Document and Entity Information
Document and Entity Information | 6 Months Ended |
Jun. 30, 2020 | |
Document and Entity Information [Abstract] | |
Entity Registrant Name | Gamida Cell Ltd. |
Entity Central Index Key | 0001600847 |
Current Fiscal Year End Date | --12-31 |
Document Type | 6-K |
Amendment Flag | false |
Document Period End Date | Jun. 30, 2020 |
Document Fiscal Year Focus | 2020 |
Document Fiscal Period Focus | Q2 |
Entity File Number | 001-38716 |
Interim Consolidated Statements
Interim Consolidated Statements of Financial Position - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 | Jun. 30, 2019 |
CURRENT ASSETS: | |||
Cash and cash equivalents | $ 88,638 | $ 41,838 | $ 37,078 |
Available-for-sale financial assets | 13,559 | 4,618 | |
Prepaid expenses and other current assets | 2,241 | 1,306 | 886 |
Total current assets | 90,879 | 56,703 | 42,582 |
NON-CURRENT ASSETS: | |||
Property, plant and equipment, net | 14,204 | 6,298 | 3,437 |
Right-of-use assets | 7,490 | 5,133 | 6,157 |
Other assets | 642 | 641 | 1,355 |
Total non-current assets | 22,336 | 12,072 | 10,949 |
Total assets | 113,215 | 68,775 | 53,531 |
CURRENT LIABILITIES: | |||
Trade payables | 2,738 | 1,164 | 2,121 |
Employees and payroll accruals | 3,187 | 3,443 | 2,753 |
Current maturities of lease liabilities | 2,145 | 1,870 | 1,945 |
Accrued expenses and other payables | 5,509 | 4,918 | 2,699 |
Total current liabilities | 13,579 | 11,395 | 9,518 |
NON-CURRENT LIABILITIES: | |||
Liabilities presented at fair value | 4,551 | 5,221 | 7,654 |
Employee benefit liabilities, net | 773 | 773 | 274 |
Lease liabilities | 5,946 | 4,101 | 4,627 |
Liability to Israel Innovation Authority (IIA) | 13,816 | 12,302 | 10,906 |
Total non-current liabilities | 25,086 | 22,397 | 23,461 |
SHAREHOLDERS' EQUITY: | |||
Share capital- | 137 | 92 | 69 |
Share premium | 304,175 | 238,992 | 199,402 |
Capital reserve due to actuarial gains | (541) | (541) | (160) |
Available-for-sale reserve | 4 | (1) | |
Accumulated deficit | (229,221) | (203,564) | (178,758) |
Total shareholders' equity | 74,550 | 34,983 | 20,552 |
Total liabilities and shareholders' equity | $ 113,215 | $ 68,775 | $ 53,531 |
Interim Consolidated Statemen_2
Interim Consolidated Statements of Financial Position (Parenthetical) - Ordinary shares [member] - ₪ / shares | Jun. 30, 2020 | Dec. 31, 2019 | Jun. 30, 2019 |
IfrsStatementLineItems [Line Items] | |||
Ordinary shares, par value | ₪ 0.01 | ₪ 0.01 | ₪ 0.01 |
Ordinary shares, authorized | 100,000,000 | 100,000,000 | 100,000,000 |
Ordinary shares, issued | 49,471,817 | 33,670,926 | 25,606,423 |
Ordinary shares, outstanding | 49,471,817 | 33,670,926 | 25,606,423 |
Interim Consolidated Statemen_3
Interim Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | |
Profit or loss [abstract] | |||||
Research and development, net | $ 9,319 | $ 7,253 | $ 17,198 | $ 14,536 | $ 31,462 |
Commercial activities | 1,029 | 1,092 | 2,497 | 2,090 | 4,692 |
General and administrative | 2,496 | 2,452 | 5,490 | 5,267 | 12,091 |
Operating loss | 12,844 | 10,797 | 25,185 | 21,893 | 48,245 |
Finance expense | 2,320 | 1,336 | 1,366 | 1,604 | 3,325 |
Finance income | (109) | (18,169) | (894) | (14,052) | (17,149) |
Loss before taxes on income | 15,055 | (6,036) | 25,657 | 9,445 | 34,421 |
Taxes on income (benefit) | 74 | 100 | (70) | ||
Net loss (income) | 15,055 | (5,962) | 25,657 | 9,545 | 34,351 |
Items that will be reclassified subsequently to profit or loss: | |||||
Actuarial net loss of defined benefit plans | 83 | 464 | |||
Changes in the fair value of available for sale financial assets | (9) | 4 | (42) | (47) | |
Total comprehensive loss (income) | $ 15,055 | $ (5,971) | $ 25,661 | $ 9,586 | $ 34,768 |
Net loss (income) per share: | |||||
Basic loss (income) per share | $ 0.37 | $ (0.23) | $ 0.69 | $ 0.38 | $ 1.17 |
Diluted loss per share | $ 0.37 | $ 0.44 | $ 0.69 | $ 0.87 | $ 1.69 |
Interim Consolidated Statemen_4
Interim Consolidated Statements of Changes in Equity - USD ($) $ in Thousands | Ordinary shares | Preferred shares | Share premium | Available-for-sale reserve | Capital reserve due to actuarial losses | Accumulated deficit | Total |
Balance at Dec. 31, 2018 | $ 67 | $ 193,953 | $ (43) | $ (77) | $ (169,213) | $ 24,687 | |
Balance, shares at Dec. 31, 2018 | 24,930,736 | ||||||
IfrsStatementLineItems [Line Items] | |||||||
Net loss | (9,545) | (9,545) | |||||
Other comprehensive (loss) income | 42 | (83) | (50) | ||||
Total comprehensive (loss) income | 42 | (83) | (9,646) | (9,586) | |||
Exercise of options | $ 1 | 116 | 117 | ||||
Exercise of options, shares | 466,375 | ||||||
Exercise of warrants | $ 1 | 2,923 | 2,924 | ||||
Exercise of warrants, shares | 209,312 | ||||||
Share-based compensation | 2,410 | 2,410 | |||||
Balance at Jun. 30, 2019 | $ 69 | 199,042 | (1) | (160) | (178,758) | 20,552 | |
Balance, shares at Jun. 30, 2019 | 25,606,423 | ||||||
Balance at Dec. 31, 2018 | $ 67 | 193,953 | (43) | (77) | (169,213) | 24,687 | |
Balance, shares at Dec. 31, 2018 | 24,930,736 | ||||||
IfrsStatementLineItems [Line Items] | |||||||
Net loss | (34,351) | (34,351) | |||||
Other comprehensive (loss) income | 47 | (464) | (417) | ||||
Total comprehensive (loss) income | 47 | (464) | (34,351) | (34,768) | |||
Issuance of ordinary shares in a secondary offering, net of issuance expenses | $ 23 | 37,117 | 37,140 | ||||
Issuance of ordinary shares in a secondary offering, net of issuance expenses, shares | 8,050,000 | ||||||
Exercise of options | $ 1 | 131 | 132 | ||||
Exercise of options, shares | 480,878 | ||||||
Exercise of warrants | $ 1 | 2,923 | 2,924 | ||||
Exercise of warrants, shares | 209,312 | ||||||
Share-based compensation | 4,868 | 4,868 | |||||
Balance at Dec. 31, 2019 | $ 92 | 238,992 | 4 | (541) | (203,564) | 34,983 | |
Balance, shares at Dec. 31, 2019 | 33,670,926 | ||||||
Balance at Mar. 31, 2019 | $ 68 | 197,967 | (10) | (160) | (184,720) | 13,145 | |
Balance, shares at Mar. 31, 2019 | 25,140,048 | ||||||
IfrsStatementLineItems [Line Items] | |||||||
Net loss | 5,962 | 5,962 | |||||
Other comprehensive (loss) income | 9 | 9 | |||||
Total comprehensive (loss) income | 9 | 5,962 | 5,971 | ||||
Exercise of options | $ 1 | 116 | 117 | ||||
Exercise of options, shares | 466,375 | ||||||
Share-based compensation | 1,319 | 1,319 | |||||
Balance at Jun. 30, 2019 | $ 69 | 199,042 | (1) | (160) | (178,758) | 20,552 | |
Balance, shares at Jun. 30, 2019 | 25,606,423 | ||||||
Balance at Dec. 31, 2019 | $ 92 | 238,992 | 4 | (541) | (203,564) | 34,983 | |
Balance, shares at Dec. 31, 2019 | 33,670,926 | ||||||
IfrsStatementLineItems [Line Items] | |||||||
Net loss | (15,055) | (25,657) | |||||
Other comprehensive (loss) income | |||||||
Total comprehensive (loss) income | (15,055) | (25,661) | |||||
Issuance of ordinary shares in a secondary offering, net of issuance expenses | $ 44 | 63,816 | 63,860 | ||||
Issuance of ordinary shares in a secondary offering, net of issuance expenses, shares | 15,333,334 | ||||||
Exercise of options | $ 1 | 140 | 141 | ||||
Exercise of options, shares | 441,901 | ||||||
Share-based compensation | 322 | 322 | |||||
Balance at Jun. 30, 2020 | $ 137 | 304,175 | (541) | (229,221) | 74,550 | ||
Balance, shares at Jun. 30, 2020 | 49,471,817 | ||||||
Balance at Mar. 31, 2020 | $ 92 | 239,897 | (541) | (214,166) | 25,282 | ||
Balance, shares at Mar. 31, 2020 | 33,696,582 | ||||||
IfrsStatementLineItems [Line Items] | |||||||
Net loss | (15,055) | (15,055) | |||||
Other comprehensive (loss) income | |||||||
Total comprehensive (loss) income | (15,055) | (15,055) | |||||
Issuance of ordinary shares in a secondary offering, net of issuance expenses | $ 44 | 63,816 | 63,860 | ||||
Issuance of ordinary shares in a secondary offering, net of issuance expenses, shares | 15,333,334 | ||||||
Exercise of options | $ 1 | 140 | 141 | ||||
Exercise of options, shares | 441,901 | ||||||
Share-based compensation | 322 | 322 | |||||
Balance at Jun. 30, 2020 | $ 137 | $ 304,175 | $ (541) | $ (229,221) | $ 74,550 | ||
Balance, shares at Jun. 30, 2020 | 49,471,817 |
Interim Consolidated Statemen_5
Interim Consolidated Statements of Changes in Equity (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended |
Jun. 30, 2020 | Jun. 30, 2020 | Dec. 31, 2019 | |
Ordinary shares | |||
IfrsStatementLineItems [Line Items] | |||
Issuance expenses | $ 1,000 | $ 1,000 | $ 694 |
Interim Consolidated Statemen_6
Interim Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | |
Cash flows from operating activities: | |||||
Net (loss) income | $ (15,055) | $ 5,962 | $ (25,657) | $ (9,545) | $ (34,351) |
Adjustments to reconcile net loss to net cash (used in) provided by operating activities: | |||||
Depreciation of property, equipment and right-of-use assets | 556 | 703 | 1,106 | 1,245 | 2,143 |
Financial income, net | (128) | (378) | (260) | (569) | (775) |
Cost of share-based compensation | 322 | 1,319 | 1,221 | 2,410 | 4,868 |
Change in employee benefit liabilities, net | (3) | 8 | 126 | ||
Amortization of premium on available-for-sale financial asses | 51 | 4 | 101 | 184 | |
Revaluation of financial derivatives | 1,778 | (17,378) | (670) | (13,471) | (15,904) |
Revaluation of liability to IIA | 593 | 631 | 1,315 | 1,199 | 2,531 |
Adjustments to reconcile profit (loss) | 3,121 | (15,055) | 2,716 | (9,077) | (6,827) |
Decrease (increase) in prepaid expenses, other current assets and other assets | (607) | (292) | (1,065) | 117 | (150) |
Increase (decrease) in trade payables | (360) | 1,088 | 1,574 | 244 | (821) |
Increase (decrease) in accrued expenses and other payables | 2,472 | 141 | (624) | 162 | 2,807 |
Cash flows from (used in) operations | 1,505 | 937 | (115) | 523 | 1,836 |
Cash received during the period for: | |||||
Interest received | 9 | 309 | 357 | 830 | 1,546 |
Interest paid | (33) | (23) | (80) | (51) | (134) |
Interest, net | (24) | 286 | 277 | 779 | 1,412 |
Net cash used in operating activities | (10,453) | (7,870) | (22,779) | (17,320) | (37,930) |
Cash flows from investing activities: | |||||
Purchase of property, plant and equipment | (4,990) | (528) | (7,109) | (878) | (3,055) |
Purchase of marketable securities | (32,021) | ||||
Proceed from sale of marketable securities | 1,847 | 13,551 | 15,740 | ||
Proceed from maturity of marketable securities | 38,742 | ||||
Net cash provided by (used in) investing activities | (4,990) | 1,319 | 6,442 | 14,862 | 3,666 |
Cash flows from financing activities: | |||||
Receipt of grants from the IIA | 147 | 167 | 200 | 167 | 224 |
Proceeds from secondary offering, net | 63,860 | (108) | 63,860 | (346) | 37,140 |
Proceeds from issuance of shares, initial public offering (payment of issuance expenses), net | (238) | ||||
Payment of lease liabilities | (335) | (324) | (1,122) | (764) | (1,529) |
Exercise of options | 141 | 117 | 147 | 117 | 132 |
Net cash (used in) provided by financing activities | 63,813 | (148) | 63,085 | (826) | 35,729 |
Exchange differences on balances of cash and cash equivalents | (24) | 28 | 52 | 90 | 101 |
Increase (decrease) in cash and cash equivalents | 48,346 | (6,671) | 46,800 | (3,194) | 1,566 |
Cash and cash equivalents at beginning of period | 40,292 | 43,749 | 41,838 | 40,272 | 40,272 |
Cash and cash equivalents at end of period | 88,638 | 37,078 | 88,638 | 37,078 | 41,838 |
Significant non-cash transactions: | |||||
Exercise of warrants liabilities to equity | 2,924 | 2,924 | |||
Increase in other assets on credit | (592) | (592) | |||
Purchase of property, plant and equipment on credit | $ 960 | $ (400) | $ 960 | $ (400) | $ 1,255 |
General
General | 6 Months Ended |
Jun. 30, 2020 | |
General [Abstract] | |
GENERAL | NOTE 1:- GENERAL a. Gamida Cell Ltd. (the "Company"), founded in 1998, is an advanced cell therapy company committed to finding cures for patients with blood cancers and serious blood diseases and develops novel curative treatments using stem cells and natural killer (NK) cells. b. The Company has created a novel NAM-based cell expansion platform that is designed to enhance the number and functionality of allogenic donor cells. This proprietary therapeutic platform may enable the development of therapies with the potential to improve treatment outcomes beyond what is possible with current donor-derived therapies. The lead product candidate, omidubicel, is an advanced cell therapy in development as a potential life-saving treatment option for patients in need of a bone marrow transplant (BMT). In May 2020, the Company reported that omidubicel met its primary endpoint in an international, randomized, multi-center Phase 3 clinical study in 125 patients with high-risk hematologic malignancies undergoing bone marrow transplant and who had no available matched donor. The study evaluated the safety and efficacy of omidubicel compared to standard umbilical cord blood. BMT with a graft derived from bone marrow or peripheral blood cells of a matched donor is currently the standard of care treatment for many of these patients, but there is a significant unmet need for patients who cannot find a fully matched donor. Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has received orphan drug designation in the U.S. and in Europe. In addition to omidubicel, the Company is developing GDA-201, an investigational NK cell-based cancer immunotherapy to be used in combination with standard-of-care therapeutic antibodies. NK cells have potent anti-tumor properties and have the advantage over other oncology cell therapies of not requiring genetic matching, potentially enabling NK cells to serve as a universal donor-based therapy when combined with certain antibodies. GDA-201 is currently in an investigator-sponsored Phase 1/2 study for the treatment of relapsed or refractory non-Hodgkin lymphoma (NHL) and multiple myeloma (MM). In December 2019, the Company reported preliminary data at the Annual Meeting of the American Society of Hematology, or ASH, which was subsequently updated by means of an abstract published by The European Society for Blood Marrow Transplantation, or EBMT. The data from the first 25 patients demonstrated that GDA-201 was clinically active and generally well tolerated. Among the eleven patients with NHL, seven achieved a complete response and one achieved a partial response. c. The Company is devoting substantially all of its efforts toward research and development activities. In the course of such activities, the Company has sustained operating losses and expects such losses to continue in the foreseeable future. The Company's accumulated deficit as of June 30, 2020 is $229,221 and negative cash flows from operating activities during the six month period ended June 30, 2020 is $22,779. These conditions raise substantial doubt about the Company's ability to continue as a going concern. The interim consolidated financial statements do not include any adjustments to the carrying amounts and classifications of assets and liabilities that would result if the Company was unable to continue as a going concern. The Company requires additional financing in order to continue to fund its current operations and pay existing and future liabilities. d. On July 1, 2019, the Company closed a follow-on offering of its ordinary shares on the Nasdaq Global Market, which resulted in the sale of 7,000,000 ordinary shares at a public offering price of $5.00 per share, before underwriting discounts. The underwriters had a 30-day option to purchase up to 1,050,000 additional shares at a public offering price of $5.00 per share, and exercised in full their option to purchase such shares. The exercise of the underwriters' option closed on July 8, 2019. The Company received net proceeds from the offering of $37,140 (net of issuance costs and underwriting discounts of $3,110). e. On May 21, 2020, the Company closed a second follow-on offering of its ordinary shares on the Nasdaq Global Market, which resulted in the sale of 13,333,334 ordinary shares at a public offering price of $4.50 per share, before underwriting discounts. The underwriters had a 30-day option to purchase up to 2,000,000 additional shares at a public offering price of $4.50 per share, and exercised in full their option to purchase such shares. The exercise of the underwriters' option closed on May 26, 2020. The Company received net proceeds from the offering of $63,860 (net of issuance costs and underwriting discounts of $5,140). f. Definitions: In these financial statements: The Company - Gamida Cell Ltd. and its subsidiary Subsidiary Gamida Cell Inc. incorporated in 2000 and intended to focus on sales and marketing upon product approval. Related parties - As defined in IAS 24 Dollar - U.S. dollar |
Significant Accounting Policies
Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2020 | |
Disclosure of initial application of standards or interpretations [abstract] | |
SIGNIFICANT ACCOUNTING POLICIES | NOTE 2:- SIGNIFICANT ACCOUNTING POLICIES a. The accompanying unaudited interim consolidated financial statements as of June 30, 2020 and for the six and three months periods ended June 30. 2020 and 2019 have been prepared in accordance with IAS 34 "Interim Financial Reporting" for interim financial information. The interim consolidated financial statements do not include all the information and disclosures required in the annual financial statements, and should be read in conjunction with the Company's annual consolidated financial statements as of December 31, 2019 and their accompanying disclosures. The interim consolidated financial statements reflect all normal recurring adjustments necessary to present fairly the financial position, results of operations, and cash flows for the interim periods, but are not necessarily indicative of the results of operations to be anticipated for the full year ending December 31, 2020. b. The accounting policies adopted in the preparation of the interim consolidated financial statements are consistent with those followed in the preparation of the Company's annual consolidated financial statements for the year ended December 31, 2019. c. Leases: Set out below, are the carrying amounts of the Company's right-of-use assets and lease liabilities and the movements during the period: Right-of-use assets Offices and labs Vehicles Production Total Lease As of January 1, 2020 $ 934 $ 175 $ 4,024 $ 5,133 $ 5,971 Depreciation expense (607 ) (75 ) (261 ) (943 ) - Interest expense - - - - 19 Additions 3,282 63 - 3,345 3,345 Disposals - (16 ) - (16 ) (13 ) Adjustments for indexation - - (29 ) (29 ) (29 ) Payments - - - - (1,202 ) As of June 30, 2020 (unaudited) $ 3,609 $ 147 $ 3,734 $ 7,490 $ 8,091 |
Share-Based Payment
Share-Based Payment | 6 Months Ended |
Jun. 30, 2020 | |
Share-Based Payment [Abstract] | |
SHARE-BASED PAYMENT | NOTE 3:- SHARE-BASED PAYMENT The total compensation cost related to all of the Company's equity-based awards, recognized during the presented periods was comprised as follows: Six months ended June 30, Three months ended June 30, Year ended December 31, 2020 2019 2020 2019 2019 Unaudited Audited Research and development $ 613 $ 736 $ 419 $ 507 $ 1,600 Commercial activities (177 ) 634 (355 ) 434 879 General and administrative 785 1,040 258 378 2,389 $ 1,221 $ 2,410 $ 322 $ 1,319 $ 4,868 The Company estimates the fair value of stock options granted using the Binominal option-pricing model. The option-pricing model requires a number of assumptions, of which the most significant are the expected stock price volatility and the expected option term. Expected volatility was calculated based upon historical volatilities of similar entities in the related sector index. The expected term of the options granted is derived from output of the option valuation model and represents the period of time that options granted are expected to be outstanding. The risk-free interest rate is based on the yield from U.S. treasury bonds with an equivalent term. The Company has historically not paid dividends and has no foreseeable plans to pay dividends. The following table lists the inputs to the Binomial option pricing model used for the fair value measurement of equity-settled share options for the following periods: Based on the above inputs, the fair value of the options was determined at $2.65 - $11.01 at the grant dates during 2020 and 2019. June 30, December 31, 2020 2019 2019 Unaudited Dividend yield (%) 0 0 0 Expected volatility of the share prices (%) 76% 88%-95% 78%-84% Risk-free interest rate (%) 0.6 2.52-2.7 1.92-2.63 Movement during the periods: Six months ended June 30, Year ended December 31, 2020 2019 2019 Unaudited Unaudited Number of Weighted Number of Weighted Number of Weighted USD USD USD Outstanding at beginning of period 3,405,188 $ 4.76 3,197,616 $ 3.07 3,197,616 3.07 Granted during the period 621,200 4.68 544,800 10.93 790,300 8.82 Expired during the period (10,938 ) 8.00 - - 39,094 5.21 Exercised during the period (467,557 ) 0.31 (466,375 ) 0.25 480,878 0.27 Forfeited during the period (211,482 ) 8.23 - - 62,756 6.16 Share options outstanding at end of period 3,336,411 5.14 3,276,041 4.78 3,405,188 4.76 Share options exercisable at end of period 1,973,898 $ 3.01 1,438,658 $ 2.16 1,865,572 2.68 As of June 30, 2020, there is $3,185 of total unrecognized cost related to non-vested share based compensation that is expected to be recognized over a period of up to four years. |
Liabilities Presented at Fair V
Liabilities Presented at Fair Value | 6 Months Ended |
Jun. 30, 2020 | |
Liabilities Presented At Fair Value [Abstract] | |
LIABILITIES PRESENTED AT FAIR VALUE | NOTE 4:- LIABILITIES PRESENTED AT FAIR VALUE a. W The Company measured the fair value of the warrants by using the Option Pricing Method utilized in a Black- Scholes simulation model. The option-pricing model requires a number of assumptions, of which the most significant are the expected stock price volatility and the expected time until liquidation. Expected volatility was calculated based upon historical volatilities of similar entities in the related sector index. The expected time until liquidation is the maximum contractual term of the warrants. The risk-free interest rate is based on the yield from U.S. treasury bonds with an equivalent term. The Company has historically not paid dividends and has no foreseeable plans to pay dividends. June 30, December 31, 2020 2019 2019 Unaudited Risk-free interest rate 0.2 % 1.71 % 1.7 % Expected volatility 76 % 80 % 80 % Expected life (in years) 2 3 2.5 Expected dividend yield 0 0 0 b. Changes in the fair value of warrants classified as Level 3 in the fair value hierarchy: Fair value Balance at January 1, 2020 $ 5,221 Revaluation of financial derivatives (670 ) Balance at June 30, 2020 (unaudited) $ 4,551 |
Loss Per Share
Loss Per Share | 6 Months Ended |
Jun. 30, 2020 | |
Loss Per Share [Abstract] | |
LOSS PER SHARE | NOTE 5:- LOSS PER SHARE a. Details of the number of shares and loss used in the computation of loss per share: Six months ended June 30, 2020 Three months ended June 30, 2020 Unaudited Unaudited Weighted Loss Weighted Loss For the computation of basic and diluted loss 37,141,582 $ 25,477 49,589,719 $ 14,875 |
Significant Accounting Polici_2
Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Disclosure of initial application of standards or interpretations [abstract] | |
Schedule of right-of-use assets and lease liabilities and the movements | Right-of-use assets Offices and labs Vehicles Production Total Lease As of January 1, 2020 $ 934 $ 175 $ 4,024 $ 5,133 $ 5,971 Depreciation expense (607 ) (75 ) (261 ) (943 ) - Interest expense - - - - 19 Additions 3,282 63 - 3,345 3,345 Disposals - (16 ) - (16 ) (13 ) Adjustments for indexation - - (29 ) (29 ) (29 ) Payments - - - - (1,202 ) As of June 30, 2020 (unaudited) $ 3,609 $ 147 $ 3,734 $ 7,490 $ 8,091 |
Share-Based Payment (Tables)
Share-Based Payment (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Share-based Payment [Abstract] | |
Schedule of compensation related costs | Six months ended June 30, Three months ended June 30, Year ended December 31, 2020 2019 2020 2019 2019 Unaudited Audited Research and development $ 613 $ 736 $ 419 $ 507 $ 1,600 Commercial activities (177 ) 634 (355 ) 434 879 General and administrative 785 1,040 258 378 2,389 $ 1,221 $ 2,410 $ 322 $ 1,319 $ 4,868 |
Schedule of fair value measurement of equity-settled share options | June 30, December 31, 2020 2019 2019 Unaudited Dividend yield (%) 0 0 0 Expected volatility of the share prices (%) 76% 88%-95% 78%-84% Risk-free interest rate (%) 0.6 2.52-2.7 1.92-2.63 |
Schedule of stock option activity | Six months ended June 30, Year ended December 31, 2020 2019 2019 Unaudited Unaudited Number of Weighted Number of Weighted Number of Weighted USD USD USD Outstanding at beginning of period 3,405,188 $ 4.76 3,197,616 $ 3.07 3,197,616 3.07 Granted during the period 621,200 4.68 544,800 10.93 790,300 8.82 Expired during the period (10,938 ) 8.00 - - 39,094 5.21 Exercised during the period (467,557 ) 0.31 (466,375 ) 0.25 480,878 0.27 Forfeited during the period (211,482 ) 8.23 - - 62,756 6.16 Share options outstanding at end of period 3,336,411 5.14 3,276,041 4.78 3,405,188 4.76 Share options exercisable at end of period 1,973,898 $ 3.01 1,438,658 $ 2.16 1,865,572 2.68 |
Liabilities Presented At Fair_2
Liabilities Presented At Fair Value (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Liabilities Presented At Fair Value [Abstract] | |
Shedule of warrants to purchase preferred shares | June 30, December 31, 2020 2019 2019 Unaudited Risk-free interest rate 0.2 % 1.71 % 1.7 % Expected volatility 76 % 80 % 80 % Expected life (in years) 2 3 2.5 Expected dividend yield 0 0 0 |
Schedle of changes in the fair value of warrants | Fair value Balance at January 1, 2020 $ 5,221 Revaluation of financial derivatives (670 ) Balance at June 30, 2020 (unaudited) $ 4,551 |
Loss Per Share (Tables)
Loss Per Share (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Loss Per Share [Abstract] | |
Schedule of number of shares and loss used in the computation of loss per share | Six months ended June 30, 2020 Three months ended June 30, 2020 Unaudited Unaudited Weighted Loss Weighted Loss For the computation of basic and diluted loss 37,141,582 $ 25,477 49,589,719 $ 14,875 |
General (Details)
General (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
May 21, 2020 | Jul. 01, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | |
IfrsStatementLineItems [Line Items] | |||||||
Net proceeds from IPO | $ 238 | ||||||
Accumulated deficits | $ (229,221) | $ (178,758) | (229,221) | $ (178,758) | (203,564) | ||
Cash flows from operating activities | $ (10,453) | $ (7,870) | $ (22,779) | $ (17,320) | $ (37,930) | ||
Initial Public Offering [Member] | |||||||
IfrsStatementLineItems [Line Items] | |||||||
Ordinary shares sold (in shares) | 15,333,334 | 8,000,050 | |||||
Share price (in dollars per share) | $ 4.50 | $ 5 | |||||
Net proceeds from IPO | $ 63,860 | $ 37,140 | |||||
Issuance costs related to equity | $ 5,140 | $ 3,110 | |||||
Underwriters [Member] | |||||||
IfrsStatementLineItems [Line Items] | |||||||
Ordinary shares sold (in shares) | 2,000,000 | 1,050,000 | |||||
Share price (in dollars per share) | $ 4.50 | $ 5 |
Significant Accounting Polici_3
Significant Accounting Policies (Details) $ in Thousands | 6 Months Ended |
Jun. 30, 2020USD ($) | |
IfrsStatementLineItems [Line Items] | |
As of January 1, 2020 | $ 5,133 |
Depreciation expense | (943) |
Interest expense | |
Additions | 3,345 |
Disposals | (16) |
Adjustments for indexation | (29) |
Payments | |
As of June 30, 2020 (unaudited) | 7,490 |
Offices and labs [Member] | |
IfrsStatementLineItems [Line Items] | |
As of January 1, 2020 | 934 |
Depreciation expense | (607) |
Interest expense | |
Additions | 3,282 |
Disposals | |
Adjustments for indexation | |
Payments | |
As of June 30, 2020 (unaudited) | 3,609 |
Vehicles [member] | |
IfrsStatementLineItems [Line Items] | |
As of January 1, 2020 | 175 |
Depreciation expense | (75) |
Interest expense | |
Additions | 63 |
Disposals | (16) |
Adjustments for indexation | |
Payments | |
As of June 30, 2020 (unaudited) | 147 |
Production Plant [Member] | |
IfrsStatementLineItems [Line Items] | |
As of January 1, 2020 | 4,024 |
Depreciation expense | (261) |
Interest expense | |
Additions | |
Disposals | |
Adjustments for indexation | (29) |
Payments | |
As of June 30, 2020 (unaudited) | 3,734 |
Lease liabilities[Member] | |
IfrsStatementLineItems [Line Items] | |
As of January 1, 2020 | 5,971 |
Depreciation expense | |
Interest expense | 19 |
Additions | 3,345 |
Disposals | (13) |
Adjustments for indexation | (29) |
Payments | (1,202) |
As of June 30, 2020 (unaudited) | $ 8,091 |
Share-Based Payment (Details)
Share-Based Payment (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | |
Share-Based Payment [Abstract] | |||||
Research and development | $ 419 | $ 507 | $ 613 | $ 736 | $ 1,600 |
Commercial activities | (355) | 434 | (177) | 634 | 879 |
General and administrative | 258 | 378 | 785 | 1,040 | 2,389 |
Total compensation cost | $ 322 | $ 1,319 | $ 1,221 | $ 2,410 | $ 4,868 |
Share-Based Payment (Details 1)
Share-Based Payment (Details 1) | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | |
IfrsStatementLineItems [Line Items] | |||
Dividend yield (%) | 0.00% | 0.00% | 0.00% |
Expected volatility of the share prices (%) | 76.00% | ||
Risk-free interest rate (%) | 0.60% | ||
Bottom of Range [Member] | |||
IfrsStatementLineItems [Line Items] | |||
Expected volatility of the share prices (%) | 88.00% | 78.00% | |
Risk-free interest rate (%) | 2.52% | 1.92% | |
Top of Range [Member] | |||
IfrsStatementLineItems [Line Items] | |||
Expected volatility of the share prices (%) | 95.00% | 84.00% | |
Risk-free interest rate (%) | 2.70% | 2.63% |
Share-Based Payment (Details 2)
Share-Based Payment (Details 2) - USD ($) $ / shares in Units, $ in Thousands | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | |
Number of Options [Abstract] | |||
Outstanding at beginning of year | $ 3,405,188 | $ 3,197,616 | $ 3,197,616 |
Granted during the year | 621,200 | 544,800 | 790,300 |
Expired during the year | (10,938) | 39,094 | |
Exercised during the year | (467,557) | (466,375) | 480,878 |
Forfeited during the year | (211,482) | 62,756 | |
Share options outstanding at end of period | 3,336,411 | 3,276,041 | 3,405,188 |
Share options exercisable at end of period | $ 1,973,898 | $ 1,438,658 | $ 1,865,572 |
Weighted Average Exercise Price [Abstract] | |||
Outstanding at beginning of year | $ 4.76 | $ 3.07 | $ 3.07 |
Granted during the year | 4.68 | 10.93 | 8.82 |
Expired during the year | 8 | 5.21 | |
Exercised during the year | 0.31 | 0.25 | 0.27 |
Forfeited during the year | 8.23 | 6.16 | |
Share options outstanding at end of period | 5.14 | 4.78 | 4.76 |
Share options exercisable at end of period | $ 3.01 | $ 2.16 | $ 2.68 |
Share-Based Payment (Details Te
Share-Based Payment (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | 6 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2019 | |
Share-Based Payment (Textual) | ||
Option vesting period | 4 years | |
Share based compensation non vested unrecognized cost | $ 3,185 | |
Weighted average grant-date fair value | $ 2.65 | $ 11.01 |
Liabilities Presented at Fair_3
Liabilities Presented at Fair Value (Details) | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | |
Liabilities Presented At Fair Value [Abstract] | |||
Risk-free interest rate | 0.20% | 1.71% | 1.70% |
Expected volatility | 76.00% | 80.00% | 80.00% |
Expected life (in years) | 2 years | 3 years | 2 years 6 months |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Liabilities Presented at Fair_4
Liabilities Presented at Fair Value (Details 1) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | |
IfrsStatementLineItems [Line Items] | |||||
Revaluation of financial derivatives | $ (1,778) | $ 17,378 | $ 670 | $ 13,471 | $ 15,904 |
Level 3 [Member] | |||||
IfrsStatementLineItems [Line Items] | |||||
Balance at beginning of period | 5,221 | ||||
Revaluation of financial derivatives | (670) | ||||
Balance at end of period | $ 4,551 | $ 4,551 | $ 5,221 |
Loss Per Share (Details)
Loss Per Share (Details) - For the computation of basic and diluted loss [Member] - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended |
Jun. 30, 2020 | Jun. 30, 2020 | |
IfrsStatementLineItems [Line Items] | ||
Weighted Number of Shares | 49,589,719 | 37,141,582 |
Net loss Attributed to equity holders of the Company | $ 14,875 | $ 25,477 |