Exhibit 99.1
Gamida Cell ltd. AND ITS SUBSIDIARY
INTERIM CONSOLIDATED FINANCIAL STATEMENTS
AS OF JUNE 30, 2020
U.S. DOLLARS IN THOUSANDS
UNAUDITED
INDEX
- - - - - - - - - - - - - -
GAMIDA CELL LTD. AND ITS SUBSIDIARY
INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
U.S. dollars in thousands
| | June 30 | | | December 31, | |
| | 2020 | | | 2019 | | | 2019 | |
| | Unaudited | | | | |
| | | | | | | | | |
ASSETS | | | | | | | | | |
| | | | | | | | | |
CURRENT ASSETS: | | | | | | | | | |
| | | | | | | | | |
Cash and cash equivalents | | $ | 88,638 | | | $ | 37,078 | | | $ | 41,838 | |
Available-for-sale financial assets | | | - | | | | 4,618 | | | | 13,559 | |
Prepaid expenses and other current assets | | | 2,241 | | | | 886 | | | | 1,306 | |
| | | | | | | | | | | | |
Total current assets | | | 90,879 | | | | 42,582 | | | | 56,703 | |
| | | | | | | | | | | | |
NON-CURRENT ASSETS: | | | | | | | | | | | | |
Property, plant and equipment, net | | | 14,204 | | | | 3,437 | | | | 6,298 | |
Right-of-use assets | | | 7,490 | | | | 6,157 | | | | 5,133 | |
Other assets | | | 642 | | | | 1,355 | | | | 641 | |
| | | | | | | | | | | | |
Total non-current assets | | | 22,336 | | | | 10,949 | | | | 12,072 | |
| | | | | | | | | | | | |
Total assets | | $ | 113,215 | | | $ | 53,531 | | | $ | 68,775 | |
The accompanying notes are an integral part of the interim consolidated financial statements.
GAMIDA CELL LTD. AND ITS SUBSIDIARY
INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
U.S. dollars in thousands (except share and per share data)
| | June 30, | | | December 31, | |
| | 2020 | | | 2019 | | | 2019 | |
| | Unaudited | | | | |
| | | | | | | | | |
LIABILITIES AND EQUITY | | | | | | | | | |
| | | | | | | | | |
CURRENT LIABILITIES: | | | | | | | | | |
Trade payables | | $ | 2,738 | | | $ | 2,121 | | | $ | 1,164 | |
Employees and payroll accruals | | | 3,187 | | | | 2,753 | | | | 3,443 | |
Current maturities of lease liabilities | | | 2,145 | | | | 1,945 | | | | 1,870 | |
Accrued expenses and other payables | | | 5,509 | | | | 2,699 | | | | 4,918 | |
| | | | | | | | | | | | |
Total current liabilities | | | 13,579 | | | | 9,518 | | | | 11,395 | |
| | | | | | | | | | | | |
NON-CURRENT LIABILITIES: | | | | | | | | | | | | |
Liabilities presented at fair value | | | 4,551 | | | | 7,654 | | | | 5,221 | |
Employee benefit liabilities, net | | | 773 | | | | 274 | | | | 773 | |
Lease liabilities | | | 5,946 | | | | 4,627 | | | | 4,101 | |
Liability to Israel Innovation Authority (IIA) | | | 13,816 | | | | 10,906 | | | | 12,302 | |
| | | | | | | | | | | | |
Total non-current liabilities | | | 25,086 | | | | 23,461 | | | | 22,397 | |
| | | | | | | | | | | | |
SHAREHOLDERS’ EQUITY: | | | | | | | | | | | | |
Share capital - | | | | | | | | | | | | |
Ordinary shares of NIS 0.01 par value - Authorized: 100,000,000 shares at June 30, 2020 and 2019 (unaudited) and December 31, 2019; Issued and outstanding: 49,471,817 and 25,606,423 shares at June 30, 2020 and 2019 (unaudited) and 33,670,926 shares at December 31, 2019, respectively | | | 137 | | | | 69 | | | | 92 | |
Share premium | | | 304,175 | | | | 199,402 | | | | 238,992 | |
Capital reserve due to actuarial gains | | | (541 | ) | | | (160 | ) | | | (541 | ) |
Available-for-sale reserve | | | - | | | | (1 | ) | | | 4 | |
Accumulated deficit | | | (229,221 | ) | | | (178,758 | ) | | | (203,564 | ) |
| | | | | | | | | | | | |
Total shareholders’ equity | | | 74,550 | | | | 20,552 | | | | 34,983 | |
| | | | | | | | | | | | |
Total liabilities and shareholders’ equity | | $ | 113,215 | | | $ | 53,531 | | | $ | 68,775 | |
The accompanying notes are an integral part of the interim consolidated financial statements.
, 2020 | | | | |
Date of approval of the | | Julian Adams | | Shai Lankry |
financial statements | | Director and Chief Executive Officer | | Chief Financial Officer |
GAMIDA CELL LTD. AND ITS SUBSIDIARY
INTERIM CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
U.S. dollars in thousands (except share and per share data)
| | Six months ended June 30, | | | Three months ended June 30, | | | Year ended December 31, | |
| | 2020 | | | 2019 | | | 2020 | | | 2019 | | | 2019 | |
| | Unaudited | | | Audited | |
| | | | | | | | | | | | | | | |
Operating expenses: | | | | | | | | | | | | | | | |
Research and development, net | | $ | 17,198 | | | $ | 14,536 | | | $ | 9,319 | | | $ | 7,253 | | | $ | 31,462 | |
Commercial activities | | | 2,497 | | | | 2,090 | | | | 1,029 | | | | 1,092 | | | | 4,692 | |
General and administrative | | | 5,490 | | | | 5,267 | | | | 2,496 | | | | 2,452 | | | | 12,091 | |
| | | | | | | | | | | | | | | | | | | | |
Operating loss | | | 25,185 | | | | 21,893 | | | | 12,844 | | | | 10,797 | | | | 48,245 | |
| | | | | | | | | | | | | | | | | | | | |
Finance expense | | | 1,366 | | | | 1,604 | | | | 2,320 | | | | 1,336 | | | | 3,325 | |
Finance income | | | (894 | ) | | | (14,052 | ) | | | (109 | ) | | | (18,169 | ) | | | (17,149 | ) |
| | | | | | | | | | | | | | | | | | | | |
Loss before taxes on income | | | 25,657 | | | | 9,445 | | | | 15,055 | | | | (6,036 | ) | | | 34,421 | |
Taxes on income (benefit) | | | - | | | | 100 | | | | - | | | | 74 | | | | (70 | ) |
| | | | | | | | | | | | | | | | | | | | |
Net loss (income) | | | 25,657 | | | | 9,545 | | | | 15,055 | | | | (5,962 | ) | | | 34,351 | |
| | | | | | | | | | | | | | | | | | | | |
Other comprehensive loss (income): | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | |
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 | | | 4 | | | | (42 | ) | | | - | | | | (9 | ) | | | (47 | ) |
| | | | | | | | | | | | | | | | | | | | |
Total comprehensive loss (income) | | $ | 25,661 | | | $ | 9,586 | | | $ | 15,055 | | | $ | (5,971 | ) | | $ | 34,768 | |
| | | | | | | | | | | | | | | | | | | | |
Net loss (income) per share: | | | | | | | | | | | | | | | | | | | | |
Basic loss (income) per share | | $ | 0.69 | | | $ | 0.38 | | | $ | 0.37 | | | $ | (0.23 | ) | | $ | 1.17 | |
| | | | | | | | | | | | | | | | | | | | |
Diluted loss per share | | $ | 0.69 | | | $ | 0.87 | | | $ | 0.37 | | | $ | 0.44 | | | $ | 1.69 | |
The accompanying notes are an integral part of the interim consolidated financial statements.
GAMIDA CELL LTD. AND ITS SUBSIDIARY
INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
U.S. dollars in thousands (except share and per share data)
| | Ordinary shares | | | Preferred shares | | | Share | | | Available- for-sale | | | Capital reserve due to actuarial | | | Accumulated | | | Total | |
| | Number | | | Amount | | | Number | | | Amount | | | Premium | | | reserve | | | losses | | | deficit | | | equity | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | |
Balance as of January 1, 2020 | | | 33,670,926 | | | $ | 92 | | | | - | | | $ | - | | | $ | 238,992 | | | $ | 4 | | | $ | (541 | ) | | $ | (203,564 | ) | | $ | 34,983 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Net loss | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | (25,657 | ) | | | (25,657 | ) |
Other comprehensive loss | | | - | | | | - | | | | - | | | | - | | | | - | | | | (4 | ) | | | - | | | | - | | | | (4 | ) |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Total comprehensive loss | | | - | | | | - | | | | - | | | | - | | | | - | | | | (4 | ) | | | - | | | | (25,657 | ) | | | (25,661 | ) |
Exercise of options | | | 467,557 | | | | 1 | | | | - | | | | - | | | | 146 | | | | - | | | | - | | | | - | | | | 147 | |
Issuance of ordinary shares in a secondary offering, net of issuance expenses of $1,000 | | | 15,333,334 | | | | 44 | | | | - | | | | - | | | | 63,816 | | | | - | | | | - | | | | - | | | | 63,860 | |
Share-based compensation | | | - | | | | - | | | | - | | | | - | | | | 1,221 | | | | - | | | | - | | | | - | | | | 1,221 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Balance as of June 30, 2020 (unaudited) | | | 49,471,817 | | | $ | 137 | | | | - | | | $ | - | | | $ | 304,175 | | | $ | - | | | $ | (541 | ) | | $ | (229,221 | ) | | $ | 74,550 | |
| | Ordinary shares | | | Preferred shares | | | Share | | | Available- for-sale | | | Capital reserve due to actuarial | | | Accumulated | | | Total | |
| | Number | | | Amount | | | Number | | | Amount | | | Premium | | | reserve | | | losses | | | deficit | | | equity | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | |
Balance as of January 1, 2019 | | | 24,930,736 | | | $ | 67 | | | | - | | | $ | - | | | $ | 193,953 | | | $ | (43 | ) | | $ | (77 | ) | | $ | (169,213 | ) | | $ | 24,687 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Net loss | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | (9,545 | ) | | | (15,507 | ) |
Other comprehensive (loss) income | | | - | | | | - | | | | - | | | | - | | | | - | | | | 42 | | | | (83 | ) | | | - | | | | (50 | ) |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Total comprehensive (loss) income | | | - | | | | - | | | | - | | | | - | | | | - | | | | 42 | | | | (83 | ) | | | (9,646 | ) | | | (15,557 | ) |
Exercise of options | | | 466,375 | | | | 1 | | | | | | | | | | | | 116 | | | | | | | | | | | | | | | | 117 | |
Exercise of warrants | | | 209,312 | | | | 1 | | | | - | | | | - | | | | 2,923 | | | | - | | | | - | | | | - | | | | 2,924 | |
Share-based compensation | | | - | | | | - | | | | - | | | | - | | | | 2,410 | | | | - | | | | - | | | | - | | | | 2,410 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Balance as of June 30, 2019 (unaudited) | | | 25,606,423 | | | $ | 69 | | | | - | | | $ | - | | | $ | 199,042 | | | $ | (1 | ) | | $ | (160 | ) | | $ | (178,758 | ) | | $ | 20,552 | |
| *) | represents an amount lower than 1 USD |
The accompanying notes are an integral part of the interim consolidated financial statements.
GAMIDA CELL LTD. AND ITS SUBSIDIARY
INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
U.S. dollars in thousands (except share and per share data)
| | Ordinary shares | | | Preferred shares | | | Share | | | Available- for-sale | | | Capital reserve due to actuarial | | | Accumulated | | | Total | |
| | Number | | | Amount | | | Number | | | Amount | | | premium | | | reserve | | | losses | | | deficit | | | equity | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | |
Balance as of April 1, 2020 (unaudited) | | | 33,696,582 | | | $ | 92 | | | | - | | | $ | - | | | $ | 239,897 | | | $ | - | | | $ | (541 | ) | | $ | (214,166 | ) | | $ | 25,282 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Net Loss | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | (15,055 | ) | | | (15,055 | ) |
Other comprehensive loss | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Total comprehensive loss | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | (15,055 | ) | | | (15,055 | ) |
Exercise of options | | | 441,901 | | | | 1 | | | | - | | | | - | | | | 140 | | | | - | | | | - | | | | - | | | | 141 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Issuance of ordinary shares in a secondary offering, net of issuance expenses of $1,000 | | | 15,333,334 | | | | 44 | | | | - | | | | - | | | | 63,816 | | | | - | | | | - | | | | - | | | | 63,860 | |
Share-based compensation | | | - | | | | - | | | | - | | | | - | | | | 322 | | | | - | | | | - | | | | - | | | | 322 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Balance as of June 30, 2020 (unaudited) | | | 49,471,817 | | | $ | 137 | | | | - | | | $ | - | | | $ | 304,175 | | | $ | - | | | $ | (541 | ) | | $ | (229,221 | ) | | $ | 74,550 | |
| | Ordinary shares | | | Preferred shares | | | Share | | | Available- for-sale | | | Capital reserve due to actuarial | | | Accumulated | | | Total | |
| | Number | | | Amount | | | Number | | | Amount | | | premium | | | reserve | | | losses | | | deficit | | | equity | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | |
Balance as of April 1, 2019 (unaudited) | | | 25,140,048 | | | $ | 68 | | | | - | | | $ | - | | | $ | 197,967 | | | $ | (10 | ) | | $ | (160 | ) | | $ | (184,720 | ) | | $ | 13,145 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Net income | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | 5,962 | | | | 5,962 | |
Other comprehensive income | | | - | | | | - | | | | - | | | | - | | | | - | | | | 9 | | | | - | | | | - | | | | 9 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Total comprehensive income | | | - | | | | - | | | | - | | | | - | | | | - | | | | 9 | | | | - | | | | 5,962 | | | | 5,971 | |
Exercise of options | | | 466,375 | | | | 1 | | | | - | | | | - | | | | 116 | | | | - | | | | - | | | | - | | | | 117 | |
Share-based compensation | | | - | | | | - | | | | - | | | | - | | | | 1,319 | | | | - | | | | - | | | | - | | | | 1,319 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Balance as of June 30, 2019 (unaudited) | | | 25,606,423 | | | $ | 69 | | | | - | | | $ | - | | | $ | 199,402 | | | $ | (1 | ) | | $ | (160 | ) | | $ | (178,758 | ) | | $ | 20,552 | |
| *) | Represents an amount lower than 1 USD. |
The accompanying notes are an integral part of the interim consolidated financial statements.
GAMIDA CELL LTD. AND ITS SUBSIDIARY
INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
U.S. dollars in thousands (except share and per share data)
| | Ordinary shares | | | Preferred shares | | | Share | | | Available- for-sale | | | Capital reserve due to actuarial | | | Accumulated | | | Total | |
| | Number | | | Amount | | | Number | | | Amount | | | premium | | | reserve | | | losses | | | deficit | | | equity | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | |
Balance as of January 1, 2019 | | | 24,930,736 | | | $ | 67 | | | | - | | | $ | - | | | $ | 193,953 | | | $ | (43 | ) | | $ | (77 | ) | | $ | (169,213 | ) | | $ | 24,687 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
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 of $694 | | | 8,050,000 | | | | 23 | | | | - | | | | - | | | | 37,117 | | | | - | | | | - | | | | - | | | | 37,140 | |
Exercise of options | | | 480,878 | | | | 1 | | | | - | | | | - | | | | 131 | | | | - | | | | - | | | | - | | | | 132 | |
Exercise of warrants | | | 209,312 | | | | 1 | | | | - | | | | - | | | | 2,923 | | | | - | | | | - | | | | - | | | | 2,924 | |
Share-based compensation | | | - | | | | - | | | | - | | | | - | | | | 4,868 | | | | - | | | | - | | | | - | | | | 4,868 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Balance as of December 31, 2019 | | | 33,670,926 | | | $ | 92 | | | | - | | | $ | - | | | $ | 238,992 | | | $ | 4 | | | $ | (541 | ) | | $ | (203,564 | ) | | $ | 34,983 | |
The accompanying notes are an integral part of the interim consolidated financial statements.
GAMIDA CELL LTD. AND ITS SUBSIDIARY
INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S. dollars in thousands
| | Six months ended June 30, | | | Three months ended June 30, | | | Year ended December 31, | |
| | 2020 | | | 2019 | | | 2020 | | | 2019 | | | 2019 | |
| | Unaudited | | | Audited | |
Cash flows from operating activities: | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | |
Net (loss) income | | $ | (25,657 | ) | | $ | (9,545 | ) | | $ | (15,055 | ) | | $ | 5,962 | | | $ | (34,351 | ) |
| | | | | | | | | | | | | | | | | | | | |
Adjustments to reconcile net loss to net cash (used in) provided by operating activities: | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | |
Adjustments to the profit or loss items: | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | |
Depreciation of property, equipment and right-of-use assets | | | 1,106 | | | | 1,245 | | | | 556 | | | | 703 | | | | 2,143 | |
Financial income, net | | | (260 | ) | | | (569 | ) | | | (128 | ) | | | (378 | ) | | | (775 | ) |
Cost of share-based compensation | | | 1,221 | | | | 2,410 | | | | 322 | | | | 1,319 | | | | 4,868 | |
Change in employee benefit liabilities, net | | | - | | | | 8 | | | | - | | | | (3 | ) | | | 126 | |
Amortization of premium on available-for-sale financial asses | | | 4 | | | | 101 | | | | - | | | | 51 | | | | 184 | |
Revaluation of financial derivatives | | | (670 | ) | | | (13,471 | ) | | | 1,778 | | | | (17,378 | ) | | | (15,904 | ) |
Revaluation of liability to IIA | | | 1,315 | | | | 1,199 | | | | 593 | | | | 631 | | | | 2,531 | |
| | | | | | | | | | | | | | | | | | | | |
| | | 2,716 | | | | (9,077 | ) | | | 3,121 | | | | (15,055 | ) | | | (6,827 | ) |
Changes in asset and liability items: | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | |
Decrease (increase) in prepaid expenses, other current assets and other assets | | | (1,065 | ) | | | 117 | | | | (607 | ) | | | (292 | ) | | | (150 | ) |
Increase (decrease) in trade payables | | | 1,574 | | | | 244 | | | | (360 | ) | | | 1,088 | | | | (821 | ) |
Increase (decrease) in accrued expenses and other payables | | | (624 | ) | | | 162 | | | | 2,472 | | | | 141 | | | | 2,807 | |
| | | | | | | | | | | | | | | | | | | | |
| | | (115 | ) | | | 523 | | | | 1,505 | | | | 937 | | | | 1,836 | |
| | | | | | | | | | | | | | | | | | | | |
Cash received during the period for: | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | |
Interest received | | | 357 | | | | 830 | | | | 9 | | | | 309 | | | | 1,546 | |
Interest paid | | | (80 | ) | | | (51 | ) | | | (33 | ) | | | (23 | ) | | | (134 | ) |
| | | | | | | | | | | | | | | | | | | | |
| | | 277 | | | | 779 | | | | (24 | ) | | | 286 | | | | 1,412 | |
| | | | | | | | | | | | | | | | | | | | |
Net cash used in operating activities | | | (22,779 | ) | | | (17,320 | ) | | | (10,453 | ) | | | (7,870 | ) | | | (37,930 | ) |
| | | | | | | | | | | | | | | | | | | | |
Cash flows from investing activities: | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | |
Purchase of property, plant and equipment | | | (7,109 | ) | | | (878 | ) | | | (4,990 | ) | | | (528 | ) | | | (3,055 | ) |
Purchase of marketable securities | | | - | | | | - | | | | - | | | | - | | | | (32,021 | ) |
Proceed from sale of marketable securities | | | 13,551 | | | | 15,740 | | | | - | | | | 1,847 | | | | - | |
Proceed from maturity of marketable securities | | | - | | | | - | | | | - | | | | - | | | | 38,742 | |
| | | | | | | | | | | | | | | | | | | | |
Net cash provided by (used in) investing activities | | $ | 6,442 | | | $ | 14,862 | | | $ | (4,990 | ) | | $ | 1,319 | | | $ | 3,666 | |
The accompanying notes are an integral part of the interim consolidated financial statements.
GAMIDA CELL LTD. AND ITS SUBSIDIARY
INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S. dollars in thousands
| | Six months ended June 30, | | | Three months ended June 30, | | | Year ended December 31, | |
| | 2020 | | | 2019 | | | 2020 | | | 2019 | | | 2019 | |
| | Unaudited | | | | |
| | | | | | | | | | | | | | | |
Cash flows from financing activities: | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | |
Receipt of grants from the IIA | | $ | 200 | | | $ | 167 | | | $ | 147 | | | $ | 167 | | | $ | 224 | |
Proceeds from secondary offering, net | | | 63,860 | | | | (346 | ) | | | 63,860 | | | | (108 | ) | | | 37,140 | |
Proceeds from issuance of shares, initial public offering (payment of issuance expenses), net | | | | | | | | | | | | | | | | | | | (238 | ) |
Payment of lease liabilities | | | (1,122 | ) | | | (764 | ) | | | (335 | ) | | | (324 | ) | | | (1,529 | ) |
Exercise of options | | | 147 | | | | 117 | | | | 141 | | | | 117 | | | | 132 | |
| | | | | | | | | | | | | | | | | | | | |
Net cash (used in) provided by financing activities | | | 63,085 | | | | (826 | ) | | | 63,813 | | | | (148 | ) | | | 35,729 | |
| | | | | | | | | | | | | | | | | | | | |
Exchange differences on balances of cash and cash equivalents | | | 52 | | | | 90 | | | | (24 | ) | | | 28 | | | | 101 | |
| | | | | | | | | | | | | | | | | | | | |
Increase (decrease) in cash and cash equivalents | | | 46,800 | | | | (3,194 | ) | | | 48,346 | | | | (6,671 | ) | | | 1,566 | |
Cash and cash equivalents at beginning of period | | | 41,838 | | | | 40,272 | | | | 40,292 | | | | 43,749 | | | | 40,272 | |
| | | | | | | | | | | | | | | | | | | | |
Cash and cash equivalents at end of period | | $ | 88,638 | | | $ | 37,078 | | | $ | 88,638 | | | $ | 37,078 | | | $ | 41,838 | |
| | | | | | | | | | | | | | | | | | | | |
Supplemental disclosure of non-cash financing activities: | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | |
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 | |
The accompanying notes are an integral part of the interim consolidated financial statements.
GAMIDA CELL LTD. AND ITS SUBSIDIARY
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
| 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.
GAMIDA CELL LTD. AND ITS SUBSIDIARY
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
| 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). |
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 |
GAMIDA CELL LTD. AND ITS SUBSIDIARY
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
| 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. |
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 Plant | | | Total | | | Lease liabilities | |
| | | | | | | | | | | | | | | |
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 | |
GAMIDA CELL LTD. AND ITS SUBSIDIARY
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
| 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 | |
GAMIDA CELL LTD. AND ITS SUBSIDIARY
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
| NOTE 3:- | SHARE-BASED PAYMENT (Cont.) |
Movement during the periods:
| | Six months ended June 30, | | | Year ended December 31, | |
| | 2020 | | | 2019 | | | 2019 | |
| | Unaudited | | | Unaudited | | | | |
| | Number of options | | | Weighted average exercise price | | | Number of options | | | Weighted average exercise price | | | Number of options | | | Weighted average exercise price | |
| | | | | 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.
| NOTE 4:- | LIABILITIES PRESENTED AT FAIR VALUE |
| a. | Warrants to purchase Company’s shares: |
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 | |
GAMIDA CELL LTD. AND ITS SUBSIDIARY
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
| NOTE 4:- | LIABILITIES PRESENTED AT FAIR VALUE (Cont.) |
| b. | Changes in the fair value of warrants classified as Level 3 in the fair value hierarchy: |
| | Fair value of financial derivatives | |
| | | |
Balance at January 1, 2020 | | $ | 5,221 | |
| | | | |
Revaluation of financial derivatives | | | (670 | ) |
| | | | |
Balance at June 30, 2020 (unaudited) | | $ | 4,551 | |
| 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 Number of Shares | | | Loss Attributed to equity holders of the Company | | | Weighted Number of Shares | | | Loss Attributed to equity holders of the Company | |
| | | | | | | | | | | | | | | | |
For the computation of basic and diluted loss | | | 37,141,582 | | | $ | 25,477 | | | | 49,589,719 | | | $ | 14,875 | |
- - - - - - - - - - - - - -
- 15 -