Document And Entity Information
Document And Entity Information | 12 Months Ended |
Dec. 31, 2020shares | |
Document Information [Line Items] | |
Document Type | 20-F |
Amendment Flag | false |
Document Period End Date | Dec. 31, 2020 |
Document Fiscal Year Focus | 2020 |
Document Fiscal Period Focus | FY |
Entity File Number | 001-36345 |
Entity Registrant Name | Galmed Pharmaceuticals Ltd. |
Entity Address, Address Line One | 16 Tiomkin Street |
Entity Address, City or Town | Tel Aviv |
Entity Address, Postal Zip Code | 6578317 |
Entity Address, Country | IL |
Entity Central Index Key | 0001595353 |
Current Fiscal Year End Date | --12-31 |
Entity Well-known Seasoned Issuer | No |
Entity Voluntary Filers | No |
Entity Current Reporting Status | Yes |
Entity Incorporation, State or Country Code | L3 |
Document Registration Statement | false |
Document Annual Report | true |
Document Transition Report | false |
Document Shell Company Report | false |
Entity Interactive Data Current | Yes |
Entity Filer Category | Accelerated Filer |
Title of 12(b) Security | Ordinary shares, par value NIS 0.01 per share |
Trading Symbol | GLMD |
Security Exchange Name | NASDAQ |
Entity Common Stock, Shares Outstanding | 21,325,975 |
Entity Shell Company | false |
Entity Emerging Growth Company | false |
Document Accounting Standard | U.S. GAAP |
ICFR Auditor Attestation Flag | true |
Business Contact [Member] | |
Document Information [Line Items] | |
Entity Address, Address Line One | 16 Tiomkin Street |
Entity Address, City or Town | Tel Aviv |
Entity Address, Postal Zip Code | 6578317 |
Entity Address, Country | IL |
Contact Personnel Name | Allen Baharaff |
Contact Personnel Email Address | ab@galmedpharma.com |
City Area Code | +972.3 |
Local Phone Number | 693.8448 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Current assets | ||
Cash and cash equivalents | $ 6,947 | $ 15,931 |
Restricted cash | 113 | 112 |
Short-term deposits | 3,807 | 27,938 |
Marketable debt securities | 40,132 | 31,622 |
Other accounts receivable | 812 | 827 |
Total current assets | 51,811 | 76,430 |
Right of use assets | 394 | 538 |
Property and equipment, net | 176 | 171 |
Total non-current assets | 570 | 709 |
Total assets | 52,381 | 77,139 |
Current liabilities | ||
Trade payables | 7,046 | 5,999 |
Other accounts payable | 966 | 935 |
Total current liabilities | 8,012 | 6,934 |
Non-current liabilities | ||
Lease obligation | 216 | 352 |
Total non-current liabilities | 216 | 352 |
Stockholders' equity: | ||
Ordinary shares par value NIS 0.01 per share; Authorized 50,000,000 shares; Issued and outstanding: 000 shares as of December 31, 2020; 21,139,385 shares as of December 31, 2019 | 58 | 58 |
Additional paid-in capital | 179,530 | 176,696 |
Accumulated other comprehensive income | 272 | 35 |
Accumulated deficit | (135,707) | (106,936) |
Total stockholders' equity | 44,153 | 69,853 |
Total liabilities and stockholders' equity | $ 52,381 | $ 77,139 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - ₪ / shares | Dec. 31, 2020 | Dec. 31, 2019 |
Consolidated Balance Sheets | ||
Ordinary shares, Par or Stated Value Per Share | ₪ 0.01 | ₪ 0.01 |
Ordinary shares, Shares Authorized | 50,000,000 | 50,000,000 |
Ordinary shares, Shares, Issued | 21,325,975 | 21,139,385 |
Ordinary shares, Shares, Outstanding | 21,325,975 | 21,139,385 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Consolidated Statements of Operations | |||
Revenue | $ 0 | $ 0 | $ 2,038 |
Research and development expenses | 26,082 | 18,180 | 8,313 |
General and administrative expenses | 4,128 | 4,196 | 4,440 |
Total operating loss | 30,210 | 22,376 | 10,715 |
Financial income, net | (1,439) | (1,915) | (934) |
Loss before income taxes | 28,771 | 20,461 | 9,781 |
Income taxes | 0 | 0 | 75 |
Net loss | $ 28,771 | $ 20,461 | $ 9,856 |
Basic and diluted net loss per share (in dollars per share) | $ 1.35 | $ 0.97 | $ 0.54 |
Weighted-average number of shares outstanding used in computing basic and diluted net loss per share | 21,280,787 | 21,114,399 | 18,137,689 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Consolidated Statements of Comprehensive Loss | |||
Net loss | $ 28,771 | $ 20,461 | $ 9,856 |
Other comprehensive loss (income): | |||
Net unrealized loss (gain) on available for sale securities | (237) | (46) | 4 |
Comprehensive loss | $ 28,534 | $ 20,415 | $ 9,860 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - USD ($) $ in Thousands | Ordinary shares [Member] | Additional paid-in capital [Member] | Accumulated other comprehensive income (loss) [Member] | Accumulated deficit [Member] | Total | |
Balance at Dec. 31, 2018 | $ 58 | $ 174,322 | $ (11) | $ (86,475) | $ 87,894 | |
Balance (in shares) at Dec. 31, 2018 | 21,018,919 | |||||
Stock-based compensation | $ 0 | 2,231 | 0 | 0 | 2,231 | |
Exercise of options and restricted stock units | $ 0 | 143 | 0 | 0 | 143 | |
Exercise of options and restricted stock units (in shares) | 120,466 | |||||
Unrealized gain (loss) on marketable debt securities | $ 0 | 0 | 46 | 0 | 46 | |
Net loss | 0 | 0 | 0 | (20,461) | (20,461) | |
Balance at Dec. 31, 2019 | $ 58 | 176,696 | 35 | (106,936) | 69,853 | |
Balance (in shares) at Dec. 31, 2019 | 21,139,385 | |||||
Stock-based compensation | $ 0 | 2,066 | 0 | 0 | 2,066 | |
Exercise of options and restricted stock units | $ 0 | [1] | 61 | 0 | 0 | $ 61 |
Exercise of options and restricted stock units (in shares) | 50,290 | 2,781 | ||||
Issuance of common stock upon stock option exercises | $ 61 | |||||
Issuance of Ordinary Shares | $ 0 | 707 | 0 | 0 | 707 | |
Issuance of Ordinary Shares (In shares) | 136,300 | |||||
Unrealized gain (loss) on marketable debt securities | $ 0 | 0 | 237 | 0 | 237 | |
Net loss | 0 | 0 | 0 | (28,771) | (28,771) | |
Balance at Dec. 31, 2020 | $ 58 | $ 179,530 | $ 272 | $ (135,707) | $ 44,153 | |
Balance (in shares) at Dec. 31, 2020 | 21,325,975 | |||||
[1] | Represents amount less than $1 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | ||
Cash flow from operating activities | ||||
Net loss for the year | $ (28,771) | $ (20,461) | $ (9,856) | |
Adjustments required to reconcile net loss to net cash used in operating activities: | ||||
Depreciation and amortization | 39 | 35 | 387 | |
Amortization of discount/premium on marketable debt securities | 90 | (105) | (144) | |
Loss (gain) on sale of marketable debt securities | (527) | (9) | 12 | |
Interest income from short-term deposits | (285) | (63) | 0 | |
Stock-based compensation expense | 2,066 | 2,231 | 1,783 | |
Changes in operating assets and liabilities: | ||||
Decrease in deferred revenue from collaboration agreement | 0 | 0 | (538) | |
Decrease (increase) in other accounts receivable | 15 | (609) | (63) | |
Increase (decrease) in trade payables | 1,047 | 4,185 | (462) | |
Increase (decrease) in other accounts payable | 39 | (141) | (142) | |
Net cash used in operating activities | (26,287) | (14,937) | (9,023) | |
Cash flow from investing activities | ||||
Purchase of property and equipment | (44) | (12) | (90) | |
Investment in securities, available for sale | (55,034) | (72,600) | (92,279) | |
Proceeds from sale of securities, available for sale | 47,198 | 101,098 | 38,421 | |
Proceeds (investment) in short-term deposits, net | 24,416 | (21,808) | (6,067) | |
Net cash provided by (used in) investing activities | 16,536 | 6,678 | (60,015) | |
Cash flow from financing activities | ||||
Issuance of ordinary shares and warrants, net of issuance costs | [1] | 707 | 0 | 79,149 |
Proceeds from exercise of options | 61 | 143 | 1,027 | |
Net cash provided by financing activities | 768 | 143 | 80,176 | |
Increase (decrease) in cash and cash equivalents and restricted cash | (8,983) | (8,116) | 11,138 | |
Cash and cash equivalents and restricted cash at the beginning of the year | 16,043 | 24,159 | 13,021 | |
Cash and cash equivalents and restricted cash at the end of the year | 7,060 | 16,043 | 24,159 | |
Supplemental disclosure of cash flow information: | ||||
Cash received from interest | 1,192 | 1,953 | 865 | |
Cash paid for taxes | 0 | 0 | 75 | |
Non-cash transactions: | ||||
Recognition of right-of-use asset and lease liabilities from adoption of ASU 2016-02 | $ 35 | $ 653 | $ 0 | |
[1] | See also Note 10. |
General
General | 12 Months Ended |
Dec. 31, 2020 | |
General | |
General | Note 1 – General Galmed Pharmaceuticals Ltd. (the “Company”) is a clinical-stage biopharmaceutical company primarily focused on the development of therapeutics for the treatment of liver diseases. The Company was incorporated in Israel on July 31, 2013 and commenced operations on 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 are incorporated in Israel. The Company is a clinical-stage biopharmaceutical company with an operating history limited to pre-clinical and clinical drug development and has no approved products. To date, the Company has focused almost exclusively on developing its product candidate, Aramchol. 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, 2020, the Company had cash and cash equivalents of $6.9 million, restricted cash of $0.1 million, short-term deposits of $3.8 million and marketable debt securities of $40.1 million. 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, 2018, 2019, and 2020 was approximately $9.9 million, $20.5 million, and $28.8 million, respectively. As of December 31, 2020, the Company had an accumulated deficit of $135.7 million. Substantially all of its operating losses resulted from costs incurred in connection with the Company’s development program and from general and administrative costs associated with its operations. 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, 2020 | |
Significant Accounting Policies | |
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. 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. Marketable debt securities are considered to be available for sale and are carried at fair value. Unrealized gains and losses net of tax, if any, are reported as a separate component of stockholders’ equity. The cost of marketable debt securities classified as available for sale is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization and accretion are included in interest income. Realized gains and losses and declines in value judged to be other than temporary, if any, are also included in other income, net. Interest on securities classified as available for sale is included in interest income. The cost of securities sold is based on the specific identification method. For all investments in marketable debt securities, the Company assesses whether the impairment is other-than-temporary. If the fair value of a security is less than its amortized cost basis, an impairment is considered other-than-temporary if (i) the Company has the intent to sell the security or it is more likely than not that the Company will be required to sell the security before recovery of its entire amortized cost basis, or (ii) the Company does not expect to recover the entire amortized cost of the security. If an impairment is considered other-than-temporary based on condition (i), the entire difference between the amortized cost and the fair value of the security is recognized in earnings. If an impairment is considered other-than-temporary based on condition (ii), the amount representing credit losses, defined as the difference between the present value of the cash flows expected to be collected and the amortized cost basis of the security, will be recognized in earnings, and the amount relating to all other factors will be recognized in other comprehensive income. The Company evaluates both qualitative and quantitative factors such as duration and severity of the unrealized Note 2 – Significant Accounting Policies (Cont.) G. Marketable debt securities (Cont.) losses, credit ratings, default and loss rates of the underlying collateral, structure and credit enhancements to determine if a credit loss may exist. During the years ended December 31, 2020 and 2019 no other-than-temporarily impaired losses were realized. H. Concentrations of credit risk Financial instruments which potentially subject us to credit risk consist primarily of cash, cash equivalents, marketable securities and short-term deposits. We 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. We have not experienced any credit losses in such accounts and do not believe we are exposed to any significant credit risk on these funds. We have 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: % Office furniture and equipment 7–16 Computer software and electronic equipment 15–33 Leasehold improvements 10 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 2020 and 2019, no impairment losses were identified. K. Severance pay The Company employees are included under section 14 of the Severance Compensation Act, 1963 (“Section 14”) for a portion of their salaries. According to Section 14, these employees are entitled to monthly deposits at a rate of 8.33% of their monthly salary, made in their name with such insurance companies. Under the Severance Compensation Act, 1963, payments in accordance with Section 14 release the Company from any future severance payments to those employees. The aforementioned deposits are not recorded as an asset in the Company’s balance sheet. 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. 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. Note 2 – Significant Accounting Policies (Cont.) M. Accounting for stock-based compensation (Cont.) In June 2018, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2018-07, “Compensation-Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting”, which simplifies the accounting for non-employee share-based payment transactions by aligning the measurement and classification guidance, with certain exceptions, to that for share-based payment awards to employees. The amendments expand the scope of the accounting standard for share-based payment awards to include share-based payment awards granted to non-employees in exchange for goods or services used or consumed in an entity’s own operations and supersedes the guidance related to equity-based payments to non-employees. The Company elected to early adopt these amendments on June 1, 2018. The adoption of these amendments did not have a significant impact on the Company's consolidated financial statements and related disclosures. 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 is has recognized revenues to date. On January 1, 2018, the Company adopted ASC 606 with full retrospective application. The adoption of did not have an effect on either revenue recognized in prior periods, nor to accumulated deficit as of January 1, 2017. The new revenue standard amended revenue recognition principles and provides a single, comprehensive set of criteria for revenue recognition within and across all industries. The standard applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. The new revenue standard provides a five-step framework whereby revenue is recognized when control of promised goods or services is transferred to a customer at an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. To determine revenue recognition for arrangements that we determine are within the scope of the new revenue standard, we perform the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the performance obligations are satisfied. Note 2 – Significant Accounting Policies (Cont.) N. Revenue Recognition (Cont.) The Company only applies the five-step model to contracts when collectability of the consideration to which the Company is entitled in exchange for the goods or services transferred to the customer is determined to be probable. At contract inception, once the contract is determined to be within the scope of the new revenue standard, the Company assesses whether the goods or services promised within each contract are distinct and, therefore, represent a separate performance obligation. Goods and services that are determined not to be distinct are combined with other promised goods and services until a distinct bundle is identified. The Company then allocates the transaction price (the amount of consideration the Company expects to be entitled to from a customer in exchange for the promised goods or services) to each performance obligation and recognizes the associated revenue when (or as) each performance obligation is satisfied. The Company’s estimate of the transaction price for each contract includes all variable consideration to which we expect to be entitled. 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, 2020, and 2019, the Company had a full valuation allowance against deferred tax assets. ASC 740-10 requires a two-step approach to recognizing and measuring uncertain tax positions. The first step is to evaluate the tax position for recognition by determining if the weight of available evidence indicates that it is more likely than not that the position will be sustained on audit, including resolution of related appeals or litigation processes, if any. The second step is to measure the tax benefit as the largest amount that is more than 50% likely of being realized upon ultimate settlement. The Company has not recorded any liability for uncertain tax positions for the years ended December 31, 2020 and 2019. 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, 2020, 2019 and 2018, because all such securities have an anti-dilutive effect. 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 ASU 2016-02, “Leases (Topic 842)” was issued by the FASB in February 2016. The Company adopted this ASU 2016-02 effective January 1, 2019 using the modified retrospective application, applying the new standard to leases in place as of the adoption date. Prior periods have not been adjusted. Leases existing for the reporting period beginning January 1, 2019 are presented under ASU 2016-02. Arrangements that are determined to be leases at inception are recognized as right of use assets and lease liabilities in the consolidated balance sheet at lease commencement. Operating lease liabilities are recognized based on the present value of the future lease payments over the lease term at commencement date. As the Company’s leases do not provide an implicit rate, the Company applies its incremental borrowing rate based on the economic environment at the commencement date in determining the present value of future lease payments. Lease terms include options to extend the lease when it is reasonably certain that the Company will exercise that option. Lease expense for operating leases or payments are recognized on a straight-line basis over the lease term. The Company elected to adopt a package of practical expedients offered by the FASB which removes the requirement to reassess whether expired or existing contracts contain leases and removes the requirement to reassess the lease classification for any existing leases prior to the adoption date of January 1, 2019. The Company has also elected the practical expedient to include both lease and non-lease components as a single component and account for it as a lease. Additionally, 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. Note 2 – Significant Accounting Policies (Cont.) U. Recently adopted accounting pronouncements (Cont.) In June 2016, FASB issued ASU No. 2016-13, “Financial Instruments – Credit Losses – Measurement of Credit Losses on Financial Instruments”, which introduces a model based on expected losses to estimate credit losses for most financial assets and certain other instruments. In addition, for available-for-sale debt securities with unrealized losses, the losses will be recognized as allowances rather than reductions in the amortized cost of the securities. The ASU is effective for the Company in the first quarter of 2020, with early adoption permitted. The Company adopted ASU 2016-13 in 2020. The adoption did not have a material effect on the Company’s consolidated financial statements. In August 2018, the FASB issued ASU 2018-13, “Changes to Disclosure Requirements for Fair Value Measurements”, which will improve the effectiveness of disclosure requirements for recurring and nonrecurring fair value measurements. The standard removes, modifies, and adds certain disclosure requirements, and is effective for the Company beginning on January 1, 2020. The Company adopted ASU 2016-13 in 2020. The adoption did not have a material effect on the Company’s consolidated financial statements. V. Recently issued accounting pronouncements 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 and is not expected to have a material impact on the Company's consolidated financial statements and disclosures. |
Marketable debt securities
Marketable debt securities | 12 Months Ended |
Dec. 31, 2020 | |
Marketable debt securities | |
Marketable debt securities | Note 3 – Marketable debt securities The Company's financial assets 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, 2020, the Company doesn't 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): December 31, 2020 Fair Level 1 Level 2 Level 3 Value Marketable debt securities $ 25,449 14,683 — 40,132 December 31, 2019 Fair Level 1 Level 2 Level 3 Value Marketable debt securities $ — 31,622 — 31,622 Note 3 – Marketable debt securities (Cont.) The following table summarizes the Company’s marketable debt securities as of December 31, 2020 and 2019. 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 Mutual funds 25,285 181 (17) 25,449 Total short-term investments $ 39,860 $ 305 $ (33) $ 40,132 As of December 31, 2019 Gross Gross Amortized Unrealized Unrealized Estimated Cost Gains Losses Fair Value (in thousands) Corporate bonds $ 19,893 $ 49 $ (37) $ 19,905 Commercial papers 11,694 $ 23 $ — $ 11,717 Total short-term investments $ 31,587 $ 72 $ (37) $ 31,622 The contractual maturity of the aforementioned marketable securities varies between less than one year to two years. The Company reviews the individual securities in its portfolio to determine whether a decline in a security’s fair value below the amortized cost basis is other-than-temporary. The Company determined that as of December 31, 2020 and 2019 there were no investments in its portfolio that were other-than-temporarily impaired. |
Other Accounts Receivable
Other Accounts Receivable | 12 Months Ended |
Dec. 31, 2020 | |
Other Accounts Receivable | |
Other Accounts Receivable | Note 4 – Other Accounts Receivable As of December 31, 2020 2019 (in thousands) Government institutions $ 66 $ 178 Prepaid expenses 746 601 Others — 48 $ 812 $ 827 |
Leases
Leases | 12 Months Ended |
Dec. 31, 2020 | |
Leases | |
Leases | Note 5 – Leases On January 1, 2019, the Company adopted ASU 2016-02, using the modified retrospective approach for all lease arrangements at the beginning period of adoption. Leases existing for the reporting period beginning January 1, 2019 are presented under ASU 2016-02. The Company leases, approximately 590 square meters at a facility located in Tel-Aviv, Israel under an operating lease agreement expiring on March 22, 2021 with additional two options to extend In addition, the Company leases vehicles under various operating lease agreements. Note 5 – Leases (Cont.) At December 31, 2020, the Company’s operating lease assets and lease liabilities 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, 2020, the Company's operating leases had a weighted average remaining lease term of 2.25 years and a weighted average borrowing rate of 2.75%. Upon adoption of ASC 842, discount rates for existing operating leases were established as of January 1, 2019. The following table summarizes the Company’s significant contractual lease obligations at December 31, 2020: Less than Total 1 year 1 ‑ 3 years (in thousands) Facility leases $ 403 $ 193 $ 210 Car leases 30 13 17 Total $ 433 $ 206 $ 227 |
Property and equipment, net
Property and equipment, net | 12 Months Ended |
Dec. 31, 2020 | |
Property and equipment, net | |
Property and equipment, net | Note 6 – Property and equipment, net As of December 31, 2020 2019 (in thousands) Medical equipment $ 737 $ 737 Office furniture and equipment 56 55 Computer software and electronic equipment 78 88 Leasehold improvements 221 198 1,092 1,078 Less - Accumulated depreciation 916 907 Net book value $ 176 $ 171 |
Revenue
Revenue | 12 Months Ended |
Dec. 31, 2020 | |
Revenue | |
Revenue | Note 7 – Revenue Samil Agreement On July 28, 2016, the Company entered into a license agreement ("Samil Agreement") with Samil Pharm. Co., Ltd. (the “Samil”), 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 million. Samil has also agreed to pay additional clinical and regulatory-based milestone payments, which may aggregate up to $6.0 million, as well as tiered, double-digit royalties payable on sales (under certain limitations). In September 2018, the Company received a milestone payment of $1.5 million from Samil in connection with the completion of its ARREST study. 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. Note 7 – Revenue (Cont.) The Company determined that the transaction price at contract inception was $2.1 million consisting of the upfront, non-refundable payment. None of the clinical or regulatory milestones were included in the transaction price upon inception, as all milestone amounts were fully constrained. Management assessed that the likelihood of occurrence of the other performance obligations in the Agreement was remote upon contract inception. As such, the stand-alone value of such performance obligations was deemed de minimis and none of the transaction price was allocated to those obligations. Any consideration related to sales-based milestones and royalties will be recognized when the related sales occur, and therefore have also been excluded from the transaction price. During 2018, when the Company determined that the achievement of its first milestone was probable, it included the variable consideration of $1.5 million as a part of the transaction price allocated to the combined performance obligation including the delivery of the license and completion of the ARREST study. As of December 31, 2020, 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, 2020. 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. Revenue allocated to the combined performance obligation of the license and associated ARREST study was recognized ratably, based on the input method, from contract inception through conclusion of the ARREST study in June 2018. |
Related Parties
Related Parties | 12 Months Ended |
Dec. 31, 2020 | |
Related Parties | |
Related Parties | Note 8 – Related Parties 1. As of December 31, 2020, and 2019, the Company had an accrual in the amount of approximately $0.5 million and $0.6 million, respectively, pursuant to an employment agreement with its officers and directors’ fee. 2. During 2020, 2019 and 2018, the Company recorded salary expenses, stock-based compensation expenses and directors’ fee to its related parties in the amount of $3.5 million, $3.6 million and $3.7 million respectively. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2020 | |
Commitments and Contingencies | |
Commitments and Contingencies | Note 9 – Commitments and Contingencies 1. As of December 31, 2020, the Company recorded a pledge on its short-term deposit in favor of its bank in the amount of approximately $113 thousand to secure the Company’s commitments to the bank, including a bank guarantee in favor Mintz K. Construction Company, the lessor of the Company's headquarters, totaling $54 thousands as of December 31, 2020. 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. Note 9 – Commitments and Contingencies (Cont.) 4. 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, 2020 and 2019. |
Shareholders' Equity
Shareholders' Equity | 12 Months Ended |
Dec. 31, 2020 | |
Shareholders' Equity | |
Shareholders' Equity | Note 10– 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 (File No. 333-223923) the Company may offer and sell, from time to time through Stifel, its ordinary shares having an aggregate offering price of up to $35 million. On May 15, 2020, the Company amended and restated the Sales Agreement dated December 22, 2017 between the Company and Stifel, Nicolaus & Company, Incorporated to include Cantor Fitzgerald & Co. as an additional sales agent for the Company's "at the market offering" program (the "ATM Program"). Pursuant to a prospectus supplement filed with the SEC on May 15, 2020, the Company may offer and sell up to $31.9 million of its ordinary shares. As of December 31,2020 the Company sold 136,300 ordinary shares under the ATM Program for total net proceeds of approximately $0.8 million. 3. During February 2021, subsequent to the balance sheet date, the Company sold an additional 1,541,400 ordinary shares under the ATM Program for total net proceeds of approximately $8.2 million. As a result, the Company has approximately $22.7 million remaining available for future sales under the ATM Program as of February 28, 2021. 4. During February 2021, subsequent to the balance sheet date, 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 ordinary shares (the "Firm Shares") of the Company (the "Ordinary Shares"). The Underwriter agreed to purchase the Firm Shares from the Company at a price of $4.3258 per share. The net proceeds to the Company were approximately $9.3 million. Under the terms of the Underwriting Agreement, the Company granted the Underwriter an option, exercisable for 30 days, to purchase up to an additional 329,670 ordinary shares (the "Option Shares" and together with the Firm Shares, the "Shares") at the same price per share as the Firm Shares. Note 10– 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, 2020, a total of 687,973 shares were reserved for issuance under the 2013 Plan. The 2013 Plan, which was adopted by the Board on September 2, 2013, and approved by the Company’s shareholders on December 30, 2013 (as was amended by the Board and the Company’s shareholders on March 30, 2015, May 11, 2015, and August 30, 2018 respectively), provides for the grant of options to purchase the ordinary shares and the issuance of restricted stock units (“RSUs”) to the Company’s officers, directors, employees, service providers and consultants. The 2013 Plan provides for such equity-based compensation under various and different tax regimes. 2. During the year ended December 31, 2020, certain current and former office holders exercised options into 47,509 ordinary shares of the Company, NIS 0.01 par value per share, for total consideration of $61 thousand. 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 ordinary shares of the Company, NIS 0.01 par value per share. 4. In March 2020, the Company granted options to purchase 67,500 ordinary shares of the Company to several employees. The options are exercisable at $4.21 per share, have a 10-year term and vest over a period of four years . The aggregate grant date fair value of such options was approximately $0.2 million. 5. In August 2020, the Company granted options to purchase 30,000 ordinary shares of the Company to a director. The options are exercisable at $4.77 per share, have a 10-year term and vest over a period of four years . The aggregate grant date fair value of such options was approximately $0.2 million. In addition, the Company granted options to purchase 220,000 ordinary shares of the Company to the Company's chief executive officer (after shareholders' approval). The options are exercisable at $5.12 per share, have a 10-year term and vest over a period of four years . The aggregate grant date fair value of such options was approximately $0.8 million. 6. In November 2020, the Company granted options to purchase 267,500 ordinary shares of the Company to several employees. The options are exercisable at $3.33 per share, have a 10-year term and vest over a period of four years . The aggregate grant date fair value of such options was approximately $0.6 million. In addition, the Company's Board approved to grant options to purchase 220,000 ordinary shares of the Company to Company's chief executive officer subject to shareholders' approval (as of December 31, 2020 shareholders’ approval was still pending). The options are exercisable at $3.33 per share, have a 10-year term and vest over a period of four years . Note 10– Shareholders’ Equity (Cont.) B. Stock-based compensation (Cont.) 7. A summary of the status of the Company’s option plans as of December 31, 2020 and 2019 and changes during the years then ended are presented below: 2020 2019 Weighted Weighted average Number of average Number of exercise share exercise share options price options price Options outstanding at beginning of year 2,393,715 $ 6.12 2,349,054 $ 5.92 Granted 585,000 $ 4.18 282,500 $ 5.07 Forfeited (208,195) $ 7.49 (121,250) $ 6.37 Exercised (47,509) $ 1.27 (116,589) $ 1.23 Outstanding at end of year 2,723,011 $ 5.70 2,393,715 $ 6.12 Options exercisable at year end 1,754,261 $ 5.42 1,647,048 $ 5.02 The following assumptions were used for the fiscal year 2020, 2019 and 2018 grants: - dividend yield of 0.00% for all periods. - risk-free interest rate between 2.67% and 3.01% for the fiscal year 2018, 1.61% and 2.43% for the fiscal year 2019 and 0.42% and 0.74% for the fiscal year 2020. - an expected life between 5 and 6.25 years for all periods. - and a volatility rate ranging between 78% and 92% for the fiscal year 2018; and 87% and 95% for the fiscal year 2019 and 83% and 88% for the fiscal year 2020. As of December 31, 2020, and 2019, the weighted-average remaining contractual term of the outstanding options, excluding the 38,637 options granted in 2002 that have no expiration date, is 6.60 and 6.36 years, respectively. The weighted average grant date fair value of the options granted during the years ended December 31, 2020, 2019 and 2018 is $2.76, $4.85, and $8.19 respectively. As of December 31, 2020, a total of the 390,905 outstanding and exercisable options are “in the money” with aggregate intrinsic value of $1.1 million; while as of December 31, 2019 a total of 1,179,398 outstanding and exercisable options were “in the money” with aggregate intrinsic value of $3.1 million. The unrecognized compensation expense calculated under the fair-value method for stock options expected to vest as of December 31, 2020, 2019 and 2018 is approximately $4.0 million, $5.5 million, and $6.5 million, respectively, and is expected to be recognized over a weighted-average period of 2.41 years, 2.9 years and 3.1 years, respectively. For the years ended 2020, 2019 and 2018, the Company recorded a total of $2.1 million, $2.2 million, and $1.8 million of stock-based compensation expenses, in connection with the above-mentioned options. Note 10– Shareholders’ Equity (Cont.) B. Stock-based compensation (Cont.) During 2016, the Company issued a total of 78,750 restricted stock units ("RSU"). Upon vesting, each RSU will settle by the issuance of one ordinary share. The RSUs vest over four years. As of December 31, 2020, a total of 59,528 ordinary shares were issued upon vesting of 2,781 RSUs and there are no outstanding RSUs, while as of December 31, 2019, a total of 56,747 ordinary shares were issued upon vesting of 54,316 RSUs and a total of 2,781 RSUs were outstanding. For the years 2020, 2019 and 2018, with respect to the above-mentioned RSUs, the Company recorded stock-based compensation expenses in the amount of $5 thousand, $70 thousand and $94 thousand, respectively. All of the above-mentioned stock-based compensation expenses are recorded under general and administrative expenses. as of December 31, 2020, there are no unrecognized compensation expense. The unrecognized compensation expense calculated under the fair-value method for RSU's expected to vest as of December 31, 2019 is approximately $5 thousand, and is expected to be recognized over a weighted-average period of one year. As of December 31, 2020 there are no outstanding RSU's. |
Research and Development Expens
Research and Development Expenses | 12 Months Ended |
Dec. 31, 2020 | |
Research and Development Expenses | |
Research and Development Expenses | Note 11 – Research and Development Expenses Year ended December 31, 2020 2019 2018 (in thousands) Chemistry and formulation studies $ 5,856 $ 3,439 $ 968 Salaries 2,570 2,283 1,617 Stock-based compensation 871 883 582 Research and preclinical studies 1,873 1,962 963 Clinical studies 13,225 8,346 3,575 Regulatory and other expenses 1,687 1,267 608 $ 26,082 $ 18,180 $ 8,313 |
General and Administrative Expe
General and Administrative Expenses | 12 Months Ended |
Dec. 31, 2020 | |
General and Administrative Expenses | |
General and Administrative Expenses | Note 12 – General and Administrative Expenses Year ended December 31, 2020 2019 2018 (in thousands) Stock-based compensation $ 1,194 $ 1,349 $ 1,201 Professional fees 796 877 896 Salaries and benefits 828 856 1,346 Rent and office-maintenance fees 430 482 308 Investor relations and business development expenses 293 364 464 Insurance and other expenses 587 268 225 $ 4,128 $ 4,196 $ 4,440 |
Financial income, net
Financial income, net | 12 Months Ended |
Dec. 31, 2020 | |
Financial income, net | |
Financial income, net | Note 13 – Financial income, net Year ended December 31, 2020 2019 2018 (in thousands) Bank fees $ 31 $ 33 $ 42 Interest income (1,192) (1,953) (959) Gain from sale of marketable debt securities (397) (106) (12) Foreign currency (gains) losses 119 111 (5) $ (1,439) $ (1,915) $ (934) |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2020 | |
Income Taxes | |
Income Taxes | Note 14 – 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 Israeli Companies: In January 2016, the Israeli corporate income tax law was amended and reduced as of January 1, 2016 to 25% (from 26.5%). In December 2016, the Israeli corporate income tax law was further amended and reduced as of January 1, 2017 to 24% and as of January 1, 2018 and onwards to 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% on any future taxable "technological income" which includes sales, licenses and royalties from its IP protected products. The tax ruling applies for five years until 2022 and may be extended for further periods subject to meeting certain requirements. Maltese subsidiary: Taxable income of Maltese companies was subject to tax at the rate of 35% in 2020. C. Net Operating Loss Carry forward As of December 31, 2020, the Company had approximately $110.9 million net-operating-loss carry forwards, consisting of approximately $11.7 million of Maltese net-operating-loss carry forwards and approximately $99.2 million Israeli net-operating-loss carry forward. Additionally, the Company had approximately $2.4 million of capital loss carry forward from the sale of marketable debt securities in Israel. The Maltese and the Israeli loss carry forwards have no expiration date. Note 14 – Income Taxes (Cont.) D. Deferred income taxes Deferred-tax assets for carry forward losses in Malta and Israel are calculated using the applicable tax rate at the time of expected realization of the carry forward losses. The Company has provided full valuation allowances in respect of deferred-tax assets. Management currently believes that it is more likely than not that those deferred taxes will not be realized in the foreseeable future. Significant components of the Company’s and its subsidiaries’ assets are as follows As of December 31, 2020 2019 (in thousands) Deferred tax assets Israeli companies net-operating-loss carry forward $ 11,906 $ 10,085 Maltese subsidiary net-operating-loss carry forward 4,090 4,081 Israeli subsidiary capital-loss carry forward 577 881 Other reserves and allowances 27 21 Total deferred-tax assets 16,600 15,068 Valuation allowance (16,600) (15,068) Net deferred-tax assets $ — $ — E. Tax assessment The Israeli subsidiaries received final tax assessments through the year ended December 31, 2015. F. Effective tax expense A reconciliation of the Company’s effective tax expense to the Company’s theoretical statutory tax benefit is as follows: Year ended December 31, 2020 2019 2018 (in thousands) Loss before taxes on income, as reported in the consolidated statements of operations $ 28,771 $ 20,461 $ 9,781 Statutory tax rate 12 % 12 % 12 % Theoretical tax benefit 3,453 2,455 1,174 Losses and other items for which a valuation allowance was provided or benefit from loss carry forwards (3,453) (2,455) (1,174) Tax withheld from upfront payment from Samil — — 75 Actual tax expense $ — $ — $ 75 |
Subsequent events
Subsequent events | 12 Months Ended |
Dec. 31, 2020 | |
Subsequent events | |
Subsequent events | Note 15 - Subsequent events 1. During February 2021, the Company sold 1,541,400 ordinary shares under its ATM Program for total net proceeds of approximately $8.2 million. See also Note 10A.3 2. 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 ordinary shares (the "Firm Shares") of the Company. The Underwriter purchased the Firm Shares from the Company at a price of $4.3258 per share. The net proceeds to the Company, Were approximately $9.3 million. See also Note 10A.4. 3. On March 2021, the Company has signed with with Mintz K. Construction Company a lease extension two |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2020 | |
Significant Accounting Policies | |
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. Marketable debt securities are considered to be available for sale and are carried at fair value. Unrealized gains and losses net of tax, if any, are reported as a separate component of stockholders’ equity. The cost of marketable debt securities classified as available for sale is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization and accretion are included in interest income. Realized gains and losses and declines in value judged to be other than temporary, if any, are also included in other income, net. Interest on securities classified as available for sale is included in interest income. The cost of securities sold is based on the specific identification method. For all investments in marketable debt securities, the Company assesses whether the impairment is other-than-temporary. If the fair value of a security is less than its amortized cost basis, an impairment is considered other-than-temporary if (i) the Company has the intent to sell the security or it is more likely than not that the Company will be required to sell the security before recovery of its entire amortized cost basis, or (ii) the Company does not expect to recover the entire amortized cost of the security. If an impairment is considered other-than-temporary based on condition (i), the entire difference between the amortized cost and the fair value of the security is recognized in earnings. If an impairment is considered other-than-temporary based on condition (ii), the amount representing credit losses, defined as the difference between the present value of the cash flows expected to be collected and the amortized cost basis of the security, will be recognized in earnings, and the amount relating to all other factors will be recognized in other comprehensive income. The Company evaluates both qualitative and quantitative factors such as duration and severity of the unrealized Note 2 – Significant Accounting Policies (Cont.) G. Marketable debt securities (Cont.) losses, credit ratings, default and loss rates of the underlying collateral, structure and credit enhancements to determine if a credit loss may exist. During the years ended December 31, 2020 and 2019 no other-than-temporarily impaired losses were realized. |
Concentrations of credit risk | H. Concentrations of credit risk Financial instruments which potentially subject us to credit risk consist primarily of cash, cash equivalents, marketable securities and short-term deposits. We 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. We have not experienced any credit losses in such accounts and do not believe we are exposed to any significant credit risk on these funds. We have no off-balance sheet concentrations of credit risk, such as foreign currency exchange contracts, option contracts, or other hedging arrangements. |
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: % Office furniture and equipment 7–16 Computer software and electronic equipment 15–33 Leasehold improvements 10 |
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 2020 and 2019, no impairment losses were identified. |
Severance pay | K. Severance pay The Company employees are included under section 14 of the Severance Compensation Act, 1963 (“Section 14”) for a portion of their salaries. According to Section 14, these employees are entitled to monthly deposits at a rate of 8.33% of their monthly salary, made in their name with such insurance companies. Under the Severance Compensation Act, 1963, payments in accordance with Section 14 release the Company from any future severance payments to those employees. The aforementioned deposits are not recorded as an asset in the Company’s balance sheet. |
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. |
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. Note 2 – Significant Accounting Policies (Cont.) M. Accounting for stock-based compensation (Cont.) In June 2018, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2018-07, “Compensation-Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting”, which simplifies the accounting for non-employee share-based payment transactions by aligning the measurement and classification guidance, with certain exceptions, to that for share-based payment awards to employees. The amendments expand the scope of the accounting standard for share-based payment awards to include share-based payment awards granted to non-employees in exchange for goods or services used or consumed in an entity’s own operations and supersedes the guidance related to equity-based payments to non-employees. The Company elected to early adopt these amendments on June 1, 2018. The adoption of these amendments did not have a significant impact on the Company's consolidated financial statements and related disclosures. 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 is has recognized revenues to date. On January 1, 2018, the Company adopted ASC 606 with full retrospective application. The adoption of did not have an effect on either revenue recognized in prior periods, nor to accumulated deficit as of January 1, 2017. The new revenue standard amended revenue recognition principles and provides a single, comprehensive set of criteria for revenue recognition within and across all industries. The standard applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. The new revenue standard provides a five-step framework whereby revenue is recognized when control of promised goods or services is transferred to a customer at an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. To determine revenue recognition for arrangements that we determine are within the scope of the new revenue standard, we perform the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the performance obligations are satisfied. Note 2 – Significant Accounting Policies (Cont.) N. Revenue Recognition (Cont.) The Company only applies the five-step model to contracts when collectability of the consideration to which the Company is entitled in exchange for the goods or services transferred to the customer is determined to be probable. At contract inception, once the contract is determined to be within the scope of the new revenue standard, the Company assesses whether the goods or services promised within each contract are distinct and, therefore, represent a separate performance obligation. Goods and services that are determined not to be distinct are combined with other promised goods and services until a distinct bundle is identified. The Company then allocates the transaction price (the amount of consideration the Company expects to be entitled to from a customer in exchange for the promised goods or services) to each performance obligation and recognizes the associated revenue when (or as) each performance obligation is satisfied. The Company’s estimate of the transaction price for each contract includes all variable consideration to which we expect to be entitled. |
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, 2020, and 2019, the Company had a full valuation allowance against deferred tax assets. ASC 740-10 requires a two-step approach to recognizing and measuring uncertain tax positions. The first step is to evaluate the tax position for recognition by determining if the weight of available evidence indicates that it is more likely than not that the position will be sustained on audit, including resolution of related appeals or litigation processes, if any. The second step is to measure the tax benefit as the largest amount that is more than 50% likely of being realized upon ultimate settlement. The Company has not recorded any liability for uncertain tax positions for the years ended December 31, 2020 and 2019. |
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, 2020, 2019 and 2018, 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 ASU 2016-02, “Leases (Topic 842)” was issued by the FASB in February 2016. The Company adopted this ASU 2016-02 effective January 1, 2019 using the modified retrospective application, applying the new standard to leases in place as of the adoption date. Prior periods have not been adjusted. Leases existing for the reporting period beginning January 1, 2019 are presented under ASU 2016-02. Arrangements that are determined to be leases at inception are recognized as right of use assets and lease liabilities in the consolidated balance sheet at lease commencement. Operating lease liabilities are recognized based on the present value of the future lease payments over the lease term at commencement date. As the Company’s leases do not provide an implicit rate, the Company applies its incremental borrowing rate based on the economic environment at the commencement date in determining the present value of future lease payments. Lease terms include options to extend the lease when it is reasonably certain that the Company will exercise that option. Lease expense for operating leases or payments are recognized on a straight-line basis over the lease term. The Company elected to adopt a package of practical expedients offered by the FASB which removes the requirement to reassess whether expired or existing contracts contain leases and removes the requirement to reassess the lease classification for any existing leases prior to the adoption date of January 1, 2019. The Company has also elected the practical expedient to include both lease and non-lease components as a single component and account for it as a lease. Additionally, 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 and issued accounting pronouncement | 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. Note 2 – Significant Accounting Policies (Cont.) U. Recently adopted accounting pronouncements (Cont.) In June 2016, FASB issued ASU No. 2016-13, “Financial Instruments – Credit Losses – Measurement of Credit Losses on Financial Instruments”, which introduces a model based on expected losses to estimate credit losses for most financial assets and certain other instruments. In addition, for available-for-sale debt securities with unrealized losses, the losses will be recognized as allowances rather than reductions in the amortized cost of the securities. The ASU is effective for the Company in the first quarter of 2020, with early adoption permitted. The Company adopted ASU 2016-13 in 2020. The adoption did not have a material effect on the Company’s consolidated financial statements. In August 2018, the FASB issued ASU 2018-13, “Changes to Disclosure Requirements for Fair Value Measurements”, which will improve the effectiveness of disclosure requirements for recurring and nonrecurring fair value measurements. The standard removes, modifies, and adds certain disclosure requirements, and is effective for the Company beginning on January 1, 2020. The Company adopted ASU 2016-13 in 2020. The adoption did not have a material effect on the Company’s consolidated financial statements. V. Recently issued accounting pronouncements 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 and is not expected to have a material impact on the Company's consolidated financial statements and disclosures. |
Significant Accounting Polici_3
Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Significant Accounting Policies | |
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: % Office furniture and equipment 7–16 Computer software and electronic equipment 15–33 Leasehold improvements 10 |
Marketable debt securities (Tab
Marketable debt securities (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Marketable debt securities | |
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): December 31, 2020 Fair Level 1 Level 2 Level 3 Value Marketable debt securities $ 25,449 14,683 — 40,132 December 31, 2019 Fair Level 1 Level 2 Level 3 Value Marketable debt securities $ — 31,622 — 31,622 The following table summarizes the Company’s marketable debt securities as of December 31, 2020 and 2019. 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 Mutual funds 25,285 181 (17) 25,449 Total short-term investments $ 39,860 $ 305 $ (33) $ 40,132 As of December 31, 2019 Gross Gross Amortized Unrealized Unrealized Estimated Cost Gains Losses Fair Value (in thousands) Corporate bonds $ 19,893 $ 49 $ (37) $ 19,905 Commercial papers 11,694 $ 23 $ — $ 11,717 Total short-term investments $ 31,587 $ 72 $ (37) $ 31,622 |
Other Accounts Receivable (Tabl
Other Accounts Receivable (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Other Accounts Receivable | |
Schedule of accounts, notes, loans and financing receivable | As of December 31, 2020 2019 (in thousands) Government institutions $ 66 $ 178 Prepaid expenses 746 601 Others — 48 $ 812 $ 827 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Leases | |
Summary of Company's significant contractual lease obligations | The following table summarizes the Company’s significant contractual lease obligations at December 31, 2020: Less than Total 1 year 1 ‑ 3 years (in thousands) Facility leases $ 403 $ 193 $ 210 Car leases 30 13 17 Total $ 433 $ 206 $ 227 |
Property and equipment, net (Ta
Property and equipment, net (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Property and equipment, net | |
Schedule of property and equipment, net | As of December 31, 2020 2019 (in thousands) Medical equipment $ 737 $ 737 Office furniture and equipment 56 55 Computer software and electronic equipment 78 88 Leasehold improvements 221 198 1,092 1,078 Less - Accumulated depreciation 916 907 Net book value $ 176 $ 171 |
Shareholders' Equity (Tables)
Shareholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Shareholders' Equity | |
Summary of status of Company's option plans and its changes | 2020 2019 Weighted Weighted average Number of average Number of exercise share exercise share options price options price Options outstanding at beginning of year 2,393,715 $ 6.12 2,349,054 $ 5.92 Granted 585,000 $ 4.18 282,500 $ 5.07 Forfeited (208,195) $ 7.49 (121,250) $ 6.37 Exercised (47,509) $ 1.27 (116,589) $ 1.23 Outstanding at end of year 2,723,011 $ 5.70 2,393,715 $ 6.12 Options exercisable at year end 1,754,261 $ 5.42 1,647,048 $ 5.02 |
Research and Development Expe_2
Research and Development Expenses (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Research and Development Expenses | |
Schedule of research and development expenses | Year ended December 31, 2020 2019 2018 (in thousands) Chemistry and formulation studies $ 5,856 $ 3,439 $ 968 Salaries 2,570 2,283 1,617 Stock-based compensation 871 883 582 Research and preclinical studies 1,873 1,962 963 Clinical studies 13,225 8,346 3,575 Regulatory and other expenses 1,687 1,267 608 $ 26,082 $ 18,180 $ 8,313 |
General and Administrative Ex_2
General and Administrative Expenses (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
General and Administrative Expenses | |
Schedule of general and administrative expenses | Year ended December 31, 2020 2019 2018 (in thousands) Stock-based compensation $ 1,194 $ 1,349 $ 1,201 Professional fees 796 877 896 Salaries and benefits 828 856 1,346 Rent and office-maintenance fees 430 482 308 Investor relations and business development expenses 293 364 464 Insurance and other expenses 587 268 225 $ 4,128 $ 4,196 $ 4,440 |
Financial income, net (Tables)
Financial income, net (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Financial income, net | |
Schedule of financial income, net | Year ended December 31, 2020 2019 2018 (in thousands) Bank fees $ 31 $ 33 $ 42 Interest income (1,192) (1,953) (959) Gain from sale of marketable debt securities (397) (106) (12) Foreign currency (gains) losses 119 111 (5) $ (1,439) $ (1,915) $ (934) |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Income Taxes | |
Schedule of components of income tax expense (benefit) | Significant components of the Company’s and its subsidiaries’ assets are as follows As of December 31, 2020 2019 (in thousands) Deferred tax assets Israeli companies net-operating-loss carry forward $ 11,906 $ 10,085 Maltese subsidiary net-operating-loss carry forward 4,090 4,081 Israeli subsidiary capital-loss carry forward 577 881 Other reserves and allowances 27 21 Total deferred-tax assets 16,600 15,068 Valuation allowance (16,600) (15,068) Net deferred-tax assets $ — $ — |
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: Year ended December 31, 2020 2019 2018 (in thousands) Loss before taxes on income, as reported in the consolidated statements of operations $ 28,771 $ 20,461 $ 9,781 Statutory tax rate 12 % 12 % 12 % Theoretical tax benefit 3,453 2,455 1,174 Losses and other items for which a valuation allowance was provided or benefit from loss carry forwards (3,453) (2,455) (1,174) Tax withheld from upfront payment from Samil — — 75 Actual tax expense $ — $ — $ 75 |
General (Details)
General (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
General | |||
Date Of Incorporation | Jul. 31, 2013 | ||
Operations Commenced Date | Feb. 2, 2014 | ||
Entity Incorporation Place | Israel | ||
Cash and cash equivalents | $ 6,947 | $ 15,931 | |
Restricted cash | 113 | 112 | |
Short-term deposits | 3,807 | 27,938 | |
marketable debt securities | 40,100 | ||
Loss attributable to holders of its ordinary shares | 28,771 | 20,461 | $ 9,856 |
Accumulated deficit | $ (135,707) | $ (106,936) |
Significant Accounting Polici_4
Significant Accounting Policies (Details) | Dec. 31, 2020 |
Office furniture and equipment [Member] | Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Depreciation, Percentage | 7.00% |
Office furniture and equipment [Member] | Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Depreciation, Percentage | 16.00% |
Computer software, electronic and medical equipment [Member] | Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Depreciation, Percentage | 15.00% |
Computer software, electronic and medical equipment [Member] | Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Depreciation, Percentage | 33.00% |
Leasehold improvements [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Depreciation, Percentage | 10.00% |
Significant Accounting Polici_5
Significant Accounting Policies - Additional Information (Details) | 12 Months Ended |
Dec. 31, 2020segment | |
Monthly Deposits of Employees, Percentage on Monthly Salary | 8.33% |
Number of reportable segment | 1 |
Restricted Stock [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Method Used | Black-Scholes option-pricing model |
Marketable debt securities (Det
Marketable debt securities (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Marketable Securities [Line Items] | ||
Marketable debt securities | $ 40,132 | $ 31,622 |
Recurring | ||
Marketable Securities [Line Items] | ||
Marketable debt securities | 40,132 | 31,622 |
Recurring | Level 1 | ||
Marketable Securities [Line Items] | ||
Marketable debt securities | 25,449 | |
Recurring | Level 2 | ||
Marketable Securities [Line Items] | ||
Marketable debt securities | $ 14,683 | $ 31,622 |
Marketable debt securities - su
Marketable debt securities - summarizes the marketable debt securities (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | $ 39,860 | $ 31,587 |
Gross Unrealized Gains | 305 | 72 |
Gross Unrealized Losses | (33) | (37) |
Estimated Fair Value | 40,132 | 31,622 |
Corporate bonds [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 14,575 | 19,893 |
Gross Unrealized Gains | 124 | 49 |
Gross Unrealized Losses | (16) | (37) |
Estimated Fair Value | 14,683 | 19,905 |
Mutual Fund [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 25,285 | |
Gross Unrealized Gains | 181 | |
Gross Unrealized Losses | (17) | |
Estimated Fair Value | $ 25,449 | |
Commercial papers [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 11,694 | |
Gross Unrealized Gains | 23 | |
Gross Unrealized Losses | 0 | |
Estimated Fair Value | $ 11,717 |
Other Accounts Receivable (Deta
Other Accounts Receivable (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Other Accounts Receivable | ||
Government institutions | $ 66 | $ 178 |
Prepaid expenses | 746 | 601 |
Others | 0 | 48 |
Receivables, Net, Current | $ 812 | $ 827 |
Leases - Additional Information
Leases - Additional Information (Details) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020USD ($)ft²Options | Dec. 31, 2019USD ($) | |
Leases | ||
Area of land under operating lease agreement | ft² | 590 | |
Lessee, Operating Lease, Existence of Option to Extend [true false] | true | |
Number of additional options to extend | Options | 2 | |
Lease renewal term | 2 years | |
Bank guarantee | $ 50 | |
Operating lease assets | 394 | $ 538 |
Operating lease liabilities | $ 419 | |
Operating Lease, Liability, Statement of Financial Position [Extensible List] | Operating Lease, Liability, Noncurrent | |
Operating leases, weighted average remaining lease term (in years) | 2 years 3 months | |
Operating leases, weighted average borrowing rate | 2.75% |
Leases - Company's Significant
Leases - Company's Significant Contractual Lease Obligations (Details) $ in Thousands | Dec. 31, 2020USD ($) |
Leases | |
Total | $ 433 |
Less than 1 year | 206 |
1-3 years | 227 |
Facility Leases [Member] | |
Leases | |
Total | 403 |
Less than 1 year | 193 |
1-3 years | 210 |
Car Leases [Member] | |
Leases | |
Total | 30 |
Less than 1 year | 13 |
1-3 years | $ 17 |
Property and equipment, net (De
Property and equipment, net (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Property and equipment, net | ||
Medical equipment | $ 737 | $ 737 |
Office furniture and equipment | 56 | 55 |
Computer software and electronic equipment | 78 | 88 |
Leasehold improvements | 221 | 198 |
Property and equipment, gross | 1,092 | 1,078 |
Less - Accumulated depreciation | 916 | 907 |
Net book value | $ 176 | $ 171 |
Revenue (Details)
Revenue (Details) - Samil Pharm. Co. Ltd [Member] - USD ($) $ in Millions | Jul. 28, 2016 | Sep. 30, 2018 | Dec. 31, 2018 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Milestone Method Revenue Payment | $ 2.1 | $ 1.5 | $ 1.5 |
Accrued Royalties | 6 | ||
Revenue Recognition Non Refundable Upfront Payment | $ 2.1 |
Related Parties (Details)
Related Parties (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Chief Executive Officer [Member] | |||
Related Party Transaction [Line Items] | |||
Related Party Transaction, Expenses from Transactions with Related Party | $ 3.5 | $ 3.6 | $ 3.7 |
Officers And Directors [Member] | |||
Related Party Transaction [Line Items] | |||
Due to Related Parties | $ 0.5 | $ 0.6 |
Commitments and Contingencies (
Commitments and Contingencies (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Loss Contingencies [Line Items] | |
Bank Lien On Marketable Securities | $ 113 |
Guarantee of Indebtedness of Others [Member] | |
Loss Contingencies [Line Items] | |
Bank guarantee, commitment | $ 54 |
Shareholders' Equity - Company'
Shareholders' Equity - Company's Option Plans (Details) - $ / shares | 1 Months Ended | 12 Months Ended | |||
Nov. 30, 2020 | Aug. 31, 2020 | Mar. 31, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of share options, Granted (in shares) | 267,500 | 30,000 | 67,500 | ||
Number of share options, Exercised (in shares) | (47,509) | ||||
Weighted average exercise price, Exercised (in dollars per share) | $ 3.33 | $ 4.77 | $ 4.21 | ||
Employee Stock Option [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of share options, Outstanding at beginning of year (in shares) | 2,393,715 | 2,349,054 | |||
Number of share options, Granted (in shares) | 585,000 | 282,500 | |||
Number of share options, Forfeited (in shares) | (208,195) | (121,250) | |||
Number of share options, Exercised (in shares) | (47,509) | (116,589) | |||
Number of share options, Outstanding at end of year (in shares) | 2,723,011 | 2,393,715 | |||
Number of share options, Options exercisable at year end (in shares) | 1,754,261 | 1,647,048 | |||
Weighted average exercise price, Options outstanding at beginning of year (in dollars per share) | $ 6.12 | $ 5.92 | |||
Weighted average exercise price, Granted (in dollars per share) | 4.18 | 5.07 | |||
Weighted average exercise Price, Forfeited (in dollars per share) | 7.49 | 6.37 | |||
Weighted average exercise price, Exercised (in dollars per share) | 1.27 | 1.23 | |||
Weighted average exercise price, Outstanding at end of year (in dollars per share) | 5.70 | 6.12 | |||
Weighted average exercise price, Options exercisable at year end (in dollars per share) | $ 5.42 | $ 5.02 |
Shareholders' Equity - Addition
Shareholders' Equity - Additional Information (Details) | 1 Months Ended | 12 Months Ended | ||||||||||
Feb. 28, 2021USD ($)$ / sharesshares | Nov. 30, 2020USD ($)$ / sharesshares | Aug. 31, 2020USD ($)$ / sharesshares | Mar. 31, 2020USD ($)$ / sharesshares | Dec. 31, 2020USD ($)$ / sharesshares | Dec. 31, 2019USD ($)$ / sharesshares | Dec. 31, 2018USD ($)$ / shares | Dec. 31, 2017 | Dec. 31, 2016shares | Dec. 31, 2020₪ / shares | May 15, 2020USD ($) | Dec. 22, 2017USD ($) | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Stock Issued During Period, Value, New Issues | $ 707,000 | |||||||||||
Risk-free interest rate, minimum | 0.42% | |||||||||||
Risk-free interest rate, maximum | 0.74% | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | shares | 267,500 | 30,000 | 67,500 | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term | 10 years | 10 years | 10 years | |||||||||
Share-based Compensation Arrangements by Share-based Payment Award, Options, Exercises in Period, Weighted Average Exercise Price | $ / shares | $ 3.33 | $ 4.77 | $ 4.21 | |||||||||
Vested term period | 4 years | 4 years | 4 years | |||||||||
Aggregate grant fair value | $ 600,000 | $ 200,000 | $ 200,000 | |||||||||
Share-based Compensation | $ 2,066,000 | $ 2,231,000 | $ 1,783,000 | |||||||||
Shares Issued, Price Per Share | ₪ / shares | ₪ 0.01 | |||||||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized | $ 5,000 | |||||||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 1 year | |||||||||||
Stock Issued During Period, Shares, Restricted Stock Award, Gross | shares | 2,781 | |||||||||||
Ordinary shares offered | $ 31,900,000 | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Vested in Period | shares | 2,781 | 56,747 | 78,750 | |||||||||
Total consideration | $ 61,000 | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 4 years | |||||||||||
At-The-Market Offering [Member] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Maximum Amount Of Shares To Be Issued | $ 35,000,000 | |||||||||||
Incentive Share Option Plan 2013 [Member] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Common Stock, Capital Shares Reserved for Future Issuance | shares | 687,973 | |||||||||||
Employee Stock Option [Member] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Dividend yield | 0.00% | 0.00% | 0.00% | |||||||||
Risk-free interest rate, minimum | 1.61% | 2.67% | ||||||||||
Risk-free interest rate, maximum | 2.43% | 3.01% | ||||||||||
Volatility rate, minimum | 83.00% | 87.00% | 78.00% | |||||||||
Volatility rate, maximum | 88.00% | 95.00% | 92.00% | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | shares | 38,637 | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term | 6 years 7 months 6 days | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Remaining Contractual Term | 6 years 4 months 9 days | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Intrinsic Value | $ 1,100,000 | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Intrinsic Value | $ 3,100,000 | |||||||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized | $ 4,000,000 | $ 5,500,000 | $ 6,500,000 | |||||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 2 years 4 months 28 days | 2 years 10 months 24 days | 3 years 1 month 6 days | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | $ / shares | $ 2.76 | $ 4.85 | $ 8.19 | |||||||||
Stock Issued During Period, Shares, Restricted Stock Award, Gross | shares | 59,528 | 54,316 | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Number | shares | 390,905 | 1,179,398 | ||||||||||
Allocated Share-based Compensation Expense | $ 2,100,000 | $ 2,200,000 | $ 1,800,000 | |||||||||
Employee Stock Option [Member] | Minimum [Member] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Expected life | 5 years | 5 years | 5 years | |||||||||
Employee Stock Option [Member] | Maximum [Member] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Expected life | 6 years 3 months | 6 years 3 months | 6 years 3 months | |||||||||
Employee Stock Option And Restricted Stock Units [Member] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number | shares | 2,781 | |||||||||||
Restricted Stock Units (RSUs) [Member] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Share-based Compensation | $ 5,000 | $ 70,000 | $ 94,000 | |||||||||
Chief Executive Officer [Member] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | shares | 220,000 | 220,000 | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term | 10 years | 10 years | ||||||||||
Share-based Compensation Arrangements by Share-based Payment Award, Options, Exercises in Period, Weighted Average Exercise Price | $ / shares | $ 3.33 | $ 5.12 | ||||||||||
Vested term period | 4 years | 4 years | ||||||||||
Aggregate grant fair value | $ 800,000 | |||||||||||
Ordinary shares [Member] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Stock Issued During Period, Shares, New Issues | shares | 136,300 | |||||||||||
Stock Issued During Period, Value, New Issues | $ 0 | |||||||||||
Stock Issued During Period, Shares, Restricted Stock Award, Gross | shares | 50,290 | 120,466 | ||||||||||
Ordinary shares [Member] | At-The-Market Offering [Member] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Stock Issued During Period, Shares, New Issues | shares | 136,300 | |||||||||||
Total proceeds from sale of ordinary shares | $ 800,000 | |||||||||||
Ordinary shares [Member] | Subsequent Event [Member] | At-The-Market Offering [Member] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Stock Issued During Period, Shares, New Issues | shares | 1,541,400 | |||||||||||
Stock Issued During Period, Value, New Issues | $ 1,541,400 | |||||||||||
Common Stock, Capital Shares Reserved for Future Issuance | shares | 22,700,000 | |||||||||||
Total proceeds from sale of ordinary shares | $ 8,200,000 | |||||||||||
Ordinary shares [Member] | Subsequent Event [Member] | Underwritten Public Offering [Member] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Stock Issued During Period, Shares, New Issues | shares | 2,197,803 | |||||||||||
Shares Issued, Price Per Share | $ / shares | $ 4.3258 | |||||||||||
Option exercisable period | 30 days | |||||||||||
Additional shares to purchase | shares | 329,670 | |||||||||||
Total proceeds from sale of ordinary shares | $ 9,300,000 |
Research and Development Expe_3
Research and Development Expenses (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Research and Development Expenses [Line Items] | |||
Research and Development Expense, Total | $ 26,082 | $ 18,180 | $ 8,313 |
Research and Development Expense [Member] | |||
Research and Development Expenses [Line Items] | |||
Chemistry and formulation studies | 5,856 | 3,439 | 968 |
Salaries | 2,570 | 2,283 | 1,617 |
Stock-based compensation | 871 | 883 | 582 |
Research and preclinical studies | 1,873 | 1,962 | 963 |
Clinical studies | 13,225 | 8,346 | 3,575 |
Regulatory and other expenses | 1,687 | 1,267 | 608 |
Research and Development Expense, Total | $ 26,082 | $ 18,180 | $ 8,313 |
General and Administrative Ex_3
General and Administrative Expenses (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
General and Administrative Expenses [Line Items] | |||
General and Administrative Expense, Total | $ 4,128 | $ 4,196 | $ 4,440 |
General and Administrative Expense [Member] | |||
General and Administrative Expenses [Line Items] | |||
Stock-based compensation | 1,194 | 1,349 | 1,201 |
Professional fees | 796 | 877 | 896 |
Salaries and benefits | 828 | 856 | 1,346 |
Rent and office-maintenance fees | 430 | 482 | 308 |
Investor relations and business development expenses | 293 | 364 | 464 |
Insurance and other | 587 | 268 | 225 |
General and Administrative Expense, Total | $ 4,128 | $ 4,196 | $ 4,440 |
Financial income, net (Details)
Financial income, net (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Financial income, net | |||
Bank Fees | $ 31 | $ 33 | $ 42 |
Interest income | (1,192) | (1,953) | (959) |
Gain from sale of marketable debt securities | (397) | (106) | (12) |
Foreign currency (gains) losses | 119 | 111 | (5) |
Financial income net | $ (1,439) | $ (1,915) | $ (934) |
Income Taxes - Components of In
Income Taxes - Components of Income Tax (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Deferred tax assets | ||
Capital-loss carry forward | $ 2,400 | |
Other reserves and allowances | 27 | $ 21 |
Total deferred-tax assets | 16,600 | 15,068 |
Valuation allowance | (16,600) | (15,068) |
Net deferred-tax assets | 0 | 0 |
Israeli Subsidiary [Member] | ||
Deferred tax assets | ||
Net-operating-loss carry forward | 11,906 | 10,085 |
Capital-loss carry forward | 577 | 881 |
Maltese subsidiary [Member] | ||
Deferred tax assets | ||
Net-operating-loss carry forward | $ 4,090 | $ 4,081 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of the Company's Effective Tax Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Taxes | |||
Loss before taxes on income, as reported in the consolidated statements of operations | $ 28,771 | $ 20,461 | $ 9,781 |
Statutory tax rate | 12.00% | 12.00% | 12.00% |
Theoretical tax benefit | $ 3,453 | $ 2,455 | $ 1,174 |
Losses and other items for which a valuation allowance was provided or benefit from loss carry forwards | (3,453) | (2,455) | (1,174) |
Tax withheld from upfront payment from Samil | 0 | 0 | 75 |
Actual tax expense | $ 0 | $ 0 | $ 75 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) $ in Thousands | Feb. 07, 2019 | Jan. 31, 2016 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2015 |
Income Taxes [Line Items] | |||||||
Effective income tax rate reconciliation, at federal statutory income tax rate, percent | 12.00% | 12.00% | 12.00% | ||||
Operating loss carry forwards | $ 110,900 | ||||||
Deferred tax assets, capital loss carry forwards | 2,400 | ||||||
Minimum [Member] | |||||||
Income Taxes [Line Items] | |||||||
Effective income tax rate reconciliation, at federal statutory income tax rate, percent | 6.00% | ||||||
Maximum [Member] | |||||||
Income Taxes [Line Items] | |||||||
Effective income tax rate reconciliation, at federal statutory income tax rate, percent | 12.00% | ||||||
Israeli Subsidiary [Member] | |||||||
Income Taxes [Line Items] | |||||||
Effective income tax rate reconciliation, at federal statutory income tax rate, percent | 25.00% | 24.00% | 26.50% | ||||
Operating loss carry forwards | 99,200 | ||||||
Deferred tax assets, capital loss carry forwards | $ 577 | $ 881 | |||||
Israeli Subsidiary [Member] | Scenario, Plan [Member] | |||||||
Income Taxes [Line Items] | |||||||
Effective income tax rate reconciliation, at federal statutory income tax rate, percent | 23.00% | 23.00% | |||||
Maltese subsidiary [Member] | |||||||
Income Taxes [Line Items] | |||||||
Effective income tax rate reconciliation, at federal statutory income tax rate, percent | 35.00% | ||||||
Operating loss carry forwards | $ 11,700 |
Subsequent events (Details)
Subsequent events (Details) | 1 Months Ended | 12 Months Ended | ||
Mar. 31, 2021ILS (₪) | Feb. 28, 2021USD ($)$ / sharesshares | Dec. 31, 2020USD ($)shares | Dec. 31, 2020₪ / shares | |
Subsequent Event [Line Items] | ||||
Issuance of Ordinary Shares | $ 707,000 | |||
Price per share | ₪ / shares | ₪ 0.01 | |||
Lessee, Operating Lease, Existence of Option to Extend [true false] | true | |||
Lease renewal term | 2 years | |||
Subsequent Event [Member] | ||||
Subsequent Event [Line Items] | ||||
Lessee, Operating Lease, Existence of Option to Extend [true false] | true | |||
Lease renewal term | 2 years | |||
Aggregate quarterly rental payment | ₪ | ₪ 133,497 | |||
Ordinary shares [Member] | ||||
Subsequent Event [Line Items] | ||||
Issuance of Ordinary Shares | $ 0 | |||
Issuance of Ordinary Shares (In shares) | shares | 136,300 | |||
Ordinary shares [Member] | Subsequent Event [Member] | Underwritten Public Offering [Member] | ||||
Subsequent Event [Line Items] | ||||
Issuance of Ordinary Shares (In shares) | shares | 2,197,803 | |||
Net proceeds | $ 9,300,000 | |||
Price per share | $ / shares | $ 4.3258 | |||
At-The-Market Offering [Member] | Ordinary shares [Member] | ||||
Subsequent Event [Line Items] | ||||
Issuance of Ordinary Shares (In shares) | shares | 136,300 | |||
Net proceeds | $ 800,000 | |||
At-The-Market Offering [Member] | Ordinary shares [Member] | Subsequent Event [Member] | ||||
Subsequent Event [Line Items] | ||||
Issuance of Ordinary Shares | $ 1,541,400 | |||
Issuance of Ordinary Shares (In shares) | shares | 1,541,400 | |||
Net proceeds | $ 8,200,000 |