12 % 12 % 12 % Theoretical tax benefit 3,896 3,453 2,455 Losses and other items for which a valuation allowance was provided or benefit from loss carry forwards (3,896 ) (3,453 ) (2,455 ) Actual tax expense $ — $ — $ — Exhibit No. Description 1.1 Form of Amended and Restated Articles of Association of Galmed Pharmaceuticals Ltd. (English Translation) * 2.1 Description of Securities Registered under Section 12 of the Exchange Act (13) 4.1 Form of Indemnification Agreement (1) 4.2 Galmed Pharmaceuticals Ltd. 2013 Incentive Share Option Plan (4) 4.3 Registration and Information Rights Agreement, dated December 2013, by and among Galmed Pharmaceuticals Ltd., Shirat HaChaim Ltd., David & Debora Goldfarb, Medgal S.A. and G. Yarom Medical Research Ltd. (2) 4.4 Personal Employment Agreement, dated December 23, 2013, by and between Galmed Medical Research Ltd. and Allen Baharaff (2) 4.5 Amendment No.1 to Employment Agreement by and between Galmed Research and Development Ltd. and Allen Baharaff (10) 4.6 Amendment No.2 to Employment Agreement by and between Galmed Research and Development Ltd. and Allen Baharaff(13) 4.7 Amendment No.3 to Employment Agreement by and between Galmed Research and Development Ltd. And Allen Baharaff* 4.8 Compensation Policy of Galmed Pharmaceuticals Ltd.(5) 4.9 Lease, dated March 22, 2015, between Galmed Research and Development Ltd. and Mintz K. Construction Company Ltd.(8) 4.10 Addendum to Lease, dated February 27, 2017, between Galmed Research and Development Ltd. and Mintz K. Construction Company Ltd.(8) 4.11 Addendum to Lease, dated August 8, 2018, between Galmed Research and Development Ltd. and Mintz K. Construction Company Ltd.(12) 4.12 Addendum to Lease, dated March 11, 2021, between Galmed Research and Development Ltd. and Mintz K. Construction Company Ltd.(14) 4.13 Sales Agreement, dated March 26, 2021, among Galmed Pharmaceuticals Ltd., Cantor Fitzgerald & Co. and Canaccord Genuity LLC.(9) 4.14 Underwriting Agreement between Galmed Pharmaceuticals Ltd. and Cantor Fitzgerald &Co., as representative of the several underwriters, dated February 16, 2021 (11) 8.1 List of subsidiaries of Galmed Pharmaceuticals Ltd.(13) 11.1 Code of Business Conduct and Ethics of Galmed Pharmaceuticals Ltd.(7) 12.1 Certification of Chief Executive Officer pursuant to Exchange Act Rules 13a-14(a) and 15d-14(a) as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002* 12.2 Certification of Chief Accounting Officer pursuant to Exchange Act Rules 13a-14(a) and 15d-14(a) as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002* 13.1 Certification of Chief Executive Officer and Chief Financial Officer pursuant to Exchange Act Rules 13a-14(b) and 15d-14(b) and 18 U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002* 15.1 Consent of Brightman Almagor Zohar & Co.* 101 The following financial information from Galmed Pharmaceuticals Ltd.’s Annual Report on Form 20-F for the year ended December 31, 2021, formatted in Inline Extensible Business Reporting Language (XBRL): (i) Consolidated Balance Sheets, (ii) Consolidated Statements of Operations, (iii) Consolidated Statements of Comprehensive Loss, (iii) Consolidated Statements of Changes in Shareholders’ Equity (iii) the Consolidated Statements of Cash Flows, and (iv) Notes to Consolidated Financial Statements 101.INS Inline XBRL Instance Document 101.SCH Inline XBRL Taxonomy Extension Schema Document 101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase Document 101.DEF Inline XBRL Taxonomy Extension Definition Linkbase Document 101.LAB Inline XBRL Taxonomy Extension Label Linkbase Document 101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase Document 104 Cover Page Interactive Data File (embedded within the Inline XBRL document) (1) Incorporated herein by reference to Amendment No. 1 to the Registration Statement on Form F-1, filed with the SEC on February 28, 2014. (2) Incorporated herein by reference to the Registration Statement on Form F-1, filed with the SEC on February 6, 2014. (3) Incorporated herein by reference to the Company’s Report on Form 6-K filed with the SEC on June 1, 2016. (4) Incorporated herein by reference to Exhibit A to the Company’s Report on Form 6-K filed with the SEC on April 2, 2015. (5) Incorporated herein by reference to Annex A to the Company’s Report on Form 6-K filed with the SEC on July 8, 2020. (6) Incorporated herein by reference to the Company’s Annual Report on Form 20-F filed with the SEC on March 31, 2015. (7) Incorporated herein by reference to the Company’s Annual Report on Form 20-F filed with the SEC on March 22, 2016. (8) Incorporated herein by reference to the Company’s Annual Report on Form 20-F filed with the SEC on March 23, 2017. (9) Incorporated herein by reference to Exhibit 1.1 to the Company’s Report on Form 6-K filed with the SEC on March 26, 2021. (10) Incorporated herein by reference to the Company’s Annual Report on Form 20-F filed with the SEC on March 13, 2018. (11) Incorporated herein by reference to Exhibit 1.1 to the Company’s Report on Form 6-K filed with the SEC on February 18, 2021. (12) Incorporated herein by reference to the Company’s Annual Report on Form 20-F filed with the SEC on March 13, 2019. (13) Incorporated herein by reference to the Company’s Annual Report on Form 20-F filed with the SEC on March 12, 2020. (14) Incorporated herein by reference to the Company’s Annual Report on Form 20-F filed with the SEC on March 18, 2021. * Filed herewith. SIGNATURES The registrant hereby certifies that it meets all of the requirements for filing on Form 20-F and that it has duly caused and authorized the undersigned to sign this annual report on its behalf. GALMED PHARMACEUTICALS LTD. By: /s/ Allen Baharaff Allen Baharaff President, Chief Executive Officer and Chairman Date: May 2, 2022 |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Basis of presentation | A. Basis of presentation The consolidated financial statements have been prepared in accordance with United States Generally Accepted Accounting Principles (“U.S. GAAP”). |
Use of estimates | B. Use of estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities as of the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. |
Financial statement in U.S. dollars | C. Financial statement in U.S. dollars The functional currency of the Company and its subsidiaries is in U.S dollar (the “dollar”), because the dollar is the currency of the primary economic environment in which the Company and its subsidiaries operate, and expect to continue operating in the foreseeable future. Transactions and balances denominated in dollars are presented in their original amounts. Non-dollar denominated transactions and balances have been re-measured to dollars in accordance with the provisions of ASC 830-10, “Foreign Currency Translation.” All transaction gains and losses from re-measurement of monetary balance sheet items denominated in non-dollar currencies are reflected in the statement of operations as financial income or expenses, as appropriate. |
Principles of consolidation | D. Principles of consolidation The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries: Galmed Research and Development Ltd., Galmed International Ltd. and Galtopa Therapeutics Ltd. All intercompany balances and transactions have been eliminated upon consolidation. |
Cash and cash equivalents | E. Cash and cash equivalents Cash equivalents are short-term, highly liquid investments that are readily convertible into cash with maturities of three months or less as of the date acquired. |
Restricted Cash | F. Restricted Cash Cash that is held for a specific purpose and is not available for immediate or general business use due to external restrictions is classified in our consolidated balance sheets as restricted cash. |
Marketable debt securities | G. Marketable debt securities The Company invests most of its excess cash primarily in debt securities. The Company accounts for its investments in investment grade debt securities in accordance with ASC 320 “Investments - Debt and Equity Securities”. Management determines the appropriate classification of its investments in debt securities at the time of purchase and re-evaluates such determinations at each balance sheet date. Marketable debt securities are considered to be available for sale and are carried at fair value on the consolidated balance sheet. Unrealized gains and losses net of tax, if any, are reported in a separate component of shareholders’ equity in accumulated other comprehensive income (“OCI”). Gains and losses are recognized when realized, on a specific identification basis, in the Company’s consolidated statements of operations. Following the adoption of ASC 326 in January 2020, current expected credit losses on the Company’s marketable grade debt securities are recorded, if expected, through an allowance for current expected credit losses. The amount of allowance for current expected credit losses is limited to the amount that the fair value is less than the amortized cost basis. Any remaining unrealized losses are included in accumulated other comprehensive loss in shareholders’ equity. If the Company intends to sell the debt security (that is, it has decided to sell the security), or more likely than not will be required to sell the security before recovery of its amortized cost basis, any allowance for current expected credit losses is written off and the amortized cost basis shall be written down to the debt security’s fair value at the reporting date with any incremental impairment reported in earnings. Based on management’s assessment, the Company does not intend to sell its securities for less than amortized cost; therefore, an allowance for current expected credit losses has not been recorded as of December 31, 2021 and 2020. |
Property and equipment | I. Property and equipment Property and equipment are stated at cost, less accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the assets. The annual depreciation rates are as follows: Schedule of Depreciation Rates for Property, Plant and Equipment % Office furniture and equipment 7 16 Computer software and electronic equipment 15 33 Leasehold improvements Shorter of lease term or useful life |
Impairment of long-lived assets | J. Impairment of long-lived assets The Company’s and its subsidiaries’ long-lived assets are reviewed for impairment in accordance with ASC 360-10, “Accounting for the Impairment or Disposal of Long-Lived Assets,” whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of the assets to the future undiscounted cash flows expected to be generated by the assets. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds their fair value. During 2021 and 2020, no impairment losses were recorded. |
Severance pay | K. Severance pay The Company employees are included under section 14 of the Severance Compensation Act, 1963 (“Section 14”) in Israel for a portion of their salaries. According to Section 14, these employees are entitled to monthly deposits at a rate of 8.33% |
Fair value of financial instruments | L. Fair value of financial instruments The estimated fair value of financial instruments was determined by the Company using available market information and valuation methodologies. Considerable judgment is required in estimating fair values. Accordingly, the estimates may not be indicative of the amounts the Company could realize in a current market exchange. The following methods and assumptions were used by the Company in estimating its fair value disclosures for financial instruments: The carrying amounts of cash and cash equivalents, short-term bank deposits, other accounts receivables, trade payables and other trade payables approximate their fair value due to the short-term maturity of such instruments. Fair value is an exit price representing the amount that would be received upon selling an asset or that would be paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions used by market participants in pricing an asset or a liability. A three-tier fair-value hierarchy was established as a basis for considering such assumptions and for inputs used in the valuation methodologies in measuring fair value: ● Level 1 - Observable inputs that reflect quoted prices (unadjusted) for identical assets or liabilities in active markets ● Level 2 - Other inputs that are directly or indirectly observable in the marketplace; and ● Level 3 - Unobservable inputs that are supported by little or no market activity The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The Company’s marketable debt securities are measured at fair value on a recurring basis by level within the fair value hierarchy. Other than the marketable debt securities, which includes corporate bonds and mutual funds as of December 31, 2021, the Company does not have any other financial assets or financial liabilities marked to market at fair value. The fair value of the Company’s marketable debt securities measured at fair value on a recurring basis by level within the fair value hierarchy are as follows (in thousands): Schedule of Marketable Debt Securities December 31, 2021 Fair Level 1 Level 2 Level 3 Value Marketable debt securities $ 26,467 $ 5,464 — $ 31,931 December 31, 2020 Fair Level 1 Level 2 Level 3 Value Marketable debt securities $ 25,449 $ 14,683 — 40,132 |
Accounting for stock-based compensation | M. Accounting for stock-based compensation The Company applies ASC 718-10, “Share-Based Payment,” which requires the measurement and recognition of compensation expense for all share-based payment awards made to employees and directors, including employee stock options under the Company’s stock plans, based on estimated fair values. ASC 718-10 requires companies to estimate the fair value of equity-based payment awards on the date of grant using an option-pricing model. The value of the portion of the award that is ultimately expected to vest is recognized as expense over the requisite service periods in the Company’s consolidated statement of operations. GALMED PHARMACEUTICALS LTD. Notes to Consolidated Financial Statements Note 2 – Significant Accounting Policies (Cont.) M. Accounting for stock-based compensation (Cont.) All issuances of stock options or other equity instruments to non-employees as consideration for goods or services received by the Company are accounted for based on the fair value of the equity instruments issued. The Company estimates the fair value of restricted shares based on the market price of the shares at the grant date and estimates the fair value of stock options granted using a Black-Scholes option-pricing model . The option-pricing model requires a number of assumptions, the most significant of which are the expected stock-price volatility and the expected option term (the time from the grant date until the options are exercised or expire). The Company’s calculations of the expected volatility were based upon actual historical stock-price movements over the period, which was equal to the expected option term. The expected option term was calculated for options granted to employees and directors in accordance with ASC-718-10-S99, using the “simplified” method, and grants to non-employees were based on the contractual term. Historically, the Company has not paid dividends, and has no foreseeable plans to do so. The risk-free interest rate is based on the yield from U.S. Treasury zero-coupon bonds with an equivalent term. |
Revenue Recognition | N. Revenue Recognition The Company only has one license agreement for which it has recognized revenues to date, from a license agreement with Samil Pharm. Co., Ltd. (“Samil” or “Samil Agreement”). The Samil Agreement was signed on July 28, 2016, for an exclusive, royalty-bearing license for the commercialization of Aramchol (with an option to manufacture) for the treatment of fatty liver indications including NASH in the Republic of Korea. Additionally, following the ARREST Study, Samil has an option to extend the License to Vietnam, which, if exercised, would increase the clinical- and regulatory-based milestone payments. Under the terms of the Samil Agreement, the Company received an up-front payment of approximately $ 2.1 1.5 4.5 In accordance with ASC 606 the Company determined that the Agreement included a combined performance obligation representing the delivery of the exclusive license and completion of the ARREST study. As of December 31, 2021, management evaluated the remaining clinical and regulatory milestones and determined that the variable consideration should not be recorded as revenue for the period ended December 31, 2021. The Company will re-evaluate the transaction price in each reporting period when events whose outcomes are resolved or other changes in circumstances occur that would indicate it is appropriate to recognize variable consideration as revenue. GALMED PHARMACEUTICALS LTD. Notes to Consolidated Financial Statements Note 2 – Significant Accounting Policies (Cont.) |
Research and development expenses | O. Research and development expenses Research and development expenses are charged to the statement of operations as incurred. |
Income taxes | P. Income taxes The Company accounts for income taxes utilizing the asset and liability method in accordance with ASC 740, “Income Taxes.” Current tax liabilities are recognized for the estimated taxes payable on tax returns for the current year. Deferred tax liabilities or assets are recognized for the estimated future tax effects attributable to temporary differences between the income-tax bases of assets and liabilities and their reported amounts in the financial statements and for tax loss carry forwards. Measurement of current and deferred tax liabilities and assets is based on provisions of enacted tax laws, and deferred tax assets are reduced, if necessary, by the amount of tax benefits, the realization of which is not considered more likely than not based on available evidence. As of December 31, 2021, and 2020, the Company had a full valuation allowance against deferred tax assets. The Company is subject to the provisions of ASC 740-10-25, “Income Taxes” (“ASC 740”). ASC 740 prescribes a more likely-than-not threshold for the financial statement recognition of uncertain tax positions. ASC 740 clarifies the accounting for income taxes by prescribing a minimum recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. On a yearly basis, the Company undergoes a process to evaluate whether income tax accruals are in accordance with ASC 740 guidance on uncertain tax positions. The Company has not recorded any liability for uncertain tax positions for the years ended December 31, 2021 and 2020. |
Basic and diluted net loss per share | Q. Basic and diluted net loss per share Basic net loss per share is computed based on the weighted-average number of shares outstanding during each year. Diluted net loss per share is computed based on the weighted-average number of shares outstanding during each year, plus the dilutive potential of the ordinary shares considered outstanding during the year, in accordance with ASC 260-10, “Earnings Per Share.” All outstanding stock options and warrants were excluded from the calculation of the diluted loss per share for the years ended December 31, 2021, 2020 and 2019, because all such securities have an anti-dilutive effect. |
Segment Reporting | R. Segment Reporting The chief operating decision maker for the Company is the Chief Executive Officer. The Chief Executive Officer reviews financial information presented on a consolidated basis for purposes of allocating resources and evaluating financial performance. Accordingly, management has determined that the Company operates in one reportable segment. |
Comprehensive Loss | S. Comprehensive Loss The purpose of reporting comprehensive income is to report a measure of all changes in equity of an entity that result from recognized transactions and other economic events of the period resulting from transactions from non-owner sources. |
Leases | T. Leases Under Accounting Standards Update, “Leases” (“ASC 842”), the Company determines if an arrangement is a lease at inception. Upon initial recognition, the Company recognizes a liability at the present value of the lease payments to be made over the lease term, and concurrently recognizes a right-of-use asset at the same amount of the liability, adjusted for any prepaid or accrued lease payments, plus initial direct costs incurred in respect of the lease. The Company uses its incremental borrowing rate based on the information available at the commencement date to determine the present value of the lease payments. The subsequent measurement depends on whether the lease is classified as a finance lease or an operating lease. During the reporting periods, the Company has only operating leases. Lease terms include options to extend the lease when it is reasonably certain that the Company will exercise that option. Lease expenses for operating leases are recognized on a straight-line basis over the lease term. The Company has made a policy election not to capitalize leases with a term of 12 months or less. In accordance with ASC 360-10, management reviews operating lease assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable based on estimated future undiscounted cash flows. If so indicated, an impairment loss would be recognized for the difference between the carrying amount of the asset and its fair value. |
Recently adopted accounting pronouncements | U. Recently adopted accounting pronouncements From time to time, new accounting pronouncements are issued by FASB, or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the impact of recently issued standards that are not yet effective will not have a material impact on our financial position or results of operations upon adoption. GALMED PHARMACEUTICALS LTD. Notes to Consolidated Financial Statements Note 2 – Significant Accounting Policies (Cont.) U. Recently adopted accounting pronouncements (Cont.) In December 2019, the FASB issued ASU 2019-12, “Simplifying the Accounting for Income Taxes”, which will simplify the accounting for income taxes to improve consistency of accounting methods and remove certain exceptions. The amendment is effective for the Company beginning January 1, 2021. The adoption did not have a significant impact on the Company’s consolidated financial statements. |
Recently issued accounting pronouncements | V. Recently issued accounting pronouncements In May 2021, the FASB issued Update 2021-04, Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options (a consensus of the FASB Emerging Issues Task Force). The amendments in this Update affect all entities that issue freestanding written call options that are classified in equity. Specifically, the amendments affect those entities when a freestanding equity-classified written call option is modified or exchanged and remains equity classified after the modification or exchange. The amendments that relate to the recognition and measurement of EPS for certain modifications or exchanges of freestanding equity-classified written call options affect entities that present EPS in accordance with the guidance in Topic 260, Earnings Per Share. The effect of implementing this ASU is immaterial. |
Significant Accounting Polici_3
Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Schedule of Depreciation Rates for Property, Plant and Equipment | Property and equipment are stated at cost, less accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the assets. The annual depreciation rates are as follows: Schedule of Depreciation Rates for Property, Plant and Equipment % Office furniture and equipment 7 16 Computer software and electronic equipment 15 33 Leasehold improvements Shorter of lease term or useful life |
Schedule of Marketable Debt Securities | The fair value of the Company’s marketable debt securities measured at fair value on a recurring basis by level within the fair value hierarchy are as follows (in thousands): Schedule of Marketable Debt Securities December 31, 2021 Fair Level 1 Level 2 Level 3 Value Marketable debt securities $ 26,467 $ 5,464 — $ 31,931 December 31, 2020 Fair Level 1 Level 2 Level 3 Value Marketable debt securities $ 25,449 $ 14,683 — 40,132 |
Marketable debt securities (Tab
Marketable debt securities (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Cash and Cash Equivalents [Abstract] | |
Summary of Marketable Debt Securities | The following table summarizes the Company’s marketable debt securities as of December 31, 2021 and 2020. Summary of Marketable Debt Securities As of December 31, 2021 Gross Gross Amortized Unrealized Unrealized Estimated Cost Gains Losses Fair Value (in thousands) Corporate bonds $ 5,505 $ 9 $ (50 ) $ 5,464 Mutual funds 26,597 58 (188 ) 26,467 Total short-term investments $ 32,102 $ 67 $ (238 ) $ 31,931 As of December 31, 2020 Gross Gross Amortized Unrealized Unrealized Estimated Cost Gains Losses Fair Value (in thousands) Corporate bonds $ 14,575 $ 124 $ (16 ) $ 14,683 Commercial papers 25,285 $ 181 $ (17 ) $ 25,449 Total short-term investments $ 39,860 $ 305 $ (33 ) $ 40,132 |
Other Accounts Receivable (Tabl
Other Accounts Receivable (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Receivables [Abstract] | |
Schedule of Accounts, Notes, Loans and Financing Receivable | Schedule of Accounts, Notes, Loans and Financing Receivable 2021 2020 As of December 31, 2021 2020 (in thousands) Prepaid expenses $ 1,046 $ 746 Government institutions 79 66 Total $ 1,125 $ 812 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Leases | |
Summary of Company's significant contractual lease obligations | The following table summarizes the Company’s significant contractual lease obligations at December 31, 2021: Summary of Company's significant contractual lease obligations Less than Total 1 year 1-3 years (in thousands) Facility leases $ 376 $ 161 $ 215 Car leases 41 24 17 Total $ 417 $ 185 $ 232 |
Property and equipment, net (Ta
Property and equipment, net (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment, Net | Schedule of Property and Equipment, Net 2021 2020 As of December 31, 2021 2020 (in thousands) Medical equipment $ 737 $ 737 Office furniture and equipment 56 56 Computer software and electronic equipment 78 78 Leasehold improvements 231 221 Property and equipment, gross 1,102 1,092 Less - Accumulated depreciation 957 916 Net book value $ 145 $ 176 |
Shareholders_ Equity (Tables)
Shareholders’ Equity (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
Summary of Status of Company's Option Plans and Changes | Summary of Status of Company's Option Plans and Changes 2021 2020 Weighted Weighted Number of average Number of average share options exercise price share options exercise price Options outstanding at beginning of year 2,723,011 $ 5.70 2,393,715 $ 6.12 Granted 402,500 $ 3.32 585,000 $ 4.18 Forfeited (253,100 ) $ 5.25 (208,195 ) $ 7.49 Exercised (18,736 ) $ 0.01 (47,509 ) $ 1.27 Outstanding at end of year 2,853,675 $ 5.42 2,723,011 $ 5.70 Options exercisable at year end $ 2,027,431 $ 5.67 1,754,261 $ 5.42 |
Research and Development Expe_2
Research and Development Expenses (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Research and Development [Abstract] | |
Schedule of Research and Development Expenses | Schedule of Research and Development Expenses Year ended December 31, 2021 2020 2019 (in thousands) Chemistry and formulation studies $ 5,009 $ 5,856 $ 3,439 Salaries 2,963 2,570 2,283 Stock-based compensation 660 871 883 Research and preclinical studies 2,163 1,873 1,962 Clinical studies 14,937 13,225 8,346 Regulatory and other expenses 1,488 1,687 1,267 $ 27,220 $ 26,082 $ 18,180 |
General and Administrative Ex_2
General and Administrative Expenses (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
General And Administrative Expenses | |
Schedule of General and Administrative Expenses | Schedule of General and Administrative Expenses Year ended December 31, 2021 2020 2019 (in thousands) Stock-based compensation $ 1,225 $ 1,194 $ 1,349 Professional fees 897 796 877 Salaries and benefits 1,617 828 856 Rent and office-maintenance fees 530 430 482 Investor relations and business development expenses 242 293 364 Insurance and other expenses 1,150 587 268 $ 5,661 $ 4,128 $ 4,196 |
Financial income, net (Tables)
Financial income, net (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Revenue from Contract with Customer [Abstract] | |
Schedule of Financial Income, Net | Schedule of Financial Income, Net 2021 2020 2019 Year ended December 31, 2021 2020 2019 (in thousands) Bank fees $ 43 $ 31 $ 33 Interest income (562 ) (1,192 ) (1,953 ) Loss (gain) from sale of marketable debt securities 80 (397 ) (106 ) Foreign currency losses 25 119 111 Financial income net $ (414 ) $ (1,439 ) $ (1,915 ) |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Schedule of Effective Income Tax Rate Reconciliation | A reconciliation of the Company’s effective tax expense to the Company’s theoretical statutory tax benefit is as follows: Schedule of Effective Income Tax Rate Reconciliation 2020 2021 2019 Year ended December 31, 2021 2020 2019 (in thousands) Loss before taxes on income, as reported in the consolidated statements of operations $ 32,467 $ 28,771 $ 20,461 Statutory tax rate 12 % 12 % 12 % Theoretical tax benefit 3,896 3,453 2,455 Losses and other items for which a valuation allowance was provided or benefit from loss carry forwards (3,896 ) (3,453 ) (2,455 ) Actual tax expense $ — $ — $ — |
General (Details Narrative)
General (Details Narrative) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Date Of Incorporation | Jul. 31, 2013 | ||
Operations Commenced Date | Feb. 2, 2014 | ||
Cash and cash equivalents | $ 2,800 | ||
Restricted cash | 114 | $ 113 | |
Short-term deposits | 31,900 | ||
Profit loss | 32,400 | 28,800 | $ 20,500 |
Retained earnings accumulated deficit | $ 168,174 | $ 135,707 |
Schedule of Depreciation Rates
Schedule of Depreciation Rates for Property, Plant and Equipment (Details) | 12 Months Ended |
Dec. 31, 2021 | |
Leasehold Improvements [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, depreciation, description | Shorter of lease term or useful life |
Minimum [Member] | Office Equipment [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Depreciation, Percentage | 7.00% |
Minimum [Member] | Computer Software Electronic And Medical Equipment [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Depreciation, Percentage | 15.00% |
Maximum [Member] | Office Equipment [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Depreciation, Percentage | 16.00% |
Maximum [Member] | Computer Software Electronic And Medical Equipment [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Depreciation, Percentage | 33.00% |
Schedule of Marketable Debt Sec
Schedule of Marketable Debt Securities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Defined Benefit Plan Disclosure [Line Items] | ||
Marketable debt securities | $ 31,931 | $ 40,132 |
Fair Value, Inputs, Level 1 [Member] | ||
Defined Benefit Plan Disclosure [Line Items] | ||
Marketable debt securities | 26,467 | 25,449 |
Fair Value, Inputs, Level 2 [Member] | ||
Defined Benefit Plan Disclosure [Line Items] | ||
Marketable debt securities | 5,464 | 14,683 |
Fair Value, Inputs, Level 3 [Member] | ||
Defined Benefit Plan Disclosure [Line Items] | ||
Marketable debt securities |
Significant Accounting Polici_4
Significant Accounting Policies (Details Narrative) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2018 | Dec. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Monthly Deposits of Employees, Percentage on Monthly Salary | 8.33% | ||
Samil Pharm Co Ltd [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Milestone Method Revenue Payment | $ 1.5 | $ 2.1 | |
Accrued Royalties | $ 4.5 | ||
Restricted Stock [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Method Used | Black-Scholes option-pricing model |
Summary of Marketable Debt Secu
Summary of Marketable Debt Securities (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Net Investment Income [Line Items] | ||
Amortized Cost | $ 32,102 | $ 39,860 |
Gross Unrealized Gains | 67 | 305 |
Gross Unrealized Losses | (238) | (33) |
Estimated Fair Value | 31,931 | 40,132 |
Corporate Debt Securities [Member] | ||
Net Investment Income [Line Items] | ||
Amortized Cost | 5,505 | 14,575 |
Gross Unrealized Gains | 9 | 124 |
Gross Unrealized Losses | (50) | (16) |
Estimated Fair Value | 5,464 | 14,683 |
Mutual Fund [Member] | ||
Net Investment Income [Line Items] | ||
Amortized Cost | 26,597 | |
Gross Unrealized Gains | 58 | |
Gross Unrealized Losses | (188) | |
Estimated Fair Value | $ 26,467 | |
Commercial Paper [Member] | ||
Net Investment Income [Line Items] | ||
Amortized Cost | 25,285 | |
Gross Unrealized Gains | 181 | |
Gross Unrealized Losses | (17) | |
Estimated Fair Value | $ 25,449 |
Schedule of Accounts, Notes, Lo
Schedule of Accounts, Notes, Loans and Financing Receivable (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Receivables [Abstract] | ||
Prepaid expenses | $ 1,046 | $ 746 |
Government institutions | 79 | 66 |
Total | $ 1,125 | $ 812 |
Summary of Company's significan
Summary of Company's significant contractual lease obligations (Details) $ in Thousands | Dec. 31, 2021USD ($) |
Other Commitments [Line Items] | |
Total | $ 417 |
Less than 1 year | 185 |
1-3 years | 232 |
Facility Leases [Member] | |
Other Commitments [Line Items] | |
Total | 376 |
Less than 1 year | 161 |
1-3 years | 215 |
Car Leases [Member] | |
Other Commitments [Line Items] | |
Total | 41 |
Less than 1 year | 24 |
1-3 years | $ 17 |
Leases (Details Narrative)
Leases (Details Narrative) | 12 Months Ended | ||
Dec. 31, 2021USD ($)ft² | Dec. 31, 2021ILS (₪) | Dec. 31, 2020USD ($) | |
Leases | |||
Area of land under operating lease agreement | ft² | 590 | ||
Option to extend lease | two additional options to extend until March 22, 2023. | two additional options to extend until March 22, 2023. | |
Lease renewal term | 2 years | ||
Lease rental payment | ₪ | ₪ 134,508 | ||
Maintenance fees | $ 144,476 | ||
Bank guarantee | 50,000 | ||
Operating lease assets | 406,000 | $ 394,000 | |
Operating lease liabilities | $ 435,000 | $ 419,000 | |
Operating leases, weighted average remaining lease term (in years) | 2 years 1 month 13 days | ||
Operating leases, weighted average borrowing rate | 2.30% |
Schedule of Property and Equipm
Schedule of Property and Equipment, Net (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Property, Plant and Equipment [Abstract] | ||
Medical equipment | $ 737 | $ 737 |
Office furniture and equipment | 56 | 56 |
Computer software and electronic equipment | 78 | 78 |
Leasehold improvements | 231 | 221 |
Property and equipment, gross | 1,102 | 1,092 |
Less - Accumulated depreciation | 957 | 916 |
Net book value | $ 145 | $ 176 |
Related Parties (Details Narrat
Related Parties (Details Narrative) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Officers And Directors [Member] | |||
Related Party Transaction [Line Items] | |||
Due to related parties | $ 0.6 | $ 0.5 | |
Chief Executive Officer [Member] | |||
Related Party Transaction [Line Items] | |||
Related party transaction, expenses from transactions with related party | $ 4.1 | $ 3.5 | $ 3.6 |
Commitments and Contingencies (
Commitments and Contingencies (Details Narrative) - USD ($) $ in Thousands | Jun. 28, 2021 | Dec. 31, 2021 |
Loss Contingencies [Line Items] | ||
Bank lien on marketable securities | $ 114 | |
Upfront license fee | $ 100 | |
Maximum [Member] | ||
Loss Contingencies [Line Items] | ||
Payments to regulatory milestones | $ 950 | |
Guarantee of Indebtedness of Others [Member] | ||
Loss Contingencies [Line Items] | ||
Bank guarantee, commitment | $ 54 |
Summary of Status of Company's
Summary of Status of Company's Option Plans and Changes (Details) - $ / shares | 1 Months Ended | 12 Months Ended | |||||||
Aug. 31, 2021 | Jul. 31, 2021 | Mar. 31, 2021 | Feb. 28, 2021 | Nov. 30, 2020 | Aug. 31, 2020 | Mar. 31, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | |
Option Indexed to Issuer's Equity [Line Items] | |||||||||
Number of share options, Granted | 37,500 | 100,000 | 45,000 | 267,500 | 30,000 | 67,500 | |||
Number of share options, Exercised | (18,736) | (47,509) | |||||||
Number of share options exercisable, Ending | 333,532 | 390,905 | |||||||
Weighted average exercise price, Options exercisable, Ending | $ 2.83 | $ 3.10 | $ 4.16 | $ 3.33 | $ 4.77 | $ 4.21 | |||
Share-based Payment Arrangement, Option [Member] | |||||||||
Option Indexed to Issuer's Equity [Line Items] | |||||||||
Number of share options, Beginning | 2,723,011 | 2,393,715 | |||||||
Weighted average exercise price, Beginning | $ 5.70 | $ 6.12 | |||||||
Number of share options, Granted | 402,500 | 585,000 | |||||||
Weighted average exercise price, Granted | $ 3.32 | $ 4.18 | |||||||
Number of share options, Forfeited | (253,100) | (208,195) | |||||||
Weighted average exercise price, Forfeited | $ 5.25 | $ 7.49 | |||||||
Number of share options, Exercised | (18,736) | (47,509) | |||||||
Weighted average exercise price, Exercised | $ 0.01 | $ 1.27 | |||||||
Number of share options, Ending | 2,853,675 | 2,723,011 | |||||||
Weighted average exercise price, Ending | $ 5.42 | $ 5.70 | |||||||
Number of share options exercisable, Ending | 2,027,431 | 1,754,261 | |||||||
Weighted average exercise price, Options exercisable, Ending | $ 5.67 | $ 5.42 |
Shareholders_ Equity (Details N
Shareholders’ Equity (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | Nov. 30, 2021 | Aug. 31, 2021 | Jul. 31, 2021 | Mar. 31, 2021 | Feb. 28, 2021 | Nov. 30, 2020 | Aug. 31, 2020 | Mar. 31, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2016 | Mar. 26, 2021 | May 15, 2020 | Dec. 22, 2017 |
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||||||||||
Ordinary shares offered | $ 31,900 | ||||||||||||||
Proceeds from sale of ordinary shares | $ 9,221 | $ 707 | |||||||||||||
Options, exercised | 18,736 | 47,509 | |||||||||||||
Total consideration | $ 1 | $ 61 | |||||||||||||
Stock issued, restricted stock award | 2,781 | ||||||||||||||
Options, granted | 37,500 | 100,000 | 45,000 | 267,500 | 30,000 | 67,500 | |||||||||
Options exercisable, per share | $ 2.83 | $ 3.10 | $ 4.16 | $ 3.33 | $ 4.77 | $ 4.21 | |||||||||
Options, term | 10 years | 10 years | 10 years | 10 years | 10 years | 10 years | |||||||||
Options vested, term | 3 years | 3 years | 4 years | 4 years | 4 years | 4 years | |||||||||
Aggregate grant fair value | $ 10 | $ 200 | $ 100 | $ 600 | $ 100 | $ 200 | |||||||||
Options, exercisable | 333,532 | 390,905 | |||||||||||||
Options, intrinsic value | $ 600 | $ 1,100 | |||||||||||||
Share-based Compensation | $ 1,886 | $ 2,066 | $ 2,231 | ||||||||||||
Share-based Payment Arrangement, Option [Member] | |||||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||||||||||
Stock issued, restricted stock award | 59,528 | ||||||||||||||
Options, granted | 38,637 | ||||||||||||||
Options, term | 5 years 10 months 24 days | 6 years 7 months 6 days | |||||||||||||
Dividend yield | 0.00% | ||||||||||||||
Risk-free interest rate, minimum | 0.80% | 0.42% | 0.42% | ||||||||||||
Risk-free interest rate, maximum | 1.34% | 0.74% | 2.35% | ||||||||||||
Volatility rate, minimum | 64.00% | 83.00% | 87.00% | ||||||||||||
Volatility rate, maximum | 81.00% | 88.00% | 95.00% | ||||||||||||
Weighted average grant date fair value | $ 2.19 | $ 2.76 | $ 4.85 | ||||||||||||
Unrecognized share based compensation | $ 3,400 | $ 4,000 | $ 5,500 | ||||||||||||
Unrecognized compensation, term | 1 year 9 months | 2 years 10 months 24 days | 3 years 1 month 6 days | ||||||||||||
Allocated stock based compensation | $ 1,900 | $ 2,100 | $ 2,200 | ||||||||||||
Share-based Payment Arrangement, Option [Member] | Minimum [Member] | |||||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||||||||||
Expected life, term | 5 years | ||||||||||||||
Share-based Payment Arrangement, Option [Member] | Maximum [Member] | |||||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||||||||||
Expected life, term | 6 years 3 months | ||||||||||||||
Restricted Stock Units (RSUs) [Member] | |||||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||||||||||
Shares issued, shares | 78,750 | ||||||||||||||
Options vested, term | 4 years | ||||||||||||||
Unrecognized share based compensation | $ 0 | ||||||||||||||
Share-based Compensation | $ 0 | $ 5 | $ 70 | ||||||||||||
Chief Executive Officer [Member] | |||||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||||||||||
Options, granted | 220,000 | 220,000 | |||||||||||||
Options exercisable, per share | $ 3.33 | $ 5.12 | |||||||||||||
Options, term | 10 years | 10 years | |||||||||||||
Options vested, term | 4 years | 4 years | |||||||||||||
Aggregate grant fair value | $ 500 | $ 800 | |||||||||||||
New Sales Agreement [Member] | |||||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||||||||||
Maximum amount of shares to be issued | $ 5,000 | ||||||||||||||
Common Stock [Member] | |||||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||||||||||
Shares issued, shares | 4,500 | 2,197,803 | |||||||||||||
Options, exercised | 23,236 | 50,290 | |||||||||||||
Common Stock [Member] | Underwritten Public Offering [Member] | |||||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||||||||||
Shares issued, shares | 2,197,803 | ||||||||||||||
Proceeds from sale of ordinary shares | $ 9,200 | ||||||||||||||
Share price | $ 4.3258 | ||||||||||||||
Option exercisable term | 30 days | ||||||||||||||
Additional shares to purchase | 329,670 | ||||||||||||||
Atthemarket Offering [Member] | |||||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||||||||||
Maximum amount of shares to be issued | $ 35,000 | ||||||||||||||
Atthemarket Offering [Member] | Common Stock [Member] | |||||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||||||||||
Shares issued, shares | 1,541,400 | 136,300 | |||||||||||||
Proceeds from sale of ordinary shares | $ 8,200 | $ 800 | |||||||||||||
Incentive Share Option Plan2013 [Member] | |||||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||||||||||
Shares reserved for future issuance | 375,743 |
Schedule of Research and Develo
Schedule of Research and Development Expenses (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Research and development expense | $ 27,220 | $ 26,082 | $ 18,180 |
Chemistry And Formulation Studies [Member] | |||
Research and development expense | 5,009 | 5,856 | 3,439 |
Salaries [Member] | |||
Research and development expense | 2,963 | 2,570 | 2,283 |
Stock Based Compensation [Member] | |||
Research and development expense | 660 | 871 | 883 |
Research And Preclinical Studies [Member] | |||
Research and development expense | 2,163 | 1,873 | 1,962 |
Clinical Studies [Member] | |||
Research and development expense | 14,937 | 13,225 | 8,346 |
Regulatory And Other Expenses [Member] | |||
Research and development expense | $ 1,488 | $ 1,687 | $ 1,267 |
Schedule of General and Adminis
Schedule of General and Administrative Expenses (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
General and administrative expenses | $ 5,661 | $ 4,128 | $ 4,196 |
Stock Based Compensation [Member] | |||
General and administrative expenses | 1,225 | 1,194 | 1,349 |
Professional Fees [Member] | |||
General and administrative expenses | 897 | 796 | 877 |
Salaries And Benefits [Member] | |||
General and administrative expenses | 1,617 | 828 | 856 |
Rent And Office Maintenance Fees [Member] | |||
General and administrative expenses | 530 | 430 | 482 |
Investor Relations And Business Development Expenses [Member] | |||
General and administrative expenses | 242 | 293 | 364 |
Insurance And Other Expenses [Member] | |||
General and administrative expenses | $ 1,150 | $ 587 | $ 268 |
Schedule of Financial Income, N
Schedule of Financial Income, Net (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Revenue from Contract with Customer [Abstract] | |||
Bank fees | $ 43 | $ 31 | $ 33 |
Interest income | (562) | (1,192) | (1,953) |
Loss (gain) from sale of marketable debt securities | 80 | (397) | (106) |
Foreign currency losses | 25 | 119 | 111 |
Financial income net | $ (414) | $ (1,439) | $ (1,915) |
Schedule of Effective Income Ta
Schedule of Effective Income Tax Rate Reconciliation (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |||
Loss before taxes on income, as reported in the consolidated statements of operations | $ 32,467 | $ 28,771 | $ 20,461 |
Statutory tax rate | 12.00% | 12.00% | 12.00% |
Theoretical tax benefit | $ 3,896 | $ 3,453 | $ 2,455 |
Losses and other items for which a valuation allowance was provided or benefit from loss carry forwards | (3,896) | (3,453) | (2,455) |
Actual tax expense |
Income Taxes (Details Narrative
Income Taxes (Details Narrative) - USD ($) $ in Thousands | Feb. 07, 2018 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Significant Change in Unrecognized Tax Benefits is Reasonably Possible [Line Items] | ||||
Effective income tax rate reconciliation, at federal statutory income tax rate, percent | 12.00% | 12.00% | 12.00% | |
Operating loss carry forwards | $ 137,900 | |||
Deferred tax assets, capital loss carry forwards | 126,000 | |||
Research and Development Expense | 27,220 | $ 26,082 | $ 18,180 | |
Deferred Income Tax Charge [Member] | ||||
Significant Change in Unrecognized Tax Benefits is Reasonably Possible [Line Items] | ||||
Research and Development Expense | $ 37,000 | |||
Minimum [Member] | ||||
Significant Change in Unrecognized Tax Benefits is Reasonably Possible [Line Items] | ||||
Effective income tax rate reconciliation, at federal statutory income tax rate, percent | 6.00% | |||
Maximum [Member] | ||||
Significant Change in Unrecognized Tax Benefits is Reasonably Possible [Line Items] | ||||
Effective income tax rate reconciliation, at federal statutory income tax rate, percent | 12.00% | |||
Israeli Subsidiary [Member] | ||||
Significant Change in Unrecognized Tax Benefits is Reasonably Possible [Line Items] | ||||
Effective income tax rate reconciliation, at federal statutory income tax rate, percent | 23.00% | |||
Operating loss carry forwards | $ 126,200 | |||
Deferred tax assets, capital loss carry forwards | $ 1,900 | |||
Maltese Subsidiary [Member] | ||||
Significant Change in Unrecognized Tax Benefits is Reasonably Possible [Line Items] | ||||
Effective income tax rate reconciliation, at federal statutory income tax rate, percent | 35.00% | 35.00% | 35.00% | |
Operating loss carry forwards | $ 11,700 |