Exhibit 99.1
GAMIDA CELL LTD. AND ITS SUBSIDIARY
INTERIM CONSOLIDATED FINANCIAL STATEMENTS
AS OF JUNE 30, 2019
U.S. DOLLARS IN THOUSANDS
UNAUDITED
INDEX
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Interim Consolidated Statements of Financial Position | 2 - 3
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Interim Consolidated Statements of Comprehensive Loss | 4
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Interim Consolidated Statements of Changes in Equity | 5 – 7
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Interim Consolidated Statements of Cash Flows | 8 - 9
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Notes to Interim Consolidated Financial Statements | 10 - 17 |
INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
U.S. dollars in thousands
| | June 30, | | | December 31, | |
| | 2019 | | | 2018 | | | 2018 | |
| | Unaudited | | | Audited | |
ASSETS | | | | | | | | | |
| | | | | | | | | |
CURRENT ASSETS: | | | | | | | | | |
Cash and cash equivalents | | $ | 37,078 | | | $ | 19,004 | | | $ | 40,272 | |
Available-for-sale financial assets | | | 4,618 | | | | 9,632 | | | | 20,417 | |
Prepaid expenses and other current assets | | | 886 | | | | 1,525 | | | | 1,502 | |
| | | | | | | | | | | | |
Total current assets | | | 42,582 | | | | 30,161 | | | | 62,191 | |
| | | | | | | | | | | | |
NON-CURRENT ASSETS: | | | | | | | | | | | | |
Property and equipment, net | | | 3,437 | | | | 1,546 | | | | 2,311 | |
Right-of-use assets | | | 6,157 | | | | - | | | | - | |
Other assets | | | 1,355 | | | | 1,141 | | | | 662 | |
| | | | | | | | | | | | |
Total non-current assets | | | 10,949 | | | | 2,687 | | | | 2,973 | |
| | | | | | | | | | | | |
Total assets | | $ | 53,531 | | | $ | 32,848 | | | $ | 65,164 | |
The accompanying notes are an integral part of the interim consolidated financial statements.
INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
U.S. dollars in thousands (except share and per share data)
| | June 30, | | | December 31, | |
| | 2019 | | | 2018 | | | 2018 | |
| | Unaudited | | | Audited | |
LIABILITIES AND EQUITY | | | | | | | | | |
| | | | | | | | | |
CURRENT LIABILITIES: | | | | | | | | | |
Trade payables | | $ | 2,121 | | | $ | 1,158 | | | $ | 1,985 | |
Employees and payroll accruals | | | 2,753 | | | | - | | | | 2,888 | |
Current maturities of lease liabilities | | | 1,945 | | | | - | | | | - | |
Accrued expenses and other payables | | | 2,699 | | | | 4,057 | | | | 1,832 | |
| | | | | | | | | | | | |
Total current liabilities | | | 9,518 | | | | 5,215 | | | | 6,705 | |
| | | | | | | | | | | | |
NON-CURRENT LIABILITIES: | | | | | | | | | | | | |
Liabilities presented at fair value | | | 7,654 | | | | 13,700 | | | | 24,049 | |
Employee benefit liabilities, net | | | 274 | | | | 217 | | | | 183 | |
Lease liability | | | 4,627 | | | | - | | | | - | |
Liability to Israel Innovation Authority (IIA) | | | 10,906 | | | | 9,753 | | | | 9,540 | |
| | | | | | | | | | | | |
Total non-current liabilities | | | 23,461 | | | | 23,670 | | | | 33,772 | |
| | | | | | | | | | | | |
SHAREHOLDERS' EQUITY: | | | | | | | | | | | | |
Share capital - | | | | | | | | | | | | |
Ordinary shares of NIS 0.01 par value - Authorized: 100,000,000, 23,277,000 and 100,000,000 shares at June 30, 2019 and 2018 and December 31, 2018, respectively; Issued and outstanding: 25,606,423, 689,898 and 24,930,736 shares at June 30, 2019 and 2018 and December 31, 2018, respectively | | | 69 | | | | 2 | | | | 67 | |
Preferred shares of NIS 0.01 par value - Authorized: 0, 16,723,000 and 0 shares at June 30, 2019 and 2018 and December 31, 2018, respectively; Issued and outstanding: 0, 14,154,743 and 0 shares at June 30, 2019 and 2018 and December 31, 2018, respectively | | | - | | | | 38 | | | | - | |
Share premium | | | 199,402 | | | | 140,934 | | | | 193,953 | |
Capital reserve due to actuarial gains | | | (160 | ) | | | (79 | ) | | | (77 | ) |
Available-for-sale reserve | | | (1 | ) | | | (169 | ) | | | (43 | ) |
Accumulated deficit | | | (178,758 | ) | | | (136,763 | ) | | | (169,213 | ) |
| | | | | | | | | | | | |
Total shareholders' equity | | | 20,552 | | | | 3,963 | | | | 24,687 | |
| | | | | | | | | | | | |
Total liabilities and shareholders' equity | | $ | 53,531 | | | $ | 32,848 | | | $ | 65,164 | |
The accompanying notes are an integral part of the interim consolidated financial statements.
August 5, 2019 | | /s/ Julian Adams | | /s/ Shai Lankry |
Date of approval of the | | Julian Adams | | Shai Lankry |
financial statements | | Director and CEO | | Chief Financial Officer |
INTERIM CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
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, | |
| | 2019 | | | 2018 | | | 2019 | | | 2018 | | | 2018 | |
| | Unaudited | | | Audited | |
| | | | | | | | | | | | | | | |
Operating expenses: | | | | | | | | | | | | | | | |
Research and development, net | | $ | 14,319 | | | $ | 12,037 | | | $ | 7,036 | | | $ | 6,977 | | | $ | 22,045 | |
General and administrative | | | 7,574 | | | | 4,570 | | | | 3,761 | | | | 2,917 | | | | 11,599 | |
| | | | | | | | | | | | | | | | | | | | |
Operating loss | | | 21,893 | | | | 16,607 | | | | 10,797 | | | | 9,894 | | | | 33,644 | |
| | | | | | | | | | | | | | | | | | | | |
Finance expenses | | | 1,604 | | | | 4,204 | | | | 1,336 | | | | 3,230 | | | | 20,259 | |
Finance expenses (income) | | | (14,052 | ) | | | (330 | ) | | | (18,169 | ) | | | (34 | ) | | | (1,042 | ) |
| | | | | | | | | | | | | | | | | | | | |
Loss (income) before taxes on income | | | 9,445 | | | | 20,481 | | | | (6,036 | ) | | | 13,090 | | | | 52,861 | |
Taxes on income | | | 100 | | | | - | | | | 74 | | | | - | | | | 70 | |
| | | | | | | | | | | | | | | | | | | | |
Net loss (income) | | | 9,545 | | | | 20,481 | | | | (5,962 | ) | | | 13,090 | | | | 52,931 | |
| | | | | | | | | | | | | | | | | | | | |
Other comprehensive loss (income): | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | |
Items that will be reclassified subsequently to profit or loss: | | | | | | | | | | | | | | | | | | | | |
Actuarial net loss of defined benefit plans | | | 83 | | | | - | | | | - | | | | - | | | | (2 | ) |
Changes in the fair value of available for sale financial assets | | | (42 | ) | | | 135 | | | | (9 | ) | | | 86 | | | | 9 | |
| | | | | | | | | | | | | | | | | | | | |
Total comprehensive loss (income) | | $ | 9,586 | | | $ | 20,616 | | | $ | (5,971 | ) | | $ | 13,176 | | | $ | 52,938 | |
| | | | | | | | | | | | | | | | | | | | |
Net loss (income) per share: | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | |
Basic net loss (income) per share | | $ | 0.38 | | | $ | 29.69 | | | $ | (0.23 | ) | | $ | 18.97 | | | $ | 10.53 | |
| | | | | | | | | | | | | | | | | | | | |
Diluted net loss (income) per share | | $ | 0.87 | | | $ | 29.69 | | | $ | 0.44 | | | $ | 18.97 | | | $ | 10.53 | |
The accompanying notes are an integral part of the interim consolidated financial statements.
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 (audited) | | | 24,930,736 | | | $ | 67 | | | | - | | | $ | - | | | $ | 193,953 | | | $ | (43 | ) | | $ | (77 | ) | | $ | (169,213 | ) | | $ | 24,687 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Net loss | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | (9,545 | ) | | | (9,545 | ) |
Other comprehensive loss | | | - | | | | - | | | | - | | | | - | | | | - | | | | 42 | | | | (83 | ) | | | - | | | | (41 | ) |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Total comprehensive loss | | | - | | | | - | | | | - | | | | - | | | | - | | | | 42 | | | | (83 | ) | | | (9,545 | ) | | | (9,586 | ) |
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 | | | | - | | | $ | - | | | $ | 199,402 | | | $ | (1 | ) | | $ | (160 | ) | | $ | (178,758 | ) | | $ | 20,552 | |
| | 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, 2018 (audited) | | | 689,898 | | | $ | 2 | | | | 14,154,743 | | | $ | 38 | | | $ | 139,311 | | | $ | (34 | ) | | $ | (79 | ) | | $ | (116,282 | ) | | $ | 22,956 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Net loss | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | (20,481 | ) | | | (20,481 | ) |
Other comprehensive loss | | | - | | | | - | | | | - | | | | - | | | | - | | | | (135 | ) | | | - | | | | - | | | | (135 | ) |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Total comprehensive loss | | | - | | | | - | | | | - | | | | - | | | | - | | | | (135 | ) | | | - | | | | (20,481 | ) | | | (20,616 | ) |
Share-based compensation | | | - | | | | - | | | | - | | | | - | | | | 1,623 | | | | - | | | | - | | | | - | | | | 1,623 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Balance as of June 30, 2018 (unaudited) | | | 689,898 | | | $ | 2 | | | | 14,154,743 | | | $ | 38 | | | $ | 140,934 | | | $ | (169 | ) | | $ | (79 | ) | | $ | (136,763 | ) | | $ | 3,963 | |
The accompanying notes are an integral part of the interim consolidated financial statements.
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, 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 | |
| | 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, 2018 (unaudited) | | | 689,898 | | | $ | 2 | | | | 14,154,743 | | | $ | 38 | | | $ | 140,155 | | | $ | (83 | ) | | $ | (79 | ) | | $ | (123,673 | ) | | $ | 16,360 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Net loss | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | (13,090 | ) | | | (13,090 | ) |
Other comprehensive loss | | | - | | | | - | | | | - | | | | - | | | | - | | | | (86 | ) | | | - | | | | - | | | | (86 | ) |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Total comprehensive loss | | | - | | | | - | | | | - | | | | - | | | | - | | | | (86 | ) | | | - | | | | (13,090 | ) | | | (13,176 | ) |
Share-based compensation | | | - | | | | - | | | | - | | | | - | | | | 779 | | | | - | | | | - | | | | - | | | | 779 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Balance as of June 30, 2018 (unaudited) | | | 689,898 | | | $ | 2 | | | | 14,154,743 | | | $ | 38 | | | $ | 140,934 | | | $ | (169 | ) | | $ | (79 | ) | | $ | (136,763 | ) | | $ | 3,963 | |
The accompanying notes are an integral part of the interim consolidated financial statements.
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, 2018 (audited) | | | 689,898 | | | $ | 2 | | | | 14,154,743 | | | $ | 38 | | | $ | 139,311 | | | $ | (34 | ) | | $ | (79 | ) | | $ | (116,282 | ) | | $ | 22,956 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Net loss | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | (52,931 | ) | | | (52,931 | ) |
Other comprehensive loss | | | - | | | | - | | | | - | | | | - | | | | - | | | | (9 | ) | | | 2 | | | | - | | | | (7 | ) |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Total comprehensive loss | | | - | | | | - | | | | - | | | | - | | | | - | | | | (9 | ) | | | 2 | | | | (52,931 | ) | | | (52,938 | ) |
Issuance of additional preferred shares following Anti-dilution Protection | | | - | | | | - | | | | 3,134,546 | | | | 8 | | | | (8 | ) | | | - | | | | - | | | | - | | | | - | |
Exercise of options | | | 9,692 | | | | - | | | | - | | | | - | | | | 2 | | | | - | | | | - | | | | - | | | | 2 | |
Conversion of preferred shares | | | 17,289,289 | | | | 46 | | | | (17,289,289 | ) | | | (46 | ) | | | - | | | | - | | | | - | | | | - | | | | - | |
Issuance of ordinary shares in initial public offering, net of issuance expenses in an amount of $5,947 | | | 6,648,368 | | | | 18 | | | | - | | | | - | | | | 47,223 | | | | - | | | | - | | | | - | | | | 47,241 | |
Exercise of warrants | | | 293,489 | | | | 1 | | | | - | | | | - | | | | 3,850 | | | | - | | | | - | | | | - | | | | 3,851 | |
Share-based compensation | | | - | | | | - | | | | - | | | | - | | | | 3,575 | | | | - | | | | - | | | | - | | | | 3,575 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Balance as of December 31, 2018 (audited) | | | 24,930,736 | | | $ | 67 | | | | - | | | $ | - | | | $ | 193,953 | | | $ | (43 | ) | | $ | (77 | ) | | $ | (169,213 | ) | | $ | 24,687 | |
The accompanying notes are an integral part of the interim consolidated financial statements.
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, | |
| | 2019 | | | 2018 | | | 2019 | | | 2018 | | | 2018 | |
| | Unaudited | | | Audited | |
Cash flows from operating activities: | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | |
Net (loss) income | | $ | (9,545 | ) | | $ | (20,481 | ) | | $ | 5,962 | | | $ | (13,090 | ) | | $ | (52,931 | ) |
| | | | | | | | | | | | | | | | | | | | |
Adjustments to reconcile net loss to net cash used in operating activities: | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | |
Adjustments to the profit or loss items: | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | |
Depreciation of property, plant and equipment and right-of-use assets | | | 1,245 | | | | 97 | | | | 703 | | | | 48 | | | | 269 | |
Financial income, net | | | (569 | ) | | | (375 | ) | | | (378 | ) | | | (362 | ) | | | (858 | ) |
Cost of share-based compensation | | | 2,410 | | | | 1,623 | | | | 1,319 | | | | 779 | | | | 3,575 | |
Change in employee benefit liabilities, net | | | 8 | | | | 17 | | | | (3 | ) | | | 33 | | | | (15 | ) |
Amortization of premium on available-for-sale financial assets | | | 101 | | | | (9 | ) | | | 51 | | | | (90 | ) | | | 272 | |
Revaluation of financial derivatives | | | (13,471 | ) | | | 3,400 | | | | (17,378 | ) | | | 3,000 | | | | 17,600 | |
Revaluation of liability to IIA | | | 1,199 | | | | 2,600 | | | | 631 | | | | 2,188 | | | | 2,037 | |
| | | | | | | | | | | | | | | | | | | | |
| | | (9,077 | ) | | | 7,353 | | | | (15,055 | ) | | | 5,596 | | | | 22,880 | |
Changes in asset and liability items: | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | |
Decrease (Increase) in prepaid expenses and other current assets and other assets | | | 117 | | | | (1,156 | ) | | | (292 | ) | | | (1,256 | ) | | | 942 | |
Increase (decrease) in trade payables | | | 244 | | | | (1,232 | ) | | | 1,088 | | | | 306 | | | | (405 | ) |
Increase in accrued expenses and other payables and employee and payroll accrual | | | 162 | | | | 1,871 | | | | 141 | | | | 1,611 | | | | 2,296 | |
| | | | | | | | | | | | | | | | | | | | |
| | | 523 | | | | (517 | ) | | | 937 | | | | 661 | | | | 2,833 | |
| | | | | | | | | | | | | | | | | | | | |
Cash received during the period for: | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | |
Interest received | | | 830 | | | | 391 | | | | 309 | | | | 378 | | | | 792 | |
Interest paid | | | (51 | ) | | | - | | | | (23 | ) | | | - | | | | - | |
| | | | | | | | | | | | | | | | | | | | |
| | | 779 | | | | 391 | | | | 286 | | | | 378 | | | | 792 | |
| | | | | | | | | | | | | | | | | | | | |
Net cash used in operating activities | | | (17,320 | ) | | | (13,254 | ) | | | (7,870 | ) | | | (6,455 | ) | | | (26,426 | ) |
| | | | | | | | | | | | | | | | | | | | |
Cash flows from investing activities: | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | |
Purchase of property and equipment | | | (878 | ) | | | (703 | ) | | | (528 | ) | | | (472 | ) | | | (1,645 | ) |
Purchase of of available-for-sale financial assets | | | - | | | | - | | | | - | | | | - | | | | (10,905 | ) |
Proceed from sale of available-for-sale financial assets | | | - | | | | 4,984 | | | | - | | | | - | | | | 4,949 | |
Proceed from maturity of available-for-sale financial assets | | | 15,740 | | | | - | | | | 1,847 | | | | - | | | | - | |
Proceeds from bank deposits | | | - | | | | 5,000 | | | | - | | | | - | | | | 5,000 | |
Investment in restricted bank deposits | | | - | | | | - | | | | - | | | | - | | | | (150 | ) |
| | | | | | | | | | | | | | | | | | | | |
Net cash provided by (used in) investing activities | | | 14,862 | | | | 9,281 | | | | 1,319 | | | | (472 | ) | | | (2,751 | ) |
The accompanying notes are an integral part of the interim consolidated financial statements.
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, | |
| | 2019 | | | 2018 | | | 2019 | | | 2018 | | | 2018 | |
| | Unaudited | | | Audited | |
Cash flows from financing activities: | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | |
Receipt of grants from the IIA | | | 167 | | | | 1,653 | | | | 167 | | | | - | | | | 612 | |
Proceeds from issuance of shares, net | | | (346 | ) | | | - | | | | (108 | ) | | | - | | | | 47,479 | |
Payment of lease liabilities | | | (764 | ) | | | - | | | | (324 | ) | | | - | | | | - | |
Exercise of options | | | 117 | | | | - | | | | 117 | | | | - | | | | 2 | |
| | | | | | | | | | | | | | | | | | | | |
Net cash provided by (used in) financing activities | | | (826 | ) | | | 1,653 | | | | (148 | ) | | | - | | | | 48,093 | |
| | | | | | | | | | | | | | | | | | | | |
Exchange differences on balances of cash and cash equivalents | | | 90 | | | | - | | | | 28 | | | | - | | | | 31 | |
| | | | | | | | | | | | | | | | | | | | |
Increase (decrease) in cash and cash equivalents | | | (3,194 | ) | | | (2,321 | ) | | | (6,671 | ) | | | (6,927 | ) | | | 18,947 | |
Cash and cash equivalents at beginning of period | | | 40,272 | | | | 21,325 | | | | 43,749 | | | | 25,931 | | | | 21,325 | |
| | | | | | | | | | | | | | | | | | | | |
Cash and cash equivalents at end of period | | $ | 37,078 | | | $ | 19,004 | | | $ | 37,078 | | | $ | 19,004 | | | $ | 40,272 | |
| | | | | | | | | | | | | | | | | | | | |
Supplemental disclosure of non-cash financing activities: | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | |
Significant non-cash transactions: | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | |
IIA liability for grants to be received | | $ | - | | | $ | 264 | | | $ | - | | | $ | 133 | | | $ | - | |
| | | | | | | | | | | | | | | | | | | | |
Exercise of warrants liabilities to equity | | $ | 2,924 | | | $ | - | | | $ | - | | | $ | - | | | $ | 3,851 | |
| | | | | | | | | | | | | | | | | | | | |
Increase in other assets on credit | | $ | (592 | ) | | $ | (791 | ) | | $ | (592 | ) | | $ | (791 | ) | | $ | (238 | ) |
Purchase of property, plant and equipment on credit | | $ | (400 | ) | | $ | - | | | $ | (400 | ) | | $ | - | | | $ | - | |
The accompanying notes are an integral part of the interim consolidated financial statements.
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
| a. | Gamida Cell Ltd. (the "Company"), founded in 1998, is a clinical-stage biopharmaceutical company that develops novel curative treatments for orphan indications, including hematological malignancies and rare genetic diseases using stem cells and Natural Killer (NK) cells. |
| b. | The Company uses its proprietary platform NAM technology to expand in culture, highly functional cells derived from umbilical cord blood or peripheral blood, while enhancing the potential therapeutic efficacy of these cells. |
The lead product candidate, Omidubicel (formally known as NiCord®), is currently developed in a pivotal registration phase III clinical study to treat patients with high-risk hematological malignancies (blood cancers) such as leukemia or lymphoma who are indicated to receive a donor derived (allogeneic) Bone Marrow Transplantation (BMT). BMT transplantation 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 designed as a universal bone marrow donor graft which can be available to all patients in need.
Omidubicel was granted a Breakthrough Therapy designation from the FDA and an orphan drug designation in the US and in Europe.
In December 2017, the Company presented at the ASH annual meeting final results from the phase I/II trial evaluating Omidubicel. The study met its primary endpoint, demonstrating rapid neutrophil engraftment with manageable side effects.
In addition to hematologic malignancies, the Company pursuing the development of Omidubicel for the treatment of bone marrow failure disorders. Omidubicel is currently being evaluated in a Phase 1/2 clinical trial sponsored by the National Institutes of Health in patients with severe aplastic anemia, a rare, life-threatening hematological disorder.
Beyond Omidubicel, the Company develops another product candidate, GDA-201 (formally known as NAM-NK), for innate immunotherapy of expanded natural killer, or NK cells, 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. A phase I/II investigator initiated study to treat patients with B cell lymphoma and multiple myeloma is enrolling patients.
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
| 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, 2019 is $178,758 and negative cash flows from operating activities during the six month period ended June 30, 2019 is $17,320. 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, subsequent to the reporting date, the Company closed a follow-on offering ("offering") of its ordinary shares on the Nasdaq, which resulted in the sale of 7,000,000 ordinary shares at a public offering price of $5 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 per share, and exercised in full their option to purchase an additional 1,050,000 ordinary shares at the public offering price of $5.00 per share. The exercise of the underwriters’ option closed on July 8, 2019. The Company received net proceeds from the offering of $37,135 (net of issuance costs and underwriting discounts of $3,115). |
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 |
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
NOTE 2:- | SIGNIFICANT ACCOUNTING POLICIES |
| a. | The accompanying unaudited interim consolidated financial statements for the six and three months periods ended June 30, 2019 and 2018 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, 2018 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, 2019.
| 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, 2018, except for the adoption of new standards effective as of January 1, 2019. The Company has not early adopted any other standard, interpretation or amendment that has been issued but is not yet effective. |
The Company applies, for the first time, IFRS 16 Leases . As required by IAS 34, the nature and effect of these changes are disclosed below.
The Company adopted IFRS 16 using the modified retrospective method of adoption with the date of initial application of January 1, 2019. Under this method, the standard is applied retrospectively with the cumulative effect of initially applying the standard recognised at the date of initial application. The Company elected to use the transition practical expedient allowing the standard to be applied only to contracts that were previously identified as leases applying IAS 17 and IFRIC 4 at the date of initial application. The Company also elected to use the recognition exemptions for lease contracts that, at the commencement date, have a lease term of 12 months or less and do not contain a purchase option (‘short-term leases’), and lease contracts for which the underlying asset is of low value (‘low-value assets’).
The Company has a number of lease contracts, mainly leases of an office building and a production plant. Before the adoption of IFRS 16, the Company classified each of its leases (as lessee) at the inception date as an operating lease. The leased property was not capitalized and the lease payments were recognized as rent expense in profit or loss on a straight-line basis over the lease term. Any prepaid rent and accrued rent were recognized under prepaid expenses and other current assets and accrued expenses and other payables, respectively.
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
NOTE 2:- | SIGNIFICANT ACCOUNTING POLICIES (Cont.) |
Upon adoption of IFRS 16, the Company applied a single recognition and measurement approach for all leases, except for short-term leases and leases of low-value assets. The standard provides specific transition requirements and practical expedients, which has been applied by the Company.
The Company recognized right-of-use assets and lease liabilities for those leases previously classified as operating leases, except for short-term leases and leases of low-value assets. The right-of-use assets for most leases were recognised based on the carrying amount as if the standard had always been applied, apart from the use of incremental borrowing rate at the date of initial application. In some leases, the right-of-use assets were recognised based on the amount equal to the lease liabilities, adjusted for any related prepaid and accrued lease payments previously recognized. Lease liabilities were recognized based on the present value of the remaining lease payments, discounted using the incremental borrowing rate at the date of initial application.
Based on the foregoing, as at January 1, 2019:
• | Right-of-use assets of $7,106 were recognized and presented separately in the statement of financial position. |
• | Additional lease liabilities of $7,032 were recognized and presented separately in the statement of financial position. |
• | Prepaid expenses and other current assets of $256 and accrued expenses and other payables of $182 related to previous operating leases were derecognized. |
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 | | | Vechicles | | | Production Plant | | | Total | | | Lease liabilities | |
| | | | | | | | | | | | | | | |
As of January 1, 2019 (audited) | | $ | 2,104 | | | $ | 291 | | | $ | 4,711 | | | $ | 7,106 | | | $ | 7,032 | |
| | | | | | | | | | | | | | | | | | | | |
Depreciation expenses | | | (588 | ) | | | (67 | ) | | | (438 | ) | | | (1,093 | ) | | | - | |
Interest expenses | | | - | | | | - | | | | - | | | | - | | | | 211 | |
Re-measurement | | | - | | | | 2 | | | | 56 | | | | 58 | | | | 58 | |
Additions | | | - | | | | 86 | | | | - | | | | 86 | | | | 86 | |
Payments | | | - | | | | - | | | | - | | | | - | | | | (815 | ) |
| | | | | | | | | | | | | | | | | | | | |
As of June 30, 2019 (unaudited) | | | 1,516 | | | | 312 | | | | 4,329 | | | | 6,157 | | | | 6,572 | |
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
NOTE 2:- | SIGNIFICANT ACCOUNTING POLICIES (Cont.) |
The lease liabilities as of January 1, 2019 reconcilliation to the operating lease commitments as of December 31, 2018 are as follows:
Operating lease commitments as of December 31, 2018 | | $ | 7,441 | |
Weighted average incremental borrowing rate as of January 1, 2019 (%) | | | 1.45-4.01 | |
Discounted operating lease commitments of January 1, 2019 | | | 7,032 | |
| | | | |
Lease liabilities as of January 1, 2019 | | $ | 7,032 | |
Set out below are the new accounting policies of the Company upon adoption of IFRS 16,
which have been applied from the date of initial application:
1. Right-of-use assets:
The Company recognizes right-of-use assets at the commencement date of the lease (i.e., the date the underlying asset is available for use). Right-of-use assets are measured at cost, less any accumulated depreciation and impairment losses, and adjusted for any remeasurement of lease liabilities.
The cost of right-of-use assets includes the amount of lease liabilities recognized, initial direct costs incurred, and lease payments made at or before the commencement date less any lease incentives received. Unless the Company is reasonably certain to obtain ownership of the leased asset at the end of the lease term, the recognized right-of-use assets are depreciated on a straight-line basis over the shorter of its estimated useful life and the lease term. Right-of- use assets are subject to impairment.
2. Lease liabilities:
At the commencement date of the lease, the Company recognizes lease liabilities measured at the present value of lease payments to be made over the lease term. The lease payments include fixed payments (including insubstance fixed payments) less any lease incentives receivable, variable lease payments that depend on an index or a rate, and amounts expected to be paid under residual value guarantees. The lease payments also include the exercise price of a purchase option reasonably certain to be exercised by the Company and payments of penalties for terminating a lease, if the lease term reflects the Company exercising the option to terminate.The variable lease payments that do not depend on an index or a rate are recognized as expense in the periodon which the event or condition that triggers the payment occurs.
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
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, | |
| | 2019 | | | 2018 | | | 2019 | | | 2018 | | | 2018 | |
| | Unaudited | | | Audited | |
| | | | | | | | | | | | | | | |
Research and development | | $ | 593 | | | $ | 627 | | | $ | 364 | | | $ | 145 | | | $ | 705 | |
General and administrative | | | 1,817 | | | | 996 | | | | 955 | | | | 634 | | | | 2,870 | |
| | | | | | | | | | | | | | | | | | | | |
| | $ | 2,410 | | | $ | 1,623 | | | $ | 1,319 | | | $ | 779 | | | $ | 3,575 | |
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 dividend.
The following table lists the inputs to the binomial model used for the fair value measurement of equity-settled share options for the above plan for the following periods:
Based on the above inputs, the fair value of the options was determined at $10.50 - $11.01 at the grant dates during 2019.
| | June 30, | | | December 31, | |
| | 2019 | | | 2018 | | | 2018 | |
| | Unaudited | | | Audited | |
| | | | | | | | | |
Dividend yield (%) | | | 0 | | | | 0 | | | | 0 | |
Expected volatility of the share prices (%) | | | 88%-95 | % | | | 89%-94 | % | | | 93%-95 | % |
Risk-free interest rate (%) | | | 2.52-2.7 | | | | 2.28-3 | | | | 2.88-2.63 | |
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
NOTE 3:- | SHARE-BASED PAYMENT (Cont.) |
Movement during the periods:
| | Six months ended June 30, | | | Year ended December 31, | |
| | 2019 | | | 2018 | | | 2018 | |
| | Number of options | | | Weighted average
exercise price | | | Number of options | | | Weighted average exercise price | | | Number of options | | | Weighted average exercise price | |
| | | | | | | | | | | | | | | | | | |
Outstanding at beginning of period | | | 3,197,616 | | | $ | 3.07 | | | | 2,467,023 | | | $ | 2.28 | | | | 2,467,023 | | | $ | 2.28 | |
Granted | | | 544,800 | | | | 10.93 | | | | 401,921 | | | | 4.9 | | | | 751,977 | | | | 5.60 | |
Expired | | | - | | | | - | | | | - | | | | - | | | | (2,000 | ) | | | 6.00 | |
Exercised | | | (466,375 | ) | | | 0.25 | | | | - | | | | - | | | | (9,692 | ) | | | 0.25 | |
Forfeited | | | - | | | | - | | | | (9,692 | ) | | | 0.25 | | | | (9,692 | ) | | | 0.25 | |
| | | | | | | | | | | | | | | | | | | | | | | | |
Share options outstanding at end of period | | | 3,276,041 | | | | 4.78 | | | | 2,859,252 | | | | 2.65 | | | | 3,197,616 | | | | 3.07 | |
| | | | | | |
| | | | | | | | | | | | | | | | | |
Share options exercisable at end of period | | | 1,438,658 | | | $ | 2.16 | | | | 1,664,152 | | | $ | 1.08 | | | | 1,705,256 | | | $ | 1.21 | |
As of June 30, 2019, there are $5,645 of total unrecognized cost related to non-vested share based compensation that are expected to be recognized over a period of up to 4 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 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 period in which liquidation event will occurred subject to the Company's expectations. 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, | |
| | 2019 | | | 2018 | | | 2018 | |
| | Unaudited | | | Audited | |
| | | | | | | | | |
Risk-free interest rate | | | 1.71 | % | | | 2.5 | % | | | 2.52 | % |
Expected volatility | | | 80 | % | | | 90 | % | | | 80 | % |
Expected life (in years) | | | 3 | | | | 2 | | | | 3.5 | |
Expected dividend yield | | | 0 | | | | 0 | | | | 0 | |
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
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, 2019 (audited) | | $ | 24,049 | |
| | | | |
Exercise of warrants | | | (2,924 | ) |
| | | | |
Revaluation of financial derivatives | | | (13,471 | ) |
| | | | |
Balance at June 30, 2019 (unaudited) | | $ | 7,654 | |
NOTE 5:- | LOSS (INCOME) PER SHARE |
| a. | Details of the number of shares and loss (income) used in the computation of loss (income) per share: |
| | Six months ended June 30, 2019 | | | Three months ended June 30, 2019 | |
| | Weighted Number of Shares | | | Loss (Income) Attributed to equity holders of the Company | | | Weighted Number of Shares | | | Loss (Income)
Attributed to equity holders of the Company | |
| | | | | | | | | | | | |
For the computation of basic loss (income) | | | 25,268,501 | | | $ | 9,545 | | | | 25,495,236 | | | $ | (5,962 | ) |
Effect of potential dilutive ordinary shares (Warrants) | | | 1,078,165 | | | | 13,471 | | | | 476,457 | | | | 17,378 | |
| | | | | | | | | | | | | | | | |
For the computation of diluted loss (income) | | | 26,346,666 | | | $ | 23,016 | | | | 25,971,693 | | | $ | 11,416 | |
| b. | The total weighted number of shares that used for the basic and diluted loss per share calculations, for the six and three month period ended June 30, 2018 was 689,898 and for the year ended December 31, 2018 was 5,025,213. |