Document and Entity Information
Document and Entity Information | 6 Months Ended |
Jun. 30, 2021 | |
Document And Entity Information | |
Entity Central Index Key | 0001684693 |
Current Fiscal Year End Date | --12-31 |
Document Fiscal Year Focus | 2021 |
Document Fiscal Period Focus | Q2 |
Amendment Flag | false |
Document Type | 6-K |
Document Period End Date | Jun. 30, 2021 |
Entity Registrant Name | SOL-GEL TECHNOLOGIES LTD. |
Entity Address, Address Line One | 7 Golda Meir Street |
Entity Address, City or Town | Ness Ziona |
Entity Address, Postal Zip Code | 7403650 |
Entity Address, Country | IL |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 11,152 | $ 7,122 |
Bank deposits | 20,900 | 21,400 |
Marketable securities | 6,830 | 21,652 |
Receivables from collaborative arrangements | 956 | 2,153 |
Prepaid expenses and other current assets | 1,556 | 1,074 |
TOTAL CURRENT ASSETS | 41,394 | 53,401 |
NON-CURRENT ASSETS: | ||
Restricted long-term deposits and cash | 1,291 | 1,293 |
Property and equipment, net | 1,397 | 1,817 |
Operating lease right-of-use assets | 1,579 | 1,896 |
Funds in respect of employee rights upon retirement | 744 | 754 |
TOTAL NON-CURRENT ASSETS | 5,011 | 5,760 |
TOTAL ASSETS | 46,405 | 59,161 |
CURRENT LIABILITIES: | ||
Accounts payable | 1,345 | 1,203 |
Other accounts payable | 3,164 | 4,088 |
Current maturities of operating leases liabilities | 649 | 673 |
TOTAL CURRENT LIABILITIES | 5,158 | 5,964 |
LONG-TERM LIABILITIES - | ||
Operating leases liabilities | 958 | 1,299 |
Liability for employee rights upon retirement | 1,042 | 1,049 |
TOTAL LONG-TERM LIABILITIES | 2,000 | 2,348 |
COMMITMENTS | ||
TOTAL LIABILITIES | 7,158 | 8,312 |
SHAREHOLDERS' EQUITY: | ||
Ordinary Shares, NIS 0.1 par value - authorized: 50,000,000 as of December 31, 2020 and June 30, 2021; issued and outstanding: 23,000,782 and 23,029,951 as of December 31, 2020 and June 30, 2021, respectively. | 635 | 635 |
Additional paid-in capital | 232,071 | 231,577 |
Accumulated deficit | (193,459) | (181,363) |
TOTAL SHAREHOLDERS' EQUITY | 39,247 | 50,849 |
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ 46,405 | $ 59,161 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (Parenthetical) - ₪ / shares | Jun. 30, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Ordinary shares, par value per share | ₪ 0.1 | ₪ 0.1 |
Ordinary shares, shares authorized | 50,000,000 | 50,000,000 |
Ordinary shares, shares issued | 23,029,951 | 23,000,782 |
Ordinary shares, shares outstanding | 23,029,951 | 23,000,782 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Income Statement [Abstract] | ||||
COLLABORATION REVENUES | $ 928 | $ 1,133 | $ 1,629 | $ 4,598 |
RESEARCH AND DEVELOPMENT EXPENSES | 6,933 | 6,451 | 9,399 | 14,381 |
GENERAL AND ADMINISTRATIVE EXPENSES | 2,037 | 2,233 | 4,496 | 4,994 |
TOTAL OPERATING LOSS | 8,042 | 7,551 | 12,266 | 14,777 |
FINANCIAL INCOME, net | (9) | (481) | (170) | (597) |
LOSS FOR THE PERIOD | $ 8,033 | $ 7,070 | $ 12,096 | $ 14,180 |
BASIC AND DILUTED LOSS PER ORDINARY SHARE | $ 0.35 | $ 0.31 | $ 0.53 | $ 0.64 |
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE | 23,028,508 | 22,920,557 | 23,016,104 | 22,143,099 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY (Unaudited) - USD ($) $ in Thousands | Ordinary shares [Member] | Additional Paid-In Capital [Member] | Accumulated Deficit [Member] | Total |
Balance at Dec. 31, 2019 | $ 561 | $ 203,977 | $ (152,073) | $ 52,465 |
Balance, shares at Dec. 31, 2019 | 20,402,800 | |||
Loss for the period | (14,180) | (14,180) | ||
Issuance of shares and warrants through public offering, net of issuance costs | $ 61 | 21,245 | 21,306 | |
Issuance of shares and warrants through public offering, net of issuance costs, shares | 2,091,907 | |||
Issuance of shares and warrants through private placement from the controlling shareholder | $ 13 | 4,987 | 5,000 | |
Issuance of shares and warrants through private placement from the controlling shareholder, shares | 454,628 | |||
Vesting of restricted shares units | ||||
Vesting of restricted shares units, shares | 19,166 | |||
Exercise of options | 151 | 151 | ||
Exercise of options, shares | 28,447 | |||
Share-based compensation | 779 | 779 | ||
Balance at Jun. 30, 2020 | $ 635 | 231,139 | (166,253) | 65,521 |
Balance, shares at Jun. 30, 2020 | 22,996,948 | |||
Balance at Mar. 31, 2020 | $ 622 | 225,693 | (159,183) | 67,132 |
Balance, shares at Mar. 31, 2020 | 22,514,488 | |||
Loss for the period | (7,070) | (7,070) | ||
Issuance of shares and warrants through private placement from the controlling shareholder | $ 13 | 4,987 | 5,000 | |
Issuance of shares and warrants through private placement from the controlling shareholder, shares | 454,628 | |||
Vesting of restricted shares units | ||||
Vesting of restricted shares units, shares | 3,833 | |||
Exercise of options | 144 | 144 | ||
Exercise of options, shares | 23,999 | |||
Share-based compensation | 315 | 315 | ||
Balance at Jun. 30, 2020 | $ 635 | 231,139 | (166,253) | 65,521 |
Balance, shares at Jun. 30, 2020 | 22,996,948 | |||
Balance at Dec. 31, 2020 | $ 635 | 231,577 | (181,363) | $ 50,849 |
Balance, shares at Dec. 31, 2020 | 23,000,782 | 23,000,782 | ||
Loss for the period | (12,096) | $ (12,096) | ||
Vesting of restricted shares units | ||||
Vesting of restricted shares units, shares | 15,333 | |||
Exercise of options | 83 | 83 | ||
Exercise of options, shares | 13,836 | |||
Share-based compensation | 411 | 411 | ||
Balance at Jun. 30, 2021 | $ 635 | 232,071 | (193,459) | $ 39,247 |
Balance, shares at Jun. 30, 2021 | 23,029,951 | 23,029,951 | ||
Balance at Mar. 31, 2021 | $ 635 | 231,849 | (185,426) | $ 47,058 |
Balance, shares at Mar. 31, 2021 | 23,028,264 | |||
Loss for the period | (8,033) | (8,033) | ||
Exercise of options | 9 | 9 | ||
Exercise of options, shares | 1,687 | |||
Share-based compensation | 213 | 213 | ||
Balance at Jun. 30, 2021 | $ 635 | $ 232,071 | $ (193,459) | $ 39,247 |
Balance, shares at Jun. 30, 2021 | 23,029,951 | 23,029,951 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | |||||
Loss | $ (8,033) | $ (7,070) | $ (12,096) | $ (14,180) | |
Adjustments required to reconcile loss to net cash used in operating activities: | |||||
Depreciation | 474 | 470 | |||
Changes in accrued liability for employee rights upon retirement, net | 3 | 17 | |||
Share-based compensation | 213 | 315 | 411 | 779 | |
Financial expenses (income), net | 15 | (14) | |||
Net changes in operating leases | (48) | (30) | |||
Changes in fair value of marketable securities | (59) | 76 | $ 138 | ||
Changes in operating asset and liabilities: | |||||
Receivables from collaborative arrangements | 1,197 | 2,949 | |||
Prepaid expenses and other current assets | (482) | (201) | |||
Accounts payable, accrued expenses and other | (782) | 553 | |||
Net cash used in operating activities | (11,367) | (9,581) | |||
CASH FLOWS FROM INVESTING ACTIVITIES: | |||||
Purchase of property and equipment | (54) | (358) | |||
Investment in marketable securities | (4,065) | (19,640) | (32,322) | ||
Proceeds from sales and maturity of marketable securities | 18,946 | 19,852 | 51,498 | ||
Short-term deposits | 500 | (19,900) | |||
Long-term deposits | 2 | (12) | |||
Net cash provided by (used in) investing activities | 15,329 | (20,058) | |||
CASH FLOWS FROM FINANCING ACTIVITIES: | |||||
Proceed from exercise of options | 83 | 151 | |||
Proceeds from issuance of shares, net of issuance costs | 26,306 | ||||
Net cash provided by financing activities | 83 | 26,457 | |||
EFFECT OF EXCHANGE RATE ON CASH AND CASH EQUIVALENTS | (15) | 14 | |||
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS AND RESTRICTED CASH | 4,030 | (3,168) | |||
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH AT BEGINNING OF THE PERIOD | 8,272 | 9,762 | 9,762 | ||
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH AT END OF THE PERIODs | 12,302 | 6,594 | 12,302 | 6,594 | 8,272 |
Cash and Cash equivalents | 11,152 | 5,444 | 11,152 | 5,444 | $ 7,122 |
Restricted cash | 1,150 | 1,150 | 1,150 | 1,150 | |
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH SHOWN IN STATEMENT OF CASH FLOWS | $ 12,302 | $ 6,594 | 12,302 | 6,594 | |
SUPPLEMENTARY INFORMATION: | |||||
Interest received | $ 582 | $ 628 |
NATURE OF OPERATIONS
NATURE OF OPERATIONS | 6 Months Ended |
Jun. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
NATURE OF OPERATIONS | NOTE 1 - NATURE OF OPERATIONS Sol-Gel Technologies Ltd. (collectively with its U.S. subsidiary, the Company) is an Israeli Company incorporated in 1997. The Company is a clinical stage specialty pharmaceutical company focused on developing and commercializing topical dermatological drug products. The Company’s lead product candidates are based upon its proprietary microencapsulation delivery system, consisting of microcapsules made of precipitated silica. The most advanced investigational drugs in the Company's product pipeline are: (i) Twyneo®, which is developed for the treatment of acne vulgaris and (ii) Epsolay®, a potential treatment for subtype II rosacea. The New Drug Application ("NDA") for Twyneo® was accepted by the U.S. Food and Drug Administration (the “FDA”), which assigned a Prescription Drug User Fee Act ("PDUFA") goal date of August 1, 2021. The NDA for Epsolay® was accepted by the FDA, which assigned a PDUFA goal date of April 26, 2021. On such PDUFA goal date, the Company received confirmation from the FDA that action on the NDA could not be taken since a pre-approval inspection of the production site of Epsolay® still needs to be conducted. In June 2021, the Company entered into two exclusive license agreements with a third party for the commercialization of Twyneo® and Epsolay®, in the United States, see note 5. On July 27, 2021, the Company announced that the FDA approved the drug product, Twyneo®, see note 9. In addition to the novel product candidates, the Company’s products include the generic products Acyclovir, Ivermectin and other generic product candidates. Risk and Uncertainties Since incorporation through June 30, 2021, the Company has an accumulated deficit of $193,459 and its activities have been funded mainly by its shareholders and collaboration revenues, see also Notes 4 and 5. The Company expects to continue to incur significant research and development and other costs related to its ongoing operations. In June 2021, the Company entered into two exclusive license agreements with a third party for the commercialization of two of the Company's most advanced investigational drug products in the United States including upfront and milestone payments and related royalties, see note 5. In addition, management is continuing to analyze cash resources and considering raising additional funding from different sources, such as corporate collaborations, public or private equity offerings and/or debt financings, and/or selling shares under the Company's Open Market Sale Agreement with Jefferies LLC. Management expects that the Company's cash and cash equivalents, deposits and marketable securities as of June 30, 2021 will allow the Company to fund its operating plan through at least the next 12 months from the condensed financial statement issuance date. The Company is subject to risks and uncertainties as a result of the COVID-19 pandemic. The full extent to which the COVID-19 pandemic will directly or indirectly impact the Company's business, results of operations and financial condition, including revenues from collaboration arrangements, expenses, reserves and allowances, manufacturing, supply, regulatory approvals, clinical trials, commercial launch of branded and generic product candidates, research and development costs and employee-related amounts, will depend on future developments that are highly uncertain and cannot be predicted. The Company continues to monitor and assess new information related to the COVID-19 pandemic, the actions taken to contain or treat COVID-19, as well as the economic impact on various markets. Furthermore, the estimation process required to prepare the Company’s consolidated financial statements requires assumptions to be made about future events and conditions and the impact of COVID-19 on its financial results, and while management believes such assumptions are reasonable, they are inherently subjective and uncertain. The Company’s actual results could differ materially from those estimates. |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES: | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
SIGNIFICANT ACCOUNTING POLICIES: | NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES: a. Basis of Presentation The unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America ("U.S. GAAP") for interim financial statements. Accordingly, they do not include all of the information and notes required by U.S. GAAP for annual financial statements. In the opinion of management, these unaudited condensed consolidated financial statements reflect all adjustments, which include normal recurring adjustments, necessary for a fair statement of the Company’s consolidated financial position as of June 30, 2021, the consolidated results of operations and the statements of changes in shareholders' equity for the six month and three month periods ended June 30, 2020 and 2021 and the statements of cash flows for the six month period ended June 30, 2020 and 2021. The consolidated results for the six month period ended June 30, 2021 are not necessarily indicative of the results to be expected for the year ending December 31, 2021. These unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements of the Company for the year ended December 31, 2020. The comparative balance sheet at December 31, 2020 has been derived from the audited financial statements at that date but does not include all disclosures required by U.S. GAAP. b. Loss per share Basic loss per share is computed on the basis of the net loss for the period divided by the weighted average number of ordinary shares outstanding during the period. Diluted loss per share is based upon the weighted average number of ordinary shares and of potential ordinary shares outstanding when dilutive. Potential ordinary shares equivalents include outstanding stock options, restricted shares and warrants, which are included under the treasury stock method when dilutive. The calculation of diluted loss per share does not include 3,437,843 and 3,463,710 options, restricted shares and warrants for the six and three months ended June 30, 2021 and 1,244,731 and 1,197,028 options and restricted shares for the six and the three months ended June 30, 2020, respectively, because the effect would be anti-dilutive. |
MARKETABLE SECURITIES_
MARKETABLE SECURITIES: | 6 Months Ended |
Jun. 30, 2021 | |
Investments, Debt and Equity Securities [Abstract] | |
MARKETABLE SECURITIES | NOTE 3 - MARKETABLE SECURITIES: The following table sets forth the Company’s marketable securities for the indicated periods: December June 30, 31, 2020 2021 Level 2 securities: U.S government and agency bonds $ 4,192 $ 2,716 Canada government bonds - - Other foreign government bonds 2,006 - Corporate bonds* 15,454 4,114 Total $ 21,652 $ 6,830 * Investments in Corporate bonds rated A or higher. The Company’s debt securities are classified within Level 2 because it uses quoted market prices or alternative pricing sources and models utilizing market observable inputs to determine their fair value. The table below sets forth a summary of the changes in the fair value of the Company’s marketable securities for the indicated periods: Marketable securities For the year ended December 31, 2020 For the Six Months ended June 30, 2021 Balance at beginning of the period $ 40,966 $ 21,652 Additions 32,322 4,065 Sale or maturity (51,498 ) (18,946 ) Changes in fair value during the period (138 ) 59 Balance at end of the period $ 21,652 $ 6,830 As of June 30, 2021, the Company’s debt securities had the following maturity dates: Market value June 30, 2021 Due within one year 6,830 The carrying amount of the cash and cash equivalents, bank deposits, restricted cash, restricted long term deposits, accrued expenses and other liabilities approximates their fair value. |
COLLABORATION AGREEMENTS_
COLLABORATION AGREEMENTS: | 6 Months Ended |
Jun. 30, 2021 | |
Revenue from Contract with Customer [Abstract] | |
COLLABORATION AGREEMENTS: | NOTE 4 - COLLABORATION AGREEMENTS: a. In 2007, the Company granted rights to a third party for use and commercialization of a product for skin protection. Under this b. In 2016 through 2021, the Company entered into several collaboration agreements with two third parties for the development, Upon FDA approval, the third parties have exclusive rights and are required to use diligent efforts to commercialize these products in territories defined under the agreements, including all required sales, marketing and distributing activities associated with the agreements. The Company is entitled to 50% of the third parties’ gross profits related to the sale of these products, as such term is defined in the agreements. During the six and three months ended June 30, 2021, respectively, the Company recognized revenues from royalties related to sales of two generic products in the U.S. under these agreements in the amount of $1,582 and $904. The Agreements are considered to be within the scope of ASC 808, as the parties are active participants and exposed to the risks and rewards of the collaborative activity. The Company recognizes collaboration revenue when the related sales occur. |
LICENSE AGREEMENTS_
LICENSE AGREEMENTS: | 6 Months Ended |
Jun. 30, 2021 | |
License Agreements | |
LICENSE AGREEMENTS: | NOTE 5 - LICENSE AGREEMENTS: In June 2021, the Company entered into two exclusive license agreements with a third party for the commercialization of two of the Company most advanced investigational drug products (Twyneo® and Epsolay®) in the United States. The Company is entitled to up to $7.5 million per product in upfront payments and regulatory approval milestone payments assuming 2021 approval of each respective product. The Company is also eligible to receive tiered double-digit royalties ranging from mid-teen to high-teen percentage of net sales as well as up to $9 million in sales milestone payments. According to the agreement, the Company has an option to regain commercialization rights five years following first commercialization. Subsequent to June 30, 2021, the Company received $4 million per product of upfront payments, which are refundable if FDA approval for each respective product is not received by December 31, 2021. As to FDA approval, received subsequent to June 30, 2021, with respect to Twyneo® , see note 9. |
COMMITMENTS_
COMMITMENTS: | 6 Months Ended |
Jun. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS: | NOTE 6 - COMMITMENTS: In June 2021, the Company entered into a new agreement with a third party for the commercialization of a product candidate. According to the agreement the Company shall receive from the third party an upfront payment of $1,250 and additional milestone payments in the future. In connection with the development of the product candidate, the Company is expected to sign an agreement with another third party. Both third parties are expected to sign a manufacture and supply agreement. In case either the development and/or supply agreements will not be executed during the 3rd quarter of 2021, the Company shall be required to refund the third party with the aforementioned upfront payment. In July 2021, the Company received the upfront payment. |
SHARE CAPITAL_
SHARE CAPITAL: | 6 Months Ended |
Jun. 30, 2021 | |
Stockholders' Equity Note [Abstract] | |
SHARE CAPITAL: | NOTE 7 – SHARE CAPITAL: Options grants During the six months ended June 30, 2021, the Company granted 248,600 options to employees and directors: i. In January 2021 and March 2021, the Company granted a total of 20,000 options and 3,600 options, respectively, to several employees to purchase ordinary shares at an exercise price of $10.44 and $9.93 per share, respectively. The options vest over a period of 4 years; one quarter of the options vest on the first anniversary of the vesting commencement date (as described in each agreement) and the rest vest quarterly over the following three years. The options expire on the tenth anniversary of their grant date. ii. In February 2021, the Company granted a total of 225,000 options to several directors to purchase ordinary shares at an exercise price of $10.02 per share. The options vest over a period of 3 years; one third of the options vest on the first anniversary of the vesting commencement date (as described in each agreement) and the rest vest quarterly over the following two years. The options expire on the tenth anniversary of their grant date. The fair value of options granted in 2021 was $1,061. The underlying data used for computing the fair value of the options are as follows: 2021 Value of one ordinary share $9.56-$10.44 Dividend yield 0% Expected volatility 59.52%-70.48% Risk-free interest rate 0.55%-1.14% Expected term 3.25-7 years Ordinary shares On February 19, 2020, the Company completed an underwritten public offering, in which it issued 2,091,907 ordinary shares and 2,091,907 warrants to purchase up to 1,673,525 ordinary shares, at a public offering price of $11.00 per ordinary shares for total proceeds, net of issuance costs of approximately $21,306. The warrants are exercisable over a six-years period from the date of issuance at a per share exercise price of $14, subject to certain adjustments as defined in the agreement. In addition and in parallel to the public offering, the Company completed private placement with its controlling shareholder for an additional investment of approximately $5,000 in consideration of 454,628 ordinary shares and 454,628 warrants to purchase up to 363,702 ordinary shares, at the same terms of the underwritten public offering mentioned above. |
RELATED PARTIES_
RELATED PARTIES: | 6 Months Ended |
Jun. 30, 2021 | |
Related Party Transactions [Abstract] | |
RELATED PARTIES: | NOTE 8 - RELATED PARTIES: a. Related parties include the controlling shareholder and companies under his control, the board of directors and the executive b. As to the private placement with the controlling shareholder, see note 7. |
SUBSEQUENT EVENT_
SUBSEQUENT EVENT: | 6 Months Ended |
Jun. 30, 2021 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENT: | NOTE 9 – SUBSEQUENT EVENT: i. On July 27, 2021, the Company announced that the FDA approved the Company’s first proprietary drug product, Twyneo® . ii. In July 2021, the Company received the upfront payment related to a new agreement with a third party for the |
SIGNIFICANT ACCOUNTING POLICI_2
SIGNIFICANT ACCOUNTING POLICIES: (Policies) | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
Basis of presentation | a. Basis of Presentation The unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America ("U.S. GAAP") for interim financial statements. Accordingly, they do not include all of the information and notes required by U.S. GAAP for annual financial statements. In the opinion of management, these unaudited condensed consolidated financial statements reflect all adjustments, which include normal recurring adjustments, necessary for a fair statement of the Company’s consolidated financial position as of June 30, 2021, the consolidated results of operations and the statements of changes in shareholders' equity for the six month and three month periods ended June 30, 2020 and 2021 and the statements of cash flows for the six month period ended June 30, 2020 and 2021. The consolidated results for the six month period ended June 30, 2021 are not necessarily indicative of the results to be expected for the year ending December 31, 2021. These unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements of the Company for the year ended December 31, 2020. The comparative balance sheet at December 31, 2020 has been derived from the audited financial statements at that date but does not include all disclosures required by U.S. GAAP. |
Loss per share | b. Loss per share Basic loss per share is computed on the basis of the net loss for the period divided by the weighted average number of ordinary shares outstanding during the period. Diluted loss per share is based upon the weighted average number of ordinary shares and of potential ordinary shares outstanding when dilutive. Potential ordinary shares equivalents include outstanding stock options, restricted shares and warrants, which are included under the treasury stock method when dilutive. The calculation of diluted loss per share does not include 3,437,843 and 3,463,710 options, restricted shares and warrants for the six and three months ended June 30, 2021 and 1,244,731 and 1,197,028 options and restricted shares for the six and the three months ended June 30, 2020, respectively, because the effect would be anti-dilutive. |
MARKETABLE SECURITIES_ (Tables)
MARKETABLE SECURITIES: (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of Marketable Securities | The following table sets forth the Company’s marketable securities for the indicated periods: December June 30, 31, 2020 2021 Level 2 securities: U.S government and agency bonds $ 4,192 $ 2,716 Canada government bonds - - Other foreign government bonds 2,006 - Corporate bonds* 15,454 4,114 Total $ 21,652 $ 6,830 * Investments in Corporate bonds rated A or higher. |
Summary of Changes in Fair Value of Marketable Securities | The table below sets forth a summary of the changes in the fair value of the Company’s marketable securities for the indicated periods: Marketable securities For the year ended December 31, 2020 For the Six Months ended June 30, 2021 Balance at beginning of the period $ 40,966 $ 21,652 Additions 32,322 4,065 Sale or maturity (51,498 ) (18,946 ) Changes in fair value during the period (138 ) 59 Balance at end of the period $ 21,652 $ 6,830 |
Schedule of Debt Securities | As of June 30, 2021, the Company’s debt securities had the following maturity dates: Market value June 30, 2021 Due within one year 6,830 |
SHARE CAPITAL_ (Tables)
SHARE CAPITAL: (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Stockholders' Equity Note [Abstract] | |
Schedule of Assumptions Used to Estimate Fair Value | The fair value of options granted in 2021 was $1,061. The underlying data used for computing the fair value of the options are as follows: 2021 Value of one ordinary share $9.56-$10.44 Dividend yield 0% Expected volatility 59.52%-70.48% Risk-free interest rate 0.55%-1.14% Expected term 3.25-7 years |
NATURE OF OPERATIONS (Details)
NATURE OF OPERATIONS (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Accumulated deficit | $ 193,459 | $ 181,363 |
SIGNIFICANT ACCOUNTING POLICI_3
SIGNIFICANT ACCOUNTING POLICIES: (Narrative) (Details) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Accounting Policies [Abstract] | ||||
Anti-dilutive shares | 3,463,710 | 1,197,028 | 3,437,843 | 1,244,731 |
MARKETABLE SECURITIES_ (Schedul
MARKETABLE SECURITIES: (Schedule of Company's Marketable Securities) (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Level 2 securities: | ||||
Marketable securities | $ 6,830 | $ 21,652 | $ 40,966 | |
U.S government and agency bonds [Member] | ||||
Level 2 securities: | ||||
Marketable securities | 2,716 | 4,192 | ||
Canada government bonds [Member] | ||||
Level 2 securities: | ||||
Marketable securities | ||||
Other foreign government bonds [Member] | ||||
Level 2 securities: | ||||
Marketable securities | 2,006 | |||
Corporate bonds [Member] | ||||
Level 2 securities: | ||||
Marketable securities | [1] | $ 4,114 | $ 15,454 | |
[1] | Investments in Corporate bonds rated A or higher. |
MARKETABLE SECURITIES_ (Summary
MARKETABLE SECURITIES: (Summary of Changes in Fair Value of Company's Marketable Securities) (Details) - USD ($) $ in Thousands | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Investments, Debt and Equity Securities [Abstract] | |||
Balance at beginning of the period | $ 21,652 | $ 40,966 | $ 40,966 |
Additions | 4,065 | 19,640 | 32,322 |
Sale or maturity | (18,946) | (19,852) | (51,498) |
Changes in fair value during the period | 59 | $ (76) | (138) |
Balance at end of the period | $ 6,830 | $ 21,652 |
MARKETABLE SECURITIES_ (Sched_2
MARKETABLE SECURITIES: (Schedule of Company's debt marketable securities) (Details) $ in Thousands | Jun. 30, 2021USD ($) |
Investments, Debt and Equity Securities [Abstract] | |
Due within one year | $ 6,830 |
COLLABORATION AGREEMENTS_ (Deta
COLLABORATION AGREEMENTS: (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended |
Jun. 30, 2021 | Jun. 30, 2021 | |
Percentage of gross profits related to sale products | 50.00% | |
Revenues recognized | $ 904 | $ 1,582 |
Minimum [Member] | ||
Royalties Maturity | 2016 | |
Maximum [Member] | ||
Royalties Maturity | 2024 |
LICENSE AGREEMENTS_ (Details)
LICENSE AGREEMENTS: (Details) - USD ($) $ in Millions | 1 Months Ended | 6 Months Ended |
Dec. 31, 2021 | Jun. 30, 2021 | |
Upfront payments | $ 7.5 | |
Royalties company is eligible to receive | $ 9 | |
Subsequent Event [Member] | ||
Upfront payments | $ 4 |
COMMITMENTS_ (Details)
COMMITMENTS: (Details) | 6 Months Ended |
Jun. 30, 2021USD ($) | |
Commitments and Contingencies Disclosure [Abstract] | |
Receive from third party upfront payment | $ 1,250 |
SHARE CAPITAL_ (Narrative) (Det
SHARE CAPITAL: (Narrative) (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 6 Months Ended | |||
Mar. 31, 2021 | Feb. 28, 2021 | Jan. 31, 2021 | Feb. 19, 2020 | Jun. 30, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Fair value of options granted | $ 1,061 | ||||
Private Placement [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Shares issued | 454,628 | ||||
Warrants to purchase ordinary shares | 363,702 | ||||
Proceeds from private placement | $ 5,000 | ||||
Underwritten Public Offering [member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Exercise price | $ 14 | ||||
Ordinary shares issued | 2,091,907 | ||||
Per share price | $ 11 | ||||
Warrants to purchase ordinary shares | 1,673,525 | ||||
Expected term | 6 years | ||||
Procceds from Initial public offering, net of issuance costs | $ 21,306 | ||||
Employees and Director [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Option grants | 248,600 | ||||
Option vesting period | 4 years | ||||
Employees [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Option grants | 3,600 | 20,000 | |||
Exercise price | $ 9.93 | $ 10.44 | |||
Director [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Option grants | 225,000 | ||||
Exercise price | $ 10.02 | ||||
Option vesting period | 3 years |
SHARE CAPITAL_ (Schedule of Ass
SHARE CAPITAL: (Schedule of Assumptions Used to Estimate Fair Value) (Details) | 6 Months Ended |
Jun. 30, 2021$ / shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Dividend yield | 0.00% |
Minimum [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Value of one ordinary share | $ 9.56 |
Expected volatility | 59.52% |
Risk-free interest rate | 0.55% |
Expected term | 3 years 3 months |
Maximum [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Value of one ordinary share | $ 10.44 |
Expected volatility | 70.48% |
Risk-free interest rate | 1.14% |
Expected term | 7 years |